Royalty Report: Drugs, Delivery – Collection: 372607

$100.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 3

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: 3

Primary Industries

  • Drugs
  • Delivery

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: 372607

License Grant
Licensor hereby grants to Israeli Licensee and its Affiliates an exclusive, non-transferable (except to the extent permitted in this Agreement license, without the right to grant sublicenses, under the IR IP, to use, offer for sale, sell, import and have imported IR Products, solely for sale to their distributors and customers in the Territory for ultimate resale by such distributors and customers to consumers for use in the Territory.

Licensor hereby grants to Licensee and its Affiliates a non-transferable (except to the extent permitted in Agreement) license, without the right to grant sublicenses, under all IR IP and those foreign counterparts to the IR IP in the territories next specified, to manufacture and have manufactured IR Products (including Compound to the extent necessary to manufacture IR Products) in the United States, Canada and Israel and such other countries as the Parties may mutually agree upon in writing, but if outside the Territory, only for the importation of such IR Products and Compound (solely for the purposes of manufacturing IR Products) into the Territory and the other activities in the Territory permitted by the license granted.

Licensor hereby grants to Licensee and its Affiliates an exclusive non-transferable (except to the extent permitted in Agreement) license, without the right to grant sublicenses, under the XR IP, to use, offer for sale, sell, import and have imported XR Products, solely for sale to their distributors and customers in the Territory for ultimate resale by such distributors and customers to consumers for use in the Territory.

Licensor hereby grants to Israeli Licensee and its Affiliates a non-exclusive non-transferable (except to the extent permitted in Agreement) license, without the right to grant sublicenses, under the XR IP, to use, offer for sale, sell, import and have imported XR Products, solely for sale to their distributors and customers in the Territory for ultimate resale by such distributors and customers to consumers for use in the Territory.

License Property
IR Product shall mean the immediate release tablet, which tablet contains venlafaxine hydrochloride as its sole active ingredient and is marketed by Licensee or any of its Affiliates as a generic product AB Rated to IR Reference Product (in any dosage strength) in the Territory. For the sake of clarity, IR Product shall not include any IR Reference Product.

Venlafaxine hydrochloride is an antidepressant.

Compound shall mean venlafaxine hydrochloride and any form thereof including polymorphs and solvates, and other pharmaceutically acceptable salts of venlafaxine and any form thereof including polymorphs and solvates.

IR Reference Product shall mean the immediate release tablet containing, as its sole active ingredient, venlafaxine hydrochloride equivalent to either 25mg, 37.5mg, 50mg, 75mg or 100mg of venlafaxine (or other approved dosage strengths) which tablet is marketed in the Territory by Licensor or any of its Affiliates or licensees as Effexor® under NDA No. 20-151.

IR IP shall mean (i) Patent Rights under U.S. Patent No. 4,535,186, (ii) all other U.S. Patent Rights owned or controlled as of the Signing Date or as of the Settlement Effective Date by Licensor or any of its Affiliates that, but for the licenses contained herein, would be infringed by, the manufacture, use, sale, offer for sale or importation of any IR Product (including Compound to the extent necessary to manufacture IR Product), and (iii) all U.S. Patent Rights, claiming (directly or indirectly) priority to such U.S. patent and U.S. Patent Rights identified in clause (i) and (ii) or any of the applications to which any such U.S. patent or U.S. Patent Rights claim (directly or indirectly) priority, that, but for the licenses contained herein, would be infringed by the manufacture, use, sale, offer for sale or importation of any IR Product (including Compound to the extent necessary to manufacture IR Product).
U.S. Patent No. 4,535,186 – 2-Phenyl-2-(1-hydroxycycloalkyl or 1-hydroxycycloalk-2-enyl)ethylamine derivatives

XR IP shall mean the IR IP, plus (i) U.S. Patent Nos. 5,916,923, 6,274,171, 6,403,120, 6,419,958, and 6,444,708, (ii) all other U.S. Patent Rights owned or controlled as of the Signing Date or as of the Settlement Effective Date by Licensor or any of its Affiliates that, but for the licenses contained herein, would be infringed by the manufacture, use, sale, offer for sale or importation of any XR Product (including Compound to the extent necessary to manufacture XR Product), and (iii) all U.S. Patent Rights, claiming (directly or indirectly) priority to such U.S. patents and U.S. Patent Rights identified in clause (i) and (ii) or any of the applications to which any such U.S. patents or U.S. Patent Rights claim (directly or indirectly) priority, that, but for the licenses contained herein, would be infringed by the manufacture, use, sale, offer for sale or importation of any XR Product (including Compound to the extent necessary to manufacture XR Product).

U.S. Patent No. 5,916,923 – Venlafaxine for the treatment of generalized anxiety disorder
U.S. Patent No. 6,274,171 – Extended release formulation of venlafaxine hydrochloride

XR Product shall mean once-daily extended release capsule, which capsule contains venlafaxine hydrochloride as its sole active ingredient and is marketed by Licensee or any of its Affiliates as a generic product AB Rated to XR Reference Product (in any dosage strength) in the Territory. For the sake of clarity, XR Product shall not include XR Reference Product.

Field of Use
Field of use is for the treatment of anxiety disorders.

IPSCIO Record ID: 240625

License Grant
For the Puerto Rico Territory Intellectual Property Grant,  Licensor grants a non-transferable license, with no right to grant sublicenses, under the Patents in the Puerto Rico Territory, to offer for sale and sell Licensor Supplied Product and Licensor Product to Licensee s distributors and other customers only for the purpose of ultimate sale by such distributors and other customers to consumers in the Puerto Rico Territory.

Effective as of the Puerto Rico Effective Date, Licensor grants a non-transferable license, with no right to grant sublicenses, under the Patents in the Commercial Generic Entry Territory, to import Licensors Supplied Product from Licensors Cidra, Puerto Rico facility to Licensees Suffern, NY facility, and Licensor grants a non-transferable license, with no right to grant sublicenses, under the Patents in the Puerto Rico Territory, to re-import such Licensor Supplied Product from Licensees Suffern, NY facility to Licensees distributors and other customers in the Puerto Rico Territory only for the purpose of ultimate sale by such distributors and other customers to consumers in the Puerto Rico Territory.

For the Competitive Generic Entry Territory Intellectual Property Grant, effective as of the Competitive Generic Entry Effective Date, Licensor grants a nontransferable license, with no right to grant sublicenses, under the Patents in the Competitive Generic Entry Territory, to offer for sale and sell Licensor Supplied Product and Licensee Product to Licensees distributors and other customers only for the purpose of ultimate sale by such distributors and other customer to consumers in the Competitive Generic Entry Territory.

License Property
The patent is for Anti-depressant crystalline paroxetine hydrochloride hemihydrate.

Paroxetine Hydrochloride' shall mean (-)- trans -4 R -{4-fluorophenyl)-3 S -[(3,4 methylenedioxyphenoxy) methyl] piperidine hydrochloride.

Product shall mean, collectively or individually, depending on context, the following drug products
– any tablet containing Paroxetine Hydrochloride that is A/B Rated to the product(s) approved under Licensors immediate release NOA No. 20-03 provided that such tablet is in a dosage form which is marketed for commercial sale by Licensor in the Competitive Generic Entry Territory; and,
– any capsule containing Paroxetine Hydrochloride that is A/B Rated to the product(s) approved under Licensors NOA No. 20-885; and,
– any PAR Product.

Field of Use
The Licensee manufactures and distributes of generic pharmaceuticals principally in the United States.  In addition, the License develops  and manufactures, in small quantities, complex synthetic  active pharmaceutical ingredients.

IPSCIO Record ID: 266811

License Grant
Licensor grants a license, under the Adderall XR Intellectual Property and under any and all statutory and regulatory exclusivities issued by any Governmental Authority to import, Manufacture, have Manufactured and Market Licensee Product in the Territory on and after the License Effective Date. Notwithstanding the foregoing, Licensee shall have the limited right to Manufacture and/or import reasonable quantities of Licensee Product prior to the License Effective Date for the sole purpose of launching and selling such Product in the Territory under the foregoing license on and after the License Effective Date.

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.

License Property
Licensor is the owner of a New Drug Application, No. 21-303, which was approved by the Food and Drug Administration for the manufacture and sale of a pharmaceutical composition containing mixed amphetamine salts for the treatment of Attention Deficit Hyperactivity Disorder, all strengths of which Licensor sells under the trade name Adderall XR.

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.

Field of Use
The field of  use is as a pulsed dose delivery system for amphetamine salts and mixtures.

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').

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