Confidential treatment has been requested for
portions of this exhibit. The copy filed herewith omits the
information subject to the confidential treatment request.
Omissions are designated as * * *. A complete version of this
exhibit has been filed separately with the Securities and Exchange
Commission.
Exhibit 10.50
AMENDMENT NO. 1 TO FEASIBILITY,
DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
This Amendment No. 1 to
Feasibility, Development And Commercialization Agreement (“
Amendment No. 1 ”) is entered into effective
January 23, 2007 (the “ Amendment Date ”)
by and between DURECT Corporation (“DURECT”) and
Voyager Pharmaceutical Corporation (“ Voyager
”).
PRELIMINARY STATEMENTS
A. Southern BioSystems, Inc., an
Alabama corporation (“ SBS ”), and Voyager have
previously entered into that certain Feasibility, Development and
Commercialization Agreement dated July 22, 2002 (the “
Agreement ”). Effective December 31, 2002, SBS
merged with and into DURECT, with DURECT as the surviving
corporation. As a result of such merger, DURECT succeeded to all of
the rights and obligations of SBS under the Agreement.
B. Voyager is currently engaged in
collection and analysis of data from a clinical trial conducted for
the Product prior to the Amendment Date, namely Study VP-AD-301
(the “ Specified Clinical Trial ”), and desires
financial and other assistance from DURECT to complete such
collection and analysis.
C. DURECT is willing to provide
financial and other assistance to Voyager.
D. DURECT and Voyager desire to make
certain amendments to the Agreement as set forth below.
THEREFORE, in consideration of the
premises and mutual promises and covenants herein contained and for
good and valuable consideration, the sufficiency of which is hereby
acknowledged, DURECT and Voyager hereby agree as
follows:
1. Unless otherwise defined herein,
all terms used herein shall have the same meaning ascribed to such
terms in the Agreement.
2. DURECT hereby permanently waives
its right to receive payment from Voyager under Section 7.1
for any and all Development Costs accrued up to the Amendment Date
which remain unpaid as of the Amendment Date, including amounts due
under Invoice Nos. 2006027 $286,609.01 (Aug), 2006028 $253,444.56
(Sept), 2006039 $100,919.30 (Oct), 2006053 $62,310.73 (Nov) and
2006066 $23,654.22 (Dec) (the “ Outstanding Development
Costs ”) and also permanently waives its right to
terminate the Agreement under Section 11.2(c)(ii) relating to
non-payment of the Outstanding Development Costs by
Voyager.
3. For the period commencing from
the Amendment Date until April 30, 2007 (the “ Data
Analysis Period ”), DURECT hereby agrees to not exercise
its right to terminate the Agreement under Section 11.2(c)(ii)
for non-payment of amounts owed to DURECT by Voyager that accrue
during the Data Analysis Period. The parties agree that DURECT
shall not accrue any such amounts, such as Development Costs, and
shall not be obligated to perform any work under the Agreement, in
each case during the Data Analysis Period without the prior written
agreement of the parties.
4. DURECT shall pay Voyager an
amount equal to One Million Dollars ($1,000,000). Such payment
shall be made, at DURECT’s election, by check delivered to
Voyager or wire transfer to the bank account designated by Voyager
within two (2) business days of the execution of this
Amendment by both parties.
5. Voyager shall use best efforts to
collect, compile and analyze the data from the Specified Clinical
Trial in accordance with all Applicable Laws (including Good
Clinical Practices) as expeditiously as possible in an accurate and
scientifically sound fashion, provided that initial data analysis
shall be completed by [* * ]. Voyager shall provide DURECT via
email with an update of the status of its efforts no less than [*
*], and promptly provide to DURECT any information, including
status, data, analyses and conclusions, etc. as reasonably
requested by DURECT from time to time. In addition, Voyager shall
provide DURECT within [* * * ] after the completion of data
analyses from the Specified Clinical Trial with [* * *], as well as
any other supporting documentation related to the Specified
Clinical Trial that DURECT may reasonably request, provided that
the same is in Voyager’s possession or reasonably obtainable
by Voyager. Voyager shall use its best efforts to obtain all data
required in the statistical analysis plan agreed to by the
parties.
6. Section 7.3(a) shall be
replaced in its entirety to read as follows:
(a) Subject to the terms and
conditions of this Section 7.3, Voyager shall pay to DURECT
the following royalties based on aggregate Net Sales of the Product
by Voyager, its Affiliates and sublicensees in the Territory during
each calendar year (or part thereof):
Ten Percent (10%) of Net Sales
for that portion of aggregate Net Sales in such calendar year that
is less than or equal to $[* * *];
[* * *] of Net Sales for that
portion of aggregate Net Sales in such calendar year that exceeds
$[* * *] but is less than or equal to $[* * *]; and
Fourteen Percent (14%) of Net
Sales for that portion of aggregate Net Sales in such calendar year
that exceeds $[* * *];
provided that Voyager shall pay
DURECT at least $[* * *] in royalties annually (the “
Minimum Royalty ”) commencing with the year in which
the First Commercial Sale in any country in the Territory is made.
In the event that the First Commercial Sale is made at some time
other than the beginning of a calendar year, the Minimum Royalty
for such first year shall be prorated.
7. Section 7.3(b) of the
Agreement shall be replaced in its entirety to read as
follows:
(b) Voyager’s royalty payment
obligations under this Section 7.3 shall commence with the
First Commercial Sale of the Product and shall continue so long as
Voyager and/or any Affiliate, successor, assign or sublicensee
thereof sells the Product. To the extent that royalties may not be
collected in a certain country in the Territory under Applicable
Law for the full royalty term hereunder, then the royalty due on
sales in such country shall terminate after the maximum period
under which royalties may be collected under Applicable Law without
effect on the royalties due hereunder with respect to sales made in
other countries in the Territory. [* * *]
8. The following shall be added as
Section 7.3(f) to the Agreement:
(f) In the event that Voyager or any
Affiliate, successor or assign thereof sublicenses its rights under
Section 8.2(b), in addition to royalties and milestone
payments under Section 7.2 and 7.3(a), DURECT shall be
entitled to receive ten percent (10%) of any upfront,
milestone or any special fees, payments or other consideration
(including equity) received by Voyager or any Affiliate, successor
or assign thereof on account of such sublicense, but excluding any
royalties on Product sales received by Voyager, as provision is
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