Royalty Report: Delivery, Drugs, Medical – Collection: 294293

License Grant

Licensor grants an exclusive, worldwide license under the Licensor IP Rights, Licensor Research IP Rights, and Licensors rights under the Joint Research IP Rights to develop, make, have made, use, offer for sale, sell, have sold, export and import the Product for use in the Field.

License Property

The Product shall mean a biodegradable, preformed, macroscopic implant device consisting of the Active Agent, as the sole active pharmaceutical ingredient, incorporated into the Delivery Matrix.

The joint research is for Implants for the treatment of dopamine associated states, meaning Biodegradable implant containing a dopamine modluating compound.

Licensor patents include Methods for manufacturing delivery systems and systems, and, Modulating burst and release profiles from coestruded implants by treating implant ends, and, Influencing drug release  profiles from implants by selectively adjusting the location and amount of drug loading, and, Implant devices that differ by release profile and methods of making and using same.

Field of Use

Parties have been collaborating since on the development of a biodegradable sustained release formulation of an approved dopamine agonist. The result is Licensee’s NP201, the first long-acting treatment available in broadly acceptable dose form that maintains the potential to provide sustained relief from Parkinson’s disease without motor response complications. NP201 leverages Licensee’s long-acting delivery (LAD™) technology and Licensee’s proprietary biodegradable polymer matrix implant technology to achieve optimal drug release over an extended period of time.

License Grant

University grants to Company an exclusive, world-wide license to make, have made, use, import, offer for sale and sell Licensed Products in the Field of Use during the Term.

License Property

The Party have a joint interest in a that certain patent application titled, “Implants for the Treatment of Dopamine Associated States”, US No. 60/789,961

LAD to improve the control, consistency and convenience of medication delivery. LAD is comprised of a biodegradable polymer matrix using commonly available medical polymers and an active drug. It is formed into a small implant for injection just below the skin. We designed LAD to improve the control, consistency and convenience of medication delivery.

M2281 Polymer-based Surgically Implantable Haloperidol Delivery Systems and Methods for Their Production and Use – US Patent Application 60/242,304

Q3399-PCT Long-Term Delivery Formulations and Methods of Use Thereof  -PCT Application US05/00884

S4072 Drug- Containing Implants and Methods of Use Thereof  – US Provisional Patent Application 11/183,232

S4084 Drug containing Implants and Methods of Use Thereof – US Provisional Patent Application 11/195,845

S4236 Ropinerol Implants for the Treatment of Parkinson’s Disease – US No. 60/789,961

Field of Use

The patent is for Implants for the Treatment of Dopamine Associated States, known as the Ropinirole Patent.

Ropinirole is used to treat symptoms of Parkinson's disease (stiffness, tremors, muscle spasms, and poor muscle control). Ropinirole is also used to treat restless legs syndrome (RLS).

License Grant

Licensor will undertake the Project exclusively for Licensee.  The purpose of the Project is to develop the Product.

Licensor will grant an exclusive license to Licensors interest in Research Inventions and Licensors Technology, including, without limitation, all know how and present and future patents, patent applications, certificates of invention, or applications for certificates of invention and any supplemental protection certificates together with any extensions, registrations, confirmations, reissues, substitutions, divisions, continuations or continuations-in-part, reexamination or renewals thereof to the extent necessary for Licensee to make, have made, use, import, sell, have sold and offer for sale the Product in the Field in the Territory.

Licensor grants an exclusive option to license Licensors interest in Research Inventions and Licensor Technology necessary to make, have made, use and sell the Product developed.

With respect to the Project, Licensor shall provide the services of such personnel, laboratory facilities, equipment, chemicals, and other supplies as are required to conduct its activities under this agreement.

License Property

The Product is Injectable, biodegradable implant (single preformed macroscopic device) formulation of the Active Agent for the treatment of Parkinsons Disease and/or Restless Leg Syndrome in humans.

Licensors patent is for  Methods for Manufacturing delivery Systems and Systems Thereof.

Licensors technology includes
• Designing and developing depot formulations and devices with biodegradable polymers and non-biodegradable polymers.
• Microparticle compositions to achieve sustained release.
• Nanoparticle compositions to increase bioavailability (includes polymeric and lipid excipients).
• Process technology (laboratory scale, pilot scale, and manufacturing) to fabricate depot formulations, including microparticles.
• Analytical testing useful for the development and registration of depot formulations and devices.
• Design and synthesis of biodegradable polymers.
• Attachment of small molecules and macromolecules to biodegradable polymers]

Field of Use

The product field of use is for the treatment of Parkinsons Disease and/or Restless Leg Syndrome in humans.  The agreement field of use is prevention, treatment or control of any human or animal condition, disease or physiological function.

Licensee designed NP201 to provide continuous delivery of Parkinson’s disease medication in an easy to administer andtolerable dose formulation. After administration, NP201 isdesigned to slowly release ropinirole, an FDA approvedmedication. Based on data from our preclinical studies, webelieve that NP201 has the potential to provide continuoussymptomatic relief for up to two months per dose and tosignificantly decrease the incidence of adverse eventsassociated with current treatments.

License Grant

The University grants an exclusive, world-wide license to make, have made, use, import, offer for sale and sell Licensed Products in the Field .

License Property

The University has intellectual property relating to surgically implantable drug delivery systems.

The patents include Polymer-based Surgically Implantable Haloperidol Delivery Systems and Methods for Their Production and Use, and, Drug Containing Implants and Methods of Use Thereof.

M2281    Polymer-based Surgically Implantable Haloperidol Delivery Systems and Methods for Their Production and Use  60/242,304

Q3399-PCT    Long-Term Delivery Formulations and Methods of Use Thereof  US05/00884

S4072    Drug-Containing Implants and Methods od Use Thereof  11/183,232

S4084    Drug containing Implants and Methods of Use Thereof  11/195,845

S4236    Ropinerol Implants for the Treatment of Parkinson’s Disease  S No. 60/789,961

Field of Use

The license from University patent applications and other intellectual property related to the LAD technology to develop and commercialize licensed products

LAD to improve the control, consistency and convenience of medication delivery. LAD is comprised of a biodegradable polymer matrix using commonly available medical polymers and an active drug. It is formed into a small implant for injection just below the skin. We designed LAD to improve the control, consistency and convenience of medication delivery.

License Grant

The Parties previously entered into a related Feasibility Study Agreement.  This agreement is for the development, manufacture and commercialization of an injectable long-acting formulation of AC2993 (synthetic exendin–4).

Licensor grants an exclusive, worldwide license in the Field under Licensor Patents and Licensor Know-How, together with the right to grant sublicenses, to make, have made, use, import, offer to sell, sell and have sold Products.

This agreement includes a non-exclusive grant back from Licensee to Licensor.

License Property

The intellectual property rights are relating to injectable, sustained release formulation systems, including the Medisorb(R) microsphere system, a patented and proprietary (Medisorb(R)) injectable sustained release drug delivery technology.

AC2993 means synthetic exendin-4.

The patents include Preparation of Biodegradable Microparticles Containing a Biologically Active Agent, Preparation of Extended Shelf-Life Biodegradable, Biocompatible Microparticles Containing a Biologically Active Agent,  Method for Preparing Microparticles Having a Selected Release Profile, Apparatus and Method for Preparing Microparticles Using an In-line Solvent Extraction;  and, Apparatus and Method for Preparing Micropartides.

Field of Use

Field means System formulations of Field Products.  

Field Products mean Exendins (including AC2993), exendin agonists, GLP-1 and GLP-1 agonists. The initial Field Product will be AC2993.

AC2993 is a diabetes drug candidate.

License Grant

Licensor grants to the Licensee of Denmark and its Affiliates a worldwide, exclusive license, with the right to sublicense, to the Licensed Patents and Licensed Know-How, to research, develop, make, have made, use, import, export, sell, offer for sale, and otherwise transfer the Licensed Product in the Territory.

Licensee desires to obtain, and Licensor is willing to grant, an exclusive, worldwide license to the proprietary DepoFoam® delivery system in order to develop and commercialize  formulations of Liraglutide.

License Property

Licensor is a biopharmaceutical company specializing in the discovery, development and commercialization of DepoFoam® a proprietary injectable sustained-release delivery system (multivesicular liposomes).

Formulation Intellectual Property means all Know-How arising from activities performed under this Agreement regarding formulations of Liraglutide with DepoFoam and/or methods or processes for making or using such formulations.

Liraglutide means Licensees proprietary, human Glucagon-Like Peptide-1 (GLP-1} analogue.
Liraglutide is a medication used to treat diabetes mellitus type 2 and obesity.

Field of Use

DepoFoam is a drug delivery technology which consists of multi-vesicular liposome particles that contain internal chambers for encapsulated drugs. DepoFoam is capable of sustained release of a drug over a period of between one and 30 days. It works with narrow gauge needles and pen systems and offers flexible delivery that can be designed to for an immediate release dose followed by sustained delivery.

License Grant

The Netherlands Licensee hereby grants to Licensor, and Licensor hereby accepts, the right of first refusal to be granted a license under all future patents and patent applications in connection with the PolyActive Technology for the non-exclusive use by Licensor of the PolyActive Technology in the Orthopedic Field and/or for use as a medical device not containing a biological active agent(s). Such right will be subject to a royalty.

Licensee grants to Licensor and Licensor accepts, as from the Effective Date, an exclusive, unlimited, world-wide, perpetual, royalty-free license, with the right to grant sub-licenses to make, use, sell, market and develop any PolyActive Rights B relating to osseouschondral and/or osteochondral plugs, fillers, cement restrictors, or the like, including but not limited to SynPlug(TM) (Licensee License B.)

Licensee grants to Licensor and Licensor accepts, as from the Effective Date, an exclusive, unlimited, world-wide, perpetual, royalty-free license, with the right to grant sub-licenses to make, use, sell, market and develop any PolyActive Rights A and/or PolyActive Rights B related to the use of the PolyActive Technology in a medical device to be used to measure and/or monitor blood glucose (Licensor License AB).

License Property

PolyActive Technology shall mean a drug delivery system controlling the release of biologically active molecules, which is based on PolyActive. Products based on PolyActive Technology can be used for both local and systemic administration, and have applications in pharmaceutics and medical technology.

PolyActive shall mean a biodegradable (amphiphilic) poly(ether-ester) multiblock copolymer based on PEGT and PBT.

CHIENNA-Patents shall mean the patents and patent applications defined and listed in Annex I(A) to the ACLA.

PolyActive Rights A shall mean the PolyActive Rights A as defined and listed in Annex 3.2, consisting of the CHIENNA-Patents but not including all previously abandoned and/or transferred patents and patent applications.

6,685,957 – Preparation of fibrous polymer implant containing bioactive agents using wet spinning technique
5,980,948 – Polyetherester copolymers as drug delivery matrices

PolyActive Rights B Shall mean the PolyActive Rights B as defined and listed in Annex 3.1, consisting of the Licensor-Patents but not including (1) all previously abandoned and/or transferred patents and patent applications; (2) the Osteoinduction patent family; and (3) the Cement Restrictor 4th Design.

6,479,418 – Porous ceramic body
6,069,295 – Implant material

Field of Use

PolyActive is a biodegradable polymeric drug delivery system.  Licensee uses PolyActive to develop its controlled-release alfa interferon product LocteronTM.

Locteron is a controlled release formulation of interferon alfa for the treatment of chronic hepatitis C, currently in Phase IIa studies.

Orthopedic Field shall mean that part of the Licensees patents and patent application which relate to a therapeutic application to the musculoskeletal system, including bone, cartilage, joints, related connective tissues, ligaments, tendons and nerves.

PolyActive technology and its intellectual property in certain strategic areas, including additional applications in orthopedics.