Royalty Report: Drugs, Delivery, Therapeutic – Collection: 279333

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

Field means all pharmaceutical uses of the Compound alone or in combination with other active ingredients.  This agreement pertains to the drug industry for Intellectual Property relating to the drug delivery and formulation technologies.

License Grant

Licensor grants an exclusive right and license in the Field, with the right to grant sublicenses to Affiliates of Licensee and of Parent at the time of such grant, to practice under the Licensors Intellectual Property, solely to use, import, offer for sale, and Promote Product in the Territory;  and an exclusive, even as to Licensor, right and license in the Field, with the right to grant sublicenses to Affiliates of Licensee and of Parent at the time of such grant, to practice under the Licensors Intellectual Property, solely to sell and distribute Product in the Territory.

License Property

The licensed property relates to the chemical compound known as trospium chloride whose specific chemical name is 3-alpha-benziloyloxynortropane-8-spiro-1’-pyrrolidinium chloride, also known as spiro[8-azoniabicyclo[3,2,1]octane-8,1’-pyrrolidinium]-3-[(hydroxydiphenyl-acetyl)-oxy]chloride(1a, 3ß, 5a)-(9Cl) and any related analogues, homologues, derivative and other pharmaceutically active salts.

The Product means any pharmaceutical preparation in final form (or, where the context so indicates, the form under development) containing Compound as a primary active therapeutic ingredient, which requires a prescription from a physician or other health care professional, for use in the Territory.

The Finished Product means the oral dosage formulation of Trospium Twice-Daily described in the Specifications and packaged and labeled and in a form ready for distribution in the Territory.

Trospium chloride is used to treat overactive bladder.

Field of Use

The Field means any oral formulation of Product for any human pharmaceutical use, and any transdermal or intravesicle formulation of Product for ·use in the treatment of overactive bladder and/or urinary incontinence in any form.

License Grant

The Parties entered into an amendment to resolve and settle between themselves certain issues that have arisen under the Agreement and to enter into certain other agreements between them, all upon the terms and subject to the conditions set forth in this Amendment.  The Parties hereto agree to the following but not limited to:
– the Parties agree that Licensor has satisfied its obligation to pay the Licensor Cost Share and that Licensor has no responsibility or obligation for Product Expenses incurred by the Parties after November 28, 2004.
– the Parties agree that Licensee shall pay Sublicensing Royalties to Licensor.
– the Parties agree that Licensee shall pay Third Party Royalties to Licensor.
– Licensor agrees to pay Licensee a percent back as a contribution towards the cost of those Phase IV post-approval marketing studies.

License Property

The licensed property relates to the chemical compound known as trospium chloride whose specific chemical name is 3-alpha-benziloyloxynortropane-8-spiro-1’-pyrrolidinium chloride, also known as spiro[8-azoniabicyclo[3,2,1]octane-8,1’-pyrrolidinium]-3-[(hydroxydiphenyl-acetyl)-oxy]chloride(1a, 3ß, 5a)-(9Cl) and any related analogues, homologues, derivative and other pharmaceutically active salts. The Product means any pharmaceutical preparation in final form (or, where the context so indicates, the form under development) containing Compound as a primary active therapeutic ingredient, which requires a prescription from a physician or other health care professional, for use in the Territory. The Finished Product means the oral dosage formulation of Trospium Twice-Daily described in the Specifications and packaged and labeled and in a form ready for distribution in the Territory.

Field of Use

The Field means any oral formulation of Product for any human pharmaceutical use, and any transdermal or intravesicle formulation of Product for ·use in the treatment of overactive bladder and/or urinary incontinence in any form.

License Grant

The English Licensor hereby grants, on behalf of itself and its Affiliates, to the English Licensee, effective on the Effective Date, a royalty-bearing, exclusive (even as to Licensor (except to the extent necessary for Licensor to perform the Licensor Development Activities)) worldwide license, with the right to sublicense, under the Licensor Technology to Manufacture, Develop and Commercialize the Products in the Field in the Territory.

Licensee hereby grants, on behalf of itself and its Affiliates, to Licensor, effective on the Effective Date, a royalty-free, non-exclusive license, with the right to sublicense, (i) under the Licensee Technology to the extent necessary for Licensor to perform the Licensor Development Activities and (ii) under any Licensee Improvement Manufacturing Patent Rights for use other than for the Manufacture, Development and/or Commercialization of the Products in the Field in the Territory.

License Property

Xodol means the product currently marketed under the brand name 'Xodol', which is a combination of 5, 7.5 or 10 milligrams (mg) ofhydrocodone, in each case, combined with 300 mg of acetaminophen (it being understood that (x) Licensors existing sublicensee currently markets such product under a different name and (y) such product, whether marketed under such different name or any other name in the future, shall be deemed to be 'Xodol' for the purposes of this Agreement).

Product means any Hydrocodone Product or Combination Product.

Hydrocodone Product means any pharmaceutical product containing Hydrocodone as its sole Active Ingredient that is in a formulation containing the Licensee Technology and which is Developed, Manufactured and Commercialized pursuant to, and in accordance with, this Agreement.

Combination Product means any pharmaceutical product comprised of Hydrocodone and any non-opioid agonist drug as the Active Ingredients.  For purposes of clarity, S-297995 (also known as Naldemedine) is a non-opioid agonist drug.

S-297995 means (5R, 14S)-17-(Cyclopropylmethyl)-6, 7-didehydro-4,5-epoxy-3 ,6, 14-trihydroxy-N-[1-methyl-l-(3-phenyl-1,2,4-oxadiazol-5-yl)ethyl]morphinan-7-carboxamide Monotosylate including any metabolites, prodrugs, solvates (including hydrates), esters, salts, stereoisomers, racemates, tautomers and polymorphs (including crystal forms), of such compound.

Licensor Technology means the (a) Licensor Know-How and the Licensor Patent Rights, including Licensor Core Technology (b) the Licensor Core Technology Improvements, and (c) all intellectual property rights therein.

Licensor Patent Rights means any Patent Right that Licensor or its Affiliates Controls on the Effective Date or that comes into the Control of Licensor or its Affiliates during the Term (other than any Patent Rights which are Licensee Patent Rights), to the extent that such Patent Right is necessary or useful to Develop, Manufacture, or Commercialize in the Territory, the Products in the Field, including any method of making the Products, any composition or formulations of the Products, or any method of using or administering the Products provided that Licensee Patent Rights excludes any Patent Rights to the extent relating to an Licensee API.  The Licensor Patent Rights existing on the Effective Date are set forth.
8,298,581 – Matrix compositions for controlled delivery of drug substances
8,563,038 – Formulations and methods for the controlled release of active drug substances

Licensor Core Technology means, to the extent covered by any Licensor Patent Rights or Licensor Know-How, in each case, Controlled by Licensor and its Affiliates as of the Effective Date,  (i) any abuse-deterrent drug delivery system, (ii) the formulation of products for which any such abuse-deterrent drug delivery system is used and/or (iii) manufacturing of products containing any such abuse-deterrent drug delivery system.  

Licensor Core Technology includes the Licensor Patent Rights and Licensor Know-How, in each case, Controlled by Licensor and its Affiliates as of the Effective Date to the extent covered by clause (i), (ii) and/or (iii) above.  Notwithstanding anything herein to the contrary, in the event there is a dispute as to whether anything in clause (i), (ii) and/or (iii) above was covered by any such Licensor Know-How as of the Effective Date, Licensor shall have the burden of proof with respect to establishing that it was so covered.

Generic Product means, on a country-by-country basis, any pharmaceutical product that (a) is sold by a Third Party that is not an Affiliate or Sublicensee of Licensee under a marketing authorization granted by a Regulatory Authority to a Third Party and (b) results from (i) an abbreviated new drug application including any amended or successor abbreviated route of approval thereof in the United States (ANDA) or (ii) abbreviated routes of approval in any other countries in the Territory that are comparable to ANDA, which in the case of clause (i) and/or (ii), references the applicable Product, provided that (x) such pharmaceutical product has the same Active Ingredient as the Product and an abuse deterrent system or (y) the Product is the primary basis for the approval of such pharmaceutical product.

Patent Right means any and all (a) patent applications filed in any jurisdiction, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, and all patents granted thereon; (b) all patents, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including supplementary protection certificates or the equivalent thereof; and (c) any other form of government-issued right substantially similar to any of the foregoing, including certificates of invention and applications for certificates of invention.

Field of Use

Field means all therapeutic uses of a Product for any condition, disorder or disease indication in humans or non-human animals, including the treatment, palliation, prevention, diagnosis, and management thereof.

The collaboration is for the development and commercialization of abuse-deterrent hydrocodone-based product candidates.  Abuse-deterrent is for the treatment of pain and in other indications.

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.

License Grant

Licensor of Ireland grants an exclusive, sublicensable license to the Licensor Intellectual Property for the sole purpose of, and only to the extent necessary for, using, marketing, distributing, selling, having sold, offering for sale, importing and exporting the Product in the Field in the Territory.

Licensor grant a non-exclusive sublicensable license in the Field in the Territory to the Licensor Intellectual Property for the sole purpose of, and only to the extent necessary for, Licensee to make and have made the Product Intermediate in Canada, the United States, Ireland, UK, France, Germany, Italy, Spain, Portugal, Netherlands, Belgium, Switzerland, Sweden, Finland, Norway, Denmark, Japan, Australia and New Zealand for use in the Field or to make and have made the Product Intermediate in any other country in the Territory as agreed by EPIL at its sole discretion.

Licensor grants a worldwide, irrevocable, nonexclusive license, with the right to grant sublicenses, to all Licensor Developed Technology to the extent that such Licensor Developed Technology does not incorporate NanoCrystal® Technology.

License Property

Products shall mean sterile, aqueous formulations of Compound, regardless of stabilizer, made using Licensor Intellectual Property, alone or in combination with a currently marketed long-acting Beta agonist; a currently marketed short-acting Beta agonist; or any Beta agonist to which Licensee has proprietary rights and packaged for commercial sale.

Compound shall mean the steroid budesonide.

Device shall mean a unit dose nebulizer.

NanoCrystal® Technology shall mean EPILs proprietary technology directed to:
—  nanoparticulate dispersions of compounds stabilized against particle growth or agglomeration and materials, methods and equipment used for making such dispersions; and,
—  formulations including finished formulations derived from or incorporating said dispersions and materials, methods and equipment used for making such formulations including the NanoMill® System.

NanoMill® System shall mean the milling system designed and developed by or on behalf of Licensor and its Affiliates for preparing nanoparticulate dispersions for pharmaceutical formulations, including the milling equipment and appropriate milling media and stabilizing materials, and associated manuals, protocols and know-how.

Field of Use

The Field shall mean the pulmonary delivery of Product by means of the Device for therapeutic pharmaceutical use by humans.