Item 1.01. Entry into a Material Definitive Agreement.
On December 18, 2008, VIA Pharmaceuticals, Inc. (the "Company") entered into
two Research, Development and Commercialization Agreements (the "Roche
Licenses") with Hoffmann-La Roche Inc. and Hoffmann-La Roche Ltd (together,
"Roche") to develop and commercialize two sets of compounds. The first was for
Roche's thyroid hormone receptor ("THR") beta agonist, a clinically ready
candidate for the control of cholesterol, triglyceride levels and potential in
insulin sensitization/diabetes. The second was for multiple compounds from
Roche's preclinical diacylglycerol acyl transferase 1 ("DGAT1") metabolic
disorders program. Under the terms of the Roche Licenses, VIA will assume
control of all development and commercialization of the compounds, and will own
exclusive worldwide rights for all potential indications.
Roche will receive up to $22.8M in upfront and milestone payments, the
majority of which is tied to the achievement of product development and
regulatory milestones. In addition, once products containing the compounds are
approved for marketing, Roche will receive single-digit royalties based on net
sales, subject to certain reductions.
The Company must use commercially reasonable efforts to conduct clinical and
commercial development programs for products containing the compounds. Under the
Roche License for THR, if the Company has not completed a Phase I clinical trial
with respect to a lead product containing this compound within three years, then
either the Company must commit to developing another of Roche's compounds or
Roche may terminate the Roche License for that compound.
If the Company determines that it is not reasonable to continue clinical
trials or other development of the compounds, it may elect to cease further
development and Roche may terminate the Roche Licenses. If the Company
determines not to pursue the development or commercialization of the compounds
in the United States, Japan, the United Kingdom, Germany, France, Spain or
Italy, Roche may terminate the Roche Licenses solely for such territories.
The Roche Licenses will expire, unless earlier terminated pursuant to other
provisions of the Roche Licenses, on the last to occur of (i) the expiration of
the last valid claim of a licensed patent covering the manufacture, use or sale
of products containing the compounds, or (ii) ten years after the first sale of
a product containing the compounds.
On December 23, 2008, the Company issued a press release announcing the Roche
Licenses. A copy of the press release is filed as Exhibit 99.1 to this report
and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
* 10.1 Research, Development and Commercialization Agreement, dated as of
December 18, 2008, by and between Hoffmann-La Roche Inc., F. Hoffmann-La
Roche Ltd and VIA Pharmaceuticals, Inc.
* 10.2 Research, Development and Commercialization Agreement, dated as of
December 18, 2008, by and between Hoffmann-La Roche Inc., F. Hoffmann-La
Roche Ltd and VIA Pharmaceuticals, Inc.
99.1 Press Release dated December 23, 2008
* Confidential
treatment
requested
for certain
portions of
this Exhibit
pursuant to
Rule 24b-2
under the
Securities
Exchange Act
of 1934, as
amended,
which
portions are
omitted and
filed
separately
with the
Securities
and Exchange
Commission.