Royalty Report: Drugs, Delivery, Disease – Collection: 1185

$100.00

Curated Royalty Rate Report
Created On: 2020-07-15, Record Count: 5

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.
Created On: 2020-07-15
Record Count: 5

Primary Industries

  • Drugs
  • Delivery
  • Disease
  • Therapeutic
  • Pharmaceuticals
  • 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: 1185

License Grant
Irish Licensor grants, and Licensee accepts, upon the terms set forth in this Agreement, an Exclusive, irrevocable right and license in the Territory, under the Patents and the Know-How, to develop, market, use, distribute, import, export, offer to sell and sell (but not produce or manufacture) the Products and any Improvements thereto.

Licensee desires to acquire from Licensor, and Licensor is willing to grant to Licensee, an Exclusive (as hereinafter defined) license under Licensor’s Patents, Know-How and Trademarks relating to the Products in the Territory.

License Property
Patents means: as for Product A as hereinafter defined: (a) International Application WO/2000/76478, US App. No. 10/009,532 titled Controlled Release And Taste Masking Oral Pharmaceutical Compositions, US App. No. 11, 268/500 titled Controlled Release And Taste Masking Oral Pharmaceutical Compositions, and related applications thereof, including all other provisional and other patent applications including, but not limited to, US App. No 12/210,969, (c) any and all patents that have issued or in the future issue from the foregoing patent applications, including utility, model and design patents and certificates of invention, including, but not limited to, US Patent No. 7,410,651 titled Controlled release and taste masking oral pharmaceutical compositions, US Patent No. 7.431,943 titled Controlled release and taste masking oral pharmaceutical compositions.

Product A: any oral formulation product containing Budesonide or other anti-inflammatory corticosteroids as an active ingredient, formulated with a multi-matrix (MMX) drug releasing technology, for the treatment of patients with Ulcerative Colitis and all other human uses.

Product B: any oral formulation product containing Rifamycin SV as an active ingredient, formulated with a multi-matrix (MMX) drug releasing technology, for the treatment of patients with Travelers’ Diarrhea and all other human uses.  

Budesonide MMX is an oral corticosteroid currently being investigated in two multi-center phase III clinical trials and Rifamycin SV MMX is a broad spectrum, semi-synthetic antibiotic that also has targeted release characteristics when taken orally. MMX is a proprietary technology platform designed to produce a controlled release, homogeneous local application of the active pharmaceutical ingredient throughout the colon, thereby limiting systemic absorption and offering an opportunity for reduced side effects. The MMX technology is covered by two issued U.S. patents that expire in mid-2020, and additional patent applications are pending at the U.S. Patent and Trademark Office.

Field of Use
Licensee possesses capabilities in marketing, development and commercialization of pharmaceutical products in the Territory.

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: 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.

The term Patents shall mean the patents, and patent applications (and any patents issuing on such applications) and any divisional, continuation and continuation-in-part applications thereof, reissues, reexaminations, substitutions, additions and any extensions to such patents as well as foreign counterparts thereof.

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: 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

The Licensed Assets include but not limited to the following:
(i) all current and future regulatory filings, approvals, registrations and governmental authorizations that relate to the Products in the Territory;
(ii) the Licensor Intellectual Property; and
(iii) the Licensor Marketing and Market Research Data.

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: 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.