Royalty Report: Drugs, Pharmaceuticals, Delivery – Collection: 5768

License Grant

Licensor hereby grants to Licensee an exclusive, non-transferable royalty-bearing sublicense to and under the Licensed Assets to develop, make, have made, use, market, offer for sale, sell, distribute, and import the Licensed Products solely during the License Term in North America (the Sublicense).

License Property

Orapred ODT is prescribed primarily for acute exacerbations of asthma in children.  This will be the first orally disintegrating tablet form of prednisolone available in the United States.  The FDA recently granted marketing approval.

The Orapred product line is also used to control severe, persistent asthma and to reduce inflammation seen in numerous medical conditions including arthritis and cancer.  Orapred ODT utilizes a proprietary orally disintegrating tablet technology to provide a taste-masked, non-refrigerated and convenient formulation of prednisolone.  Licensor retains rights outside North America.

New Drug Applications

Abbreviated New Drug Applications

Orapred (Prednisolone Sodium Phosphate Oral Solution), 20.2 mg/ 5 ML, (equivalent to 15 mg (base)/ 5 ML) – ANDA 75-117

Orapred RT (Prednisolone Sodium Phosphate Oral Solution), 20.2 mg/ 5 ML, (equivalent to 15 mg (base)/ 5 ML) – ANDA 77-485

505(B)(2) New Drug Application

Orapred ODT (Prednisolone Sodium Phosphate

Orally Disintegrating Tablets, 10 mg, 15 mg, and 30 mg Prednisolone base) – NDA 21-959

Development Licensed Patents

Patent/Application Number

OraSolv® Technology

US 5178878 A

US 08/468,913

CA 2,061,917

PakSolv® Technology

US 6,155,423

CA 2284132

US 6,269,615

US 6,311,462

DuraSolv® Technology

US 6,024,981

US 6,221,392

CA 2284663

Licensed Trademarks

Orapred

Orapred ODT

CIMA

CIMA LABS INC.

OraSolv®

PakSolv®

DuraSolv®

CIMA, CIMA LABS INC. OraSolv®, PakSolv®, DuraSolv®, and are Cima Trademarks.

Taste Masking Related Licensed Patents

Patent/Application Number

Pleasant Tasting Aqueous Liquid Composition of a Bitter-Tasting Drug

Anaebonam, Aloysius O.

Clemente, Emmett

Fawzy, Abdel A.

08/692,081

5763449

United States

09/011,156

5962461

United States

2260852

2260852

Canada

991273

Mexico

Room Temperature Stable Aqueous Liquid Pharmaceutical Composition

Emmett Clemente, Bhiku Patel, Kuljit Bhatia, Frank L. Sorgi, and Emil D. Kakkis

Medicis Pharmaceutical Corporation, Ascent Pediatrics Inc., BioMarin Pharmaceutical Inc.

11/066,113

United States

PCT/US2005/006576

Transferred Inventory of Orapred

Description

8 oz. Trade bottles

  
Lot Numbers
  
Expiration Date
  
Units
  
NDC Number

  
RM0421
  
39416
  
24204
  
68135-455-02

RM0501

39447

12108

Institutional packs

RM0502

39447

12192

RM0504

39478

10740

8 oz. Samples

  
RM0502A
  
39447
  
12960
  
68135-455-03

6 pack, 20 ml samples

  
RM0505
  
39538
  
10656
  
68135-455-04

8 oz. Authorized generic bottles
  
RM0504A
  
39538
  
13315
  
68135-455-01

RM0505A

22408

  
05PSP05
  
39568
  
24144
  
NA

05PSP06

39568

24288

05PSP07

39599

24348

Field of Use

A North American license and acquisition agreement signed  in March 2006 granted rights to a privately held pediatric specialty pharmaceutical company covering Orapred ODT (prednisolone sodium phosphateorally disintegrating tablets).

License Grant

The Company transferred all of the North American intellectual property relating to the Orapred product.

The Licensor receives royalty revenues on Orapred products, a product acquired in 2004 and subLicensed in 2006.

License Property

Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets) is a prescription drug product indicated for the control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with asthma or asthma caused by respiratory disorders.

Field of Use

The rights granted apply to the medical industry.

License Grant

Licensor grants to Licensee an exclusive license, even as to Licensor, with the right to grant sublicenses, under the Licensor Licensed Technology to use, make, have made, develop, have developed, offer to sell, sell, have sold, distribute, import or otherwise dispose of Licensed Products in the Field in the Territory.

Licensor grants to Licensee and its permitted sublicensees and Affiliates a non-exclusive license to the Licensor Trademarks identified during the term of this Agreement for the purpose of performing its obligations under this Agreement.  The Trademarks are to be used in labeling of Licensed Product as requested as well as use name and derivations thereof in promoting, marketing and selling of Licensed Product in the Territory.

License Property

Licensed Product shall mean oral disintegrating tablets containing prednisolone sodium phosphate, prednisolone, or any salt or base thereof and all improvements and line extensions thereof.

Oral Disintegrating Tablets shall mean a solid tablet dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds when taken orally.

Trademarks shall mean the trademarks, tradenames (and registrations and applications therefor) controlled by each of the parties and used on Licensed Product, (Oral Disintegrating Tablets) including, initially the applicable Licensor Trademarks listed hereto and the applicable Ascent Trademarks listed hereto.
CIMA
CIMA LABS INC.
OraSolv®
PakSolv®
DuraSolv®
CIMA
ORA.FRED®

Licensor Technical Information shall mean (a) techniques and data, including ideas, inventions (including patentable inventions, but excluding inventions covered by Licensor Licensed  Patents), practices methods, knowledge, know-how, trade secrets, skill, experience, documents, apparatus, test data, including pharmacological, toxicological and clinical test data, analytical and quality control data, manufacturing, patent data or descriptions relating to Licensed Product, including, but not limited to, those that relate to DuraSolv(R)Technology, PakSolv(R)Technology and/or OraSolv(R)Technology, owned or Controlled by Licensor and/or its Affiliates and (b) chemical formulations, compositions of matter, product samples and assays relating to Licensed Product, including, but not limited to, those that relate to DuraSolv(R)Technology, PakSolv(R)Technology and/or OraSolv(R)Technology, owned or Controlled by Licensor and/or its Affiliates. Licensor Technical Information shall include Developed Intellectual Property. Licensor Technical Information shall not include any Work Product.

Licensor Licensed Patents shall mean the patents and patent applications owned or Controlled by Licensor and/or its Affiliates that claim Licensed Product, the DuraSolv(R) Technology, the PakSolv(R) Technology and/or the OraSolv(R) Technology as related to Licensed Product, and its manufacture, its packaging, or its use, its import or its sale and including any extension, reissue, renewal, reexamination or continuation-in-part of such patents or patent applications. Licensor Licensed Patents shall include Developed Intellectual Property. Licensor Licensed Patents shall not include any Work Product. The initial list of Licensor Licensed Patents is set forth.

U.S. Pat. No. 5,178,878 – Effervescent dosage form with microparticles
U.S. Pat. No. 6,155,423 – Blister package and packaged tablet
U.S. Pat. No. 6,024,981 – Rapidly dissolving robust dosage form
U.S. Pat. No. 6,221,392 – Rapidly dissolving robust dosage form

DuraSolv(R)Technology shall mean the fast-dissolving drug delivery system generally described in U.S. Patents 6,024,981 and 6,221,392 and PCT Published Application No. WO 98/46215.

PakSolv(R)Technology shall mean the packaging system generally described in U.S. Patents 6,155,423; 6,269,615 and 6,311,462.

OraSolv(R)Technology shall mean the fast-dissolving drug delivery system generally described in U.S. Patent 5,178,878 and U.S. Patent Application 08/468,913.

Field of Use

Field shall mean the treatment of all human conditions.  Exclusive Field shall mean any product containing prednisolone sodium phosphate, prednisolone, or any salt or base thereof.

License Grant

Licensor hereby grants to Licensee an exclusive license for the term of this Agreement under the following assets to market, distribute and sell the Products, for all indications and for all agreed upon Product line extensions, in the Territory.

Licensor grants to Licensee an exclusive, royalty bearing license to use the Licensor Trademarks to market, distribute and sell the Products, during the term of this Agreement, for all indications and for all agreed upon Product line extensions in the Territory.

License Property

Product shall mean any of the pharmaceutical products described, it being understood that additional products may be added after the date hereof in accordance with this agreement.

Product (API)
                                                Strengths
                                   LicensorTarget Completion Date
#1metoclopramide HCl
                        5mg 10mg
                                   December 01, 2002
#2 carbidopallevodopa
                        10m!V100mg
                                                                        25m!V 100mg
                                                                        2Smg/250mg

#3 baclofen
                                                10mg
                                                                        20mg

#4 alprazolam
                                        HCI 0.25 mg
                                                                        0.5mg
                                                                        1mg
                                                                         2mg
                                           March 31, 2003
#5 selegiline HCI
5mg

#6 diphenoxylate HCVatropine sulfate
2.5 mw0.025 mg

#7 dicyclomine HCI
                                10mg
                                                                        20mg

Licensor Patents shall mean United States patent nos. 6,024,981 and 6,221,392 (Rapidly Dissolving Robust Dosage Form) and any patents and patent applications resulting therefrom, including any extension, reissue, renewal, reexamination or continuation-in-part of such patent or patent application. To the extent that the OraSolv(R) and PakSolv(TM) technology is used with respect to any Product pursuant, the term 'Licensor Patents' shall, with respect to such Product, be deemed to include United States patent nos. 5,178,878, 6,155,423, 6,269,615 and 6,311,462 and any patents and patent applications resulting therefrom, including any extension, reissue, renewal, reexamination or continuation-in-part of such patent or patent application.

Licensor Trademarks shall mean the Licensor(R), DuraSolv(R), PakSolv(TM), OraSolv(R) and Meltabs(R) trademarks.

Licensor Technology shall mean all of the Licensor Patents and all of Licensors trade secrets, technology, know-how and all other information necessary for the manufacture of the Products including, without limitation, that relate to Licensors DuraSolv(R), PakSolv(TM) and OraSolv(R) technologies.

OraSolv technology is an oral dosage form that combines taste masked drug ingredients with a fast dissolving, low-effervescence system. The OraSolv tablet dissolves quickly in the mouth without chewing or the need for water.

Field of Use

This agreement pertains to the drug industry relating to pharmaceutical products through proprietary drug delivery technologies.  DuraSolv(R)Technology shall mean the fast-dissolving drug delivery system.

License Grant

Licensor hereby grants to Licensee and its Affiliates an exclusive royalty-bearing transferable license, under the Licensed Intellectual Property solely to use and sell the Products for use in the Field within the Territory and to manufacture or have Products manufactured by Third Parties solely on behalf of Licensee and its Affiliates for subsequent sale for use in the Field within the Territory as and to the extent permitted herein. Licensee and its Affiliates shall have the right to sublicense any of rights granted in this Section to contract manufacturers, distributors, co-promotion partners, contract sales organizations and other service providers assisting Licensee and its Affiliates in the commercialization of the Product.

License Property

Licensor has developed a phentermine orally disintegrating tablet (ODT) which is the subject of NDA # 20-2088, and holds rights to the Licensed Intellectual Property.

Intellectual Property relates to orally disintegrating tablet formulations of pharmaceutical products.

Certain Licensed Patent Rights
U.S. Patent No. 6,149,938
U.S. Patent Application Serial No. 12/034,928

'Product' or 'Products' means (i) the finished pharmaceutical forms of phentermine hydrochloride orally disintegrating tablets in 15 mg, 30 mg and 37.5 mg dosages and (ii) any Improvements.

'Product NDA' means NDA # 20-2088.

Field of Use

'Field' means the treatment or prevention of diseases or conditions in humans.