Royalty Report: Drugs, Therapeutic, Disease – Collection: 118

License Grant

The Licensor granted the Licensee exclusive rights to commercialize Fenoglide® (fenofibrate) prescription products in the U.S.

Under the terms of the License Agreement, the Licensee is responsible for commercial, manufacturing and regulatory activities for Fenoglide.

License Property

Fenoglide is approved by the U.S. Food and Drug Administration as an adjunct to diet to reduce elevated low-density lipoprotein-cholesterol (LDL-C), total cholesterol, triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein-cholesterol (HDL-C) in adult patients with primary hyperlipidemia or mixed dyslipidemia. Fenoglide is also indicated as an adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia.  Fenofibrate is also effective in the treatment of Diabetes Type II and metabolic syndrome.

In connection with the assumption of these responsibilities, the Licensor's existing Agreements relating to the manufacture and supply of Fenoglide, as well as existing inventory, have been assigned to the Licensee.

The Licensee has agreed to use commercially reasonable efforts to commercialize Fenoglide within the U.S. In addition, prior to the entry of any generic version of Fenoglide, the Licensee is required to provide certain minimum detailing efforts and sales and marketing expenditures.

During the term of the License Agreement, the Licensor is not permitted to, directly or indirectly, develop, manufacture or commercialize any fenofibrate products for human use in the U.S

The Licensee also has exclusive rights to use the Fenoglide trademark in the U.S.

Country

Issue Date/ Filing Date

Patent Number/ Application No.

Title

USA

09FEB2010

7658944

Solid Dosage Form Comprising a Fibrate

USA

18DEC2009

12/642,563

Solid Dosage Form Comprising a Fibrate

USA

9DEC2011

13/315,030

Solid Dosage Form Comprising a Fibrate

Canada

08FEB2011

2,540,984

Solid Dosage Form Comprising a Fibrate

USA

09JUN2006

11/449,918

Tablet Comprising a Fibrate

Canada

12APR2006 (PCT)

2,604,970

Tablet Comprising a Fibrate

The present invention relates to novel solid dosage forms and pharmaceutical compositions comprising a fibrate, notably fenofibrate. Particularly, the invention discloses solid dosage forms having increased bioavailability. The solid dosage forms of the invention comprise fibrate dissolved in a suitable vehicle or mixture of vehicles. The dosage forms are especially intended for oral use and exhibit excellent storage stability, i.e. are stable. The invention also relates to methods for preparation of the solid dosage forms and pharmaceutical compositions and the use thereof.

“Product Trademarks” means (a) Fenoglide® and all other Trademarks used by Licensor.

Field of Use

Field means the prevention, palliation or treatment of any condition, indication or diseases in humans.

License Grant

For Licensees Right to Licensor Clinical Data for Canada and Mexico, Licensor shall grant the French Licensee access to the Licensor Clinical Data for use solely in Canada and Mexico in order that Licensee may use such Licensor Clinical Data for the limited purpose of obtaining registrations with the appropriate Canadian and Mexican regulatory authorities in order to allow License to commercialize the Product in such country.

License Property

The Clinical Data is all preclinical, clinical, technical and other information relative to the clinical program, data, analyses, studies or similar information, including, without limitation, all Intellectual Property, generated or developed by or on behalf of the parties after the date hereof as a result of or in connection with the Product Development Program and the clinical trials conducted by Licensor.

Active Pharmaceutical Ingredient means the raw non-micronized fenofibrate used in the Product manufactured by a party other than Licensor or any of its Affiliates.

Product means a product composed of or containing micronized fenofibrate, in any dosage form, including encapsulated or bulk beads, granules or similar presentations, including, without limitation, the fenofibrate product developed by Licensor for Licensee pursuant to this Agreement and the Product Development Program.

Antara (fenofibrate) is a lipid-regulating agent called a fibrate used to treat high cholesterol and high triglyceride levels.

Field of Use

The products are for cardiovascular use.

License Grant

Licensor grants an exclusive, even as to Licensor, world-wide license under the Patent Rights and the Know-How to develop, make, have made, use, sell, have sold, offer for sale, import or otherwise commercialize Licensed Products and Improvements in the Field.

License Property

The Compounds shall mean doxepin, amitriptyline, trimipramine, trazodone and nortriptyline, as well as any respective prodrugs, hydrates, salts, esters, isomers, polymorphs or analogues thereof.

'Patent Rights' shall mean: (i) U.S. Patent Nos. 5,502,047, 5,643,897, 6,211,229 and 6,344,487

Field of Use

The Field shall mean the prevention, treatment or control of insomnia, and any other use of the Compounds within the Ranges.