Royalty Report: Drugs, Pain, Therapeutic – Collection: 240601

The Licensor of Denmark grants to an exclusive, even as to Licensor; in the Field in the Exclusive Territory to use the Licensor Product Deliverables and investigational new drug, or IND, Deliverables to make, have made under contract, use, develop and have developed under contract pharmaceutical products containing Lornoxicam, or any salts, solvates or polymorphs thereof, as the single active drug substance and pharmaceutical products containing Lornoxicam, or any salts, solvates or polymorphs thereof, as an active drug substance in combination with one or more other active drug substances, in each case during the Option Period solely in connection with the Initial Development Program.

Licensor grants an exclusive option during the Option Period to license the Licensed Technology for the research, development and Commercialization of Licensee Products on the terms set forth in this Agreement.

Licensor grants an exclusive, even as to Licensor, with the right to grant sublicenses, under the Licensed Technology to develop, have developed under contract, use, offer to sell, sell, have sold, distribute and import pharmaceutical products containing Lornoxicam, or any salts, solvates or polymorphs thereof, as the single active drug substance and pharmaceutical products containing Lornoxicam, or any salts, solvates or polymorphs thereof, as an active drug substance in combination with one or more other active drug substances in the Exclusive Territory in the Field.

Licensor grants an exclusive, except as to Licensor or its licensees or sublicensees, license, with the right to grant sublicenses, under the Licensed Technology to develop, have developed under contract, use, offer to sell, sell, have sold, distribute and import pharmaceutical products containing Lornoxicam, or any salts, solvates or polymorphs thereof, as an active drug substance in combination with one or more other active drug substances in the Limited Territory in the Field.

Licensor grants an exclusive, even as to Licensor, license, with the right to grant sublicenses, under the Licensed Technology to make and have made under contract pharmaceutical products containing Lornoxicam, or any salts, solvates or polymorphs thereof, as the single active drug substance and pharmaceutical products containing Lornoxicam, or any salts, solvates or polymorphs thereof, as an active drug substance in combination with one or more other active drug substances for the Field in the Exclusive Territory.

Licensor grants a non-exclusive, license under the Licensed Technology, with the right to grant sublicenses, to make and have made under contract pharmaceutical products containing Lornoxicam, or any salts, solvates or polymorphs thereof, as the single active drug substance and pharmaceutical products containing Lornoxicam, or any salts, solvates or polymorphs thereof, as an active drug substance in combination with one or more other active drug substances for the Field outside the Exclusive Territory.

For the Isomer Option, Licensor grants a right of first refusal on an exclusive license, with the right to grant sublicenses, under any applicable Patent, Know-How or intellectual property other than Patents, Controlled by Licensor relating to any Isomer Product to develop, have developed under contract, make, have made under contract, use, offer to sell, sell, have sold, distribute and import such Isomer Product in the Field in the Exclusive Territory.

Combination Product means a pharmaceutical product containing Lomoxicam, or any salts, solvates or polymorphs thereof, as an active drug substance in combination with one or more additional active drug substances, and developed or manufactured by or on behalf of Licensee or Sublicensees using or referencing the Licensed Technology or any part thereof, or the use, manufacture or sale of which would, but for the licenses granted herein, infringe any Licensed Patents or intellectual property right other than Patents included in the Licensed Technology.

Isomer Product means a pharmaceutical product containing an isomer of Lornoxicam as either the single active drug substance or as an active drug substance in combination with one or more other active drug substances, developed solely by Licensor, and for which Licensor files an IND or equivalent filing in the Exclusive Territory within five years of the Effective Date.

Lornoxicam means the active drug substance known as lornoxicam, having the chemical structure set forth in this Agreement.

Lornoxicam, also known as chlortenoxicam, is a nonsteroidal anti-inflammatory drug (NSAID) of the oxicam class with analgesic (pain relieving), anti-inflammatory and antipyretic (fever reducing) properties.

Licensor grants a license to use the Licensor House Marks in connection with the Commercialization of Licensor Products in the Field of Use in the Territory.

Licensor grants an option for a period of twenty-four months the Japan Option Period after the Effective Date to include Japan in the Territory to Licensee.

Esomeprazole means that certain pharmaceutical compound with the name (5-methoxy-2-{(S)-[ ( 4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl }-1 H-benzimidazole ), including any salts, hydrates, solvates, polymorphs and tautomers thereof.

Naproxen means that certain pharmaceutical compound with the chemical name (S)-6-methoxy-(alpha)-methyl-2-naphthaleneaceti,c acid, including any esters, salts, hydrates, solvates and polymorphs thereof.

The patent is for Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs.

IP relates to the sublicenses’s proprietary fixed dose combinations of the proton pump inhibitor (PPI) esomeprazole magnesium with the non-steroidal anti-inflammatory drug (NSAID) naproxen, in a single tablet.  Naproxen is used to relieve pain from various conditions such as headache, muscle aches, tendonitis, dental pain, and menstrual cramps. It also reduces pain, swelling, and joint stiffness caused by arthritis, bursitis, and gout attacks. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID).

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.