Exhibit 10.1
*Confidential Treatment has
been
requested for the marked portions
of this exhibit pursuant to Rule
24b-2 of the Securities Exchange
Act of 1934, as amended.
AMENDMENT NO. 4 TO
EXCLUSIVE SUBLICENSE
AGREEMENT
THIS AMENDMENT NO. 4 (the “
Amendment ”) dated as of May 8, 2009 to the
Exclusive Sublicense Agreement by and between Alkermes, Inc., a
Pennsylvania corporation with its principal offices at 88 Sidney
Street, Cambridge, MA 02139 (“ Alkermes ”), and
Targeted Genetics Corporation, a Washington corporation with its
principal offices at 1100 Olive Way, Suite 100, Seattle, Washington
98101 (“ Targeted ”),
WITNESSETH:
WHEREAS, Alkermes and Targeted
entered into an Exclusive Sublicense Agreement dated June 9,
1999, as previously amended on March 12,
2002, May 29, 2003 and March 9, 2007 (the “
Agreement ”); and
WHEREAS, Alkermes, on the one hand,
and Children’s Hospital Research Foundation and
Children’s Hospital Inc., on the other hand, have entered
into various amendments to the License Agreement between these
parties, dated as of April 10, 1996 (the “ AAV
License Agreement ”), which is the license agreement
underlying the Agreement; and
WHEREAS, in accordance with the
terms and conditions hereinafter set forth, Alkermes and Targeted
now wish to amend the Agreement to conform to the changes made to
the AAV License Agreement pursuant to such amendments;
NOW, THEREFORE, in consideration of
the foregoing premises and the mutual covenants and agreements set
forth herein, the Parties agree as follows:
1. Definitions
. Unless otherwise provide herein,
all defined terms used in this Amendment shall have the same
meanings as set forth in the Agreement. The Agreement shall be
amended to add the following new definitions:
“1.18 “Customers”
means research institutes, academic institutions, universities and
other organizations of higher education, and/or hospitals that
contract with Licensor for the manufacture of Licensed Products. In
no event shall a Customer be (a) a for-profit entity or
(b) a not-for-profit foundation, such as the [*] . A
Customer must own or control rights in the product, or use thereof,
that it desires Licensor to manufacture and supply using the rights
Licensor retains under the AAV License Agreement, which ownership
or control may be evidenced solely from a filing of a patent
application regarding such Licensed Product or its use.
1.19 “Educational and Research
Purposes” means education and/or research activities which
includes clinical trials up to or consisting of Phase II Clinical
Trials.
1.20 “Funders” means not-for-profit
organizations, including not-for-profit foundations such as the
[*] , and governmental entities such as the National
Institutes of Health.
1.21 “Licensor” means
Children’s Hospital Research Foundation and Children’s
Hospital Inc.”
2.
Section 2.2 .
Section 2.2 of the Agreement shall be deleted in its entirety
and replaced with a new Section 2.2 which shall read as
follows:
“2.2 Reserved Rights
.
(a) Alkermes reserves unto itself
the personal, non-transferable right to make, have made, and use
Licensed Product(s) and Licensed Material in the Fields of Use for
internal research purposes only, and for no other purpose in the
Fields of Use.
(b) Alkermes reserves for Licensor
the non-exclusive right to use and have used the Licensed Patent
Rights, Licensed Products and/or Licensed Processes, and associated
information and technology of Licensor, (i) for research
and/or educational purposes; and (ii) subject to Sections 2.2
(c) and (d), to manufacture products containing AAV vectors
for use by Licensor and Customers for Educational and Research
Purposes. The reservation of rights in this Section 2.2(b)
does not permit, in any way, any entity except Licensor from using
the Licensed Patent Rights, Licensed Products or Licensed
Processes, and associated information and technology of Licensor,
to manufacture Licensed Products.
(c) Customers may only receive
funding for the manufacture by Licensor of Licensed Products under
this Section 2.2 by either self-funding or receiving money
from Funders. Licensed Products manufactured and supplied by
Licensor pursuant to this Section 2.2 shall not, in whole or
in part, be funded by, owned by, optioned or licensed for
development and commercialization to a for-profit entity at the
time the Licensed Product is so manufactured by Licensor or during
the conduct of clinical trials utilizing such Licensed Product so
manufactured. A not-for-profit organization, including Licensor,
may receive funding from a Funder for the manufacture by Licensor
of products pursuant to this Section 2.2; provided
however , that such funding for the manufacture by Licensor by
any one Funder shall not exceed [*] per year per Licensed
Product manufactured and, in the event that the Customer receives
funding from a Funder that is a not-for-profit foundation, the
not-for-profit foundation must not own or have licensed any patent
rights necessary or useful for the Licensed Products manufactured
by Licensor, other than a non-exclusive license or option to any
inventions made during the manufacture by Licensor of Licensed
Products pursuant to Section 2.2 and funded by such
not-for-profit foundation. In no instance shall Licensor receive
any funding from [*] relating to the manufacture of Licensed
Products consistent with this Section 2.2. Nothing herein
shall limit Licensor’s or a Customer’s ability to
receive funding from any source for any purpose, including
Educational and Research Purposes, not related to the manufacture
of a Licensed Product under this Section 2.2.
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(d) Restrictions on
Manufacturing . In no event shall Licensor manufacture and
supply any Licensed Products pursuant to this Section 2.2 for
Educational and Research Purposes on the following without the
prior written consent of Alkermes, which consent shall be provided
on behalf of Alkermes by its sublicensee Targeted: [*] .
Alkermes shall be informed by Licensor of any such consent provided
by Alkermes’ sublicensee, Targeted. Licensor will not grant
the right to use Licensed Products manufactured and supplied to
Customers by Licensor pursuant to this Section 2.2 by
for-profit entities (excluding those conducting the clinical
trials, e.g. hospitals, and the CROs administering
them).”
3. Section 2.4
. The penultimate
sentence of Section 2.4 of the Agreement shall be deleted in
its entirety and replaced with a new penultimate sentence which
shall read as follows:
“Targeted shall keep Alkermes
apprised of all ongoing sublicensing negotiations and the general
nature of same in a timely manner; Targeted shall also give
Alkermes prompt notification of the identity and address of each
Sublicensee with whom it concludes a Sublicense Agreement and shall
supply Alkermes with a copy of each such Sublicense
Agreement.”
4. Section 2.6
. Section 2.6 of the
Agreement shall be deleted in its entirety and replaced with a new
Section 2.6 which shall read as follows:
“2.6