Royalty Report: Drugs, Delivery – Collection: 266767

License Grant

Licensor grants a non-exclusive license under and to its respective rights and interests in Licensors Background IP solely for use by Licensee and its Affiliates in the performance of Licensees obligations under this Agreement and the development, the manufacture, obtaining regulatory approvals, the importation, the use, the marketing, the distribution and the sale of the Target Formulations in and for the Territory.

License Property

Licensor has certain expertise in formulating, manufacturing, and developing new formulations of metaxalone that present bioavailability profile that is higher than the Reference Product.

Reference Product shall mean that drug product containing a dosage of 800 mg of metaxalone as described in NDA # 13-217.

Target Formulation A shall mean pharmaceutical product for human use developed under this Agreement in solid oral dosage form, containing no more than 640 mg of metaxalone that is bioequivalent to the Reference Product with respect to metaxalone Cmax and AUC and approximately equivalent with respect to metaxalone Tmax, and intended to be dosed with the same frequency as the Reference Product.

Target Formulation B shall mean pharmaceutical product for human use metaxalone developed under this Agreement that is intended to be dosed twice per day.

Field of Use

Licensor possesses rights in certain intellectual property pertaining to product formulations of the active pharmaceutical ingredient metaxalone.  Metaxalone is a moderate to strong muscle relaxant used in the symptomatic treatment of musculoskeletal pain caused by strains, sprains, and other musculoskeletal conditions.

License Grant

For the Product, Licensor grants a nonexclusive, personal, non-transferable and, nonassignable license under the Licensor Patent Rights to make, use, offer for sale, sell and import the Product in the Territory.

For the Launch Timing of Authorized Generic Product, the Parties agree that the Authorized Generic Product may only be marketed, distributed or sold by Licensee beginning on the Authorized Generic Launch Date and continuing through the Term of this Agreement.

For the License to Manufacture. Licensor grants a nonexclusive, personal, non-transferable and, nonassignable license under the Licensor Authorized Generic Patent Rights to Manufacture the Authorized Generic Product in the Territory during the Term.

For the License to Commercialize,  Licensor grants a non-exclusive, personal, non-transferable and, non-assignable license under the Licensor Authorized Generic Patent Rights to Commercialize the Authorized Generic Product in the Territory during the Term.

For the Assignment, Licensor agrees to, and hereby does, and shall cause each of its employees, consultants, subcontractors, and Affiliates to, assign exclusively to Licensee all right, title, and interest in and to Licensees Manufacturing Equipment Improvements and Licensees Manufacturing Process Improvements developed, conceived, or created by such Licensor Assignors, alone or jointly with others, including all intellectual property rights associated therewith.

License Property

The product is Skelaxin® (metaxalone) tablets in an 800 mg dosage strength.

Field of Use

The Licensor is a pharmaceutical company that performs basic research and develops, manufactures, markets and sells branded prescription pharmaceutical products and animal health products.  Skelaxin® is use as a muscle relaxer.

License Grant

Licensor grants a worldwide, co-exclusive, with Licensor license under the Licensed Patent Rights and under the Licensed Know-How, in each case to make, use, offer for sale, sell and import Licensed Products.  For the avoidance of doubt, the license granted to Licensee herein shall include, without limitation, the right to use Licensed Know-How and License Patent Rights in connection with the regulatory approval, labeling and marketing of Licensed Products.

License Property

This certain intellectual property is pertaining to the pharmaceutical active ingredient known as metaxalone.

The licensed know-how includes studies titled Determination of Metaxalone Metabolism in Expressed Recombinant Human Enzymes;  and, Determination of the Inhibitory Potential ofMetaxalone on the Activities ofCYPlA2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2El, and CYP3A4 in Human Liver Microsomes; and,  Determination of the induction of CYP1A2, CYP2B6, CYP2A6, CYP2C8, CYP2C9, CYP2Cl 9, CYP2D6, CYP2El , and CYP3A4 activities by Metaxalone in human hepatocytes.

Metaxalone is a skeletal muscle relaxant prescribed for the short-term treatment of painful muscle spasms.

Field of Use

Licensee is a pharmaceutical company that develops, manufactures, markets and sells branded prescription pharmaceutical products.  Licensees product containing metaxalone competes in a market with other muscle relaxants.

License Grant

Licensor grants to Irish Licensee the worldwide, non-transferable sub-licensable, exclusive, license (with the right to make improvements to the LDS Patents) to promote, distribute, market, develop, research, make, have made, use and/or sell any product in the LDS Patents field.

License Property

Products shall mean the following compounds and all complexes, mixtures and other combinations, prodrugs, metabolites, enantiomers, salt forms, racemates, polymorphs and isomers of the following compounds
Metaxalone
Zaleplon (being N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide)
Antegrenâ„¢
Zonisamide
Botulinum Toxin Type B
Ziconotide
Frovatriptan
Tizanidine
Pergolide

Metaxalone is a muscle relaxant used to relax muscles and relieve pain caused by strains, sprains, and other musculoskeletal conditions.
Zaleplon is a sedative-hypnotic, almost entirely used for the management/treatment of insomnia.
Antegren is a humanized monoclonal antibody against the cell adhesion molecule a4-integrin. Natalizumab is used in the treatment of multiple sclerosis and Crohn's disease.
Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents.

Field of Use

Field shall mean any and all uses except  
(a) to the extent required for Elan to comply in all respects with the Orasense Agreements;  
(b) to the extent required for Elan to comply in all respects with the Avlan Agreements;  
(c) to the extent required for Elan to comply in all respects with the GlycoGenesys Licence Agreement;  
(d) to the extent required for Elan to comply in all respects with the Emisphere Settlement Agreement;  
(e) to the extent required for Elan to comply in all respects with the Targeted Genetics Agreements; and  
(f) with respect to any and all Elan Exclusive Products.