drrx-ex101_437.htm



Exhibit 10.1

 

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. 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            



 

 
 


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.

 



Title:VP, Chief Patent Counsel   Title:  President

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




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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

 

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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Non-Provisional, Serial No. 13/766,839, filed February 14, 2013]
	
[Nuclear Sulfated Oxysterol, Potent Regulator of Lipid Homeostasis, for Therapy of Hypercholesterolemia, Hypertriglycerides, Fatty Liver Diseases, and Atherosclerosis

	
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Provisional Serial No. 61/920,617, filed December 24, 2013
	
Use of Oxysterol Sulfates 5-Cholesten-3,25-Diol, 3-Sulfate (25HC3S) and 5-Cholesten 3,25-Diol, Disulfate (25HCDS) to Treat Necrosis, Apoptosis, Acute Liver Failure, and/or Kidney Failure




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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.

 


		
	
Non-Provisional Serial No. 14/391,929, filed October 10, 2014
	
Novel Cholesterol Metabolite, 5-Cholesten, 3-Beta-25-diol, Disulfate (25HCDS) for Therapy of Metabolic Disorders, Hyperlipidemia, Diabetes, Fatty Liver Diseases and Atherosclerosis

	
Provisional Serial No. 62/062,260, filed October 10, 2014
	
Cholesterol Metabolite, 5-Cholesten, 3-25-Diol, 3-Sulfate (25HC3S) for Therapy of Leptin-Resistant Hyperlipidemia and Fatty Liver Diseases

	
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Non-Provisional Serial No. 14/689,822, filed April 17, 2015
	
Sulfated Oxysterol and Oxysterol Sulfation by Hydroxysterol Sulfotransferase Promote Lipid Homeostasis and Liver Proliferation




 

Foreign Patent Applications:

 


		
	
PCT Application No. US05/33874
	
Nuclear Sulfated Oxysterol, Potent Regulator of Cholesterol Homeostasis for Therapy of Hypercholesterolemia, Hyperlipidemia and Atherosclerosis

	
Australian Application No. 2013246435
	
A Novel Cholesterol Metabolite, 5-Cholesten, 3-Beta-25-diol, Disulfate (25HCDS) for Therapy of Metabolic Disorders, Hyperlipidemia, Diabetes, Fatty Liver Diseases and Atherosclerosis

	
Brazilian Application No. BR112014025081-2
	
A Novel Cholesterol Metabolite, 5-Cholesten, 3-Beta-25-diol, Disulfate (25HCDS) for Therapy of Metabolic Disorders, Hyperlipidemia, Diabetes, Fatty Liver Diseases and Atherosclerosis

	
Canadian Application No. 2,867,694
	
A Novel Cholesterol Metabolite, 5-Cholesten, 3-Beta-25-diol, Disulfate (25HCDS) for Therapy of Metabolic Disorders, Hyperlipidemia, Diabetes, Fatty Liver Diseases and Atherosclerosis

	
Chinese Application No. 201380019476.3
	
A Novel Cholesterol Metabolite, 5-Cholesten, 3-Beta-25-diol, Disulfate (25HCDS) for Therapy of Metabolic Disorders, Hyperlipidemia, Diabetes, Fatty Liver Diseases and Atherosclerosis

	
Eurasian Application No. 201491859
	
A Novel Cholesterol Metabolite, 5-Cholesten, 3-Beta-25-diol, Disulfate (25HCDS) for Therapy of Metabolic Disorders, Hyperlipidemia, Diabetes, Fatty Liver Diseases and Atherosclerosis

	
European Application No. 13775974.2
	
A Novel Cholesterol Metabolite, 5-Cholesten, 3-Beta-25-diol, Disulfate (25HCDS) for Therapy of Metabolic Disorders, Hyperlipidemia, Diabetes, Fatty Liver Diseases and Atherosclerosis

	
Hong Kong Application No. 15102737.7
	
A Novel Cholesterol Metabolite, 5-Cholesten, 3-Beta-25-diol, Disulfate (25HCDS) for Therapy of Metabolic Disorders, Hyperlipidemia, Diabetes, Fatty Liver Diseases and Atherosclerosis




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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.

 


		
	
Israeli Application No. 234892
	
A Novel Cholesterol Metabolite, 5-Cholesten, 3-Beta-25-diol, Disulfate (25HCDS) for Therapy of Metabolic Disorders, Hyperlipidemia, Diabetes, Fatty Liver Diseases and Atherosclerosis

	
Indian Application No. 2366/KOLNP/2014
	
A Novel Cholesterol Metabolite, 5-Cholesten, 3-Beta-25-diol, Disulfate (25HCDS) for Therapy of Metabolic Disorders, Hyperlipidemia, Diabetes, Fatty Liver Diseases and Atherosclerosis

	
Japanese Application No. 2015-505762
	
A Novel Cholesterol Metabolite, 5-Cholesten, 3-Beta-25-diol, Disulfate (25HCDS) for Therapy of Metabolic Disorders, Hyperlipidemia, Diabetes, Fatty Liver Diseases and Atherosclerosis

	
South Korean Application No. 2014-7031567
	
A Novel Cholesterol Metabolite, 5-Cholesten, 3-Beta-25-diol, Disulfate (25HCDS) for Therapy of Metabolic Disorders, Hyperlipidemia, Diabetes, Fatty Liver Diseases and Atherosclerosis

	
Mexican Application No. MX/a/2014/012324
	
A Novel Cholesterol Metabolite, 5-Cholesten, 3-Beta-25-diol, Disulfate (25HCDS) for Therapy of Metabolic Disorders, Hyperlipidemia, Diabetes, Fatty Liver Diseases and Atherosclerosis

	
PCT Application No. PCT/US2013/031861
	
A Novel Cholesterol Metabolite, 5-Cholesten, 3-Beta-25-diol, Disulfate (25HCDS) for Therapy of Metabolic Disorders, Hyperlipidemia, Diabetes, Fatty Liver Diseases and Atherosclerosis

	
South African Application No. 2014/06981
	
A Novel Cholesterol Metabolite, 5-Cholesten, 3-Beta-25-diol, Disulfate (25HCDS) for Therapy of Metabolic Disorders, Hyperlipidemia, Diabetes, Fatty Liver Diseases and Atherosclerosis

	
PCT Application No. PCT/US2014/072128
	
Uses of Oxygenated Cholesterol Sulfates

	
Taiwanese Application No. 103145013
	
Uses of Oxygenated Cholesterol Sulfates




 

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




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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-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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