Royalty Report: cardiac, Therapeutic, Drugs – Collection: 27221

License Grant

In 1998, the Company entered into a cooperative drug discovery agreement to identify and develop an antisense therapy as a potential treatment for pulmonary hypertension.

License Property

Pulmonary hypertension (PH or PHT) is an increase in blood pressure in the pulmonary artery, pulmonary vein, or pulmonary capillaries, together known as the lung vasculature, leading to shortness of breath, dizziness, fainting, and other symptoms, all of which are exacerbated by exertion. Pulmonary hypertension can be a severe disease with a markedly decreased exercise tolerance and heart failure.

Field of Use

The Field of Use apply to the medical industry.

License Grant

The Amendment expands the scope of the Licensee's license from the Licensor. Under the Cross-License Amendment, the Licensee will continue to develop the pulse program in the field of cardiopulmonary disease.

License Property

The Licensor manufactures and markets pharmaceutical drugs and devices.

INOpulse is based on the Company’s proprietary pulsatile nitric oxide delivery device. The Company is currently developing two product candidates under its INOpulse program one for the treatment of pulmonary arterial hypertension, or PAH, for which the Company intends to commence Phase 3 clinical trials in the second half of 2015, and the other for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease, or PH COPD, which is in Phase 2 development.

The INOpulse device is designed to be portable for use by ambulatory patients on a daily basis inside or outside their homes. The device is programmed to automatically adjust based on a patient’s breathing pattern to deliver a constant and appropriate dose of the inhaled nitric oxide over time, independent of the patient’s activity level, thus ensuring more consistent dosing in the alveoli of the lungs. In addition, we have developed a proprietary triple-lumen nasal cannula which enables more accurate delivery of the dose to the patient. The INOpulse device is also compatible with many long-term oxygen therapy systems that operate via a nasal cannula.

Field of Use

The Licensee will develop its Licensor pulse program for the treatment of three additional cardiopulmonary diseases chronic thromboembolic pulmonary hypertension (CTEPH), pulmonary hypertension associated with sarcoidosis and pulmonary hypertension associated with pulmonary edema from high altitude sickness.

License Grant

Licensor hereby grants to Licensee a license under the Licensor's IP to research, develop, use, import, make, have made, sell, and offer for sale Licensee Products in the Field in the Territory.

The Channel Agreement grants the Licensee a worldwide License to use specified patents and other intellectual property of the Licensor in connection with the research, development, use, importing, manufacture, sale, and offer for sale of products involving the production of PGIS (prostacylin synthase) through the use of an in vivo conditionally regulated embedded controllable bioreactor for the treatment of Pulmonary arterial hypertension (PAH)  in humans.

Licensee may not subLicense the rights described without Licensor's written consent.

License Property

Licensor has expertise in and owns or controls proprietary technology relating to the design and production of DNA vectors or their in vivo expression or the control of expression, as well as control over cell function.

The synthetic biologic product candidate is intended to treat PAH, a serious life-threatening lung disease. This product is designed to deliver DNA that encodes a therapeutic protein called prostacyclin synthase (PGIS) locally to the pulmonary arteries of PAH patients via a single procedure, and, via an oral daily pill, control the long-term local expression of such therapeutic protein.

Field of Use

The field of use include the production of prostaglandin synthase (PGIS) through the use of an in vivo conditionally regulated embedded controllable bioreactor for the treatment of PAH in humans.

Pulmonary arterial hypertension (PAH) is high blood pressure in the arteries of your lungs. It’s a serious condition that can make it difficult for blood to flow through your lungs. This can force your heart to work harder than normal.

The Licensee intends to use the Licensor's technology directed towards the production of PGIS, through the use of in vivo conditionally regulated embedded controllable bioreactors for the treatment of PAH.

License Grant

The Swiss Licensor hereby grants to the Canadian Licensee a perpetual, world-wide exclusive license, with the right to grant sub-licenses, at the royalty rates set out to the Purchased Assets and the Arising Patents and the know how related thereto for Cardiovascular Indications, which Licensee shall exploit at its own risk and without any possible recourse of whatever nature against Licensor or any of its Affiliates.

License Property

For the purposes of this Agreement, 'Cardiovascular Indications' means heart failure, coronary artery disease, arterial hypertension or systemic hypertension, arrhythmias (including atrial, nodal, and ventricular), hypertension, peripheral vascular disorders, shock, endocarditis, pericardial disease, cardiac tumors, vaivular heart disease and angina only. For the avoidance of doubt, Cardiovascular Indications do not include cerebrovascular diseases, pulmonary hypertension and Chronic Obstructive Pulmonary Disease. Within a reasonable time after the invention or creation of any Arising Patents and the know how related thereto, Licensor will notify and provide reasonable particulars of same to Licensee.

'Existing Patents' means the RSD930 and RSD1236 Patent Families (ApplicationNumbers US 09/328,540; PCT/CA99/00535; US 09/328,541; PCT/CA99/00534; PCT/CA00/01506; PCT/CA00/01507; PCT/CA00/01508; PCT/CA98/00842 and Thailand Patent Appl.# 045858; Taiwan Patent Appl.# 87114395; The Philippines Patent Appl. # 98/2246; and Malaysia Patent Appl. # Pl 9804017 and all patentm applications claiming priority therefrom or sharing at least one common priority therewith).

Field of Use

The rights granted apply to the drug industry in the respiratory field for cardiovascular indications.

License Grant

The Company has an exclusively license for patents and a patent application for the composition and production of the stable prostacyclin analog now known as UT-15 for the treatment of pulmonary hypertension and congestive heart failure and for late-stage peripheral vascular disease.

License Grant

The parties wish to amend certain provisions of the Supply Agreement to, among other things, change the pricing terms; and the parties wish to amend certain provisions of the License Agreement to, among other things, add royalty terms, as additional consideration for the Products to be supplied under the Supply Agreement.

License Property

INOpulse is based on the Company’s proprietary pulsatile nitric oxide delivery device and the other for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease, or PH COPD.  The INOpulse device is designed to be portable for use by ambulatory patients on a daily basis inside or outside their homes. The device is programmed to automatically adjust based on a patient’s breathing pattern to deliver a constant and appropriate dose of the inhaled nitric oxide over time, independent of the patient’s activity level, thus ensuring more consistent dosing in the alveoli of the lungs.

Field of Use

This agreement pertains to the drug industry.

License Grant

Licensor hereby grants to Licensee an exclusive, non-transferable, sublicenseable license, under the Licensor Know-How and the Licensor Patents, to Develop and Commercialize the Product in the Field in the Territory during the Term. Notwithstanding the foregoing, Licensor may conduct research and other development activities with the Compound including, in connection with Licensor’s Development, manufacture and Commercialization of the Product in Licensor’s Domain; provided that Licensor shall not have the right to conduct any clinical study of the Product in the Field in the Territory.

License Property

Competitive Product shall mean any phosphodiesterase 5 inhibitor.
Compound shall mean the bulk active pharmaceutical ingredient tadalafil.
Pulmonary Arterial Hypertension or PAH shall mean all WHO classifications of pulmonary arterial hypertension identified in the Venice 2003 Revised Classification system.
Protocol H6D-MC-LVGX(f) An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension.

Patents
5,859,006, Granted January, 12, 1999

6,821,975, Granted November 23, 2004

7, 182, 958, Granted February 27, 2007

US Application 10/521,393

Field of Use

Field shall mean the treatment, amelioration, and prevention of any and all forms of pulmonary hypertension in humans, including (a) all WHO classifications of pulmonary hypertension in the Venice 2003 Revised Classification system and (b) all forms of pulmonary hypertension secondary to other indications.

License Grant

The amendment extends the exclusive license to market, promote and commercialize tadalafil.

License Property

The licensed product tadalafil is solely under the brand name Adcirca®.

U.S. Patent Nos. 6,821,975 (expiring November 19, 2020) (“975”) and 7,182,958 (expiring April 26, 2020) (“958”)

Field of Use

ADCIRCA (tadalafil), an oral treatment for pulmonary arterial hypertension, is a selective inhibitor of cyclic guanosine monophosphate (cGMP).specific phosphodiesterase type 5 (PDE5).