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Exhibit
10.28
CDC IV, LLC
47 HULFISH STREET, SUITE
310
PRINCETON, NEW JERSEY
08542
September 5, 2007
BioDelivery Sciences International,
Inc.
Arius Pharmaceuticals, Inc.
and
Arius Two, Inc.
2501 Aerial Center Parkway, Suite
205
Morrisville, North Caroline
27560
Attn: Mark A. Sirgo, President and Chief
Executive Officer
RE: Clinical Development and License
Agreement
Dear Mr. Sirgo:
The purpose of this letter
(this “Letter Agreement”) is to set out certain
understandings and agreements between (i) CDC IV, LLC
(“CDC”) and (ii) BioDelivery Sciences
International, Inc. (“BioDelivery”), Arius
Pharmaceuticals, Inc., a wholly-owned subsidiary of BDSI
(“Arius”) and Arius Two, Inc., a wholly-owned
subsidiary of BioDelivery (“Arius Two”).
Reference is hereby made to
that certain Clinical Development and License Agreement (as
amended, the “CDC License”), dated as of July 14,
2005 among CDC (as successor in interest to Clinical Development
Capital LLC), BioDelivery and Arius. Pursuant to the terms of the
CDC License, BioDelivery, Arius and Arius Two have requested that
CDC consent to, among other things, (i) the acquisition by
Arius Two of certain assets related to the BEMA Fentanyl product
from QLT USA, Inc., and (ii) the amendment of the CDC License
in connection with such acquisition and the subsequent license of
certain rights with respect to such assets by Arius to Meda AB; in
each case pursuant to the terms of (A) that certain
Sublicensing Consent and Amendment, entered into as of the date
hereof, by BDSI, Arius and CDC (the “Sublicensing
Consent”) and (B) that certain BEMA Acquisition Consent,
Amendment and Waiver, entered into as of the date hereof, by BDSI,
Arius, Arius Two and CDC (the “Acquisition Consent” and
together with the Sublicensing Consent, collectively, the
“CDC Consents”). As a condition to CDC entering into
the CDC Consents, CDC is requiring BDSI, Arius and Arius Two to
enter into this Letter Agreement. Capitalized terms used herein,
but not otherwise defined herein, shall have the meanings set forth
in the Acquisition Consent.
1. Defaults and
Terminations under the New License . Notwithstanding anything
to the contrary set forth in the CDC License, the QLT License, the
New License, the Acquisition Agreements, the CDC Consents or any
agreements entered into by any of BDSI, Arius or Arius Two in
connection with any of the foregoing, BDSI, Arius and Arius Two
hereby agree and acknowledge that (i) in no event shall Arius
Two declare any default against Arius under the New License, or
otherwise exercise any right to terminate the New License or other
remedy thereunder, without the written consent of CDC, in its sole
and absolute discretion and (ii) in no
event shall CDC be required to cure any
defaults by Arius under the New License in order to exercise its
rights under Sections 2.04(d) or 14.06 or other similar provisions
of the New License. The foregoing restrictions shall terminate to
the extent Arius Two fails to satisfy its Obligations (as such term
is defined in the certain Security Agreement by and between Arius
Two and QLT, dated as of the date hereof (the “QLT Security
Agreement”)), QLT thereafter exercises its rights with
respect to the Collateral (as defined in the QLT Security
Agreement) pursuant to the Acquisition Agreements, and Arius
Two’s rights and obligations under the New License are
assigned to an Arius Two Assignee.
2. Transfer of Acquired
Assets to Arius and Termination of New License . BDSI, Arius
and Arius Two hereby agree and acknowledge that upon the
termination of the security interest created in favor of QLT under
the Acquisition Agreements (i) the New License shall
automatically terminate and (ii) simultaneously therewith,
Arius Two shall assign and transfer all of its right, title and
interest in and to the Acquired Assets to Arius and to the extent
any such Acquired Assets are not already subject to a security
interest in favor of CDC pursuant to the Security Agreement, such
Acquired Assets shall automatically, and without the need for
further a
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