i8-k.htm
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 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): November 8, 2008
(Exact
Name of Registrant as Specified in Its Charter)
(State or
Other Jurisdiction of Incorporation)
(Commission File
Number) (IRS
Employer Identification No.)
8720
Stony Point Parkway, Suite 200, Richmond,
Virginia 23235
(Address of Principal
Executive
Offices) (Zip
Code)
(Registrant’s
Telephone Number, Including Area Code)
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:
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
INFORMATION
TO BE INCLUDED IN THE REPORT
Section
1—Registrant’s Business and Operations
Item
1.01. Entry
into a Material Definitive Agreement.
On November 8, 2008, Genentech and
Ipsen/Tercica signed a letter of intent whereby they have consented to amend the
March 7, 2007 Court-Ordered Settlement, Development and License Agreement (the
“Agreement”) between Genentech, Inc. (“Genentech”) Tercica, Inc. (“Tercica”) and
Insmed Incorporated (“Insmed”) to permit Insmed to supply IPLEX™ in connection
with named-patient ALS programs worldwide on a royalty-free basis. Insmed’s
ability to do so will be dependent on satisfying any regulatory requirements in
any country where a request for treatment is made.
On
November 10, 2008 Insmed issued a Press Release announcing a joint statement
from Genentech, Ipsen/Tercica and Insmed stating that Insmed had gained
royalty-free worldwide rights for IPLEX™ from Genentech and Ipsen/Tercica in
connection with potential Named Patient (Expanded Access) Programs for ALS. A
copy of the Press Release is attached hereto as Exhibit 99.1 and is incorporated
herein by this reference.
Item
9.01. Financial
Statements and Exhibits
(d)
Exhibits
99.1 Press Release, dated November 10
2008
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.
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Insmed
Incorporated
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Date: November
10, 2008
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By: /s/ Kevin P. Tully
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Name: Kevin
P. Tully C.G.A.,
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Title: Executive
Vice President & Chief Financial Officer
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EXHIBIT
INDEX
Exhibit
No. Description
99.1 Press Release, dated November 10,
2008