Certain portions of this document have been omitted pursuant to a request for confidential treatment which has been filed separately with the SEC. THIRD AMENDMENT TO KRISTALOSE AGREEMENT
EXHIBIT 10.9.3
*Certain portions of this document have been omitted pursuant to a request for
confidential treatment which has been filed separately with the SEC.
confidential treatment which has been filed separately with the SEC.
THIRD AMENDMENT TO
KRISTALOSE AGREEMENT
KRISTALOSE AGREEMENT
This Third Amendment to Kristalose Agreement (the “Third Amendment”) is entered
into this 6th day of April, 2009 by and between Inalco S.P.A. (“Inalco
Italy”), Inalco Biochemicals, Inc. (“Inalco U.S.”) and Cumberland Pharmaceuticals
Inc. (“Cumberland”). Inalco Italy and Inalco U.S. are hereinafter collectively
referred to as “Inalco.”
WHEREAS, Inalco and Cumberland entered into a certain Kristalose Agreement in
April 2006 (the “Original Agreement”) and subsequently entered into a certain
Amendment to the Kristalose Agreement on April 3, 2008 (“First Amendment”) and into
a certain Second Amendment to the Kristalose Agreement on July 1, 2008 (“Second
Amendment")(The Original Agreement, First Amendment, and Second
Amendment, as amended hereby, are collectively referred to herein as the “Kristalose
Agreement”);
WHEREAS, Inalco and Cumberland desire to further amend the Kristalose Agreement
in certain respects as set forth herein.
NOW, THEREFORE, for and in consideration of the mutual covenants and agreements
hereinafter set forth, and for other good and valuable consideration, the parties
hereto agree as follows:
l . The following paragraph is hereby inserted at the end of Section 4.1:
[***]
2. Exhibit A is hereby amended by deleting all existing text beneath the
heading “Exhibit A” and preceding the paragraph beginning “Provided, however...” and
by substituting the following in lieu thereof:
Minimum Purchases for each calendar year during the Term shall be 25%
of the actual purchases and deliveries of Product recorded
by Cumberland in the immediately preceding calendar year.
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3. Section 4.3 is hereby amended by deleting the paragraph beginning
“Cumberland will meet...” (the second paragraph thereof) and by substituting the
following in lieu thereof:
[***]
4. The following sentence is hereby inserted at the end of Paragraph C. of Section 2.6:
In the event that Inalco fails to fill a purchase order by the
mutually agreed Delivery Date, then the supply price for such order
shall be reduced by one percent (1%) for each two full weeks between
the mutually agreed Delivery Date and the actual delivery date for
such order.
5. The following sentences are hereby inserted at the end of Paragraph G. of Section 2.5:
In cooperation with Cumberland, Inalco shall diligently prepare and
submit all filings required to seek Regulatory Approval, provided it is
an ANDA, for use of the Product in the Territory to treat [***] and any
other treatment indications identified by Cumberland for the Product.
Inalco shall be responsible for all expenses incurred in the
preparation and submission of all such filings and all fees associated
with obtaining or maintaining such Regulatory Approval. Cumberland will
be responsible for the cost of any clinical studies associated with any
such indication. In the event that the Regulatory Authorities require
the introduction of a new product (that is, they do not agree to add an
additional indication to the existing product) the pricing structure of
the new product will be discussed with Inalco and Inalco Biochemicals,
Inc.
6. Capitalized terms not defined in this Third Amendment shall have the
meaning set forth in the Kristalose Agreement.
7. It is mutually agreed that all covenants, conditions and agreements set
forth in the Kristalose Agreement (as amended hereby) shall remain binding
upon the parties and inure to the benefit of the parties hereto and their respective
successors and assigns.
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