Document:

drrx-ex104_346.htm

Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

Exhibit 10.4

AMENDMENT NO. 1 TO EXCLUSIVE LICENSE AGREEMENT

THIS AMENDMENT No. 1 TO EXCLUSIVE LICENSE AGREEMENT is entered into on July 2, 2015 (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 (the “Agreement”), and

 

WHEREAS, the parties now wish to 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.
	
   All capitalized terms not otherwise defined in this Amendment shall have the same meanings that are ascribed to them in the Agreement.

 

	
 
	
3.
	
   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

	

	
INTELLECTUAL PROPERTY FOUNDATION

 

By:/s/ Steve HelmerBy:/s/ Ivelina Metcheva

 

Name:Steve Helmer                Name:Ivelina Metcheva Phd, MBA            

1

 

Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

          

Title:VP, Chief Patent Counsel   Title:  President

 

Date: July 2, 2015Date:  July 1,2015

2

 

Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

APPENDIX A

LICENSED PATENT RIGHTS

 

U.S. Patent Applications: 

 

		
	
Provisional Serial No. 60/621,537, filed  October 25, 2004
	
Nuclear Oxysterol, Potent Regulator Of Cholesterol Homeostasis, For Therapy Of Hypercholesterolemia, Hyperlipidemia, and Atherosclerosis

	
Non-Provisional Serial No. 11/739,330, filed April 26, 2007
	
Nuclear Sulfated Oxysterol, Potent Regulator Of Cholesterol Homeostasis, For Therapy Of Hypercholesterolemia, Hyperlipidemia, and Atherosclerosis

	
Provisional Serial No. 61/154,063, filed  February 20, 2009
	
5-Cholesten-3b , 25-diol 3-sulfate (25HC3S), an authentic PPARy agonist and LXR antagonist, or the therapy of inflammatory diseases

	
Non-Provisional Serial No. 12/708,803, filed  February 19, 2010
	
Nuclear Sulfated Oxysterol, Potent Regulator Of Lipid Homeostasis, For Therapy Of Hypercholesterolemia, Hypertriglycerides, Fatty Liver Diseases, and Atherosclerosis 

	
Provisional Serial No. 61/472,293, filed April 6, 2011
	
Hydroxysteroid sulfotransferase (SULT2B1b) for therapy of hyperlipidemia and fatty liver diseases 

	
Non-Provisional Serial No.  13/441,241, filed April 6, 2012
	
Sulfated Oxysterol and Oxysterol Sulfation by Hydroxysterol Sulfotransferase Promote Lipid Homeostasis and Liver Proliferation

	
Provisional Serial No. 61/604,711, filed February 29, 2012
	
Sulfated oxysterol, 25HC3S and oxysterol sulfation by hydroxysterol sulfotransferase (SULT2Blb) promote liver proliferation: therapy for cirrhosis, injury,  recovery following hepatectomy, and other applications

	
Provisional Serial No. 61/623,203, filed April 12, 2012

Provisional Serial No. 61/623,414, filed April 12, 2012

 
	
A Novel Cholesterol Metabolite, 5-Cholesten, 3-,25-diol, Disulfate (25HCDS) for Therapy of Metabolic Disorders, Hyperlipidemia, Fatty Liver Disease, Diabetes and Atherosclerosis 

	
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3

 

Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

		
	
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VCU Invention Disclosures

 

		
	
VCU Invention Disclosure No.
	
Title

	
REN-04-072, disclosed September 24, 2004
	
Nuclear oxysterol, potent regulator of cholesterol hemeostasis, for therapy of hypercholesterolemia, hyperlipidemia, and atherosclerosis

	
REN-08-078, disclosed December 15, 2008
	
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, disclosed April 5, 2011
	
Hydroxysteroid sulfotransferase (SULT2B1b) for therapy of hyperlipidemia and fatty liver diseases

4

 

Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

		
	
 

REN-11-93, disclosed November 7, 2011
	
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, disclosed November 7, 2011
	
A novel cholesterol metabolite, 5-cholesten, 3-,25-diol, disulfate (25HCDS) for therapy of metabolic disorders, hyperlipidemia, diabetes, fat liver diseases, and atherosclerosis 

	
REN-12-025, disclosed March 26, 2012
	
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, disclosed June 21, 2012
	
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

	
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5drrx-ex105_347.htm

Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

Exhibit 10.5

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 [* * *].

 

	
 
	
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.

1

Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 

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

	

	
INTELLECTUAL PROPERTY FOUNDATION

 

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

 

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

          

Title:CEO   Title:  President

 

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

 

 

 

2

Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

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
	
 
	
 

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

	
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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
	
 
	
 

	
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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

	
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Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

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

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

	
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Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

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Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

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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 

 

 

Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

		
	
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 

	
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

	
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