Exhibit 10.31
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH THE
SYMBOL "[***]".
A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY
WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934.
SUBLICENSE AGREEMENT
This Sublicense Agreement (this "Agreement") is made as of October 13, 2006 (the
"Effective Date") by and between PharmaNova Inc. a Delaware corporation with its
principal place of business located at 50 Lucius Gordon Drive, Ste 206, West
Henrietta, NY 14586 ("Licensor"), and Depomed, Inc., a California corporation
with its principal place of business located at 1360 O'Brien Drive, Menlo Park,
CA 94025 ("Licensee") (each, a "Party" and collectively, the "Parties").
1.
PREAMBLE
1.1
LICENSOR HAS EXCLUSIVELY LICENSED THE RIGHTS
(WITH THE RIGHT TO SUB-LICENSE) TO CERTAIN INTELLECTUAL PROPERTY SPECIFICALLY
COVERING THE USE OF GABAPENTIN FOR CERTAIN CONDITIONS SECONDARY TO HORMONAL
VARIATION.
1.2
LICENSEE HAS IN CLINICAL DEVELOPMENT A
GABAPENTIN PRODUCT UTILIZING LICENSEE'S PROPRIETARY DRUG DELIVERY TECHNOLOGY
CURRENTLY REFERRED TO AS THE ACUFORM TECHNOLOGY ("GABAPENTIN GR").
LICENSEE
DESIRES, PURSUANT TO TERMS AND SUBJECT TO CONDITIONS SET FORTH IN THIS
AGREEMENT, TO CREATE A UNIQUE DOSAGE FORM OF GABAPENTIN GR, UTILIZING THE SAME
PROPRIETARY DRUG DELIVERY TECHNOLOGY AND A UNIQUE STRENGTH, RELEASE PROFILE OR
MECHANISM OF DRUG DELIVERY RELATIVE TO LICENSEE'S CURRENT FORMULATION OF
GABAPENTIN GR, FOR THE TREATMENT OF CERTAIN CONDITIONS SECONDARY TO HORMONAL
VARIATION, AND TO SEEK TO OBTAIN REGULATORY APPROVALS FOR SUCH PRODUCT IN THE
US.
1.3
LICENSOR DESIRES TO GRANT TO LICENSEE A
LICENSE FOR CERTAIN OF THE USE AND TERRITORIAL RIGHTS TO GABAPENTIN HELD BY
LICENSOR.
NOW, THEREFORE, The Parties agree as follows:
2.
DEFINITIONS:
TERMS DEFINED IN THIS ARTICLE 2, AND
PARENTHETICALLY DEFINED ELSEWHERE IN THIS AGREEMENT, WILL THROUGHOUT THIS
AGREEMENT HAVE THE MEANING HERE OR THERE PROVIDED.
DEFINED TERMS MAY BE USED IN
THE SINGULAR OR IN THE PLURAL, AS SENSE REQUIRES.
2.1
"'098 PATENT" MEANS U.S. PATENT NO.
6,310,098, INCLUDING ALL RE-EXAMINATIONS, REISSUES, SUPPLEMENTAL PROTECTION
CERTIFICATES AND EXTENSIONS THEREOF.
2.2
"AFFILIATE" MEANS ANY CORPORATION OR OTHER
BUSINESS ENTITY THAT CONTROLS, IS CONTROLLED BY OR IS UNDER COMMON CONTROL WITH
THE LICENSEE OR LICENSOR.
"CONTROLS," "CONTROL" OR "CONTROLLED" AS USED IN THIS
PARAGRAPH MEANS DIRECT OR INDIRECT OWNERSHIP OF MORE THAN FIFTY PERCENT (50%) OF
THE VOTING STOCK OF SUCH CORPORATION OR THE ABILITY TO EXCLUSIVELY DIRECT,
EITHER DIRECTLY OR INDIRECTLY, THE DECISION-MAKING AUTHORITY OF SUCH OTHER
UNINCORPORATED BUSINESS ENTITY.
2.3
"API" MEANS GABAPENTIN [1-(AMINOMETHYL)
CYCLOHEXANEACETIC ACID].
2.4
"CANCER INDICATIONS" MEANS TREATMENT,
DIAGNOSIS OR PREVENTION OF VASOMOTOR SYMPTOMS ASSOCIATED WITH CANCER (E.G.,
CONDITIONS SUCH AS BREAST, ENDOMETRIAL, UTERINE AND PROSTATE CANCER) AND/OR DRUG
TREATMENT FOR CANCER AND/OR CHEMOTHERAPY FOR CANCER.
2.5
"CANCER PRODUCT" MEANS A PRODUCT WHEN
LABELED FOR USE FOR ANY OF THE CANCER INDICATIONS.
2.6
"CLINICAL INFORMATION" SHALL MEAN ALL
IN-VIVO OR CLINICAL, PHARMACOLOGY, TOXICOLOGY, SAFETY AND EFFICACY DATA,
FORMULARY SUBMISSIONS, PHARMACOECONOMIC DATA, PHASE I, II AND III CLINICAL DATA
AND RESULTS, AND OTHER SUCH INFORMATION NOW