Amendment No. 1 to Exclusive License Agreement between the Company and Virginia Commonwealth University Intellectual Property Foundation dated July 2, 2015
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
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
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 |
| [***] | [***] |
| 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 |
| [***] | [***] |
| [***] | [***] |
| [***] | [***] |
| 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 |
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.
| 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 |
| [***] | [***] |
| [***] | [***] |
| 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 |
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.
| 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 ###-###-#### | 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 |
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.
|
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 |
| [***] | [***] |
| [***] | [***] |
| [***] | [***] |
| [***] | [***] |
6
