Amendment No. 2 to Exclusive License Agreement between the Company and Virginia Commonwealth University Intellectual Property Foundation dated March 6, 2018

EX-10.5 4 drrx-ex105_347.htm EX-10.5 drrx-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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US

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Inactive

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12-Apr-2012

 

 

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02

PRO

Inactive

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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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