Royalty Report: Drugs, Delivery, Disease – Collection: 266776

License Grant

For the Licensed Patents,  Licensor grants an exclusive, nontransferable license during the Term under the Licensed Patents, solely to develop, make, have made, use, market, distribute, import, offer to sell and sell the Licensed Product in the Territory.

For the CAPTISOL Data Package, Licensor grants a non-exclusive, nontransferable license during the Term under Licensors right in and to the CAPTISOL Data Package, solely to develop, make, have made, use, market, distribute, import, offer to sell and sell the Licensed Product in the Territory.

License Property

Licensor is engaged in the business of developing and commercializing novel drug delivery technologies designed to enhance the solubility and effectiveness of existing and development-stage drugs.

Licensor is the exclusive worldwide licensee of CAPTISOL®, a patented drug formulation system.

CAPTISOL means the drug formulation technology marketed by Licensor as CAPTISOL®, also known scientifically as sulfobutylether ~(beta) cyclodextrin, sodium salt.

The CAPTISOL Data Package means all toxicology/safety and other relevant scientific safety data owned, licensed or developed by Licensor and its Affiliates; all toxicology/safety and other relevant scientific data owned, licensed or developed by the licensees or sublicensees of Licensor or its Affiliates or other third parties on CAPTISOL alone, and not in conjunction with a product formulation; and all CMC and manufacturing process data relating to the preparation of CAPTISOL, in each case to the extent necessary or useful for the formulation of the Licensed Product.

Licensed Product means the Compound combined with or formulated using CAPTISOL in an injectable dosage form/formulation for ultimate use in humans.

Captisol® is a modified cyclodextrin that can form ionic and inclusion complexes with many types of drugs. Complexation can significantly increase the solubility and often times, the physico chemical stability of the drug. Complexation has also been used to improve dissolution and bioavailability, reduce volatility, allow incorporation of liquids into solid formulations, and reduce unpleasant side effects such as taste and irritation caused by drug contact with tissues, e.g. extravasation at injection sites and GI irritation.

Field of Use

The technology is designed to enhance the solubility and stability of drugs.  patented Captisol technology improves water solubility, bioavailability and complexation characteristics of insoluble and/or unstable drugs.

Captisol® enabling technology is for the development of an injectable formulation of zileuton (ZYFLO®).
ZYFLO CR and ZYFLO are indicated for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. The injectable formulation of zileuton is being developed for use in emergency room or urgent care settings for patients experiencing acute exacerbations of asthma.

License Grant

Licensor grants an exclusive, nontransferable license during the Term under the Licensed Patents, solely to develop, make, have made, use, market, distribute, sell, offer for sale and import the Product in the Field in the Territory.

License Property

The Product is the Compound combined with or formulated using CAPTISOL in a parenteral dosage form/formulation.  CAPTISOL® is also known scientifically as sulfobutylether b(beta) cyclodextrin, sodium salt.

Captisol may be applied in drug delivery in many ways. The primary applications are to enhance solubility and stability. Solubility increases of tens of thousand are possible, and when combined with pH and selected salts, solubility increases of hundreds of thousands have been observed.

Field of Use

The Field means the treatment of any and all diseases and conditions in humans, except for the treatment or prophylaxis of fungal infections; or as a topical ocular treatment of dry eye.

License Grant

Licensor grants to Company an exclusive, nontransferable license during the Term under the Licensed Intellectual Property, solely to develop, make, have made, use, sell, market, offer for sale, import and otherwise commercially exploit the Licensed Products.

License Property

The licensed property is all trade secret and Know-How rights which relate to the preparation, combination and/or formulation of a Compound with Captisol, including proprietary and confidential information contained in the Captisol Data Package.  The Licensed Patents are all worldwide patents and patent applications which cover Captisol or any Licensed Product  owned by or licensed to Licensor with the right to sublicense.  Captisol means sulfobutylether ß(beta) cyclodextrin, sodium salt.  Captisol® is a patented drug formulation system designed to enhance the solubility and stability of drugs.

Field of Use

The field is the entire field of prevention, diagnosis and treatment of all human and animal diseases and disorders with certain exceptions.

License Grant

Licensor hereby grants to Company, an exclusive, nontransferable license in the Field during the Term under the Licensed Patents, solely to make, use, sell, offer for sale and import the Licensed Product in the Territory. Company may not make, use, sell, offer for sale, or import the Licensed Product for any other purposes. Company may not sublicense the Licensed Patents, except as expressly set forth in the Agreement.

Licensor hereby grants to Company a non-exclusive, nontransferable license during the Term under Licensor’s right in and to the Captisol Data Package, solely to make, use, sell, offer for sale and import the Licensed Product in the Territory in the Field. Company may not sublicense its rights to the Captisol Data Package.

License Property

Licensed Product means the Compound combined with or formulated using Captisol covered by the Licensed Patents in all dosage forms/formulations for ultimate use in humans. For clarity, the Licensed Product shall not include any product which is a combination product incorporating the Compound with any other active pharmaceutical ingredient.

Captisol means Captisol , also known scientifically as sulfobutylether ~(beta) cyclodextrin, sodium salt.

Compound means that certain pharmaceutical compound known as NS-2 with the chemical name 2-(3-amino-6-chloroquinolin-2-yl)-propan-2-ol, owned by or licensed to Company and developed and manufactured by or on behalf of Company.

Licensed Patents means all patents and patent applications in the Territory which cover Captisol and which now or at any time during the Term are owned by or licensed to Licensor or any Licensor Affiliate with the right to sublicense, including any and all extensions, renewals, continuations, substitutions, continuations-in-part, divisions, patents-of-addition, reissues, reexaminations and/or supplementary protection certificates to any such patents. Set forth hereto is a list of the Licensed Patents as of the Effective Date. Such list may be updated by Licensor from time to time during the Term.

5,134,127 – Derivatives of cyclodextrins exhibiting enhanced aqueous solubility and the use thereof
5,376,645 – Derivatives of cyclodextrins exhibiting enhanced aqueous solubility and the use thereof
7,629,331 – Sulfoalkyl ether cyclodextrin compositions and methods of preparation thereof  
7,635,773 – Sulfoalkyl ether cyclodextrin compositions

Field of Use

Field means any ocular treatment for retinal degeneration excluding (i) any products by any company with which Licensor has a pre-existing license agreement in which retinal degeneration has not been excluded as a licensed field, (ii) monoclonal antibodies, or (iii) any ocular formulation of an Androgen Hormone ( e.g. a testosterone) which includes sulfobutyl ether beta-cyclodextrin.

License Grant

Licensor grants an exclusive right to use a specific compound.

License Property

The licensors compound is Captisol®.

Captisol® is a patent protected, uniquely modified cyclodextrin, whose chemical structure was rationally designed to enable the creation of new products by significantly improving solubility, stability, bioavailability and dosing of active pharmaceutical ingredients (APIs).

Field of Use

Licensee is using the compound in its development and commercialization of a Captisol®-enabled version of a specified compound.

License Grant

The Licensor announced the signing of exclusive global license and supply agreements with the Licensee for three captisol enabled programs, one of which is Fosphenytoin.

License Property

Captisol is a modified cyclodextrin preparation, designed to optimize the solubility and stability of drugs.

Captisol-enabledâ„¢ Fosphenytoin is an IV and IM compound specifically formulated for patients at risk for or to control status epilepticus seizures occurring during or following neurosurgery or neurologic trauma.

Fosphenytoin (fosphenytoin sodium) is a water-soluble phenytoin prodrug that is administered intravenously to deliver phenytoin, potentially more safely than intravenous phenytoin. It is most commonly used in the acute treatment convulsive status epilepticus.

Licensor is a biopharmaceutical company focused on developing and acquiring technologies that help pharmaceutical companies discover and develop medicines.  IM/IV CE Fosphenytoin is for patients with seizures.

Field of Use

This agreement is for the drug industry.

License Grant

The Licensor hereby grants the Licensee an exclusive, non-transferable License for the duration of the Evaluation Period under the Licensed Patents and know-how, solely for research and development of drug products combining or formulating one or more of the Compounds, alone or as part of the Combination, with Captisol for the field of use consisting of all therapeutic uses in humans. The Licensee shall have the right to grant sub-licenses to any Third Party.

License Property

The Licensor is the exclusive supplier of Captisol®.  Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to solubilize and stabilize active drug ingredients.

Field of Use

Field means all therapeutic uses in humans.

License Grant

The Licensor announced the signing of exclusive global license and supply agreements with the Licensee for three captisol enabled programs –  intramuscular (IM)/IV meloxicam, IM/IV fosphenytoin and intranasal budesonide.

License Property

Captisol is a modified cyclodextrin preparation, designed to optimize the solubility and stability of drugs. IM/IV CE Meloxicam for patients with acute pain, IM/IV CE Fosphenytoin for patients with seizures, IN CE Budesonide + Azelastine for patients with allergic rhinitis.

Field of Use

The Licensee will be responsible for all costs related to development and commercialization of the programs.

License Grant

The Licensor announced the signing of exclusive global license and supply agreements with the Licensee for three captisol enabled programs, one of which is intranasal budesonide.

License Property

Captisol is a modified cyclodextrin preparation, designed to optimize the solubility and stability of drugs.

Captisol-enabledâ„¢ Budesonide + Azelastine is a fixed-dose combination of a corticosteroid and antihistamine in an intranasal (IN) formulation for the treatment of allergic rhinitis. Compared with sequential separate intranasal dosing of these patients with similar agents, Captisol-enabledâ„¢ Budesonide + Azelastine holds potential for improved compliance in once-daily and twice-daily dosing.

Licensor is a biopharmaceutical company focused on developing and acquiring technologies that help pharmaceutical companies discover and develop medicines.  IN CE Budesonide + Azelastine is for patients with allergic rhinitis.

Field of Use

This agreement is for the drug industry.

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 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 Licensed Technology shall mean Licensor Licensed Patents and Licensor Technical Information.

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.