CytoSorbents Corporation (CTSO)

[ping_pow_princess]

Summary of the Biocon Deal

Territories:
1. India
2. Sri Lanka

Applications Included:
Non-surgical, Critical Care Use, Intra-operative Surgical Procedures
(Critical Care including Sepsis, Cardiac Surgery, including Cardiopulmonary Bypass and Extracorporeal Membrane Oxygenation (ECMO), Graft vs. Host Disease, Allogeneic Bone Marrow Transplant, Organ Transplant, and Hemorrhagic Fever)

Product registration:
Biocon to register. If additional clinical trial of CytoSorb is required for marketing approval in Sri Lanka, then distribution agreement will be amended to remove Sri Lanka and substitue with another country/region not requiring human trials.

Minimum Purchase Requirements for each year:
not disclosed

Clinical studies:
Biocon to initate 4 (small) Investigator Initiated Trials (IIT). At least one substantial in nature with 20 patients. Qty limited to number of CytoSorb required to meet enrollment and not exceed 100 in total across all studies. Biocon shall publish at least 2 patient case studies in each of four (4) Applications pursuant to the IIT or routine use of CytoSorb in the Territory.

Investigator Initiated Trials (IIT) Focus Areas
(i) Sepsis.
(ii) Lung related diseases such as Acute Respiratory Distress Syndrome (ARDS) and Acute Lung Injury (ALI).
(iii) Intra-abdominal indications such as complicated intra-abdominal infections, Abdominal Compartment Syndrome.
(iv) Severe Acute Pancreatitis.
(v) Liver Disease; infective or non-infective associated ALF.
(vi) Post- operative SIRS.
(vii) Tropical disease; Dengue and Malaria.
(viii) Intra-operative use in Cardiopulmonary Bypass surgery

Effective date:
Four years from Oct 30, 2014 unless terminated

Export listing:
https://www.zauba.com/import-cytosorb-hs-code.html
(Cytosorb comes in units of 12 per case. So quantity of 300 is 25 cases.)