Royalty Report: Drugs, Therapeutic, Pharmaceuticals – Collection: 789

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

The Licensor hereby agrees, unconditionally and irrevocably, that the Licensee shall have the exclusive and unrestricted right worldwide, to exercise, use and commercialize and allow third parties to exercise, use and commercialize the Invention during the Agreed Term.

Invention shall thereafter mean the inventions covered by any claim(s) of a Patent issued or validated in the USA, the United Kingdom, France or Germany and not subsequently invalidated.

License Property

Patent and Patent Applications

Israel Patent Application 123998 (which is priority document for all patents/patent applications listed below)

PCT/IL99/00173 (all patents/patent applications listed below via this application).

Europe   European Patent Application EP 1071702 B1 covering   Austria Belgium Cyprus Denmark Finland France Germany Greece

Ireland

Italy

Latvia

Lithuania

Luxembourg

Monaco

Netherlands

Portugal

Romania

Slovenia

Spain

Sweden

Switzerland (+Liechtenstein)

United Kingdom

Other European Applications

Czech Republic
PV 2000-3625

Hungary
P 01 01653

Norway
20004998

Poland
P 343 360

Ukraine
20000095546

Eurasia

Eurasian Application No. 200000888 covering

Armenia
Azerbaijan
Belarus
Kazakhstan
Kirgizstan
Moldova
Russia
Tajikistan
Turkmenistan

Americas

Brazil
9909908-0

Canada
2,325,933

Mexico
009863

United States  6,395,722(granted), 6,384,024(granted), 10/078,671

Others

Australia
30515/99 (granted)

China
99804903.4

Indonesia
W2000 1998

Japan
2000-543488

New Zealand
507309

South Korea
10-2000-7010903

Turkey
84564

License Grant

The Licensor grants to the German Licensee an exclusive royalty bearing license and, as the case may be, an exclusive royalty bearing Sublicense under the Patents, the Trademarks, the Product Know-How and the Product Data (all as defined below and collectively referred to as the licensed assets) to the extent necessary to obtain marketing authorisations for, and to manufacture,  have manufactured, to market, have marketed, to distribute, have distributed, and to sell and have sold the Product in the field of dermatology in the Territory.

License Property

The Product is Food and Drug Administration approved, New Drug Application 50/805 covering the marketing and sale of a 40mg controlled release doxycycline monohydrate capsule conforming to the specifications described in such application.

The Patents relate to Oracea, the Company’s dermatology product for the systemic treatment of rosacea.  Methods of treating acne.

License Grant

The Swiss Licensor grants to the English Licensee an exclusive right and license to use the Intellectual Property and the Technical Information to Manufacture, or procure the Manufacture, distribute and sell the Product for the Field of Use in the Territory.

License Property

The product means the optical gel comprising up to 3% diclofenac and 2.5%  hyaluronic acid.  The Active Ingredient is diclofenac.

Intellectual Property and Intellectual Property Rights means the trade marks and Patent Rights.  The patent information is referred to as Solarase I, II,  and III.

Solaraze Gel is a treatment for the chronic skin condition actinic keratosis.

Actinic keratosis is a pre-cancerous patch of thick, scaly, or crusty skin.

Field of Use

The Field of Use means the use of the Product for actinic keratosis.

License Grant

Licensor hereby grants to Licensee, a UK Corporation, an exclusive sublicensable, transferrable license under the Licensor's Patents, Know-How,  Inventions and Licensor’s rights in the Joint Inventions and/or Joint Invention Patents to Commercialize the Licensed Product in the Field in the Territory.

License Property

Licensor invented a proprietary compound known as Telavancin (VIBATIV®) for the treatment of serious Gram-positive bacterial infections in humans.

VIBATIV®  is for the treatment of nosocomial pneumonia (hospital-acquired), including ventilator-associated pneumonia, known or suspected to be caused by MRSA when other alternatives are not suitable.

VIBATIV® is a bactericidal, once-daily injectable lipoglycopeptide antibiotic approved in the U.S. and Canada for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains.

Field of Use

Field means veterinary or human pharmaceutical use of the Licensed Product.

License Grant

The Licensor grants Licensee of the United Kingdom, an exclusive nontransferable, right and license, with the right of sublicense, as specifically set forth herein, to use the New Drug Application, Know How, Trademark, Patent Rights and all Improvements and Proprietary Information of Licensor related thereto or to the Product together with the Licensed Intellectual Property during the Term, solely in the Territory, and solely for the purposes of (I) preparing applications for Marketing Authorizations and obtaining and maintaining Registrations and packaging, labeling, promoting, marketing, selling and distributing the Product under the Trademark in the Territory solely for the Licensed Indications, and, (ii) exercising its other rights under this Agreement.

License Property

The Product means Licensor’s proprietary pharmaceutical product Xyrem containing the active pharmaceutical ingredient as its active ingredient in bulk, unlabeled bottles, for use as a treatment for the Licensed Indications and all Components therefor unless Licensee shall elect to source such Components from a Third Party.  

Xyrem® is (sodium oxybate) oral solution.  Trademark” means the trademark Xyrem®  

Xyrem is used to treat narcolepsy.

Field of Use

The Licensed Indications means narcolepsy and its associated conditions including without limitation cataplexy and excessive daytime sleepiness.

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

The Korean Licensor grants to Licensee the sole and exclusive license to use, import, package, sell, and offer for sale Products within the Field in the Territory, and the exclusive right to use the Trademarks in the Territory in conjunction with the use or sale of the Products.  Licensor agrees to supply to Licensee Final Product or Active Pharmaceutical Ingredient (“API”).

License Property

Product means any compound containing Gemifloxacin as an active ingredient, including API and Final Product.

API means Active Pharmaceutical Ingredient.

Field of Use

Gemifloxacin is used to treat a variety of bacterial infections. This medication belongs to a class of drugs known as quinolone antibiotics.  Gemifloxacin is used to treat different types of bacterial infections in the lungs.