Royalty Report: Drugs, Disease, Therapeutic – Collection: 223112

License Grant

Licensor, government public health organization, hereby grants and the Canadian Licensee accepts, subject to the terms and conditions of this Agreement an exclusive license for drug delivery system; and methods of treating fibroproliferative vascular diseases including restenosis and atherosclerosis utilizing local administration of mlcrotubule stabilizing agent, as encompassed by the subject patent(s) and/or patent application(s), including paclitaxel, watersoluble derivatives of paclitaxel, and deuterium oxide; and drug delivery systems and methods of treating fibroproliferative vascular diseases utilizing systemic, non-local administration of mlcrotubule stabilizing agents as encompassed by the subject patent(s) and/or patent application(s), excluding paclitaxel and water-soluble derivative, of paclitaxel; and a nonexclusive license for drug delivery systems and methods of treating restenosis and atherosclerosis utilizing systemic, non-local administration of paclitaxel and water-soluble derivatives of paclitaxel.

License Property

Llcensed Patent Rights shall mean U.S. Patents and Patent Applications.

5,616,608 – Method of treating atherosclerosis or restenosis using microtubule stabilizing agent

Licensed Product(s) means tangible·materials which, in the course of manufacture, use, or sale would, in the absence of this Agreement, infringe one or more cl.aims of the Licensed Patent Rights that have not been held invalid or unenforceable by an unappealed or unapproachable Judgment of a court of compact jurisdiction.

Field of Use

This agreement pertains to drug delivery systems and methods of treating fibroprolifertive vascular diseases.

Fibroproliferative vascular diseases include restenosis, using local and systemic administration of paclitaxel and other microtubule stabilizing agents.
Restenosis is the recurrence of stenosis, a narrowing of a blood vessel, leading to restricted blood flow. And atherosclerosis is a disease in which the inside of an artery narrows due to the build up of plaque. Initially, there are generally no symptoms.

License Grant

In consideration of the mutual covenants set forth herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Canadian Licensee and Licensor, government organization, agree to amend the Original Agreement.  The Parties wish to adjust the earned royalty rates to reflect the additional intellectual property rights that were granted to the Licensee by another Party that is needed to practice the invention.  They also wish to further define the active components of certain Combined Products and to expedite the ultimate clinical use of Licensed Products which are at a later stage of development by severing certain legal obligations from other Licensed Products which are at earlier stages of development.

The Original Agreement by and between Licensor and Licensee grants Licensee, among other things, an exclusive license under the Licensed Patent Rights in the Licensed Territory to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import Licensed Products in the Licensed Fields of Use and to practice and have practiced any Licensed Processes in the Licensed Fields of Use.

Licensor grants Licensee an exclusive license in two different Licensed Fields of Use and a nonexclusive license in a third Licensed Field of Use.

License Property

Llcensed Patent Rights shall mean U.S. Patents and Patent Applications.

5,616,608 – Method of treating atherosclerosis or restenosis using microtubule stabilizing agent

Licensed Product(s) means tangible·materials which, in the course of manufacture, use, or sale would, in the absence of this Agreement, infringe one or more cl.aims of the Licensed Patent Rights that have not been held invalid or unenforceable by an unappealed or unapproachable Judgment of a court of compact jurisdiction.

Field of Use

Fields of Use is the treatment of coronary restenosis and/or atherosclerosis.

Restenosis is the recurrence of stenosis, a narrowing of a blood vessel, leading to restricted blood flow. And atherosclerosis is a disease in which the inside of an artery narrows due to the build up of plaque. Initially, there are generally no symptoms.

License Grant

In consideration of the mutual covenants set forth herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Canadian Licensee and Licensor agree to amend the agreement.  The Parties wish to allow Licensee additional time to submit royalty reports and royalty payments under the Original Agreement and to modify the method of measuring the value of access to the valid and enforceable Licensed Patent Rights with respect to certain Licensed Products.

The Original Agreement by and between Licensor and Licensee grants Licensee, among other things, an exclusive license under the Licensed Patent Rights in the Licensed Territory to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import Licensed Products in the Licensed Fields of Use and to practice and have practiced any Licensed Processes in the Licensed Fields of Use.

License Property

Llcensed Patent Rights shall mean U.S. Patents and Patent Applications.

5,616,608 – Method of treating atherosclerosis or restenosis using microtubule stabilizing agent

Field of Use

This Agreement pertains to the drug industry relating to the Fields of Use for treatment of coronary restenosis and/or atherosclerosis.

Restenosis is the recurrence of stenosis, a narrowing of a blood vessel, leading to restricted blood flow. Restenosis usually pertains to an artery or other large blood vessel that has become narrowed, received treatment to clear the blockage and subsequently become renarrowed.

Atherosclerosis is a disease in which the inside of an artery narrows due to the build up of plaque.

License Grant

The Licensor of Ireland grants a license, with rights to sublicense, the Licensors Proprietary Rights to make, have made, use, import, offer for sale, and sell Licensee Devices incorporating Product in the Territory pursuant to the terms of this Agreement.

License Property

Licensor has experience and expertise in the manufacture of paclitaxel and owns or controls intellectual property rights relating to paclitaxel.

Product shall mean the bulk form of the compound paclitaxel and/or any compound that is a modification or derivative of the compound paclitaxel that Licensor manufactures at any time during the term of this Agreement.

Field of Use

The Field of Use shall mean the treatment and/or prevention of restenosis, coronary diseases, and/or vascular diseases, the Vascular Applications.

License Grant

Under the initial agreement, the Canadian Licensor agreed to license on a co-exclusive certain patent rights, license rights, and technology.

This agreement is extending Licensee’s worldwide right and license to use, manufacture, have manufactured, distribute and sell, and to grant sublicenses to its Affiliates to use, manufacture, have manufactured, distribute and sell, the Licensor Technology in the Peripheral Vascular Field of Use and the GI Field of Use.

Licensor newly grants its licensee, the right for Licensee to have third party Distributors distribute Eligible Peripheral Vascular and/or GI Products.

This agreement is co-exclusive with an option to become exclusive.

License Property

This agreement is for paclitaxel or certain other agents as a coating for certain medical devices.

The license agreement regards paclitaxel-eluting stent products and related technologies.  Paclitaxel is released from the balloon or stent to prevent scar tissue formation in the blood vessel that can re-obstruct the artery (restenosis).

Field of Use

As used herein, the Coronary Vascular Field of Use means endoluminal vascular Licensed Applications for the treatment and/or prevention of disease of the coronary arteries and their branches, or other vasculature providing blood flow to the heart.

As used herein, the Peripheral Vascular Field of Use means the endoluminal vascular licensed applications for the treatment or preventionof disease of the peripheral blood vessels of the body.  Notwithstanding the foregoing, Peripheral Vascular Field of Use excludes any application in the Coronary Vascular Field of Use.  

GI Field of Use means the endoluminal licensed applications for the treatment or prevention of disease of the alimentary tract or liver.

License Grant

Licensor grants the Licensee of Japan the right and license, with no right to sublicense except as provided under the Licensor Patents and the Know-How, solely to use the Licensed Compounds to conduct Development and to import, use, and sell Products solely for use in the Field within the Territory.

For Other Indications for Licensed Compounds, Licensor grants a right of first refusal to obtain licenses to use Licensed Compounds for other applications or indications outside the Field.

For Rights to Related Compounds. Licensor grants the right to include within the license rights granted under the License specific Related Compounds.

The Parties are to develop  and  commercialize LR-3280 and certain related oligonucleotide compounds in Japan and certain other countries in Asia for the prevention or treatment of restenosis in any blood vessel  following an angioplasty or similar procedure,  and Licensor will supply Licensee quantities of product containing such compounds for clinical use and commercial sale.

License Property

Licensor is engaged in research and  development of, among other things, oligonucleotides and oligonucleotide  analogs that may be useful for therapeutic treatment of disease conditions.   Licensor is presently developing  one such oligonucleotide compound, identified as LR-3280 targeted to c-myc mRNA, as a pharmaceutical product for the prevention or treatment of restenosis in any blood vessel following an angioplasty or similar procedure.

The patents subject matter includes but is not limited to
–  Method of inhibition smooth muscle cell proliferation by treating with c-myc antisense;
–  Method of treating restenosis by administrating c-myr antisense;
–  Method of Inhibiting collagen synthesis by treating with c-myr antisense;
–  Method of treating vascular grafts to reduce stenosis by applying c-myr antisense to graft; and,
–  Pharmaceutical compositions for the above methods.

Licensed Compounds means the oligonucleotide compound identified by Licensor as LR-3280, and any other phosphorothioated oligonucleotidc compounds that now or hereafter are owned or Controlled by Licensor or its Affiliates and that specifically target the mRNA transcribed from the c-myc gene, or contain four deoxyguanosine nucleotides in a row and are developed by Licensor for use in the Field.

Clinical Trial Product means a product,  appropriate for use in clinical trials, containing a Licensed  Compound or placebo, as applicable, in the formulation as determined by Licensee.

Field of Use

Field means the prevention or treatment of restenosis in humans in any blood vessel by use of a Licensed Compound delivered to the affected blood vessel via a Delivery Means following any stenosis-reducing medical procedure that is Transient in nature and that is intended to reduce the obstruction of the blood flow in a stenosed vessel (including without limitation percutaneous transluminal angioplasty, percutaneous transluminal coronary angioplasty and angioplasty involving placement of an intravascular stent).

Restenosis is the recurrence of stenosis, a narrowing of a blood vessel, leading to restricted blood flow. Restenosis usually pertains to an artery or other large blood vessel that has become narrowed, received treatment to clear the blockage and subsequently become renarrowed.

License Grant

The Irish Licensor grants a license, with rights to sublicense, the Licensor Proprietary Rights to make, have made, use, import, offer for sale, and sell Licensee Devices incorporating Product in the Territory.

Licensee covenants that, it will only manufacture and supply Product to two (2) other Third Parties for incorporation into implantable medical devices for the Field of Use.

License Property

The Product shall mean the bulk form of the compound paclitaxel and/or any compound that is a modification or derivative of the compound paclitaxel that Licensor manufactures at any time during the term of this Agreement.

Paclitaxel is an anti-proliferative drug.  It is an anti-cancer chemotherapy drug.

Field of Use

The Field of Use shall mean the treatment and/or prevention of restenosis, coronary diseases, and/or vascular diseases.

Paclitaxel is used in Licensee's stent.