Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment which has been filed separately with the SEC. SECOND AMENDMENT TO MANUFACTURING AND SUPPLY AGREEMENT FOR N-ACETYLCYSTEINE
EXHIBIT 10.3.1
* Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment
which has been filed separately with the SEC.
which has been filed separately with the SEC.
SECOND AMENDMENT TO MANUFACTURING AND SUPPLY AGREEMENT
FOR N-ACETYLCYSTEINE
FOR N-ACETYLCYSTEINE
THIS SECOND AMENDMENT (the “Second Amendment”) to that certain Manufacturing and
Supply Agreement for N-Acetylcysteine, dated as of January 15, 2002 (the “Original
Agreement”), as modified by that certain Novation Agreement, dated as of January 27, 2006 (the
“Novation Agreement”), and as amended by that certain First Amendment to Manufacturing and
Supply Agreement for N-Acetylcyesteine dated as of November 16, 2006 (the “First
Amendment”) 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 March 25, 2008 (The Original Agreement, the Novation
Agreement, and the First Amendment are collectively referred to herein as the “Agreement”).
Capitalized terms used but not defined in this Second Amendment shall have the meanings that are
set forth in the Agreement.
WITNESSETH:
WHEREAS, BIONICHE is the assignee under the Agreement of BIONICHE PHARMA GROUP LIMITED, an
Affiliate thereof.
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:
1. | 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: | ||
The United States of America, Australia, New Zealand, Singapore, Malaysia, Hong Kong, China, Vietnam, Thailand, Taiwan, Korea, the Philippines and each of their territories and possessions on the Effective Date of this Second Amendment. | |||
2. | Paragraph 5.6 is hereby amended by adding clause (d) as follows: |
(d) Notwithstanding the foregoing, CUMBERLAND may establish a
secondary supply arrangement with a third party. For Drug Product manufactured
by a third party supplier for commercial sale by CUMBERLAND during the term of
the Original Agreement, CUMBERLAND will pay BIONICHE at a rate of [***] CDN
for each 30 xX xxxx of the Drug Product that CUMBERLAND purchases from such
third party. Payment will be made by CUMBERLAND to BIONICHE within [***] days
after the Drug Product is delivered by the third party and released for sale by
CUMBERLAND.
3. | The following is hereby added to the end of Paragraph 2.7 of the existing Agreement: | ||
In the event that CUMBERLAND arranges to sell Drug Product or have Drug Product sold in a region or market whose regulatory authority requires a unique label; or if CUMBERLAND contracts a third party to sell Drug Product, and this third party requires a unique label, then BIONICHE shall divide the Labeling of Drug Product in the applicable Purchase Order between the unique label and the usual and customary CUMBERLAND label in accordance with CUMBERLAND’s request. In such an event, CUMBERLAND will provide such unique label to BIONICHE and clearly identify the division of Drug Product between the two labels on any applicable Purchase Order. | |||
Upon request by CUMBERLAND, BIONICHE will ship a whole or partial Order of the Drug Product to fulfill the commitments in a given region or market directly to a secondary distributor or to a third party or its identified distributor. In such an event, CUMBERLAND will identify on the applicable Purchase Order the requested shipment destination and any shipping instructions. |
4. | In the section entitled “Pricing” in SCHEDULE I, the first paragraph is hereby amended and restated as follows: | ||
Pursuant to Paragraph 2.10(a) of the Original Agreement, the price to be paid by CUMBERLAND to BIONICHE in the year 2008 for the Drug Products ordered from BIONICHE is as follows: |
N-acetylcysteine 30 mL Canadian $[***]
Any price adjustment after 2008 shall be made in accordance with Paragraph
2.10(b)
5. | In the section entitled “Pricing” in SCHEDULE I, the first sentence of the fourth paragraph is hereby amended and restated as follows: | ||
In addition, CUMBERLAND shall pay to BIONICHE a royalty equal to [***] percent ([***]%) of Net Sales (as defined herein) during each calendar year through December 31, 2010, and during the period thereafter ending January 23, 2011 on product manufactured by BIONICHE or by a 3rd party contractor for CUMBERLAND provided that CUMBERLAND shall pay BIONICHE such royalty on a quarterly basis within [***] days after the last day of the applicable calendar quarter. |
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6. | Miscellaneous. |
(a) Authorization. Each party to this Second Amendment hereby
represents and warrants that the execution, delivery and performance of this
Second Amendment is within the powers of such party and has been duly
authorized by the party, is in accordance with all applicable laws and
regulations, and this Second Amendment constitutes the valid and enforceable
obligation of each party in accordance with its terms.
(b) Effect of Second Amendment. Each party acknowledges that this
Second Amendment constitutes a written instrument as contemplated by Paragraph
11.2 of the Agreement. Except as specifically amended above, the Agreement
shall remain in full force and effect, and is hereby ratified and confirmed.
(c) Counterparts. This Second Amendment may be executed in any number
of counterparts, each of which may be executed by only one of the parties
hereto, and each of which shall be enforceable against the party actually
executing such counterpart, and all of which shall together constitute one
instrument.
(d) Titles and Subtitles. The titles and subtitles used in this
Second Amendment are used for convenience only and are not to be considered in
construing or interpreting this Second Amendment.
(e) Governing Law and Dispute Resolution. This Second Amendment shall
be construed in accordance with the laws of the State of New York without
regard to applicable conflicts of laws provisions and any dispute,
controversy, or claim arising out of or relating to this Second Amendment
shall be governed by the provisions of Paragraph 11.7 of the Agreement.
(f) Severability. Should any part of this Second Amendment be invalid
or unenforceable, such invalidity or unenforceability shall not affect the
validity and enforceability of the remaining portion.
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IN WITNESS WHEREOF, each of the undersigned has caused this Second Amendment to be effective as of
the date first above written.
CUMBERLAND: CUMBERLAND PHARMACEUTICALS INC. |
||||
By: | /s/ X.X. Xxxxxx | |||
Name: | X. X. Xxxxxx | |||
Title: | Chief Executive Officer | |||
Date: Xxxxx 00, 0000
XXXXXXXX: BIONICHE TEORANTA |
||||
By: | /s/ Xxxxxx Xxxxxx | |||
Name: | Xxxxxx X Xxxxxx | |||
Title: | President, North American Operations | |||
Date: April 1, 2008
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