Royalty Report: Drugs, Delivery, Pain – Collection: 203528


Curated Royalty Rate Report
Created On: 2020-07-15, Record Count: 4


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.
Created On: 2020-07-15
Record Count: 4

Primary Industries

  • Drugs
  • Delivery
  • Pain
  • cardiac
  • Drug Discovery
  • Disease

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: 203528

License Grant
Licensor hereby grants to Licensee and Licensee hereby accepts, an exclusive  license, without the right to grant any sublicense, under the Patent Rights and the Know-How to use and sell Product in the Territory. No license is granted for any other product than sustained release propranolol which is bio-equivalent to to lnderal LA.
License Property
Product shall mean any and all bulk or finished pharmaceutical products in solid oral dosage form which are  developed or manufactured using the Patent Rights or Know How that contain sustained-release propranolol as the active pharmaceutical ingredient and are intended to be bioequivalent to lnderal LA.

Patent Rights means (i) the claims of pending patent applications and issued patents, if any, in the Territory, listed, as of the Commencement Date, attached hereto and made a part hereof;  (ii) claims of any patent applications or issued patents in the Territory filed or issued during the term of this Agreement owned, controlled or licensed with right of sublicense by Licensor which relate to any  composition, process, or methods of use or  propranolo, and (iii) and reissues, extensions, continuations, continuations-in-part or divisions of which are hereafter granted in the Territory. Below lists the relevant patents and patent applications of Licensor or patents or patent  applications under which Licensor has rights as of the Commencement Date and shall be updated periodically by Licensor to reflect the current status of the Patent Rights.

Application Serial No. 09/554,102   Filed May 4, 2000
Application Serial No. 09/555.095   Filed May 24, 2000

Field of Use
Inderal LA (Propranolol) is a beta-blocker used to treat high blood pressure, irregular heartbeats, shaking (tremors), and other conditions. It is used after a heart attack to improve the chance of survival. It is also used to prevent migraine headaches and chest pain (angina). Inderal LA is formulated to provide a sustained release of propranolol hydrochloride

IPSCIO Record ID: 299227

License Grant
The parties have entered into a Development, License and Supply Agreement dated January 27, 2000 for Extended Release Propranolol.

For the Development Program, Licensee engages Licensor to perform the scope of work for Development and Commercialization of AB rated Modified Release Dosage forms of Propranolol.

Licensor grants a sole and exclusive license under the Know-How with the right to sublicense within the Territory to use the Product in the manufacture of the Finished Dosage Form, and use, offer for sale, market and sell the Finished Dosage Form provided, however, that Licensee shall not grant sublicenses in the United States without the consent of Licensor, which consent shall not be unreasonably withheld.

Licensor grants a non exclusive license to use and sublicense the right to use the Trademark.

License Property
Licensor is the owner of original processes, patents, trademarks and know-how for the development and manufacture of modified release pharmaceutical products.

The Active Ingredient means Propranolol HC1.

Product means a Modified Release Composition containing the Active Ingredient and certain excipients, said compositions being bioequivalent to Inderal® LA and produced by Licensor and meeting the Specifications.

The trademark use permitted is Produced with Eurand Trademark technology.

Propranolol is a beta-blocker. Beta-blockers affect the heart and circulation (blood flow through arteries and veins). Propranolol is used to treat tremors, angina (chest pain), hypertension (high blood pressure), heart rhythm disorders, and other heart or circulatory conditions.

Propranolol HCl is a novel bedtime-dosed, extended-release formulation of this beta blocker for the treatment of hypertension.

Field of Use
The filed of use of propranolol is for the treatment of hypertension and migraines.

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.

The term Licensed Patent Rights shall mean all claims of any patent applications or issued patents in the Territory, whether in existence as of the date of this Agreement, or filed or issued during the Term of this
Agreement, to which Licensor and/or its Affiliates has or acquires any right and which cover the manufacture, use or sale of Licensed Product, including, without limitation, the United States and foreign patent applications and issued patents which:
(a)   are listed, as of the effective date of this Agreement, which shall be periodically updated by written notice from Licensor to Licensee in a timely fashion during the term of the Agreement;
(b)   relate to the OraSolv Technology or the Licensor Know-How;
(c)   arise out of or are developed during and under the performance of the Development Program by Licensor or its Affiliates; and/or
(d)   cover any patentable Improvement of any of the foregoing.

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

Licensed Patent Rights shall include any reissues, reexaminations, extensions (or other governmental actions which provide exclusive rights to the patent holder in the patented subject matter beyond the original patent expiration date), substitutions, confirmations, registrations, revalidations, additions, continuations, continuations-in-part, or divisions of or to any patent applications or issued patents described.

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.

The term Proprietary Information shall mean Licensor Know-How, Licensee Know-How and all other scientific, clinical, regulatory, marketing, financial and commercial information or data, whether communicated in writing, verbally or electronically, which is provided by one party to the other party in connection with this Agreement.

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: 294017

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.

Disclaimer: The information gathered from RoyaltySource® database was sourced from the U.S. Securities and Exchange Commission EDGAR Filings and other public records. While we believe the sources to be reliable, this does not guarantee the accuracy or completeness of the information provided. Further, the information is supplied as general guidance and is not intended to represent or be a substitute for a detailed analysis or professional judgment. This information is for private use only and may not be resold or reproduced without permission.