-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, VIrAlwl1G4cWy2gvJh4gUF5Bu94xLdiiub5x3c+j8RSqqkR8VL2AK2IpQ7ABoiVS HcWk2RNosFOBaC3Rxh7UVw== 0000950134-02-009728.txt : 20020813 0000950134-02-009728.hdr.sgml : 20020813 20020813155300 ACCESSION NUMBER: 0000950134-02-009728 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20020630 FILED AS OF DATE: 20020813 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CIMA LABS INC CENTRAL INDEX KEY: 0000833298 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 411569769 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-24424 FILM NUMBER: 02729703 BUSINESS ADDRESS: STREET 1: 10000 VALLEY VIEW ROAD CITY: EDEN PRAIRIE STATE: MN ZIP: 55344-9361 BUSINESS PHONE: 9529478700 MAIL ADDRESS: STREET 1: 10000 VALLEY VIEW ROAD CITY: EDEN PRAIRIE STATE: MN ZIP: 55344-9361 10-Q 1 c71161e10vq.htm FORM 10-Q FOR QUARTER ENDING JUNE 30, 2002 Cima Labs Inc.
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SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

x Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended June 30, 2002
   
o Transition report pursuant to section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from _______ to _______
Commission File Number 0-24424
 

CIMA LABS INC.
(Exact name of registrant as specified in its charter)

Delaware 41-1569769
(State or other jurisdiction of (I.R.S. Employer Identification Number)
incorporation or organization)  
   
10000 Valley View Road, Eden Prairie,
MN 55344-9361

(Address of principal executive offices
and zip code)
(952) 947-8700
(Registrant’s telephone number,
including area code)

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months, and (2) has been subject to such filing requirements for the past 90 days.

                   Yes    [X]       No       [  ]

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practical date.

Common Stock, $.01 par value 14,214,589


(Class) (Outstanding at August 2, 2002)




PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
Balance Sheets
Statements of Operations
Statements of Cash Flows
Notes to Financial Statements
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 3. Quantitative and Qualitative Disclosures about Market Risks
PART II - OTHER INFORMATION
Item 4. Submission of Matters to Vote of Security Holders
Item 6. Exhibits and Reports on Form 8-K
SIGNATURE
EX-10.1 Development, License and Supply Agreement
EX-10.2 Development and License Agreement
EX-10.3 Supply Agreement
EX-99.1 Certification of Chief Executive Officer
EX-99.1 Certification of Chief Financial Officer


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INDEX
CIMA LABS INC.

PART I. FINANCIAL INFORMATION Page No.
 
   
Item 1. Financial Statements (Unaudited)  
   
Balance Sheets - June 30, 2002 and December 31, 2001. 3
   
Statements of Operations - Three and six months ended June 30, 2002 and June 30, 2001. 5
   
Statements of Cash Flows - Six months ended June 30, 2002 and June 30, 2001. 6
   
Notes to Financial Statements. 7
   
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations. 10
   
Item 3. Quantitative and Qualitative Disclosures about Market Risks. 27
   
PART II. OTHER INFORMATION  
   
Items 1, 2, 3 and 5 have been omitted since all items are inapplicable or answers negative.  
Item 4. Submission of Matters to a Vote of Security Holders 28
Item 6. Exhibits and Reports on Form 8-K 29
             Signature 30

All other trademarks used in this report are the property of their respective owners. We have registered “CIMA®,” “CIMA LABS INC.®,” “OraSolv®,” “OraVescent®,” “DuraSolv®” and “PakSolv®” as trademarks with the U.S. Patent and Trademark Office. We also use the trademarks “OraSolv®SR/CR,” “OraVescent®SL/BL” and “OraVescent®SS.” “Triaminic®” and “Softchews®” are trademarks of Novartis. “Zomig®,” “Zomig-ZMT™” and “Rapimelt™” are trademarks of AstraZeneca. “Remeron®” and “SolTab™” are trademarks of Organon. “Tempra®” is a registered trademark of a Canadian affiliate of Bristol-Myers Squibb. “FirsTabs™” is a trademark of Bristol-Myers Squibb. “NuLev™” is a trademark of Schwarz P harma. “Actiq®” is a registered trademark of Anesta Corporation. “Claritin®” and “Reditabs®” are registered trademarks of Schering Corporation. “Maxalt-MLT®” is a registered trademark of Merck & Co., Inc. “Zydis®” is a registered trademark of Cardinal Health, Inc. “FlashDose®” is a registered trademark of Biovail Corporation. “WOWTab®” is a registered trademark of Yamanouchi Pharma Technologies, Inc. “Flashtab®” is a registered trademark of Ethypharm.

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PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
Balance Sheets
CIMA LABS INC.


  June 30,   December 31,
  2002   2001
  (Unaudited)   (See note)
 
 
Assets              
Current assets:              
     Cash and cash equivalents $ 7,417,959     $ 1,879,647  
     Available-for-sale securities   48,358,111       20,085,284  
     Trade accounts receivable, net   8,870,329       8,963,105  
     Interest receivable   1,551,303       2,127,151  
     Inventories, net   3,991,295       3,770,807  
     Deferred taxes   700,000       700,000  
     Prepaid expenses   428,967       170,516  
   
     
 
Total current assets   71,317,964       37,696,510  
               
Other assets:              
     Available-for-sale securities   88,280,875       127,539,806  
     All other, net   8,384,568       5,933,652  
   
     
 
Total other assets   96,665,443       133,473,458  
               
Property and equipment:              
     Property, plant and equipment   55,056,501       37,490,871  
     Accumulated depreciation   (11,187,782 )     (9,729,963 )
   
     
 
    43,868,719       27,760,908  
   
     
 
Total assets $  211,852,126     $  198,930,876  
   
     
 
               
Liabilities and stockholders’ equity              
Current liabilities:              
     Accounts payable $ 7,979,819     $ 1,607,378  
     Accrued expenses   2,260,853       1,771,849  
     Deferred revenue   543,334       775,000  
   
     
 
Total current liabilities   10,784,006       4,154,227  
               
Stockholders’ equity:              
     Convertible preferred stock, $.01 par value; 5,000,000 shares              
       authorized; none outstanding   -       -  
     Common stock, $.01 par value; 60,000,000 shares authorized;              
       14,810,995 and 14,739,116 shares issued and outstanding              
       (including 619,425 and 533,700 treasury shares), respectively   148,110       147,391  
     Additional paid-in capital   239,343,563       237,271,364  
     Accumulated deficit   (19,431,118 )     (27,003,219 )
     Accumulated other comprehensive income   1,007,457       2,217,364  
     Treasury stock   (19,999,892 )     (17,856,251 )
   
     
 
Total stockholders’ equity   201,068,120       194,776,649  
   
     
 
Total liabilities and stockholders’ equity $ 211,852,126     $  198,930,876  
   
     
 

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Note: The balance sheet at December 31, 2001 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements.

See accompanying notes.



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Statements of Operations
CIMA LABS INC.
(Unaudited)

  For the Three Months Ended   For the Six Months Ended
 
 
  June 30,   June 30,   June 30,   June 30,
  2002   2001   2002   2001
 
 
 
 
Revenues:                              
   Net sales $ 4,638,800     $ 4,600,935     $ 8,876,264     $ 7,897,109  
   Product development fees and licensing   3,060,348       2,043,100       5,367,601       3,911,317  
   Royalties   2,500,855       1,414,750       4,339,016       2,206,411  
   
     
     
     
 
    10,200,003       8,058,785       18,582,881       14,014,837  
   
     
     
     
 
Operating expenses:                              
   Cost of goods sold   3,811,641       4,116,781       7,167,768       6,718,205  
   Research and product development   2,486,930       1,363,820       4,538,923       2,850,048  
   Selling, general and administrative   1,943,474       1,310,008       3,420,155       2,427,647  
   
     
     
     
 
    8,242,045       6,790,609       15,126,846       11,995,900  
   
     
     
     
 
                               
Operating income   1,957,958       1,268,176       3,456,035       2,018,937  
                               
Other income:                              
   Investment income   1,935,188       2,383,589       3,671,273       4,887,723  
   Other income (expense)   2,550       (115 )     5,496       (1,245 )
   
     
     
     
 
    1,937,738       2,383,474       3,676,769       4,886,478  
   
     
     
     
 
                               
Income before provision for income taxes   3,895,696       3,651,650       7,132,804       6,905,415  
Provision for income taxes (benefit)   (271,800 )     157,510       (439,297 )     234,921  
   
     
     
     
 
                               
Net income $  4,167,496     $ 3,494,140     $ 7,572,101     $ 6,670,494  
   
     
     
     
 
                               
Net income per share:                              
   Basic $ .29     $ .24     $ .53     $ .46  
   Diluted $ .28     $ .22     $ .52     $ .43  
                               
Weighted average shares outstanding:                              
   Basic   14,168,694       14,605,909       14,164,072       14,524,699  
   Diluted   14,630,735       15,647,303       14,630,575       15,542,942  
                               
      See accompanying notes.                              

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Statements of Cash Flows
CIMA LABS INC.

(Unaudited)

  For the Six Months Ended
  June 30,
 
  2002   2001
 
 
               
Operating activities:              
Net income $ 7,572,101     $ 6,670,494  
Adjustments to reconcile net income to net cash              
  provided by operating activities:              
   Depreciation and amortization   1,531,214       1,086,050  
   Income tax benefit on stock options exercised   1,664,000       2,700,000  
   Deferred income taxes   (2,445,598 )     (2,700,000 )
   Gain on sale of investment securities   (473,960 )     -  
   Changes in operating assets and liabilities:              
      Accounts receivable   92,776       1,336,260  
      Interest receivable   575,848       (1,314,509 )
      Inventories   (220,488 )     (2,302,947 )
      Other assets   (230,326 )     (79,221 )
      Accounts payable   6,372,442       1,368,138  
      Accrued expenses and other   489,001       281,712  
      Deferred revenue   (231,666 )     8,333  
   
   
Net cash provided by operating activities   14,695,344       7,054,310  
               
Investing activities:              
   Purchases of property, plant and equipment   (17,565,631 )     (5,957,491 )
   Patents and trademarks   (106,837 )     (168,894 )
   Purchases of available-for-sale securities   (49,040,740 )     (119,763,794 )
   Proceeds from sales of available-for-sale securities   59,290,897       36,960,661  
   
   
Net cash used in investing activities   (7,422,311 )     (88,929,518 )
               
Financing activities:              
   Proceeds from exercises of stock options   312,640       2,788,606  
   Purchases of treasury stock   (2,143,641 )     -  
   Issuance of common stock related to employee stock purchase plan   96,280       -  
   
   
Net cash (used in) provided by financing activities   (1,734,721 )     2,788,606  
   
   
               
Increase (decrease) in cash and cash equivalents   5,538,312       (79,086,602 )
Cash and cash equivalents at beginning of period   1,879,647       91,587,716  
   
   
Cash and cash equivalents at end of period $  7,417,959     $  12,501,114  
   
   
               
See accompanying notes.              

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CIMA LABS INC.
Notes to Financial Statements

(Unaudited)

1. Basis of Presentation
CIMA LABS INC. (the “Company”), a Delaware corporation, develops and manufactures fast-dissolve and enhanced-absorption oral drug delivery systems. OraSolv and DuraSolv, the Company’s leading proprietary fast-dissolve technologies, are oral dosage forms incorporating taste-masked active drug ingredients into tablets, which dissolve quickly in the mouth without chewing or the need for water. The Company develops applications for technologies that are licensed to pharmaceutical company partners. The Company currently manufactures and packages five pharmaceutical brands incorporating its proprietary fast-dissolve technologies. Revenues are comprised of three components: net sales of products it manufactures; product development fees and licensing revenues for development activities conducted through collaborative agreements with pharmaceutical companies; and royalties on the sales of products sold by pharmaceutical companies under license from the Company.

The accompanying unaudited financ ial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. These financial statements do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring accruals, which are considered necessary for fair presentation have been included. Operating results for the three and six month periods ended June 30, 2002, are not necessarily indicative of the results that may be expected for the year ended December 31, 2002. For further information, you should refer to the audited financial statements and accompanying notes contained in our Annual Report on Form 10-K for the year ended December 31, 2001.

2. Use of Estimates
The preparation of financial statements in conformity with generally accepted accounting principles requires us to make estimates and assumptions that may affect the amounts we report in our financial statements and accompanying notes. Actual results could differ from those estimates.

3. Cash Equivalents and Investments
The Company’s investments in available-for-sale securities are carried at fair value, with unrealized gains and losses included in accumulated other comprehensive income as a separate component of stockholders’ equity. As of June 30, 2002, the amortized cost and estimated market value of available-for-sale securities, all of which have contractual maturities of three years or less, are as follows:

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  Amortized
Cost
  Gross
Unrealized
Gains
  Gross
Unrealized
Losses
  Estimated
Market
Value
 
As of June 30, 2002:                      
    Asset backed securities $ 28,595,681   $ 265,062   $ 8,201   $  28,852,542
    Commercial paper   3,733,506     -     190     3,733,316
    Corporate bonds and notes   70,225,247     568,436     90,514     70,703,169
    Euro notes   14,075,663     322,874     23,653     14,374,884
    Floating rate notes   15,641,940     5,298     47,413     15,599,825
    U.S. government securities   3,359,492     15,758     -     3,375,250
 
Totals – June 30, 2002 $ 135,631,529   $  1,177,428   $ 169,971   $  136,638,986
 
                       
As of December 31, 2001:                      
    Asset backed securities $ 30,476,440   $ 377,781   $ 14,235   $  30,839,986
    Corporate bonds and notes   85,770,912     1,371,649     52,536     87,090,025
    Euro notes   14,392,231     537,290     -     14,929,521
    Floating rate notes   12,696,395     17,283     -     12,713,678
    U.S. government securities   2,071,748     -     19,868     2,051,880
 
Totals – December 31, 2001 $ 145,407,726   $ 2,304,003   $ 86,639   $  147,625,090
 

4. Income Per Share
Income per share for the three and six months ended June 30, 2002, and 2001 are summarized in the following table:

  Three Months Ended   Six Months Ended
 
 
  June 30, 2002   June 30, 2001   June 30, 2002   June 30, 2001
 
 
 
 
Numerator:                      
    Net income $ 4,167,496   $ 3,494,140   $ 7,572,101   $ 6,670,494
   
   
   
   
                       
Denominator:                      
    Denominator for basic earnings per share – weighted average shares
       outstanding
  14,168,694     14,605,909     14,164,072     14,524,699
    Effect of dilutive stock options   462,041     1,041,394     466,503     1,018,243
   
   
   
   
Denominator for diluted earnings per share – weighted average shares
    outstanding
  14,630,735     15,647,303     14,630,575     15,542,942
   
   
   
   
                       
Basic earnings per share $ .29     .24   $ .53   $ .46
Diluted earnings per share $ .28     .22   $ .52   $ .43

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5. Comprehensive Income
Comprehensive income consists of net income and net unrealized gains (losses) on available-for-sale securities.

  Three Months Ended   Six Months Ended
 
 
  June 30, 2002   June 30, 2001   June 30, 2002   June 30, 2001
 
 
 
 
                           
Net income $ 4,167,496     $ 3,494,140   $ 7,572,101     $ 6,670,494
Unrealized (loss) gain on available-for-sale securities   (183,336 )     127,737     (1,209,907 )     1,667,028
 
                           
Total comprehensive income $ 3,984,160     $ 3,621,877   $ 6,362,194     $ 8,337,522
 

6. Inventories
Inventories are stated at the lower of cost (first in, first out) or fair market value.

  June 30, 2002   December 31, 2001
 
 
Raw materials $ 3,247,086   $ 3,659,288
Work in process   57,805     -
Finished products   686,404     111,519
   
   
  $ 3,991,295   $ 3,770,807
   
   

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Forward-Looking Statements

We make many statements in this Quarterly Report on Form 10-Q under the captions Management’s Discussion and Analysis of Financial Condition and Results of Operations, and Factors That Could Affect Future Results and elsewhere, which are forward-looking and are not based on historical facts. These statements relate to our future plans, objectives, expectations and intentions. We may identify these statements by the use of words such as believe, expect, will, anticipate, intend, plan and other similar expressions. These forward-looking statements involve a number of risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those we discuss in Factors That Could Affect Future Results and elsewhere in this report. These forward-looking statements speak only as of the date of this report, and we caution you not to rely on these statements wit hout considering the risks and uncertainties associated with these statements and our business that are addressed in this report.

These forward-looking statements include statements relating to the expected growth in operating revenues in the second half of 2002; the timing of expected improvements to our Eden Prairie manufacturing facility; the timing for completion of improvements to our Brooklyn Park R&D center, including the construction of a second site for manufacturing; future expense levels; the timing of availability of products; expected demand for products using our technologies; the adequacy of our production capacity; and future research and development activities relating to our current or new technologies. We are not under any duty to update any of the forward-looking statements after the date of this report to conform these statements to actual results, except as required by law.

Overview

We develop and manufacture pharmaceutical products based on our proprietary OraSolv and DuraSolv fast dissolve technologies. We currently manufacture five pharmaceutical brands utilizing our fast dissolve technologies: three prescription and two over-the-counter brands. These products include Triaminic Softchews for Novartis, Tempra FirsTabs for a Canadian affiliate of Bristol-Myers Squibb, AstraZeneca’s Zomig-ZMT and its equivalent for non-U.S. markets, Remeron SolTab for Organon and NuLev for Schwarz Pharma. The FDA is currently reviewing Wyeth’s (formerly known as American Home Products) regulatory submission for an orally disintegrating dosage form of loratadine that we developed. We are also currently developing other oral drug delivery technologies for ourselves and for others. We operate within a single business segment, the development and manufacture of fast dissolve and enhanced-absorption oral drug delivery systems. Our revenues ar e comprised of three components, including net sales of products we manufacture for pharmaceutical companies using our proprietary fast dissolve technologies, product development fees and licensing revenues for development activities we conduct through collaborative agreements with pharmaceutical companies, and royalties on the sales of our products which are sold by pharmaceutical companies under licenses from us.

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Revenues from product sales and from royalties will fluctuate from quarter to quarter and from year to year depending on, among other factors, demand by consumers for the products we produce, new product introductions, the seasonal nature of some of the products we produce to treat seasonal ailments, pharmaceutical company ordering patterns and our production schedules. Revenues from product development fees and licensing revenue will fluctuate depending on, among other factors, the number of new collaborative agreements that we enter into, the number and timing of product development milestones that we achieve under our collaborative agreements and the level of our development activity conducted for pharmaceutical companies.

Critical Accounting Policies and Estimates

General
The following discussion and analysis of our financial condition and results of operations are based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of our financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, we evaluate our estimates, including those related to bad debts, inventories, income taxes, and contingencies and litigation. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from thes e estimates under different assumptions or conditions.

We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our financial statements.

Revenue Recognition

We recognize revenue in accordance with the Securities and Exchange Commission’s Staff Accounting Bulletin No. 101, or SAB 101, “Revenue Recognition in Financial Statements.” SAB 101 requires that four basic criteria must be met before revenue can be recognized: (1) persuasive evidence of an agreement exists; (2) delivery has occurred or services rendered; (3) the fee is fixed and determinable; and (4) collectibility is reasonably assured. Revenues from our business activities are recognized from net sales of manufactured products upon shipment; from product development fees as the contracted services are rendered; from product development milestones upon completion and acceptance; from up-front product development license fees as they are amortized over the expected development term of the proposed products; and from royalties on the sales of products sold by pharmaceutical companies under license from us. The determination of SAB 101 c riteria (3) and (4) for each source of revenue is based on our judgments regarding the fixed nature and collectibility of each source of revenue. Revenue recognized for any reporting period could be adversely affected should changes in conditions cause us to determine that these criteria are not met for certain future transactions.

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Deferred Taxes

The carrying value of our net deferred tax assets assumes that we will be able to generate sufficient taxable income in the United States, based on management’s current estimates and assumptions. We record a valuation allowance to reduce the carrying value of our net deferred tax assets to the amount that is more likely than not to be realized. While we have considered future taxable income and ongoing prudent and feasible tax planning strategies in assessing the requirements for the valuation allowance, in the event we were to determine that we would be able to realize our deferred tax assets in the future in excess of our net recorded amount, an adjustment to the deferred tax asset would increase net income in the period such determination is made. Likewise, should we determine that we would not be able to realize all or part of our net deferred tax asset in the future, an adjustment to the net deferred tax asset would decrease net income in the period such determination is made. On a quarterly basis, we evaluate the realizability of our deferred tax assets and assess the requirements for a valuation allowance. For the six months ended June 30, 2002, we have recorded an $11.5 million valuation allowance related to our net deferred tax assets of $20.1 million, compared to a valuation allowance of $16.2 million related to our net deferred tax assets of $22.4 million for the year ended December 31, 2001.

Results of Operations

Three and Six Month Periods Ended June 30, 2002 and 2001

Components of revenue, expenses, and net income as a percentage of total operating revenue for the three and six month periods ended June 30 were as follows:

  Three months ended June 30,   Six months ended June 30,
 
 
  2002   2001   2002   2001
 
 
 
 
                       
Net sales 45 %   57 %   48 %   56 %
Product development fees & licensing revenues 30 %   25 %   29 %   28 %
Royalty revenues 25 %   18 %   23 %   16 %
Cost of goods sold 37 %   51 %   39 %   48 %
Research & product development expenses 24 %   17 %   24 %   20 %
Selling, general & administrative expenses 19 %   16 %   18 %   17 %
Net income 41 %   43 %   41 %   48 %

Operating Revenues. Total operating revenues for the second quarter ended June 30, 2002 were $10.2 million, an increase of $2.1 million, or 27%, over the same period in 2001, and for the first half of 2002, total operating revenues were $18.6 million, an increase of $4.6 million, or 33%, over same period in 2001. The second quarter and first half increases in total operating revenue resulted from increases in all three of our revenue components: (1) royalties on the sales of our products which are sold by pharmaceutical companies under licenses from us, (2) product development fees and licensing revenue, and (3) revenues from the sales of products we manufacture.

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Revenues from net sales of products we manufacture in the second quarter of 2002 were $4.6 million, an increase of $38,000, or 1%, over the same period of 2001, and for the first half of 2002, revenues from net sales of products we manufacture were $8.9 million, an increase of $1.0 million, or 12%, over the same period of 2001. The second quarter and first half increases were primarily due to higher manufacturing volumes of Remeron SolTab for Organon that were partially offset by lower sales of Triaminic Softchews for Novartis. As a category, sales of branded prescription products increased; representing 81% and 77% of our total product sales in the second quarter and first half of 2002, respectively, compared with 50% and 60% in last year’s second quarter and first half, respectively. Triaminic Softchews are expected to account for a higher proportion of manufacturing volumes in the third quarter, which is typically the peak quarter for this over - -the-counter product due to its seasonal nature.

Revenues from product development fees and licensing were $3.1 million in the second quarter of 2002, an increase of $1.0 million, or 50%, from the same period of 2001, and for the first half of 2002, revenues from product development fees and licensing were $5.4 million, an increase of $1.5 million, or 37%, from the same period of 2001. These increases resulted from agreements for proposed new products, our achievement of certain milestones under existing agreements, and an overall increase in development activity. Revenues from product development fees and licensing included amortization of deferred revenue of $206,000 and $282,000 in the second quarter and first half of 2002, respectively, compared to $13,000 and $92,000 in the same periods of 2001, respectively. For full-year 2002, we expect combined revenues attributable to product development fees and licensing revenues to increase by approximately 20 to 25% from 2001 levels.

Revenues from royalties were $2.5 million in the second quarter of 2002, an increase of $1.1 million or 77% over the same period of 2001, and for the first half of 2002, revenues from royalties were $4.3 million, an increase of $2.1 million, or 97%, over the same period of 2001. The increases were due primarily to increased end-customer sales by Organon of Remeron SolTab and increased end-customer sales by AstraZeneca of Zomig Rapimelt (the non-U.S. equivalent of Zomig-ZMT) in Europe and Zomig-ZMT in the United States. For full-year 2002, we expect royalties to increase by approximately 100% from 2001 levels.

Cost of goods sold. Cost of goods sold was $3.8 million in the second quarter of 2002, a decrease of $305,000 from $4.1 million in the second quarter of 2001, and cost of goods sold in the first half of 2002 increased to $7.2 million from $6.7 million for the same period of 2001. The second quarter decrease of $305,000 was principally due to an improved mix in the products we manufactured and shipped compared to the same period last year. The first half of 2002 cost of goods sold increase of $450,000 was due mainly to higher production volumes and higher levels of depreciation expense over the same period in 2001. For 2002, we expect cost of goods sold to increase from 2001 in terms of dollar amounts, but decrease as a percentage of net sales of products we manufacture.

Gross profits on product sales were $827,000 and $1.7 million in the second quarter and first half of 2002, respectively, compared to $484,000 and $1.2 million in the same periods of 2001, respectively. The second quarter and first half improvements were principally due

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to increased production volumes of higher margin branded prescription products. Gross profits on product sales were 18% and 19% of total product sales in the second quarter and first half of 2002, respectively, compared to 11% and 15% for the same periods in 2001, respectively, reflecting the increased mix of branded prescription products. For full-year 2002, we expect gross profits on product sales to increase from 2001 levels in terms of dollar amounts and as a percentage of product sales.

Research and product development expenses. Research and product development expenses were $2.5 million in the second quarter of 2002, an increase of $1.1 million, or 82%, over the same period of 2001, and for the first half of 2002, these expenses were $4.5 million, an increase of $1.7 million, or 59%, over the same period of 2001. These increases were due primarily to additional staffing, development activity for our proprietary products, including OraVescent fentanyl, and infrastructure investments. For full-year 2002, we expect research and product development expenses to increase by approximately 50% from 2001 levels due to a significant increase in development work for our collaborative pharmaceutical company partners, as well as development efforts related to our proprietary products

Selling, general and administrative expenses. Selling, general and administrative expenses were $1.9 million in the second quarter of 2002, an increase of $633,000, or 48%, over the same period of 2001. Selling, general and administrative expenses of $3.4 million for the first half of 2002 increased $1.0 million, or 41%, over the same period of 2001. These increases were due primarily to costs associated with increased professional staffing. In the second quarter of 2002, selling, general and administrative expenses included approximately $200,000 of one-time executive recruitment and relocation costs. For full-year 2002, we expect selling, general and administrative expenses to increase approximately 40% from 2001 levels as we continue to make investments in people and systems to support our anticipated growth.

Other income (expense). Other income was $1.9 million in the second quarter of 2002, a decrease of $446,000, over the same period of 2001. For the first half of 2002 other income of $3.7 million decreased $1.2 million from the same period of 2001. Other income consists primarily of investment income comprised of interest earned on securities and gains realized on the sale of securities. The decreases from 2001 were due primarily to lower levels of cash available for investment and from lower interest rates on our investments. For full-year 2002, we expect other income to decrease in the range of 35 to 40% from 2001 levels due to lower interest rates and expected capital expenditures, which will reduce the level of cash available for investment.

Liquidity and Capital Resources

We have financed our operations to date primarily through private and public sales of equity securities, other income, and from operating revenues consisting of product sales, product development fees and licensing revenues, and royalties.

Working capital increased from $33.5 million at December 31, 2001, to $60.5 million at June 30, 2002. The increase of $27.0 million resulted primarily from the reclassification of $28.3 million of non-current available-for-sale securities to current available-for-sale

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securities when the maturities of those securities became less than one year. Cash and available-for-sale securities, including both current and non-current securities, were $144.1 million at June 30, 2002, compared to $149.5 million at December 31, 2001. This decrease of $5.4 million resulted from $17.6 million of capital expenditures made by the Company (including $5.7 million used to purchase our Eden Prairie corporate headquarters and manufacturing facility), and common stock repurchases of $2.1 million, partially offset by $14.7 million of cash generated from our operating activities. We invest excess cash in interest-bearing money market accounts and investment grade securities.

During the next six months, we plan to spend approximately $15.0 to $20.0 million to add granulation capabilities and expand taste-masking capacity to our Eden Prairie manufacturing facility, expand and renovate our Brooklyn Park R&D center, and to initiate work on a second manufacturing site, which will be located at our Brooklyn Park R&D center. We expect this second manufacturing site, which will include a bottling production line, to be operational in the second half of 2003. In addition, we expect to fund additional product development activities related to our OraVescent technology and to develop proprietary products using our OraSolv and DuraSolv technologies. We may also acquire technologies that complement our current portfolio of oral drug delivery technologies. We believe that our cash and cash equivalents and available-for-sale securities, together with expected revenues from operations, will be sufficient to meet our anticipated capital requirements for the foreseeable future. However, we may require additional funds to support our working capital requirements or for other purposes and may seek to raise such additional funds through public or private equity financings or from other sources. We cannot be certain that additional financing will be available on terms favorable to us, or at all, or that any additional financing will not be dilutive.

Factors That Could Affect Future Results

Certain statements made in this Quarterly Report on Form 10-Q are forward-looking statements based on our current expectations, assumptions, estimates and projections about our business and our industry. These forward-looking statements involve risks and uncertainties. Our business, financial condition and results of operations could differ materially from those anticipated in these forward-looking statements as a result of certain factors, as more fully described below and elsewhere in this Form 10-Q. You should consider carefully the risks and uncertainties described below, which are not the only ones facing our company. Additional risks and uncertainties also may impair our business operations.

The Loss Of One Of Our Major Customers Could Reduce Our Revenues Significantly.
Revenues from AstraZeneca, Organon and Novartis together represented approximately 70% of our total operating revenues for both the quarter ended June 30, 2002, and for the six months ended June 30, 2002, compared to 85% and 84% for the corresponding periods in 2001. The loss of any one of these customers could cause our revenues to decrease significantly, resulting in losses from our operations. If we cannot broaden our customer base, we will continue to depend on a few customers for the majority of our revenues. We may be unable to negotiate favorable business terms with customers that represent a significant portion of our revenues. If we cannot, our revenues and

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gross profits may not grow as expected and may be insufficient to allow us to achieve sustained profitability.

We Rely On Third Parties To Market, Distribute And Sell The Products Incorporating Our Drug Delivery Technologies And Those Third Parties May Not Perform.
Our pharmaceutical company partners market and sell the products we develop and manufacture. If one or more of our pharmaceutical company partners fails to pursue the marketing of our products as planned, our revenues and gross profits may not reach our expectations, or may decline. We often cannot control the timing and other aspects of the development of products incorporating our technologies because our pharmaceutical company partners may have priorities that differ from ours. Therefore, our commercialization of products under development may be delayed unexpectedly. Because we incorporate our drug delivery technologies into the oral dosage forms of products marketed and sold by our pharmaceutical company partners, we do not have a direct marketing channel to consumers for our drug deli very technologies. The marketing organizations of our pharmaceutical company partners may be unsuccessful, or they may assign a low level of priority to the marketing of our products that is different from our priorities. Further, they may discontinue marketing the products that incorporate our drug delivery technologies. If marketing efforts for our products are not successful, our revenues may fail to grow as expected or may decline.

If We Do Not Enter Into Additional Collaborative Agreements with Pharmaceutical Companies, We May Not Be Able To Achieve Sustained Profitability.
We depend upon collaborative agreements with pharmaceutical companies to develop, test and obtain regulatory approval for, and commercialize oral dosage forms of, active pharmaceutical ingredients using our drug delivery technologies. The number of products that we successfully develop under these collaborative agreements will affect our revenues. If we do not enter into additional agreements in the future, or if our current or future agreements do not result in successful marketing of our products, our revenues and gross profits may be insufficient to allow us to achieve sustained profitability.

      We face additional risks related to our collaborative agreements, including the risks that:

any existing or future collaborative agreements may not result in additional commercial products;
additional commercial products that we may develop may not be successful;
we may not be able to meet the milestones established in our current or future collaborative agreements;
we may not be able to successfully develop new drug delivery technologies that will be attractive in the future to potential pharmaceutical company partners; and
our pharmaceutical company partners may exercise their limited rights to terminate their collaborative agreement with us.

If We Cannot Increase Our Production Capacity, We May Be Unable To Meet Expected Demand For Our Products And We May Lose Revenues.
We must increase our production capacity to meet expected demand for our products. We currently have two production lines and are planning to add a bottling line and other manufacturing equipment in 2003. If we are unable to increase our production capacity as

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scheduled, we may be unable to meet expected demand for our products, we may lose revenues and we may not be able to maintain our relationships with our pharmaceutical company partners. Production lines in the pharmaceutical industry generally take 16 to 24 months to complete due to the long lead times required for precision production equipment to be manufactured and installed, as well as the required testing and validation process that must be completed once the equipment is installed. We may not be able to increase our production capacity quickly enough to meet the requirements of our pharmaceutical company partners.

If We Do Not Properly Manage Our Growth, We May Be Unable To Sustain The Level Of Revenues We Have Attained Or Effectively Pursue Additional Business Opportunities.
Compared to the corresponding periods a year earlier, our operating revenues increased 34% and 33% for the year ended December 31, 2001, and for the six month period ended June 30, 2002, respectively, placing significant strain on our management, administrative and operational resources. If we do not properly manage the growth we have recently experienced and expect in the future, our revenues may decline or we may be unable to pursue sources of additional revenues. To properly manage our growth, we must, among other things, implement additional (and improve existing) administrative, financial and operational systems, procedures and controls on a timely basis. We will also need to expand our finance, administrative and operations staff. We may not be able to complete the improveme nts to our systems, procedures and controls necessary to support our future operations in a timely manner. We may not be able to hire, train, integrate, retain, motivate and manage required personnel and may not be able to successfully identify, manage and pursue existing and potential market opportunities. Improving our systems and increasing our staff will increase our operating expenses. If we fail to generate additional revenue in excess of increased operating expenses in any fiscal period we may incur losses, or our losses may increase in that period.

We May Be Unable To Achieve Our Anticipated Revenues and Profits Because The Markets For The Products We Develop And Manufacture For Our Pharmaceutical Company Partners Are Subject To Market Risks From The Introduction of Generic Prescription Products, The Pricing Strategies Of Generic Competitors And From Regulatory Strategies That Could Switch A Prescription Product To An Over-The-Counter Product.
In January 2002, Mylan Laboratories and Teva Pharmaceutical Industries announced that they received tentative approval from the FDA for mirtazapine tablets, which are expected to be generic substitutes for Organon’s Remeron standard tablets. In March 2002, Akzo Nobel NV, Organon’s parent company, reported that Organon sued seven generic pharmaceutical companies, including Teva and Mylan, for the infringement of Organon’s U.S. patent for Remeron (mirtazapine standard tablets). In May 2002, Organon announced that it sued Barr Laborato ries, Inc. for infringing on its U.S. patent for Remeron SolTab (mirtazapine orally disintegrating tablets). The U.S. market launch of generic mirtazapine standard tablets by Mylan Laboratories, Teva Pharmaceutical Industries, and five other unnamed generic pharmaceutical companies, as well as the U.S. market launch of generic orally disintegrating mirtazapine tablets by Barr Laboratories, is subject to final FDA approval, which could occur after the resolution of all legal issues related to Organon’s patent rights. Organon is vigorously defending its patent rights, which it believes apply through June 2017. There can be no assurance that Organon’s market for Remeron SolTab would not be negatively affected by generic mirtazapine competition due to the potential impact of lower product pricing

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resulting from generic competition from either or both standard and orally disintegrating tablets. Due to the large number of variables and high degree of uncertainty, we are unable to predict the timing for the market introduction of a generic mirtazapine standard tablet or a generic mirtazapine orally disintegrating tablet, or the effect of such generic product introductions on our business.

Another pharmaceutical active that involves a high degree of uncertainty is loratadine, which is currently a prescription product. We have developed for Wyeth (formerly known as American Home Products) a fast dissolve formulation of loratadine for both the prescription pharmaceutical and the over-the-counter markets, which Wyeth expects to market as a competitive product to Claritin Reditabs in 2003, unless Schering Corporation, the loratadine patent holder, is successful in its efforts to secure extended exclusive rights to market Claritin. In August 2002, Schering Corporation received a summary judgement from a United States District Court that invalidates their patent. Schering Corporation is expected to appeal this Court’s decision.

In May 2001, a joint committee of the FDA’s Nonprescription Drugs Advisory Committee and Pulmonary-Allergy Drugs Advisory Committee made a non-binding recommendation that loratadine, the active drug ingredient in Claritin, has a safety profile acceptable for over-the-counter marketing. In March 2002, Schering Corporation announced that the FDA has accepted for filing its application to switch all formulations of Claritin to over-the-counter products. In April 2002, the FDA’s Nonprescription Advisory Committee endorsed Claritin (loratadine) for over-the-counter treatment in chronic idiopathic urticaria, or chronic hives of unknown cause. We have developed for Wyeth a fast dissolve formulation of loratadine for the over-the-counter market, which Wyeth is expected to launch in the U.S. market, subject to the FDA’s approval to switch loratadine to the over-the-counter market and the resolution of certain legal and patent issues brought by Sc hering Corporation in their efforts to secure extended exclusive rights to market loratadine.

The ongoing litigation against Wyeth and others by Schering Corporation to prevent or delay the market entry of a loratadine product, as well as Schering Corporation’s application to switch loratadine to the over-the-counter market, could affect our anticipated revenues and profits. The potential switch of loratadine from the prescription market to the over-the-counter market affects pricing, distribution channels, advertising, insurance reimbursement and a variety of other marketing and regulatory factors. The effects of a delayed market entry of Wyeth’s generic alternative to Claritin Reditabs and the potential switch from the prescription market to the over-the-counter market involve a high degree of uncertainty and we are unable to predict the effect of such changes on our business.

We May Experience Significant Delays In Expected Product Releases While Our Pharmaceutical Company Partners Seek Regulatory Approvals For The Products We Develop And, If They Are Not Successful In Obtaining The Approvals, We May Be Unable To Achieve Our Anticipated Revenues And Profits.
The federal government, principally the U.S. Food and Drug Administration, and state and local government agencies regulate all new pharmaceutical products, including our existing products and those under development. Our pharmaceutical company partners may experience significant delays in expected product releases while attempting to obtain regulatory approval for the products we develop. If

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they are not successful, our revenues and profitability may decline. We cannot control, and our pharmaceutical company partners cannot control, the timing of regulatory approval for the products we develop.

Applicants for FDA approval often must submit extensive clinical data and supporting information to the FDA. Varying interpretations of the data obtained from pre-clinical and clinical testing could delay, limit or prevent regulatory approval of a drug product. Changes in FDA approval policy during the development period, or changes in regulatory review for each submitted new drug application, also may cause delays or rejection of an approval. Even if the FDA approves a product, the approval may limit the uses or “indications” for which a product may be marketed, or may require further studies. The FDA also can withdraw product clearances and approvals for failure to comply with regulatory requirements or if unforeseen problems follow initial marketing.

Manufacturers of drugs also must comply with applicable good manufacturing practices requirements. If we cannot comply with applicable good manufacturing practices, we may be required to suspend the production and sale of our products, which would reduce our revenues and gross profits. We may not be able to comply with the applicable good manufacturing practices and other FDA regulatory requirements for manufacturing as we expand our manufacturing operations.

If our products are marketed in foreign jurisdictions, we, and the pharmaceutical company partners with which we are developing our technologies, must obtain required regulatory approvals from foreign regulatory agencies and comply with extensive regulations regarding safety and quality. If approvals to market our products are delayed, if we fail to receive these approvals, or if we lose previously received approvals, our revenues would be reduced. We may be required to incur significant costs in obtaining or maintaining foreign regulatory approvals.

Our Commercial Products Are Subject To Continuing Regulations And We May Be Subject To Adverse Consequences If We Fail To Comply With Applicable Regulations.
Even if our products receive regulatory approval, either in the U.S. or internationally, we will continue to be subject to extensive regulatory requirements. These regulations are wide-ranging and govern, among other things:

adverse drug experience reporting regulations;
product promotion;
product manufacturing, including good manufacturing practice requirements; and
product changes or modifications.

If we fail to comply or maintain compliance with these laws and regulations, we may be fined or barred from selling our products. If the FDA determines that we are not complying with the law, it can:

issue warning letters;
impose fines;
seize products or order recalls;
issue injunctions to stop future sales of products;

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refuse to permit products to be imported into, or exported out of, the U.S.;
totally or partially suspend our production;
withdraw previously approved marketing applications; and
initiate criminal prosecutions.

We Have A Single Manufacturing Facility And We May Lose Revenues And Be Unable To Maintain Our Relationships With Our Pharmaceutical Company Partners If We Lose Its Production Capacity.
We manufacture all our products on our existing production lines in our Eden Prairie facility. If our existing production lines or facility becomes incapable of manufacturing products for any reason, we may be unable to meet production requirements, we may lose revenues and we may not be able to maintain our relationships with our pharmaceutical company partners. Without our existing production lines, we would have no other means of manufacturing products incorporating our drug delivery technologies until we were able to restore the manufacturing capability at our facility or develop an alternative manufacturing facility. Although we carry business interruption insurance to cover lost revenues and profits in an amount we consider adequate, this insurance does not cover all possible situations. In addition, our business interruption insurance would not compensate us for the loss of opportunity and potential adverse impact on relations with our existing pharmaceutical company partners resulting from our inability to produce products for them. Although we currently plan to add a second manufacturing site at our Brooklyn Park, Minnesota facility to reduce this risk, we may encounter unforeseen difficulties or delays in doing so.

We Rely On Single Sources For Some Of Our Raw Materials And We May Lose Revenues And Be Unable To Maintain Our Relationships With Our Pharmaceutical Company Partners If Those Materials Were Not Available.
We rely on single suppliers for some of our raw materials and packaging supplies. If these raw materials or packaging supplies were no longer available we may be unable to meet production requirements, we may lose revenues and we may not be able to maintain our relationships with our pharmaceutical company partners. Without adequate supplies of raw materials or packaging supplies, our manufacturing operations may be interrupted until another supplier could be identified, its products validated and trading terms with it negotiated. We may not be able to identify an alternative supplier in a timely manner, or at all. Furthermore, we may not be able to negotiate favorable terms with an alternative supplier. Any disruptions in our manufacturing operations from the loss of a supplier could potentially damage our relations with our pharmaceutical company partners.

If We Cannot Develop Additional Products, Our Ability To Increase Our Revenues Would Be Limited.
We intend to continue to enhance our current technologies and pursue additional proprietary drug delivery technologies. If we are unable to do so, we may be unable to achieve our objectives of revenue growth and sustained profitability. Even if enhanced or additional technologies appear promising during various stages of development, we may not be able to develop commercial applications for them because:

the potential technologies may fail clinical studies;

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we may not find a pharmaceutical company willing to adopt the technologies;
it may be difficult to apply the technologies on a commercial scale; or
the technologies may be uneconomical to market.

If We Cannot Keep Pace With The Rapid Technological Change And Meet The Intense Competition In Our Industry, We May Lose Business.
Our success depends, in part, on maintaining a competitive position in the development of products and technologies in a rapidly evolving field. If we cannot maintain competitive products and technologies, our current and potential pharmaceutical company partners may choose to adopt the drug delivery technologies of our competitors. Fast dissolve tablet technologies that compete with our OraSolv and DuraSolv technologies include the Zydis technology developed by R.P. Scherer Corporation, a wholly-owned subsidiary of Cardinal Health, Inc., the WOWTab technology developed by Yamanouchi Pharma Technologies, the Flashtab technology developed by Ethypharm and the FlashDose technology developed by Fuisz Technologies Ltd., a wholly-owned subsidiary of Biovail Corporation. We also compete generally with other drug deliver y, biotechnology and pharmaceutical companies engaged in the development of alternative drug delivery technologies or new drug research and testing. Many of these competitors have substantially greater financial, technological, manufacturing, marketing, managerial and research and development resources and experience than we do and represent significant competition for us.

Our competitors may succeed in developing competing technologies or obtaining governmental approval for products before us. The products of our competitors may gain market acceptance more rapidly than our products. Developments by competitors may render our products, or potential products, noncompetitive or obsolete.

If We Cannot Adequately Protect Our Technology And Proprietary Information, We May Be Unable To Sustain A Competitive Advantage.
Our success depends, in part, on our ability to obtain and enforce patents for our products, processes and technologies and to preserve our trade secrets and other proprietary information. If we cannot do so, our competitors may exploit our innovations and deprive us of the ability to realize revenues and profits from our developments. We have been granted more than fourteen patents on our drug delivery and packaging systems in the U.S., which will expire beginning in 2010.

Any patent applications we may have made or may make relating to our potential products, processes and technologies may not result in patents being issued. Our current patents may not be valid or enforceable. They may not protect us against competitors that challenge our patents, obtain patents that may have an adverse effect on our ability to conduct business or are able to circumvent our patents. Further, we may not have the necessary financial resources to enforce our patents.

To protect our trade secrets and proprietary technologies and processes, we rely, in part, on confidentiality agreements with our employees, consultants and advisors. These agreements may not provide adequate protection for our trade secrets and other proprietary information in the event of any unauthorized use or disclosure, or if others lawfully develop the information.

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Third Parties May Claim That Our Technologies, Or The Products In Which They Are Used, Infringe On Their Rights And We May Incur Significant Costs Resolving These Claims.
Third parties may claim that the manufacture, use or the sale of our drug delivery technologies infringe on their patent rights. If such claims are asserted, we may have to seek licenses, defend infringement actions or challenge the validity of those patents in court. If we cannot obtain required licenses, are found liable for infringement or are not able to have these patents declared invalid, we may be liable for significant monetary damages, encounter significant delays in bringing products to market or be precluded from participating in the manufacture, use or sale of products or methods of drug delivery covered by the patents of others. We may not have identified, or be able to identify in the future, U.S. and foreign patents that pose a risk of potential infringement c laims.

We enter into collaborative agreements with pharmaceutical companies to apply our drug delivery technologies to drugs developed by others. Ultimately, we receive license revenues and product development fees, as well as revenues from, and royalties on, the sale of products incorporating our technology. The drugs to which our drug delivery technologies are applied are generally the property of the pharmaceutical companies. Those drugs may be the subject of patents or patent applications and other forms of protection owned by the pharmaceutical companies or third parties. If those patents or other forms of protection expire, are challenged or become ineffective, sales of the drugs by the collaborating pharmaceutical company may be restricted or may cease.

Because We Have A Limited Operating History, Potential Investors In Our Stock May Have Difficulty Evaluating Our Prospects.
We recorded the first commercial sales of products using our fast dissolve technologies in early 1997. Accordingly, we have only a limited operating history, which may make it difficult for you and other potential investors to evaluate our prospects. The difficulty investors may have in evaluating our prospects may cause volatile fluctuations, including decreases, in the market price of our common stock as investors react to information about our prospects. Since 1997, we have generated revenues from product development fees and licensing arrangements, sales of products using our fast dissolve technologies and royalties. We are currently making the transition from research and product development operations with limited production to commercial operations with expanding production capabilities in addition to research and product development activities. Our business and prospects, therefore, must be evaluated in light of the risks and uncertainties of a company with a limited operating history and, in particular, one in the pharmaceutical industry.

If We Are Not Profitable In The Future, The Value Of Our Stock May Fall.
Although we were profitable for the year ended December 31, 2001, and the six months ended June 30, 2002, we have accumulated aggregate net losses from inception of approximately $19.4 million. If we are unable to sustain profitable operations in future periods, the market price of our stock may fall. The costs for research and product development of our drug delivery technologies and general and administrative expenses have been the principal causes of our losses. Our ability to achieve sustained profitable operations depends on a number of factors, many of which are beyond our direct control. These factors include:

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the demand for our products;
our ability to manufacture our products efficiently and with the required quality;
our ability to increase our manufacturing capacity;
the level of product and price competition;
our ability to develop additional commercial applications for our products;
our ability to control our costs; and
general economic conditions.

We May Require Additional Financing, Which May Not Be Available On Favorable Terms Or At All And Which May Result In Dilution Of The Equity Interest Of An Investor.
We may require additional financing to fund the development and possible acquisition of new drug delivery technologies and to increase our production capacity beyond what is currently anticipated. If we cannot obtain financing when needed, or obtain it on favorable terms, we may be required to curtail any plans to develop or acquire new drug delivery technologies or may be required to limit the expansion of our manufacturing capacity. We believe our cash and cash equivalents, and expected revenues from operations will be sufficient to meet our anticipated capital requirements for the foreseeable future. However, we may elect to pursue additional financing at any time to more aggressively pursue development of new drug delivery technologies and expand manufacturing capacity beyond that currently planned.

Other factors that will affect future capital requirements and may require us to seek additional financing include:

the level of expenditures necessary to develop and, or, acquire new products or technologies;
the progress of our research and product development programs;
the need to construct a larger than currently anticipated manufacturing facility, or additional manufacturing facilities, to meet demand for our products;
the results of our collaborative efforts with current and potential pharmaceutical company partners; and
the timing of, and amounts received from, future product sales, product development fees and licensing revenue and royalties.

Demand For Some Of Our Products Is Seasonal, And Our Sales And Profits May Suffer During Periods When Demand Is Light.
Certain non-prescription products that we manufacture for our pharmaceutical company partners treat seasonal ailments such as colds, coughs and allergies. Our pharmaceutical company partners may choose to not market those products in off-seasons and our sales and profits may decline in those periods as a result. For full-year 2001 and for the first six months of 2002, operating revenues from Novartis, which included revenues related to Triaminic, a seasonal cold, cough and allergy product, represented 33% and 16%, respectively, of our total operating revenues for such periods. We may not be successful in developing a mix of products to reduce these seasonal variations.

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If The Marketing Claims Asserted About Our Products Are Not Approved, Our Revenues May Be Limited.
Once a drug product incorporating our technologies is approved by the FDA, the Division of Drug Marketing, Advertising and Communication, the FDA’s marketing surveillance department within the Center for Drug Evaluation and Research, must approve marketing claims asserted about it by our pharmaceutical company partners. If our pharmaceutical company partners fail to obtain from the Division of Drug Marketing acceptable marketing claims for a product incorporating our drug technology, our revenues from that product may be limited. Marketing claims are the basis for a product’s labeling, advertising and promotion. The claims our pharmaceutical company partners are asserting about our drug delivery technology, or the drug product itself, may not be approved by the Division of Drug Marketing.

We May Face Product Liability Claims Related To Participation In Clinical Trials Or The Use Or Misuse Of Our Products.
The testing, manufacturing and marketing of products using our drug delivery technologies may expose us to potential product liability and other claims resulting from their use. If any such claims against us are successful, we may be required to make significant compensation payments. Any indemnification that we have obtained, or may obtain, from contract research organizations or pharmaceutical companies conducting human clinical trials on our behalf may not protect us from product liability claims or from the costs of related litigation. Similarly, any indemnification we have obtained, or may obtain, from pharmaceutical companies with which we are developing our drug delivery technologies may not protect us from product liability claims from the consumers of those products or from the costs of related litigation. If we are subject to a product liability claim, our product liability insurance may not reimburse us, or be sufficient to reimburse us, for any expenses or losses we may suffer. A successful product liability claim against us, if not covered by, or if in excess of, our product liability insurance, may require us to make significant compensation payments, which would be reflected as expenses on our statement of operations and reduce our earnings.

Anti-Takeover Provisions Of Our Corporate Charter Documents, Delaware Law And Our Stockholders’ Rights Plan May Affect The Price Of Our Common Stock.
Our corporate charter documents, Delaware law and our stockholders’ rights plan include provisions that may discourage or prevent parties from attempting to acquire us. These provisions may have the effect of depriving our stockholders of the opportunity to sell their stock at a price in excess of prevailing market prices in an acquisition of us by another company. Our board of directors has the authority to issue up to 5,000,000 shares of preferred stock and to determine the rights, preferences and privileges of those shares without any further vote or action by our stockholders. The rights of holders of our common stock may be adversely affected by the rights of the holders of any preferred stock that may be issued in the future. Additional provisions of our certificate of incorporat ion and bylaws could have the effect of making it more difficult for a third party to acquire a majority of our outstanding voting common stock. These include provisions that limit the ability of stockholders to call special meetings or remove a director for cause.

We are subject to the provisions of Section 203 of the Delaware General Corporation Law, which prohibits a publicly-held Delaware corporation from engaging in a “business combination” with an “interested stockholder” for a period of three years after the date of the

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transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner. For purposes of Section 203, a “business combination” includes a merger, asset sale or other transaction resulting in a financial benefit to the interested stockholder, and an “interested stockholder” is a person who, either alone or together with affiliates and associates, owns (or within the past three years, did own) 15% or more of the corporation’s voting stock.

We also have a stockholders’ rights plan, commonly referred to as a poison pill, which makes it difficult, if not impossible, for a person to acquire control of us without the consent of our board of directors.

Our Stock Price Has Been Volatile And May Continue To Be Volatile.
The trading price of our common stock has been, and is likely to continue to be, highly volatile. The market value of your investment in our common stock may fall sharply at any time due to this volatility. In the year ended December 31, 2001, the closing sale price for our common stock ranged from $30.05 to $85.75. For the six months ended June 30, 2002, the closing sale price for our common stock ranged from $18.94 to $35.45. The market prices for securities of drug delivery, biotechnology and pharmaceutical companies historically have been highly volatile. Factors that could adversely affect our stock price include:

fluctuations in our operating results;
announcements of technological collaborations, innovations or new products by us or our competitors;
governmental regulations;
developments in patent or other proprietary rights owned by us or others;
public concern as to the safety of drugs developed by us or others;
the results of pre-clinical testing and clinical studies or trials by us or our competitors;
litigation;
decisions by our pharmaceutical company partners relating to the products incorporating our technologies;
actions by the FDA in connection with submissions related to the products incorporating our technologies; and
general market conditions.

Our Operating Results May Fluctuate, Causing Our Stock Price To Fall.
Fluctuations in our operating results may lead to fluctuations, including declines, in our stock price. Our operating results may fluctuate from quarter to quarter and from year to year depending on:

demand by consumers for the products we produce;
new product introductions;
the seasonal nature of the products we produce to treat seasonal ailments;
pharmaceutical company ordering patterns;
our production schedules;
the number of new collaborative agreements that we enter into;

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the number and timing of product development milestones that we achieve under collaborative agreements;
the level of our development activity conducted for, and at the direction of, pharmaceutical companies under collaborative agreements; and
the level of our spending on new drug delivery technology development and technology acquisition, and internal product development.

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Item 3. Quantitative and Qualitative Disclosures about Market Risks

The Company is subject to interest rate and foreign currency risks. Our investments in fixed-rate debt securities, which are classified as available-for-sale at June 30, 2002, have remaining maturities ranging from 3 to 36 months and thus are exposed to the risk of fluctuating interest rates. Available-for-sale securities had a market value of $136.6 million at June 30, 2002, and represented 64% of total assets. The primary objective of our investment activities is to preserve capital. We have not used derivative financial instruments in our investment portfolio.

We performed a sensitivity analysis assuming a hypothetical 10% adverse movement in interest rates applicable to fixed rate investments maturing during the next twelve months that are subject to reinvestment risk. As of June 30, 2002, the analysis indicated that these hypothetical market movements would not have a material effect on our financial position, results of operations or cash flow.

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PART II - OTHER INFORMATION

Item 4. Submission of Matters to Vote of Security Holders

The Annual Meeting of the Stockholders of the Company was held on Wednesday, June 5, 2002. There were 14,149,929 shares of the Company’s common stock entitled to vote and a total of 13,222,905 shares were represented at the Annual Meeting. Two matters were submitted to the stockholders for approval: (1) the election of six directors and (2) the ratification of the selection of Ernst & Young LLP as the independent public accountants for the Company.

Six nominees, namely John M. Siebert, Ph.D., Terrence W. Glarner, Steven B. Ratoff, Joseph R. Robinson, Ph.D., John F. Chappell, and Steven D. Cosler, were duly elected as directors of the Company until the next annual meeting of stockholders. Each nominee received at least ninety-eight percent of the votes cast in favor of his election. Further results of the voting were as follows:

  Votes Cast    
  for the   Votes
Director Director   Withheld
 
 
John M. Siebert, Ph.D. 13,193,334   129,571
Terrence W. Glarner 13,065,463   257,442
Steven B. Ratoff 13,115,736   207,169
Joseph R. Robinson, Ph.D. 13,218,009   104,896
John F. Chappell 13,196,811   126,094
Steven D. Cosler 13,109,673   213,232

There were no abstentions and no broker non-votes.

The proposal to approve the selection of Ernst & Young LLP as the independent public accountants for the Company was approved by the Company’s stockholders. A total of 12,890,503 shares of the Company’s common stock were voted in favor of the proposal, 427,161 shares of the Company’s common stock were voted against the proposal and holders of 5,241 shares of the Company’s common stock abstained from voting. There were no broker non-votes. The proposal to approve the selection of Ernst & Young LLP as the independent public accountants for the Company received approximately ninety-seven percent of the vote cast.

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Item 6. Exhibits and Reports on Form 8-K

(a)   Exhibits    
 
  Exhibit Description of Document Method of Filing
 


  3.1 Fifth Restated Certificate of Incorporation of CIMA, as amended. (1)
       
  3.2 Third Restated Bylaws of CIMA. (2)
       
  4.1 Form of Certificate for Common Stock. (3)
       
  4.2 Amended and Restated Rights Agreement dated June 26, 2001, between CIMA and Wells Fargo Bank Minnesota, N.A. as Rights Agent. (4)
       
  10.1 Development, License and Supply Agreement made as of May 20, 2002, by and between CIMA and Schering-Plough Ltd.* Filed herewith
 
  10.2 Development and License Agreement dated June 18, 2002, between CIMA and WYETH (formerly known as American Home Products Corporation), acting through its Wyeth Consumer Healthcare Division.* Filed herewith
 
  10.3 Supply Agreement dated June 18, 2002, between CIMA and WYETH (formerly known as American Home Products Corporation), acting through its Wyeth Consumer Healthcare Division.* Filed herewith
 
  99.1 Certification of Chief Executive Officer Filed herewith
 
  99.2 Certification of Chief Financial Officer Filed herewith


 * Denotes confidential information that has been omitted from the exhibit and filed separately, accompanied by a confidential treatment request, with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934.
 
(1) Filed as an exhibit to CIMA’s Registration Statement on Form S-8, filed June 13, 2001, File No. 333-62954, and incorporated herein by reference.
 
(2) Filed as an exhibit to CIMA’s Quarterly Report on Form 10-Q for the period ended June 30, 1999, File No. 333-62954, and incorporated herein by reference.
 
(3) Filed as an exhibit to CIMA’s Registration Statement on Form S-1, File No. 33-80194, and incorporated herein by reference.
 
(4) Incorporated by reference to Exhibit 1 to CIMA’s Amendment No. 1 to Registration Statement on Form 8-A/A, filed July 18, 2001, File No. 0-24424.


(b)


Reports on Form 8-K
No reports on Form 8-K were filed for the quarter ended June 30, 2002.

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.



      CIMA LABS INC.
     
      Registrant
       
       
Date August 9, 2002 By /s/David A. Feste
 
 
      David A. Feste
      Chief Financial Officer
      (principal financial and accounting officer,
      duly authorized to sign on behalf of the
      registrant)

30

EX-10.1 3 c71161exv10w1.txt EX-10.1 DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT EXHIBIT 10.1 DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT BY AND BETWEEN CIMA LABS INC. AND SCHERING-PLOUGH LTD. TABLE OF CONTENTS
Page ARTICLE I - DEFINITIONS......................................................................... 2 ARTICLE II - LICENSE; DISCLOSURE OF INFORMATION DEVELOPMENT AND COMMERCIALIZATION............................................................................... 9 2.1 EXCLUSIVE LICENSE GRANT................................................................ 9 2.2 DISCLOSURE OF INFORMATION.............................................................. 10 2.3 DEVELOPMENT PROGRAM.................................................................... 10 2.4 SPECIFICATIONS AND BULK SPECIFICATIONS................................................. 10 2.5 COMPLETION OF DEVELOPMENT PROGRAM...................................................... 11 2.6 SCHERING COOPERATION IN DEVELOPMENT PROGRAM............................................ 11 2.7 COSTS OF DEVELOPMENT PROGRAM........................................................... 11 2.8 REPORTING RELATING TO DEVELOPMENT PROGRAM.............................................. 11 2.9 LIAISONS FOR DEVELOPMENT PROGRAM....................................................... 11 2.10 DELIVERY OF ACTIVE INGREDIENT FOR DEVELOPMENT PROGRAM.................................. 12 2.11 SHIPMENT OF LICENSED PRODUCT FOR DEVELOPMENT PROGRAM................................... 12 2.12 OUTSIDE SERVICES AGREEMENT............................................................. 12 ARTICLE III - PAYMENTS; ROYALTIES AND REPORTS................................................... 12 3.1 CONSIDERATION FOR LICENSE.............................................................. 12 3.2 ROYALTIES.............................................................................. 13 3.3 REPORTS AND PAYMENT OF ROYALTY......................................................... 15 3.4 MAINTENANCE OF RECORDS; AUDITS......................................................... 16 ARTICLE IV - PATENTS............................................................................ 17 4.1 FILING, PROSECUTION AND MAINTENANCE OF PATENTS......................................... 17 4.2 OPTION OF SCHERING TO PROSECUTE AND MAINTAIN PATENTS................................... 17 4.3 ENFORCEMENT............................................................................ 18 4.4 INFRINGEMENT AND THIRD PARTY LICENSES.................................................. 19 4.5 THIRD PARTY INFRINGEMENT SUIT.......................................................... 20 4.6 ABANDONMENT............................................................................ 21 4.7 IDENTIFICATION OF CIMA ON PACKAGING OF LICENSED PRODUCT................................ 21 ARTICLE V - QUALITY CONTROL AND REGULATORY COMPLIANCE........................................... 21 5.1 FACILITY COMPLIANCE AND RELATED MATTERS................................................ 21 5.2 QUALITY CONTROL PROGRAM................................................................ 22 5.3 APPROVAL FOR MANUFACTURING CHANGES; THIRD PARTY MANUFACTURING.......................... 22 5.4 RETENTION OF SAMPLES................................................................... 22 5.5 BATCH FAILURE.......................................................................... 22 5.6 NOTIFICATION OF REGULATORY INSPECTIONS................................................. 23 5.7 INSPECTION BY SCHERING................................................................. 23 5.8 ENVIRONMENTAL AND OTHER LAWS........................................................... 23 ARTICLE VI - PRODUCT RECALL..................................................................... 24 6.1 NOTIFICATION AND RECALL................................................................ 24 6.2 RECALL EXPENSES........................................................................ 24 ARTICLE VII - APPROVAL SUPPORT; REGULATORY MATTERS.............................................. 25
-i- 7.1 APPROVAL SUPPORT....................................................................... 25 7.2 FILING AND MAINTENANCE OF THE HEALTH REGISTRATIONS..................................... 25 7.3 REGULATORY ASSISTANCE FOR MAINTAINING FILINGS.......................................... 26 7.4 SPECIFICATIONS AND BULK SPECIFICATIONS; AMENDMENTS..................................... 26 7.5 COMPLAINTS OR ADVERSE EXPERIENCES...................................................... 26 7.6 RECORD KEEPING......................................................................... 27 7.7 CIMA APPROVALS......................................................................... 28 ARTICLE VIII - SUPPLY OF BULK ACTIVE AND RAW MATERIALS.......................................... 28 8.1 SCHERING OBLIGATION.................................................................... 28 8.2 CIMA OBLIGATION........................................................................ 29 8.3 ACCEPTANCE OF BULK ACTIVE.............................................................. 29 8.4 STORAGE AND FORMULATION OF BULK ACTIVE AND RAW MATERIALS; OWNERSHIP OF BULK ACTIVE..... 29 8.5 YIELD LOSSES........................................................................... 29 ARTICLE IX - SUPPLY OF MANUFACTURED PRODUCT..................................................... 29 9.1 SUPPLY OF SCHERING'S REQUIREMENTS...................................................... 29 9.2 GOOD FAITH FORECASTS................................................................... 30 9.3 PURCHASE ORDERS........................................................................ 30 9.4 STOPPAGE DUE TO GOOD CAUSE............................................................. 31 9.5 SCHERING OPTION TO MANUFACTURE......................................................... 31 ARTICLE X - DELIVERY AND RELATED MATTERS........................................................ 33 10.1 CERTIFICATE OF ANALYSIS................................................................ 33 10.2 RISK OF LOSS........................................................................... 33 10.3 STORAGE................................................................................ 33 10.4 DELAY AND FAILURE TO SUPPLY............................................................ 33 10.5 REJECTION.............................................................................. 34 ARTICLE XI - PAYMENT............................................................................ 35 11.1 PRICE.................................................................................. 35 11.2 PRICE ADJUSTMENT....................................................................... 35 11.3 MAXIMUM PRICE INCREASE................................................................. 37 11.4 TAXES.................................................................................. 37 ARTICLE XII - CONFIDENTIALITY AND PUBLICATION................................................... 37 12.1 CONFIDENTIALITY........................................................................ 37 12.2 NO PUBLICITY........................................................................... 39 12.3 PUBLICATION............................................................................ 39 12.4 ORAL DISCLOSURE OF PROPRIETY INFORMATION............................................... 40 ARTICLE XIII - REPRESENTATIONS AND WARRANTIES................................................... 40 13.1 REPRESENTATIONS AND WARRANTIES OF EACH PARTY........................................... 40 13.2 CIMA'S REPRESENTATIONS AND WARRANTIES.................................................. 41 13.3 CIMA COVENANTS......................................................................... 42 13.4 SCHERING'S REPRESENTATIONS AND WARRANTIES.............................................. 43 13.5 SCHERING COVENANTS..................................................................... 44 13.6 COVENANTS OF EACH PARTY................................................................ 44 13.7 CONTINUING REPRESENTATIONS............................................................. 44 13.8 NO INCONSISTENT AGREEMENTS............................................................. 44 13.9 REPRESENTATION BY LEGAL COUNSEL....................................................... 44 ARTICLE XIV - INDEMNIFICATION AND LIMITATION ON LIABILITY....................................... 45
-ii- 14.1 INDEMNIFICATION BY SCHERING......................................................... 45 14.2 INDEMNIFICATION BY CIMA............................................................. 45 14.3 CONDITIONS TO INDEMNIFICATION....................................................... 45 14.4 SETTLEMENTS......................................................................... 46 14.5 LIMITATION OF LIABILITY............................................................. 46 14.6 INSURANCE........................................................................... 46 ARTICLE XV - TERM AND TERMINATION............................................................... 46 15.1 TERM AND EXPIRATION................................................................. 46 15.2 TERMINATION BY SCHERING............................................................. 47 15.3 TERMINATION......................................................................... 47 15.4 EFFECT OF TERMINATION............................................................... 49 ARTICLE XVI - MISCELLANEOUS..................................................................... 49 16.1 ASSIGNMENT.......................................................................... 50 16.2 GOVERNING LAW....................................................................... 50 16.3 WAIVER.............................................................................. 50 16.4 INDEPENDENT RELATIONSHIP............................................................ 50 16.5 EXPORT CONTROL...................................................................... 51 16.6 ENTIRE AGREEMENT; AMENDMENT......................................................... 51 16.7 NOTICES............................................................................. 51 16.8 PROVISIONS FOR INSOLVENCY........................................................... 52 16.9 FORCE MAJEURE....................................................................... 54 16.10 SEVERABILITY........................................................................ 54 16.11 COUNTERPARTS........................................................................ 55 16.12 CAPTIONS............................................................................ 55 16.13 RECORDING........................................................................... 55 16.14 FURTHER ACTIONS..................................................................... 55
APPENDIX A - CHEMICAL FORMULA OF [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] APPENDIX B - BULK SPECIFICATIONS FOR BULK ACTIVE APPENDIX C - DEVELOPMENT PROGRAM APPENDIX D - LICENSED PATENTS RIGHTS APPENDIX E - COPY OF OUTSIDE SERVICES AGREEMENT APPENDIX F - PACKAGING COMPONENTS FOR LICENSED PRODUCT APPENDIX G - PRICE OF LICENSED PRODUCT SUPPLIED BY CIMA FOR COMMERCIAL USE APPENDIX H - SPECIFICATIONS FOR LICENSED PRODUCT APPENDIX I - ADVERSE EVENT REPORTING PROCEDURES FOR PRODUCTS -iii- SAFETY AGREEMENT APPENDIX I SAFETY AGREEMENT APPENDIX 2 APPENDIX J - STORAGE CONDITIONS APPENDIX K - EXPENSE GUIDELINES APPENDIX L - KEY SCHERING MARKETS APPENDIX M - ARBITRATION PROVISIONS -iv- THIS DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT (the "Agreement") is made as of the last date on the signature page hereof (the "Effective Date") by and between CIMA LABS INC., a Delaware corporation having its principal place of business at 10,000 Valley View Road, Eden Prairie, Minnesota 55344 (hereinafter referred to as "CIMA") and Schering-Plough Ltd., a corporation duly organized and existing under the laws of Switzerland, with an office at Toepferstrasse 5, CH 6004 Lucerne, Switzerland (hereinafter referred to as "Schering"). CIMA and Schering are sometimes referred to herein individually as a party and collectively as the parties. References to "Schering" and "CIMA" shall include their respective Affiliates (as hereinafter defined). WHEREAS, CIMA and its Affiliates have developed a fast-dissolving drug delivery system and possess confidential technology, manufacturing know-how and experience related thereto; and WHEREAS, Schering and its Affiliates have developed a proprietary pharmaceutical product, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], which will be sold in various finished pharmaceutical dosage forms by Schering; and WHEREAS, the parties have entered into an Outside Services Agreement (as defined below), under which CIMA has performed and will perform certain development work relating to the Licensed Product (as defined below); and WHEREAS, the parties desire to enter into an agreement whereby, subject to the terms of this Agreement, CIMA shall continue to develop the Licensed Product for Schering including, without limitation, scale-up and validation of the manufacturing process, and shall provide data necessary to support an NDA for the Licensed Product and shall manufacture the Licensed Product for Schering; and WHEREAS, Schering, together with its Affiliates, possess extensive capabilities in the development and commercialization of pharmaceutical products on a worldwide basis; and WHEREAS, Schering desires to obtain and CIMA is willing to grant to Schering, an exclusive license under the Licensed Patent Rights (as hereinafter defined) and to use the CIMA Know-How (as hereinafter defined) in combination with the Active Ingredient (as hereinafter defined) upon the terms and conditions set forth herein; and -1- NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, Schering and CIMA hereby agree as follows: ARTICLE I DEFINITIONS As used in this Agreement, the following capitalized terms, whether used in the singular or plural, shall have the respective meanings set forth below: 1.1 The term "Active Ingredient" shall mean [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], having the chemical formula contained in Appendix A, and its pharmaceutically acceptable salts. 1.2 The term "Approved Facility" shall mean that FDA approved facility of CIMA located at 10,000 Valley View Road, Eden Prairie, Minnesota, to be used by CIMA in its performance of this Agreement or such other facility as may be approved by Schering in accordance with Section 5.1, including, all of the equipment, machinery and facilities of CIMA at such location that are to be used in the Manufacturing and storage of Licensed Product. 1.3 The term "Affiliate" shall mean any individual or entity directly or indirectly controlling, controlled by or under common control with, a party to this Agreement. For purposes of this Agreement, the direct or indirect ownership of fifty percent (50%) or more of the outstanding voting securities of an entity, or the right to receive fifty percent (50%) or more of the profits or earnings of an entity shall be deemed to constitute control. Such other relationship as in fact results in actual control over the management, business and affairs of an entity shall also be deemed to constitute control. 1.4 The term "Bulk Active(s)" shall mean the Active Ingredient in bulk form and meeting the Bulk Specifications. 1.5 The term "Bulk Specifications" shall mean the specifications and quality control testing procedures for the Bulk Active set forth in Appendix B hereto, as amended from time to time, in accordance with the terms of this Agreement. 1.6 The term "Calendar Quarter" shall mean the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31, for so long as this Agreement is in effect. -2- 1.7 The term "Calendar Year" shall mean each successive period of twelve (12) months commencing on January 1 and ending on December 31, for so long as this Agreement is in effect. 1.8 The term "CIMA Know-How" shall mean any of CIMA's or its Affiliates' proprietary information and materials relating to the research, development, registration, or Manufacture of Licensed Product which during the Term of this Agreement are in CIMA's or its Affiliates' possession or control, through license or otherwise, and which are not generally known or become known during the Term of the Agreement. CIMA Know-How shall include, without limitation, discoveries, methods, knowledge, Improvements, processes, formulas, data, ideas, experience, inventions, know-how, technology, trade secrets, manufacturing procedures, purification and isolation techniques, test data and other intellectual property, patentable or otherwise, developed by or on behalf of CIMA relating to the OraSolv Technology or its use in combination with the Active Ingredient. 1.9 The term "CIMA Trademark" shall mean any trademark(s) proposed, chosen, owned or controlled by CIMA or its Affiliates. 1.10 The term "CMC" shall mean the chemistry, manufacturing, and controls section(s) and data in the Health Registrations that cover the chemical composition of the Licensed Product and its components and the control and Manufacturing process for the Licensed Product, as amended or supplemented from time to time. 1.11 The term "Development Program" shall mean all development work undertaken under the Outside Services Agreement or hereunder by or on behalf of CIMA or its Affiliates with respect to development of Licensed Product including, without limitation, the work set forth in Appendix C hereto, as well as all development work undertaken by Schering or its Affiliates as set forth in Appendix C hereto, as such Appendix C may be amended by mutual written agreement of the parties hereto. 1.12 The term "EXW" shall mean Ex Works as that term is used in Incoterms 2000. 1.13 The term "FDA" shall mean the United States Food and Drug Administration or any successor agency thereof. 1.14 The term "FDCA" shall mean the Federal Food, Drug and Cosmetic Act, 21 U.S.C. [sec]301-397, as amended. 1.15 The term "First Commercial Sale" shall mean, with respect to any Licensed Product, the first sale for end use of such Licensed Product. -3- 1.16 The term "GMPs" shall mean current good manufacturing practices for the methods to be used in, and the facilities and controls to be used for, the manufacture, processing, packing and holding of drugs, all as set forth from time to time by the FDA and any other relevant Regulatory Authorities in the Territory. 1.17 The term "Health Registrations" shall mean the technical, medical and scientific licenses, registrations, authorizations and/or approvals of the Licensed Product (including the prerequisite manufacturing approvals or authorizations, marketing authorization based upon such approvals and pricing, third party reimbursement and labeling approvals related thereto) that are required by any national, supra-national (e.g., the European Commission or the Council of the European Union), regional, state or local regulatory agency, department, bureau or other governmental entity in the Territory, for the Manufacture, distribution, use or sale of Licensed Product in the Territory, as amended or supplemented from time to time. With respect to the United States, the term Health Registrations shall include, without limitation, an "Investigational New Drug Application" or a "New Drug Application," as defined in 21 C.F.R. pt. 312 and 21 C.F.R. pt. 314 respectively, for the Licensed Product, as amended or supplemented from time to time. 1.18 The term "Improvement" shall mean any enhancement in the formulation, ingredients, preparation, presentation, means of delivery, dosage, packaging of, manufacture, or any new or expanded therapeutic indications(s) for the Licensed Product, in each case which is developed prior to or during the Term of this Agreement by or on behalf of CIMA or by or on behalf of Schering, as applicable. 1.19 The term "Independent Auditor" shall mean a nationally recognized certified public accounting firm, provided, however, no certified public accounting firm shall be engaged for the purpose of determining a Price adjustment if that firm has, or at any time within the last five (5) years prior to such engagement has had, any business relations or affiliations with either Schering or CIMA. 1.20 The term "IND" shall mean an investigational new drug application submitted to the FDA or its equivalent in countries outside the United States, approval of which permits the clinical investigation of Licensed Product. 1.21 The term "Law" or "Laws" shall mean all applicable federal, state, local or foreign statutes or laws and shall be deemed also to refer to all rules and regulations promulgated thereunder by any Regulatory Authorities in the Territory, unless context requires otherwise. Any reference to a particular statute, law, rule or regulation will be interpreted to include any revision of or -4- successor to such statute, law, rule or regulation regardless of how it is numbered or classified. 1.22 The term "Licensed Patent Rights" shall mean all claims of any patent applications or issued patents in the Territory, whether in existence as of the date of this Agreement, or filed or issued during the Term of this Agreement, to which CIMA and/or its Affiliates has or acquires any right and which cover the manufacture, use or sale of Licensed Product, including, without limitation, the United States and foreign patent applications and issued patents which: (a) are listed, as of the effective date of this Agreement, in Appendix D which is attached hereto and made a part hereof and which shall be periodically updated by written notice from CIMA to Schering in a timely fashion during the term of the Agreement; (b) relate to the OraSolv Technology or the CIMA Know-How; (c) arise out of or are developed during and under the performance of the Development Program by CIMA or its Affiliates; and/or (d) cover any patentable Improvement of any of the foregoing. Licensed Patent Rights shall include any reissues, reexaminations, extensions (or other governmental actions which provide exclusive rights to the patent holder in the patented subject matter beyond the original patent expiration date), substitutions, confirmations, registrations, revalidations, additions, continuations, continuations-in-part, or divisions of or to any patent applications or issued patents described in (a)-(d) of this Section. 1.23 The term "Licensed Product" shall mean any dosage form utilizing any material elements of the CIMA Know-How, and/or the Licensed Patent Rights, in its Manufacture or use, and which contains the Active Ingredient as a pharmaceutically active ingredient. 1.24 The term "Manufacture", "Manufactured" or "Manufacturing" shall mean the manufacture, formulating, finishing (including packaging), filling, and quality control testing (including in-process, release, and stability testing) of the Licensed Product. 1.25 The term "NDA" shall mean a New Drug Application, Product License Application or its equivalent filed with the FDA seeking approval to market and sell a Licensed Product in the United States. -5- 1.26 The term "Net Sales" shall mean the sales invoiced by Schering, its Affiliates or sublicensees on all sales of Licensed Product to an unaffiliated third party (whether an end-user, a distributor or otherwise), and exclusive of intercompany transfers or sales in the Territory, less the reasonable and customary deductions utilized in the pharmaceutical industry, from such gross amounts including: (i) normal and customary trade, cash and quantity discounts, allowances and credits; (ii) credits or allowances actually granted for damaged goods, returns or rejections of Licensed Product and retroactive price reductions; (iii) sales or similar taxes (including duties or other governmental charges levied on, absorbed or otherwise imposed on the sale of Licensed Product including, without limitation, value added taxes or other governmental charges otherwise measured by the billing amount, when included in billing); (iv) freight, postage, shipping, customs duties and insurance charges; and (v) charge back payments and rebates granted to managed health care organizations or to federal, state and local governments, their agencies, and purchasers and reimbursers or to trade customers, including but not limited to, wholesalers and chain and pharmacy buying groups. 1.27 The term "OraSolv Technology" shall mean the fast-dissolving drug delivery system described in U.S. Patent 5,178,878 and U.S. Patent Application 08/468,913 including, formulations, materials, methods and other technologies which are owned by CIMA or licensed to CIMA with the right to grant sublicenses. 1.28 The term "Outside Services Agreement" shall mean the Outside Services Agreement by and between the parties effective May 21, 2001, as amended by the Amendment #1 to Outside Services Agreement entered into on September 25, 2001 and Amendment #2 to Outside Services Agreement entered into on December 3, 2001, copies of which are attached hereto as Appendix E, as amended from time to time. 1.29 The term "Packaging Insert" shall mean the written materials approved by the FDA and required to be inserted into any packaged Licensed Product utilized by patients after approval of all Health Registrations necessary to sell the Licensed Product in the Territory. -6- 1.30 The term "Packaging Components" shall mean the packaging materials meeting the specifications described on Appendix F, to be provided by CIMA for the packaging of Licensed Product Manufactured by CIMA after approval of all Health Registrations necessary to sell the Licensed Product in the Territory. 1.31 The term "Price" shall mean the price of Licensed Product supplied to Schering by CIMA as set forth on Appendix G hereto. 1.32 The term "Proprietary Information" shall mean CIMA Know-How, Schering Know-How and all other scientific, clinical, regulatory, marketing, financial and commercial information or data, whether communicated in writing, verbally or electronically, which is provided by one party to the other party in connection with this Agreement. 1.33 The term "Raw Materials" shall mean, inter alia, all raw materials, components, and excipients, other than Bulk Active or Active Ingredient, useful or necessary for the Manufacture of the Licensed Product in accordance with this Agreement. 1.34 The term "Regulatory Authority" shall mean the applicable government regulatory authority in each country in the Territory involved in granting the Health Registrations for the Licensed Product. Such term includes, without limitation, the FDA and any successor thereto. 1.35 The term "Requirements" shall mean all quantities of the Licensed Product that shall be required by Schering for clinical trial materials (including for new indications) and for distribution, marketing (including samples) or other research and development activities, and sale of the Licensed Product in the Territory during the term hereof. 1.36 The term "Schering Know-How" shall mean any of Schering's or its Affiliates' information and materials relating to the research, development, registration, manufacture, marketing, use or sale of Active Ingredient, Bulk Active and/or Licensed Product which during the Term of this Agreement are in Schering's or its Affiliates' possession or control, through license or otherwise, and which are not generally known, including without limitation such information and materials that become known as a result of the Development Program during the Term of this Agreement. Schering Know-How shall include, without limitation, discoveries, methods, knowledge, Improvements, processes, formulas, data, ideas, experience, inventions, know-how, technology, trade secrets, manufacturing procedures, purification and isolation techniques, test data and other intellectual property, patentable or otherwise, developed by or on behalf of Schering or its Affiliates relating to Licensed -7- Product, which relate primarily to the Active Ingredient or the therapeutic class [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the Licensed Product, including without limitation, test procedures and other new technologies derived therefrom. Without limitation, Schering Know How shall include the Specifications, the Bulk Specifications, the CMC, the production monograph setting forth the master batch records and quality control testing, and all other data, ideas, inventions, instructions, processes, formulae, expert opinion and information which are owned or controlled by Schering or its Affiliates as of the effective date of this Agreement or during the Term of this Agreement and which are necessary for the Manufacture of the Licensed Product. 1.37 The term "Schering Trademark" shall mean any trademark(s) proposed, chosen, owned or controlled by Schering or its Affiliates for use with Active Ingredient and/or the Licensed Product in the Territory. 1.38 The term "Specifications" means the specifications and quality control testing procedures for the Licensed Product as set forth in Appendix H hereto, as amended from time to time in accordance with the terms of this Agreement. 1.39 The term "Supply Failure" shall mean CIMA's inability to Manufacture enough Licensed Product to deliver in a timely manner at least seventy-five percent (75%) of the Licensed Product actually ordered by Schering in accordance with the most recent forecast for the specified period. 1.40 The term "Territory" shall mean all of the countries and territories in the world. 1.41 The term "Term" shall mean the period commencing on the Effective Date and unless terminated earlier pursuant to the relevant provisions of Article XV shall continue on a country by country basis until the later of (i) ten (10) years after the First Commercial Sale of the Licensed Product in such country or (ii) the expiration of the last to expire of the Licensed Patent Rights in such country incorporating a Valid Claim. 1.42 The term "Valid Claim" shall mean a composition of matter or method of use claim, or equivalent thereof, of an issued and unexpired patent in the Territory covering Licensed Product(s) included within the Licensed Patent Rights, which (i) has not been revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal; or -8- (ii) has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue or disclaimer or otherwise. 1.43 The term "Yield Losses" or "Yield Loss" shall mean the percentage of Bulk Active that is lost or wasted during Manufacturing and not included in the Licensed Product. ARTICLE II LICENSE; DISCLOSURE OF INFORMATION DEVELOPMENT AND COMMERCIALIZATION 2.1 Exclusive License Grant. (a) License to Patent Rights of CIMA. CIMA hereby grants to Schering, as of the Effective Date, an exclusive license, exclusive even as to CIMA, in the Territory under the Licensed Patent Rights, and to use CIMA Know-How to develop, make, have made, import, export, use, distribute, market, promote, offer for sale and sell Licensed Product(s). Any Improvements shall be included in CIMA Know-How or Licensed Patent Rights, as the case may be, for all purposes of this Agreement. Without limiting the foregoing, CIMA hereby grants Schering an irrevocable, worldwide, paid-up, exclusive license to use CIMA Know-How or other intellectual property rights relating to the Development Program and Manufacture of Licensed Product that are necessary for Schering's filings for the purpose of obtaining and maintaining the Health Registrations in the Territory for the Licensed Product, including but not limited to the Manufacturing of Licensed Product as provided in the Health Registrations. Notwithstanding the foregoing, Schering has granted certain rights to Manufacture Licensed Product to CIMA, which rights are set forth in Section 2.1 (c) below. (b) Right to Sublicense. The licenses granted to Schering under Section 2.1(a) shall include the right to grant sublicenses to Affiliates. Schering shall provide CIMA with notice of any sublicense to an Affiliate. In addition, in the event that Schering exercises its option rights to Manufacture Licensed Product(s) under Section 9.5 of this Agreement, Schering shall also have the right, with the written consent of CIMA, which consent shall not be unreasonably withheld or delayed, to grant sublicenses to any third party to Manufacture the Licensed Product(s) for Schering and its Affiliates by providing CIMA with sixty (60) days' prior written notice of the proposed sublicense. (c) License to Manufacture. Notwithstanding the provisions of Section 2.1 (a) above, Schering hereby grants to CIMA an exclusive -9- license, exclusive even as to Schering, in the Territory, to Manufacture Licensed Product(s) during the Term for the sale of Licensed Product(s) to Schering in accordance with the terms of this Agreement, subject only to Schering's option rights to Manufacture Licensed Product(s) under Section 9.5 of this Agreement. 2.2 Disclosure of Information. Promptly after the Effective Date, CIMA shall disclose to Schering in writing, or via electronic media acceptable to Schering, all CIMA Know-How not previously disclosed to Schering as reasonably necessary in order to enable Schering to exploit its rights granted under Section 2.1 of this Agreement. In addition, during the Term of this Agreement CIMA shall promptly disclose to Schering in writing, or via electronic media acceptable to Schering, CIMA Know-How relating to any Improvements. Such CIMA Know-How and other information shall be automatically deemed to be within the scope of the licenses granted herein without payment of any additional compensation. Notwithstanding the foregoing, the parties recognize that CIMA will Manufacture the Licensed Product until such time as Schering exercises its option rights under Section 9.5, and CIMA shall not be obligated to provide CIMA Know-How relating to the Manufacture of the Licensed Product, except as necessary for Schering to file and maintain any Health Registrations, until such time as Schering exercises its option rights under Section 9.5. 2.3 Development Program. (a) Outside Services Agreement. The parties acknowledge and agree that all development activities set forth in the Outside Services Agreement through Phase IVa, Pilot Scale Biobatch and Definitive Stability Batches: Manufacture and Stability, as described on Attachment B-1 of the Outside Services Agreement, have been or shall be performed pursuant to and under the terms of the Outside Services Agreement. (b) Other Development. All development activities relating to Phase IVb, Full Scale Demonstration and Stability Batches: Manufacture and Stability, as described on Appendix C, and thereafter (Phase V and Phase VI) shall be performed pursuant to and under the terms of this Agreement, including all activities set forth on Appendix C. 2.4 Specifications and Bulk Specifications. The Specifications for the Licensed Product set forth in Appendix H and the Bulk Specifications set forth in Appendix B hereof may be amended at any time by Schering in accordance with Section 7.4 of this Agreement. -10- 2.5 Completion of Development Program. CIMA and/or its Affiliates shall use diligent efforts to carry out in a timely fashion its obligations under the Development Program, except if CIMA has obtained the prior written approval of Schering to modify a portion of the Development Program. The terms of the Development Program may only be changed by written agreement of both parties hereto. 2.6 Schering Cooperation in Development Program. Schering and/or its Affiliates shall use diligent efforts, at its sole cost and expense, to carry out all tests and clinical trials set forth in the Development Program. CIMA shall supply Schering in a timely fashion and at no additional cost to Schering with the quantities of Licensed Product set forth in the Development Program as shall be reasonably required to carry out such tests and clinical trials. Quantities of Licensed Product provided for this purpose in excess of those set forth in Appendix C hereto shall be purchased from CIMA by Schering at a cost equal to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] (U.S.) per batch (minimum of 100,000 tablets per batch). 2.7 Costs of Development Program. Except for the cost of Bulk Active, which is to be supplied to CIMA at no cost by Schering pursuant to this Agreement, the cost of tooling unique to the Licensed Product described in Appendix G (which costs shall be set forth in another written agreement), and the costs specifically set forth on Appendix C as costs for which Schering shall be responsible, CIMA shall be responsible for all direct and indirect costs and expenses of personnel and for materials, plant and equipment which CIMA and/or its Affiliates employs or utilizes in carrying out its obligations under the Development Program, including, without limitation, (1) the cost of any work performed by its personnel and/or third parties retained by CIMA under the Development Program, and (2) all transportation, hotel and other travel expenses incurred by CIMA's or its Affiliates' employees, agents and third party contractors while carrying out tasks under the Development Program. 2.8 Reporting Relating to Development Program. CIMA shall keep Schering informed of its progress under the Development Program by way of periodic meetings and telephone conferences and, upon Schering's request, by means of periodic written summary reports. In addition, Schering will have reasonable access to CIMA's facilities and relevant records during and after the Development Program to monitor the progress of the Development Program. 2.9 Liaisons for Development Program. CIMA and Schering shall each designate one (1) senior employee as technical liaison to handle all technical matters and communications relating to the Development Program. -11- 2.10 Delivery of Active Ingredient for Development Program. Schering has provided CIMA with certain Schering Know-How relating to the Active Ingredient and shall provide CIMA with any additional Schering Know-How in Schering's possession as CIMA shall reasonably request and Schering shall reasonably agree is necessary to enable CIMA to perform the Development Program. Schering shall also supply to CIMA, at no cost, sufficient quantities of Bulk Active, reasonably required for CIMA to carry out its activities under the Development Program as required by Section 2.3(b) and Appendix C hereof. CIMA agrees to advise Schering, at least sixty (60) days in advance of the requested delivery thereof, of its requirements for the Bulk Active. 2.11 Shipment of Licensed Product for Development Program. CIMA shall ship each batch of Licensed Product for the Development Program within five (5) calendar days of Manufacture and receipt by CIMA of shipping instructions from Schering. Within five (5) calendar days of Manufacture of each batch of Licensed Product, CIMA shall prepare, and deliver to Schering, all documentation relating to the individual batch of Licensed Product that is required by any Regulatory Authority for Schering and/or CIMA to demonstrate that the Manufacture of the batch of Licensed Product complies with Laws and Specifications. 2.12 Outside Services Agreement. All services performed under the Outside Services Agreement by CIMA relating to the Development Program shall be performed in compliance with all applicable Laws. ARTICLE III PAYMENTS; ROYALTIES AND REPORTS 3.1 Consideration for License. In partial consideration for the licenses granted to Schering hereunder, Schering shall make the following payments to CIMA on the first occurrence of the indicated triggering events. $250,000 Within five (5) days after execution of this Agreement $250,000 [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] (already paid 01/23/02) -12- [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Each of the milestones payments set forth in this Section 3.1 shall be payable once upon the initial achievement of such event and no amounts shall be due hereunder for subsequent or repeated achievement of such event. 3.2 Royalties. (a) Royalty Rates. In further consideration for the licenses granted to Schering hereunder, starting on a country by country basis with the First Commercial Sale of Licensed Product in the country, Schering shall pay to CIMA, royalties of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of annual Net Sales of Licensed Product in the Territory. (b) Term and Scope of Royalty Obligations. Subject to the terms of Sections 4.3(b) and 14.1, royalties on each Licensed Product at the rate set forth in Section 3.2(a) shall continue on a country by country basis until the later of (i) ten (10) years from the First Commercial Sale of the first Licensed Product in the country or (ii) the expiration of the last applicable Licensed Patent Right incorporating a Valid Claim. No royalties shall be due upon the sale or other transfer among Schering, its Affiliates or sublicensees, but in such cases the royalty shall be due and calculated upon Schering's or its Affiliates' or its sublicensees' Net Sales to the first independent third party. No royalties shall accrue on the disposition of Licensed Product by Schering, its Affiliates or its sublicensees as donations (for example, to non-profit institutions or government agencies for a non-commercial purpose), or at minimal pricing for charitable purposes to financially disadvantaged patients, directly or indirectly, through Schering's "Commitment to Care" and successor programs, professional samples, or Licensed Product provided at no cost to any third party or for clinical studies. (c) Third Party Licenses. In the event that patent licenses from third parties are required by Schering, its Affiliates and sublicensees in order to use the OraSolv Technology to develop, make, have made, import, export, use, distribute, promote, market, offer for sale or sell Licensed Product(s) (hereinafter "Third Party Patent Licenses"), then the royalty rates set forth in Section 3.2(a) shall be adjusted such that the royalty rate for Net Sales of Licensed Product which Schering is obligated -13- to pay CIMA shall be reduced by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] in royalties which Schering is obligated to pay under Third Party Patent Licenses obtained pursuant to Section 4.4, provided, however, that the royalty rate hereunder shall not be reduced by more than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. By way of example and for avoidance of doubt, if Schering is obligated to pay royalties to CIMA on Net Sales of a Licensed Product and is also obligated to pay a [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] percent [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] royalty on sales of the same Licensed Product under a Third Party Patent License in order to use the OraSolv Technology, then the royalty rate under this Agreement would be reduced by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. For further example, if the third party royalty obligation in the above example were [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] percent [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], the calculated royalty rate would be reduced by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. Schering acknowledges that such reductions will be triggered only to the extent necessary for Schering to use the OraSolv Technology, and there will be no reductions for royalties unrelated to the use of the OraSolv Technology that Schering may be required to pay in connection with the Licensed Product(s). (d) Cap on Reductions. No provision of this Agreement shall be interpreted to permit Schering to reduce any individual royalty payment due CIMA by more than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. -14- 3.3 Reports and Payment of Royalty. (a) Royalties Paid Quarterly. Within sixty (60) calendar days following the close of each Calendar Quarter, following the First Commercial Sale of a Licensed Product, Schering shall furnish to CIMA a written report for the Calendar Quarter showing the Net Sales of Licensed Product sold by Schering, its Affiliates and its sublicensees in the Territory during such Calendar Quarter and the royalties payable under this Agreement for such Calendar Quarter. Simultaneously with the submission of the written report, Schering shall pay to CIMA, for the account of Schering or the applicable Affiliate or sublicensee, as the case may be, a sum equal to the aggregate royalty due for such Calendar Quarter calculated in accordance with this Agreement (reconciled for any previous overpayments or underpayments). (b) Maximum Royalties. If the royalties set forth herein are higher than the maximum royalties permitted by the Laws (without reference to deductibility for tax purposes) in any country in the Territory, the royalty payable for sales in such country shall be equal to the maximum permitted royalty under such Laws. (c) Tax Withholding. If any taxes, withholding or otherwise, are levied by any taxing authority in connection with accrual or payment of any royalties payable under this Agreement, Schering shall have the right to pay such taxes to the local tax authorities on behalf of CIMA and the payment to CIMA of the net amount due after reduction by the amount of such taxes, together with evidence of payment of such taxes, shall fully satisfy Schering's royalty obligations under this Agreement. Withholding payments made by Schering pursuant to this Section 3.3(c) shall be made based upon financial information provided to Schering by CIMA, and to the extent that such information is incorrect CIMA shall be liable for any deficiency, and any fine, assessment or penalty imposed by any taxing authority in the Territory for any deficiency in the amount of any such withholding or the failure to make such withholding payment. If Schering is required to pay any such deficiency, or any fine, assessment or penalty for any such deficiency, CIMA shall promptly reimburse Schering for such payments, which shall not be included in the calculation of Net Sales. (d) Method of Payment. Payments to be made by Schering to CIMA under this Agreement shall be paid by bank wire transfer in immediately available funds to such bank account as is designated in writing by CIMA from time to time. Royalty payments shall be made in United States dollars. -15- (e) Binding Records. Upon the expiration of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] following the end of any Calendar Year, the calculation of royalties payable under this Agreement with respect to such year shall be binding and conclusive upon the parties, and Schering and its Affiliates and its sublicensees shall be released from any liability or accountability with respect to royalties for such Calendar Year. Nothing in this Section shall limit the parties' rights under Section 3.4. (f) Notice of First Sale. Schering shall provide CIMA with notice of the First Commercial Sale of the Licensed Product in the Territory within a reasonable period of time following such sale. 3.4 Maintenance of Records; Audits. (a) Record Keeping by Schering. Schering and its Affiliates shall keep complete and accurate records in sufficient detail to enable the royalties payable hereunder to be determined. Upon forty-five (45) days' prior written notice from CIMA, Schering shall permit an independent certified public accounting firm of nationally recognized standing selected by CIMA and acceptable to Schering, at CIMA's expense, to have access during normal business hours to examine pertinent books and records of Schering and/or its Affiliates as may be reasonably necessary to verify the accuracy of the royalty reports hereunder. The public accounting firm must agree in writing with Schering to be bound by confidentiality obligations no more onerous than those set forth in this Agreement. The examination shall be limited to pertinent books and records for any Calendar Year ending not more than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] prior to the date of such request. An examination under this Section 3.4(a) shall not occur more than once in any Calendar Year, and shall not exceed one month in duration, unless otherwise agreed by Schering in writing. Schering may designate competitively sensitive information which such auditor may not disclose to CIMA, provided, however, that such designation shall not encompass the auditor's conclusions. The accounting firm shall disclose to CIMA only whether the royalty reports are correct or incorrect and the specific details concerning any discrepancies and such other information as may be reasonably necessary to resolve any dispute over the auditor's conclusions. No other information shall be provided to CIMA. All such accounting firms shall sign a confidentiality agreement (in form and substance reasonably acceptable to Schering) as to any of Schering's or its Affiliate's confidential information which they are provided, or to -16- which they have access, while conducting any audit pursuant to this Section 3.4(a). (b) Underpayments/Overpayments. If such accounting firm correctly concludes that additional royalties were owed during such period, Schering shall pay the additional royalties within thirty (30) days of the date CIMA delivers to Schering such accounting firm's written report so correctly concluding. If such underpayment exceeds five percent (5%) of the royalty correctly due CIMA then the fees charged by such accounting firm for the work associated with the underpayment audit shall be paid by Schering. Any underpayment shall include interest at the prime rate quoted in the Wall Street Journal from the date such payment was originally due by Schering. Any overpayments by Schering will be credited against future royalty obligations. In the event that Schering disagrees with the audit report and the chief financial officers of Schering and CIMA fail to resolve such disagreement, the dispute will be resolved through the dispute resolution mechanism set forth in Section 16.2. ARTICLE IV PATENTS 4.1 Filing, Prosecution and Maintenance of Patents. Subject to Section 4.2, CIMA agrees to diligently file, prosecute and maintain in all of the countries listed in Appendix D, any Licensed Patent Rights owned in whole or in part by CIMA and licensed to Schering under this Agreement. CIMA shall give Schering an opportunity to review the text of the applications that relate to the Licensed Product, before filing, shall consult with Schering with respect thereto, and shall supply Schering with a copy of the applications as filed, together with notice of its filing date and serial number. CIMA shall keep Schering advised of the status of all actual and prospective patent filings that relate to the Licensed Product, including grant of any such patent, and upon the written request of Schering shall provide advance copies of any substantive papers related to the filing, prosecution and maintenance of such patent filings that relate to the Licensed Product. 4.2 Option of Schering to Prosecute and Maintain Patents. CIMA shall give ninety (90) days' notice to Schering of any desire to cease prosecution and/or maintenance of a particular Licensed Patent Right and, in such case, shall permit Schering, at its sole discretion, to continue prosecution or maintenance at its own expense. If Schering elects to continue prosecution or maintenance, CIMA shall execute such documents and perform such acts, at Schering's expense, as may be reasonably necessary to effect an assignment of such Licensed Patent Rights to Schering. Any such assignment shall be -17- completed in a timely manner to allow Schering to continue such prosecution or maintenance. Any patents or patent applications so assigned shall thereafter not be considered Licensed Patent Rights. 4.3 Enforcement. In the event that either Schering or CIMA becomes aware of any infringement within the Territory of any issued patent within the Licensed Patent Rights, it will notify the other party in writing to that effect. Any such notice shall include evidence to support an allegation of infringement by such third party. (a) Discontinuance of Infringement. Provided that Schering has not commenced exercise of its rights under Section 4.3(b), CIMA shall have the right, but not the obligation, to obtain a discontinuance of such infringement or bring suit against the third party. CIMA shall bear all the expenses of any suit brought by it. Schering shall have the right, prior to commencement of the trial, suit or action brought by CIMA, to join any such suit or action, and in such event shall pay one-half of the costs of such suit or action. In the event that Schering has joined in the action and shared in the costs thereof as set forth above, no settlement, consent judgment or other voluntary final disposition of the suit may be entered into without the consent of Schering, which consent shall not be unreasonably withheld. In the event that Schering has not joined the suit or action, Schering will reasonably cooperate with CIMA in any such suit or action and shall have the right to consult with CIMA and be represented by its own counsel at its own expense, provided that CIMA shall periodically reimburse Schering for its reasonable out-of-pocket costs (excluding the costs of retaining its own outside counsel) incurred in cooperating with CIMA. Any recovery or damages derived from a suit which Schering has joined and shared costs shall be used first to reimburse each of CIMA and Schering for its documented out-of-pocket legal expenses relating to the suit, with any remaining amounts to be shared equally by the parties. Any recovery of damages derived from a suit which Schering has not joined shall be retained by CIMA. In the event that a third party has joined in any such suit or action, the parties agree that any costs, or recovery of damages, will be shared equitably by CIMA, Schering and such third party. (b) Continuance of Infringement. If, within three (3) months from the date of notice of infringement, CIMA has not commenced, or if commenced is not actively pursuing, legal action against an infringer as specified in Subsection 4.3(a), and such infringement is continuing, then Schering shall have the right [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] on a country by country -18- basis, for any country(ies) in the Territory where the infringement [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] provided, however, that [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall not be [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] by more than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] in the respective country. Schering shall have [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] until said infringement ceases and, thereafter, the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] In addition, Schering shall have the right, but not the obligation, to bring suit against such infringer under the Licensed Patent Rights and join CIMA as a party plaintiff, provided that Schering shall bear all the expenses of such suit. CIMA will cooperate with Schering in any suit for infringement of a Licensed Patent Right brought by Schering against a third party, and shall have the right to consult with Schering and to participate in and be represented by its own counsel in such litigation at its own expense. Schering shall periodically reimburse CIMA for its reasonable out-of-pocket costs (excluding CIMA's costs of retaining its own counsel) incurred in cooperating with Schering. Schering shall incur no liability to CIMA as a consequence of such litigation or any unfavorable decision resulting therefrom, including any decision holding any of the Licensed Patent Rights invalid or unenforceable. In the event that Schering recovers any sums in such litigation by way of damages or in settlement thereof, such recovery shall be (i) first applied to reimburse Schering for its documented out-of-pocket legal expenses relating to the suit, (ii) then applied to reimburse Schering for any lost sales in the Territory during the pendency of such suit (which shall be deemed for purposes hereof to be equal to the sales of infringing products during such period), (iii) then applied to reimburse CIMA for royalty reductions by Schering and (iv) shall thereafter be retained by Schering. 4.4 Infringement and Third Party Licenses. In the event that Schering's, its Affiliates' or its sublicensees' use of the OraSolv Technology in connection with making, having made, importing, exporting, using, distributing, marketing, promoting, offering for sale or selling Licensed -19- Product(s) infringes, will infringe or is alleged by a third party to infringe a third party's patent, the party becoming aware of same shall promptly notify the other. If Schering in good faith concludes that such use of the OraSolv Technology infringes or may infringe a third party's patent, Schering shall negotiate with said third party for a suitable license or assignment. In the event that such negotiation results in a consummated agreement, then any lump sum payment made thereunder shall be paid by Schering [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] but only to the extent of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] in any Calendar Quarter. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall be [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] any [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] CIMA [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Any [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] can be [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] to subsequent quarters. Schering shall periodically advise CIMA of the status of negotiations under this Section 4.4, and CIMA may provide its comments regarding the negotiations to Schering, with Schering determining, in its sole discretion, whether to incorporate such comments of CIMA into its negotiations with the third party. 4.5 Third Party Infringement Suit. In the event that a third party sues Schering alleging that Schering's, its Affiliates' or its sublicensees' use of the OraSolv Technology in connection with making, having made, importing, exporting, using, distributing, marketing, promoting, offering for sale or selling Licensed Product(s) infringes or will infringe said third party's patent, then Schering shall defend such suit and, during the period in which such suit is pending, Schering shall have the right to apply up to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the royalties due CIMA on sales of the allegedly infringing Licensed Product against its litigation expenses, including settlement costs and royalties paid in settlement of any such suit, provided, however, that in the event Schering recovers any such expenses such recovery shall be first applied to pay any royalties applied by Schering against -20- its litigation expenses. CIMA shall have the right to participate in and be represented by its own counsel at its own expense. CIMA or its counsel may provide CIMA's comments regarding the litigation to Schering, and Schering shall determine, in its sole discretion, whether to incorporate such comments into its litigation strategy. Schering shall have sole discretion to settle any such suit, or enter into any consent judgment or other voluntary final disposition of the suit without the consent of CIMA, except that Schering may not enter into any such consent judgment or other voluntary final disposition if such consent judgment or other voluntary final disposition constitutes an admission of CIMA which will foreclose CIMA from raising the issue in any future litigation, without the written consent of CIMA, which consent shall not be unreasonably withheld. Upon Schering's request and in connection with Schering's defense of any such third party infringement suit, CIMA shall provide reasonable assistance to Schering for such defense. 4.6 Abandonment. Subject to Schering's rights pursuant to Section 4.2, CIMA shall at the earliest known date give notice to Schering of the grant lapse, revocation, surrender, invalidation or abandonment of any Licensed Patent Rights licensed to Schering for which CIMA is responsible for the filing, prosecution and maintenance under this Agreement. 4.7 Identification of CIMA on Packaging of Licensed Product. Any Licensed Product Manufactured by or on behalf of Schering, if requested in writing by CIMA, shall reference CIMA's name and patent numbers and/or patent application numbers, as listed on Appendix D. In addition, CIMA may request that Schering consent to additional language or markings suggested by CIMA in writing, in order to assist CIMA in obtaining or preserving CIMA's rights in its intellectual property. Schering, in its sole discretion, shall determine whether such additional language or markings shall be added to the packaging. Except as set forth in this Section, there shall be no other references to CIMA on packaging of Licensed Product. ARTICLE V QUALITY CONTROL AND REGULATORY COMPLIANCE 5.1 Facility Compliance and Related Matters. CIMA shall maintain the Approved Facility and shall conduct the Development Program and all Manufacturing in compliance with all Laws, including but not limited to GMPs, the Specifications, and any written instructions provided by Schering, at all times during the Term of this Agreement. CIMA shall be responsible for all costs and expenses related to the compliance of the Approved Facility with such Laws, Specifications, and any written instructions provided by Schering. CIMA agrees to manufacture the Licensed Product at the Approved Facility, and not to change the location thereof without Schering's prior written consent, -21- which consent shall not be unreasonably withheld or delayed. In the event CIMA gains access to a second manufacturing facility and Schering desires that CIMA Manufacture Licensed Product at the second manufacturing facility as well as at the Approved Facility, Schering will reimburse CIMA for all reasonable expenses associated with establishing the second manufacturing facility to Manufacture Licensed Product. The parties shall agree in advance in writing to the costs reimbursable to CIMA under this Section. 5.2 Quality Control Program. CIMA shall maintain a quality control program consistent with GMPs, as required by the applicable Regulatory Authorities in the Territory. CIMA shall, within thirty (30) days of the date of this Agreement, provide Schering with a written description of such program establishing that it has met such GMPs, which may be amended or supplemented from time to time; provided that CIMA gives Schering prompt written notice of such amendments or supplements. 5.3 Approval for Manufacturing Changes; Third Party Manufacturing. CIMA shall not make any changes in any materials, equipment or methods of production or testing used in the Manufacture of the Licensed Product without Schering's prior written consent, which consent shall not be unreasonably withheld or delayed. CIMA shall notify Schering promptly in writing of any such changes that may be required by GMPs or other applicable Laws in the Territory. CIMA agrees not to contract with any third party to conduct any part or all of the Manufacturing or testing of the Licensed Product without Schering's prior written consent. 5.4 Retention of Samples. CIMA shall retain a sufficient quantity of each batch of Licensed Product to perform at least two full sets of quality control tests (which shall be in addition to the quality control testing performed by CIMA prior to delivery). CIMA shall maintain samples of each batch in a suitable storage facility until at least the first anniversary of the end of the approved shelf life of all Licensed Product from such batch, or such longer period as may be required under applicable Laws. All such samples shall be available for inspection and testing by Schering or a third party chosen by Schering at its sole discretion, including but not limited to any Affiliate, upon reasonable notice. 5.5 Batch Failure. CIMA agrees to notify Schering within seventy-two (72) hours of discovery after any batch failure which could result in CIMA's inability to meet Schering's requested delivery dates, or of learning of any failure of any batch of Licensed Product to meet Specifications. CIMA shall notify Schering within seventy-two (72) hours after any failure of a released batch during stability testing. CIMA shall provide Schering with an -22- investigative report setting forth the reasons for the batch failure within seven (7) days of such batch failure. 5.6 Notification of Regulatory Inspections. CIMA agrees to notify Schering within forty-eight (48) hours after the initiation of any inquiries, notifications, or inspection activity by any Regulatory Authority in regard to the Licensed Product. In furtherance and not in limitation of the foregoing, CIMA shall notify Schering prior to the commencement of any inspection activity by any Regulatory Authority in regard to or potentially related to the Licensed Product, unless such inspection activity is an unannounced inspection. Schering shall have the right to be present at any such inspection, subject to such limitations or restrictions as CIMA may reasonably require to maintain trade secrets of CIMA or confidential information of its customers. Further, CIMA shall provide a reasonable description to Schering of any such governmental inquiries, notifications or inspections promptly (but in no event later than five (5) calendar days) after such visit or inquiry. CIMA shall furnish to Schering, (a) within two (2) days after receipt, any report or correspondence issued by the Regulatory Authority in connection with such visit or inquiry, including but not limited to, any FDA Form 483, Establishment Inspection Report, or warning letter, and (b) copies of any and all responses or explanations to any Regulatory Authority relating to items set forth above, in each case purged only of trade secrets of CIMA or confidential information of its customers prior to the submission of such responses or explanations to any Regulatory Authority by CIMA. 5.7 Inspection by Schering. Schering shall have the right, during normal business hours and with reasonable advance notice, to visit the Approved Facility for the purpose of observing the Manufacturing, testing, and storage of the Licensed Product, and to inspect for compliance with Laws. CIMA's quality assurance, environmental and other departments shall cooperate with Schering, as necessary and useful, in any inspection conducted pursuant to this Section 5.7. 5.8 Environmental and Other Laws. Except as otherwise set forth in this Section 5.8, in carrying out its obligations under this Agreement, CIMA shall have sole responsibility for compliance with all applicable Laws, including without limitation environmental and health and safety Laws, as amended from time to time. CIMA shall immediately notify Schering in writing of any event, including the receipt of any notice, warning, citation, finding, report or service of process or the occurrence of any release, spill, upset, or discharge of hazardous wastes or substances, relating to the Manufacture of the Licensed Product that may give rise to liability on the part of CIMA under the Laws or this Agreement. In the event Schering conducts an environmental inspection of CIMA's facility for the purpose of determining compliance with -23- environmental Laws, Schering shall share the results of any such environmental inspection with the Laws and does not constitute a waiver of any right otherwise available to Schering. ARTICLE VI PRODUCT RECALL 6.1 Notification and Recall. In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with the Licensed Product, or in the event either party hereto determines an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal, the party notified of or determining the need for such recall or similar action shall, within twenty-four (24) hours, advise the other party thereof by telephone or facsimile. Following notification of a recall, within forty-eight (48) hours, the parties shall discuss whether or not to conduct a recall, and if so, the timing of the recall, the breadth, extent and level of customer to which the recall shall reach, the strategies and notifications to be used, and other related issues. In the event that the parties cannot agree on any such decision, the issue shall be resolved by Schering. 6.2 Recall Expenses. (a) CIMA shall bear the expenses of any recall to the extent it results from a breach of its obligations hereunder. Such obligation shall only apply to Licensed Product Manufactured by CIMA that is not in compliance with Specifications or written instructions of Schering. Such expenses of recall shall include, without limitation and without duplication, the expenses of notification and destruction or return of the recalled Licensed Product, Schering's costs relating to the testing, packaging, and shipping of the recalled Licensed Product, the agreed upon cost to Schering for the Bulk Active, as set forth in Section 6.2 (b) below, and the cost of Package Inserts supplied by Schering and used in the Manufacture of the recalled Licensed Product. In addition, CIMA shall within sixty (60) days replace any such Licensed Product. If CIMA is unable to replace any such Licensed Product within sixty (60) days (or at any time that CIMA fails to deliver the replacement Licensed Product at an agreed upon date, as set forth below), Schering shall have the right, at its sole discretion, to extend the timeframe for delivery of replacement Licensed Product to a mutually agreed upon date, or, in the alternative, to require CIMA to reimburse Schering for all expenses of notification and destruction or return of the recalled Licensed Product set forth above, as well as the sum paid by Schering to CIMA for the Manufacture of the recalled Licensed Product. Such reimbursement shall be made, if -24- requested by Schering, within thirty (30) days of such notice. CIMA shall not be liable for, and Schering hereby waives any right to, any claim by Schering for consequential, incidental, special, or punitive damages, including all claims for lost profits or lost opportunities resulting from any such recall. The rights of Schering under this Section 6.2 shall be in addition to, and not in lieu of, any other rights not inconsistent with this Agreement that Schering may have under this Agreement or at law. (b) In order to avoid any issues or disputes regarding the cost of Bulk Active, including but not limited to damages, the parties agree that CIMA's sole obligation with respect to reimbursement to Schering by CIMA for the cost of Bulk Active under this Agreement shall be to pay Schering [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] per gram in order to partially compensate Schering for its cost of Bulk Active. In such event, Schering shall provide CIMA with replacement Bulk Active within a reasonable period of time, it being understood that Schering and its Affiliates have a limited supply of Bulk Active. ARTICLE VII APPROVAL SUPPORT; REGULATORY MATTERS 7.1 Approval Support. CIMA shall produce stability batches and validation batches of the Licensed Product, engage in various development activities and perform various tests as reasonably necessary to support Schering's Health Registrations in the Territory, including without limitation, being prepared for the pre-approval inspections by the Regulatory Authorities and performing the other activities as set forth in Appendix C hereto. 7.2 Filing and Maintenance of the Health Registrations. Schering shall be the sole owner of all Health Registrations. Schering shall have responsibility for the preparation and filing of the Health Registrations, including the CMC, with the applicable Regulatory Authorities. The Health Registrations shall include a designation of CIMA and the Approved Facility as a Manufacturer and Manufacturing site of the Licensed Product. Schering shall provide CIMA with a copy of those sections of the CMC applicable to CIMA to the extent necessary to facilitate its Manufacture of the Licensed Product in accordance with this Agreement and the Health Registrations. In the event Schering subsequently modifies any relevant Health Registration (or the CMC related to the Manufacture of the Licensed Product), it shall notify CIMA of any modifications that affect CIMA's obligations under this Agreement and provide it with copies of applicable sections, or summaries of, such Health Registration (or CMC) supplements or amendments. -25- 7.3 Regulatory Assistance for Maintaining Filings. CIMA shall provide Schering with such information and assistance as Schering may reasonably require for purposes of applying for and maintaining all relevant Health Registrations for the Licensed Product including without limitation, providing Schering with any or all reports, authorizations, certificates, methodologies, specifications and other documentation in the possession or under the control of CIMA relating to the Development Program and Manufacture of Licensed Product that are reasonably necessary for Schering's filings. CIMA shall not provide such information, data or other intellectual property rights, as they relate to the Licensed Product, to any third party or use such information, data or other intellectual property rights relating to the Licensed Product for any purpose other than performing its obligations under this Agreement. 7.4 Specifications and Bulk Specifications; Amendments. Schering reserves the right upon thirty (30) day's notice to amend and/or supplement the Specifications and/or Bulk Specifications unilaterally for the purpose of complying with GMPs or applicable Health Registrations, incorporating Improvements, or for any other reasonable business purpose. Schering will provide CIMA with prompt notice of changes in the Specifications and/or Bulk Specifications required by Regulatory Authorities. Subject to agreement on the respective responsibilities of the parties for equitable costs associated with implementing any changes, CIMA shall implement any changes in the Specifications and/or Bulk Specifications within a mutually agreed upon and reasonable time frame. The costs of implementing changes in the Specifications and/or Bulk Specifications shall be agreed by the parties in advance in writing. Without limiting the foregoing, with respect to amendments of the Specifications and/or Bulk Specifications required by Regulatory Authorities that are not specific to the Licensed Product, such costs shall be allocated to Schering equitably and in a manner generally consistent with other customers of CIMA. 7.5 Complaints or Adverse Experiences. CIMA agrees to notify Schering by phone within twenty-four (24) hours (and in writing within forty-eight (48) hours) of the receipt of any complaints and reports of adverse drug events ("AEs") associated with the Manufacture of Licensed Product by CIMA. With respect to complaints and reports of adverse drug events ("AEs") associated with the Manufacture of Licensed Product by CIMA, Schering shall have primary responsibility for fielding, investigating and responding to all Licensed Product complaints and AEs. CIMA's quality assurance department shall cooperate with Schering, as necessary and useful, to investigate such complaints or AEs and to provide such information including without limitation, providing Schering with the information and complying with the policy set forth on Appendix I hereto, as amended from time to time by -26- Schering, or assistance as is requested by Schering in order to support Schering's compliance with AE's, field alert and other reporting requirements imposed by the Regulatory Authorities. The parties shall exchange reports on the resolution of complaints monthly, or more frequently if requested by Schering. CIMA shall cooperate with Schering in investigating and responding to Licensed Product complaints and CIMA shall assume all responsibility for investigating and preparing initial responses to complaints or AEs which are determined to result from the Manufacture of the Licensed Product by CIMA and shall provide responses, which shall include any revisions of the initial responses, to Schering for submission to the Regulatory Authority. CIMA shall report to Schering on a monthly basis, or more frequently if requested by Schering, on all actions that CIMA is taking, if necessary, to prevent future complaints of the same type. In the event the parties' expenses to undertake the activities described in this paragraph result in, or may result in, extraordinary costs of investigation or testing (other than expenses associated with the resolution of Manufacturing problems of CIMA), Schering and CIMA agree to negotiate whether to incur, and how to allocate, such costs. 7.6 Record Keeping. (a) Development Program and Manufacturing Records. CIMA shall maintain all records necessary to comply with the Laws and in accordance with the Health Regulations, including but not limited to those relating to the Development Program and the Manufacturing of Licensed Product. Without limitation, CIMA shall prepare and adhere to batch process documentation consistent in accordance with Laws, its normal procedures, and Section 7.6(b) below. All such records shall be maintained for the longest period as may be required by the Laws; provided, however, that all records relating to the Manufacture, stability and quality control of each batch of the Licensed Product shall be retained at least until the first anniversary of the end of the approved shelf life for all Licensed Product from such batch. Prior to destruction of any record relating to the Licensed Product, CIMA shall give notice to Schering, which shall have the right to request delivery of such record to Schering at Schering's expense. (b) Batch Documentation and Master Batch Record. Prior to the Manufacture of any Licensed Product, CIMA shall prepare a form of master batch record, which must be approved by Schering in writing before any Manufacture of any Licensed Product. Such documentation shall include, without limitation, copies of batch records, a statement setting forth that the batch of Licensed Product was Manufactured in compliance with GMP's, release information and -27- recertification dates for all Active Ingredient and Raw Materials, batch reconciliation and yield calculations, applicable variance reports, and such other information as may be reasonably requested by Schering from time to time ("Batch Documentation"). An authorized employee in CIMA's Quality Assurance department shall sign all Batch Documentation, and print his or her name, title and contact information. (c) Deliveries to Schering. All Batch Documentation, as well as the Master Batch Record, relating to the Development Program shall be sent to: Schering-Plough Research Institute 2015 Galloping Hill Road, K-11-2, J3 Kenilworth, New Jersey 07033 Attention: Stanley Zweibel, Manager of Operations. (d) All Batch Documentation, as well as the Master Batch Record, relating to the commercial supply of Licensed Product in the United State shall be sent to: Schering Corporation 2000 Galloping Hill Road, K-2-1 Kenilworth, New Jersey 07033 Attention: Tom Jacobs, Manager of Operations. 7.7 CIMA Approvals. Except as otherwise specifically set forth in this Agreement, CIMA shall be responsible for obtaining and maintaining all approvals, licenses and permits from the Regulatory Authorities and any other governmental authorities required in connection with the performance of its obligations hereunder. ARTICLE VIII SUPPLY OF BULK ACTIVE AND RAW MATERIALS 8.1 Schering Obligation. Schering shall supply to CIMA, at Schering's sole expense, the Bulk Active and Package Inserts, or procure the supply of the Bulk Active and Package Inserts for CIMA, at Schering's sole expense, in quantities sufficient to Manufacture the Licensed Product for which Schering has placed firm orders pursuant to Article IX hereof, subject to Schering's ability to obtain a sufficient supply of the Bulk Active. Schering will supply CIMA with the Bulk Active and Package Inserts no less than ninety (90) days prior to the date of Manufacture. Schering shall notify CIMA in the event that a shortage of the Bulk Active is likely to impact Schering's ability to supply pursuant to this Section 8.1. -28- 8.2 CIMA Obligation. Other than Package Inserts, CIMA shall be responsible for procuring the supply of all Raw Materials and Packaging Components that comply with the Specifications as well as the specifications for packaging as set forth on Appendix F, that are necessary for the Manufacture of Licensed Product in accordance with this Agreement. 8.3 Acceptance of Bulk Active. Each delivery of Bulk Active to CIMA will be accompanied by a certificate of analysis and CIMA shall not incorporate any Bulk Active into the Manufacture of the Licensed Product that is not accompanied by a certificate of analysis. Before incorporating any Bulk Active into the Manufacture of the Licensed Product, CIMA shall conduct such quality control inspection and testing as it deems necessary, which tests shall include those tests set forth in the Bulk Specifications and/or written instructions provided by Schering from time to time. CIMA shall promptly (and in any event within twenty (20) business days of delivery of Bulk Active) notify Schering of any defective Bulk Active which does not meet the Bulk Specifications. Absent any such notification, CIMA shall be deemed to have accepted the Bulk Active supplied by Schering as of the date of delivery. 8.4 Storage and Formulation of Bulk Active and Raw Materials; Ownership of Bulk Active. CIMA shall store the Bulk Active and Raw Materials used in the Manufacture of the Licensed Product under suitable conditions at the Approved Facility, including those set forth on Appendix J, as amended from time to time by Schering, at its reasonable discretion. The Bulk Active shall at all times remain the property of Schering, and CIMA shall indemnify and hold harmless Schering against any expenses, claims, demands or costs arising out of any loss or damage to the Bulk Active after it has been delivered to CIMA, to the extent that such losses or damages result from the negligent or intentional acts of CIMA, its employees and/or agents, except for Yield Losses which the parties agree are acceptable, as set forth below. 8.5 Yield Losses. CIMA shall use its commercially reasonable efforts to minimize Yield Losses. The parties shall agree in writing upon the Yield Loss of the Bulk Active that shall not be exceeded on an annual basis. CIMA shall be responsible for excess Yield Loss. Periodically, but not less than annually, CIMA shall provide Schering with a written accounting of the disposition of each lot of Bulk Active provided by Schering, utilizing a format mutually agreed upon by the parties. ARTICLE IX SUPPLY OF MANUFACTURED PRODUCT 9.1 Supply of Schering's Requirements. Subject to the terms and conditions of this Agreement, including Schering's obligations to provide Bulk -29- Active, CIMA shall Manufacture and supply to Schering, and Schering shall purchase from CIMA, Schering's Requirements of Licensed Product. 9.2 Good Faith Forecasts. At the time of an NDA filing (or Supplemental NDA filing), Schering shall provide CIMA with a written eighteen (18) month forecast estimating Schering's monthly Requirements of the Licensed Product, broken down to set forth Requirements by dosage strength (and the desired delivery dates therefor). Thereafter, on or before the first day of each calendar quarter during the Term hereof, Schering shall provide CIMA with an updated written rolling forecast estimating Schering's monthly Requirements of the Licensed Product (and the desired delivery dates therefor) for the succeeding eighteen (18) month period. Such rolling forecasts shall include the forecast from the previously forecasted fifteen (15) month period in addition to a forecast for the new calendar quarter added. Such estimates shall be prepared in good faith, but shall not be binding on Schering. Schering shall not be responsible for any loss or expense incurred by CIMA arising from such forecasts. 9.3 Purchase Orders. Schering shall issue to CIMA firm purchase orders for each delivery, not later than three (3) months prior to the forecasted delivery date, and provide CIMA with the Bulk Active no later than ninety (90) days prior to the forecasted delivery date. The quantities ordered shall not be less than seventy-five percent (75%) nor more than one hundred twenty-five percent (125%) of the quantities set forth in the preceding quarterly good faith forecast. Subject to the terms of this Agreement, Schering shall be obligated to purchase, and CIMA shall be obligated to sell, such quantities of the Licensed Product as are set forth in the purchase order, on the delivery schedule set forth therein. In the event that the terms of any such purchase order are not consistent with this Agreement, the terms of this Agreement shall prevail. In the event that the amount of the purchase order exceeds 125% of the most recent good faith forecast, then CIMA shall make all commercially reasonable efforts to modify its production schedule so as to deliver such additional quantities of Licensed Product to Schering as soon as practicable. CIMA shall promptly confirm receipt of the purchase order as well as the delivery dates contained in the purchase order by written acknowledgment. If CIMA provides Schering with written notice of issues relating to the delivery schedule set forth in the purchase order, the parties agree to negotiate in good faith to modify the delivery dates to reasonably accommodate CIMA's manufacturing schedule and Schering's requested delivery schedule, provided that nothing in this paragraph shall be interpreted to modify or eliminate the parties' respective obligations to purchase or sell, as the case may be the quantities of Licensed Product (not be less than seventy-five percent (75%) nor more than one hundred twenty-five percent (125%)) set forth in the preceding quarterly good faith forecast. -30- 9.4 Stoppage Due to Good Cause. Upon Schering's written notice, CIMA shall stop a scheduled production run of the Licensed Product, provided that such request is based upon good cause. Good cause is deemed to include CIMA's failure to comply, or its inability to assure compliance with, any Laws, including but not limited to any GMPs, the Specifications, or any written instructions provided by Schering. Exercise by Schering of its rights under this Section 9.4 shall not prejudice any other rights or remedies that Schering may have at law or under this Agreement. 9.5 Schering Option to Manufacture. (a) Option Notice. At any time on or after the third anniversary of the First Commercial Sale of the Licensed Product in any country, Schering, at its sole discretion, shall have the option to assume all Manufacturing of the Licensed Product. Schering shall provide CIMA with a minimum of six (6) months' prior written notice of its exercise of such option (the "Option Notice"). CIMA shall provide information concerning the process and personnel time for a technology transfer. This will allow the parties to address the issue of payment, if any, for personnel time of CIMA relating to the transfer. (b) Protocol. Following CIMA's receipt of the Option Notice, the parties shall establish a mutually acceptable protocol for transfer of the CIMA Know-How necessary to enable Schering to assume responsibility for the Manufacture of the Licensed Product. This shall include, among other things, the identification of all machinery necessary to Manufacture the Licensed Product, the time necessary for the machinery to be delivered, installed and validated, the training necessary to Manufacture the Licensed Product, the estimated transfer period for the CIMA Know-How ("Transfer Period") and the criteria for determining when the CIMA Know-How has been successfully transferred (the "Protocol"). Both parties shall diligently follow the Protocol, and advise the other party in a timely manner of any difficulties encountered. The Protocol shall be modified only in writing, and the parties agree to modify the Protocol as necessary to accomplish the transfer of the CIMA Know-How. During the Transfer Period and throughout the Term of this Agreement, CIMA shall provide such reasonable assistance to Schering as is necessary for Schering to Manufacture the Licensed Product. (c) Technical Liaison. CIMA and Schering shall each designate one (1) senior employee as technical liaison to handle all technical matters and communications relating to the transfer and implementation of Manufacturing technology during the Transfer Period. -31- (d) Transfer Payments. In the event of Schering's exercise of its option under this Section 9.5, Schering shall pay CIMA the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] fee set forth in Section 3.1. The payment of the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] fee shall be made as follows: [***CONFIDENTIAL TREATMENT Within thirty (30) days REQUESTED, PORTION OMITTED after Schering's delivery of FILED SEPARATELY WITH THE the Option Notice SECURITIES AND EXCHANGE COMMISSION.***] [***CONFIDENTIAL TREATMENT Within thirty (30) days REQUESTED, PORTION OMITTED after establishment of the FILED SEPARATELY WITH THE Protocol SECURITIES AND EXCHANGE COMMISSION.***] [***CONFIDENTIAL TREATMENT Within thirty (30) days of REQUESTED, PORTION Schering completing three OMITTED FILED SEPARATELY full-size validation WITH THE SECURITIES batches for each Licensed AND EXCHANGE Product that comply with all COMMISSION.***] Laws Schering's royalty obligation set forth in Section 3.2 shall continue in accordance with the terms of this Agreement and payment of the payments set forth in this Section 9.5 shall not impact Schering's obligation to pay such royalties. (e) Except for direct personnel costs and reasonable out of pocket costs incurred by CIMA in connection with its obligations under this Section 9.5 and agreed upon in writing in advance of the Transfer Period by the parties, Schering shall not be responsible for any costs incurred by CIMA relating to the Transfer Period. CIMA shall comply with Schering's guidelines for reimbursement of expenses set forth on Appendix K. (f) After the Transfer Period has been completed, notwithstanding anything else to the contrary contained in this Agreement, Schering may, without any additional payments to CIMA, -32- subcontract Manufacture of the Licensed Product to a third party at any time, including but not limited to Affiliates of Schering, and provide a limited nontransferable license to any such third party to the CIMA Know-How, solely to fulfill its Manufacturing obligations to Schering. (g) Nothing in this Section 9.5 shall be interpreted to provide Schering with any rights to utilize the CIMA Know-How other than for those license rights set forth in Section 2.1, or to amend the parties' confidentiality obligations set forth in Article XII. ARTICLE X DELIVERY AND RELATED MATTERS 10.1 Certificate of Analysis. CIMA shall provide Schering with each shipment of Licensed Product a certificate from CIMA's quality assurance department that includes the results of quality control testing in accordance with the Specifications and which indicates that the Licensed Product contained in the shipment meets the specifications set forth in the Specifications. 10.2 Risk of Loss. Delivery of each shipment of the Licensed Product shall be made EXW. CIMA shall arrange for transportation of the Licensed Product to a destination designated by Schering and by a common carrier designated by Schering. CIMA shall clear the shipment for export and obtain, at its own risk and expense, any export license or other official authorization and carry out, where applicable, all customs formalities necessary for the export of the Product. Schering shall obtain, at its own risk and expense, any import license or other official authorization required and carry out, where applicable, all customs formalities for the import of the Product. Title to and risk of loss of the Licensed Product shall pass to Schering at the time of delivery to the carrier. CIMA shall promptly invoice Schering for all Licensed Product shipped. 10.3 Storage. CIMA, at its own expense, for a period not to exceed fifteen (15) days, shall maintain adequate and reasonably segregated facilities for storage of the Licensed Product pending delivery to the designated carrier pursuant to Section 10.2 hereof. 10.4 Delay and Failure to Supply. (a) In the event that CIMA shall have reason to believe that it will be unable to supply Schering with the full quantity of the Licensed Product forecasted to be ordered or actually ordered by Schering in a timely manner, CIMA shall promptly (and in any event within thirty (30) -33- business days) notify Schering thereof. If CIMA shall so notify Schering, or if CIMA shall fail to provide Schering with adequate assurances of timely performance upon Schering's request therefor (regardless of whether past performance has complied herewith or not), Schering and CIMA shall promptly meet to discuss how to thereafter supply Schering's Requirements in a timely manner. (b) In the event of a Supply Failure, CIMA shall exercise diligent efforts to resume production as quickly as possible and shall notify Schering in writing upon resumption of production, whereupon it shall supply Schering with such modified requirements for the Licensed Product as Schering may have for the remaining Term of this Agreement. (c) Notwithstanding the foregoing, the parties agree that a Supply Failure shall be a material breach of this Agreement. 10.5 Rejection. Schering shall promptly (and in any event within forty-five (45) days after delivery) notify CIMA of any Licensed Product which did not, at the time of delivery to the carrier designated by Schering, comply with the covenants in Section 13.3(a). If Schering claims that any shipment of Licensed Product did not, at the time of delivery to the carrier designated by Schering, meet the representations and warranties in Section 13.2, or covenants set forth in Sections 13.3 (and in any event within forty-five (45) days after discovery), Schering shall promptly notify CIMA. If CIMA agrees with Schering's claim, CIMA at its option shall either replace such Licensed Product or reimburse Schering for any payment Schering may have made to CIMA for such Licensed Product and for any out-of-pocket expense Schering may have incurred with respect thereto prior to its discovery of the defect, including without limitation shipping, insurance and taxes. In either case, CIMA shall reimburse or credit Schering (as Schering shall elect), at the agreed upon cost to Schering, for the Bulk Active as set forth in Section 6.2(b), destruction costs, and the cost of Package Inserts, used in the non-conforming Licensed Product. If Schering and CIMA are unable to agree as to whether such Licensed Product met the warranties or whether CIMA complied with the covenants, the parties shall cooperate to have the Licensed Product in dispute analyzed by an independent testing laboratory of recognized repute jointly selected by Schering and CIMA. If the Licensed Product is determined to meet the Specifications, then Schering shall bear the cost of the independent laboratory testing and pay for the Licensed Product in accordance with this Agreement. If the Licensed Product is determined not to have met the Specifications at time of delivery, then CIMA shall bear the cost of the independent laboratory testing. In addition, CIMA shall either replace the rejected Licensed Product within sixty (60) days after the date of such determination, at no cost to Schering, or refund or credit, as designated by Schering, the price paid for such Licensed Product plus any -34- applicable delivery charges, including, without limitation, shipping, insurance and taxes, within sixty (60) days after written notice from Schering. If CIMA is unable to replace any such Licensed Product within sixty (60) days (or at any time that CIMA fails to deliver the replacement Licensed Product at an agreed upon date, as set forth below), Schering shall have the right, at its sole discretion, to extend the timeframe for delivery of replacement Licensed Product to a mutually agreed upon date, or, in the alternative, to require CIMA to reimburse Schering for the price paid for such Licensed Product plus out-of-pocket expense Schering may have incurred. Such reimbursement shall be made, if requested by Schering, within thirty (30) days of such notice. In either case, CIMA shall reimburse or credit Schering (as Schering shall elect), at the agreed upon cost to Schering, for the Bulk Active (as set forth in Section 6.2(b)) and Package Inserts used in the non-conforming Licensed Product, as well as destruction costs. Such laboratory costs, refund, credit or replacement shall constitute CIMA's sole and exclusive liability for claims under this Section 10.5. ARTICLE XI PAYMENT 11.1 Price. The Price to be paid by Schering to CIMA for the Licensed Product for commercial supply of the Licensed Product shall be as set forth on Appendix G hereto, as adjusted pursuant to this Article XI, and shall be made in United States dollars within thirty (30) days from date of invoice therefor. 11.2 Price Adjustment. (a) The Price shall be effective from the first date that CIMA Manufactures Licensed Product pursuant to Article IX ("Manufacturing Date") and shall be effective through December 31, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. Thereafter, subject to Section 11.2 (c) hereof, the Price shall be subject to an annual review, initiated by CIMA as set forth below. Such annual review shall take into account any increase or decrease in CIMA's costs of labor, raw materials and/or components directly allocable to the Manufacture of the Licensed Product ("Raw Materials"), and Overhead, with all such allocable costs being calculated in an equitable manner, in accordance with CIMA's accounting principles and reasonably acceptable to Schering at the time of execution of this Agreement, consistent with generally accepted accounting principles, and on the same basis and utilizing the same criteria as for other pharmaceutical products of CIMA that are subject to similar pricing adjustments. -35- CIMA shall determine the amount of any increase or decrease by no later than the following February 28, and CIMA shall notify Schering of such amount in writing at that time. If Schering disagrees with the price adjustment, Schering shall notify CIMA in writing on or before March 31, and the parties shall discuss and resolve any issues relating to the price adjustment. Licensed Product delivered to Schering between January 1 and February 28 each year, and during any time period that the parties are resolving issues relating to the price adjustment, shall be invoiced to Schering at the price applicable to Licensed Product delivered to Schering during the immediately preceding calendar year. Then on or about February 28 of each year, or within thirty (30) days following the parties' resolution of issues relating to the price adjustment, CIMA shall transmit to Schering a corrected invoice for Licensed Product delivered between January 1 and February 28 of each year, and during any time period that the parties were resolving issues relating to the price adjustment, taking into account the final amount of any such price increase or decrease, and setting forth the applicable additional charges or credits. (b) Without limiting the foregoing, the parties hereto acknowledge that significant cost reductions may be available to CIMA through improvements in the technology for Manufacturing the Licensed Product, through negotiated changes in applicable regulatory standards or specifications with Regulatory Authorities or otherwise. In the event that any cost reductions are realized, then the parties shall agree on a mechanism by which the benefits of such cost reductions are equitably allocated to the parties, taking account of their relative contributions to the cost reduction. Further, CIMA agrees to use commercially reasonable efforts to obtain competitive prices for Raw Materials, materials used in the manufacture of Packaging Components, and services from any qualified third party vendor. (c) If, within thirty (30) days following CIMA's receipt of Schering's notice that Schering disagrees with the suggested price adjustment, the parties are unable to reach agreement on a Price adjustment, Schering shall appoint an Independent Auditor, who shall be reasonably acceptable to CIMA, to determine the adjusted Price. The Independent Auditor's determination of the adjusted Price shall reflect any net increase or decrease in CIMA's costs of labor, Raw Materials, and Overhead. CIMA shall promptly make its cost documentation available on a confidential basis to the Independent Auditor, and both parties shall submit in writing to the Independent Auditor a proposed adjusted Price. The parties agree that the determination by the Independent Auditor of the adjusted Price shall be final and binding, subject to Section 11.3 -36- hereof. The fees and disbursements of the Independent Auditor shall be borne by the party whose proposed adjusted Price differs most from the adjusted Price as determined by the Independent Auditor. 11.3 Maximum Price Increase. Any increase or decrease in the costs of Raw Materials, as such term is defined in Section 11.2, shall be passed directly on to Schering by CIMA, and Schering shall be responsible for the entire increase in such costs, subject to Schering's audit and other rights set forth in Section 11.2(c), or, alternatively, Schering shall receive the entire benefit from any decrease in such costs. In no event shall the weighted average percentage of increased costs attributable to CIMA's Overhead and labor costs combined, stated as a percentage of the then-current Price, exceed the lesser of either (i) the increase, if any, in the national Producer's Price Index, as reported in the Wall Street Journal, for the calendar year immediately preceding the proposed price increase; or (ii) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. 11.4 Taxes. Schering shall pay any applicable taxes or duties relating to Bulk Active. CIMA and Schering agree to cooperate in order to minimize, in the manner permitted under applicable tax and customs Laws, the taxes (including value-added taxes) and duties associated with the importation and/or exportation of the Bulk Active and the Licensed Product, as the case may be. ARTICLE XII CONFIDENTIALITY AND PUBLICATION 12.1 Confidentiality. (a) Nondisclosure Obligation. Each of CIMA and Schering shall use only in accordance with this Agreement and shall not disclose to any third party any Proprietary Information received by it from the other party, without the prior written consent of the other party. The foregoing obligations shall survive the expiration or termination of this Agreement for a period of ten (10) years. These obligations shall not apply to Proprietary Information that: (i) is known by the receiving party at the time of its receipt, and not through a prior disclosure by the disclosing party, as documented by business records; (ii) is at the time of disclosure or thereafter becomes published or otherwise part of the public domain without breach of this Agreement by the receiving party; -37- (iii) is subsequently disclosed to the receiving party by a third party who has the right to make such disclosure; (iv) is developed by the receiving party independently of Proprietary Information or other information received from the disclosing party and such independent development can be documented by the receiving party; (v) is disclosed to any institutional review board of any entity conducting clinical trials or any governmental or other regulatory agencies in order to obtain patents or to gain approval to conduct clinical trials or to market Active Ingredient and/or Licensed Product, but such disclosure may be made only to the extent reasonably necessary to obtain such patents or authorizations; or (vi) is required by Law, or order of any governmental authority or agency to be disclosed by a party, provided that notice is promptly delivered to the other party in order to provide an opportunity to seek a protective order or other similar order with respect to such Proprietary Information and thereafter the disclosing party discloses to the requesting entity only the minimum Proprietary Information required to be disclosed in order to comply with the request, whether or not a protective order or other similar order is obtained by the other party. (b) Disclosure to Agents. Notwithstanding the provisions of Section 12.1(a) and subject to the other terms of this Agreement, Schering shall have the right to disclose CIMA Proprietary Information to Schering's sublicensees, agents, consultants, Affiliates or other third parties (collectively "Agents") in accordance with this Section 12.1(b). Such disclosure shall be limited only to those Agents directly involved in the research, development, manufacturing, marketing or promotion of Licensed Product(s) (or for such Agents to determine their interest in performing such activities) in accordance with this Agreement. Any such Agents must agree in writing to be bound by confidentiality and non-use obligations essentially the same as those contained in this Agreement. The term of confidentiality and non-use obligations for such Agents shall be no less than ten (10) years following the termination or expiration of this Agreement. Schering shall be responsible for any breach of this confidentiality provision by its agents. (c) Disclosure to a Third Party. Notwithstanding anything herein to the contrary, CIMA shall not disclose, provide or transfer to any -38- third party without the prior written approval of Schering (i) any Schering Know-How, or (ii) any CIMA Know-How relating to the combination of the OraSolv Technology and Active Ingredient. 12.2 No Publicity. A party may not use the name of the other party in any publicity or advertising and, except as provided in Section 12.1, may not issue a press release or otherwise publicize or disclose any information related to the existence of this Agreement or the terms or conditions hereof, without the prior written consent of the other party. The parties shall agree on a form and timing of the initial press release that may be used by either party to describe this Agreement. Nothing in the foregoing, however, shall prohibit a party from making such disclosures to the extent deemed necessary under applicable federal or state securities laws or any rule or regulation of any nationally recognized securities exchange including, without limitation, NASDAQ. In such event, however, the disclosing party shall use good faith efforts to consult with the other party prior to such disclosure and, where applicable, shall request confidential treatment to the extent available. 12.3 Publication. Schering and CIMA each acknowledge the potential benefit in publishing results of certain studies to obtain recognition within the scientific community and to advance the state of scientific knowledge. Each party also recognizes the mutual interest in obtaining valid patent protection and in protecting business interests and trade secret information. No publication of a party's Proprietary Information may be made by the other party without the prior written consent of such party. The parties agree that Schering, its Affiliates, employees or consultants shall be free to make any publication which does not disclose CIMA's Proprietary Information, and CIMA shall be free to make any publication which does not (i) disclose Schering's Proprietary Information; or (ii) substantially relate to the Licensed Product or the Active Ingredient. In the event that any proposed publication (as defined below) discloses Proprietary Information, the following procedure shall apply: either party, its Affiliates, employees or consultants wishing to make a publication shall deliver to the other party a copy of the proposed written publication or an outline of an oral disclosure at least sixty (60) days prior to submission for publication or presentation. For purposes of this Agreement, the term "publication" shall include, without limitation, abstracts and manuscripts for publication, slides and texts of oral or other public presentations, and texts of any transmission through any electronic media, e.g. any computer access system such as the Internet or World Wide Web. The reviewing party shall have the right (i) to propose modifications to the publication for patent reasons, trade secret reasons or business reasons or (ii) to request delay of the publication or presentation in order to protect patentable information. If the reviewing party requests a delay, the publishing party shall delay submission or presentation for a period not less than eighteen -39- (18) months from the filing date of the first patent application covering the information contained in the proposed publication or presentation. If the reviewing party requests modifications to the publication, the publishing party shall edit such publication to prevent disclosure of trade secret or proprietary business information prior to submission of the publication or presentation. 12.4 Oral Disclosure of Propriety Information. When Propriety Information is disclosed in a manner other than in writing, it shall be reduced to written form, marked "Confidential" and transmitted to the receiving party within twenty (20) business days of disclosure to the receiving party. ARTICLE XIII REPRESENTATIONS AND WARRANTIES 13.1 Representations and Warranties of Each Party. Each of CIMA and Schering hereby represents and warrants to the other party hereto as follows: (a) it is a corporation or entity duly organized and validly existing under the laws of the state or other jurisdiction of its incorporation or formation; (b) the execution, delivery and performance of this Agreement by such party has been duly authorized by all requisite corporate action; (c) it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder; (d) the execution, delivery and performance by such party of this Agreement and its compliance with the terms and provisions hereof does not and will not conflict with or result in a breach of any of the terms and provisions of or constitute a default under (i) a loan agreement, guaranty, financing agreement, agreement affecting a product or other agreement or instrument binding or affecting it or its property; (ii) the provisions of its charter or operative documents or bylaws; or (iii) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound; (e) except for the Health Registrations required to market the Licensed Product in the Territory, the execution, delivery and performance of this Agreement by such party does not require the consent, approval or authorization of, or notice, declaration, filing or registration with, any governmental or regulatory authority and the execution, delivery or performance of this Agreement will not violate any Law applicable to such party; and -40- (f) this Agreement has been duly authorized, executed and delivered and constitutes such party's legal, valid and binding obligation enforceable against it in accordance with its terms subject, as to enforcement, to bankruptcy, insolvency, reorganization and other laws of general applicability relating to or affecting creditors' rights and to the availability of particular remedies under general equity principles. 13.2 CIMA's Representations and Warranties. CIMA hereby represents and warrants to Schering as follows: (a) the Licensed Patent Rights are subsisting and are not invalid or unenforceable, in whole or in part, in countries set forth on Appendix L, and, to the best knowledge of CIMA, are subsisting and are not invalid or unenforceable, in whole or in part, in any other country; (b) it has the full right, power and authority to grant all of the right, title and interest in the licenses granted under Article II hereof; (c) In the countries set forth on Appendix L, and, to the best knowledge of CIMA, in countries other than countries set forth on Appendix L, it is the sole and exclusive owner of the Licensed Patent Rights, all of which are free and clear of any liens, charges and encumbrances, other than license rights granted to other parties which are not inconsistent with the license rights granted hereunder, and no other person, corporate or other private entity, or governmental entity or subdivision thereof, has or shall have any claim of ownership with respect to the Licensed Patent Rights or CIMA Know-How, whatsoever; (d) To the best of its knowledge, it is the sole and exclusive owner of the CIMA Know-How, all of which is free and clear of any liens, charges and encumbrances, other than license rights granted to other parties which are not inconsistent with the license rights granted hereunder, and no other person, corporate or other private entity, or governmental entity or subdivision thereof, has or shall have any claim of ownership or use of the CIMA Know-How which in any manner interferes with or will interfere with the ability of Schering to practice the Licensed Patent Rights; (e) it has not assigned, transferred, conveyed or otherwise encumbered, and during the Term of this Agreement will not assign, transfer, convey or otherwise encumber, its right, title and interest in the Licensed Patent Rights in any manner that interferes with or will interfere with the ability of Schering to practice the Licensed Patent Rights; -41- (f) it has not assigned, transferred, conveyed or otherwise encumbered, and during the Term of this Agreement will not assign, transfer, convey or otherwise encumber, its right, title and interest in the CIMA Know-How in any manner that interferes with or will interfere with the ability of Schering to practice the Licensed Patent Rights; (g) to the best of its knowledge, as of the date hereof, the Licensed Patent Rights and CIMA Know-How, and the development, manufacture, use, distribution, marketing, promotion and sale of Licensed Product, do not interfere or infringe on any intellectual property rights owned or possessed by any third party; (h) to the best of its knowledge, as of the date hereof, there are no third party pending patent applications which, if issued, may cover the use of the OraSolv Technology in connection with development, manufacture, use or sale of Licensed Product; (i) to the best of its knowledge, as of the date hereof, there are no claims, judgments or settlements against or owed by CIMA, or pending or threatened claims or litigation, relating to the Licensed Patent Rights or CIMA Know-How; (j) as of the date hereof, it has no knowledge of any circumstances that would materially and adversely affect the commercial utility of the Licensed Product and/or the use of the OraSolv Technology in combination with Active Ingredient, or that would render Schering liable to a third party for patent infringement as a consequence of Schering's sale of Licensed Product; (k) there are no collaborative, licensing, material transfer, supply, distributorship or marketing agreements or arrangements or other similar agreements to which it or any of its Affiliates are party relating to the combination of the OraSolv Technology and Active Ingredient, nor has it granted any rights to any third party with respect to such combination; and (l) as of the date hereof, it is in compliance in all material respects with any agreements with third parties which provide for intellectual property rights applicable to the development, manufacture, use or sale of the OraSolv Technology. 13.3 CIMA Covenants. CIMA hereby agrees as follows: (a) at the time of delivery of the Licensed Product to the designated carrier pursuant to this Agreement, the Licensed Product -42- shall (i) have been Manufactured, stored and shipped in accordance with applicable Laws in the Territory; (ii) have been Manufactured in accordance with the Specifications, any written instructions provided by Schering, and the CMC; (iii) not be adulterated or misbranded under the FDCA or the Laws; and (iv) be in good and usable condition; (b) it will have good and marketable title, free and clear of any liability, pledge, lien, restriction, claim, charge, security interest or other encumbrance, to all Licensed Product delivered to the designated carrier pursuant to this Agreement; (c) it and/or its Affiliates shall neither use nor seek to register any trademarks which are confusingly similar to any Schering Trademark, or any other trademarks, trade names, trade dress or logos used in connection with the Licensed Product; (d) it will inform Schering in writing immediately if it or any person who is performing services hereunder is debarred or is the subject of a conviction described in [sec]306 of the FDCA, or if any action, suit, claim, investigation, or legal or administrative proceeding is pending or, to the best of CIMA's knowledge, is threatened, relating to the debarment or conviction of CIMA or any person performing services hereunder; and (e) during the Term of this Agreement, it will use best efforts not to diminish the rights under the Licensed Patent Rights and CIMA Know-How licensed to Schering hereunder, including, without limitation, by not committing or permitting any actions or omissions which would cause the breach of any agreements between itself and third parties which provide for intellectual property rights applicable to the development, manufacture, use or sale of the OraSolv Technology in connection with the Licensed Product(s) and that it will provide Schering promptly with notice of any such alleged breach. 13.4 Schering's Representations and Warranties. Schering hereby represents and warrants to CIMA as follows: (a) to the best of its knowledge, it is the sole and exclusive owner and/or licensee of all rights to Active Ingredient which is free and clear of any liens, charges and encumbrances, and no other person, corporate or other private entity, or governmental entity or subdivision thereof, has or shall have any claim of ownership with respect to Active Ingredient, whatsoever; -43- (b) to the best of its knowledge, Active Ingredient and the development, manufacture, use, distribution, marketing, promotion and sale of Active Ingredient does not interfere or infringe on any intellectual property rights owned or possessed by any third party; (c) there are no claims, judgments or settlements against or owed by Schering or pending or threatened claims or litigation relating to Active Ingredient; and (d) it will launch the Licensed Product within a commercially reasonable period of time after approval of all Health Registrations necessary to sell the Licensed Product in the Territory. 13.5 Schering Covenants. Schering hereby agrees that it will use diligent efforts for obtaining and maintaining all Health Registrations necessary to sell the Licensed Product in the Territory and launch the Licensed Product within a commercially reasonable period of time after approval of all Health Registrations necessary to sell the Licensed Product in the Territory. 13.6 Covenants of Each Party. Each of the parties hereby agrees as follows: (a) it shall comply with all applicable Laws relating to its activities under this Agreement; and (b) during the Term of this Agreement it will not use in any capacity, in connection with any services to be performed under this Agreement, any individual who has been debarred pursuant to the FDCA or been excluded from participating in a federal health care program, including, without limitation, the Medicare or Medicaid programs. 13.7 Continuing Representations. The representations and warranties of each party contained in Sections 13.1, 13.2 and 13.4 shall survive the execution of this Agreement and shall remain true and correct after the date hereof with the same effect as if made as of the date hereof. 13.8 No Inconsistent Agreements. Neither party has in effect and after the Effective Date neither party shall enter into any oral or written agreement or arrangement that would be inconsistent with its obligations under this Agreement. 13.9 Representation by Legal Counsel. Each party hereto represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting hereof. In interpreting and applying the terms and provisions of this Agreement, the -44- parties agree that no presumption shall exist or be implied against the party which drafted such terms and provisions. ARTICLE XIV INDEMNIFICATION AND LIMITATION ON LIABILITY 14.1 Indemnification by Schering. Schering shall indemnify, defend and hold harmless CIMA and its Affiliates, and each of its and their respective employees, officers, directors and agents (each, a "CIMA Indemnified Party") from and against any and all liability, loss, damage, cost, and expense (including reasonable attorneys' fees) (collectively, a "Liability"), subject to the limitations in Section 14.5 which the CIMA Indemnified Party may incur, suffer or be required to pay resulting from or arising out of (i) Schering's negligent acts and/or omissions related to the marketing, distribution and sale of the Active Ingredient or Licensed Product, (ii) the sale or use of the Licensed Product, except to the extent that such liability is attributable to the CIMA Know-How and/or the Licensed Patent Rights, or (iii) any breach of Schering's covenants, representations and warranties hereunder by Schering, its Affiliates or sublicensees. Notwithstanding the foregoing, Schering shall have no obligation under this Agreement to indemnify, defend or hold harmless any CIMA Indemnified Party with respect to claims, demands, costs or judgments which result from willful misconduct or negligent acts or omissions of CIMA, its Affiliates, or any of their respective employees, officers, directors or agents. 14.2 Indemnification by CIMA. CIMA shall indemnify, defend and hold harmless Schering and its Affiliates, and each of its and their respective employees, officers, directors and agents (each, a "Schering Indemnified Party") from and against any Liability, subject to the limitations in Section 14.5, which the Schering Indemnified Party may incur, suffer or be required to pay resulting from or arising in connection with (i) Schering's use of the CIMA Know-How and/or the Licensed Patent Rights (subject to Schering's rights under Section 4.5) (ii) negligent acts and/or omissions by CIMA and/or its Affiliates related to the development or Manufacture of Licensed Product by CIMA or the failure of Licensed Product Manufactured by CIMA to meet the Specifications set forth in Appendix H hereto, or (iii) any breach of CIMA's covenants, representations and warranties hereunder. Notwithstanding the foregoing, CIMA shall have no obligation under this Agreement to indemnify, defend or hold harmless any Schering Indemnified Party with respect to claims, demands, costs or judgments which result from willful misconduct or negligent acts or omissions of Schering, its Affiliates, or any of their respective employees, officers, directors or agents. 14.3 Conditions to Indemnification. The obligations of the indemnifying party under Sections 14.1 and 14.2 are conditioned upon the delivery of -45- written notice to the indemnifying party of any potential Liability promptly after the indemnified party becomes aware of such potential Liability; provided, however, that any delay on the part of a party to provide notice to the indemnifying party shall not relieve the indemnifying party of its obligation to indemnify unless the indemnifying party has been materially prejudiced by such delay. The indemnifying party shall have the right to assume the defense of any suit or claim related to the Liability if it has assumed responsibility for the suit or claim in writing; however, if in the reasonable judgment of the indemnified party, such suit or claim involves an issue or matter which could have a materially adverse effect on the business operations or assets of the indemnified party, the indemnified party may waive its rights to indemnity under this Agreement and control the defense or settlement thereof, but in no event shall any such waiver be construed as a waiver of any indemnification rights such party may have at law or in equity. If the indemnifying party defends the suit or claim, the indemnified party may participate in (but not control) the defense thereof at its sole cost and expense. 14.4 Settlements. Neither party may settle a claim or action related to a Liability without the consent of the other party, if such settlement would impose any monetary obligation on the other party or require the other party to submit to an injunction or otherwise limit the other party's rights under this Agreement. Any payment made by a party to settle any such claim or action shall be at its own cost and expense. 14.5 Limitation of Liability. With respect to any claim by one party against the other arising out of the performance or failure of performance of the other party under this Agreement, the parties expressly agree that the liability of such party to the other party for such breach shall be limited under this Agreement or otherwise at law or equity to direct damages only and in no event shall a party be liable for, punitive, exemplary or consequential damages. 14.6 Insurance. Each party acknowledges and agrees that during the Term of this Agreement it shall maintain adequate insurance and/or a self-insurance program for liability insurance, including products liability and contractual liability insurance, to cover such party's obligations under this Agreement. Each party shall provide the other party with evidence of such insurance and/or self-insurance program, upon request. ARTICLE XV TERM AND TERMINATION 15.1 Term and Expiration. This Agreement shall be effective as of the Effective Date and unless terminated earlier by mutual written agreement of the parties or pursuant to Sections 15.2 or 15.3 below, the Term of this -46- Agreement shall continue in effect in each country in the Territory until the later of (i) ten (10) years after the First Commercial Sale of the Licensed Product in each such country or (ii) expiration of the last to expire Licensed Patent Right incorporating a Valid Claim in each such country. Upon expiration of this Agreement due to expiration of the last to expire Licensed Patent Right incorporating a Valid Claim, Schering's licenses pursuant to Section 2.1 and 2.2 shall become fully paid-up, perpetual licenses, provided, however, that CIMA's exclusive right to Manufacture shall continue unless Schering has exercised its option to Manufacture under Section 9.5 of this Agreement. 15.2 Termination by Schering. (a) Notwithstanding anything contained herein to the contrary, Schering shall have the unilateral right to terminate this Agreement, without cause, at any time by giving ninety (90) days advance written notice to CIMA, or one hundred and eighty (180) days advance written notice at any time after the first good faith forecast provided by Schering pursuant to Section 9.2. In the event of the exercise by Schering of such termination rights, the rights and obligations hereunder, including any payment obligations not due and owing as of the termination date shall terminate and all rights to Licensed Patent Rights and CIMA Know-How shall revert to CIMA. (b) In the event the ownership or control of CIMA is to be acquired by a pharmaceutical company, CIMA shall promptly notify Schering in writing to that effect, and to the extent practicable and within CIMA's control, it shall provide such notice not less than sixty (60) days prior to such transfer of control. For the avoidance of doubt, CIMA shall have the obligation to disclose to any such pharmaceutical company that it is obligated to provide the notice set forth in this Section, and CIMA shall not provide, in any such agreement with a pharmaceutical company, that such notice will be delayed or omitted. Schering shall have the unilateral right, but not the obligation, by giving sixty (60) days' advance written notice to CIMA to terminate this Agreement following receipt of such notice. Such right shall terminate one hundred and twenty (120) days following Schering's receipt of notice of such transfer of control. CIMA shall use best efforts to ensure that such acquiring party does not have any access to any of Schering's Proprietary Information. For purposes of this section, control shall mean the ability to control the management decisions of CIMA, and the direct or indirect acquisition of thirty percent (30%) or more of CIMA's stock shall be deemed control. -47- 15.3 Termination. (a) Termination for Cause. This Agreement may be terminated by written notice by either party at any time during the Term of this Agreement: (i) subject to Section 16.2, if the other party is in breach of its material obligations hereunder and has not cured such breach within ninety (90) days after notice requesting cure of the breach with reasonable detail of the particulars of the alleged breach or initiated actions reasonably expected to cure the cited failure within ninety (90) days of receiving notice and thereafter diligently pursued such actions to cure the failure (even if requiring longer than the ninety (90) days set forth in this subsection); or (ii) upon the filing or institution of bankruptcy, reorganization, liquidation or receivership proceedings, or upon an assignment of a substantial portion of the assets for the benefit of creditors by the other party, or in the event a receiver or custodian is appointed for such party's business, or if a substantial portion of such party's business is subject to attachment or similar process; provided, however, that in the case of any involuntary bankruptcy proceeding such right to terminate shall only become effective if the proceeding is not dismissed within sixty (60) days after the filing thereof. (b) Effect of Termination for Cause on License. (i) Termination by Schering under Section 15.3(a)(i). In the event Schering terminates this Agreement under Section 15.3(a)(i) Schering's licenses pursuant to Sections 2.1 and 2.2 shall continue so long as Schering is not in default of its payment obligations hereunder (including royalty payments), subject to such offset as may be awarded to Schering as damages for CIMA's breach of this Agreement in accordance with the dispute resolution provisions set forth in Section 16.2. Notwithstanding the foregoing, nothing in this Section shall be interpreted to eliminate or restrict any rights Schering has or may have relating to a default by CIMA under applicable Laws. (ii) Other Terminations. In the event of a termination of this Agreement for any reason other than by Schering under Section 15.3(a)(i), then the rights and licenses granted to Schering under Sections 2.1 and 2.2 of this Agreement shall terminate and -48- all rights to Licensed Patent Rights and CIMA Know-How shall revert to CIMA. (iii) Effect of Bankruptcy. In the event Schering terminates this Agreement under Section 15.3(a)(ii) or this Agreement is otherwise terminated under Section 15.3(a)(ii), the parties agree that Schering, as a licensee of rights to intellectual property under this Agreement, shall retain and may fully exercise all of its rights and elections under Title 11, including as set forth in Section 16.8 hereof. (iv) Return of Bulk Active and Proprietary Information. Upon termination or expiration of this Agreement for any reason, or at Schering's request at any time during this Agreement, CIMA shall promptly deliver to Schering all unused Bulk Active and Licensed Product, all documentation and all copies thereof in whatever form or media in its possession or control relating to Bulk Specifications, CMCs, Specifications, Schering Know-How and all other Proprietary Information of Schering and any and all other documents and materials (and all copies thereof) in its possession or control containing any Proprietary Information of Schering. 15.4 Effect of Termination. Expiration or termination of the Agreement shall not relieve the parties of any obligation accruing prior to such expiration or termination, and the provisions of Articles XII and XIV shall survive the expiration of the Agreement. Any expiration or early termination of this Agreement shall be without prejudice to the rights of either party against the other accrued or accruing under this Agreement prior to termination, including the obligation to pay royalties for Licensed Product(s) sold prior to such termination. Schering shall have the right to continue to sell its existing inventory of Licensed Product(s) and, if this Agreement is terminated by Schering pursuant to Section 15.3(a)(i), Schering's other payment obligations shall survive, including royalties to CIMA, on sales of Licensed Product(s) in accordance with this Agreement, subject to such offset as may be awarded to Schering as damages for CIMA's breach of this Agreement in accordance with the dispute resolution provisions set forth in Section 16.2. Notwithstanding the foregoing, nothing in this Section shall be interpreted to eliminate or restrict any rights Schering has or may have relating to a default by CIMA under applicable Laws. ARTICLE XVI MISCELLANEOUS -49- 16.1 Assignment. Except as set forth in this Section 16.1, neither this Agreement nor any or all of the rights and obligations of a party hereunder shall be assigned, delegated, sold, transferred, sublicensed (except as otherwise provided herein) or otherwise disposed of, by operation of law or otherwise, to any third party other than an Affiliate of such party, without the prior written consent of the other party, and any attempted assignment, delegation, sale, transfer, sublicense or other disposition, by operation of law or otherwise, of this Agreement or of any rights or obligations hereunder contrary to this Section 16.1 shall be a material breach of this Agreement by the attempting party, and shall be void and without force or effect. Schering may, upon written notice to CIMA, assign to an Affiliate(s) any or all of its (i) obligations to pay royalties to CIMA; or (ii) option and other rights to Manufacture Licensed Product pursuant to Section 9.5 of this Agreement, except that no such assignment shall release Schering from its liability to pay royalties, or payments relating to Schering's exercise of its option to Manufacture Licensed Product, should the Affiliate default in its obligations. The forgoing notwithstanding, either party may, without such consent, assign the Agreement and its rights and obligations hereunder to an Affiliate or in connection with the transfer or sale of all or substantially all of its assets related to the division or the subject business, or in the event of its merger or consolidation or change in control or similar transaction. This Agreement shall be binding upon, and inure to the benefit of, each party, its Affiliates, and its permitted successors and assigns. Each party shall be responsible for the compliance by its Affiliates with the terms and conditions of this Agreement. 16.2 Governing Law. This Agreement shall be governed, interpreted and construed in accordance with the laws of the State of New Jersey, without giving effect to conflict of law principles. Subject to the terms of this Agreement, all disputes under this Agreement shall be governed by binding arbitration pursuant to the mechanism set forth in Appendix M attached hereto and incorporated hereby. 16.3 Waiver. Any delay or failure in enforcing a party's rights under this Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of such party's rights to the future enforcement of its rights under this Agreement, nor operate to bar the exercise or enforcement thereof at any time or times thereafter, excepting only as to an express written and signed waiver as to a particular matter for a particular period of time. 16.4 Independent Relationship. Nothing herein contained shall be deemed to create an employment, agency, joint venture or partnership relationship between the parties hereto or any of their agents or employees, or any other legal arrangement that would impose liability upon one party for the act or failure to act of the other party. Neither party shall have any power to -50- enter into any contracts or commitments or to incur any liabilities in the name of, or on behalf of, the other party, or to bind the other party in any respect whatsoever. 16.5 Export Control. This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States of America which may be imposed upon or related to CIMA or Schering from time to time by the government of the United States of America. Furthermore, each party agrees that it will not export, directly or indirectly, any technical information acquired from the other party under this Agreement or any products using such technical information to any country for which the United States government or any agency thereof at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the Department of Commerce or other agency of the United States government when required by an applicable statute or regulation. 16.6 Entire Agreement; Amendment. This Agreement, including the Attachments hereto and all the covenants, promises, agreements, warranties, representations, conditions and understandings sets forth the complete, final and exclusive agreement between the parties and supersedes and terminates all prior and contemporaneous agreements and understandings between the parties, whether oral or in writing. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the parties other than as are set forth herein. No subsequent alteration, amendment, change, waiver or addition to this Agreement shall be binding upon the parties unless reduced to writing and signed by an authorized officer of each party. No understanding, agreement, representation or promise, not explicitly set forth herein, has been relied on by either party in deciding to execute this Agreement. 16.7 Notices. Any notice required or permitted to be given or sent under this Agreement shall be hand delivered or sent by express delivery service or certified or registered mail, postage prepaid, or by facsimile transmission (with written confirmation copy by registered first-class mail) to the parties at the addresses and facsimile numbers indicated below. If to CIMA, to: CIMA LABS INC. 10,000 Valley View Road Eden Prairie, Minnesota 55344 Attn.: President and CEO Fax No.: (952) 947-8711 -51- If to Schering, to: Schering-Plough Ltd. Toepferstrasse 5, CH 6004 Lucerne, Switzerland Attention: President with copies to: Schering Corporation 2000 Galloping Hill Road Kenilworth, New Jersey 07033 Attn.: Vice President, Business Development Fax No.: (908) 298-7366 Schering Corporation 2000 Galloping Hill Road Kenilworth, New Jersey 07033 Attn.: Law Department - Senior Legal Director, Licensing Fax No.: (908) 298-2739 with copies of any notices regarding commercial supply of Licensed Product in the United States to: Schering Corporation 1095 Morris Avenue Union, NJ 07083 Attn.: Vice President Materials Management Fax No.: 908-629-3062 Any such notice shall be deemed to have been received on the date actually received. Either party may change its address or its facsimile number by giving the other party written notice, delivered in accordance with this Section. 16.8 Provisions for Insolvency. All rights and licenses granted under or pursuant to this Agreement by CIMA to Schering are, for all purposes of Section 365(n) of Title 11 of the United States Code ("Title 11"), licenses of rights to "intellectual property" as defined in Title 11. (a) Effect on Licenses. CIMA agrees that Schering, as licensee of such rights under this Agreement shall retain and may fully exercise all of its rights and elections under Title 11. CIMA agrees during the Term of this Agreement to create and maintain current copies or, if not amenable to copying, detailed descriptions or other appropriate embodiments, to the extent feasible, of all such intellectual property. If a -52- case is commenced by or against CIMA under Title 11, CIMA (in any capacity, including debtor-in-possession) and its successors and assigns (including, without limitation, a Title 11 Trustee) shall, (i) as Schering may elect in a written request, immediately upon such request: (A) perform all of the obligations provided in this Agreement to be performed by CIMA including, where applicable and without limitation, providing to Schering portions of such intellectual property (including embodiments thereof) held by CIMA and such successors and assigns or otherwise available to them; or (B) provide to Schering all such intellectual property (including all embodiments thereof) held by CIMA and such successors and assigns or otherwise available to them; and (ii) not interfere with the rights of Schering under this Agreement, or any agreement supplemental hereto, to such intellectual property (including such embodiments), including any right to obtain such intellectual property (or such embodiments) from another entity. (b) Rights to Intellectual Property. If a Title 11 case is commenced by or against CIMA, and this Agreement is rejected as provided in Title 11, and Schering elects to retain its rights hereunder as provided in Title 11, then CIMA (in any capacity, including debtor-in-possession) and its successors and assigns (including, without limitation, a Title 11 Trustee) shall provide to Schering all such intellectual property (including all embodiments thereof) held by CIMA and such successors and assigns, or otherwise available to them, immediately upon Schering's written request. Whenever CIMA or any of its successors or assigns provides to Schering any of the intellectual property licensed hereunder (or any embodiment thereof) pursuant to this Section 16.8, Schering shall have the right to perform the obligations of CIMA hereunder with respect to such intellectual property, but neither such provision nor such performance by Schering shall release CIMA from any such obligation or liability for failing to perform it. (c) Schering's Rights. All rights, powers and remedies of Schering provided herein are in addition to and not in substitution for any and all other rights, powers and remedies now or hereafter existing at law or in equity (including, without limitation, Title 11) in the event of -53- the commencement of a Title 11 case by or against CIMA. Schering, in addition to the rights, powers and remedies expressly provided herein, shall be entitled to exercise all other such rights and powers and resort to all other such remedies as may now or hereafter exist at law or in equity (including, without limitation, Title 11) in such event. The parties agree that they intend the foregoing Schering rights to extend to the maximum extent permitted by Law, including, without limitation, for purposes of Title 11: (i) the right of access to any intellectual property (including all embodiments thereof) of CIMA, or any third party with whom CIMA contracts to perform an obligation of CIMA under this Agreement, and, in the case of the third party, which is necessary for the development, registration, manufacture and marketing of Active Ingredient and/or Licensed Product; and (ii) the right to contract directly with any third party described in (i) to complete the contracted work. 16.9 Force Majeure. Failure of any party to perform its obligations under this Agreement (except the obligation to make payments when properly due) shall not subject such party to any liability or place them in breach of any term or condition of this Agreement to the other party if such failure is due to any cause beyond the reasonable control of such non-performing party ("force majeure"). Causes of non-performance constituting force majeure shall include, without limitation, acts of God, fire, explosion, flood, drought, war, riot, sabotage, embargo, strikes or other labor trouble, failure in whole or in part of suppliers to deliver on schedule materials, equipment or machinery, interruption of or delay in transportation, a national health emergency or compliance with any order or regulation of any government entity acting with color of right. The party affected shall promptly notify the other party of the condition constituting force majeure as defined herein and shall exert reasonable efforts to eliminate, cure and overcome any such causes and to resume performance of its obligations with all possible speed. If a condition constituting force majeure as defined herein exists for more than ninety (90) consecutive days, the parties shall meet to negotiate a mutually satisfactory resolution to the problem, if practicable. 16.10 Severability. If any provision of this Agreement is declared illegal, invalid or unenforceable by a court having competent jurisdiction, it is mutually agreed that this Agreement shall endure except for the part declared invalid or unenforceable by order of such court, provided, however, that in the event that the terms and conditions of this Agreement are materially altered, the parties will, in good faith, renegotiate the terms and conditions of this -54- Agreement to reasonably substitute such invalid or unenforceable provisions in light of the intent of this Agreement. 16.11 Counterparts. This Agreement shall become binding when any one or more counterparts hereof, individually or taken together, shall bear the signatures of each of the parties hereto. This Agreement may be executed in any number of counterparts, each of which shall be an original as against either party whose signature appears thereon, but all of which taken together shall constitute but one and the same instrument. 16.12 Captions. The captions of this Agreement are solely for the convenience of reference and shall not affect its interpretation. 16.13 Recording. Each party shall have the right, at any time, to record, register, or otherwise notify relevant portions of this Agreement in appropriate governmental or regulatory offices anywhere in the world, and each party shall provide reasonable assistance to the other in effecting such recording, registering or notifying and in obtaining or maintaining such confidential treatment as may be reasonably available. 16.14 Further Actions. Each party agrees to execute, acknowledge and deliver such further instruments, and to do all other acts, as may be reasonably necessary or appropriate in order to carry out the purposes and intent of this Agreement including, without limitation, any filings with any antitrust agency which may be required. IN WITNESS WHEREOF, this Agreement has been executed by the duly authorized representatives of the parties as of the dates set forth below. CIMA LABS INC. SCHERING-PLOUGH LTD. By: /s/ John M. Siebert By: /s/ David Poorvin ---------------------------------- -------------------------------- John M. Siebert David Poorvin Title: President & CEO Title: Prokurist ------------------------------- ---------------------------- Date: May 20, 2002 Date: May 17, 2002 ------------------------------- ----------------------------- -55- APPENDIX A CHEMICAL FORMULA OF [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] -1- APPENDIX B BULK SPECIFICATIONS FOR BULK ACTIVE Specifications for [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Specification Number [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Date [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Supercedes: [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Test Acceptance Limits Procedure Reference [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] -1- APPENDIX C DEVELOPMENT PROGRAM [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] DEVELOPMENT ACTIVITIES, COSTS AND TIMING [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. THREE PAGES OMITTED.***] -1- APPENDIX D LICENSED PATENTS RIGHTS
- --------------------------------------------------------------------------------------------------------- Patent or Patent Patents by Country Expiration Application Title - --------------------------------------------------------------------------------------------------------- "Effervescent Dosage U.S. Patent 5,178,878 January 12, 2010 Form with US Microparticles" - US Australian Patent 646,232 "Effervescent Dosage Canada Patent 2,061,917 Form and Method of Administering Same" - EU Patent 494,972 issued in Austria EU [E145,551], Belgium, Denmark, France, Australian & Canada Great Britain, Germany [69029273.2], Italy, Spain [2,097,155], Sweden, and Switzerland. Japanese patent application (2-514500) "Effervescent Dosage filed August 29, 1990 Unknown Form and Method of Administering Same" - US - --------------------------------------------------------------------------------------------------------- "Blister Package and U.S. Patent 6,155,423 April 1, 2018 US Packaged Tablet" Australian Patent No. 732,118 issued April 12, 2001 Foreign applications were also filed on April 1, 1998 in: Canada (2,284,132) European Patent Office (98913352.5) (EP 1,015,351 A1) Japan (541,960/1998) - ---------------------------------------------------------------------------------------------------------
-1-
- --------------------------------------------------------------------------------------------------------- "Apparatus for U.S. Patent 6,269,615 March 9, 2019 US Handling and Packaging Friable Australian Patent No. Tablets" 734,383 issued September 27, 2001 Foreign applications were also filed on March 9, 1999 in: European Patent Office (99914893.5) (EP 1,107,411 A1) Japan (535,554/2000) - --------------------------------------------------------------------------------------------------------- "Apparatus for U.S. Patent 6,311,462 March 9, 2019 Handling and US Packaging Friable No foreign counterparts Tablets" CIMA 3.0-028 DIV - ---------------------------------------------------------------------------------------------------------
"( )" indicates an application number "[ ]" indicates a patent number -2- APPENDIX E OUTSIDE SERVICES AGREEMENT AGREEMENT effective as of the last date of signature hereof ("Effective Date"), by and between Schering-Plough Research Institute, 2015 Galloping Hill Road, Kenilworth, New Jersey 07033 ("SPRI") and CIMA Labs, Inc., 10000 Valley View Road, Eden Prairie, MN 55344, and its Affiliates ("CIMA") for services to be performed by CIMA. In consideration of CIMA's engagement hereunder, the parties hereto agree to the following terms and conditions. CIMA will provide to SPRI research services including but not limited to feasibility studies for [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] orally disintegrating tablet in CIMA's ODT drug delivery technology as set forth in Phase IB and Phase II of Attachment B (the "Project"). The Project shall be subject to the following terms and conditions: 1. CIMA will perform the Project for SPRI during the term of this Agreement at such times as are reasonably available to CIMA and in response to SPRI's needs. In addition, SPRI shall have the option to expand the Project to include the additional services provided for in Attachment C (attached hereto), at the cost set forth in such Attachment C, by providing written notice to CIMA to that effect. 2. The term of this Agreement shall be retroactively effective from April 1, 2001, and continue until March 31, 2002 and may be extended or modified by written agreement by both SPRI and CIMA. 3. This Agreement and/or any service to be performed hereunder shall be immediately terminable at any time by SPRI upon ten (10) days' written notice to CIMA. Upon the delivery of such notice by SPRI, CIMA shall immediately cease work on the Project, deliver to SPRI all work in progress, and return all Confidential Information (as defined in paragraph 7) with respect thereto. Upon termination, SPRI's sole obligation to CIMA shall be to pay any monies due and owing up to the time of termination for services actually performed and all reasonable expenses actually incurred. 4. SPRI will pay CIMA for services performed hereunder pursuant to detailed invoices to be provided by CIMA. In addition, CIMA shall be reimbursed for all reasonable and customary travel expenses, if any, incurred in the performance of such services for SPRI. Requests for -1- payment for services and/or travel reimbursement shall be submitted upon completion on detailed invoices, with original supporting documentation attached. All reimbursements will be subject to SPRI's Reimbursement Policy (Attachment A). The total payment for services rendered and travel reimbursement shall not exceed [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. All invoices will be paid by SPRI within thirty (30) days of receipt. 5. SPRI or its authorized agents shall have the right to audit financial documentation (e.g., time logs) relating to the Project to verify amounts billed under this Agreement. "Pass-through" costs (i.e., direct third party costs that may be billed to SPRI) shall not include any overhead or profit and must be supported by original invoices (not merely itemized or referenced in a billing). 6. In connection with services to SPRI, CIMA will have access to certain valuable materials and technical information and data which SPRI considers to be confidential and proprietary. This will include information relating to research and development and commercial plans of SPRI and affiliated companies of Schering-Plough Corporation (the corporate parent of SPRI). 7. During the term of this Agreement and for a period of five (5) years thereafter (including following any termination or expiration), CIMA agrees to retain in confidence and to refrain from disclosing and/or using for its benefit or the benefit of any third party, any and all information and/or data disclosed to CIMA as a result of its services under this Agreement and/or obtained by CIMA or its representatives while visiting SPRI's facilities and any and all data and/or analyses and studies arising or derived from such information and/or data ("Confidential Information"). This restriction shall not apply to Confidential Information: (i) which is or becomes public knowledge (through no fault of CIMA or its representatives); or (ii) which is lawfully made available to CIMA by an independent third party (and such lawful availability can be properly demonstrated by CIMA); or (iii) which is already in its possession at the time of initial receipt from SPRI (and such prior possession can be properly demonstrated by CIMA); or (iv) which is independently developed by CIMA or its representatives (and such independent development can be properly demonstrated by CIMA); or (v) which is required by law, regulation, rule, act or order of any governmental authority or agency to be disclosed by CIMA provided, however, that CIMA gives SPRI sufficient advance written notice to permit it to seek a protective order or other similar order with -2- respect to such information and thereafter CIMA discloses only the minimum Confidential Information required to be disclosed in order to comply, whether or not a protective order or other similar order is obtained by SPRI. 8. CIMA agrees that it will not, without the prior written permission of SPRI, use information and data received by it under paragraphs 6 or 7 hereof for any purpose other than in carrying out this Agreement CIMA further agrees not to submit for publication any paper containing such information or data without the prior written permission of SPRI's legal department. Neither party may use the name of the other party in any publicity or advertising nor issue a press release or otherwise publicize or disclose any information related to the existence of this Agreement or the terms and conditions hereof, without the prior written consent of the other party. 9. CIMA agrees to promptly inform SPRI in writing of any event or circumstance which could reasonably affect its ability to perform hereunder in the manner contemplated by SPRI. 10. Intellectual Property a. In this Agreement, "SPRI Intellectual Property Rights" means any intellectual and industrial property (including, without limitation, any ideas, trade secrets, inventions, discoveries, copyright material or confidential know-how) relating to the Compound (including the Compound itself) or any other compound, product, technology, design, process, or method existing, created, discovered, conceived or under development prior to the date of this Agreement first written above owned or licensed by SPRI or any of its associated companies and which is used in or disclosed for the purposes of the study. b. In this Agreement "CIMA Intellectual Property Rights" means any intellectual and industrial property (including, without limitation, any ideas, trade secrets, inventions, discoveries, copyright material or confidential know-how) relating to the technology (including the technology itself) or any other product, technology, design, process, -3- or method existing, created, discovered, conceived or under development prior to the date of this agreement first written above, owned or licensed by CIMA or any of its associated companies and which is used in or disclosed for the purposes of the study. c. In this Agreement, "SPRI Intellectual Property Discoveries" means any intellectual property (including, without limitation, any invention, discovery or confidential know-how) which arises in the course of the study (i) relating to the Compound, SPRI Intellectual Property Rights and the Formulation (but not including CIMA Intellectual Property Rights); or (ii) arises from SPRI information protected under clause 7 above or work carried out by SPRI. d. In this Agreement, "CIMA Intellectual Property Discoveries" means any intellectual property (including, without limitation, any ideas, trade secrets, inventions, discoveries, copyright material or confidential know-how) which may be made or discovered by any of CIMA's employees or other members of its staff relating to technology and which arises in the course of any study carried out under this Agreement and which is not SPRI Intellectual Property Rights or SPRI Intellectual Property Discoveries. e. Ownership (i) SPRI Intellectual Property Rights and SPRI Intellectual Property Discoveries shall belong absolutely to SPRI and shall not be used by CIMA in any way other than for the purposes of carrying out the study. (ii) CIMA Intellectual Property Rights and CIMA Intellectual Property Discoveries shall belong absolutely to CIMA and shall not be used by SPRI in any way other than for the purposes contemplated by the parties under this Agreement. For the avoidance of doubt, SPRI shall not commercialize the resultant formulation, without a license to CIMA's Intellectual Property Rights. -4- (iii) Each party agrees, at the request of the other, to do all acts and execute all documents necessary and/or desirable to give effect to the provisions of sub-clauses 10(e)(i) and (ii) above at the cost of the party making the request and each party shall inform the other promptly of any results arising out of the study relating to the other's Intellectual Property Rights which may be patentable and provide full details thereof. (iv) Other than as contemplated in this Agreement, each party acknowledges that they are granted no other right to license to use, exploit or otherwise derive any advantage from the other's Intellectual Property Rights under this Agreement. 11. CIMA warrants and represents that as of the date of this Agreement CIMA (i) has the authority to execute this Agreement; and (ii) is not a party to any oral or written contract or understanding with any third party that is inconsistent with this Agreement and/or its performance hereunder, or that will in any way limit or conflict with its ability to fulfill the terms of this Agreement. CIMA further represents that it will not enter into any such agreement during the term of this Agreement. 12. CIMA understands and agrees that in its relationship with SPRI under this Agreement, CIMA is not a SPRI employee but, instead, CIMA is acting in the capacity of an independent contractor and has no authority to represent or act on behalf of SPRI. SPRI shall assume no liability for any damages and/or losses which may result from CIMA's negligence or from the performance of CIMA's services and obligations hereunder, and CIMA shall indemnify and hold SPRI, its officers, directors and employees harmless from and against any suits, claims, actions and/or liabilities arising from CIMA's breach of any of CIMA's obligations under this Agreement or from CIMA's negligent acts, omissions or failure to act and CIMA hereby acknowledges that CIMA is totally responsible for the payment of any and all taxes, including any quarterly estimated payments, applicable to CIMA's performance hereunder. CIMA understands and agrees that it is not entitled to participate in any of the employee benefit plans, including but not limited to the group health insurance plan, the Schering-Plough Retirement Plan, the Schering-Plough Employees' 401K Savings Plan, the Schering- -5- Plough Employees' Profit-Sharing Incentive Plan, and the Schering-Plough Stock Incentive Plan. CIMA further understands and agrees that, if it is found to be a common law or statutory employee by (i) the Internal Revenue Service; (ii) any other taxing authority; (iii) any regulatory authority; or (iv) a court of law, then CIMA hereby waives any right of eligibility which might thereby accrue to CIMA to participate in the aforesaid benefit plans of SPRI. CIMA agrees that during the term of this Agreement and for a period of six (6) months thereafter, it shall neither directly nor indirectly solicit for employment, or otherwise retain employees of SPRI, whom CIMA has met as a result of CIMA's performance of services for SPRI. 13. CIMA warrants that all services shall be performed in a professional and workmanlike manner. If the scope of the Project pertains to programming and/or software maintenance, CIMA warrants and represents that all software shall have logic pertaining to dates which will enable SPRI to identify and use the century portion of date fields without special processing; thus enabling the software to calculate and to store dates accurately including and following January 1, 2000. 14. This Agreement shall be construed in accordance with New Jersey law without regard to its conflict of laws, rules or principles. It is understood and agreed that both parties hereby submit to the jurisdiction of New Jersey state and federal courts. 15. CIMA represents and warrants that neither it nor its representatives or employees involved with the Project have been debarred pursuant to the Federal Food, Drug and Cosmetic Act, or excluded from a federal health care program. 16. CIMA warrants and represents that CIMA has insurance sufficient to cover CIMA's obligations and/or any liability assumed by CIMA under this Agreement. CIMA shall produce proof of such insurance within thirty (30) days of SPRI's request. 17. CIMA shall not assign this Agreement to any person, firm, partnership, corporation or other entity (including by operation of law, judicial process or otherwise) without the prior written consent of SPRI, which consent may be withheld for any reason. SPRI shall be entitled to assign this Agreement to any of its subsidiaries, affiliates, and/or its parent corporation, or any of such parent corporation's subsidiaries -6- and/or affiliates (including by operation of law, judicial process or otherwise) without the prior written consent of CIMA. 18. No term, condition or other provision of any attachment(s) or addenda to this Agreement shall supersede any term, condition or other provision of this Agreement and the Reimbursement Policy, and with respect to any inconsistency or ambiguity, this Agreement, together with the Reimbursement Policy shall control. This Agreement represents the entire understanding of the parties and hereby supersedes all prior understandings and agreements, whether oral or written, between the parties with respect to the services to be performed. This Agreement may only be amended by a written instrument signed by both parties. IN WITNESS WHEREOF, the parties have caused this Agreement to be executed, by duly authorized representatives, as of the last date written below. CIMA LABS, INC. SCHERING-PLOUGH RESEARCH INSTITUTE By:/s/John M. Siebert By: /s/ Lisbeth Hume --------------------- ------------------------------ Name: John M. Siebert Name: L. Hume, Ph.D. Title: President and CEO Title: Group Director SPC Development Operations Date: 27 April 2001 Date: May 21, 2001 -7- ATTACHMENT A REIMBURSEMENT POLICY In accordance with SPRI's standard policies and procedures, the following are types of expenses for which SPRI will not reimburse, unless expressly agreed to in a prior writing by the parties: - - Commuting expenses to and/or from the CIMA's place of business or residence (excluding commuting to and/or from airport for SPRI-requested business). - - First-class or business-class air travel - - Add-on costs with respect to outside services - - Mark-up for the work product of outside professionals, including but not limited to freelancers - - Meals (excluding meals while traveling for SPRI-requested business). - - Administrative and/or overhead percentages - - Agency presentations for new business - - Gifts to SPRI's employees - - Entertainment of SPRI's employees - - Mark-up on any out-of-pocket expenses Note: This list sets forth the major items for which SPRI will not reimburse CIMA and is meant to be merely illustrative and not exhaustive. All CIMA expenses shall be reviewed with respect to the reasonableness of such expenses. -1- ATTACHMENT B [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Development Activities, Costs and Timing: Outside Services Agreement
- ------------------------------------------------------------------------------- Phase Activity Anticipated Costs ($) Completion/Duration - ------------------------------------------------------------------------------- [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. TWO PAGES OMITTED***] - -------------------------------------------------------------------------------
-1- ATTACHMENT C [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Product: [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Format: [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] only Quantity: [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Delivery date: [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Ship to: Jim Kou, Schering-Plough Cost: [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] -1- Amendment #1 THIS AMENDMENT #1 to Outside Services Agreement is entered into as of this 25th day of September, 2001. Whereas, CIMA LABS Inc. ("CIMA") and Schering-Pough Research Institute ("SPRI") have entered into an Outside Services Agreement with an Effective Date of May 21, 2001 ("Outside Services Agreement") regarding research on the development of a pharmaceutical product containing [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]; Whereas, CIMA has been conducting research and development activities according to Attachment B of the Outside Services Agreement; and Whereas, CIMA and SRI have determined that changes to the Outside Services Agreement, including the inclusion of development milestone payments, are desirable; Therefore, for good and valid consideration, the Parties agree to amend the Outside Services Agreement as follows: 1) In Paragraph 4 line 1 - after "services performed" insert "or milestones achieved"; 2) In Paragraph 4 after the first sentence - insert "In the event that the pilot biostudy conducted by SPRI indicates that CIMA's [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] oral disintegration table prototype is bioequivalent to SPRI's [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] solid oral dosage form, SPRI shall pay CIMA a milestone payment ("Milestone Payment") of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]"; 3) In Paragraph 4, change "[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]"; and 4) In Paragraph 4 in the last sentence - after "thirty (30) days of receipt" insert ", provided, however that the Milestone Payment shall be due and payable, within five (5) days after the execution of a development, license and supply agreement for a pharmaceutical product containing [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] between CIMA and Schering Corporation. 5) In all other respects, the terms and conditions of the Outside Services Agreement remain in full force and effect. Capitalized terms in this Amendment shall have the same meaning as in the Outside Services Agreement. CIMA LABS Inc. Schering-Plough Research Institute -1- By: /s/ John M. Siebert By: /s/ Cecil B. Pickett --------------------------- ---------------------------- Signature Signature John M. Siebert Cecil B. Pickett --------------------------- ---------------------------- (Print or Type Name) (Print or Type Name) Title: President & CEO Title: Acting President -------------------------- ---------------------------- 25 September 01 -2- Amendment #2 to Outside Services Agreement THIS AMENDMENT #2 to the Outside Services Agreement is entered into as of this 3rd day of December, 2001. Whereas, CIMA LABS Inc. (CIMA) and Schering-Plough Research Institute (SPRI) have entered into an Outside Services Agreement with an Effective Date of May 21, 2001 (Outside Services Agreement) regarding research on the development of a pharmaceutical product containing [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]; Whereas, the Outside Services Agreement was subsequently amended by Amendment #1 to the Outside Services Agreement dated September 25, 2001; Whereas, CIMA has been conducting research and development activities according to Attachment B of the Outside Services Agreement as amended; and Whereas, CIMA and SPRI have determined that further changes to the Outside Services Agreement, including the payment of a development milestone payment and additional development activities, are desirable; Therefore, for good and valid consideration, the Parties agree to further amend the Outside Services Agreement as follows: 1) Attachment B is replaced with Attachment B-1 of this Amendment; 2) In the second preamble paragraph replace "Phase 1B and Phase II of Attachment B" with "Phase IIa, Phase IIb, Phase III and Phase IVa of Attachment B-1"; 3) In Paragraph 4, change "[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]" ; and 4) In Paragraph 4 in the last sentence delete "the Milestone Payment shall be due and payable, upon the completion of a development, license and supply agreement for a pharmaceutical product containing [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] between CIMA and Schering Corporation." and replace with "the Milestone Payment shall be payable thirty (30) days from the date of execution by SPRI of this Amendment #2." 5) In all other respects, the terms and conditions of the Outside Services Agreement, as amended by Amendment #1, remain in full force and effect. Capitalized terms in this Amendment #2 shall have the same meaning as in the Outside Services Agreement and Amendment #1. CIMA LABS Inc. Schering-Plough Research Institute By: /s/ John M. Siebert By: /s/ Cecil B. Pickett --------------------------- ----------------------------- Signature Signature John M. Siebert Cecil B. Pickett --------------------------- ----------------------------- -3- (Print or Type Name) (Print or Type Name) Title: President & CEO Title: Acting President ------------------------- --------------------------- Date: 3 Dec 2001 Date: 1/7/02 ------------------------- --------------------------- -4- ATTACHMENT B-1 [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] DEVELOPMENT ACTIVITIES, COSTS AND TIMING 05 DECEMBER 01
- ------------------------------------------------------------------------------- Phase Activity Anticipated Costs ($) Completion/ Duration - -------------------------------------------------------------------------------
[*** CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. TWO PAGES OMITTED.***] -5- APPENDIX F PACKAGING COMPONENTS FOR LICENSED PRODUCT [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] -1- APPENDIX G PRICE OF LICENSED PRODUCT SUPPLIED BY CIMA FOR COMMERCIAL USE Estimated prices per OraSolv(R) tablet
- ------------------------------------------------------------------------- Type Potency Packaging Price/tab ($) in Configuration Cartons* - ------------------------------------------------------------------------- Samples [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] - ------------------------------------------------------------------------- Trade [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] - -------------------------------------------------------------------------
NOTE: Price per tablet is an estimate and assumes that Schering will provide [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] for manufacturing of tablets and package inserts. Price per tablet is based on a 550 kilogram batch (~3,000,000 tablets) and a five (5) batch minimum order. Final price will be determined upon final formulation and packaging configuration of the Product. * Tablet Prices for the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] tablets will not exceed the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] price quoted herein. Final [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] prices will be determined upon final formulation and packaging configuration of these Products. ** If the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] format is used there will be an additional tooling charge of up to -1- [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] for each tablet size. -2- APPENDIX H SPECIFICATIONS FOR LICENSED PRODUCT Specifications for [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
- ------------------------------------------------------------------------------------------------- Physical Appearance [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] - ------------------------------------------------------------------------------------------------- Identity [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] - ------------------------------------------------------------------------------------------------- Assay [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]label claim - ------------------------------------------------------------------------------------------------- Uniformity of Dosage Units Meets the requirements of the current USP for Content Uniformity of Compressed Tablets - ------------------------------------------------------------------------------------------------- Dissolution To be determined prior to regulatory submission - ------------------------------------------------------------------------------------------------- Degradation Products To be determined prior to regulatory submission - ------------------------------------------------------------------------------------------------- Tablet Disintegration Not more than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] - -------------------------------------------------------------------------------------------------
-1- APPENDIX I ADVERSE EVENT REPORTING PROCEDURES FOR PRODUCTS 1.0 PURPOSE The purpose of this agreement is to describe the procedures and define the responsibilities which Schering and CIMA, will employ to ensure that adverse event notification and reporting requirements meet current health agency regulations and guidelines worldwide. Schering and CIMA (the "Parties") understand and agree that these procedures are intended to comply with 21 CFR 310.305(a), 312.32, 314.80(b), and 314.98 concerning standard written procedures for adverse event reporting in the United States and Laws applicable to Adverse Event (AE) and Adverse Drug Reaction (ADR) reporting outside the US. References within this document to AEs also include ADRs as appropriate. These procedures may be amended by the Parties at any time by mutual written agreement to ensure that they fully and accurately reflect the procedures in place for surveillance, receipt, evaluation and reporting of adverse drug experiences by the Pharmacovigilance departments of the Parties and comply with applicable Laws in the countries in which the product is marketed and/or is under investigation. In that regard, upon the written request of either Party, the Parties shall meet to renegotiate in good faith, all or some of these procedures. Notwithstanding the foregoing, the procedures set forth in this Attachment shall not be construed as restricting either Party's ability to take action that it deems to be appropriate or required of it under applicable Law. All defined terms used in this agreement are intended to be interpreted in a manner consistent with the corresponding definitions in ICH E2A1 and E2C, and with FDA regulations and guidelines (Appendix 1). 2.0 EXCHANGE OF ADVERSE EVENT INFORMATION The language of all exchanges of AE information will be English. Each party can also elect not to receive documents. 2.1 Spontaneous Reports - Marketed Product. - ------------------------- (1) Directive 75/319 EEC chapter Va - Pharmacovigilance and EC valid guidelines such as Notice to Marketing Authorization Holders - Pharmacovigilance guide, and CPMP/ICH-guidelines - CPMP/ICH/287/95 (E2A), CPMP/ICH/377/95 (E2B) CPMP/ICH/288/95 (E2C). -1- a) Each party will send the other party for all Serious Adverse Events reported to it regardless of source (other than from disclosure by or on behalf of the other Party) a completed CIOMS/MEDWATCH within eight calendar days after the first person in the receiving party (Schering or CIMA) is first made aware of it, or source documents within two calendar days after the first person in the receiving party (Schering or CIMA) is made aware of it by Fax. This applies to initial and all follow-up information. If both parties have the capabilities, by mutual agreement, data exchange can be done electronically. b) Each party will send the other party for all Non-Serious Adverse Events regardless of source (other than from disclosure by or on behalf of the other Party) a CIOMS/MEDWATCH line listing, by fax or courier mail, for all initial and follow-up Non-Serious adverse events on a monthly basis. If both parties have the capabilities, by mutual agreement, data exchange can be done electronically. 2.2 Serious Adverse Events (SAEs) from Clinical Studies a) For Fatal or Life-threatening adverse events reported to a party regardless of source (other than from disclosure by or on behalf of the other Party) the party will send to the other party a completed CIOMS/MEDWATCH within three calendar days after the first person in the receiving party (Schering or CIMA) is first made aware of it, by fax or source documents within Two calendar days after the first person in the receiving party (Schering or CIMA) is first made aware of it via Fax. . This applies to initial and all follow-up information. If both parties have the capabilities, by mutual agreement, data exchange can be done electronically. b) Each party will send the other party for all Serious Adverse Events reported to it regardless of source (other than from disclosure by or on behalf of the other Party) a completed CIOMS/MEDWATCH within eight calendar days after the first person in the receiving party (Schering or CIMA) is first made aware of it, or source documents within two calendar days after the first person in the receiving party (Schering or CIMA) is first made aware of it by Fax. This applies to initial and all follow-up information. -2- If both parties have the capabilities, by mutual agreement, data exchange can be done electronically. c) Non-serious AE reports from Clinical Studies will not be exchanged between the Parties' Pharmacovigilance departments. 2.3 Pregnancy Reports. All reports of drug exposure to a pregnancy (male or female partner using the product) received by either party, including both, those reports associated with an adverse event and those reports not associated with an adverse event, will be exchanged. Serious AE's will be treated as explained in sections 2.1 and 2.2. If a non-serious AE or no adverse event is involved and the report is simply one of a pregnancy in a patient or partner on a S-P product the report is to be sent to DSS within 7 calendar days. The pregnancy will be followed to term by the reporting group and/or DSS to obtain the outcome of the pregnancy (Pregnancy Register). 2.4 Animal Studies. A written report for AEs for animal studies which suggest a potential significant risk for humans shall be forwarded to the other Party via fax within two working days of receipt by the Party making the report. 3.0 ASSESSMENT OF ADVERSE EVENTS 3.1 Spontaneous Reports - Marketed Product. N/A. 3.2 Serious AEs from Clinical Studies. Causality: Each party will be responsible for the causality assessment of AEs in their own clinical studies. 4.0 REPORTING RESPONSIBILITIES Each party will send via fax to the other party a copy of all reports sent to Health Authorities within one day of transmission to the Heath Authority, except for those already sent to the other party. For example, but not limited to, PSUR, Periodic reports, etc. 4.1 Spontaneous Reports-Marketed Product. Each party will have the responsibility for the reporting of AEs to Health Authorities where they hold the Marketing Authorization. 4.2 Product in Clinical Trials. Each party will have the responsibility for the reporting of AEs to Health Authorities and its investigators in those territories where they are conducting clinical trials. Alterations in this -3- procedure may be agreed upon by both parties in writing at any time during the Term of this Agreement. 5.0 QUESTIONS FROM HEALTH AUTHORITIES Each Party will be responsible for responding to Health Authorities where they hold the Marketing Authorization. Each party will immediately (within 2 working days) advise the other Party of any Product safety communication received from a health authority and consult with the other Party with respect to any proposed change to product warnings, labeling or an Investigator's Brochure involving safety issues, including, but not limited to, safety issues agreed to by the Parties. Each party will send the other party a copy of correspondence sent to the Health Authority when sent to the Health Authority. 6.0 LITERATURE REVIEW Each party will be responsible for reviewing all published/unpublished articles in the territories where they are the Marketing Authorization holder or are conducting clinical trials. All adverse events identified in the literature will be processed as described in Section 2.1 and Section 2.2. 7.0 SIGNALING Each Party will signal unexpected adverse events from their databases. Each party will notify the other in writing of any proposed safety changes in U.S. and/or core labeling documents for discussion and comment prior to implementation of the label change. 8.0 AUDIT Each Party agrees to maintain accurate and complete records of all adverse events relating to product(s) and submissions to government authorities relating thereto (collectively, "Records"). Each party agrees to permit representatives of the other party to examine and audit the Records, during normal business hours and at no charge, upon reasonable written notice; provided, however, that such audit must be reasonable in scope and in relationship to the adverse events for the product(s). Both parties shall have the opportunity to participate in any post-audit meeting and receive a copy of any audit report relating thereto; and provided further that, if either party -4- seeks to use the services of a Third Party in such an audit, the Third Party must be acceptable to both Parties and be willing to comply with reasonable requirements of the party being audited, such as signing a confidentiality agreement. 9.0 TERM This Agreement will become active as of the latest date signed below and supersedes all previous agreements for the exchange of AE information. This Agreement will remain in effect until such time that a new agreement is negotiated by the parties and approved by the Law Department and DSS. This agreement will survive the termination of the contract that it is attached to up until the point that the product is no longer being sold. 10.0 MISCELLANEOUS a) Definitions: Each party accepts the definitions in the Safety Agreement Appendix 1 for the interchange AE information. b) Contact List: Each party will supply the required information found in the Safety Agreement Appendix 2 and will notify the other party within five working days via fax of any changes to this information. c) Amendments to the license contract: Each party will notify the other party's safety contact of any amendments, extensions, terminations of the License contract within five working days via Fax. d) Amendments to this safety agreement: Both parties by mutual agreement may add written amendments to this agreement covering arrangements for the handling of other safety issues (e.g. labeling, periodic safety update report preparation, exceptional issues in one or more countries etc.). -5- SAFETY AGREEMENT APPENDIX 1 DEFINITIONS A. MARKETED DRUG Refers to a human drug, biological product, or device that is being commercialized anywhere in the world. This includes products sold "under license". B. ADVERSE EVENT (AE) 1. Any undesirable medical occurrence (and for devices, any malfunction with or without an accompanying untoward medical occurrence), in a patient or clinical investigation subject administered a pharmaceutical product/biologic (at any dose), or device. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product: - occurring in the course of the use of a drug, biological product or device - associated with, or observed in conjunction with product overdose, whether accidental or intentional, - associated with, or observed in conjunction with product abuse, and/or - associated with, or observed in conjunction with product withdrawal. 2. Any failure of expected pharmacological or biologic therapeutic action (with the exception of such failure occurring in a clinical trial). C. ADVERSE DRUG REACTION (ADR) 1. Post-marketing: A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the modification of physiological functions. 2. In the pre-approval clinical experience with a new medicinal product or its new usages: any response to a medicinal product which is noxious or unintended, and which occurs at any dose used or tested in humans for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiologic function. -6- D. SERIOUS ADVERSE EVENT (SAE) is an event meeting one or both of the following definitions: 1. Definition = FDA Definition Serious. Any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse. 2. Serious Adverse Event (experience) or Reaction Definition from ICH E2A. Any untoward medical occurrence that at any dose: - results in death, - is life-threatening, - requires inpatient hospitalization or prolongation of existing hospitalization, - results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. E. NON-SERIOUS ADVERSE EVENT Any AE which does not meet the criteria for serious. F. UNEXPECTED ADVERSE EVENT (UNLABELED) 1. Marketed Product. Any AE, the nature, severity or frequency of which is inconsistent with the most current SmPC for within the EU; US PI for within the US; or Local Package Insert for countries outside the EU/US. This includes reports of adverse events which add significant information on the specificity of an already known adverse event. Events considered more severe or specific than those in the SmPC, US PI or Local PI constitute unexpected events. For example: a) Acute renal failure is labeled, with a report of interstitial nephritis (nephritis is not labeled). -7- b) Hepatitis with new report of fulminant hepatitis (fulminant hepatitis is not labeled). 2. Product in Clinical Trials. a) Based on the Investigator Brochure (IB) b) Any adverse event, the nature, severity or frequency of which is not consistent with information in the most current SmPC (Phase IV studies for indications approved in the SmPC) or IB (Phase I-III or Phase IV studies for indications not approved in the SmPC), as described above. G. STUDY DURATION Adverse events will be collected for the duration of all studies. Study completion (closure) is defined as later of: - the last dose of the study medication, - the last visit by the subject or patient or, - the last subject or patient contact (e.g., phone contact) with the Investigator or designee as defined in the protocol. SAEs that occur within 30 days after this closure must be reported. For survival studies, only deaths (not all serious AE's), that occur after the 30 day period (study completion for each patient) need be reported. H. RELATED OR POSSIBLY OR PROBABLY RELATED TO THE "BIOMEDICAL RESEARCH" For the purposes of this agreement, all events attributed to the trial or study or imposed by it, including drugs (study drugs, placebo, concomitant drugs given for the study or "no treatment"), investigations performed and the conditions in which they are carried out. Events which are not related to the biomedical research are those which are due to the underlying disease being treated. That is, events are considered possibly or probably related to the biomedical research if they cannot be clearly attributed to the underlying disease. Thus, any event in the trial which is due to the study drug, to placebo, to concomitant medications, to a trial procedure, to a trial investigation or any other "constraint" imposed by the trial is to be reported as an adverse event. I. INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE A drug, biological product or device in clinical trials. This includes clinical trials being conducted for new indications with marketed products. -8- J. CLINICAL INVESTIGATION/TRIAL/STUDY All experiments or systematic studies in which a drug is administered or dispensed to or used in dosing one or more human subjects. K. SIGNALING The purpose of signaling is to identify "possible signals" which need further review and consideration for possible label changes. These events are generally unexpected (unlabeled). These events may or may not be serious and may or may not be due to or caused by the drug. L. INITIAL RECEIPT DATE The day the regulatory clock starts and is the earliest date that an employee, agent, representative etc. of either party, first becomes aware of the event. -9- SAFETY AGREEMENT APPENDIX 2 CONTACT PEOPLE FOR EXCHANGE OF SAFETY INFORMATION: Schering Plough or Affiliate Company Name:
- ---------------------------------------------------------------------------------------------- Primary Back-up - ---------------------------------------------------------------------------------------------- NAME Taiwo Omolodun Kathy Rodriguez - ---------------------------------------------------------------------------------------------- TITLE Manager, Drug Surveillance Manager, Training and Compliance - ---------------------------------------------------------------------------------------------- PHONE NUMBER 1 973-921-7415 973-921-7452 - ---------------------------------------------------------------------------------------------- PHONE NUMBER 2 - ---------------------------------------------------------------------------------------------- FAX NUMBER 1 973-921-7424 973-921-7425 - ---------------------------------------------------------------------------------------------- FAX NUMBER 2 - ---------------------------------------------------------------------------------------------- E-MAIL 1 Taiwo.Omolodun@spcorp.com Kathy.Rodriguez@spcorp.com - ---------------------------------------------------------------------------------------------- E-MAIL 2 - ---------------------------------------------------------------------------------------------- MAILING ADDRESS Schering Plough Research Institute Schering Plough Research Institute - ---------------------------------------------------------------------------------------------- 50 Lawrence Road 50 Lawrence Road - ---------------------------------------------------------------------------------------------- Springfield, NJ Springfield, NJ - ---------------------------------------------------------------------------------------------- 07081-0735 07081-0735 - ----------------------------------------------------------------------------------------------
-10- LICENSE PARTNER OR AFFILIATE Company Name:
- ------------------------------------------------------------------------------------------------------------------------------ Primary Back-up - ------------------------------------------------------------------------------------------------------------------------------ NAME Ken Manning Jackie Torfin - ------------------------------------------------------------------------------------------------------------------------------ TITLE Vice President, Quality Director, Quality Systems - ------------------------------------------------------------------------------------------------------------------------------ PHONE NUMBER 1 952-947-8714 952-947-8773 - ------------------------------------------------------------------------------------------------------------------------------ PHONE NUMBER 2 952-947-8707 (after hours at CIMA) 952-947-8707 - after hours at CIMA [***CONFIDENTIAL TREATMENT REQUESTED, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION PORTION OMITTED OMITTED FILED SEPARATELY WITH THE SECURITIES AND FILED SEPARATELY WITH THE EXCHANGE COMMISSION.***] (emergencies only) SECURITIES AND EXCHANG COMMISSION.***] (emergencies only) - ------------------------------------------------------------------------------------------------------------------------------ FAX NUMBER 1 952-947-8770 952-947-8948 - ------------------------------------------------------------------------------------------------------------------------------ FAX NUMBER 2 952-947-8770 - ------------------------------------------------------------------------------------------------------------------------------ E-MAIL 1 kenm@cimalabs.com Jackiet@cimalabs.com - ------------------------------------------------------------------------------------------------------------------------------ E-MAIL 2 - ------------------------------------------------------------------------------------------------------------------------------ MAILING ADDRESS 10000 Valley View Road 10000 Valley View Road Eden Prairie, MN 55344 Eden Prairie, MN 55344 - ------------------------------------------------------------------------------------------------------------------------------ - ------------------------------------------------------------------------------------------------------------------------------ - ------------------------------------------------------------------------------------------------------------------------------ - ------------------------------------------------------------------------------------------------------------------------------
-11- APPENDIX J STORAGE CONDITIONS A recertification period of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] has been assigned for [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. An assessment for the extension of the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] recertification period will be made when additional data become available. -1- APPENDIX K EXPENSE GUIDELINES In accordance with Schering's standard policies and procedures, the following are types of expenses for which Schering will not reimburse, unless expressly agreed to in a prior writing by the parties: - - Taxi/Sedans/Limousines to and/or from Schering, to and/or from Company's place of business (excluding taxis to and/or from airports for Schering-requested business) - - First-class or business-class air travel - - Add-on costs with respect to outside services - - Mark-up on the work product of outside professionals, including but not limited to freelancers - - Lunches and dinners - - Administrative and/or overhead percentages - - Presentations for new business - - Gifts to Schering employees - - Entertainment of Schering employees - - Mark-up on out-of-pocket expenses Note: This list sets forth the major items for which Schering will not reimburse Company and is meant to be merely illustrative and not exhaustive. All Company expenses shall be reviewed with respect to the reasonableness of such expenses. -1- APPENDIX L KEY SCHERING MARKETS [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] -1- APPENDIX M ARBITRATION PROVISIONS (a) Scope. Subject to and in accordance with the terms of this Agreement and this Appendix M, all differences, disputes, claims or controversies arising out of or in any way connected or related to this Agreement, whether arising before or after the expiration of the term of this Agreement, and including, without limitation, its negotiation, execution, delivery, enforceability, performance, breach, discharge, interpretation and construction, existence, validity and any damages resulting therefrom or the rights, privileges, duties and obligations of the parties under or in relation to this Agreement (including any dispute as to whether an issue is arbitrable) shall be referred to binding arbitration in accordance with the rules set forth herein and of the American Arbitration Association, as in effect at the time of the arbitration. The time frames set forth herein shall control the timing of the arbitration procedure. (b) Parties to Arbitration. For the purposes of each arbitration under this Agreement, Schering shall constitute one party to the arbitration and CIMA shall constitute the other party to the arbitration. (c) Notice of Arbitration. A party requesting arbitration hereunder (the "Requesting Party") shall give a notice of arbitration to the other party (the "Non-requesting Party") containing a concise description of the matter submitted for arbitration (a "Notice of Arbitration"). Notice of Arbitration shall be delivered to the other party in accordance with Section 16.7 of the Agreement. (d) Response. The Non-requesting Party must respond in writing within thirty (30) days of receiving a Notice of Arbitration with an explanation, including references to the relevant provisions of the Agreement. The Non-requesting Party may add additional issues to be resolved. (e) Meeting. Within fifteen (15) days of receipt of the response from the Non-requesting Party pursuant to Paragraph (d), the parties shall meet and discuss in good faith options for resolving the dispute. The Requesting Party must initiate the scheduling of this resolution meeting. Each party shall make available appropriate personnel to meet and confer with the other party during such fifteen (15) day period. (f) Selection of Arbitrator. Any and all disputes that cannot be resolved pursuant to Paragraphs (c), (d) and (e) shall be submitted to an arbitrator (the "Arbitrator") to be selected by mutual agreement of the parties. The Arbitrator shall be a retired judge of a state or federal court, to be chosen -1- from a list of such retired judges to be prepared jointly by the parties within fifteen days following the response, with each party entitled to submit the names of three such retired judges for inclusion in the list, provided that to the extent the dispute involves issues of patent law the parties shall limit such list to judges from federal courts having jurisdiction over patent law issues. Upon completion of the list, the parties shall decide within ten (10) days thereafter which of the retired judges will be selected as the Arbitrator. No Arbitrator appointed or selected hereunder shall be an employee, director or shareholder of, or otherwise have any current or previous relationship with, any party or its respective Affiliates. If the parties fail to agree on the selection of the Arbitrator within the allotted time frame, the Arbitrator shall be designated by the then President of the American Arbitration Association. (g) Powers of Arbitrator. The Arbitrator may determine all questions of law and jurisdiction (including questions as to whether a dispute is arbitrable) and all matters of procedure relating to the arbitration, except that the Arbitrator shall be bound by the time frames set forth herein in connection with such arbitration. The Arbitrator shall have the right to grant legal and equitable relief (including injunctive relief and to award costs (including reasonable legal fees and costs of arbitration) and interest. Nothing contained herein shall be construed to permit the Arbitrator to award punitive, exemplary or any similar damages. (h) Arbitration Procedure. The arbitration shall take place in the City of Chicago, Illinois at such place and time, consistent with the time frames set forth herein, as the Arbitrator may fix for the purpose of hearing the evidence and representations that the parties may present. The law applicable to the arbitration shall be the law of the State of New Jersey. No later than twenty (20) business days after hearing the representations and evidence of the parties, the Arbitrator shall make its determination in writing and deliver one copy to each of the parties. (i) Discovery and Hearing. During the meeting referred to in Paragraph (e), the parties shall negotiate in good faith the scope and schedule of discovery, relating to depositions, document production and other discovery devices, taking into account the nature of the dispute submitted for resolution. If the parties are unable to reach agreement as to the scope and schedule of discovery, the Arbitrator may order such discovery as it deems necessary. The parties and the Arbitrator must adhere to the following schedule: (1) all discovery shall be completed within sixty (60) days from the date of the selection of the Arbitrator, and (2) the arbitration hearing shall commence no earlier than twenty (20) business days and no later than thirty (30) business days after completion of such discovery. At the arbitration hearing, the parties may present testimony (either live witness or deposition), subject to cross-examination, and documentary evidence. To the extent practicable taking into account the nature of the dispute submitted for resolution and the availability -2- of the Arbitrator, the hearing shall be conducted over a period not to exceed thirty (30) consecutive business days, with each party entitled to approximately half of the allotted time. (j) Witness Lists. At least fifteen (15) business days prior to the date set for the hearing, each party shall submit to each other party and the Arbitrator a list of all documents on which such party intends to rely in any oral or written presentation to the Arbitrator and a list of all witnesses, if any, such party intends to call at such hearing and a brief summary of each witness' testimony. Each party shall be given the opportunity to depose any such designated witnesses not already deposed during the discovery phase. At least five (5) business days prior to the hearing, each party must submit to the Arbitrator and serve on each other party a proposed findings of fact and conclusions of law on each issue to be resolved. Following the close of hearings, the parties shall each submit such post-hearing briefs to the Arbitrator addressing the evidence and issues to be resolved as may be required or permitted by the Arbitrator. (k) Confidentiality. The arbitration proceedings shall be confidential and, except as required by Law, no party shall make, or instruct the Arbitrator to make, any public announcement with respect to the proceedings or decision of the Arbitrator without the prior written consent of the other party. The existence of any dispute submitted to arbitration and the award of the Arbitrator shall be kept in confidence by the parties and the Arbitrator, except as required in connection with the enforcement of such award or as otherwise required by Law. (l) Awards and Appeal. Subject to the provisions of this Appendix M, the decision of the Arbitrator shall be final and binding upon the parties in respect of all matters relating to the arbitration, the conduct of the parties during the proceedings, and the final determination of the issues in the arbitration. There shall be no appeal from the final determination of the Arbitrator to any court, except in the case of fraud or bad faith on the part of the Arbitrator or any party to the arbitration proceeding in connection with the conduct of such proceedings. Judgment upon any award rendered by the Arbitrator may be entered in any court having jurisdiction thereof. (m) Costs of Arbitration. The costs of any arbitration hereunder shall be borne by the parties in the manner specified by the Arbitrator in its determination. (n) Performance of the Agreement. During the pendency of the arbitration proceedings, the parties shall continue to fully perform their respective obligations under the Agreement. Any aspects of such performance which encompass the matter which is the subject of such arbitration proceedings shall be performed by the parties in accordance with Schering's -3- position with respect to such matter. For purposes of this Paragraph (n) the term "pendency of the arbitration proceeding" shall mean the period starting on the date on which arbitration proceedings are commenced by a party in accordance with Paragraph (c) of this Appendix M and ending on the date on which the Arbitrator delivers its final determination in writing to the parties. -4-
EX-10.2 4 c71161exv10w2.txt EX-10.2 DEVELOPMENT AND LICENSE AGREEMENT EXHIBIT 10.2 DEVELOPMENT AND LICENSE AGREEMENT BETWEEN CIMA LABS INC. AND WYETH ACTING THROUGH ITS WYETH CONSUMER HEALTHCARE DIVISION FOR NON-PRESCRIPTION RAPID DISSOLVING LORATADINE TABLETS TABLE OF CONTENTS ARTICLE I DEFINITIONS........................................................ 1 ARTICLE II GRANT OF RIGHTS; EXCLUSIVITY...................................... 5 ARTICLE III DEVELOPMENT ACTIVITIES........................................... 6 ARTICLE IV DILIGENCE OBLIGATIONS............................................. 7 ARTICLE V ROYALTY PAYMENTS TO CIMA........................................... 8 ARTICLE VI REPRESENTATIONS AND WARRANTIES.................................... 9 ARTICLE VII INDEMNIFICATION.................................................. 11 ARTICLE VIII CONFIDENTIALITY................................................. 12 ARTICLE IX TECHNOLOGY AND DATA OWNERSHIP RIGHTS; INFRINGEMENT................ 14 ARTICLE X TERM AND TERMINATION............................................... 17 ARTICLE XI EFFECT OF EXPIRATION AND TERMINATION.............................. 18 ARTICLE XII TRADEMARKS....................................................... 19 ARTICLE XIII PRESS RELEASES AND PUBLICATIONS................................. 20 ARTICLE XIV MISCELLANEOUS.................................................... 21 EXHIBIT A - CIMA PATENTS EXHIBIT B - ADVERSE EXPERIENCE REPORTING PROCEDURES
-i- DEVELOPMENT AND LICENSE AGREEMENT THIS AGREEMENT dated the 18th day of June 2002 between CIMA LABS INC., a corporation organized and existing under the laws of the State of Delaware with offices located at 10000 Valley View Road, Eden Prairie, Minnesota 55344 (hereafter, together with its Affiliates, referred to as "CIMA"), and WYETH (formerly known as American Home Products Corporation), acting through its Wyeth Consumer Healthcare Division, a corporation organized and existing under the laws of the State of Delaware with offices located at Five Giralda Farms, Madison, New Jersey 07940 ("WCH"). W I T N E S S E T H WHEREAS, CIMA and Wyeth, acting through its ESI Lederle Division ("ESI"), entered into a Development and License Agreement, dated January 14, 2000 (the "Original Development and License Agreement"); and WHEREAS, CIMA and WCH wish to amend the Original Development and License Agreement to remove the OTC Field (as defined herein) and to enter into this Development and License Agreement which relates only to the OTC Field, all on the terms and subject to the conditions set forth herein. NOW, THEREFORE, in consideration of the representations, warranties and covenants set forth herein, the parties hereto agree as follows: ARTICLE I DEFINITIONS 1.1 "ACTIVE INGREDIENT" means ethyl 4-(8-chloro-5, 6-dihydro-11H-benzo [5,6] cyclohepta [1,2-b] pyridin-11-ylid-ene)-1 piperidinecarboxylate, known as loratadine. 1.2 "ADVERSE EXPERIENCE" means the definition in the current 21 CFR Sections 312.32 and 314.80, as in effect from time to time. 1.3 "AFFILIATE" means (i) any Person which at the time of determination is directly or indirectly controlled by any party hereto; (ii) any Person which at the time of determination directly or indirectly controls any party hereto; or (iii) any Person which is under the direct or indirect control of any such Person as described in subparagraphs (i) or (ii). "Control" in this Section means ownership of greater than fifty percent (50%) of the voting stock or other voting interests in the Person in question. 1.4 "AGENCY" means any governmental regulatory authority responsible for granting approvals, including Regulatory Approvals and/or Pricing Approvals, for the sale of the Product in the OTC Field in a country in the Territory. 1.5 "ANDA" means an Abbreviated New Drug Application, as defined in the United States Federal Food, Drug and Cosmetic Act, as amended, and applicable FDA rules and regulations. 1.6 "CIMA PATENTS" shall mean those Patents and Patent applications owned or Controlled by CIMA during the Term of this Agreement that claim the Product, its manufacture or method of use, the DuraSolv(TM) technology or the OraSolv(R) technology, including the Patents and Patent applications which are set forth on Exhibit A hereto. 1.7 "COMMERCIALLY REASONABLE EFFORTS" means efforts and resources normally used by a party for a compound or product owned by it or to which it has rights, which is of similar market potential at a similar stage in its product life, taking into account the competitiveness of the marketplace, the proprietary position of the compound or product, the regulatory structure involved, the profitability of the applicable products, and other relevant factors. It is anticipated that the level of effort and resources may change at different times during the product life cycle of a compound or product. 1.8 "COMPETING PRODUCT" means a rapid dissolving solid dosage form product containing 10 mg of Active Ingredient as the only active ingredient (other than the Product) that competes with the Product in the OTC Field in the Territory. 1.9 "CONTROL" or "CONTROLLED" in the context of intellectual property rights means rights to intellectual property sufficient to allow a grant of rights to a party. 1.10 "EFFECTIVE DATE" means January 14, 2000. 1.11 "FDA" means the United States Food and Drug Administration, or any successor thereto. 1.12 "FTO STATUS" means that (i) final Regulatory Approval (which includes without limitation WCH's consumer labeling and packaging) and, if applicable, Pricing Approval to market the Product have been obtained, (ii) all legal claims, actions, proceedings and appeals with respect to the Product have been finally resolved in WCH's and in CIMA'S favor, and (iii) all relevant patents have expired, been declared invalid or determined by WCH not to be infringed by the Product. 1.13 "GOOD CLINICAL PRACTICE" or "GCP" means the then current standards for clinical trials for pharmaceuticals, as set forth in the United States Federal Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good clinical practice as are required by the European Union and other organizations and governmental agencies in countries in which Product is intended to be sold, to the extent such standards are not inconsistent with United States GCP. 1.14 "GOOD LABORATORY PRACTICE" or "GLP" means the then current standards for laboratory activities for pharmaceuticals, as set forth in the United States Federal Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder, as amended from time to time, -2- and such standards of good laboratory practice as are required by the European Union and other organizations and governmental agencies in countries in which Product is intended to be sold, to the extent such standards are not inconsistent with United States GLP. 1.15 "GOOD MANUFACTURING PRACTICE" or "GMP" means the then current standards for the manufacture of pharmaceuticals, as set forth in the United States Federal Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good manufacturing practices as are required by the European Union and other organizations and governmental agencies in countries in which Product is intended to be sold, to the extent such standards are not inconsistent with United States GMP. 1.16 "JOINT PATENT RIGHTS" has the meaning set forth in Section 9.1(b). 1.17 "LAUNCH DATE" means the date of first commercial shipment of the Product in the OTC Field by WCH or its Affiliates or their respective subdistributors to Third Parties in a country in the Territory. 1.18 "MARKET" means each country (i.e., United States, United Kingdom, France, etc.) within the Territory that requires Regulatory Approval for the sale of Product within that country. 1.19 "NDA" means a New Drug Application, as defined in the United States Federal Food, Drug and Cosmetic Act, as amended, and applicable FDA rules and regulations. 1.20 "NET SALES" means the gross invoice price for Product sold by WCH or its Affiliates or sublicensees or subcontractors to a Third Party customer less the reasonable and customary accrual-basis deductions from such gross amounts for: (i) normal and customary trade, cash and other discounts, allowances and credits actually allowed and taken directly with respect to sales of Product; (ii) credits or allowances actually granted for damaged goods, returns or rejections of Product; (iii) sales or similar taxes (including duties or other governmental charges levied on, absorbed or otherwise imposed directly on the sales of Product, including, without limitation, value added taxes or other governmental charges otherwise measured by the billing amount) which are included in billing amount, and excluding any taxes imposed on or measured by the net income or profits of the selling party; (iv) uncollectable accounts; (v) charge back payments and rebates granted to managed health care organizations or to federal, state and local governments, their agencies and purchasers and reimbursers or to trade customers, including but not limited to, wholesalers and chain and pharmacy buying groups; and (vi) rebates (or equivalents thereof) that are granted to or charged by national, state, provincial or local governmental authorities in countries other than the United States. Such amounts shall be determined from the books and records of WCH, its Affiliates and their respective sublicensees and subdistributors maintained in accordance with U.S. generally accepted accounting principles consistently applied, and such amounts shall be calculated using the same accounting principles used for other WCH products. Sales between or among WCH, its Affiliates and its sublicensees and subdistributors shall be excluded from the computation of Net Sales if such Affiliates or sublicensees and subdistributors are not end-users, but Net Sales shall include the subsequent final sales to Third Parties by any such Affiliates or sublicensees or subdistributors. Where (i) -3- Product is sold by WCH, its Affiliates or its sublicensees and subdistributors other than in an arms-length sale or as one of a number of items without a separate invoiced price; or (ii) consideration for Product shall include any non-cash element, the Net Sales applicable to any such transaction shall be deemed to be WCH's average Net Sales for the applicable quantity of the Product at that time. 1.21 "OTC FIELD" means the area of non-prescription (i.e., not requiring, by law or regulation, a prescription from a medical doctor) and/or over-the-counter sales for all human pharmaceutical uses. 1.22 "PATENTS" means all patents and patent applications, and all additions, divisions, continuations, continuations in-part, pipeline protection, substitutions, reissues, reexamination certificates, extensions, registrations, patent term extensions, supplementary protection certificates and renewals of any of the above. 1.23 "PERSON" means an individual, a corporation, a partnership, an association, a trust or other entity or organization, including a government or political subdivision or an agency thereof. 1.24 "PRICING APPROVAL" means any approval for price or reimbursement as may be necessary or appropriate as a prerequisite for marketing the Product in the OTC Field in a particular country of the Territory. 1.25 "PRODUCT" means rapid dissolving tablets containing 10 milligrams Active Ingredient meeting the Specifications. The Product shall be pharmaceutically equivalent and bioequivalent to CLARITIN(R) REDITABS containing 10 milligrams Active Ingredient. 1.26 "REGULATORY APPROVAL" means the product license or marketing approval necessary as a prerequisite for marketing the Product in the OTC Field in a particular country in the Territory. 1.27 "REGULATORY DOCUMENTS" means all regulatory submissions, Regulatory Approvals and Pricing Approvals. 1.28 "SPECIFICATIONS" means the specifications for the Product as set forth in ANDA 75-822 and NDA 21-375, as may be amended from time to time by the parties in the course of Product development and in accordance with the regulatory submissions and/or Regulatory Approvals, or as otherwise required by any Agency. 1.29 "SUPPLY AGREEMENT" means the Supply Agreement for the exclusive supply of Product by CIMA to WCH for the OTC Field between the parties signed contemporaneously with this Agreement. 1.30 "TECHNICAL INFORMATION" means (a) techniques and data, including ideas, inventions (including patentable inventions), practices, methods, knowledge, know-how, trade secrets, skill, experience, documents, apparatus, clinical and regulatory strategies, test data, -4- including pharmacological, toxicological and clinical test data, analytical and quality control data, manufacturing, patent data or descriptions relating to Product, and (b) chemical formulations, compositions of matter, product samples and assays relating to Product. 1.31 "TERM" has the meaning set forth in Section 10.1. 1.32 "TERRITORY" means the world. 1.33 "THIRD PARTY" means any Person other than a party to this Agreement or an Affiliate of a party to this Agreement. 1.34 "$" means United States dollars. ARTICLE II GRANT OF RIGHTS; EXCLUSIVITY 2.1 GRANT OF RIGHTS. During the Term of this Agreement and thereafter as provided in Section 11.3(b), CIMA hereby grants to WCH, an exclusive license under the CIMA Patents and Technical Information, and CIMA's interest in Joint Patent Rights, to market, promote, use, distribute, sell, have sold and to import and export Product for the OTC Field within the Territory, provided that CIMA grants only a non-exclusive license under U.S. Patent No. 5,225,197 and corresponding patents throughout the world. In addition to the foregoing, WCH shall have an exclusive license under the CIMA Patents and Technical Information, and CIMA's interest in the Joint Patent Rights, to make (and to have made) Product for the OTC Field in the Territory subject to, and in accordance with, the provisions of Section 11.3(b) and the applicable provisions of the Supply Agreement. 2.2 SUBLICENSE RIGHTS. The rights granted to WCH hereunder include the right to sublicense all or part of such rights to WCH Affiliates and/or Third Parties in all or part of the Territory; provided that (a) the terms and conditions of such grant of sublicense rights (i) are consistent with and do not violate the terms and conditions of this Agreement, and (ii) provide WCH with the right and obligation to enforce such terms and conditions; (b) WCH remains primarily liable and responsible for the performance of any such Affiliates and Third Parties according to the terms of this Agreement; and (c) if WCH grants a sublicense to a Third Party, then WCH shall promptly notify CIMA of the identity of the Third Party; provided, however, that any sublicense of the rights contained in Section 2.9 of the Supply Agreement shall be subject to the prior written consent of CIMA, such consent not to be unreasonably withheld or delayed. 2.3 EXCLUSIVITY. During the Term of this Agreement, with respect to countries not subject to European Union ("EU") competition law, neither party shall manufacture, license, distribute or sell any Competing Product for the OTC Field in the Territory. With respect to countries of the Territory subject to EU competition law, during the Term of this Agreement, neither party shall manufacture or distribute any Competing Product for the OTC Field in the Territory. Notwithstanding anything contained in this Section 2.3, nothing contained herein shall prevent WCH or any Affiliate of WCH from acquiring an interest in a business (the "Acquired Business") which is developing, has developed or is selling any Competing Product for the OTC -5- Field in the Territory (the "Competing Operations") where the annual revenues of the Competing Operations do not exceed twenty percent (20%) of the aggregate annual revenues of the Acquired Business. 2.4 RIGHT OF FIRST REFUSAL. If during the Term CIMA determines to develop any other product containing Active Ingredient, CIMA shall notify WCH, in writing. WCH may elect, by written notice provided to CIMA within sixty (60) days after receipt of CIMA's notice, to negotiate an agreement with CIMA under which WCH would obtain exclusive rights to such product for the OTC Field. In the event WCH elects to negotiate such an agreement, the parties shall use their Commercially Reasonable Efforts to negotiate, in good faith, such an agreement within ninety (90) days (or such longer period of time as the parties may mutually agree upon in writing) after WCH has provided CIMA with such written notice. If the parties have not signed a definitive agreement prior to the end of such ninety (90) day period (or such longer period of time as the parties may mutually agree upon in writing), CIMA shall be free to enter into an agreement with any third party with respect to such product. ARTICLE III DEVELOPMENT ACTIVITIES 3.1 DEVELOPMENT AND REGISTRATION RESPONSIBILITIES FOR THE PRODUCT. Each party shall comply with all applicable GLP, GCP and GMP in the conduct of the development of the Product. CIMA shall (a) be responsible for conducting the ongoing development work for Product; (b) design and conduct all dosage form, formulation, process, and chemistry manufacturing and control ("CMC") and related technical studies on Product, including preparation of dosage form CMC regulatory documents; and (c) conduct scale-up activities for the manufacture and registration of Product in the United States. WCH shall be responsible for and shall file, own and maintain all submissions for Regulatory Approval and Regulatory Approvals of Product for the OTC Field in the United States. CIMA shall be responsible for providing the CMC and related technical components of such submissions for registration within the United States, as jointly determined by the parties, and WCH shall be responsible for formatting such documentation for, and submitting such documentation to, the appropriate Agencies in the United States. The applications for Regulatory Approval shall be filed with CIMA as approved manufacturer. The parties shall cooperate with, and assist, each other in connection with their activities hereunder including addressing regulatory questions, and preparing updates and supplements to regulatory filings for Product for the OTC Field in the United States. WCH, however, shall be responsible for all communications with the FDA and post-Regulatory Approval regulatory requirements for Product for the OTC Field in the United States, including pharmacovigilance and Adverse Drug Experience reporting, unless otherwise agreed in advance in writing by the parties. 3.2 FUNDING OF PRODUCT DEVELOPMENT. WCH shall pay to CIMA, within thirty (30) days of receipt of CIMA's invoice, development costs on successful completion of the development activities for the Product agreed to be performed by the parties and in amounts not to exceed the budgeted amounts agreed to by the parties therefor. It is understood that any development activities for which CIMA has been reimbursed by WCH and/or ESI prior to June 18, 2002 shall not be subsequently invoiced to WCH hereunder. -6- 3.3 APPROVAL SUPPORT FOR TERRITORIES OUTSIDE THE UNITED STATES. CIMA shall produce stability batches and validation batches of the Product, engage in various development activities and perform various tests as reasonably necessary to support WCH's registrations outside the United States, including without limitation being prepared for the pre-approval inspections by appropriate regulatory authorities and performing the other activities in support of such registrations. WCH shall compensate CIMA for such activities based on CIMA's usual and customary charge for such activities. ARTICLE IV DILIGENCE OBLIGATIONS 4.1 PERFORMANCE OBLIGATIONS. WCH shall, subject to supply by CIMA of launch quantities of Product, use Commercially Reasonable Efforts to launch Product in the United States in the OTC Field within three (3) months following the Product having FTO Status for the OTC Field in the United States. If CIMA believes that the Product should be launched outside of the United States, CIMA agrees to give written notice to WCH of the Market in the OTC Field where CIMA desires to have the Product launched and WCH will advise CIMA within ninety (90) days after receipt of such notice whether it desires to launch the Product in the Market. If WCH gives CIMA notice that it desires to launch a Product in the OTC Field in a Market, WCH shall, subject to supply by CIMA of launch quantities of Product, use Commercially Reasonable Efforts to launch Product in such Market in the OTC Field within five (5) months following the Product having FTO Status for the OTC Field in such Market. In the event WCH gives CIMA notice that it does not desire to launch the Product in a Market or fails to launch Product in the OTC Field in a Market as required by this Section 4.1, CIMA shall have, as its sole and exclusive remedy, the right upon written notice to WCH to convert the exclusive licenses granted hereunder with respect to CIMA Patents and Technical Information in such Market to non-exclusive unless within thirty (30) days after such written notice WCH launches Product in the OTC Field in such Market. 4.2 RECORD KEEPING. Each party shall record, to the extent practical and customary in the industry, all Technical Information relating to the Product development in written form, which writing shall be signed, dated and witnessed, consistent with standard practices of each party. All such written records of the parties shall be maintained in a form sufficient to satisfy Regulatory Agencies. 4.3 ADVERSE DRUG EXPERIENCES. To the extent either party receives any information regarding Adverse Drug Experiences related to the use of the Product, such party shall promptly provide the other party with such information in accordance with the Adverse Event Reporting Procedures set forth in Exhibit B hereto (as may be amended from time to time upon written agreement of the parties). -7- ARTICLE V ROYALTY PAYMENTS TO CIMA 5.1 ROYALTIES PAYABLE BY WCH. (a) Following the Launch Date of Product in the OTC Field in any country in the Territory, WCH shall pay to CIMA, on a quarterly basis, a royalty of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] on Net Sales of the Product in the OTC Field during the previous quarter. (b) WCH shall either (i) pay to CIMA quarterly royalties on Net Sales of Product sold by any Third Party sublicensee, or (ii) provide in such sublicense that such sublicensee shall pay to WCH quarterly royalties on Net Sales of Product sold by such sublicensee, in either case at the royalty rate set forth in Section 5.1(a), and provided that in either case, WCH shall remain liable for the timely payment of all such quarterly royalties. 5.2 ROYALTY REPORTS. During the Term of this Agreement following the Launch Date of Product in any country, WCH shall, within forty-five (45) days after each calendar quarter for sales of Product in the OTC Field in the United States and within sixty (60) days after each calendar quarter for sales of Product in the OTC Field outside the United States, furnish to CIMA a written quarterly report showing (i) the gross sales of Product in the OTC Field sold by WCH and its Affiliates and sublicensees during the reporting period and the calculation of Net Sales from such gross sales; (ii) the royalties and other payments which shall have accrued hereunder in respect of such sales; (iii) withholding taxes, if any, required by law to be deducted in respect of such royalty payments; (iv) the Launch Date(s) of Product in the OTC Field in any country(ies) during the reporting period; and (v) the exchange rates used in determining the amount of payment hereunder. Payments accrued in such quarter shall be paid to CIMA no later than the respective time periods for the United States (45 days) and other countries (60 days) for submission of royalty reports after each calendar quarter for sales of Product in a country. In addition, WCH shall provide CIMA with a non-binding estimate of its annual Net Sales of Product by quarter ninety (90) days prior to the Launch Date of Product in the OTC Field. Thereafter, prior to September 30th in any year following the Launch of Product, WCH shall provide CIMA with non-binding estimates of its annual Net Sales of Product by quarter for the following year. 5.3 INSPECTION OF RECORDS. The parties shall maintain at their offices, accurate and complete books and records consistent with sound business and accounting practices and in such form and in such detail as to enable the amount of payments payable under this Agreement by the respective party to be determined. WCH and CIMA shall permit an independent certified accountant (subject to obligations of confidentiality) appointed by the other party and reasonably acceptable to WCH or CIMA (as applicable), at the other party's expense, to examine such books and records at all reasonable times for the sole purpose of (i) verifying WCH's or CIMA's (as applicable) reports and accounting submitted to the other party hereunder and (ii) determining the correctness of payments. In the event of any underpayment of any payment by at least five percent (5%), the costs of such inspection shall be borne by the party who made such -8- underpayment and such underpayment shall be forthwith paid by such party to the other party with a penalty at the rate specified in Section 5.5 from the date such payment was originally due until payment. 5.4 PAYMENTS. Each party shall make all payments due to the other party hereunder in $ by wire transfer in immediately available funds to an account designated by the payee party. 5.5 LATE PAYMENTS. The parties shall pay a penalty on unpaid amounts overdue by more than thirty (30) calendar days at a rate equal to one and one-half percent (1.5%) per month for each month a payment is past due. Such penalty shall not exceed eighteen percent (18%) per year. 5.6 EXCHANGE RATES. All royalty payments to be made pursuant to this Agreement shall be made in $. Amounts based on Net Sales in currencies other than $ shall be converted to $ at the WCH financial statement exchange rate applied by WCH on a consistent basis in WCH's own financial accounting on the date such payment is due, in accordance with U.S. generally accepted accounting principles, consistently applied. 5.7 WITHHOLDINGS. Any and all income or similar taxes imposed or levied on account of the receipt of payments under this Agreement which are required to be withheld shall be paid by WCH on behalf of CIMA and shall be paid to the proper taxing authority. Proof of payment shall be secured, if available, and sent to CIMA by WCH as evidence of such payment in such form as required by the tax authorities having jurisdiction over WCH. Such taxes shall be deducted from the payments that would otherwise be remittable by WCH. WCH shall take reasonable measures including providing evidence of payment to assist CIMA in obtaining credit for such taxes against CIMA's United States tax liabilities. ARTICLE VI REPRESENTATIONS AND WARRANTIES 6.1 REPRESENTATIONS AND WARRANTIES OF EACH PARTY. Each of CIMA and WCH hereby represents and warrants to the other party hereto as follows: (a) it is a corporation or entity duly organized and validly existing under the laws of the state or other jurisdiction of incorporation or formation; (b) the execution, delivery and performance of this Agreement by such party has been duly authorized by all requisite corporate action and does not require any shareholder action or approval; (c) it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder; and (d) the execution, delivery and performance by such party of this Agreement and its compliance with the terms and provisions hereof does not and will not conflict with or result in a breach of any of the terms and provisions of -9- or constitute a default under (i) a loan agreement, guaranty, financing agreement, agreement affecting a product or other agreement or instrument binding or affecting it or its property; (ii) the provisions of its charter or operative documents or bylaws; or (iii) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound. 6.2 REPRESENTATIONS AND WARRANTIES OF CIMA. In addition to the representations and warranties made by CIMA under Section 6.1 above, CIMA hereby further represents and warrants to WCH that: (a) as of the Effective Date, the CIMA Patents are existing and, to the best of its knowledge, are not invalid or unenforceable, in whole or in part; (b) it has the full right, power and authority to grant all of the right, title and interest in the licenses granted under Article II hereof; (c) it has not, prior to the Effective Date, previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in Product, or the CIMA Patents, or Technical Information, with respect to which WCH has been granted a license or other rights hereunder in the OTC Field in the Territory, provided that CIMA has granted, and may in the future grant, licenses to Third Parties under such CIMA Patents and Technical Information which licenses do not conflict with the rights granted to WCH under this Agreement; (d) it is the sole and exclusive owner of the CIMA Patents and Technical Information existing as of the Effective Date, all of which are free and clear of any liens, charges and encumbrances, except as provided in Section 6.2(c), and no other person, corporate or other private entity, or governmental entity or subdivision thereof, has or shall have any claim of ownership with respect to the CIMA Patents or Technical Information in the Territory, provided that CIMA has only a non-exclusive license under U.S. Patent No. 5,225,197 and its corresponding foreign counterparts; (e) to the best of its knowledge the CIMA Patents and Technical Information do not, as of the Effective Date, interfere or infringe on any valid intellectual property rights owned or possessed by any Third Party in the Territory, provided that whereas WCH is aware of the possibility of interference between one or more of the CIMA Patents and United States Patent 5,464,632 (the "632 Patent"), and WCH is aware of patents corresponding to said 632 Patent in other jurisdictions, no such representation is made with respect to said 632 Patent or with respect to any corresponding patent; -10- (f) as of the Effective Date, there are no claims, judgments or settlements against or owed by CIMA or, to the best of its knowledge, pending or threatened claims or litigation relating to the CIMA Patents or Technical Information; (g) during the Term of this Agreement it will use Commercially Reasonable Efforts not to diminish the rights under the CIMA Patents and Technical Information licensed to WCH hereunder by not committing or permitting any actions or omissions which would cause the breach of any agreements between itself and Third Parties which provide for intellectual property rights applicable to the development, manufacture, use or sale of Product, that it will provide WCH promptly with notice of any such alleged breach, and that as of the Effective Date, it is in compliance in all material respects with any agreements with Third Parties relating to the CIMA Patents and Technical Information. 6.3 REPRESENTATION BY LEGAL COUNSEL. Each party hereto represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting hereof. In interpreting and applying the terms and provisions of this Agreement, the parties agree that no presumption shall exist or be implied against the party which drafted such terms and provisions. ARTICLE VII INDEMNIFICATION 7.1 INDEMNIFICATION BY WCH. Except as provided in Section 9.3, WCH shall indemnify, defend and hold harmless CIMA and its Affiliates, and each of its and their respective employees, officers, directors and agents (each a "CIMA Indemnified Party") from and against any and all liability, loss, damage, cost and expense (including reasonable attorney's fees) (collectively, a "Liability") which the CIMA Indemnified Party may incur, suffer or be required to pay resulting from or arising in connection with (i) the breach by WCH of any representation, warranty or covenant contained in this Agreement, or (ii) the manufacture, promotion, distribution, use, testing, marketing, sale or other disposition of Product by WCH, its Affiliates or sublicensees. Notwithstanding the foregoing, WCH shall have no obligation under this Agreement to indemnify, defend or hold harmless any CIMA Indemnified Party with respect to claims, demands, costs or judgments which result from either (x) the failure of Product supplied by CIMA or its Affiliates to comply with the Specifications or the applicable Regulatory Approvals or (y) the willful misconduct or negligent acts or omissions of CIMA, its Affiliates, or any of their respective employees, officers, directors or agents. 7.2 INDEMNIFICATION BY CIMA. Except as provided in Section 9.3, CIMA shall indemnify, defend and hold harmless WCH and its Affiliates, and each of its and their respective employees, officers, directors and agents (each, an "WCH Indemnified Party") from and against any Liability which the WCH Indemnified Party may incur, suffer or be required to pay resulting from or arising in connection with the breach by CIMA of any representation, warranty or covenant contained in this Agreement. Notwithstanding the foregoing, CIMA shall have no -11- obligation under this Agreement to indemnify, defend, or hold harmless any WCH Indemnified Party with respect to claims, demands, costs or judgments which result from the willful misconduct or negligent acts or omissions of WCH, its Affiliates, or any of their respective employees, officers, directors or agents. 7.3 CONDITIONS TO INDEMNIFICATION. The obligations of the indemnifying party under Sections 7.1 and 7.2 are conditioned upon delivery of written notice to the indemnifying party of any potential Liability promptly after the indemnified party becomes aware of such potential Liability, provided, however, that the failure to give such notice promptly shall not impair a party's rights to indemnification under this Article VII unless the delay in providing such notice has a material adverse effect on the ability of the indemnifying party to defend against such Liability. The indemnifying party shall have the right to assume the defense of any suit or claim related to the Liability if it has assumed responsibility for the suit or claim in writing; however, if in the reasonable judgment of the indemnified party, such suit or claim involves an issue or matter which could have a materially adverse effect on the business operations or assets of the indemnified party, the indemnified party may waive its rights to indemnity under this Agreement and control the defense or settlement thereof, but in no event shall any such waiver be construed as a waiver of any rights such party may have against any Third Party at law or in equity. If the indemnifying party defends the suit or claim, the indemnified party may participate in (but not control) the defense thereof at its sole cost and expense. 7.4 SETTLEMENTS. Neither party may settle a claim or action related to a Liability without the consent of the other party, if such settlement would impose any monetary obligation on the other party or require the other party to submit to an injunction or otherwise limit the other party's rights under this Agreement. Any payment made by a party to settle any such claim or action shall be at its own cost and expense except in the event that such payment was made with the prior written consent of the indemnifying party, in which case such payment will be subject to the indemnification obligations of the parties as set forth in this Article VII. 7.5 INSURANCE. CIMA shall carry in full force and effect product liability insurance in respect of Product in the amount of One Million Dollars ($1,000,000) per occurrence and in the aggregate and policies of Ten Million Dollars ($10,000,000) of excess coverage in the aggregate. WCH shall obtain and carry in full force and effect product liability insurance, or be self insured, in respect of Product in the amount of One Million Dollars ($1,000,000) per occurrence and in the aggregate and policies of Ten Million Dollars ($10,000,000) of excess coverage in the aggregate. ARTICLE VIII CONFIDENTIALITY 8.1 NONDISCLOSURE. During the Term of this Agreement and for a period of five (5) years thereafter, all proprietary and confidential business, technical, scientific and/or regulatory information, including Technical Information, disclosed to the receiving party or its Affiliates (herein collectively, the "Receiving Party") by the other party or its Affiliates (herein collectively, the "Disclosing Party") hereunder or under the existing Confidentiality Agreement between the parties which is marked as confidential at the time of disclosure, or if disclosed or -12- obtained orally or visually (or otherwise in a non-written form), was described or summarized in a writing or other tangible form and identified as confidential and forwarded to the Receiving Party within thirty (30) days of such disclosure (collectively, "Confidential Information") shall be deemed to be confidential and shall be treated as such by the Receiving Party and shall not be disclosed, in whole or in part, by the Receiving Party to any other Person except as expressly set forth herein, and shall be used only for the purposes of this Agreement. Notwithstanding the foregoing, these mutual obligations of confidentiality shall not apply to any information to the extent that such information is: (i) independently developed by such party as documented by prior written records outside the scope and not in violation of this Agreement; (ii) legally in the public domain at the time of its receipt or thereafter legally becomes part of the public domain through no fault of the recipient; (iii) received without an obligation of confidentiality from a Third Party having the right to disclose such information; (iv) released from the restrictions of this Article VIII by the express written consent of the Disclosing Party; or (v) as may be required for securing Regulatory Approval, or as may be required to be disclosed to an Agency or as otherwise required by a court order or any law or regulation (including as may be required in connection with any filings made with the Securities and Exchange Commission or by the disclosure policies of a major stock exchange in the Territory); provided, however, that at the other party's request, the disclosing party shall request that the relevant legal or regulatory authority, or major stock exchange, treat as confidential any Confidential Information of either party included in any such disclosure and generally use diligent efforts to seek confidential treatment where available. 8.2 SCOPE OF CONFIDENTIALITY. CIMA and WCH agree to limit the disclosure of any Technical Information and other Confidential Information received hereunder to such Affiliates, officers and employees as are necessary to carry out the provisions of this Agreement and who are likewise bound by provisions equivalent to this Article VIII, except that, with CIMA's written consent, which shall not be unreasonably withheld or delayed, WCH may disclose Confidential Information of CIMA to consultants, to distributors, and to actual or potential sublicensees and subdistributors, provided that they are likewise bound by confidentiality provisions similar to, or more stringent than, those set forth in this Article VIII. The parties shall take reasonable measures to assure that no unauthorized use or disclosure is made by Persons to whom access to such Confidential Information is granted. Unauthorized use or disclosure by any person who has been given access to Confidential Information by a Receiving Party hereunder shall be deemed to be unauthorized use or disclosure by such Receiving Party, and the Receiving Party shall be responsible to the Disclosing Party hereunder. -13- ARTICLE IX TECHNOLOGY AND DATA OWNERSHIP RIGHTS; INFRINGEMENT 9.1 OWNERSHIP OF DATA AND TECHNICAL INFORMATION. (a) CIMA shall solely own all formulation, system design, CMC and manufacturing process data and documents that arise out of the development program ("CIMA Data"), and WCH shall execute such documents and take such actions as are necessary to implement the foregoing. WCH shall solely own all clinical data and documents arising from the development program for Product funded by WCH ("WCH Data"), and CIMA shall execute such documents and take such actions as are necessary to implement the foregoing. WCH agrees to disclose to CIMA, on an ongoing basis, in writing, all WCH Data, provided that CIMA shall not be permitted to use such WCH Data except for internal research purposes, and further provided that CIMA shall not disclose such WCH Data to any Third Party. (b) Inventorship of any inventions acquired or developed in connection with the development program shall be determined by reference to United States patent laws pertaining to inventorship. Accordingly, if an invention is made in connection with the development program by one (1) or more employees or consultants of each party, it shall be deemed to be a "Joint Invention." If one or more claims included in an issued Patent or pending patent application which is filed in a patent office in the Territory claim such Joint Invention, the following rules shall govern ownership of such Patent or patent application: (i) Joint Inventions which relate specifically to loratadine and/or administration of loratadine shall be the sole property of WCH; (ii) Joint Inventions which relate to rapidly-dissolving dosage forms shall be the sole property of CIMA but shall be included in the CIMA Patents and shall be subject to the license granted hereunder; and (iii) any other Joint Inventions shall be jointly owned by CIMA and WCH as joint patent rights hereunder ("Joint Patent Rights"). If an invention is made in connection with the development program solely by an employee or consultant of a party, it shall be solely owned by such party, and any Patent filed claiming such solely owned invention shall also be solely owned by such party. Each party shall require its employees and consultants to disclose to it any inventions relating to the Product in writing promptly after conception, and each party shall, subsequent to any such disclosures to it by its employees or consultants, promptly disclose such inventions to the other party. Each party shall ensure that its employees and consultants shall assign his/her interest in such invention(s) to his/her respective party employer, as the case may be, and such rights shall therefore vest in the respective party employer to whom the inventor assigns his/her rights. CIMA shall use Commercially Reasonable Efforts to obtain and maintain CIMA Patents for the CIMA DuraSolv(TM) technologies in the United States, Germany and the United Kingdom. The parties shall mutually agree upon how and where to file and prosecute any Joint Patent Rights, the maintenance of any ensuing Joint Patent Rights, and how to license, enforce, defend and protect any such Joint Patent Rights and how to share the costs relating thereto. -14- 9.2 INFRINGEMENT. (a) Each party shall promptly report in writing to the other party during the Term of this Agreement any known infringement or suspected infringement of any of the CIMA Patents in the Territory by manufacture, use or sale of a Product on a commercial scale in derogation of the rights granted to WCH hereunder (hereinafter, a "Related Infringement") of which it becomes aware, and shall provide the other party with all available evidence supporting said infringement or suspected infringement. (b) Except as provided in paragraph (d) below, CIMA shall have the right to initiate an infringement or other appropriate suit anywhere in the Territory against any Third Party who at any time has infringed, or is suspected of infringing, any of the CIMA Patents. CIMA shall give WCH sufficient advance notice of its intent to file any suit on account of a Related Infringement and the reasons therefor, and shall provide WCH with an opportunity to make suggestions and comments regarding such suit. CIMA shall keep WCH promptly informed, and shall from time to time consult with WCH regarding the status of any such suit on account of a Related Infringement and shall provide WCH with copies of all documents filed in, and all written communications relating to, such suit. (c) CIMA shall have the sole and exclusive right to select counsel for any suit referred to in subsection (b) above and shall, except as provided below, pay all expenses of the suit, including without limitation attorneys' fees and court costs. WCH, in its sole discretion, may elect, within sixty (60) days after the commencement of such litigation on account of a Related Infringement, to contribute to the costs incurred by CIMA in connection with such litigation and, if it so elects, any damages, royalties, settlement fees or other consideration received by CIMA as a result of such litigation shall be shared by CIMA and WCH pro rata based on their respective sharing of the costs of such litigation provided that such pro rata share shall not exceed fifty percent (50%) unless CIMA has consented to a higher share in writing. In the event that WCH elects not to contribute to the costs of such litigation, CIMA shall be entitled to retain any damages, royalties, settlement fees or other consideration for infringement resulting therefrom. If necessary, WCH shall join as a party to the suit but shall be under no obligation to participate except to the extent that such participation is required as the result of being a named party to the suit. WCH shall offer reasonable assistance to CIMA therewith at no charge to CIMA except for reimbursement of reasonable out-of-pocket expenses incurred in rendering such assistance. WCH shall have the right to participate and be represented in any such suit by its own counsel at its own expense. CIMA shall not settle any such suit on terms which grant any license to any other party in derogation of the rights granted to WCH hereunder without obtaining the prior written consent of WCH, which consent shall not be unreasonably withheld. (d) In the event that CIMA elects not to initiate an infringement or other appropriate suit pursuant to subsection (b) above on account of a Related Infringement after reasonable efforts to abate such Related Infringement without litigation have failed, but in no event later than ninety (90) days after WCH's notice to CIMA under Section 9.2(a), CIMA shall promptly advise WCH of its intent not to initiate such a suit, WCH shall have the right, at the expense of WCH, of initiating an infringement or other appropriate suit against the party or parties committing such Related Infringement. In exercising its rights pursuant to this subsection -15- (d), WCH shall have the sole and exclusive right to select counsel and shall, except as provided below, pay all expenses of the suit including without limitation attorneys' fees and court costs. CIMA, in its sole discretion, may elect, within sixty (60) days after the commencement of such litigation, to contribute to the costs incurred by WCH in connection with such litigation, and, if it so elects, any damages, royalties, settlement fees or other consideration received by WCH as a result of such litigation shall be shared by WCH and CIMA pro rata based on their respective sharing of the costs of such litigation provided that such pro rata share shall not exceed fifty percent (50%) unless WCH has consented to a higher share in writing. In the event that CIMA elects not to contribute to the costs of such litigation, WCH shall be entitled to retain any damages, royalties, settlement fees or other consideration for infringement resulting therefrom. If necessary, CIMA shall join as a party to the suit but shall be under no obligation to participate except to the extent that such participation is required as a result of being named a party to the suit. At WCH's request, CIMA shall offer reasonable assistance to WCH in connection therewith at no charge to WCH except for reimbursement of reasonable out-of-pocket expenses incurred and a reasonable allocation of salary and wages based on time spent by CIMA employees in rendering such assistance. CIMA shall have the right to participate and be represented in any such suit by its own counsel at its own expense. 9.3 CLAIMED INFRINGEMENT. (a) In the event that a Third Party at any time provides written notice of a claim to, or brings an action, suit or proceeding against, either party or any of their respective Affiliates, claiming infringement of its patent rights, based upon an assertion or claim arising out of the filing of an NDA in the OTC Field by WCH for Product, or the use, manufacture, distribution or sale of Product in the OTC Field, such party shall promptly notify the other party of the claim or the commencement of such action, suit or proceeding, enclosing a copy of the claim and/or all papers served. (b) If a Third Party at any time brings an action, suit or proceeding against WCH and/or CIMA and/or their Affiliates, claiming infringement of its patent rights (i) based upon the filing of an NDA in the OTC Field by WCH for Product in the Territory or (ii) based on U.S. Patent No. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] (provided that CIMA has complied with its obligations under Section 2.8(a) of the Supply Agreement), WCH shall be responsible for the defense costs and expenses, including attorney's fees thereof. WCH shall have the right to use counsel of its own choice and shall control the defense of any such action, suit or proceeding. If CIMA desires to have additional counsel of its own choice participate in the defense, CIMA shall be solely responsible for the costs and expenses of its counsel. WCH shall have the authority to settle any such action, suit or proceeding with the prior written consent of CIMA, such consent not to be unreasonably withheld or delayed. If WCH receives any payment(s) as part of the settlement of any such threatened or actual action, suit or proceeding, then after deduction of WCH's costs and expenses, including attorney's fees, the balance (if any) of such payment(s) shall be split eighty percent (80%) to WCH and twenty percent (20%) to CIMA. -16- (c) Except as expressly provided in Section 9.3(b), if a Third Party at any time brings an action, suit or proceeding against WCH and/or its Affiliates, claiming infringement of its patent rights (i) based upon an assertion or claim arising out of the manufacture of Product or (ii) based on an assertion that the Product infringes U.S. Patent No. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] (provided that CIMA failed to comply with its obligations pursuant to Section 2.8(a) of the Supply Agreement), CIMA shall be responsible for and indemnify and hold harmless WCH for any and all costs and expenses associated with such legal actions including, without limitation, damages, settlement payments, attorneys' fees and court costs. WCH shall offer reasonable assistant to CIMA in connection therewith at no charge to the other party except for reimbursement of reasonable out-of-pocket expenses incurred in rendering such assistance. (d) Except as expressly provided in Sections 9.3(b) or 9.3(c), if a Third Party at any time brings an action, suit or proceeding against WCH and/or its Affiliates, claiming infringement of its patent rights, based upon an assertion or claim arising out of the use, importation, distribution, offer for sale or sale of Product for the OTC Field in the Territory, the parties shall share equally responsibility for any and all costs and expenses associated with such legal actions including, without limitation, damages, settlement payments, attorneys' fees and court costs. Each party shall offer reasonable assistance to the other party in connection therewith at no charge to the other party except for reimbursement of reasonable out-of-pocket expenses incurred in rendering such assistance. (e) This Section 9.3 states the entire responsibility of the parties to each other in the case of any claimed infringement or violation of any Third Party's patent rights. ARTICLE X TERM AND TERMINATION 10.1 TERM. This Agreement shall be effective as of the Effective Date, and, unless sooner terminated by mutual agreement or pursuant to any other provision of this Agreement, shall continue in full force and effect, on a country-by-country basis, until the later to occur of (a) ten (10) years from the Launch Date of Product in such country, or (b) expiration of the last to expire of the CIMA Patents in each such country (the "Term"). 10.2 TERMINATION FOR DEFAULT. Each party may terminate this Agreement if the other party commits a material breach of any material obligation under this Agreement and fails to remedy such breach within sixty (60) days after receipt of notice in writing from such party, or other longer period of time if mutually agreed; provided that if the defaulting party initiates steps within the sixty (60) day notice period to remedy or cure the breach, unless the parties mutually agree otherwise, such termination shall become effective only if the breach is not remedied within one hundred and twenty (120) days after the initial notice from the non-defaulting party. For purposes of clarification, unless otherwise mutually agreed by the parties in writing, in no event shall a defaulting party have longer than one hundred twenty (120) days to remedy a material breach under this Section. -17- 10.3 TERMINATION BY WCH. WCH shall have the right, in its sole discretion, to terminate this Agreement at any time upon six (6) months' prior written notice to CIMA. ARTICLE XI EFFECT OF EXPIRATION AND TERMINATION 11.1 EXPIRATION. Upon expiration (but not termination) of this Agreement, WCH shall have the fully paid-up, royalty free, perpetual, irrevocable, non-exclusive right, itself and/or through its Affiliates, to make, have made, promote, market, distribute, sell, have sold, import and export Product for the OTC Field pursuant to the Regulatory Documents and Technical Information (including manufacturing know-how). 11.2 DEVELOPMENT COMMITMENTS. In the event that CIMA terminates this Agreement pursuant to Section 10.2 or WCH terminates this Agreement pursuant to Section 10.3, all development commitments (internal and external) of CIMA incurred or committed up through the effective date of such termination shall become due and payable to CIMA by WCH on the effective date of such termination. 11.3 TRANSFER OF DOCUMENTS. (a) In the event that CIMA terminates this Agreement pursuant to Section 10.2 or WCH terminates this Agreement pursuant to Section 10.3, (i) WCH promptly but no later than within forty-five (45) days of such termination, shall assign and transfer to CIMA all WCH Data as relates to Product and (ii) WCH shall, within sixty (60) days of a request by CIMA, execute all documents necessary to assign to CIMA and/or its Affiliates all Regulatory Documents in the countries in the Territory where the Agreement has been terminated which relate to Product for the OTC Field. In the event that no such assignment may legally be made in any country in the Territory, WCH shall continue to maintain such Regulatory Documents and provide to CIMA and/or CIMA's Affiliates and/or their designees continuing access and/or the right to cross-reference all such Regulatory Documents. Upon CIMA's request, WCH shall within the same period deliver to CIMA or its designees full copies (both paper and electronic, where available) of any Regulatory Documents in WCH's or its Affiliates' possession or control. In such event, CIMA shall pay to WCH [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of CIMA's gross profit (including payments to CIMA by the Third Parties) on Product for the OTC Field in the Territory, payable quarterly with supporting documentation, sold by CIMA or a Third Party marketing partner up to the total of WCH's out-of-pocket costs for Product development, consisting of raw materials, biostudy costs, and amounts paid under Section 3.2 or by ESI pursuant to the Original Development and License Agreement for product development costs. (b) In the event that WCH terminates this Agreement pursuant to Section 10.2, CIMA shall grant to WCH the exclusive right to, and shall use Commercially Reasonable Efforts to transfer to WCH, the CIMA Data and manufacturing know-how used by CIMA that is reasonably necessary to enable WCH to develop and register Product in the OTC Field in the Territory, and to enable WCH either itself or through a contract manufacturer to manufacture -18- Product. WCH shall pay CIMA, on a country-by-country basis, a royalty on Product for the OTC Field sold by WCH thereafter equal to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of WCH's Net Sales during the Term. (c) After the Term WCH shall have a fully paid-up, irrevocable, non-exclusive right in the Territory to use the data and documents and other Technical Information arising out of the development program for Product in the OTC Field that are owned by CIMA (including any and all Technical Information relating primarily to the manufacture of the Product, including all manufacturing know-how) and CIMA shall use Commercially Reasonable Efforts to transfer to WCH the manufacturing know-how that is reasonably necessary to enable WCH to make and have made Product for the OTC Field. 11.4 NO DAMAGES UPON EXPIRATION OR TERMINATION. Except as otherwise set forth in this Agreement, neither party shall be entitled to any compensation whatsoever as a result of expiration or termination of this Agreement, but without limiting either party's damages for any breach of this Agreement. 11.5 CONTINUING OBLIGATIONS. Termination or expiration of this Agreement for any reason shall be without prejudice to any obligations which shall have accrued to the benefit of either party prior to such termination or expiration. Upon termination or expiration of this Agreement, any payments owed to the other party on or before the effective date of termination shall be due within thirty (30) days of the effective date of such termination or expiration. The following provisions of this Agreement shall survive expiration or termination hereof: Article VII, VIII, Section 9.1, Section 9.3, Articles XI and XIV. ARTICLE XII TRADEMARKS 12.1 USE OF CIMA'S TRADEMARK BY WCH. WCH shall market the Product in the OTC Field under its own tradename. However, WCH may refer to CIMA's DuraSolv(TM) trademarks (the "Marks") as applicable on the package, internal leaflet and promotional material of the Product by printing "Produced with CIMA DuraSolv(TM) technology" or word DuraSolv(TM). For this purpose CIMA grants to WCH and its Affiliates a non-exclusive license to use CIMA's DuraSolv(TM) trademarks during the Term. Prior to printing, WCH (or an Affiliate) shall send CIMA a sample of the packaging, internal leaflet and related promotional material for CIMA's prior approval of WCH's use of the Marks. 12.2 TRADEMARK OWNERSHIP AND USE. (a) WCH recognizes CIMA's exclusive ownership of and title in and to the Marks, and shall not at any time do or permit to be done any act or thing which would in any way impair the rights of CIMA in and to the Marks or in any trademark registration application therefor, and shall not at any time claim any right of interest in or to the Marks or the aforesaid trademark application therefor. -19- (b) WCH agrees that during the term of the Agreement and after its termination, however occurring, that WCH shall not: (i) use the Marks or any other mark confusingly similar thereto in connection with any goods not covered by this Agreement which would be likely to cause confusion between the parties; or (ii) apply for or seek registration anywhere in the world, at any time, for the Marks or any other mark confusingly similar thereto; or (iii) commit or do any act which might prejudice or adversely affect the validity of the Marks or CIMA's ownership thereof or dilute or diminish the value of the Marks to CIMA. (c) WCH shall use the Marks only in a proper trademark sense and shall identify the Marks as a registered trademark of CIMA by including use of the registered trademark symbol(R)or the symbol(TM)in association with the Marks as specified by CIMA. (d) WCH agrees that all goodwill resulting from its use of the Marks shall inure to the exclusive benefit of CIMA. (e) WCH shall assist CIMA in obtaining or maintaining registrations for the Marks by supplying specimens, other proofs of use and other information or documents reasonably necessary to obtain or maintain registration of the Marks in all jurisdictions within the Territory. 12.3 QUALITY CONTROL. WCH agrees that, to the extent the Product is manufactured by a party other than CIMA pursuant to this Agreement, the Product shall be manufactured in accordance with the Specifications. CIMA shall have the right to inspect the Products sold in connection with the Marks so that CIMA can determine that the Products meet the Specifications. If the quality of any Products is determined not to meet the Specifications, then WCH shall not use any of the Marks in connection with such Products and WCH shall, at its option, either (i) destroy such Products or (ii) repackage such Products to eliminate use of the Marks. ARTICLE XIII PRESS RELEASES AND PUBLICATIONS 13.1 PRESS RELEASES. All press releases and public announcements related to this Agreement shall be approved in advance in writing by the other party. 13.2 PUBLICATIONS. The parties shall mutually agree upon publications and the publication strategy with respect to work undertaken by the parties relating to Product, and neither party shall publish any result or study generated or developed under this Agreement except upon review by the other party at least sixty (60) days prior to submission of an abstract or manuscript for publication. -20- ARTICLE XIV MISCELLANEOUS 14.1 FORCE MAJEURE. Neither party shall be liable for delay or failure to perform its obligations hereunder for so long as that failure or delay is the result of an event beyond its control which it could not have avoided by the exercise of reasonable diligence, (a "Force Majeure Event"), provided that such party uses Commercially Reasonable Efforts to comply with the terms of this Agreement as soon as practicable. A party asserting a Force Majeure Event shall notify the other party promptly, giving an indication of the likely extent and duration thereof. 14.2 ASSIGNMENT; SUCCESSORS AND ASSIGNS. Neither party shall at any time, without obtaining the prior written consent of the other party, assign or transfer this Agreement to any Person. Notwithstanding the foregoing, each party shall be permitted to assign this Agreement to its Affiliates or to perform this Agreement, in whole or in part, through its Affiliates, provided that such party shall be primarily liable and responsible for performance by such Affiliate hereunder; and each party may also assign this Agreement to any successor by merger or upon a sale of all or substantially all of the assets or business to which this Agreement relates. This Agreement shall be binding upon and shall inure to the benefit of the parties and their successors and permitted assigns. 14.3 NOTICES. Any notices required or permitted to be given hereunder shall be in writing in the English language and shall be delivered by air courier service (requiring signature upon receipt) or sent by first class air mail, postage prepaid, or telefax (confirmed by phone conversation with the recipient) to the addresses set forth below. The parties may change the address at which notice is to be given by giving notice to the other party as herein provided. All notices shall be deemed effective upon receipt by the party to whom it is addressed. If to CIMA: CIMA LABS, Inc. 10000 Valley View Road Eden Prairie, Minnesota 55344 Attention: President and CEO Telephone: 612-947-8762 Telefax: 612-947-8770 If to WCH: Wyeth Consumer Healthcare Five Giralda Farms Madison, New Jersey 07940 Attention: President Telephone: 973-660-5773 Telefax: 973-660-7199 -21- With a copy to: Wyeth 5 Giralda Farms Madison, New Jersey 07940 Attention: General Counsel Telephone: 973-660-6040 Telefax: 973-660-7050 14.4 GOVERNING LAW. This Agreement and its execution, validity and interpretation shall be governed in all respects in accordance with the laws of the State of New York, excluding conflicts of law rules. 14.5 SEVERABILITY. In the event that any provision of this Agreement shall be held to be unenforceable, invalid or in contravention of applicable law, such provision shall be of no effect, and the parties shall negotiate in good faith to replace such provision with a provision which effects to the extent possible the original intent of such provision. 14.6 COMPLETE AGREEMENT; MODIFICATIONS. This Agreement, together with the Supply Agreement and all Exhibits attached hereto and thereto, constitutes the entire agreement between the parties with respect to the present subject matter, all prior negotiations, agreements and understandings being expressly canceled hereby. This Agreement may be amended only by a written agreement embodying the full terms of the amendment signed by authorized representatives of both parties. 14.7 NO AGENCY. Neither party shall by virtue of this Agreement have any power to bind the other to any obligation nor shall this Agreement create any relationship of agency, partnership or joint venture. 14.8 NO WAIVER. No term or condition of this Agreement shall be considered waived unless reduced to writing and duly executed by an officer of the waiving party. Any waiver by any party of a breach of any term or condition of this Agreement will not be considered as a waiver of any subsequent breach of this Agreement, of that term or condition or any other term or condition hereof. 14.9 COUNTERPARTS. This Agreement may be executed in counterparts, each of which together shall constitute one and the same Agreement. 14.10 COMPLIANCE ISSUES. The parties acknowledge that the export of technical data, materials or products is subject to the exporting party receiving the necessary export licenses and that the parties cannot be responsible for any delays attributable to export controls which are beyond the reasonable control of either party. The parties agree that regardless of any disclosure made by the party receiving an export of any ultimate destination of any technical data, materials or products, the receiving party will not re-export, either directly or indirectly, any technical data, material or products without first obtaining the applicable validated or general license from the -22- United States Department of Commerce, FDA and/or any other agency or department of the United States Government as required. 14.11 AMENDMENT OF THE ORIGINAL DEVELOPMENT AND LICENSE AGREEMENT. The parties agree that, with effect from the Effective Date, the Original Development and License Agreement is hereby amended to exclude the OTC Field from its scope and that this Agreement and the Supply Agreement constitutes the entire agreement between the parties with respect to the subject matter hereof and thereof for the OTC Field. -23- IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written. CIMA LABS INC. By: /s/ John Hontz ----------------------------------------- Name: John Hontz Title: Chief Operating Officer WYETH, acting through its Wyeth Consumer Healthcare Division By: /s/ Gregory F. Bobyock ------------------------------------------ Name: Gregory F. Bobyock Title: Vice President, Global Business Development -24- EXHIBIT A CIMA PATENTS 1. United States Patent No. 5,178,878 2. United States Patent No. 5,225,197 3. United States Patent No. 6,024,981 4. All foreign counterparts to the above listed patents and patent applications EXHIBIT B ADVERSE EXPERIENCE REPORTING PROCEDURES The parties hereby agree that the following terms will govern disclosures of each party to the other with respect to adverse event reporting relating to Product as clinically tested or marketed by or on behalf of either party. 1. DEFINITIONS. 1.1 ADVERSE EXPERIENCE OR EVENT (AE): An AE is defined by WCH as any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a human being in a temporal relationship to use of an WCH product regardless of causal relationship. This includes: - any clinically significant worsening of a pre-existing condition; - an AE occurring from overdose (i.e., a dose higher than that prescribed by a health care professional for clinical reasons) of an WCH product, whether accidental or intentional; - an AE occurring from abuse (i.e., use for non-clinical reasons) of an WCH product; - an AE that has been associated with the discontinuation of the use of an WCH product; - any failure of expected pharmacological action (for spontaneous reports). If there is any doubt whether the information constitutes an AE, the information will be treated as an AE. 1.2 SERIOUS AE: A serious AE is defined by WCH as an AE occurring at any dose that: results in death; is life-threatening (see below); requires inpatient hospitalization or prolongation of an existing hospitalization; results in a persistent or significant disability or incapacity (see below); results in cancer; results in a congenital anomaly or birth defect. Additionally, IMPORTANT MEDICAL EVENTS that may not result in death, be life-threatening, or require hospitalization may be considered a serious AE when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home; blood dyscrasias or convulsions that do not result in hospitalization; or the development of drug dependency or abuse. 1.2.1 Life-threatening refers to immediate risk of death as the event occurred. A life-threatening experience does not include an experience that, had it occurred in a more severe form, might have caused death but as it actually occurred did not create an immediate risk of death. For example, hepatitis that resolved without evidence of hepatic failure would not be considered life-threatening even though hepatitis of a more severe nature can be fatal. Similarly, an allergic reaction resulting in angioedema of the face would not be life-threatening, even though angioedema of the larynx, allergic bronchospasm, or anaphylaxis can be fatal. 1.2.2 Disability is defined as a substantial disruption in a person's ability to conduct normal life functions. 1.2.3 For studies, all pregnancies and all overdoses will be reported to GSSE in the same time frame as serious AEs. 1.2.4 A serious AE obtained from tests in laboratory animals includes any experience suggesting a significant risk for human subjects, including any findings of mutagenicity, teratogenicity, or carcinogenicity. 1.2.5 If there is any doubt whether the information constitutes a serious AE, the information will be treated as a serious AE. 1.3 NON-SERIOUS AE: is any AE which does not meet the criteria for a serious AE. 1.4 UNEXPECTED AE: An unexpected AE is one that is not listed in the current product labeling. The current product labeling is either the package insert (for marketed WCH products) or the current investigator's brochure (for investigational WCH products). An unexpected AE includes any event that may be symptomatically and pathophysiologically related to an event listed in the labeling, but differs from the labeled event because of greater severity or specificity. For example, hepatic necrosis would be unexpected (by virtue of greater severity) if the product labeling referred only to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism and cerebral vasculitis would be unexpected (by virtue of greater specificity) if the labeling only listed cerebral vascular accidents. 1.5 PRODUCT (DRUG, VACCINE, BIOLOGICAL, DEVICE)-RELATED: For the purposes of regulatory reporting for investigational products, an AE will be considered "product-related" (i.e., drug-related, vaccine-related, etc.) for studies if either the investigator, the Medical Monitor, the CR&D Clinical Project Team Medical Monitor (or designee), or the Local Monitor (if applicable) assesses the AE(s) as possibly, probably, or definitely related. -B-2- 1. An AE will be considered "not product-related" for studies if the investigator AND the medical monitor(s) AND the local monitor (if applicable) assess the AE(s) as probably not related or definitely not related, or "relationship remote." 2. Whenever the investigator's or monitor's assessment is unknown or unclear, the AE(s) will be treated as product-related for the purposes of reporting to regulatory authorities. 1.6 PROTOCOL-RELATED: AEs from studies that are not product-related may nevertheless be considered by the investigator OR the medical monitor(s) OR the local monitor (if applicable) to be protocol-related. For purposes of reporting to GSSE and regulatory authorities, these will be reported in the same manner as product-related events. 1.7 ANDA HOLDER is defined as: An "Applicant" for regulatory approval of a Product in any regulatory jurisdiction, including a holder of a foreign equivalent thereto. 1.8 Capitalized terms not defined in this Exhibit shall have the meaning assigned thereto in the Agreement. 2. With respect to the Product or Active Ingredient, the Parties agree as follows: a. All initial reports and any follow-up information (oral or written) for any and all Serious AEs as defined above, (other than with respect to animal studies) which become known to either party (other than from disclosure by or on behalf of the other party) must be communicated by telephone, telefax or electronically directly to the other party and/or the ANDA Holder, ("Holder") within forty-eight (48) hours of receipt of the information. Written confirmation of the Serious AE received by such party should be sent to the other party and/or the Holder as soon as it becomes available, but in any event within forty-eight (48) hours of initial report of the Serious AE by such party. b. Both parties shall exchange Medwatch and/or CIOMs forms and other health authority reports within forty-eight (48) hours of submission to any Regulatory Authority. c. All initial reports and follow-up information received for all Non-Serious AEs for marketed Product which become known to a party (other than from disclosure by or on behalf of the other party) must be communicated in writing, by telefax or electronically to the other party within ten (10) days, on Medwatch or CIOMs forms (where possible). d. Each party shall coordinate and cooperate with the other whenever practicable to prepare a single written report regarding all Serious and/or Non-Serious AEs, -B-3- provided, however, that neither party shall be obligated to delay reporting of any AE in violation of applicable law or regulations regarding the reporting of AEs. 3. The parties further agree that: a. A written report be forwarded to the other party within forty-eight (48) hours of a receipt by the party making the report, for AEs for animal studies which suggest a potential significant risk for humans; b. Each party will give the other party a report via a print-out or computer disk of all AEs reported to it and its Affiliates relating to the Product or Active Ingredient within the last year, within thirty (30) days of receipt of a request from the other party but not more often than four (4) times a year; c. If either party wishes access to AE Reports of the other party relating to the Product or Active Ingredient, upon request of that party, the other party shall make available its AE records relating to the Product or Active Ingredient (including computer disks) for viewing and copying by the other party. The parties may discuss the transfer of AE Reports by computer disk. d. Disclosure of information hereunder by a party to the other party shall continue as long as either party and/or its Affiliates or designees continue to clinically test or market Product or Active Ingredient. 4. Each party shall diligently undertake the following further obligations where both parties are or will be performing clinical trials with respect to the Product or Active Ingredient: a. Upon the Effective Date, each party shall identify individuals who shall be responsible for identifying all AE reporting requirements in all countries of the Territory as set forth in the Agreement, and any amendments thereto; b. To immediately consult with the other party, with respect to the investigation and handling of any serious AE disclosed to it by the other party or by a Third Party and to allow the other party to review the Serious AE and to participate in the follow-up investigation; c. To immediately advise the other party of any Product and/or Active Ingredient safety communication received from a health authority and consult with the other party with respect to any Product and/or Active Ingredient warning, labeling change or change to an investigators' brochure involving safety issues proposed by the other party, including, but not limited to the safety issues agreed to by the parties; d. To diligently handle in a timely manner the follow-up investigation and resolution of each AE reported to it; -B-4- e. To provide the other party mutually agreed upon audit rights of its AE reporting system and documentation, upon prior notice, during normal business hours, at the expense of the auditing party and under the confidentiality obligations set forth in the Agreement; f. To meet in a timely fashion from time to time as may be reasonably required to implement the adverse event reporting and consultation procedures described in this Exhibit B, including identification of those individuals in each party's Drug Safety group who will be responsible for reporting to and receiving AE information from the other party, and the development of a written standard operating procedure with respect to adverse event reporting responsibilities, including reporting responsibilities to investigators; g. Where possible, to transmit all data electronically; h. To report to each other any addenda, revisions or changes to the Agreement (e.g., change in territories, local regulations, addition of new licensors/licensees to the Agreement, etc.) which might alter the adverse event reporting responsibilities hereunder; i. To utilize English as the language of communication and data exchange between the parties; j. To develop a system of exchange of documents and information in the event that the Agreement involves more than two parties; k. To work together to develop an electronic system to transmit AE data. 5. The parties may meet after the Effective Date of the Agreement to establish a separate agreement for adverse event exchange which will supersede this Exhibit B. -B-5-
EX-10.3 5 c71161exv10w3.txt EX-10.3 SUPPLY AGREEMENT EXHIBIT 10.3 SUPPLY AGREEMENT BETWEEN CIMA LABS INC. AND WYETH ACTING THROUGH ITS WYETH CONSUMER HEALTHCARE DIVISION FOR NON-PRESCRIPTION RAPID DISSOLVING LORATADINE TABLETS TABLE OF CONTENTS ARTICLE I DEFINITIONS........................................................ 1 ARTICLE II SUPPLY AND MANUFACTURING.......................................... 4 ARTICLE III [INTENTIONALLY OMITTED]......................................... 13 ARTICLE IV REGULATORY COMPLIANCE............................................ 13 ARTICLE V PAYMENT PROVISIONS................................................ 13 ARTICLE VI REPRESENTATIONS AND WARRANTIES................................... 14 ARTICLE VII INDEMNIFICATION................................................. 15 ARTICLE VIII CONFIDENTIALITY................................................ 16 ARTICLE IX TERM AND TERMINATION............................................. 17 ARTICLE X PUBLICATIONS...................................................... 18 ARTICLE XI MISCELLANEOUS..................................................... 18 EXHIBIT A - PRICE EXHIBIT B - PACKAGING EXHIBIT C - QUALITY AGREEMENT EXHIBIT D - ADVERSE EXPERIENCE REPORTING PROCEDURES
-i- SUPPLY AGREEMENT THIS AGREEMENT dated the 18th day of June 2002 between CIMA LABS INC., a corporation organized and existing under the laws of the State of Delaware with offices located at 10000 Valley View Road, Eden Prairie, Minnesota 55344-9361 (hereafter, together with its Affiliates, referred to as "CIMA"), and WYETH (formerly known as American Home Products Corporation), acting through its Wyeth Consumer Healthcare division, a corporation organized and existing under the laws of the State of Delaware with offices located at Five Giralda Farms, Madison, New Jersey 07940 ("WCH"). W I T N E S S E T H WHEREAS, CIMA and Wyeth, acting through its ESI Lederle Division, have entered into a Supply Agreement, dated January 14, 2000 (the "Original Supply Agreement"); and WHEREAS, CIMA and WCH wish to amend the Original Supply Agreement to remove the OTC Field (as defined herein) and to enter into this Supply Agreement which relates only to the OTC Field, all on the terms and subject to the conditions set forth herein. NOW, THEREFORE, in consideration of the representations, warranties and covenants set forth herein, the parties hereto agree as follows: ARTICLE I DEFINITIONS 1.1 "ACTIVE INGREDIENT" means ethyl 4-(8-chloro-5,6-dihydro-11 H-benzo [5,6] cyclohepta [1,2-b] pyridin-11-ylid-ene)-1 piperidine carboxylate, known as loratadine. 1.2 "ADVERSE DRUG EXPERIENCE" means the definition in the current 21 CFR Sections 312.32 and 314.80, as in effect from time to time. 1.3 "AFFILIATE" means (i) any Person which at the time of determination is directly or indirectly controlled by any party hereto; (ii) any Person which at the time of determination directly or indirectly controls any party hereto; or (iii) any Person which is under the direct or indirect control of any such Person as described in subparagraphs (i) or (ii). "Control" shall in this Section mean ownership of greater than fifty percent (50%) of the voting stock or other voting interests in the Person in question. 1.4 "AGENCY" means any governmental regulatory authority responsible for granting approvals, including Regulatory Approvals and/or Pricing Approvals, for the sale of a Product in the OTC Field in a country in the Territory. 1.5 "ANDA" means an Abbreviated New Drug Application, as defined in the United States Food, Drug and Cosmetic Act, as amended, and applicable FDA rules and regulations. 1.6 "API COST PER TABLET" means the actual net price paid per kilo by CIMA to its Active Ingredient supplier (the "AI Price") plus [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the AI Price (to reflect a [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] price yield factor), plus [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the AI Price (to cover all related expenses, including handling and testing), the sum of which is divided by 100,000 (to reflect 10mg Active Ingredient per tablet). For example, assuming CIMA's cost of Active Ingredient is [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], the API Per Tablet Cost would be [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] per tablet. 1.7 "CIMA'S MANUFACTURING COST" means CIMA's manufacturing costs for Finished Product based on a four hundred twenty (420) kilogram batch size comprised of raw materials (including packaging, but excluding Active Ingredient), direct labor, and overhead costs allocable to such Finished Product, as determined in accordance with United States generally accepted accounting practices consistently applied. 1.8 "COMMERCIALLY REASONABLE EFFORTS" means efforts and resources normally used by a party for a compound or product owned by it or to which it has rights, which is of similar market potential at a similar stage in its product life, taking into account the competitiveness of the marketplace, the proprietary position of the compound or product, the regulatory structure involved, the profitability of the applicable products, and other relevant factors. It is anticipated that the level of effort and resources may change at different times during the product life cycle of a compound or product. 1.9 "CONTROL" or "CONTROLLED" in the context of intellectual property rights means rights to intellectual property sufficient to allow a grant of rights without any obligation to any Third Party. 1.10 "DEVELOPMENT AND LICENSE AGREEMENT" means the Development and License Agreement for the OTC Field between the parties signed contemporaneously with this Agreement. 1.11 "EFFECTIVE DATE" means January 14, 2000. 1.12 "FACILITY" means CIMA's manufacturing facility located at 10000 Valley View Road, Eden Prairie, Minnesota or any other facility approved in writing by WCH for the manufacture of Product. 1.13 "FDA" means the United States Food and Drug Administration, or any successor thereto. -2- 1.14 "FINISHED PRODUCT" means fully finished and packaged Product meeting the Specifications. 1.15 "GOOD MANUFACTURING PRACTICE" or "GMP" means the then current standards for the manufacture of pharmaceuticals, as set forth in the United States Federal, Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good manufacturing practices as are required by the European Union and other organizations and governmental agencies in countries in which Product is intended to be sold, to the extent such standards are not inconsistent with United States GMP. 1.16 "[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Test" means the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] for Active Ingredient and Product provided in writing by WCH to CIMA, as the same may be amended from time to time by the mutual agreement of the parties. 1.17 "[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Criteria" means the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] provided in writing by WCH to CIMA, as the same may be amended from time to time by the mutual agreement of the parties. 1.18 "LABOR" has the meaning set forth in Section 2.16(a). 1.19 "LAUNCH DATE" means the date of first commercial shipment of a Product in the OTC Field by WCH or its Affiliates or their respective subdistributors of Product to Third Parties in a country of the Territory. 1.20 "NDA" means a New Drug Application, as defined in the United States Federal Food, Drug and Cosmetic Act, as amended, and applicable FDA rules and regulations. 1.21 "OTC Field" means the area of non-prescription (i.e., not requiring, by law or regulation, a prescription from a medical doctor) and/or over-the-counter sales for all human pharmaceutical uses. 1.22 "OVERHEAD" has the meaning set forth in Section 2.16(a). 1.23 "PERSON" means an individual, a corporation, a partnership, an association, a trust or other entity or organization, including a government or political subdivision or an agency thereof. -3- 1.24 "PRICING APPROVAL" means any approval for price or reimbursement as may be necessary or appropriate as a prerequisite for marketing Product in the OTC Field in a particular country of the Territory. 1.25 "PRODUCT" means rapid dissolving tablets containing 10 milligrams Active Ingredient meeting the Specifications. 1.26 "PROFIT" has the meaning set forth in Section 2.16(a). 1.27 "RAW MATERIALS" has the meaning set forth in Section 2.16(a). 1.28 "REGULATORY APPROVAL" means the product license or marketing approval necessary as a prerequisite for marketing Product in the OTC Field in a particular country in the Territory. 1.29 "REGULATORY DOCUMENTS" means all regulatory submissions, Regulatory Approvals and Pricing Approvals. 1.30 "SPECIFICATIONS" means the specifications for the Product as set forth in ANDA 75-822 and NDA 21-375, as may be amended from time to time by the parties in the course of Product development and in accordance with the regulatory submissions and/or Regulatory Approvals, or as otherwise required by an Agency. 1.31 "TECHNICAL INFORMATION" means (a) techniques and data, including ideas, inventions (including patentable inventions), practices, methods, knowledge, know-how, trade secrets, skill, experience, documents, apparatus, clinical and regulatory strategies, test data, including pharmacological, toxicological and clinical test data, analytical and quality control data, manufacturing, patent data or descriptions relating to Product, and (b) chemical formulations, compositions of matter, product samples and assays relating to Product. 1.32 "TERM" shall have the meaning set forth in Section 9.1. 1.33 "TERRITORY" has the meaning set forth in the Development and License Agreement, as the same may be amended from time to time in accordance with the provisions thereof. 1.34 "THIRD PARTY" means any Person other than a party to this Agreement or an Affiliate of a party to this Agreement. 1.35 "$" means United States dollars. ARTICLE II SUPPLY AND MANUFACTURING 2.1 MANUFACTURING. During the Term of this Agreement, CIMA shall manufacture and supply WCH with, and WCH shall purchase from CIMA, Product in accordance with the -4- terms specified in this Article II. Subject to Section 2.9, WCH shall exclusively purchase all of WCH's requirements of Product for the OTC Field in the Territory from CIMA and CIMA shall exclusively supply Product for the OTC Field to WCH in the Territory. 2.2 SUPPLY PRICE. (a) Quantities of Product shall be delivered to WCH F.O.B. Origin Freight Collect (latest edition of incoterms) and risk of loss shall pass at the time of such delivery. (b) The price for Finished Product (the "Finished Product Supply Price"), in the packaging set forth in Exhibit B attached hereto, for all countries of the Territory shall be [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] per tablet (which amount is comprised of the Raw Materials, Labor, Overhead and Profit components set forth on Exhibit A attached hereto, based on a four hundred twenty (420) kilogram batch size) plus the API Per Tablet Cost. For Finished Product shipped to WCH after December 31, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] and each calendar year thereafter, the Finished Product Supply Price shall be adjusted for such calendar year for changes in Raw Materials and Labor costs, but not Overhead or Profit until January 1, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], as provided in Section 2.16. The Finished Product Supply Price for each country in the Territory, except the United States, shall be increased for packaging variant costs, including pre-printed lidding foil costs (if any), at CIMA's actual cost as determined under Section 2.16. CIMA shall purchase Active Ingredient with sufficient lead times to fill WCH's firm orders based on forecasts given pursuant to Section 2.3. CIMA shall provide WCH in writing with the API Cost Per Tablet (specifying the per kilo AI Price and quantity ordered or to be ordered at such AI Price) as soon as possible. (c) WCH may place firm orders for Product having imprinting, labeling or packaging variants or in less than full batch sizes (four hundred twenty (420) kilograms), provided that the price for Finished Product ordered in such variants less than full batch sizes shall be increased [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] per tablet to reimburse CIMA for making modifications to labeling, imprinting or packaging to accommodate such partial batch size variants. (d) Notwithstanding any provision herein to the contrary, if at any time CIMA makes sales of Product to any person at a price lower than the price then in effect hereunder for Product, or on payment and delivery terms more favorable than those in effect hereunder, such lower price and/or more favorable terms shall be made available to WCH hereunder, with respect to WCH's inventory of Product as well as future purchases of Product, for so long as CIMA continues to make sales to such person at such lower price and/or on such more favorable terms. -5- 2.3 FORECASTS. (a) Upon first NDA submission, WCH shall provide to CIMA a non-binding rolling three (3) year Product forecast (based on calendar years and updated at least semi-annually) for long-term manufacturing planning purposes. (b) Thereafter, during the Term of this Agreement, WCH shall provide CIMA on a calendar quarter basis, with a non-binding one (1) year rolling forecast, providing CIMA with a written estimate of the quantities of Product required during the next four (4) calendar quarters. Each such quarterly estimate shall contain an update of the immediately preceding estimate with respect to the calendar quarters referred to in such preceding estimate. 2.4 FIRM ORDERS. (a) WCH shall place a firm order with CIMA for Product requirements at least one hundred twenty (120) days in advance of the delivery date for Product for sales by WCH in the United States. WCH shall place a firm order with CIMA for Product requirements at least six (6) months in advance of the delivery date for Product for the first order placed for Product in any country of the Territory other than the United States, or for any order for Product which would require any modification to the labeling or packaging thereof; otherwise WCH may place a firm order at least ninety (90) days in advance of the delivery date for Product. A firm order is a purchase order authorizing manufacture of the Product. Notwithstanding the foregoing, if a modification to Product or to the Specifications (exclusive of labeling) is required for any country in the Territory, CIMA shall have at least six (6) months from the approval of such modification by the applicable Agency to fill any firm order for modified Product placed by WCH prior to such required modification. CIMA shall supply Product to WCH as required hereunder, provided that WCH provides CIMA with label copy which has been agreed to by both parties as required hereunder and WCH's order for Product is in accordance with the terms and conditions of this Agreement. Such order for Product placed by WCH shall be in accordance with the provisions of this Agreement and made pursuant to a purchase order in a form mutually acceptable to the parties. CIMA shall ship Product in such quantities and on the dates specified in WCH's purchase orders. (b) Notwithstanding the foregoing, CIMA has the right to satisfy WCH's firm order requirements pursuant to this Article II by supplying WCH with Product in full batch quantities provided that CIMA may round up or down WCH's actual order for Product to the nearest full batch. 2.5 LIMITS ON FIRM ORDERS. If a firm order made pursuant to Section 2.4 is greater than one hundred fifty percent (150%) of the one (1) year rolling forecast received by CIMA for such ninety (90) day period, then CIMA shall use Commercially Reasonable Efforts, but shall not be obligated, to ship that portion of the excess over one hundred fifty percent (150%). 2.6 CANCELLATIONS OF ORDERS. If WCH cancels a firm order made pursuant to Section 2.4, then WCH shall reimburse CIMA for all costs incurred by CIMA as a result of such cancellation of such order, including materials, labor, work in progress, obsolete inventory (including the AI Price for up to the quantity of Active Ingredient purchased by CIMA to cover -6- such canceled purchase order plus an additional two months supply based on WCH's most recent forecast), disposal and overhead; but this obligation shall not cover capital costs. 2.7 PAYMENT TERMS. WCH shall pay invoices for Products delivered hereunder thirty (30) days after the invoice date. WCH shall pay a penalty on unpaid amounts overdue by more than thirty (30) days of one and one-half percent (1.5%) per month for each month a payment is past due. Such penalty shall not exceed eighteen percent (18%) per year. 2.8 QUALITY ASSURANCE. (a) CIMA shall provide samples from each batch of Active Ingredient to be used in the manufacture of Product and samples from each batch of Product to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] (or such other contract laboratory specified by WCH) to perform the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Tests to ensure that such Active Ingredient and Product, as the case may be, meets the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Criteria, until WCH notifies CIMA in writing that such practice may be suspended. CIMA shall provide WCH with the results of such [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Tests. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall bill WCH directly for such services, and such amounts shall not be included in CIMA's Manufacturing Cost. If any batch of Active Ingredient or Product fails to meet the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Criteria, the parties shall be relieved of their respective obligations hereunder to supply and accept delivery of Product relating to such failed batch. CIMA shall not use any Active Ingredient in the manufacture of Product that does not meet the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Criteria and shall not ship any Product to WCH that does not meet the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Criteria. Any batch of Active Ingredient or Product that does not meet the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Criteria shall be disposed of by CIMA as directed by WCH. WCH shall reimburse CIMA the AI Price for Active Ingredient and the Finished Product Supply Price for Product (less any amount allocated to Raw Materials, Labor and Overhead not actually incurred by CIMA in the Manufacture of such Product) that is deemed unacceptable hereunder solely by reason of its failure to meet the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Criteria as determined by such [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED -7- SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Testing; provided that CIMA assigns to WCH all of its rights and interest in and to any claim that it may have against the supplier of Active Ingredient for breach of warranty or otherwise and CIMA fully cooperates with WCH in pursuing any claim by WCH against the supplier of Active Ingredient. WCH shall be entitled to retain any recovery it may receive from the supplier of Active Ingredient with respect to any such claim. (b) Prior to the shipment of Product to WCH, CIMA shall test representative samples of each of the batch(es) to be shipped in accordance with validated, approved methods of analysis defined in the Specifications. CIMA shall provide WCH with a Certificate of Analysis for each batch of Product shipped to WCH stating that the Product so shipped conforms to the Specifications. The Certificate of Analysis shall be in a format agreed upon by the parties. (c) CIMA shall retain production samples and batch records from each batch of Product for the longer of (i) two (2) years after the expiry date of each such batch of Product or (ii) the time period required under GMP. Upon request, CIMA shall provide WCH's Quality Control Department with production samples of Product and/or copies of completed Batch records. (d) Master batch process documentation will be prepared and approved by CIMA as per its normal procedures. The parties agree that deviations from master batch process documentation may be necessary from time to time. Such deviations shall be discussed with WCH before any proposed shipment of Product. Individual batch process documentation shall be photocopied from the approval master and issued for each batch as per CIMA's routine system. Original batch records will be filed securely by CIMA. CIMA will perform all in-process control tests demanded by the approved batch process. The parties shall execute and deliver to each other a Quality Agreement substantially in the form of Exhibit C. Each party agrees to perform is respective obligations in accordance with this Agreement. (e) (i) WCH shall have the right to test Product to verify compliance with Specifications and applicable Regulatory Approvals and CIMA shall supply WCH with its testing procedures. WCH may, by written notice provided to CIMA within sixty (60) days of WCH's receipt of a shipment of Product, reject all or part of such shipment of Product if, based upon the testing of such Product conducted under this Section 2.8(e), such Product does not comply with the Specifications or applicable Regulatory Approvals. If WCH fails to notify CIMA within such sixty (60) day period, that it is rejecting such Product, WCH shall be deemed to have accepted such Product. (ii) If CIMA, after good faith consultation with WCH, disputes any finding by WCH that Product does not comply with the Specifications or applicable Regulatory Approvals, samples of such Product shall be forwarded to a Third Party jointly selected by WCH and CIMA for analysis, which analysis shall be performed in compliance with applicable regulatory requirements. The findings of such Third Party regarding whether Product complies with the Specifications and the applicable Regulatory Approvals shall be binding upon the parties for purposes of this Section 2.8(e). The cost of such analysis by such Third Party shall be borne by the party whose findings differed from those generated by such Third Party. -8- (iii) If as determined in accordance with this Section 2.8(e), a shipment of Product does not conform to the Specifications or applicable Regulatory Approvals, CIMA shall replace such shipment free of charge (which includes without limitation CIMA paying for the cost of any Active Ingredient included therein) with a substitute shipment which meets such Specifications and applicable Regulatory Approvals according to the following time frame. If the Product is in inventory then conforming Product will be shipped so as to arrive as soon as practicable. If the Product is not in inventory, CIMA will take all reasonable steps to ensure expeditious manufacture of conforming Product which will be shipped on the next shipping day after completion of manufacture so as to arrive as soon as possible thereafter. In the event that testing at WCH indicates that Product does not conform with Specifications or applicable Regulatory Approvals: (I) WCH shall immediately notify CIMA; (II) WCH and CIMA shall mutually agree on an investigation program to determine the cause of the discrepancy and the outcome of this investigation shall be used to determine disposition of the batch; (III) where appropriate, given the timetable for the agreed upon investigation program, CIMA shall take all reasonable steps to ensure expeditious manufacture and shipment of conforming Product; and (IV) shipment of such replacement Product shall take place the next shipping day following completion of analytical work to demonstrate conformance with Specifications and applicable Regulatory Approvals. Shipment shall be by the quickest agreed route. At CIMA's expense and at WCH's sole option: the non-conforming shipment shall be (A) returned to CIMA; or (B) disposed of by WCH, upon final determination in accordance with this Section 2.8(e) that it does not meet the Specifications or applicable Regulatory Approvals. 2.9 WCH MANUFACTURE RIGHTS DURING THE TERM. Upon WCH's written request, made at any time after the first ANDA submission, CIMA shall grant to WCH the exclusive, irrevocable, transferable right to, and shall use Commercially Reasonable Efforts to transfer to WCH, the manufacturing know-how used by CIMA that is reasonably necessary to enable WCH to manufacture Product for the OTC Field. If WCH exercises this right, except as provided below, WCH shall pay CIMA (a) a [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] technical transfer fee upon successful completion of the transfer process (defined as manufacture of validation batches of Product meeting the Specifications), and (b) out of pocket expenses incurred by CIMA directly related to the technical assistance needed to facilitate the transfer process. If WCH exercises this right due to the inability of CIMA to meet WCH firm orders for Product, for any reason other than a condition of force majeure that lasts less than sixty (60) days, then WCH shall pay CIMA only out-of-pocket expenses incurred by CIMA directly related to the technical assistance needed to facilitate the transfer process. 2.10 NOTIFICATION OF INSPECTIONS. Each party agrees to notify the other within two (2) business days of its receipt of notification of any inquiries, notifications, or inspection activity by any Agency, regulatory authority or other authority in regard to or affecting Product. The recipient party shall provide a reasonable description to the other party of any such governmental inquiries, notifications or inspections promptly (but in no event later than five (5) calendar days) after notification of completion of such visit or inquiry. The recipient party shall furnish to the other party, (i) within two (2) business days after receipt any report or correspondence issued by the Agency or regulatory authority in connection with such visit or inquiry, including but not -9- limited to, any FDA Form 483, Establishment Inspection Reports or warning letters and (ii) at the same time it provides to any Agency or regulatory authority, copies of any and all documents, responses or explanations relating to items set forth above, in each case purged only of trade secrets of the recipient that are unrelated to the obligations under this Agreement or are unrelated to Product. In the event such governmental agency or authority requests or requires any action to be taken to address any citations, the recipient agrees, after consultation with the other party, to take such action as necessary to address such citations, and agrees to cooperate with the other party with respect to any such citation and/or action taken with respect thereto. 2.11 INSPECTION BY WCH. CIMA shall permit WCH (at its own expense) to visit, during normal business hours and with reasonable advance notice CIMA's manufacturing facility(ies) and warehouse, subject to the confidentiality provisions of this Agreement, for the purposes of (a) observing the manufacture, packaging, testing and warehousing of Product and to inspect for compliance with GMPs, applicable regulatory requirements, the requirements of any applicable Regulatory Approvals, and environmental monitoring, (b) solving technical or quality problems, (c) examining the premises, equipment, procedures and personnel used when producing, testing or controlling Product and (d) all books and records relating to (a), (b) or (c). CIMA representatives shall be entitled to accompany WCH representatives on any such inspection. 2.12 ENVIRONMENTAL AND OTHER LAWS AND REGULATIONS. (a) In carrying out its obligations under this Agreement, CIMA shall comply with all applicable environmental, health and safety laws (current or as amended or added, collectively "Laws"), and shall be solely responsible for determining how to comply with same. CIMA represents and warrants that it has the appropriate skills, personnel, equipment, permits or approvals necessary to perform its services under this Agreement in compliance with all applicable Laws. (b) CIMA shall notify WCH, in writing, no later than one (1) business day after the event, of any circumstances, including the receipt of any notice, warning, citation, finding, report or service of process, relating to compliance with the Laws, or the occurrence of any release, spill, upset or discharge of "Hazardous Substances" as defined by the Comprehensive Environmental Response, Compensation and Liability Act of 1980, as amended, which relates to CIMA's ability to manufacture or supply Product. WCH reserves the right to conduct an environmental inspection of CIMA's facility(ies), during normal business hours and with reasonable advance notice, for the purpose of determining compliance with this Section 2.12(b), no more frequently than once per year during the term hereof and under conditions of confidentiality as provided under Article VIII. Upon CIMA's request, WCH shall share the results of any environmental inspection with CIMA. Such inspection, if it occurs, does not relieve CIMA of its sole obligation to comply with the Laws and does not constitute a waiver of any right otherwise available to WCH. 2.13 SPECIFICATIONS AMENDMENTS. The Specifications shall be amended or supplemented to comply with GMPs and to comply with any applicable Agency directive and may also be amended or supplemented (including, without limitation, for the purpose of -10- incorporating improvements) from time to time. In the event CIMA intends to amend the Specifications, WCH shall receive prompt advance notice of any such amendments. No such amendment shall be filed with any applicable Agency or otherwise become effective without the prior written mutual approval of WCH and CIMA. In the event that after the parties have initially agreed upon the Specifications, WCH requests that the Specifications be amended, CIMA shall receive prompt advance notice of any such amendment for the purpose of determining what, if any, impact the proposed amendment would have on the manufacture of Product for WCH hereunder and WCH shall reimburse CIMA for the actual costs incurred by CIMA (provided that such costs are approved in writing by WCH prior to being incurred by CIMA) because such amendment requires changes to be made in the processes, equipment, testing procedures, or components used to manufacture Product for WCH hereunder. Upon WCH's request, CIMA shall use Commercially Reasonable Efforts to eliminate animal derived materials from the Product and WCH shall reimburse CIMA for the actual costs incurred by CIMA (provided that such are approved in writing by WCH prior to being incurred by CIMA) in connection therewith. In each case, such costs may include, without limitation, validation of new processes, equipment and facilities, development of testing methods and start-up costs. To the extent that any costs incurred by CIMA in implementing an amendment of the Specifications under this Section have been reimbursed by WCH such costs shall not be included in CIMA's Direct Manufacturing Cost. 2.14 APPROVAL FOR MANUFACTURING CHANGES; THIRD PARTY MANUFACTURING. CIMA agrees that no changes will be made to any materials, equipment or methods of production or testing which are specified in the Specifications or any Regulatory Approval by any Agency for Product without WCH's prior written approval, which approval shall not be unreasonably withheld. All Product delivered hereunder shall be manufactured at the Facility. Under no circumstances will CIMA contract out all or any part of the manufacturing of Product to a Third Party without prior written approval from WCH. 2.15 PERMITTED SUBCONTRACTORS. CIMA shall ensure that the permitted contract manufacturers for the manufacture of Product have sufficient knowledge and expertise to carry out the manufacture of Product and other subcontracted responsibilities. In addition, CIMA shall ensure that (i) each such contract manufacturer shall be in compliance with GMPs and shall be under the inspection of all relevant Agencies and audited to be in compliance therewith, and (ii) WCH will have the right to inspect and audit each such subcontractor's facilities and records as provided in Section 2.11 hereof. 2.16 CIMA'S MANUFACTURING COST CHANGES. (a) On January 1, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], and on each January 1 thereafter during the Term of this Agreement, the Finished Product Supply Price shall be adjusted [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] percent [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of any net change in the cost of (i) raw materials (including -11- packaging but excluding Active Ingredient) necessary to the manufacture of Product (collectively, the "Raw Materials") and (ii) direct labor (collectively, the "Labor"), in each case actually incurred by CIMA in producing the Product during the twelve (12) month period ending on the preceding December 31. On January 1, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], the Finished Product Supply Price shall be adjusted [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] percent [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of any net change in the overhead costs attributable to the manufacture of Products determined in accordance with United States generally accepted accounting practices consistently applied (collectively, the "Overhead") during the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] year period ending on December 31, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] and a similar adjustment shall be made on each January 1 after January 1, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] during the remainder of the Term for the twelve (12) month period ending on the preceding December 31. Such increases shall be effective with respect to Finished Product delivered to WCH on or after the January 1 effective date of the applicable price adjustment. CIMA may not propose any increase in the profit ("Profit") component of Finished Product Supply Price prior to January 1, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. (b) On or before July 1, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], and on or before each July 1 thereafter during the Term of this Agreement, CIMA shall provide WCH with a non-binding estimate of the amount by which the price will increase pursuant to this Section 2.16 on the succeeding January 1. CIMA shall determine the final amount of any such price increase by no later than the following February 28, and CIMA shall notify WCH of such amount in writing at that time. Product delivered to WCH between January 1 and February 28, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] (or the same two-month period thereafter during each year of this Agreement) shall be invoiced by WCH at the price applicable to Product delivered to WCH during the immediately preceding calendar year. Then on or about February 28 of each year, CIMA shall transmit to WCH a corrected invoice for Product delivered between January 1 and February 28 of each year, taking into account the final amount of any such price increases, and setting forth the applicable additional charges. (c) To determine the amount by which the cost of Raw Materials, Labor and/or Overhead have increased during a period, the Raw Materials, Labor and/or Overhead -12- costs at the beginning of the period shall be compared to the Raw Materials, Labor and/or Overhead costs at the end of the period, without regard to intervening fluctuations. (d) In no event shall any increase in price pursuant to Section 2.16(a) for Labor, Overhead and Profit exceed, on a percentage basis, the percentage which the Producer's Price Index, published by the U.S. Department of Labor, Bureau of Labor Statistics, increased during the period since the last adjustment under Section 2.16(a). (e) At WCH's request, the parties shall informally discuss the factors that contributed to any price adjustment hereunder. ARTICLE III [INTENTIONALLY OMITTED] ARTICLE IV REGULATORY COMPLIANCE 4.1 ADVERSE DRUG EXPERIENCES. In order for the parties to comply with their respective responsibilities under this Article IV and otherwise relating to the reporting of Adverse Drug Experiences, to the extent either party receives any information regarding Adverse Drug Experiences related to use of Product, such party shall promptly provide the other party with such information in accordance with the Adverse Event Reporting Procedures set forth in Exhibit D hereto (as may be amended from time to time upon written agreement of the parties). 4.2 PRODUCT COMPLAINTS. WCH shall be solely responsible for interacting with the public with respect to customer complaints regarding Product quality. With respect to any such complaints, each party shall have the responsibility for promptly conducting an investigation of any activities conducted by it under this Agreement which may be relevant to the complaint. Each party shall inform the other party of the nature, scope and details of any such complaint which requires an investigation by the other party, and each party shall promptly report the results of such investigation to the other party. Either party shall cooperate in any investigation by the other party of each such complaint which involves the parties' duties under this Agreement. 4.3 COMPLIANCE ISSUES. The parties acknowledge that the export of technical data, materials or products is subject to the exporting party receiving the necessary export licenses and that the parties cannot be responsible for any delays attributable to export controls which are beyond the reasonable control of either party. The parties agree that regardless of any disclosure made by the party receiving an export of any ultimate destination of any technical data, materials or products, the receiving party will not re-export either directly or indirectly, any technical data, material or products without first obtaining the applicable validated or general license from the United States Department of Commerce. ARTICLE V PAYMENT PROVISIONS -13- 5.1 INSPECTION OF RECORDS. The parties shall maintain at their offices, accurate and complete books and records consistent with sound business and accounting practices and in such form and in such detail as to enable the amount of payments payable under this Agreement by the respective party to be determined. WCH and CIMA shall permit an independent certified accountant (subject to obligations of confidentiality) appointed by the other party and reasonably acceptable to WCH or CIMA (as applicable), at the other party's expense, to examine such books and records at all reasonable times for the sole purpose of (i) verifying WCH's or CIMA's (as applicable) reports and accounting submitted to the other party hereunder and (ii) determining the correctness of payments. In the event of any underpayment of any payment by at least five percent (5%), the costs of such inspection shall be borne by the party who made such underpayment and such underpayment shall be forthwith paid by such party to the other party with a penalty at the rate specified in Section 2.7 from the date such payment was originally due until payment. ARTICLE VI REPRESENTATIONS AND WARRANTIES 6.1 REPRESENTATIONS AND WARRANTIES OF EACH PARTY. Each of CIMA and WCH hereby represents and warrants to the other party hereto as follows: (a) it is a corporation or entity duly organized and validly existing under the laws of the state or other jurisdiction of incorporation or formation; (b) the execution, delivery and performance of this Agreement by such party has been duly authorized by all requisite corporate action and does not require any shareholder action or approval; (c) it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder; and (d) the execution, delivery and performance by such party of this Agreement and its compliance with the terms and provisions hereof does not and will not conflict with or result in a breach of any of the terms and provisions of or constitute a default under (i) a loan agreement, guaranty, financing agreement, agreement affecting a product or other agreement or instrument binding or affecting it or its property; (ii) the provisions of its charter or operative documents or bylaws; or (iii) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound. 6.2 REPRESENTATIONS AND WARRANTIES OF CIMA. In addition to the representations and warranties made by CIMA under Section 6.1 above, CIMA hereby further represents and warrants to WCH that: (a) At the time of delivery of Product to the specified point of delivery, Product shall (i) have been manufactured, stored and shipped in accordance with GMPs, as applicable, and all other applicable laws, rules, regulations or requirements in effect at the time of manufacture in the country of manufacture (for example, in accordance with the procedures -14- described in the applicable Regulatory Approval); (ii) conform to the Specifications; (iii) meet the provisions of the Specifications; (iv) not be adulterated or misbranded as provided for under any applicable law, order or regulation in effect in the country of manufacture and the country in which Product is being sold; (v) have a minimum shelf life of approved expiry minus three (3) months; and (vi) have been shipped in accordance with approved procedures agreed between WCH and CIMA. (b) It shall have good and marketable title to all Product delivered to WCH. 6.3 NO INCONSISTENT AGREEMENTS. Neither party has in effect and after the Effective Date neither party shall enter into any oral or written agreement or arrangement that would be inconsistent with its obligations under this Agreement. 6.4 REPRESENTATION BY LEGAL COUNSEL. Each party hereto represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting hereof. In interpreting and applying the terms and provisions of this Agreement, the parties agree that no presumption shall exist or be implied against the party which drafted such terms and provisions. ARTICLE VII INDEMNIFICATION 7.1 INDEMNIFICATION BY WCH. WCH shall indemnify, defend and hold harmless CIMA and its Affiliates, and each of its and their respective employees, officers, directors and agents (each a "CIMA Indemnified Party") from and against any and all liability, loss, damage, cost and expense (including reasonable attorney's fees) (collectively, a "Liability") which the CIMA Indemnified Party may incur, suffer or be required to pay resulting from or arising in connection with (i) the breach by WCH of any representation, warranty or covenant contained in this Agreement, or (ii) subject to Sections 9.3(c) and 9.3(d) of the Development and License Agreement, the manufacture, promotion, distribution, use, testing, marketing, sale or other disposition of Product by WCH, its Affiliates or sublicensees. Notwithstanding the foregoing, WCH shall have no obligation under this Agreement to indemnify, defend or hold harmless any CIMA Indemnified Party with respect to claims, demands, costs or judgments which result from either (x) the failure of Product supplied by CIMA or its Affiliates to comply with the Specifications or the applicable Regulatory Approvals or (y) the willful misconduct or negligent acts or omissions of CIMA, its Affiliates, or any of their respective employees, officers, directors or agents. 7.2 INDEMNIFICATION BY CIMA. CIMA shall indemnify, defend and hold harmless WCH and its Affiliates, and each of its and their respective employees, officers, directors and agents (each, an "WCH Indemnified Party") from and against any Liability which the WCH Indemnified Party may incur, suffer or be required to pay resulting from or arising in connection with the breach by CIMA of any representation, warranty or covenant contained in this Agreement. Notwithstanding the foregoing, CIMA shall have no obligation under this Agreement to indemnify, defend, or hold harmless any WCH Indemnified Party with respect to claims, demands, costs of judgments which result from the willful misconduct or negligent acts -15- or omissions of WCH, its Affiliates, or sublicensees or any of their respective employees, officers, directors or agents. 7.3 CONDITIONS TO INDEMNIFICATION. The obligations of the indemnifying party under Sections 7.1 and 7.2 are conditioned upon delivery of written notice to the indemnifying party of any potential Liability promptly after the indemnified party becomes aware of such potential Liability, provided, however, that the failure to give such notice promptly shall not impair a party's rights to indemnification under this Article VII unless the delay in providing such notice has a material adverse effect on the ability of the indemnifying party to defend against such Liability. The indemnifying party shall have the right to assume the defense of any suit or claim related to the Liability if it has assumed responsibility for the suit or claim in writing; however, if in the reasonable judgment of the indemnified party, such suit or claim involves an issue or matter which could have a materially adverse effect on the business operations or assets of the indemnified party, the indemnified party may waive its rights to indemnity under this Agreement and control the defense or settlement thereof, but in no event shall any such waiver be construed as a waiver of any indemnification rights such party may have at law or in equity. If the indemnifying party defends the suit or claim, the indemnified party may participate in (but not control) the defense thereof at its sole cost and expense. 7.4 SETTLEMENTS. Neither party may settle a claim or action related to a Liability without the consent of the other party, if such settlement would impose any monetary obligation on the other party or require the other party to submit to an injunction or otherwise limit the other party's rights under this Agreement. Any payment made by a party to settle any such claim or action shall be at its own cost and expense except in the event that such payment was made with the prior written consent of the indemnifying party, in which case such payment will be subject to the indemnification obligations of the parties as set forth in this Article VII. 7.5 INSURANCE. CIMA shall obtain and carry in full force and effect product liability insurance in respect of Product in the amount of One Million Dollars ($1,000,000) per occurrence and in the aggregate and policies of Ten Million Dollars ($10,000,000) of excess coverage in the aggregate. WRH shall obtain and carry in full force and effect product liability insurance, or be self insured, in respect of Product in the amount of One Million Dollars ($1,000,000) per occurrence and in the aggregate and policies of Ten Million Dollars ($10,000,000) of excess coverage in the aggregate. ARTICLE VIII CONFIDENTIALITY 8.1 NONDISCLOSURE. During the Term of this Agreement and for a period of five (5) years thereafter, all proprietary and confidential business, technical, scientific and/or regulatory information, including Technical Information, disclosed to the receiving party or its Affiliates (herein collectively, the "Receiving Party") by the other party or its Affiliates (herein collectively, the "Disclosing Party") hereunder or under the existing Confidentiality Agreement between the parties, which is marked as confidential at the time of disclosure, or if disclosed or obtained orally or visually (or otherwise in a non-written form), was described or summarized in a writing or other tangible form and identified as Confidential and forwarded to the Receiving -16- Party within thirty (30) days of such disclosure (collectively, "Confidential Information"), shall be deemed to be confidential and shall be treated as such by the Receiving Party and shall not be disclosed, in whole or in part, by the Receiving Party to any other Person except as expressly set forth herein, and shall be used only for the purposes of this Agreement. Notwithstanding the foregoing, these mutual obligations of confidentiality shall not apply to any information to the extent that such information is: (i) independently developed by such party as documented by prior written records outside the scope and not in violation of this Agreement; (ii) legally in the public domain at the time of its receipt or thereafter legally becomes part of the public domain through no fault of the recipient; (iii) received without an obligation of confidentiality from a Third Party having the right to disclose such information; (iv) released from the restrictions of this Article VIII by the express written consent of the Disclosing Party; or (v) as may be required for securing Regulatory Approval, or as may be required to be disclosed to an Agency or as otherwise required by a court order or any law or regulation (including, as may be required in connection with any filings made with the Securities and Exchange Commission or by the disclosure policies of a major stock exchange in the Territory); provided, however, that at the other party's request, the disclosing party shall request that the relevant legal or regulatory authority, or major stock exchange, treat as confidential any Confidential Information of either party included in any such disclosure and generally use diligent efforts to seek confidential treatment where available. 8.2 SCOPE OF CONFIDENTIALITY. CIMA and WCH agree to limit the disclosure of any Technical Information and other Confidential Information received hereunder to such Affiliates, employees, consultants and distributors as are necessary to carry out the provisions of this Agreement and who are likewise bound by provisions equivalent to this Article VIII, except that, WCH may disclose Confidential Information to actual or potential sublicensees and subdistributors, provided that they are likewise bound by confidentiality provisions similar to, or more stringent than, those set forth in this Article VIII. The parties shall take reasonable measures to assure that no unauthorized use or disclosure is made by Persons to whom access to such Confidential Information is granted. ARTICLE IX TERM AND TERMINATION 9.1 TERM. This Agreement shall be effective as of the Effective Date, and, unless sooner terminated by mutual agreement or pursuant to any other provision of this Agreement, shall continue in full force and effect in each country of the Territory for a period of ten (10) -17- years after the Launch Date of Product in the United States which shall be deemed to occur no later than six (6) months after obtaining Regulatory Approval in the United States. If the Development and License Agreement is terminated for any reason other than expiration, then this Agreement shall automatically terminate. 9.2 TERMINATION FOR DEFAULT. Each party may terminate this Agreement as a whole if the other party commits a material breach of any material obligation under this Agreement and fails to remedy such breach within sixty (60) days after receipt of notice in writing from such party, or such longer period of time if mutually agreed. 9.3 TERMINATION BY WCH. WCH shall have the right, in its sole discretion, to terminate this Agreement at any time during the Term of this Agreement upon six (6) months' prior written notice to CIMA. 9.4 NO DAMAGES UPON EXPIRATION OR TERMINATION. Except as otherwise set forth in this Agreement, neither party shall be entitled to any compensation whatsoever as a result of expiration or termination of this Agreement, but without limiting either party's damages for any breach of this Agreement. 9.5 CONTINUING OBLIGATIONS. Termination or expiration of this Agreement for any reason shall be without prejudice to any obligations which shall have accrued to the benefit of either party prior to such termination or expiration. Upon termination or expiration of this Agreement, any payments owed to the other party on or before the effective date of termination shall be due within thirty (30) days of the effective date of such termination or expiration. The following provisions of this Agreement shall survive expiration or termination hereof: Articles VII, VIII, IX and XI. ARTICLE X PUBLICATIONS 10.1 PUBLICATIONS. The parties shall mutually agree upon publications and the publication strategy with respect to work undertaken by the parties relating to Product, and neither party shall publish any result or study generated or developed under this Agreement except upon review by the other party at least sixty (60) days prior to submission of an abstract or manuscript for publication. ARTICLE XI MISCELLANEOUS 11.1 FORCE MAJEURE. Neither party shall be liable for delay or failure to perform its obligations hereunder for so long as that failure or delay is the result of an event beyond its control which it could not have avoided by the exercise of reasonable diligence, (a "Force Majeure Event"), provided that such party uses Commercially Reasonable Efforts to comply with the terms of this Agreement as soon as practicable. A party asserting a Force Majeure Event shall notify the other party promptly, giving an indication of the likely extent and duration thereof. -18- 11.2 ASSIGNMENT; SUCCESSORS AND ASSIGNS. Neither party shall at any time, without obtaining the prior written consent of the other party, assign or transfer this Agreement to any Person. Notwithstanding the foregoing, each party shall be permitted to assign this Agreement to its Affiliates or to perform this Agreement, in whole or in part, through its Affiliates, provided that such party shall be primarily liable and responsible for performance by such Affiliate hereunder; and each party may also assign this Agreement to any successor by merger or upon a sale of all or substantially all of its assets or business to which this Agreement relates. This Agreement shall be binding upon and shall inure to the benefit of the parties and their successors and permitted assigns. 11.3 NOTICES. Any notices required or permitted to be given hereunder shall be in writing in the English language and shall be delivered by international courier service (requiring signature upon receipt) or sent by first class air mail, postage prepaid, or telefax (confirmed by phone conversation with the recipient) to the addresses set forth below. The parties may change the address at which notice is to be given by giving notice to the other party as herein provided. All notices shall be deemed effective upon receipt by the party to whom it is addressed. If to CIMA: CIMA Labs. Inc. 10000 Valley View Road Eden Prairie, Minnesota 55344 Attention: President and CEO Telephone: 612-947-8762 Telefax: 612-947-8770 If to WCH: Wyeth Consumer Healthcare Division Wyeth Five Giralda Farms Madison, New Jersey 07940 Attention: President Telephone: 973-660-5773 Telefax: 973-660-7199 With a copy to: Wyeth 5 Giralda Farms Madison, New Jersey 07940 Attention: General Counsel Telephone: 973-660-6040 Telefax: 973-660-7050 -19- 11.4 GOVERNING LAW AND JURISDICTION. This Agreement and its execution, validity and interpretation shall be governed in all respects in accordance with the laws of the State of New York, excluding conflicts of law rules. 11.5 SEVERABILITY. In the event that any provision of this Agreement shall be held to be unenforceable, invalid or in contravention of applicable law, such provision shall be of no effect, and the parties shall negotiate in good faith to replace such provision with a provision which effects to the extent possible the original intent of such provision. 11.6 COMPLETE AGREEMENT; MODIFICATIONS. This Agreement, together with the Development and License Agreement and all Exhibits attached hereto and thereto, constitutes the entire Agreement between the parties with respect to the present subject matter, all prior negotiations, agreements and understandings being expressly canceled hereby. This Agreement may be amended only by a written agreement embodying the full terms of the amendment signed by authorized representatives of both parties. 11.7 NO AGENCY. Neither party shall by virtue of this Agreement have any power to bind the other to any obligation nor shall this Agreement create any relationship of agency, partnership or joint venture. 11.8 NO WAIVER. No term or condition of this Agreement shall be considered waived unless reduced to writing and duly executed by an officer of the waiving party. Any waiver by any party of a breach of any term or condition of this Agreement will not be considered as a waiver of any subsequent breach of this Agreement, of that term or condition or any other term or condition hereof. 11.9 COUNTERPARTS. This Agreement may be executed in counterparts, each of which together shall constitute one and the same Agreement. 11.10 AMENDMENT OF THE ORIGINAL SUPPLY AGREEMENT. The parties agree that, with effect from the Effective Date, the Original Supply Agreement is hereby amended to exclude the OTC Field from its scope and that this Agreement and the Development and License Agreement constitutes the entire agreement between the parties with respect to the subject matter hereof and thereof for the OTC Field. -20- IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written. CIMA LABS INC By: /s/ John Hontz -------------------------------------------------- Name: John Hontz Title: Chief Operating Officer WYETH, acting through its Wyeth Consumer Healthcare Division By: /s/ Gregory F. Bobyock -------------------------------------------------- Name: Gregory F. Bobyock Title: Vice President, Global Business Development -21- EXHIBIT A PRICE Finished Product Supply Price per Tablet Components API Cost Per Raw Tablet * Materials Labor Overhead Profit [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] * Assumes a net purchase price of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] per kilo of Active Ingredient. EXHIBIT B PACKAGING [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] EXHIBIT C QUALITY AGREEMENT [Wyeth LOGO] QUALITY AGREEMENT Quality Agreement for: This document constitutes the quality agreement for purchase of PRODUCT, a pharmaceutical product manufactured for Wyeth. Also described is the FDA approved product application under which the product will be manufactured as well as the operations to blister, label, carton, test, release and distribute the product to Wyeth. It defines the individual responsibilities of Wyeth and the Supplier, and in particular defines who is responsible for the cGMP aspects of manufacturing and specifies the way in which the Qualified Person releasing product batches for sale ensures that they comply with the FDA approved product application. The quality agreement takes the form of a detailed check list of all the activities associated with pharmaceutical production, analysis, release, distribution. Responsibility for each activity is assigned to either Wyeth, Supplier or Not Applicable in the appropriate tick box. It is then appended to the legal contract which covers the commercial and other aspects of the agreement between the parties. WYETH CONSUMER HEALTHCARE, SUPPLIER DIVISION OF WYETH 555 East Lancaster Avenue St. David's, PA 19087, USA Position: _______________________ Position: _______________________ Name:____________________________ Name:____________________________ Signature:_______________________ Signature:_______________________ Date:____________________________ Date:____________________________ Position: _______________________ Position: Name:____________________________ Name:____________________________ Signature:_______________________ Signature:_______________________ Date:____________________________ Date:____________________________
- --------------------------------------------------------------------------------------------------------------------------------- RESPONSIBILITIES NOT WYETH SUPPLIER APPLICABLE - --------------------------------------------------------------------------------------------------------------------------------- 1 COMPLIANCE REQUIREMENTS - --------------------------------------------------------------------------------------------------------------------------------- 1.1 Warrant that PRODUCT will be manufactured, tested, packaged, and held in accordance with all applicable FDA requirements and/or applicable regulatory agencies. - --------------------------------------------------------------------------------------------------------------------------------- 1.2 Manufacture and package product in strict adherence to the approved drug application. - --------------------------------------------------------------------------------------------------------------------------------- 1.3 Permit audits of all relevant premises, procedures, and documentation by Wyeth, and permit inspection by Regulatory Authorities. - --------------------------------------------------------------------------------------------------------------------------------- 1.4 Not to subcontract any of the work to a third party without prior agreement. - --------------------------------------------------------------------------------------------------------------------------------- 1.5 Have copies available for inspection of all supplements, annual reports, annual product reviews, correspondence to approved drug application on CMC or labeling issues for products supplied to WA during periodic inspections of Suppliers facilities and systems. - --------------------------------------------------------------------------------------------------------------------------------- 1.6 Supplier shall not file any amendment or supplement to it's ANDA that would significantly impact Supplier's ability to supply the PRODUCT to Wyeth in the manner described in the supply agreement, without prior written notice to Wyeth for their product. - --------------------------------------------------------------------------------------------------------------------------------- 1.7 Supplier shall notify Wyeth of any FDA Form 483s, Warning Letters or the like from applicable regulatory agencies within seven (7) days of receipt and subsequent responses(s) relating to the product or facilities used to produce, test, or package the product. - --------------------------------------------------------------------------------------------------------------------------------- 1.8 Copies of responses to regulatory agencies request(s) for product sample, batch records, or notice of inspections for product supplied for Wyeth will be provide within seven (7) days of correspondence forwarded to the agency. - --------------------------------------------------------------------------------------------------------------------------------- 1.9 Notify Wyeth within 24 hours of any recall and / or confirmed stability failure for product supplied to Wyeth. - --------------------------------------------------------------------------------------------------------------------------------- 1.10 Represent that it is not debarred under the U. S. Generic Drug Enforcement Act of 1992 or employ or use the services of any individual who is debarred or who has engaged in activities that could lead to being debarred. - --------------------------------------------------------------------------------------------------------------------------------- 1.11 Perform and maintain all validation current including but not limited to: process, analytical method, cleaning, computer, packaging, sanitization. - --------------------------------------------------------------------------------------------------------------------------------- 1.12 Conduct operations in compliance with applicable environmental, occupational health and safety laws and regulations. - --------------------------------------------------------------------------------------------------------------------------------- 1.13 Investigate and resolve all medical and non-medical product complaints. (Refer to Schedule "Reporting Adverse Drug Experiences"). - --------------------------------------------------------------------------------------------------------------------------------- 1.14 Notify Wyeth of any requests for information, notices of violations or other communication from a government agency relating to environmental, occupational health and safety compliance. - --------------------------------------------------------------------------------------------------------------------------------- 1.15 Notify Wyeth of any incident affecting compliance to environmental, occupational health and safety laws. - --------------------------------------------------------------------------------------------------------------------------------- 1.16 Conduct stability testing according to ANDA protocol - --------------------------------------------------------------------------------------------------------------------------------- 1.17 Product Stability Monitoring as filed in ANDA and "Annual Stability Reports" will be made available for annual inspection by WA. - --------------------------------------------------------------------------------------------------------------------------------- 1.18 Issue and follow up on FDA Field Alerts - ---------------------------------------------------------------------------------------------------------------------------------
-C-2- - --------------------------------------------------------------------------------------------------------------------------------- 1.19 Complaints - Product Quality and Adverse Drug Experience - --------------------------------------------------------------------------------------------------------------------------------- Collection and logging - --------------------------------------------------------------------------------------------------------------------------------- Investigation and issue of reports - --------------------------------------------------------------------------------------------------------------------------------- Follow up corrective action - --------------------------------------------------------------------------------------------------------------------------------- 1.20 Annual product review: Manufacturing and Analytical Testing - --------------------------------------------------------------------------------------------------------------------------------- 1.21 Final Annual Product Review that includes results from 1.19 and 1.20. - --------------------------------------------------------------------------------------------------------------------------------- 1.22 Product Recall - --------------------------------------------------------------------------------------------------------------------------------- Decision to initiate recall - --------------------------------------------------------------------------------------------------------------------------------- Communicate decision to initiate recall - --------------------------------------------------------------------------------------------------------------------------------- Approval of wording of notification to appropriate regulatory agencies - --------------------------------------------------------------------------------------------------------------------------------- Notification to appropriate regulatory agencies - --------------------------------------------------------------------------------------------------------------------------------- Management of recall - --------------------------------------------------------------------------------------------------------------------------------- Reconciliation of returned product - --------------------------------------------------------------------------------------------------------------------------------- 1.23 Responsibility to Authorities - --------------------------------------------------------------------------------------------------------------------------------- Liaison with Regulatory Authorities on product inquires - --------------------------------------------------------------------------------------------------------------------------------- Maintain safety /hazard and handling data on product and raw materials - --------------------------------------------------------------------------------------------------------------------------------- Liaison with Heath and Safety Authorities - --------------------------------------------------------------------------------------------------------------------------------- Liaison with Environmental Protection Authorities (Pollution Prevention) - --------------------------------------------------------------------------------------------------------------------------------- 2 PRODUCTION AND TESTING OF BULK TABLET PRODUCT - --------------------------------------------------------------------------------------------------------------------------------- 2.1 Master Formula - --------------------------------------------------------------------------------------------------------------------------------- 2.2 Product specification - --------------------------------------------------------------------------------------------------------------------------------- 2.3 Batch identification system for bulk tablet product manufacture - --------------------------------------------------------------------------------------------------------------------------------- 2.4 Qualification, approval of additional active pharmaceutical ingredient (API) supplier(s). - --------------------------------------------------------------------------------------------------------------------------------- 2.5 Procurement of API's, (include. Certificates of analysis, COA). - --------------------------------------------------------------------------------------------------------------------------------- 2.6 Storage of API's. - --------------------------------------------------------------------------------------------------------------------------------- 2.7 Sampling of API's - --------------------------------------------------------------------------------------------------------------------------------- 2.8 Test method for API's, including method validation. - --------------------------------------------------------------------------------------------------------------------------------- 2.9 Analysis of API's (include documentation, COA) - --------------------------------------------------------------------------------------------------------------------------------- 2.10 Release of API's - --------------------------------------------------------------------------------------------------------------------------------- 2.11 Retain reference samples of API's, including samples of periodic re-tests, for one (1) year beyond product expiry date. - ---------------------------------------------------------------------------------------------------------------------------------
-C-3- - --------------------------------------------------------------------------------------------------------------------------------- 2.12 Qualification, approval of inactive substance suppliers. - --------------------------------------------------------------------------------------------------------------------------------- 2.13 Procurement of inactive substances (include COA) - --------------------------------------------------------------------------------------------------------------------------------- 2.14 Storage of inactive substances - --------------------------------------------------------------------------------------------------------------------------------- 2.14 Sampling of inactive substances - --------------------------------------------------------------------------------------------------------------------------------- 2.15 Test method and method validation for inactive substances - --------------------------------------------------------------------------------------------------------------------------------- 2.16 Analysis of inactive substances (include documentation, COA) - --------------------------------------------------------------------------------------------------------------------------------- 2.17 Release of inactive substances - --------------------------------------------------------------------------------------------------------------------------------- 2.18 Retain reference samples of inactive substances, including samples of periodic re-tests, for one (1) year beyond product expiry date. - --------------------------------------------------------------------------------------------------------------------------------- 2.19 Process Validation - --------------------------------------------------------------------------------------------------------------------------------- 2.20 Cleaning Validation - --------------------------------------------------------------------------------------------------------------------------------- 2.21 Bill of Materials (BOM) for bulk tablet manufacturing - --------------------------------------------------------------------------------------------------------------------------------- 2.22 Manufacturing Instructions (Production Operating Instructions) - --------------------------------------------------------------------------------------------------------------------------------- 2.23 Production of bulk tablet material (include batch documentation) - --------------------------------------------------------------------------------------------------------------------------------- 2.24 Document, investigate and resolve deviations from approved manufacturing instructions or specifications. All deviations shall be recorded and justified. Supply a copy to Wyeth of all incident reviews and/or out-of-spec results that correspond with the given batch. - --------------------------------------------------------------------------------------------------------------------------------- 2 PRODUCTION AND TESTING OF BULK TABLET PRODUCT - --------------------------------------------------------------------------------------------------------------------------------- 2.25 Bulk tablet product sampling plan - --------------------------------------------------------------------------------------------------------------------------------- 2.26 Sampling of bulk tablet product - --------------------------------------------------------------------------------------------------------------------------------- 2.27 Test method and method validation for bulk tablet product - --------------------------------------------------------------------------------------------------------------------------------- 2.28 Analysis of bulk tablet product - --------------------------------------------------------------------------------------------------------------------------------- 2.29 Certificate of analysis for bulk tablet product - --------------------------------------------------------------------------------------------------------------------------------- 2.30 Equipment and instrument maintenance and calibration. - --------------------------------------------------------------------------------------------------------------------------------- 2.31 Stability testing of product in bulk tablet storage according to ANDA protocol - --------------------------------------------------------------------------------------------------------------------------------- 2.32 Maintain all batch records for a minimum of one year beyond product expiry date. Validation batch production and testing records should be kept permanently - --------------------------------------------------------------------------------------------------------------------------------- 2.33 Release of bulk tablet product by QA - --------------------------------------------------------------------------------------------------------------------------------- 3. STORAGE AND TRANSPORTATION OF BULK PRODUCT AND WASTE DISPOSAL - --------------------------------------------------------------------------------------------------------------------------------- 3.1 Storage of bulk product up to packaging or delivery to Wyeth - --------------------------------------------------------------------------------------------------------------------------------- 3.2 Storage of bulk product tablets. - ---------------------------------------------------------------------------------------------------------------------------------
-C-4- - --------------------------------------------------------------------------------------------------------------------------------- 3.3 Storage of bulk product according to labeled storage conditions - --------------------------------------------------------------------------------------------------------------------------------- 3.4 Transportation of bulk product to Wyeth or designated third party. - --------------------------------------------------------------------------------------------------------------------------------- 3.5 Disposal of waste - --------------------------------------------------------------------------------------------------------------------------------- 3.6 Disposal of special waste, e.g. toxic waste, solvents, etc. (specify nature of waste and special disposal methods required) ____________________________________________ ____________________________________________ ____________________________________________ - --------------------------------------------------------------------------------------------------------------------------------- 4. PACKAGING OF FINISHED PRODUCT - --------------------------------------------------------------------------------------------------------------------------------- 4.1 Finished product specification - --------------------------------------------------------------------------------------------------------------------------------- 4.2 Batch identification system for finished product - --------------------------------------------------------------------------------------------------------------------------------- 4.3 Artwork and labeling text (blister, carton, leaflet, label, etc.) - --------------------------------------------------------------------------------------------------------------------------------- 4.4 Labeling review and approval - --------------------------------------------------------------------------------------------------------------------------------- 4.5 Specifications for packaging materials - --------------------------------------------------------------------------------------------------------------------------------- 4.6 Test methods and method validation for packaging materials - --------------------------------------------------------------------------------------------------------------------------------- 4.7 Qualification and approval of packaging components and labeling suppliers - --------------------------------------------------------------------------------------------------------------------------------- 4.8 Procurement of packaging materials - --------------------------------------------------------------------------------------------------------------------------------- 4.9 Analysis of packaging materials - --------------------------------------------------------------------------------------------------------------------------------- 4.10 Release of packaging materials - --------------------------------------------------------------------------------------------------------------------------------- 4.11 Retain samples of packaging materials for one year past product expiry date. - --------------------------------------------------------------------------------------------------------------------------------- 4.12 Validation of packaging process - --------------------------------------------------------------------------------------------------------------------------------- 4.13 Bill of Materials (BOM) for packaging - --------------------------------------------------------------------------------------------------------------------------------- 4.14 Packaging Instructions (POI for packaging) - --------------------------------------------------------------------------------------------------------------------------------- 4.15 Packaging operations (include documentation) - --------------------------------------------------------------------------------------------------------------------------------- 4.16 In-process control instructions - --------------------------------------------------------------------------------------------------------------------------------- 4.17 In-process controls during packaging (include documentation) - --------------------------------------------------------------------------------------------------------------------------------- 4.18 Finished product sampling plan - --------------------------------------------------------------------------------------------------------------------------------- 4.19 Sampling of finished product including retain samples, stability sample, release samples, customer sample. - --------------------------------------------------------------------------------------------------------------------------------- 4.20 Retain reference samples of finished product for one year past product expiry date - ---------------------------------------------------------------------------------------------------------------------------------
-C-5- - --------------------------------------------------------------------------------------------------------------------------------- 4.21 Reconciliation of packaging materials - --------------------------------------------------------------------------------------------------------------------------------- 4.22 Equipment and instrument maintenance and calibration - --------------------------------------------------------------------------------------------------------------------------------- 4.23 Document, investigate and resolve any deviation from approved packaging instructions or specifications. - --------------------------------------------------------------------------------------------------------------------------------- 5. TESTING AND RELEASE OF FINISHED PRODUCT - --------------------------------------------------------------------------------------------------------------------------------- 5.1 Test method and method validation for finished product - --------------------------------------------------------------------------------------------------------------------------------- 5.2 Equipment and instrument maintenance and calibration - --------------------------------------------------------------------------------------------------------------------------------- 5.3 Analysis of finished product by QA - --------------------------------------------------------------------------------------------------------------------------------- 5.4 Release of finished product by QA - --------------------------------------------------------------------------------------------------------------------------------- 5.5 - Certificate of analysis for finished product testing. Supplier to supply Cof A which contains info needed: - Written description of tablet. - Test Name - Release Specification - Results - Bulk hold expiration date - Expiration date when packaged in final container. - --------------------------------------------------------------------------------------------------------------------------------- 6. DOCUMENTATION - --------------------------------------------------------------------------------------------------------------------------------- 6.1 - Provide Certificate of Compliance including: No In Process OOS data. - No Investigation Reports issued against lot or See attached IR# ________. - Batch records have been audited and approved by Supplier QA. - All raw materials used in the MFG of this batch have been QA approved and sourced from approved suppliers. - Manufacture Date: ________. - Bulk Retest Date: ________. - Expiration when PKG in final container: ________. - Manufacturing and testing was conducted against approved procedures. - --------------------------------------------------------------------------------------------------------------------------------- 6.2 - Provide the following documentation to Wyeth for batches: - C of A - Cof C as part of the C of A - Packaging Records (Blistering) Line Clearance Assembly instructions In Process test results Component Check-in Yield/reconciliation calculations. - Packaging Records (Cartoning) - Representative Packaged Product Samples (AQL sampling) - --------------------------------------------------------------------------------------------------------------------------------- 6.3 Accountabilities for all critical manufacturing steps. Any accountability outside pre-established limits must be investigated and a copy of the investigation included with batch records. - ---------------------------------------------------------------------------------------------------------------------------------
-C-6- EXHIBIT D ADVERSE EXPERIENCE REPORTING PROCEDURES The parties hereby agree that the following terms will govern disclosures of each party to the other with respect to adverse event reporting relating to Product as clinically tested or marketed by or on behalf of either party. 1. DEFINITIONS. 1.1 ADVERSE EXPERIENCE OR EVENT (AE): An AE is defined by WCH as any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a human being in a temporal relationship to use of an WCH product regardless of causal relationship. This includes: - any clinically significant worsening of a pre-existing condition; - an AE occurring from overdose (i.e., a dose higher than that prescribed by a health care professional for clinical reasons) of an WCH product, whether accidental or intentional; - an AE occurring from abuse (i.e., use for non-clinical reasons) of an WCH product; - an AE that has been associated with the discontinuation of the use of an WCH product; - any failure of expected pharmacological action (for spontaneous reports). If there is any doubt whether the information constitutes an AE, the information will be treated as an AE. 1.2 SERIOUS AE: A serious AE is defined by WCH as an AE occurring at any dose that: results in death; is life-threatening (see below); requires inpatient hospitalization or prolongation of an existing hospitalization; results in a persistent or significant disability or incapacity (see below); results in cancer; or results in a congenital anomaly or birth defect. Additionally, IMPORTANT MEDICAL EVENTS that may not result in death, be life-threatening, or require hospitalization may be considered a serious AE when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home; blood dyscrasias or convulsions that do not result in hospitalization; or the development of drug dependency or abuse. 1.2.1 Life-threatening refers to immediate risk of death as the event occurred. A life-threatening experience does not include an experience that, had it occurred in a more severe form, might have caused death but as it actually occurred did not create an immediate risk of death. For example, hepatitis that resolved without evidence of hepatic failure would not be considered life-threatening even though hepatitis of a more severe nature can be fatal. Similarly, an allergic reaction resulting in angioedema of the face would not be life-threatening, even though angioedema of the larynx, allergic bronchospasm, or anaphylaxis can be fatal. 1.2.2 Disability is defined as a substantial disruption in a person's ability to conduct normal life functions. 1.2.3 For studies, all pregnancies and all overdoses will be reported to GSSE in the same time frame as serious AEs. 1.2.4 A serious AE obtained from tests in laboratory animals includes any experience suggesting a significant risk for human subjects, including any findings of mutagenicity, teratogenicity, or carcinogenicity. 1.2.5 If there is any doubt whether the information constitutes a serious AE, the information will be treated as a serious AE. 1.3 NON-SERIOUS AE: is any AE which does not meet the criteria for a serious AE. 1.4 UNEXPECTED AE: An unexpected AE is one that is not listed in the current product labeling. The current product labeling is either the package insert (for marketed WCH products) or the current investigator's brochure (for investigational WCH products). An unexpected AE includes any event that may be symptomatically and pathophysiologically related to an event listed in the labeling, but differs from the labeled event because of greater severity or specificity. For example, hepatic necrosis would be unexpected (by virtue of greater severity) if the product labeling referred only to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism and cerebral vasculitis would be unexpected (by virtue of greater specificity) if the labeling only listed cerebral vascular accidents. 1.5 PRODUCT (DRUG, VACCINE, BIOLOGICAL, DEVICE)-RELATED: For the purposes of regulatory reporting for investigational products, an AE will be considered "product-related" (i.e., drug-related, vaccine-related, etc.) for studies if either the investigator, the Medical Monitor, the CR&D Clinical Project Team Medical Monitor (or designee), or the Local Monitor (if applicable) assesses the AE(s) as possibly, probably, or definitely related. -D-2- 1. An AE will be considered "not product-related" for studies if the investigator AND the medical monitor(s) AND the local monitor (if applicable) assess the AE(s) as probably not related or definitely not related, or "relationship remote." 2. Whenever the investigator's or monitor's assessment is unknown or unclear, the AE(s) will be treated as product-related for the purposes of reporting to regulatory authorities. 1.6 PROTOCOL-RELATED: AEs from studies that are not product-related may nevertheless be considered by the investigator or the medical monitor(s) or the local monitor (if applicable) to be protocol-related. For purposes of reporting to GSSE and regulatory authorities, these will be reported in the same manner as product-related events. 1.7 NDA HOLDER is defined as: An "Applicant" as defined in 21 CFR Part 314.3(b), for regulatory approval of a Product in any regulatory jurisdiction, including a holder of a foreign equivalent thereto. 1.8 IND HOLDER is defined as: A "Sponsor" as defined in 21 CFR Part 313.1(b) of an investigational new drug in any regulatory jurisdiction, including a holder of a foreign equivalent thereto. 1.9 Capitalized terms not defined in this Exhibit shall have the meaning assigned thereto in the Agreement. 2. With respect to the Product or Active Ingredient, the Parties agree as follows: a. All initial reports and any follow-up information (oral or written) for any and all Serious AEs as defined above, (other than with respect to animal studies) which become known to either Party (other than from disclosure by or on behalf of the other Party) must be communicated by telephone, telefax or electronically directly to the other Party and/or the NDA Holder, IND Holder (individually and collectively referred to as "Holders") within forty-eight (48) hours of receipt of the information. Written confirmation of the Serious AE received by such Party should be sent to the other Party and/or the Holders as soon as it becomes available, but in any event within forty-eight (48) hours of initial report of the Serious AE by such Party. b. Both Parties shall exchange Medwatch and/or CIOMs forms and other health authority reports within forty-eight (48) hours of submission to any Regulatory Authority. c. All initial reports and follow-up information received for all Non-Serious AEs for marketed Product which become known to a Party (other than from disclosure by or on behalf of the other Party) must be communicated in writing, by telefax or -D-3- electronically to the other Party within ten (10) days, on Medwatch or CIOMs forms (where possible). d. Each Party shall coordinate and cooperate with the other whenever practicable to prepare a single written report regarding all Serious and/or Non-Serious AEs, provided, however, that neither Party shall be obligated to delay reporting of any AE in violation of applicable law or regulations regarding the reporting of AEs. 3. The Parties further agree that: a. A written report be forwarded to the other Party within forty-eight (48) hours of a receipt by the Party making the report, for AEs for animal studies which suggest a potential significant risk for humans; b. Each Party will give the other Party a report via a print-out or computer disk of all AEs reported to it and its Affiliates relating to the Product or Active Ingredient within the last year, within thirty (30) days of receipt of a request from the other Party but not more often than four (4) times a year; c. If either Party wishes access to AE Reports of the other Party relating to the Product or Active Ingredient, upon request of that Party, the other Party shall make available its AE records relating to the Product or Active Ingredient (including computer disks) for viewing and copying by the other Party. The Parties may discuss the transfer of AE Reports by computer disk. d. Disclosure of information hereunder by a Party to the other Party shall continue as long as either Party and/or its Affiliates or designees continue to clinically test or market Product or Active Ingredient. 4. Each Party shall diligently undertake the following further obligations where both Parties are or will be commercializing the Product or Active Ingredient pursuant to the Agreement and/or performing clinical trials with respect to the Product or Active Ingredient: a. Upon the Effective Date, each Party shall identify individuals who shall be responsible for identifying all AE reporting requirements in all countries of the Territory as set forth in the Agreement, and any amendments thereto; b. To immediately consult with the other Party, with respect to the investigation and handling of any Serious AE disclosed to it by the other Party or by a Third Party and to allow the other Party to review the Serious AE and to participate in the follow-up investigation; c. To immediately advise the other Party of any Product and/or Active Ingredient safety communication received from a health authority and consult with the other Party with respect to any Product and/or Active Ingredient warning, labeling -D-4- change or change to an investigators' brochure involving safety issues proposed by the other Party, including, but not limited to the safety issues agreed to by the Parties; d. To diligently handle in a timely manner the follow-up investigation and resolution of each AE reported to it; e. To provide the other Party mutually agreed upon audit rights of its AE reporting system and documentation, upon prior notice, during normal business hours, at the expense of the auditing Party and under the confidentiality obligations set forth in the Agreement; f. To meet in a timely fashion from time to time as may be reasonably required to implement the adverse event reporting and consultation procedures described in this Exhibit D, including identification of those individuals in each Party's Drug Safety group who will be responsible for reporting to and receiving AE information from the other Party, and the development of a written standard operating procedure with respect to adverse event reporting responsibilities, including reporting responsibilities to investigators; g. Where possible, to transmit all data electronically; h. To report to each other any addenda, revisions or changes to the Agreement (e.g., change in territories, local regulations, addition of new licensors/licensees to the Agreement, etc.) which might alter the adverse event reporting responsibilities hereunder; i. To utilize English as the language of communication and data exchange between the Parties; j. To develop a system of exchange of documents and information in the event that the Agreement involves more than two Parties; and k. To work together to develop an electronic system to transmit AE data. 5. The Parties may meet after the Effective Date of the Agreement to establish a separate agreement for adverse event exchange which will supersede this Exhibit D. -D-5-
EX-99.1 6 c71161exv99w1.txt EX-99.1 CERTIFICATION OF CHIEF EXECUTIVE OFFICER Exhibit 99.1 CIMA LABS INC. CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Quarterly Report of CIMA LABS INC. (the "Company") on Form 10-Q for the period ending June 30, 2002 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I, John M. Siebert, President and Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. ss. 1350, as adopted pursuant to ss. 906 of the Sarbanes-Oxley Act of 2002, that: (1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. Date: 8/13/2002 /s/ John M. Siebert ------------------------------------ John M. Siebert, President and Chief Executive Officer (Principal Executive Officer) EX-99.2 7 c71161exv99w2.txt EX-99.1 CERTIFICATION OF CHIEF FINANCIAL OFFICER Exhibit 99.2 CIMA LABS INC. CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Quarterly Report of CIMA LABS INC. (the "Company") on Form 10-Q for the period ending June 30, 2002 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I, David A. Feste, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. ss. 1350, as adopted pursuant to ss. 906 of the Sarbanes-Oxley Act of 2002, that: (1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. Date: 8/13/2002 /s/ David A. Feste ----------------------------------- David A. Feste, Chief Financial Officer (Principal Financial Officer)
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