Created On: 2020-07-15
Record Count: 3
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
Licensor grants to Japanese Licensee the non-exclusive license, with the right to sublicense provided that Licensee obtains Licensorâ€™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.
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.
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
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.
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
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.
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.