SECURITIES AND EXCHANGE COMMISSION
Pursuant to Section 13 OR 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) October
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Item 1.01 Entry into a Material Definitive Agreement
On October 30, 2012 Orgenesis Inc. (the Company) and
Fraunhofer Institute for Interfacial Engineering and Biotechnology (Fraunhofer
IGB) entered into a service agreement to develop a pilot process to manufacture
human autologous insulin-producing cell transplants based on the Orgenesis
technology. It is anticipated that the subsequent establishment of a fully
GMP-compliant production process will, in turn, enable Orgenesis to obtain
authorization for the production of clinical grade material to be used in a
first-in-man study of the Companys diabetes treatment product candidate.
The Company will provide Fraunhofer IGB with required
information and cell material to perform certain experiments set out in work
packages. Times for each of the work packages are dependent on a close
collaboration with the Company providing sufficient amounts of cell material in
time, method transfer and performing functional studies with cell material
produced by the Fraunhofer IGB.
The Company will access and pay for the work packages on a case
by case arrangement. Agreements on new work packages to be included during the
project and the elimination of work packages can be made during the tenure.
Payments by the Company are due on the receipt of the final work package reports
from Fraunhofer IGB by work package:
The agreement will continue until Fraunhofer IGB completes all
their work packages or, should no essential progress in work be achieved within
a significant period of time, then each contracting party shall be entitled to
terminate the contract with one month notice.
A copy of the service agreement is attached as exhibit 10.1 to
this current report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
November 8th, 2012