Royalty Report: Drugs, Pain, Therapeutic – Collection: 245899


Curated Royalty Rate Report
Created On: 2020-07-15, Record Count: 3


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: 3

Primary Industries

  • Drugs
  • Pain
  • Therapeutic
  • Delivery
  • 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: 245899

License Grant
Licensor hereby grants to Japanese Licensee an exclusive (even as to Licensor and its Affiliate) license, including the right to grant sublicenses to Sublicensees provided that Licensee obtains Licensor’s prior written approval of the sublicense grant and the sublicensee (such approval not to be unreasonably withheld), under the Licensed Patent Rights and the Licensed Know-How solely to research, develop, manufacture, have manufacture, use, sell, have sold, offer for sale and import Licensed Products within the Field of Use in the Territory during the Term. For the avoidance of any doubt, the above license includes Licenseei’s right to import CR-845 API manufactured and supplied by Licensor, pursuant to the Supply Agreement, and to manufacture (formulate) or have manufactured (formulated) the Licensed Product in finished form from thus imported CR-845 API solely for development and commercialization in the Field of Use in the Territory. As provided in the Supply Agreement, the timing of orders and quantities of CR-845 API that Licensee orders and imports is up to Licensee’s reasonable decision (that is, at least six (6) months prior written notice to Licensor). Unless and until Licensee decides to import CR-845 API, Licensor will use reasonable efforts to supply Licensee with its requirements of the Licensed Product in finished form, pursuant to the supply terms of the Supply Agreement. Licensor shall use Commercially Reasonable Efforts to obtain Control of the Information relating to Licensed Product generated by Licensor licensees and sublicensees so that such Information will be part of the Licensed Know-How.

Licensor grants to Japanese Licensee the non-exclusive license, with the right to sublicense provided that Licensee obtains Licensor’s prior written approval of the sublicense grant and the sublicensee (such approval not to be unreasonably withheld), under the applicable Licensed Rights solely to manufacture or have manufactured the CR-845 API, in the Territory or outside the Territory, as needed for Licensee to manufacture or have manufactured, using this manufactured CR-845 API, its requirements of the Licensed Product for commercialization solely within the Field of Use in the Territory during the Term. Thus manufactured Licensed Product shall be devoted solely for development, use and sale in the Field of Use in the Territory during the Term.

License Property
Licensed Product means any pharmaceutical preparation containing CR-845 intended for use in the Field of Use, including intravenous, oral, transdermal,  subcutaneous or any other suitable pharmaceutical formulation.  CR-845 API means CR-845 in bulk active pharmaceutical ingredient form, ready for formulation into final drug product.  CR-845 means the kappa opioid receptor agonist compound of Cara known as CR-845 having the chemical structure set forth in this Agreement, [and including any stereoisomers, racemates, salts, solvates, crystalline polymorphs, hydrates, particle sizes, complexes, or clathrates] of CR845.

Drug Product means the finished dosage form that contains CR-845 API, generally, but not necessarily, in association with other active or inactive ingredients, and not
necessarily labeled or packaged . .

Licensed Patent Rights means:
(a) the patents and patent applications, plus any and all future patents and patent applications in the Territory that are Controlled by Licensor and claim CR845 or Licensed Product or their manufacture or use, including as described in subclauses ( c) – (d) below; (b) any and all patent applications that are continuations or divisionals of the patent applications described in (a) above; (c) any and all issued and unexpired patents resulting from any of the applications described in (a) or (b) above; and ( d) any and all issued and unexpired reissues, reexaminations, renewals, or term extensions of any of the patents described in (a), (b) or (c) above.

Trademark means any trade name, service mark, logo or trademark (whether or not registered), together with all goodwill associated therewith, and any renewals,
extensions or modifications thereto.

Field of Use
Field of Use means use in the treatment of acute pain and/or uremic pruritus, or any additional indication added to the scope of this defined term.

CR845 is a peripherally acting kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain and pruritus.

IPSCIO Record ID: 203524

License Grant
Licensor grants an exclusive, except as to Licensor for internal research purposes only and not for clinical development, license under Know How, the Licensed Patents arid the Process Licensed Patents, to develop, obtain Regulatory Approval for, use, make, have made, import, sell, and offer for sale New Compounds and New Products in the Territory.
License Property
The patents, related foreign equivalents and know-how relate to peripherally selective opioid antagonists.

The New Compound shall mean a chemical entity (including salts and solvates thereof, which shall be considered the same New Compound for purposes of this Agreement) covered by any valid and unexpired claim of Licensed Patents, but shall exclude in all cases the Roberts Agreement Compound.

The New Product means a finished, formulated pharmaceutical product containing a New Compound, together with all improvements and line extensions thereon which may be included in any supplement, modification or addition to the relevant Regulatory Approval to the extent that any such improvements or line extensions contain a New Compound.

Field of Use
The Field of Use means all uses as a Peripherally Selective Opioid Receptor Antagonist, where the term Peripherally Selective Opioid Receptor Antagonist shall mean a chemical entity that has a selectivity ratio of greater than 20 upon parenteral administration as measured by the ED-50 for antagonism of analgesia in the mouse writhing test in morphine-naive mice divided by the ED-50 for precipitation of diarrhea in the morphine-dependent mice test.

Licensee is developing  alvimopan, a peripherally selective mu opioid antagonist for management of postoperative ileus, opioid induced bowel dysfunction and certain other indications.  Alvimopan is in a class of medications called peripherally acting mu-opioid receptor antagonists. It works by protecting the bowel from the constipation effects of opioid (narcotic) medications that are used to treat pain after surgery.

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.

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