|
EXHIBIT 10.16
SETTLEMENT AGREEMENT
This Settlement Agreement
("Agreement") is entered into by and among: Duke University, a
North Carolina nonprofit and educational institution; Orexigen
Therapeutics, Inc., a Delaware corporation; Elan Corporation, plc,
an Irish corporation; Elan Pharma International Ltd., an Irish
corporation; Elan Pharmaceuticals, Inc., a Delaware corporation;
Eisai Inc., a Delaware corporation; Eisai Co., Ltd., a Japanese
corporation; and Julianne E. Jennings, an individual (all
collectively referred to herein as the "Parties" or, individually,
the "Party").
RECITALS
WHEREAS, on May 6, 2002, Elan
filed Provisional Application No. 60/378,446, which was
converted into U.S. Patent Application No. 10/429,474 on
May 2, 2003, relating to the use of zonisamide for weight loss
treatment and naming Jennings as the sole inventor;
WHEREAS, in April 2004, Elan
transferred any and all rights it had in U.S. Patent Application
No. 10/429,474 to Eisai Inc., and Eisai Inc. is presently the
owner of U.S. Patent Application No. 10/429,474;
WHEREAS, on May 17, 2002,
Duke filed Provisional Application No. 60/380,874, which was
converted into U.S. Patent Application No. 10/440,404 on
May 19, 2003, relating to the use of zonisamide and other
compounds for weight loss treatment and naming Kishore M. Gadde and
Ranga R. Krishnan as co-inventors;
WHEREAS, on July 12, 2004,
Duke and Orexigen filed a civil action in the United States
District Court for the Middle District of North Carolina against
Elan, Eisai, and Jennings, which action is entitled, Duke
University and Orexigen Therapeutics, Inc., v. Elan Corporation,
plc, Elan Pharma International Ltd., Elan Pharmaceuticals, Inc.,
Eisai, Inc., Eisai Co., Ltd., and Julianne E. Jennings , Civil
Action No. 1:04CV00532 ("the Action");
1
WHEREAS, in the Action, Duke and
Orexigen sought a declaration to correct inventorship and
assignment of U.S. Patent Application No. 10/429,474, and
asserted various other claims;
WHEREAS, in the Action, Elan,
Eisai, and Jennings filed motions to dismiss the Action, which were
granted in part and denied in part;
WHEREAS, the Parties recognize the
uncertainty of the outcome of disputed complex litigation, such as
the Action, and the extended period of time that it could take to
resolve matters through litigation;
WHEREAS, the Parties wish to
contain the fees, costs, and expenses associated with the Action,
and have independently concluded that their respective interests
would be best served by compromising and thereby terminating and
concluding the Action; and
WHEREAS, the Parties intend to
bring to close all current and prospective litigation in the United
States relating to the Eisai Patent(s) and the Duke Patent(s) (as
those terms are defined in this Agreement), as set forth
herein.
NOW, THEREFORE, for good,
valuable, and reciprocal consideration given and received, the
sufficiency of which is hereby acknowledged, and intending to be
legally bound, the Parties agree as follows:
1. DEFINITIONS . The following terms have the meanings
ascribed to them, whether in the singular or plural:
1.1 "Duke" means Duke University
and shall include and encompass Duke’s divisions,
subsidiaries, sub-entities, partners, joint-ventures, affiliates,
owners, executives, officers, directors, administrators,
successors, agents, insurers, underwriters, legal representatives,
and present, past, or future parents.
2
1.2 "Orexigen" means Orexigen
Therapeutics, Inc. and shall include and encompass Orexigen’s
divisions, subsidiaries, sub-entities, partners, joint-ventures,
affiliates, owners, executives, officers, directors,
administrators, successors, agents, insurers, underwriters, legal
representatives, and present, past, or future parents.
1.3 "Elan" means Elan Corporation,
plc, Elan Pharma International Ltd., and Elan Pharmaceuticals, Inc.
and shall include and encompass each of their divisions,
subsidiaries, sub-entities, partners, joint-ventures, affiliates,
owners, executives, officers, directors, administrators,
successors, agents, insurers, underwriters, legal representatives,
and present, past, or future parents.
1.4 "Eisai" means Eisai Inc. and
Eisai Co., Ltd. and shall include and encompass each of their
divisions, subsidiaries, sub-entities, partners, joint-ventures,
affiliates, owners, executives, officers, directors,
administrators, successors, agents, insurers, underwriters, legal
representatives, and present, past, or future parents, and shall
also include any successors in interest to or assigns of the Eisai
Patent(s), defined herein.
1.5 "Jennings" means Julianne E.
Jennings.
1.6 "Eisai Patent(s)" means any
patent that includes a claim which encompasses the use of
zonisamide as the sole active ingredient to treat obesity or other
weight-related disorders or conditions that (a) issues from
U.S. Patent Application No. 10/429,474 filed on May 2,
2003, or (b) issues from any other U.S. patent application claiming
in whole or in part the benefit of the filing date of, or which is
otherwise based on the disclosure in, U.S. Patent Application No.
10/429,474 filed on May 2, 2003 or U.S. Provisional
Application No. 60/378,446 filed on May 6, 2002.
1.7 "Duke Patent(s)" means any
patent that includes a claim which encompasses the use of
zonisamide as the sole active ingredient to treat obesity or other
weight-related disorders or conditions that (a) issues from
U.S. Patent Application No. 10/440,404 filed on May 19,
2003, or (b) issues from any other U.S. patent application
claiming in whole or in part the benefit of the
3
filing date of, or which is otherwise based on the disclosure
in, U.S. Patent Application No. 10/440,404 filed on May 19,
2003 or U.S. Provisional Application No. 60/380,874 filed on
May 17, 2002.
1.8 "Orexigen’s Product"
means any product containing zonisamide in combination with any
other active pharmaceutical agent, including but not limited to
bupropion, wherein zonisamide and the other active pharmaceutical
agent may be administered as a single dosage form or as separate
dosage forms, the product being intended for use in the treatment
of humans, including but not limited to the treatment of obesity or
other weight-related disorders or conditions.
1.9 "Effective Date" means the
date that this Agreement has been signed by all of the Parties,
which may be accomplished by counterparts.
1.10 "Zonegran Product" means the
pharmaceutical product currently approved by the FDA pursuant to
NDA 20-789 and marketed in the United States by Eisai Inc. under
the trademark ZONEGRAN ®
.
1.11 "Gadde" means Kishore M.
Gadde.
1.12 "Krishnan" means Ranga R.
Krishnan.
1.13 "Person" means any
individual, entity, corporation, partnership, joint venture,
limited liability company, trust or unincorporated
organization.
2. DISMISSAL AND RELEASES
2.1 Dismissal of Action .
Within five (5) days of the Effective Date, the Parties shall
execute, and Duke and Orexigen shall cause their counsel to file, a
Stipulation of Dismissal in the form attached as Exhibit A,
which the Parties intend will dismiss Duke’s and
Orexigen’s
4
pending claims in the Action with prejudice in accordance with
Federal Rule of Civil Procedure 41(a)(1)(ii).
2.2 Release by Duke and
Orexigen . Duke and Orexigen, in consideration of the
agreements set forth herein, and intending to be legally bound,
irrevocably release and forever discharge Elan, Eisai, and Jennings
from any actions, causes of action, claims, suits, obligations,
liabilities, and demands whatsoever, whether in law, in equity or
otherwise, arising under the laws of the United States or any State
within the United States, whether known or unknown, asserted or
unasserted, existing as of the Effective Date, based upon, arising
out of or in any way relating to either (a) the Action, or
(b) the Duke Patent(s).
2.3 Release by Elan, Eisai, and
Jennings . Elan, Eisai, and Jennings, in consideration of the
agreements set forth herein, and intending to be legally bound,
irrevocably release and forever discharge Duke and Orexigen from
any actions, causes of action, claims, suits, obligations,
liabilities, and demands whatsoever, whether in law, in equity or
otherwise, arising under the laws of the United States or any State
within the United States, whether known or unknown, asserted or
unasserted, existing as of the Effective Date, based upon, arising
out of or in any way relating to either (a) the Action, or
(b) the Eisai Patent(s).
2.4 Limitations on Releases
. The releases set forth above in Paragraphs 2.2 and 2.3 are
limited to the United States only and do not apply to, and the
Parties expressly reserve their rights with respect to, any and all
actions, causes of action, claims, suits, obligations, liabilities,
and demands whatsoever outside the United States. In addition, the
releases set forth above in Paragraphs 2.2 and 2.3 do not apply
to:
(a) Any claims based upon or
arising out of the rights and obligations created by this
Agreement; or
(b) The rights of the Parties
with respect to the Duke Patent(s) and the Eisai Patent(s) in any
and all present or future proceedings in the U.S. Patent and
Trademark Office, including but not limited to any interference
proceeding relating to the Duke P
|
