Royalty Report: Drugs, Delivery, Coating – Collection: 372496

License Grant

Licensor grants an exclusive, worldwide license to make, use, sell, offer for sale and import all inventions described and claimed in the Licensed Patent Applications (A) in all fields and Territory including improvements thereto.

Licensor grants an exclusive, worldwide license to make, use, sell, offer for sale and import NRobeâ„¢ Film, NRobeâ„¢ Equipment and NRobeâ„¢ Process under the Licensed Patent Applications (B) in the field of the NRobeâ„¢ System in the Territory including improvements thereto.

Licensor grants an exclusive, worldwide license to use the Technical Information in the field of the NRobeâ„¢ system.

License Property

The term NRobeâ„¢ System as used herein refers to all technology, know-how, technical data, improvements or other information regarding a platform of technologies defined as any enrobed compacted powder solid form having a degree of compaction less than that degree of compaction for a Tablet NRobeâ„¢ Solid Form, the process for making or using the NRobeâ„¢ Solid Form (NRobeâ„¢ Process), film to be used in the NRobeâ„¢ Solid Form (whether constituted by HPMC (hydroxyl propyl methyl cellulose) or otherwise) (any such film, NRobeâ„¢ Film) and machines, devices and equipment to be used in making the NRobeâ„¢ Solid Form (NRobeâ„¢ Equipment).

The Licensed Patents Applications (A) are titled
Powder Compaction and Enrobing; and, Improvements in Powder Compaction and Enrobing.

The Licensed Patents Applications (B) are titled
Improvements in or Relating to Encapsulation;
Capsule Based Drug Delivery System;
Improvements in/ or Relating to Modified Cellulose Films;
Modified Polymeric Films;
Oxygen Scavenger in Films;
Glue Compositions;
Improvements in Glues; and,
Improvements in Glues and their Applications.

Field of Use

The field of use is the distinct dosage forms identified as TabWrap, Septum and Swallow.  TabWrap is defined as any Tablet enrobed by film. Septum is defined as an enrobed solid form having more than one compartment separated by a film. Swallow is defined as a solid form having a soft film enrobing a liquid, paste or suspension.

NRobe is a solid oral dose system capable of enrobing a variety of powders and particulates within dry polymer films to produce an elegant dose form comparable in appearance to film-coated or gel-dipped tablets, or two-piece hard capsules. This system can deliver benefits such as unique appearance, improved drug release, simplified formulation and processing, and the avoidance of problematic excipients.

License Grant

In connection with the rights Licensee has acquired, this amendment adds exclusivity and clarifies terms and royalties.

During the term, Licensor agrees not to manufacture a prescription prenatal vitamin product for sale or distribution within the United States which uses any of the following Pantone® colors 247C, 248C, 249C, 253C, 254C and 255C, or has enrobing containing the two colors to be mutually agreed upon in writing by the Parties.

License Property

The Licensee has  rights, title and interest in certain prescription prenatal vitamin products.

With this amendment, Products shall be gelatin enrobed using the patented Soflet® technology and patents.

Field of Use

The field of use of the invention pertains to film-enrobed unitary-core products such as medicine tablets.  Licensee is a specialty pharmaceutical company that markets and sells brand name prescription products.

License Grant

The Licensor of the United Kingdom grants to the Licensee
– a non-exclusive license to use the Licensed Technology to use, adapt and modify and enhance the Prototype Machine to develop and produce Tabwrap Machines in the Territory for the duration of this Agreement;
– an exclusive license to use the Licensed Technology to manufacture, have manufactured, use or sell the Products in the Exclusive Field in the Territory for the duration of this Agreement;
– a non-exclusive license to use the Licensed Technology to manufacture, have manufactured, use or sell the Products in the Non-exclusive Field in the Territory for the duration of this Agreement;
– a non-exclusive license to use the Licensed Technology and/or the Xgel Tabwrap Film Technology to manufacture, have manufactured, use or sell the XGel Tabwrap Film in the Territory for the duration of this Agreement.

License Property

The intellectual property includes all Intellectual Property Rights in and relating to the XGel System, the Tabwrap Technology and the Prototype Machine, including without limitation the Patents.

The product means any Tablet which is manufactured using the Licensed Technology or any Improvements.

The patent applications are for a drug delivery system and encapsulation.
  

The know-how means all confidential information, including that comprised in formulae, techniques, designs, specifications, drawings, components lists, manuals, instructions and catalogues, whether in human or machine readable form that does not comprise Patents and relating to the XGel System, the Tabwrap Technology, the Prototype Machine and the XGel Tabwrap Film Technology;  the Products and/or the composition or production of the Products using the Prototype Machine and/or the XGel System and/or the Tabwrap Technology;  the design, development, manufacture or use of the Products using the Prototype Machine and/or the XGel System and/or the Tabwrap Technology; and  the repair and maintenance of the Products and the Prototype Machine.

The TABWRAPâ„¢ process is revolutionary and incorporates state of the art technology in fast tablet processing, innovative film cutting and a unique overlap film tamper-evident sealing process.  The ability to manipulate the dissolution rates of the tablet wrapping film formulations enables BioProgress to design-in advanced rapid active release characteristics.

Field of Use

The exclusive field means the market for /over-the-counter orally ingestible pharmaceutical or nutritional Products for humans, but not animals, sold as Generic Drug, Private Label, Store Brand, Retailer Brand or Value Brand pharmaceutical or nutritional products; it being understood and agreed that Exclusive Field shall, in all cases, exclude any Products which are regularly advertised by national broadcast, print, direct mail, or other media for the purpose of establishing brand recognition of the manufacturer, marketer, or distributor with the general public, including without limitation any prescription or over-the-counter Products advertised as described above in this proviso, and sold, directly or indirectly, by any pharmaceutical company which holds the NDA to such product (as such term is defined in the for the US Federal Food Drug and Cosmetics Act) which shall be deemed to be part of the Non-exclusive Field and any Retained Products.

The non-exclusive field means the market for orally ingestible pharmaceutical and nutritional Products for humans (but not animals) outside the Exclusive Field.

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.