Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment which has been filed separately with the SEC. THIRD AMENDMENT TO MANUFACTURING AND SUPPLY AGREEMENT FOR N-ACETYLCYSTEINE
EXHIBIT 10.3.2
*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.
THIRD AMENDMENT TO MANUFACTURING AND SUPPLY AGREEMENT
FOR N-ACETYLCYSTEINE
FOR N-ACETYLCYSTEINE
THIS THIRD AMENDMENT (the “Third 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”), as amended by that certain First Amendment to Manufacturing and Supply Agreement
for N-Acetylcyesteine dated as of November 16, 2006 (the “First Amendment”) and as amended
by that certain Second Amendment to Manufacturing and Supply Agreement for N-Acetylcyesteine dated
as of March 25, 2008 (the “Second 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 April 25, 2011 (The Original
Agreement, the Novation Agreement, the First Amendment, the Second Amendment and the Third
Amendment are collectively referred to herein as the “Agreement”). Capitalized terms used
but not defined in this Third 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. | Section 2.1, is amended to remove the words “all of” from second line of
the first sentence. |
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2. | 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 April 15, 2014, unless sooner terminated pursuant to Paragraph 3.2 hereof
or extended pursuant to this Paragraph 3.1. The Agreement may be extended for
two (2) year upon the mutual written consent of both parties; otherwise, the
Agreement shall expire on such date in accordance with its terms. |
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3. | Paragraph 3.2 is amended by inserting the following Subparagraph 3.2(e)
after Subparagraph 3.2(d): |
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In the event that the parties mutually agree to extend the Agreement after
April 15, 2014, either party may terminate the Agreement upon twelve (12)
months prior written notice to the other Party. |
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4. | Paragraph 5.6(b) is deleted in its entirety. Subparagraphs 5.6(c) and (d)
are re-lettered as 5.6(b) and (c), respectively; and Subparagraph 5.6(d)
(re-lettered 5.6(c)) is amended and restated in its entirety as follows: |
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(c) Notwithstanding the foregoing, CUMBERLAND may establish supply arrangements
with third parties. |
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5. | Paragraph 5.7 is deleted in its entirety and restated in its entirety as
follows: |
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“Minimum Purchase Quantities: CUMBERLAND shall be required to purchase [***]
batches annually of the Dug Product being sold in the Territory from BIONICHE.
In the event CUMBERLAND is required to procure Drug Product from other sources
in accordance with Paragraph 2.7, the minimum annual purchase obligation set
forth in this Paragraph 5.7 shall be decreased by the quantity that BIONICHE
failed to deliver hereunder. |
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6. | In the Section entitled “Pricing” in SCHEDULE I, the first paragraph is
hereby amended and restated as follows: |
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Pursuant to Paragraph 2.10(a) of the Original Agreement, the price to be paid
by CUMBERLAND to BIONICHE for the Drug Products ordered from BIONICHE is as
follows: |
N-acetylcysteine 30 ml
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US | $[***] per vial for the first [***] batches of product received annually | ||
N-acetylcysteine 30 ml
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US | $[***] for subsequent batches of product received annually |
7. | In the Section entitled “Pricing” in SCHEDULE I, the second paragraph is
hereby amended and restated as follows: |
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Beginning on January 1, 2012, BIONICHE shall have the annual right to increase
price set forth above, provided, however, that such annual price increase shall
not exceed the annual percentage increase for the most recent twelve (12) month
period for which information is available in the Product Price Index,
Pharmaceutical Preparations, Ethical (Prescription), commodity code PCU325412,
issued by the Bureau of Labor Statistics, U.S. Department of Labor. |
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8. | In the Section entitled “Pricing” in SCHEDULE I, the following language
will be added to the fourth paragraph as follows: |
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CUMBERLAND will have no obligation to pay any royalties that would
accrue after January 23, 2011 to BIONICHE on any purchases of product
manufactured by BIONICHE or by a third party contractor. Provided, |
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however, CUMBERLAND shall pay all royalties that would accrue on or
before January 23, 2011 to BIONICHE on any purchases of product
manufactured by BIONICHE or by a third party contractor. |
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9. | In the Section entitled “Territory” in SCHEDULE III, the language
shall be amended and restated as “Worldwide”. |
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10. | Miscellaneous. |
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(a) Authorization. Each party to this Third Amendment hereby
represents and warrants that the execution, delivery and performance of this
Third 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 Third Amendment constitutes the valid and enforceable obligation of each
party in accordance with its terms. |
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(b) Effect of Third Amendment. Each party acknowledges that this
Third 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. |
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(c) Counterparts. This Third 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. |
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(d) Titles and Subtitles. The titles and subtitles used in this
Third Amendment are used for convenience only and are not to be considered in
construing or interpreting this Third Amendment. |
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(e) Governing Law and Dispute Resolution. This Third 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 Third Amendment shall be governed
by the provisions of Paragraph 11.7 of the Agreement. |
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(f) Severability. Should any part of this Third 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 Third Amendment to be executed
effective as of the date first above written.
CUMBERLAND: | ||||
CUMBERLAND PHARMACEUTICALS INC. | ||||
By: | /s/ X.X. Xxxxxx | |||
Name: | X. X. Xxxxxx |
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Title: | Chief Executive Officer | |||
BIONICHE: | ||||
BIONICHE TEORANTA | ||||
By: | /s/ Xxxxxx Xxxxx | |||
Name: | Xxxxxx Xxxxx | |||
Title: | Chief Financial Officer |
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