drrx-ex102_436.htm



Exhibit 10.2

 

Certain information identified by bracketed asterisks ([***]) has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted information.

 

AMENDMENT NO. 2 TO EXCLUSIVE LICENSE AGREEMENT

THIS AMENDMENT No. 2 TO EXCLUSIVE LICENSE AGREEMENT is entered into on March 6, 2018 (the “Effective Date of the Amendment”), by and between DURECT Corporation (“Company”) and Virginia Commonwealth University Intellectual Property Foundation (“VCUIPF”).

WHEREAS, Company and VCUIPF are parties to an Exclusive License Agreement dated December 5, 2012, as amended (the “Agreement”), and

WHEREAS, the parties now wish to further amend the Agreement as provided for herein.

NOW, THEREFORE, in consideration of the foregoing and the covenants and promises contained in this Amendment, the parties do hereby agree as follows:


	
 
	
1.
	
Appendix A of the Agreement is hereby amended by deleting it in its entirety and replacing it with the Appendix A attached hereto and made a part hereof.





	
 
	
2.
	
Section 1.10 of the Agreement is hereby amended by deleting it in its entirety and replacing it with the following:




“IMPROVEMENT(S)” means [***] and, with respect to any and all of the foregoing, [***] and thereto including any and [***] and [***].


	
 
	
3.
	
Section 1.26 of the Agreement is hereby amended by deleting it in its entirety and replacing it with the following:




“SRA” means the Sponsored Research Agreement by and between VCU and LICENSEE, effective May 7, 2012, as amended.”


	
 
	
4.
	
Sections 2.3(b), (c) and (d) of the Agreement are hereby amended by [***]  





	
 
	
5.
	
All capitalized terms not otherwise defined in this Amendment shall have the same meanings that are ascribed to them in the Agreement.





	
 
	
6.
	
Except as expressly amended by this Amendment, the Agreement shall remain unchanged and continue in full force and effect as provided therein.  This Amendment and the Agreement constitute the complete, final and exclusive understanding and agreement of the parties with respect to the subject matter of the Agreement, and supersede any and all prior or contemporaneous negotiations, correspondence, understandings and agreements, whether oral or written, between the parties respecting the subject matter of the Agreement.  This Amendment may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.




IN WITNESS WHEREOF, the parties hereto have executed this Amendment in duplicate originals by their authorized officers as of the Effective Date of the Amendment.

 


	
DURECT CORPORATION
	
 
	
VIRGINIA COMMONWEALTH UNIVERSITY






 

 
 


Certain information identified by bracketed asterisks ([***]) has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted information.


	
 
	
 
	
INTELLECTUAL PROPERTY FOUNDATION

	
 
	
 
	
 
	
 
	
 
	
 
	
 

	
By:
	
 
	
/s/ James E. Brown
	
 
	
By:
	
 
	
/s/ Ivelina Metcheva

	
Name:
	
 
	
James E. Brown, D.V.M
	
 
	
Name:
	
 
	
Ivelina Metcheva Phd, MBA

	
Title:
	
 
	
CEO
	
 
	
Title:
	
 
	
President

	
Date:
	
 
	
March 6, 2018
	
 
	
Date:
	
 
	
March 8, 2018




 




2



 

 
 


Certain information identified by bracketed asterisks ([***]) has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted information.

APPENDIX A

LICENSED PATENT RIGHTS

 

Patents and Applications:

Nuclear Sulfated Oxysterol, Potent Regulator of Cholesterol Homeostasis, for Therapy of Hypercholesterolemia, Hyperlipidemia, and Atherosclerosis


								
	
Country
	
Sub Case
	
Case Type
	
Status
	
App. No.
	
Filing Date
	
Patent No.
	
Issue Date

	
US
	
 
	
PRI
	
Inactive
	
60/621,537
	
25-Oct-2004
	
 
	
 

	
US
	
0
	
ORD
	
Published
	
11/739,330
	
24-Apr-2007
	
 
	
 

	
US
	
00
	
PRO
	
Inactive
	
61/154,063
	
20-Feb-2009
	
 
	
 

	
US
	
01
	
CON
	
Granted
	
13/766,839
	
14-Feb-2013
	
9,321,802
	
26-Apr-2016

	
US
	
02
	
CON
	
Published
	
15/042,244
	
12-Feb-2016
	
 
	
 

	
US
	
1
	
CIP
	
Granted
	
12/708,803
	
19-Feb-2010
	
8,399,441
	
19-Mar-2013

	
WO
	
 
	
ORD
	
Inactive
	
PCT/ US2005/33874
	
21-Sep-2005
	
 
	
 




 

Sulfated Oxysterol and Oxysterol Sulfation by Hydroxysterol Sulfotransferase Promote Lipid Homeostasis and Liver Regeneration


								
	
Country
	
Sub Case
	
Case Type
	
Status
	
App. No.
	
Filing Date
	
Patent No.
	
Issue Date

	
US
	
 
	
ORD
	
Granted
	
13/441,241
	
06-Apr-2012
	
9,034,859
	
19-May-2015

	
US
	
0
	
PRO
	
Inactive
	
61/604,711
	
29-Feb-2012
	
 
	
 

	
US
	
00
	
PRO
	
Inactive
	
61/472,293
	
06-Apr-2011
	
 
	
 

	
US
	
1
	
CON
	
Granted
	
14/689,822
	
17-Apr-2015
	
9,480,692
	
01-Nov-2016

	
US
	
2
	
CON
	
Published
	
15/273,897
	
23-Sep-2016
	
 
	
 




 

A Novel Cholesterol Metabolite, 5-cholesten, 3B- 25- diol, disulfate (25HCDS) for Therapy of Metabolic Disorders, Hylerlipidemia, Diabetes, Fatty Liver Diseases, and Atherosclerosis

 


								
	
Country
	
Sub Case
	
Case Type
	
Status
	
App. No.
	
Filing Date
	
Patent No.
	
Issue Date

	
AT
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
AU
	
 
	
PCT
	
Granted
	
2013246435
	
15-Mar-2013
	
2013246435
	
18-Jan-2018

	
AU
	
1
	
DIV
	
Pending
	
2017268646
	
30-Nov-2017
	
 
	
 

	
BE
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
BR
	
 
	
PCT
	
Pending
	
112014025081-2
	
15-Mar-2013
	
 
	
 

	
CA
	
 
	
ORD
	
Published
	
2,867,694
	
15-Mar-2013
	
 
	
 

	
CH
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
CN
	
 
	
PCT
	
Granted
	
201380019476.3
	
15-Mar-2013
	
ZL201380019476.3
	
06-Jul-2016

	
CN
	
1
	
DIV
	
Allowed
	
201610412359.9
	
13-Jun-2016
	
 
	
 

	
CZ
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
DE
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
602013024450.2
	
02-Aug-2017

	
DK
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
EA
	
 
	
PCT
	
Granted
	
201491859
	
15-Mar-2013
	
026683
	
31-May-2017

	
EP
	
 
	
PCT
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
EP
	
1
	
DIV
	
Published
	
17167122.5
	
15-Mar-2013
	
 
	
 

	
ES
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
FI
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
FR
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
GB
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017




3



 

 
 


Certain information identified by bracketed asterisks ([***]) has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted information.


								
	
GR
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
HK
	
 
	
REP
	
Published
	
15102737.7
	
17-Mar-2015
	
 
	
 

	
HU
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
IE
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
IL
	
 
	
PCT
	
Pending
	
234892
	
15-Mar-2013
	
 
	
 

	
IN
	
 
	
PCT
	
Pending
	
2366/KOLNP/2014
	
15-Mar-2013
	
 
	
 

	
IT
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
JP
	
 
	
PCT
	
Granted
	
2015-505762
	
15-Mar-2013
	
612561
	
14-Apr-2017

	
JP
	
1
	
DIV
	
Published
	
2017-074866
	
05-Apr-2017
	
 
	
 

	
KR
	
 
	
PCT
	
Pending
	
2014-7031567
	
15-Mar-2013
	
 
	
 

	
LU
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
MC
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
MX
	
 
	
PCT
	
Pending
	
MX/a/2014/012324
	
15-Mar-2013
	
 
	
 

	
NL
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
NO
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
PL
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
PT
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
SE
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
SI
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
SK
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
TR
	
 
	
EPC
	
Granted
	
13775974.2
	
15-Mar-2013
	
2836502
	
02-Aug-2017

	
US
	
 
	
PCT
	
Abandoned
	
14/391,929
	
10-Oct-2014
	
 
	
 

	
US
	
01
	
PRO
	
Inactive
	
61/623,203
	
12-Apr-2012
	
 
	
 

	
US
	
02
	
PRO
	
Inactive
	
61/623,414
	
12-Apr-2012
	
 
	
 

	
US
	
1
	
CON
	
Abandoned
	
15/241,171
	
19-Aug-2016
	
 
	
 

	
US
	
2
	
CON
	
Pending
	
15/728,827
	
10-Oct-2017
	
 
	
 

	
WO
	
 
	
PRI
	
Inactive
	
PCT/US2013/031861
	
15-Mar-2013
	
 
	
 

	
ZA
	
 
	
PCT
	
Granted
	
2014/06981
	
15-Mar-2013
	
2014/06981
	
25-May-2016




 

[***]


								
	
Country
	
Sub Case
	
Case Type
	
Status
	
App. No.
	
Filing Date
	
Patent No.
	
Issue Date

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
 
	
 

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
 
	
 




 

[***]


								
	
Country
	
Sub Case
	
Case Type
	
Status
	
App. No.
	
Filing Date
	
Patent No.
	
Issue Date

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
 
	
 

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
 
	
 

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
 
	
 

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
 
	
 

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
 
	
 

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
 
	
 

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
 
	
 

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
 
	
 

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
 
	
 

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
 
	
 




 

Use of Oxygenated Cholesterol Sulfates (OCS)


								
	
Country
	
Sub Case
	
Case Type
	
Status
	
App. No.
	
Filing Date
	
Patent No.
	
Issue Date




4



 

 
 


Certain information identified by bracketed asterisks ([***]) has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted information.


								
	
AU
	
 
	
PCT
	
Pending
	
2014369916
	
23-Dec-2014
	
 
	
 

	
BR
	
 
	
PCT
	
Pending
	
BR112016014611-5
	
23-Dec-2014
	
 
	
 

	
CA
	
 
	
PCT
	
Published
	
2,932,300
	
23-Dec-2014
	
 
	
 

	
CN
	
 
	
PCT
	
Published
	
201480070815.5
	
23-Dec-2014
	
 
	
 

	
EA
	
 
	
ORD
	
Published
	
201691305
	
21-Jul-2016
	
 
	
 

	
EP
	
 
	
PCT
	
Published
	
14874617.5
	
23-Dec-2014
	
 
	
 

	
HK
	
 
	
REP
	
Published
	
17104071.5
	
20-Apr-2017
	
 
	
 

	
IL
	
 
	
PCT
	
Pending
	
246339
	
20-Jun-2016
	
 
	
 

	
IN
	
 
	
PCT
	
Published
	
201617019059
	
02-Jun-2016
	
 
	
 

	
JP
	
 
	
PCT
	
Published
	
2016-542662
	
23-Dec-2014
	
 
	
 

	
KR
	
 
	
PCT
	
Pending
	
2016-7020206
	
22-Jul-2016
	
 
	
 

	
MX
	
 
	
PCT
	
Pending
	
MX/a/2016/008459
	
23-Jun-2016
	
 
	
 

	
TW
	
 
	
ORD
	
Published
	
103145013
	
23-Dec-2014
	
 
	
 

	
US
	
 
	
PCT
	
Published
	
15/106,883
	
21-Jun-2016
	
 
	
 

	
US
	
0
	
PRI
	
Inactive
	
61/920,617
	
24-Dec-2013
	
 
	
 

	
WO
	
 
	
ORD
	
Inactive
	
PCT/US2014/072128
	
23-Dec-2014
	
 
	
 

	
ZA
	
 
	
PCT
	
Pending
	
2016/03580
	
23-Dec-2014
	
 
	
 




 

Oxygenated Cholesterol Sulfates For Therapy Of Disorders Caused By At Least One Of Attenuated Leptin Activity And A Lipid Storage Disorder


								
	
Country
	
Sub Case
	
Case Type
	
Status
	
App. No.
	
Filing Date
	
Patent No.
	
Issue Date

	
AU
	
 
	
PCT
	
Pending
	
2015329716
	
13-Oct-2015
	
 
	
 

	
BR
	
 
	
PCT
	
Published
	
112017007025-1
	
13-Oct-2015
	
 
	
 

	
CA
	
 
	
PCT
	
Published
	
2,962,500
	
13-Oct-2015
	
 
	
 

	
CN
	
 
	
ORD
	
Published
	
201580054842.8
	
10-Apr-2017
	
 
	
 

	
EA
	
 
	
ORD
	
Published
	
201790791
	
04-May-2017
	
 
	
 

	
EP
	
 
	
PCT
	
Published
	
15791393.0
	
13-Oct-2015
	
 
	
 

	
IL
	
 
	
ORD
	
Pending
	
Not yet known
	
13-Oct-2015
	
 
	
 

	
IN
	
 
	
ORD
	
Pending
	
201747019645
	
05-Jun-2017
	
 
	
 

	
JP
	
 
	
PCT
	
Published
	
2017-518508
	
13-Oct-2015
	
 
	
 

	
KR
	
 
	
PCT
	
Pending
	
10-2017-7011640
	
27-Apr-2017
	
 
	
 

	
MX
	
 
	
PCT
	
Published
	
MX/a/2017/004658
	
07-Apr-2017
	
 
	
 

	
US
	
 
	
ORD
	
Published
	
15/517,395
	
06-Apr-2017
	
 
	
 

	
US
	
0
	
PRI
	
Inactive
	
62/062,260
	
10-Oct-2014
	
 
	
 

	
WO
	
 
	
ORD
	
Inactive
	
PCT/US2015/055262
	
13-Oct-2015
	
 
	
 




 

Use of Oxygenated Cholesterol Sulfates (OCS) to Treat Inflammatory Skin Disease and Skin Lesions


								
	
Country
	
Sub Case
	
Case Type
	
Status
	
App. No.
	
Filing Date
	
Patent No.
	
Issue Date

	
TW
	
 
	
ORD
	
Pending
	
106125933
	
01-Aug-2017
	
 
	
 

	
US
	
0
	
PRO
	
Pending
	
62/370,036
	
02-Aug-2016
	
 
	
 

	
US
	
02
	
PRO
	
Pending
	
62/470,576
	
13-Mar-2017
	
 
	
 

	
WO
	
 
	
ORD
	
Pending
	
PCT/US2017/044821
	
01-Aug-2017
	
 
	
 




 




5



 

 
 


Certain information identified by bracketed asterisks ([***]) has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted information.

 

Compositions Comprising 5-Cholesten-3, 25-Diol, 3-Sulfate (25HC3S) or Pharmaceutically Acceptable Salt Thereof and At Least One Cyclic Oligosaccharide, and Methods for Their Use


								
	
Country
	
Sub Case
	
Case Type
	
Status
	
App. No.
	
Filing Date
	
Patent No.
	
Issue Date

	
TW
	
 
	
ORD
	
Pending
	
106125936
	
01-Aug-2017
	
 
	
 

	
US
	
0
	
PRO
	
Pending
	
62/370,024
	
02-Aug-2016
	
 
	
 

	
US
	
02
	
PRO
	
Pending
	
62/470,578
	
13-Mar-2017
	
 
	
 

	
WO
	
 
	
ORD
	
Pending
	
PCT/US2017/044840
	
01-Aug-2017
	
 
	
 




 

[***]


								
	
Country
	
Sub Case
	
Case Type
	
Status
	
App. No.
	
Filing Date
	
Patent No.
	
Issue Date

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
 
	
 

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
 
	
 




 

VCU Invention Disclosures

 


		
	
VCU Invention Disclosure No.
	
Title

	
REN-04-072
	
Nuclear oxysterol, potent regulator of cholesterol hemeostasis, for therapy of hypercholesterolemia, hyperlipidemia, and atherosclerosis

	
REN-08-078F
	
5-Cholesten-3b, 25-diol 3-sulfate (25HC3S), an authentic PPARy agonist and LXR antagonist, for the therapy of inflammatory diseases, such as inflammatory bowel diseases, fat liver diseases, and atheroclerotic diseases

	
REN-11-030
	
Hydroxysteroid sulfotransferase (SULT2B1b) for therapy of hyperlipidemia and fatty liver diseases

	
REN-11-93
	
Sulfated oxysterols, 25HC3S and 25HCDS, and oxysterol sulfation by hydroxysterol sulfotransferase (SULT2B1b) promote liver proliferation: therapy for cirrhosis, injury, and recovery following hepatectomy 

 

	
REN-11-94
	
A novel cholesterol metabolite, 5-cholesten, 3-,25-diol, disulfate (25HCDS) for therapy of metabolic disorders, hyperlipidemia, diabetes, fat liver diseases, and atherosclerosis 




6



 

 
 


Certain information identified by bracketed asterisks ([***]) has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted information.


		
	
REN-12-025
	
A Novel Cholesterol Metabolite, 5-Cholesten, 3-,25-diol, Disulfate (25HCDS) for Therapy of Metabolic Disorders, Hyperlipidemia, Diabetes, Fat Liver Diseases, and Atherosclerosis

	
REN-12-061
	
Novel Oxysterol, 5-Cholesten 3,27-diol 27-Glucuronide, for Therapy of Hypertriglyceridemia

	
REN-12-075
	
Low Levels of Oxysterol Sulfates, 25-,24, and 27(26)-hydroxycholesterol Sulfates, as biomarkers for diagnosis of lipid metabolic disorders, nonalcoholic fatty liver diseases

	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]




 

7