Exhibit 10.28
Confidential Materials omitted and filed
separately with the
Securities and Exchange Commission. Asterisks
denote omissions.
AMENDMENT TO DECEMBER 5, 1997
EXCLUSIVE
LICENSE AGREEMENT BETWEEN SCHERING AND
SEPRACOR
This amendment to the
December 5, 1997 Exclusive License Agreement between Schering
and Sepracor (“the Amendment”) is made as of this 7th
day of November, 2008 by Schering-Plough Ltd., a Swiss corporation
having a place of business at Topferstrasse 5, 6004 Lucerne,
Switzerland (“Schering”), and Sepracor Inc., a Delaware
corporation having a place of business at 84 Waterford Drive,
Marlborough, Massachusetts 01752 (“Sepracor”)
(collectively, “the Parties”).
WHEREAS, the Parties mutually desire
to amend their December 5, 1997 Exclusive License Agreement
(“the Agreement”) as set forth herein; and
WHEREAS, the Parties acknowledge
that this Amendment conforms to Article IX, Section 9.6
of the Agreement and is a permitted amendment to that
Agreement.
NOW THEREFORE, in consideration of
the rights and obligations set forth herein, the sufficiency of
which is hereby acknowledged, Schering and Sepracor agree as
follows.
1.
All capitalized
terms not otherwise defined herein shall have the meaning ascribed
to same in the Agreement.
(a)
Schering and
Sepracor agree that the term “Sepracor Actions” shall
include any action for infringement of certain patents listed in
Schedule 1.18 of the Agreement or otherwise included in the
definition of “Patent Rights” in Article I,
Section 1.18 of the Agreement (the “Sepracor
Patents”) brought by Sepracor against certain Abbreviated New
Drug Application (“ANDA”) filers with respect to one or
more of New Drug Application (“NDA”) Nos. 021300,
021312, 021313, 021605, and/or 021165, several of which are
currently pending in the United States District Court for the
District of New Jersey.
(b)
Schering and
Sepracor agree that the term “Exempted Sublicensee”
shall mean any Sublicensee where: [**].
(c)
Schering and
Sepracor agree that the term “NDA Product” shall mean a
Licensed Product under the Agreement approved for marketing in the
United States pursuant to a New Drug Application.
(d)
Schering and
Sepracor agree that the term “Prescription NDA Product”
shall mean a NDA Product, as defined above, that requires a
prescription to be sold in the United States.
(e)
Schering and
Sepracor agree that the term “[**] NDA Product” shall
mean a NDA Product, as defined above, that does [**] in the United
States.
(f)
Schering and
Sepracor agree that the term “Generic Equivalent” shall
mean a pharmaceutical product that has received U.S. Food and Drug
Administration (“FDA”)
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