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)
 
         
Tennessee   2834   62-1765329
(State or other jurisdiction of
incorporation or organization)
  (Primary Standard Industrial
Classification Code Number)
  (I.R.S. Employer
Identification No.)
 
 
2525 West End Avenue, Suite 950
Nashville, Tennessee 37203
(615) 255-0068
(Address, including zip code, and telephone number, including
area code, of registrant’s 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:
     
  Martin S. Brown, Esq.
Virginia Boulet, Esq.
Adams and Reese LLP
424 Church Street, Suite 2800
Nashville, Tennessee 37219
(615) 259-1450
  Donald J. Murray, Esq.
Dewey Ballantine LLP
1301 Avenue of the Americas
New York, New York 10019-6092
(212) 259-8000
 
 
 
 
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
 
ITEM 13.   OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION.
 
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:
 
         
Item   Amount  
   
 
SEC registration fee
  $             
NASD filing fee
  $    
NASDAQ listing fee
  $    
Printing expenses
  $    
Legal fees and expenses
  $    
Accounting fees and expenses
  $    
Transfer agent and registrar expenses
  $    
Total
  $  
 
ITEM 14.   INDEMNIFICATION OF DIRECTORS AND OFFICERS.
 
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 individual’s conduct was in good faith, and the individual reasonably believed: in the case of conduct in the individual’s official capacity with the corporation, that the individual’s conduct was in its best interest; and in all other cases, that the individual’s 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 individual’s 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.
 
ITEM 15.   RECENT SALES OF UNREGISTERED SECURITIES.
 
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

 
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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

 
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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.
 
ITEM 16.   EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.
 
(a)
 
     
No.   Description
 
 
1.1*
  Form of Underwriting Agreement.
3.1**
  Second Amended and Restated Charter of Cumberland Pharmaceuticals Inc.
3.2**
  Amended and Restated Bylaws of Cumberland Pharmaceuticals Inc.
4.1*
  Specimen Common Stock Certificate of Cumberland Pharmaceuticals Inc.
4.2**
  Warrant to Purchase Common Stock of Cumberland Pharmaceuticals Inc., issued to Bank of America, N.A. on October 21, 2003.
4.3**
  Stock Purchase Warrant, issued to S.C.O.U.T. Healthcare Fund L.P. on April 15, 2004.
4.4**
  Warrant to Purchase Common Stock of Cumberland Pharmaceuticals Inc., issued to Bank of America, N.A. on April 6, 2006.
4.5#**
  Form of Option Agreement under 1999 Stock Option Plan of Cumberland Pharmaceuticals Inc.
4.6.1#
  Form of Incentive Stock Option Agreement under 2007 Long-Term Incentive Compensation Plan of Cumberland Pharmaceuticals Inc.
4.6.2#
  Form of Nonstatutory Stock Option Agreement under 2007 Long-Term Incentive Compensation Plan of Cumberland Pharmaceuticals Inc.
4.7#
  Form of Nonstatutory Stock Option Agreement under 2007 Directors’ Compensation Plan of Cumberland Pharmaceuticals Inc.
5.1*
  Opinion of Adams and Reese LLP.
10.1†
  Manufacturing and Supply Agreement for N-Acetylcysteine, dated January 15, 2002, by and between Bioniche Life Sciences, Inc. and Cumberland Pharmaceuticals Inc.
10.2**
  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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Part II
 

     
No.   Description
 
 
10.3†
  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†
  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†
  First Amendment to Contract Sales and Service Agreement, dated July 19, 2006, by and between Cardinal Health PTS, LLC and Cumberland Pharmaceuticals Inc.
10.6
  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.
10.7†
  Distribution Services Agreement, dated August 3, 2000, by and between CORD Logistics, Inc. and Cumberland Pharmaceuticals Inc.
10.8†
  Strategic Alliance Agreement, dated July 21, 2000, by and between F.H. Faulding & Co. Limited and Cumberland Pharmaceuticals Inc.
10.9†
  Kristalose Agreement, dated April 7, 2006, by and among Inalco Biochemicals, Inc., Inalco S.p.A., and Cumberland Pharmaceuticals Inc.
10.10†
  License Agreement, dated May 28, 1999, by and between Vanderbilt University and Cumberland Pharmaceuticals Inc.
10.11#**
  Employment Agreement effective as of January 1, 2007 by and between A.J. Kazimi and Cumberland Pharmaceuticals Inc.
10.12#**
  Employment Agreement effective as of January 1, 2007 by and between Jean W. Marstiller and Cumberland Pharmaceuticals Inc.
10.13#**
  Employment Agreement effective as of January 1, 2007 by and between Leo Pavliv and Cumberland Pharmaceuticals Inc.
10.14#**
  Employment Agreement effective as of January 1, 2007 by and between J. William Hix and Cumberland Pharmaceuticals Inc.
10.15#**
  Employment Agreement effective as of January 1, 2007 by and between David L. Lowrance and Cumberland Pharmaceuticals Inc.
10.16.1†
  Second Amended and Restated Loan Agreement by and between Cumberland Pharmaceuticals Inc. and Bank of America, N.A., dated April 6, 2006.
10.16.2
  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#**
  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.

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Part II
 

     
No.   Description
 
 
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 Registration Statement on Form S-1 filed on May 1, 2007).
  To be filed by amendment.
 
**  Previously filed.
 
  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.
 
(b)   See Schedule II—Valuation and qualifying accounts included in our audited financial statements included elsewhere in this registration statement.
 
All other schedules have been omitted because they are not applicable.
 
ITEM 17.   UNDERTAKINGS.
 
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

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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.
 
  By: 
/s/  a.j. kazimi
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.
 
             
Signature   Title   Date
 
 
/s/  a.j. kazimi

A.J. Kazimi
  Chairman and CEO (Principal Executive Officer)   July 11, 2007
/s/  david l. lowrance

David L. Lowrance
  Vice President and CFO (Principal Financial and Accounting Officer)   July 11, 2007
*

Robert G. Edwards
  Director   July 11, 2007
*

Thomas R. Lawrence
  Director   July 11, 2007
*

Lawrence W. Greer
  Director   July 11, 2007
*

Martin E. Cearnal
  Director   July 11, 2007
*By:  
/s/  a.j. kazimi

A.J. Kazimi
Attorney-in-Fact
       

 
S-1


 

 
Exhibit Index
 
     
No.   Description
 
 
1.1*
  Form of Underwriting Agreement.
3.1**
  Second Amended and Restated Charter of Cumberland Pharmaceuticals Inc.
3.2**
  Amended and Restated Bylaws of Cumberland Pharmaceuticals Inc.
4.1*
  Specimen Common Stock Certificate of Cumberland Pharmaceuticals Inc.
4.2**
  Warrant to Purchase Common Stock of Cumberland Pharmaceuticals Inc., issued to Bank of America, N.A. on October 21, 2003.
4.3**
  Stock Purchase Warrant, issued to S.C.O.U.T. Healthcare Fund L.P. on April 15, 2004.
4.4**
  Warrant to Purchase Common Stock of Cumberland Pharmaceuticals Inc., issued to Bank of America, N.A. on April 6, 2006.
4.5#**
  Form of Option Agreement under 1999 Stock Option Plan of Cumberland Pharmaceuticals Inc.
4.6.1#
  Form of Incentive Stock Option Agreement under 2007 Long-Term Incentive Compensation Plan of Cumberland Pharmaceuticals Inc.
4.6.2#
  Form of Nonstatutory Stock Option Agreement under 2007 Long-Term Incentive Compensation Plan of Cumberland Pharmaceuticals Inc.
4.7#
  Form of Nonstatutory Stock Option Agreement under 2007 Directors’ Compensation Plan of Cumberland Pharmaceuticals Inc.
5.1*
  Opinion of Adams and Reese LLP.
10.1†
  Manufacturing and Supply Agreement for N-Acetylcysteine, dated January 15, 2002, by and between Bioniche Life Sciences, Inc. and Cumberland Pharmaceuticals Inc.
10.2**
  Novation Agreement, dated January 27, 2006, by and among Bioniche Life Sciences, Inc., Bioniche Pharma Group Ltd., and Cumberland Pharmaceuticals Inc.
10.3†
  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†
  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†
  First Amendment to Contract Sales and Service Agreement, dated July 19, 2006, by and between Cardinal Health PTS, LLC and Cumberland Pharmaceuticals Inc.
10.6
  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.
10.7†
  Distribution Services Agreement, dated August 3, 2000, by and between CORD Logistics, Inc. and Cumberland Pharmaceuticals Inc.
10.8†
  Strategic Alliance Agreement, dated July 21, 2000, by and between F.H. Faulding & Co. Limited and Cumberland Pharmaceuticals Inc.
10.9†
  Kristalose Agreement, dated April 7, 2006, by and among Inalco Biochemicals, Inc., Inalco S.p.A., and Cumberland Pharmaceuticals Inc.
10.10†
  License Agreement, dated May 28, 1999, by and between Vanderbilt University and Cumberland Pharmaceuticals Inc.
10.11#**
  Employment Agreement effective as of January 1, 2007 by and between A.J. Kazimi and Cumberland Pharmaceuticals Inc.


 

     
No.   Description
 
 
10.12#**
  Employment Agreement effective as of January 1, 2007 by and between Jean W. Marstiller and Cumberland Pharmaceuticals Inc.
10.13#**
  Employment Agreement effective as of January 1, 2007 by and between Leo Pavliv and Cumberland Pharmaceuticals Inc.
10.14#**
  Employment Agreement effective as of January 1, 2007 by and between J. William Hix and Cumberland Pharmaceuticals Inc.
10.15#**
  Employment Agreement effective as of January 1, 2007 by and between David L. Lowrance and Cumberland Pharmaceuticals Inc.
10.16.1†
  Second Amended and Restated Loan Agreement by and between Cumberland Pharmaceuticals Inc. and Bank of America, N.A., dated April 6, 2006.
10.16.2
  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#**
  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.
 
** Previously filed.
 
#   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 Company’s Board of Directors (the “Board”); and
     WHEREAS, as an increased incentive to contribute to the Company’s 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 Company’s 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 Participant’s 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 Participant’s 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 Participant’s employment with the Company is terminated due to his/her death during the term of this Option, the Participant’s legal representative, or the person so entitled under the Participant’s 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 Participant’s 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 Company’s Board of Directors (the “Board”); and
     WHEREAS, as an increased incentive to contribute to the Company’s 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 Company’s 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 Participant’s 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 Participant’s employment with the Company or any of its subsidiaries is terminated by the Participant or the Company (or if the Participant’s 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 Participant’s employment (or consulting engagement) with the Company is terminated due to his/her death during the term of this Option, the Participant’s legal representative, or the person so entitled under the Participant’s 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 Participant’s 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 Company’s Board of Directors (the “Board”); and
     WHEREAS, as an increased incentive to contribute to the Company’s 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 Company’s 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 Participant’s Board service with the Company is terminated due to his/her death during the term of this Option, the Participant’s legal representative, or the person so entitled under the Participant’s 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 Participant’s 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 Participant’s 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 CUMBERLAND’s 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 CUMBERLAND’s 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 CUMBERLAND’s 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 CUMBERLAND’s 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 CUMBERLAND’s 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 CUMBERLAND’s 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 CUMBERLAND’s claim of non-conformity be sustained by the testing organization, BIONICHE shall, at CUMBERLAND’S 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 CUMBERLAND’s 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 BIONICHE’s 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, BIONICHE’s 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 BIONICHE’s 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 CUMBERLAND’s 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 BIONICHE’s 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 CUMBERLAND’s 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, CUMBERLAND’S SUCCESSORS OR ASSIGNS OR ANY THIRD PARTY WITH RESPECT TO ANY CLAIM ARISING FROM CUMBERLAND’S OR ANY THIRD PARTY’S 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 CUMBERLAND’s 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 CUMBERLAND’S 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, CUMBERLAND’s 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 CUMBERLAND’s 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 CUMBERLAND’s 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 BIONICHE’s 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 CUMBERLAND’s request and expense, take such actions and execute such documents as necessary or desirable, in CUMBERLAND’s sole judgment, to create, maintain, enforce or defend CUMBERLAND’s 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 attorney’s 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) CUMBERLAND’s 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 attorney’s 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 BIONICHE’s manufacture or handling of the Drug Product otherwise than in accordance with the Specifications and CUMBERLAND’S written directions; (iii) BIONICHE’s 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):
             
    If to CUMBERLAND:   CUMBERLAND PHARMACEUTICALS INC.
 
           
 
          209 Tenth Avenue South, Suite 332
 
          Nashville, Tennessee 37203
 
          Attn: Chief Executive Officer
 
          Telephone:          615-255-0068
 
          Facsimile:            615-255-0094
 
           
    If to BIONICHE:   BIONICHE LIFE SCIENCES, INC.
 
          231 Dundas Street East,
 
          Belleville, Ontario, Canada K8N 1E2
 
          Attn: Chief Executive Officer
 
          Telephone:          800-265-5464
 
          Facsimile:            613-966-4177
 
           
    With a copy to:   BIONICHE PHARMA (CANADA) LIMITED
 
          151 Dundas Street, Suite 507
 
          London, Ontario, Canada N6A 5R7
 
          Attn: President
 
          Telephone:          519-453-0641
 
          Facsimile:            519-453-6169
 
           
    And to:   BIONICHE LIFE SCIENCES, INC.
 
          Attn: Vice President, Corporate Counsel
 
          Telephone:          800-265-5464
 
          Facsimile:            613-966-4177
     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.
                     
CUMBERLAND PHARMACEUTICALS INC.       BIONICHE LIFE SCIENCES, INC.    
 
                   
/s/
  A. J. Kazimi       /s/   Albert Beraldo    
 
                   
Authorized Signature   Authorized Signature    
 
A.J. Kazimi       Albert Beraldo    
Chief Executive Officer       Vice President, Business Development    

 


 

SCHEDULE I
Shipping and Storage
  1.   Finished Drug Product shall be stored by BIONICHE after completion, at 20 degrees C to 25 degrees C.
 
  2.   Drug product will be delivered by BIONICHE to CUMBERLAND by air on the basis of FCA (ex works) ex works BIONICHE’s plant in Galway, Ireland with the carrier to be selected by CUMBERLAND.
 
  3.   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.
 
  4.   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 firm’s 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:
I.   Purpose.
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 GMP’s or other relevant equivalent cGMP’s, agreed by Bioniche and Cumberland.
1.1 Product
     Bioniche will supply Cumberland with Products, as follows:
         
  1.1.1    
Acetadote® — Acetylcysteine Injection
       
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.
II.   General Quality Issues
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.
III.   Specifications.
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.   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 Bioniche’s 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 Bioniche’s 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:
    The name and dosage form of the medicinal product.
 
    The batch number or test number of the API and all other raw materials (excluding water).
 
    The date of manufacture and the Product’s batch number.
 
    Details of the amounts of Product manufactured during each operation and the quantity of the Product in the various stages.
 
    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.
 
    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.
 
    Special observations made during manufacturing.
 
    Certification that the process operating lines have been cleared, at the beginning of the batch processing.
 
    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.   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
VI.   Quality Audit
During normal working hours and upon reasonable notice, Cumberland shall be entitled to inspect such areas of Bioniche’s 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.   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 Cumberland’s responsibility to notify Bioniche of such reports, if such reports relate to Bioniche’s 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.   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.
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Technical Agreement Rev 1             5th April 2005
Bioniche/Cumberland
IX.   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.
X.   Modifications
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.
         
  Bioniche Teoranta
 
 
  By:   /s/ Andrew Hall    
         
     
  Date:   5th April 2005  
       
       
 
         
  Andrew Hall BSc(Hons) M.RS.C. M.I.Q.A
Director Of Quality and Qualified Person


Cumberland Pharmaceuticals Inc.
 
 
  By:   /s/ Leo Pavliv    
         
     
  Date:   26 April 2005  
       
    Leo Pavliv
Vice President Operations 
 
 
6

 


 

Technical Agreement Rev 1             5th April 2005
Bioniche/Cumberland
Exhibit I
DETAILED RESPONSIBILITES
X = Responsible
A = Approval/Authority
             
        BIONICHE   CUMBERLAND
     1
  SPECIFICATIONS/DOCUMENTATION        
  1.1
  Specification of Active Bulk Ingredient   X   A
  1.2
  Master Manufacturing Formula   X   A
  1.3
  Product Lot Identification System   X    
  1.4
  Specification of Inactive Ingredients   X   A
  1.5
  Test Method for ID of Active Bulk   X    
  1.6
  Test Method for Inactive Ingredients   X    
  1.7
  Test Method for Release of Product   X    
  1.8
  Local Manufacturing and Packaging Instructions   X    
  1.9
  Specification for In-Process Control   X    
1.10
  Change Control for Active Ingredient   X   A
1.11
  Change Control for Manufacturing Formulas   X   A
1.12
  Change Control for Inactive ingredients   X   A
1.13
  Bulk product package specification, box & labels   X    
1.14
  Finished Artwork   A   X
1.15
  Change Control for Artwork/Finishing Materials   X   A
 
           
     2
  PRODUCTION        
  2.1
  Procurement of Bulk Active ingredient   X    
  2.2
  Purchase Inactive Substances   X    
  2.3
  Store Active/Inactive Substances   X    
  2.4
  Sample/Test/Acceptance of Active & Inactive Substances   X    
  2.5
  Test Method Transfer   N/A    
  2.6
  On-Going Stability Testing of Product   X    
  2.7
  Retention of Certificate of Analysis for Active Substance   X    
  2.8
  Validation of Manufacturing Processes   X    
  2.9
  Bills of Material for Manufacturing Process   X    
2.10
  In Process Control Instructions and Testing   X    
2.11
  Batch Record Reconciliation   X    
2.12
  Batch Record Retention   X    
2.13
  Retention of Samples of Active Ingredient   X    
2.14
  Retention of Samples of other Materials (Except water)   X    
2.15
  Retention of Samples of Product   X    
2.16
  Maintenance of Pharmaceutical Manufacturing Licenses   X    
2.17
  Disposal of Waste   X    
7

 


 

Technical Agreement Rev 1             5th April2005
Bioniche/Cumberland
             
        BIONICHE   CUMBERLAND
3.0
  TESTING & RELEASE OF FINISHED PRODUCT        
3.1
  Analysis of Product   X    
3.2
  Certificate of Analysis for the Product   X    
3.3
  Internal QP certification of the Product as per approved production and control documents   X    
3.4
  Final QP Release of the product to Cumberland   X    
3.5
  Complaint        
 
  - Collection and Logging   X   X
 
  - Investigation and Report Issue   X    
 
  - Follow Up Corrective Action   X    
 
  - Response to Customer       X
3.6
  Product Recall        
 
  - Decision to Initiate Recall   X   X
 
  - Approval of Notification Wording   X   X
 
  - Management of Recall   X   X
 
  - Reconciliation of Returned Product   X   X
3.7
  Liaison with Regulatory Authorities for Approval, Maintenance and Updating Marketing Authorisations/Product Authorisations (NDA)       X
 
           
3.8
  Final Release to Market       X
8

 


 

     Technical Agreement Rev 1             5th April 2005 Bioniche/Cumberland
Exhibit II
Qualified Person
(14th January 2004)
Qualified Persons of Bioniche Teoranta
         
Mr. A. Hall      
  Signature : /s/ Andrew Hall    
     
     
 
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:
  1.   Paragraph 1.7 is amended and restated in its entirety as follows:
 
      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.
 
  2.   Paragraph 1.9 is hereby amended and restated as follows:
 
      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.
 
  3.   Paragraph 1.18 defines TERRITORY as having the meaning set forth in Schedule III. Schedule III of the Agreement, and therefore the TERRITORY, is hereby amended and restated as follows:
 
      The United States of America and all its possessions and territories, and Australia.

 


 

  4.   Paragraph 3.1 is amended and restated in its entirety as follows:
 
      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.
 
  5.   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).
 
  6.   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.)
 
  7.   Subparagraph 5.6(a) is amended and restated in its entirety as follows:
 
  (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 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.
 
  8.   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:
 
  (b)   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.
  9.   Paragraph 5.7 is amended and restated in its entirety as follows:
 
      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.
 
      Schedule V of the Agreement is hereby stated as follows:
 
      CUMBERLAND’s annual minimum purchase requirements shall be ***% of the average actual purchases for the prior three (3) years.
  10.   Paragraph 11.1 is amended by replacing the address for notice (and relevant copies) for CUMBERLAND and BIONICHE, as follows:
             
    If to CUMBERLAND:   CUMBERLAND PHARMACEUTICALS INC.
 
          2525 West End Avenue, Suite 950
 
          Nashville, Tennessee 37203
 
          Attn: Chief Executive Officer
 
          Telephone:          615-255-0068
 
          Facsimile:            615-255-0094
 
           
    If to BIONICHE:   BIONICHE TEORANTA
 
          Inverin,
Co. Galway,
 
          Ireland
 
          Attn: Managing Director
 
          Telephone:          +353 91 593202
 
          Facsimile:            +353 91 593228
  11.   Miscellaneous.
 
      (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.
 
      (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.
             
    CUMBERLAND:    
 
           
    CUMBERLAND PHARMACEUTICALS INC.    
 
           
 
  By:   /s/ A.J. Kazimi    
 
           
 
           
 
  Title:   Chief Executive Officer    
 
           
 
  Date:   December 13, 2006    
 
           
 
           
    BIONICHE:    
 
           
    BIONICHE TEORANTA    
 
           
 
  By:   /s/ John Kavanagh    
 
           
 
           
 
  Title:   Managing Director    
 
           
 
  Date:   November 16, 2006    
 
           

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
         
Article I
  Definitions and References to Cardinal Health   Page 3
Article II
  Appointment of Cardinal Health; General Scope of Activities   Page 5
Article III
  Compensation   Page 8
Article IV
  Representations, Warranties and Covenants   Page 9
Article V
  Status of Cardinal Health and the Representatives   Page 10
Article VI
  Training   Page 11
Article VII
  Samples   Page 11
Article VIII
  Trademarks and Intellectual Property Rights   Page 12
Article IX
  Communications; Monitoring the Program   Page 12
Article X
  Insurance   Page 13
Article XI
  Adverse Reaction Reporting and Regulatory Matters   Page 14
Article XII
  Return/Recall   Page 15
Article XIV
  Term and Termination   Page 16
Article XV
  Recordkeeping; Audit Rights   Page 18
Article XVI
  Indemnification   Page 18
Article XVII
  Notice   Page 21
Article XVIII
  Miscellaneous   Page 21
Schedule 1.1(k)
  List of Products   Page 25
Schedule 1.1(0)
  Definition of Territory   Page 26
Schedule 3.1
  Service Fees and Payment Schedule   Page 27

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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 Cumberland’s 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 Representative’s or Manager’s 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 Health’s policies and procedures, as determined by Cardinal Health’s 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 Cumberland’s 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.

-5-


 

          (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 Health’s 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 Cumberland’s sole discretion.
     2.5. Representatives’ Activity
     (a) Subject to Cumberland’s 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 Cumberland’s request for reassignment or termination other than a request pursuant to Section 2.5(b) or resulting from the Representative’s 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 Cumberland’s 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 Cumberland’s 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 party’s 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 worker’s 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 Health’s 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 Cumberland’s 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, Cumberland’s sales training and marketing personnel to assist Cardinal Health’s 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 Cumberland’s 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 Health’s 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 Cumberland’s 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 Cumberland’s 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 Cumberland’s 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 Cumberland’s 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.   Worker’s 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.   Worker’s 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 Cumberland’s 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 Health’s out-of-pocket shipping costs arising from its handling of such returned Products within 30 days of delivery to Cumberland of Cardinal Health’s statement for such costs. Upon request Cardinal Health shall provide Cumberland with documentation relating to such costs.
          (b) At Cumberland’s 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 Health’s statement for such costs.
ARTICLE XIII
CONFIDENTIAL INFORMATION
13.1 Mutual Obligation. Cardinal Health and Cumberland agree that they will not disclose the other party’s 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 party’s 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 party’s 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 party’s 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 party’s 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 Cumberland’s request, the parties shall discuss in good faith an appropriate phase-out of Cardinal Health’s 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 Cumberland’s 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 Cumberland’s reasonable request made during or within one (1) year after the term of this Agreement, and at Cumberland’s expense, Cardinal Health shall permit Cumberland’s 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 Health’s 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 Health’s 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 Cumberland’s 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) Cumberland’s 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) Cumberland’s 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;

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     (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) Cumberland’s 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 Health’s 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 lndemnitee’s 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 Health’s 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):
         
 
  To Cumberland:   A.J. Kazimi, CEO
 
      Cumberland Pharmaceuticals Inc.
 
      2525 West End Avenue, Suite 950
 
      Nashville, Tennessee 37203
 
      Facsimile (615) 255-0094
 
       
 
  With a copy to:   Adams and Reese / Stokes Bartholomew LLP
 
      424 Church Street, Suite 2800
 
      Nashville, Tennessee 37219
 
      Attn. Martin S. Brown, Jr.
 
      Facsimile (615) 259-1470
 
       
 
  To Cardinal Health:   Cardinal Health PTS, LLC
 
      7000 Cardinal Place
 
      Dublin, Ohio 43017
 
      Attn: Thomas Dimke, SVP/GM
 
      Cardinal Health Contract Sales and Services
 
      Facsimile: (614) 757-6117
 
       
 
  With a copy to:   Cardinal Health, Inc.
 
      7000 Cardinal Place
 
      Dublin, Ohio 43017
 
      Attn: Associate General Counsel,
 
      Pharmaceutical Technologies and Services
 
      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 party’s 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 attorney’s 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 party’s 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 Health’s 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 party’s performance hereunder if such default or delay is caused by events beyond such party’s 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 party’s 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.
                 
CARDINAL HEALTH PTS, LLC       CUMBERLAND PHARMACEUTICALS INC.
 
               
By:
  /s/ Thomas G. Dimke       By:   /s/ AJ Kazimi
 
               
Name:
  Thomas G. Dimke       Name:   AJ Kazimi
Title:
  SVP/GM HCSS       Title:   C.E.O.
Date:
  5-18-06       Date:   5-17-06

-23-


 

Schedule 1.1(k)
List of Products
CeraLyte®
Kristalose®

-24-


 

Schedule 1.1(o)

Definition of Territory
The mutually agreed upon headquarter locations for the twenty four representatives are as follows:
 
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:
     
Invoice Date   Payment
September 30, 2006
  $258,482.00
October 31, 2006
  $258,482.00
November 30, 2006
  $258,482.00
December 31, 2006
  $258,482.00
January 31, 2006
  $258,482.00
February 28, 2006
  $258,482.00
March 31, 2006
  $258,482.00
April 30, 2007
  $258,482.00
May 31, 2007
  $258,482.00
June 30, 2007
  $258,482.00
July 31, 2007
  $258,482.00
August 31, 2007
  $258,482.00
September 30, 2007
  $258,482.00
October 31, 2007
  $258,482.00
November 30, 2007
  $258,482.00
December 31, 2007
  $258,482.00
January 31, 2008
  $258,482.00
February 28, 2008
  $258,482.00
March 31, 2008
  $258,482.00
April 30, 2008
  $258,482.00
May 31, 2008
  $258,482.00
June 30, 2008
  $258,482.00
July 31, 2008
  $258,482.00
August 31, 2008
  $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)   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
 
  (ii)   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.

-27-


 

     D. Performance Incentive. Cardinal Health shall be eligible to receive a Performance Incentive based upon Cardinal Health’s 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.
1.   Amendments.
  A.   Section 2.1 of the agreement is hereby amended to the add the following to the end of Section 2.1:
 
      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.
 
  B.   Section 2.2 of the Agreement is hereby amended to add the following to the end of Section 2.2:
 
      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.
 
  C.   Schedule 3.1 is hereby amended to add the following at the end:
 
      SYNDICATED SALES FORCE
 
      Cardinal Health’s 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


 

      Detailing of all required Products (i.e., where Target Customers will not listen to all Details).
 
      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:
     
Month   Invoice Amount
July, 2006
  37,500
August
  37,500
September
  37,500
October
  37,500
November
  37,500
December
  37,500
January, 2007
  37,000
February
  37,500
March
  37,500
April
  37,500
May
  37,500
June, 2007
  37,500
 
   
 
$450,000  
      Cardinal Health will invoice Cumberland the amount set forth in the above table on the last day of each month for service fees.
 
      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.
    The following expenses shall be direct pass-through to Cumberland for the syndicated program:
 
    Actual travel expenses for all required participation in any subsequent POA meetings.
 
    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.
 
2.   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.

2


 

                     
    CUMBERLAND PHARMACEUTICALS, INC.       CARDINAL HEALTH PTS, LLC.
 
                   
 
  By:   /s/ James D. Aderhold, Jr       By:   /s/ Thomas G. Dimke
 
                   
 
  Name:   James D. Aderhold, Jr       Name:   Thomas G. Dimke
 
  Title:   V-P       Title:   SVP/GM
 
  Date:   7/13/06       Date:   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 Health’s 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 Corporation’s 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.
         
  INVENTIV COMMERCIAL
SERVICES, LLC

 
 
  By:   /s/ Paul Mignon    
    Name:   Paul Mignon   
    Its: President & COO [illegible]   
 
         
  CUMBERLAND PHARMACEUTICALS INC.
 
 
  By:   /s/ Jean W. Marstiller    
    Name:   Jean W. Marstiller   
    Its: Senior Vice President,
      Administrative Services 
 
 

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 Cumberland’s 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. CORD’s 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 CORD’s 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 Cumberland’s 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 Product’s 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 CORD’s procedures or requirements which are unique and specific to the Product or the Services resulting in a material increase to CORD’s 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 CORD’s 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 CORD’s 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 CORD’s information system development (separate from the Information System Access Fees described below) and implementation for Cumberland’s 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. Cumberland’s 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 Cumberland’s access to CORD’s or an affiliate of CORD’s 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 Cumberland’s 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 Cumberland’s 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 Cumberland’s 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 Cumberland’s information systems located at Cumberland’s 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 CORD’s 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 CORD’s 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 Party’s 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 Party’s 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 CORD’s 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.

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     (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 CORD’s 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 attorney’s 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 CORD’S LIABILITY HEREUNDER EXCEED CORD’S 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 CORD’s 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 CORD’S 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.

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     §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 side’s 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 Party’s 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 Party’s 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 it’s 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.
     
CUMBERLAND PHARMACEUTICALS, INC.
  CORD LOGISTICS, INC.
 
   
/s/ A.J. Kazimi
  /s/ Frank C. Wegerson
 
   
A.J. Kazimi
  Frank C. Wegerson
Chief Executive Officer
  Vice President and General Manager
Initials: /s/ AJK
  Initials: /s/ FCW
 
   
209 10th Avenue South
  15 Ingram Blvd, #100
Nashville, TN 37203
  LaVergne, TN 37086
 
   
Facsimile No. (615) 255-0094
  Facsimile No. (615) 793-4783

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          Schedule 8 (c) -1
OPERATING SYSTEM BASE PACKAGE
A. System Access
Includes access to CORD’s 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 CORD’s or an affiliate of CORD’s standard software. CORD or an affiliate of CORD shall perform at it’s own expense any necessary modification to bring the systems in compliance with the standard functionality described below.
  Customer service
  Reports necessary to perform Medicaid rebate calculations
  Billing (Customization of invoicing/packing slips)
  Inventory tracking and reporting
  Lot tracking
  Order entry
  Warehousing
  Returns processing
  Ability to download system data to Cumberland’s processors for reporting writing
  All standard reports
  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:
  Systems and software development—$120 per hour per person, plus travel.
  On-site training—$120 per hour per person, plus travel.
  Supplies, equipment and other, to be agreed upon by both parties.

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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 Licensor’s 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 Licensee’s 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 Licensor’s 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 Licensee’s 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 LICENSEE’S 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 Licensor’s 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 Licensee’s 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

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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 Licensee’s data relating to its pre-termination operations, and Licensor shall reasonably cooperate with Licensee to preserve the integrity and accessibility of Licensee’s 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 party’s 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.
                 
CUMBERLAND PHARMACEUTICALS, INC.       CORD LOGISTICS, INC.
 
               
By:
  /s/ A.J. Kazimi       By:   /s/ Frank C. Wegerson
 
               
 
  A.J. Kazimi           Frank C. Wegerson
 
  Chief Executive Officer           Vice President and General Manager
 
  Initials: /s/ AJK           Initials: /s/ FCW
 
               
209 10th Avenue South, Suite 332       15 Ingram Blvd., #100
Nashville, TN 37203       LaVergne, TN 37086
 
               
Facsimile No. (615) 255-0094       Facsimile No. (615) 793-4783

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Exhibit A
CUMBERLAND PHARMACEUTICALS
PROPOSED FEE SCHEDULE
         
Program Implementation
       
One Time Start-up Fee
  $ * **
 
       
Distribution Services
       
Monthly per pallet ambient storage
  $ * **
Per bottle ambient product pick/pack/stage — first bottle (1)
  $ * **
Per bottle ambient product pick/pack/stage — each add’l bottle (1)
  $ * **
Per case ambient product pick/pack/stage — first case (1)
  $ * **
Per case ambient product pick/pack/stage — each add’l case (1)
  $ * **
Per unit return goods processing
  $ * **
Monthly distribution system access and use (2)
  $ * **
Monthly account management fee
  $ * **
Packing/Shipping Supplies
  Cost plus ***% handling fee
(includes ordering, receiving, storage)
       
Shipping Charges (3)
  List minus ***%
 
       
Customer Service
       
Monthly fixed fee
  $ * **
Per order fee
  $ * **
Preprinted Forms
  Cost plus ***% handling fee
 
       
Financial Services
       
Monthly fixed fee Accounts Receivable Management
  $ * **
Per order fee Accounts Receivable Management
  $ * **
Monthly fixed fee Chargeback Management
  $ * **
Per submission Chargeback Processing & Government Reporting
  $ * **
Preprinted Forms
  Cost plus ***% handling fee
     
Note (1):
  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.
 
   
Note (2):
  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.
 
   
Note (3):
  List minus ***% is incorporated to UPS and FedEx rates only, all other freight carriers will be billed back at cost plus ***%.
 
   
Note (4):
  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 CUMBERLAND’s 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 CUMBERLAND’s 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 CUMBERLAND’s 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 CUMBERLAND’s 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 CUMBERLAND’s 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 CUMBERLAND’s 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. CUMBERLAND’s 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 FAULDING’s 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

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CUMBERLAND’s 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 FAULDING’s 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 CUMBERLAND’s 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.

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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 FAULDING’s manufacturing facility and makes an inquiry regarding FAULDING’s 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 FAULDING’s 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 CUMBERLAND’s 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

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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 CUMBERLAND’s 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, CUMBERLAND’s 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 CUMBERLAND’s 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

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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 CUMBERLAND’s 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 FAULDING’s 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:

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     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 CUMBERLAND’s 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 CUMBERLAND’s 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

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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 FAULDING’s 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

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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, attorney’s 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) CUMBERLAND’s 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

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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 attorney’s 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 FAULDING’s manufacture or handling of the Drug Product otherwise than in accordance with the Specifications and CUMBERLAND’S written directions; (iii) FAULDING’s 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 FAULDING’s advisers for review at FAULDING’s 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 FAULDING’s advisers for review at FAULDING’s 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 CUMBERLAND’S 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):
             
    If to CUMBERLAND:   Cumberland Pharmaceuticals Inc.
        209 Tenth Avenue South, Suite 332
        Nashville, Tennessee 37203
        Attn: Chief Executive Officer
 
      Telephone:   615-255-0068
 
      Facsimile:   615-255-0094
 
           
    If to FAULDING:   F.H. Faulding & Co. Limited
        115 Sherriff Street
        Underdale, South Australia 5032
        Attn: Company Secretary
 
      Telephone:   61-8-8205-6500
 
      Facsimile:   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

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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.
             
CUMBERLAND PHARMACEUTICALS INC.
      F.H. FAULDING & CO. LIMITED    
 
           
/s/ A.J. Kazimi
      /s/ Alex Bell    
 
Authorized Signature
     
 
Authorized Signature
   
Printed Name
      Printed Name    
 
           
A.J. Kazimi
      Alex Bell    
 
           
Printed Name
      Printed Name    
 
      Title    
 
           
CEO
      V.P. Tech Ops.    
 
           
Title
           

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:
     
Product -
  Amelior™. Ibuprofen for intravenous injection.
 
   
Timing -
  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.
 
   
Special Issues -
  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.
 
   
cGMP or GMP -
  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.
 
   
Storage -
   
1.   FAULDING shall store and handle Bulk Drug Substance and finished Drug Product at 20E to 25E C.
Composition, Process & Container
[***]

15


 

     
Preparation -
  Additional details regarding preparation shall be incorporated herein upon adoption thereof by written agreement of FAULDING and CUMBERLAND.
 
   
[***]
   
 
   
Disposal -
  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 FAULDING’s 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 –
1.   Master batch record for review and approval by FAULDING and CUMBERLAND.
 
2.   Product specific validation summaries.
 
3.   Executed batch records.
 
4.   Analytical records.
 
5.   Inventory records.
 
6.   Disposal records.
     
Compensation -
  The price to be paid by CUMBERLAND to FAULDING for the satisfactory performance of its obligations under this Agreement are as follows:
 
   
[***]
   
     
Reimbursement of Development Costs -
  CUMBERLAND shall reimburse FAULDING for development costs incurred and approved as agreed by the parties.
 
   
Reimbursement of Regulatory Costs -
  CUMBERLAND shall reimburse FAULDING for regulatory costs incurred and approved as agreed by the parties.
 
   
Reimbursement of Inspection and Audit
Costs -
  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”))
             
        Responsibility
Documentation/Activity   FHF   CPI   Comments
GMP certificate and other permits
  /        
 
           
Active Pharmaceutical Ingredient (“API”)
           
 
           
Supply of API
  /       CPI to identify source
 
           
Provide specifications
      /    
 
           
Approval of API specifications
  /   /    
 
           
Provide sampling and testing methods
      /    
 
           
Approval of sampling and testing methods
  /   /    
 
           
Sampling and testing
  /        
 
           
Release
  /        
 
           
Storage of samples
  /        
 
           
Storage of documents
  /   /    
 
           
Starting Materials (except API)
           
 
           
Supply of starting materials
  /       CPI to identify arginine source
 
           
Provide specifications of starting materials
      /    
 
           
Approval of starting materials specifications
  /   /    
 
           
Providing sampling and testing methods
  /        
 
           
Approval of sampling and testing materials
  /   /    
 
           
Sampling and testing
  /        
 
           
Release
  /        
 
           
Storage of samples
  /        
 
           
Storage of documentation
  /   /    
 
           
Manufacturing Formula
           
 
           
Development of manufacturing formula
  /   /    
 
           
Approval of manufacturing formula
  /   /    
 
           
Processing Instructions
           
 
           
Development of processing instructions
  /        
 
           
Approval of processing instructions
  /   /    

17


 

             
    FHF   CPI   Comments
Bulk Product
           
 
           
Supply of Bulk Product
  /        
 
           
Provide specifications of Bulk Product
  /   /    
 
           
Approval of Bulk Product specifications
  /   /    
 
           
Providing sampling and testing methods
  /        
 
           
Approval of sampling and testing methods
  /   /    
 
           
Sampling and testing
  /        
 
           
Release
  /        
 
           
Storage of samples
  /        
 
           
Prepare stability data for Bulk Product
  /        
 
           
Storage of documentation
  /        
 
           
Packaging
           
 
           
Supply of packaging materials
  /        
 
           
Provide packaging materials specifications
  /        
 
           
Approval of specifications
  /        
 
           
Providing sampling and testing methods
  /        
 
           
Approval of sampling and testing methods
  /   /    
 
           
Sampling and testing
  /        
 
           
Release
  /        
 
           
Storage of samples
  /        
 
           
Storage of documentation
  /   /    
 
           
Batch Processing Records
           
 
           
Preparation of batch processing records
  /        
 
           
Review of batch processing records
  /        
 
           
Release of batch processing records
  /   /    
 
           
Storage of batch processing records
  /   /    
 
           
Product
           
 
           
Providing sampling and testing methods
  /        
 
           
Approval of sampling and testing methods
  /   /    
 
           
Sampling and testing
  /        
 
           
Release
  /        
 
           
Storage of samples
  /        
 
           
Storage of documentation
  /   /    
 
           
Prepare stability data for Product
  /        

18


 

Supply of Materials
             
        Supplier (check one):
Documentation/Activity   FHF   CPI   Comments
Starting Materials
           
 
           
Active Pharmaceutical Ingredient
  /       CPI will identify source
 
           
Other Starting Materials
           
 
           
(Auxiliaries, fluids, gases, etc.):
           
 
           
Excipients
  /        
 
           
WFI
  /        
 
           
N2
  /        
 
           
Packaging Materials
           
 
           
Vials
  /        
 
           
Stoppers
  /        
 
           
Seals
  /        
 
           
Boxes
  /        
 
           
Shippers
  /        
 
           
Labeling
  /        
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:
             
        Supplier (check one):
Documentation/Activity   FHF   CPI   Comments
Active Pharmaceutical Ingredient
           
 
           
Providing sampling and testing methods
  /   /    
 
           
Approval of sampling and testing methods
  /   /    
 
           
Sampling and testing
  /        
 
           
Release
  /        
 
           
Storage of samples
  /        
 
           
Storage of documentation
  /   /    
 
           
Starting Materials (except API)
           
 
           
Providing sampling and testing methods
  /   /    
 
           
Approval of sampling and testing methods
  /   /    

19


 

             
        Supplier (check one):
Documentation/Activity   FHF   CPI   Comments
Sampling and testing
  /        
 
           
Release
  /        
 
           
Storage of samples
  /        
 
           
Storage of documentation
  /        
 
           
Bulk Product
           
 
           
Providing sampling and testing methods
  /        
 
           
Approval of sampling and testing methods
  /   /    
 
           
Sampling and testing
  /        
 
           
Release
  /        
 
           
Storage of samples
           
 
           
Storage of documentation
  /   /    
 
           
Prepare stability data for Bulk Product
  /   /    
 
           
Packaging Materials
           
 
           
Providing sampling and testing methods
  /        
 
           
Approval of sampling and testing methods
  /   /    
 
           
Sampling and testing
  /        
 
           
Release
  /        
 
           
Storage of samples
  /        
 
           
Storage of documentation
  /   /    
             
    FHF   CPI   Comments
Batch Documentation
           
 
           
Assignment of batch numbers
  /        
 
           
Preparation of batch processing records
  /        
 
           
Review of batch processing records
      /    
 
           
Release of batch processing records
  /        
 
           
Storage of batch processing records
  /   /    
 
           
Product
           
 
           
Providing sampling and testing methods
  /        
 
           
Approval of sampling and testing methods
  /   /    
 
           
Sampling and testing
  /        
 
           
Release
  /        
 
           
Storage of samples
           
 
           
Storage of documentation
  /   /    
 
           
Prepare stability data for Product
  /        

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
         
1. DEFINITIONS
    1  
 
       
2. REGULATORY APPROVAL, MARKETING AND DISTRIBUTION
    6  
 
       
3. TERM AND TERMINATION
    16  
 
       
4. PAYMENTS
    18  
 
       
5. CONFIDENTIALITY
    20  
 
       
6. PROTECTION AND OWNERSHIP OF INTELLECTUAL PROPERTY
    22  
 
       
7. REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION
    23  
 
       
8. GENERAL
    27  
 
       
9. ARBITRATION
    29  
 
       
EXHIBIT A — Minimum Purchases
       
 
       
EXHIBIT B — Patents
       
 
       
EXHIBIT C — Transition Plan
       
 
       
EXHIBIT D — Specifications
       
 
       
EXHIBIT E — Adverse Event Reporting
       
 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.
 
1.3   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.
 
1.4   Calendar Quarter shall mean each three (3) month period ending March 31, June 30, September 30, and December 31.
 
1.5   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.
 
1.6   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.
 
1.7   Confidential Information shall have the meaning set forth in Subsection 5.1(A) hereof.
 
1.8   Delivery Date is the date of delivery for Products agreed to by the parties.
 
1.9   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.
 
1.10   FDA shall mean the U.S. Food and Drug Administration.
 
1.11   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.
 
1.12   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   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.
 
1.14   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.
 
1.15   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 CUMBERLAND’s prior written approval.
 
1.16   Laws shall mean:
  (i)   all constitutions, treaties, laws, statutes, codes, ordinances, orders, decrees, rules, regulations, and municipal by-laws, whether domestic, foreign or international;
 
  (ii)   all judgments, orders, writs, injunctions, decisions, rulings, decrees, and awards of any Governmental Body; and
 
  (iii)   all policies, practices and guidelines of any Governmental Body;
    in each case binding on or affecting the party or Person referred to in the context in

3


 

    which such word is used; and “Law” shall mean any one of them.
1.17   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.
 
1.18   Minimum Purchases shall mean the minimum number of commercial pouches of the Product that CUMBERLAND must purchase, as set forth in Exhibit A.
 
1.19   Mylan shall have the meaning set forth in Section 2.5(A).
 
1.20   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.
 
1.21   Order is defined in Section 2.6(C).
 
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.
 
1.23   Person shall mean an individual, corporation, company, co-operative, partnership, organization or any similar entity.
 
1.24   Product shall mean INALCO’s 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.
 
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.
 
1.26   Product Payments shall have the meaning set forth in Section 4.3.
 
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.
 
1.28   Regulatory Approval(s) shall mean all approvals, licenses, registrations, or authorizations

4


 

  of any Competent Authority necessary for the manufacturing, marketing, distribution and/or sale of the Product in the Territory.
 
1.29   Royalty Payment shall have the meaning set forth in Section 4.2.
 
1.30   Subcontractor shall mean a Third Person to whom either party hereto has delegated responsibilities under this Agreement.
 
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.
 
1.32   Term shall mean the term of this Agreement, as set forth in Section 3.1.
 
1.33   Territory shall mean the U.S., subject to potential modifications pursuant to Section 4.2, Exhibit A, and the following understandings:
  (a)   As of the Effective Date of this Agreement, INALCO does not have Regulatory Approval for the Product in Canada.
 
  (b)   INALCO cannot guarantee that Regulatory Approval will be granted for the Product in Canada.
 
  (c)   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.
 
  (d)   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   Third Person shall mean any Person other than one of the parties hereto or an Affiliate or Subsidiary of one of the parties hereto.
 
1.35   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®.
 
1.36   U.S. shall mean the United States of America and each of its territories and possessions.

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1.37   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.
 
1.38   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 INALCO’s 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.
 
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.

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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 Mylan’s commitment to processing and payment of rebates, returns and chargebacks for Product sold by Mylan. The transition plan shall also include Mylan’s 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.
 
  B.   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.
 
  C.   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.
 
  D.   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.
 
  E.   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

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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.
 
  F.   Product Specifications. INALCO shall manufacture all Product in compliance with (i) the Product DMF as submitted to the FDA, (ii) the FDA’s 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 CUMBERLAND’s 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.
 
  G.   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.
 
  H.   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.
 
  I.   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).
 
  J.   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.

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2.6   Certain Responsibilities of CUMBERLAND.
  A.   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.
 
  B.   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 INALCO’s 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.
 
  C.   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.
 
  D.   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.
 
  E.   Minimum Purchases. CUMBERLAND agrees to meet Minimum Purchases annually in accordance with Exhibit A.
 
  F.   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.
 
  G.   Compliance. CUMBERLAND shall market, distribute, and sell the Product in the Territory in accordance with applicable Laws.

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  H.   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.
 
  I.   Interaction with DDMAC. CUMBERLAND shall be responsible for interacting with the FDA Division of Drug Marketing, Advertising and Communication regarding the Product.
 
  J.   Formulary Listings. CUMBERLAND shall be responsible for filing and maintaining Listings to obtain formulary listing approval from states or localities in the Territory.
 
  K.   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.
 
  L.   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.
 
  M.   Non-Compete Obligation. CUMBERLAND will not without INALCO’s prior written approval, itself promote, sell or distribute in the Territory during the Term hereof, any laxative product which competes with the Product.
 
  N.   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   Certain Responsibilities of Both Parties.
  A.   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 CUMBERLAND’s or INALCO’s 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.
 
  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

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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 CUMBERLAND’s Approval to Ship form, packing slip, Certificate of Analysis, and any required FDA shipment notification.

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  B.   Following receipt of CUMBERLAND approval to ship, INALCO will deliver the Products to CUMBERLAND F.O.B. the facility of INALCO’s 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 INALCO’s 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 INALCO’s election and expense be either:
  a.   returned to INALCO, and packed and shipped according to

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      instructions provided by INALCO; or
 
  b.   destroyed by CUMBERLAND under INALCO’s 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.
2.11   Product Warranties:
  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.
  B.   Product Defects:
  (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.

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  (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
3.1   Term.
  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 (15‘h) 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

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      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 CUMBERLAND’s 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.

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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,

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    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 INALCO’s request and expense, provide certified statements from CUMBERLAND’s 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 CUMBERLAND’s 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 INALCO’s 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 INALCO’s 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.

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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 Recipient’s 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 party’s 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 CUMBERLAND’s 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 INALCO’s 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 CUMBERLAND’s 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 CUMBERLAND’s 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 INALCO’s 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 INALCO’s 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 counsel’s 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


 

  C.   the Agreement constitutes a valid and binding obligation by each of INALCO ITALY and INALCO U.S., enforceable in accordance with its terms; and
 
  D.   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:
  (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 INALCO;
 
  (ii)   violate any provision of, or require any consent, authorization, or approval under, any Law applicable to INALCO; or
 
  (iii)   conflict with, result in a breach of, or constitute a default under, any material agreement or obligation to which INALCO is a party.
  E.   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;
 
  F.   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;
 
  G.   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;
 
  H.   INALCO has licensed to CUMBERLAND all Intellectual Property Rights necessary for CUMBERLAND to perform its obligations under this Agreement;
 
  I.   INALCO has not granted to any other Person in the Territory the rights it is granting to CUMBERLAND hereunder in respect of the Product;
 
  J.   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;
 
  K.   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


 

      marketing and sales of the Product in the Territory may be adversely affected in any material respect; and
 
  L.   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 INALCO’s 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 INALCO’s knowledge.
7.3   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.
 
7.4   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.
 
7.5   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


 

    defense and settlement of which shall be under the complete control of the Indemnitor; provided, however, that such settlement shall not adversely affect the Indemnitee’s 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   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.
 
    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.
 
8.2   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):
     
If to CUMBERLAND:
  If to INALCO U.S.:
 
   
Cumberland Pharmaceuticals Inc.
  Inalco Biochemicals, Inc.
2525 West End Ave., Suite 950
  3440 Empresa Drive, Suite A
Nashville, Tennessee 37203
  San Luis Obispo, CA 93401
Fax: 615-255-0094
  Fax: 805-782-0719
Attn: Chief Executive Officer
  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   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.
 
8.4   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 CUMBERLAND’s 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.
 
8.5   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.
 
8.6   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.
 
8.7   Successors in Interest. This Agreement shall inure to the benefit of and be binding on the parties’ permitted assigns or successors in interest.
 
8.8   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

25


 

  otherwise be unenforceable, such provision shall be ineffective to the extent of such violation without invalidating any other provision hereof.
 
8.9   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.
 
8.10   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.
 
8.11   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.
                     
CUMBERLAND PHARMACEUTICALS INC.
     
INALCO BIOCHEMICALS, INC.
   
 
By:
  /s/ A.J. Kazimi       By:   /s/ Eric A. Lowe    
 
                   
 
  A.J. Kazimi           Eric A. Lowe    
 
  Title: Chief Executive Officer           Title: President    
 
                   
            INALCO S.p.A.    
 
                   
 
          By:   /s/ Giovanni Cipolletti    
 
                   
 
              Giovanni Cipolletti    
 
              Title: President    

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.


 

EXHIBIT B
Patents


 

United States Patent
Bimbi
     
 
  US005480491A
Patent Number:
   5,480,491
Date of Patent:
   Jan. 2, 1996
PROCESS FOR THE PREPARATION OF CRYSTALLINE LACTULOS FROMCOMMERCIAL SYRUPS
     
Inventor:
  Giuseppe Bimbi, Pontedera, Italy
 
   
Assignee:
  Inalco S.p.A., Milan, Italy
 
   
Appl. No.:
   229,559
 
   
Filed:
  April 18, 1994
Foreign Application Priority Data
         
Apr. 28, 1993 [IT] Italy
    MI93A0833  
Int. Cl6
    C13F 1/00; C13F 1/02  
U.S. Cl.
    127/61;127/46.2;127/55;  
 
    127/56; 127/58  
Field of Search
    127/61; 58, 56,  
 
    127/55, 46.2  
References Cited
U.S. PATENT DOCUMENTS
         
4,555,271 11/1985 Carobbi et al
    127/46.2  
4,978,397 12/1990 Carobbi et al
    127/46.2  
5,034,064 7/1991 Deya et al
    127/46.2  
5,304,251 4/1994 Tomita et al
    127/42  
FOREIGN PATENT DOCUMENTS
             
0132509
  2/1985   European Pat. Off   C13K 13/00
0159521
  10/1985   European Pat. Off   CO8F 8/42
0158148
  6/1988   European Pat. Off   C13K 13/00
0284959
  1/1992   European Pat. Off   CO8F 8/42
0284960
  6/1992   European Pat. Off   C08F 8/42
OTHER PUBLICATIONS
J. Agric. Chem. 1984, 32, 288-292 Jul./Dec. 1983.
Primary Examiner—Paul Lieberman Assistant
Examiner—
Patricia Halley
Attorney, Agent, or Firm—Hedman, 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 eliminating—as crystallizations do—the 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 found—and this finding constitutes a fundamental feature of the present invention—that 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 state—and not of few seed crystals—can 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)   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)   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)   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)   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
                                                 
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
                                                                                                 
                                                            total    
                            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).
* * * * *

 


 

             
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 Examiner—Ronald W. Griffin
Assistant Examiner—Nancy S. Carson
Attorney, Agent, or Firm—Parkhurst, 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:
  (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.;
 
  (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.
     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.
* * * * *

 


 

UNITED STATES PATENT AND TRADEMARK OFFICE
CERTIFICATE OF CORRECTION
     
PATENT NO.
   5,003,061
 
   
DATED
  March 26, 1991
 
   
INVENTORS) :
  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—
         
         
        Signed and Sealed this

Fifth Day of January, 1993
         
    Attest:    
         
        DOUGLAS B. COMER
         
    Attesting Officer   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:
    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 Recipient’s 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 Mylan’s 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 Mylan’s NDC Code have been sold. Immediately upon expiration of such period, Recipient shall be fully responsible for such Services and shall immediately cease using Mylan’s 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 Provider’s 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, Recipient’s sole and exclusive remedy and Service Provider’s 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 Recipient’s own name and NDC Code; (ii) termination of the Services set forth in Section 2.1 of this Agreement; (iii) Service Provider’s receipt of written notice from Recipient that Recipient no longer requires the sublicense; or (iv) thirty (30) days after Recipient’s 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.

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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 Provider’s 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