Royalty Report: Drugs, Respiratory, Disease – Collection: 344506

License Grant

Licensor of Malta grants the exclusive right and license under the Licensor Patents and Licensor Know-How to Develop, have Developed, market, have marketed, use, have used, Commercialize, have Commercialized, distribute, have distributed, offer for sale, sell and have sold the Product in the Territory and to package, distribute, sell, market and promote the Product in and throughout the Territory, including the right to grant sub-licenses, subject to all of the terms and conditions of this Agreement.

License Property

Licensor has material capabilities, resources and experience in the development and analytical testing of inhalation pharmaceutical products, and has made substantial progress in development of the Product.

Product means Licensors levalbuterol/ipratropium combination inhalation solution product in current and all future formulations and delivery modes, any Additional Product and any Improvement.

Field of Use

The Levalbuterol/ipratropium Product candidate is  an inhalation solution with the potential to treat chronic obstructive pulmonary disease, or COPD.

Competing Products means any nasal or inhaled formulations, whether containing a single or two or more active ingredients, for the treatment of asthma or COPD, in the Territory, other than products currently marketed by Licensor as of the Effective Date and products containing budesonide, fluticasone or salmeterol, alone or in combination with any other active pharmaceutical ingredient other than levalbuterol.

License Grant

Licensor of Malta grants the exclusive right and license under the Licensor Patents and Licensor Know-How to Develop, have Developed, market, have marketed, use, have used, Commercialize, have Commercialized, distribute, have distributed, offer for sale, sell and have sold the Products in the Territory and to package, distribute, sell, market and promote the Products in and throughout the Territory, including the right to grant sub-licenses, subject to all of the terms and conditions of this Agreement.

License Property

Licensor controls certain Licensor Know-How and Licensor Patents relating to the Products, including technology essential to the Development of stable and acceptable preparations, suspensions, or other chemical mixtures of ingredient required to Develop a product containing a corticosteriod, including Ciclesonide.

Ciclesonide, alone is the Standalone Product.
Arformoterol is the Combination Product.

Ciclesonide means the compound ciclesonide including all its isomers, titrates, hydrates, metabolites, polymorphs, prodrugs, epimers, and salts.

Field of Use

Ciclesonide is an inhaled corticosteroid that is intended for the treatment of asthma symptoms, regardless of asthma severity.

The  license and development agreement is for know-how and intellectual property rights related to stable sterile suspension formulations, for use in the development, commercialization, marketing, sale and distribution of an inhalation pharmaceutical product containing ciclesonide as its only active ingredient and an inhalation pharmaceutical product containing both ciclesonide and arformoterol as its active ingredients, throughout the world, collectively referred to as the Ciclesonide Products.

Competing Products means any nasal or inhaled corticosteroid formulations, arformoterol or formoterol, whether containing a single or two or more active ingredients, in the Territory, other than products currently marketed by Licensor as of the Effective Date and products containing budesonide, fluticasone or salmeterol, alone or in combination with any other active pharmaceutical ingredient other than Ciclesonide, arformoterol, or formoterol,

Licensee has material capabilities, resources and experience in the development, clinical testing, regulatory approvals, commercialization, marketing and distribution of branded inhalation pharmaceutical products.

License Grant

Under this agreement the parties will collaborate to develop and commercialize once-daily LABA products for the treatment of chronic obstructive pulmonary disease (“COPD”) and asthma.

License Property

Products consist of Laba, a Long-Acting Beta2 Agonist, as well as the respiratory assets listed below.

Laba, a Long-Acting Beta2 Agonist, is a type of bronchodilator medicine. Bronchodilator medicine opens the airways in the lungs by relaxing smooth muscle around the airways. LABA are also long-term control medicines.

RELVAR®/BREO® is a once-a-day combination inhaled respiratory medicine consisting of vilanterol (VI), a long-acting beta2-agonist (LABA), and fluticasone furoate (FF), an inhaled corticosteroid (FF/VI), delivered via the ELLIPTA® dry powder inhaler.

ANORO® ELLIPTA® is a dual bronchodilator consisting of umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA), and vilanterol (VI), a long-acting beta2-agonist (LABA) for the treatment of chronic obstructive pulmonary diseases (COPD). This once-a-day combination inhaled respiratory medicine is delivered via the ELLIPTA® dry powder inhaler.

TRELEGY® ELLIPTA® is a combination of fluticasone furoate (FF), an inhaled corticosteroid (ICS); umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA); and vilanterol (VI), a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) and to reduce exacerbations of COPD in patients with a history of exacerbations. This three-way combination inhaled respiratory medicine is self-administered by patients through the ELLIPTA® dry powder inhaler.

Field of Use

The field of use is for COPD/Asthma patients. Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease that causes obstructed airflow from the lungs. Symptoms include breathing difficulty, cough, mucus (sputum) production and wheezing.

License Grant

Effective as of August 20, 2012, Licensor grants to Licensee of the United Kingdom a license under the Licensor Patents, including any continuations, divisions, reissues or reexaminations thereof, without the right to grant sublicenses, to make, have made, use, promote, offer to sell, sell, import, or otherwise dispose of Licensed Products in the Territory. The license granted shall be exclusive as to any other levalbuterol hydrochloride product marketed as a generic equivalent of Xopenex® brand products covered by Licensors NDA for a period of 180 days the Exclusivity Period from the License Effective Date.

License Property

The Licensor products are Xopenex® brand, levalbuterol hydrochloride, inhalation solutions products.

XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol is for the treatment or prevention of bronchospasm (narrowing of the airways) in adults, adolescents, and children 4 years of age and older with reversible obstructive airway disease.

Field of Use

The field of use is for the treatment or prevention of bronchospasm in patients six years of age and older with reversible obstructive airway disease.

Bronchospasm or a bronchial spasm is a sudden constriction of the muscles in the walls of the bronchioles. It is caused by the release (degranulation) of substances from mast cells or basophils under the influence of anaphylatoxins. It causes difficulty in breathing which ranges from mild to severe.

License Grant

The Company entered into its collaboration agreement to develop and commercialize a long-acting beta2 agonist (LABA) product candidate both as a single agent new medicine for the treatment of chronic obstructive pulmonary disease (COPD) and as part of a new combination medicine with an inhaled corticosteroid (ICS) for the treatment of asthma and/or a long-acting muscarinic antagonist (LAMA) for COPD.

License Property

The collaboration's resources are focused on the development of the lead LABA, GW642444, together with fluticasone furoate.

Field of Use

The rights granted apply to the healthcare industry.

License Grant

Australia Licensor hereby grants Licensee an exclusive license to the Licensor Intellectual Property and the Third Party Patents in relation to the Field in the Territory, with the right to grant sublicense, to develop, use, make (subject to the terms and conditions of this Agreement and any other agreement between the Parties relating to the manufacture and supply of the Products or Product Intermediates), sell, offer for sale, export and import the Products. In no event shall Licensee use the Licensor Intellectual Property or the Third Party Patents for purposes not related to Licensee obligations to Licensor under this Agreement or any other agreement between the Parties relating to the manufacture and supply of the Products or Product Intermediates.

License Property

Licensor Intellectual Property shall mean the Licensor Know-How, the Licensor Patents and the Licensor Developed Technology. Licensor Intellectual Property excludes (a) technologies solely relating to the Compound, Formulation, or the Product; and (b) products, processes, methods, technologies and other inventions in the public domain or that are owned or made by Third Parties (other than on behalf of Licensor or its Affiliates) and not Controlled by Licensor or its Affiliates.

Licensor Developed Technology shall mean improvements to the Licesor Know-How and Licensor Patents conceived, created, developed or otherwise invented or acquired solely by an employee or agent of Licensor or one of its Affiliates or a Third Party (under contract with Licensor or one of its Affiliates) as a direct result of fulfilling obligations or exercising rights, including the sharing of Confidential Information, under this Agreement or any other agreement between the Parties.

Licensor Patents shall mean any and all rights under the Patent Applications and/or Patents as set forth as of the Effective Date and as amended from time to time, and any foreign counterparts thereof and all divisionals, continuations, continuations-in-part, any foreign counterparts thereof and all patents issuing on any of the foregoing, and any foreign counterparts thereof, together with all registrations, reissues, re-examinations, supplemental protection certificates, or extensions thereof, and any foreign counterparts thereof. In the event any additional Licensor Patent or Patent Application is necessary or useful to allow Licensee to practice the rights granted to it by Licensor herein, Licensor shall include such Patent or Patent Application as applicable.
US application 10/497715 – Method of Particle Formation
US application 10/017135 – Synthesis of small particles.

Compound shall mean (i) any beta-agonist in combination with any steroid; (ii) any steroid; and (iii) insulin, as well as any salts, isomorphs, polymorphs, cogeners or isomers of the preceding. Initial specifications for each Compound will be agreed to by the parties and after such agreement shall be considered an original part of this Agreement.

Product shall mean the Formulation comprising the Product Intermediate and, to the extent required to effect delivery to a patient, a delivery device for use in the Field.

Formulation shall mean a composition of Product Intermediate suitable for administration by inhalation via pulmonary or nasal delivery, as applicable. A Formulation may comprise a mixture, blend or solution of the Product Intermediate combined with excipients and/or adjuvants or neat Product Intermediate and a single Product Intermediate may be covered by more than one Formulation. Specifications for each Formulation will be developed by MAP and after such development shall be considered an original part of this Agreement.

Beta-agonist shall mean any short-acting beta-agonist or any long-acting beta agonist as those terms may be further defined from time to time in a generally accepted pharmacology textbook.

Field of Use

Field shall mean the administration of a Product by inhalation as follows (i) for a Product containing any Beta-agonists and any steroid, the Field shall be limited to administration via pulmonary delivery; (ii) for a Product containing a steroid as the sole active ingredient, the Field shall include administration by pulmonary or nasal delivery; and (iii) for any Product containing Insulin as the sole active ingredient, the Field shall include administration by pulmonary or nasal delivery. The parties may add additional fields to the definition of Field as the parties may mutually agree from time to time, under the terms of this Agreement.

Licensee is engaged in the research and development of proprietary drug delivery systems for inhalation therapy by pulmonary or nasal delivery, including devices and formulations suitable for those devices.