Royalty Report: Drugs, Delivery, Pharmaceuticals – Collection: 243442

$150.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 20

Description

This collection of transactions and supporting information was developed using our AI algorithm to curate similar royalty reports into a cohesive collection to support your licensing, transfer pricing or other transaction scenarios where documented royalty rates and/or deal terms are important.
Category: Technology Licenses
Created On: 2022-04-28
Record Count: 20

Primary Industries

  • Drugs
  • Delivery
  • Pharmaceuticals
  • Disease
  • Therapeutic
  • Supplements
  • Nutraceutical
  • Time-released
  • cardiac
  • Coating

IPSCIO Report Record List

Below you will find the records curated into this collection.  This summary includes the complete licensed property description so that you can review and determine if this collection covers the topics, technology or transaction type that is relevant for your needs.  The full report will include all relevant deal data such as the royalty base, agreement date, term description, royalty rates and other deal terms.  For reference, here is a sample of a full IPSCIO curated royalty rate report: Sample Report

IPSCIO Record ID: 243442

License Grant
Assignor sells, transfers, assigns and delivers to Assignee all of Assignors right, title and interest in and to the Patent Application and the Intellectual Property.
License Property
The Licensors technology is known as oral extended release dosage form based on the principle of controlled hydration.

The CDT system is used in solid oral dosage forms, the preferred route for drug administration. This technology is designed to produce tablets or capsules that release their active agents predictably and programmably over a specified timeframe of up to 24 hours. We believe we can apply our technology to create significant enhancements to existing pharmaceutical, OTC and nutraceutical products.

Proprietary CDT technology improves upon conventional multiple daily dose immediate release forms of existing products by providing the therapeutic benefits of controlled release drug delivery. In addition, we believe our technology can provide enhanced dosage formats for existing medications that provide superior patient convenience and product differentiation.

Field of Use
The use is for oral extended release dosage.

The technology has allowed Assignor cost-effectively develop formulations for the OTC and nutritional industries, such as  glucosamine, glucosamine/chondroitin, niacin, pseudoephedrine, caffeine, vitamin C, Novasoy®, and other difficult compounds and branded ingredients.

IPSCIO Record ID: 26627

License Grant
The Licensor grants a limited license to use CDT to manufacture, package, ship, distribute and sell the Products to Customers, as defined below, in the United States in accordance with and for the Term of this Agreement (the License).
License Property
Our CDT (Controlled Delivery Technology) platform currently consists of three patented drug delivery technologies for prescription drugs, over-the-counter (OTC) products, and nutraceuticals.  The CDT platform is used in solid oral dosage forms, the preferred route for drug administration. This technology is designed to produce tablets or capsules that release their active agents predictably and programmable over a specified time frame of up to 24 hours.
Field of Use
Licensee manufactures and distributes vitamins and dietary and nutritional supplements for various third party customers.

IPSCIO Record ID: 279364

License Grant
Licensor grants to Licensee during the Term of this Agreement as to each particular Product the right and license to practice and use the CDT Rights in the manufacture, marketing, distribution, sale and use of the Products in the U.S., including the right to manufacture or have manufactured, market, distribute and sell to third parties. Licensee shall have the right to sublicense the foregoing rights to third parties, in a single tier only, to the extent reasonably necessary to supplement the manufacturing and distribution capabilities of Licensee, subject to the prior approval of Licensor, which shall not be unreasonably withheld.
License Property
Product means any of the Dietary Supplement products listed on this Agreement that use the CDT Rights or any additional Dietary Supplement product using CDT Rights that is added to this Agreement in accordance with the provisions of this Agreement. Products shall not include any product which is not a Dietary Supplement.
List of Products
Glucosamine/Chondroitin
Glucosamine/Chondroitin MSM
Glucosamine Complex
EsterC

Controlled Delivery Technology (CDT)

Patent Rights means all rights to (a) the patents and patent applications identified in this Agreement, (b) any other United States patent or patent application that is owned by Licensor as of the Effective Date and that relates directly or indirectly to any CDT Know-How, any Product, or the design, development, manufacture, testing or use of any Product; and (c) any United States patent or patent application that is filed or acquired by Licensor on or after the Effective Date and that relates directly or indirectly to any CDT Know-How, any CDT Improvements, any Product, or the design, development, manufacture, testing or use of any Product.

US Patent No. 6,337,091-Matrix for controlled delivery of highly soluble pharmaceutical agents
US Patent No. 6,090,411 -Monolithic tablet for controlled drug release

CDT Rights means the Patent Rights, the CDT Know-How, the Other Rights, and the CDT Improvements.

Other Rights means (a) the trademarks identified in this Agreement; (b) any other trademark or service mark that is owned by Licensor as of the Effective Date and that relates directly or indirectly to any Patent Right, any CDT Know-How or any Product; (c) any other Proprietary Right that is owned by Licensor as of the Effective Date (other than the Patent Rights and the CDT Know-How) and that relates directly or indirectly to any Patent Rights, any CDT Know-How, or any Product, (d) any Proprietary Right that is developed or acquired by Licensor on or after the Effective Date (other than any such right that becomes part of the Patent Rights, CDT Know-How, or the CDT Improvements) and that relates directly or indirectly to any Patent Right, any CDT Know-How, any CDT Improvement or any Product; and (e) all goodwill of Licensor associated with the foregoing.

The trademarks identified on this Agreement have been duly registered in the U.S. Patent and Trademark Office. None of the trademarks included in the Other Rights is or has been involved in any opposition or cancellation proceeding, and, to the best of Licensors knowledge, there is no basis for the commencement of any such proceeding. To the best of Licensors knowledge, there are no trademarks owned by third parties that are confusingly similar or dilute any of the trademarks included in the Other Rights.

1. CDT Controlled Delivery Technology trademark with Federal Registration Serial Number 78261152.
2. CDT trademark with Federal Registration Number 2507519.

Field of Use
Licensor's CDT technology to Perrigo for the manufacture, marketing, distribution, and sale of specific dietary supplements.

Licensor's innovative proprietary and patented Controlled Delivery Technology (CDT®) drug delivery technologies enable us to formulate tablets or capsules that release their active agents predictably and programmably over a specified timeframe of up to 24 hours. Our CDT technology platform is designed to reduce the frequency of drug administration, improve the effectiveness of the drug treatment, ensure greater patient compliance with a treatment program, and reduce side effects or increase drug safety. In addition, our amino-acid technology can be incorporated into oral formulations to increase the solubility characteristics of previously non-soluble and sparingly soluble drugs without employing costly micro-milling and coated particle technologies.

IPSCIO Record ID: 243441

License Grant
The parties agree that the Original License should be further amended and restated in its entirety.

The University grants a world-wide exclusive license under patent rights and technical information, with the right to grant sub licenses, to make, have made, use, sell, offer for sale, export, import and otherwise deal with Licensed Product. This license shall be perpetual.

License Property
The Patent Application 08/958,470 and technical information related thereto, are for application thereof to dietary supplements and pharmaceutical products, including over-the-counter products, prescription drugs, OTC drugs and generic drugs.

The Product shall mean
– any dietary supplement,as defined in the 1994 Dietary Supplement and Health Education Act;
– any drug which can be purchased by the general public without a prescription, referred to as an OTC Drug; and,
– any prescription drug, whether existing at the time of this Agreement or yet to be discovered.

Field of Use
The technology is for application to dietary supplements and pharmaceutical products, including over-the-counter products, prescription drugs, OTC drugs and generic drugs.

The new technology has been shown to be rugged and robust during in-vitro studies on a wide range of established pharmaceuticals, such as nifedipine, theophylline, propanolol, diltiazem, and verapamil, as well as OTC and nutritional supplements such as pseudoephedrine, glucosamine and niacin.

Licensee has applied materials science, colloid chemistry and biopharmaceutics in the development of these simple monolithic matrix systems collectively referred to as 'self-correcting matrix delivery systems.'
These approaches use the conventional tableting technologies to form swellable, erodible matrix tablets, caplets or capsules that can potentially yield first-order, bimodal and zero-order drug release profiles. In addition any combinations of soluble, highly soluble, insoluble, low drug dose, high drug load and drug combinations can be easily formulated with these technologies.

IPSCIO Record ID: 178743

License Grant
Australian Licensor shall grant an exclusive license to the Pellet Technology for the remainder of the term of this Agreement for the sole purpose of manufacturing and selling the Formulated Product in the Territory.
License Property
Licensor is engaged in the development of certain Pellet Technology to enable Licensor to manufacture Pellets.  The pellet is a tablet dosage form containing pseudoephedrine hydrochloride in sustained release pellets compressed into tablets with pseudoephedrine hydrochloride and terfenadine, approved by the U.S. FDA as an A/B rated substitutable equivalent of Marion Merrell Dows Seldane  D tablets.

The present invention relates to a pharmaceutical tablet composition for oral administration comprising extended-release pseudoephedrine together with a second active drug in an immediate release form.

Field of Use
Licensee is engaged in the development of certain Tabletting Technology.

IPSCIO Record ID: 200

License Grant
The Licensor, a Delaware corporation, entered into a License Agreement with a newly formed Arizona limited liability company, providing the Licensee with exclusive rights in Canada to manufacture and sell four extended release dietary supplements using the Licensor's proprietary CDT® drug delivery platform.  In addition, the Licensee was granted the rights to manufacture and sell two of such products in the United States on a nonexclusive basis.
License Property
Products
Glucosamine/Chondroitin (24 hour)
Calcium (600 mg) with Vitamin D (500 IU) (24 hour)
Vitamin C mineral ascorbate (500 mg of Ascorbic Acid) (12 hour)
Glucosamine/Chondroitin/Boswellia Serrata/Hyaluronic Acid

Canadian Patent No. 2,323,102 (Monolithic Tablet for Controlled Drug Release) 2. Canadian Patent No. 2,459,014 (Amino Acid Modulated Extended Release Dosage Form)  A controlled release drug delivery tablet for improving linearity of drug delivery over a sustained period of time comprising a hydrophilic swellable matrix a pharmaceutically effective amount of an active agent having a degree of solubilization that is substantially independent of pH over a pH  in the range of pH 1.5 to pH 7.5 dispersed in said matrix, and  a salt selected from the group consisting of sodium chloride, sodium bicarbonate, potassium bicarbonate, sodium citrate, sodium  bisulfate, sodium sulfite, magnesium sulfate, calcium chloride, potassium chloride, sodium carbonate-and a binary salt system comprising at least  two of said salts, said salt being dispersed in said matrix at a concentration which,  upon exposure of the tablet to an aqueous medium, causes hardened  boundary around the periphery of the matrix, said boundary subsequently  progressing inwardly toward the center of the tablet as the aqueous  medium permeates the matrix, said hardened boundary controlling the  rate at which said active agent is released from the tablet, the release rate  of the tablet being substantially independent of the pH of the surrounding  environment, with the provisos,  said tablet does not include polyacrylic acid or a pharmaceutically  acceptable salt thereof, and  said tablet is a monolithic tablet which is a compressed blend of  homogeneous powders comprising said hydrophilic matrix, said active  agent and said salt.

IPSCIO Record ID: 299234

License Grant
Licensor grants under the Licensed  Patents, the non-exclusive, except the Pediatric exclusivity, license and right to  make, have made, use and sell each Licensed Product in the Licensed Field and in the Territory.

For the Pediatric exclusivity, until May 15, 1998, the license granted shall be an exclusive license with respect to Licensed Products in the Pediatric Market in the United States and Canada and including Puerto Rico.

License Property
Licensor is the owner or licensee of certain patent rights pertaining to an effervescent, fast-dissolving, oral drug-delivery tablet technology;

Licensed Product means a product comprised of an effervescent agent together with micro-particles of either
—  where a Licensed Product is, by active ingredient, any active ingredient listed for the relevant country or region in the Territory which, as of the Effective Date, is approved by the appropriate regulatory agency for sale in the OTC market in such country or region of the Territory; and
—  where a Licensed Product is, by product category, such as cough/cold, one or more active ingredients used or useful in such product category, such as Pseudoephrine HC1, provided that, as of the Effective Date, all such active ingredients are approved by the appropriate regulatory agency for sale in the OTC market in the relevant country or region of the Territory, coated by a rupturable or non-rupturable coating material, such product being adapted to dissolve in the mouth of a human being and to provide a distinct sensation of effervescence on dissolution, the manufacture, use or sale of which would, but for this Agreement, constitute infringement of Licensed Patents.

The patents relate to effervescent dosage form.

Field of Use
Licensed Field means the OTC market for sale of any Licensed Product in the Adult Market or the Pediatric Market.

The Agreement covers full-scale production of an over-the-counter product in Licensor's OraSolv dosage form.  OraSolv is an oral dosage formulation incorporating microencapsulated active drug ingredients into a tablet which dissolves quickly in the mouth without chewing or water and which effectively masks the taste of the medication being delivered. OraSolv's fast-dissolving capability may enable patients in certain age groups or those with a variety of conditions that limit their ability to swallow conventional tablets to receive medication in a more convenient oral dosage form.

IPSCIO Record ID: 338651

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.

IPSCIO Record ID: 319177

License Grant
Licensor grants an exclusive license to its Intellectual Property only to the extent necessary to research, develop, make, have made, offer for sale, sell Products in the United States and its territories.
License Property
Licensor has developed the following extended-release liquid Products to be sold by doctors prescription only containing the following active pharmaceutical ingredients in accordance with the terms hereof using Neos patent-pending Dynamic Time Release Suspension technology.  Products include Chlorpheniramine and Hydrocodone; Promethazine with Hydrocodone; Fexofenadine with Pseudoephedrine combination product; and Guaifenesin with Hydrocodone or Codeine.

Licensor has developed a broad, proprietary modified-release drug delivery technology that enables the manufacture of single and multiple ingredient extended-release (XR) pharmaceuticals in patient- and caregiver-friendly orally disintegrating tablet (ODT) and oral suspension dosage forms.

Field of Use
The field of use is pharmaceutical products in the form of an extended release liquid.

Licensee is a specialty pharmaceutical company focused on commercializing products for the hospital and adjacent specialty markets.

IPSCIO Record ID: 27061

License Grant
The Company has previously agreed to pay royalties to CONSULTANT, a member of the Company's Board of Directors, in recognition of the patents developed by CONSULTANT for TIMERx.
License Property
The Company has developed the TIMERx delivery system, a novel drug delivery technology, to address the limitations of currently available oral controlled release delivery systems. The Company believes that the TIMERx system is a major advancement in oral drug delivery that represents the first easily-manufactured oral controlled release drug delivery system that is applicable to a wide variety of drug classes, including soluble drugs, insoluble drugs and drugs with a narrow therapeutic index. The Company is utilizing the TIMERx system to formulate generic versions of branded controlled release drugs, controlled release formulations of currently-marketed.

The TIMERx drug delivery system is a hydrophilic matrix combining primarily a heterodispersed mixture, usually polysaccharides xanthan and locust bean gums, in the presence of dextrose. The physical interaction between these components works to form a strong, binding gel in the presence of water. Drug release is controlled by the rate of water penetration from the gastrointestinal tract into the TIMERx gum matrix, which expands to form a gel and subsequently releases the active drug substance. The TIMERx system can precisely control the release of the active drug substance in a tablet by varying the proportion of the gums, together with the third component, the tablet coating and the tablet manufacturing process. Drugs using TIMERx technology are formulated by combining the active drug substance, the TIMERx drug delivery system and additional excipients and compressing such materials into a tablet.

1)  Directly compressible sustained release excipient.

2)  Sustained release excipient and tablet formulation.

3)  Compressible sustained release solid dosage forms.

4)  EPO Application No. 89309518.2; filed September 19, 1989.

5)  Australian Patent Application No. 43057/89

6)  Japanese Patent Application No. 1-510135

7)  Irish Patent Application No. 2968/89

8)  Canadian Patent Application No. 611,700

9)  Verapamil Tablet Application, Serial No. 736,031 & EPO PCT Applications.

10)  2 U.S. Applications on Bi-modal release.

IPSCIO Record ID: 282865

License Grant
For the Research License, Licensor grants an exclusive license under the Licensor Intellectual Property Rights and the Formulation, in the Territory to use the CTM, or clinical trial material, manufactured by Licensor to conduct the Clinical Studies required to file and maintain the Regulatory Filings.

For the Commercial License, Licensor grants an exclusive license under the Licensor Intellectual Property Rights in the Territory to use, offer for sale, import and sell the Product. Licensor grants a license under the  Intellectual Property Rights, in the Territory to make, and have made, the Product to the extent permitted under the Commercial Supply Agreement.

Licensor grants a non-exclusive license to use, and sublicense the right to use, the Licensor Trademarks in the sale and marketing of the Product provided the Product has been manufactured by, on behalf of, or under a license from Licensor.

License Property
Licensor is the owner or licensee of certain technology including processes, patents, trade secrets, trademarks and know-how for the development and manufacture of orally administered pharmaceutical formulations, including controlled release technologies.

DIFFUCAPS® Trademarks

This agreement is for the development of a once-a-day controlled release (CR) capsule dosage form containing a combination of dextromethorphan hydrobromide (DM) and quinidine sulfate (Q). The new product, Neurodex CR, is projected to have 60 mg of DM and up to 60 mg of Q and will be based on Licensors proprietary multi-particulate Diffucaps® technology. Diffucaps beads will allow separate adjustment of the DM and Q doses based on the fill volume of beads in the capsules.

The API or active pharmaceutical ingredients are dextromethorphan hydrobromide or quinidine sulfate separately, or dextromethorphan hydrobromide and quinidine sulfate together.

Product means the pharmaceutical dosage form resulting from the Formulation developed by Licensor pursuant to this agreement.

Formulation means both the identification and selection of ingredients, including the Drug Combination, and the Licensor Patent Rights and Know-How solely related to the Product and improvements thereto.

Field of Use
The field of use is orally administered pharmaceutical formulations, including controlled release technologies.  Diffucaps® incorporate release-controlling polymers or protective coatings onto drug-layered cores, granules, or crystals with one or more drugs.

IPSCIO Record ID: 248396

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 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.

IPSCIO Record ID: 221

License Grant
Licensor grants to Israeli Licensee an exclusive worldwide, perpetual license under the Patents and the Licensed Know-How for the sole purpose of developing, manufacturing, commercializing, making, using, selling, offering for sale and importing Products, in the Field of Use (the “License”).
License Property
“Product” shall mean all extended release (including, but not limited to, 24 hour extended release) and all other Ondansetron tablet formulations, that infringe one or more claims of the Patents and Licensed Know How, including CDT® delivery technology.

Ondansetron is a serotonin 5-HT3 receptor antagonist used mainly as an antiemetic to treat nausea and vomiting, often following chemotherapy.

IPSCIO Record ID: 203317

License Grant
Licensor grants a license, without the right to sublicense, other than to Licensees Affiliates, under the Licensed Intellectual Property, to
– manufacture for sale to Licensor and its Affiliates or sublicensees at any time, as requested by Licensor pursuant to the License and Manufacturing Agreement,
– make, have made and import in the Territory commencing prior to the Marketing License Effective Date for sale and offering for sale only commencing on or after the Marketing License Effective Date, and
– sell and offer for sale only commencing on or after the Marketing License Effective Date and thereafter, to market, sell and have sold in the Territory.
The License will be exclusive.

Licensee will have the right to enter the market for Niaspan and Advicor at least four (4) years prior to the expiration of the last to expire of Licensors currently issued patents in the Territory, thereby benefiting consumers by permitting generic entry that may not have occurred if the Lawsuit was allowed to proceed.

License Property
Licensed Products shall mean the Niacin Licensed Products and the Niacin-Lovastatin Licensed Products.

Niacin Licensed Products shall mean 1 gm, 750 mg and/or 500 mg extended release oral niacin tablets and any oral dosage form containing niacin (empirical formula of C(6)H(5)NO(2)) as the single active ingredient which is manufactured pursuant to any Niacin ANDA.

Niacin-Lovastatin Licensed Products shall mean lovastatin 20 mg/niacin 1 gm, lovastatin 20 mg/niacin 750 mg and lovastatin 20 mg/niacin 500 mg and any oral dosage form containing niacin (empirical formula of C(6)H(5)NO(2)) and lovastatin (empirical formula of C(24)H(36)O(5)) as the only active ingredients which is manufactured pursuant to any Niacin-Lovastatin ANDA.

Field of Use
The prescription extended release niacin 1gm tablet product is for human use, currently for affecting lipoprotein.

Medication and supplemental niacin are primarily used to treat high blood cholesterol and pellagra (niacin deficiency).

Lovastatin is a statin drug, used for lowering cholesterol in those with hypercholesterolemia to reduce risk of cardiovascular disease.

IPSCIO Record ID: 203479

License Grant
Licensor hereby grants to Licensee, as of the Effective Date, an exclusive license, exclusive even as to Licensor, in the Territory under the Licensed Patent Rights, and to use Licensor Know-How to develop, make, have made, import, export, use, distribute, market, promote, offer for sale and sell Licensed Product(s). Any Improvements shall be included in Licensor Know-How or Licensed Patent Rights, as the case may be, for all purposes of this Agreement. Without limiting the foregoing, Licensor hereby grants Licensee an irrevocable, worldwide, paid-up, exclusive license to use Licensor Know-How or other intellectual property rights relating to the Development Program and  Manufacture of Licensed Product that are necessary for Licensees filings for the purpose of obtaining and maintaining the Health Registrations in the Territory for the Licensed Product, including but not limited to the Manufacturing of Licensed Product as provided in the Health Registrations. Notwithstanding the foregoing, Licensee has granted certain rights to Manufacture Licensed Product to Licensor.
License Property
The term Licensed Product shall mean any dosage form utilizing any material elements of the Licensor Know-How, and/or the Licensed Patent Rights, in its Manufacture or use, and which contains the Active Ingredient as a pharmaceutically active ingredient.

5,178,878 – Effervescent dosage form with microparticles
6, 155,423 – Blister Package and Packaged Tablet

The term OraSolv Technology shall mean the fast-dissolving drug delivery system described in U.S. Patent 5,178,878 and U.S. Patent Application 08/468,913 including, formulations, materials, methods and other technologies which are owned by Licensor or licensed to Licensor with the right to grant sublicenses.

OraSolv technology is an oral dosage form that combines taste masked drug ingredients with a fast dissolving, low-effervescence system. The OraSolv tablet dissolves quickly in the mouth without chewing or the need for water.

Field of Use
This agreement pertains to the drug industry.

IPSCIO Record ID: 245882

License Grant
With this amendment, the French Licensor desires to amend the list of patent applications and patents encompassed within Licensors Patents Rights with the Licensee of Ireland.
License Property
Patents are added for Medicinal and/or nutritional microcapsules for oral administration, and,  Galenic microparticulate oral formulation for delayed and controlled release of pharmaceutical active principles.  This agreement also includes a list of deleted patents.
Field of Use
Per the original agreement, the Micropump® technology is a controlled release and taste-masking technology for the oral administration of small molecule drugs.

IPSCIO Record ID: 227284

License Grant
Licensor hereby grants to Licensee an exclusive license for the term of this Agreement under the following assets to market, distribute and sell the Products, for all indications and for all agreed upon Product line extensions, in the Territory.

Licensor grants to Licensee an exclusive, royalty bearing license to use the Licensor Trademarks to market, distribute and sell the Products, during the term of this Agreement, for all indications and for all agreed upon Product line extensions in the Territory.

License Property
Product shall mean any of the pharmaceutical products described, it being understood that additional products may be added after the date hereof in accordance with this agreement.

Product (API)
                                                Strengths
                                   LicensorTarget Completion Date
#1metoclopramide HCl
                        5mg 10mg
                                   December 01, 2002
#2 carbidopallevodopa
                        10m!V100mg
                                                                        25m!V 100mg
                                                                        2Smg/250mg

#3 baclofen
                                                10mg
                                                                        20mg

#4 alprazolam
                                        HCI 0.25 mg
                                                                        0.5mg
                                                                        1mg
                                                                         2mg
                                           March 31, 2003
#5 selegiline HCI
5mg

#6 diphenoxylate HCVatropine sulfate
2.5 mw0.025 mg

#7 dicyclomine HCI
                                10mg
                                                                        20mg

Licensor Patents shall mean United States patent nos. 6,024,981 and 6,221,392 (Rapidly Dissolving Robust Dosage Form) and any patents and patent applications resulting therefrom, including any extension, reissue, renewal, reexamination or continuation-in-part of such patent or patent application. To the extent that the OraSolv(R) and PakSolv(TM) technology is used with respect to any Product pursuant, the term 'Licensor Patents' shall, with respect to such Product, be deemed to include United States patent nos. 5,178,878, 6,155,423, 6,269,615 and 6,311,462 and any patents and patent applications resulting therefrom, including any extension, reissue, renewal, reexamination or continuation-in-part of such patent or patent application.

Licensor Trademarks shall mean the Licensor(R), DuraSolv(R), PakSolv(TM), OraSolv(R) and Meltabs(R) trademarks.

Licensor Technology shall mean all of the Licensor Patents and all of Licensors trade secrets, technology, know-how and all other information necessary for the manufacture of the Products including, without limitation, that relate to Licensors DuraSolv(R), PakSolv(TM) and OraSolv(R) technologies.

OraSolv technology is an oral dosage form that combines taste masked drug ingredients with a fast dissolving, low-effervescence system. The OraSolv tablet dissolves quickly in the mouth without chewing or the need for water.

Field of Use
This agreement pertains to the drug industry relating to pharmaceutical products through proprietary drug delivery technologies.  DuraSolv(R)Technology shall mean the fast-dissolving drug delivery system.

IPSCIO Record ID: 282823

License Grant
Licensor hereby grants to Swiss Licensee (a) an exclusive license under the Know-How and the Licensor-Patents regarding the Product, during the term of this Agreement, to use, sell, offer to sell or otherwise distribute the Product in the Territory and (b) an exclusive license under the Manufacturing Know-How and the Licensee-Patents to make a Product, have the Product made, solely under Licensees right to the extent permitted to self-supply in the Toll Manufacturing Agreement and (c) a non-exclusive license under US Patent 5,225,197 and corresponding patents in foreign countries to make, have made, sell, use, or offer for sale or otherwise distribute the Product in the Territory.

Licensee has the right to sub-license the rights granted to an Affiliated Company of Licensee and/or a Non Affiliated Company of Licensee for the purposes of marketing or distributing the Product.

License Property
The term Product shall mean a tablet for the treatment of depression manufactured using the technology of Licensor commonly known as Orasolv(R) as patented by the Patents as described hereof, containing the Substance as the active ingredient and adapted to disperse in the mouth of a human adult, which tablet incorporates the Substance together with a matrix or coating in microparticles or microcapsules which provide essentially complete release of the Substance into the gastrointestinal tract in a period of less than one hour after dissolution of the tablet.
5,178,878 – Effervescent dosage form with microparticles
5,225,197 – Pharmaceutical formulation

The term Licensor-Patents shall mean the Patents excluding US patent no. 5,225,197 d.d. July 6, 1993, and corresponding patents in other countries.

OraSolv(R) is a drug delivery technology. OraSolv(R) ODT formulation dissolves quickly in the mouth without chewing or the need for water.

Field of Use
Remeron SolTab, an antidepressant that incorporates Licensor's OraSolv(R) fast-dissolve drug delivery system with Licensee's active drug ingredient, mirtazapine.

IPSCIO Record ID: 245879

License Grant
The French Licensor grants to the Licensee in Puerto Rico, an exclusive license, even as to Licensor, with the right to grant sublicenses, under Licensed Technology, to make, have made, use, sell, offer for sale The Parties  have undertaken a feasibility study to develop a Formulation by applying the Licensors Micropump Technology to Carvedilol.
License Property
Licensor has developed certain proprietary technology related to Licensor Micropump Technology.

Carvedilol11 means (l-(9H-carbazol-4-yloxy)-[[2-2(2-methoxyphenoxy)ethyl] amino ]-2-propanol), the compound that is known by the generic name of Carvedilol and including all racemates, chelates, complexes, enantiomers, diastereoisomers, salts, bases, esters, hydrates, solvates, polymorphs, crystal forms, crystal habits, prodrugs, isotopic or radiolabeled equivalents, metabolites, or the like, thereof and all mixtures and any of the foregoing, and compositions comprising Carvedilol.

Licensor Micropump Technology means a multiple-dose system containing a large number of microparticles that may be contained in capsule, tablet, orally dispersible, sachet or suspension formulations. It is expected that the microparticles are released in the stomach and pass into the small intestine, where each microparticle operates as a miniature delivery system, releasing the drug at a controlled rate and over an extended period of time.

Licensor Patent Rights means all patents and patent applications in existence as of the Effective Date or during the Term of this Agreement claiming generically or specifically a product or process using the Licensors Micropump Technology.

Product means any presentation or presentations of Carvedilol that incorporate the Licensed Technology, alone or in combination with other therapeutically active compounds, for the therapeutic or prophylactic treatment of diseases and conditions in humans in any dosage or strength.

Field of Use
The Micropump® technology is a controlled release and taste-masking technology for the oral administration of small molecule drugs.

IPSCIO Record ID: 372496

License Grant
Licensor grants an exclusive, worldwide license to make, use, sell, offer for sale and import all inventions described and claimed in the Licensed Patent Applications (A) in all fields and Territory including improvements thereto.

Licensor grants an exclusive, worldwide license to make, use, sell, offer for sale and import NRobeâ„¢ Film, NRobeâ„¢ Equipment and NRobeâ„¢ Process under the Licensed Patent Applications (B) in the field of the NRobeâ„¢ System in the Territory including improvements thereto.

Licensor grants an exclusive, worldwide license to use the Technical Information in the field of the NRobeâ„¢ system.

License Property
The term NRobeâ„¢ System as used herein refers to all technology, know-how, technical data, improvements or other information regarding a platform of technologies defined as any enrobed compacted powder solid form having a degree of compaction less than that degree of compaction for a Tablet NRobeâ„¢ Solid Form, the process for making or using the NRobeâ„¢ Solid Form (NRobeâ„¢ Process), film to be used in the NRobeâ„¢ Solid Form (whether constituted by HPMC (hydroxyl propyl methyl cellulose) or otherwise) (any such film, NRobeâ„¢ Film) and machines, devices and equipment to be used in making the NRobeâ„¢ Solid Form (NRobeâ„¢ Equipment).

The Licensed Patents Applications (A) are titled
Powder Compaction and Enrobing; and, Improvements in Powder Compaction and Enrobing.

The Licensed Patents Applications (B) are titled
Improvements in or Relating to Encapsulation;
Capsule Based Drug Delivery System;
Improvements in/ or Relating to Modified Cellulose Films;
Modified Polymeric Films;
Oxygen Scavenger in Films;
Glue Compositions;
Improvements in Glues; and,
Improvements in Glues and their Applications.

Field of Use
The field of use is the distinct dosage forms identified as TabWrap, Septum and Swallow.  TabWrap is defined as any Tablet enrobed by film. Septum is defined as an enrobed solid form having more than one compartment separated by a film. Swallow is defined as a solid form having a soft film enrobing a liquid, paste or suspension.

NRobe is a solid oral dose system capable of enrobing a variety of powders and particulates within dry polymer films to produce an elegant dose form comparable in appearance to film-coated or gel-dipped tablets, or two-piece hard capsules. This system can deliver benefits such as unique appearance, improved drug release, simplified formulation and processing, and the avoidance of problematic excipients.

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