Royalty Report: Drugs, Delivery, Pharmaceuticals – Collection: 8452

License Grant

Licensor hereby grants to Licensee and its Affiliates a worldwide, exclusive right and license with the right to grant sublicenses under the Licensed IP Rights in the Prescription Drug Field to conduct research and to develop, make, have made, use, offer for sale, sell and import such Products.

License Property

Product shall mean any product comprising an optimized, formulated or delivered active pharmaceutical ingredient that incorporates, uses or is based on the Technology or the Licensed IP Rights for use in the prevention or treatment of any disease, state or condition in humans or other animals.

Licensed IP Rights shall mean, collectively, all right, title and interest of Licensor or any of its Affiliates, as of the Effective Date or thereafter, in or to Patent Rights, Know-How Rights and other intellectual property rights in or to the Technology.

Prescription Drug Field shall mean the optimization, formulation and delivery of active pharmaceutical ingredients, and the development, manufacture and commercialization thereof in the prevention or treatment of any disease, state or condition in humans or other animals, in each case excluding compounding pharmacy activities.

Technology shall mean, collectively, all right, title and interest of Licensor or any of its Affiliates, as of the Effective Date or thereafter, in or to Drug Delivery Technology, Formulation Consulting Knowledge Base, Formulation Technology, and any other technology related to formulation or optimization of active pharmaceutical ingredients.

Formulation Consulting Knowledge Base shall mean all data an information relating to the formulation including topical, oral and suspension formulations of prescription drugs that is generated or derived by or on behalf of Licensor in connection with Licensor's consulting activities with or for Member/Customers, excluding data and information specific to Contract Formulations.

Drug Delivery Technology shall mean all inventions, discoveries, data, information, samples, and other technology relating to the delivery of active pharmaceutical ingredients.

License Grant

Licensor of Ireland grants the Licensee, also of Ireland, an exclusive, sublicensable license, solely in the field in the territory to use the Licensor technology, including intellectual property rights to sell and market and exploit the regulatory filings for the products in the field in the territory

License Property

LiquiTime® is a drug delivery platform for modified, extended and controlled release of liquid oral drugs.

Licensor has technology called Liquitime that may be used for developing modified/controlled release oral pharmaceutical products in a liquid suspension formulation.

The patent is titled Oral pharmaceutical formulation in the form of aqueous suspension for modified release of active principle(s).

Field of Use

Licensee has licensed rights to the LiquiTime® drug delivery platform for the U.S. Over-the-Counter (OTC) drug market.

The exclusive license includes Licensor’s LiquiTime® Ibuprofen and LiquiTime® Guaifenesin oral suspensions; ibuprofen, an anti-inflammatory and Guaifenesin, an expectorant.  These are the initial products.

License Grant

Licensor hereby grants to Licensee for the Term of this Agreement an exclusive (even as to Licensor) license in the Field under the Licensor Intellectual Property to develop, make, have made, use, sell, offer for sale and import Licensed Product(s) in the Territory.

License Property

Licensed Product(s) means all finished pharmaceutical oral formulations for commercial sale (or, where the context so indicates, a Formulation Candidate) that (i) contain the Compound alone as a therapeutically active ingredient or in combination with any other pharmaceutically active ingredient, and (ii) utilize Licensor Intellectual Property.

Intellectual Property means the Licensed Patents, the Licensor Know-How and the Licensor Technology.

Licensed Patents means Patents owned or controlled by Licensor or which Licensor, through license or otherwise, has or acquires rights, which are necessary or useful for the manufacture, use or sale of Licensed Product, including, but not limited to, compositions, formulations, methods of their manufacture, or methods of their use, or otherwise relate to Licensor Know-How or Licensor Technology, including (i) any of the Patents set forth hereto that contain claims that cover, or which relate to, any aspect of Licensed Product, (ii) the Development Patents and (iii) such other Patents as the Parties may agree in writing from time to time.

5,447,729 – Multilamellar drug delivery systems
5,484,608 – Sustained-release drug delivery system

Licensor Technology means  Licensor’s bioavailability enhancement and/ or controlled-release delivery, formulation, process and manufacturing technologies, including but not limited to the Licensor Lead Technology and the technologies embodied in the Licensed Patents and the Licensor Know-How.

Licensor Lead Technology means Microtrol® multi particulate technology or, as subsequently agreed between the Parties, one of the Other Licensor Technologies as may be applied to the Compound pursuant to the Development Plan.

Compound means trospium chloride, the chemical compound whose specific chemical name is 3-alpha benziloyJoxynortropane-8-spiro-1-pyrrolidinium; chloride, or any other trospium salt.

Field of Use

Trospium chloride (“trospium”) is  indicated for urinary incontinence. Trospium is currently under evaluation in a Phase III clinical study.

License Grant

Licensor hereby grants to Licensee an exclusive royalty-bearing license under the Licensor Technology to use, develop, market, advertise, promote, distribute, offer for sale, sell, export and import, but not Manufacture, the Product in the Territory for use in the Field, without the right to sublicense; provided Licensee shall have the right to grant a sublicense or otherwise enter into a marketing agreement with respect to the Product for Mexico and/or Canada.

License Property

Product means, individually or collectively, as the context requires, the formulation comprised of Dapsone in an SMP(TM) delivery system, including the Acne Product and any other current and future indication(s) (including indications for burn itch, acne rosacea, psoriasis and atopic dermatitis as determined by the JDMC) for all concentrations, sizes of volume, configurations and combinations of Dapsone in an SMP(TM) delivery system for use in the Field.

Dapsone means 4,4 diaminodiphenylsulfone and all salts, polymorphs and isomers thereof.

Licensor Patent Rights or Licensor Patent means
5,863,560 – Compositions and Methods for Topical Application of Therapeutic Agents
6,060,085 – Compositions and Methods for Topical Application of Therapeutic Agents
09/236,909 (*pending application)

SMP(TM) technology or SMP(TM) delivery system means a technology and delivery system consisting of a combination of a dissolved drug with a microparticle suspension of the drug to allow a controlled amount of the dissolved drug to permeate the epidermal layer of the skin. The SMP(TM) technology includes, but is not limited to, topical formulations containing Dapsone.

Acne Product means the 3% Acne Product or the 5% Acne Product and any other concentrations of the Product that may be used for the treatment of acne vulgaris, depending on the decision of the JDMC.

Field of Use

Field means the topical treatment of skin in humans.

License Grant

Australian Licensor grants
— an exclusive, even as to Licensor, worldwide license, with the right to sublicense, under the Licensor Technology, the Licensor Program Technology, and the Licensor Confidential Information and
— an exclusive, even as to Licensor, royalty-bearing worldwide sublicense, with a right of further sublicense, under the Licensed University Technology, in each case to make, have made, use, sell or import Licensed Products, Devices and Formulations in the Territory in the Field; and,
—  an exclusive, even as to Licensor, worldwide license, with the right to sublicense, under the Licensor Patent Rights, and the Licensor Program Patent Rights and
—  an exclusive, even as to Licensor, worldwide sublicense, with a right of further sublicense, under the Licensed University Patent Rights, in each case to make, have made, use, sell or import Licensed Products, Devices and Formulations in the Territory in the Field; and,
—  a non-exclusive sublicense, without a right to further sublicense, to use the Licensor Trademarks with the Licensed Products, Devices and Formulations in the Territory in the Field.

License Property

Licensor owns or otherwise controls certain patents, patent applications, technology, know-how and scientific and technical information relating to formulations for drug delivery and compatible devices, including Medidurâ„¢.

Licensor has extensive expertise in designing and developing innovative ophthalmic drug delivery systems.

Medidur is a tiny injectable, non-erodible, intravitreal device for the treatment of Diabetic Macular Edema (DME), which can lead to blindness. The implant is injected into the back of the eye in an office setting rather than a surgical one. It releases a constant amount of drug and lasts between 18 to 36 months.

Field of Use

The Field means the delivery of formulations for the treatment, control or prevention of any ophthalmic diseases and conditions in humans or animals.

The Licensee's Compound means any composition of matter, including, small and large molecules, therapeutic proteins, polynucleotides, both double-stranded and singlestranded, and antibodies, or biosimilars.

Collaborative research and license agreement is for Licensor’s controlled drug delivery technologies, including the MedidurTM technology, in ophthalmic applications.