*Certain portions of this exhibit
have been omitted pursuant to a request for confidential
treatment which has been filed separately with the SEC.
FIRST AMENDMENT TO MANUFACTURING
AND SUPPLY AGREEMENT
FOR N-ACETYLCYSTEINE
THIS FIRST
AMENDMENT (the “ First Amendment ”) to that
certain Manufacturing and Supply Agreement for N-Acetylcysteine
(the "
Agreement ”), dated as of January 15, 2002, as
modified by that certain Novation Agreement, dated as of
January 27, 2006 (to be attached hereto), is entered into by
and between CUMBERLAND PHARMACEUTICALS INC., a corporation
organized and existing under the laws of Tennessee, United States
(“ CUMBERLAND ”), and BIONICHE TEORANTA, a
corporation organized and existing under the laws of Ireland
(“ BIONICHE ”), and is effective as of
November 16, 2006. Capitalized terms used but not defined in
this First Amendment shall have the meanings that are set forth in
the Agreement.
WHEREAS, BIONICHE
is the assignee under the Agreement of BIONICHE PHARMA GROUP
LIMITED, an Affiliate thereof.
WHEREAS,
CUMBERLAND and BIONICHE agree that the exceptions to the
exclusivity provisions set forth in Paragraph 5.6 of the
Agreement which permit BIONICHE to (i) sell Excluded Products
or Other Products or (ii) market or distribute Excluded
Products or Other Products in association with any third Person
other than CUMBERLAND in certain circumstances shall be deleted
from the Agreement.
NOW, THEREFORE, in
consideration of the mutual covenants, agreements, representation
and warranties contained herein, and for other good and valuable
consideration, the receipt of which is hereby acknowledged, the
parties hereto hereby agree as follows:
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1.
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Paragraph 1.7 is amended and
restated in its entirety as follows:
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DRUG PRODUCT shall mean the N-acetylcysteine
pharmaceutical product developed by CUMBERLAND and marketed for any
current or future approved indications under the trade name
ACETADOTE or any other trade name selected by
CUMBERLAND.
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2.
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Paragraph 1.9 is hereby amended
and restated as follows:
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FACILITY shall mean the manufacturing
facility and the real property underlying such manufacturing
facility operated by BIONICHE, located at Inverin, Co, Galway,
Republic of Ireland.
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3.
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Paragraph 1.18 defines
TERRITORY as having the meaning set forth in Schedule III.
Schedule III of the Agreement, and therefore the TERRITORY, is
hereby amended and restated as follows:
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The
United States of America and all its possessions and territories,
[***].
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4.
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Paragraph 3.1 is amended and
restated in its entirety as follows:
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This Agreement shall commence on the
date first above written and will continue until January 23,
2011, unless sooner terminated pursuant to Paragraphs 3.2 or 3.3
hereof or extended pursuant to this Paragraph 3.1. CUMBERLAND
shall have the option to extend the duration of this Agreement for
five (5) years upon prior written notice provided by
CUMBERLAND to BIONICHE at least 180 days prior to
January 23, 2011; otherwise, the Agreement shall expire on
such date in accordance with its terms. If CUMBERLAND exercises
such option, then subject to Paragraphs 3.2 and 3.3, the Agreement
shall be automatically renewed for successive three-year terms
after expiration of the initial extended term, unless either party
notifies the other party in writing at least twelve
(12) months in advance of the expiration of the then current
term that the party is terminating the Agreement.
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5.
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Subpa
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