Description
Category: Technology Licenses
Created On: 2022-04-28
Record Count: 7
Primary Industries
- Drugs
- Delivery
- Time-released
- Disease
- Therapeutic
- Drug Discovery
- Pain
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: 282865
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.
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.
IPSCIO Record ID: 266811
In the event a Third Party, without any cooperation or assistance from Licensee, markets a Generic Equivalent in the Territory prior to the License Effective Date, and Licensor elects, in its sole discretion, to market or have marketed a Generic Product to compete with such Third Party prior to the License Effective Date, then Licensor shall appoint Licensee as the exclusive, even as to Licensor, but except as to the Third Party Licensee.
Adderall XR Intellectual Property shall mean U.S. Patent Nos. 6,322,819, 6,605,300, and 6,913,768 and any patent that issues as a result of a reexamination or reissue thereof; any patent that issues from, or any continuation, continuation-in-part or divisional application relating to, U.S. Patent Application Serial Nos. 09/176,542, 10/353,073, 10/758,417, 10/774,697, and 11/030,174; and any other present or future U S. patent owned or controlled by Licensor and its Affiliates which may be infringed by the making, using, selling or importing of the Generic Product.
Compound shall mean mixed amphetamine salts, as further defined in the NDA.
Licensor has settled all pending litigation with Licensee in connection with Barr's Abbreviated New Drug Application ('ANDA') and its attempt to market generic versions of Licensor's ADDERALL XR (extended-release mixed amphetamine salts) for the treatment of Attention Deficit Hyperactivity Disorder ('ADHD').
IPSCIO Record ID: 171994
Products
Buspirone CR Anxiety, Depression Buspar
Bupropion CR Depression Wellbutrin
Lovastatin/Niacin CR Hyperlipidemia Mevacor
IPSCIO Record ID: 319167
Licensor grants a limited license, under the Adderall XR Intellectual Property and under any and all statutory and regulatory exclusivities to Manufacture, have Manufactured and Market Impax Product in the Territory on and after the License Effective Date.
Licensor authorizes Licensee to Market Licensees AG Product in the Territory from and after the License Effective Date. In connection with and solely for purposes of such authorization, Licensor grants a limited license under the Adderall XR Intellectual Property and under any and all statutory and regulatory exclusivities to Market such Licensee AG Product in the Territory from and after the License Effective Date.
The Authorization and License shall be on an Exclusive basis.
Adderall XR Intellectual Property shall mean
(i) U. S. Patent Nos. 6,322,819, 6,605,300, and 6,913,768 and any patent that issues as a result of a reexamination or reissue thereof;
(ii) any patent that issues from, or from any continuation, continuation-in-part or divisional application relating to, U.S. Patent Application Serial Nos. 09/176,542, 10/353,073, 10/758,417, 10/774,697, and 11/030,174; and
(iii) any other present or future U.S. patent owned or controlled by Licensor which may read upon the making, using, selling or importing of a Generic Product.
AG Product shall mean generically Labeled Adderall XR, commonly called an authorized generic product, approved for sale by the FDA pursuant to a labeling supplement to Licensors NDA.
Compound shall mean mixed amphetamine salts.
Adderall XR is combination medication used to treat attention deficit hyperactivity disorder – ADHD. It works by changing the amounts of certain natural substances in the brain. Amphetamine/dextroamphetamine belongs to a class of drugs known as stimulants.
IPSCIO Record ID: 319184
Licensor authorizes Licensee to Market such AG Product in the Territory, but only from and after the License Effective Date.
Licensor grants to a limited license under the Adderal- XR Intellectual Property and under any and all statutory and regulatory exclusivities to Market such AG Product in the Territory from and after the applicable License Effective Date.
A Licensor Affiliate is the owner of New Drug Application No. 21-303, which was approved by the FDA for the Manufacture and sale of Adderall XR for the treatment of Attention Deficit Hyperactivity Disorder.
Adderall XR shall mean the pharmaceutical product that contains the Compound as its sole active ingredient which is approved for Marketing in the Territory.
Compound shall mean mixed amphetamine salts.
AG Product shall mean generically Labeled Adderall XR, commonly called an authorized generic product, approved for sale by the FDA pursuant to a labeling supplement to Licensor’s NDA.
IPSCIO Record ID: 294017
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.
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.
IPSCIO Record ID: 372611
— an exclusive license, or sublicense as the case may be with respect to Know-How and Patent Rights arising under the Kyowa Agreement, with the right to grant sublicenses, under the Licensor Intellectual Property Rights, excluding the Licensor Trademarks, to use, sell, offer for sale, package, and import Product in the Field in the Territory;
— a worldwide, exclusive license, or sublicense as the case may with respect to Know-How and Patent Rights arising under the Kyowa Agreement, with the right to grant sublicenses under the Licensor Intellectual Property Rights, excluding the Licensor Trademarks, in the Field to make and have made Product solely to the extent that Licensee is permitted to make or have made Product under the Clinical Supply Agreement and Commercial Supply Agreement; and,
— a worldwide, exclusive license, or sublicense as the case may be with respect to Know-How and Patent Rights arising under the Kyowa Agreement, with the right to grant sublicenses, under the Licensor Intellectual Property Rights, excluding the Licensor Trademarks, to package Product in any country outside of the territory and to use Product for the purpose of conducting Clinical Studies in any country outside of the territory.
Licensor grants
— an exclusive right, with the right to grant sublicenses, to use the Licensor Trademarks in connection with the using, selling, offering for sale and importing of Product in the Field in the Territory;
— a worldwide, exclusive right to use the Licensor Trademarks in connection with the making and having made of Product solely to the extent that Licensee is permitted to make or have made Product under the Clinical Supply Agreement and Commercial Supply Agreement; and
— a worldwide, exclusive right to use the Licensor Trademarks in connection with the packaging of Product outside of the Territory and the use of Product for the purpose of conducting Clinical Studies in any country outside of the Territory.
Product means an immediate-release, i.e., lacking any substantial sustained or controlled release component to the drug release, pharmaceutical composition containing the Compound, as the sole active ingredient and regardless of presentation or dosage, which is developed by or on behalf of the Parties pursuant to this Agreement, and which uses the Formulation and incorporates the ODT Technology.
ODT Technology means the proprietary oral dissolve dmg delivery and related technology Controlled by Licensor and/or its Affiliates as of the Effective Date or during the Term, including, without limitation, the Microcaps® taste masking microencapsulation technology and the AdvaTab® oral disintegrating tablet technology and, in each case, any manufacturing processes relating thereto.
Compound means 3,5-diantino-6-(2,3-dichlorophenyl)-1 ,2,4-triazine, the compound that is known by the generic name lamotrigine and its prodrugs, metabolites, isomers, esters, salts, hydrates, solvates and polymorphs, Lamotrigine IR Orally Disintegrating Tablets (25, 50, 100 & 200 mg).
Licensor Trademarks means MICROCAPS, and, ADVATAB.
EUR-1048 is a tastemasked orally disintegrating tablet developed using our AdvaTab® and Microcaps® technologies,
Microcaps taste-masking. The ability to mask the bitter or irritant characteristics of many drugs with flavors and sugars is limited, and coating of the drug is generally required to achieve maximum taste-masking effectiveness. Our Microcaps technology deposits a polymer layer around the drug particles to form a complete and continuous barrier. Fluid-bed layering techniques, in which a solution of the polymer is sprayed onto particles that are 'fluidized' by blowing air through a bed of drug particles, are typically unable to match this level of coating integrity and hence performance.
