UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C.
20549
FORM 8-K
CURRENT
REPORT PURSUANT
TO
SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF
1934
Date of
report (Date of earliest event reported): December 11, 2009
GENTA
INCORPORATED
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
(State or
Other Jurisdiction of Incorporation)
0-19635
(Commission
File Number)
|
|
33-0326866
(IRS
Employer Identification No.)
|
|
200 Connell
Drive
Berkeley Heights,
NJ
(Address
of Principal Executive Offices)
|
|
07922
(Zip
Code)
|
(908)
286-9800
(Registrant’s
Telephone Number, Including Area Code)
(Former
Name or Former Address, if Changed Since Last Report)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the Registrant under any of the following
provisions:
¨ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
¨ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a
-12)
¨ Pre
-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR 240.14d -2(b))
¨ Pre
-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act
(17 CFR 240.13e-4(c))
Explanatory
Note: This Form 8-K is being filed merely to file a new copy of the redacted
agreement referenced herein. Other than the agreement, the disclosure herein as
not changed.
Item 1.01 Entry into a Material
Definitive Agreement.
As
previously reported on March 7, 2007, Genta Incorporated, (the “Company”),
announced that on March 6, 2007 it had entered into a Supply and Distribution
Agreement (the “Agreement”) with IDIS (“IDIS”) whereby IDIS will distribute two
of the Company’s oncology products, Ganite® (gallium nitrate injection) and
Genasense® (oblimersen sodium) Injection, on a “named patient” basis. The
global agreement covers territories outside the United States. “Named
patient” distribution refers to the distribution or sale of a product to a
specific healthcare professional for the treatment of an individual patient.
IDIS, a privately owned company based in the United Kingdom, will manage the
named patient programs for the Company.
The
Agreement provides that the Company will supply the two products to IDIS on a
consignment basis. The Company will be paid after sales are made by IDIS, which
payment shall be based off of a monthly sales report received from IDIS. The
Company will invoice IDIS based upon this monthly report which invoice shall be
calculated based upon a price minus a fee credited to IDIS. The agreement also
provides for distribution by IDIS of a limited amount of drug product free of
charge to indigent patients. The Company intends that a percentage of proceeds
from the named patient program will be used to support the compassionate use
program. The Company has agreed to pay a nominal one time start-up fee for this
program to IDIS, and the Company will pay IDIS a termination fee in the event
it terminates either or both products within the first three years. Other
financial terms of the agreement have not been disclosed.
Although
a copy of the Agreement was filed as an exhibit to the Company’s Report on Form
10-Q for the quarter ended March 31, 2007, the Company is filing a modified
redacted copy of the Agreement attached hereto as Exhibit 10.1. The
Agreement has not be amended, but the Company is revising its redacted copy in
response to comments the Company has received from the Securities and Exchange
Commission with respect to its confidential treatment request to the SEC
covering this Agreement.
Item 9.01 Financial Statements and
Exhibits.
(d)
Exhibits.
|
|
|
10.1
|
|
Supply
and Distribution Agreement, dated March 6, 2007, by and between IDIS and
the Company. +
|
+ Confidential
Treatment Requested. Confidential materials omitted and filed
separately with the Securities and Exchange Commission.
SIGNATURES
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.
|
|
GENTA
INCORPORATED
|
|
|
|
Date:
|
December
11, 2009
|
|
By:
|
/s/
Gary Siegel
|
|
|
|
|
Name:
|
Gary
Siegel
|
|
|
|
|
Title:
|
Vice
President,
Finance
|