Royalty Report: Drugs, Disease, Diabetes Treatment – Collection: 275800

License Grant

Licensor grants to Licensee of Barbados an exclusive license in the Territory under the Patent Rights, Know-How and Technical Information, with the right, to grant sublicenses of the same scope as the license granted by this Agreement, or to appoint a Distributor, to Manufacture and Market 500mg Product in, and import 500mg Product into, the Territory.

Licensor grants to Licensee of Barbados a non-exclusive license under the Foreign Patent Rights, Know-How and Technical Information, with the right, to grant sublicenses of the same scope as the license granted, to Manufacture 500mg Product in the United States or Puerto Rico for export to the Territory for sale in the Territory in compliance with this Agreement.

License Property

The Active Ingredient shall mean the chemical compound known as metformin HCl.

The 500mg Product shall mean the once-daily oral formulation of the Active Ingredient in combination with the AcuForm Delivery Technology.

The 1000mg Product shall mean the once daily oral tablet formulation of the Active Ingredient in a 1000 mg strength to be developed using proprietary Licensee drug delivery technology pursuant to the Supply Agreement.

Invention shall mean the 500mg Product, any improvement to the 500mg Product, any new use of the 500mg Product, any new performance characteristic of the 500mg Product, any new process used to Manufacture the 500mg Product, or any step or steps in any such process, and includes all formulations of the 500mg Product developed pursuant to the Prior Agreement.

The patents are titles  Extending the Duration of Drug Release Within the Stomach During the Fed Mode; Gastric-Retentive, Oral Drug Dosage Forms for the Controlled Release of Sparingly Soluble Drugs and Insoluble Matter;  Alkyl-Substituted Cellulose-Based Sustained Release Oral Drug Dosage Forms;  and, Sustained-release oral drug dosage form.

Field of Use

The field of use for the metformin product is Type II diabetes.

License Grant

Licensor grants to Dutch Licensee under the Licensor's Technology (i) an exclusive license to develop, have developed, make, have made, use, market, have marketed, promote, have promoted, commercialize, have commercialized, exploit, import, export, sell, have sold and offer to sell the Product and (ii) a nonexclusive license to develop, have developed, make, have made, import and export the Product.

The Licensor will remain responsible for completion of the ongoing Phase 3 clinical trial for DM-1796 for the treatment of pain associated with post-herpetic neuralgia.  The Licensee will be responsible for the NDA filing and has the option to develop DM-1796 in further pain indications other than post-herpetic neuralgia.

License Property

Licensor has used its proprietary AcuForm™ gastric retentive technology to develop an oral dosage form of gabapentin known as Gabapentin GR®, and is conducting Phase III clinical development of Gabapentin GR®.

“Product” means the product known as Gabapentin GR® in the formulation and at the dosage being studied in Depomed Protocol 81-0062, “A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study of the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Patients with Postherpetic Neuralgia,” dated the 25th day of January, 2008, and any alternative strengths of such dosage form, or line extensions of such product for use within the Field.

Extending the duration of drug release within the stomach during the fed mode

6,340,475

1/22/2002

U.S.

Extending the duration of drug release within the stomach during the fed mode

6,635,280

10/21/2003

U.S.

Optimal polymer mixtures for gastric retentive tablets

6,723,340

4/20/2004

U.S.

Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage form

6,488,962

12/3/2002

U.S.

Methods of Treatment using a Gastric Retained Gabapentin Dosage

7,438,927

10/21/2008

U.S.

Field of Use

Field means the treatment or amelioration of pain, including without limitation treatment of post-herpetic neuralgia (“PHN”), pain associated with diabetic neuropathy (“DPN”), Phantom Pain and fibromyalgia.

License Grant

In consideration of Licensors performance, to date, under the Agreement and its agreement herein to relinquish all of its rights in and to the Licensee Products.

License Property

The rights relate to the sale of Metformin in the United States.  Metformin is the first-line medication for the treatment of type 2 diabetes, particularly in people who are overweight.

Field of Use

This agreement is for the pharmaceutical industry.

Metformin is used in the treatment of diabetes.

License Grant

Licensor grants a license, without the right to sublicense, other than to Licensees Affiliates, under the Licensed Intellectual Property, to
– manufacture for sale to Licensor and its Affiliates or sublicensees at any time, as requested by Licensor pursuant to the License and Manufacturing Agreement,
– make, have made and import in the Territory commencing prior to the Marketing License Effective Date for sale and offering for sale only commencing on or after the Marketing License Effective Date, and
– sell and offer for sale only commencing on or after the Marketing License Effective Date and thereafter, to market, sell and have sold in the Territory.
The License will be exclusive.

Licensee will have the right to enter the market for Niaspan and Advicor at least four (4) years prior to the expiration of the last to expire of Licensors currently issued patents in the Territory, thereby benefiting consumers by permitting generic entry that may not have occurred if the Lawsuit was allowed to proceed.

License Property

Licensed Products shall mean the Niacin Licensed Products and the Niacin-Lovastatin Licensed Products.

Niacin Licensed Products shall mean 1 gm, 750 mg and/or 500 mg extended release oral niacin tablets and any oral dosage form containing niacin (empirical formula of C(6)H(5)NO(2)) as the single active ingredient which is manufactured pursuant to any Niacin ANDA.

Niacin-Lovastatin Licensed Products shall mean lovastatin 20 mg/niacin 1 gm, lovastatin 20 mg/niacin 750 mg and lovastatin 20 mg/niacin 500 mg and any oral dosage form containing niacin (empirical formula of C(6)H(5)NO(2)) and lovastatin (empirical formula of C(24)H(36)O(5)) as the only active ingredients which is manufactured pursuant to any Niacin-Lovastatin ANDA.

Field of Use

The prescription extended release niacin 1gm tablet product is for human use, currently for affecting lipoprotein.

Medication and supplemental niacin are primarily used to treat high blood cholesterol and pellagra (niacin deficiency).

Lovastatin is a statin drug, used for lowering cholesterol in those with hypercholesterolemia to reduce risk of cardiovascular disease.