Royalty Report: Drugs, Delivery, Biotechnology – Collection: 28567

License Grant

Grant of Exclusive License.  Licensor hereby grants to Licensee an exclusive, irrevocable, perpetual and transferable license under the Licensed Intellectual Property to manufacture, have manufactured, use, market, sell, have sold, offer to sell, import or otherwise exploit the Product in the Field of Use in the Territory, with the right to grant sublicenses subject to the Agreement.

Sublicenses.  Licensee shall have the right to grant sublicenses (with rights to further sublicense) under the licenses to sublicensees, provided that Licensee shall ensure that its sublicensees shall be subject to a written agreement with terms and conditions that are consistent with, and no less protective of, Licensor than the terms and conditions hereunder.

Licensed Intellectual Property means (a) the Licensed Trade Dress; (b) the Licensed Patents; (c) the Licensed Know How; and (d) the Licensed Inventions.

Licensed Inventions means (a) the Licensor Inventions; and (b) Licensor's and its Affiliates' interest in and to the Joint Inventions.

Licensed Trade Dress means the layout, designs and coloring used on the packaging of the Product solely to the extent also used by the Licensor or its current Affiliates on product packaging of their products other than the Products.

Licensed Know How means all the know-how, trade secrets, expertise, inventions, discoveries, technical information and other unpatented information related to the Product that is owned or controlled by, or licensed to, Licensor or its Affiliates, including, but not limited to, all information reasonably necessary for Licensee and its Affiliates to make, have made, use or sell the Product, but expressly excluding any Product Know How as defined in the APA, which Product Know How is assigned to Licensee pursuant to the APA executed concurrently herewith.

License Property

Product means the prescription drug product approved by the U.S. Food and Drug Administration (FDA) on June 19, 2003, as referenced in NDA 21-543, and sold under the name Striant® in the United States, together with any improvements, enhancements, modifications or extensions of said product, including without limitation any new uses, kits, formulations, and dosage forms.

STRIANT® (testosterone buccal system) was approved by the FDA in June 2003 for a deficiency or absence of endogenous testosterone associated with hypogonadism in men.
This novel product uses our buccal delivery technology to deliver testosterone across the buccal mucosa (the lining of the cheek and gum) and into the bloodstream in a controlled, sustained manner.

Licensed Patents – 6,248,358  –  Bioadhesive Progressive Hydration Tablets and Methods of making and using the same.  A bio adhesive tablet wherein the active ingredient may be protected from water or the surrounding environment, thereby protecting it from metabolism or from other degradation caused by moisture, enzymes, or pH effects, and making it bioavailable only at a controlled rate. The active ingredient may be protected from moisture during the manufacturing process and more importantly may be protected from moisture and the immediate septic environment until after the patient has applied the tablet, and then only at a slow and controlled rate. It is by this process of progressive hydration that the active ingredient remains protected for many hours after administration. It is also by the process of progressive hydration that controlled and sustained release is achieved because only that part of the active ingredient that is the hydrated (aqueous) fraction of the tablet is available for absorption (bioavailable).

Field of Use

Field of Use means the treatment with testosterone of any and all levels of hypogonadism or other indications for the treatment of low testosterone in men.

License Grant

Licensor of Bermuda hereby grants to Licensee of England for the Term an exclusive license for and in the Territory to and under the Patent Rights (and to and under the copyright in the Technical Documents to use and copy, and have used and copied, the Technical Documents) to, use, import, have imported, manufacture, have manufactured, market, distribute and sell or have marketed, distributed and sold the Product.  Urology Company shall only have the right to sub-license any such rights with Licensor's prior written approval (which approval may not be unreasonably withheld or delayed).

License Property

Patent Rights means all Patent Rights owned by or licensed to Licensor or its Affiliates containing claims reciting or covering Product including but not limited to the patents set out in this Agreement.

Extended Release Buccal Bioadhesive Tablet  The present invention relates to a bioadhesive, bioerodible tablet for the extended and controlled release of active ingredients. More particularly, the present invention relates to a progressive hydration tablet for adhesion to the wall of a body cavity for the sustained release of active ingredients without premature degradation of the active ingredients caused by metabolism, or by moisture, enzymes or pH effects.

Patents and Applications
Patent No.  Title  Country  Current Status  Expiration Date  

1,105,104 Extended Release Buccal Bioadhesive Tablet
United Kingdom  Issued  8/24/2019
France  Issued  8/24/2019
Switzerland  Issued  8/24/2019
Austria  Issued  8/24/2019
Spain  Issued  8/24/2019
Sweden  Issued  8/24/2019
Denmark  Issued  8/24/2019
Netherlands  Issued  8/24/2019
Belgium  Issued  8/24/2019
Italy  Issued  8/24/2019
Ireland  Issued  8/24/2019
Portugal  Issued  8/24/2019
Monaco  Issued  8/24/2019
Finland  Issued  8/24/2019
Cyprus  Issued  8/24/2019
Luxembourg  Issued  8/24/2019

3,055,843 Extended Release Buccal Bioadhesive Tablet
Greece  Issued  8/24/2019

226,591 Extended Release Buccal Bioadhesive Tablet
Hungary  Issued  8/24/2019

2/8/69927694 Extended Release Buccal Bioadhesive Tablet
Germany  Issued  8/24/2019

Extended Release Buccal Bioadhesive Tablet
Norway  Pending  8/24/2019

Field of Use

The rights granted apply to the extended and controlled release of active ingredients relating to the Extended Release Buccal Bioadhesive Tablet.

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, as of the Effective Date, an exclusive license, exclusive even as to Licensor, in the Territory under the Licensed Patent Rights, and to use Licensor Know-How to develop, make, have made, import, export, use, distribute, market, promote, offer for sale and sell Licensed Product(s). Any Improvements shall be included in Licensor Know-How or Licensed Patent Rights, as the case may be, for all purposes of this Agreement. Without limiting the foregoing, Licensor hereby grants Licensee an irrevocable, worldwide, paid-up, exclusive license to use Licensor Know-How or other intellectual property rights relating to the Development Program and  Manufacture of Licensed Product that are necessary for Licensees filings for the purpose of obtaining and maintaining the Health Registrations in the Territory for the Licensed Product, including but not limited to the Manufacturing of Licensed Product as provided in the Health Registrations. Notwithstanding the foregoing, Licensee has granted certain rights to Manufacture Licensed Product to Licensor.

License Property

The term Licensed Product shall mean any dosage form utilizing any material elements of the Licensor Know-How, and/or the Licensed Patent Rights, in its Manufacture or use, and which contains the Active Ingredient as a pharmaceutically active ingredient.

5,178,878 – Effervescent dosage form with microparticles
6, 155,423 – Blister Package and Packaged Tablet

The term OraSolv Technology shall mean the fast-dissolving drug delivery system described in U.S. Patent 5,178,878 and U.S. Patent Application 08/468,913 including, formulations, materials, methods and other technologies which are owned by Licensor or licensed to Licensor with the right to grant sublicenses.

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.