Royalty Report: Drugs, Delivery, Pain – Collection: 273417

Valproic Acid EnteriCare™ Product shall mean enteric release soft gelatin capsules containing the Active Ingredient in the dosage strengths and dosage forms for the Valproic Acid EnteriCare™ Product described in Agreement and made using Licensor’s EnteriCare™ technology.

EnteriCare technology creates a seamless, one-piece design that is uniquely tamper-evident.

Valproic Acid Versatrol™ Product shall mean extended release soft gelatin capsules containing the Active Ingredient in the dosage strengths and dosage forms for the Valproic Acid Versatrol™ Product described in Agreement and made using Licensor’s Versatrol™ technology.

Versatrolâ„¢ controlled release softgel technology uses a standard softgel shell combined with lipid assisted drug delivery, enhancing the absorption of poorly soluble compounds.

Packaged Product shall mean quantities of Product(s) packaged in retail size containers or as physician samples, as the case may be, and not intended for repackaging or re-labeling under the Act.

Intellectual Property shall mean any patent, patent application, trademark, service mark, trade name, trade dress, copyright, trade secret, proprietary know-how, discovery, development or invention, whether or not patentable.

Licensor grants a non-exclusive license, with the right to grant sublicenses, in the territory for the term to use the Licensor trademark upon or in relation to the product.

The drug specificed for this agreement is Once-daily oral morphine capsules, containing SODAS® beads.

The trademark shall mean SODAS®.

The Product to be supplied to Licensee by Licensor shall be in the form of bulk two-piece hard gelatin capsules containing microparticulate SODAS® particles.

SODAS® (Spheroidal Oral Drug Absorption System) is Licensor’s Multiparticulate drug delivery system. Based on the production of controlled release beads, the SODAS® technology is characterized by its inherent flexibility, enabling the production of customized dosage forms that respond directly to individual drug candidate needs.

Licensor is knowledgeable in the development of drug specific dosage forms and has developed a unique range of delivery systems designed to provide newer and better formulations of medicaments,

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.