Royalty Report: Delivery, Drugs, Disease – Collection: 266858

Licensor has licensed certain rights to Active Agents as locally delivered therapeutics in the Field with rights to sublicense to Licensee pursuant to an Amended and Restated Agreement between Institut National de la Sante et de la Recherche Medicate and Licensor.

Licensor owns or has rights to certain proprietary technology for site-specific and time-released delivery of drugs, defined as the Licensor Drug Delivery Platforms.

Gacyclidine shall mean cis-1-(2-thienyl)-1-N-piperidinyl-2-methycyclohexane hydrochloride in its racemic form.

Licensed Product shall mean any pharmaceutical formulation containing an Active Agent or,  a product incorporating an active ingredient and a Licensor Drug Delivery Platform pursuant to Licensee opting to develop such Licensed Product, in any case for use in the Field.

Licensor Know-How shall mean all proprietary data, information and materials owned or Controlled by Licensor relating to the development and manufacturing of Licensor Drug Delivery Platforms, any Active Agent and the Joint Patent Rights including, without limitation, know-how, test results, knowledge, techniques, discoveries, inventions, specifications, designs, regulatory filings, reports and all other documents, and specifically includes, but is not limited to, the Licensor Data.

Licensor Data shall mean all data and information owned or Controlled by Licensor as of or after the Effective Date related to the development, manufacturing, administration and use of Active Agent, the Joint Patent Rights, and any Licensor Drug Delivery Platforms, in each case in the Field.

Licensor Patent Rights shall mean any existing and future Patent Rights anywhere in the world owned or Controlled by Licensor specific to the Licensor Drug Delivery Platforms, the Active Agent and the Joint Patent Rights, including without limitation, Licensor Core Inventions.

Licensor Drug Delivery Platforms shall mean the following drug delivery technology or methods owned or Controlled by Licensor:  the DUROS Technology Platform,  the SABER Delivery System,  the DORIN Biodegradable Implant Technology,  the MICRODUR Biodegradable Microparticle Technology, and any other drug delivery technology owned or Controlled by Licensor as of the Effective Date.

The Intellectual Property is to market and sell products for the treatment of certain inner ear disorders including chronic tinnitus (ringing in the ears).  Over eight million people in the U.S. suffer from chronic ringing, hissing, buzzing or other noises in one or both ears, a condition known as tinnitus.

The patents include Polymer-based Surgically Implantable Haloperidol Delivery Systems and Methods for Their Production and Use, and, Drug Containing Implants and Methods of Use Thereof.

M2281    Polymer-based Surgically Implantable Haloperidol Delivery Systems and Methods for Their Production and Use  60/242,304

Q3399-PCT    Long-Term Delivery Formulations and Methods of Use Thereof  US05/00884

S4072    Drug-Containing Implants and Methods od Use Thereof  11/183,232

S4084    Drug containing Implants and Methods of Use Thereof  11/195,845

S4236    Ropinerol Implants for the Treatment of Parkinson’s Disease  S No. 60/789,961

LAD to improve the control, consistency and convenience of medication delivery. LAD is comprised of a biodegradable polymer matrix using commonly available medical polymers and an active drug. It is formed into a small implant for injection just below the skin. We designed LAD to improve the control, consistency and convenience of medication delivery.

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.