Cumberland Pharmaceuticals Inc.
As filed with the Securities and Exchange Commission on
July 11, 2007
Registration No. 333-142535
UNITED STATES SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
Amendment No. 3
to
FORM S-1
REGISTRATION
STATEMENT
UNDER
THE SECURITIES ACT OF
1933
Cumberland Pharmaceuticals
Inc.
(Exact name of registrant as
specified in its charter)
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Tennessee
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2834
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62-1765329
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(State or other jurisdiction
of
incorporation or organization)
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(Primary Standard Industrial
Classification Code Number)
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(I.R.S. Employer
Identification No.)
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2525 West End Avenue,
Suite 950
Nashville, Tennessee
37203
(615) 255-0068
(Address, including zip code,
and telephone number, including
area code, of registrants
principal executive offices)
A.J. Kazimi
Chairman and CEO
2525 West End Avenue,
Suite 950
Nashville, Tennessee
37203
(615) 255-0068
(Name, address, including zip
code, and telephone number, including area code, of agent for
service)
Copies to:
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Martin S.
Brown, Esq.
Virginia Boulet, Esq.
Adams and Reese LLP
424 Church Street, Suite 2800
Nashville, Tennessee 37219
(615) 259-1450
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Donald J. Murray, Esq.
Dewey Ballantine LLP
1301 Avenue of the Americas
New York, New York 10019-6092
(212) 259-8000
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Approximate date of commencement of proposed offering to the
public: As soon as practicable after this
registration statement becomes effective.
If any of the securities being registered on this Form are to be
offered on a delayed or continuous basis pursuant to
Rule 415 under the Securities Act of 1933 check the
following box: o
If this Form is filed to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act,
please check the following box and list the Securities Act
registration statement number of the earlier effective
registration statement for the same
offering. o
If this Form is a post-effective amendment filed pursuant to
Rule 462(c) under the Securities Act, check the following
box and list the Securities Act registration statement number of
the earlier effective registration statement for the same
offering. o
If this Form is a post-effective amendment filed pursuant to
Rule 462(d) under the Securities Act, check the following
box and list the Securities Act registration statement number of
the earlier effective registration statement for the same
offering. o
The registrant hereby amends this registration statement on
such date or dates as may be necessary to delay its effective
date until the registrant shall file a further amendment which
specifically states that this registration statement shall
thereafter become effective in accordance with Section 8(a)
of the Securities Act of 1933 or until the registration
statement shall become effective on such date as the Commission,
acting pursuant to said Section 8(a), may determine.
Part II
Information not
required in prospectus
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ITEM 13.
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OTHER EXPENSES OF
ISSUANCE AND DISTRIBUTION.
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The expenses relating to the registration of the shares of
common stock being offered hereby, other than underwriting
discounts and commissions, will be borne by us. Such expenses
are estimated to be as follows:
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Item
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Amount
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SEC registration fee
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$
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NASD filing fee
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$
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NASDAQ listing fee
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$
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Printing expenses
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$
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Legal fees and expenses
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$
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Accounting fees and expenses
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$
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Transfer agent and registrar
expenses
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$
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Total
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$
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ITEM 14.
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INDEMNIFICATION
OF DIRECTORS AND OFFICERS.
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Our charter and bylaws provide for indemnification of our
directors to the fullest extent permitted by the Tennessee
Business Corporation Act, as amended from time to time. Our
directors shall not be liable to the corporation or its
shareholders for monetary damages for breach of fiduciary duty
as a director. The Tennessee Business Corporation Act provides
that a Tennessee corporation may indemnify its directors and
officers against expenses, judgments, fines and amounts paid in
settlement actually and reasonably incurred by them in
connection with any proceeding, whether criminal or civil,
administrative or investigative if, in connection with the
matter in issue, the individuals conduct was in good
faith, and the individual reasonably believed: in the case of
conduct in the individuals official capacity with the
corporation, that the individuals conduct was in its best
interest; and in all other cases, that the individuals
behavior was at least not opposed to its best interest; and in
the case of a criminal proceeding, the individual had no reason
to believe the individuals conduct was unlawful. In
addition, we have entered into indemnification agreements with
our directors. These provisions and agreements may have the
practical effect in certain cases of eliminating the ability of
our shareholders to collect monetary damages from directors. We
believe that these contractual agreements and the provisions in
our charter and bylaws are necessary to attract and retain
qualified persons as directors.
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ITEM 15.
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RECENT SALES OF
UNREGISTERED SECURITIES.
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In September 2003, we borrowed $500,000 from nine existing and
accredited shareholders pursuant to uncollateralized secured
notes payable with original maturity dates of 130 days.
These notes bore interest at 12% for the first 30 days and
15% thereafter. The holders of the notes had, at their option,
until the maturity date of the notes payable, the right to
convert all or a portion of the unpaid principal and interest
into shares of our common stock at a rate of $12.00 per share.
We also issued to these lenders options to purchase shares of
our common stock, at an exercise price of $12.00 per share,
and at the rate of 1,540 shares of common stock per $50,000
face value of the notes. If we had not prepaid all amounts due
and owing under the notes, we agreed to grant additional options
at the rate of 770 shares of common stock per $50,000 face
value on each of (i) the 30th day after the date of
the notes and (ii) on a continuing basis, each successive
30-day
period thereafter, or portion thereof, as the notes remained
outstanding. At December 31, 2003, the notes payable had
not been prepaid, so we granted options to acquire an additional
30,800 shares. We amended the notes agreements in
January 2004 to extend the maturity date 130 days. The
amendments granted an additional option to
II-1
Part II
purchase 1,540 shares per $50,000 face value upon extension
of the notes and contained similar provisions for granting
options in the event of nonpayment on the
agreed-upon
due dates. Based on the extension of the maturity date, rights
to purchase a total of 61,600 shares were earned by the
holders of the notes in 2004. We repaid these notes or settled
these notes in shares in May 2004. The issuance of these
securities was exempt from registration under the Securities Act
in reliance on Section 4(2) of the Securities Act.
In September 2003, we borrowed $1,000,000 from S.C.O.U.T.
Healthcare Fund, L.P., or S.C.O.U.T., in the form of a
convertible promissory note with a maturity date of September
2004. The President and majority shareholder of the general
partner of S.C.O.U.T., Dr. Lawrence W. Greer, serves on our
board of directors. Pursuant to the terms of the note, on its
maturity date, S.C.O.U.T. converted the principal value of the
note plus all interest accrued at a fixed rate of ten percent
per annum into 91,667 shares of our common stock at a price
of $12.00 per share.
On April 15, 2004, we issued 43,000 common shares at
$12.00 per share, for an aggregate consideration of
$516,000 and a five-year warrant to purchase 20,000 common
shares at $12.00 per share to S.C.O.U.T., which represented
to us that it was an accredited investor. This issuance was
exempt from registration under the Securities Act in reliance on
Section 4(2) of the Securities Act.
By an offering memorandum dated April 1, 2005, we offered
100,000 shares of our common stock at a purchase price of
$18.00 per share. Thirty investors subscribed for
100,000 shares in the aggregate, for an aggregate
consideration of $1,800,000. This issuance was exempt from
registration under the Securities Act in reliance on
Section 4(2) of the Securities Act.
By an offering memorandum dated May 5, 2005, we received
approximately $2,000,000 from approximately 41 investors in
exchange for uncollateralized convertible promissory notes with
a maturity date six months from the date of issuance. Upon
maturity, the principal and accrued interest payable on the
notes converted into 112,916 shares of common stock at a
rate of $18.00 per share. This issuance was exempt from
registration under the Securities Act in reliance on
Section 4(2) of the Securities Act.
In April 2006, we issued a ten-year warrant to purchase 1,979
common shares at $18.00 per share to Bank of America. The
issuance of this security was exempt from registration under the
Securities Act in reliance on Section 4(2) of the
Securities Act.
Since January 1, 2004, we have granted options to purchase
287,610 shares of our common stock under the
1999 Option Plan to our employees, directors and
consultants at exercise prices ranging from $12.00 to
$22.00 per share. Of these, an aggregate of 775 shares
of our common stock were issued upon the exercise of stock
options.
Since January 1, 2004, we also issued an aggregate of
75,645 shares of common stock as compensation for services
pursuant to contracts. Restricted-stock legends were affixed to
the securities issued in these transactions. Our board of
directors determined that the fair value of the services
received equaled the value of the stock granted with values
ranging from $12.00 to $22.00 per share. The issuances of
common stock in connection with awards of restricted stock were
exempt either pursuant to Rule 701 or pursuant to
Section 4(2) of the Securities Act as transactions by an
issuer not involving a public offering.
The issuances of securities described in the first six
paragraphs of Item 15 were exempt from registration under
the Securities Act of 1933, as amended, in reliance on
Section 4(2) of the Securities Act of 1933, as amended,
and/or Regulation D promulgated thereunder, as transactions
by an issuer not involving any public offering. The purchasers
of the securities in these transactions represented that they
were accredited investors and they were acquiring the securities
for investment only and not with a view
II-2
Part II
toward the public sale or distribution thereof. Such purchasers
received written disclosures that the securities had not been
registered under the Securities Act of 1933, as amended, and
that any resale must be made pursuant to a registration
statement or an available exemption from registration. All
purchasers either received adequate financial statement or
non-financial statement information about the registrant or had
adequate access, through their relationship with the registrant,
to financial statement or non-financial statement information
about the registrant. The sale of these securities was made
without general solicitation or advertising.
The issuances of securities described in the seventh and eighth
paragraphs of Item 15 were exempt from registration under
the Securities Act of 1933, as amended, in reliance on either
(1) Rule 701 of the Securities Act of 1933, as
amended, as offers and sales of securities pursuant to
compensatory benefit plans and contracts relating to
compensation in compliance with Rule 701 or
(2) Section 4(2) of the Securities Act as transactions
by an issuer not involving any public offering.
All certificates representing the securities issued in these
transactions described in this Item 15 included appropriate
legends setting forth that the securities had not been offered
or sold pursuant to a registration statement and describing the
applicable restrictions on transfer of the securities. There
were no underwriters employed in connection with any of the
transactions set forth in this Item 15.
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ITEM 16.
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EXHIBITS AND
FINANCIAL STATEMENT SCHEDULES.
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(a)
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No.
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Description
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1.1*
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Form of Underwriting Agreement.
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3.1**
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Second Amended and Restated
Charter of Cumberland Pharmaceuticals Inc.
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3.2**
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Amended and Restated Bylaws of
Cumberland Pharmaceuticals Inc.
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4.1*
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Specimen Common Stock Certificate
of Cumberland Pharmaceuticals Inc.
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4.2**
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Warrant to Purchase Common Stock
of Cumberland Pharmaceuticals Inc., issued to Bank of America,
N.A. on October 21, 2003.
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4.3**
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Stock Purchase Warrant, issued to
S.C.O.U.T. Healthcare Fund L.P. on April 15, 2004.
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4.4**
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Warrant to Purchase Common Stock
of Cumberland Pharmaceuticals Inc., issued to Bank of America,
N.A. on April 6, 2006.
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4.5#**
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Form of Option Agreement under
1999 Stock Option Plan of Cumberland Pharmaceuticals Inc.
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4.6.1#
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Form of Incentive Stock Option
Agreement under 2007 Long-Term Incentive Compensation Plan of
Cumberland Pharmaceuticals Inc.
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4.6.2#
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Form of Nonstatutory Stock Option
Agreement under 2007 Long-Term Incentive Compensation Plan of
Cumberland Pharmaceuticals Inc.
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4.7#
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Form of Nonstatutory Stock Option
Agreement under 2007 Directors Compensation Plan of
Cumberland Pharmaceuticals Inc.
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5.1*
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Opinion of Adams and Reese LLP.
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10.1
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Manufacturing and Supply Agreement
for N-Acetylcysteine, dated January 15, 2002, by and
between Bioniche Life Sciences, Inc. and Cumberland
Pharmaceuticals Inc.
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10.2**
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Novation Agreement, dated
January 27, 2006, by and among Bioniche Life Sciences,
Inc., Bioniche Pharma Group Ltd., and Cumberland Pharmaceuticals
Inc.
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II-3
Part II
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No.
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Description
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10.3
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First Amendment to Manufacturing
and Supply Agreement for N-Acetylcysteine, dated
November 16, 2006, by and between Bioniche Teoranta and
Cumberland Pharmaceuticals Inc.
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10.4
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Cardinal Health Contract Sales and
Services for Cumberland Pharmaceuticals Inc. Dedicated Sales
Force Agreement, dated May 16, 2006, by and between
Cardinal Health PTS, LLC and Cumberland Pharmaceuticals Inc.
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10.5
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First Amendment to Contract Sales
and Service Agreement, dated July 19, 2006, by and between
Cardinal Health PTS, LLC and Cumberland Pharmaceuticals Inc.
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10.6
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Second Amendment to Contract Sales
and Service Agreement, dated June 1, 2007, by and between
Cumberland Pharmaceuticals Inc. and Inventiv Commercial
Services, LLC, as successor in interest to Cardinal Health PTS,
LLC.
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10.7
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Distribution Services Agreement,
dated August 3, 2000, by and between CORD Logistics, Inc.
and Cumberland Pharmaceuticals Inc.
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10.8
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Strategic Alliance Agreement,
dated July 21, 2000, by and between F.H.
Faulding & Co. Limited and Cumberland Pharmaceuticals
Inc.
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10.9
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Kristalose Agreement, dated
April 7, 2006, by and among Inalco Biochemicals, Inc.,
Inalco S.p.A., and Cumberland Pharmaceuticals Inc.
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10.10
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License Agreement, dated
May 28, 1999, by and between Vanderbilt University and
Cumberland Pharmaceuticals Inc.
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10.11#**
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Employment Agreement effective as
of January 1, 2007 by and between A.J. Kazimi and
Cumberland Pharmaceuticals Inc.
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10.12#**
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Employment Agreement effective as
of January 1, 2007 by and between Jean W. Marstiller and
Cumberland Pharmaceuticals Inc.
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10.13#**
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Employment Agreement effective as
of January 1, 2007 by and between Leo Pavliv and Cumberland
Pharmaceuticals Inc.
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10.14#**
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Employment Agreement effective as
of January 1, 2007 by and between J. William Hix and
Cumberland Pharmaceuticals Inc.
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10.15#**
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Employment Agreement effective as
of January 1, 2007 by and between David L. Lowrance and
Cumberland Pharmaceuticals Inc.
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10.16.1
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Second Amended and Restated Loan
Agreement by and between Cumberland Pharmaceuticals Inc. and
Bank of America, N.A., dated April 6, 2006.
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10.16.2
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First Amendment to Second Amended
and Restated Loan Agreement by and between Cumberland
Pharmaceuticals Inc. and Bank of America, N.A., dated
December 31, 2006.
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10.17#**
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1999 Stock Option Plan of
Cumberland Pharmaceuticals Inc.
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10.18#**
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2007 Long-Term Incentive
Compensation Plan of Cumberland Pharmaceuticals Inc.
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10.19#**
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2007 Directors
Compensation Plan of Cumberland Pharmaceuticals Inc.
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10.20**
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Form of Indemnification Agreement
between Cumberland Pharmaceuticals Inc. and all members of its
Board of Directors.
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10.21
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Lease Agreement, dated
September 10, 2005, by and between Nashville Hines
Development, LLC and Cumberland Pharmaceuticals Inc.
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10.22.1
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Sublease Agreement, dated
December 14, 2006, by and between Robert W.
Baird & Co. Incorporated and Cumberland
Pharmaceuticals Inc.
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II-4
Part II
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No.
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Description
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10.22.2
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Addendum to Sublease Agreement,
dated May 5, 2007, by and between Robert W.
Baird & Co. Incorporated and Cumberland
Pharmaceuticals Inc. and consented to by Nashville Hines
Development, LLC.
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10.23**
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Amended and Restated Lease
Agreement, dated November 11, 2004, by and between The
Gateway to Nashville LLC and Cumberland Emerging Technologies,
Inc.
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10.24**
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First Amendment to Amended and
Restated Lease Agreement, dated August 23, 2005, by and
between The Gateway to Nashville LLC and Cumberland Emerging
Technologies, Inc.
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21**
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Subsidiaries of Cumberland
Pharmaceuticals Inc.
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23.1**
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Consent of KPMG LLP.
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23.2*
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Consent of Adams and Reese, LLP
(contained in Exhibit 5).
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23.3**
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Consent of Morgan Joseph &
Co. Inc.
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24**
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Powers of Attorney (contained on
the signature page of Registration Statement on Form S-1
filed on May 1, 2007).
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*
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To be filed by amendment.
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#
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Indicates a management contract or compensatory plan.
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Confidential treatment has been requested for portions of this
exhibit. These portions have been omitted from the Registration
Statement and submitted separately to the Securities and
Exchange Commission.
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(b) |
See Schedule IIValuation and qualifying accounts
included in our audited financial statements included elsewhere
in this registration statement.
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All other schedules have been omitted because they are not
applicable.
The undersigned registrant hereby undertakes to provide to the
underwriters at the closing specified in the underwriting
agreement certificates in such denominations and registered in
such names as required by the underwriters to permit prompt
delivery to each purchaser.
Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to directors, officers,
and controlling persons of the registrant pursuant to the
foregoing provisions, or otherwise, the registrant has been
advised that in the opinion of the Securities and Exchange
Commission such indemnification is against public policy as
expressed in the Securities Act of 1933 and is, therefore,
unenforceable. In the event that a claim for indemnification
against such liabilities (other than the payment by the
registrant of expenses incurred or paid by a director, officer,
or controlling person of the registrant in the successful
defense of any action, suit, or proceeding) is asserted by such
director, officer, or controlling person in connection with the
securities being registered, the registrant will, unless in the
opinion of its counsel the matter has been settled by
controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is
against public policy as expressed in the Securities Act of 1933
and will be governed by the final adjudication of such issue.
The undersigned registrant hereby undertakes that:
1) For purposes of determining any liability under
the Securities Act of 1933, the information omitted from the
form of prospectus filed as part of this Registration Statement
in reliance upon Rule 430A and contained in a form of
prospectus filed by the Registrant pursuant to
II-5
Part II
Rule 424(b)(1) or (4) or 497(h) under the Securities
Act shall be deemed to be part of this Registration Statement as
of the time it was declared effective.
2) For the purpose of determining any liability under
the Securities Act of 1933, each post-effective amendment that
contains a form of prospectus shall be deemed to be a new
Registration Statement relating to the securities offered
therein, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering thereof.
II-6
Signatures
Pursuant to the requirements of the Securities Act of 1933, the
registrant has duly caused this Amendment No. 3 to the
Registration Statement to be signed on its behalf by the
undersigned, thereunto duly authorized in the City of Nashville,
State of Tennessee, on the 11th day of July, 2007.
CUMBERLAND PHARMACEUTICALS INC.
A.J. Kazimi
Chairman and CEO
(Principal Executive Officer)
Pursuant to the requirements of the Securities Act of 1933, this
Amendment No. 3 to the Registration Statement has been
signed by the following persons in the capacities and on the
dates indicated.
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Signature
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Title
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Date
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/s/ a.j.
kazimi
A.J.
Kazimi
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Chairman and CEO (Principal
Executive Officer)
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July 11, 2007
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/s/ david
l. lowrance
David
L. Lowrance
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Vice President and CFO (Principal
Financial and Accounting Officer)
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July 11, 2007
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*
Robert
G. Edwards
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Director
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July 11, 2007
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*
Thomas
R. Lawrence
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Director
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July 11, 2007
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*
Lawrence
W. Greer
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Director
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July 11, 2007
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*
Martin
E. Cearnal
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Director
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July 11, 2007
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*By:
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/s/ a.j.
kazimi
A.J.
Kazimi
Attorney-in-Fact
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S-1
Exhibit Index
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No.
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Description
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1.1*
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Form of Underwriting Agreement.
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3.1**
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|
Second Amended and Restated
Charter of Cumberland Pharmaceuticals Inc.
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3.2**
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Amended and Restated Bylaws of
Cumberland Pharmaceuticals Inc.
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4.1*
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|
Specimen Common Stock Certificate
of Cumberland Pharmaceuticals Inc.
|
4.2**
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|
Warrant to Purchase Common Stock
of Cumberland Pharmaceuticals Inc., issued to Bank of America,
N.A. on October 21, 2003.
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4.3**
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|
Stock Purchase Warrant, issued to
S.C.O.U.T. Healthcare Fund L.P. on April 15, 2004.
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4.4**
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Warrant to Purchase Common Stock
of Cumberland Pharmaceuticals Inc., issued to Bank of America,
N.A. on April 6, 2006.
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4.5#**
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Form of Option Agreement under
1999 Stock Option Plan of Cumberland Pharmaceuticals Inc.
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4.6.1#
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Form of Incentive Stock Option
Agreement under 2007 Long-Term Incentive Compensation Plan of
Cumberland Pharmaceuticals Inc.
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4.6.2#
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|
Form of Nonstatutory Stock Option
Agreement under 2007 Long-Term Incentive Compensation Plan of
Cumberland Pharmaceuticals Inc.
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4.7#
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Form of Nonstatutory Stock Option
Agreement under 2007 Directors Compensation Plan of
Cumberland Pharmaceuticals Inc.
|
5.1*
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Opinion of Adams and Reese LLP.
|
10.1
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|
Manufacturing and Supply Agreement
for N-Acetylcysteine, dated January 15, 2002, by and
between Bioniche Life Sciences, Inc. and Cumberland
Pharmaceuticals Inc.
|
10.2**
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|
Novation Agreement, dated
January 27, 2006, by and among Bioniche Life Sciences,
Inc., Bioniche Pharma Group Ltd., and Cumberland Pharmaceuticals
Inc.
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10.3
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First Amendment to Manufacturing
and Supply Agreement for N-Acetylcysteine, dated
November 16, 2006, by and between Bioniche Teoranta and
Cumberland Pharmaceuticals Inc.
|
10.4
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|
Cardinal Health Contract Sales and
Services for Cumberland Pharmaceuticals Inc. Dedicated Sales
Force Agreement, dated May 16, 2006, by and between
Cardinal Health PTS, LLC and Cumberland Pharmaceuticals Inc.
|
10.5
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First Amendment to Contract Sales
and Service Agreement, dated July 19, 2006, by and between
Cardinal Health PTS, LLC and Cumberland Pharmaceuticals Inc.
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10.6
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Second Amendment to Contract Sales
and Service Agreement, dated June 1, 2007, by and between
Cumberland Pharmaceuticals Inc. and Inventiv Commercial
Services, LLC, as successor in interest to Cardinal Health PTS,
LLC.
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10.7
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Distribution Services Agreement,
dated August 3, 2000, by and between CORD Logistics, Inc.
and Cumberland Pharmaceuticals Inc.
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10.8
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Strategic Alliance Agreement,
dated July 21, 2000, by and between F.H.
Faulding & Co. Limited and Cumberland Pharmaceuticals
Inc.
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10.9
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Kristalose Agreement, dated
April 7, 2006, by and among Inalco Biochemicals, Inc.,
Inalco S.p.A., and Cumberland Pharmaceuticals Inc.
|
10.10
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License Agreement, dated
May 28, 1999, by and between Vanderbilt University and
Cumberland Pharmaceuticals Inc.
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10.11#**
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Employment Agreement effective as
of January 1, 2007 by and between A.J. Kazimi and
Cumberland Pharmaceuticals Inc.
|
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No.
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Description
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10.12#**
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Employment Agreement effective as
of January 1, 2007 by and between Jean W. Marstiller and
Cumberland Pharmaceuticals Inc.
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10.13#**
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Employment Agreement effective as
of January 1, 2007 by and between Leo Pavliv and Cumberland
Pharmaceuticals Inc.
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10.14#**
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Employment Agreement effective as
of January 1, 2007 by and between J. William Hix and
Cumberland Pharmaceuticals Inc.
|
10.15#**
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Employment Agreement effective as
of January 1, 2007 by and between David L. Lowrance and
Cumberland Pharmaceuticals Inc.
|
10.16.1
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|
Second Amended and Restated Loan
Agreement by and between Cumberland Pharmaceuticals Inc. and
Bank of America, N.A., dated April 6, 2006.
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10.16.2
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First Amendment to Second Amended
and Restated Loan Agreement by and between Cumberland
Pharmaceuticals Inc. and Bank of America, N.A., dated
December 31, 2006.
|
10.17#**
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|
1999 Stock Option Plan of
Cumberland Pharmaceuticals Inc.
|
10.18#**
|
|
2007 Long-Term Incentive
Compensation Plan of Cumberland Pharmaceuticals Inc.
|
10.19#**
|
|
2007 Directors
Compensation Plan of Cumberland Pharmaceuticals Inc.
|
10.20**
|
|
Form of Indemnification Agreement
between Cumberland Pharmaceuticals Inc. and all members of its
Board of Directors.
|
10.21
|
|
Lease Agreement, dated
September 10, 2005, by and between Nashville Hines
Development, LLC and Cumberland Pharmaceuticals Inc.
|
10.22.1
|
|
Sublease Agreement, dated
December 14, 2006, by and between Robert W.
Baird & Co. Incorporated and Cumberland
Pharmaceuticals Inc.
|
10.22.2
|
|
Addendum to Sublease Agreement,
dated May 5, 2007, by and between Robert W.
Baird & Co. Incorporated and Cumberland
Pharmaceuticals Inc. and consented to by Nashville Hines
Development, LLC.
|
10.23**
|
|
Amended and Restated Lease
Agreement, dated November 11, 2004, by and between The
Gateway to Nashville LLC and Cumberland Emerging Technologies,
Inc.
|
10.24**
|
|
First Amendment to Amended and
Restated Lease Agreement, dated August 23, 2005, by and
between The Gateway to Nashville LLC and Cumberland Emerging
Technologies, Inc.
|
21**
|
|
Subsidiaries of Cumberland
Pharmaceuticals Inc.
|
23.1**
|
|
Consent of KPMG LLP.
|
23.2*
|
|
Consent of Adams and Reese, LLP
(contained in Exhibit 5).
|
23.3**
|
|
Consent of Morgan Joseph &
Co. Inc.
|
24**
|
|
Powers of Attorney (contained on
the signature page of the Registration Statement on
Form S-1 filed on May 1, 2007).
|
|
|
* |
To be filed by amendment.
|
|
|
#
|
Indicates a management contract or compensatory plan.
|
|
|
Confidential treatment has been requested for portions of this
exhibit. These portions have been omitted from the Registration
Statement and submitted separately to the Securities and
Exchange Commission.
|
Ex-4.6.1
EXHIBIT
4.6.1
CUMBERLAND PHARMACEUTICALS INC.
2007 LONG-TERM INCENTIVE COMPENSATION PLAN
INCENTIVE STOCK OPTION AGREEMENT
This Option Agreement is entered into and effective on ___, by and between
Cumberland Pharmaceuticals Inc., a Tennessee corporation (the Company), and
___, (the Participant).
WHEREAS, the Company has adopted the 2007 Long-Term Incentive Compensation Plan (the Plan),
which is administered by the Companys Board of Directors (the Board); and
WHEREAS, as an increased incentive to contribute to the Companys future success and
prosperity, the Company will, subject to the Participant continuing to provide services to the
Company (or any of its current or future subsidiaries), provide the Participant an opportunity to
acquire shares of the Companys common stock, no par value (the Stock).
NOW, THEREFORE, in consideration of the promises and mutual covenants contained herein and for
other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged,
the parties hereto agree as follows:
1. Grant of Option. Subject to the terms of the Plan and the terms of this Option
Agreement, the Company grants to the Participant an option (the Option) to purchase from the
Company up to ___shares of Stock (the Shares), subject to adjustment as provided
in the Plan. This Option is intended to qualify as an incentive stock option (an ISO) within the
meaning of Section 422 of the Internal Revenue Code of 1986, as amended.
2. Exercise Price. If the Option is exercised, the purchase price per Share shall be
___.
3. Method of Exercise. The Option granted under this Agreement shall be exercisable
from time to time, in whole or in part, by written notice in the manner set forth in Section 8
hereof, accompanied by payment of the purchase price for the Shares which the Participant elects to
purchase by cash, check, or such other instrument as the Company may accept. The Company shall make
prompt delivery of such Shares; provided that if any law or regulation which requires the Company
to take any action with respect to the Shares specified in such notice before issuance thereof,
then the date of delivery of such Shares shall be extended for the period necessary to take such
action.
4. Vesting.
(a) Participant shall become vested in the Option up to the amount of ___
shares on the 31st day of each December during the ___year period from
___to ___, subject to the achievement of certain Performance Criteria and amount of
time contributed, as determined in the sole and absolute discretion of the Board.
1
(b) Upon the Participants Employment Termination, the Option, to the extent unvested, shall
lapse and be cancelled, and be of no further force and effect, as of midnight of such date, unless
the Board resolves (under Section 4(b) of the Plan) to cancel or cause the forfeiture of the
Incentive Option at an earlier time.
(c) Upon an Acquisition Event and/or a Change in Control Event, the Option will vest to the
extent provided in the Plan.
5. Termination of Option; Restrictions on Exercise. Except as otherwise stated in
this Agreement, this Option, to the extent not previously exercised, shall expire on the
___anniversary (the Expiration Date) of the date of this Agreement. The following
additional provisions shall apply to the exercise of this Option:
(a) Termination of Employment. Except as otherwise provided in this Agreement or in the Plan,
if Participants employment with the Company or any of its subsidiaries is terminated by the
Participant or the Company, this Option, to the extent that it is vested in accordance with the
applicable provisions of Section 4 hereof, may not be exercised after the earlier of (i) ninety
(90) days after such termination or (ii) the expiration date of this Option stated above. Except
as expressly set forth otherwise herein, this Option shall terminate in all other respects upon
such termination of employment.
(b) Death of Participant. If the Participants employment with the Company is terminated due
to his/her death during the term of this Option, the Participants legal representative, or the
person so entitled under the Participants last will and testament, or under applicable intestate
laws, shall have the right to exercise this Option for the number of shares to which the
Participant was entitled in accordance with applicable provisions of Section 4 hereof, and such
right shall expire and this Option shall terminate on the Expiration Date. Except as expressly set
forth otherwise herein, this Option shall terminate in all other respects upon such termination of
employment.
6. Provisions of Plan. This Option is subject to the Plan as defined herein. The
terms and provisions of the Plan as it may be amended from time to time are hereby incorporated
herein by reference. In the event of a conflict between the terms or provisions contained herein
and the terms or provisions of the Plan, the applicable terms and provisions of the Plan will
govern and prevail; however, in the event of a conflict regarding specific terms and provisions
addressing the duration of this Option after termination of employment, the terms and provisions
of this Option will govern.
7. Tax Treatment of Option. This Option is intended to qualify as an ISO within the
meaning of Section 422 of the Internal Revenue Code of 1986, as amended. This Option will
automatically be converted to a nonqualified option to the extent that the Option or exercise
thereof does not meet the conditions of the Internal Revenue Code, as amended, to maintain status
as an ISO. The Participant is responsible for any federal, state, local, or foreign tax, including
income tax, social security tax, payroll tax, payment on account, or other tax-related withholding
with respect to this Option (including the grant, vesting and exercise of the Option and the
receipt of Stock and sale of Stock). The Company does not guarantee any particular tax treatment
or results in connection with the grant, vesting or exercise of the Option.
8. Notices. Any notice, request, instruction or other document given under this
Option Agreement shall be in writing and shall be addressed and delivered in the case of the
Company, to the Secretary of the Company at the principal office of the Company and, in the
2
case of the Participant, the Participants address as set forth herein or to such other
address as the Participant may provide in a written notice to the Company, a copy of which shall
be on file with the Secretary of the Company.
9. Governing Law. This Option Agreement shall be construed in accordance with and
governed by the law of the State of Tennessee, without giving effect to the conflict of law
provisions thereof.
10. Relation to Other Benefits. Unless otherwise provided, the benefits received by
the Participant under this Agreement will not be taken into account or treated as normal salary or
compensation in determining any benefits to which the Participant may be entitled under any profit
sharing, retirement, bonus, long service, or other benefit or compensation plan maintained by the
Company, including the amount of any life insurance coverage available to any beneficiary of the
Participant under any life insurance plan covering employees of the Company, or as part of the
calculation of any severance, resignation, termination, redundancy or end of service payments. The
grant of this Option does not create any contractual or other right to receive future grants of
Options, or benefits in lieu of Options, even if the Participant has a history of receiving Options
or other stock awards.
IN WITNESS WHEREOF, each of the parties hereto has caused this Option Agreement to be executed
by its duly authorized representative.
|
|
|
|
|
CUMBERLAND PHARMACEUTICALS INC.:
|
|
|
By: |
____________________
|
|
|
|
Name: |
____________________ |
|
|
|
Title: |
____________________ |
|
|
|
|
|
|
|
|
PARTICIPANT:
|
|
|
Signature: |
____________________
|
|
|
|
Name: |
____________________ |
|
|
|
Address: ____________________ |
|
|
|
OPTION NO. _________________
3
FOR FUTURE USE
NOTICE OF EXERCISE
Cumberland Pharmaceuticals Inc.:
The undersigned hereby elects to exercise the purchase rights granted thereto pursuant to the
attached Option Agreement # ___. In accordance with the terms thereof, the undersigned
elects to purchase ______ shares of Common Stock of Cumberland Pharmaceuticals Inc. and tenders herewith
payment of the purchase price for such shares in full.
In exercising such rights, the undersigned hereby confirms and acknowledges that the shares of
Common Stock are being acquired solely for investment, and that the undersigned will not offer,
sell, or otherwise dispose of any such shares of Common Stock, except under circumstances that will
not result in a violation of the Securities Act of 1933, as amended, or any state securities laws.
Please issue and deliver to the undersigned a certificate or certificates representing said
shares of Common Stock in the name of the undersigned. Please issue and deliver to the undersigned
a new Option for any unexercised portion of the attached Option in the name of the undersigned.
Date: _____________
|
|
|
|
|
|
|
|
|
Signature: |
___________________________________
|
|
|
|
Name: |
________________________________ |
|
|
|
Title: |
________________________________ |
|
|
|
|
|
|
|
Delivery Information:
|
|
Address: |
|
|
|
|
|
|
|
|
|
City, State, Zip: |
|
|
|
|
|
|
|
|
|
Phone Number: |
|
|
|
|
|
|
|
|
|
|
|
(for express mailing purposes) |
$_________________________
Payment Attached
4
Ex-4.6.2
EXHIBIT
4.6.2
CUMBERLAND PHARMACEUTICALS INC.
2007 LONG-TERM INCENTIVE COMPENSATION PLAN
NONSTATUTORY STOCK OPTION AGREEMENT
This Option Agreement is entered into and effective on ___, by and between
Cumberland Pharmaceuticals Inc., a Tennessee corporation (the Company), and
___, (the Participant).
WHEREAS, the Company has adopted the 2007 Long-Term Incentive Compensation Plan (the Plan),
which is administered by the Companys Board of Directors (the Board); and
WHEREAS, as an increased incentive to contribute to the Companys future success and
prosperity, the Company will, subject to the Participant continuing to provide services to the
Company (or any of its current or future subsidiaries), provide the Participant an opportunity to
acquire shares of the Companys common stock, no par value (the Stock).
NOW, THEREFORE, in consideration of the promises and mutual covenants contained herein and for
other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged,
the parties hereto agree as follows:
1. Grant of Option. Subject to the terms of the Plan and the terms of this Option
Agreement, the Company grants to the Participant an option (the Option) to purchase from the
Company up to ___shares of Stock (the Shares), subject to adjustment as provided
in the Plan. This Option is not intended to qualify as an incentive stock option within the meaning
of Section 422 of the Internal Revenue Code of 1986, as amended.
2. Exercise Price. If the Option is exercised, the purchase price per Share shall be
___.
3. Method of Exercise. The Option granted under this Agreement shall be exercisable
from time to time, in whole or in part, by written notice in the manner set forth in Section 8
hereof, accompanied by payment of the purchase price for the Shares which the Participant elects to
purchase by cash, check, or such other instrument as the Company may accept. The Company shall make
prompt delivery of such Shares; provided that if any law or regulation which requires the Company
to take any action with respect to the Shares specified in such notice before issuance thereof,
then the date of delivery of such Shares shall be extended for the period necessary to take such
action.
4. Vesting.
(a) Participant shall become vested in the Option up to the amount of ___shares on
the 31st day of each December during the ___year period from ___to
___, subject to the achievement of certain Performance Criteria and amount of time
contributed, as determined in the sole and absolute discretion of the Board.
1
(b) Upon the Participants Employment Termination (or the termination of the consulting
engagement), the Option, to the extent unvested, shall lapse and be cancelled, and be of no
further force and effect, as of midnight of such date, unless the Board resolves (under Section
4(b) of the Plan) to cancel or cause the forfeiture of the Option at an earlier time.
(c) Upon an Acquisition Event and/or a Change in Control Event, the Option will vest to the
extent provided in the Plan.
5. Termination of Option; Restrictions on Exercise. Except as otherwise stated in
this Agreement, this Option, to the extent not previously exercised, shall expire on the
___anniversary (the Expiration Date) of the date of this Agreement. The following
additional provisions shall apply to the exercise of this Option:
(a) Termination of Employment. Except as otherwise provided in this Agreement or in the Plan,
if Participants employment with the Company or any of its subsidiaries is terminated by the
Participant or the Company (or if the Participants consulting engagement is terminated), this
Option, to the extent that it is vested in accordance with the applicable provisions of Section 4
hereof, may not be exercised after the earlier of (i) ninety (90) days after such termination or
(ii) the expiration date of this Option stated above. Except as expressly set forth otherwise
herein, this Option shall terminate in all other respects upon such termination of employment (or
consulting engagement).
(b) Death of Participant. If the Participants employment (or consulting engagement) with the
Company is terminated due to his/her death during the term of this Option, the Participants legal
representative, or the person so entitled under the Participants last will and testament, or
under applicable intestate laws, shall have the right to exercise this Option for the number of
shares to which the Participant was entitled in accordance with applicable provisions of Section 4
hereof, and such right shall expire and this Option shall terminate on the Expiration Date. Except
as expressly set forth otherwise herein, this Option shall terminate in all other respects upon
such termination of employment (or consulting engagement).
6. Provisions of Plan. This Option is subject to the Plan as defined herein. The
terms and provisions of the Plan as it may be amended from time to time are hereby incorporated
herein by reference. In the event of a conflict between the terms or provisions contained herein
and the terms or provisions of the Plan, the applicable terms and provisions of the Plan will
govern and prevail; however, in the event of a conflict regarding specific terms and provisions
addressing the duration of this Option after termination of employment (or consulting engagement),
the terms and provisions of this Option will govern.
7. Tax Treatment of Option. The Participant is responsible for any federal, state,
local, or foreign tax, including income tax, social security tax, payroll tax, payment on account,
or other tax-related withholding with respect to this Option (including the grant, vesting and
exercise of the Option and the receipt of Stock and sale of Stock). The Company does not guarantee
any particular tax treatment or results in connection with the grant, vesting or exercise of the
Option.
8. Notices. Any notice, request, instruction or other document given under this
Option Agreement shall be in writing and shall be addressed and delivered in the case of the
Company, to the Secretary of the Company at the principal office of the Company and, in the case
of the Participant, the Participants address as set forth herein or to such other address as the
2
Participant may provide in a written notice to the Company, a copy of which shall be on file
with the Secretary of the Company.
9. Governing Law. This Option Agreement shall be construed in accordance with and
governed by the law of the State of Tennessee, without giving effect to the conflict of law
provisions thereof.
10. Relation to Other Benefits. Unless otherwise provided, the benefits received by
the Participant under this Agreement will not be taken into account or treated as normal salary or
compensation in determining any benefits to which the Participant may be entitled under any profit
sharing, retirement, bonus, long service, or other benefit or compensation plan maintained by the
Company, including the amount of any life insurance coverage available to any beneficiary of the
Participant under any life insurance plan covering employees of the Company, or as part of the
calculation of any severance, resignation, termination, redundancy or end of service payments. The
grant of this Option does not create any contractual or other right to receive future grants of
Options, or benefits in lieu of Options, even if the Participant has a history of receiving Options
or other stock awards.
IN WITNESS WHEREOF, each of the parties hereto has caused this Option Agreement to be executed
by its duly authorized representative.
|
|
|
|
|
CUMBERLAND PHARMACEUTICALS INC.:
|
|
|
By: |
____________________
|
|
|
|
Name: |
____________________ |
|
|
|
Title: |
____________________ |
|
|
|
|
|
|
|
|
PARTICIPANT:
|
|
|
Signature: |
____________________
|
|
|
|
Name: |
____________________ |
|
|
|
Address: ____________________ |
|
|
|
OPTION NO. _________________
3
FOR FUTURE USE
NOTICE OF EXERCISE
Cumberland Pharmaceuticals Inc.:
The undersigned hereby elects to exercise the purchase rights granted thereto pursuant to the
attached Option Agreement # ___. In accordance with the terms thereof, the undersigned
elects to purchase ______ shares of Common Stock of Cumberland Pharmaceuticals Inc. and tenders herewith
payment of the purchase price for such shares in full.
In exercising such rights, the undersigned hereby confirms and acknowledges that the shares of
Common Stock are being acquired solely for investment, and that the undersigned will not offer,
sell, or otherwise dispose of any such shares of Common Stock, except under circumstances that will
not result in a violation of the Securities Act of 1933, as amended, or any state securities laws.
Please issue and deliver to the undersigned a certificate or certificates representing said
shares of Common Stock in the name of the undersigned. Please issue and deliver to the undersigned
a new Option for any unexercised portion of the attached Option in the name of the undersigned.
Date: ______________
|
|
|
|
|
|
|
|
|
Signature: |
_____________________________
|
|
|
|
Name: |
____________________________ |
|
|
|
Title: |
____________________________ |
|
|
|
|
|
|
|
Delivery Information:
|
|
Address: |
|
|
|
|
|
|
|
|
|
City, State, Zip: |
|
|
|
|
|
|
|
|
|
Phone Number: |
|
|
|
|
|
|
|
|
|
|
|
(for express mailing purposes) |
$_________________________
Payment Attached
4
Ex-4.7
EXHIBIT
4.7
CUMBERLAND PHARMACEUTICALS INC.
2007 DIRECTORS INCENTIVE PLAN
NONSTATUTORY STOCK OPTION AGREEMENT
This Option Agreement is entered into and effective on ___, by and between
Cumberland Pharmaceuticals Inc., a Tennessee corporation (the Company), and
___, (the Participant).
WHEREAS, the Company has adopted the 2007 Directors Incentive Plan (the Plan), which is
administered by the Compensation Committee of the Companys Board of Directors (the Board); and
WHEREAS, as an increased incentive to contribute to the Companys future success and
prosperity, the Company will, subject to the Participant continuing to serve on the Board, provide
the Participant an opportunity to acquire shares of the Companys common stock, no par value (the
Stock).
NOW, THEREFORE, in consideration of the promises and mutual covenants contained herein and for
other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged,
the parties hereto agree as follows:
1. Grant of Option. Subject to the terms of the Plan and the terms of this Option
Agreement, the Company grants to the Participant an option (the Option) to purchase from the
Company up to ___shares of Stock (the Shares), subject to adjustment as provided
in the Plan. This Option is not intended to qualify as an incentive stock option within the meaning
of Section 422 of the Internal Revenue Code of 1986, as amended.
2. Exercise Price. If the Option is exercised, the purchase price per Share shall be
___.
3. Method of Exercise. The Option granted under this Agreement shall be exercisable
from time to time, in whole or in part, by written notice in the manner set forth in Section 8
hereof, accompanied by payment of the purchase price for the Shares which the Participant elects to
purchase by cash, check, or such other instrument as the Company may accept. The Company shall make
prompt delivery of such Shares; provided that if any law or regulation which requires the Company
to take any action with respect to the Shares specified in such notice before issuance thereof,
then the date of delivery of such Shares shall be extended for the period necessary to take such
action.
4. Vesting.
(a) Participant shall become vested in the Option up to the amount of ___shares on
the 31st day of each December during the ___year period from ___to
___.
1
(b) If the Participant ceases to serve on the Board for any reason, the Option, to the extent
unvested, shall be forfeited, automatically cancelled, and be of no further force and effect, as
of midnight of such date.
(c) Upon an Acquisition Event and/or a Change in Control Event, the Option will vest to the
extent provided in the Plan.
5. Termination of Option; Restrictions on Exercise. Except as otherwise stated in
this Agreement, this Option, to the extent not previously exercised, shall expire on the tenth
anniversary (the Expiration Date) of the date of this Agreement. The following additional
provisions shall apply to the exercise of this Option:
(a) Termination of Board Service. If the Participant ceases to serve on the Board for any
reason, this Option, to the extent that it is vested in accordance with the applicable provisions
of Section 4 hereof, may not be exercised after the earlier of (i) two (2) years after such
termination or (ii) the Expiration Date of this Option stated above. Except as expressly set forth
otherwise herein, this Option shall terminate in all other respects upon such termination.
(b) Death of Participant. If the Participants Board service with the Company is terminated
due to his/her death during the term of this Option, the Participants legal representative, or
the person so entitled under the Participants last will and testament, or under applicable
intestate laws, shall have the right to exercise this Option for the number of shares to which the
Participant was entitled in accordance with applicable provisions of Section 4 hereof, and such
right shall expire and this Option shall terminate on the Expiration Date. Except as expressly set
forth otherwise herein, this Option shall terminate in all other respects upon the Participants
death.
6. Provisions of Plan. This Option is subject to the Plan as defined herein. The
terms and provisions of the Plan as it may be amended from time to time are hereby incorporated
herein by reference. In the event of a conflict between the terms or provisions contained herein
and the terms or provisions of the Plan, the applicable terms and provisions of the Plan will
govern and prevail; however, in the event of a conflict regarding specific terms and provisions
addressing the duration of this Option after termination of Board service, the terms and
provisions of this Option will govern.
7. Tax Treatment of Option. The Participant is responsible for any federal, state,
local, or foreign tax, including income tax, social security tax, payroll tax, payment on account,
or other tax-related withholding with respect to this Option (including the grant, vesting and
exercise of the Option and the receipt of Stock and sale of Stock). The Company does not guarantee
any particular tax treatment or results in connection with the grant, vesting or exercise of the
Option.
8. Notices. Any notice, request, instruction or other document given under this
Option Agreement shall be in writing and shall be addressed and delivered in the case of the
Company, to the Secretary of the Company at the principal office of the Company and, in the case
of the Participant, the Participants address as set forth herein or to such other address as the
Participant may provide in a written notice to the Company, a copy of which shall be on file with
the Secretary of the Company.
2
9. Governing Law. This Option Agreement shall be construed in accordance with and
governed by the law of the State of Tennessee, without giving effect to the conflict of law
provisions thereof.
10. Relation to Other Benefits. Unless otherwise provided, the benefits received by
the Participant under this Agreement will not be taken into account or treated as normal salary or
compensation in determining any benefits to which the Participant may be entitled under any profit
sharing, retirement, bonus, long service, or other benefit or compensation plan maintained by the
Company, including the amount of any life insurance coverage available to any beneficiary of the
Participant under any life insurance plan covering employees of the Company, or as part of the
calculation of any severance, resignation, termination, redundancy or end of service payments. The
grant of this Option does not create any contractual or other right to receive future grants of
Options, or benefits in lieu of Options, even if the Participant has a history of receiving Options
or other stock awards.
IN WITNESS WHEREOF, each of the parties hereto has caused this Option Agreement to be executed
by its duly authorized representative.
|
|
|
|
|
CUMBERLAND PHARMACEUTICALS INC.:
|
|
|
By: |
____________________
|
|
|
|
Name: |
____________________ |
|
|
|
Title: |
____________________ |
|
|
|
|
|
|
|
|
PARTICIPANT:
|
|
|
Signature: |
____________________
|
|
|
|
Name: |
____________________ |
|
|
|
Address: ____________________ |
|
|
|
OPTION NO. _________________
3
FOR FUTURE USE
NOTICE OF EXERCISE
Cumberland Pharmaceuticals Inc.:
The undersigned hereby elects to exercise the purchase rights granted thereto pursuant to the
attached Option Agreement # ___. In accordance with the terms thereof, the undersigned
elects to purchase ______ shares of Common Stock of Cumberland Pharmaceuticals Inc. and tenders herewith
payment of the purchase price for such shares in full.
In exercising such rights, the undersigned hereby confirms and acknowledges that the shares of
Common Stock are being acquired solely for investment, and that the undersigned will not offer,
sell, or otherwise dispose of any such shares of Common Stock, except under circumstances that will
not result in a violation of the Securities Act of 1933, as amended, or any state securities laws.
Please issue and deliver to the undersigned a certificate or certificates representing said
shares of Common Stock in the name of the undersigned. Please issue and deliver to the undersigned
a new Option for any unexercised portion of the attached Option in the name of the undersigned.
Date: _______________
|
|
|
|
|
|
|
|
|
Signature: |
___________________________
|
|
|
|
Name: |
________________________________ |
|
|
|
Title: |
_______________________________ |
|
|
|
|
|
|
|
Delivery Information:
|
|
Address: |
|
|
|
|
|
|
|
|
|
City, State, Zip: |
|
|
|
|
|
|
|
|
|
Phone Number: |
|
|
|
|
|
|
|
|
|
|
|
(for express mailing purposes) |
$_________________________
Payment Attached
4
EX-10.1 MANUFACTURING AND SUPPLY AGREEMENT
EXHIBIT 10.1
*Certain portions of this exhibit have been omitted pursuant to a request for confidential
treatment which has been filed separately with the SEC.
MANUFACTURING AND SUPPLY AGREEMENT
for
N-ACETYLCYSTEINE
CUMBERLAND PHARMACEUTICALS INC.
and
BIONICHE LIFE SCIENCES, INC.
January 15, 2002
MANUFACTURING AND SUPPLY
AGREEMENT FOR N-ACETYLCYSTEINE
THIS AGREEMENT is made and entered into as of the 15th day of January, 2002.
BY AND BETWEEN:
CUMBERLAND PHARMACEUTICALS INC., a corporation organized and existing under the laws of Tennessee,
United States, with its principal offices located at 209 Tenth Avenue South, Suite 332, Nashville,
Tennessee, 37203 (hereinafter referred to as CUMBERLAND)
AND:
BIONICHE LIFE SCIENCES INC., a corporation organized and existing under the laws of Ontario,
Canada, with its principal place of business located at 231 Dundas Street, East Belleville,
Ontario, Canada K8N 1E2 (hereinafter referred to as BIONICHE);
WHEREAS, CUMBERLAND is the owner of certain intellectual property rights with respect to a Drug
Product (as hereinafter defined);
WHEREAS, BIONICHE has the expertise and the manufacturing facility suitable for the pharmaceutical
preparation and production of the Drug Product;
WHEREAS, CUMBERLAND wishes to have BIONICHE manufacture the Drug Product on an exclusive basis for
sale in the Territory (as hereinafter defined) and BIONICHE wishes to supply the Drug Product on an
exclusive basis to CUMBERLAND on and subject to the terms and conditions set out herein;
NOW, THEREFORE, in consideration of the premises and the undertakings, terms, conditions and
covenants set forth below, the parties hereto agree as follows:
1. DEFINITIONS
1.1 AFFILIATE shall mean, with respect to any Person, any other Person that controls, is
controlled by or is under common control with, such Person. A Person shall be regarded as in
control of another Person if such Person owns, or directly or indirectly controls, more than fifty
percent (50%) of the voting securities (or comparable equity interests) or other ownership
interests of the other Person, or if such Person directly or indirectly possesses the power to
direct or cause the direction of the management or policies of the other Person, whether
through the ownership of voting securities, by contract or any other means whatsoever.
1.2 BUFFER SOLUTION shall mean the buffer solution used for the manufacture of the Drug
Product.
1.3 BULK DRUG SUBSTANCE shall mean the active ingredients in the Drug Product.
1.4 cGMP or GMP shall have the meaning set forth in Schedule I.
1.5 CONFIDENTIAL INFORMATION shall have the meaning set forth in Article 9.
1.6 DEVELOPMENT shall mean all work necessary to develop a process to manufacture the Drug
Product in full accord with cGMP and to supply the Drug Product conforming to the Specifications.
Development activities shall include, but not be limited to, pilot batches, scale-up batches,
validation of the manufacturing process, and successful completion of the Drug Product manufacture
and delivery as defined in Schedule I attached hereto.
1.7 DRUG PRODUCT shall mean the N-Acetylcysteine pharmaceutical product developed by
CUMBERLAND and marketed under the trade name ACETADOTE or any other trade name selected by
CUMBERLAND.
1.8 EXCIPIENT shall mean any inert substance selected by CUMBERLAND and used to give the Drug
Product proper consistency.
1.9 FACILITY shall mean the manufacturing facility and the real property underlying such
manufacturing facility operated by Bioniche Teoranta, an Affiliate of BIONICHE, located at
Inverin, Co. Galway, Republic of Ireland.
1.10 FDA shall mean the United States Food and Drug Administration (FDA) or any successor
entity thereto.
1.11 IN-PROCESS SOLUTION shall mean all Buffer Solutions and Excipients needed to produce
Drug Product in the finished dosage form set forth in Schedule I.
1.12 INVENTION shall have the meaning set forth in Paragraph 9.4.
1.13 LABELING shall mean all labels and other written, printed, or graphic matter upon: (i)
the Drug Product or any container or wrapper utilized with the Drug Product and (ii) any written
material accompanying the Drug Product, including without limitation, package inserts.
1.14 MANUAL shall mean the Manufacturing Project Manual attached as Schedule II to this
Agreement and reviewed and accepted by CUMBERLAND and BIONICHE, the terms and provisions of which
are incorporated by reference as though fully set forth herein.
1.15 MANUFACTURE shall mean the act of compounding, component preparations, filling,
packaging, testing and any other pharmaceutical manufacturing procedures, or any part thereof,
involved in manufacturing the Drug Product from the Bulk Drug Substance.
1.16 PERSON shall mean an individual, corporation, partnership, limited liability company, or
any other form of entity not specifically listed herein.
1.17 SPECIFICATIONS shall mean those specifications set forth in Attachment I to the Manual.
1.18 TERRITORY shall have the meaning set forth in Schedule III.
2. DEVELOPMENT AND MANUFACTURING
2.1 Initiation: Upon request by CUMBERLAND and subject to the provisions hereof, BIONICHE,
directly or through an Affiliate thereof, shall Manufacture and package at the Facility all of
CUMBERLANDs requirements for Drug Product in the Territory in the batch size set forth in
Schedule I in accordance with the terms hereof, including without limitation, Schedules I and II
hereof, the Specifications, and all applicable laws and regulations. Prior to distributing and
selling the Drug Product, CUMBERLAND shall prepare and file submissions to the FDA in order to
obtain and maintain during the term hereof regulatory approval of the Drug Product, BIONICHE shall
prepare and test the Drug Product in accordance with cGMP.
2.2 Documentation: BIONICHE shall provide CUMBERLAND with required supporting documentation
for the manufacture of the Drug Product in a form suitable for CUMBERLANDs submission to the FDA
or applicable governmental authorities for any country into which the Drug Product will be
distributed. BIONICHE shall provide draft Chemistry, Manufacturing, and Controls sections for
CUMBERLANDs FDA submissions,
2.3 Bulk Drug Substance Supply: BIONICHE shall be responsible for the supply of all Bulk Drug
Substance in accordance with Schedules I and II hereto; provided that the supply of Bulk Drug
Substance shall be exclusively from such suppliers and in such grades as have been approved in
writing by CUMBERLAND as reflected on an approved list to be attached hereto as Schedule IV, and
provided further that such suppliers and
grades may not be changed without CUMBERLANDs prior written consent, which consent shall not
be unreasonably withheld or delayed. BIONICHE shall maintain, at its expense, secure storage areas
for the Bulk Drug Substance at the Facility.
2.4 Supply of Components: BIONICHE shall be responsible for the supply of all Buffer Solution,
Excipients, and all other components of the finished Drug Product in accordance with Schedules I
and II hereto; provided that the supply of these components shall be exclusively from such
suppliers and in such grades as have been approved in writing by CUMBERLAND as reflected on an
approved list to be attached hereto as Schedule IV, and provided further that such suppliers and
grades may not be changed without CUMBERLANDs prior written consent which consent shall not be
unreasonably withheld or delayed. BIONICHE shall maintain, at its expense, secure storage areas for
the Buffer Solution, Excipients, and all other components at the Facility.
2.5 Delivery Terms: All deliveries of Drug Product under this Agreement shall be made by
BIONICHE to CUMBERLAND in the manner set forth in Schedule I. CUMBERLAND shall, within twenty (20)
working days after its receipt of any shipment, notify BIONICHE in writing, of any claim relating
to a Drug Product not conforming to GMP or to the Specifications, and, failing such notification,
notwithstanding Paragraph 5.1 of this Agreement, CUMBERLAND shall be deemed to have accepted the
Drug Product. If BIONICHE disputes CUMBERLANDs claim that the Drug Product is non-conforming, then
such dispute shall be resolved by an independent testing organization of recognized repute within
the pharmaceutical industry mutually agreed upon by BIONICHE and CUMBERLAND, the appointment of
which shall not be unreasonably withheld or delayed by either party. In such event, CUMBERLAND
shall ship the testing organization representative samples of the Drug Product from the disputed
production lot, and the fees and costs of such testing organization and related shipping and supply
costs shall be borne by the party whose position is not sustained by the testing organization.
Should CUMBERLANDs claim of non-conformity be sustained by the testing organization, BIONICHE
shall, at CUMBERLANDS sole option, (a) credit towards future orders, or (b) refund within thirty
(30) days thereof; the payment for such non-conforming goods, plus the cost to CUMBERLAND of
Manufacturing and shipping the related Bulk Drug Substance and components.
2.6 Forecasts: In order to permit BIONICHE to regularly supply CUMBERLAND with Drug Product
hereunder, at least [***] prior to its first requested delivery date, CUMBERLAND shall provide
BIONICHE a non-binding twelve (12) month rolling forecast (the Forecast) of CUMBERLANDs
estimated requirements of Drug Product, itemized for use as commercial product or Regulatory
Samples (as defined below), for the term of this Agreement. The Forecast shall be reviewed and
updated by CUMBERLAND on a monthly basis, with copies delivered to BIONICHE. BIONICHE shall have an
opportunity to confirm its ability to deliver the quantities set out in the Forecast and each
update thereto, or to request amendments thereto to ensure its ability to supply. Once accepted by
BIONICHE, the first three (3) months of each Forecast shall constitue a firm order for Drug
Product. Each such Forecast shall reflect a good faith attempt by CUMBERLAND to estimate quantity
requirements of Drug Product, based on anticipated demand therefore.
2.7 Periodic Orders: A purchase order (the Purchase Order) shall be provided by CUMBERLAND
to BIONICHE with respect to Drug Product to be supplied at least [***] prior to the scheduled
delivery date of such Drug Product. Such Purchase Order shall specify the quantities ordered by
CUMBERLAND for delivery by BIONICHE hereunder and the requested delivery date therefore, and, once
delivered to BIONICHE, and shall be firm and binding on the parties (the Delivery Date). Each
such Purchase Order shall become firm and binding on the parties and, except as specifically
provided for herein, may not be increased or decreased by more than [***] from the quantities shown
in the Forecast accepted by BIONICHE pursuant to Section 2.6 without the prior written approval of
the parties. If CUMBERLAND requires quantities of Drug Product exceeding those mentioned in the
Forecast, as updated, BIONICHE shall deliver the amount indicated in the Forecast on the scheduled
Delivery Date and shall use reasonable efforts to supply the additional amount exceeding such
Forecast on the scheduled Delivery Date, but shall have no liability for failure to deliver the
additional amount. Each Purchase Order shall constitute a separate agreement to purchase Drug
Product but where in conflict with the terms and conditions of this Agreement, this Agreement, and
not the standard terms and conditions set forth in the purchase orders, shall govern the
Manufacturing, purchase and sale of the Drug
Product under this Agreement. Any Purchase Order for Drug Product shall be placed in the minimum
amounts listed below or in integral multiples thereof.
For the 10mL form of Drug Product [***]
For the 30mL form of Drug Product [***]
2.8 Failure to Supply: Subject to the provisions of Article 7, BIONICHE shall supply all of
the Drug Product ordered by CUMBERLAND within [***] of receipt of a written order from CUMBERLAND.
If BIONICHE is unable to meet its supply obligations with respect to any Purchase Order,
CUMBERLAND shall be free to procure from third parties part or all of the quantities of the Drug
Product covered by the relevant Purchase Order. In the event that BIONICHE is unable to supply the
Drug Product to CUMBERLAND for any reason other than for Force Majeure or failure of CUMBERLAND to
fulfill its obligations hereunder, BIONICHE will reimburse CUMBERLAND for any increase in the
price of obtaining the Drug Product from an alternate supplier; provided that such replacement
Drug Product was purchased on reasonable commercial terms, and provided further that such failure
to supply was in respect of Drug Product that was the subject of a Purchase Order provided by
CUMBERLAND and accepted by BIONICHE under Paragraph 2.7. Should BIONICHE reimburse CUMBERLAND as
set out in this paragraph, BIONICHE shall have no further liability to CUMBERLAND for said failure
to supply.
2.9 Payment for the Drug Product: At the time of each shipment, BIONICHE shall invoice
CUMBERLAND for BIONICHEs manufacturing services at the prices set forth in Schedule I. Payment
shall be made in Canadian dollars within [***] of each such shipment of conforming Product in
accordance with the terms hereof.
2.10 Price Variations:
(a) Prices are as set on Schedule I for the term hereof unless changed pursuant to Paragraph
2.10(b).
(b) Subject to Subparagraph 2.10(c), prices are subject to annual adjustment beginning two
(2) years after the date hereof. Price increases or decreases will be commensurate with documented
Manufacturing cost increases or decreases since the date that the then-current prices became
effective. For purposes hereof, Manufacturing cost shall mean, with respect to the Drug Product,
BIONICHEs actual and documented cost of raw materials, direct labor, Manufacturing, packaging,
and overhead amounts directly applicable to such Manufacturing costs (including appropriately
amortized capital equipment costs and excluding non-manufacturing overhead and allocations and
excluding costs representing Manufacturing changes for which CUMBERLAND does not provide prior
written consent pursuant to Article 8), calculated in accordance with generally accepted
accounting principles consistently applied (the allocation of overhead to be consistent with
BIONICHEs allocation of overhead as of the date of this Agreement). CUMBERLAND reserves the right
to audit the records of BIONICHE in order to determine that such increases and/or decreases are
appropriate. Any increase in price shall not exceed the twelve (12) month percent increase in the
Producer Price Index as published by the U.S. government and shall be further subject to a maximum
increase of five percent (5%) per year over the life of the Agreement.
(c) Notwithstanding any of the contrary herein contained, should CUMBERLAND: (i) request a
change in Specifications, or (ii) unreasonably withhold the consent requested under Paragraphs 2.3
or 2.4, which request or refusal results in an increase in Manufacturing Costs, BIONICHE shall be
entitled to pass on such costs to CUMBERLAND immediately in the form of a Drug Product price
increase.
3. TERM AND TERMINATION
3.1 Term: This Agreement shall commence on the date first above written and will continue
until the fifth anniversary of the date on which the FDA grants approval to market and sell the
Drug Product, unless sooner terminated pursuant to Paragraphs 3.2 or 3.3 hereof. Subject to
Paragraphs 3.2 and 3.3, the Agreement shall be automatically renewed for successive three-year
terms 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.
3.2 Termination: This Agreement may be terminated at any time upon the occurrence of any of
the following events:
(a) Default: Thirty (30) days following written notice, by either party to the other party, in
the event that the other party breaches any provision of this Agreement, and such party fails to
remedy the breach prior to the expiration of the thirty (30) day period; provided that, in the case
of nonpayment of sums due hereunder, the remedy period shall be decreased to ten (10) days.
(b) Insolvency: Written notice by either party to the other upon insolvency or bankruptcy of
the other party, and the failure of any such insolvency or bankruptcy to be dismissed within sixty
(60) days.
(c) Force majeure: If, as a result of causes described in Paragraph 7.1, either party is
unable to fully perform its obligations hereunder for a period of one hundred fifty (150)
consecutive days, the other party shall have the right to terminate this Agreement upon at least
thirty (30) days prior written notice; provided that if the required performance is met during that
thirty-day period, this Agreement shall continue in full force and effect as if the notice had not
been given.
(d) Costs: Immediately upon written notice by BIONICHE to CUMBERLAND if the Manufacturing cost
per unit of Drug Product calculated in the manner set forth in Paragraph 2.10(a) hereof exceeds the
purchase price per unit of Drug Product set forth in Schedule I, as adjusted pursuant to Paragraphs
2.10(b) and/or (c) hereof.
(e) No FDA Approval: Immediately upon written notice by BIONICHE to CUMBERLAND if the FDA does
not grant CUMBERLAND approval to market and sell the Drug Product on or before the second
anniversary of the date of this Agreement.
(f) By mutual agreement of the parties hereto.
Except as otherwise specifically set forth in this Paragraph 3.2, termination, expiration,
cancellation or abandonment of this Agreement, through any means and for any reason, shall not
relieve the parties of any obligation accruing prior thereto and shall be without prejudice to the
rights and remedies of either party with respect to any antecedent breach of any of the provisions
of this Agreement. Without limiting the generality of the foregoing, termination, expiration,
cancellation, or abandonment of this Agreement shall not relieve CUMBERLAND of its obligation to
pay the royalty provided for under Schedule I for Drug Product manufactured by BIONICHE hereunder.
3.3 Minimum Quantities Purchased: If the parties fail to agree on minimum purchase quantities
as provided under Paragraph 5.7, or if following such agreement, CUMBERLAND should fail to meet the
agreed upon minimum purchase requirements, BIONICHE shall have the right (but not the obligation)
to terminate this Agreement in its entirety or with respect to any one or more format of the Drug
Product upon ninety (90) days notice; provided, however, that CUMBERLAND shall have the right (but
not the obligation) within such ninety (90) day period to pay BIONICHE any short-fall and avoid
such termination. Such shortfall shall be calculated by subtracting the purchase price of the
amount of each format of Drug Product actually ordered from the amount calculated by multiplying
the minimum quantity of such format under Schedule V by the purchase price thereof. It is
understood and agreed between the parties that BIONICHE shall not be required to supply Drug
Product for such payment. Should BIONICHE exercise its right to terminate under this Paragraph 3.3,
CUMBERLAND shall have no liability to BIONICHE for failing to purchase any minimum quantity of Drug
Product hereunder.
3.4 Impact of Termination on Outstanding Purchase Orders: Upon termination of the Agreement
for any reason whatsoever (except for termination by either party pursuant to Paragraphs 3.2(a),
(b), or (c), or upon expiration of this Agreement), BIONICHE will, at CUMBERLANDs written request
delivered after termination, continue to supply Drug Product to CUMBERLAND in satisfaction of
Purchase Orders already submitted to BIONICHE, subject to the same terms and conditions as applied
during the term of the Agreement, for a period of sixty (60) days from the date of termination or
expiration.
3.5 Survival: Paragraphs 2.5, 2.8, 3.2, 3.3, and 3.5 and Articles 5, 6, 9, and 10 shall
survive the termination or cancellation of the Agreement for any reason.
4. CERTIFICATES OF ANALYSIS AND MANUFACTURING COMPLIANCE
4.1 Certificates of Analysis: BIONICHE shall perform, or cause to be performed, certain tests
requested by CUMBERLAND in writing and as indicated in the Specifications on each batch of the Drug
Product manufactured pursuant to this Agreement before delivery to CUMBERLAND. A certificate of
analysis for each batch delivered shall be delivered with each batch and shall set forth the items
tested, specifications, and test results. BIONICHE shall also indicate on the certificate of
analysis that all batch production and control records have been reviewed and approved by the
appropriate quality control unit. Subject to Paragraph 2.5, CUMBERLAND shall test, or cause to be
tested, prior to final release, each batch of the Drug Product as meeting the Specifications. As
required by the FDA (see Paragraph 5.2 below), CUMBERLAND shall assume full responsibility for
final release of each lot of the Drug Product.
4.2 Manufacturing Compliance: BIONICHE shall advise CUMBERLAND immediately if an authorized
agent of any regulatory body visits the Facility and makes an inquiry regarding BIONICHEs method
of manufacture of the Drug Product for CUMBERLAND. Upon receipt of any Form 483 Notice of
Inspectional Observations issued by the FDA or notice of deficit from any other regulatory
inspection after a visit to the Facility, BIONICHE shall immediately send CUMBERLAND a copy
thereof; provided that it may redact any language that is subject to a written confidentiality
agreement between BIONICHE and a third party.
4.3 Regulatory Agency Requirements: BIONICHE shall prepare and test the Drug Product in
conformity with GMP. Subject to the allocation of responsibility for regulatory compliance as set
forth in Paragraph 5.2, each party shall consult with the other party hereto before implementing
additional regulatory agency requirements concerning the control of Drug Product components,
manufacture of the Drug Product, or storage and handling of the Drug Product. The full text of
regulatory agency requests or comments will be provided by the party receiving such requests or
comments to the other party hereto. The parties will mutually agree on how to respond to such
requests and comments and on the allocation of the costs thereof; provided that BIONICHE shall be
entitled to reimbursement from CUMBERLAND for any out-of-pocket expenses or extraordinary costs
previously approved in writing by CUMBERLAND and required in connection with implementing such
regulatory requirements other than the ordinary costs of compliance with GMP.
4.4 Regulatory Documents: Each party will advise the other party hereto of its intention to
change any Drug Product regulatory documents prior to submission of the document to any regulatory
body. If the change affects the rights and obligations of a party hereto under this Agreement, such
party may seek to review or alter any part of the document at any time within ten (10) business
days after receipt of notification thereof; provided that if no alterations are submitted to the
other party within such ten-day period, each party will be deemed to have consented to the
documents, as amended.
5. REPRESENTATIONS AND WARRANTIES
5.1 Conformity with Specifications: BIONICHE represents and warrants that, at the time of
Manufacture, the Drug Product is prepared and tested in accordance with cGMP and meets the
Specifications. In the event that any production lot of a Drug Product is not Manufactured in
accordance with the Specifications or other requirements hereunder, BIONICHE shall, at CUMBERLANDs
request, perform new Manufacturing as necessary to fulfill any then outstanding purchase order of
CUMBERLAND. BIONICHE shall be fully responsible for the costs of any Bulk Drug Substance or
components required for such new Manufacturing. Because BIONICHE has no control of the conditions
under which the Drug Product is used, the diagnosis of the patient before or after treatment with
the Drug Product, the method of use or administration of the Drug Product, and handling of the Drug
Product after delivery to CUMBERLAND, BIONICHE does not warrant either a good effect, or against an
ill effect, following the use of the Drug Product. The foregoing warranty is exclusive and in lieu
of all other warranties either written, oral, or implied. No representative of BIONICHE may change
any of the foregoing warranties and CUMBERLAND accepts the Drug Product subject to all terms
hereof.
EXCEPT AS SPECIFICALLY PROVIDED FOR IN THIS ARTICLE 5 AND PARAGRAPH 11.4, BIOMCHE MAKES NO
REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED (i) OF COMMERCIAL UTILITY; (ii) OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE; OR (iii) THAT THE USE OF THE DRUG PRODUCTS BY
CUMBERLAND OR ANY THIRD PARTY WILL NOT INFRINGE ANY PATENT, COPYRIGHT OR TRADEMARK OR OTHER
PROPRIETARY OR PROPERTY
RIGHTS OF OTHERS. EXCEPT AS PROVIDED FOR HEREIN, BIONICHE WILL NOT BE LIABLE TO CUMBERLAND,
CUMBERLANDS SUCCESSORS OR ASSIGNS OR ANY THIRD PARTY WITH RESPECT TO ANY CLAIM ARISING FROM
CUMBERLANDS OR ANY THIRD PARTYS USE OF THE DRUG PRODUCTS.
CUMBERLAND ACCEPTS ALL RISK AND RESPONSIBILITY FOR DETERMINING THE MANNER IN WHICH CUMBERLAND
WILL USE THE DRUG PRODUCTS, AND BIONICHE MAKES NO REPRESENTATIONS OR WARRANTIES CONCERNING, AND
ASSUMES NO RESPONSIBILITY FOR, THE PERFORMANCE OF ANY OTHER PRODUCT(S) INTO WHICH THE DRUG
PRODUCTS MAY BE INCORPORATED.
5.2 Compliance: CUMBERLAND represents and warrants that CUMBERLAND assumes responsibility for
coordinating all contact with the FDA and other regulatory bodies, pertaining specifically to the
Drug Product. During the term of this Agreement, BIONICHE authorizes CUMBERLANDs representatives
to inspect the methods used in and facilities used for manufacturing, processing, packaging, and
handling of the Drug Product; provided that each such inspection shall be at CUMBERLANDS own
cost, on reasonable prior notice, and subject to the prior execution of reasonable confidentiality
agreement by each inspector who is not an employee of CUMBERLAND but has been selected by
CUMBERLAND to represent it; and provided further that CUMBERLAND shall have no such obligation
under this Agreement. Except as otherwise required by applicable regulations, CUMBERLANDs
inspections shall be conducted during normal business hours; provided that CUMBERLAND may inspect
such facilities immediately after any regulatory inspection thereof.
5.3 Debarring: BIONICHE represents and warrants that it has not been debarred in the United
States within the meaning of 21 U.S.C. § 335a(a) and 335a(b), nor will it use, knowingly after due
inquiry, in any capacity the services of any person debarred pursuant to subsections 3.06(a) or
3.06(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Section 335(a) and (b).
5.4 FDA Submission: BIONICHE represents and warrants that it has submitted to the FDA
information about the Facility and the operating procedures, and personnel at such site in the
form required by the FDA. BIONICHE shall keep and maintain the equipment necessary for the
Manufacture of any Drug Product in a manufacture-ready state and in good repair. During the term
hereof and until the fifth anniversary of termination or expiration, BIONICHE shall maintain
written documentation of all use, repair, service, and maintenance of such equipment and shall
provide CUMBERLAND copies of such documentation; provided that in the event that a Person acquires
substantially all of the assets and business of BIONICHE, BIONICHE may send all such documentation
to CUMBERLAND promptly after such acquisition.
5.5 Reimbursement: BIONICHE shall not incur any costs for which it intends to seek
reimbursement from CUMBERLAND unless BIONICHE has the prior written consent of CUMBERLAND.
CUMBERLAND shall reimburse BIONICHE at a rate equal to one hundred fifty percent (150%) of all
such costs actually incurred and documented and directly related to the production of materials or
data for submissions to the FDA (Pre-Approval Costs) hereunder, provided that reimbursement of
such Pre-Approval Costs shall be paid by means of twelve (12) equal installments thereof to be
made on the first day of each of the twelve (12) months following the date on which the FDA issues
final approval to CUMBERLAND to market and sell the Drug Product commercially in the United States
(the Approval Date); and provided further that if the Approval Date has not occurred on or
before one year from the date of signing of the Agreement then CUMBERLAND shall immediately
reimburse BIONICHE at a rate equal to one hundred percent (100%) of all Pre-Approval Costs
incurred prior to such date in complete satisfaction of its obligations to reimburse such
Pre-Approval Costs.
5.6 Exclusivity:
(a) Neither BIONICHE nor any Affiliate thereof will sell, give away, or deliver to any other
person, firm, or corporation any form of the Drug Product in the Territory for indications
currently approved as of the date of signing this Agreement (currently-approved indications),
while this Agreement is effective and for two years after the termination of this Agreement;
provided that such restrictions shall not apply in the event of termination by BIONICHE pursuant to
Subparagraphs 3.2 (a), (b), (e), or Paragraph 3.3 and shall not apply to the sale by BIONICHE of a
product that contains the same active ingredients as the Drug Product for use as a chemoprotectant
(Excluded Products) or Other Products, as defined below, subject to the rights set out in
Subparagraph 5.6 (d).
(b) If, during the term hereof, BIONICHE wishes to market or distribute Excluded Products in
the Territory in association with any third Person, BIONICHE shall give CUMBERLAND written notice
thereof, and CUMBERLAND shall have thirty (30) days to notify BIONICHE of its interest in entering
into an arrangement with BIONICHE, on terms to be negotiated by the parties in good faith during
the period of one hundred twenty (120) days immediately following the receipt by CUMBERLAND of
such notice (the Option Period). If the parties negotiate in good faith but do not conclude an
agreement within the Option Period, BIONICHE agrees not to enter into an agreement covering the
Excluded Products in the Territory with any third Person on terms that are more favorable than the
terms previously offered to CUMBERLAND without first offering to enter into an agreement with
CUMBERLAND, to be negotiated during an additional thirty day period, such offer to be made on
terms no less favorable than the terms being offered to the third Person. If CUMBERLAND does not
enter into negotiations with BIONICHE within thirty (30) days following receipt of such notice,
then BIONICHE shall be free to negotiate with third Persons with no further obligation to
CUMBERLAND.
(c) Notwithstanding the provisions of Subparagraph 5.6 (b) above, BIONICHE shall have no
obligation to make any offer to CUMBERLAND with respect to any development, marketing or sale of
Excluded Products in the Territory if it chooses to so develop, market or sell directly, rather
than in association with any third Person.
(d) With respect to any product that contains the same active ingredient as the Drug Product
for indications other than Excluded Products that BIONICHE may seek to develop (Other Products),
BIONICHE shall provide notice to CUMBERLAND as set out in Subparagraph 5.6 (b) above, and the same
procedures shall apply. Likewise, with respect to any indications other than currently-approved
indications for the Drug Product that CUMBERLAND seeks to develop, CUMBERLAND shall provide notice
to BIONICHE regarding the possibility of supply of said Drug Product to CUMBERLAND and the
procedures described in Subparagraph 5.6 (b) above shall apply.
(e) If CUMBERLAND does not acquire rights to Excluded Products or to Other Products as
described in Subparagraphs 5.6 (c) and (d) above, and CUMBERLAND establishes, through the dispute
resolution process set forth in Paragraph 11.7, that sales by BIONICHE of said products have
detrimentally impacted sales of the Drug Product then BIONICHE shall pay CUMBERLAND an amount
equal to the lost profits so established by CUMBERLAND. CUMBERLAND shall bear the burden of
establishing lost sales.
(f) Except in the event that BIONICHE fails to supply all Drug Product ordered within ninety
(90) days of receipt of a Purchase Order in accordance with Paragraph 2.7, or in the event of
Force Majeure, CUMBERLAND will order its entire requirement of the Drug Product for the Territory
from BIONICHE, If CUMBERLAND notifies BIONICHE that it intends. to distribute the Drug Product in
countries other than the United States and its territories, then the parties shall negotiate in
good faith, for a period not to exceed one hundred twenty (120) days after CUMBERLAND provides
such notice, to amend this agreement to expand the Territory hereunder; provided that if the
parties fail to agree upon the terms of supply for an expanded Territory within such 120-day
period, CUMBERLAND shall have no obligation to purchase requirements of Drug Products for such
other countries from BIONICHE, but its obligations hereunder with respect to the United States and
its territories shall remain in full force and effect.
(g) In the event of breach of this Paragraph 5.6, the parties shall have the right, in
addition to other rights hereunder, to seek injunctive relief, notwithstanding any other provision
of this Agreement.
5.7 Minimum Purchase Quantities: CUMBERLAND shall have no minimum purchase requirements for
the first year following FDA approval of the Drug Product. The parties shall, no later than three
(3) months before the end of the first year following FDA approval, negotiate in good faith to set
on the minimum quantities applicable to the second to fifth years of commercial sale, which shall
be incorporated into Schedule V and shall form part of this Agreement. The parties shall negotiate
in good faith to set additional minimum purchase requirements for any extension of the Term of
this Agreement under Paragraph 3.1. CUMBERLAND shall use its best efforts to achieve the minimum
purchase requirements set forth in Schedule V of this Agreement for each format of Drug Product
being sold in the Territory by CUMBERLAND. 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 out in Schedule V shall be decreased by the quantity BIONICHE failed to deliver
hereunder.
6. DRUG PRODUCT RECALLS
6.1 Drug Product Recalls: In the event: (a) any government authority issues a request,
directive or order that the Drug Product be recalled, or (b) a court of competent jurisdiction
orders such a recall, (c) CUMBERLAND determines that the Drug Product should be recalled, or (d)
BIONICHE recommends to CUMBERLAND that a recall be initiated, the parties shall take all
appropriate corrective actions; provided that a recall pursuant to Subparagraph 6.1 (c) shall be
without prejudice to the parties rights under Paragraph 2.5. In the event that BIONICHE
recommends a recall of Drug Product by CUMBERLAND, such recommendation must take the form of a
notice as per Paragraph 11.1, and CUMBERLAND shall respond promptly indicating to BIONICHE whether
the Drug Product will be recalled. In no event, however, shall BIONICHE have responsibility for
regulatory compliance in connection with any recall, except to the extent and under the
circumstances set forth in the Manual or any other written agreement between the parties hereto or
as required by law. All costs and expenses incurred in connection with such recall shall be the
responsibility of CUMBERLAND unless caused by the negligence of BIONICHE.
7. FORCE MAJEURE; FAILURE TO SUPPLY
7.1 Force Majeure Events: Failure of either party to perform under this Agreement (except the
obligation to make payments) shall not subject such party to any liability to the other if such
failure is caused by acts such as, but not limited to, acts of God, fire, explosion, flood, war,
riot, sabotage, embargo, or by any cause beyond the reasonable control of the parties, provided
that written notice of such event is promptly given to the other party.
8. MANUFACTURING CHANGES
BIONICHE may implement commercially reasonable changes in the equipment used for
Manufacturing of the Drug Product in the Facility, or the Manufacturing methods, labeling, or
packaging of the Drug Product only as expressly provided in the Specifications unless BIONICHE has
the prior written consent of CUMBERLAND, which consent shall not be unreasonably withheld or
delayed.
9. CONFIDENTIALITY
9.1 Confidential Information: Confidential Information means collectively Confidential
Information of CUMBERLAND (as defined herein) and Confidential Information of BIONICHE (as defined
herein).
9.2 Confidential Information of CUMBERLAND: Except as expressly set forth herein,
Confidential Information of CUMBERLAND means all information obtained or developed by BIONICHE
which relates to CUMBERLANDs business or the Drug Product, regardless of the form in which such
information is transmitted. The following shall not be considered Confidential Information of
CUMBERLAND for purposes hereof:
(a) Information that is already in the possession of BIONICHE at the time it is received from
CUMBERLAND or developed by BIONICHE on CUMBERLANDs behalf, if BIONICHE notifies CUMBERLAND of its
belief that the information is excepted under the terms of this subsection;
(b) Information received by BIONICHE from a person which has the right to disclose the same,
when BIONICHE notifies CUMBERLAND of its belief that the information is excepted under the terms
of this subsection;
(c) Information that is or becomes published, or is or becomes otherwise publicly available
without the fault of BIONICHE;
(d) An Invention as defined in Paragraph 9.4; or
(e) Confidential Information of BIONICHE.
In the event of a dispute regarding the applicability of the above exceptions to the
definition of Confidential Information of CUMBERLAND, BIONICHE shall have the burden of producing
clear and convincing proof that the information should be excepted from the definition of
Confidential Information of CUMBERLAND. BIONICHE shall not use or permit the use of the
Confidential Information of CUMBERLAND other than for the limited purposes expressly permitted by
or consistent with this Agreement. Recipients of Confidential Information of CUMBERLAND shall be
granted access thereto strictly on a need-to-know basis. BIONICHE shall take all reasonable steps
to ensure that recipients comply with the terms of this Agreement, including all restrictions on
use, disclosure and dissemination of Confidential Information of CUMBERLAND. BIONICHE shall notify
CUMBERLAND immediately upon becoming aware of any breach hereof and shall take all reasonable steps
to prevent any further disclosure or unauthorized use.
Upon termination or expiration of this Agreement, BIONICHE shall deliver to CUMBERLAND all
Confidential Information of CUMBERLAND, all copies thereof, and all documents or data storage media
containing such Confidential Information of CUMBERLAND, except that one copy of such information
may be retained by BIONICHE as required by regulation or law for future reference. The Confidential
Information of CUMBERLAND shall remain confidential and not be disclosed by BIONICHE for a period
of ten (10) years following the date of expiration or termination of this Agreement except as
expressly set forth herein or in any other written agreement between the parties.
9.3 Confidential Information of BIONICHE: Except as expressly set forth herein, Confidential
Information of BIONICHE means all information obtained or developed by CUMBERLAND which relates to
the manufacture, sale, and distribution of pharmaceutical products by BIONICHE, regardless of the
form in which such information is transmitted. The following shall not be considered Confidential
Information of BIONICHE for purposes hereof:
(a) Information that is already in the possession of CUMBERLAND at the time it is received
from BIONICHE or developed by CUMBERLAND on BIONICHEs behalf, if CUMBERLAND notifies BIONICHE of
its belief that the information is excepted under the terms of this subsection;
(b) Information received by CUMBERLAND from a person which has the right to disclose the same,
when CUMBERLAND notifies BIONICHE of its belief that the information is excepted under the terms of
this subsection;
(c) Information that is or becomes published, or is or becomes otherwise publicly available
without the fault of CUMBERLAND; or
(d) Confidential Information of CUMBERLAND.
In the event of a dispute regarding the applicability of the above exceptions to the
definition of Confidential Information of BIONICHE, CUMBERLAND shall have the burden of producing
clear and convincing proof that the information should be excepted from the definition of
Confidential Information of BIONICHE. CUMBERLAND shall not use or permit the use of the
Confidential Information of BIONICHE other than for the limited purposes expressly permitted by or
consistent with this Agreement. Recipients of Confidential Information of BIONICHE shall be granted
access thereto strictly on a need-to-know basis. CUMBERLAND shall take all reasonable steps to
ensure that recipients comply with the terms of this Agreement, including all restrictions on use,
disclosure and dissemination of Confidential Information of BIONICHE. CUMBERLAND shall notify
BIONICHE immediately upon becoming aware of any breach hereof and shall take all reasonable steps
to prevent any further disclosure or unauthorized use.
Upon termination or expiration of this Agreement, CUMBERLAND shall deliver to BIONICHE all
Confidential Information of BIONICHE, all copies thereof, and all documents or data storage media
containing such Confidential Information of BIONICHE, except that one copy of such information may
be retained by CUMBERLAND as required by regulation or law for future reference. The Confidential
Information of BIONICHE shall remain confidential and not be disclosed by CUMBERLAND for a period
of ten (10) years following the date of expiration or termination of this Agreement except as
expressly set forth herein or in any other written agreement between the parties.
9.4 Invention: As between the parties, CUMBERLAND owns all intellectual property rights in any
improvement to the Drug Product and, subject to Paragraph 5.6, any existing or further developments
or modifications of the Drug Product in the Territory (Invention). Subject to Article 10,
BIONICHE shall, at CUMBERLANDs request and expense, take such actions and execute such documents
as necessary or desirable, in CUMBERLANDs sole judgment, to create, maintain, enforce or defend
CUMBERLANDs rights in any such Invention.
9.5 Press Release; Other Disclosure: Except pursuant to a press release subject to the prior
written approval of both parties hereto, the parties agree that the contents of this Agreement
shall not be disclosed to any third party except (i) the controlling companies of the parties, (ii)
the companies controlled by the parties, (iii) individuals and entities providing paid services to
either of the parties who are bound by confidentiality obligations, and (iv) governmental
regulatory agencies, including, but not limited to, environmental protection authorities, without
prior written consent of the other party.
9.6 Production of Records: BIONICHE shall prepare, maintain, and submit all documents or
reports required under applicable laws and regulations or as reasonably requested by CUMBERLAND
concerning the Manufacture of the Drug Products, including without limitation, batch production
records for each Drug Product. Notwithstanding the restrictions set forth in this Agreement,
BIONICHE shall retain production records for batches of Drug Product for a period of at least one
year after the respective expiration date for each batch. These records will be stored by
appropriate means, including without limitation, optical disk or microfilm in a secure manner in
compliance with current GMP with duplicate copies submitted to CUMBERLAND promptly after the
creation thereof and shall be made available on request of the FDA or any other authorized
regulatory body.
10. INDEMNIFICATION
10.1 Indemnification by CUMBERLAND: Subject to Paragraph 5.1, CUMBERLAND shall indemnify and
hold BIONICHE (and any Affiliate and their officers, directors, shareholders, agents, and the
employees and insurers of any of them and/or their successors and assigns thereto), free and
harmless from any and all claims, demands, liability, actions or causes of actions, and any and all
expenses associated therewith (including, without limiting the generality of the foregoing, defense
costs and reasonable attorneys fees), arising out of or in connection with, as a result of, or
otherwise related to any third party claims arising from: (i) any negligence or recklessness of
CUMBERLAND, its agents, or employees; (ii) the promotion, distribution, use, misuse or sale or
effects of the Drug Product except to the extent any alleged Drug Product defects were caused by
BIONICHE; (iii) CUMBERLANDs non-compliance with any applicable FDA or other applicable
regulations; or, (iv) any failure of CUMBERLAND to perform, in whole or in part, any of its
obligations hereunder in each case, unless caused by the acts or omissions of BIONICHE. Beginning
prior to delivery of the first order of Drug Products pursuant to this Agreement and continuing
until the third anniversary of termination of this Agreement, CUMBERLAND shall maintain products
liability insurance with limits of liability of not less than Five Million U.S. Dollars
($5,000,000) and shall name BIONICHE as additional insured under said policy.
10.2 Indemnification by BIONICHE: Subject to Paragraph 5.1, BIONICHE will indemnify and hold
CUMBERLAND (and any Affiliate and their officers, directors, shareholders, agents, and the
employees and issuers of any of them and/or their successors and assigns thereto), free and
harmless from any and all claims, demands, liability, actions or causes of action, and any and all
expenses associated therewith (including, without limiting the generality of the foregoing, defense
costs and reasonable attorneys fees), arising out of or in connection with, as a result of, or
otherwise related to any third party claims arising from: (i) any negligence or recklessness of
BIONICHE, its agents or employees; (ii) personal injury (including death) or property damage
arising out of or in connection with BIONICHEs manufacture or handling of the Drug Product
otherwise than in accordance with the Specifications and CUMBERLANDS written directions; (iii)
BIONICHEs non-compliance with any applicable FDA or other applicable regulations; or (iv) any
failure of BIONICHE to perform any of its obligations hereunder, in each case, unless caused by the
acts or omissions of CUMBERLAND. Beginning prior to delivery of the first order for Drug Product
pursuant to this Agreement and continuing until the third anniversary of termination of this
Agreement, BIONICHE shall maintain products liability insurance with limits of liability of not
less than U.S. $5,000,000 and shall name CUMBERLAND as additional insured under said policy.
10.3 Conditions of Indemnification: If either party seeks indemnification from the other
under Paragraphs 10.1 or 10.2, it shall promptly give written notice to the other party of any
such claim or suit threatened, made or filed against it, which forms the basis for such claim of
indemnification and shall cooperate fully with the other party in the defense of all such claims
or suits. No settlement or compromise shall be binding on a party hereto without its prior written
consent.
10.4 Limitation: Except as expressly set forth herein, neither party will be liable to the
other for any claim for loss of profits, for loss or interruption of business or for indirect,
special or consequential damages of any kind under this Agreement.
11. GENERAL PROVISIONS
11.1 Notices: Any notice permitted or required by this Agreement may be sent by facsimile with
the original document being sent by certified (or registered) mail, return receipt requested, or
overnight delivery and shall be effective when received (or refused) via facsimile or mail or
overnight if faxed and sent and addressed as follows (or to such other facsimile number or address
as may be designated by a party in writing):
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If to CUMBERLAND: |
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CUMBERLAND PHARMACEUTICALS INC. |
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209 Tenth Avenue South, Suite 332 |
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Nashville, Tennessee 37203 |
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Attn: Chief Executive Officer |
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Telephone: 615-255-0068 |
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Facsimile: 615-255-0094 |
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If to BIONICHE: |
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BIONICHE LIFE SCIENCES, INC. |
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231 Dundas Street East, |
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Belleville, Ontario, Canada K8N 1E2 |
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Attn: Chief Executive Officer |
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Telephone: 800-265-5464 |
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Facsimile: 613-966-4177 |
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With a copy to: |
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BIONICHE PHARMA (CANADA) LIMITED |
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151 Dundas Street, Suite 507 |
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London, Ontario, Canada N6A 5R7 |
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Attn: President |
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Telephone: 519-453-0641 |
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Facsimile: 519-453-6169 |
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And to: |
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BIONICHE LIFE SCIENCES, INC. |
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Attn: Vice President, Corporate Counsel |
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Telephone: 800-265-5464 |
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11.2 Master Agreement; Amendment: This Agreement is being entered into pursuant to the
Strategic Alliance Agreement dated January 15, 2002, between CUMBERLAND and BIONICHE (the Master
Agreement), and this Agreement (including any and all exhibits hereto, whether entered into now or
hereafter) constitutes an Addendum (as defined in the Master Agreement). In the event of any
conflict or inconsistency between the terms of this Agreement and the Master Agreement, the terms
of this Agreement shall govern. No modification of any of the terms of this Agreement, or any
amendments thereto, shall be deemed to be valid unless in writing and signed by both parties
hereto. No course of dealing or usage of trade shall be used to modify the terms and conditions
herein.
Without limiting the generality of the foregoing, no provisions of any CUMBERLAND purchase order
that are inconsistent with the terms of this Agreement shall apply.
11.3 Waiver: None of the provisions of the Agreement shall be considered waived by any party
hereto unless such waiver is agreed to, in writing, by both parties. The failure of a party to
insist upon strict conformance to any of the terms and conditions hereof, or failure or delay to
exercise any rights provided herein or by law shall not be deemed a waiver of any rights of any
party hereto.
11.4 Obligations to Third Parties: Each party warrants and represents that this Agreement is
not inconsistent with any contractual obligations, expressed or implied, undertaken with any third
party.
11.5 Assignment: This Agreement shall be binding upon and inure to the benefit of the
successors or permitted assigns of each of the parties and may not be assigned, transferred, or
subcontracted by either party without the prior written consent of the other, which consent will
not be unreasonably withheld or delayed, except that no consent shall be required in the case of a
transfer to an Affiliate of a party hereto or transaction involving the merger, consolidation or
sale of substantially all of the assets of the party seeking such assignment or transfer and such
transaction relates to the business covered by this Agreement and the resulting entity assumes all
the obligations of the assigning party under this Agreement.
11.6 Independent Contractor: BIONICHE shall act as an independent contractor for CUMBERLAND
in providing the services required hereunder and shall not be considered an agent of or joint
venturer with CUMBERLAND. Unless otherwise provided herein to the contrary, BIONICHE shall furnish
all expertise, labor, supervision, machining and equipment necessary for performance hereunder and
shall obtain and maintain all building and other permits and licenses required by public
authorities.
11.7 Governing Law and Dispute Resolution: This Agreement is subject to and shall be governed
by the laws of the State of New York. Any dispute, controversy, or claim arising out of or
relating to this Agreement, any purchase orders between the parties hereto, or the breach,
termination, or invalidity thereof shall be settled under the Rules of the American Arbitration
Association by one or more arbitrators appointed in accordance with said Rules. The place of
arbitration shall be within the State of New York. The parties agree that the award of the
arbitrator(s) shall be the sole and exclusive remedy between them regarding any claims,
counterclaims, issues or accountings presented or pled to the arbitrator(s); that it shall be made
and shall promptly be payable in U.S. dollars free of any tax, deduction, or offset; that any
costs and attorney fees incurred by the prevailing party as determined by the arbitrator(s)
incident to the arbitration, shall be included as part of the arbitration award; and that any
costs. fees, or taxes incident to enforcing the award shall, to the maximum extent permitted by
law, be charged against the party resisting such enforcement. The award shall include interest
from the date of any damages incurred for breach or other violation of the Agreement, and from the
date of the award until paid in full, at a rate to be fixed by the arbitrator(s), but in no event
less than the prime interest rate for Bank of America in Nashville, Tennessee, U.S.A.
11.8 Severability: In the event that any term or provision of this Agreement shall violate
any applicable statute, ordinance, or rule of law in any jurisdiction in which it is used, or
otherwise be unenforceable, such provision shall be ineffective to the extent of such violation
without invalidating any other provision hereof.
11.9 Headings, Interpretation: The headings used in this Agreement are for convenience only
and are not part of this Agreement.
11.10 Conflict: In the event of conflict between the terms and provisions of this Agreement
and the terms and provisions of the Manual, the terms of this Agreement shall control.
11.11 Limitation: The parties hereto acknowledge and agree that the International Sale of
Goods Act and the United Nations Convention on Contracts for the International Sale of Goods have
no application to this Agreement.
IN WITNESS WHEREOF, the parties hereto have each caused this Agreement to be executed by their
duly authorized representatives effective as of the date first above written.
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CUMBERLAND PHARMACEUTICALS INC. |
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BIONICHE LIFE SCIENCES, INC. |
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A. J. Kazimi |
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Albert Beraldo |
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Authorized Signature |
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Authorized Signature |
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A.J. Kazimi |
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Albert Beraldo |
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Chief Executive Officer |
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Vice President, Business Development |
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SCHEDULE I
Shipping and Storage
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Finished Drug Product shall be stored by BIONICHE after
completion, at 20 degrees C
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Drug product will be delivered by BIONICHE to CUMBERLAND by air on the basis of FCA
(ex works) ex works BIONICHEs plant in Galway, Ireland with the carrier to be selected
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The terms FCA (ex works) and DDP and the Parties respective obligations
shall be determined in accordance with the INCOTERMS adopted by the International
Chamber of Commerce, effective July 1, 1990, unless otherwise specifically provided in
this Agreement. |
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Additional details regarding packaging shall be incorporated herein upon adoption
thereof by written agreement of BIONICHE and CUMBERLAND. |
Pricing
The prices to be paid by CUMBERLAND to BIONICHE for the Drug Products arc as follows:
N-acetylcysteine 30 mL
Canadian [***]
N-acetylcysteine 10 mL
Canadian [***]
Canadian currency conversions will be based upon the then current exchange rate listed in the Wall
Street Journal.
The minimum size of any order of the Drug Product shall be one production lot of [***] for the 30
mL Drug Product and [***] for the 10 mL Drug Product.
In
addition, CUMBERLAND shall pay to BIONICHE a royalty equal to [***]
percent ([***]%) of Net Sales
(as defined herein) during each calendar year; provided that CUMBERLAND shall pay BIONICHE such
royalty within [***] days after the last day of the applicable calendar year, For purposes
hereof, Net Sales shall mean the aggregate amount billed for sales of the Drug Product by
CUMBERLAND, less returns, hospital buying group chargebacks, hospital buying group/group
purchasing organization administration fees, managed care organization rebates, sales/purchasing
discounts, federally mandated discounts and rebates, and state medical assistance program rebates
and discounts, and determined on an accrual basis by CUMBERLAND.
Within sixty (60) days following the close of each calendar quarter following the first sale of a
Drug Product, CUMBERLAND shall furnish to BIONICHE a written report for the calendar quarter
showing the Net Sales for each format of the Drug Product during such calendar quarter and the
corresponding amount payable to BIONICHE under this Agreement for such calendar quarter.
Simultaneously with the submission of the written report, CUMBERLAND shall pay to BIONICHE a sum
equal to the aggregate royalty due for such calendar quarter calculated in accordance with this
Agreement.
Payments to be made by CUMBERLAND to BIONICHE under this Agreement shall be made by cheque made to
the order of BIONICHE or by bank wire transfer in immediately available funds to such bank account
designated in writing by BIONICHE from time to time.
For a period of at least five (5) years after the end of each calendar quarter following the first
sale of each Drug Product, CUMBERLAND shall keep complete and accurate records in sufficient
detail to enable the royalties payable hereunder to be determined. Upon the written request of
BIONICHE and not more than once in each calendar year and only with reasonable prior notice to
CUMBERLAND, CUMBERLAND shall permit an independent certified public accounting firm of nationally
recognized standing selected by BIONICHE and reasonably acceptable to CUMBERLAND to have access
during normal business hours to such of the records of CUMBERLAND as may be reasonably necessary
to verify the accuracy of the Royalty reports hereunder for any calendar year ending not more than
twenty-four (24) months prior to the date of such request.
If such accounting firm concludes in its review that additional royalties were owed during such
period, CUMBERLAND shall pay the additional amounts within forty-five (45) days of the date
BIONICHE delivers to CUMBERLAND such accounting firms written report so concluding. The fees
charged by such accounting firm shall be paid by BIONICHE, except CUMBERLAND shall pay such fees in
the event that the additional amounts owed by CUMBERLAND vary from amounts paid with respect to the
calendar year in question by five percent (5%) or greater.
SCHEDULE II
Technical
Agreement
Technical Agreement Rev 1 5th April 2005
Bioniche/Cumberland
TECHNICAL AGREEMENT
This Agreement is entered into on this 5th day of April, 2005, by and between Cumberland
Pharmaceuticals Inc., a company organized and existing under the laws of the United States, with
offices located at 2525 West End Avenue, Suite 950 Nashville, Tennessee 37203 USA. (Cumberland)
and Bioniche Teoranta, a company organized and existing under the laws of the Republic of Ireland,
having a principal place of business, Inverin, Co. Galway, Republic of Ireland. (Bioniche).
Whereas, Cumberland requested Bioniche to manufacture and supply the Products (as defined in
section 1.1 hereof); and
Whereas the parties to this Agreement wish to establish in greater detail, the responsibilities of
Cumberland as the Contractor, and Bioniche as Suppliers, for the manufacture of the Products; and
Whereas, a detailed listing of responsibilities of the Contractor and Suppliers, is attached as
Exhibit I;
Now therefore, in consideration of the mutual covenants and promises contained herein, the parties
agree as follows:
This Technical Agreement is intended to serve as the Manufacturing Project Manual to be attached
as Schedule II to the Manufacturing and Supply Agreement, dated January 15, 2002, between
Cumberland and Bioniche Life Sciences, Inc. (the Manufacturing Agreement), and is not intended
to supersede any of the parties rights and obligations set forth therein. Only in the event that
this Technical Agreement expressly amends and restates specified subsections of the Manufacturing
Agreement shall this Technical Agreement serve as an amendment of the parties rights and
obligations set forth in the Manufacturing Agreement. Except as specifically amended hereby, the
Manufacturing Agreement shall remain in full force and effect, and any conflicting provision
hereof shall be null and void. The parties have entered into this Agreement to clearly define the
responsibilities of each party and to ensure that the Products are manufactured, packaged,
released, stored and shipped in accordance with current European and US GMPs or other relevant
equivalent cGMPs, agreed by Bioniche and Cumberland.
1.1 Product
Bioniche will supply Cumberland with Products, as follows:
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1.1.1 |
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Acetadote® Acetylcysteine Injection |
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200mg/mL Bioniche Code Number : 0164AI01 |
1
Technical Agreement Rev 1 5th April 2005
Bioniche/Cumberland
All references to Bioniche or Cumberland shall include Affiliates of these companies.
Affiliate shall be defined as any entity (i) at least fifty percent (50%) of whose outstanding
securities or assets are owned or controlled, directly or indirectly, by said party, or (ii) which
owns or controls directly or indirectly fifty percent (50%) of the outstanding securities or assets
of said party, or (iii) is owned or controlled directly or indirectly, to the extent of fifty
percent (50%) or more of the outstanding securities or assets by any of the entities described in
(i) and (ii) above. The term Manufacture as used in this Agreement shall be understood to include
the specification and the purchase of all necessary components of the Product, the manufacturing
process, quality control and assurance. The term Packaging as used in this Agreement shall be
understood to include the specification and purchase of all necessary components of the Product,
the packaging and the final quality control and assurance.
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2.1 Good Manufacturing Practices
Bioniche represents that it shall observe and adhere to the requirements of the current EU
Guide to Good Manufacturing Practice for Medicinal Products for Human Use, including
supplementary recommendations issued by the Commission of the European Communities (cGMPs)
and current US cGMPs. All terms defined in the cGMPs shall have the same meaning when used in
this document. Bioniche represents and warrants that all processes and equipment used in the
manufacture of the Product shall have been validated or are in the process of being validated
in accordance with the cGMPs and current US cGMPs. The reference to other regulatory
requirements will be agreed between the two parties.
2.2 Qualified Persons
The Qualified Person (QP), as defined in EU Directive 75/319/EEC, for Bioniche is named in
Exhibit II, and sample of the signature is affixed.
2.3 Supplier Quality Monitoring and Assessments
It is the responsibility of Bioniche to perform quality monitoring and assessment on suppliers
of all materials, involved in the manufacturing of the Product, in accordance with written
quality monitoring protocols.
2.4 Traceability
It is the responsibility of Bioniche to properly track each batch number of the Product, for
traceability, so as to be able to provide a full manufacturing history. Bioniche shall keep
manufacturing records, analytical records and reference samples for each batch of Product.
Copies of records and reference samples shall be made available to Cumberland promptly upon
request. Reference samples shall be kept for a period of one (1) year after the expiration
date for the batch. Manufacturing and quality control records shall be kept for a minimum
period of six (6) years from the date of manufacture or a minimum of one (1) year after the
expiration date, whichever is longer.
2
Technical Agreement Rev 1 5th April 2005
Bioniche/Cumberland
2.5 Stability Studies
Bioniche has the responsibility for the performance of 36-month stability studies on the
Products in accordance with Bioniche stability SOP ST.001 Stability data are to be reported
to Cumberland on request but Cumberland will be alerted concerning any out-of-specification
results within 48 hours.
Attached hereto is a complete set of every Specification related to Products, which are
referenced in 1.1. Bioniche shall prepare the Master Manufacturing Formula and the
Manufacturing and Packaging Batch Instructions for the Product. The Batch Instruction will be
approved by Bioniche. Copies of completed Batch Instructions will be provided to Cumberland
following the completion of manufacture if requested.
IV. |
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Manufacture, Controls, Release and Shipment |
4.1 Purchases and Management of Materials.
It is the responsibility of Bioniche to source the Active Pharmaceutical Ingredients (APIs),
from Bioniches designated approved suppliers, for the manufacture of the Products. Bioniche
shall supply excipients and materials required for the manufacture of the Product, and/or
ancillary operating materials used in the manufacture. Bioniche is responsible for all
quality control testing and release of materials used in the manufacturing of the Product
4.2 Product Testing & Release
Bioniche shall test or cause to be tested by an approved, qualified entity each lot of the
Product pursuant to the Specifications before release to Cumberland. Each test shall set
forth the items tested, the specific release Specifications and test results in a certificate
of analysis for each lot delivered and be certified by Bioniches QP and sent separately to
Cumberland. Cumberland shall be entitled to rely on the certificate of analysis and is not
required to perform any further testing,
4.3 Non Conforming Activities
During the course of manufacture:
4.3.1 All deviations and events not affecting the agreed Technical Specifications will be
documented by Bioniche. These documents will be retained as part of the batch record. Bioniche
shall inform Cumberland of all deviations prior to release of the batch.
3
Technical Agreement Rev 1 5th April 2005
Bioniche/Cumberland
4.4 Manufacturing Batch Records
4.4.1 Bioniche shall also provide as part of the Batch Certificate of Analysis, a
manufacturing compliance statement with each lot delivered to Cumberland. This certificate
will certify that the lot of Product was manufactured in accordance with the Specifications
and applicable cGMP laws or regulations.
4.4.2 The manufacturing lot records shall contain, at a minimum, the following information:
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The name and dosage form of the medicinal product. |
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The batch number or test number of the API and all other raw materials (excluding water). |
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The date of manufacture and the Products batch number. |
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Details of the amounts of Product manufactured during each operation and the quantity
of the Product in the various stages. |
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Both the expected and actual results of the in-process controls. If expected results
are expressed in a quantified manner, actual results shall also be quantified. |
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Confirmation that the critical steps of the operations proceeded in accordance with
the Manufacturing Instructions by the signature of the persons in charge of the various
stages. |
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Special observations made during manufacturing. |
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Certification that the process operating lines have been cleared, at the beginning of
the batch processing. |
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A list of deviations and their resolution. |
4.4.3 Labeling of the product for Clinical Trials will be the responsibility of Cumberland.
4.5 Shipment
Bioniche shall ship the Product in accordance with instructions agreed to by the parties.
Bioniche shall only place one lot number on any single pallet. Shipment of Product batches
under quarantine shall be made only when specifically authorized in writing by Cumberland, and
will be according to the Bioniche procedure.
V. |
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Changes in Site, Quality Standards, Formula and Manufacturing Procedures |
5.1 Changes Control
Bioniche shall inform Cumberland of any proposed intent to change the site of manufacture, the
specifications, labeling, the procedures for the manufacturing processes or record keeping of
Product.
4
Technical Agreement Rev 1 5th April 2005
Bioniche/Cumberland
During normal working hours and upon reasonable notice, Cumberland shall be entitled to
inspect such areas of Bioniches plant where the Product is manufactured or otherwise
stored or handled. Such inspections will include, but not be limited to:
A review of Production facilities and utilities
The taking of physical inventory samples
Reviewing of Quality and Documentation Control systems
Reviewing batch records
A written report of observation shall be issued by Cumberland quality auditors, including a
listing of significant items, which must be corrected prior to the supply of further Product
to Cumberland.
VII. |
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Product Complaints/Recall |
Bioniche and Cumberland shall each notify the other of any claims related to damage,
defective or nonconforming Product. Bioniche shall supply Cumberland with all relevant
information for the investigation of complaints related to the Product.
Cumberland shall be responsible for the collection of adverse events reported on the
Finished Product. It shall be Cumberlands responsibility to notify Bioniche of such
reports, if such reports relate to Bioniches manufacture of the Product, and to keep the
appropriate records and to promptly report such adverse reports to the appropriate
regulatory authorities. In the event any adverse events are reported to Bioniche, Bioniche
shall notify Cumberland in writing within 3 business days.
VIII. |
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Regulatory Communications |
8.1 Maintenance of Licenses
Cumberland is the current Authorization Holder (NDA) for the Finished Product to be
manufactured under this Technical Agreement and shall be responsible for the maintenance and
renewal of said Marketing Authorizations.
Bioniche shall be responsible for the maintenance and renewal of its manufacturing
license.
8.2 Notifications
Cumberland and Bioniche shall promptly inform each other of any material communications to or
from governmental authorities or agencies relating to the Product, including but not limited
to providing each other promptly with copies of any written communications, and reports of
visits by a governmental authority or agency to any areas within the facilities where the
Product is manufactured that could impact upon the continued supply of Product. The parties
shall consult with each other regarding any issues raised in such communications and shall
attempt in good faith to agree upon any action to be taken or response to be made in
connection with such communications.
5
Technical Agreement Rev 1 5th April 2005
Bioniche/Cumberland
IX. |
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Effective Date and Term, Interpretation |
This Technical Agreement shall become effective on the date first written above and shall
remain in force until the termination of the Agreement between the parties for the supply of
Products.
Any modifications or amendments to this Agreement must be in writing and signed by
both parties to be effective.
In Witness Whereof, the parties hereto have caused this Agreement to be executed by their
respective duly authorized officers, effective as of the first day above written.
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Bioniche Teoranta
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By: |
/s/ Andrew Hall
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Andrew Hall BSc(Hons) M.RS.C. M.I.Q.A
Director Of Quality and Qualified Person
Cumberland Pharmaceuticals Inc.
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By: |
/s/ Leo Pavliv
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Date: |
26 April 2005 |
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Leo Pavliv
Vice President Operations |
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6
Technical Agreement Rev 1 5th April 2005
Bioniche/Cumberland
Exhibit I
DETAILED RESPONSIBILITES
X = Responsible
A = Approval/Authority
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BIONICHE |
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CUMBERLAND |
1
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SPECIFICATIONS/DOCUMENTATION |
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1.1
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Specification of Active Bulk Ingredient
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X
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A |
1.2
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Master Manufacturing Formula
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X
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A |
1.3
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Product Lot Identification System
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X |
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1.4
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Specification of Inactive Ingredients
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X
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A |
1.5
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Test Method for ID of Active Bulk
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X |
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1.6
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Test Method for Inactive Ingredients
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X |
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1.7
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Test Method for Release of Product
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X |
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1.8
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Local Manufacturing and Packaging Instructions
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X |
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1.9
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Specification for In-Process Control
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X |
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1.10
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Change Control for Active Ingredient
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X
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A |
1.11
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Change Control for Manufacturing Formulas
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X
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A |
1.12
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Change Control for Inactive ingredients
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X
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A |
1.13
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Bulk product package specification, box & labels
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X |
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1.14
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Finished Artwork
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A
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X |
1.15
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Change Control for Artwork/Finishing Materials
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X
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A |
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2
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PRODUCTION |
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2.1
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Procurement of Bulk Active ingredient
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X |
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2.2
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Purchase Inactive Substances
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X |
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2.3
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Store Active/Inactive Substances
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X |
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2.4
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Sample/Test/Acceptance of Active & Inactive Substances
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X |
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2.5
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Test Method Transfer
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N/A |
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2.6
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On-Going Stability Testing of Product
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X |
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2.7
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Retention of Certificate of Analysis for Active Substance
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X |
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2.8
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Validation of Manufacturing Processes
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X |
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2.9
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Bills of Material for Manufacturing Process
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X |
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2.10
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In Process Control Instructions and Testing
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X |
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2.11
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Batch Record Reconciliation
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X |
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2.12
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Batch Record Retention
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X |
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2.13
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Retention of Samples of Active Ingredient
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X |
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2.14
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Retention of Samples of other Materials (Except water)
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X |
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2.15
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Retention of Samples of Product
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X |
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2.16
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Maintenance of Pharmaceutical Manufacturing Licenses
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X |
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2.17
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Disposal of Waste
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X |
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7
Technical Agreement Rev 1 5th April2005
Bioniche/Cumberland
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BIONICHE |
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CUMBERLAND |
3.0
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TESTING & RELEASE OF FINISHED PRODUCT |
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3.1
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Analysis of Product
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X |
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3.2
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Certificate of Analysis for the Product
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X |
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3.3
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Internal QP certification of the Product as per approved production
and control documents
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X |
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3.4
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Final QP Release of the product to Cumberland
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X |
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3.5
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Complaint |
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- Collection and Logging
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X
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X |
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- Investigation and Report Issue
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X |
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- Follow Up Corrective Action
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X |
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- Response to Customer
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X |
3.6
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Product Recall |
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- Decision to Initiate Recall
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X
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X |
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- Approval of Notification Wording
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X
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X |
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- Management of Recall
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X
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X |
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- Reconciliation of Returned Product
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X
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X |
3.7
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Liaison with Regulatory Authorities for Approval, Maintenance and
Updating Marketing Authorisations/Product Authorisations (NDA)
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X |
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3.8
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Final Release to Market
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X |
8
Technical Agreement Rev 1 5th April 2005 Bioniche/Cumberland
Exhibit II
Qualified Person
(14th January 2004)
Qualified Persons of Bioniche Teoranta
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Mr. A. Hall |
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Signature : /s/ Andrew Hall
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9
SCHEDULE III
Territory
The United States of America and all its possessions and territories
SCHEDULE IV
Approved Suppliers
[***]
Schedule V
Minimum Purchase Quantities
[Intentionally
omitted. Exhibit 10.3 to Form S-1 filed on May 1, 2007 (File No. 333-142535) incorporated by reference herein.]
EX-10.3 FIRST AMENDMENT TO MANUFACTURING AGREEMENT
EXHIBIT 10.3
*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.
WITNESSETH:
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, and Australia. |
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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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Subparagraphs 3.2(d) and (e) are deleted from the Agreement in their entirety and
Subparagraph 3.2(f) is re-lettered as 3.2(d). |
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6. |
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Paragraph 3.5 is amended by adding a reference to Paragraph 3.4 thereto (such that
Paragraph 3.4 is identified as a surviving provision.) |
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7. |
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Subparagraph 5.6(a) is amended and restated in its entirety as follows: |
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(a) |
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Neither BIONICHE nor any Affiliate thereof will sell, give away, or deliver to any
other person, firm, or corporation any form of the Drug Product in the Territory for
any indications, while this Agreement is effective and for two years after the
termination of this Agreement; provided that such restrictions shall not apply in the
event of termination by BIONICHE pursuant to Subparagraphs 3.2(a) or (b), or Paragraph
3.3. |
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8. |
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Subparagraphs 5.6(b), (c), (d), and (e) are deleted from the Agreement in their entirety;
Subparagraphs 5.6(f) and (g) are re-lettered as 5.6(b) and (c), respectively; and
Subparagraph 5.6(f) (re-lettered 5.6(b)) is amended and restated in its entirety as
follows: |
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(b) |
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Except in the event that BIONICHE fails to supply all Drug Product ordered within
[***] of receipt of a Purchase Order in accordance with Paragraph 2.7, or in the event
of Force Majeure, CUMBERLAND will order its entire requirement of the Drug Product for
the Territory from BIONICHE. If CUMBERLAND notifies BIONICHE that it intends to
distribute the Drug Product in countries not included in the Territory, then the
parties shall negotiate in good faith, for a period not to exceed [***] after
CUMBERLAND provides such notice, to amend this Agreement to expand the Territory
hereunder (and to add additional minimum purchase quantities for such expanded
Territory, as contemplated under Paragraph 5.7); provided that, if the parties fail to
agree upon the terms of supply for an expanded Territory within such [***], CUMBERLAND
shall have no obligation to purchase requirements of such Drug Products for such other
countries |
2
from BIONICHE, but its obligations hereunder with respect to the Territory shall
remain in full force and effect.
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Paragraph 5.7 is amended and restated in its entirety as follows: |
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CUMBERLAND shall use its best efforts to achieve the minimum purchase quantities set forth
in Schedule V to this Agreement for each format of Drug Product sold in the Territory by
CUMBERLAND. 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 out in Schedule
V shall be decreased by the quantity BIONICHE failed to deliver hereunder. |
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Schedule V of the Agreement is hereby stated as follows: |
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CUMBERLANDs annual minimum purchase requirements shall
be ***% of the average actual purchases for the prior three (3) years. |
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Paragraph 11.1 is amended by replacing the address for notice (and relevant copies) for
CUMBERLAND and BIONICHE, as follows: |
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If to CUMBERLAND: |
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CUMBERLAND PHARMACEUTICALS INC. |
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2525 West End Avenue, Suite 950 |
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Nashville, Tennessee 37203 |
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Attn: Chief Executive Officer |
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Telephone: 615-255-0068 |
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Facsimile: 615-255-0094 |
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If to BIONICHE: |
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BIONICHE TEORANTA |
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Inverin,
Co. Galway, |
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Ireland |
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Attn: Managing Director |
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Telephone: +353 91 593202 |
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Facsimile: +353 91 593228 |
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Miscellaneous. |
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(a) Authorization. Each party to this First Amendment hereby represents and warrants
that the execution, delivery and performance of this First 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 First Amendment constitutes the valid and enforceable
obligation of each party in accordance with its terms. |
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(b)Effect of First Amendment. Each party acknowledges that this First 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. |
3
(c) Counterparts. This First 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 First
Amendment are used for convenience only and are not to be considered in construing or
interpreting this First Amendment.
(e) Governing Law and Dispute Resolution. This First 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 First Amendment shall be governed by the
provisions of Paragraph 11.7 of the Agreement.
(f) Severability. Should any part of this First Amendment be invalid or
unenforceable, such invalidity or unenforceability shall not affect the validity and
enforceability of the remaining portion.
IN WITNESS WHEREOF, each of the undersigned has caused this First Amendment to be
executed as of the date first above written.
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CUMBERLAND: |
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CUMBERLAND PHARMACEUTICALS INC. |
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By:
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/s/ A.J. Kazimi |
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Title:
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Chief Executive Officer |
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Date:
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December 13, 2006 |
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BIONICHE: |
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BIONICHE TEORANTA |
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By:
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/s/ John Kavanagh |
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Title:
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Managing Director |
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Date:
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November 16, 2006 |
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4
EX-10.4 CARDINAL HEALTH CONTRACT SALES AND SERVICE
EXHIBIT 10.4
* Certain portions of this exhibit have been omitted pursuant to a request for confidential
treatment which has been filed separately with the SEC.
Contract Sales and Services Agreement
Between
Cumberland Pharmaceuticals, Inc.
&
Cardinal Health Contract Sales & Services
For
Cumberland Pharmaceuticals Dedicated Sales Force
May 16, 2006
TABLE OF CONTENTS
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Article I |
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Definitions and References to Cardinal Health |
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Page 3 |
Article II |
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Appointment of Cardinal Health; General Scope of Activities |
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Page 5 |
Article III |
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Compensation |
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Page 8 |
Article IV |
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Representations, Warranties and Covenants |
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Page 9 |
Article V |
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Status of Cardinal Health and the Representatives |
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Page 10 |
Article VI |
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Training |
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Page 11 |
Article VII |
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Samples |
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Page 11 |
Article VIII |
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Trademarks and Intellectual Property Rights |
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Page 12 |
Article IX |
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Communications; Monitoring the Program |
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Page 12 |
Article X |
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Insurance |
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Page 13 |
Article XI |
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Adverse Reaction Reporting and Regulatory Matters |
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Page 14 |
Article XII |
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Return/Recall |
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Page 15 |
Article XIV |
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Term and Termination |
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Page 16 |
Article XV |
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Recordkeeping; Audit Rights |
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Page 18 |
Article XVI |
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Indemnification |
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Page 18 |
Article XVII |
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Notice |
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Page 21 |
Article XVIII |
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Miscellaneous |
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Page 21 |
Schedule 1.1(k) |
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List of Products |
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Page 25 |
Schedule 1.1(0) |
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Definition of Territory |
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Page 26 |
Schedule 3.1 |
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Service Fees and Payment Schedule |
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Page 27 |
-2-
AGREEMENT
This AGREEMENT (Agreement) is dated as of May 16, 2006 by and between Cardinal Health PTS, LLC
(Cardinal Health) with a place of business at 7000 Cardinal Place, Dublin, Ohio, and Cumberland
Pharmaceuticals, Inc. (Cumberland), having a principal place of business at 2525 West End,
Suite 950, Nashville, Tennessee 37203.
Background Information
Cumberland is a Tennessee-based company which focuses on the acquisition, marketing, and
distribution of a portfolio of niche pharmaceutical products. Cardinal Health provides medical
representatives who Detail (as hereinafter defined) pharmaceutical products for third parties.
Cumberland desires Cardinal Health to provide representatives to Detail certain products as
determined and directed by Cumberland in the geographical territory hereinafter specified,
pursuant to the terms and conditions of this Agreement, and Cardinal Health desires to provide
the Representatives and perform such services pursuant to the terms and conditions set forth in
this Agreement.
The parties hereby agree as follows:
ARTICLE I
DEFINITIONS AND REFERENCES TO CARDINAL HEALTH
1.1. Definitions. The following terms when used in this Agreement shall, except
where the context otherwise requires, have the following meanings:
(a) Act means the Federal Food, Drug and Cosmetic Act, as amended, and the regulations
promulgated thereunder from time to time.
(b) Affiliate means any corporate or non-corporate business entity that controls, is
controlled by, or is under common control with a party to this Agreement. A corporation or
non-corporate business entity shall be regarded as in control of another corporation if it owns
or directly or indirectly controls at least forty percent (40%) of the voting stock of the other
corporation, or (i) in the absence of the ownership of at least forty percent (40%) of the voting
stock of a corporation or (ii) in the case of a non-corporate business entity, if it possesses
directly or indirectly, the power to direct or cause the direction of the management and policies
of such corporation or non-corporate business entity, as applicable.
(c) Agency means any governmental regulatory authority in the Territory responsible for
granting approvals for the sale or maintaining regulatory oversight of the Products, including,
without limitation, the FDA.
(d) Cardinal Health means Cardinal Health PTS, LLC and shall be deemed to include the
Representatives and Managers.
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(e) Detail means an interactive, face-to-face visit by a Representative
with a Target Customer or his or her legally empowered designee in the Territory, during
which the FDA-approved indicated uses, safety, effectiveness, contraindications, side
effects, warnings and other relevant characteristics of one or more of the Products (as
defined herein) are described by the Representative in a fair and balanced manner consistent
with the requirements of the Act, and using, as necessary or desirable, the Product Labeling
(as defined herein) and the Product Promotional Materials (as defined herein). Product
Detail means Detail of a Product between Target Customer and Representative. When used as a
verb, Detail or Detailing shall mean to engage in a Detail as defined in this Section
1.1(f).
(f) FDA means the United States Food and Drug Administration and any successor agency
having substantially the same functions.
(g) Manager means an individual hired by and retained as an employee of Cardinal
Health to oversee activities of Representatives under this Agreement, including a project
manager.
(h) PDMA means the Prescription Drug Marketing Act of 1987, as amended, and the
regulations promulgated thereunder from time to time.
(i) Product Labeling means all labels and other written, printed, or graphic matter
provided by Cumberland including (i) any container or wrapper utilized with a Product, or
(ii) any written material accompanying a Product, including, without limitation, Product
package inserts.
(j) Product Promotional Materials means all written, printed or graphic material
provided by Cumberland, including Product Labeling, intended for use by Representatives
during a Detail, including visual aids, file cards, premium items, clinical studies,
reprints, drug information updates and any other promotional support items that Cumberland
deems necessary or appropriate to conduct the Program. Product Promotional Materials shall
include FDA approved indicated uses, safety, effectiveness, contraindications, side effects,
warnings and other relevant characteristics of each of the Products.
(k) Products means the pharmaceutical products to be detailed by Representatives and
marketed by Cumberland as set forth on attached Schedule 1.1(k) and such other products as
may be added by Cumberland from time to time to Schedule 1.1(k) attached hereto.
(l) Program means the program of Detailing to be conducted by the Representatives
pursuant to this Agreement beginning as of September 5, 2006 and continuing thorugh the
remainder of the Term, as defined in Section 14.1.
(m) Representative and Representatives mean an individual or individuals hired
by and retained as an employee of Cardinal Health to conduct Detailing of Cumberland
Products only in connection with the Program.
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(n) Target or Target Customer means a physician or other specialist identified by
Cumberland.
(o) Territory means the geographical area specified in the attached Schedule 1.1(o).
ARTICLE II
APPOINTMENT OF CARDINAL HEALTH; GENERAL SCOPE OF ACTIVITIES
2.1. Detailing. Cardinal Health shall provide twenty four (24) Representatives to
engage in Product Detail activities in the Territory. Cardinal Health shall assign
Representatives for such Target Customers, in such numbers, and in such Territories as
shall be designated by Cumberland during the term of this Agreement. Each Representative shall
make Product Details to his or her assigned Target Customers based on any reasonable
general direction given by Cumberlands designated management team. The duties of such
Representatives shall be exclusively to Detail the Products and perform other related
activities reasonably agreed upon by Cardinal Health as deemed necessary for the establishment
and maintenance of new and existing customers of the Products in the Territories. Cumberland
shall at all times retain the right to promote the Products by whomever, wherever, and to
whomever it chooses.
2.2 Furnishing Managers. Cardinal Health shall provide two Managers to oversee
the activities of Representatives and to perform this Agreement in such numbers and for such
Territories (when relevant) as mutually agreed upon by Cardinal Health and Cumberland.
2.3. Scope of Activities. The parties shall perform the following activities as
applicable to each in connection with the Program:
(a) Cardinal Health shall have sole and exclusive authority to discipline or terminate the
employment of Representatives. Cumberland may reasonably request that a Representative or
Manager be terminated or reassigned if such Representatives or Managers activities or conduct
are not adequately achieving the performance goals of the Product, or if the Representative or
Manager fails to comply with all applicable laws, regulations, and Cumberland requirements for
Detailing the Product. Cardinal Health shall use its best efforts to comply with such request;
provided that such action complies with applicable laws and is in accordance with Cardinal
Healths policies and procedures, as determined by Cardinal Healths human resources manager. In
the event Cardinal Health determines that its policies and procedures or applicable laws
prohibit the termination or reassignment of any Representative so requested by Cumberland, it
shall notify Cumberland of such determination and submit a corrective action plan for
Cumberlands approval.
(b) Cardinal Health shall cause each Representative to attend and successfully complete the
Training Program (as defined in Section 6.1) conducted by Cumberland for each of the Products
prior to participating in the Program. Any such Representative who shall not successfully
complete all such requirements shall be removed and replaced by another Representative who shall
comply with such requirements.
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(c) Cumberland shall provide the Representatives without cost with sufficient
quantities of the Product Promotional Materials and Product Labeling for the performance of
Detailing. Cumberland shall be solely responsible for the preparation, content, and method
of distribution of the Product Promotional Materials and the Product Labeling. In
connection with the Detailing of the Products, the Representatives shall use only the
Product Labeling and the Product Promotional Materials provided by Cumberland; and under no
circumstances shall Cardinal Health or the Representatives develop, create, or use any
other promotional material or literature for the Detailing of the Products. Cumberland
shall advise Cardinal Health immediately of any inaccuracy or incompleteness of the Product
Promotional Materials or the Product Labeling, and upon such notice Cardinal Health and the
Representatives shall immediately cease the use of any portion or all of the Product
Promotional Materials or Product Labeling so identified by Cumberland.
(d) Cardinal Health shall instruct the Representatives to limit their verbal
statements and claims regarding the Products, including efficacy and safety, to those that
are consistent with the Product Labeling and the Product Promotional Materials. The
Representatives shall not add, delete, or modify claims of efficacy or safety in the
Detailing of the Products, nor make any changes (including underlining or otherwise
highlighting any language or adding any notes thereto) in the Product Promotional
Materials. Representatives shall not make any disparaging, untrue, or misleading statements
about Cumberland or its Affiliates, employees, competitors, or competing products.
Representatives shall Detail the Products in strict adherence to all applicable laws,
regulations, and professional requirements, including, but not limited to, the Act, the
Medicare and Medicaid Anti-Kickback Statute, and the American Medical Association Gifts to
Physicians from Industry Guidelines.
(e) The Representatives shall remain under the direct authority and control of
Cardinal Health, but shall cooperate with the members of Cumberland and shall receive
advice and direction related to Detail activities on the Products from Cumberland and
Cardinal Health mutually. Cumberland shall make all decisions with respect to the overall
strategy in connection with the Detailing of the Products. Any Cumberland personnel
interacting with Cardinal Health Representatives shall not discipline the Representatives
or implement terms or conditions of employment or personnel policies and/or practices with
respect to the Representatives. Cumberland shall provide Cardinal Health with copies of all
reports, memoranda, audits and other data it develops pertaining to (i) the
Representatives, Detailing, and the Program within 30 days of the preparation of such
documents, and (ii) any negligent or wrongful acts or omissions of Representatives as
promptly as practicable.
(f) In the event Cardinal Health supplies Representatives and Managers with fleet
vehicles for their use in performing the Detailing as described in the Schedules of this
Agreement, Cumberland shall reimburse Cardinal Health for all of its out-of-pocket costs
related to using such vehicles for Detailing, including but not limited to costs related to
owning, leasing, maintaining, insuring, and/or operating such vehicles (including fuel
costs). Cumberland shall reimburse Cardinal Health for all reasonable out-of-pocket costs
and expenses (i.e., airline tickets and other travel expenses, hotel, rent-a-car,
business meals, travel meals) of
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Representatives and Managers in connection with performing services pursuant to this
Agreement. Cumberland and Cardinal Health shall establish a mutually acceptable budget for
the costs and expenses referenced in this subparagraph for each Territory.
(g) Cumberland shall provide Cardinal Health with a list of Target Customers in the
Territory and with data on prescriptions and sales in the Territory for Cardinal Healths use
in performing this Agreement. Cumberland shall also provide Cardinal Health with other sales
and marketing information concerning the Products that Cumberland obtains or prepares during
the term of this Agreement and deems useful to Cardinal Health.
2.4. Orders for Products. Cumberland shall be solely responsible for
establishing the terms and conditions of the sale of the Products, including without
limitation, the price at which the Products will be sold, whether sales of the Products will
be subject to any discounts, the method of distribution of the Products, and whether any
credit will be granted or refused in connection with the sale or return of any Product.
Cumberland shall be exclusively responsible for accepting and filling all purchase orders for
the Products, billing and returns for the Products, and all other activities in connection
with the sale and delivery of the Products, other than Detailing. If Cardinal Health or the
Representatives receive an order for the Products, they shall immediately transmit such order
to Cumberland for further handling and communications with the submitter of the order,
including acceptance or rejection, which shall be in Cumberlands sole discretion.
2.5. Representatives Activity
(a) Subject to Cumberlands obligations and representations and warranties in this
Agreement, any negligent or wrongful act or omission on the part of the Representatives (both
individually and as a group) that occur during the term of this Agreement and that arise
during the course and within the scope of their employment with Cardinal Health pursuant to
this Agreement shall be deemed to be negligent or wrongful acts or omissions of Cardinal
Health. Notwithstanding the foregoing, any acts or omissions of the Representatives pursuant
to the exclusive direction, control or supervision of Cumberland or its employees or agents
shall not be deemed to be negligent or wrongful acts or omissions of Cardinal Health.
(b) Each party shall notify the other in writing as promptly as practicable of any such
material alleged negligent or wrongful acts or omissions on the part of the Representatives
of which it becomes aware along with a plan to remedy such acts or omissions, and Cumberland
shall provide Cardinal Health with a reasonable opportunity to remedy such acts or omissions,
and if indicated, to replace the involved Representatives.
2.6 Vacancies/Turnover. In the event of a Representative vacancy due to
resignation, reassignment or termination of a Representative, Cardinal Health shall fill any
such vacancy within a six (6) week period. Cumberland shall be responsible for paying the
Service Fees (as defined in Section 3.1 below) during such vacancy, unless such vacancy
exceeds the six (6) week period, in which event, the associated Service Fees for such vacancy
shall be suspended after the six (6) week period and shall resume once the vacancy is filled
by Cardinal Health. All recruiting and other related expenses for filling a vacancy shall
be borne by Cardinal Health;
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provided, however, that Cumberland shall be responsible for all recruiting and other
related expenses for filling any vacancy occurring pursuant to Cumberlands request for
reassignment or termination other than a request pursuant to Section 2.5(b) or resulting from
the Representatives failure to comply with any one or more of the provisions of Section 2.3.
In addition, if Cumberland desires to interview any candidates, Cumberland shall bear its own
cost of attending any final interview conducted by Cardinal Health or the costs of any
separate interview arranged for by Cumberland.
2.7 Management Reports. Cardinal Health or its third party designee shall provide
Cumberland with monthly reports in the form agreed between Cumberland and Cardinal Health
within fifteen (15) days after the end of each month. At the request of Cumberland, Cardinal
Health shall furnish Cumberland at reasonable times such documentation as Cumberland
reasonably requests for purposes of verifying the accuracy of any monthly report.
2.8 Project Manager. Cardinal Health shall appoint a Project Manager to serve
as a liaison between Cardinal Health, Representatives and Cumberland regarding the performance
by Cardinal Health and Cumberland of their respective obligations under this Agreement.
2.9 Non-compete. During the term hereof and until the first anniversary of the
expiration thereof, the Representatives shall not, directly or indirectly, solicit or
influence or attempt to solicit or influence any Target Customer to acquire pharmaceutical
products manufactured by a competitor of Cumberland for a laxative product, an oral
rehydration solution or other Products added to Schedule 1.1(k) by Cumberland.
ARTICLE III
COMPENSATION
3.1. Amount and Time of Payment. For services hereunder, Cumberland shall pay
to Cardinal Health the fees set forth in Schedule 3.1 attached hereto and incorporated by
reference (the Service Fees), which shall be payable as set forth in the payment schedule
set forth therein.
3.2 Cumberlands Hiring of Representatives. Cumberland shall not solicit,
directly or indirectly, any Representative or other employee of Cardinal Health to terminate
their employment with Cardinal Health and/or hire any such Representative or employee during
the Term of this Agreement without the prior written consent of Cardinal Health, which consent
shall not be unreasonably withheld or delayed. At the expiration or termination of this
Agreement, Cumberland shall have the right to hire as its own employee or as an independent
contractor or agent any one or more of the Representatives or Managers (collectively, the
Targeted Employees). Cumberland shall have the right to negotiate with any Targeted
Employee concerning the terms on which Cumberland might hire that Targeted Employee prior to
the end of the Term only upon the prior written consent of Cardinal Health, which shall not be
unreasonably withheld or delayed. Cardinal agrees not to interfere with or restrict in any
manner Cumberlands solicitation and hiring of the Targeted Employees and Cardinal Health will
assist Cumberland in the transition of Targeted Employees from Cardinal Health to Cumberland.
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3.3. Reimbursement of Expenses. All expenses of Cardinal Health for which
Cumberland is obligated to reimburse Cardinal Health as expressly provided in this
Agreement, including but not limited to travel expenses and vehicle expenses under Section
2.3(e), shall be paid by Cumberland within [***] days after Cardinal Health has submitted a
statement itemizing such expenses. Cardinal Health shall submit such expense statements to
Cumberland monthly.
3.4 Past Due Amounts. All amounts owing by Cumberland to Cardinal Health
pursuant to this Agreement that are not timely paid by Cumberland will bear interest at the
rate of twelve (12%) per annum from the due date. An invoice will be considered late and
begin to accrue interest if unpaid 30 days past its due date.
ARTICLE IV
REPRESENTATIONS, WARRANTIES AND COVENANTS
4.1. By Cardinal Health. Cardinal Health represents, warrants, and covenants to
Cumberland, as of execution of this Agreement and during the term of this Agreement, as
follows:
(a) that Cardinal Health and the Representatives shall perform the Detailing in a
professional and timely manner;
(b) that Cardinal Health and the Representatives shall comply with all laws, rules and
regulations that apply to the performance of services under this Agreement, including but
not limited to the PDMA, the Medicare and Medicaid Anti-Kickback Act (42 U.S.C. §
1320a-7b(a)), the Civil False Claims Act (31 U.S.C. § 3729(a)), Sections 1128A, 1128B, and
1877 of the Social Security Act (42 U.S.C. §§ 1320a-7a, -7b, and 1395nn), the Health Care
Fraud Act (18 U.S.C. § 1347), and the Criminal False Claims Act (18 U.S.C. § 287), as
amended from time to time, as well as similar applicable state laws; and
(c) that Cardinal Health is under no obligation to any third party that would prevent
the execution of this Agreement or interfere with its performance under this Agreement.
4.2. By Cumberland. Cumberland represents, warrants, and covenants to
Cardinal Health, as of execution of this Agreement and during the term of this Agreement,
as follows:
(a) that Cumberland is under no obligation to any third party that would prevent the
execution of this Agreement or interfere with its performance under this Agreement;
(b) that Cumberland shall comply with all laws, rules and regulations that apply to the
Products and their sale, the Program, and this Agreement, including but not limited to the
Act, the PDMA, the Medicare and Medicaid Anti-Kickback Act (42 U.S.C. § 1320a-7b(a)), the
Civil False Claims Act (31 U.S.C. § 3729(a)), Sections 1128A, 1128B, and 1877 of the Social
Security Act (42 U.S.C. §§ 1320a-7a, -7b, and 1395nn), the Health Care Fraud Act (18
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U.S.C. § 1347), and the Criminal False Claims Act (18 U.S.C. § 287), as amended from
time to time, as well as similar applicable state laws;
(c) that the Product Labeling and Product Promotional Materials are accurate,
complete, and in compliance with the Act and all applicable rules and regulations of the
FDA; and
(d) that to the best knowledge of Cumberland, the manufacture, sale, and distribution
of the products do not and will not during the term of this Agreement, infringe any patent
or other proprietary rights of third parties, and the Products have all necessary
governmental approvals and may be lawfully Detailed and sold by Cumberland and the
Representatives.
ARTICLE V
STATUS OF CARDINAL HEALTH AND THE REPRESENTATIVES
5.1. Cardinal Health Independent Contractor. Cardinal Health is being
retained and shall perform hereunder strictly as an independent contractor. Representatives
and Managers of Cardinal Health performing services hereunder shall not be, and shall not
be considered to be, employees of Cumberland for any purpose, and shall at all times remain
employees of Cardinal Health, subject to Section 3.3. Neither party shall have any
responsibility for the hiring, termination, compensation, benefits or other conditions of
employment of the other partys employees, except as otherwise provided in this Agreement.
5.2. No Cumberland Benefits. While employees of Cardinal Health, the
Managers and Representatives are not eligible to participate in any benefits programs or
sales bonuses offered by Cumberland to its employees, or in any pension plans, profit
sharing plans, insurance plans or any other employee benefit plans offered from time to
time by Cumberland to its employees, provided that the Representatives shall be eligible to
participate in Cumberland sales contests and bonus plans if so requested by Cumberland and
approved by Cardinal Health. Cardinal Health acknowledges and agrees that Cumberland does
not, and will not, maintain or procure any workers compensation or unemployment
compensation insurance for or on behalf of the Managers or Representatives while they are
employees of Cardinal Health. Cardinal Health acknowledges and agrees that it shall be
solely responsible for paying all salaries, wages, benefits and other compensation which
its employees (including Representatives and Managers) may be entitled to receive in
connection with the performance of the services hereunder.
5.3 Sales, Use and Excise Taxes. If any state or local government or other
taxing authority determines that sales, use or excise Taxes (Taxes) are applicable to
Cardinal Healths services performed hereunder, Cardinal Health shall promptly accrue and
Cumberland shall pay such Taxes on behalf of Cardinal Health to the appropriate taxing
authorities. In addition, Cumberland shall be responsible for the payment of any applicable
Taxes related to Cumberlands supply to Cardinal Health of Product Promotional Materials
and Product Samples.
5.4. No Joint Venture. Nothing contained in this Agreement shall be
construed as creating a joint venture or, except as otherwise provided herein, as granting
to either party the
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authority to bind or contract any obligations in the name of or on the account of the
other party or to make any guarantees or warranties on behalf of the other party.
ARTICLE VI
TRAINING
6.1. Training Programs.
(a) Cumberland shall conduct a training program for new Representatives and Managers
prior to participating in the Program, which shall include such medical and technical
information about the Products and such sales training as Cumberland, along with Cardinal
Health, deems necessary and appropriate (the Training Program). The Training Program
shall also include instruction on compliance with applicable laws, Company policies and
procedures, and computer training. Cardinal Health shall assist Cumberland with
the Training Program only to the extent requested by Cumberland.
(b) In order to qualify for assignment in a Territory, a Representative must
demonstrate thorough knowledge of the Products by passing Cumberland approved Product
tests at a level of proficiency agreed upon by Cumberland and Cardinal Health.
6.2. Training Materials. Cumberland shall prepare written training
materials for the Training Program and an up-to-date programmed learning unit for the
Products, to be sent to each Representative for at home study a minimum of five (5) days
prior to the commencement of the Training Program.
6.3. Cumberland Assistance. During the term of this Agreement,
Cumberland shall make available to Cardinal Health, free of charge, a reasonable number
of, and for a reasonable amount of time, at locations reasonably agreed by Cumberland and
Cardinal Health, Cumberlands sales training and marketing personnel to assist Cardinal
Healths Representatives and Managers with respect to the Training Program and additional
orientation and ongoing training for the Representatives.
ARTICLE VII
SAMPLES
7.1. Provision of Samples. Cumberland shall provide samples of the Products
to the Representatives at Cumberlands option and at its expense. Cumberland shall
determine the quantity and types of samples to be provided to the Representatives and the
method of distribution of the samples. In the event Cumberland elects to have Cardinal
Health manage the storage and distribution of samples, Cardinal Health shall pass on to
Cumberland the actual invoice costs for storage, distribution and other related costs and
use prudent business sense in costs incurred. All samples shall be stored and handled by
Cumberland and Cardinal Health in compliance with the PDMA and applicable law.
7.2 Sample Accountability. Cardinal Health shall prepare and provide to
Cumberland for approval a sample accountability program applicable to the samples
provided by
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Cumberland. After the parties agree in writing to adopt a sample accountability
program Cardinal Health shall comply with such program.
7.3. Return of Samples. Within 30 days following the termination or
expiration of this Agreement or within 30 days from the termination or removal from the
Program of a Representative (unless such Representative has been hired or retained by
Cumberland), Cardinal Health shall cause the Representatives to return to Cumberland all
unused Product samples provided to Cardinal Health or the Representatives by Cumberland.
Cumberland shall pay or reimburse Cardinal Health for all out-of-pocket costs and expenses
in connection with the storage and shipment of returned samples.
ARTICLE VIII
TRADEMARKS AND INTELLECTUAL PROPERTY RIGHTS
The Products shall be Detailed by Cardinal Healths Representatives under trademarks
owned or licensed by Cumberland or an Affiliate of Cumberland. This Agreement does not
constitute a grant to Cardinal Health of any property right or interest in the Products or
any trademarks which Cumberland or an Affiliate of Cumberland uses with respect to the
Products or to the name or business style of Cumberland. Cardinal Health and the
Representatives shall use the Product Promotional Materials only for the purposes of this
Agreement, and all copyright and other intellectual property rights in the Product
Promotional Materials shall remain with Cumberland.
ARTICLE IX
COMMUNICATIONS; MONITORING THE PROGRAM
9.1. Communications from Third Parties. Cardinal Health and its
Representatives shall advise Cumberland promptly of all comments, statements, requests and
inquiries of the medical profession or any other third parties relating to the Products
that are not addressed by either Product Labeling or the Product Promotional Materials, of
which Cardinal Health becomes aware. All responses to such communications to the medical
profession or such other third parties shall be handled solely by Cumberland. Cardinal
Health shall provide reasonable assistance to Cumberland to the extent requested by
Cumberland, and at Cumberlands cost and expense, to fully respond to such communications.
9.2. Government Agencies. All communications with government agencies,
including the FDA, concerning the Products shall be the sole responsibility of Cumberland.
Cardinal Health shall assist Cumberland with respect to such communications with
government agencies to the extent requested by Cumberland, and at Cumberlands cost
and expense. Cardinal Health shall provide Cumberland with any documents or information
reasonably requested by Cumberland for purposes of responding to any communications with
government agencies within 72 hours of Cumberlands request.
9.3. Cumberland Communications. In addition to Detailing, Cardinal Health shall assist
Cumberland with respect to customer communications (as reasonably requested by Cumberland and at
Cumberlands cost and expense) within the Territory and shall regularly
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advise Cumberland of market, economic, regulatory and other developments of which Cardinal
Health may become aware which may affect the sale of the Products in the Territory.
9.4. Review of Results. The parties shall meet periodically, but at least once per
calendar quarter, to review and discuss the actual results compared to the marketing plans for
Detailing of the Products. Cumberland shall regularly and promptly share with Cardinal Health
all reports, audits and other data it develops relative to the Program.
ARTICLE X
INSURANCE
10.1 Cardinal Health Insurance.
|
(a) |
|
During the Term of this Agreement, Cardinal Health shall
obtain and maintain the following insurance with limits not less than those
specified below: |
|
i. |
|
Commercial General Liability Insurance with a
limit of One Million Dollars ($1,000,000) per occurrence. |
|
|
ii. |
|
Workers Compensation and Employers Liability
Insurance with statutory limits for Workers Compensation and
Employers Liability limits of One Million Dollars ($1,000,000) per
accident. |
|
|
iii. |
|
Automobile Liability Insurance with a combined
single limit of $1,000,000. |
|
|
iv. |
|
Products Liability Insurance with a limit of
Five Million Dollars ($5,000,000) per occurrence. |
(b) Cardinal Health may self-insure any or a portion of the required insurance.
In the event that any of the required policies of insurance are written on a claims
made basis, then such policies shall be maintained during the entire term of this
Agreement and for a period of not less than five (5) years following the
termination or expiration of this Agreement.
(c) Cardinal Health shall waive subrogation rights against Cumberland for
workers compensation benefits and shall obtain a waiver from any insurance
carriers with which Cardinal Health carries workers compensation insurance
releasing their subrogation rights against Cumberland.
(d) Each insurance policy which is required under this Section shall be
obtained from an insurance carrier with an A.M. Best rating of at least A- VII.
10.2 Cumberland Insurance.
|
(a) |
|
During the Term of this Agreement, Cumberland shall obtain and
maintain the following insurance with limits not less than those specified
below. |
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|
i. |
|
Commercial General Liability Insurance with a limit of One
Million Dollars ($1,000,000) per occurrence. |
|
|
ii. |
|
Products Liability Insurance with a
limit of Five Million Dollars ($5,000,000) per occurrence. |
|
|
iii. |
|
Workers Compensation and Employers
Liability Insurance with statutory limits for Workers
Compensation and Employers Liability limits of One Million
Dollars ($1,000,000) per accident. |
(b) Cumberland may self-insure any or a portion of the required insurance. In
the event that any of the required policies of insurance are written on a
claims made basis, then such policy(ies) shall be maintained during the
entire period of this Agreement and for a period of not less than five (5)
years following the termination or expiration of this Agreement.
(c) Cumberland shall waive subrogation rights against Cardinal Health for
workers compensation benefits and shall obtain a waiver from any insurance
carriers with which Cumberland carries workers compensation insurance
releasing their subrogation rights against Cardinal Health.
(d) Each insurance policy which is required under this Section shall be
obtained from an insurance carrier with an A.M. Best rating of at least A-
VII.
ARTICLE XI
ADVERSE REACTION REPORTING AND REGULATORY MATTERS
11.1. Immediate Notification. Cardinal Health and Cumberland agree to notify the
other party as soon as reasonably practicable of any information that each may obtain or
learn concerning any Product or package complaint or any serious unexpected side effect,
injury, toxicity, or sensitivity reaction or any unexpected incidence of severity thereof
associated with the clinical uses, studies, investigations, tests and marketing of the
Products, whether or not determined to be attributable to the Products. Serious as used in
this Section 11.1 refers to an experience which results in death, permanent or substantial
disability, in-patient hospitalization, prolongation of existing in-patient hospitalization,
a congenital anomaly or cancer, or a result of an overdose or life threatening condition.
Unexpected as used in this Section 11.1 refers to (i) conditions or developments not
previously submitted to governmental Agencies or encountered during clinical studies of the
Products and not reflected in the Product Promotional Materials or the Product Labeling, or
(ii) conditions or developments occurring with greater frequency, severity, or specificity
than shown by information previously submitted to governmental Agencies or encountered
during clinical studies of the Products and not reflected in the Product Promotional
Materials or the Product Labeling. Each party shall also notify the other in a timely manner
of any other adverse experience, i.e., any unfavorable and unintended change in the
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structure (signs), function (symptoms) or chemistry (laboratory data) of the body
temporally associated with the use of the Products, whether or not considered related
thereto.
11.2. Threatened Agency Action. Cardinal Health and Cumberland shall each
immediately notify the other party of any information that each may obtain or learn
regarding any threatened or pending action by an Agency which may affect the Products.
Cardinal Health shall, at the request of Cumberland and at the cost and expense of
Cumberland, cooperate with Cumberland in formulating a procedure for taking appropriate
action in response to such information. Unless compelled by law, Cardinal Health shall not
respond to an Agency without the prior written consent of Cumberland.
11.3. Training. Cardinal Health and Cumberland shall develop appropriate
instructions in the Training Program for Representatives as to handling of information
received or obtained subject to Sections 11.1 and 11.2.
ARTICLE XII
RETURN/RECALL
12.1. Returned Products.
(a) Cumberland shall be responsible for handling all returned Products, including
shipment and compensation or credit for the returned Products. Any Products inadvertently
returned to Cardinal Health shall be shipped to Cumberland or at its direction, in
compliance with Cumberlands returned goods policy, and Cardinal Health shall advise the
customer who made the return that the Products have been returned to Cumberland. Cumberland
shall reimburse Cardinal Healths out-of-pocket shipping costs arising from its handling of
such returned Products within 30 days of delivery to Cumberland of Cardinal Healths
statement for such costs. Upon request Cardinal Health shall provide Cumberland with
documentation relating to such costs.
(b) At Cumberlands request, Cardinal Health shall assist Cumberland in obtaining and
receiving any Products that have been recalled, and any costs incurred by Cardinal Health,
agreed upon in advance by Cumberland, with respect to participating in any such recall shall
be reimbursed by Cumberland within 30 days of delivery to Cumberland of Cardinal Healths
statement for such costs.
ARTICLE XIII
CONFIDENTIAL INFORMATION
13.1 Mutual Obligation. Cardinal Health and Cumberland agree that they will not
disclose the other partys Confidential Information (defined below) to any third party
without the prior written consent of the other party except as required by law, regulation or
court or administrative order; provided, however, that prior to making any such legally
required disclosure, the party making such disclosure shall give the other party as much
prior notice of the requirement for and contents of such disclosure as is practicable under
the circumstances. Notwithstanding the foregoing, each party may disclose the other partys
Confidential Information to any of its Affiliates that (A) need to know such
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Confidential Information for the purpose of performing under this Agreement, (B) are
advised of the contents of this Article, and (C) agree to be bound by the terms of this
Article.
13.2 Definition. As used in this Agreement, the term Confidential Information
includes all such information furnished by Cardinal Health or Cumberland, or any of their
respective representatives or Affiliates, to the other or its representatives or Affiliates,
whether furnished before, on or after the date of this Agreement and furnished in any form,
including but not limited to written, verbal, visual, electronic or in any other media or
manner. Confidential Information includes all proprietary technologies, know-how, trade
secrets, discoveries, inventions and any other Intellectual Property (whether or not
patented), analyses, compilations, business or technical information and other materials
prepared by either party, or any of their respective representatives, containing or based in
whole or in part on any such information furnished by the other party or its representatives.
Confidential Information also includes the existence of this Agreement and its terms.
13.3 Exclusions. Notwithstanding Section 13.2, Confidential Information does not
include information that (A) is or becomes generally available to the public or within the
industry to which such information relates other than as a result of a breach of this
Agreement, or (B) is already known by the receiving party at the time of disclosure as
evidenced by the receiving partys written records, or (C) becomes available to the
receiving party on a non-confidential basis from a source that is entitled to disclose it on
a non-confidential basis, or (D) was or is independently developed by or for the receiving
party without reference to the Confidential Information, as evidenced by the receiving
partys written records.
13.4 No Implied License. The receiving party will obtain no right of any kind or
license under any patent application or patent by reason of this Agreement. All Confidential
Information will remain the sole property of the party disclosing such information or data.
13.5 Return of Confidential Information. Upon written request or termination of this
Agreement, the receiving party shall promptly return within thirty (30) days all such
information, including any copies thereof, and cease its use or, at the request of the
disclosing party, shall promptly destroy the same and certify such destruction to the
disclosing party; except for a single copy thereof, which may be retained for the sole
purpose of determining the scope of the obligations incurred under this Agreement.
13.6 Survival. The obligations of this Article 13 will terminate five (5) years from
the expiration of this Agreement.
ARTICLE XIV
TERM AND TERMINATION
14.1. Term. This Agreement shall take effect as of September 5, 2006 and shall
continue in effect until August 30, 2008 (the Initial Term), unless terminated earlier
as set forth herein. Notwithstanding the foregoing, Cumberland may, at its option
upon written notice to Cardinal Health at least ninety (90) days prior to the expiration of
the Initial Term, and with the written consent of Cardinal Health, extend the Initial
Term for one additional year (the Renewal Term). If Cumberland desires to exercise the
Renewal Term, parties shall negotiate in good faith provisions of Section 3.1 regarding
Service Fees. References in this Agreement to the term of this Agreement include both the
Initial Term and the Renewal Term, if applicable.
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14.2. Bankruptcy: Insolvency. Either party may terminate this Agreement
upon notice to the other upon the occurrence of: (a) the entry of a decree or order for
relief by a court of proper jurisdiction in an involuntary case of the other party under the
Federal Bankruptcy Code, as now constituted or hereafter amended, or any other applicable
federal or state insolvency or other similar laws, and the continuance of any such decree or
order in effect for a period of sixty (60) consecutive days; or (b) the filing by the other
party of a petition for relief under the Federal Bankruptcy Code, as now constituted or
hereafter amended, or any other applicable federal or state insolvency or similar laws.
14.3 Termination For Breach. Subject to Section 3.2 and other continuing
obligations, either party may terminate this Agreement (i) in the event of a material breach
of the other partys obligations under this Agreement, provided that such breach has not
been cured within thirty (30) days after written notice thereof from the non-breaching party.
14.4 Termination Due To Regulatory And Other Problems. If the Product is not
being marketed due to regulatory problems, court or administrative proceedings, product
liability claims, recalls, raw materials shortages, or similar factors beyond the control of
Cumberland, then, subject to Section 3.2, either party may terminate this Agreement upon
thirty (30) days written notice to the other.
14.5 Termination Due To Assignment or Change in Control. In the event of a
Change of Control (defined herein), the party that has had a Change In Control (the
Affected Party) shall give written notice to the other party (the Non-Affected Party)
within thirty (30) days of the occurrence of such Change In Control. If the Change In
Control involves a material and direct competitor of the Non-Affected Party, the
Non-Affected Party may terminate this Agreement by written notice to the Affected Party
within 60 days after receipt of the Notice of a Change In Control . If the Change In Control
does not involve a material and direct competitor of the Non-Affected Party, this
Agreement may not be terminated by the Non-Affected Party. For purposes of this Section,
Change In Control includes a purchase, assignment or transfer of a controlling interest
in the Affected Party or substantially all of its business and assets and any merger or
consolidation involving the Affected Party or any Affiliate of the Affected Party that
requires a vote of the stockholders of the Ultimate Parent of the Affected Party. Ultimate
Parent for Cardinal Health is Cardinal Health, Inc. and the Ultimate Parent for Cumberland
is its stockholders.
14.6. Termination: Phase Out. In the event that this Agreement is terminated
pursuant to Sections 14.2 through 14.5, and at Cumberlands request, the parties shall
discuss in good faith an appropriate phase-out of Cardinal Healths Detailing activities.
14.7 Termination: Written Notice. Cumberland may terminate the Agreement, with
or without cause, upon 60 days prior written notice.
14.8. Termination: Continuing Rights. The termination or expiration of this Agreement
shall not affect Cumberlands obligation to reimburse or pay Cardinal Health any amount then
due and owing under this Agreement. Further, the termination or expiration of this
Agreement
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shall not affect any rights or obligations of any party under this Agreement which are
intended by the parties to survive such termination. The Service Fee paid by Cumberland
for the month in which this Agreement is terminated shall be prorated based on the number of
days in that month, and Cardinal Health shall refund any overpayment to Cumberland.
14.9 Termination: Return of Materials. Within sixty (60) days following the
termination or expiration of this Agreement, Cardinal Health shall return to Cumberland all
Confidential Information, Product Promotional Materials, marketing plans, forms, territory
lists, reports and any and all other tangible items provided to Cardinal Health by Cumberland.
ARTICLE XV
RECORDKEEPING; AUDIT RIGHTS
15.1. Cardinal Health Record Keeping: Inspection by Cumberland. Cardinal Health
shall keep accurate records in sufficient detail as to costs and expenses for which Cumberland must reimburse Cardinal Health under this Agreement. Upon Cumberlands reasonable
request made during or within one (1) year after the term of this Agreement, and at
Cumberlands expense, Cardinal Health shall permit Cumberlands designated employees or
agents to have access during ordinary business hours to records of such costs and expenses in
order to verify the accuracy of amounts reimbursed by Cumberland to Cardinal Health. Cumberland
and its designated employees or agents shall maintain in confidence all such cost and expense
records of Cardinal Health.
ARTICLE XVI
INDEMNIFICATION
16.1 Definitions. As used in this Article 16 and this Agreement, Damages shall
mean all liabilities, damages, assessments, levies, losses, fines, penalties, costs,
and expenses, including, without limitation, reasonable attorneys, accountants,
investigators, and experts fees and expenses, sustained or incurred as a result of any
claims, suits, liabilities, or actions by any third party.
16.2. Indemnification by Cardinal Health. Except to the extent that any of the
following Damages arises from the negligence or willful misconduct of Cumberland or breach
of this Agreement by Cumberland, Cardinal Health shall indemnify and hold Cumberland, its
Affiliates, directors, officers, employees and agents harmless from and against any and all
Damages arising directly or indirectly from:
(a) Cardinal Healths breach of or failure to comply with any of its obligations
under this Agreement;
(b) any inaccuracy in or breach or failure of any representation, warranty, or
covenant made by Cardinal Health in this Agreement;
(c) any negligent or wrongful act or omission on the part of Cardinal Health or
its employees or agents;
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(d) Cardinal Healths violation of or failure to comply with all applicable laws
relating to the promotion, distribution and sale of the Products, including but not limited
to the Act, the PDMA, the Medicare and Medicaid Anti-Kickback Act (42 U.S.C. §
1320a-7b(a)), the Civil False Claims Act (31 U.S.C. § 3729(a)), Sections 1128A,
1128B, and 1877 of the Social Security Act (42 U.S.C. §§ 1320a-7a, -7b, and 1395nn),
the Health Care Fraud Act (18 U.S.C. § 1347), and the Criminal False Claims Act
(18 U.S.C. § 287), as amended from time to time, as well as similar applicable
state laws;
(e) Detailing of the Products, except to the extent such Damages arise from a negligent or
wrongful act or omission of Cumberland;
(f) any federal or state claim or assessment for nonpayment or late payment by
Cardinal Health of any tax or contribution based on the status of any Representatives
as employees of Cardinal Health:; or
(g) except as limited by Section 2.3(a) or by Cumberlands indemnification obligations, any
employment actions and/or employment related claims alleging violation of any state or federal
employment laws arising out of any action taken or omission made independently by Cardinal
Health.
16.3. Indemnification by Cumberland. Except to the extent that any of the following
Damages arise from the negligence or willful misconduct of Cardinal Health or breach of this
Agreement by Cardinal Health, Cumberland shall indemnify and hold Cardinal Health and its
Affiliates, directors, officers, employees and agents harmless from and against any and all
Damages arising directly or indirectly from:
(a) Cumberlands breach of or failure to comply with any of its obligations under this
Agreement;
(b) any inaccuracy in or breach or failure of any representation, warranty, or covenant made
by Cumberland in this Agreement;
(c) any negligent or wrongful act or omission on the part of Cumberland or its employees or
agents;
(d) Cumberlands violation of or failure to comply with all applicable laws relating to the
manufacture, sale, distribution, possession and use of the Product, the Program and this
Agreement, including but not limited to the Act, the PDMA, the Medicare and Medicaid
Anti-Kickback Act (42 U.S.C. § 1320a-7b(a)), the Civil.False Claims Act (31 U.S.C. § 3729(a)),
Sections 1128A, 1128B, and 1877 of the Social Security Act (42 U.S.C. §§ 1320a-7a, -7b, and
1395nn), the Health Care Fraud Act (18 U.S.C. § 1347), and the Criminal False Claims Act (18
U.S.C. § 287), as amended from time to time, as well as similar applicable state laws;
-19-
(e) Detailing of the Products, except to the extent such Damages arise from a
negligent or wrongful act or omission of Cardinal Health;
(f) the accuracy or completeness of the Product Labels, Product Promotional
Materials, or the Training Program;
(g) any claims or liabilities for injury to or death of persons, regardless of
when such claim or liability is asserted or incurred, resulting from or arising out
of the manufacture, use, sale, distribution, possession of the Products, or a
manufacturing design or defect of the Products, or any failure to warn or inadequacy
of warning regarding the Products;
(h) Cumberlands failure to pay when due or to reimburse Cardinal Health for
any Taxes (as defined in Section 5.3);
(i) any negligent or wrongful acts or omissions on the part of Cumberland with
respect to Cardinal Healths employees or Representatives or those individuals who
have made application to be Representatives of Cardinal Health;
(j) any federal or state claim or assessment for nonpayment or late payment by
Cumberland of any tax or contribution based on the status of any former
Representatives as employees or agents of Cumberland; or
(k) the use by Cardinal Health, in the performance of its duties hereunder and
as specified or directed by Cumberland, of any trademark, trade name, copyright,
patent or other rights which use actually or allegedly infringes on the rights of
any third party.
16.4. Indemnification Procedures. A party (the Indemnitee) which intends to
claim indemnification under this Article 16 shall promptly notify the other party (the
lndemnitor) in writing of any action, claim or liability in respect of which the
lndemnitee or any of its employees or agents are entitled to indemnification. The
Indemnitee shall permit, and shall cause its employees and agents to permit, the Indemnitor
at its discretion, to settle any such action, claim or liability and agrees to the complete
control of such defense or settlement by the Indemnitor; provided, however, that such
settlement or defense does not adversely affect the lndemnitees rights hereunder or impose
any obligations on the Indemnitee in addition to those set forth in this Agreement. The
Indemnitee, its employees, and agents, shall cooperate fully with the Indemnitor and its
legal representatives in the investigation and defense of any action, claim or liability
subject to indemnification. The Indemnitee shall have the right, but not the obligation, to
be represented by counsel of its own selection and at its own expense: in connection with
any indemnified claim.
16.5. Limitation on Cardinal Health Liability. In no event shall Cardinal
Healths total liability under this Agreement exceed an amount equal to the total fees paid
to Cardinal Health under this Agreement.
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16.6 No Consequential Damages. Notwithstanding any provision of this
Agreement to the contrary, and except with regard to claims by third parties, neither party
shall be liable to the other for any special, indirect, incidental or consequential damages
(other than liability for personal injury as provided in this Article 16), including lost
profits.
ARTICLE 17
NOTICE
All notices and other communications hereunder shall be in writing and shall be deemed
given: (A) when delivered personally; (B) when delivered by facsimile transmission (receipt
verified); (C) when received or refused, if mailed by registered or certified mail (return
receipt requested), postage prepaid; or (D) when delivered if sent by express courier
service,
to the parties at the following addresses (or at such other address for a party as shall be
specified by like notice; provided, that notices of a change of address shall be effective only upon receipt thereof):
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To Cumberland:
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A.J. Kazimi, CEO |
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Cumberland Pharmaceuticals Inc. |
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2525 West End Avenue, Suite 950 |
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Nashville, Tennessee 37203 |
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Facsimile (615) 255-0094 |
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With a copy to:
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Adams and Reese / Stokes Bartholomew LLP |
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424 Church Street, Suite 2800 |
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Nashville, Tennessee 37219 |
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Attn. Martin S. Brown, Jr. |
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Facsimile (615) 259-1470 |
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To Cardinal Health:
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Cardinal Health PTS, LLC |
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7000 Cardinal Place |
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Dublin, Ohio 43017 |
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Attn: Thomas Dimke, SVP/GM |
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Cardinal Health Contract Sales and Services |
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Facsimile: (614) 757-6117 |
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With a copy to:
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Cardinal Health, Inc. |
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7000 Cardinal Place |
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Dublin, Ohio 43017 |
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Attn: Associate General Counsel, |
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Pharmaceutical Technologies and Services |
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Facsimile: (614) 757-5051 |
ARTICLE 18
MISCELLANEOUS
18.1 Entire Agreement; Amendments. This Agreement, the attachments, and any
amendments thereto constitute the entire understanding between the parties and supersede
any
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contracts, agreements or understanding (oral or written) of the parties with respect
to the subject matter hereof. No term of this Agreement may be amended except upon written
agreement of both parties, unless otherwise provided in this Agreement.
18.2 Captions. The captions in this Agreement are for convenience only and
are not to be interpreted or construed as a substantive part of this Agreement.
18.3 Further Assurances. The parties agree to execute, acknowledge and
deliver such further instruments and to take all such other incidental acts as may be
reasonably necessary or appropriate to carry out the purpose and intent of this Agreement.
18.4 No Waiver. Failure by either party to insist upon strict compliance
with any term of this Agreement in any one or more instances will not be deemed to be a
waiver of its rights to insist upon such strict compliance with respect to any subsequent
failure.
18.5 Severability. If any term of this Agreement is declared invalid or
unenforceable by a court or other body of competent jurisdiction, the remaining terms of
this Agreement will continue in full force and effect.
18.6 Independent Contractors. The relationship of the parties is that of
independent contractors, and neither party will incur any debts or make any commitments for
the other party except to the extent expressly provided in this Agreement. Nothing in this
Agreement is intended to create or will be construed as creating between the parties the
relationship of joint ventures, co-partners, employer/employee or principal and agent.
18.7 Successors and Assigns. This Agreement will be binding upon and inure
to the benefit of the parties, their successors and permitted assigns. Neither party may
assign this Agreement, in whole or in part, without the prior written consent of the other
party, except that either party may, without the other partys consent, assign this
Agreement to an Affiliate or to a successor to substantially all of the business or assets
of the assigning company.
18.8 Governing Law. This Agreement shall be governed by and construed under
the laws of the State of Tennessee, excluding its conflicts of law provisions. The United
Nations Convention on Contracts for the International Sale of Goods shall not apply to this
Agreement.
18.9 Alternative Dispute Resolution. If any Dispute arises between the
parties, such Dispute shall be presented to the respective presidents or senior executives
of Cardinal Health and Cumberland for their consideration and resolution. If such parties
cannot reach a resolution of the Dispute, then such Dispute shall be resolved by binding
alternative dispute resolution in accordance with the then existing commercial arbitration
rules of CPR Institute for Dispute Resolution, 366 Madison Avenue, New York, NY 10017.
Arbitration shall be conducted in the jurisdiction of the defendant party.
18.10 Prevailing Party. In any dispute resolution proceeding between the
parties in connection with this Agreement, the prevailing party will be entitled to its
reasonable attorneys fees and costs in such proceeding.
18.11 Counterparts. This Agreement may be executed in one or more counterparts, each
of which will be deemed an original but all of which together will constitute one and the
same
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instrument. Any photocopy, facsimile or electronic reproduction of the executed Agreement
shall constitute an original.
18.12 Publicity. Neither party will make any press release or other public
disclosure regarding this Agreement or the transactions contemplated hereby without the
other partys express prior written consent, except as required under applicable law or by
any governmental agency, in which case the party required to make the press release or
public disclosure shall use commercially reasonable efforts to obtain the approval of the
other party as to the form, nature and extent of the press release or public disclosure
prior to issuing the press release or making the public disclosure.
18.13 Setoff. Without limiting Cardinal Healths rights under law or in
equity, Cardinal Health and its Affiliates, parent or related entities, collectively or
individually, may exercise a right of set-off against any and all amounts due to Cardinal
Health from Cumberland. For purposes of this Article, Cardinal Health, its Affiliates,
parent or related entities shall be deemed to be a single creditor.
18.14 Survival. The rights and obligations of the parties shall continue
under Articles 6 (Confidentiality), 7 (Intellectual Property), 9 (Indemnification), 10
(Limitations of Liability), 11 (Insurance), to the extent expressly stated therein, 13
(Notice), 14 (Miscellaneous) and Section 12.3 (Effect of Termination), notwithstanding
expiration or termination of this Agreement.
18.15 Force Majeure. Except as to payments required under this Agreement,
neither party shall be liable in damages for, nor shall this Agreement be terminable or
cancelable by reason of, any delay or default in such partys performance hereunder if such
default or delay is caused by events beyond such partys reasonable control including, but
not limited to, acts of God, regulation or law or other action or failure to act of any
government or agency thereof, war or insurrection, civil commotion, destruction of
production facilities or materials by earthquake, fire, flood or storm, labor disturbances,
epidemic, or failure of suppliers, public utilities or common carriers; provided however,
that the party seeking relief hereunder shall immediately notify the other party of such
cause(s) beyond such partys reasonable control. The party that may invoke this section
shall use all reasonable endeavors to reinstate its ongoing obligations to the other. If the
cause(s) shall continue unabated for one hundred eighty (180) days, then both parties shall
meet to discuss and negotiate in good faith what modifications to this Agreement should
result from this force majeure.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly
authorized officers.
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CARDINAL HEALTH PTS, LLC |
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CUMBERLAND PHARMACEUTICALS INC. |
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By:
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/s/ Thomas G. Dimke
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By:
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/s/ AJ Kazimi |
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Name:
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Thomas G. Dimke
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Name:
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AJ Kazimi |
Title:
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SVP/GM HCSS
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Title:
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C.E.O. |
Date:
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5-18-06
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Date:
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5-17-06 |
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Schedule 1.1(k)
List of Products
CeraLyte®
Kristalose®
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Schedule 1.1(o)
Definition of Territory
The mutually agreed upon headquarter locations for the twenty four representatives are
as follows:
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Atlanta, GA |
Birmingham, AL |
Boston, MA |
Charlotte, NC |
Chicago, IL |
Dallas, TX |
Dayton, OH |
Detroit, MI |
Hartford, CT |
Houston, TX |
Knoxville, TN |
Lafayette, LA |
Long Island, NY |
Manhattan, NY |
Miami, FL |
Mobile, AL |
Newark, NJ |
Philadelphia N, PA |
Philadelphia S, PA |
Cleveland, OH |
San Antonio, TX |
Tampa, FL |
Washington, DC |
Yonkers, NY |
Each Territory shall include the Target Customers identified by Cumberland and Cardinal
Health.
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Schedule 3.1
Service Fees and Payment Schedule
With respect to the Program defined herein, the following fees shall apply:
A. As compensation for the satisfactory performance by Cardinal Health of its obligations
under the Agreement, Cumberland agrees to pay Cardinal Health Service
Fees at the annual rate of three million one hundred one thousand
seven hundred eighty four dollars ($3,101,784.00). The Service Fees shall be billed in monthly installments on the last day of each month
during the term hereof. Each such installment shall be in the amount
of two hundred fifty-eight thousand four hundred eighty-two dollars
($258,482.00) or pro rata portion
thereof in the event of early termination. The payment schedule for the term is as follows:
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Invoice Date |
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Payment |
September 30, 2006 |
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$258,482.00 |
October 31, 2006 |
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$258,482.00 |
November 30, 2006 |
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$258,482.00 |
December 31, 2006 |
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$258,482.00 |
January 31, 2006 |
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$258,482.00 |
February 28, 2006 |
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$258,482.00 |
March 31, 2006 |
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$258,482.00 |
April 30, 2007 |
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$258,482.00 |
May 31, 2007 |
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$258,482.00 |
June 30, 2007 |
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$258,482.00 |
July 31, 2007 |
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$258,482.00 |
August 31, 2007 |
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$258,482.00 |
September 30, 2007 |
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$258,482.00 |
October 31, 2007 |
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$258,482.00 |
November 30, 2007 |
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$258,482.00 |
December 31, 2007 |
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$258,482.00 |
January 31, 2008 |
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$258,482.00 |
February 28, 2008 |
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$258,482.00 |
March 31, 2008 |
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$258,482.00 |
April 30, 2008 |
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$258,482.00 |
May 31, 2008 |
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$258,482.00 |
June 30, 2008 |
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$258,482.00 |
July 31, 2008 |
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$258,482.00 |
August 31, 2008 |
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$258,482.00 |
B. In addition to the Service Fees, Cardinal Health will invoice Cumberland for
the following pass through costs:
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(i) |
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bonuses to Representatives in amounts as agreed in writing by Cardinal
Health and Cumberland before payment and based upon well-defined
performance criteria (typically [***] of salaries); and |
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(ii) |
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actual expenses associated with regular territory
business travel for Detailing, training meetings, and plan of action
meetings including airfare, hotels, meals, meeting rooms, A/V
equipment, materials, parking and tolls, each of which is subject to
the Territory Budget as set forth in the Agreement |
C. The expiration or termination of this Agreement shall not release Cumberland from
any obligation to pay Cardinal Health any amounts accrued under this Agreement in
connection with activities completed, expenses accrued prior to the effective date of
such expiration or termination; provided that the Service Fee paid by Cumberland for the
month in which this Agreement is terminated shall be prorated based on the number of days
in that month, and Cardinal Health shall refund any overpayment to Cumberland.
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D. Performance Incentive. Cardinal Health shall be eligible to receive a
Performance Incentive based upon Cardinal Healths performance resulting in Kristalose sales
during the term hereof in excess of a mutually agreed upon threshold which is based on sales
to targeted physicians, over which Cardinal Health will be paid a maximum of [***] in
Performance Incentives according to the scale below:
[***]
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EX-10.5 FIRST AMENDMENT TO CONTRACT SALES AGRMT
EXHIBIT 10.5
* 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
CONTRACT SALES AND SERVICES AGREEMENT
This First Amendment to Contract Sales and Services Agreement (the Amendment),
between Cardinal Health PTS, LLC (Cardinal Health) and Cumberland Pharmaceuticals, Inc.
(Cumberland) is entered into by and between Cardinal Health and Cumberland to modify
the terms of the Contract Sales and Services Agreement between the parties dated May 16,
2006 (Agreement). All capitalized terms used in this Amendment shall have the meaning
ascribed to them in the Agreement.
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A. |
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Section 2.1 of the agreement is hereby amended to the add the following
to the end of Section 2.1: |
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In addition to the twenty-four Representatives dedicated to Detailing Products
for Cumberland under this Section, Cardinal Health shall also provide Cumberland
with access to a syndicated sales force which will provide Details for
Cumberland products as well as products of other Cardinal Health customers
(Syndicated Sales Force). Upon agreement of the parties, the Syndicated Sales
Force shall provide Details in accordance with terms set forth in amendments to
Schedule 3.1 of this Agreement. Such amendment shall set forth the details of
the Details, priority of Details, Products, services and fees to be provided by
Cardinal Health through the Syndicated Sales Force. The provisions of Sections
2.3(a) and 3.2 shall not apply with respect to the Syndicated Sales Force.
Cumberland agrees that it will not recruit, solicit or hire any Representative
which is a member of the Syndicated Sales Force during the Term of this
Agreement and for one year thereafter. |
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B. |
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Section 2.2 of the Agreement is hereby amended to add the following to
the end of Section 2.2: |
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The two Managers shall be responsible for oversight of the dedicated sales force
and not the Syndicated Sales Force. The Syndicated Sales Force shall continue to
be managed by individuals appointed by Cardinal Health to manage the Syndicated
Sales Force. |
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C. |
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Schedule 3.1 is hereby amended to add the
following at the end: |
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SYNDICATED SALES FORCE |
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Cardinal Healths Syndicated Sales Force will make Calls on Target Customers
identified by Cumberland within the territory currently served by the
Syndicated Sales Force. The Syndicated Sales Force will Detail up to 3
Cumberland products during calls that are dedicated exclusively to Cumberland.
For purposes of this Agreement, a Call means a visit by a Representative or
Manager to a Target Customer in which multiple Products shall be Detailed to
the Target Customer, with the understanding that a small number (less than
10%) of Calls may not involve the |
1
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Detailing of all required Products (i.e., where Target Customers will not listen
to all Details). |
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The Call schedule shall begin on July 1, 2006 and end on June 30, 2007. Cardinal will
deliver [***] during this period. The service fee schedule will be as follows: |
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Month |
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Invoice Amount |
July, 2006 |
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37,500 |
August |
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37,500 |
September |
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37,500 |
October |
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37,500 |
November |
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37,500 |
December |
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37,500 |
January, 2007 |
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37,000 |
February |
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37,500 |
March |
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37,500 |
April |
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37,500 |
May |
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37,500 |
June, 2007 |
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37,500 |
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$450,000 |
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Cardinal Health will invoice Cumberland the amount set forth in the above table on the
last day of each month for service fees. |
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Cardinal Health will also have the ability to earn up to [***] in performance incentive
for mutually agreed upon sales achievement levels on the target audience. |
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The following expenses shall be direct pass-through to Cumberland for the syndicated program: |
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Actual travel expenses for all required participation in any subsequent POA meetings. |
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Actual promotional expenses and percentage of representative sample storage cost. The
parties will agree upon and manage to a budget based upon marketing programs and storage
requirements. |
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2. |
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Effective Date. This Amendment shall be effective upon full execution hereof
(Effective Date). Except as otherwise amended herein, the terms and conditions of the
Addendum shall remain in full force and effect.
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CUMBERLAND PHARMACEUTICALS, INC. |
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CARDINAL HEALTH PTS, LLC. |
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By:
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/s/ James D. Aderhold, Jr
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By:
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/s/ Thomas G. Dimke |
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Name:
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James D. Aderhold, Jr
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Name:
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Thomas G. Dimke |
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Title:
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V-P
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Title:
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SVP/GM |
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Date:
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7/13/06
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Date:
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7/19/06 |
3
Ex-10.6
EXHIBIT 10.6
SECOND AMENDMENT TO
CONTRACT SALES AND SERVICE AGREEMENT
This Second Amendment to Contract Sales and Service Agreement (the Second Amendment) is
entered into this 1st day of June, 2007 by and between Inventiv Commercial Services, LLC
(Inventiv) and Cumberland Pharmaceuticals Inc. (Cumberland).
WHEREAS, Cardinal Health PTS, LLC (Cardinal Health) entered into that certain Contract Sales
and Service Agreement (the Agreement) with Cumberland on May 16, 2006; and
WHEREAS, Cardinal Health and Cumberland previously executed a First Amendment to Contract
Sales and Service Agreement wherein the parties amended the Agreement and the schedules to the
Agreement; and
WHEREAS, Cardinal Health sold its Healthcare Marketing Services division and Cumberland
previously consented to an assignment of all of Cardinal Healths rights, title, interest and
obligations under the Agreement, as amended by the First Amendment, to PG Holding Corporation; and
WHEREAS, Inventiv, as successor in interest to PG Holding Corporation, desires to assume all
of PG Holding Corporations rights, title interest and obligations under the Agreement, as amended
by the First Amendment, and Cumberland desires to consent to such assignment.
NOW, THEREFORE, for and in consideration of the premises and other good and valuable
consideration, the parties hereto agree as follows:
1. Inventiv shall assume all rights, title, interest and obligations under the Agreement of
Cardinal Health, as amended by that certain First Amendment and herein, arising from and after June
1, 2007.
2. Capitalized terms not defined in this Second Amendment shall have the meaning set forth in
the Agreement. It is mutually agreed that all covenants, conditions and agreements set forth in
the 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.
Signature page follows.
1
IN WITNESS WHEREOF, the parties have executed this Second Amendment to Contract Sales and
Services Agreement as of the day and year first written above.
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INVENTIV COMMERCIAL
SERVICES, LLC
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By: |
/s/ Paul Mignon
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Name: |
Paul Mignon |
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Its: President & COO [illegible] |
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CUMBERLAND PHARMACEUTICALS INC.
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By: |
/s/ Jean W. Marstiller
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Name: |
Jean W. Marstiller |
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Its: Senior Vice President,
Administrative Services |
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2
EX-10.7 DISTRIBUTION SERVICES AGREEMENT
EXHIBIT 10.7
* Certain portions of this exhibit have been omitted pursuant to a request for confidential
treatment which has been filed separately with the SEC.
DISTRIBUTION SERVICES AGREEMENT
This agreement is made as of August 3, 2000, between Cumberland Pharmaceuticals Inc., a
Tennessee corporation (Cumberland), and CORD Logistics, Inc., an Ohio corporation
(CORD).
Background Information
A. Cumberland is a Tennessee-based company formed primarily to acquire and market a
portfolio of niche pharmaceutical products to specific physician segments in the United
States, the District of Columbia and Puerto Rico (the Territory).
B. CORD is in the business of distributing pharmaceutical products to wholesalers,
specialty distributors, physicians, clinics, hospitals, retail pharmacies, and other health
care providers in the Territory, and of providing Information Systems and other services
that support its customers use of its distribution capabilities (collectively, the
Services).
C. Cumberland desires to engage CORD as its exclusive distribution agent (described
below) for the pharmaceutical products described on the exhibits attached hereto (each, a
Product) and, with respect to each Product, to perform certain other services described in
this agreement, all upon the terms and conditions set forth in this agreement. This
agreement is being entered into pursuant to a letter of intent from CORD dated April 5,
2000, which was accepted and executed by Cumberland as of April 10, 2000.
Statement of Agreement
Cumberland and CORD (the Parties) hereby acknowledge the accuracy of the above
Background Information and agree as follows:
§1. Appointment. Upon the terms and conditions described in this agreement,
Cumberland hereby appoints CORD as its exclusive distribution agent in and for the Territory
for distribution of each Product (including samples) to Cumberlands direct customers
(Customers).
The Services for each Product or group of Products identified on the same
Product-specific exhibit to this agreement shall be implemented pursuant to the
Implementation Schedule included in such exhibit (each, an Implementation Schedule), with
distribution of each Product to begin on the date specified in the Implementation Schedule
for such Product (the Commencement Date). In performing the Services, CORD will provide,
at its discretion, the services of either the Vice President and General Manager, Director
of Sales or other such representative as mutually agreed to by Cumberland and CORD. CORDs
designated representative will be the primary liaison with Cumberland, unless otherwise
agreed to by the parties.
§2. Product Supply. Warehousing and Storage. Cumberland shall ship each Product
to CORD at CORDs distribution facility currently located at 15 Ingram Boulevard, Suite 100,
La Vergne, TN 37086 or to such other distribution facility as may be designated by CORD
(individually or collectively, the CORD Facility) and agreed by Cumberland, in sufficient
quantities to meet Cumberlands anticipated Customer orders. CORD shall visually inspect
each shipment of each Product for external damage or loss in transit and, in the event of
any such damage or loss, shall, within a commercially reasonable period of time following
discovery of such damage or loss by CORD, notify Cumberland that such damage or loss has
occurred.
With respect to each Product or group of Products identified on the same Product-specific
exhibit to this agreement: (a) Cumberland shall, during the Product Term set forth on such exhibit,
provide CORD with applicable regulatory storage and handling requirements and projections of such
Products volume requirements not less often than quarterly, at least 30 days in advance of the
quarter and written instructions setting forth the storage and handling requirements applicable to
such Product; and (b) CORD shall store such Product in the CORD Facility and comply with applicable
regulatory storage and handling requirements and the storage and handling requirements applicable
to such Product, as such requirements may be supplemented or amended from time to time in writing
by Cumberland with reasonable prior notice to CORD and its prior approval, which approval shall not
be unreasonably withheld or delayed. If CORD notifies Cumberland in good faith that any such
supplement or amendment will require any material modification to the CORD Facility or CORDs
procedures or requirements which are unique and specific to the Product or the Services resulting
in a material increase to CORDs anticipated costs and expenses, then Cumberland and CORD shall
consult regarding such reasonable costs and expenses (hereinafter, simply unique costs) and
Cumberland shall pay such unique costs resulting from that modification.
Cumberland shall pay all costs and expenses of delivering each Product to the CORD Facility.
CORD will never take title to any Product, even when such Product is located at the CORD Facility.
§3. Standard Product Distribution. With respect to each Product or group of Products
identified on the same Product-specific exhibit to this agreement, and during the Product Term set
forth on such exhibit, all Customer orders shall be taken by CORD as described in the Operating
Guidelines (defined in §6, below). CORD shall confirm the receipt of and process each order and, so
long as the ordered Product is then in stock at the CORD Facility and the orders are received no
later than 2:00 p.m. local time at the CORD Facility, routinely have that order available for
shipment within 24 hours of CORDs receipt of the order (exclusive of holidays and weekends) or
such longer period as may be designated or permitted by Cumberland.
Customer orders will be delivered by a courier mutually chosen by Cumberland and CORD. CORD
will invoice Cumberland for such handling services and freight cost on a monthly basis. CORD will
use best efforts to manage any claims by Cumberland against the courier, provided, however, that
Cumberland shall be responsible for all lost or damaged shipments.
In addition, Cumberland shall reimburse CORD for all documented costs and expenses of
packaging material used for shipping the Product and all business forms unique to Cumberland (e.g.,
packing slips, invoices, etc.); provided that the use of such packaging material and business forms
is authorized in advance by Cumberland.
Each Product shall be shipped on a first expiration date, first out basis or as otherwise
directed by Cumberland. In addition, CORD shall establish (and Cumberland shall approve) procedures
for the processing and shipment of emergency orders on weekends and holidays, provided that
Cumberland shall separately pay all increased costs resulting from such orders.
§4. Product Prices. With respect to each Product or group of Products identified in
the same Product-specific exhibit to this agreement, Cumberland shall, upon execution of such
exhibit, deliver to CORD a price list for Customers who purchase such Product or Products (the
Customer Price List). Cumberland shall notify CORD of any change in the Customer Price List not
less than 10 business days prior to the effective date of any such change. The Parties hereby
acknowledge that Cumberland, and not CORD, is the seller of each Product to Customers.
Page 2 of 14
§5. Financial Support Services.
(a) Subject to Section 5(b), during each Product Term set forth on the Product-specific
exhibits to this agreement, CORD shall perform the customer credit research, billing, cash
application, collections, and reporting services described in the Operating Guidelines in
accordance with the policies and procedures set forth in such Operating Guidelines, as such
policies and procedures may be supplemented or amended from time to time by Cumberland with
reasonable prior notice to CORD and with its prior approval (the Financial Support Services);
provided that if CORD notifies Cumberland in good faith that any such supplement or amendment will
require any material modification to CORDs procedures or requirements for providing the Services,
then Cumberland shall pay all unique costs resulting from that modification.
(b) CORD shall have no obligation to pay for any Product or to reimburse Cumberland for any
losses incurred in connection with the failure of any Customer to pay Cumberland any amount due.
(c) Customers shall be directed to make payments for the Products in accordance with the
Operating Guidelines.
§6. Operating Guidelines. As soon as practicable after the date of this agreement,
CORD and Cumberland shall develop operating guidelines relating to the Products and the Services,
which guidelines (the Operating Guidelines) will be in writing, in a form satisfactory to CORD
and Cumberland, and will define and document the responsibilities of CORD and Cumberland in
support of the relationship described in this agreement. All Operating Guidelines shall be
developed and implemented in good faith and in a commercially reasonable manner, subject to the
qualifications set forth therein; provided that in the event of any inconsistency between the
Operating Guidelines and the other provisions of this agreement (including each Product-specific
exhibit to this agreement), the other provisions of this agreement shall control. The Operating
Guidelines may be amended from time to time upon the mutual agreement of CORD and Cumberland.
§7. Returns and Recalls. Pursuant to this agreement and any applicable Operating
Guidelines, CORD shall assist in the processing of Product returns (excluding recall returns,
which will be dealt with as described below) in coordination with the third party returns company
chosen by Cumberland to facilitate return of Product. No such assistance will involve handling by
CORD of the Product being returned. The fees to be paid to CORD for these return services are
described in Section 8.
CORD shall process Customer Product return authorizations and credits as set forth in the
Operating Guidelines. The fee for such Services by CORD will be included as a part of the Customer
Service Fees described in Section 8.
If Cumberland is required to recall, or on its own initiative recalls, any Product, CORD will
assist Cumberland with that recall as reasonably requested by Cumberland; provided that Cumberland
shall pay to CORD an amount equal to all costs incurred by CORD in connection with any such
recall.
§8. Fees. As compensation for services being provided by CORD in connection with the
development and implementation of the infrastructure for the relationship contemplated by this
agreement, including CORDs information system development (separate from the Information System
Access Fees described below) and implementation for Cumberlands use, Cumberland shall pay CORD a
one-time implementation fee of [***] (the Implementation Fee), one-half of which shall be
payable on the first anniversary of the date of this agreement and one-half of which shall be
payable on the second anniversary of the date of this agreement. Cumberlands obligation to pay
the Implementation
Page 3 of 14
Fee is not contingent upon the acquisition by Cumberland of any Product marketing and distribution
rights and shall survive the termination of this agreement. However, the Implementation Fee shall
not be due and payable if this Agreement is terminated early for any reason other than breach by
Cumberland.
In addition, with respect to each Product or group of Products identified on the same
Product-specific exhibit to this agreement, Cumberland shall pay CORD, as compensation for the
Services related to such Product or Products, the fees described in such exhibit (the Fees). CORD
will use commercially reasonable efforts to keep total fees in line with industry standards. The
Fees shall include:
(a) Storage/Distribution Fees. The Storage and Distribution Fees shall be in the
amounts set forth in each applicable Product Exhibit. This component of the Fees shall cover
storage of Product and distribution services, which fees (the Storage and Distribution Fees),
with respect to each Product or group of Products identified on the same Product-specific exhibit
to this agreement, shall be in the amount specified in such exhibit.
The Storage Fees shall be based upon the average weekly number of pallets in storage. The
Distribution Fees, for each calendar month during the Term of this Agreement, shall be based upon
the aggregate number of units (or cases) shipped by CORD from the warehouse. Cumberland shall be
charged an initial price per unit or case (collectively referred to as pick) on the first pick of
each order placed by Cumberland each month, and then a recurring amount per pick for each
incremental pick shipped from the same order thereafter. For example, for the distribution of
Reglan and Donnatal, on a monthly basis, Cumberland shall be charged the sum of [***] per pick of
each order of product shipped that month and the sum of [***] per pick for each incremental pick
from the same order.
(b) Information System Access Fees. This component of the Fees shall cover
Cumberlands access to CORDs or an affiliate of CORDs standard Information Systems, consisting of
the computer hardware and software and other components described in the attached Schedule 8(c)-1
(the System), and other services relating to Cumberlands access to the System as described in
Schedule 8(c)-1, which fees (the System Access Fees), with respect to each Product or group of
Products identified on the same Product-specific exhibit to this agreement, shall be in the amount
specified in such exhibit. Access to the System shall be provided pursuant to a System Access
Agreement in the form of the attached Schedule 8(c)-2, which agreement (the System Access
Agreement) shall be executed by the Parties concurrently with this agreement. Access to the System
shall be made available to Cumberlands facility for each Product at the prices set forth in the
exhibit for such Product, so long as Cumberland first has in place a local area network sufficient
to support all Cumberland terminals and personal computers which will have access to the System and
a centralized server sufficient for data storage related to Cumberlands access to the System. All
costs and expenses associated with establishing initial hook-up of all communication and electronic
information lines necessary for interface of the System with Cumberlands information systems
located at Cumberlands address set forth at the end of this agreement are included in the
Implementation Fee and are separate from the services and costs and expenses covered by the System
Access Fees. Cumberland shall have sole responsibility for payment of all costs and expenses of
maintaining all such communication and electronic information lines. CORD and Cumberland shall each
assign knowledgeable and qualified employees to facilitate the access to the System as contemplated
by this agreement.
(c) Financial Support Services Fees. This component of the Fees shall be payment for cash
application, collections and chargeback processing services (including chargeback system access)
described in the Operating Guidelines, which fees (the Financial Support Services Fees), with
respect to each Product or group of Products identified on the same Product-specific exhibit to this
agreement, shall be in the amount specified in such exhibit.
Page 4 of 14
(d) Customer Service Fees. This component of the Fees shall be payment for the
customer services performed by CORD pursuant to the Operating Guidelines, which fees (the
Customer Support Fees), with respect to each Product or group of Products identified in the same
Product-specific exhibit to this agreement, shall be in the amount specified in such exhibit.
(e) EDI Set-up, Maintenance, Access Fees. This component of the Fees shall be
payment for services related to the set-up and maintenance of Electronic Data Interchange (EDI)
transaction capabilities between Cumberland and its Customers and access and use of a mutually
agreed upon EDI provider. These fees are included in the System Access Fees described in §8(b)
above.
With respect to each Product or group of Products identified on the same Product-specific
exhibit to this agreement, following the end of each calendar month with respect to Product Term
set forth on such exhibit, CORD shall issue an invoice to Cumberland for the Fees payable with
respect to CORDs performance of the Services for the prior month. The Fees or other amounts owed
to CORD by Cumberland under this agreement shall be payable within 30 days of the date of CORDs
invoice for such Fees or other amounts.
The Fees shall be held firm for the first contract year. Thereafter, CORD shall adjust the
price not more often than once per contract year by not more than the increase in the Producer
Price Index All Commodities published by the United States Department of Labor, Bureau of
Statistics, as amended from time to time.
Notwithstanding the above Price Increase, if CORD can demonstrate that the costs for
providing the Services have materially increased, or are likely to materially increase in the
coming year due to the adoption of any applicable law or regulation, or any material change in the
interpretation or administration thereof, then upon notice from CORD, the Parties agree to meet in
good faith and negotiate a mutually acceptable adjustment to the Fees, which compensates CORD for
the change.
§9. Term and Termination.
(a) The initial term of this agreement shall begin upon the day Cumberland signs a letter of
intent to acquire its first Product and shall continue for a period of three (3) years (the
Initial Term), unless terminated earlier pursuant to this agreement. Thereafter, this agreement
shall automatically renew for additional terms of one (1) year each, unless written notice of
termination is given by either Party at least 90 days prior to the end of the Initial Term, or
such other term, in which case this agreement shall terminate at the end of the relevant term. Any
reference in this agreement to the term of this agreement shall include the Initial Term and any
such renewal terms. Upon termination of this agreement or upon the written request of Client, all
Product shall be expeditiously returned to the Client or a designee of the Client.
(b) Either Party shall have the right to terminate this agreement or any Product-specific exhibit
to this agreement upon the breach by the other Party of a material provision of this agreement or
such exhibit and that Partys failure to cure such breach within 60 days following written notice
thereof from the non-breaching Party or, in the event such failure is not capable of being cured
within such 60-day period, the non-breaching Partys failure to continue to diligently prosecute
such cure thereafter; provided, that, with respect to any failure to make any payment when due under this agreement
or any Product-specific exhibit to this agreement, such period in which to cure shall be reduced
to 30 days.
Page 5 of 14
(c) Either Party shall have the right to terminate this agreement or any Product-specific
exhibit to this agreement immediately upon notice to the other Party following the commencement of
any bankruptcy or insolvency proceeding (whether voluntary or involuntary) with respect to such
other Party or its assets, the general assignment for the benefit of creditors by such other
Party, or the appointment of a receiver, trustee or liquidator by or for such other Party.
(d) Sections 8 and Sections 14 through 17, inclusive, of this agreement shall survive the
termination or expiration of this agreement and each Product-specific exhibit to this agreement,
and except as set forth herein, no termination of this agreement or any Product-specific exhibit
to this agreement shall affect any liabilities arising, or based upon acts or omissions occurring,
prior to the date of such termination.
§ 10. Audits. In connection with any services being provided pursuant to this
Agreement, CORD agrees to maintain written records and data during and after the term of this
Agreement in compliance with all applicable legal and regulatory requirements, including without
limitation applicable requirements of the United States Food and Drug Administration. Further,
CORD shall furnish Cumberland within thirty (30) days following each March 31, June 30, September
30, and December 31 of each calendar year a complete and accurate statement for the immediately
preceding calendar quarterly period of (a) the number of units of Products sold; (b) information
as to returns actually credited; (c) current inventory levels for Products; and (d) such other
information as Cumberland may reasonably request. In order to verify compliance, CORD shall
provide Cumberland with such records and agrees to permit representatives of Cumberland to visit
facilities of CORD at which Services are being performed during normal business hours (i.e., 8:00
a.m. to 5:00 p.m. local time), upon 15 business days prior notice, to: (a) review and audit CORDs
records relating directly to Product received at and shipped from the CORD Facility; and (b)
conduct, together with representatives of CORD, an inventory of the Product at the CORD Facility.
§11. Compliance With Laws. Each Party shall conduct its activities in connection with
this agreement in substantial compliance with all applicable laws, rules, regulations, and orders
of governmental entities.
§ 12. Representations and Warranties.
(a) Mutual Representations and Warranties. Each Party represents and warrants to
the other that: (i) it has full power and authority to enter into this agreement and perform and
observe all obligations and conditions to be performed or observed by it under this agreement
without any restriction by any other agreement or otherwise; (ii) the execution, delivery and
performance of this agreement have been duly authorized by all necessary corporate action of that
Party; and (iii) this agreement constitutes the legal, valid and binding obligation of that Party.
(b) Cumberland Representations and Warranties. Cumberland further represents and
warrants to CORD that (i) each Product is and shall be manufactured in conformity with the Food,
Drug, and Cosmetic Act, as amended, and all other applicable laws, rules, regulations and orders
of governmental entities, and (ii) as of the effective date of any Product-specific exhibit
hereto, Cumberland will have (and will have provided CORD with written documentation in form
reasonably satisfactory to CORD that Cumberland has, as of such effective date) title to such
Product or Products and the right to market and distribute such Product or Products as
contemplated hereby.
Page 6 of 14
(c) CORD Representations and Warranties. CORD hereby represents and warrants that it
has the experience, capability and resources, including without limitation, sufficient personnel
and supervisors, to perform the Services offered hereunder in a commercially reasonable manner in
conformity with applicable regulations of any governmental authority, including the United States
Food and Drug Administration. CORD further represent that it will at all times devote the necessary
personnel and supervisors to perform the Services in such a manner.
CORD shall not make any representations, warranties, or guarantees to Customers with respect
to the Products that are inconsistent with information provided by Cumberland to CORD, including
without limitation, representations, warranties, and guarantees concerning specifications,
features, efficacy, prices, or availability of the Products.
§13. Taxes. Cumberland shall pay when due all sales, use, gross receipts, excise,
personal property taxes associated with each Product (excluding any personal property tax
associated with CORDs equipment used in connection with the Services), and other taxes or similar
charges now or hereafter imposed as a result of the transactions contemplated by this agreement,
none of which have been included in the fees payable to CORD under this agreement; provided that
the amounts payable by Cumberland under this section shall not include taxes based on the net
income of CORD.
§ 14. Trademarks and Proprietary Rights.
14.1 Neither party hereto shall have the right to use the trademarks, service marks, logos, or
other similar marks of the party hereto, or any of its affiliates, in any manner except with the
prior written approval of the party that has rights to such intellectual property.
14.2 All materials, documents, information, inventions, improvements, data, programs and
suggestions of every kind and description, whether or not patentable, and all copyrightable works
supplied to CORD by Cumberland pursuant to this Agreement shall be the property of Cumberland
solely and exclusively (the Cumberland Property); provided that any and all information,
processes, documents, computer software or other proprietary information used, owned, licensed or
developed by CORD shall be the property of CORD.
§15. Master Agreement. This agreement is being entered into pursuant to the Strategic
Alliance Agreement dated June 6, 2000, between Cardinal Health (as defined below) and Cumberland
(the Master Agreement), and this agreement (including any and all exhibits hereto, whether
entered into now or hereafter) constitutes an Addendum, as defined in the Master Agreement. In the
event of any conflict or inconsistency between the terms of this agreement (including any and all
exhibits hereto) and the terms of the Master Agreement, the terms of this agreement shall govern.
For purposes of this agreement, Cardinal Health means the following affiliated operating
companies: Cardinal MarketForce, a division of RedKey, Inc., an Ohio corporation (Dublin, OH); CORD
Logistics, Inc., an Ohio corporation (Dublin, OH); and any other subsidiary of Cardinal Health,
Inc., an Ohio corporation (CHI), as may be designated by CHI and agreed by client in writing.
§ 16. Indemnification. Each Party shall indemnify and hold harmless the other and its
parent and affiliates, and each of their respective directors, officers, employees, agents, and
representatives from and against all claims, liabilities, losses, damages, costs, and expenses
(including without limitation reasonable attorneys fees) arising directly or indirectly out of any
failure of that Party to perform and observe fully all obligations and conditions to be performed
or observed by that Party pursuant to this agreement or any breach of any warranty made by that
Party in this agreement. Cumberland further agrees to indemnify and hold harmless CORD and its parent and affiliates and each of their
respective directors, officers, employees, agents and representatives from and against all claims,
liability, losses, damages, costs, and expenses (including without limitation reasonable attorneys
fees) arising directly or
Page 7 of 14
indirectly out of injury or death to person or property alleged to have
been caused by any defect in any
Product. NOTWITHSTANDING THE FOREGOING, OR ANY OTHER PROVISION OF THIS AGREEMENT TO THE
CONTRARY, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY CONSEQUENTIAL, INCIDENTAL,
INDIRECT, SPECIAL, OR OTHER SIMILAR DAMAGES ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT,
AND IN NO EVENT SHALL CORDS LIABILITY HEREUNDER EXCEED CORDS INSURANCE LIMITS SET FORTH BELOW IN
SECTION 17(b)(i).
§17. Insurance.
(a) Promptly after Cumberland acquires rights to distribute its first Product and for as long
thereafter as necessary to cover claims resulting from this agreement, Cumberland shall obtain and
maintain: (i) product liability and commercial general liability insurance having a limit of not
less than $10 million; and (ii) property damage insurance at replacement value for each Product
located at the CORD Facility or in transit to or from the CORD Facility, pursuant to one or more
insurance policies with reputable insurance carriers. Cardinal Health, Inc. and its subsidiaries
shall be designated as additional insureds under the product liability and commercial general
liability insurance policy(ies), and as loss payees under the property damage insurance
policy(ies). Prior to CORDs receipt of Product, Cumberland shall deliver to CORD certificates
evidencing such insurance. Cumberland shall not cause or permit such insurance to be canceled or
modified to materially reduce its scope or limits of coverage during the term of this agreement or
thereafter as provided above. Except for any losses resulting from the negligence or intentional
misconduct of CORD, Cumberland shall bear all risk of loss or damage with respect to each Product,
whether located at the CORD Facility or otherwise.
(b) Promptly after Cumberland acquires rights to distribute its first Product and for as long
thereafter as necessary to cover claims resulting from this agreement, CORD shall obtain and
maintain: (i) product liability and commercial general liability insurance having a limit of not
less than $1 million; and (ii) property damage insurance at replacement value for each Product
located at the CORD Facility or in transit to or from the CORD Facility, pursuant to one or more
insurance policies with reputable insurance carriers. Cumberland shall be designated as additional
insureds under the product liability and commercial general liability insurance policy(ies), and
as loss payees under the property damage insurance policy(ies). Prior to CORDS receipt of
Product, CORD shall deliver to Cumberland certificates evidencing such insurance. CORD shall not
cause or permit such insurance to be canceled or modified to materially reduce its scope or limits
of coverage during the term of this agreement or thereafter as provided above.
§18. Relationship of the Parties. The relationship among the Parties is and shall be
that of independent contractors. This agreement does not establish or create a partnership or joint
venture among the Parties.
§19. Notices. Any notice or other communication required or desired to be given to any
Party under this agreement shall be delivered in writing to the address or facsimile number set
forth beneath the authorized signatures on this agreement and shall be deemed given: (a) three
business days after such notice is deposited in the United States mail, first-class postage
prepaid, and addressed to that Party at the address for such Party set forth at the end of this
agreement; (b) one business day after delivered to Federal Express, Airborne, or any other similar
express delivery service for delivery to that Party at that address; or (c) when sent by facsimile
transmission, with electronic confirmation, to that Party at its
facsimile number set forth at the end of this agreement. Any notice delivered by facsimile
transmission will be deemed delivered upon electronic confirmation provided the notice is also
deposited in the U.S. mail, first-class postage prepaid. Any Party may change its address or
facsimile number for notices under this agreement by giving the other Parties notice of such
change.
Page 8 of 14
§20. Alternative Dispute Resolution.
The Parties agree to use good faith efforts to resolve all disputes within ninety (60) days of
written notice that such a dispute exists. If dispute under this Agreement cannot be resolved by
the Parties within such sixty (60) day period, the Parties agree to refer the matter to one
executive from each Party not directly involved in the dispute for review and resolution. A copy
of the terms of this Agreement, agreed upon facts and areas of disagreement, and a concise summary
of the basis for each sides contentions will be provided to both executives who shall review the
same, confer, and attempt to reach a mutual resolution of the issue within forty-five (45) days
after receipt of the materials referenced above. If the matter has not been resolved within such
forty-five (45) day period, either or both Parties may pursue resolution of the matter through
litigation or other process available under law or equity.
§21. Remedies. Each Party acknowledges that in the event of any violation by that
Party of any of the provisions of Section 14 of this agreement or Article III., Sections D or E of
the Master Agreement, the other Party would suffer irreparable harm and its remedies at law would
be inadequate. Accordingly, in the event of any violation or attempted violation of any such
provisions by either Party, the other Party shall be entitled to a temporary restraining order,
temporary and permanent injunctions, specific performance, and other equitable relief, without any
showing of irreparable harm or damage or the posting of any bond. The rights and remedies of each
Party under this agreement shall be cumulative and in addition to any other rights or remedies
available to such Party, whether under any other agreement, at law, or in equity.
§22. Governing Law. All questions concerning the validity or meaning of this
agreement or relating to the rights and obligations of the Parties with respect to performance
under this agreement shall be construed and resolved under the laws of the State of Tennessee ,
without regard to principles of conflicts of laws. The parties agree that any claims asserted in
any legal proceeding by one party against the other shall be commenced and maintained in any state
or federal court in Nashville, Tennessee or Columbus, Ohio and the parties submit to the
jurisdiction of these courts.
§23. Severability. The intention of the Parties is to comply fully with all laws and
public policies, and this agreement shall be construed consistently with all laws and public
policies to the extent possible. If and to the extent that any court of competent jurisdiction
determines that it is impossible to construe any provision of this agreement consistently with any
law or public policy and consequently holds that provision to be invalid, such holding shall in no
way affect the validity of the other provisions of this agreement, which shall remain in full
force and effect.
§24. Non-waiver. No failure by either Party to insist upon strict compliance with any
term of this agreement, to exercise any option, to enforce any right, or to seek any remedy upon
any default of the other Party shall affect, or constitute a waiver of, the first Partys right to
insist upon strict compliance, to exercise that option, to enforce that right, or to seek that
remedy with respect to that default or any prior, contemporaneous, or subsequent default. No
custom or practice of the Parties at variance with any provision of this agreement shall affect,
or constitute a waiver of, that Partys right to demand strict compliance with all provisions of
this agreement.
§25. Force Majeure. If the performance of any part of this agreement by either Party shall
be affected for any length of time by fire or other casualty, government restrictions, war, riots,
strikes or labor disputes, lock out, transportation delays, acts of God, or any other causes which
are beyond the control of the Parties, such Party shall not be responsible for delay or failure of
performance of this agreement for such length of time, provided, however, that the obligation of
one Party to pay amounts due to any other Party shall not be subject to the provisions of this
section
Page 9 of 14
§26. Genders and Numbers. Where permitted by the context, each pronoun in this
agreement includes the same pronoun in the other genders or numbers and each noun used in this
agreement includes the same noun in other genders.
§27. Complete Agreement. This agreement (together with the Master Agreement, the
Product-specific exhibits hereto, and the other documents referred to herein, all of which are
hereby incorporated herein by reference) contains the entire agreement between the Parties and
supersedes all prior or contemporaneous discussions, negotiations, representations, warranties, or
agreements relating to the subject matter of this agreement. CORD and Cumberland agree to comply
with the obligations of confidentiality set forth in Article III, Section E of the Master
Agreement. No changes to this agreement shall be made or be binding on either Party unless made in
writing and signed by both Parties.
§28. Successors. This Agreement may not be assigned or transferred by a party without
the prior written consent of the other party hereto, provided, however, that either party may
assign this Agreement to any subsidiary, affiliate or an entity which acquires substantially all of
its assets and business that is not in direct competition with CORD. Any such assignment shall not
materially or adversely affect the rights or obligations of either party to this Agreement.
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CUMBERLAND PHARMACEUTICALS, INC.
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CORD LOGISTICS, INC.
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/s/ A.J. Kazimi
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/s/ Frank C. Wegerson |
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A.J. Kazimi
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Frank C. Wegerson |
Chief Executive Officer
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Vice President and General Manager |
Initials: /s/ AJK
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Initials: /s/ FCW |
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209 10th Avenue South
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15 Ingram Blvd, #100 |
Nashville, TN 37203
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LaVergne, TN 37086 |
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Facsimile No. (615) 255-0094
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Facsimile No. (615) 793-4783 |
Page 10 of 14
Schedule 8 (c) -1
OPERATING SYSTEM BASE PACKAGE
A. System Access
Includes access to CORDs processor and operating system Monday through Friday, excluding
holidays, 12 hours per day (5:30 am to 5:30 p.m., Pacific local time).
B. Software Access and Maintenance
Includes access to CORDs or an affiliate of CORDs standard software. CORD or an affiliate of CORD
shall perform at its own expense any necessary modification to bring the systems in compliance
with the standard functionality described below.
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Reports necessary to perform Medicaid rebate calculations |
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Billing (Customization of invoicing/packing slips) |
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Inventory tracking and reporting |
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Ability to download system data to Cumberlands processors for reporting writing |
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Contracts/Pricing maintenance and chargeback processing |
Systems Development/Additional Services:
Cumberland bears financial responsibility for customization beyond the standard systems
functionality described above. Such customization performed by CORD or its representatives
(exclusive of the base package) in connection with this agreement shall be billed to Cumberland
as follows:
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Systems and software development$120 per hour per person, plus travel. |
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On-site training$120 per hour per person, plus travel. |
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Supplies, equipment and other, to be agreed upon by both parties. |
Page 11 of 14
Schedule 8 (c) -2
SYSTEM ACCESS AGREEMENT
This agreement is made as of July ___, 2000, between CORD Logistics, Inc., an Ohio corporation
(Licensor), and Cumberland Pharmaceuticals Inc., a Tennessee corporation (Licensee), who hereby
agree as follows:
1. System Access; Maintenance Obligations. On the terms and subject to the conditions
described in this agreement and the Distribution Services Agreement having the same date as this
agreement between Licensor and Licensee (the Distribution Agreement), Licensor hereby grants to
Licensee a nonexclusive license (the License) to utilize Licensors Order Entry System,
consisting of the computer hardware, software and other components described in Schedule 8(c)-1 to
the Distribution Agreement (collectively, the System), for the information processing needs of
Licensee in connection with the Services to be provided by Licensor under the Distribution
Agreement. Licensee shall maintain during the term of this agreement the network and local area
network (including without limitation centralized server) requirements for the System described in
the Distribution Agreement.
During the term of this agreement, Licensee shall employ reasonable security measures and
policies designed to safeguard the integrity, accessibility, and confidentiality of all of
Licensees data resident on the System and establish reasonable disaster and emergency recovery
plans designed to minimize disruption from System operation interruptions. Licensee shall have the
right to review the operation of the System from time to time upon reasonable prior notice from
Licensee to Licensor; provided that such reviews shall be conducted in a manner to avoid disruption
of Licensors business operations to the extent possible.
2. Proprietary Rights. Licensee shall have the right to use the System during the term
of this agreement as expressly provided in paragraph 1 of this agreement, but not otherwise.
Licensee shall not assign or otherwise transfer, disclose, copy, modify, or decompile the System or
any part thereof without prior written consent of the Licensor. The System and all parts thereof,
in all of their tangible and intangible manifestations, all existing or new enhancements,
developments, derivative works, and other adaptations or modifications to the System (or any part
thereof), and all related proprietary rights, are and shall remain the exclusive property of
Licensor. Except for the License, Licensee shall have no right, title, or interest in or to the
System or any part thereof. Upon termination of this agreement, Licensee shall promptly return to
Licensor all portions of the System then in Licensees possession or under its control.
3. Warranties. Licensee acknowledges that it has had adequate opportunity to review
the System and its features and operation and Licensee accepts the System AS IS for its use as
contemplated in the Distribution Agreement. EXCEPT AS EXPRESSLY SET FORTH HEREIN OR IN THE
DISTRIBUTION AGREEMENT, LICENSOR MAKES NO REPRESENTATIONS OR WARRANTIES, AND HEREBY EXPRESSLY
DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED RELATING DIRECTLY OR INDIRECTLY TO
THE SYSTEM OR ANY PART THEREOF, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF QUALITY,
PERFORMANCE, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE.
4. Limitation On Liability. LICENSOR SHALL NOT BE LIABLE FOR ANY CONSEQUENTIAL,
INDIRECT, SPECIAL, OR OTHER SIMILAR DAMAGES ARISING DIRECTLY OR INDIRECTLY OUT OF THE USE OR
INABILITY TO USE THE SYSTEM OR ANY PART THEREOF, EVEN IF INFORMED OF THE POSSIBILITY OF SUCH
DAMAGES, WHETHER CLAIMED UNDER CONTRACT, TORT, OR ANY OTHER LEGAL THEORY.
IF ANY OF THE LIMITATIONS ON THE LIABILITY OF LICENSOR CONTAINED IN THIS AGREEMENT ARE FOUND
TO BE INVALID OR UNENFORCEABLE FOR ANY REASON THEN LICENSOR AND LICENSEE EXPRESSLY AGREE THAT THE
MAXIMUM AGGREGATE LIABILITY OF LICENSOR FOR ALL CLAIMS RELATING TO THE SYSTEM SHALL NOT EXCEED 100%
OF THE AGGREGATE BASE PACKAGE FEES PAID BY LICENSEE TO LICENSOR FOR LICENSEES USE OF THE SYSTEM
UNDER THE DISTRIBUTION AGREEMENT.
5. Taxes. Licensee shall pay when due all sales, use, gross receipts, excise,
property, and other taxes or similar charges (other than taxes based upon Licensors net income)
now or hereafter imposed as a result of the transactions contemplated by this agreement.
6. Term. The term of this agreement shall begin upon Licensees initial use of the
System as evidenced by the first entry of inventory into the System (which may be a date earlier
than the Commencement Date specified for the Distribution Agreement) and shall end: (a)
automatically upon the termination of the Distribution Agreement (for any reason), or (b) on any
earlier date specified by Licensee in notice to Licensor given not less than 180 days prior to
Page 12 of 14
the specified termination date; provided that: (i) paragraph 2 through 5 inclusive, and
paragraph 8 of this agreement shall survive the termination of this agreement, and (ii)
no termination of this agreement shall affect any liabilities arising, or based upon acts or
omissions occurring, prior to such termination.
Licensee shall continue to have access to the System for a reasonable period of time (not be
exceed 60 days) following termination of this agreement solely for purposes of retrieving and
transferring to a separate system Licensees data relating to its pre-termination operations, and
Licensor shall reasonably cooperate with Licensee to preserve the integrity and accessibility of
Licensees data during such period; provided that, during such period, Licensee shall continue to
pay the full Base Package and other fees payable by Licensee under the Distribution Agreement and
comply with all other requirements imposed upon Licensee under this agreement.
7. Notices. Any notice or other communication required or desired to be given to
either party under this agreement shall be in writing and shall be deemed given: (a) three days
after mailing, if deposited in the United States mail, first-class postage prepaid,
and-addressed to that party at its address set forth at the end of this agreement; (b)
when received if delivered to Federal Express or any other similar overnight, delivery
service for delivery to that party at that address; or (c) when sent by facsimile transmission,
with electronic confirmation, to that party at its facsimile number set forth at the end of this
agreement. Either party may change its address or facsimile number for notices under this agreement
by giving the other party notice of such change.
8. Remedies. Licensee shall indemnify Licensor and its affiliates, directors,
officers, employees, agents, and representatives against all claims, liabilities, losses, damages,
costs and expenses (including without limitation reasonable attorneys fees) arising directly or
indirectly out of any failure of Licensee to perform and observe fully all obligations and
conditions to be performed or observed by Licensee pursuant to this agreement. Licensee
acknowledges that in the event of any violation by it of any of the provisions of paragraph 2 of
this agreement, Licensor would suffer irreparable harm and its remedies at law would be inadequate.
Accordingly, in the event of any violation or attempted violation of any such provisions by
Licensee, Licensor shall be entitled to a temporary restraining order, temporary and permanent
injunctions, specific performance, and other equitable relief, without any showing of irreparable
harm or damage or the posting of any bond, in addition to any other rights or remedies which may be
available to Licensor.
9. Force Majeure. Notwithstanding any other provisions of this agreement or the
Distribution Agreement to the contrary, each partys obligations under this agreement (exclusive of
payment obligations) shall be excused if and to the extent that any delay or failure to perform
such obligations is due to fire or other casualty, material shortages, strikes or labor disputes,
acts of God, or other causes beyond the reasonable control of that party.
10. Successors. Licensee shall not assign or otherwise transfer this agreement or any
of its rights or obligations under this agreement without the prior written consent of Licensor,
which consent shall not be unreasonably withheld. Subject to the preceding sentence, this agreement
shall be binding upon, inure to the benefit of, and be enforceable by and against the respective
successors and assigns of each party.
11. Interpretation. This agreement shall be governed by and construed in accordance
with the laws of the State of Tennessee. If and to the extent that any court of competent
jurisdiction determines that it is impossible to construe any provision of this agreement
consistently with any law or public policy and consequently holds that provision to be invalid,
such holding shall in no way affect the validity or the other provisions of this agreement, which
shall remain in full force and effect.
12. Complete Agreement. This agreement (together with the Distribution Agreement,
which is hereby incorporated herein by reference) constitutes the entire agreement between the
parties with respect to the subject matter of this agreement and supersedes all prior or
contemporaneous discussions, negotiations, representations, warranties, or agreements relating to
the subject matter of this agreement. This agreement may not be amended or otherwise modified
except by a written instrument signed by each party.
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CUMBERLAND PHARMACEUTICALS, INC. |
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CORD LOGISTICS, INC. |
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By:
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/s/ A.J. Kazimi
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By:
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/s/ Frank C. Wegerson |
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A.J. Kazimi
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Frank C. Wegerson |
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Chief Executive Officer
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Vice President and General Manager |
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Initials: /s/ AJK
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Initials: /s/ FCW |
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209 10th Avenue South, Suite 332 |
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15 Ingram Blvd., #100 |
Nashville, TN 37203 |
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LaVergne, TN 37086 |
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Facsimile No. (615) 255-0094 |
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Facsimile No. (615) 793-4783 |
Page 13 of 14
Exhibit A
CUMBERLAND PHARMACEUTICALS
PROPOSED FEE SCHEDULE
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Program Implementation |
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One Time Start-up Fee |
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$ |
* |
** |
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Distribution Services |
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Monthly per pallet ambient storage |
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$ |
* |
** |
Per bottle ambient product pick/pack/stage first bottle (1) |
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$ |
* |
** |
Per bottle ambient product pick/pack/stage each addl bottle (1) |
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$ |
* |
** |
Per case ambient product pick/pack/stage first case (1) |
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$ |
* |
** |
Per case ambient product pick/pack/stage each addl case (1) |
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$ |
* |
** |
Per unit return goods processing |
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$ |
* |
** |
Monthly distribution system access and use (2) |
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$ |
* |
** |
Monthly account management fee |
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$ |
* |
** |
Packing/Shipping Supplies |
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Cost plus ***% handling fee |
(includes ordering, receiving, storage) |
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Shipping Charges (3) |
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List minus ***% |
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Customer Service |
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Monthly fixed fee |
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$ |
* |
** |
Per order fee |
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$ |
* |
** |
Preprinted Forms |
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Cost plus ***% handling fee |
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Financial Services |
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Monthly fixed fee Accounts Receivable Management |
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$ |
* |
** |
Per order fee Accounts Receivable Management |
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$ |
* |
** |
Monthly fixed fee Chargeback Management |
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$ |
* |
** |
Per submission Chargeback Processing & Government Reporting |
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$ |
* |
** |
Preprinted Forms |
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Cost plus ***% handling fee |
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Note (1):
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This proposal is based on the distribution of Reglan and Donnatal only, any
additional products requiring distribution services will be quoted separately. The pricing
will be based on the buying patterns of the wholesalers. |
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Note (2):
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System access fee includes licenses for two concurrent users. Any additional
licenses required by Cumberland Pharmaceuticals will Increase the monthly fee by $*** per
concurrent user. |
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Note (3):
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List minus ***% is incorporated to UPS and FedEx rates only, all other freight
carriers will be billed back at cost plus ***%. |
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Note (4):
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The implementation fee will be paid in two equal installments at the beginning of
contract year two and three. The monthly fixed fees will be assessed at a ***% discount
in year one and a ***% increase in year three. |
Page 14 of 14
EX-10.8 STRATEGIC ALLIANCE AGREEMENT
EXHIBIT 10.8
*Certain portions of this exhibit have been omitted pursuant to a request for confidential
treatment which has been filed separately with the SEC.
STRATEGIC ALLIANCE AGREEMENT
THIS AGREEMENT is made and entered into as of the 21st day of July, 2000.
BY AND BETWEEN:
CUMBERLAND PHARMACEUTICALS INC., a corporation organized and existing under the laws of Tennessee,
with its principal offices located at 209 Tenth Avenue South, Suite 332, Nashville, Tennessee,
37203 (hereinafter referred to as CUMBERLAND)
AND:
F.H. FAULDING & CO. LIMITED (ABN 88 007 870 984), a corporation organized under the laws of South
Australia, with its principal place of business located at 115 Sheriff Street, Underdale, South
Australia 5032 (hereinafter referred to as FAULDING);
WHEREAS, CUMBERLAND is the owner of intellectual property rights, formulations and know- how
related to intravenous formulations of a certain pharmaceutical product set forth in Schedule I;
WHEREAS, FAULDING has the expertise and the manufacturing facility suitable for the pharmaceutical
preparation and production of the Drug Product;
WHEREAS, CUMBERLAND wishes to have FAULDING manufacture the Drug Product and FAULDING wishes to
supply the Drug Product to CUMBERLAND;
WHEREAS, CUMBERLAND will appoint FAULDING as its preferred manufacturer for CUMBERLANDs products;
WHEREAS, FAULDING and CUMBERLAND will explore opportunities to collaborate on the manufacture and
distribution of other pharmaceutical products of CUMBERLAND;
NOW, THEREFORE, in consideration of the premises and the undertakings, terms, conditions and
covenants set forth below, the parties hereto agree as follows:
1. DEFINITIONS
1.1 BUFFER SOLUTION shall mean the buffer solution selected by CUMBERLAND for the manufacture
of the Drug Product.
1.2 BULK DRUG SUBSTANCE shall mean the active ingredients in the Drug Product.
1.3 cGMP or GMP shall have the meaning set forth in Schedule I.
1.4 CONFIDENTIAL INFORMATION shall have the meaning set forth in Paragraph 9.
1.5 DEVELOPMENT shall mean all work necessary to develop a process to manufacture the Drug
Product in full accord with cGMP and to supply the Drug Product conforming to the Specifications.
Development activities shall include, but not be limited to, pilot batches, scale- up batches,
validation of the manufacturing process, and successful completion of the Drug Product manufacture
and delivery as defined in Schedule I attached hereto.
1.6 DRUG PRODUCT shall mean the Ibuprofen for injection pharmaceutical product developed by
Cumberland and marketed under the trade name AMELIOR.
1.7 EXCIPIENT shall mean any inert substance selected by CUMBERLAND and used to give the Drug
Product proper consistency.
1.8 FDA shall mean the United States Food and Drug Administration (FDA).
1.9 IN-PROCESS SOLUTION shall mean all Buffer Solutions and Excipients needed to produce Drug
Product in the finished dosage form set forth in Schedule I.
1.10 INVENTION shall have the meaning set forth in Paragraph 9.4.
1.11 LABELING shall mean all labels and other written, printed, or graphic matter upon: (i)
the Drug Product or any container or wrapper utilized with the Drug Product or (ii) any written
material accompanying the Drug Product, including without limitation, package inserts.
1.12 MANUAL shall mean the Manufacturing Project Manual attached as Schedule II to this
Agreement and reviewed and accepted by CUMBERLAND and FAULDING, the terms and provisions of which
are incorporated by reference as though fully set forth herein.
1.13 SPECIFICATIONS shall mean those specifications set forth in Attachment I to the Manual.
2. DEVELOPMENT AND MANUFACTURING
2.1 Initiation: Upon request by CUMBERLAND, FAULDING shall proceed with the schedule for
completing Development of the Drug Product. Upon request by CUMBERLAND, FAULDING shall manufacture
the Drug Product in the batch size set forth in Schedule I in accordance with the terms hereof, the
Specifications, and all applicable laws and
regulations. Prior to distributing and selling the Drug Product, CUMBERLAND shall prepare and
file submissions to the FDA in order to obtain and maintain during the term hereof regulatory
approval of the Drug Product. FAULDING shall prepare and test the Drug Product in accordance with
cGMP.
2
2.2 Processing and Manufacturing: FAULDING shall manufacture and package the Drug Product in
accordance with Schedules I and II hereto.
2.3 Documentation: Subject to CUMBERLANDs prior consent pursuant to Paragraph 5.5 hereof to
reimburse FAULDING for all out-of-pocket expenses and reasonable internal costs, FAULDING shall
provide CUMBERLAND with required supporting documentation for the Development of the Drug Product
in a form suitable for CUMBERLANDs submission to the FDA or applicable governmental authorities
for any country into which the Drug Product will be distributed with the prior written consent of
FAULDING, which consent shall not be unreasonably withheld or delayed.
2.4 Bulk Drug Substance Supply: FAULDING shall be responsible for the supply of all Bulk Drug
Substance in accordance with Schedules I and II hereto; provided that the supply of Bulk Drug
Substance shall be exclusively from such suppliers and in such grades as have been approved in
writing by CUMBERLAND as reflected on an approved list to be attached hereto as Schedule III, and
provided further that such suppliers and grades may not be changed without CUMBERLANDs prior
written consent.
2.5 Supply of Components: FAULDING shall be responsible for the supply of all components in
accordance with Schedules I and II hereto; provided that the supply of components shall be
exclusively from such suppliers and in such grades as have been approved in writing by CUMBERLAND
as reflected on an approved list to be attached hereto as Schedule III, and provided further that
such suppliers and grades may not be changed without CUMBERLANDs prior written consent.
2.6 Delivery Terms: All deliveries of Drug Product under this Agreement shall be made by
FAULDING to CUMBERLAND in the manner set forth in Schedule I. CUMBERLAND shall, within twenty (20)
working days after its receipt of any shipment, notify FAULDING in writing, of any claim relating
to a Drug Product not conforming to the Specifications, and, failing such notification,
notwithstanding Paragraph 5.1 of this Agreement, CUMBERLAND shall be deemed to have accepted the
Drug Product. If FAULDING disputes CUMBERLANDs claim that the Drug Product is non-conforming, then
such dispute shall be resolved by an independent testing organization of recognized repute within
the pharmaceutical industry mutually agreed upon by FAULDING and CUMBERLAND, the appointment of
which shall not be unreasonably withheld by either party. In such event, CUMBERLAND shall ship the
testing organization representative samples of the Drug Product from the disputed production lot,
and the fees and costs of such testing organization and related shipping and supply costs shall be
borne by the party whose position is not sustained by the testing organization. CUMBERLANDs sole
remedy for non-conforming product (other than indemnification under Paragraph 10.2) is to be
provided with replacement Drug Product free of charge, including compensation for all CUMBERLAND
inputs and all freight charges.
2.7 Payment for the Drug Product: At the time of each shipment, FAULDING shall invoice
CUMBERLAND for FAULDINGs manufacturing services at the cost per batch as set forth in Schedule I.
Payment shall be made in Australian dollars of the latter of the invoice date or
3
CUMBERLANDs acceptance of
shipment of conforming Product at its designated receiving facility.
2.8
Price Variations:
(i) Prices are as set on Schedule I for the term hereof unless changed pursuant to Paragraph
2.8(ii).
(ii) A party may request not less than two months prior to the second anniversary of the
effective date of this Agreement and each anniversary thereof thereafter to renegotiate the price
per batch having regard to varying costs of manufacture. The requesting party shall provide the
other party with evidence of varying costs of manufacture if an increase or decrease in price is
sought. Any increase in price shall not exceed the twelve (12) month percent increase in the
Consumer Price Index as published by the Australian government and shall be further subject to a
maximum of [***] percent ([***]%) unless (a) CUMBERLAND consents in writing to an increase in excess
of such Consumer Price Index and (b) FAULDING provides CUMBERLAND with evidence that the proposed
increase in price per batch is equivalent to FAULDINGs increased cost of manufacturing per batch
(excluding non-manufacturing overhead) as calculated in accordance with generally accepted
accounting principles consistently applied. If CUMBERLAND does not consent in writing to an
increase in excess of such Consumer Price Index within thirty (30) days of written notification
thereof, then FAULDING may withdraw the proposed amount of the increase in excess of the Consumer
Price Index or may terminate this Agreement upon at least ninety (90) days prior written notice.
3. TERM AND TERMINATION
3.1 Term: This Agreement shall commence on the date first above written and will continue
until the fifth anniversary of the date on which the FDA grants approval to market and sell the
Drug Product, unless sooner terminated pursuant to Paragraph 3.2 herein. The Agreement shall be
automatically renewed for successive three-year terms 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.
3.2 Termination: This Agreement may be terminated at any time upon the occurrence of any of
the following events:
(a) Default: Forty-five (45) days following written notice, by either party to the other
party, in the event that the other party breaches any provision of this Agreement, and such party
fails to remedy the breach prior to the expiration of the forty-five (45) day period.
(b) Insolvency: Written notice by either party to the other upon insolvency or bankruptcy of
the other party, and the failure of any such insolvency or bankruptcy to be dismissed within sixty
(60) days.
(c) If, as a result of causes described in Paragraph 7.1, either party is unable to fully
perform its obligations hereunder for a period of one hundred eighty (180) consecutive days, the
other party shall have the right to terminate this Agreement upon at least thirty (30) days prior
written notice; provided that if the required performance is met during that thirty-day period,
this Agreement shall continue in full force and effect as if the notice had not been given.
Termination, expiration, cancellation or abandonment of this Agreement, through any means and
for any reason, shall not relieve the parties of any obligation accruing prior thereto and shall be
without the prejudice to the rights and remedies of either party with respect to any antecedent
breach of any of the provisions of this Agreement or CUMBERLANDs purchase order issued hereunder.
3.3 Survival: Paragraphs 5, 6, 9, and 10 shall survive the termination or cancellation of the
Agreement for any reason.
4. CERTIFICATES OF ANALYSIS AND MANUFACTURING COMPLIANCE
4.1 Certificates of Analysis: FAULDING shall perform, or cause to be performed, certain tests
requested by CUMBERLAND as indicated in the Specifications on each batch of the Drug Product
manufactured pursuant to this Agreement before delivery to CUMBERLAND.
4
A certificate of analysis
for each batch delivered shall be delivered with each batch and shall set forth the items tested,
specifications, and test results. FAULDING shall also indicate on the certificate of analysis that
all batch production and control records have been reviewed and approved by the appropriate quality
control unit. FAULDING shall send, or cause to be sent, such certificates to CUMBERLAND prior to
the shipment of the Drug Product. CUMBERLAND shall test, or cause to be tested, prior to final
release, each batch of the Drug Product as meeting the Specifications. As required by the FDA (see
Paragraph 5.2 below), CUMBERLAND shall assume full responsibility for final release of each lot of
the Drug Product.
4.2 Manufacturing Compliance: FAULDING shall advise CUMBERLAND immediately if an authorized
agent of any regulatory body visits FAULDINGs manufacturing facility and makes an inquiry
regarding FAULDINGs method of manufacture of the Drug Product for CUMBERLAND. Upon receipt of any
Form 483 Notice of Inspectional Observations issued by the FDA or notice of deficit from any other
regulatory inspection after a visit to FAULDINGs manufacturing facility, FAULDING shall
immediately send CUMBERLAND a copy thereof; provided that it may redact any language that is
subject to a legally enforceable confidentiality agreement between FAULDING and a third party.
4.3 Regulatory Agency Requirements: FAULDING shall prepare and test the Drug Product in
conformity with GMP. Subject to the allocation of responsibility for regulatory compliance as set
forth in Paragraph 5.2, each party shall consult with the other party hereto before implementing
additional regulatory agency requirements concerning the control of Drug Product components,
manufacture of the Drug Product, or storage and handling of the Drug Product. The full text of
regulatory agency requests or comments will be provided by the party receiving such requests or
comments to the other party hereto. The parties will mutually agree on how to respond to such
requests and comments and on the allocation of the costs thereof; provided that FAULDING shall be
liable only for its reasonable internal costs and not for any out-of-pocket expenses or
extraordinary costs required in connection with implementing such regulatory requirements other
than the ordinary costs of compliance with GMP.
4.4 Regulatory Documents: Each party will advise the other party hereto of its intention to
change any Drug Product regulatory documents prior to submission of the document to any regulatory
body. If the change affects the rights and obligations of a party hereto under this Agreement, such
party may seek to review or alter any part of the document at any time within ten (10) business
days after receipt of notification thereof; provided that if no alterations are submitted to the
other party within such ten-day period, each party will be deemed to have consented to the
alteration. CUMBERLAND shall reimburse FAULDING for all out-of-pocket expenses and reasonable
internal costs of changes to Drug Product regulatory documents, subject to CUMBERLANDs prior
consent pursuant to Paragraph 5.5.
5. REPRESENTATIONS AND WARRANTIES
5.1 Conformity with Specifications: FAULDING warrants that, at the time of manufacture, the
Drug Product is prepared and tested in accordance with cGMP and meets the Specifications. Because
FAULDING has no control of the conditions under which the Drug Product is used, the diagnosis of
the patient before or after treatment with the Drug Product, the
5
method of use or administration of
the Drug Product, and handling of the Drug Product after delivery to CUMBERLAND, FAULDING does not
warrant either a good effect, or against an ill effect, following the use of the Drug Product. The
foregoing warranty is exclusive and in lieu of all other warranties either written, oral, or
implied. THERE ARE NO WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. No
representative of FAULDING may change any of the foregoing warranties and CUMBERLAND accepts the
Drug Product subject to all terms hereof.
5.2 Compliance: CUMBERLAND assumes responsibility for coordinating all contact with the FDA
and other regulatory bodies, pertaining specifically to Drug Product. FAULDING authorizes
CUMBERLANDs representatives to supervise and inspect the methods used in and facilities used for
manufacturing, processing, packaging, and handling of the Drug Product, but CUMBERLAND shall have
no such obligation under this Agreement. Except as otherwise required by applicable regulations,
CUMBERLANDs inspections shall be limited to two per year, each to occur upon seven days notice and
to be conducted during normal business hours; provided that CUMBERLAND may also inspect such
facilities promptly after any regulatory inspection thereof.
5.3 Debarring: FAULDING represents and warrants that it has not been debarred in the United
States within the meaning of 21 U.S.C. § 335a(a) and 335a(b), nor will it use in any capacity the
services of any person debarred pursuant to subsections 3.06(a) or 3.06(b) of the Federal Food,
Drug, and Cosmetic Act, 21 U.S.C. Section 335(a) and (b).
5.4 FDA Submission: FAULDING represents and warrants that it has submitted to the FDA
information about the manufacturing site to be used for the Drug Product and the facilities,
operating procedures, and personnel at such site.
5.5 Reimbursement: FAULDING shall not incur any development costs for which it intends to seek
reimbursement from CUMBERLAND for the manufacturing facility, equipment, or manufacturing method
unless FAULDING has the prior written consent of CUMBERLAND.
5.6 Exclusivity: FAULDING will not sell, give away, or deliver to any other person, firm, or
corporation any Drug Product without CUMBERLANDs prior written consent while this Agreement is
effective and for two years after the termination of this Agreement. In the event of breach,
CUMBERLAND shall have the right, in addition to other rights, to seek injunctive relief.
6. DRUG PRODUCT RECALLS
6.1 Drug Product Recalls: In the event: (a) any government authority issues a request,
directive or order that the Drug Product be recalled, or (b) a court of competent jurisdiction
orders such a recall, (c) CUMBERLAND determines that the Drug Product should be recalled because
the Drug Product does not conform to Specifications, or (d) FAULDING
recommends to CUMBERLAND that a recall be initiated, the parties shall take all appropriate
corrective actions. In the event that FAULDING recommends a recall of Drug Product by CUMBERLAND,
such recommendation must take the form of a notice as per Paragraph 14.1, and CUMBERLAND shall
respond promptly indicating to FAULDING whether the Drug
6
Product will be recalled. In no event,
however, shall FAULDING have responsibility for regulatory compliance in connection with any
recall, except to the extent and under the circumstances set forth in the Manual or any other
written agreement between the parties hereto or as required by law. All costs and expenses incurred
in connection with such recall shall be the responsibility of CUMBERLAND unless caused by the
negligence of FAULDING.
7. FORCE MAJEURE; FAILURE TO SUPPLY
7.1 Force Majeure Events: Failure of either party to perform under this Agreement (except the
obligation to make payments) shall not subject such party to any liability to the other if such
failure is caused by acts such as, but not limited to, acts of God, fire, explosion, flood,
drought, war, riot, sabotage, embargo, strikes or other labor trouble, compliance with any order or
regulation of any government entity, or by any cause beyond the reasonable control of the parties,
provided that written notice of such event is promptly given to the other party.
7.2 Failure to Supply; Delivery Dates; Forecasts: FAULDING shall supply all of the Drug
Product ordered by CUMBERLAND within sixty (60) days of receipt of a written order from CUMBERLAND.
On the date that CUMBERLAND makes its first order, CUMBERLAND will supply FAULDING with a
non-binding forecast of its future orders of Drug Product for each of the eleven calendar months
following the month in which the initial order is made. CUMBERLAND will update the forecasts on the
first day of the calendar month and on a monthly basis thereafter throughout the term of this
Agreement. The quantity of any Drug Product ordered pursuant to this Agreement shall not be less
than seventy percent (70%) nor more than one hundred thirty percent (130%) of the quantity
indicated in the most recent monthly forecast provided hereunder for the month in which the order
is placed. If CUMBERLAND fails to provide orders, or forecasts by agreed dates, FAULDING shall not
be required to deliver the quantity ordered by CUMBERLAND within sixty (60) days. The provisions of
this Paragraph 7.2 shall be without prejudice to CUMBERLANDs rights under Paragraph 3.2 and
remedies provided for thereunder.
8. IMPROVEMENTS
8.1 Changes by CUMBERLAND:
When CUMBERLAND seeks to change the Drug Product Specifications, such change shall be
incorporated within the Specifications only with the prior written consent of FAULDING, such
consent not to be unreasonably withheld or delayed. The price of the Drug Product may be adjusted
for such change, and CUMBERLAND shall pay FAULDING the agreed costs associated with such change,
including any development work, if necessary, based upon FAULDINGs then-prevailing development
rates. Such prices and costs shall be set forth in a written amendment to this Agreement. It is the
responsibility of CUMBERLAND to ensure that proper regulatory agencies approve the suggested
changes. CUMBERLAND will notify
FAULDING if it intends to change the process or test specifications related to the preparation
of the Bulk Drug Substance.
8.2 Changes by FAULDING:
7
FAULDING shall inform CUMBERLAND in writing of all proposed changes in the manufacturing
facility, equipment, or manufacturing methods and labeling of the Drug Product, each as approved by
applicable regulatory authorities, including the FDA, in advance of the time such changes are
intended to be made to allow CUMBERLAND sufficient time to provide any notice required by FDA
regulations. FAULDING shall not implement any such changes without prior written authorization by
the FDA or other applicable regulatory authorities and the prior written consent of CUMBERLAND,
which consent shall not be unreasonably withheld or delayed. FAULDING shall be liable only for its
reasonable internal costs and not for extraordinary costs in connection with such manufacturing
changes.
9. CONFIDENTIALITY
9.1 Confidential Information: Confidential Information means collectively Confidential
Information of CUMBERLAND (as defined herein) and Confidential Information of FAULDING (as defined
herein).
9.2 Confidential Information of CUMBERLAND: Confidential Information of CUMBERLAND means all
information obtained or developed by FAULDING or any third party which related to CUMBERLANDs
business or the Drug Product, regardless of the form in which such information is transmitted. The
following shall not be considered Confidential Information of CUMBERLAND for purposes hereof:
(a) Information that is already in the possession of FAULDING at the time it is received from
CUMBERLAND or developed on CUMBERLANDs behalf, if FAULDING notifies CUMBERLAND of its belief that
the information is excepted under the terms of this subsection;
(b) Information received by FAULDING from a person which has the right to disclose the same,
when FAULDING notifies CUMBERLAND of its belief that the information is excepted under the terms of
this subsection;
(c) Information that is or becomes published, or is or becomes otherwise publicly available
without the fault of FAULDING; or
(d) An Invention as defined in Paragraph 9.4.
In the event of a dispute regarding the applicability of the above exceptions to the
definition of Confidential Information of CUMBERLAND, FAULDING shall have the burden of producing
clear and convincing proof that the information should be excepted from the definition of
Confidential Information of CUMBERLAND. FAULDING shall not use or permit the use of the
Confidential Information of CUMBERLAND other than for the limited purposes
expressly permitted by or consistent with this Agreement. Recipients of Confidential
Information of CUMBERLAND shall be granted access thereto strictly on a need-to-know basis.
FAULDING shall take all reasonable steps to ensure that recipients comply with the terms of this
Agreement, including all restrictions on use, disclosure and dissemination of Confidential
8
Information of CUMBERLAND. FAULDING shall notify CUMBERLAND immediately upon becoming aware of any
breach hereof and shall take all reasonable steps to prevent any further disclosure or unauthorized
use.
Upon termination or expiration of this Agreement, FAULDING shall deliver to CUMBERLAND all
Confidential Information of CUMBERLAND, all copies thereof, and all documents or data storage media
containing such Confidential Information of CUMBERLAND, except as expressly set forth herein or in
any other written agreement between the parties.
9.3 Confidential Information of FAULDING: Confidential Information of FAULDING means all
information obtained by CUMBERLAND which relates to FAULDINGs business, regardless of the form in
which such information is transmitted. The following shall not be considered Confidential
Information of FAULDING for purposes hereof:
(a) Information that is already in the possession of CUMBERLAND at the time it is received
from FAULDING, if CUMBERLAND notifies FAULDING of its belief that the information is excepted under
the terms of this subsection; or
(b) Information received by CUMBERLAND from a person which has the right to disclose the same,
when CUMBERLAND notifies FAULDING of its belief that the information is excepted under the terms of
this subsection; or
(c) Information that is or becomes published, or is or becomes otherwise publicly available
without the fault of CUMBERLAND.
In the event of a dispute regarding the applicability of the above exceptions to the
definition of Confidential Information of FAULDING, CUMBERLAND shall have the burden of producing
clear and convincing proof that the information should be excepted from the definition of
Confidential Information of FAULDING. CUMBERLAND shall not use or permit the use of the
Confidential Information of FAULDING other than for the limited purposes expressly permitted by or
consistent with this Agreement. Recipients of Confidential Information of FAULDING shall be
granted access thereto strictly on a need-to-know basis. CUMBERLAND shall take all reasonable
steps to ensure that recipients comply with the terms of this Agreement, including all restrictions
on use, disclosure and dissemination of Confidential Information of FAULDING. CUMBERLAND shall
notify FAULDING immediately upon becoming aware of any breach hereof and shall take all reasonable
steps to prevent any further disclosure or unauthorized use.
Upon termination or expiration of this Agreement, CUMBERLAND shall deliver to FAULDING all
Confidential Information of FAULDING, all copies thereof, and all documents or data storage media
containing such Confidential Information of FAULDING, except as expressly set forth herein or in
any other written agreement between the parties.
9.4 Invention: CUMBERLAND owns all intellectual property rights in any improvement to or
derived from the Drug Product and any existing or further developments or modifications of the Drug
Products (Invention), except to the extent that a manufacturing
9
process used therewith is
developed exclusively by FAULDING, in which case the intellectual property rights for such process
shall be retained by FAULDING.
9.5 Disclosure: The parties agree that the existence of this Agreement may be disclosed to
third parties but that the contents of this Agreement shall not be disclosed to any third party
except (i) the controlling companies of the parties, (ii) the companies controlled by the parties,
(iii) individuals and entities providing paid services to either of the parties, and (iv)
governmental regulatory agencies, including, but not limited to, environmental protection
authorities, without prior written consent of the other party.
9.6 Retention of Records: Notwithstanding the restrictions set forth in this Agreement,
FAULDING shall retain production records (a) for batches of Drug Products manufactured prior to
establishment by CUMBERLAND of an expiry date (CTM and validation batches) for three (3) years
after (i) issuance of regulatory approval of the Drug Product necessary for distribution thereof or
(ii) withdrawal of the IND (Notice of Claimed Investigational Exemption for a New Drug) and (b) for
batches of Drug Product manufactured after establishment by CUMBERLAND of an expiry date for a
period of at least one year after the respective expiry date for each batch. These records will be
stored by appropriate means, including without limitation, optical disk or microfilm in a secure
manner in compliance with current GMP with duplicate copies submitted to CUMBERLAND promptly after
the creation thereof and shall be made available on request of the FDA or any other authorized
regulatory body.
9.7 Confidential Information Upon Termination: Upon termination of this Agreement for whatever
reason, FAULDING shall return to CUMBERLAND originals, copies, and derivative forms of disclosed or
developed information relating to the purpose of this Agreement; except that one copy of such
information may be retained as required by regulation or law for future reference. The Confidential
Information shall remain confidential and not be disclosed by either party for a period of ten (10)
years following the date of expiration or termination of this Agreement.
10. INDEMNIFICATION
10.1 Indemnification by CUMBERLAND: CUMBERLAND shall indemnify and hold FAULDING (and any
parent, subsidiary, or affiliate company or corporation, and their officers, directors,
shareholders, agents, and the employees and insurers of any of them and/or their successors and
assigns thereto), free and harmless from any and all claims, demands, liability, actions or causes
of actions, and any and all expenses associated therewith (including, without limiting the
generality of the foregoing, attorneys fees), arising out of or in connection with, as a result
of, or otherwise related to any third party claims arising from: (i) any negligence or recklessness
of CUMBERLAND, its agents, or employees; (ii) the promotion, distribution, use, misuse or sale or
effects of the Drug Product except to the extent the alleged Drug Product
defects were caused by FAULDING; (iii) CUMBERLANDs non-compliance with any applicable FDA or
other applicable regulations; or, (iv) any failure of CUMBERLAND to perform, in whole or in part,
any of its obligations hereunder in each case, unless caused by the acts or omissions of FAULDING.
Beginning prior to use of the Drug Product in humans and
10
continuing until the third anniversary of
termination of this Agreement, CUMBERLAND shall maintain products liability insurance with limits
of liability of not less than [***] and shall name
FAULDING as additional insured under said policy.
10.2 Indemnification by FAULDING: FAULDING will indemnify and hold CUMBERLAND (and any parent,
subsidiary, or affiliate company or corporation, and their officers, directors, shareholders,
agents, and the employees and issuers of any of them and/or their successors and assigns thereto),
free and harmless against any and all claims, demands, actions or causes of action, and any and all
expenses associated therewith (including, without limiting the generality of the foregoing, defense
costs and attorneys fees), arising out of or in connection with, as a result of, or otherwise
related to any third party claims arising from (i) any negligence or recklessness of FAULDING, its
agents or employees; (ii) personal injury (including death) or property damage arising out of or in
connection with FAULDINGs manufacture or handling of the Drug Product otherwise than in accordance
with the Specifications and CUMBERLANDS written directions; (iii) FAULDINGs non-compliance with
any applicable FDA or other applicable regulations; provided that CUMBERLAND perform its
obligations under Paragraph 2.1, or (iv) any failure of FAULDING to perform any of its obligations
hereunder, unless caused by the acts or omissions of CUMBERLAND. Beginning prior to delivery of the
first order for Drug Product pursuant to this Agreement and continuing until the third anniversary
of termination of this Agreement, FAULDING shall maintain products liability insurance with limits
of liability of not less than [***] and shall name CUMBERLAND as additional insured under
said policy.
10.3 Patent Indemnity: Subject to Paragraph 5.1, CUMBERLAND further warrants that importation,
manufacture (excluding manufacturing not specific to the manufacture of the Drug Product to be
performed by FAULDING for CUMBERLAND), use, supply, and sale of the Drug Product and Bulk Drug
Substance will not infringe any patent rights or any other third-party intellectual property rights
and that CUMBERLAND will indemnify, defend, and hold FAULDING free and harmless from any damage,
judgment, liability, loss, cost or expense, including legal expenses, arising from claims that the
Drug Product and Bulk Drug Substance infringe patent rights of a third party or any third-party
intellectual property rights.
10.4 Conditions of Indemnification: If either party seeks indemnification from the other under
Paragraphs 10.1, 10.2, or 10.3, it shall promptly give written notice to the other party of any
such claim or suit threatened, made or filed against it, which forms the basis for such claim of
indemnification and shall cooperate fully with the other party in the defense of all such claims or
suits. No settlement or compromise shall be binding on a party hereto without its prior written
consent.
10.5 Disclaimer of Warranties; Limited Liability: Under no circumstances shall either party be
liable to the other on account of any claim (whether based upon principles of
contract, warranty, negligence, or other tort, breach of any statutory duty, principles of
indemnity, the failure of any expressly limited remedy to achieve its essential purpose) for any
special, consequential, incidental or exemplary damages, or including but not limited to lost
profits.
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11. APPOINTMENT AS PREFERRED MANUFACTURER
Until the expiration or earlier termination of this Agreement, CUMBERLAND agrees to provide
FAULDING with the first opportunity to negotiate to manufacture each CUMBERLAND pharmaceutical
product to be sold anywhere in the world in addition to the Drug Product; provided that the
foregoing shall not apply to pharmaceutical products in respect of which CUMBERLAND is unable to
enter into a manufacturing arrangement with FAULDING, due to contractual obligations applicable to
CUMBERLAND or where to enter into such an arrangement with FAULDING would adversely affect any
existing regulatory approval or application for regulatory approval for the product, in either case
as reasonably determined by CUMBERLAND having regard to documented evidence which CUMBERLAND shall
provide to FAULDING or FAULDINGs advisers for review at FAULDINGs request. Except as set forth to
the contrary in the preceding sentence, CUMBERLAND agrees not to manufacture, or to have
manufactured, such a product anywhere in the world unless CUMBERLAND first notifies FAULDING of the
opportunity hereunder and unless CUMBERLAND negotiates in good faith with FAULDING for sixty (60)
days after providing such notice in an attempt to enter into a written agreement on substantially
the same terms as this Agreement with respect to such additional product.
12. LICENSING AND DISTRIBUTION OF CUMBERLAND PRODUCTS
Until the expiration or earlier termination of this Agreement, CUMBERLAND agrees to provide
FAULDING with the first opportunity to negotiate to license and distribute each pharmaceutical
product of CUMBERLAND in Australia, New Zealand, Canada, and mutually agreed Southeast Asian and
Latin American countries; provided that the foregoing shall not apply to pharmaceutical products in
respect of which CUMBERLAND is unable to enter into a license and distribution arrangement with
FAULDING, due to contractual obligations applicable to CUMBERLAND as reasonably determined by
CUMBERLAND having regard to documented evidence which CUMBERLAND shall provide to FAULDING or
FAULDINGs advisers for review at FAULDINGs request, and further provided that CUMBERLAND shall
use good faith efforts to initiate such negotiations with FAULDING as soon as such a product is
reasonably available for license and distribution in such territory. Except as set forth to the
contrary in the preceding sentence, CUMBERLAND agrees not to license or distribute such a product
in such territory unless CUMBERLAND first notifies FAULDING of the opportunity hereunder and unless
CUMBERLAND negotiates in good faith with FAULDING for sixty (60) days after providing such notice
in an attempt to enter into a written agreement with respect to the services that are being
negotiated.
13. REGULATORY SUPPORT
If requested by CUMBERLAND, and at CUMBERLANDS cost at reasonable fees to be agreed
by the parties, FAULDING shall provide CUMBERLAND with reasonable assistance in relation to the
Development of, and applications for regulatory approval for, pharmaceutical products other than
the Drug Product which are identified by CUMBERLAND, including but not limited to the preparation
of development reports, stability reports, manufacturing documentation and
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instructions for use
necessary to support applications for regulatory approval.
14. GENERAL PROVISIONS
14.1 Notices: Any notice permitted or required by this Agreement may be sent by facsimile with
the original document being sent by certified (or registered) mail, return receipt requested, or
overnight delivery and shall be effective when received (or refused) via facsimile or mail or
overnight if faxed and sent and addressed as follows (or to such other facsimile number or address
as may be designated by a party in writing):
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If to CUMBERLAND: |
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Cumberland Pharmaceuticals Inc. |
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209 Tenth Avenue South, Suite 332 |
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Nashville, Tennessee 37203 |
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Attn: Chief Executive Officer |
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Telephone:
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615-255-0068 |
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Facsimile:
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615-255-0094 |
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If to FAULDING: |
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F.H. Faulding & Co. Limited |
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115 Sherriff Street |
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Underdale, South Australia 5032 |
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Attn: Company Secretary |
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Telephone:
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61-8-8205-6500 |
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Facsimile:
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61-8-8234-8380 |
14.2 Entire Agreement: Amendment: The parties hereto acknowledge that this Agreement sets
forth the entire agreement and understanding of the parties and supersedes all prior written or
oral agreements or understandings with respect to the subject matter hereof; provided that the
Confidentiality Agreement dated August 1, 1999, between FAULDING and CUMBERLAND shall remain in
effect and that the terms thereof shall supersede any conflicting term of Paragraph 9 hereof. No
modification of any of the terms of this Agreement, or any amendments thereto, shall be deemed to
be valid unless in writing and signed by both parties hereto. No course of dealing or usage of
trade shall be used to modify the terms and conditions herein.
14.3 Waiver: None of the provisions of the Agreement shall be considered waived by any party
hereto unless such waiver is agreed to, in writing, by both parties. The failure of a party to
insist upon strict conformance to any of the terms and conditions hereof, or failure or delay to
exercise any rights provided herein or by law shall not be deemed a waiver of any rights of any
party hereto.
14.4 Obligations to Third Parties: Each party warrants and represents that this Agreement is
not inconsistent with any contractual obligations, expressed or implied, undertaken
with any third party.
14.5 Assignment: This Agreement shall be binding upon and inure to the benefit of the
successors or permitted assigns of each of the parties and may not be assigned, transferred, or
13
subcontracted by either party without the prior written consent of the other, which consent will
not be unreasonably withheld or delayed, except that no consent shall be required in the case of a
transfer to a wholly-owned subsidiary or transaction involving the merger, consolidation or sale of
substantially all of the assets of the party seeking such assignment or transfer and such
transaction relates to the business covered by this Agreement and the resulting entity assumes all
the obligations under this Agreement.
14.6 Independent Contractor: FAULDING shall act as an independent contractor for CUMBERLAND in
providing the services required hereunder and shall not be considered an agent of or joint venturer
with CUMBERLAND. Unless otherwise provided herein to the contrary, FAULDING shall furnish all
expertise, labor, supervision, machining and equipment necessary for performance hereunder and
shall obtain and maintain all building and other permits and licenses required by public
authorities.
14.7 Governing Law: This Agreement is subject to and shall be governed by the laws of the
State of Tennessee. The parties hereby submit to the jurisdiction of the courts of the State of
Tennessee in respect to all disputes arising out of or in connection with this Agreement and waive
any and all objections to such venue.
14.8 Severability: In the event that any term or provision of this Agreement shall violate any
applicable statute, ordinance, or rule of law in any jurisdiction in which it is used, or otherwise
be unenforceable, such provision shall be ineffective to the extent of such violation without
invalidating any other provision hereof.
14.9 Headings, Interpretation: The headings used in this Agreement are for convenience only
and are not part of this Agreement.
14.10 Conflict: In the event of conflict between the terms and provisions of this Agreement
and the terms and provisions of the Manual, the terms of this Agreement shall control.
IN WITNESS WHEREOF, the parties hereto have each caused this Agreement to be executed by their
duly authorized representatives effective as of the date first above written.
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CUMBERLAND PHARMACEUTICALS INC.
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F.H. FAULDING & CO. LIMITED |
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/s/ A.J. Kazimi
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/s/ Alex Bell |
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Authorized Signature
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Printed Name
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Printed Name |
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A.J. Kazimi
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Alex Bell |
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Printed Name
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Printed Name |
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Title |
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CEO
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V.P. Tech Ops. |
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Title |
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14
SCHEDULE I
DEVELOPMENT ACTIVITIES AND PRICING
Development of the Drug Product for use in Clinical Studies and for sale will consist of the
following:
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Product -
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Amelior. Ibuprofen for intravenous injection. |
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Timing -
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CUMBERLAND shall provide FAULDING with non-binding
forecasts of its requirements in the manner set forth in
Paragraph 7.2 of this Agreement. FAULDING shall
manufacture the number of batches of Drug Product
corresponding to each purchase order therefor within 60
days of receipt of any such order. |
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Special Issues -
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All product contact components must be dedicated or
disposed of after use. CUMBERLAND may be present for
manufacturing. The initial batches are for an FDA
submission, and may subsequently be used in clinical
studies or sold. FAULDING shall provide process
validation (scale-up and three validation batches) in
accordance with this Agreement and the Schedules thereto. |
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cGMP or GMP -
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GMP or cGMP shall mean the current good manufacturing
practices as defined from time in regulations promulgated
under the Federal Food, Drug and Cosmetic Act of the
United States or any successor laws or regulations
governing the manufacture of the Drug Product. |
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Storage - |
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FAULDING shall store and handle Bulk Drug Substance and finished Drug Product at 20E to 25E
C. |
Composition, Process & Container
[***]
15
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Preparation -
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Additional details regarding preparation shall be
incorporated herein upon adoption thereof by written
agreement of FAULDING and
CUMBERLAND. |
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[***] |
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Disposal -
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Method of disposal is incineration. Any disposal costs
incurred by FAULDING will be charged back to CUMBERLAND;
provided that CUMBERLAND shall not be required to reimburse
FAULDING for such costs if the Drug Product is disposed of
because of FAULDINGs negligence or breach of this
Agreement. FAULDING shall prepare and provide CUMBERLAND
with complete documentation of disposal throughout the chain
of custody. |
Documentation by FAULDING
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Master batch record for review and approval by FAULDING and CUMBERLAND. |
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Product specific validation summaries. |
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Executed batch records. |
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Analytical records. |
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Inventory records. |
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Disposal records. |
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Compensation -
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The price to be paid by CUMBERLAND to FAULDING for the satisfactory performance of its obligations under this Agreement are as
follows: |
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[***] |
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Reimbursement of Development Costs -
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CUMBERLAND shall reimburse FAULDING
for development costs incurred and
approved as agreed by the parties. |
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Reimbursement of Regulatory Costs -
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CUMBERLAND shall reimburse FAULDING
for regulatory costs incurred and
approved as agreed by the parties. |
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Reimbursement of Inspection and Audit
Costs -
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CUMBERLAND shall reimburse FAULDING
for inspection and audit costs
incurred and approved as agreed by
the parties. |
16
SCHEDULE II
MANUFACTURING PROJECT MANUAL
(To be expanded by mutual written consent of F.H. Faulding & Co., Limited (FHF) and
Cumberland Pharmaceuticals, Inc. (CPI))
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Responsibility |
Documentation/Activity |
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FHF |
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CPI |
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Comments |
GMP certificate and other permits
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Active Pharmaceutical Ingredient
(API) |
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Supply of API
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CPI to identify source |
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Provide specifications
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Approval of API specifications
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Provide sampling and testing
methods
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Approval of sampling and testing
methods
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Sampling and testing
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Release
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Storage of samples
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Storage of documents
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Starting Materials (except API) |
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Supply of starting materials
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CPI to identify arginine source |
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Provide specifications of starting
materials
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Approval of starting materials
specifications
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Providing sampling and testing
methods
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Approval of sampling and testing
materials
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Sampling and testing
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Release
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Storage of samples
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Storage of documentation
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Manufacturing Formula |
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Development of manufacturing
formula
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Approval of manufacturing formula
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Processing Instructions |
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Development of processing
instructions
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Approval of processing instructions
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17
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FHF |
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CPI |
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Comments |
Bulk Product |
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Supply of Bulk Product
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Provide specifications of Bulk Product
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Approval of Bulk Product specifications
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Providing sampling and testing methods
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Approval of sampling and testing methods
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Sampling and testing
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Release
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Storage of samples
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Prepare stability data for Bulk Product
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Storage of documentation
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Packaging |
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Supply of packaging materials
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Provide packaging materials specifications
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Approval of specifications
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Providing sampling and testing methods
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Approval of sampling and testing methods
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Sampling and testing
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Release
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Storage of samples
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Storage of documentation
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Batch Processing Records |
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Preparation of batch processing records
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Review of batch processing records
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Release of batch processing records
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Storage of batch processing records
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Product |
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Providing sampling and testing methods
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Approval of sampling and testing methods
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Sampling and testing
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Release
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Storage of samples
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Storage of documentation
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Prepare stability data for Product
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18
Supply of Materials
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Supplier (check one): |
Documentation/Activity |
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FHF |
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CPI |
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Comments |
Starting Materials |
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Active Pharmaceutical Ingredient |
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CPI will identify source |
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Other Starting Materials |
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(Auxiliaries, fluids, gases, etc.): |
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Excipients |
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WFI |
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N2 |
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Packaging Materials |
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Vials |
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Stoppers |
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Seals |
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Boxes |
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Shippers |
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Labeling |
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Quality Control
Distribution of responsibilities:
F.H. Faulding & Co. (FHF) shall ensure that all quality control measures follow the applicable cGMP
guidelines. The responsibilities shall be distributed between FAULDING and CPI as follows:
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Supplier (check one): |
Documentation/Activity |
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FHF |
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CPI |
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Comments |
Active Pharmaceutical Ingredient |
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Providing sampling and testing methods
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Approval of sampling and testing methods
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Sampling and testing
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Release
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Storage of samples
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Storage of documentation
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Starting Materials (except API) |
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Providing sampling and testing methods
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Approval of sampling and testing methods
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Supplier (check one): |
Documentation/Activity |
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FHF |
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CPI |
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Comments |
Sampling and testing
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Release
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Storage of samples
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Storage of documentation
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Bulk Product |
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Providing sampling and testing methods
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Approval of sampling and testing methods
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Sampling and testing
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Release
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Storage of samples |
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Storage of documentation
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Prepare stability data for Bulk Product
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Packaging Materials |
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Providing sampling and testing methods
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Approval of sampling and testing methods
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Sampling and testing
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Release
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Storage of samples
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Storage of documentation
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FHF |
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CPI |
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Comments |
Batch Documentation |
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Assignment of batch numbers
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Preparation of batch processing records
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Review of batch processing records
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Release of batch processing records
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Storage of batch processing records
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Product |
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Providing sampling and testing methods
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Approval of sampling and testing methods
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Sampling and testing
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Release
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Storage of samples |
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Storage of documentation
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Prepare stability data for Product
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20
ATTACHMENT I
BULK DRUG SUBSTANCE
AND DRUG PRODUCT SPECIFICATIONS
AND PROCEDURES
Bulk Drug Substance -
To be agreed.
Drug Product Specifications and Procedures -
To be decided.
21
SCHEDULE 3
Ibuprofen Injection 100mg/ml
[***]
22
EX-10.9 KRISTALOSE AGREEMENT
EXHIBIT 10.9
*Certain portions of this exhibit have been omitted pursuant to a request for confidential
treatment which has been filed separately with the SEC.
KRISTALOSE AGREEMENT
Between
CUMBERLAND PHARMACEUTICALS INC.
And
INALCO BIOCHEMICALS, INC.
And
INALCO S.P.A.
APRIL 2006
TABLE OF CONTENTS
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1. DEFINITIONS |
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1 |
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2. REGULATORY APPROVAL, MARKETING AND DISTRIBUTION |
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6 |
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3. TERM AND TERMINATION |
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16 |
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4. PAYMENTS |
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18 |
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5. CONFIDENTIALITY |
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20 |
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6. PROTECTION AND OWNERSHIP OF INTELLECTUAL PROPERTY |
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22 |
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7. REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION |
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23 |
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8. GENERAL |
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27 |
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9. ARBITRATION |
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29 |
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EXHIBIT A Minimum Purchases |
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EXHIBIT B Patents |
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EXHIBIT C Transition Plan |
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EXHIBIT D Specifications |
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EXHIBIT E Adverse Event Reporting |
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i
THIS AGREEMENT, by and among CUMBERLAND PHARMACEUTICALS INC. (CUMBERLAND), a corporation
organized and existing under the laws of the State of Tennessee, U.S.A., with its principal place
of business located at 2525 West End Avenue, Suite 950, Nashville, Tennessee, U.S.A., 37203, and
INALCO BIOCHEMICALS, INC., a corporation organized and existing under the laws of California, with
its principal place of business located at 3440 Empresa Drive, Suite A, San Luis Obispo,
California 93401 (INALCO U.S.), and INALCO S.p.A., a corporation organized and existing under
the laws of Italy, with its principal place of business located at Via Calabiana 18, 20139 Milan,
Italy (INALCO ITALY) (INALCO U.S. and INALCO ITALY are hereinafter collectively referred to as
INALCO) is entered into as of the day of April, 2006 (the Execution Date).
RECITALS
WHEREAS, INALCO is negotiating the acquisition of the Kristalose Trademark from Mylan Laboratories
Inc. and this Agreement is conditional upon the successful acquisition of the Kristalose
Trademark;
WHEREAS, INALCO owns or has the right to use all Intellectual Property Rights related to the
Product (each as defined herein);
WHEREAS, CUMBERLAND is a pharmaceutical company with capabilities in the marketing, development,
registration and distribution of various pharmaceutical products in the Territory;
WHEREAS, INALCO has obtained and is willing to seek all necessary regulatory approvals for the
marketing and distribution of the Product in the Territory (as defined herein);
WHEREAS, CUMBERLAND wishes to acquire the exclusive distribution and marketing rights to the
Product in the Territory, in accordance with and subject to the terms and conditions set forth in
this Agreement;
WHEREAS, INALCO is willing to grant an exclusive license to CUMBERLAND to market and distribute
the Product in the Territory;
NOW, THEREFORE, in consideration of the mutual covenants and agreements herein contained, it is
agreed by the parties as follows:
1. DEFINITIONS
1.1 |
|
Affiliate shall mean, with respect to any Person, any other Person that controls, is
controlled by or is under common control with, such Person. A Person shall be regarded as in
control of another Person if such Person owns, or directly or indirectly controls, more than
fifty percent (50%) of the voting securities (or comparable equity interests) or other
ownership interests of the other Person, or if such Person directly or indirectly possesses
the power to direct or cause the direction of the management or policies of the other Person,
whether through the ownership of voting securities, by
contract or any other means whatsoever. |
1
1.2 |
|
Agreement shall mean this Agreement and all instruments supplemental hereto or in
amendment or confirmation hereof; herein, hereof, hereto, hereunder and similar
expressions mean and refer to this Agreement and not to any particular Article, Section,
Subsection or other subdivision; Article, Section, Subsection or other subdivision of
this Agreement means and refers to the specified Article, Section, Subsection or other
subdivision of this Agreement. |
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1.3 |
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ANDA shall mean any Abbreviated New Drug Application covering the Product and filed
with the FDA pursuant to the U.S. Federal Food, Drug, and Cosmetic Act, as amended, or any
regulations thereunder. |
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1.4 |
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Calendar Quarter shall mean each three (3) month period ending March 31, June 30,
September 30, and December 31. |
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1.5 |
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Certificate of Analysis means a document which is signed and dated by a duly
authorized representative of INALCO certifying that the Product conforms with the Product
Specifications. |
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1.6 |
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Competent Authority shall mean each and every Governmental Body from which approvals
are required for the manufacture, marketing, distribution or sale of the Product within the
Territory. |
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1.7 |
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Confidential Information shall have the meaning set forth in Subsection 5.1(A) hereof. |
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1.8 |
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Delivery Date is the date of delivery for Products agreed to by the parties. |
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1.9 |
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Effective Date shall mean the date on which an authorized representative of INALCO
certifies in a writing delivered to CUMBERLAND that INALCO has met all requirements in order
to transfer exclusive marketing and distribution rights to the Product in accordance with this
Agreement, including without limitation, obtaining all rights to the Trademarks from Mylan
Pharmaceuticals, Inc.; provided that such certificate must be in a form reasonably
satisfactory to CUMBERLAND. |
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1.10 |
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FDA shall mean the U.S. Food and Drug Administration. |
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1.11 |
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Governmental Body shall mean (i) any domestic or foreign national, federal,
provincial, state, municipal or other government or body, (ii) any international or
multilateral body, (iii) any subdivision, ministry, department, secretariat, bureau, agency,
commission, board, instrumentality or authority of any of the foregoing governments or
bodies, (iv) any quasi-governmental or private body exercising any regulatory, expropriation
or taxing authority under or for the account of any of the foregoing governments or bodies,
or (v) any domestic, foreign, international, multilateral, or multinational judicial,
quasi-judicial, arbitration or administrative court, grand jury, tribunal, commission, board
or panel. |
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1.12 |
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Independent Analyst is an analyst which is acceptable to the parties for the purposes
of
Sections 2.7(C) or 2.10. |
2
1.13 |
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Intellectual Property Rights shall mean whether or not reduced to writing, all
discoveries, inventions, all rights to inventions, patents, patent applications and issued
patents, data, including patient records, proprietary formulation, non-clinical and clinical
data, FDA registrations, market information and plans, designs, design applications and design
registrations, trade marks, trade mark applications, trade mark registration, trade names,
trade dresses, service marks, logos (whether registered or unregistered), copyright, copyright
applications and registrations, and all other rights and intellectual property relating to the
Product now or hereafter owned, held or used by INALCO or any of its Affiliates or
Subsidiaries; without limiting the generality of the foregoing, Intellectual Property Rights
shall include the Patent Rights, the Trademarks, the Know-How (each as defined herein) and all
other rights and intellectual property now or hereafter owned, held or used by INALCO or any
of its Affiliates or Subsidiaries. |
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1.14 |
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Know-How shall mean all know-how, information, data, knowledge, discoveries, trade
secrets, works, data, analytical reference materials and confidential or proprietary processes
relating to the Product or to the manufacturing, distribution or sale of the Product in the
Territory, and other information relating to the Product, owned or developed by, in the
possession of, known to or used by INALCO or its Affiliates or Subsidiaries prior to the
Effective Date. Without limiting the generality of the foregoing, Know-How shall include all
techniques, technology, processes, and know-how related to production and purification of the
Product, including systems for fully processing and purifying the Product; types and
configuration of processing equipment; lists of suppliers, customers and prospective
customers; market research data and reports, customer segmentation reports, detail pieces and
any other marketing information relating to Product; development plans; methods of operation
and management; cost control methods of setting prices; reporting methods; quality assurance
programs; information systems; training manuals; databases; production solutions; financial
information; and all other trade secrets of INALCO. |
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1.15 |
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Labels shall mean all labels and packaging and other written, printed, or graphic
matter approved by the Competent Authority upon or containing: (i) the Product or any
packaging, container or wrapper utilized with the Product, and (ii) any written material
accompanying the Product, including without limitation, package inserts, produced by INALCO
with CUMBERLANDs prior written approval. |
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1.16 |
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Laws shall mean: |
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(i) |
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all constitutions, treaties, laws, statutes, codes, ordinances, orders,
decrees, rules, regulations, and municipal by-laws, whether domestic, foreign or
international; |
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(ii) |
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all judgments, orders, writs, injunctions, decisions, rulings, decrees, and
awards of any Governmental Body; and |
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(iii) |
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all policies, practices and guidelines of any Governmental Body; |
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in each case binding on or affecting the party or Person referred to in the context in |
3
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which such word is used; and Law shall mean any one of them. |
1.17 |
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Listing means obtaining approval from the relevant pricing authority in the
Territory to qualify the Product for price reimbursement and/or (as appropriate) obtaining
formulary listing approval in the Territory. |
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1.18 |
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Minimum Purchases shall mean the minimum number of
commercial pouches of the Product that CUMBERLAND must purchase, as set forth in Exhibit A. |
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1.19 |
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Mylan shall have the meaning set forth in Section 2.5(A). |
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1.20 |
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Net Sales shall mean the aggregate amount billed by CUMBERLAND for the sale of the
Product, less returns, buying group chargebacks, group purchasing organization administrative
fees, managed care organization rebates, sales/purchasing discounts, prompt payment
discounts, federally mandated discounts or rebates, state medical assistance program rebates
and discounts, adjustments for quantities shipped, and other discounts and fees, all as
determined on an accrual basis. |
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1.21 |
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Order is defined in Section 2.6(C). |
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1.22 |
|
Patent Rights shall mean all issued patents and patent applications relating to the
Product in the Territory, whether owned by INALCO or its Affiliates or Subsidiaries and/or
made available in any other way to INALCO or its Affiliates or Subsidiaries, including those
listed in Exhibit B hereto, and every divisional, continuation, continuation-in-part,
substitution and confirmation application based thereon, and any reissue or extension based
on any of the foregoing. |
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1.23 |
|
Person shall mean an individual, corporation, company, co-operative, partnership,
organization or any similar entity. |
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1.24 |
|
Product shall mean INALCOs pharmaceutical product lactulose crystals sold under the
Kristalose® trademark or any other trademark agreed by the parties, containing the
Label and packaged for sale in 10-gram and 20-gram pouches and all other strengths and dosage
forms. |
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1.25 |
|
Product Drug Master File shall mean all confidential reference files submitted to the
FDA or other applicable Competent Authorities in the Territory for use in the review of the
ANDA or in connection with obtaining or maintaining Regulatory Approval for the Product in the
Territory. |
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1.26 |
|
Product Payments shall have the meaning set forth in Section 4.3. |
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1.27 |
|
Product Specifications means the specifications contained in Exhibit D or any
later approved specification of the Products by the Competent Authority in the Territory which
may also include specifications for packaging material, labeling and product information. |
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1.28 |
|
Regulatory Approval(s) shall mean all approvals, licenses, registrations, or
authorizations |
4
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of any Competent Authority necessary for the manufacturing, marketing, distribution and/or
sale of the Product in the Territory. |
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1.29 |
|
Royalty Payment shall have the meaning set forth in Section 4.2. |
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1.30 |
|
Subcontractor shall mean a Third Person to whom either party hereto has delegated
responsibilities under this Agreement. |
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1.31 |
|
Subsidiaries shall mean any and all existing and future subsidiaries of Inalco S.p.A.
and/or Inalco Biochemicals, Inc. and their Affiliates, or of Cumberland Pharmaceuticals Inc.
and its Affiliates. |
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1.32 |
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Term shall mean the term of this Agreement, as set forth in Section 3.1. |
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1.33 |
|
Territory shall mean the U.S., subject to potential modifications pursuant to Section
4.2, Exhibit A, and the following understandings: |
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(a) |
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As of the Effective Date of this Agreement, INALCO does not have Regulatory
Approval for the Product in Canada. |
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(b) |
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INALCO cannot guarantee that Regulatory Approval will be granted for the
Product in Canada. |
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(c) |
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CUMBERLAND and INALCO agree to cooperate reasonably to determine the
feasibility of and develop a strategy for registering and commercializing the Product
in Canada. Upon mutual agreement between INALCO and CUMBERLAND that commercialization
of the Product in Canada is justified, INALCO will act in good faith in order to obtain
the Regulatory Approvals required to register the Product in Canada, and at such time
as the Regulatory Approvals are obtained, the Territory shall be deemed to include
Canada. |
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(d) |
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In the event that Regulatory Approval in Canada is granted and CUMBERLAND is
not actively marketing and distributing the Product in Canada (as evidenced by its
distribution of the Product in such country or by entering into an agreement with a
Subcontractor to market and distribute the Product) within two (2) years of the date of
issuance of Regulatory Approval for the Product in Canada, then INALCO has the right to
remove Canada from the defined Territory upon ninety (90) days written notice to
CUMBERLAND. |
1.34 |
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Third Person shall mean any Person other than one of the parties hereto or an
Affiliate or Subsidiary of one of the parties hereto. |
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1.35 |
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Trademarks shall mean all trademarks, trademark applications and registrations, trade
names, trade dresses, service logos and other designations of origin owned by INALCO or its
Affiliates or Subsidiaries pursuant to Section 6 and used on or in connection with the
Product, whether registered or not, including without limitation,
Kristalose®. |
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1.36 |
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U.S. shall mean the United States of America and each of its territories and
possessions. |
5
1.37 |
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Valid Claim shall mean, with respect to the Patent Rights; (i) a claim of an issued
and unexpired patent that has not been revoked or held unenforceable or invalid by a decision
of a court or other Governmental Body of competent jurisdiction, unappealable or unappealed
within the time allowed for appeal, and which has not been disclaimed, denied or admitted to
be invalid or unenforceable through reissue, disclaimer or otherwise; or (ii) a claim included
in a pending patent application that is actively prosecuted and which has not been cancelled,
withdrawn, finally determined to be unallowable by the applicable Governmental Body pursuant
to an unappealable decision and/or abandoned in accordance with the terms hereof. |
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1.38 |
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Year shall mean the twelve (12) month period commencing on the first date that INALCO
delivers an order of Product to CUMBERLAND pursuant to this Agreement, and each twelve month
period beginning on the anniversary thereof. |
2. REGULATORY APPROVAL, MARKETING AND DISTRIBUTION
2.1 |
|
Regulatory Approval. INALCO shall, at INALCOs expense, secure with the least
possible delay, and maintain Regulatory Approval for the Product from all relevant Competent
Authorities in the Territory, and fulfill any reasonable additional requirements for approval
from the Competent Authorities in the Territory. All registrations and approvals obtained
shall be the sole and exclusive property of INALCO. INALCO agrees to provide additional
information in its possession or control to support CUMBERLAND in answering or attending to
any queries or requests of the Competent Authorities in relation to the Product. |
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2.2 |
|
Know-How. INALCO hereby grants to CUMBERLAND, and CUMBERLAND hereby accepts, an
exclusive license to use the Know-How to the extent reasonably required by CUMBERLAND in
order to market, distribute, advertise, promote and sell the Product in the Territory in
accordance with and subject to the terms and conditions set forth herein. |
|
2.3 |
|
Trademarks. INALCO is negotiating the acquisition of the Kristalose Trademark from
Mylan Laboratories Inc. and this Agreement is conditional upon the successful acquisition of
the Kristalose Trademark. INALCO hereby grants to CUMBERLAND, and CUMBERLAND hereby accepts,
an exclusive license to use the Trademarks on the Product and in connection with the
marketing, advertisement, promotion, distribution and sale of the Product in the Territory
during the Term. In order to have authority to grant such license to CUMBERLAND, INALCO
agrees to obtain all rights to the Trademarks from Mylan Pharmaceuticals, Inc., prior to the
Effective Date hereof. |
|
2.4 |
|
Patent Rights. INALCO hereby grants to CUMBERLAND, and CUMBERLAND hereby accepts, an
exclusive license to the Patent Rights for purposes of marketing, distribution, and sale of
the Product in the Territory during the Term. |
|
2.5 |
|
Certain Responsibilities of INALCO. |
6
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A. |
|
Transition Plan. Prior to the Effective Date, INALCO will submit to
CUMBERLAND for consideration a transition plan for Mylan Pharmaceuticals Inc. (Mylan)
to transfer commercial responsibilities for the Product to CUMBERLAND, which plan will
include accurate and complete customer lists, customer data, customer contracts, and
market, financial and other information relating to the Product, as well as provisions
for transitioning Product inventory, Product returns and chargebacks processing,
government reporting, and regulatory reporting. The transition plan will also include
Mylans commitment to processing and payment of rebates, returns and chargebacks for
Product sold by Mylan. The transition plan shall also include Mylans commitment to
provide information necessary to comply with the CMS Medicaid Drug Rebate Program
Release Number 48, which requires that a termination date be supplied equal to the shelf
life of the last lot sold under the old NDC number, as well as pricing data extending
four (4) Calendar Quarters beyond the shelf life. The transition plan shall be finalized
after INALCO and CUMBERLAND agree to any amendments thereto, and in any event, the
parties hereto agree to finalize the transition plan on or before the thirtieth
(30th) day after the Effective Date. The transition plan shall be attached
hereto as Exhibit C when it is completed and shall be a part of this Agreement
effective as of the date thereof. INALCO shall complete all of its responsibilities
under the transition plan. At all times until such transition plan has been completed,
INALCO shall make best efforts to resolve any outstanding items in the transition plan
as promptly as possible. |
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|
B. |
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Exclusive Appointment. INALCO hereby appoints CUMBERLAND as exclusive
(even as to INALCO) distributor, marketer, advertiser, promoter, and seller of the
Product in the Territory during the Term. INALCO will not without
CUMBERLANDs prior written approval, itself promote, sell or distribute, nor
appoint nor allow any third party to promote, sell or distribute in the Territory any
presentation of the Product nor any product which competes with the Product; provided
that INALCO may make sales in the Territory of its liquid lactulose products in
existence as of the date hereof. INALCO will ensure that its Affiliates and licensees do
not supply the Products to any other party which it knows, or has reasonable grounds for
suspecting, will store, promote, sell or distribute the Products in or to the Territory. |
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C. |
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Maintenance of Patent Rights and Trademark. INALCO shall diligently
prosecute and maintain Patent Rights and the Trademarks at its own expense throughout
the Territory in accordance with Article 6. |
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D. |
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Supply of the Product. INALCO shall manufacture, package or have
packaged, and supply the Product to CUMBERLAND for resale during the Term. Except as
otherwise set forth in the transition plan pursuant to Section 2.5(A) for the first
one-hundred-twenty (120) days of the Term, INALCO shall manufacture, label, store, and
ship the Product with existing packaging from Mylan. At the end of one hundred twenty
(120) days or sooner pursuant to the written agreement of both parties hereto, INALCO
shall manufacture, label, store, and ship the Product with packaging designed by
CUMBERLAND. INALCO shall deliver the Product to CUMBERLAND in finished packages that
shall include the CUMBERLAND NDC number and logo. |
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E. |
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Provide Promotional Pouches. INALCO shall provide up to 1,000,000
promotional pouches of Product to CUMBERLAND per Year upon request at a price per pouch
as |
7
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set forth in Section 4.3 for Promotional Unit Payments. In the event that CUMBERLAND
identifies the need for additional promotional pouches in any given Year, the parties
agree to negotiate in good faith regarding the price and delivery of such additional
pouches. |
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F. |
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Product Specifications. INALCO shall manufacture all Product in
compliance with (i) the Product DMF as submitted to the FDA, (ii) the FDAs Good
Manufacturing Practices, as promulgated under the U.S. Food, Drug and Cosmetic Act, as
amended, (iii) the Abbreviated New Drug Application for the Product, (iv) the Patent
Rights, and (v) all other applicable Laws, requirements and regulations of the FDA or
other applicable Competent Authorities. In no event will INALCO implement any alteration
(that requires approval of the Competent Authority) to the materials or processes
described in the Drug Master File in relation to any of the Products supplied to
CUMBERLAND under this Agreement until INALCO has provided reasonable prior written
notice of such alteration to CUMBERLAND and the Competent Authority in the Territory has
approved all requisite amendments to the applicable Regulatory Approval. INALCO will not
change the Product Specifications during the Term without CUMBERLANDs prior written
consent. INALCO shall provide for or arrange on-site inspections of each of the
facilities related to manufacturing or packaging the Product at least one time per year
by authorized representatives of CUMBERLAND at any time during regular business hours
and shall provide all reasonably requested information to confirm that the Product is
manufactured and packaged in accordance with the Specifications. |
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G. |
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Fulfillment of Regulatory Requirements. INALCO shall maintain all
Regulatory Approvals for the Product required to enable the Product to be sold in the
Territory at its own expense. INALCO shall maintain and fulfill all applicable
regulatory requirements with respect to the Product, including reporting and
pharmacovigilance in the Territory, and shall fully cooperate with CUMBERLAND to fulfill
and meet all requirements imposed by applicable law. INALCO shall inform CUMBERLAND of
any governmental submissions relating to the Product. |
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H. |
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Adverse Events. INALCO shall promptly notify CUMBERLAND of any event that
materially affects or could materially affect the marketing of the Product. With respect
to adverse events, the parties hereto shall report such events to Competent Authorities
per Exhibit E, Adverse Event Reporting. |
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I. |
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Additional Markets. At any time during the Term, CUMBERLAND may notify
INALCO of its interest in distributing the Product in a country outside of the Territory
for which INALCO does not, as of the date of such notice, already have a distribution
arrangement in effect or pending, as evidenced by a fully executed letter of intent. For
up to ninety (90) days after providing such notice, the parties hereto shall negotiate
in good faith toward developing an agreement for marketing and distribution rights for
the Product in the relevant country(ies). |
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J. |
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Delivery of Product. INALCO shall deliver Product to Cumberland in a
timely manner and in compliance with specifications for the Product and its packaging in
accordance with Section 2.11, et seq. |
8
2.6 |
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Certain Responsibilities of CUMBERLAND. |
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A. |
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Marketing Plans. Within sixty (60) days after the Effective Date,
CUMBERLAND shall provide INALCO with a summary of marketing plans for the Product in
the Territory, including five (5) year sales forecasts. CUMBERLAND shall provide
updated marketing plans thereafter on an annual basis. |
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B. |
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Package Design. Except as otherwise set forth in Section 2.5(D),
CUMBERLAND, at its expense, shall design all labeling and exterior packaging to be
used on the Product. CUMBERLAND shall provide such package designs to INALCO within
thirty (30) days of the Effective Date. In the event of a change in the package design
for the Product, CUMBERLAND shall notify INALCO of the package design at least one
hundred fifty (150) days prior to its required use thereof. All labeling and packaging
designs for the Product must be in compliance with the rules and regulations of all
Competent Authorities. CUMBERLAND shall not implement any changes in labeling and
packaging for the Product unless CUMBERLAND has INALCOs prior written consent, not to
be unreasonably withheld or delayed. INALCO and CUMBERLAND agree to work together to
minimize cost increases related to packaging design changes. |
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C. |
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Purchase Orders. CUMBERLAND shall submit to INALCO a purchase order
setting forth the quantity of Product ordered, Delivery Date, destination, and any
other delivery instructions at least ninety (90) days in advance of its requested
Delivery Date for such purchase order. INALCO will respond to CUMBERLAND promptly
after receipt of any purchase order, and each such response shall (i) accept the
Delivery Date or (ii) reject the Delivery Date and propose an alternative Delivery
Date. When such a purchase order for Product is accepted in writing or by facsimile,
it shall become binding upon INALCO and CUMBERLAND, and shall not be changed or
cancelled by CUMBERLAND without written approval of INALCO. Such approval shall not be
unreasonably withheld or delayed. |
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D. |
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Rolling Forecasts. Within thirty (30) days after the Effective Date,
and every thirty (30) days thereafter, CUMBERLAND shall complete and provide INALCO a
twelve (12) month rolling forecast of its projected monthly purchases of the Product
and shall adjust them thereafter on a monthly basis. |
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E. |
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Minimum Purchases. CUMBERLAND agrees to meet Minimum Purchases
annually in accordance with Exhibit A. |
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F. |
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Sales Reports. Within thirty (30) days after each month in which
CUMBERLAND sells any Product to a third party, CUMBERLAND shall prepare and provide
INALCO with a monthly sales report for the Product. |
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G. |
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Compliance. CUMBERLAND shall market, distribute, and sell the Product
in the Territory in accordance with applicable Laws. |
9
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H. |
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Adverse Drug Experiences. CUMBERLAND shall provide reasonable
cooperation and assistance to INALCO in the investigation of complaints and adverse
events with respect to the Product (see Exhibit E). Each party will bear its
own expenses associated with its duties set forth in Exhibit E. |
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I. |
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Interaction with DDMAC. CUMBERLAND shall be responsible for
interacting with the FDA Division of Drug Marketing, Advertising and Communication
regarding the Product. |
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J. |
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Formulary Listings. CUMBERLAND shall be responsible for filing and
maintaining Listings to obtain formulary listing approval from states or localities in
the Territory. |
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K. |
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Rebate and Managed Care Programs. CUMBERLAND shall have administrative
responsibility for the Product in any rebate and managed care programs through which
the Product is made available in the Territory. |
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L. |
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Product Returns. CUMBERLAND shall be responsible for administering
returns, discounts, and chargebacks involving third-party purchasers of the Product
during the Term in the Territory. |
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M. |
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Non-Compete Obligation. CUMBERLAND will not without INALCOs prior
written approval, itself promote, sell or distribute in the Territory during the Term
hereof, any laxative product which competes with the Product. |
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N. |
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Inspections. CUMBERLAND shall provide for or arrange on-site
inspections of all facilities related to the storage and distribution of the Product
at least one time per year by authorized representatives of INALCO at any time during
regular business hours and shall provide all reasonably requested information to
confirm that the Product is stored, handled, and distributed in accordance with all
applicable rules and regulations of Competent Authorities. |
2.7 |
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Certain Responsibilities of Both Parties. |
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A. |
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Insurance. Beginning on the Effective Date, both CUMBERLAND and INALCO
shall have in place, and shall maintain during the Term and until the third
anniversary of the expiration or earlier termination of this Agreement, comprehensive
product liability insurance in amounts not less than $5,000,000 U.S. per incident and
$5,000,000 U.S. annual aggregate. The minimum amounts of insurance coverage required
shall not be construed to create or limit CUMBERLANDs or INALCOs liability with
respect to its indemnification under this Agreement. Both INALCO and CUMBERLAND shall
provide evidence of insurance to one another on or within thirty (30) days after the
Effective Date and each anniversary date thereof. |
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B. |
|
Publicity. Either party may issue a press release or other public
announcement relating to the existence or terms of this Agreement, subject to the
prior review and written approval of the other party, which approval shall not be
unreasonably withheld or delayed; except where required by Law, in which event the
parties |
10
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|
|
will use all reasonable efforts to consult with each other and cooperate with
respect to the wording of any such announcement. The parties shall cooperate in
issuing (an) initial public release(s) with respect to the signing of this
Agreement, either separately or as a joint release. |
|
|
C. |
|
Recalls: |
|
(i) |
|
If either party determines that any quantity of the Product
should be recalled for any reason, that party will give to the other party
written notice of its intention to recall that quantity and specify its
reasons. |
|
|
(ii) |
|
If within three (3) days of the receipt of the notice the
parties are unable to agree upon the need to carry out the recall, the parties
agree to submit a sample of the Product to an Independent Analyst for a
report. |
|
|
(iii) |
|
The costs of the report of the Independent Analyst and of the
recall will be paid by the party against which the report is unfavourable. |
|
|
(iv) |
|
Notwithstanding paragraphs (i) to (iii), CUMBERLAND will
administer any such recall in the Territory. |
|
|
(v) |
|
Any Product recall initiated by a Competent Authority due to
the negligence or breach of warranty by a party hereto shall be the
responsibility of such party at its sole cost. |
|
|
(vi) |
|
Each of CUMBERLAND and INALCO agrees to comply with the
obligations set forth in Exhibit E with respect to any adverse drug
event (as defined therein) or any similar event described in Exhibit E
for the Product. |
|
|
(vii) |
|
If a recall results from a cause other than 2.7C (v), then
INALCO and CUMBERLAND will share equally all out-of-pocket costs to administer
the recall. |
2.8 |
|
Subcontractors. CUMBERLAND may make such arrangements with Subsidiaries, Affiliates
or Third Persons as it, in its reasonable judgment, believes is necessary to assure the
diligent and adequate registration, approval, release testing (if applicable), distribution
and sale of the Product in the Territory. Any such Third Persons or Affiliates or
Subsidiaries engaged by CUMBERLAND shall be referred to as Subcontractors. |
|
2.9 |
|
Delivery: |
|
A. |
|
Prior to shipping, INALCO will submit to CUMBERLAND appropriate shipment
notification documents for signature and approval to ship. These documents shall
include CUMBERLANDs Approval to Ship form, packing slip, Certificate of Analysis, and
any required FDA shipment notification. |
11
|
B. |
|
Following receipt of CUMBERLAND approval to ship, INALCO will deliver the
Products to CUMBERLAND F.O.B. the facility of INALCOs packager, which facility shall
be located in the U.S. or Canada unless otherwise agreed in writing by INALCO and
CUMBERLAND, to such location in the Territory as is designated by CUMBERLAND in the
applicable purchase order. |
|
|
C. |
|
All risk of loss or of damage to, and title to the Product, will pass to
CUMBERLAND upon delivery of the Products to the, freight company specified by
CUMBERLAND in the purchase order in accordance with the terms of Article 2 of this
Agreement. |
|
|
D. |
|
CUMBERLAND shall be responsible for all costs of transportation from the
facility of INALCOs packager to the location in the Territory as designated by
CUMBERLAND in the applicable purchase order, except that INALCO shall be responsible
for any costs associated with Customs Clearance at an international border (including
but not limited to brokers fees, import duties, taxes, permits, and licenses). |
2.10 |
|
Acceptance of the Products: |
|
A. |
|
INALCO will supply a Certificate of Analysis with each delivery of the
Products. |
|
|
B. |
|
If CUMBERLAND does not notify INALCO in accordance with the following
paragraph, then CUMBERLAND will, for the purposes of this Section 2.10 only, be deemed
to have accepted the Products upon the expiration of the thirty (30) day period
referred to in that paragraph. |
|
|
C. |
|
If CUMBERLAND notifies INALCO within thirty (30) days of the receipt of any
shipment of the Product that CUMBERLAND believes any of the Product does not conform
to the warranty set out in Section 2.11 (Defective Product) the parties agree to
consult with each other in order to resolve the issue (during which time INALCO may
conduct its own retention sample testing). If such consultation does not resolve the
discrepancy within a further thirty (30) days from receipt of the notice, the parties
agree to nominate an Independent Analyst within the Territory, acceptable to both
parties, that will carry out tests on representative samples taken from such shipment,
and the results of such tests will be binding on the parties. |
|
|
D. |
|
If the Independent Analyst determines that the Defective Product does not
conform to the warranty set out in Section 2.11: |
|
(i) |
|
INALCO will, at its expense, replace any such Defective Product
and reimburse CUMBERLAND for the costs of the Independent Analyst; and |
|
|
(ii) |
|
all quantities of Defective Product will, at INALCOs election and
expense be either: |
|
a. |
|
returned to INALCO, and packed and shipped
according to |
12
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|
|
instructions provided by INALCO; or |
|
|
b. |
|
destroyed by CUMBERLAND under INALCOs direction. |
|
E. |
|
If the Independent Analyst determines that the Defective Product does conform
to the warranty set out in Section 2.11, CUMBERLAND will for the purposes of Section
2:10 only, be deemed to have accepted the Product and will reimburse INALCO for the
costs of the Independent Analyst. |
|
|
F. |
|
Replacement of Defective Product is in addition to any other obligations,
indemnities or warranties given by INALCO under this Agreement. |
|
A. |
|
INALCO represents and warrants that: |
|
(i) |
|
any Product supplied under this Agreement will, upon delivery
to CUMBERLAND, have a shelf life of at least two (2) years nine (9) months; |
|
|
(ii) |
|
any Product supplied under this Agreement will upon delivery: |
|
a. |
|
conform in all respects to the Product
Specifications and to any applicable Regulatory Approval in the
Territory; |
|
|
b. |
|
be manufactured, identically labelled and
identically packaged for the Territory and tested in accordance with
applicable laws and regulations in the Territory relating to the
manufacture, labelling, packaging and testing of the Product, subject
to any alterations required by law or applicable regulations; and |
|
|
c. |
|
will not be adulterated or misbranded in
contravention of applicable Law; |
|
(iii) |
|
it will, at its expense, apply for, prosecute, maintain,
defend and enforce the Trademarks, the Patent Rights, and any Intellectual
Property Rights concerning the Product which are owned by or licensed to it to
the maximum extent commercially feasible and will also apply for any
appropriate extension of term for any patents covering the Product in
accordance with the laws and regulations in the Territory. |
|
(i) |
|
Any quantities of the Product that do not conform with Section
2.11(A) or that contravene applicable Law, regulations, or Regulatory approvals
will, for the purposes of this Agreement, be deemed to have a defect. |
|
|
(ii) |
|
If either party becomes aware of any defect in the Product, it
will immediately notify the other party and provide it with a full disclosure
of
that defect. |
13
|
(iii) |
|
Where any defect in the Product arises either partially or
wholly as a result of a defect in raw material supplied to INALCO by a third
party, INALCO will make best efforts to ensure that the third party conforms to
any demands of the Competent Authority concerning the defect. |
|
|
(iv) |
|
Except as otherwise set forth in this Agreement,
INALCOs remedy for breach of warranty pertaining to the Product
provided hereunder shall be limited solely to replacement of such Product. |
|
C. |
|
UNLESS OTHERWISE EXPRESSLY STATED IN THIS AGREEMENT, NEITHER PARTY SHALL BE
LIABLE FOR INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, IRRESPECTIVE OF WHETHER
ATTRIBUTABLE TO CONTRACT, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE. |
3. TERM AND TERMINATION
|
A. |
|
Condition for Commencement of Term. Notwithstanding any other provision
hereof, the commencement of the Term is subject to the satisfaction as of the Effective
Date of the following conditions: (i) the termination of any letter agreements
currently in effect between Mylan Bertek Pharmaceuticals Inc. (f/k/a Bertek
Pharmaceuticals Inc.) (Mylan Bertek) and CUMBERLAND (the Letter Agreements), and
(ii) the full and final mutual release of Mylan Bertek and Mylan by CUMBERLAND and of
CUMBERLAND by Mylan Bertek and Mylan for any and all obligations and/or liabilities in
connection with the Co-Promotion Agreement between CUMBERLAND and Mylan Bertek dated
January 4, 2002, as amended (the Co-Promotion Agreement), and the Letter Agreements;
provided that the sections listed as surviving provisions in Section 11.6 of the
Co-Promotion Agreement survive the termination and release set forth hereinabove. |
|
|
B. |
|
Duration. This Agreement shall commence on the Effective Date and will
continue until the fifteenth (15h) anniversary thereof. Thereafter, subject
to Section 3.2 hereof, the Agreement will automatically renew for successive terms of
three (3) years unless either party gives written notice of its intention not to renew
this Agreement to the other party at least twelve (12) months prior to the expiration
of the period. |
3.2 |
|
Termination. This Agreement may be terminated prior to expiration of the Term under
the following circumstances: |
|
A. |
|
Material Breach. In the event that one party commits a material breach
of this Agreement, the non-breaching party may, at its option, terminate this Agreement
by giving the breaching party written notice pursuant to Section 8.2 of its election |
14
|
|
|
to terminate as of a stated date, but not less than forty-five (45) days from the
date of the notice. Such notice shall state the nature of the breach claimed by the
non-breaching party. The breaching party, during said forty-five (45) day period or
such longer period as may be indicated by the other, may correct any breach stated
in said notice and if such breach is corrected, this Agreement shall continue in
full force and effect as if such notice had not been given. If the breaching party
does not cure the breach to the reasonable satisfaction of the notifying party
within said forty-five (45) day period, or such longer period indicated by the
non-breaching party, then the notifying party may terminate this Agreement. For
purposes hereof, material breach shall mean failure by CUMBERLAND to comply with
any of its obligations under Sections 2.6(G), 2.6(M), 4.1, 4.2, or 4.3 hereunder or
failure by INALCO to comply with any of its obligations under Section 2.5(B),(C),
(D), (F), and (G). |
|
|
B. |
|
Anniversary. If CUMBERLAND gives INALCO written notice at least ninety
(90) days prior to the fourth anniversary of the Effective Date or any subsequent such
anniversary during the Term, CUMBERLAND may terminate the Agreement on the day
immediately preceding such anniversary date without any further liability except as
expressly set forth herein. Notwithstanding the foregoing, in no event shall
termination under this Section 3.2.B. terminate or modify CUMBERLANDs obligations to
make the payments set forth in Section 4.1. |
3.3 |
|
Effect of Expiration or Termination. Upon expiration or termination of this
Agreement, |
|
A. |
|
CUMBERLAND shall cease the sale of all Product for the Territory; provided,
however, that CUMBERLAND may continue to store, promote, sell and distribute its stock
on hand and fill all orders accepted by it prior to the expiration or termination of
the Agreement. INALCO will fill all orders accepted by INALCO hereunder prior to
expiration or termination of the Agreement. All applicable provisions of this
Agreement shall survive termination for such purpose; and |
|
|
B. |
|
all rights, title and interest in and to the Product and the Intellectual
Property Rights in the Product and the Know-How and the Patent Rights and the
Trademarks that INALCO owned prior to this Agreement shall revert to INALCO. |
3.4 |
|
Remedies Not Limited. Except as otherwise provided herein, the termination of this
Agreement by either party shall not limit remedies that may be otherwise available, including
without limitation, injunctive relief. |
|
3.5 |
|
Survival. Expiration or termination of this Agreement for any reason shall not
relieve either party of its obligations that have accrued prior to the expiration or
termination of this Agreement. Without limiting the generality of the foregoing, Sections
2.11, 5.1, 5.2, and 5.3 and Article 3 of this Agreement shall survive expiration or
termination of this Agreement. |
15
3.6 |
|
Expectation of Profits. Except as otherwise provided herein, both parties
acknowledge and agree that they have no expectations and have received no assurances that any
investment by them in the development, marketing or distribution of the Product will be
recovered or recouped, or that they shall obtain any anticipated amount of profit by virtue
of this Agreement. |
|
3.7 |
|
Option Regarding Transfer. CUMBERLAND shall have the first opportunity to negotiate
to acquire all rights to the Product in the Territory. Each party hereto shall negotiate in
good faith if the parties undertake discussions regarding such option. INALCO agrees not to
transfer any rights to the Product in the Territory unless INALCO first notifies CUMBERLAND
of the opportunity hereunder and unless INALCO negotiates in good faith with CUMBERLAND for
sixty (60) days after providing such notice in an attempt to enter into a written agreement
with respect to the rights that are being negotiated. |
4. PAYMENTS
4.1 |
|
Payments. Subject to the terms and conditions contained in this Agreement, in
consideration for rights granted to CUMBERLAND hereunder, CUMBERLAND shall pay Eleven Million
Dollars to INALCO in the following installments: |
|
A. |
|
First Installment. Six Million Five Hundred Thousand
U.S. Dollars ($6,500,000 U.S.), payable upon the Effective Date of this
Agreement; |
|
|
B. |
|
Second Installment. One Million Five Hundred Thousand
U.S. Dollars ($1,500,000 U.S.), payable upon the first anniversary of the
Effective Date of this Agreement; and |
|
|
C. |
|
Third Installment. Three Million U.S. Dollars
($3,000,000 U.S.), payable upon the third anniversary of the
Effective Date of this Agreement. |
4.2 |
|
Royalty Payment. In further consideration of the rights granted to CUMBERLAND
hereunder, CUMBERLAND shall pay INALCO an amount equal to the following percentage of Net
Sales during the preceding [***] (each such payment shall hereinafter be referred to as a
Royalty Payment), within [***] of the end of each [***]: |
|
A. |
|
[***] during first Year of the Term; |
|
|
B. |
|
[***] during each of the second, third, and fourth Years of the Term; and |
|
|
C. |
|
[***] for each Year thereafter during the Term; |
|
|
provided that the accrual of any obligation to make Royalty Payments shall cease immediately
with respect to Net Sales in a country within the Territory if a generic equivalent to the
Product receives Regulatory Approval, and is commercially available in such country. |
|
4.3 |
|
Payment for Product. Subject to Section 2.10, CUMBERLAND shall pay INALCO, |
16
|
|
within [***] of receipt of Product under Section 2.5(D) during the first year of the Term,
and within [***] of receipt of Product thereafter, (a) an amount equal to [***] 10-gram
pouch and [***] per 20-gram pouch for each unit of Product supplied pursuant to purchase
orders submitted in accordance with Section 2.6(C) (Product Payments), and (b) an amount
equal to [***] per pouch for each 10-gram pouch and [***] per pouch for each 20-gram pouch
of Product pursuant to requests for promotional units submitted in accordance with Section
2.5(E) (Promotional Unit Payments). |
|
|
|
[***] |
|
|
|
Promotional Unit Prices are based upon a packaging configuration and cost that is
equivalent to the existing 30-count Commercial and/or 7-count Sample. If a new Sample
package configuration is required, then INALCO has the right to adjust the per pouch
price to reflect any increased direct costs incurred with such reconfiguration. Promotional
Units will be ordered under a unique Purchase Order Number, and such orders are subject to
the terms of Paragraph 2.6C. |
|
4.4 |
|
Payment Currency. All payments under Article 4
hereof shall be made in U.S. dollars. |
|
4.5 |
|
Records. CUMBERLAND shall maintain complete and accurate records sufficient to
enable accurate calculation of Royalty Payments due to INALCO under this Agreement.
CUMBERLAND shall, at INALCOs request and expense, provide certified statements from
CUMBERLANDs auditors, concerning Royalty Payments due pursuant to this Agreement. Once a
calendar year, INALCO shall have the right to request that a certified public accountant, the
selection of whom shall be subject to CUMBERLANDs prior written consent, not to be
unreasonably withheld or delayed, inspect, on reasonable notice and during regular business
hours, the records of CUMBERLAND to verify INALCOs statements and payments of Royalty
Payments due pursuant to this Agreement. The entire cost for such inspection shall be borne
by INALCO, unless there is a discrepancy of greater than 5% in INALCOs favor, in which case
CUMBERLAND shall bear the entire cost of the inspection. Records shall be preserved by
CUMBERLAND for three (3) years after preparation thereof for inspection by INALCO. |
|
4.6 |
|
Acquisition. In the event that INALCO or CUMBERLAND is acquired by a Third Person or
in any other way transfers all of its assets, including this Agreement to a Third Person, all
obligations of this Agreement, including the foregoing Royalty Payment terms, shall be binding
upon the party acquiring this Agreement. |
|
4.7 |
|
Manner of Payment. All payments hereunder shall be made by bank wire transfer of
immediately available funds to the account of INALCO or such other reasonable method as INALCO
may request. Each party hereto shall be responsible for and pay all fees and other charges
imposed by its own bank in connection with any such bank wire transfer. Where required to do
so by Law, CUMBERLAND shall withhold taxes required to be paid to a taxing authority on
account of such income to INALCO, and CUMBERLAND shall furnish INALCO with satisfactory
evidence of such withholding and payment in order to permit INALCO to obtain a tax credit or
other relief as may be available under the Law. |
17
5. CONFIDENTIALITY
5.1 |
|
Protection of Confidential Information. The parties recognize that during the Term,
it may be necessary that one party and/or its Affiliates or Subsidiaries hereto be given
access to certain Confidential Information (as defined herein) of the other party and/or its
Affiliates or Subsidiaries hereto. Each party must ensure that the following Subsections shall
be applicable to such Confidential Information and the words Recipient and Disclosing
Party shall be interchangeable as between each of the parties and/or their Affiliates or
Subsidiaries hereto as appropriate under the circumstances: |
|
A. |
|
Title to Confidential Information and Related Documents. Recipient
hereby acknowledges that the Confidential Information and all, including without
limitation, related documents, drawings, designs, products, or samples disclosed or
furnished hereunder by or on behalf of the Recipient are the sole and exclusive
property of Disclosing Party. Recipient hereby agrees to return all such documents,
drawings, designs, products, or samples furnished to it hereunder, together with all
reproductions and copies thereof and shall delete all references thereto stored
electronically promptly under the request of Disclosing Party or upon termination or
expiration of this Agreement, except that the Recipients legal representative may
retain one copy of such of the Confidential Information as required solely for the
purpose of determining the scope of its obligations under this Agreement. |
|
|
B. |
|
Nondisclosure or Use of Confidential Information. Recipient hereby
agrees that it shall hold all Confidential Information disclosed to it in strict
confidence and in a secure place, that it will use the same only for the purpose of
performing this Agreement and for no other purpose whatsoever, and that it will not
disclose the same to any Third Persons (except to its employees or consultants,
strictly on a need-to-know basis, to the extent such disclosure is permitted by or
consistent with this Agreement and the Third Persons are subject to written obligations
of confidentiality no less onerous than are contained in this Agreement) except to the
extent Disclosing Party agrees to it in writing. |
|
|
C. |
|
Definition of Confidential Information. Confidential Information as
used herein shall include without limitation any and all oral, written, or tangible
proprietary or confidential ideas, inventions, information, data, plans, materials,
trade secrets and know-how and the like owned, controlled or developed by or on behalf
of one party hereto and disclosed to the other party for the purposes of this
Agreement; provided however, that Confidential Information shall not include any
information, discovery, invention, improvement, or innovation which: |
|
(i) |
|
was in the public domain at the time of disclosure to the
Recipient, or which becomes generally available to the public after its
disclosure through no fault of the Recipient or breach of this Agreement; |
18
|
(ii) |
|
is already known to, or in the possession of, the Recipient
prior to disclosure by the Disclosing Party as can be demonstrated by
documentary evidence; |
|
|
(iii) |
|
is lawfully disclosed on a non-confidential basis from a
Third Person having the right to make such a disclosure; or |
|
|
(iv) |
|
is independently developed by the Recipient or its
Subsidiaries as can be demonstrated by documentary evidence. |
5.2 |
|
Unauthorized Use. In case either party becomes aware or has knowledge of any
unauthorized use or disclosure of Confidential Information, it shall promptly notify the
other party of such unauthorized use or disclosure and, thereafter, shall take all reasonable
steps to assist the other party in attempting to minimize any potential or actual damages or
losses resulting from such unauthorized use or disclosure. |
|
5.3 |
|
Permitted Disclosure. Each party may disclose Confidential Information of the other
party to the Competent Authorities or Listing authorities in the Territory where such
disclosure is reasonably necessary in the application, grant, variation, renewal or
maintenance of a Regulatory Approval or Listing. Each party may also disclose Confidential
Information where it is required to do so under any laws or regulations in the Territory,
provided that it gives the other party such notice as is reasonably practicable in the
circumstances and allows the other party, at the other partys cost, a reasonable opportunity
to resist such requirements. |
|
5.4 |
|
Term. The provisions of this Article 5 shall survive the expiration or termination
of the Agreement until all of the Confidential Information has fallen within one of the
exceptions set forth in Sections 5.I(C) (i) through (iv), inclusive. |
6. PROTECTION AND OWNERSHIP OF INTELLECTUAL PROPERTY
6.1 |
|
Registration of Trademarks. INALCO shall be responsible, at its expense, for the
preparation, filing, prosecution and maintenance of the Trademarks in the Territory and for
conducting any interferences, re-examinations, reissues, oppositions, or requests for
extension relating thereto. INALCO shall take all steps necessary to maintain the Trademarks
in the Territory in good standing. INALCO shall not use any alternative trademark in the
Territory on or in connection with the Product. Subject to Section 3.3(A), upon the
termination or expiration of this Agreement or CUMBERLANDs right to use the Trademarks,
CUMBERLAND shall cease using the Trademarks. |
|
6.2 |
|
Patent Filings: Maintenance; Prosecution. INALCO shall be responsible, at its
expense, for the preparation, filing, prosecution and maintenance of the Patent Rights in the
Territory and for conducting any interferences, re-examinations, reissues, oppositions, or
requests for extension relating thereto. INALCO shall take all steps necessary to maintain
the Patent Rights in the Territory in good standing. CUMBERLAND agrees to cooperate
reasonably with INALCO, at INALCOs expense, when requested, on matters relating to the
preparation, filing, prosecution and maintenance of the Patent Rights. |
19
6.3 |
|
Infringement by Third Persons. |
|
A. |
|
In the event that either party determines that a Third Person is making,
using, or selling a product that may infringe the Patent Rights or Trademark, it will
promptly notify the other party in writing. INALCO will, at its own cost and to the
extent commercially feasible, take all legal action it deems necessary or advisable to
eliminate or minimize the consequences of the infringement, but will not without
CUMBERLANDs prior written consent enter into any settlement in relation to such
matters nor take any step in relation to the potential or alleged infringement which
will affect CUMBERLANDs storage, promotion, sale and distribution of the Product in
the Territory or other rights under this Agreement. CUMBERLAND shall take all
reasonable steps to assist INALCO at INALCOs expense. |
|
|
B. |
|
Upon receiving any written request from CUMBERLAND to do so, INALCO will
forthwith disclose to CUMBERLAND all necessary information about the Products, their
formulation, use or process of manufacture, to enable CUMBERLAND to: |
|
(i) |
|
ascertain whether the storage, promotion, sale or other
distribution of the Products in the Territory will infringe any existing
patent or other third party intellectual property rights; and |
|
|
(ii) |
|
determine its conduct in relation to any proceedings alleging
infringement of a patent or other third party intellectual property rights in
the Territory. |
|
C. |
|
INALCO represents and warrants that any information disclosed to CUMBERLAND
under paragraph (B) above will be a full and accurate disclosure and that INALCO will
not withhold any information in its possession which might have a material adverse
impact on CUMBERLAND. |
|
|
D. |
|
If INALCO does not take any action to eliminate or minimize the consequences
of any such infringement within ninety (90) days of becoming aware of that
infringement, CUMBERLAND may take any reasonable action to prosecute such
infringement; provided that CUMBERLAND shall not retain legal counsel to prosecute any
such infringement without INALCOs prior written consent, not to be unreasonably
withheld or delayed. In the event that legal counsel is so retained, INALCO shall
reimburse CUMBERLAND for such counsels reasonable fees and expenses directly related
to the prosecution of such infringement. |
|
|
E. |
|
Each party will cooperate fully and promptly with, and provide all reasonable
assistance to, the other party in respect of any action brought by the other party
under this Agreement in relation to alleged infringement of intellectual property
rights in connection with this Agreement and will be entitled to be promptly
reimbursed for all costs and expenses incurred in connection with such co-
operation and assistance. |
20
7. REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION
7.1 |
|
Representations and Warranties of CUMBERLAND. CUMBERLAND represents and warrants
that: |
|
A. |
|
it is a corporation duly organized and validly existing under the laws of
Tennessee; |
|
|
B. |
|
the execution and delivery by CUMBERLAND of this Agreement, the performance by
CUMBERLAND of all the terms and conditions thereof to be performed by it and the
consummation of the transactions contemplated hereby have been duly authorized by all
necessary action, and no other act or approval of any person or entity is required to
authorize such execution, delivery, and performance; |
|
|
C. |
|
the Agreement constitutes a valid and binding obligation of CUMBERLAND,
enforceable in accordance with its terms; and |
|
|
D. |
|
this Agreement and the execution and delivery thereof by CUMBERLAND, does not,
and the fulfillment and compliance with the terms and conditions hereof and the
consummation of the transactions contemplated hereby will not: |
|
(i) |
|
conflict with any of, or require the consent of any person or
entity under, the terms, conditions, or provisions of the organizational
documents of CUMBERLAND; |
|
|
(ii) |
|
violate any provision of, or require any consent,
authorization, or approval under, any Law applicable to CUMBERLAND; or |
|
|
(iii) |
|
conflict with, result in a breach of, or constitute a default
under, any material agreement or obligation to which CUMBERLAND is a party. |
7.2 |
|
Representations and Warranties of INALCO. INALCO ITALY and INALCO U.S. jointly and
severally represent and warrant that: |
|
A. |
|
INALCO U.S. is a corporation duly organized and validly existing under the
laws of California and INALCO ITALY is a corporation duly organized and validly
existing under the laws of Italy and; |
|
|
B. |
|
the execution and delivery by INALCO of this Agreement, the performance by
INALCO of all the terms and conditions thereof to be performed by it and the
consummation of the transactions contemplated hereby have been duly authorized by all
necessary action, and no other act or approval of any person or entity is required to
authorize such execution, delivery, and performance; |
21
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C. |
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the Agreement constitutes a valid and binding obligation by each of INALCO
ITALY and INALCO U.S., enforceable in accordance with its terms; and |
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D. |
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this Agreement and the execution and delivery thereof by INALCO, does not, and
the fulfillment and compliance with the terms and conditions hereof and the
consummation of the transactions contemplated hereby will not: |
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(i) |
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conflict with any of, or require the consent of any person or
entity under, the terms, conditions, or provisions of the organizational
documents of INALCO; |
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(ii) |
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violate any provision of, or require any consent,
authorization, or approval under, any Law applicable to INALCO; or |
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(iii) |
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conflict with, result in a breach of, or constitute a default
under, any material agreement or obligation to which INALCO is a party. |
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E. |
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the manufacture, storage, promotion, sale or other distribution of the Product
in the Territory will not infringe any patent (whether in relation to the Products,
their formulation, use or process of manufacture) or infringe upon any other rights of
a Third Person; |
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F. |
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as of the Effective Date, INALCO has not received any notice of opposition,
interference, or refusal to register in connection with the Patent Rights in the
Territory or elsewhere; |
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G. |
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as of the Effective Date, INALCO holds, and shall continue to hold for the
duration of the Term, valid rights to the Patent Rights and all other Intellectual
Property Rights relating to the Product and has the full right, power and authority to
grant the rights granted to CUMBERLAND hereunder, free and clear of any mortgage, lien,
encumbrance or other Third Person interest of any kind; |
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H. |
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INALCO has licensed to CUMBERLAND all Intellectual Property Rights necessary
for CUMBERLAND to perform its obligations under this Agreement; |
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I. |
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INALCO has not granted to any other Person in the Territory the rights it is
granting to CUMBERLAND hereunder in respect of the Product; |
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J. |
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INALCO has informed CUMBERLAND about all information in its possession or
control concerning the safety and efficacy of the Product, and any side effects,
injury, toxicity or sensitivity reactions and incidents associated with all uses,
studies, investigations or tests involving the Product (animal or human) throughout the
world; |
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K. |
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as of the Effective Date of this Agreement, INALCO is not aware of any facts
that would reasonably lead it to conclude that the Product will be unable to maintain
Regulatory Approval in the Territory or that would indicate that future |
22
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marketing and sales of the Product in the Territory may be adversely affected in any
material respect; and |
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L. |
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no representations, warranties or covenants made by INALCO in this Agreement or
in any document, certificate, exhibit, or schedule furnished or to be furnished in
connection with the transactions contemplated hereby, contain or will contain, to the
best of INALCOs knowledge, any untrue statement of fact or omit or will omit to state
any material fact necessary to make the statement of facts contained therein not
misleading to the best of INALCOs knowledge. |
7.3 |
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Indemnification by CUMBERLAND. Without affecting any other remedies and recourses
available under this Agreement, under law and in equity, CUMBERLAND shall indemnify INALCO
and its Affiliates and Subsidiaries, and their respective directors, officers, and employees,
from and against claims, suits or demands for liability, damages, costs and expenses
(including reasonable attorney fees) arising from or relating to (i) the negligence or
willful misconduct of CUMBERLAND or its Affiliates or its Subsidiaries, or their respective
directors, shareholders, officers or employees in connection with this Agreement, or (ii) any
breach by CUMBERLAND of any of its representations and warranties provided for in Section
7.1; except to the extent that such claims, suits or demands are the result of the fault,
negligence or willful misconduct of INALCO and/or its Affiliates and/or its Subsidiaries, or
their respective directors, shareholders, officers or employees. |
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7.4 |
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Indemnification by INALCO. Without affecting any other remedies and recourses
available under this Agreement, under law and in equity, INALCO shall indemnify CUMBERLAND
and its Affiliates and Subsidiaries, and their respective directors, officers, and employees
from and against claims, suits or demands for liability, damages, costs and expenses
(including reasonable attorney fees) arising from or relating to (i) the negligence or
willful misconduct of INALCO or its Affiliates or Subsidiaries, or their respective
directors, shareholders, officers or employees in connection with this Agreement; or (ii) any
breach by INALCO of any of its representations and warranties provided for in Sections
2.5(F), 2.11 and 7.2 hereof ; (iii) the export, storage, promotion, sale or other
distribution of the Product in the Territory (including the packaging of the Product and
associated promotional and like material provided by or on behalf of INALCO, if any) will not
infringe any patent (whether in relation to the Products, their formulation, use or process
of manufacture) or infringe upon any other rights of a Third Person; except to the extent
that such claims, suits or demands are the result of the fault, negligence or willful
misconduct of CUMBERLAND or its directors, shareholders, officers or employees. |
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7.5 |
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Indemnification Procedures. A party (the Indemnitee) which intends to claim
indemnification under this Article 7 shall promptly notify the other party (the Indemnitor)
in writing of the claim, suit or demand for liability with respect to which the claim of
indemnification relates. If the Indemnitor wishes to assume the defense it must notify the
Indemnitee within sixty (60) days of receipt of such notice. Legal counsel of the Indemnitor
must be reasonably satisfactory to the Indemnitee. The Indemnitee shall permit, and shall
cause its employees and agents to permit the Indemnitor, at its discretion, to settle any
such claim, suit or demand for liability, the |
23
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defense and settlement of which shall be under the complete control of the Indemnitor;
provided, however, that such settlement shall not adversely affect the Indemnitees rights
hereunder or impose any obligations on the Indemnitee in addition to those set forth herein
in order for it to exercise those rights. No such claim, suit or demand for liability shall
be settled without the prior written consent of the Indemnitee and the Indemnitee shall not
be responsible for any legal fees or other costs incurred other than as provided herein.
The Indemnitee, its employees and agents shall co-operate fully with the Indemnitor and its
legal representatives in the investigation and defense of any claim, suit or demand for
liability covered by this indemnification. The Indemnitee shall have the right, but not the
obligation, to be represented by counsel of its own selection and expense. |
8. GENERAL
8.1 |
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Provisions Contrary to Law. In performing this Agreement, the parties shall comply
with all applicable Laws. In particular, it is understood and acknowledged that the transfer
of certain commodities and technical data is subject to U.S. Laws controlling the export of
such commodities and technical data, including all Export Administration Regulations of the
United States Department of Commerce. These Laws among other things prohibit or require a
license for the export of certain types of technical data to certain specified countries.
CUMBERLAND hereby agrees to do all things reasonably requested of it by INALCO to comply with
all U.S. Laws controlling the export of commodities and technical data. |
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Nothing in this Agreement shall be construed so as to require the violation of any Law, and
wherever there is any conflict between any provision of this Agreement and any Law, the Law
shall prevail, but in such event the affected provision of this Agreement shall be affected
only to the extent necessary to bring it within the applicable Law. |
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8.2 |
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Notices. Any notice permitted or required by this Agreement may be sent by facsimile
with the original document being sent by certified (or registered) mail, return receipt
requested, or overnight delivery and shall be effective when received (or refused) via
facsimile or mail or overnight if faxed and sent and addressed as follows (or to such other
facsimile number or address as may be designated by a party in writing): |
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If to CUMBERLAND:
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If to INALCO U.S.: |
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Cumberland Pharmaceuticals Inc.
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Inalco Biochemicals, Inc. |
2525 West End Ave., Suite 950
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3440 Empresa Drive, Suite A |
Nashville, Tennessee 37203
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San Luis Obispo, CA 93401 |
Fax: 615-255-0094
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Fax: 805-782-0719 |
Attn: Chief Executive Officer
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Attn: Eric A. Lowe |
With a copy to:
24
Adams and Reese/Stokes Bartholomew LLP
424 Church Street, 28th Floor
Nashville, Tennessee 37219
Fax: 615-259-1470
Attn: Martin S. Brown, Esq.
If to INALCO ITALY:
Inalco S.p.A.
Via Calabiana, 18
20139 Milan
ITALY
Fax: 011-39-02-55213277
Attn: Giovanni Cipolletti
Such notice shall be effective upon the earlier of (i) actual receipt by the party to whom notice
is sent, (ii) seven (7) days after deposit into the mail, or (iii) receipt of fax-back confirmation
if notice is sent via facsimile.
8.3 |
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Force Majeure. Neither party to this Agreement shall be liable for delay or failure
in the performance of any of its obligations hereunder if such delay or failure is due to
causes beyond its reasonable control, including, without limitation, acts of God, fires,
earthquakes, strikes and labor disputes, acts of war, civil unrest, or intervention of any
governmental authority, but any such delay or failure shall be notified to the other party,
and remedied by such party, as soon as is reasonably possible. |
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8.4 |
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Assignments. Except as otherwise set forth herein or in connection with the sale of
all or substantially all of the assets or business of either party or as expressly set forth
in this Agreement, rights and obligations under this Agreement may not be assigned by either
party hereto without the prior written consent of the other party hereto, which consent shall
not be unreasonably withheld or delayed; provided, however, that nothing in this Agreement
shall limit CUMBERLANDs right to assign its rights or delegate its obligations under this
Agreement to a lender to CUMBERLAND in the event of a default in its agreement with such
lender. |
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8.5 |
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Independent Contractors. The parties hereto agree that each is acting as an
independent contractor and not as an agent of the other or as joint venturers. |
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8.6 |
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Waivers and Modifications. The failure of any party to insist on the performance of
any obligation hereunder shall not act as a waiver of such obligation. No waiver,
modification, release, or amendment of any obligation under this Agreement shall be valid or
effective unless in writing and signed by both parties hereto. |
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8.7 |
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Successors in Interest. This Agreement shall inure to the benefit of and be binding
on the parties permitted assigns or successors in interest. |
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8.8 |
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Severability. In the event that any term or provision of this Agreement shall violate
any applicable statute, ordinance, or rule of law in any jurisdiction in which it is used, or |
25
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otherwise be unenforceable, such provision shall be ineffective to the extent of such
violation without invalidating any other provision hereof. |
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8.9 |
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Exhibits; Headings. All exhibits attached to and incorporated in this Agreement by
reference are deemed to be a part hereof. The headings used in this Agreement are for
convenience only and are not part of this Agreement. |
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8.10 |
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Choice of Law. This Agreement is subject to and shall be construed and enforced in
accordance with the laws of the State of Delaware, United States of America. The Parties
hereby submit to the jurisdiction of the courts of the State of Delaware in respect to all
disputes arising out of or in connection with this Agreement and waive any and all objections
to such venue. |
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8.11 |
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Entire Agreement. This Agreement, constitutes the entire agreement between the
parties as to the subject matter hereof, and all prior negotiations, representations,
agreements and understandings are merged into, extinguished by and completely expressed by
this Agreement. |
9. ARBITRATION
Any matter or disagreement arising under this Agreement shall be submitted for decision to a
panel of three neutral arbitrators with expertise in the subject matter to be arbitrated. One
arbitrator shall be selected by each party and the two arbitrators so selected shall select the
third arbitrator. The arbitration shall be conducted in accordance with the Rules of the American
Arbitration Association. The decision and award rendered by the arbitrators shall be final and
binding. Judgment upon the award may be entered in any court having jurisdiction thereof. Any
arbitration shall be held in Wilmington, Delaware, or such other place as may be mutually agreed
upon in writing by the parties.
26
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly authorized
officers on the date first written above.
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CUMBERLAND PHARMACEUTICALS INC.
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INALCO BIOCHEMICALS, INC.
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By:
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/s/ A.J. Kazimi
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By:
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/s/ Eric A. Lowe
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A.J. Kazimi
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Eric A. Lowe |
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Title: Chief Executive Officer
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Title: President |
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INALCO S.p.A. |
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By:
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/s/ Giovanni Cipolletti |
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Giovanni Cipolletti |
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Title: President |
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27
EXHIBIT A
Minimum Purchases
Year 1: 6,000,000 commercial pouches of Product
Year 2: 7,000,000 commercial pouches of Product
Year 3: 8,000,000 commercial pouches of Product
Year 4: 9,000,000 commercial pouches of Product
Year 5: 10,000,000 commercial pouches of Product
Minimum purchases for subsequent Years shall not be less than 65% of the average purchases in each
of the three immediately preceding annual periods.
Provided, however, that none of the minimums set forth in this Exhibit A shall be
applicable if a generic equivalent to the Product is introduced for sale in the United States, or
if INALCO fails to provide promotional units of Product to CUMBERLAND in accordance with the terms
of this Agreement.
If CUMBERLAND fails to meet the minimum in any given Year, CUMBERLAND shall pay INALCO within sixty
(60) days after the termination of such Year the profit on the Product Payments that INALCO would
have received on the shortfall (i.e., the difference between applicable purchases of the Product
and the applicable minimum).
Notwithstanding the foregoing, if INALCO is unable to supply Product for a period of more than
sixty (60) days in any Year during the Term, the minimum purchases for the applicable Year shall be
reduced twenty-five percent (25%) and an additional ten percent (10%) for each month thereafter
when INALCO is unable to supply; provided that the minimum purchases for the applicable Year shall
be waived altogether if INALCO fails to supply Product for a period of more than one hundred eighty
(180) consecutive days.
United States Patent
Bimbi
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US005480491A |
Patent Number:
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5,480,491 |
Date of Patent:
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Jan. 2, 1996 |
PROCESS FOR THE PREPARATION OF
CRYSTALLINE LACTULOS FROMCOMMERCIAL SYRUPS
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Inventor:
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Giuseppe Bimbi, Pontedera, Italy |
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Assignee:
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Inalco S.p.A., Milan, Italy |
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Appl. No.:
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229,559 |
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Filed:
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April 18, 1994 |
Foreign Application Priority Data
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Apr. 28, 1993 [IT] Italy |
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MI93A0833 |
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Int. Cl6 |
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C13F 1/00; C13F 1/02 |
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U.S. Cl. |
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127/61;127/46.2;127/55; |
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127/56; 127/58 |
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Field of Search |
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127/61; 58, 56, |
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127/55, 46.2 |
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References Cited
U.S. PATENT DOCUMENTS
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4,555,271 11/1985 Carobbi et al |
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127/46.2 |
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4,978,397 12/1990 Carobbi et al |
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127/46.2 |
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5,034,064 7/1991 Deya et al |
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127/46.2 |
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5,304,251 4/1994 Tomita et al |
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127/42 |
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FOREIGN PATENT DOCUMENTS
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0132509
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2/1985
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European Pat. Off
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C13K 13/00 |
0159521
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10/1985
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European Pat. Off
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CO8F 8/42 |
0158148
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6/1988
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European Pat. Off
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C13K 13/00 |
0284959
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1/1992
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European Pat. Off
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CO8F 8/42 |
0284960
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6/1992
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European Pat. Off
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C08F 8/42 |
OTHER PUBLICATIONS
J. Agric. Chem. 1984, 32, 288-292 Jul./Dec. 1983.
Primary
ExaminerPaul Lieberman Assistant
ExaminerPatricia Halley
Attorney, Agent, or FirmHedman, Gibson & Costigan
ABSTRACT
The following description sets forth a new process for the preparation of .gtoreq.98.5% pure
crystalline lactulose from commercially available aqueous syrups having the following composition:
50-70% by weight of lactulose, 3-9% by weight of lactose, 3-14% by weight of galactose, 4-7% by
weight of other carbohydrates, the total content of carbohydrates different from lactulose being of
from 10% to 30%.
8 Claims, No Drawings
PROCESS FOR THE PREPARATION OF
CRYSTALLINE LACTULOSE FROM
COMMERCIAL SYRUPS
FIELD OF THE INVENTION
The present invention relates to a process for the preparation of high-purity crystalline
lactulose by crystallization of commercially available aqueous syrups.
PRIOR ART
Lactulose,
or 4-0-b-D-galactopyranosyl-D-fructofuranose, is a semisynthetic disaccharide, used
in the form of syrup or of crystalline product on account of its laxative action, efficacy in the
treatment of hepatic dysfunctions, in particular of portal systemic encephalopathy, and as a
sweetener.
Lactulose syrups that are now available on the market are generally not pure, but contain more
or less large amounts of other carbohydrates, in particular galactose and lactose, and typically
50% by weight of lactulose; from 5 to 8% by weight of galactose; from 3 to 5% by weight of lactose;
from 5 to 10% by weight of other carbohydrates.
As may be seen, the per cent amount of carbohydrates different from lactulose contained in the
syrups of commerce is relatively high. The use of products containing other carbohydrates in
addition to lactulose for the therapy of disorders requiring administration of lactulose alone,
would be prejudicial and raise problems, e.g. in patients suffering from diabetes or requiring a
diet without galactose.
Therefore, as lactulose becomes ever more important in pharmaceutical practice, there is a
need for an adequate purification of same from contaminating carbohydrates.
As disclosed in U.S. Pat. No. 4,536,221, various processes known for lactulose purification
are based on the crystallization from alcoholic solvents, usually ethanol.
However, the lactulose crystals obtained from alcohols always contain a given amount of
solvent, probably due to the formation of hydrogen bonds between the OH groups of sugar and the OH
groups of the solvent, while the solvent residue cannot be completely removed even by prolonged
dryings.
The disadvantage of the crystallization from ethanol is not only that complex process are
required for solvent residue elimination, but also that high operating costs are generally
involved.
Some process for the direct recovery of lactulose from aqueous solutions based on the
concentration of same by drying under vacuum, lyophilization, and spray-drying are also known.
Some of them are mentioned below:
the process disclosed in JP No. 61,104,800, which comprises concentrating an aqueous solution
containing at least 60% lactulose, adding the concentrate with crystal seeds at from 60° to
110° C., kneading and pulverizing, thus affording a powder containing lactulose crystals;
the process disclosed in European patent application EP-A-333,295, for the preparation of solid
lactulose from an aqueous syrup by high-temperature evaporation to lower the water content to
10% max., followed by cooling, grinding, sieving or crumbling of the resulting solid, whose
purity is the same as that of the starting syrup;
the process disclosed in European patent application EP-A-480,519, consisting of lactulose
solidification from aqueous solutions by evaporating the water contained therein and conversion of
the resulting product into a free-flowing powder. Lactulose solidification may be initiated by
addition of crystal seeds, preferably in amounts of from 1% to 5% by weight (on dry residue
basis);
the process disclosed in patent application JP No. 2,200,693, (Derwent abstract) consisting of
lactulose crystallization from a condensed syrup, followed by condensate drying at a reduced
pressure and pulverization of the dried product.
The aforementioned processes are essentially based on the evaporation and concentration of the
starting syrup and greatly differ from crystallizations in that they simply cause the solute
solidification without eliminatingas crystallizations dothe undesirable secondary components
present in mother liquors.
Therefore, since the processes based on concentration give lactulose of the same purity as
that of the starting syrup, they cannot be utilized for the production of high-purity lactulose
from commercial syrups that, as already mentioned, contain high amounts of other carbohydrates.
Furthermore, the aforementioned processes can give crystalline lactulose only if combined with
crystallization from alcohols.
The only known process which involves a real crystallization from water, with no need of
alcoholic solvents, is disclosed in EP-A-318,630 by the Applicant. It is also the only known
process that yields highly pure (³ 98%) and non-hygroscopic crystalline lactulose. However, this
process cannot be exploited if the lactulose aqueous syrup to be crystallized contains
carbohydrates different from lactulose in amounts exceeding 14% by weight of lactulose.
In case of lactulose syrups containing carbohydrates different from lactulose in amounts
exceeding said limit value, it was always deemed it necessary to lower the content of said
carbohydrates below said limit value and, to this purpose, before crystallization from water, the
aqueous syrup was always purified according to one of the other known methods.
The ever growing importance of lactulose in pharmaceutical practice is a spur to the
development of new processes to be applied to the industrial production of high-purity crystalline
lactulose, without causing the inconveniences of the processes already known.
SUMMARY
The Applicant has now found a new process for lactulose purification that may be exploited on
an industrial scale, yielding high-purity crystalline lactulose, in particular having a content of
carbohydrates different from lactulose lower than 1% and a purity higher than 98.5%. The present
process is based on the crystallization of a commercial lactulose aqueous syrup having a total
content of carbohydrates different from lactulose higher than 10% by weight.
In particular, the process of the present invention can be applied to commercial lactulose
aqueous syrups having the following composition: from 50% to 70% by weight of lactulose; from 3% to
9% by weight of lactose; from 3% to 14% by weight of galactose; from 4% to 7% by weight of other
carbohydrates; the total content of carbohydrate different from lactulose ranging between 10% and
30% by weight.
It has surprisingly been foundand this finding constitutes a fundamental feature of the
present inventionthat by
adding a commercial lactulose aqueous syrup with trihydrated crystalline lactulose in
amounts ranging from 5% to 30% of the total lactulose present, a high-purity lactulose
crystallizes in good yields.
As known, in crystallization processes, once the right solvent and the right crystallization
conditions in respect of concentration and temperature have been found, few seed crystals are
generally enough for initiating the progressive crystallization of the product in solution,
according to laws governed by:
product concentration in the concentrated matrix;
crystallization temperature;
residence time.
As far as sugars are concerned, said conditions are generally reached in such long times that
a random self-initiation of the solutes having lower kps than the product to be
crystallized becomes highly probable: consequently, the crystalline cake recovered is still
contaminated by said solutes.
It is, therefore, surprising that the addition to a lactulose aqueous syrup of a large amount
of trihydrated lactulose in the crystal stateand not of few seed crystalscan initiate a
preferential crystallization of lactulose in respect of the other carbohydrates present in the
syrup, yielding a high-purity crystalline lactulose.
Compared with the process disclosed in European patent application EP-A-318630, the process of
the present invention has the advantage of giving very-high-purity crystalline lactulose starting
from any syrup of commerce.
DETAILED DESCRIPTION OF THE
INVENTION
Lactulose crystallization according to the present invention is characterized by the following
process: the water content of the lactulose aqueous syrup is lowered to a sugar concentration of
from 70° to 80° Brix; the resulting syrup is added at from 5° C. to 20° C. with crystalline
trihydrated lactulose, acting as a crystallization initiator, in amounts ranging from 5% to 30% by
weight of the lactulose present in the starting syrup, which temperature is maintained for a period
of from 20 to 120 hrs. The crystalline solid obtained consisted of trihydrated lactulose having a
content of carbohydrates different from lactulose below 1% by weight and a lactulose content of at
least 98.5% (on anhydrous basis).
In particular, the process for the preparation of crystalline lactulose according to the
present invention comprises the following steps:
a) |
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commercial lactulose aqueous syrup is evaporated under continuous stirring at a temperature
of from 50° to 60° C. and at a pressure of 2660 to 6650 Pa, up to a sugar concentration of
70°-80° Brix; |
b) |
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the resulting concentrated syrup is cooled to 5° to 20° C. and added with crystalline
trihydrated lactulose in an amount of from 5 to 30 parts by weight of the lactulose present in
the syrup; |
c) |
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the suspension obtained is stirred at said temperature for a period of from 20 to 120 hours
and the lactulose present in the syrup is crystallizes in the form of trihydrated lactulose; |
d) |
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the crystallized trihydrated lactulose obtained is separated by centrifuging or filtering
from mother liquors, washed with cold water, and dried at a pressure of from 6650 to 13300 Pa,
at a temperature of from 30° to 60° C., to yield crystalline lactulose having a water content
below 0.5%. |
The process of the invention gives highly pure (98.5% minimum) crystalline lactulose in yields
per cycle greater than 40% of the lactulose present in the starting syrup.
The mother liquors resulting from the separation of crystalline trihydrated lactulose are
passed once or several times through columns containing anionic or cationic exchange resins, either
individually or in sequence, as illustrated in European patent applications EP-A-132,509,
EP-A-158,148, EP-A-159,521, EP-A-284,959, and EP-A-294,960 by the Applicant, so to lower the
content of carbohydrates different from lactulose below the aforesaid limits and, therefore, to
allow the mixing of same with the commercial starting syrup to be subjected to the process of the
present invention.
This operation allows the recycling of the mother liquors and the almost complete recovery of
the lactulose present in the syrups of commerce.
In a preferred embodiment of the present invention, the concentrated syrup of step b) has a
content of 55% to 62% by weight of lactulose and the crystalline trihydrated lactulose is added in
an amount ranging between 5% and 15% by weight of the lactulose present in the commercial syrup
(the amount of trihydrated lactulose used as a crystallization initiator is expressed as % by
weight of anhydrous lactulose).
A single washing of the crystalline trihydrated lactulose obtained in d) with cold water
(3°-5° C.) is generally enough for a satisfactory removal of the residual mother liquors and for
obtaining a product of the desired purity.
The following examples illustrate some embodiments of the claimed process.
EXAMPLES
Crystallization of Lactulose Starting
From Commercially Available Syrups
Several crystallizations of commercially available lactulose syrups were carried out according
to the standard procedure described below.
Syrups characteristics are shown in Table 1 and the results obtained in Table 2.
STANDARD PROCEDURE
A syrup (1000 kg) of composition as shown in Table 1 was concentrated under vacuum at a
pressure of from 2660 to 6650 Pa, under continuous stirring, at a temperature of from 50° to 60°
C., to a sugar concentration of 70°-80° Brix.
The resulting solution was fed to a crystallizer and cooled to 8° C. under continuous
stirring. Once said conditions have been reached, crystalline trihydrated lactulose was fed in the
amounts shown in Table 2.
The obtained suspension was slowly stirred at 8° C. for the period indicated in Table 2, then
the mother liquors were removed by centrifuging, the crystal cake was squeezed to remove most
mother liquors, washed with cold water, and squeezed again.
The resulting product was dried in an air oven at a temperature not exceeding 60° C. and at a
pressure of from 6650 to 13300 Pa, until obtaining anhydrous lactulose crystals (i.e. having a
maximum water content of 0.5%) of >98.8% purity (on dry basis) (Table 2).
The purity of lactulose crystals was determined on the dried product by HPLC analysis (J.
Agric. Food Chem., 32, 288-292, 1984), by means of comparison with standard lactulose produced and
sold by MERCK.
TABLE 1
Composition (%) of the aqueous solutions used
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|
|
Item |
|
LTL |
|
LTS |
|
EPI |
|
GLT |
|
ND |
|
H2O |
|
I |
|
|
51.4 |
|
|
|
4.4 |
|
|
|
1.2 |
|
|
|
3.6 |
|
|
|
6.4 |
|
|
|
34.0 |
|
II |
|
|
50.6 |
|
|
|
4.9 |
|
|
|
2.0 |
|
|
|
3.8 |
|
|
|
5.0 |
|
|
|
33.7 |
|
III |
|
|
51.9 |
|
|
|
3.1 |
|
|
|
2.2 |
|
|
|
7.9 |
|
|
|
3.1 |
|
|
|
31.8 |
|
IV |
|
|
51.0 |
|
|
|
8.2 |
|
|
|
1.3 |
|
|
|
3.5 |
|
|
|
4.0 |
|
|
|
32.0 |
|
Remarks: all quantities are by weight percentages of the solution total weight.
Abbreviations
LTL lactulose;
LTS lactose;
EPI epilactose;
GLT galactose;
ND carbohydrates different from LTL, LTS, EPI, and GLT.
TABLE 2
Experimental results
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|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
total |
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|
|
|
|
|
|
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|
|
|
|
|
|
|
|
LTL |
|
Cone. syr. |
|
LTL as initiator |
|
LTL |
|
LTL recovered |
Ex. |
|
Syr a |
|
Brixb |
|
hc |
|
% wd |
|
Xge |
|
%f |
|
Kgg |
|
Kgh |
|
Kgi |
|
% titl |
|
% film |
|
yieldn |
|
1 |
|
|
I |
|
|
|
74 |
|
|
|
72 |
|
|
|
55.2 |
|
|
|
931 |
|
|
|
18.7 |
|
|
|
111.6 |
|
|
|
610 |
|
|
|
309 |
|
|
|
84.2 |
|
|
|
99.0 |
|
|
|
42.2 |
|
2 |
|
|
I |
|
|
|
74 |
|
|
|
96 |
|
|
|
55.3 |
|
|
|
929 |
|
|
|
7.5 |
|
|
|
46.1 |
|
|
|
553 |
|
|
|
254 |
|
|
|
83.8 |
|
|
|
98.9 |
|
|
|
38.5 |
|
3 |
|
|
I |
|
|
|
74 |
|
|
|
72 |
|
|
|
55.3 |
|
|
|
929 |
|
|
|
10.0 |
|
|
|
61.1 |
|
|
|
565 |
|
|
|
260 |
|
|
|
84.6 |
|
|
|
99.2 |
|
|
|
38.9 |
|
4 |
|
II |
|
|
78 |
|
|
|
120 |
|
|
|
57.0 |
|
|
|
888 |
|
|
|
5.0 |
|
|
|
30.3 |
|
|
|
531 |
|
|
|
212 |
|
|
|
83.9 |
|
|
|
99.0 |
|
|
|
33.5 |
|
5 |
|
II |
|
|
74 |
|
|
|
72 |
|
|
|
55.0 |
|
|
|
920 |
|
|
|
7.5 |
|
|
|
45.2 |
|
|
|
544 |
|
|
|
253 |
|
|
|
84.1 |
|
|
|
99.4 |
|
|
|
38.9 |
|
6 |
|
II |
|
|
75 |
|
|
|
88 |
|
|
|
55.6 |
|
|
|
933 |
|
|
|
7.5 |
|
|
|
46.5 |
|
|
|
558 |
|
|
|
310 |
|
|
|
83.4 |
|
|
|
99.0 |
|
|
|
46.3 |
|
7 |
|
II |
|
|
71 |
|
|
|
88 |
|
|
|
54.4 |
|
|
|
954 |
|
|
|
7.5 |
|
|
|
46.7 |
|
|
|
558 |
|
|
|
255 |
|
|
|
84.0 |
|
|
|
98.8 |
|
|
|
38.4 |
|
8 |
|
IV |
|
|
74 |
|
|
|
56 |
|
|
|
55.2 |
|
|
|
924 |
|
|
|
15.0 |
|
|
|
69.8 |
|
|
|
587 |
|
|
|
238 |
|
|
|
83.5 |
|
|
|
99.1 |
|
|
|
33.9 |
|
9 |
|
IV |
|
|
74 |
|
|
|
72 |
|
|
|
55.5 |
|
|
|
919 |
|
|
|
7.5 |
|
|
|
45.8 |
|
|
|
548 |
|
|
|
248 |
|
|
|
84.6 |
|
|
|
98.8 |
|
|
|
38.3 |
|
10 |
|
IV |
|
|
70 |
|
|
|
72 |
|
|
|
53.8 |
|
|
|
948 |
|
|
|
7.5 |
|
|
|
45.9 |
|
|
|
548 |
|
|
|
213 |
|
|
|
84.6 |
|
|
|
98.8 |
|
|
|
32.9 |
|
|
|
|
a |
|
Commercial aqueous syrup used |
|
b |
|
Brix degrees after syrup concentration |
|
c |
|
Residence time in crystallizer at 8° C |
|
d |
|
By weight %, amount of LTL after syrup concentration |
|
e |
|
Amount of concentrated syrup (kg) |
|
f |
|
By weight % amount of trihydrated LTL used as a crystallization initiator |
|
g |
|
Weight of trihydrated LTL used as a crystallization initiator |
|
h |
|
LTL total weight (LTL of the syrup + LTL used as a crystallization initiator) |
|
i |
|
Weight of trihydrated LTL recovered |
|
l |
|
titre of anhydrous LTL in trihydrated crystal before drying |
|
m |
|
titre of anhydrous LTL after drying |
|
n |
|
yield calculated by:
(anhydrous) crystalline LTL recovered (kg)
(anhydrous) total LTL In the system (kg) |
I claim:
1. A process for the preparation of crystalline lactulose having a content of carbohydrates
which are different from lactulose that is lower than 1% and a lactulose content of more than
98.5%, said process comprising the following steps:
(a) |
|
evaporating a part of the water from an aqueous lactulose syrup under continuous stirring
at a temperature of from 50° to 60° C. and at a pressure of from 2660 to 6650 Pa to obtain
a concentrated lactulose syrup with a sugar concentration of 70°-80° Brix, said aqueous
lactulose syrup having a lactulose content of from 50% to about 62% by weight and a content
of carbohydrates which are different from lactulose and include lactose, galactose and
other carbohydrates, the lactose content being from 3% to 9% by weight; the galactose
content being from 3% to 14 % and the other carbohydrate content being from 4% to 7% by
weight; |
(b) |
|
cooling the concentrated syrup obtained in step (a) to a temperature of from 5° to 20° C.
prior to adding from 5% to 30% by weight of crystalline trihydrated lactulose based on the total weight of lactulose which is present in said aqueous lactulose syrup; |
(c) |
|
stirring the product of step (c) for a period of from 20 to 120 hours to crystallize the
lactulose which is present as trihydrated lactulose; |
(d) |
|
separating the crystallized trihydrated lactulose by centrifugation or filtration of the
product of Step (c) to obtain a mother liquor and separated crystallized trihydrated
lactulose; and thereafter washing said separated crystallized trihydrate of lactulose with
cold water prior to drying the separated crystallized trihydrate of lactulose at a temperature
of from 30° to 60° C., to obtain crystalline lactulose having a water content of less that
0.5%. |
2. The process according to claim 1, wherein the crystalline trihydrated lactulose is
added in an amount of between 5% and 15% by weight of the lactulose present in said aqueous
lactulose syrup.
3. The process according to claim 1, wherein the mother liquors obtained in step (d) are
passed one or more times through columns containing ion exchange resins to reduce the content of
carbohydrates which are other than lactulose.
4. The process according to claim 3, wherein the mother liquors which are recovered after the
passage through the ion exchange columns are mixed with the aqueous lactulose syrup of step (a).
5. A process for the preparation of crystalline lactulose having a content of carbohydrates
which are different from lactulose that is lower than 1% and a lactulose content of more than
98.5%, said process consisting essentially of the following steps:
(a) evaporating a part of the water from an aqueous lactulose syrup under continuous stirring at a
temperature of from 50° to 60° C. and at a pressure of from 2660 to 6650 Pa to obtain a
concentrated lactulose
|
|
syrup with a sugar concentration of 70°80° Brix, said aqueous lactulose syrup having a
lactulose content of from 50% to about 62% by weight and a content of carbohydrates which are
different from lactulose and include lactose, galactose and other carbohydrates, the lactose
content being from 3% to 9% by weight; the galactose content being from 3% to 14 % and the other
carbohydrate content being from 4% to 7% by weight; |
(b) |
|
cooling the concentrated syrup obtained in step (a) to a temperature of from 5° to 20° C.
prior to adding from 5% to 30% by weight of crystalline trihydrated lactulose based on the
total weight of lactulose which is present in said aqueous lactulose syrup; |
(c) |
|
stirring the product of step (c) for a period of from 20 to 120 hours to crystallize the
lactulose which is present as trihydrated lactulose; |
(d) |
|
separating the crystallized trihydrated lactulose by centrifugation or filtration of the
product of step (c) to obtain a mother liquor and separated crystallized tri-
hydrated lactulose; and thereafter washing said separated crystallized trihydrate of
lactulose with cold water prior to drying the separated crystallized trihydrate of lactulose at
a temperature of from 30° to 60° C., to obtain crystalline lactulose having a water content of
less that 0.5%. |
6. The process according to claim 5, wherein the crystal-line trihydrated lactulose is added
in an amount of between 5% and 15% by weight of the lactulose present in said aqueous lactulose
syrup.
7. The process according to claim 5, wherein the mother liquors obtained in step (d) are
passed one or more times through columns containing ion exchange resins to reduce the content of
carbohydrates which are other than lactulose.
8. The process according to claim 7, wherein the mother liquors which are recovered after the
passage through the ion exchange columns are mixed with the aqueous lactulose syrup of step (a).
* * * * *
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United States Patent
|
|
Patent Number:
|
|
|
5,003,061 |
|
Carobbi et al.
|
|
Date of Patent:
|
|
Mar. 26, 1991
|
METHOD FOR PREPARING HIGH-PURITY CRYSTALLINE LACTULOSE
|
|
|
Inventors:
|
|
Renato Carobbi, Pistoia; Franco
Innocenti, Bagno a Ripoli, both of
Italy |
|
|
|
Assignee:
|
|
SIRAC Srl, Milan, Italy |
|
|
|
Appl. No.:
|
|
141,786 |
|
|
|
Filed:
|
|
Jan. 11, 1988 |
Foreign Application Priority Data
|
|
|
Dec. 1, 1987 [IT] Italy
|
|
22848 A/87 |
Int. Cl.5
|
|
C07H 1/06; C13F 1/02 |
U.S. Cl
|
|
536/127; 536/1.1; |
|
|
536/4.1; 127/30; 127/46.1; 127/58 |
Field of Search
|
|
536/1.1, 4.1, 127; |
|
|
127/30, 46.1, 58 |
References Cited
U.S. PATENT DOCUMENTS
|
|
|
|
|
|
|
|
|
|
3,110,600 |
|
|
11/1963
|
|
Bok
|
|
536/1.1 |
|
3,546,206 |
|
|
12/1970
|
|
Guth et al.
|
|
127/30 |
|
3,562,012 |
|
|
2/1971
|
|
Reinicke et al.
|
|
536/1.1 |
|
3,816,174 |
|
|
6/1974
|
|
Nagasawa et al.
|
|
127/30 |
|
3,816,394 |
|
|
6/1974
|
|
Nagasawa et al.
|
|
536/124 |
|
4,142,916 |
|
|
3/1979
|
|
Ogasa et al.
|
|
127/63 |
|
4,264,763 |
|
|
4/1981
|
|
Gasparotti
|
|
536/1.1 |
|
4,273,922 |
|
|
6/1981
|
|
Hicks
|
|
127/46.1 |
|
4.536,221 |
|
|
8/1985
|
|
Carobbi et al.
|
|
536/127 |
|
4,555,271 |
|
|
11/1985
|
|
Carobbi et al. |
|
127/46.2 |
|
4,605,646 |
|
|
8/1986
|
|
Bernardi |
|
514/53 |
|
4,812,444 |
|
|
3/1989
|
|
Mitsuhashi et al. |
|
514/53 |
FOREIGN PATENT DOCUMENTS
57-102200 6/1982 Japan.
61-104800 5/1986 Japan.
1232554 5/1971 United Kingdom.
2031430 4/1980
United Kingdom.
OTHER PUBLICATIONS
Montgomery et al; J.A.C.S. 52:2101-2106, May 1930.
Oosten; Chemical Abstracts 67:73799k (1967).
Nitsch et al; Chemical Abstracts 84:150910v (1976).
Krol et al; Chemical Abstracts 90:40510f (1979).
Takahashi; Chemical Abstracts 105:135841g (1986).
Primary ExaminerRonald W. Griffin
Assistant ExaminerNancy S. Carson
Attorney, Agent, or FirmParkhurst, Wendel & Rossi
ABSTRACT
A method for preparing high-purity crystalline lactulose and the product obtained by the method,
which comprises crystallization from aqueous solutions at a temperature of 5-40 C., the starting
aqueous solution having a lactulose concentration of 50-80% w/w, a lactose concentration of less
than 5% of the lactulose concentration by weight, a galactose concentration of less than 5% of the
lactulose concentration by weight, and a concentration of other sugars of less than 4% of the
lactulose concentration by weight.
4 Claims, No Drawings
METHOD FOR PREPARING HIGH-PURITY
CRYSTALLINE LACTULOSE
FIELD OF THE INVENTION
This invention relates to a new method for preparing high-purity crystalline lactulose by
crystallizing aqueous solutions which contain it and eliminating the secondary components during
the crystallization stage, and to the crystalline lactulose obtained in this manner.
PRIOR ART
Lactulose, or 4-O-b-D-galactopyranosyl-D-fructofuranose, is a semisynthetic disaccharide used
in the form of a syrup or crystalline product for its laxative effects, for its effectiveness in
hepatic disfunctions and particularly in portosystemic encephalopathy, or as a sweetener.
Commercially available lactulose syrup is generally impure, containing variable quantities of
other carbohydrates, particularly lactose and galactose.
A typical composition of currently available syrup is the following:
|
|
|
lactulose
|
|
50%by weight |
galactose
|
|
5-8%by weight |
lactose
|
|
3-3%by weight |
other carbohydrates
|
|
5-10%by weight |
in which relatively large percentages of carbohydrates other than lactulose are present. These
carbohydrates are also present, generally in lesser quantity, in currently commercially available
crystalline lactulose.
Carbohydrates other than lactulose are undesirable in therapeutic applications for which
lactulose is intended, and in particular for patients requiring a galactose-free diet and diabetic
patients.
There is therefore a requirement for crystalline lactulose of higher purity, in particular
with the greatest possible reduction in carbohydrates other than lactulose and with the absence of
undesirable residual alcoholic solvent concentrations, which are present when lactulose is
crystallized from alcoholic solutions.
The main currently known lactulose purification methods involve the use of alcoholic solvents,
generally ethanol, together with complex procedures based on the extreme solubility of lactulose in
an aqueous environment, or on various concentration processes by drying.
Crystalline lactulose obtained from alcoholic solvents is known to always contain a
considerable percentage of solvent retained by the crystal, probably by the formation of hydrogen
bonds between the sugar OH groups and the solvent OH groups, and it is never possible to eliminate
the solvent residue even by prolonged drying.
One example of a process of purification by crystallization from ethanol is described in
Italian patent No. 1,155,429.
The yield of such processes when calculated with respect to the lactulose contained in the
starting syrup is particularly low.
In the present text the term yield indicates the amount of crystalline product obtained in a
single step, as a weight percentage of the starting lactulose.
Thus, processes for obtaining crystalline lactulose from alcoholic solutions have the
drawbacks of greater complication, lower yields and consequent higher cost,
and a product from which the undesirable alcoholic solvent traces cannot be eliminated.
Again, processes involving concentration by direct drying of aqueous lactulose solutions, even
if of high purity and whatever drying method is used (vacuum, lyophilization, spray drying), are
known to lead to a very hygroscopic solid amorphous product or, as described in JP No. 61104800, to
a solid containing crystalline lactulose which has to undergo further mixing and grinding before it
can be used.
Thus none of the previously used methods has provided crystalline lactulose free both of
impurities in the form of other undesirable carbohydrates and of residual concentrations of
alcoholic solvent retained by the lactulose crystal.
Up to the present time it has been impossible in practice to directly obtain from aqueous
solutions high-purity crystalline lactulose having the characteristics of the lactulose claimed in
the present patent.
SUMMARY OF THE INVENTION
In accordance with the present invention we have now discovered a new industrially applicable
lactulose purification process which obviates all these drawbacks and enables crystalline lactulose
to be obtained in a particularly simple and economical manner with a degree of purity exceeding 98%
by weight and practically free of carbohydrates other than lactulose, in particular lactose and
galactose, from aqueous solutions which contain it in an impure state due to the presence of
carbohydrates other than lactulose, and/or alcohols. If the process of the present invention is
applied to lactulose crystallized from alcoholic solutions and then redissolved in water, the
crystalline lactulose finally obtained is practically free of any trace of the alcoholic solvent
used and thus has a degree of purity considerably higher than that obtainable by any process
previously used.
The final yield of the process according to the invention varies according to the
crystallization temperature, the crystallization time, the lactulose purity and the solution
purity, and lies between 10 and 70%.
In its preferred embodiments, the yield varies from 55 to 70% as indicated hereinafter, and is
therefore considerably greater than in all previously used methods, so making this process usable
more economically on an industrial scale than previous processes.
The method of the present invention enables crystalline lactulose to be obtained from aqueous
solutions which are impure because of the presence of carbohydrates other than lactulose and/or
alcohols, and in particular from aqueous solutions having the following characteristics:
(a) lactulose concentration of 50-80% w/w and preferably 65-70% w/w in the aqueous solution;
(b) lactose concentration of less than 5% of the lactulose concentration by weight;
(c) galactose concentration of less than 5% of the lactulose concentration by weight;
(d) concentration of other carbohydrates of less than 4% of the lactulose concentration by
weight;
(e) total concentration of carbohydrates other than lactulose not exceeding 6% of the
lactulose concentration by weight.
The method according to the present invention is characterised by maintaining the
crystallization conditions within precise critical values, and more specifi-
cally by simultaneously maintaining all the indicated parameters within the following
defined critical values:
a. Crystallization temperature between 5° and 40° C., and preferably
between 10° and 15° C.
b. Crystallization time between 10 and 60 hours, and preferably between 24 and 36 hours.
Outside these values an extremely low final process yield is obtained such that the process
cannot be used industrially, it being sufficient for only one of these parameters to lie outside
the range of values defined by the present invention for the final yield to be such as to make the
process unusable industrially.
This process, which is described in detail in the examples, therefore not only enables
crystalline lactulose to be obtained directly from sufficiently pure aqueous solutions, but also
enables the residual solvent to be completely eliminated from crystalline lactulose obtained by
conventional crystallization from alcoholic solvents such as methanol, ethanol and propanol.
The following examples are given as non-limiting illustration of the process according to the
invention for purifying and crystallizing lactulose from aqueous solutions.
EXAMPLE 1
1000 kg of a lactulose solution having the following composition:
|
|
|
lactulose
|
|
50% |
lactose
|
|
0.7% |
galactose
|
|
0.9% |
other sugars
|
|
0.3% |
water
|
|
to make up to 100% |
are concentrated under vacuum to a lactulose concentration of 70%.
The concentrated solution is then cooled to 13° C. and 1 kg of crystalline lactulose
is added.
The mixture is left under agitation for 24 hours maintaining the temperature at 13°
C., after which the solid obtained, consisting of crystalline lactulose, is filtered off.
The solid is dried in an air oven at a temperature not exceeding 35° -40°
C. to obtain 273 kg of crystalline lactulose with a purity exceeding 98% and a yield of 54.5%.
EXAMPLE 2
1000 kg of a lactulose solution having the following composition:
|
|
|
|
|
lactulose |
|
|
50 |
% |
lactose |
|
|
0.7 |
% |
galactose |
|
|
0.9 |
% |
other sugars |
|
|
0.3 |
% |
water to make up to |
|
|
100 |
% |
are concentrated under vacuum to a lactulose concentration of 68%.
The concentrated solution is cooled to 35° C. after which 1 kg of crystalline
lactulose is added.
Over a period of 20 hours the temperature is cooled to 15° C. while maintaining slow
agitation, this temperature then being maintained for a further 16 hours.
By centrifuging, 373 kg of wet product (KF 17%) are obtained, equivalent to 309.5 kg of dry
product, with a yield of 61.7% and a purity of 98.3%.
EXAMPLE 3
500 kg of crystalline lactulose (purity 98.7%) obtained by crystallization from ethanol, with
a residual ethanol concentration of 5000 ppm, are dissolved in 2000 l of water.
The solution obtained is concentrated under vacuum to 68% of lactulose and its temperature
allowed to reach 30° -35° C. spontaneously.
Crystallization is triggered by adding 800g of crystalline lactulose.
The solution is then cooled to about 15° C. and kept at this temperature for 30
hours.
By centrifuging, 430 kg of wet product (KF 18%) are obtained, equivalent to 342.5 kg of dry
product, with a yield of 68.5% and a purity exceeding 99%.
The residual ethanol content is reduced to less than 5 ppm.
We claim:
1. A method for preparing crystalline lactulose having less than 2% of carbohydrate other than
lactulose and a purity exceeding 98% comprising:
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adding a crystalline lactulose seed to an aqueous solution of lactulose having a
lactulose concentration of from 50% to 80% w/w, a lactose concentration of less than 5% of
the lactulose concentration by wt., a galactose concentration of less than 5% of the
lactulose concentration by wt. and concentration of other carbohydrates of less than 4% of
the lactulose concentration by wt.; |
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crystallizing said lactulose solution at a temperature between 5° and
40° C. and in a time between 10 and 60 hours; and |
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drying the obtained crystalline lactulose. |
2. A method as claimed in claim 1, wherein the lactulose concentration in the aqueous solution
is 65-70% w/w and the total concentration of carbohydrates other than lactulose does not exceed 6%
of the lactulose concentration by weight.
3. The method of claim 1 wherein said lactulose solution crystallizing temperature is between
10° C. and 15° C. and said time is between 24 and 36 hours.
4. The method of claim 1 wherein the aqueous solution of lactulose is obtained by dissolving
lactulose, which was previously crystallized from alcoholic solutions, in water.
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UNITED STATES PATENT AND TRADEMARK OFFICE
CERTIFICATE OF CORRECTION
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PATENT NO.
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5,003,061 |
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DATED
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March 26, 1991 |
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INVENTORS) :
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Renato CAROBBI et al. |
It is certified that error appears in the above-identified parent and that said Letters Patent is
hereby corrected as shown below:
Title Page:
[73] Assignee: Please change SIRAC Srl, Milan, Italy to
INALCO S.p.A., Milano, Italy
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Signed and Sealed this
Fifth Day of January, 1993 |
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Attest: |
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DOUGLAS B. COMER |
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Attesting Officer
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Acting Commissioner
of Patents and Trademarks |
REEXAMINATION CERTIFICATE
ISSUED UNDER 35 U.S.C. 307
THE PATENT IS HEREBY AMENDED AS
INDICATED BELOW.
Matter enclosed in heavy brackets [ ] appeared in the patent, but has been deleted and is no
longer a part of the patent; matter printed in italics indicates additions made to the patent.
AS A RESULT OP REEXAMINATION, IT HAS BEEN DETERMINED THAT:
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Claim 1 is determined to be patentable as amended. |
Claims 2, 3 and 4, dependent on an amended claim, are determined to be patentable.
1. A method for preparing crystalline lactulose having less than 2% of carbohydrate
other than lactulose and a purity exceeding 98% comprising;
(a) adding a crystalline lactulose seed to an aqueous solution of lactulose having a
lactulose concentration of from 50% to 80% w/w, a lactose concentration of less than 5% of the
lactulose concentration by wt., a galactose concentration of less than 5% of the lactulose
concentration by wt. and concentration of other carbohydrates of less than 4% of the lactulose
concentration by wt., said aqueous solution containing water as the only solvent;
(b) crystallizing said lactulose solution at a temperature between 5° and 40° C. and in a
time between 10 and 60 hours; and
(c) drying the obtained crystalline lactulose.
* * * * *
EXHIBIT C
Transition Plan
TRANSITION PERIOD SERVICES AGREEMENT
THIS AGREEMENT is made and entered into as of April 7 , 2006, by and between
INALCO BIOCHEMICALS, INC., a California corporation with principal offices at 3440 Empresa Drive,
Suite A, San Luis Obispo, California 93401 (Service Provider) and CUMBERLAND PHARMACEUTICALS
INC., a Tennessee corporation with principal offices located at 2525 West End Avenue, Suite 950,
Nashville, Tennessee 37203 ("Recipient"). Service Provider and Recipient are
referred to herein collectively as "Parties" and separately as a Party.
WHEREAS, this Agreement is intended to govern certain tasks to be accomplished in order to
effect the orderly transfer from Service Provider to Recipient of the certain supply chain
activities; and
WHEREAS, Recipient wishes Service Provider provide for certain transitional services related
to the Product (as defined herein) by Recipient, and Service Provider is willing to provide for
such transitional services to Recipient, on the terms and conditions set forth herein.
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the Parties, intending to be legally bound, hereby agree as follows:
ARTICLE 1
SERVICES
1.1 Services Overview. During the Term (as defined in Article 7 hereof) and subject
to the terms and conditions of this Agreement, Service Provider shall have provided to Recipient
the supply chain activity services set forth in Section 1.2 (collectively, the Services).
1.2 Supply Chain Activity Services.
(a) Description. Service Provider shall have performed the following supply chain
activity services relating to the Product: (i) customer service; (ii) maintaining inventory levels
of Product (as defined herein) based upon Recipients forecasts and reporting inventory levels
monthly to Recipient; (iii) order taking, processing and fulfillment of orders including billing
and invoicing; (iv) processing and recording of sales, credits and price concessions; (v)
warehousing and distribution; (vi) management of suppliers for transfer to Recipient; (vii)
calculation and filing of government reports; (viii) reconciling aged accounts receivable
balances; (ix) processing and destroying returned Product; (x) coordinating logistics and
obtaining and maintaining all necessary permits and all other documentation for transporting
Product; and (xi) processing of government rebates for Product identified by Mylans NDC Code
throughout the Term. For purposes hereof, Product shall mean the pharmaceutical product
lactulose crystals sold under the Kristalosee trademark in all strengths and dosage forms. For
purposes hereof, NDC Code shall mean the National Drug Code number assigned as a listing number
to each drug or class of drugs as described in Section 510(e) of the Federal Food, Drug, and
Cosmetic Act. Notwithstanding anything herein to the contrary, commencing on the Effective Date
(as defined herein), Recipient shall have sole responsibility for production forecasts and all
Product pricing decisions and any state and other governmental entity licenses for Product
commercial distribution. For purposes hereof, Effective Date shall mean the Effective Date as
defined in the Kristalose Agreement dated April 7 , 2006, among Recipient, Inalco
Biochemicals, Inc., and Inalco S.p.A (the "Master Kristalose Agreement").
With respect to the Product, the Transition Team (as defined in Section 3.1(b)) will work together
in good faith to determine how the Recipient and Service Provider will cooperate to comply with
all government price reporting obligations, including, but not limited to, average
manufacturers price, average sales price, best price, and non-federal average
manufacturing price. All Services are required to be provided in a competent manner in conformity
with applicable requirements of any governmental authority, including the United States Food and
Drug Administration.
(b) Service Period. Except for the Services set forth in Section 1.2 (a)(xi) which
Service Provider shall have performed throughout the Term, Service Provider shall have performed
the Services set forth in this Section 1.2 for the period commencing on the Effective Date and
ending on the first to occur of (i) early termination of this Agreement pursuant to Article 7
hereof; or (ii) the date upon which Recipient has begun using its own NDC Code and all inventories
of Product containing Mylans NDC Code have been sold. Immediately upon expiration of such period,
Recipient shall be fully responsible for such Services and shall immediately cease using Mylans
NDC Code, and Service Provider shall have no further responsibility whatsoever for the Services.
(c) NDC Code. Recipient shall use all reasonable efforts to establish as soon as
possible following the Effective Date its own NDC Code. Once the Recipient has received its own
number, the Transition Team will work together to transition to use of that code on the Product as
soon as possible. Within ten (10) business days of the receipt by Recipient of its own NDC Code,
the Parties, acting through their designees on the Transition Team, will agree in writing on the
date for the transition of the Services (except for Services provided pursuant to Section
1.2(a)(xi)) from Service Provider to Recipient.
(d) Sales Data. Service Provider shall supply Recipient on a monthly basis with a
written report containing information on the channels of distribution of the Product, sales
results, and remaining inventory of the Product for the period since the ending date of the prior
such report. Each report shall be delivered to Recipient no later than five (5) days after the end
of the month in question. Within thirty (30) days after the end of the month in question, Service
Provider will also provide a more detailed sales report that sets forth the information contained
in Section 2.2(a)(i),(ii), and (iii) and such other information as is reasonably requested by
Recipient.
1.3 Limitation on Service Providers Obligations. Service Provider will not be
obligated to (i) hire additional or different personnel or acquire additional resources or (ii)
retain personnel currently employed by it, but, in each case to devote such personnel as may be
reasonably necessary to provide the Services to Recipient pursuant to and in accordance with the
terms of this Agreement.
1.4 Performance of Services; Remedy. Service Provider agrees to have performed the
Services with the same skill, diligence, and expertise as have historically been applied by Service
Provider and others in the performance of Services prior to the Effective Date. Service Provider
shall have the Services performed at existing facilities of Mylan Laboratories or at such other
place as agreed in writing by Recipient in advance of performance. Each Party agrees and
acknowledges that except as otherwise set forth herein, Recipients sole and exclusive remedy and
Service Providers sole and exclusive liability for any defect or error in the Services will be
correction or re-performance of the Services.
1.5 License. Service Provider hereby represents and warrants that it has the right to
sublicense, and hereby does sublicense, to Recipient its non-exclusive license to use the names and
marks Mylan and Bertek in connection with the use, sale, marketing and distribution of the
Product. All such use shall be consistent with the use of such names in connection with the Product
prior to the Effective Date. Such sublicense shall terminate upon the earliest to occur of the
following events: (i) Recipients commencing commercial use of revised labels, printed
materials and Product samples to sell, market and distribute the Product under Recipients own name
and NDC Code; (ii) termination of the Services set forth in Section 2.1 of this Agreement; (iii)
Service Providers receipt of written notice from Recipient that Recipient no longer requires the
sublicense; or (iv) thirty (30) days after Recipients receipt of notice from Service Provider that
Recipient is in material breach of this Section 1.5 if Recipient has not, within such thirty (30)
day period, cured such material breach. Recipient shall make commercially reasonable efforts to
obtain such revised labels, printed materials and Product samples as soon as possible.
-2-
ARTICLE 2
FEES
2.1 Fees. If Recipient fails to begin performing the Services (except for Section
1.2(a)0d)) on the date agreed to by the Transition Team pursuant to Section 1.2(c), Recipient shall
begin on such date paying Service Provider the sum of [***] Dollars (US
$[***]) per month for the Services. In addition, Recipient shall reimburse Service Provider for
all documented and reasonable out-of-pocket expenses incurred during the Term and necessary for the
performance of all of Service Providers obligations under this Agreement.
2.2 Payments. (a) During the period that the Service Provider shall have the Services
set forth in Section 1.2(a) performed, Service Provider will immediately remit to Recipient
payments received from Mylan, which are to be made the first business day of each calendar month,
an amount equal to the revenu