Ventavis definition
Examples of Ventavis in a sentence
Actelion manufacturers and markets pharmaceutical products, including Tracleer, Ventavis, Veletri, and Opsumit (collectively the “Subject Drugs”), that are approved to treat pulmonary arterial hypertension (“PAH”).
Ventavis is packaged in 30 ampule cartons ($[***] WAC per carton of 30 ampules, NDC 10148-101-30) and 100 ampule cartons ($[***] WAC per carton of 100 ampules, NDC 10148-101-01).
Any right of CoTherix to distribute AAD Devices or Consumables with a pharmaceutical other than Ventavis or Iloprost would be the subject of a separate agreement.
Exhale will build a commercial team to conduct pre-launch market development activities and execute a launch campaign that will insure rapid adoption and success of Ventavis in the US.
CoTherix shall maintain a database of all complaints related to AAD Devices, Consumables, Integrated Ventavis/AAD Device Packages, and Ventavis, and any confirmed defects relating to any of the foregoing.
Profile agrees to participate with CoTherix in the Ventavis Patient Assistance Program (“PAP”) by providing Prodose Devices (and when available I-Nebs) and Consumables free of charge to patients who qualify for such program (which shall not exceed [***] of the total number of patients at any given time on Ventavis AAD therapy).
Following FDA approval of the NDA, CoTherix intends to file with the FDA an NDA Supplement seeking approval of the delivery of Ventavis through the I-Neb (“NDA Supplement”).
The terms and conditions the above Plan are detailed in a separate Agreement.
Placebo; 12 weeks Rx N = 140 (70 per Rx) 6 ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ $▇▇ Start TBD Data 20 mos • Study contingent on data from pilot study Commercialization Plan for Ventavis® (Iloprost) Ventavis will be positioned in the US as the preferred prostacyclin for the treatment of Pulmonary Arterial Hypertension (PAH) in a market that is projected to grow to over [***] million per annum by 2008.
For purposes of clarification, if CoTherix elects to pay the Exclusivity Fee in any calendar year, this Agreement does not cover the terms of any distribution by CoTherix of AAD Devices and Successor AAD Devices or Consumables and Successor Consumables with any pharmaceutical other than Ventavis or any formulation of Iloprost (or any product containing Iloprost (in any form) as its active pharmaceutical ingredient) for which required regulatory clearance(s) and approval(s) have been granted.