Exhibit 10.1
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“ ***
”
January 2, 2009
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BioDelivery
Sciences International, Inc.
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801 Corporate
Center
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Suite
210
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Raleigh, North
Carolina 27607 USA
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Attention:
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Mark A. Sirgo,
Pharm.D.
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President &
CEO
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Dear Mark:
The purpose of this Letter Amendment
(“ LA ”), effective January 2, 2009, (the
“ LA Effective Date ”) is to amend (a) the
License and Development Agreement (the “ EU License
”), entered into as of August 2, 2006 by and among
BioDelivery Sciences International, Inc., a Delaware corporation
with offices at 801 Corporate Center Drive, Suite 210, Raleigh,
North Carolina 27607 (“ Parent ”), its
wholly-owned subsidiary Arius Pharmaceutical, Inc., a Delaware
corporation with offices at the same address (“ Arius
”, and together with Parent, “ BDSI ”),
and Meda AB (“ Meda ”), a Swedish corporation
located at Pipers väg 2 A, SE-170 09, Solna, Sweden (“
Meda ”) and (b) the BEMA Fentanyl Supply
Agreement (the “ Supply Agreement ”), entered
into August 2, 2006 by and between BDSI and Meda in
conjunction with the EU License. Any capitalized terms not defined
in this LA shall have the meaning ascribed to such terms in the EU
License or the Supply Agreement, as applicable.
In consideration of the mutual
covenants herein, and intending to be legally bound hereby, BDSI
and Meda agree as follows:
1. EU License Amendments .
The EU License is hereby amended as follows:
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a.
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The following
definition shall be added to Article I:
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““ European
Countries ” means the countries specified in Exhibit
E attached hereto.”
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b.
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The title of
Exhibit E, “ TERRITORY ”, shall be replaced with
the title “ EUROPEAN COUNTRIES ”.
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c.
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The existing
definition of “ Licensed Patent Rights ” shall
be deleted and replaced in its entirety with the
following:
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““ Licensed Patent
Rights ” means all Patent Rights in the Territory that
claim the same subject matter claimed in the patents and patent
applications listed on Exhibit C, claiming BEMA or any Improvement,
or which are necessary or appropriate to develop, manufacture and
commercialize the Licensed Product in the Territory, and that are
under the Control of BDSI or Arius Two as of the Effective Date or
that come under BDSI’s or Arius Two’s Control during
the Term.”
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
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d.
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Exhibit C shall
be deleted and replaced in its entirety with the amended Exhibit
C attached to this LA and incorporated by reference.
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e.
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The two
sentences in the definition of “ Net Sales ”
corresponding to the following two sentences shall be deleted and
replaced in their entirety with the following two
sentences:
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“ ***
”
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f.
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The following
sentence shall be added immediately following the two sentences in
the definition of Net Sales amended in subsection
(e) above:
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“ ***
”
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g.
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The existing
definition of “ Territory ” shall be deleted and
replaced in its entirety with the following:
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““ Territory
” means all countries of the world other than the United
States, Canada, Mexico, Taiwan and the Republic of
Korea.”
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h.
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The first
sentence of Section 2.01(a) shall be deleted and replaced in
its entirety with the following sentence:
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“In addition to and without
limiting Sections 3.02(e) and 11.03, Meda shall use Commercially
Reasonable Efforts to pursue Product Development for the Licensed
Product in the Territory.”
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i.
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The fourth and
fifth sentences of Section 2.01(a) shall be deleted and
replaced in their entirety with the following two
sentences:
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“Notwithstanding the
exclusivity of Section 3.02(a), (i) if Meda fails to use
Commercially Reasonable Efforts to pursue Product Development in
the European Countries in accordance with this
Section 2.01(a), *** .”
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j.
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The sentence in
Section 2.07 corresponding to the following sentence shall be
deleted and replaced in its entirety with the following
sentence:
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“However, if, following
expiration of the last to expire of the Licensed Patent Rights in
the European Countries, *** .”
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k.
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The sentence in
Section 3.02(e) corresponding to the following sentence shall
be deleted and replaced in its entirety with the following
sentence:
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“Subject to the directions,
instruction, and oversight of the ESC, Meda shall prepare and file
with each of the applicable Competent Authorities the appropriate
applications and related documents necessary to obtain Governmental
Approval to market and sell the Licensed Product in each country in
the Territory in which Meda decides to market the Licensed
Product.”
2
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
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l.
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The clause in
Section 3.02(e)iii. corresponding to the following clause
shall, effective upon the termination of the security interest of
QLT USA, Inc. (“QLT”) in the Licensed Patent Rights,
BEMA License Agreement, dated August 2, 2006, between Arius
and Arius Two, Inc. (“Arius Two”), as amended, and
other BEMA-related assets of Arius Two, as established in the
Amended and Restated Security Agreement between Arius Two and QLT,
dated September 5, 2007, and Amended and Restated Patent and
Trademark Security Agreement between Arius Two and QLT, dated
September 5, 2007, regarding, in each case, Arius Two’s
BEMA-related assets to the extent concerning countries outside of
the United States, Mexico, and Canada, be deleted and replaced in
its entirety with the following clause:
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“upon receipt of Governmental
Approval to market and sell the Licensed Product in a country in
the Territory (including but not limited to Pricing and
Reimbursement Approvals, if and as necessary), Meda shall commence
the marketing and sale of the Licensed Product in such country
within *** of receipt of such Governmental Approval or, if
such country is not listed on Exhibit E, ***
.”
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m.
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The first
sentence of Section 5.01(b) shall be deleted and replaced in
its entirety with the following sentence:
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“Meda agrees to use
Commercially Reasonable Efforts to promote the sale, marketing, and
distribution of the Licensed Product in each of the European
Countrie
