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Exhibit
10.20
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
AMENDMENT
TO
CLINICAL DEVELOPMENT AND
LICENSE AGREEMENT
This Amendment (this “
Amendment ”) to the Clinical Development and License
Agreement, dated as of July 14, 2005 (as amended from time to
time, the “ CDC License ”), is dated as of
September 5, 2007, by and among CDC IV, LLC (“ CDC
”), BioDelivery Sciences International, Inc. (“
BioDelivery ”), Arius Pharmaceuticals, Inc., a
wholly-owned subsidiary of BioDelivery (“ Arius
”) and Arius Two, Inc., a wholly-owned subsidiary of
BioDelivery (“ Arius Two ” and together with
Arius and BioDelivery, collectively, the “ Company
”). Capitalized terms used herein and not otherwise defined
shall have the meanings given to them in the CDC
License.
RECITALS
WHEREAS, CDC (as successor in
interest to Clinical Development Capital LLC), BioDelivery, Arius
and Arius Two entered into the CDC License, pursuant to which,
among other things, CDC invested in the development of certain
compounds being developed by the Company;
WHEREAS, the Company and
Arius have entered into that certain License and Development
Agreement, dated as of the date hereof, with Meda AB (“
Meda ”), a Swedish corporation (the “ Meda
Agreement ”), granting Meda rights to develop and
commercialize the BEMA Fentanyl product in the United States,
Canada, and Mexico; and
WHEREAS, CDC and the Company
desire to amend the CDC License to coordinate certain of the terms
of the CDC License with the Meda Agreement.
NOW THEREFORE, in
consideration of the mutual covenants herein, and intending to be
legally bound hereby, the parties agree as follows:
1. The CDC License is hereby amended as
follows:
(a) Section 6.6.4
. Section 6.6.4 of the CDC License is hereby amended and
restated in its entirety to read as follows:
“6.6.4 Increase in
Royalty due to Reduced Selling Price . In the event that the
Average Selling Price of a Product in the United States is less
than the Average Selling Price of any Competing Product in any
calendar year, then commencing January 1 of the following
year, the First Tier Royalty and Second Tier Royalty shall be
increased to an amount equal to the product of (a) the
respective Royalty and (b) a fraction, the numerator of which
is the *** of such Competing Product, and the denominator of
which is the *** . If there are multiple Competing Products
that have an *** than the Average Selling Price of a
Product, then the Competing Product with the *** shall be
us
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