Royalty Report: Drugs, Delivery, Pharmaceuticals – Collection: 248403

License Grant

This Agreement provides for a feasibility and phase I study to be conducted to study the feasibility of oral delivery of the product cyclobenzoprine using Licensors delivery technology.

Licensor grants the exclusive option to obtain an exclusive, worldwide license under the Licensor Intellectual Property for the further development and commercialization of the Product.

License Property

Licensors property is LipralTM technology.   Lipralâ„¢ is for improved oral absorption of poorly water soluble drugs and elimination of food effects on absorption.

The Licensees property relates to very low dose cyclobenzoprine (VLD-cyclo).

Field of Use

The field is for improving absorption of poorly water-soluble compounds.

License Grant

The Irish Licensee entered into a purchase and license agreement with the Irish Licensor, to license several oral drug delivery technologies, including a large intellectual property portfolio, which included the GIPET and GIRES delivery technologies, as well as a pipeline of future products and technologies relating to oral vaccine delivery and targeting ligands.

Field of Use

The rights granted apply to the healthcare industry relating in the development of improved oral dosage forms of drugs with poor bioavailability.

License Grant

Pursuant to the terms of this agreement, upon approval by the Licensor of one or both products to be combined with NexACT® drug delivery technology, the individual product Licenses will be granted to the Licensee.  Licensee has ownership interest in Licensor.

License Property

Upon grant of such product License, the Licensee will make Milestone and Royalty Payments on sales of the Licensed Product directly or as a co-marketer.

Royalties in will be payable on a country-by-country basis for the longer of the time during which manufacture, use or sale of Licensed Product would infringe any patent rights within the Patents and 15 years from the first commercial sale of Licensed Product in such country.

NexACT, a clinically validated multi-route drug delivery technology, utilizes patented highly effective, novel excipients or penetration enhancers to dramatically improve absorption and bioavailability of drugs. Varying the concentration of the enhancer allows for local or systemic delivery of drug, as desired.

Field of Use

The NexACT® technology allows:
1.Topical/transdermal delivery of drugs (even proteins),
2.Subcutaneous delivery of drugs in a depot-like fashion with improved bioavailability, and
3.Oral delivery of poorly permeable/soluble compounds including compounds belonging to BCS 2 to 4 categories.

License Grant

For the exclusive Patent Rights, Licensor, an university,  grants to Licensee an exclusive license under such Patent Rights to manufacture, have manufactured, distribute, have distributed, use, offer for Sale, Sell, lease, loan and/or import Licensed Products in the Exclusive Field in the Territory and to perform Licensed Services in the Exclusive Field in the Territory.

For the Limited Patent Rights, Licensor grants to Licensee:
—
an exclusive license to manufacture, have manufactured, distribute, have distributed, use, offer for Sale, Sell, lease, loan and/or import Licensed Products in the Limited Exclusive Field in the Territory and to perform Licensed Services in the Limited Exclusive Field in the Territory, and
—
a non-exclusive license to manufacture, have manufactured, distribute, have distributed, use, offer for Sale, Sell, lease, loan and/or import Licensed Products in the field of vaccines the Territory and to perform Licensed Services in the field of vaccines the Territory. Both parties agree that Licensor can further license the Patent Rights listed in Exhibit C in the field of vaccines.

License Property

Exclusive Patent rights are for:
—  Enhanced Delivery of Immunosuppressive Drug Compositions for Pulmonary Delivery
—  Compositions and Methods of Making Brittle-Matrix Particles Through Blister Pack Freezing
—  Process for Production of Nanoparticles and Microparticles by Spray Freezing Into Liquid
—  Drug Particles From Freezing onto a Surface
—  Multidrug Brittle Matrix Compositions
—  Templated Open Flocs of Anisotropic Particles for Enhanced Pulmonary Delivery
—  Non-Settling Flocs for Surfactant-Free Enhanced Pulmonary Delivery with Pressurized Metered Dose Inhalers
—  Tern plated Open Flocs of Anisotropic Particles for Enhanced Pulmonary Delivery

Limited patent rights are for:
—  Formation of Stable Submicron Peptide or Protein Particles by Thin Film Freezing

Field of Use

The field of use relates to particle formation, and more particularly, to the formation of stable submicron protein particles.  The specific fields are as applicable in the Exclusive patents or Limited Exclusive patents.

Thin Film Freezing (TFF) platform can significantly improve the solubility of poorly water-soluble drugs, a class of drugs that makes up approximately 33% of the major pharmaceuticals worldwide, thereby improving the pharmacokinetic effect of those drugs. We believe that in the case of some new drugs that cannot be developed due to poor water-solubility, our TFF platform has the potential to improve the pharmacokinetic effect of the drug to a level allowing for its development and commercialization. While our TFF platform was designed to improve solubility of poorly water-soluble drugs generally, we have found that the technology is particularly useful in generating dry powder particles with properties that allow for superior inhalation delivery, especially to the deep lung, which is an area of extreme interest in respiratory medicine.