Royalty Report: Drugs, Delivery, Pharmaceuticals – Collection: 2626

License Grant

The Licensee entered into two Agreements for the development and licensing of up to twenty-five immediate release liquid generic products and seven solid oral dosage generic pharmaceutical products.

License Grant

Assignor sells, transfers, assigns and delivers to Assignee all of Assignors right, title and interest in and to the Patent Application and the Intellectual Property.

License Property

The Licensors technology is known as oral extended release dosage form based on the principle of controlled hydration.

The CDT system is used in solid oral dosage forms, the preferred route for drug administration. This technology is designed to produce tablets or capsules that release their active agents predictably and programmably over a specified timeframe of up to 24 hours. We believe we can apply our technology to create significant enhancements to existing pharmaceutical, OTC and nutraceutical products.

Proprietary CDT technology improves upon conventional multiple daily dose immediate release forms of existing products by providing the therapeutic benefits of controlled release drug delivery. In addition, we believe our technology can provide enhanced dosage formats for existing medications that provide superior patient convenience and product differentiation.

Field of Use

The use is for oral extended release dosage.

The technology has allowed Assignor cost-effectively develop formulations for the OTC and nutritional industries, such as  glucosamine, glucosamine/chondroitin, niacin, pseudoephedrine, caffeine, vitamin C, Novasoy®, and other difficult compounds and branded ingredients.

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 hereby grants to Licensee a non-exclusive license under the Patent Rights to make, have made (solely as set forth below), use, sell, offer for sale and import Generic Product in or for the United States (where “United States” for purposes of this Agreement shall include its territories and possessions, including, without limitation, the District of Columbia and the Commonwealth of Puerto Rico (but excluding direct sales of Generic Product into the Commonwealth of Puerto Rico)) from and after the AG Date (and before the AG Date for reasonable commercial preparation).

License Property

5,908,838 – Method for the treatment of acne
7,541,347 –  Minocycline oral dosage forms for the treatment of acne
7,544,373 – Minocycline oral dosage forms for the treatment of acne

Solodyn Products means the Solodyn® products listed.
Solodyn 45mg;  Solodyn 90mg;  Solodyn 135mg

SOLODYN® is the first and only extended release minocycline with five FDA-approved dosing strengths. OLODYN® is lipid soluble, and distributes in the skin and sebum and approved for once daily dosage in the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age or older.

Field of Use

The field of use is for the treatment of acne.  The dermatological field represents products for the treatment of acne and acne-related dermatological conditions.  Solodyn Products are used for once daily dosage in the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age or older.