-----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, Oju43LKynyHAxxpYFpWrGMR+bD0B9EWOzcezc3NQvKsP5QxZNK2wi9YQfBIfKNzq 3PPR4xBWevR8AlKHz7R8yQ== 0000950134-03-004791.txt : 20030328 0000950134-03-004791.hdr.sgml : 20030328 20030328112922 ACCESSION NUMBER: 0000950134-03-004791 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 10 CONFORMED PERIOD OF REPORT: 20021231 FILED AS OF DATE: 20030328 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-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-24424 FILM NUMBER: 03623313 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-K 1 c75663e10vk.htm FORM 10-K e10vk
Table of Contents

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-K

(Mark One)

þ   Annual Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2002
or
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
(State or other jurisdiction of
incorporation or organization)
  41-1569769
(I.R.S. Employer Identification Number)
     
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)

Securities registered pursuant to Section 12(b) of the Act: None

Securities registered pursuant to Section 12(g) of the Act: Common Stock, $.01 par value

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   þ    No   o

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the Registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.    þ

Indicate by check mark whether the registrant is an accelerated filer (as defined in Exchange Act Rule 12b-2).    Yes   þ    No   o

The aggregate market value of common stock held by non-affiliates of the registrant, based upon the last sale price of the common stock reported on the Nasdaq National Market tier of The Nasdaq Stock Market on June 28, 2002 was $246,960,821. Common stock outstanding at March 24, 2003 was 14,308,612 shares.

Documents Incorporated by Reference

Portions of the Registrant’s definitive Proxy Statement to be filed with the Securities and Exchange Commission in connection with the solicitation of proxies for the Registrant’s Annual Meeting of Stockholders to be held on May 21, 2003 are incorporated by reference in Part III, Items 10, 11, 12 and 13, of this Form 10-K.


PART I.
ITEM 1. BUSINESS
ITEM 2. PROPERTIES
ITEM 3. LEGAL PROCEEDINGS
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
PART II.
ITEM 5. MARKET FOR REGISTRANT’S COMMON STOCK AND RELATED STOCKHOLDER MATTERS
ITEM 6. SELECTED FINANCIAL DATA
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
PART III.
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
ITEM 11. EXECUTIVE COMPENSATION
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
ITEM 14. CONTROLS AND PROCEDURES
PART IV.
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K
SIGNATURES
CERTIFICATIONS
CERTIFICATIONS
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
EX-10.24 Master Development, License & Supply Agmt
EX-10.29 Development, License and Supply Agreement
Ex-10.30 First Amendment to Employment Agreement
Ex-10.31 Letter Agreement with David Feste
Ex10.32 Employment Agreement - James C Hawley
Ex-23.1 Consent of Ernst & Young LLP
EX-24.1 Powers of Attorney
EX-99.1 Certification of Chief Executive Officer
EX-99.2 Certification of Chief Financial Officer


Table of Contents

PART I.

Forward-Looking Statements

     We make many statements in this Annual Report on Form 10-K under the captions Business, Management’s Discussion and Analysis of Financial Condition and Results of Operations, and Factors That Could Affect Future Results and elsewhere that 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 and plan and 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 under the caption 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 without considering the risks and uncertainties associated with these statements and our business that are addressed in this report.

     These forward-looking statements include, without limitation, statements relating to expected growth in operating revenues and income; the expected decline in other income; utilization of remaining tax assets; future expense levels; the adequacy and use of our capital resources; the timing of availability of our products and our competitors’ products; expected demand for products using our technologies; the expansion and adequacy of our production capacity and facilities; 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.

     Information regarding market and industry statistics contained in the Business section is included based on information available to us that we believe is accurate. It is generally based on academic and other publications that are not produced for purposes of economic analysis. We have not reviewed or included data from all sources and cannot assure you of the accuracy of the data we have included.

ITEM 1. BUSINESS

Company Overview

     We were incorporated in Delaware in 1986. Our executive offices are located at 10000 Valley View Road, Eden Prairie, Minnesota 55344-9361. Our telephone number is (952) 947-8700 and our website is www.cimalabs.com. The information on our website is not incorporated into and is not intended to be a part of this report. We make available free of charge on or through our website our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such material with, or furnish it to, the U.S. Securities and Exchange Commission. Unless the context otherwise indicates, all references to the “Registrant,” the “Company,” or “CIMA” in this Form 10-K relate to CIMA LABS INC.

     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.” All other trademarks used in this report are the property of their respective owners. “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 Pharma. “Alavert” is a trademark of Wyeth. “Allegra®” is a registered trademark of Aventis Pharmaceuticals Inc. “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. “Zyprexa® Zydis” is a registered trademark of Eli Lilly and Company. “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. “OraQuick” is a trademark of KV Pharmaceutical Company. “Pharmaburst” is a trademark of SPI Pharma, Inc.

2


Table of Contents

     We develop and manufacture fast dissolve and enhanced-absorption oral drug delivery systems. OraSolv and DuraSolv, our proprietary fast dissolve technologies, are oral dosage forms that dissolve quickly in the mouth without chewing or the need for water. We currently manufacture six pharmaceutical brands utilizing our DuraSolv and OraSolv fast dissolve technologies: three prescription brands and three over-the counter brands. The three over-the-counter brands include Triaminic Softchews for Novartis, Tempra FirsTabs for Bristol-Myers Squibb, and Alavert for Wyeth; and the three prescription brands include AstraZeneca’s Zomig-ZMT and its equivalent for markets outside the U.S., Organon’s Remeron SolTab and its equivalent for markets outside the U.S., and NuLev for Schwarz Pharma.

     We believe that the attributes of our OraSolv and DuraSolv fast dissolve technologies may enable consumers in certain age groups or with limited ability to swallow conventional tablets to receive medication in an oral dosage form that is more convenient than traditional tablet-based oral dosage forms. Both OraSolv and DuraSolv technologies are capable of incorporating taste masked active drug ingredients into tablets that have the following potential benefits:

    ease of administration;
 
    improved dosing compliance; and
 
    increased dosage accuracy compared to liquid formulations.

     We generate revenue from 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 products we manufacture, which are sold by pharmaceutical companies under licenses from us. Net sales of products we manufacture for and the royalties we receive from Novartis for Triaminic Softchews are seasonal in nature and can be affected by the strength and duration of the cough and cold season in the U.S.

     Our proprietary technologies enable our pharmaceutical company partners to differentiate their products from competing products. In addition to providing a competitive advantage in the marketplace, our proprietary technologies also may enable our pharmaceutical company partners to extend the product life cycles of their patented drug compounds beyond existing patent expiration dates of those compounds. Our technologies may also provide benefits to the healthcare system more generally. For example, improved compliance with prescribed drug regimens can enhance therapeutic outcomes and potentially reduce overall costs.

     In addition to our proprietary OraSolv and DuraSolv fast dissolve technologies, we are developing several new drug delivery technologies. One new technology is our sustained release technology, which adds sustained release properties to the fast dissolve and taste masking attributes available with our DuraSolv and OraSolv technologies. We also are developing new OraVescent drug delivery technologies that include OraVescent SL for drug delivery under the tongue and OraVescent BL for drug delivery between the gum and the cheek. An additional OraVescent technology, OraVescent SS, is designed for site-specific administration, which may allow an active drug ingredient to be transported to a specific part of the gastrointestinal tract where it is released for absorption. We originally designed and continue to design our OraVescent technologies to improve the transport of active drug ingredients that are poorly absorbed across mucosal membranes in the oral cavity or the gastrointestinal tract. In addition, our microemulsions technology is a proprietary technology that we are evaluating which may improve the bioavailability of a wide range of active drug ingredients, which may otherwise not be suitable for administration in a solid oral dosage form.

Industry Overview

Drug Delivery Methods

     Historically, pharmaceutical products were available primarily through two delivery methods, oral dosage forms or injections. Recently, drug delivery technologies have been developed for a variety of therapeutic compounds, improving safety, efficacy, ease of patient use and patient compliance. In addition, drug delivery technologies can be used to expand markets for existing products, as well as to develop new products. Industry experts have noted that the global drug delivery market reached $39.5 billion in 2000 sales, with oral drug delivery technologies accounting for approximately 56% of sales.

3


Table of Contents

     Fast dissolve technology has recently emerged as an important type of drug delivery technology that enables tablets to dissolve quickly in the mouth without the use of water or chewing. Children and the elderly, as well as others with certain physiological or medical conditions, frequently experience difficulty in swallowing tablets. Our fast dissolve technology may improve compliance with a prescribed drug regimen, as fast dissolve medications are easier to swallow and may taste better than non-taste masked alternatives. In addition, fast dissolve technology may improve dosing accuracy relative to liquid formulations. Finally, and most importantly, fast dissolve technology may provide a significant commercial benefit, as studies we have conducted indicate that patients often prefer it to conventional tablets and other formulations.

Trends Affecting the Drug Delivery Industry

     Several significant trends in the health care industry have important implications for drug delivery companies. These trends include:

     Drug Patent Expirations. Based on an industry source, twenty-seven prescription brands with annual worldwide sales exceeding $37.0 billion will lose patent protection by 2005. In order to maintain their revenues, many large pharmaceutical companies are defending against generic competition by enhancing existing drug products with innovative drug delivery technologies. These enhancements may include increased efficacy, reduced side effects and more convenient administration. We believe that pharmaceutical companies will use drug delivery systems to preserve or increase market share, enhance therapeutic performance and, in some cases, extend product life cycles.

     Direct-to-Consumer Marketing. In the first six months of 2002, industry sources estimate that pharmaceutical companies spent approximately $2.4 billion in the U.S. on direct-to-consumer advertising of prescription medications, a $1.0 billion increase from the $1.4 billion spent during the comparable six-month period of 2001. We expect direct-to-consumer marketing and promotion spending by pharmaceutical companies to increase in the future. We also believe that the significant trend towards direct-to-consumer marketing may focus consumers on patient-friendly pharmaceutical products, including products that incorporate innovative drug delivery technologies, such as fast dissolve technology. This focus may encourage pharmaceutical companies to develop products incorporating these technologies.

     Influence of Managed Care. Many managed care plans and other insurers actively manage the costs of prescription drugs for their clients by monitoring patient dosing compliance as well as the efficacy, quality and cost of medications. Payors have demonstrated acceptance of drug delivery technologies, such as fast dissolve and taste masking, that improve patient compliance.

Our Oral Drug Delivery Products and Technologies

     Our proprietary products and technologies focus on innovative oral drug delivery methods that meet the needs of consumers for convenient and effective medications and the needs of pharmaceutical companies for differentiated products and accurate dosing methods. We have developed all of our fast dissolve technologies internally. Our most developed technologies are our OraSolv and DuraSolv fast dissolve drug delivery technologies. We currently manufacture six pharmaceutical brands incorporating our proprietary fast dissolve technologies, of which three products use our OraSolv technology and three products use our DuraSolv technology. We are also developing innovative transmucosal oral drug delivery technologies. These technologies include OraVescent SL for drug delivery under the tongue, OraVescent BL for drug delivery between the gum and the cheek and OraVescent SS for swallowable site-specific drug delivery in the gastrointestinal tract. In addition, we are evaluating our microemulsions technology, which may be useful in improving the bioavailability of a wide range of active drug ingredients that may otherwise not be suitable for oral administration in a solid oral dosage form.

Fast Dissolve Technologies

     Our two primary fast dissolve oral drug delivery technologies are OraSolv and DuraSolv. Our OraSolv technology incorporates active drug ingredients in lightly compacted fast dissolve tablets. The low level of compaction pressure applied to OraSolv tablets allows larger amounts of taste masked active drug ingredients to be

4


Table of Contents

compressed into the tablets without damage to the taste masked active drug ingredients. The low level of compaction pressure applied to OraSolv tablets also allows for a minimal portion of the tablet’s contents to be dedicated to effervescent and other fast dissolve agents, allowing for high doses of taste masked active ingredients. Our DuraSolv technology uses higher compaction pressures to produce fast dissolve tablets incorporating active drug ingredients in a more durable fast dissolve tablet. Due to their greater durability, DuraSolv tablets are easier to handle and package, and may cost less to produce, than OraSolv tablets.

     OraSolv. Our OraSolv technology is an oral dosage form that combines taste masked drug ingredients with a fast dissolving, low-effervescence system. The OraSolv tablet dissolves quickly in the mouth without chewing or the need for water. To create our fast dissolving tablets, we combine the taste masked active drug ingredients with fast dissolving tablet materials, which can include a variety of flavoring, coloring and sweetening agents, all of which are generally recognized as safe materials, and commonly used tablet ingredients, such as binding agents and lubricants. We add an effervescent system, composed of a dry acid and a dry base, to the tablet formulation to cause a mild effervescent reaction when the tablet contacts saliva. This reaction accelerates the disintegration of the tablet through the release of carbon dioxide. As our OraSolv tablet dissolves, it releases the coated particles of the drug into the saliva, forming a suspension of the drug in the saliva, which is then swallowed. The core U.S. patent for our OraSolv technology was granted in 1993.

     We mask the taste of the active drug ingredients in our OraSolv products to prevent or minimize unpleasant tastes. The active drugs are taste masked using a variety of coating techniques. The coating materials prevent the active drug substance in the OraSolv tablet from contacting the patient’s taste buds, and provide for the immediate or controlled release of the active ingredient in the stomach. The taste masking process is effective with a wide variety of active ingredients, in both prescription and non-prescription products.

     We have developed and manufacture several important OraSolv formulations, which include Triaminic Softchews for Novartis, Tempra FirsTabs for Bristol-Myers Squibb and Remeron SolTab for Organon. In addition, we are developing OraSolv formulations of Allegra for Aventis Pharmaceuticals, an undisclosed prescription product for Schering-Plough and an undisclosed prescription product for Alamo Pharmaceuticals, LLC.

     DuraSolv. The fast dissolve, taste masking and sustained release attributes of OraSolv are also available with our DuraSolv technology. DuraSolv is a fast dissolve oral dosage system that we designed to improve manufacturing efficiency, provide more packaging options and reduce production costs. DuraSolv is a higher compaction, more durable, solid oral dosage system formulated to achieve the primary benefits of the OraSolv fast dissolve dosage form. However, DuraSolv is capable of being packaged in conventional packaging such as foil pouches or bottles at much higher production rates and with lower packaging costs. DuraSolv is an appropriate technology for drug products requiring lower levels of active drug ingredient. Consumer testing by us and our pharmaceutical company partners has demonstrated high acceptability of this technology. The core U.S. patent for our DuraSolv technology was granted in 2000.

     We have developed and manufacture several important DuraSolv formulations, which include Alavert for Wyeth, AstraZeneca’s Zomig-ZMT and its equivalents marketed outside the U.S. and Nulev for Schwarz Pharma. In addition, we are developing seven new prescription products based on our DuraSolv fast dissolve drug delivery system for Schwarz Pharma.

     Sustained Release. Our OraSolv and DuraSolv technologies may be combined with a sustained release formulation to extend the period of an active drug ingredient’s effectiveness. We incorporate time-release beads into our tablets, to provide the benefits of a sustained release of an active drug ingredient with the improved convenience of a fast dissolve dosage form. To date, we have not commercialized a product incorporating our sustained release technology. In 2002, the U.S. Patent and Trademark Office issued a patent covering the use of OraSolv fast dissolve technology and our proprietary sustained release drug delivery technology with the active ingredient potassium chloride. Potassium chloride is typically prescribed as an adjunct therapy for the treatment of hypertension.

     PakSolv. PakSolv is our proprietary packaging system for soft, brittle tablets. PakSolv is a light and moisture-proof packaging system that is used for all of our OraSolv products. The U.S. Patent and Trademark Office issued two patents for our PakSolv packaging system in 2001.

5


Table of Contents

Transmucosal Technologies

     Our proprietary OraVescent technologies are designed to increase absorption of active drug ingredients across the mucosal membranes lining the oral cavity, gastrointestinal tract and colon. The enhanced absorption characteristics of an OraVescent formulation may improve the safety and efficacy of some active drug ingredients. Since 2001, the U.S. Patent and Trademark Office has issued four patents for our OraVescent technologies. We also have several foreign patent applications pending for our OraVescent technologies.

Microemulsions Technology

     Microemulsions technology is a proprietary technology that may improve the bioavailability (the rate at which a drug is absorbed or becomes available at the site of physiological activity after administration) of a wide range of active drug ingredients, which otherwise may not be suitable for administration in a solid oral dosage form. The U.S. Patent and Trademark Office issued a patent for our microemulsions technology in 2002. We are currently evaluating applications for this new technology.

Business Strategy

     Our objective is to become a leader in fast dissolve and other innovative oral drug delivery technologies. Our strategy to achieve this objective incorporates the following principal elements:

     Partner with pharmaceutical companies to develop and market new products based on our technologies. Our core business is to pursue collaborative relationships that leverage the sales and marketing capability of our pharmaceutical company partners, allowing us to focus on technology development and manufacturing. In these collaborative relationships, our partners pay us to develop new products for them based on our drug delivery technologies. We believe that pharmaceutical companies are attracted to our technologies for their significant advantages over our competition. Those advantages include excellent taste masking, applicability to a wide range of pharmaceutical compounds, enhanced convenience and other patient benefits. Our technologies also may enable pharmaceutical companies to differentiate their products in the market, facilitating the extension of product life cycles. By demonstrating the advantages and benefits of our technologies through our collaborations with leading pharmaceutical companies, we intend to establish our technology as the preferred fast dissolve drug delivery solution.

     Maximize the value of our drug delivery technologies by developing new products. Our proprietary products business is based on leveraging our technologies by actively identifying prescription products that could be differentiated or improved by incorporating our drug delivery technologies. We believe there are a large number of pharmaceutical products that are in the public domain or are about to lose patent protection that could benefit from our technologies. In these cases we may develop a new prescription product without a collaborative partner and ultimately seek FDA approval for what we believe will be promising applications of our drug delivery technologies and active drug ingredients. If our efforts are successful, we may license these new products to pharmaceutical companies with appropriate sales and marketing capabilities.

     Develop and commercialize new, innovative drug delivery technologies. We intend to develop new drug delivery technologies based on our expertise in fast dissolve, taste masking and sustained release technologies. Our OraVescent and microemulsions technologies represent an extension of this expertise, and we intend to continue developing these and other novel drug delivery technologies. We also intend to acquire or license attractive new technologies as we encounter such opportunities. In addition, we will seek patents and other intellectual property protection for new technologies to enhance our ability to commercialize them.

     Enhance and expand our manufacturing capabilities. In an effort to control our technologies and the quality of our products, we manufacture all of our products internally. We currently have two manufacturing lines at our Eden Prairie facility for product requiring blister packaging, which we expect will be adequate to meet our needs through 2003. On the basis of expected increased requirements for products that we manufacture for our current pharmaceutical partners, we have (1) added granulation capabilities and expanded taste masking capacity at our Eden Prairie facility, (2) ordered a new manufacturing line for blistered product at our Eden Prairie facility, which

6


Table of Contents

will either replace an older and less efficient manufacturing line or be added as a third production line and (3) ordered a new manufacturing line to be installed at our Brooklyn Park facility for bottled product. We expect that these expansions and enhancements will help mitigate manufacturing risks and increase our manufacturing capacity and will enhance our ability to market our products and services to pharmaceutical companies that require granulation or bottling capabilities.

Collaborations With Pharmaceutical Company Partners

     Our core business is focused on entering into collaborative development, licensing and manufacturing supply agreements with pharmaceutical companies. These agreements provide that the collaborating pharmaceutical company is responsible for marketing and distributing the developed products either worldwide or in specified markets or territories. Our collaborative agreements typically begin with a product prototyping phase. If successful, this phase may be followed by an agreement to complete development of the product. We subsequently enter into license and manufacturing supply agreements to commercialize the product. In some cases, we may develop product prototypes prior to being engaged by a pharmaceutical company and enter directly into development, manufacturing or license agreements for commercialization of those products.

     We currently have development and license agreements with AstraZeneca, Alamo Pharmaceuticals, Aventis Pharmaceuticals, Bristol-Myers Squibb, Organon, Novartis, Schering-Plough, Schwarz Pharma and Wyeth. In each of these agreements, we have received an up-front fee, which is typically a non-refundable payment for future product development activities. We have also received milestone and development payments under each of these agreements for achieving certain product development milestone events and for completing certain predetermined product development activities, as defined in the agreements. In the aggregate for all of our agreements with pharmaceutical companies, we recognized revenue of approximately $23.2 million, $14.3 million and $10.5 million in 2002, 2001 and 2000, respectively, for up-front fees, milestone and development payments and royalties.

     We have manufacturing supply agreements with Organon for Remeron SolTab, Novartis for Softchews, Wyeth for Alavert, Schering-Plough for an undisclosed prescription product, Schwarz Pharma for NuLev and seven undisclosed prescription products, Alamo Pharmaceuticals for an undisclosed prescription product and AstraZeneca for fast dissolve dosage forms of Zomig. We are currently negotiating a supply agreement with Aventis Pharmaceuticals for a fast dissolve dosage form of Allegra. Due to the small production requirements for Tempra, we do not have, nor do we expect to enter into, a manufacturing supply agreement with Bristol-Myers Squibb. Generally, the supply agreements define (1) the terms by which we will manufacture and release for shipment a product for a pharmaceutical company partner, (2) obligations relating to payment for products and services, (3) the communication process, (4) expected production requirements and (5) other economic terms for product supply. These agreements have varying terms of duration ranging from three to ten years. In general, our pharmaceutical company partners direct our production and shipments. In the pharmaceutical industry, parties to manufacturing supply agreements generally consider these arrangements long-term due to the complexity and lead-time required to qualify a new manufacturer with the FDA. The qualification of a new manufacturer can take up to a year while the new manufacturer completes scale-up, produces validation lots and implements stability programs. We do not consider the backlog for our products to be significant.

     We currently manufacture six pharmaceutical brands using our fast dissolve technologies for six major pharmaceutical company partners. Revenues from sales of our products were approximately 50%, 55% and 56% of our total revenue in 2002, 2001 and 2000, respectively. We also receive revenue from royalties on product sales from these six pharmaceutical company partners, which were approximately 25%, 17% and 7% of our total revenue in 2002, 2001 and 2000, respectively. Finally, our revenue also includes product development fees and licensing revenue for development activities from a number of pharmaceutical companies, constituting approximately 25%, 28% and 37% of our total revenue in 2002, 2001 and 2000, respectively. See Note 10 to the financial statements contained elsewhere in this report for details regarding the distribution of revenue by geographical area for each of 2002, 2001 and 2000.

     The table below sets forth the partner, product brand name or active ingredient, therapeutic application, technology and current status for each of our major collaborative agreements.

7


Table of Contents

                 
    PRODUCT            
    BRAND NAME            
PHARMACEUTICAL   OR ACTIVE   THERAPEUTIC       CURRENT
COMPANY PARTNER   INGREDIENT   APPLICATION   TECHNOLOGY   STATUS

 
 
 
 
Alamo Pharmaceuticals, LLC   Undisclosed   Undisclosed   OraSolv   In development
                 
AstraZeneca   Zomig-ZMT and equivalents outside the U.S.   Anti-migraine   DuraSolv   Commercially available in the U.S., Europe and Japan
                 
Aventis Pharmaceuticals   Allegra   Non-sedating
antihistamine
  OraSolv   In development
                 
Bristol-Myers Squibb   Tempra FirsTabs   Pediatric pain
reliever
  OraSolv   Commercially
available in Canada
                 
Organon   Remeron SolTab   Anti-depression   OraSolv   Commercially available in the U.S. and Europe
                 
Novartis   Triaminic Softchews   Pediatric cold, cough and allergy   OraSolv   Commercially available in the U.S. and Canada
                 
Schering-Plough   Undisclosed   Undisclosed   OraSolv   In development
   
Schwarz Pharma   1) NuLev

2) Seven
undisclosed
products
  1) Gastrointestinal

2) Undisclosed
  1)DuraSolv

2) DuraSolv
  1) Commercially available in the U.S.
2) In development
                 
Wyeth   Alavert   Non-sedating
antihistamine
  DuraSolv   Commercially available in the U.S.

Alamo Pharmaceuticals

     In March 2001, we entered into a product development, worldwide license and supply agreement for an OraSolv formulation of an undisclosed prescription product. At the time of entering into this collaborative agreement, we did not consider the revenues to be generated under this agreement to be material, and chose not to disclose the arrangement until we had successfully developed a fast dissolve product and Alamo Pharmaceuticals had submitted a regulatory submission for this product. In February 2003, Alamo Pharmaceuticals informed us that a regulatory submission for the fast dissolve product we developed had been submitted to the FDA. Under the agreement, we receive license and product development fees, milestone payments upon achieving specific milestones, and will receive manufacturing revenues and royalties on any sales of the undisclosed prescription product. The license agreement expires upon expiration of all patents covered under the agreement, the first of which expires in the U.S. in 2010. However, the license agreement may be terminated by either party upon the occurrence of a default event, such as a material breach of the agreement, which is not cured by the defaulting party within 60 days. For the three years ended December 31, 2002, we recognized revenue of approximately $2.3 million in up-front fees and milestone and development payments attributable to our agreement with Alamo Pharmaceuticals. In 2002, these revenues represented about 3% of our total revenues.

AstraZeneca

     In May 1999, we entered into a definitive global license agreement with an affiliate of AstraZeneca for a DuraSolv formulation of AstraZeneca’s Zomig (zolmitriptan) tablets. Under the license agreement, which is exclusive for the class of anti-migraine compounds of which Zomig is a member, we receive license and product development fees, payments upon achieving specific milestones, and royalties on any sales of the prescription

8


Table of Contents

product. The license agreement expires upon expiration of all patents covered under the agreement, the first of which expires in the U.S. in 2018. However, the license agreement may be terminated by AstraZeneca for any reason after notice of 180 days or by either party upon the occurrence of a default event, such as a material breach of the agreement, that is not cured by the defaulting party within 30 days. If AstraZeneca fails to meet minimum sales requirements or to pay the difference between the royalty amount due on the minimum sales requirements and the royalty amount due on actual sales, we may convert AstraZeneca’s exclusive license into a non-exclusive license. In August 2001, we entered into a supply agreement with an affiliate of AstraZeneca, which expires on a country-by-country basis at the same time as the definitive global license agreement expires. Under the supply agreement, we receive payments for manufacturing fast-dissolve versions of Zomig. The supply agreement may be terminated by either party upon the occurrence of a default event, such as a material breach of the agreement, which is not cured by the defaulting party within 45 days of notice, or by CIMA in the event AstraZeneca commercializes another fast dissolve formulation of Zomig (zolmitriptan) with a third party. For the three years ended December 31, 2002, we recognized revenue of approximately $18.7 million in net sales of products, up-front fees, milestone and development payments, and royalties attributable to our agreements with AstraZeneca. In 2002, these revenues represented about 19% of our total revenues.

Aventis Pharmaceuticals

     In September 2002, we announced the signing of a product development and worldwide license agreement for an OraSolv formulation of Allegra (fexofenadine), a prescription non-sedating antihistamine. Under the agreement, we receive license and product development fees, milestone payments upon achieving specific milestones, and will receive royalties on any sales of the prescription product. The license agreement expires upon expiration of all patents covered under the agreement, the first of which expires in the U.S. in 2010. However, the license agreement may be terminated by Aventis for any reason after notice of 60 days, or 180 days if the product is being manufactured by CIMA or by either party upon the occurrence of a default event, such as a material breach of the agreement, which is not cured by the defaulting party within 60 days. We are currently negotiating a manufacturing and supply agreement with Aventis. For the three years ended December 31, 2002, we recognized revenue of approximately $2.0 million in up-front fees and milestone and development payments attributable to our agreements with Aventis Pharmaceuticals. In 2002, these revenues represented less than 3% of our total revenues.

Bristol-Myers Squibb

     In June 1997, we entered into a multi-country, non-exclusive license agreement with Bristol-Myers Squibb, covering multiple products to be developed using our OraSolv technology. Tempra FirsTabs is the only product we developed under this agreement and no other new products are expected. The license agreement provides that upon the occurrence of a default event, such as a material breach of the agreement, which is not cured by the defaulting party within 60 days, either party may terminate the agreement. In November 2000, we amended the license agreement to provide that Bristol-Myers Squibb may not terminate the license agreement before December 31, 2005, and afterwards may terminate for any reason by giving us 60 days written notice and paying us any royalty payments accruing through the termination date. We expect to continue to receive at least minimum royalty payments through 2005. We do not have a supply agreement with Bristol-Myers Squibb, but we receive payments for manufacturing Tempra FirsTabs. For the three years ended December 31, 2002, we recognized revenue of approximately $1.4 million in net sales of products and royalties attributable to our agreement with Bristol-Myers Squibb. In 2002, these revenues represented less than 1% of our total revenues.

Novartis

     In July 1998, we entered into a license and a supply agreement with Novartis Consumer Health, granting to Novartis exclusive rights to use our OraSolv technology with Novartis’ Triaminic non-prescription pediatric cold, cough and allergy product line in the U.S. and Canada. Triaminic products that have been formulated using our OraSolv fast dissolve delivery system are marketed under the tradename Softchews. The license agreement, which was amended in April 2001, expires on a country-by-country basis upon the later of January 12, 2010 or the expiration of all patents covered by the agreement, the first of which expires in the U.S. in 2010. The July 1998 supply agreement was superseded by a new supply agreement in 2001, which has a term of five years and includes an automatic renewal provision subject to agreement on product pricing for the renewal periods. Under the supply agreement, we receive payments for manufacturing Triaminic Softchews. Novartis may terminate the supply

9


Table of Contents

agreement by providing 90 days notice to CIMA prior to the end of the initial five year term or any renewal period. In addition, either of the license or the supply agreement may be terminated by either party upon the occurrence of a default event, such as a material breach, which is not cured by the defaulting party within 90 days for the license agreement or within 60 days for the supply agreement. In addition, Novartis may terminate the license agreement on or after July 1, 2003, after giving us a notice of nine months and paying us a termination fee of $200,000 plus all accrued amounts owed to us under the agreement. Under various individual product development agreements, which apply to specific Triaminic products, we receive product development payments. We also receive royalties on sales of Softchews products under the license agreement. For the three years ended December 31, 2002, we recognized revenue of approximately $24.9 million in net sales of products, development payments and royalties attributable to these agreements with Novartis. In 2002, these revenues represented less than 13% of our total revenues.

Organon

     In December 1999, we entered into a definitive global license agreement with two affiliates of Akzo Nobel NV, Organon International AB and NV Organon, for an OraSolv formulation of Remeron (mirtazapine), a prescription anti-depression product. Under the license agreement, we receive license and product development fees, milestone payments upon achieving specific milestones, and royalties on any sales of the prescription product. The license agreement expires upon expiration of all patents covered under the agreement, the first of which expires in the U.S. in 2010. However, the license agreement may be terminated by either party upon the occurrence of a default event, such as a material breach of the agreement, which is not cured by the defaulting party within 90 days. In July 2000, we entered into a supply agreement with Organon Inc., a U.S. affiliate Akzo Nobel NV, which has an initial term of five years and automatic renewal provisions. Under the supply agreement, we receive payments for manufacturing Remeron SolTab. The supply agreement may be terminated by either party upon the occurrence of a default event, such as a material breach of the agreement, which is not cured by the defaulting party within 60 days of notice. For the three years ended December 31, 2002, we recognized revenue of approximately $30.4 million in net sales of products, up-front fees, milestone and development payments, and royalties attributable to these agreements with Organon. In 2002, these revenues represented more than 32% of our total revenues.

Schering-Plough

     In May 2002, we announced the signing of a product development, license and supply agreement for an OraSolv formulation of an undisclosed prescription product. Under the agreement, we receive license and product development fees, milestone payments upon achieving specific milestones, and will receive manufacturing revenues and royalties on any sales of the prescription product. The agreement expires upon expiration of all patents covered under the agreement, the first of which expires in the U.S. in 2010. However, the agreement may be terminated by Schering-Plough for any reason after notice of 90 days, or 180 days if the product is being manufactured by CIMA or by either party upon the occurrence of a default event, such as a material breach of the agreement, which is not cured by the defaulting party within 90 days. For the three years ended December 31, 2002, we recognized revenue of approximately $1.6 million in up-front fees and milestone and development payments attributable to our agreements with Schering-Plough. In 2002, these revenues represented about 1% of our total revenues.

Schwarz Pharma

     In June 2000, we entered into an exclusive development, license and supply agreement with Schwarz Pharma, Inc. to develop and manufacture NuLev, our DuraSolv formulation of a hyoscyamine sulfate prescription product, which is used to treat irritable bowel syndrome. The June 2000 agreement allows us, upon the failure of Schwarz Pharma to meet minimum sales requirements, to convert Schwarz Pharma’s exclusive license into a non-exclusive license. The June 2000 agreement expires upon the expiration of all patents covered by the agreement, the first of which expires in the U.S. in 2018. However, the June 2000 agreement may be terminated by either party upon the occurrence of a default event, such as a material breach of the agreement, which is not cured by the defaulting party within 60 days. Under the June 2000 agreement, we receive milestone payments upon achieving specific milestones as well as payments for manufacturing NuLev and royalties on Schwarz Pharma’s sales of NuLev.

     In December 2001, we entered into an exclusive development, license and supply agreement with Schwarz Pharma to develop and manufacture an additional seven undisclosed prescription products based primarily on our

10


Table of Contents

DuraSolv fast dissolve drug delivery system. Based on confidentiality concerns of Schwarz Pharma, we previously agreed to keep confidential the identity of Schwarz Pharma as a party to this agreement, and referred to Schwarz Pharma as an unnamed pharmaceutical company in our previous filings and public statements. The expiration and termination provisions of the December 2001 agreement are comparable to the expiration and termination provisions of the June 2000 agreement. In addition, Schwarz Pharma may unilaterally terminate the December 2001 agreement, in its entirety or in part, at any time prior to the market launch of any or all of the seven products by providing notice to CIMA and reimbursing CIMA for its development activities. Under the December 2001 agreement, we receive license and product development fees, milestone payments upon achieving specific milestones, and will receive manufacturing revenues and royalties on any sales of the seven undisclosed prescription products. Schwarz Pharma will be required to obtain FDA approval for each of the seven undisclosed products prior to the marketing of such products.

     For the three years ended December 31, 2002, we recognized revenue of approximately $12.1 million in net sales of products, up-front fees, milestone and development payments, and royalties attributable to the June 2000 and December 2001 agreements with Schwarz Pharma. In 2002, these revenues represented less than 18% of our total revenues. The December 2001 agreement with Schwarz Pharma provides for license and product development fees and milestone payments in the aggregate amount of $15.0 million. This is the greatest amount of such fees and payments that we may receive under this agreement. We could receive a substantially smaller amount of fees and payments for many reasons, including if we fail to achieve certain milestones or if Schwarz Pharma exercises its option to terminate the agreement. The aggregate amount of development fees and milestone payments set forth in the December 2001 agreement should not be viewed as guaranteed future payments.

Wyeth

     In January 2000, we entered into an exclusive development and license agreement and a supply agreement with Wyeth for a DuraSolv formulation of prescription loratadine, a non-sedating antihistamine. Under the January 2000 development and license agreement, we received development and milestone payments upon achieving specific milestones. Schering-Plough has several U.S. patents for loratadine, the active drug compound in both Claritin and Claritin Reditabs. In August 2002, a federal district court ruled that claims by Schering-Plough alleging that generic versions of loratadine violated Schering-Plough’s patent were not valid. This ruling permitted the production and sale of generic versions of loratadine after December 19, 2002. In November 2002, the FDA approved over-the-counter sales of prescription formulations of Claritin at their original prescription strengths. In response to the foregoing events, Wyeth desired to produce and sell an over-the-counter loratadine product instead of a prescription loratadine product. Because our January 2000 agreements with Wyeth related solely to development of a loratadine prescription product, we do not anticipate any additional revenues from those agreements.

     In anticipation of the events described above, in May 2002 we entered into a development and license agreement and a supply agreement with Wyeth for an over-the-counter version of Claritin Reditabs using our DuraSolv formulation. In December 2002, we announced that Wyeth received FDA approval of its New Drug Application for Alavert, an over-the-counter equivalent to Claritin Reditabs, using our DuraSolv formulation. In February 2003, Wyeth received its second FDA approval for its Abbreviated New Drug Application for a DuraSolv loratadine product, which is identical to Alavert, but was initially intended for the prescription market. We believe that this second FDA approval of a DuraSolv loratadine product may prevent other pharmaceutical companies from receiving final FDA approval based on an Abbreviated New Drug Application for a competitive fast-dissolve formulation of loratadine until at least 180 days after Wyeth’s launch of Alavert on December 20, 2002. The May 2002 development and license agreement expires upon the expiration of all patents covered by the agreement, the first of which expires in the U.S. in 2018. The May 2002 supply agreement expires in December 2012. However, both of these agreements may be terminated by Wyeth for any reason after a six month notice or by either party upon the occurrence of a default event, such as a material breach of the agreement, which is not cured by the defaulting party within 60 days. Under the May 2002 development and license agreement, we receive development payments and royalties on any sales of Alavert. Under the May 2002 supply agreement, we receive payments for manufacturing Alavert.

11


Table of Contents

     For the three years ended December 31, 2002, we recognized revenue of approximately $6.6 million in net sales of products, up-front fees, milestone and development payments and royalties attributable to the January 2000 and May 2002 agreements with Wyeth. In 2002, these revenues represented more than 10% of our total revenues.

Proprietary Product Development

     In addition to entering into collaborations with pharmaceutical companies, we also expect to leverage our oral drug delivery technologies by actively identifying promising applications using active drug ingredients that have already been successfully marketed by leading pharmaceutical companies. We are selecting, funding and developing products on an internal basis and will be responsible for securing FDA approvals for such products. We plan to sell or license the marketing rights to these products to pharmaceutical companies with the appropriate sales and marketing organizations. We believe this strategy represents an important opportunity for CIMA because it eliminates the need for a collaborative agreement before developing additional products for our product pipeline. Equally important, we expect to retain a greater proportion of the economic value of those proprietary products that we successfully develop.

     To date, we have selected five proprietary products based on major active drug ingredients that are either off-patent or expected to become off-patent within the next few years. These proprietary products fall within the therapeutic categories of anti-infectives, cardiovascular, gastrointestinal and pain.

     We have conducted four studies in humans with OraVescent fentanyl, a potential proprietary product for the treatment of breakthrough cancer pain. Our first study in humans compared our OraVescent BL formulation to a similar formulation without absorption enhancing characteristics and to Actiq, a commercially available prescription product. Actiq (oral transmucosal fentanyl citrate) is indicated for breakthrough cancer pain in patients already receiving, and tolerant to, opioid therapy for underlying, persistent cancer pain. We believe this first study in humans demonstrates OraVescent BL’s superior absorption enhancing characteristics across mucosal membranes when compared to Actiq and to the other formulation without absorption enhancing characteristics. Our second study in humans compared our OraVescent SL to our OraVescent BL formulation using the same active drug ingredient contained in Actiq. We believe this second study demonstrates a quicker onset of action with OraVescent SL when compared to our OraVescent BL formulation. Our third study in humans compared Actiq with OraVescent BL and OraVescent SL under simulated self-administration conditions. We believe preliminary results from the third study confirmed the results from our first two studies in humans. In November 2001, we participated in a pre-Investigational New Drug meeting with the FDA to discuss our OraVescent fentanyl human data and a possible clinical development path. In 2002, we submitted our Investigational New Drug submission to the FDA, and we completed our first pharmacokinetic clinical study designed to compare OraVescent fentanyl and Actiq at a low and high dosage level. In 2003, based on the outcome of these clinical studies, we expect to perform formulation activities to optimize the product, to conduct additional studies in humans and to complete our assessment of the commercial manufacturability of this product.

     Fentanyl citrate, the active drug ingredient in our OraVescent fentanyl product, is classified as Schedule II substance under the Controlled Substances Act and regulated by the U.S. Drug Enforcement Agency, or DEA. Schedule I substances are considered to present the highest risk of substance abuse and Schedule V substances the lowest. In addition, regulations under the Occupational Safety and Health Act establish certain standards related to safety in handling and manufacturing potent substances, such as fentanyl citrate. Under these regulations, we believe fentanyl citrate would require a specialized manufacturing environment that prevents fentanyl citrate from coming in contact with humans. None of our existing production lines could be used to manufacture OraVescent fentanyl, or any other product with a similar safety profile. We are presently assessing the feasibility of contracting with a third party manufacturer capable of manufacturing products containing potent substances or developing these capabilities internally. If we decide to manufacture OraVescent fentanyl in our facilities, we will be required to add potent substance manufacturing capabilities that comply with these safety regulations, which could require capital expenditures in excess of $10.0 million.

     In April 2002, we announced the issuance of a patent by the U.S. Patent and Trademark Office for a fast dissolve, sustained release potassium chloride product, which is typically prescribed as an adjunct therapy for the treatment of hypertension. The patent covers the use of our OraSolv SR/CR fast dissolve, sustained release drug delivery technology with the active ingredient potassium chloride. This is our first patent covering both an active

12


Table of Contents

ingredient and our drug delivery technology. We are currently evaluating potential business opportunities for a proprietary product based on this patent.

     Our progress to date on the three other proprietary products has not gone beyond the pilot study phase, which includes acquiring active drug ingredients and preliminary planning. We expect to begin work on one or more of these three proprietary products in 2003. These proprietary products are expected to incorporate active drug ingredients with one of our proprietary oral drug delivery technologies. However, the active drug ingredients for these three products are currently protected by U.S. patents registered to third parties, the first of which expires in early 2005.

Intellectual Property

     We actively seek, when appropriate, to protect our products and proprietary information by means of U.S. and foreign patents, trademarks and contractual arrangements. We hold 17 issued U.S. patents and 18 issued foreign patents covering our technologies. The core U.S. and European patents relate to our fast dissolve and taste masking technologies. We also have over 45 U.S. and foreign patent applications pending.

     A description of our more important issued U.S. patents and their dates of expiration are set forth in the table below. The majority of these patents are composition-of-matter patents. The actual scope of coverage for a patent is governed by the specific claims applicable to the patent. The descriptions set forth below are intended solely to identify patents relevant to various technologies and are not intended to represent the scope of these patents.

         
    EXPIRATION DATE
PATENTED TECHNOLOGIES    

 
Core OraSolv fast dissolve and taste masking technology     2010  
         
The production of compressed effervescent and non-effervescent tablets using a tableting aid developed by us.     2010
  and
2012
 
         
The formulation of a base coated, acid effervescent mixture manufactured by controlled acid base reaction. The obtained mixture can be used in the formulation of acid sensitive compounds with OraSolv technology or other effervescent based products     2013  
         
Taste masking of micro-particles for oral dosage forms     2015  
         
Core DuraSolv fast dissolve and taste masking technology     2018  
         
Blister package and packaged tablet     2018  
         
Fast dissolve oral dosage form containing potassium chloride     2018  
         
Core OraVescent oral transmucosal drug delivery technology     2019  
         
Core OraVescent gastrointestinal drug delivery technology     2019  
         
Microemulsions as solid oral dosage forms     2019  
         
PakSolv technology covering part of packaging system     2019  
         
PakSolv technology covering additional aspects of packaging system     2019  
         
Orally disintegrating tablet that forms a viscous slurry of microcapsules or powder     2019  

     Our success will depend in part on our ability to obtain and enforce patents for our products, processes and technology, to preserve our trade secrets and other proprietary information and to avoid infringing the patents or proprietary rights of others.

     In addition to patents, we rely on trade secrets and proprietary know-how to protect our products, processes and technologies. To protect our rights to trade secrets and proprietary know-how, we require all employees, consultants and advisors to sign confidentiality agreements that prohibit the disclosure or use of confidential information to or by any third party. These agreements also require disclosure and assignment to us of discoveries and inventions made by these individuals while devoted to our activities.

13


Table of Contents

Research and Development

     Our research and product development efforts are focused on developing new product applications for our drug delivery technologies and expanding our technology platform to new areas of drug delivery. As of December 31, 2002, we had 74 scientists and other technicians working on research and product development. In August 2001, we purchased for $5.2 million a building in Brooklyn Park, Minnesota, which we currently use for our research and development center and will use as a second manufacturing site in 2003. During 2003, we expect to complete the renovation and expansion of our Brooklyn Park research and development facility, which was begun in 2002, at an estimated capital cost of $18.3 million, exclusive of capital costs to add a second manufacturing site.

     Our research and product development personnel, support systems and facilities are organized to develop drug delivery formulations from bench-scale through one-tenth of the commercial scale production under current good manufacturing practices conditions. The key goals for our research and product development efforts include:

    developing innovative drug delivery products and systems that fulfill pharmaceutical companies’ needs;
 
    developing, expanding and supporting systems to fulfill good manufacturing practices production at commercial levels required by pharmaceutical company partners;
 
    recruiting and training high-quality technical and scientific personnel; and
 
    supporting our intellectual property portfolio development.

     For the years ended December 31, 2002, 2001 and 2000, we spent approximately $10.9 million, $6.4 million and $5.0 million, respectively, on research and product development. We estimate that most of these expenditures were directly related to product development activities for which we received fees and licensing revenues from our pharmaceutical company partners.

Business Development

     We market directly to leading pharmaceutical companies for products that we believe would benefit from our fast dissolve technologies. Our strategy has been to leverage the brand names, marketing and sales capabilities of these pharmaceutical companies to maximize the value of our fast dissolve drug delivery technologies. We build our credibility with major pharmaceutical companies by speaking at technical seminars, publishing in technical journals and exhibiting at pharmaceutical and drug delivery conferences.

     We pursue agreements with leading pharmaceutical companies to fund the development of new products incorporating our drug delivery technologies. Once specific milestones have been met under these agreements, we generally enter into license and supply agreements.

Manufacturing

     Currently, our only manufacturing facility is located at our headquarters in Eden Prairie, Minnesota. We have two production lines for product requiring blister packaging, which collectively have an estimated production capacity in excess of 500 million tablets a year. We anticipate that our existing manufacturing capacity is adequate to meet the production requirements of our pharmaceutical partners in 2003. We plan to either replace the oldest of our two Eden Prairie based production lines or to add a third production line at our Eden Prairie facility, and expect the replaced or additional manufacturing line to be completed and commissioned in the first half of 2004. We plan to construct a second manufacturing site at our Brooklyn Park facility, which we expect to be completed and commissioned in the fourth quarter of 2003.

     In 2002, we commissioned a high shear granulation unit and a second coating unit at a total capital cost of $7.9 million. We expect that the high shear granulation unit, coupled with the additional coating unit, will enable us to develop, and ultimately commercialize, a broader range of prescription products. The products we are developing for Aventis Pharmaceuticals and Schering-Plough will require these additional manufacturing capabilities. In addition, we may require these capabilities in the future for those products we may develop that have taste masking challenges based on the particle size of the active drug ingredient or require a high dose of active drug ingredient relative to the desired tablet size.

     The decision to replace an existing production line or add a third line at our Eden Prairie facility will depend on our order position at the time we take delivery of the new equipment. We ordered the new production

14


Table of Contents

equipment during the fourth quarter of 2002, and we expect to take delivery of this equipment in the second half of 2003. The new production equipment we have ordered will be identical to the production line we added in 2000, which is expected to result in greater efficiencies in terms of using common supplies, parts and operating procedures, as well as increase manufacturing capacity of blister packaged tablets. Upon delivery of the new equipment, if we decide to replace an existing production line, the older line will be removed, and we will renovate the manufacturing suite in which the new equipment will be installed. In addition, should we decide to replace one of our two existing production lines, we are currently assessing the feasibility of utilizing the old production line in our Brooklyn Park research and development center for scale-up activities for products under development. Once the new production line is commissioned, which is expected to occur in the first half of 2004, we estimate that our total annualized capacity in Eden Prairie will increase from approximately 500 million to more than 700 million tablets if we replace an existing production line, or to approximately 1.0 billion tablets if we add a new production line to the two existing production lines.

     We currently purchase from single sources of supply, or our collaborative partners provide to us without charge, the active drug ingredients that are required to manufacture our products. The inactive drug ingredients and packaging materials used to manufacture our products are generally readily available from multiple suppliers. If we are unable to purchase adequate supply of active drug ingredients, inactive drug ingredients and packaging materials from our current suppliers, our manufacturing operations could be interrupted. We may be unable to identify alternative sources of supply, and even if we do identify alternative sources of supply, our manufacturing operations may be interrupted until we successfully complete a validated qualification process of those sources and negotiate trading terms.

     We are assessing the feasibility of adding capacity for the manufacture of products containing potent substances, such as fentanyl citrate. In the event we decide to add such capacity, we estimate that the capital expenditure required to construct and install a manufacturing line for potent substances could exceed $10.0 million and take up to 24 months to fully implement. Our capital expenditure plans for 2003 do not currently include this investment, and we do not expect to make a decision regarding potent substance manufacturing capability before the second half of 2003.

     PakSolv, our proprietary packaging process, allows high-speed packing of soft, brittle tablets without breakage into specially designed protective, child resistant packages and normal blister packages. We believe that this technology, which has two issued patents, gives us a competitive advantage.

     We plan our manufacturing cycles in advance of actual production in order to address lead times our suppliers may require. We generally do not stock significant quantities of raw materials for a product in excess of a partner’s orders nor do we manufacture finished product in excess of a partner’s orders.

Competition

     Competition among pharmaceutical products and drug delivery systems is intense. Our primary competitors for developing drug delivery systems and manufacturing the products we develop include other drug delivery, biotechnology and pharmaceutical companies. Many of these competitors have substantially greater financial, technological, manufacturing, marketing, managerial and research and development resources and experience than we have. Our products compete not only with products employing advanced drug delivery systems, but also with products employing conventional dosage forms. These competing products may obtain governmental approval or gain market acceptance more rapidly than our products. New drugs or future developments in alternative drug delivery technologies also may provide therapeutic or cost advantages over our current or future products.

     Many of our pharmaceutical company partners face intense competition from manufacturers of generic drugs. Generic competition may reduce the demand and/or price for our partners’ products. Products that our pharmaceutical company partners produce may also be subject to regulatory actions that result in prescription products becoming available to consumers over-the-counter. Such a change could also reduce the demand and/or price for our partners’ products. Because we derive a significant portion of our revenue from manufacturing products for and receipt of royalties from our pharmaceutical company partners, a decline in the sales of products that we produce for our partners, whether as a result of the introduction of competitive generic products or other competitive factors, could have a material adverse effect on our revenues and profitability.

15


Table of Contents

     Fast dissolve tablet technologies that compete with our OraSolv and DuraSolv technologies include the Zydis technology developed by an affiliate of Cardinal Health, Inc., the WOWTab technology developed by Yamanouchi Pharma Technologies, the Flashtab technology developed by Ethypharm, the FlashDose technology developed by an affiliate of Biovail Corporation and OraQuick technology developed by KV Pharmaceutical Company. The Zydis technology is a fast dissolving oral drug delivery system based on a freeze-dried gelatin tablet. The WOWTab, Flashtab and OraQuick technologies are fast dissolving technologies used in an oral fast dissolving tablet, which are similar to our DuraSolv tablet. The FlashDose technology is used in an oral fast dissolve tablet, which is similar to our OraSolv tablet, but has not yet been commercialized with an FDA approved prescription product. Cardinal Health has commercialized its Zydis technology in several major prescription products in the U.S., including Claritin Reditabs, Maxalt-MLT and Zyprexa Zydis. KV Pharmaceutical Company has announced that they will commercialize their first OraQuick technology product with the introduction in 2003 of a product that is generically equivalent to Schwarz Pharma’s NuLev, which we developed based on our DuraSolv technology. On March 17, 2003, CIMA and Schwarz Pharma filed a complaint in federal district court against KV Pharmaceutical Company alleging infringement of one or more of our patents covering our DuraSolv technology. SPI Pharma, Inc., a wholly-owned subsidiary of Associated British Foods plc, recently announced Pharmaburst, a specially engineered excipient system that is capable of rapid disintegration. At this time, we are not aware of any pharmaceutical products that are based on SPI Pharma’s Pharmaburst fast dissolve tablet delivery system. In addition, Eurand, a private specialty pharmaceutical company, recently announced that it has licensed a marketed, fast dissolve drug delivery technology, which is expected to be fully integrated into Eurand’s business in the second half of 2003. We believe there may be other pharmaceutical companies that are developing fast dissolve tablet technologies, which may compete with our technologies in the future.

     The principal competitive factors in the market for fast dissolving tablet technologies are compatibility with taste masking techniques, packaging, dosage capacity, drug compatibility, cost, ease of manufacture, patient acceptance and required capital investment for manufacturing. We believe that our fast dissolving tablet technologies compete favorably with respect to each of these factors. In a 1997 quantitative consumer study that we conducted, consumers generally preferred the OraSolv formulation to the Cardinal Health Zydis’ formulation of the same active drug ingredient. Our 1997 study was confirmed by an August 2001 study we sponsored that measured migraine sufferers’ preferences between Zomig-ZMT, a CIMA DuraSolv formulation, and Maxalt-MLT, a Cardinal Health Zydis formulation. The 2001 study indicated that 70% of the study subjects preferred CIMA’s DuraSolv formulation, compared to 27% favoring the Zydis formulation. We also believe that we offer pharmaceutical companies the largest selection of oral fast dissolve drug delivery technologies.

Government Regulation

     Numerous governmental authorities in the U.S. and other countries extensively regulate the activities of pharmaceutical manufacturers. In the U.S., pharmaceutical products are subject to rigorous regulation by the Food and Drug Administration. The Federal Food, Drug, and Cosmetic Act and other federal and state statutes and regulations govern, among other things, the research, development, testing, manufacture, safety, storage, record keeping, labeling advertising, promotion, marketing and distribution of pharmaceutical products. If we fail to comply with the applicable requirements, we may be subject to administrative or judicially imposed sanctions such as warning letters, fines, injunctions, product seizures or recalls, total or partial suspension of production, or FDA refusal to approve pending pre-market approval applications or supplements to approved applications, as well as criminal prosecution.

     FDA approval generally is required before a new drug product may be marketed in the U.S. Many over-the-counter, or OTC, drug products are exempt, however, from the FDA’s pre-marketing approval requirements. Whether or not products require FDA approval, drug products remain subject to various ongoing FDA regulations, including good manufacturing practices, labeling requirements and warning statements, advertising restrictions related to product labeling and drug ingredient specifications. Products and their manufacturing facilities are subject to FDA inspection, and failure to comply with applicable regulatory requirements may lead to administrative or judicially imposed penalties.

     We expect that our pharmaceutical company partners will seek any required FDA approvals in connection with the introduction of new products we develop for them under a collaborative agreement. The FDA submission

16


Table of Contents

and approval process may require significant commitments of our time and resources. The FDA approval process may delay or prevent the marketing of our products. We cannot be sure that approvals will be obtained, or that any such approvals will have the scope necessary for successful commercialization of these products. Even after an addendum or supplement to a new drug application is approved, existing FDA procedures may delay initial product shipment and materially reduce the period during which there is an exclusive right to exploit patented products or technologies.

     Prior to marketing a product internationally, we are likely to be required to obtain foreign regulatory approval. Foreign approval procedures vary from country to country and the time required for approval may result in delays in, or ultimately prevent, the marketing of a product. We expect our pharmaceutical company partners to obtain any necessary government approvals in foreign countries in connection with the introduction of new products we develop for them under a collaborative agreement. However, we may have to spend considerable amounts of time and resources to support the submission and approval of these foreign filings. In addition, our manufacturing facility may be subject to inspections by foreign agencies, similar to the FDA, to allow for the marketing of our products in a foreign country.

     Our manufacturing facility is registered with the FDA. We must inform the FDA of every drug product we have in commercial distribution and keep an updated list of those drugs. Our manufacturing facility also is inspected by the FDA and must comply with good manufacturing practices regulations at all times during the manufacture and processing of drug products. The FDA completed pre-approval inspections of our Eden Prairie and Brooklyn Park facilities in August 2000. We were not cited for any significant shortcomings relating to the pre-approval inspections nor were we cited for any significant shortcomings in compliance with good manufacturing practices regulations. We cannot guarantee that any future FDA inspections will proceed without any compliance issues requiring time and resources to resolve. Our facilities also must be inspected by, and we have received a license from, the Minnesota Board of Pharmacy for the manufacture of drug products.

     The Controlled Substances Act imposes various registration, record-keeping and reporting requirements, procurement and manufacturing quotas, labeling and packaging requirements, security controls and a restriction on prescription refills on certain pharmaceutical products. A principal factor in determining the particular requirements of this act, if any, applicable to a product is its actual or potential abuse profile. A pharmaceutical product may be listed as a Schedule I, II, III, IV or V substance, with Schedule I substances considered to present the highest risk of substance abuse and Schedule V substances the lowest. None of our current commercialized products are listed substances. However, fentanyl citrate, the active ingredient in OraVescent fentanyl, is a Schedule II controlled substance. Schedule II substances are subject to strict handling and record keeping requirements and prescribing restrictions. In addition, should we successfully develop an OraVescent fentanyl product that is approved for marketing by the FDA, we believe it is possible that it could be subject to state controlled substance regulation, and may be placed in more restrictive schedules than those determined by the U.S. Drug Enforcement Agency and FDA.

     In addition to the statutes and regulations described above, we also are subject to regulation under the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act and other federal, state and local regulations. We believe that we have complied with these laws and regulations in all material respects, and we have not been required to take any action to correct any material noncompliance. We are unable to predict, however, the impact on our business of any changes that may be made in these laws or of any new laws or regulations that may be imposed in the future. We cannot be sure that we will not be required to incur significant compliance costs or be held liable for damages resulting from any violation of these laws and regulations.

Employees

     As of January 20, 2003, we had 219 full-time employees, with 118 engaged in manufacturing and quality assurance, 74 in research and development and 27 in executive management and office support. None of our employees is subject to a collective bargaining agreement nor have we ever experienced a work stoppage. We believe our employee relations are good.

17


Table of Contents

Executive Officers of the Registrant

     Our executive officers and their ages as of March 31, 2003 are as follows:

             
Name   Age   Title

 
 
John M. Siebert, Ph.D.     63     President and Chief Executive Officer
John Hontz, Ph.D.     46     Chief Operating Officer
David A. Feste     52     Vice President, Chief Financial Officer and Secretary until March 31, 2003
James C. Hawley     49     Vice President, Chief Financial Officer and Secretary, effective April 1, 2003

     Each of our executive officers has an employment agreement. There are no family relationships between or among any of our executive officers or directors.

     John M. Siebert, Ph.D. has been our President and Chief Executive Officer since September 1995, President and Chief Operating Officer from July 1995 to September 1995, and has served as a director since May 1992. From 1992 to 1995, Dr. Siebert was Vice President, Technical Affairs at Dey Laboratories, Inc., a pharmaceutical company. From 1988 to 1992, Dr. Siebert worked at Bayer Corporation. Dr. Siebert has also been employed by E.R. Squibb & Sons, Inc., G.D. Searle & Co. and The Procter & Gamble Company. On March 18, 2002, Dr. Siebert announced that he will retire from the Company. Our Board of Directors has appointed a search committee to identify and recruit a new President and Chief Executive Officer.

     John Hontz, Ph.D. has been our Chief Operating Officer since January 2000. From 1997 to January 2000, Dr. Hontz was our Vice President of Research and Development. From 1995 to 1997, Dr. Hontz was senior Group Leader of Product Development at Glaxo Wellcome plc, a pharmaceutical company. From 1987 to 1995, Dr. Hontz was with Burroughs-Wellcome, which was acquired by Glaxo in 1995, most recently as Section Head of Product Development.

     David A. Feste will resign as our Vice President, Chief Financial Officer and Secretary effective March 31, 2003, but has agreed to remain on staff through June 30, 2003 to facilitate the transition of his duties. Mr. Feste has been our Vice President, Chief Financial Officer and Secretary since February 2000. From 1995 to 1999, Mr. Feste was Vice President and Chief Financial Officer for Orphan Medical, Inc., a pharmaceutical company. From 1992 to 1995, Mr. Feste was self-employed as a financial consultant. From 1985 to 1991, Mr. Feste was with Tonka Corporation, most recently as its Corporate Vice President of Financial Services and Audit.

     James C. Hawley will become our Vice President, Chief Financial Officer and Secretary effective April 1, 2003. From 2000 to March 2003, Mr. Hawley was a Principal and Vice President of Manchester Companies, Inc., an investment banking and management advisory firm. From 1999 to 2000, Mr. Hawley served as Chief Executive Officer of CARA Collision & Glass, a consolidator in the damaged vehicle repair business. From 1995 to 1998, Mr. Hawley served as President & Chief Executive Officer, as well as Executive Vice President of Operations and Finance, for Harmony Brook Inc., a developer and marketer of water purification systems. From 1991 to 1994, Mr. Hawley served as Executive Vice President, as well as Vice President of Finance & Operations and Chief Financial Officer of Orthomet Inc., a developer of implantable medical devices. Prior to 1991, Mr. Hawley spent 12 years at 3M Company in various positions culminating in his role as group controller of the pharmaceutical and dental products group.

18


Table of Contents

ITEM 2. PROPERTIES

     Prior to March 2002, we leased our 75,000 square foot facility in Eden Prairie, Minnesota, which houses our corporate headquarters, manufacturing facility and warehouse space. In March 2002, we purchased this facility at a capital cost of approximately $5.7 million pursuant to the terms of an option under our lease. The facility is currently our sole manufacturing facility and contains two production lines, a granulation suite, two coating units and a warehouse. In 2003, we expect to either replace one of our two production lines or to add a third production line at an estimated capital cost of $9.3 million. We ordered the production line equipment for this project in 2002 and we expect it to be delivered in the second half of 2003.

     In August 2001, we purchased a 107,000 square foot facility in Brooklyn Park, Minnesota at a capital cost of approximately $5.2 million. This facility currently houses our research and product development center. In 2002, we commenced a $10.0 million capital expenditure program to expand the research and product development capabilities of this facility, which we expect to complete in the first quarter of 2003 at a total capital cost of $18.3 million. The capital cost for this project exceeded our initial estimates by $8.3 million principally as a result of our decision to expand the Brooklyn Park facility from a 107,000 square foot to a 150,000 square foot facility in order to accommodate future growth. In 2003, we also expect to complete the addition of manufacturing capabilities to the Brooklyn Park facility, including a tablet press and a bottling line for products utilizing our DuraSolv fast dissolve delivery system, at an estimated capital cost of $8.3 million. We ordered the production line equipment for this project in 2002, and we expect it to be delivered in the first half of 2003.

     We believe that both of these facilities are adequate to meet our foreseeable requirements.

ITEM 3. LEGAL PROCEEDINGS

     On March 17, 2003, CIMA and Schwarz Pharma filed a complaint in the United States District Court for the District of Minnesota against KV Pharmaceutical Company and its wholly owned subsidiary Ethex Corporation. The complaint alleges that KV Pharmaceutical and Ethex are manufacturing and selling orally disintegrating hyoscyamine sulfate (0.125 mg) tablets in violation of one or more of CIMA’s patents covering its DuraSolv technology. CIMA manufactures NuLev, an orally disintegrating hyoscyamine sulfate (0.125 mg) product, for Schwarz pursuant to an exclusive license agreement. CIMA and Schwarz are seeking an injunction against further infringement of the patent and compensatory damages.

ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

Not applicable.

PART II.

ITEM 5. MARKET FOR REGISTRANT’S COMMON STOCK AND RELATED STOCKHOLDER MATTERS

     Our common stock is traded on the Nasdaq National Market under the symbol CIMA. The following table presents, for the periods indicated, the range of high and low closing sale prices for our common stock as reported on the Nasdaq National Market.

19


Table of Contents

                 
    High   Low
   
 
Year ended December 31, 2002:
               
First Quarter
  $ 35.45     $ 19.60  
Second Quarter
    28.60       18.94  
Third Quarter
    25.15       16.06  
Fourth Quarter
    28.58       22.10  
 
 
Year ended December 31, 2001:
               
First Quarter
  $ 73.38     $ 46.75  
Second Quarter
    85.75       43.05  
Third Quarter
    81.35       47.97  
Fourth Quarter
    62.40       30.05  

Holders

     On March 24, 2003 the last reported bid price of our common stock was $20.10 per share. We had 75 stockholders of record and an estimated 6,650 beneficial owners of our common stock as of March 24, 2003.

Dividends

     We have never declared or paid any dividends. We anticipate that all of our earnings, if any, will be retained for development of our business, and we do not anticipate paying any cash dividends in the foreseeable future.

ITEM 6. SELECTED FINANCIAL DATA

     This section presents our historical financial data. You should read carefully the financial statements included in this Annual Report, including the notes to the financial statements, and Management’s Discussion and Analysis of Financial Condition and Results of Operations. The income statement data for the years ended December 31, 2002, 2001 and 2000 and the balance sheet data as of December 31, 2002 and 2001 have been derived from our financial statements that have been audited by Ernst & Young LLP, independent auditors, and are included elsewhere in this Annual Report on Form 10-K. The statement of operations data for the years ended December 31, 1999 and 1998 and the balance sheet data as of December 31, 2000, 1999 and 1998 have been derived from financial statements that have been audited by Ernst & Young LLP, and are not included elsewhere in this Annual Report. Historical results are not necessarily indicative of future performance. See the notes to the financial statements for an explanation of the method used to determine the number of shares used in computing basic and diluted net income (loss) per share, and see Item 7 of this report for an explanation of accounting changes regarding revenue recognition under the caption “Recent Accounting Pronouncements.”

20


Table of Contents

Selected Financial Data

                                             
        (in thousands, except per share data)
        Year Ended December 31,
       
        2002   2001   2000   1999   1998
       
 
 
 
 
Statement of Operations Data:
                                       
Operating revenues:
                                       
 
Net sales
  $ 23,391     $ 17,756     $ 13,407     $ 4,839     $ 1,097  
 
Product development fees and licensing
    11,496       8,867       8,817       7,818       6,141  
 
Royalties
    11,738       5,403       1,695       735       374  
 
   
     
     
     
     
 
Total operating revenues
    46,625       32,026       23,919       13,392       7,612  
 
   
     
     
     
     
 
Operating expenses:
                                       
 
Costs of goods sold
    18,797       16,001       12,410       7,546       4,476  
 
Research and product development
    10,869       6,385       4,958       4,388       3,307  
 
Selling, general and administrative
    7,166       5,090       3,880       2,836       3,138  
 
   
     
     
     
     
 
Total operating expenses
    36,832       27,476       21,248       14,770       10,921  
 
   
     
     
     
     
 
Operating income (loss)
    9,793       4,550       2,671       (1,378 )     (3,309 )
Other income, net
    6,383       10,334       2,114       116       122  
 
   
     
     
     
     
 
Income (loss) before cumulative effect of a change in accounting principle and income tax benefit
    16,176       14,884       4,785       (1,262 )     (3,187 )
Cumulative effect of a change in accounting principle
                (799 )            
Income tax benefit
    2,441       104                    
Net income (loss)
  $ 18,617     $ 14,988     $ 3,986     $ (1,262 )   $ (3,187 )
 
 
   
     
     
     
     
 
Net income (loss) per share:
                                       
 
Basic
                                       
   
Net income (loss) per share before cumulative effect of a change in accounting principle
  $ 1.31     $ 1.03     $ .43     $ (.13 )   $ (.33 )
   
Net loss per share from cumulative effect of a change in accounting principle
                (.07 )            
 
 
   
     
     
     
     
 
 
Net income (loss) per basic share
  $ 1.31     $ 1.03     $ .36     $ (.13 )   $ (.33 )
 
 
   
     
     
     
     
 
 
Diluted
                                       
   
Net income (loss) per share before cumulative effect of a change in accounting principle
  $ 1.28     $ .97     $ .39     $ (.13 )   $ (.33 )
   
Net loss per share from cumulative effect of a change in accounting principle
                (.07 )            
 
 
   
     
     
     
     
 
 
Net income (loss) per diluted share
  $ 1.28     $ .97     $ .32     $ (.13 )   $ (.33 )
 
 
   
     
     
     
     
 
Weighted average of number of shares:
                                       
 
Basic
    14,193       14,559       11,151       9,615       9,610  
 
Diluted
    14,599       15,503       12,385       9,615       9,610  
                                         
    As of December 31,
   
Balance Sheet Data:   2002   2001   2000   1999   1998

 
 
 
 
 
Cash and investments
  $ 131,681     $ 149,504     $ 163,162     $ 2,481     $ 2,723  
Total assets
    225,353       198,931       189,462       19,270       14,916  
Accumulated deficit
    (8,386 )     (27,003 )     (41,991 )     (45,977 )     (44,715 )
Total stockholders’ equity
    213,301       194,777       186,925       11,574       12,656  

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

     The following discussion and analysis of our financial condition and results of operations should be read together with “Selected Financial Data” and our financial statements and related notes appearing elsewhere in this report. This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. The actual results may differ materially from those anticipated in these forward-looking statements as

21


Table of Contents

a result of many factors, including but not limited to those set forth under “Factors That Could Affect Future Results” and elsewhere in this report.

Overview

     We develop and manufacture pharmaceutical products based on our proprietary OraSolv and DuraSolv fast dissolve technologies. We currently manufacture six pharmaceutical brands utilizing our fast dissolve technologies: three prescription and three over-the-counter brands. The three over-the-counter brands are Triaminic Softchews for Novartis, Tempra FirsTabs for a Canadian affiliate of Bristol-Myers Squibb and Alavert for Wyeth. The three prescription brands are AstraZeneca’s Zomig-ZMT and its equivalent for markets outside the U.S., Remeron SolTab for Organon and NuLev for Schwarz Pharma. We are currently developing other oral drug delivery technologies for ourselves and others. We operate within a single business segment, the development and manufacture of fast dissolve and enhanced-absorption oral drug delivery systems. Our revenues are comprised of three components, including (1) net sales of products we manufacture for pharmaceutical companies using our proprietary fast dissolve technologies, (2) product development fees and licensing revenues for development activities we conduct through collaborative agreements with pharmaceutical companies, and (3) royalties on the sales of products we manufacture, which are sold by pharmaceutical companies under licenses from us.

     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 collaborative agreements and the level of our development activity conducted for pharmaceutical companies.

     Components of revenue, expenses, operating income, other income, tax benefits and net income as a percentage of total operating revenue for the years ending December 31:

                         
    2002   2001   2000
   
 
 
Net sales
    50.2 %     55.4 %     56.0 %
Product development fees & licensing revenues
    24.7 %     27.7 %     36.9 %
Royalty revenues
    25.2 %     16.9 %     7.1 %
Cost of goods sold
    40.3 %     50.0 %     51.9 %
Research & product development expense
    23.3 %     19.9 %     20.7 %
Selling, general & administrative expense
    15.4 %     15.9 %     16.2 %
Operating income
    21.0 %     14.2 %     11.2 %
Other income, net
    13.7 %     32.3 %     8.8 %
Tax benefit
    5.2 %     0.3 %     0.0 %
Net income
    39.9 %     46.8 %     16.7 %

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 these estimates under different assumptions or conditions.

22


Table of Contents

     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 of milestones; from up-front product development license fees as fees are amortized over the expected development term of the proposed products; and from royalties on the sales of products that we manufacture, which are sold by pharmaceutical companies under license from us. The determination of SAB 101 criteria (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.

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 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 year ended December 31, 2002, we have recorded a $6.4 million valuation allowance related to our net deferred tax assets of $17.8 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

Years Ended December 31, 2002, 2001 and 2000

     Operating Revenues. Our total operating revenues were $46.6 million in 2002, compared to $32.0 million in 2001 and $23.9 million in 2000. Operating revenues from AstraZeneca, Organon and Schwarz Pharma, our three largest pharmaceutical company partners in 2002, together represented approximately 69%, 55% and 52% of our total revenues in 2002, 2001 and 2000, respectively. In 2002, Schwarz Pharma replaced Novartis as one of our three largest pharmaceutical company partners. Novartis accounted for approximately 13% and 33% of total operating revenues in 2002 and 2001, respectively. The increases in total operating revenues in each year were due to sequentially increasing development activity for new products that resulted in higher product development fees and licensing revenue, as well as sequentially increasing sales of products we manufacture and royalties on sales by our pharmaceutical company partners under license from us.

     We are paid by our collaborative partners for the fast dissolve products that we manufacture and ship to them. These activities resulted in net sales of fast dissolve products of $23.4 million in 2002, compared to $17.8 million in 2001 and $13.4 million in 2000. The $5.6 million increase from 2001 to 2002 was primarily attributable to a net increase of $6.1 million in shipments of branded prescription products, which was partially offset by a net reduction in shipments of over-the-counter products that was caused by a year-over-year drop off in shipments of Triaminic Softchews. The $4.4 million increase from 2000 to 2001 was attributable to higher levels of shipments of both our brand prescription and over-the-counter products. In 2003, net sales of fast dissolve products are expected to increase in the range of 50% to 70% from 2002 levels.

23


Table of Contents

     We are paid product development and licensing revenues for our activities performed under collaborative agreements with pharmaceutical companies. These activities resulted in product development fees and licensing revenues of $11.5 million in 2002, compared to $8.9 million in 2001 and $8.8 million in 2000. The $2.6 million increase from 2001 to 2002 was primarily attributable to an increase in the number of collaborative projects in our product development portfolio, which included the achievement of certain milestones for Aventis and Schwarz Pharma. The $100,000 increase from 2000 to 2001 was not significant, with similar levels of development activity for proposed new products as well as the achievement of certain milestones for AstraZeneca, Novartis and Organon. Product development fees and licensing revenues include amortization of deferred revenue of $606,000, $400,000 and $1.3 million in 2002, 2001 and 2000, respectively. In 2003, product development fees and licensing revenues are expected to be slightly above 2002 levels.

     We are paid royalties based on our collaborative partners’ sales of fast dissolve products developed and manufactured by CIMA. Our collaborative partners’ sales of CIMA manufactured fast dissolve products amounted to approximately $236.0 million in 2002, up from nearly $103.0 million in 2001 and up from about $19.0 million in 2000. As a result, we recognized royalties of $11.7 million in 2002, compared to $5.4 million in 2001 and $1.7 million in 2000. The $6.3 million increase in royalties from 2001 to 2002 was attributable to strongly growing worldwide sales of fast dissolve versions of Zomig and Remeron SolTab, as well as the U.S. market introduction of Alavert by Wyeth late in the fourth quarter of 2002. The $3.7 million increase in royalties from 2000 to 2001 was attributable to the U.S. market launch of our first three branded prescription products, AstraZeneca’s Zomig-ZMT, Organon’s Remeron SolTab and Schwarz Pharma’s NuLev. In 2003, we expect royalties to increase from 50% to 70% from 2002 levels, based on anticipated sales of CIMA fast dissolve products by our collaborative partners in the range of $360.0 to $400.0 million.

     Cost of goods sold. We incurred cost of goods sold of $18.8 million in 2002, compared to $16.0 million in 2001 and $12.4 million in 2000. The $2.8 million increase from 2001 to 2002 was primarily due to manufacturing more of our fast dissolve products, except for Triaminic Softchews, and from higher indirect labor costs associated with the expansion of our manufacturing and quality control infrastructures. The $3.6 million increase from 2000 to 2001 was primarily due to manufacturing higher levels of over-the-counter products, principally Triaminic Softchews, higher direct labor costs to staff multiple production lines for a multiple shift operation, and from higher depreciation costs associated with new manufacturing equipment.

     Research and product development expenses. We incurred research and product development expenses of $10.9 million in 2002, compared to $6.4 million in 2001 and $5.0 million in 2000. The $4.5 million increase from 2001 to 2002 was primarily due to an increase in the number of collaborative projects in our product development portfolio, including development activity for recent collaborative agreements with Aventis, Schering-Plough and Schwarz Pharma, higher payroll costs associated with increases in professional staffing levels, and higher depreciation costs associated with the newly renovated R&D center. The $1.4 million increase from 2000 to 2001 was primarily due to increased development activity for AstraZeneca, Organon, Novartis and Schwarz Pharma, as well as higher payroll costs associated with increases in professional staffing levels.

     Selling, general and administrative expenses. We incurred selling, general and administrative expenses of $7.2 million in 2002, compared to $5.1 million in 2001 and $3.9 million in 2000. The $2.1 million increase from 2001 to 2002 was primarily due to increased recruiting and relocation costs, corporate incentive payments and higher levels of staffing and consulting in support of our computer and information systems. The increase from 2000 to 2001 was primarily due to marketing and related consulting costs associated with our business development efforts, higher payroll costs associated with increased professional staffing, and higher levels of staffing and consulting in support of our computer and information systems.

     Operating income. We recognized operating income of $9.8 million in 2002, compared to $4.6 million in 2001 and $2.7 million in 2000. The $5.2 million increase from 2001 to 2002 was primarily due to the growth in operating revenues as well as significantly higher gross profit margins of the fast dissolve product we manufacture for our collaborative partners. The $1.9 million increase from 2000 to 2001 was primarily due to the growth in operating revenues as well as nominally higher gross profit margins of the fast dissolve product we manufacture for our collaborative partners. In 2003, we expect operating income to be at least 85% higher than the operating income recognized for 2002 due to anticipated operating revenues in the range of $70.0 to $75.0 million.

24


Table of Contents

     Other income, net. We recognized other income of $6.4 million in 2002, compared to $10.3 million in 2001 and $2.1 million in 2000. Other income consists primarily of investment income on invested funds and gains or losses on asset dispositions. The $3.9 million decrease from 2001 to 2002 was primarily due to the lower interest rates on funds reinvested during the year. The $8.2 million increase from 2000 to 2001 was primarily due to the full-year effect of investing the $150.3 million cash proceeds from our November 2000 public offering. In 2003, we expect other income to decrease to under $5.0 million primarily from the impact of lower interest rates on funds that we expect to reinvest during the year.

     Tax benefit. We recognized a tax benefit, or negative tax expense, of $2.4 million in 2002, compared to a tax benefit of $104,000 in 2001 and no tax benefit/expense in 2000. The $2.3 million increase of tax benefit from 2001 to 2002 was due to the recognition of approximately $8.9 million in tax credits related to the utilization of net operating loss carryforwards, which offset the tax expense we would otherwise incur. The $104,000 increase of tax benefit from 2000 to 2001 was due to the recognition of approximately $6.1 million in tax credits related to the utilization of net operating loss carryforwards, which offset the tax expense we would otherwise incur. In 2003, we expect to recognize our remaining tax benefits related to the utilization of net operating loss and tax credit carryforwards, which have a value of approximately $2.0 million, and are expected to result in a full-year effective tax rate in the range of 31% to 33%.

Liquidity and Capital Resources

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

     Working capital, which is defined as current assets less current liabilities, increased by $50.2 million from $33.5 million at December 31, 2001 to $83.7 million at December 31, 2002. The increase was primarily due to $20.1 million in net cash provided by operating activities and the sale or redemption of $67.1 million of non-current available-for-sale securities, partially offset by the use of $36.6 million for capital expenditures and the use of $2.1 million to repurchase approximately 86,000 shares of common stock. We invest excess cash in interest-bearing money market accounts and investment grade securities.

     During 2003, we plan to spend approximately $24.0 to $27.0 million, exclusive of potential capital expenditures to add capacity for the manufacture of products containing potent substances, to complete various improvements to our Eden Prairie manufacturing facility and Brooklyn Park R&D center, including a second site of manufacturing. Our second manufacturing site in our Brooklyn Park facility will be equipped to provide bottling production line capabilities and is expected to be operational late in 2003. We also expect to substantially complete either the replacement or the addition of a production line in Eden Prairie for fast dissolve product requiring blister packaging. In addition, we expect to fund additional product development activities related to our OraVescent technology, which may include adding capacity for the manufacture of products containing potent substances, 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 Annual Report on Form 10-K 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-K. 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.

25


Table of Contents

The Loss Of One Of Our Top Three Major Customers Could Reduce Our Revenues Significantly.

     Revenues from AstraZeneca, Organon and Schwarz Pharma together represented approximately 69% of our total operating revenues for the year ended December 31, 2002, compared to 55% for the corresponding period 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 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, Or The Sales Of Those Products May Be Affected By Factors Beyond The Control Of Those Third Parties.

     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 delivery 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. 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.

     For the year ended December 31, 2002, net sales from manufacturing and royalties from our partners’ sales of our top three products accounted for approximately 60% of our operating revenues. Our top three products are AstraZeneca’s Zomig-ZMT and its equivalent for markets outside the U.S., Organon’s Remeron SolTab and its equivalent for markets outside the U.S., and Wyeth’s Alavert. We cannot be certain that these products will continue to be accepted in their markets. Specifically, the following factors, among others, could affect the level of market acceptance of Remeron SolTab and its non-U.S. equivalents, Zomig-ZMT and its non-U.S. equivalents, and Alavert:

    the perception of the healthcare community of their safety and efficacy, both in an absolute sense and relative to that of competing products;
 
    unfavorable publicity regarding these products or similar products;
 
    product price relative to other competing products or treatments;
 
    changes in government and third-party payor reimbursement policies and practices; and
 
    regulatory developments affecting the manufacture, marketing or use of these products.

If We Do Not Enter Into Additional Collaborative Agreements With Pharmaceutical Companies, We May Not Be Able To Achieve Sustained Profitability.

     We primarily 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 rights to terminate their collaborative agreements with us.

26


Table of Contents

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 for product requiring blister packaging, which collectively have an estimated annualized production capacity in excess of 500 million tablets. In 2003, we plan to either replace the oldest of our two production lines or retain both of these production lines and add a third production line at our Eden Prairie facility, which is expected to be completed and commissioned in the first half of 2004. We also plan to add a production line for bottled product at our Brooklyn Park facility, which is expected to be completed and commissioned in the fourth quarter of 2003. We estimate that our total annualized capacity for the two production lines in Eden Prairie will increase from approximately 500 million to more than 700 million tablets, or to approximately 1.0 billion tablets if we add the new production line to our two existing production lines. The estimated total annualized capacity of the production line in Brooklyn Park will be approximately 700 million bottled tablets. If we are unable to increase our production capacity as scheduled or if our partners significantly increase their requirements for product deliveries prior to completing the scheduled increases in capacity, we may be required to allocate our production capacity until we have completed these capacity improvements. If this should happen, 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.

     Our operating revenues increased 46% for the year ended December 31, 2002, compared to an increase of 34% for the year ended December 31, 2001, 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 also need to expand our finance, administrative and operations staff. We may not be able to complete the improvements 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.

Sales Of Our Pharmaceutical Company Partners’ Products May Decline As A Result Of Competition From Generic Prescription Products And Regulatory Actions That Could Switch A Prescription Product To An Over-The-Counter Product, Which May Result In A Decline In Our Revenues.

     Many of our pharmaceutical company partners face intense competition from manufacturers of generic drugs. Generic competition may reduce the demand and/or price for our partners’ products. Products that our pharmaceutical company partners produce may also be subject to regulatory actions that result in prescription products becoming available to consumers over-the-counter. Such a change could also reduce the demand and/or price for our partners’ products. Because we derive a significant portion of our revenue from manufacturing products for and receipt of royalties from our pharmaceutical company partners, a decline in the sales of products that we produce for our partners, whether as a result of the introduction of competitive generic products or other competitive factors, could have a material adverse effect on our revenues and profitability.

     In January 2002, Mylan Laboratories and Teva Pharmaceutical Industries announced that they received tentative approval from the FDA to sell mirtazapine tablets, which are expected to be generic substitutes for Organon’s Remeron standard tablets. We developed and manufacture an OraSolv formulation of Remeron for Organon. 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 Laboratories, Inc. for infringing its U.S. patent for Remeron SolTab (mirtazapine orally disintegrating tablets). On December 18, 2002, a federal

27


Table of Contents

district court ruled that the generic version of mirtazapine developed by Teva did not infringe Organon’s patent covering Remeron. As a result of this ruling, we expect that Teva will launch its generic form of mirtazapine in the U.S. market in 2003. We expect other generic manufacturers, including Mylan Laboratories, to launch their generic versions of mirtazapine, subject to FDA approval, after Teva’s 180 day marketing exclusivity period expires. In addition, the U.S. market launch of generic orally disintegrating mirtazapine tablets developed by Barr Laboratories is expected to occur after it receives FDA approval. Although Organon has appealed this court’s ruling, it is unlikely that the appeals court will reverse or delay the trial court’s ruling. Organon’s market for Remeron SolTab may be affected negatively by the introduction of generic versions of standard or orally disintegrating mirtazapine tablets. The introduction of these generic tablets could be expected to lower Organon’s pricing for Remeron. Due to the large number of variables and high degree of uncertainty, we are unable to predict the timing of the market introduction of a generic orally disintegrating mirtazapine tablet or the effect that the introduction of generic mirtazapine may have on our business.

     On January 15, 2003, KV Pharmaceutical Company announced that it will begin marketing the first product utilizing its OraQuick fast dissolve technology. Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125mg, is a prescription anticholinergic/antispasmodic product. This product is expected to be equivalent to and substitutable for NuLev, which we developed and manufacture for Schwarz Pharma. Due to the large number of variables, we are unable to predict the effect of such a product introduction by KV Pharmaceutical on our business.

     On January 27, 2003, Andrx Corporation and Perrigo Company announced that they have entered into a multi-year agreement for Andrx to supply Perrigo with Andrx’s over-the-counter fast dissolve formulation of loratadine, which is expected to be equivalent to and substitutable for Schering-Plough’s Claritin RediTabs and Wyeth’s Alavert. We developed and manufacture Alavert for Wyeth. Andrx has received tentative FDA approval of its Abbreviated New Drug Application for a fast dissolve formulation of loratadine. In February 2003, Wyeth received its second FDA approval for a DuraSolv loratadine product, which is identical to Alavert, but was initially intended for the prescription market. We believe that Wyeth’s second FDA approval of a DuraSolv loratadine product may prevent Andrx from receiving final FDA approval of its competitive fast-dissolve formulation of loratadine, until at least 180 days after Wyeth’s launch of Alavert on December 20, 2002. Due to the large number of variables, we are unable to predict the effect of Perrigo’s product introduction of a fast dissolve loratadine product on our business.

We May Experience Significant Delays In Expected Product Releases While We And Our Pharmaceutical Company Partners Seek Regulatory Approvals For The Products We Develop And Manufacture And, If Either Of Us 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 they are not successful, our revenues and profitability may decline. We, 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. In addition, prior to obtaining FDA approval for a product, the manufacturing facility for the product must be pre-approved by the FDA. Failure by us to obtain FDA pre-approval of our manufacturing facilities could significantly delay or cause the rejection of FDA approval for products we and our pharmaceutical company partners intend to manufacture and sell. 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

28


Table of Contents

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. We cannot guarantee that any future inspections will proceed without any compliance issues requiring time and resources to resolve.

We May Be Exposed To Liability Claims Associated With The Use Of Hazardous Materials And Chemicals.

     Our research and development and manufacturing activities involve the controlled use of hazardous materials and chemicals. Although we believe that our safety procedures for using, storing, handling and disposing of these materials comply with federal, state and local laws and regulations, we cannot completely eliminate the risk of accidental injury or contamination from these materials. In the event of such an accident, we could be held liable for any resulting damages, and any liability could materially adversely affect our business, financial condition and results of operations. In addition, the federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of hazardous or radioactive materials and waste products may require us to incur substantial compliance costs that could materially adversely affect our business, financial condition and results of operations.

Our Products May Contain Controlled Substance And Or Potent Substances, The Supply And Manufacture Of Which May Be Limited Or Regulated By U.S. Government Agencies.

     The active ingredients in some of our current and proposed products, including OraVescent fentanyl, are controlled substances under the Controlled Substances Act of 1970 and are regulated by the U.S. Drug Enforcement Agency. These products are subject to DEA regulations relating to manufacturing, storage, distribution and physician prescription procedure. Products containing controlled substances may generate public controversy. Opponents of these products may seek restrictions on marketing and withdrawal of any regulatory approvals. In addition, these opponents may seek to generate negative publicity in an effort to persuade the medical community to reject these products. Political pressures and adverse publicity could lead to delays in, and increased expenses for, and limit or restrict the introduction and marketing of products containing controlled substances. Furthermore, the DEA could impose significant penalties and fines against us and our pharmaceutical company partners for violating the Controlled Substances Act and DEA regulations.

     Regulations under the Occupational Safety and Health Act establish certain standards related to safety in handling and manufacturing potent substances, such as fentanyl citrate. Under these regulations, we believe that our production of fentanyl citrate would require a specialized manufacturing environment that prevents fentanyl citrate from coming in contact with humans. We may develop other products that would require a specialized manufacturing environment. Currently, none of our existing production lines in Eden Prairie nor our planned production line in Brooklyn Park are capable of manufacturing potent substances. In the event we pursue the development of our OraVescent fentanyl product through regulatory submission or other potential products with a comparable safety profile to fentanyl, we will be required to identify a manufacturer with appropriate resources to manufacture potent substances or to develop those capabilities internally. We are presently assessing the feasibility of contracting with third party manufacturers that have these specialized manufacturing capabilities and of developing these capabilities internally. In the event we decide to manufacture OraVescent fentanyl or other potent products in our facilities, we will be required to add potent substance manufacturing capabilities that comply with these safety regulations, which could require capital expenditures in the excess of $10 million. If we choose not to invest in potent substance manufacturing capabilities, our future revenues may not grow as fast because we will be unable to compete in certain important therapeutic markets for our technologies.

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 practices 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:

29


Table of Contents

    issue warning letters;
 
    impose fines;
 
    seize products or order recalls;
 
    issue injunctions to stop future sales of products;
 
    refuse to permit products to be imported into, or exported out of, the U.S.;
 
    totally or partially suspend our production;
 
    delay pending marketing applications; and
 
    initiate criminal prosecutions.

We Have A Single Manufacturing Facility For Product Requiring Blister Packaging And We May Lose Revenues And Be Unable To Maintain Our Relationships With Our Pharmaceutical Company Partners If We Lose Production Capacity for Blistered Product.

     We manufacture all our products on two production lines in our Eden Prairie facility. All of our commercialized products, except for Schwarz Pharma’s NuLev, are blister packaged on one or both of our Eden Prairie production lines. 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 to 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. The production line we expect to add at our Brooklyn Park facility will be dedicated to bottled product, which is important for products currently under development, but does not reduce the risk associated with loss of capacity for product requiring blister packaging.

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;
 
    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

30


Table of Contents

Ethypharm, the FlashDose technology developed by Fuisz Technologies Ltd., a wholly-owned subsidiary of Biovail Corporation, and the OraQuick technology developed by KV Pharmaceutical Company. SPI Pharma, Inc., a wholly-owned subsidiary of Associated British Foods plc, recently announced Pharmaburst, a specially engineered excipient system that is capable of rapid disintegration. In addition, Eurand, a private specialty pharmaceutical company, recently announced that it has licensed a marketed, fast dissolve drug delivery technology, which is expected to be fully integrated into Eurand’s business in the second half of 2003. We also compete generally with other drug delivery, 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 seventeen 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.

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 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 claims.

     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

31


Table of Contents

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, 2002, we have accumulated aggregate net losses from inception of approximately $8.4 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:

    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 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 coughs and colds. 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 2002, operating revenues from Novartis, which included revenues related to Triaminic, a seasonal cough and cold product, represented nearly 13% of our total operating revenues. We may not be successful in developing a mix of products to reduce these seasonal variations.

32


Table of Contents

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, Advertising and Communication acceptable marketing claims for a product incorporating our drug delivery technologies, 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 technologies, or the drug product itself, may not be approved by the Division of Drug Marketing, Advertising and Communication.

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 incorporation 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 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, 2002, the closing sale price for our common stock ranged from $16.06 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;

33


Table of Contents

    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;
 
    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.

Recent Accounting Pronouncements

     In December 1999, the staff of the Securities and Exchange Commission issued Staff Accounting Bulletin No. 101, or SAB 101, “Revenue Recognition in Financial Statements.” SAB 101 requires that up-front license fees received from research collaborators be recognized over the term of the agreement unless the fee is in exchange for products delivered or services performed that represent the culmination of a separate earnings process. We implemented SAB 101 in the quarter ended on June 30, 2000. Implementation of SAB 101 was retroactive to January 1, 2000. We incurred a charge to earnings of $799,000 for the cumulative effect of a change in accounting principle, which is included in income for the year ended December 31, 2000. The effect of the change on the year ended December 31, 2000 was to increase income before cumulative effect of the change in accounting principle by $799,000 or $0.07 per diluted share. For the year ended December 31, 2000, we recognized $799,000 in revenue that is included in the cumulative effect adjustment as of January 1, 2000.

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

     The Company is subject to interest rate risks on cash, cash equivalents and available-for-sale securities. Our investments in fixed-rate debt securities, which are classified as available-for-sale at December 31, 2002, have remaining maturities ranging from 3 to 51 months and are exposed to the risk of fluctuating interest rates. Available-for-sale securities had a market value of $105.6 million at December 31, 2002, and represented 47% of our 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 December 31, 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.

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

     Our financial statements as of December 31, 2002 and 2001 and for each of the years ended December 31, 2002, 2001 and 2000 begin on page F-1 of this Form 10-K.

34


Table of Contents

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

     None.

PART III.

ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT

     Incorporated by reference into this Annual Report on Form 10-K is the information appearing under the headings “Election of Directors” and “Security Ownership of Certain Beneficial Owners and Management” in our Proxy Statement for Annual Meeting of Stockholders to be held on May 21, 2003. Information relating to the company’s executive officers is provided in this Annual Report on Form 10-K under the heading “Business—Executive Officers of the Registrant.”

ITEM 11. EXECUTIVE COMPENSATION

     Incorporated by reference into this Annual Report on Form 10-K is the information appearing under the heading “Executive Compensation” in our Proxy Statement for Annual Meeting of Stockholders to be held on May 21, 2003.

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

     Incorporated by reference into this Annual Report on Form 10-K is the information appearing under the headings “Security Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information” in our Proxy Statement for Annual Meeting of Stockholders to be held on May 21, 2003.

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS

     Incorporated by reference into this Annual Report on Form 10-K is the information appearing under the heading “Certain Transactions” in our Proxy Statement for Annual Meeting of Stockholders to be held on May 21, 2003.

ITEM 14. CONTROLS AND PROCEDURES

     Evaluation of disclosure controls and procedures. Based on their evaluation as of a date within 90 days of the filing date of this Annual Report on Form 10-K, the Company’s principal executive officer and principal financial officer have concluded that the Company’s disclosure controls and procedures (as defined in Rules 13a-14(c) and 15d-14(c) under the Securities Exchange Act of 1934 (the “Exchange Act”)) are effective to ensure that information required to be disclosed by the Company in reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms.

     Changes in internal controls. There were no significant changes in the Company’s internal controls or in other factors that could significantly affect these controls subsequent to the date of their evaluation. There were no significant deficiencies or material weaknesses, and therefore there were no corrective action taken.

35


Table of Contents

PART IV.

ITEM 15.   EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K

(a)(1).   Financial Statements

           
      Page Number
      in this
Description   Annual Report

Audited Financial Statements:
       
 
Report of Independent Auditors
    F-1  
 
Balance Sheets
    F-2  
 
Income Statements
    F-3  
 
Statements of Cash Flows
    F-4  
 
Statements of Changes in Stockholders’ Equity
    F-5  
 
Notes to Financial Statements
  F-6 to F-18

(a)(2).   Financial Statement Schedules

     The following financial statement schedule should be read in conjunction with the Audited Financial Statements referred to under Item 15(a)(1) above. Financial statement schedules not included in this Form 10-K have been omitted because they are not applicable or the required information is shown in the Audited Financial Statement or Notes thereto.

     
    Page Number
    in this
Description   Annual Report

 
Schedule II – Valuation and Qualifying Accounts: Years Ended December 31, 2002, 2001 and 2000   F-19

     (a)(3). Listing of Exhibits

             
Exhibit         Method of
Number   Description     Filing

3.1   Fifth Restated Certificate of Incorporation of CIMA, as amended.     (13)  
             
3.2   Third Restated Bylaws of CIMA.     (8)  
             
4.1   Form of Certificate for Common Stock.     (1)  
             
4.2   Amended and Restated Rights Agreement dated June 26, 2001, between the Registrant and Wells Fargo Bank Minnesota, N.A. as Rights Agent.     (15)  
             
4.3   Form of Stock Purchase Agreement dated March 13, 2000 between CIMA and certain institutional investors.     (9)  
             
10.1   Letter Agreement, dated January 28, 1998, between CIMA and Joseph R. Robinson, Ph.D. *#     (6)  
             
10.2   Equity Incentive Plan, as amended and restated. #     (8)  
             
10.3   1994 Directors’ Stock Option Plan, as amended. #     (2)  
             
10.4   Form of Director and Officer Indemnification Agreement.     (1)  
             
10.5   License Agreement, dated July 1, 1998, between Novartis Consumer Health Inc. and CIMA.*     (7)  
             
10.6   Supply Agreement, dated July 1, 1998, between Novartis Consumer Health Inc. and CIMA. *     (7)  
             
10.7   License Agreement, dated January 28, 1994, between SRI International and CIMA. *     (1)  
             
10.8   Non-Employee Directors’ Fee Option Grant Program. #     (3)  
             
10.9   License Agreement, dated June 26, 1997, between Bristol-Myers Squibb Company and CIMA. *     (4)  
             
10.10   License Agreement dated May 28, 1999, between IPR Pharmaceuticals, Inc. and CIMA. *     (8)
             
10.11   License Agreement dated December 29, 1999 between Organon International AG and N.V. Organon, and CIMA. *     (9)  
             
10.12   Development and License Agreement dated January 14, 2000 between CIMA and American Home Products Corporation. *     (9)  

36


Table of Contents

             
Exhibit         Method of
Number   Description     Filing

10.13   Supply Agreement dated January 14, 2000 between CIMA and American Home Products Corporation. *     (9 )
             
10.14   Employment Agreement, dated June 30, 2000, between CIMA and John M. Siebert, Ph.D. #     (10 )
             
10.15   Development, License and Supply Agreement by and between CIMA and Schwarz Pharma, Inc. dated June 30, 2000. *     (10 )
             
10.16   Employment Agreement, dated August 23, 2000, between CIMA and John Hontz, Ph.D. #     (11 )
             
10.17   Employment Agreement, dated January 26, 2001, between CIMA and David Feste. #     (12 )
             
10.18   2001 Stock Incentive Plan, as amended. #     (13 )
             
10.19   Employee Stock Purchase Plan. #     (14 )
             
10.20   Toll Manufacturing Agreement between Organon Inc. and CIMA. *     (12 )
             
10.21   Supply Agreement, dated August 31, 2001, between CIMA and AstraZeneca UK Limited.*     (16 )
             
10.22   Supply Agreement, dated January 1, 2001, and executed September 2, 2001, between Novartis Consumer Health, Inc. and CIMA. *     (16 )
             
10.23   License Agreement No. 1, executed September 2, 2001, by and between Novartis Consumer Health, Inc. and CIMA, amending that certain License Agreement dated July 1, 1998, between Novartis and CIMA. *     (16 )
             
10.24   Master Development, License & Supply Agreement, dated as of December 18, 2001, by and between CIMA and Schwarz Pharma, Inc., as amended by Letter Agreements dated March 1, 2002, October 24, 2002 and February 18, 2003. *     Filed herewith
             
10.25   Development, License and Supply Agreement made as of May 20, 2002, by and between CIMA and Schering-Plough Ltd. *     (17 )
             
10.26    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. *     (17 )
             
10.27   Supply Agreement dated June 18, 2002, between CIMA and WYETH (formerly known as American Home Products Corporation), acting through its Wyeth Consumer Healthcare Division. *     (17 )
             
10.28   Development and License Agreement by and between CIMA and Aventis Pharmaceuticals Inc. dated as of August 1, 2001, and Amendment dated November 30, 2001, Amendment #2 dated December 20, 2001, Amendment #3 dated January 18, 2002, and Amendment #4 dated February 15, 2002, thereto. *     (18 )
             
10.29   Development, License and Supply Agreement, dated as of March 2, 2001, by and between CIMA and Alamo Pharmaceuticals, LLC, and Amendment #1 executed on January 4, 2002. *     Filed herewith
             
10.30   First Amendment to Employment Agreement, dated as of December 31, 2002, by and between CIMA and John Hontz, Ph.D. #     Filed herewith
             
10.31    Letter Agreement, dated February 27, 2003, between CIMA and David Feste. #     Filed herewith
             
10.32   Employment Agreement, dated February 19, 2003, by and between CIMA and James C. Hawley. #     Filed herewith
             
23.1   Consent of Ernst & Young LLP.     Filed herewith  
             
24.1   Powers of Attorney.     Filed Herewith
             
99.1   Certification of Chief Executive Officer.     Filed Herewith
             
99.2   Certification of Chief Financial Officer.     Filed Herewith

37


Table of Contents

     
*   Denotes that confidential information 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.
     
#   Denotes management contract, compensatory plan or arrangement required to be filed as an exhibit to this Form 10-K.
     
(1)   Filed as an exhibit to CIMA’s Registration Statement on Form S-1, File No. 33-80194, and incorporated herein by reference.
     
(2)   Filed as an exhibit to CIMA’s Quarterly Report on Form 10-Q for the quarter ended September 30, 1996, File No. 0-24424, and incorporated herein by reference.
     
(3)   Filed as an exhibit to CIMA’s Quarterly Report on Form 10-Q for the quarter ended March 31, 1997, File No. 0-24424, and incorporated by reference.
     
(4)   Filed as an exhibit to CIMA’s Quarterly Report on Form 10-Q for the quarter ended June 30, 1997, File No. 0-24424, and incorporated herein by reference.
     
(5)   Filed as an exhibit to CIMA’s Quarterly Report on Form 10-Q for the quarter ended September 30, 1997, File No. 0-24424, and incorporated herein by reference.
     
(6)   Filed as an exhibit to CIMA’s Annual Report on Form 10-K for the year ended December 31, 1997, File No. 0-24424, and incorporated herein by reference.
     
(7)   Filed as an exhibit to CIMA’s Quarterly Report on Form 10-Q for the quarter ended September 30, 1998, File No. 0-24424, and incorporated herein by reference.
     
(8)   Filed as an exhibit to CIMA’s Quarterly Report on Form 10-Q for the quarter ended June 30, 1999, File No. 0-24424, and incorporated herein by reference.
     
(9)   Filed as an exhibit to CIMA’s Annual Report on Form 10-K for the year ended December 31, 1999, File No. 0-24424, and incorporated herein by reference.
     
(10)   Filed as an exhibit to CIMA’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2000, File No. 0-24424, and incorporated herein by reference.
     
(11)   Filed as an exhibit to CIMA’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2000, File No. 0-24424, and incorporated herein by reference.
     
(12)   Filed as an exhibit to CIMA’s Annual Report on Form 10-K for the year ended December 31, 2000, File No. 0-24424, and incorporated herein by reference.
     
(13)   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.
     
(14)   Filed as an exhibit to CIMA’s Registration Statement on Form S-8, filed June 14, 2001, File No. 333-63026, and incorporated herein by reference.
     
(15)   Incorporated by reference to Exhibit 1 to the Registrant’s Amendment No. 1 to Registration Statement on Form 8-A/A, filed July 18, 2001, File No. 0-24424.
     
(16)   Filed as an exhibit to CIMA’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2001, File No. 0-24424, and incorporated herein by reference.

38


Table of Contents

     
(17)   Filed as an exhibit to CIMA’s Quarterly Report on Form 10-Q for the year quarter June 30, 2002, File No. 0-24424, and incorporated herein by reference.
     
(18)   Filed as an exhibit to CIMA’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2002, File No. 0-24424, and incorporated herein by reference.

     (b). Reports on Form 8-K
     None.

     (c). Exhibits
     See Item 14(a)(3) above.

     (d). Financial Statement Schedules
     See Item 14(a)(2) above.

39


Table of Contents

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report on Form 10-K to be signed on its behalf by the undersigned thereunto duly authorized, in the City of Eden Prairie, Minnesota, on the 28th day of March, 2003.

     
  CIMA LABS INC.
  By:
    /s/ David A. Feste
 
    David A. Feste
Vice President and Chief Financial Officer

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons on behalf of the registrant and in the capacities indicated on March 28, 2003.

     
SIGNATURE   TITLE

 
/s/ John M. Siebert
John M. Siebert
  Chief Executive Officer (Principal Executive Officer) and Director
 
/s/ David A. Feste
David A. Feste
  Vice President and Chief Financial Officer (Principal Financial and Accounting Officer)
 
*
John F. Chappell
  Director
 
*
Steven D. Cosler
  Director
 
*
Terrence W. Glarner
  Director
 
*
Steven B. Ratoff
  Director
 
*
Joseph R. Robinson, Ph.D.
  Director
       
  By: /s/ David A. Feste

David A. Feste, Attorney-In-Fact


*   David A. Feste, pursuant to the Powers of Attorney executed by each of the directors above whose name is marked by a “*”, by signing his name hereto, does hereby sign and execute this Annual Report on Form 10-K on behalf of each of the directors in the capacities in which the name of each appears above.

40


Table of Contents

CERTIFICATIONS

I, John M. Siebert, certify that:

1.     I have reviewed this annual report on Form 10-K of CIMA LABS INC.;

2.     Based on my knowledge, this annual report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this annual report;

3.     Based on my knowledge, the financial statements, and other financial information included in this annual report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this annual report;

4.     The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and have:

  a)     designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this annual report is being prepared;

  b)     evaluated the effectiveness of the registrant’s disclosure controls and procedures as of a date within 90 days prior to the filing date of this annual report (the “Evaluation Date”); and

  c)     presented in this annual report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date;

5.     The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):

  a)     all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant’s ability to record, process, summarize and report financial data and have identified for the registrant’s auditors any material weaknesses in internal controls; and

  b)     any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls; and

6.     The registrant’s other certifying officers and I have indicated in this annual report whether there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.

             
Date:   March 28, 2003   By:   /s/ John M. Siebert
           
            John M. Siebert, Chief Executive Officer


Table of Contents

CERTIFICATIONS

I, David A. Feste, certify that:

1.     I have reviewed this annual report on Form 10-K of CIMA LABS INC.;

2.     Based on my knowledge, this annual report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this annual report;

3.     Based on my knowledge, the financial statements, and other financial information included in this annual report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this annual report;

4.     The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and have:

  a)    designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this annual report is being prepared;

  b)    evaluated the effectiveness of the registrant’s disclosure controls and procedures as of a date within 90 days prior to the filing date of this annual report (the “Evaluation Date”); and

  c)    presented in this annual report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date;

5.     The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):

  a)    all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant’s ability to record, process, summarize and report financial data and have identified for the registrant’s auditors any material weaknesses in internal controls; and

  b)    any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls; and

6.     The registrant’s other certifying officers and I have indicated in this annual report whether there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.

             
Date:   March 28, 2003   By:   /s/ David A. Feste
           
            David A. Feste, Chief Financial Officer


Table of Contents

REPORT OF INDEPENDENT AUDITORS

Board of Directors
CIMA LABS INC.

We have audited the accompanying balance sheets of CIMA LABS INC. as of December 31, 2002 and 2001, and the related income statements, changes in stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2002. Our audits also included the financial statement schedule listed in the index at Item 15(a)(2). These financial statements and schedule are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements and schedule based on our audits.

We conducted our audits in accordance with auditing standards generally accepted in the United States. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of CIMA LABS INC. at December 31, 2002 and 2001, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2002, in conformity with accounting principles generally accepted in the United States. Also, in our opinion, the related financial statement schedule, when considered in relation to the basic financial statements taken as a whole, presents fairly in all material respects the information set forth therein.

     
    /s/ Ernst & Young LLP
 
 
Minneapolis, Minnesota
February 14, 2003
   

F-1


Table of Contents

CIMA LABS INC.

BALANCE SHEETS

(in thousands, except per share data)
                       
          As of December 31,
         
          2002   2001
         
 
     
ASSETS
               
Current assets:
               
 
Cash and cash equivalents
  $ 26,102     $ 1,880  
 
Available-for-sale securities
    45,093       20,085  
 
Trade accounts receivable, net of allowance of $100 and $58
    14,621       8,963  
 
Interest receivable
    1,119       2,127  
 
Inventories, net
    4,082       3,771  
 
Deferred taxes
    3,790       700  
 
Prepaid expenses
    944       171  
 
 
   
     
 
Total current assets
    95,751       37,697  
Other assets:
               
 
Available-for-sale securities
    60,486       127,539  
 
Lease deposits
          45  
 
Patents and trademarks, net
    418       389  
 
Deferred taxes
    7,624       5,500  
 
 
   
     
 
Total other assets
    68,528       133,473  
Property, plant and equipment:
               
 
Construction in progress
    6,673       2,163  
 
Equipment
    27,076       19,588  
 
Building and improvements
    36,064       14,447  
 
Land
    2,059       658  
 
Furniture and fixtures
    1,547       635  
 
 
   
     
 
 
    73,419       37,491  
 
Less accumulated depreciation
    (12,345 )     (9,730 )
 
 
   
     
 
 
    61,074       27,761  
 
 
   
     
 
Total assets
  $ 225,353     $ 198,931  
 
 
   
     
 
   
 
               
   
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
Current liabilities:
               
 
Accounts payable
  $ 8,755     $ 1,607  
 
Accrued compensation
    2,118       1,021  
 
Other accrued expenses
    637       751  
 
Deferred revenue
    542       775  
 
 
   
     
 
Total current liabilities
    12,052       4,154  
Stockholders’ equity:
               
 
Convertible preferred stock, $0.01 par value:
               
   
5,000 shares authorized; none outstanding
           
 
Common stock, $0.01 par value:
               
   
60,000 shares authorized; 14,870 shares issued (including 619 treasury shares) and outstanding at December 31, 2002 and 14,739 shares issued (including 534 treasury shares) and outstanding at December 31, 2001
    149       148  
   
Additional paid-in capital
    240,027       237,270  
   
Accumulated deficit
    (8,386 )     (27,003 )
   
Accumulated other comprehensive income
    1,511       2,218  
   
Treasury stock
    (20,000 )     (17,856 )
 
 
   
     
 
Total stockholders’ equity
    213,301       194,777  
 
 
   
     
 
Total liabilities and stockholders’ equity
  $ 225,353     $ 198,931  
 
 
   
     
 

See accompanying notes.

F-2


Table of Contents

CIMA LABS INC.

INCOME STATEMENTS

(in thousands, except per share data)

                             
        Year Ended December 31,
       
        2002   2001   2000
       
 
 
Operating revenues:
                       
 
Net sales
  $ 23,391     $ 17,756     $ 13,407  
 
Product development fees and licensing
    11,496       8,867       8,817  
 
Royalties
    11,738       5,403       1,695  
 
   
     
     
 
Total operating revenues
    46,625       32,026       23,919  
 
   
     
     
 
Operating expenses:
                       
 
Costs of goods sold
    18,797       16,001       12,410  
 
Research and product development
    10,869       6,385       4,958  
 
Selling, general and administrative
    7,166       5,090       3,880  
 
 
   
     
     
 
Total operating expense
    36,832       27,476       21,248  
 
   
     
     
 
Other income (expense)
                       
 
Investment income, net
    6,511       10,335       2,172  
 
Other income (expense)
    (128 )     (1 )     (58 )
 
   
     
     
 
 
    6,383       10,334       2,114  
 
   
     
     
 
Income before cumulative effect of a change in accounting principle and income tax benefit
    16,176       14,884       4,785  
Cumulative effect of a change in accounting principle
                (799 )
Income tax benefit
    2,441       104        
 
   
     
     
 
Net income
  $ 18,617     $ 14,988     $ 3,986  
 
   
     
     
 
Net income per share:
                       
 
Basic
                       
   
Net income per share before cumulative effect of a change in accounting principle
  $ 1.31     $ 1.03     $ .43  
   
Net per share from cumulative effect of a change in accounting principle
                (.07 )
 
   
     
     
 
 
Net income per basic share
  $ 1.31     $ 1.03     $ .36  
 
   
     
     
 
 
Diluted
                       
   
Net income per share before cumulative effect of a change in accounting principle
  $ 1.28     $ .97     $ .39  
   
Net per share from cumulative effect of a change in accounting principle
                (.07 )
 
   
     
     
 
 
Net income per diluted share
  $ 1.28     $ .97     $ .32  
 
   
     
     
 
Weighted average shares outstanding:
                       
 
Basic
    14,193       14,559       11,151  
 
Diluted
    14,599       15,503       12,385  
Pro forma amounts assuming the accounting change were applied retroactively (unaudited):
                       
   
Net income
                  $ 4,785  
   
Net income per diluted share
                  $ .39  
   
Weighted average diluted shares
                    12,385  

See accompanying notes

F-3


Table of Contents

CIMA LABS INC.

STATEMENTS OF CASH FLOWS

(in thousands)
                             
        Year Ended December 31,
       
        2002   2001   2000
       
 
 
Operating activities
                       
Net income
  $ 18,617     $ 14,988     $ 3,986  
Adjustment to reconcile net income to net cash provided by operating activities:
                       
 
Depreciation and amortization
    3,294       2,334       1,804  
 
Income tax benefit of stock options exercised
    1,983       5,634        
 
Deferred income taxes
    (5,214 )     (6,200 )      
 
Gain on sale of investment securities
    (923 )     (1,425 )      
 
Loss on impairment of assets
                375  
 
Loss on disposal of property, plant, and equipment
    155              
 
Value of options granted in exchange for services
          6       186  
 
Cumulative effect of change in accounting principle
                799  
 
Changes in operating assets and liabilities:
                       
   
Accounts receivable
    (5,658 )     (1,283 )     (5,592 )
   
Interest receivable
    1,008       (1,156 )      
   
Inventories
    (311 )     (2,389 )     1,391  
   
Prepaid expenses
    (728 )     40       (154 )
   
Accounts payable
    7,148       631       (1,426 )
   
Accrued expenses
    983       287       256  
   
Deferred revenue
    (233 )     700       (861 )
 
   
     
     
 
Net cash provided by operating activities
    20,121       12,167       764  
 
   
     
     
 
Investing activities
                       
Purchases of property, plant and equipment
    (36,610 )     (14,222 )     (7,470 )
Purchases of available-for-sale securities
    (68,287 )     (180,041 )     (77,353 )
Proceeds from sales of available-for-sale securities
    110,548       107,491       5,919  
Proceeds from sale of property, plant and equipment
                15  
Patents and trademarks
    (181 )     (262 )     (157 )
 
   
     
     
 
Net cash provided by (used in) investing activities
    5,470       (87,034 )     (79,046 )
 
   
     
     
 
Financing activities
                       
Proceeds from exercises of stock options
    590       2,958       1,410  
Purchases of treasury stock
    (2,144 )     (17,856 )      
Net proceeds from stock offerings
                169,627  
Issuance of common stock related to employee stock purchase plan
    185       45        
Proceeds from (repayment of) long term debt
                (3,500 )
Notes payable
                (196 )
Security deposits on leases
          12       279  
Payments on capital lease obligations
                (231 )
 
   
     
     
 
Net cash (used in) provided by financing activities
    (1,369 )     (14,841 )     167,389  
 
   
     
     
 
Increase (decrease) in cash and cash equivalents
    24,222       (89,708 )     89,107  
Cash and cash equivalents at beginning of year
    1,880       91,588       2,481  
 
   
     
     
 
Cash and cash equivalents at end of year
  $ 26,102     $ 1,880     $ 91,588  
 
   
     
     
 
Supplemental disclosures of cash flow information
                       
Income taxes paid
  $ 509     $ 378     $ 32  
Interest paid
                205  

See accompanying notes.

F-4


Table of Contents

CIMA LABS INC.

STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(in thousands)
                   
      Common Stock
     
      Shares   Amount
     
 
Balance at Dec. 31, 1999
    9,646     $ 97  
 
Net income
           
 
Unrealized investment gain
           
 
 
               
 
Comprehensive income
               
 
Issuance of common stock in connection with a private placement, net of offering costs of $1,500
    1,100       11  
 
Issuance of common stock in connection with a public offering, net of offering costs of $10,483
    3,197       32  
 
Stock options exercised in connection with public offering
    135       1  
 
Stock options exercised
    280       3  
 
Value of options granted in exchange for services
           
 
   
     
 
Balance at Dec. 31, 2000
    14,358       144  
 
Net income
           
 
Unrealized investment gain
           
 
               
 
Comprehensive income
               
 
Stock options exercised
    380       4  
 
Issuance of common stock related to employee stock purchase plan
    1        
 
Treasury stock purchased
           
 
Income tax benefit of stock options exercised
           
 
Value of options granted in exchange for services
           
 
   
     
 
Balance at Dec. 31, 2001
    14,739       148  
 
Net income
           
 
Unrealized investment loss
           
 
               
 
Comprehensive income
               
 
Stock options exercised
    120       1  
 
Issuance of common stock related to employee stock purchase plan
    11        
 
Treasury stock purchased
           
 
Income tax benefit of stock options exercised
           
 
   
     
 
Balance at Dec. 31, 2002
    14,870     $ 149  
 
   
     
 

[Additional columns below]

[Continued from above table, first column(s) repeated]
                           
                      Other
              Retained   Compre-
      Additional   Earnings   hensive
      Paid-In Capital   (Deficit)   Income
     
 
 
Balance at Dec. 31, 1999
  $ 57,455     $ (45,977 )   $  
 
Net income
          3,986        
 
Unrealized investment gain
                141  
 
                       
 
Comprehensive income
                       
 
                       
 
Issuance of common stock in connection with a private placement, net of offering costs of $1,500
    19,389              
 
Issuance of common stock in connection with a public offering, net of offering costs of $10,483
    149,360              
 
Stock options exercised in connection with public offering
    834              
 
Stock options exercised
    1,407              
 
Value of options granted in exchange for services
    186              
 
   
     
     
 
Balance at Dec. 31, 2000
    228,631       (41,991 )     141  
 
Net income
          14,988        
 
Unrealized investment gain
                2,077  
 
                       
 
Comprehensive income
                       
 
Stock options exercised
    2,954              
 
                       
 
Issuance of common stock related to employee stock purchase plan
    45              
 
Treasury stock purchased
                 
 
Income tax benefit of stock options exercised
    5,634              
 
Value of options granted in exchange for services
    6              
 
   
     
     
 
Balance at Dec. 31, 2001
    237,270       (27,003 )     2,218  
 
Net income
          18,617        
 
Unrealized investment loss
                (707 )
 
                       
 
Comprehensive income
                       
 
Stock options exercised
    589              
 
                       
 
Issuance of common stock related to employee stock purchase plan
    185              
 
Treasury stock purchased
                 
 
Income tax benefit of stock options exercised
    1,983              
 
   
     
     
 
Balance at Dec. 31, 2002
  $ 240,027     $ (8,386 )   $ 1,511  
 
   
     
     
 

[Additional columns below]

[Continued from above table, first column(s) repeated]
                   
      Treasury        
      Stock   Total
     
 
Balance at Dec. 31, 1999
  $     $ 11,575  
 
Net income
          3,986  
 
Unrealized investment gain
          141  
 
           
 
 
Comprehensive income
            4,127  
 
           
 
 
Issuance of common stock in connection with a private placement, net of offering costs of $1,500
          19,400  
 
Issuance of common stock in connection with a public offering, net of offering costs of $10,483
          149,392  
 
Stock options exercised in connection with public offering
          835  
 
Stock options exercised
          1,410  
 
Value of options granted in exchange for services
          186  
 
   
     
 
Balance at Dec. 31, 2000
          186,925  
 
Net income
          14,988  
 
Unrealized investment gain
          2,077  
 
           
 
 
Comprehensive income
            17,065  
 
           
 
 
Stock options exercised
          2,958  
 
Issuance of common stock related to employee stock purchase plan
          45  
 
Treasury stock purchased
    (17,856 )     (17,856 )
 
Income tax benefit of stock options exercised
          5,634  
 
Value of options granted in exchange for services
          6  
 
   
     
 
Balance at Dec. 31, 2001
    (17,856 )     194,777  
 
Net income
          18,617  
 
Unrealized investment gain
          (707 )
 
           
 
 
Comprehensive income
            17,910  
 
           
 
 
Stock options exercised
          590  
 
Issuance of common stock related to employee stock purchase plan
          185  
 
Treasury stock purchased
    (2,144 )     (2,144 )
 
Income tax benefit of stock options exercised
          1,983  
 
   
     
 
Balance at Dec. 31, 2002
  $ (20,000 )   $ 213,301  
 
   
     
 

See accompanying notes.

F-5


Table of Contents

CIMA LABS INC.
NOTES TO FINANCIAL STATEMENTS

(in thousands, except per share data)

1. BUSINESS ACTIVITY

     CIMA LABS INC. (the “Company”), a Delaware corporation, develops and manufactures fast dissolve and enhanced-absorption oral drug delivery systems. The Company operates within a single business segment, the development and manufacture of fast dissolve and enhanced-absorption oral drug delivery systems. OraSolv and DuraSolv, the Company’s leading proprietary fast dissolve technologies, allow an active drug ingredient, which is frequently taste-masked, to be formulated into a new, orally disintegrating dosage form that dissolves quickly in the mouth without chewing or the need for water. The Company is also developing enhanced oral drug delivery technologies and independently developing new products based on its oral drug delivery technologies. The Company enters into collaborative agreements with pharmaceutical companies to develop products based on its oral drug delivery technologies. The Company currently manufactures six 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.

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

     Cash Equivalents

     The Company considers highly liquid investments with maturities of ninety days or less when purchased to be cash equivalents. Cash equivalents are carried at cost, which approximates fair market value.

     Available-for-sale securities

     The Company classifies its investments with maturities of over ninety days when purchased as available-for-sale. Available-for-sale securities are recorded at fair value with unrealized gains and losses reported as other comprehensive income in stockholders’ equity. Fair values of investments are based on quoted market prices, where available, and include accrued interest, if applicable. Dividend and interest income is recognized when earned. Gains and losses on securities sold are determined based on the specific identification method and are included in investment income. As of December 31, 2002, $60,486 of available-for-sale securities had remaining maturities of twelve to fifty-one months, while the balance, $45,093 had remaining maturities of less than twelve months.

     Patents and Trademarks

     Costs incurred in obtaining patents and trademarks are amortized on a straight-line basis over sixty months. Accumulated amortization was approximately $444 at December 31, 2002 and $966 at December 31, 2001. The Company wrote off some fully amortized patents and trademarks in 2002. The Company periodically reviews its patents and trademarks for impairment in value. Any adjustment from the analysis is charged to operations.

     Property, Plant and Equipment

     Property, plant and equipment are stated at cost. Depreciation is provided using the straight-line method over the estimated useful lives ranging from three to thirty-five years. Depreciation expense was approximately $3,142 in 2002; $2,203 in 2001; and $1,698 in 2000.

F-6


Table of Contents

CIMA LABS INC.
NOTES TO FINANCIAL STATEMENTS

(in thousands, except per share data)

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

     Inventories

     Inventories are valued at cost using the first-in first-out (FIFO) basis for inventory turn over and control. Inventories are shown net of reserves for obsolescence of approximately $320 at December 31, 2002, and $235 at December 31, 2001. Significant components of inventory as of December 31 are as follows:

                 
    2002   2001
   
 
Finished Goods
  $ 1,252     $ 112  
Work-in-process
    116        
Raw Materials
    2,714       3,659  
 
   
     
 
Total Inventory
  $ 4,082     $ 3,771  
 
   
     
 

     Impairment of Long-Lived Assets

     The Company records impairment losses on long-lived assets used in operations when indicators of impairment are present and the undiscounted cash flow estimated to be generated by those assets are less than the assets’ carrying amount. During the year ended December 31, 2000, the Company recognized approximately $375 of impairment losses on equipment no longer used in operations with an original cost of approximately $557, shown as other expense on the Income Statements. The cost and associated accumulated depreciation were removed from the equipment balances on the December 31, 2000 balance sheet.

     Use of Estimates

     The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.

     Revenue Recognition

     The Company recognizes 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 the Company’s 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 of milestones; from up-front product development license fees as fees are amortized over the expected development term of the proposed products; and from royalties on the sales of products manufactured by the Company, which are sold by pharmaceutical companies under licenses from the Company. The determination of SAB 101 criteria (3) and (4) for each source of revenue is based on the Company’s judgment regarding the fixed nature and collectibility of each source of revenue.

F-7


Table of Contents

CIMA LABS INC.
NOTES TO FINANCIAL STATEMENTS

(in thousands, except per share data)

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

     Stock-Based Compensation

     At December 31, 2002, the Company has stock-based employee compensation plans, which are described more fully in Note 7. The Company accounts for those plans under the recognition and measurement principles of APB Opinion No. 25, Accounting for Stock Issued to Employees, and related Interpretations. No stock-based employee compensation cost is reflected in net income for 2002 and 2001, as all options granted under those plans had an exercise price equal to the market value of the underlying common stock on the date of grant. During 2000, the Company granted options to non-employee directors at a price below market and recognized compensation expense of $72. The following table illustrates the effect on net income and net income per share if the Company had applied the fair value recognition provisions of FASB Statement No. 123, Accounting for Stock-Based Compensation (“Statement 123”), to stock-based compensation.

                           
      Year Ended December 31,
     
      2002   2001   2000
     
 
 
Net income, as reported
  $ 18,617     $ 14,988     $ 3,986  
Add: Stock-based non-employee compensation expense included in reported net income
                72  
Deduct: Total stock-based employee compensation expense determined under fair value based method for all awards
    (3,904 )     (8,851 )     (1,887 )
 
   
     
     
 
Pro forma net income
  $ 14,713     $ 6,137     $ 2,171  
 
   
     
     
 
Net income per share:
                       
 
Basic—as reported
  $ 1.31     $ 1.03     $ .36  
 
   
     
     
 
 
Basic—pro forma
  $ 1.04     $ .42     $ .19  
 
   
     
     
 
 
Diluted—as reported
  $ 1.28     $ .97     $ .32  
 
   
     
     
 
 
Diluted—pro forma
  $ 1.01     $ .40     $ .18  
 
   
     
     
 

     Income Taxes

     Income taxes are accounted for under the liability method. Deferred income taxes are provided for temporary differences between financial reporting and tax bases of assets and liabilities. A valuation reserve has been established to adjust the value of deferred income taxes. The carrying value of our net deferred tax assets assumes that the Company will be able to generate sufficient taxable income in the United States, based on estimates and assumptions. The Company records 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.

F-8


Table of Contents

CIMA LABS INC.
NOTES TO FINANCIAL STATEMENTS

(in thousands, except per share data)

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

     Research and Development Costs

     All costs of research and development activities are expensed as incurred. Research and development activities are performed under collaborative agreements with pharmaceutical partners to adapt the Company’s fast dissolve technology to specific active drug ingredients. In addition, the Company incurs research and development expenses relating to the development of new oral drug delivery technologies and new pharmaceutical products based on our oral drug delivery technologies, which are not performed under a collaborative agreement. Revenues earned from activities performed pursuant to a collaborative agreement with a pharmaceutical company are reported as product development fees, licensing revenues and royalties in the Income Statements, and the related costs are expensed as incurred as research and development expense. These costs include salaries, building costs, utilities, depreciation on equipment used for research and development, and costs of outside contractors.

     Reclassifications

     Certain amounts presented in the 2001 financial statements have been reclassified to conform to the 2002 presentation.

3. ADOPTION OF SAB 101

     The Company implemented SAB 101 in its second quarter ended on June 30, 2000, retroactive to January 1, 2000. The Company reported a charge to earnings of $799 for the cumulative effect of a change in accounting principle, which is included in income for the year ended December 31, 2000. The effect of the change on the year ended December 31, 2000 was to increase income before cumulative effect of the change in accounting principle by $724 or $0.06 per diluted share. The pro forma amounts presented in the Income Statements were calculated assuming the accounting change was made retroactive to prior periods. For the year ended December 31, 2000, the Company recognized $799 in revenue that is included in the cumulative effect adjustment as of January 1, 2000. The effect of that revenue in the year ended December 31, 2000 was to increase income by $799.

F-9


Table of Contents

CIMA LABS INC.
NOTES TO FINANCIAL STATEMENTS

(in thousands, except per share data)

4. NET INCOME PER SHARE

     Basic net income per share is computed by dividing net income by the weighted average number of common shares outstanding during the period. Diluted net income per share is computed by dividing net income by the weighted average number of common shares outstanding during the period, increased to include dilutive potential common shares issuable upon the exercise of stock options that were outstanding during the period.

                           
      Year Ended December 31,
     
      2002   2001   2000
     
 
 
Numerator:
                       
 
Net income
  $ 18,617     $ 14,988     $ 3,986  
 
   
     
     
 
Denominator:
                       
 
Denominator for basic net income per share – weighted average shares outstanding
    14,193       14,559       11,151  
 
Effect of dilutive stock options
    406       944       1,234  
 
   
     
     
 
 
Denominator for diluted net income per share – weighted average shares outstanding
  $ 14,599     $ 15,503     $ 12,385  
 
   
     
     
 
Basic net income per share
  $ 1.31     $ 1.03     $ .36  
Diluted net income per share
  $ 1.28     $ .97     $ .32  

5. AVAILABLE-FOR-SALE SECURITIES

     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 December 31, 2002 and 2001, the amortized cost and fair value of available-for-sale securities, all of which have contractual maturities of fifty-one months or less, are as follows:

                                   
              Gross   Gross        
      Amortized   Unrealized   Unrealized   Fair
      Cost   Gains   Losses   Value
     
 
 
 
As of December 31, 2002
                               
 
Asset-backed securities
  $ 35,230     $ 447     $     $ 35,677  
 
Corporate bonds and notes
    54,311       915       16       55,210  
 
Non-US corporate obligations
    8,997       64       1       9,060  
 
U.S. government securities
    5,530       102             5,632  
 
   
 
  $ 104,068     $ 1,528     $ 17     $ 105,579  
 
   
As of December 31, 2001
                               
 
Asset-backed securities
  $ 30,476     $ 378     $ 14     $ 30,840  
 
Corporate bonds and notes
    85,771       1,372       53       87,090  
 
Euro notes
    14,392       537             14,929  
 
Floating rate notes
    12,696       17             12,713  
 
U.S. government securities
    2,071             19       2,052  
 
   
 
  $ 145,406     $ 2,304     $ 86     $ 147,624  
 
   

F-10


Table of Contents

CIMA LABS INC.
NOTES TO FINANCIAL STATEMENTS

(in thousands, except per share data)

6. INCOME TAXES

     The Company’s deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. Management believes that it is more likely than not that future taxable income will be sufficient to realize a portion of the tax benefit from future deductible temporary differences and net operating loss carryforwards. Significant components of deferred income taxes as of December 31 are as follows:

                   
      2002   2001
     
 
Deferred assets:
               
 
Net operating loss
  $ 16,024     $ 20,889  
 
Research tax credit
    1,176       723  
 
Foreign tax credit
    972       337  
 
Accrued vacation
    237       185  
 
Inventory reserve
    130       95  
 
Deferred revenue
    220       314  
 
Other
    203       64  
 
   
     
 
 
    18,962       22,607  
Deferred liability:
               
 
Depreciation and amortization
    1,140       179  
 
Other
          1  
 
   
     
 
 
    1,140       180  
 
   
     
 
Net deferred income tax asset
    17,822       22,427  
Valuation allowance
    (6,408 )     (16,227 )
 
   
     
 
Net deferred income tax asset
  $ 11,414     $ 6,200  
 
   
     
 

     The income tax benefit consisted of the following for the years ended December 31:

                           
      2002   2001   2000
     
 
 
Current tax provision (benefit):
                       
 
Federal
  $ 2,132     $ 5,077     $  
 
State
    641       2,042        
 
 
   
     
     
 
 
    2,773       7,119        
Deferred tax provision (benefit):
                       
 
Federal
    3,869       (860 )     (1,927 )
 
State
    736       (163 )     (367 )
 
   
     
     
 
 
    4,605       (1,023 )     (2,294 )
Valuation allowance
    (9,819 )     (6,200 )     2,294  
 
 
   
     
     
 
Total tax provision (benefit)
  $ (2,441 )   $ (104 )   $  
 
   
     
     
 

The Company utilized net operating loss carryforwards of $13,300 in 2002 reducing the current tax provision by $4,865.

F-11


Table of Contents

CIMA LABS INC.
NOTES TO FINANCIAL STATEMENTS

(in thousands, except per share data)

6. INCOME TAXES (Continued)

     The reconciliation between the statutory federal income tax rate of 34% and the effective rate of income tax expense for the years ended December 31:

                         
    2002   2001   2000
   
 
 
Statutory federal income tax rate
    34 %     34 %     34 %
Increase (decrease) in taxes resulting from:
                       
Change in valuation allowance
    (26 )     (42 )     (40 )
Utilization of net operating loss carryforward
    (30 )                
State taxes
    7       7       6  
 
   
     
     
 
Effective income tax rate
    (15 %)     (1 %)     %
 
   
     
     
 

     The Company’s net operating loss carryforwards, foreign tax credits, and research tax credits of approximately $40,700, $972, and $1,176, respectively, may be carried forward to offset future taxable income, limited due to changes in ownership under the net operating loss limitation rules. The net operating loss, foreign tax credit, and research tax credit carryforwards expire in the years 2008 to 2021, the years 2005 to 2007, and the years 2003 to 2017, respectively.

7. STOCK OPTIONS AND PURCHASE PLANS

     Stock Options

     The Company has equity and stock incentive plans (the “Equity Plans”) under which options to purchase up to 4,150 shares of common stock may be granted to employees, directors, consultants and others. The Compensation Committee, established by the Board of Directors, establishes the terms and conditions of all stock option grants, subject to the terms and conditions of the Equity Plans and applicable provisions of the Internal Revenue Code. The options expire ten years from the date of grant and are usually exercisable in annual increments ranging from 25% to 33% beginning one year after the date of grant.

     The Company also has stock option plans for directors (the “Directors’ Plans”), which through October 4, 2001, permitted option grants to non-employee directors of the Company. On October 4, 2001, the Board discontinued the Directors’ Plans and since that date, options issued to non-employee directors have been made under the Equity Plans.

F-12


Table of Contents

CIMA LABS INC.
NOTES TO FINANCIAL STATEMENTS

(in thousands, except per share data)

7. STOCK OPTIONS AND PURCHASE PLANS (Continued)

     Shares available for grants and options granted under the Equity Plans are as follows:

                                           
                                      Weighted
Average
                                      Exercise Price
      Shares Available   Incentive Stock   Non-Qualified Stock   Total   Per
      for Grant   Options   Options   Outstanding   Share
     
 
 
 
 
Balance at Dec. 31, 1999
    417       860       588       1,448     $ 5.47  
 
Granted
    (457 )     148       309       457       24.98  
 
Forfeited
    225       (120 )     (105 )     (225 )     4.90  
 
Exercised
          (246 )     (143 )     (389 )     5.28  
 
   
     
     
     
         
Balance at Dec. 31, 2000
    185       642       649       1,291       12.53  
 
Granted
    (797 )     203       594       797       60.98  
 
Reserved
    1,500                            
 
Forfeited
    149       (65 )     (84 )     (149 )     42.98  
 
Exercised
          (101 )     (94 )     (195 )     6.48  
 
   
     
     
     
         
Balance at Dec. 31, 2001
    1,037       679       1,065       1,744       32.73  
 
Granted
    (351 )     142       209       351       24.58  
 
Forfeited
    444       (84 )     (360 )     (444 )     56.35  
 
Exercised
          (114 )           (114 )     5.07  
 
   
     
     
     
         
Balance at Dec. 31, 2002
    1,130       623       914       1,537     $ 26.21  
 
   
     
     
     
         
Exercisable:
                                       
 
December 31, 2000
                            507     $ 5.62  
 
December 31, 2001
                            488     $ 8.97  
 
December 31, 2002
                            761     $ 18.62  

     The following table summarizes information about option granted under the Equity Plans that were outstanding at December 31, 2002:

                                                 
                    Weighted Average                   Weighted  
  Range of           Remaining   Weighted Average   Number Exercisable   Average
Exercise Prices   Number Outstanding   Contractual Life   Outstanding Price   at 12/31/02   Exercise Price

 
 
 
 
 
$2.625-$5.00     231     5.1 years   $ 4.02       219     $ 4.09  
  5.01-8.00     191     4.6 years     6.55       187       6.56  
  8.01-19.00     171     7.2 years     13.90       117       13.43  
  19.01-21.00     173     8.2 years     19.98       33       20.25  
  21.01-26.00     152     8.2 years     23.76       53       24.19  
  26.01-34.00     223     9.3 years     27.01       11       27.23  
  34.01-54.00     131     8.2 years     42.49       39       42.12  
  54.01-77.00     265     8.4 years     64.41       102       64.89  
             
                     
         
$ 2.625 - $ 77.00     1,537     7.4 years   $ 26.21       761     $ 18.62  
             
                     
         

F-13


Table of Contents

CIMA LABS INC.
NOTES TO FINANCIAL STATEMENTS

(in thousands, except per share data)

7. STOCK OPTIONS AND PURCHASE PLANS (Continued)

Shares available for grants and options granted under the Directors’ Plans are as follows:

                           
                      Weighted Average
      Shares Available   Non-Qualified Stock   Exercise Price Per
      for Grant   Options   Share
     
 
 
Balance at Dec. 31, 1999
    73       331     $ 6.10  
 
Granted
    (29 )     29       16.42  
 
Exercised
          (26 )     7.39  
 
   
     
         
Balance at Dec. 31, 2000
    44       334       6.88  
 
Reduction in shares available
    (21 )            
 
Granted
    (23 )     23       66.90  
 
Exercised
          (185 )     9.17  
 
   
     
         
Balance at Dec. 31, 2001
          172       12.31  
 
Exercised
          (6 )     1.75  
 
   
     
         
Balance at Dec. 31, 2002
          166     $ 12.70  
 
   
     
         

     The following table summarizes information about options granted under the Directors’ Plans that were outstanding at December 31, 2002:

                                                     
                        Weighted Average                        
Range of           Remaining   Weighted Average   Number Exercisable   Weighted Average
Exercise Prices   Number Outstanding   Contractual Life   Outstanding Price   at 12/31/02   Exercise Price

 
 
 
 
 
   
$1.083-$2.00
      35     5.7 years   $ 1.28       35     $ 1.28  
   
2.01-4.00
      45     5.9 years     3.50       45       3.50  
   
4.01-5.00
      29     3.5 years     4.79       29       4.79  
   
5.01-10.00
      35     2.8 years     7.61       35       7.61  
   
10.01-66.90
      22     8.4 years     66.90       22       66.90  
 
           
                     
         
   
$1.083-$66.90
      166     5.1 years   $ 12.70       166     $ 12.70  
 
           
                     
         

     Options outstanding under the Equity Plans and Directors’ Plans expire at various dates during the period from March 2004 through September 2012. The weighted average fair values of options granted at market during the years ended December 31, 2002, 2001, and 2000 were $15.98, $51.25, and $15.85, respectively. Shares granted at prices other than market in the year ended December 31, 2000, had a fair value of $15.23, and an exercise price of $4.95.

F-14


Table of Contents

CIMA LABS INC.
NOTES TO FINANCIAL STATEMENTS

(in thousands, except per share data)

     7.     STOCK OPTIONS AND PURCHASE PLANS (Continued)

     Pro forma information regarding net income and income per share is required by Statement 123, and has been determined as if the Company had accounted for its stock options under the fair value method of Statement 123. The fair value for these options was estimated at the date of grant using the Black-Scholes option pricing model with the following weighted average assumptions for 2002, 2001, and 2000 respectively; risk-free interest rates of 4.31%, 5.54%, and 6.50%; volatility factor of the expected market price of the Company’s common stock of .705, .763, and .707; and a weighted-average expected life of the option of 6, 10 and 5 years.

     In management’s opinion, the model does not necessarily provide a reliable measure of the fair value of the Company’s stock options because the Company’s stock options have characteristics significantly different from those of traded options, including limits on transferability and vesting restrictions, and because changes in the subjective input assumptions can materially affect the fair value estimates. The Black-Scholes option valuation model was developed for use in estimating the fair value of traded options which have no vesting restrictions and are fully transferable. In addition, option valuation models require input of highly subjective assumptions.

     Stock Purchase Plan

     Effective August 1, 2001, the Company adopted an Employee Stock Purchase Plan to provide employees an opportunity to purchase shares of its common stock through accumulated payroll deductions. Under the plan, employees purchase shares of common stock, subject to certain limitations, at 85% of the fair market value of shares on the quarterly enrollment or exercise date, whichever is lower. A total of 200 shares were made available for purchase under the plan. During 2002, 11 shares were issued at an average price of $17.72 per share and 189 shares remained available at December 31, 2002.

F-15


Table of Contents

CIMA LABS INC.
NOTES TO FINANCIAL STATEMENTS

(in thousands, except per share data)

8. DEFINED CONTRIBUTION PLAN

     The Company has a 401(k) plan (the “Plan”), which covers substantially all employees of the Company. Contributions to the Plan are made through employee wage deferrals and employer matching contributions. The employer matching contribution percentage is discretionary and determined each year. In addition, the Company may contribute two discretionary amounts; one to non-highly compensated individuals and another to all employees. To qualify for the discretionary amounts, an employee must be employed by the Company on the last day of the Plan year or have been credited with a minimum of 500 hours of service during the Plan year.

     The 401(k) expense for the years ended December 31, 2002, 2001 and 2000 was $168, $83, and $68, respectively.

9. COMMITMENTS

     The Company has future commitments for the purchase of production equipment and remodeling of facilities at December 31, 2002, of approximately $13,600.

10. SEGMENT INFORMATION – MAJOR CUSTOMERS AND GEOGRAPHIC

     The Company operates within a single segment: the development and manufacture of fast dissolve and enhanced-absorption oral drug delivery systems. Revenues are comprised of three components: net sales of products utilizing the Company’s proprietary fast dissolve technologies; product development fees and licensing revenues for development activities conducted by the Company through collaborative agreements with pharmaceutical companies; and royalties on the sales of products manufactured by the Company, which are sold by pharmaceutical companies under licenses from the Company.

     Revenues as a percentage of total revenues from major customers are as follows:

                         
    For the Year Ended December 31,
   
    2002   2001   2000
   
 
 
Wyeth (formerly, American Home Products)
    10 %     1 %     7 %
AstraZeneca
    19       22       13  
Organon
    32       25       33  
Novartis
    13       33       36  
Schwarz Pharma
    18       8       6  
Other
    8       11       5  
 
   
     
     
 
Total
    100 %     100 %     100 %
 
   
     
     
 

     Trade accounts receivable at December 31, 2002 of approximately $14,621 were comprised primarily of the following customers: Wyeth (31%), Organon (21%), AstraZeneca (15%), and Schwarz Pharma (13%).

F-16


Table of Contents

CIMA LABS INC.
NOTES TO FINANCIAL STATEMENTS

(in thousands, except per share data)

10. SEGMENT INFORMATION – MAJOR CUSTOMERS AND GEOGRAPHIC (Continued)

     All of the Company’s assets and operations are located in the U.S. While the Company does not directly conduct its activities outside the U.S., it considers international revenues to be those arising from shipments ultimately destined for non-U.S. end-users and revenues from royalties generated by non-U.S. sales by partners.

                           
      Year Ended December 31,
     
      2002   2001   2000
     
 
 
Operating revenues by source:
                       
 
U.S.
  $ 35,425     $ 26,540     $ 21,292  
 
International
    11,200       5,486       2,627  
 
   
     
     
 
Total operating revenues
  $ 46,625     $ 32,026     $ 23,919  
 
   
     
     
 

11. QUARTERLY FINANCIAL DATA – UNAUDITED

                                   
For the three months ended   March 31   June 30   September 30   December 31

 
 
 
 
2002
                               
Total operating revenues
  $ 8,383     $ 10,200     $ 12,541     $ 15,501  
Cost of goods sold
    3,356       3,812       4,997       6,632  
Total operating expenses
    3,529       4,431       5,227       4,849  
Other income, net
    1,907       2,210       2,066       2,642  
 
   
     
     
     
 
Net income
  $ 3,405     $ 4,167     $ 4,383     $ 6,662  
 
   
     
     
     
 
Per share amounts:
                               
 
Basic — Net income per share
  $ .24     $ .29     $ .31     $ .47  
 
   
     
     
     
 
 
Diluted — Net income per share
  $ .23     $ .28     $ .30     $ .47  
 
   
     
     
     
 
Range of closing stock prices on NASDAQ
  $ 19.60 - $35.45     $ 18.94 - $28.60     $ 16.06 - $25.15     $ 22.10 - $28.58  
2001
                               
Total operating revenues
  $ 5,956     $ 8,059     $ 8,817     $ 9,193  
Cost of goods sold
    2,601       4,117       4,930       4,353  
Total operating expenses
    2,604       2,674       2,769       3,427  
Other income, net
    2,425       2,226       2,724       3,063  
 
   
     
     
     
 
Net income
  $ 3,176     $ 3,494     $ 3,842     $ 4,476  
 
   
     
     
     
 
Per share amounts:
                               
 
Basic — Net income per share
  $ .22     $ .24     $ .26     $ .31  
 
   
     
     
     
 
 
Diluted — Net income per share
  $ .20     $ .22     $ .24     $ .29  
 
   
     
     
     
 
Range of closing stock prices on NASDAQ
  $ 46.75 - $73.38     $ 43.05 - $85.75     $ 47.97 - $81.35     $ 30.05 - $62.40  

F-17


Table of Contents

CIMA LABS INC.
NOTES TO FINANCIAL STATEMENTS

(in thousands, except per share data)

       12. QUARTERLY FINANCIAL DATA — UNAUDITED (Continued)

       The following table reconciles previously reported quarterly net income per diluted share to quarterly pro forma net income per diluted share for the reported quarters of 2002 and 2001. Pro forma net income is calculated by applying a normalized tax rate of 40% to the Company’s reported pre tax income for the quarter.

                                           
      For the three months ended   Year ended
     
 
      March 31   June 30   September 30   December 31   December 31
     
 
 
 
 
2002
                                       
Net income per diluted share — As reported
  $ 0.23     $ 0.28     $ 0.30     $ 0.47     $ 1.28  
Adjust for:
                                       
 
Normalized tax rate of 40%
    (0.10 )     (0.12 )     (0.15 )     (0.25 )     (0.62 )
 
   
     
     
     
     
 
Net income per diluted share — Pro forma, fully taxed @ 40%
  $ 0.13     $ 0.16     $ 0.15     $ 0.22     $ 0.66  
 
   
     
     
     
     
 
2001
                                       
Net income per diluted share — As reported
  $ 0.20     $ 0.22     $ 0.24     $ 0.29     $ 0.97  
Adjust for:
                                       
 
Normalized tax rate of 40%
    (0.08 )     (0.08 )     (0.09 )     (0.13 )     (0.39 )
 
   
     
     
     
     
 
Net income per diluted share — Pro forma, fully taxed @ 40%
  $ 0.12     $ 0.14     $ 0.15     $ 0.16     $ 0.58  
 
   
     
     
     
     
 

F-18


Table of Contents

CIMA LABS INC.

SCHEDULE II — VALUATION AND QUALIFYING ACCOUNTS
             (all amounts in thousands)

                                   
      Balance at   Additions                
      Beginning of   Charged to Costs   Less   Balance at End of
    Year   and Expenses   Deductions   Year
   
Description
                               
Year ended December 31, 2002:
                               
Reserves and allowance deducted
                               
From asset accounts:
                               
 
Allowance for doubtful accounts
  $ 58     $ 50     $ (8 )   $ 100  
 
Obsolescence reserve
    235       372       (287 )     320  
 
 
 
Total
  $ 293     $ 422     $ (295 )   $ 420  
   
Year ended December 31, 2001:
                               
Reserves and allowance deducted
                               
From asset accounts:
                               
 
Allowance for doubtful accounts
  $ 0     $ 58     $ 0     $ 58  
 
Obsolescence reserve
    225       302       (292 )     235  
 
 
 
Total
  $ 225     $ 360     $ (292 )   $ 293  
   
Year ended December 31, 2000:
                               
Reserves and allowance deducted
                               
From asset accounts:
                               
 
Allowance for doubtful accounts
  $ 36     $ (11 )   $ (25 )   $ 0  
 
Obsolescence reserve
    536       375       (686 )     225  
 
 
 
Total
  $ 572     $ 364     $ (711 )   $ 225  
   

F-19 EX-10.24 3 c75663exv10w24.txt EX-10.24 MASTER DEVELOPMENT, LICENSE & SUPPLY AGMT EXHIBIT 10.24 EXECUTION COPY MASTER DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT by and between CIMA LABS INC. and SCHWARZ PHARMA, INC. dated as of December 18, 2001 TABLE OF CONTENTS
PAGE SECTION 1 DEFINITIONS................................................... 1 SECTION 2 GRANT OF LICENSES; LICENSE OPTION............................. 5 2.1 Grant of Licenses................................................. 5 2.2 Sublicenses....................................................... 6 2.3 Marketing, Distribution and Sale.................................. 6 SECTION 3 PRODUCT DEVELOPMENT........................................... 6 3.1 Obligations of CIMA............................................... 6 3.2 Obligations of Schwarz............................................ 7 3.3 License of Schwarz Technology..................................... 7 3.4 Additional Products............................................... 7 3.5 Regulatory Matters................................................ 7 SECTION 4 ROYALTY, COST OF GOODS AND MILESTONE PAYMENTS................. 7 4.1 Royalty and Milestone Payments.................................... 7 4.2 Records and Audit................................................. 8 4.3 Quarterly Reports of Royalties.................................... 9 4.4 Annual Reports of Costs of Goods.................................. 9 4.5 Sales and Marketing Estimates..................................... 9 SECTION 5 SUPPLY OF PRODUCT............................................. 9 5.1 Supply of Product................................................. 9 5.2 Identification.................................................... 10 5.3 Trade, Sample and Placebo Product Price........................... 11 5.4 Forecasts, Delivery and Quality................................... 11 5.5 Rejection and Replacement......................................... 11 5.6 Invoice and Payment............................................... 12 5.7 Supply Disruption; Alternate Manufacturing Site................... 12 5.8 CIMA's Obligation to Continue Manufacture......................... 12 SECTION 6 CONDITIONS PRECEDENT TO THE CLOSING; CLOSING DATE............. 13 6.1 Conditions Precedent to Schwarz's Obligations..................... 13 6.2 Conditions Precedent to CIMA's Obligations........................ 13 6.3 Closing Date...................................................... 14 SECTION 7 REPRESENTATIONS AND WARRANTIES OF CIMA........................ 14 7.1 Organization, Power and Authority................................. 14
- i - TABLE OF CONTENTS
PAGE 7.2 Due Authority; No Breach.......................................... 15 7.3 Intellectual Property............................................. 15 7.4 Technology Rights................................................. 15 7.5 Litigation........................................................ 16 7.6 Governmental Approval............................................. 16 7.7 Brokerage......................................................... 16 7.8 Supply............................................................ 16 SECTION 8 REPRESENTATIONS AND WARRANTIES OF SCHWARZ..................... 16 8.1 Organization, Power and Authority................................. 16 8.2 Due Authority; No Breach.......................................... 16 8.3 Brokerage......................................................... 17 8.4 Litigation........................................................ 17 8.5 Governmental Approval............................................. 17 SECTION 9 ADDITIONAL COVENANTS AND AGREEMENTS OF THE PARTIES............ 17 9.1 Governmental Filings.............................................. 17 9.2 Compliance with Law............................................... 18 9.3 Recall............................................................ 18 9.4 Confidentiality................................................... 18 9.5 Expenses.......................................................... 19 9.6 Reasonable Efforts................................................ 19 9.7 Publicity......................................................... 19 9.8 Cooperation....................................................... 19 9.9 Competition; No Sale for Resale................................... 20 9.10 Conflicting Rights................................................ 20 9.11 Patent and Trademark Maintenance.................................. 20 9.12 Infringement; Enforcement of Proprietary Rights................... 22 9.13 Supply of Products................................................ 22 9.14 Liability Insurance............................................... 22 9.15 Referral of Orders and Inquiries.................................. 22 9.16 Deemed Breach of Covenant......................................... 23 SECTION 10 INDEMNIFICATION............................................... 23
- ii - TABLE OF CONTENTS
PAGE 10.1 Indemnification................................................... 23 10.2 Notice and Opportunity To Defend.................................. 23 10.3 Indemnification Payment Obligation................................ 24 10.4 Indemnification Payment Adjustments............................... 24 10.5 Indemnification Payment........................................... 25 10.6 Survival.......................................................... 25 SECTION 11 TERMINATION................................................... 25 11.1 Termination....................................................... 25 SECTION 12 MISCELLANEOUS................................................. 27 12.1 Successors and Assigns............................................ 27 12.2 Notices........................................................... 27 12.3 Waiver; Remedies.................................................. 28 12.4 Survival of Representations....................................... 28 12.5 Independent Contractors........................................... 28 12.6 Entire Agreement.................................................. 28 12.7 Amendment......................................................... 28 12.8 Counterparts...................................................... 28 12.9 Governing Law..................................................... 28 12.10 Arbitration....................................................... 28 12.11 Captions.......................................................... 29 12.12 No Third-Party Rights............................................. 29 12.13 Severability...................................................... 29 12.14 Attachments....................................................... 29 12.15 Force Majeure..................................................... 29 12.16 Consents.......................................................... 29
Schedule 3.1 Master Development Schedule Schedule 4.1(a) Royalty Rates Schedule 4.1(b) Development Fee and Milestone Payments Schedule 5.1(b) Schwarz Purchase Order Schedule 5.3 Cost of Goods Schedule 5.4(d) Quality Assurance Addendum - iii - MASTER DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT This MASTER DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT (this "Agreement"), dated as of December 18, 2001, is by and between CIMA LABS INC., a Delaware corporation ("CIMA"), and Schwarz Pharma, Inc., a Delaware corporation ("Schwarz"). W I T N E S S E T H WHEREAS, CIMA is engaged, among other things, in the business of research, development, manufacturing and commercialization of pharmaceutical products through its proprietary drug delivery technologies; WHEREAS, Schwarz is engaged, among other things, in the business of marketing and selling of pharmaceutical products; WHEREAS, subject to the terms and conditions set forth in this Agreement, CIMA and Schwarz wish to collaborate in the development, registration, marketing and sale of certain prescription products; and WHEREAS, subject to the terms and conditions set forth in this Agreement, CIMA wishes to license to Schwarz and Schwarz wishes to license from CIMA rights to CIMA's DuraSolv(TM), PakSolv(TM) and OraSolv(TM) technologies for use with such prescription products. NOW, THEREFORE, the parties hereto, intending to be legally bound, hereby agree as follows: SECTION 1 DEFINITIONS For purposes of this Agreement, the following terms shall have the meanings set forth below: "Activities" shall mean the development, manufacturing, marketing, selling and distributing of the Products in the Territory as contemplated by this Agreement. "Affiliates" shall mean, with respect to any Person, any Persons directly or indirectly controlling, controlled by, or under common control with, such other Person. For purposes hereof, the term "controlled" (including the terms "controlled by" and "under common control with"), as used with respect to any Person, shall mean the direct or indirect ability or power to direct or cause the direction of management policies of such Person or otherwise direct the affairs of such Person, whether through ownership of voting securities or otherwise. "Annual Net Sales" shall mean, for any Year, the Net Sales for such Year. "API" for each Product shall mean the active ingredient specified on Schedule 3.1 hereto with respect to such Product. "cGMP" shall mean current Good Manufacturing Practices, as determined by the FDA from time to time. "CIMA" shall have the meaning given in the preamble and shall include its Affiliates. "CIMA Intellectual Property" shall mean, collectively, (i) the CIMA Patents, (ii) the CIMA Technology, (iii) the CIMA Trademarks, and (iv) the CIMA Marketing Materials. "CIMA Marketing and Market Research Data" shall mean, with respect to the Products, all CIMA marketing data, studies, market research data and reports that pertain to the Products, and any further market research data that pertains to the Products whose disclosure to Schwarz is not prohibited by confidentiality obligations under agreements, dated prior to the date hereof, between CIMA and Persons who are not Affiliates of CIMA. "CIMA Marketing Materials" shall mean all labeling, marketing and promotional materials and inserts currently used by CIMA that are useful in connection with the Activities. "CIMA Patents" shall mean United States patent nos. 6,024,981 and 6,221,392 (Rapidly Dissolving Robust Dosage Form) and any patents and patent applications resulting therefrom, including any extension, reissue, renewal, reexamination or continuation-in-part of such patent or patent application. To the extent that the OraSolv(R) and PakSolv(TM) technology is used with respect to any Product pursuant to Schedule 3.1, the term "CIMA Patents" shall, with respect to such Product, be deemed to include United States patent nos. 5,178,878, 6,155,423, 6,269,615 and 6,311,462 and any patents and patent applications resulting therefrom, including any extension, reissue, renewal, reexamination or continuation-in-part of such patent or patent application. "CIMA Technology" shall mean all of the CIMA Patents and all of CIMA's trade secrets, technology, know-how and all other information necessary for the manufacture of the Products including, without limitation, that relate to CIMA's DuraSolv(R), PakSolv(TM) and OraSolv(R) technologies. "CIMA Trademarks" shall mean the CIMA(R), DuraSolv(R), PakSolv(TM), OraSolv(R) and Meltabs(R) trademarks. "Closing Date" shall have the meaning given in Section 6.3 hereof. "Completion Date" shall mean, with respect to any Product, the date on which Schwarz determines, in its reasonable discretion, such Product is ready for submission to the FDA with three months stability data on the pilot scale (equal to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], whichever is greater). "Cost of Goods" shall have the meaning set forth on Schedule 5.3 hereto. - 2 - "Damages" shall mean any and all actions, costs, losses, claims, liabilities, fines, penalties, demands, damages and expenses, court costs, and reasonable fees and disbursements of counsel, consultants and expert witnesses incurred by a party hereto (including interest which may be imposed in connection therewith), but excluding any punitive, exemplary or consequential damages. "Defective" shall mean, as to the Product, the failure of such to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] conform to the Specifications, this Agreement and all applicable law, including, without limitation, the FFDCA and the PDMA. "Development Schedule" shall mean the schedule of development activities set forth on Schedule 3.1 hereto. "FDA" shall mean the United States Food and Drug Administration. "FFDCA" the United State Federal Food, Drug and Cosmetic Act, as amended from time to time, together with any rules or regulations promulgated thereunder. "Force Majeure" shall mean acts of God, explosion, fire, flood, tornadoes, thunderstorms, earthquake or tremor, war whether declared or not, terrorism, civil strife, riots, embargo, losses or shortages of power, labor stoppage, substance shortages, damage to or loss of product in transit, currency restrictions, or events caused by reason of laws, regulations or orders by any government, governmental agency or instrumentality or by any other supervening or unforeseeable circumstances reasonably beyond the control of each party. "GAAP" shall mean generally accepted accounting practices in the United States as in effect from time to time. "Indemnified Party" shall have the meaning given in Section 10.2 hereof. "Indemnifying Party" shall have the meaning given in Section 10.2 hereof. "Latent Defect" shall mean a defect that results in a recall under Section 9.3. "Launch or Launched" shall mean, with respect to each Product, the date when such Product is first made commercially available by Schwarz "Licensed Assets" shall have the meaning set forth in Section 2.1 hereof. "Net Sales" shall mean, with respect to the Products, the gross amount invoiced to unrelated third parties for the Products in the Territory, less: (a) trade and reasonable and customary cash discounts allowed; (b) refunds, rebates, chargebacks, retroactive price adjustments and any other allowances which effectively reduce the net selling price; - 3 - (c) returns, credits and allowances; and (d) freight, taxes and insurance. Such amounts shall be determined from books and records maintained in accordance with GAAP, consistently applied. "PDMA" shall mean the Prescription Drug Marketing Act of 1987, as amended from time to time, together with any rules or regulations promulgated thereunder. "Person" shall mean a natural person, a corporation, a partnership, a trust, a joint venture, a limited liability company, any governmental authority or any other entity or organization. "Product" shall mean any of the pharmaceutical products described on Schedule 3.1, it being understood that additional products may be added to Schedule 3.1 after the date hereof in accordance with Section 3.4. "Promotional Materials" shall mean any advertising and promotional labeling bearing a name (trade name or generic name) used in the promotion of any of the Products, including, without limitation, promotional materials produced by or on behalf of Schwarz (examples include, but are not limited to, journal ads, brochures, service items, managed care pull through sheets, formulary presentations, price lists, monographs, Internet pages and telephone or television advertisements) and materials produced by outside sources (examples include, but are not limited to, medical reprints, textbooks and CME materials) to the extent funded by, created in cooperation with, reviewed, or distributed by Schwarz The definition of Promotional Materials shall also include press releases and other releases of information to the media regarding the Products. "Quarter" shall mean, as the case may be, the three months ending on March 31, June 30, September 30 or December 31 in any Year. "Satisfactory Completion" shall mean, with respect to any Development Phase for any Product, the completion of such Development Phase in a manner that is: (i) appropriate to support the commercialization of the Product; (ii) appropriate for the completion of the development of such Product on, prior to, or within [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the target Completion Date set forth in respect of such Product on Schedule 3.1; and (iii) consistent with this Agreement. "Schwarz" shall have the meaning given in the preamble and shall include its Affiliates. "Schwarz Technology" shall mean all of Schwarz's patents, trade secrets, technology, know-how and all other information necessary to the manufacture of the Products. "Schwarz Trademarks" shall have the meaning given in Section 9.11(c). - 4 - "Specifications" shall mean with respect to any Product, at any time, the specifications for such Product that are included in the Quality Assurance Addendum set forth on Schedule 5.4(d). "Territory" shall mean Canada, Mexico and the fifty (50) states, the District of Columbia and the territories and possessions comprising the United States of America, including Puerto Rico. "Year" shall mean a calendar year during the term of this Agreement. SECTION 2 GRANT OF LICENSES; LICENSE OPTION 2.1 Grant of Licenses. (a) CIMA hereby grants to Schwarz an exclusive license for the term of this Agreement under the following assets to market, distribute and sell the Products, for all indications and for all agreed upon Product line extensions, in the Territory (such assets are referred to herein collectively as the "Licensed Assets"): (i) all current and future regulatory filings, approvals, registrations and governmental authorizations that relate to the Products in the Territory; (ii) the CIMA Intellectual Property; and (iii) the CIMA Marketing and Market Research Data. (b) CIMA grants to Schwarz an exclusive, royalty bearing license to use the CIMA Trademarks to market, distribute and sell the Products, during the term of this Agreement, for all indications and for all agreed upon Product line extensions in the Territory. (c) The license to Schwarz will be exclusive in that CIMA will not grant any licenses of the Licensed Assets or the CIMA Trademarks (i) in the Territory to any other Person with respect to the Products or any other products containing the same active ingredient [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] as any Product or (ii) anywhere in the world with respect to any products having an identical formulation as any Product, in each case, during the term of this Agreement (d) In the event that a third party is interested in developing, manufacturing or marketing an equivalent formulation of a Product outside the Territory, CIMA and Schwarz agree as follows: - 5 - (i) CIMA shall be entitled to solicit interest and enter initial discussions with any third parties for making a product having a formulation equivalent to that of a Product commercially available in any country or countries outside the Territory; (ii) upon receiving a bona fide proposal from a third party for the development and/or license of a formulation equivalent to that of a Product, but prior to initiating development activities or granting a license to such third party for such equivalent formulation, CIMA shall provide Schwarz a notice (a "License Notice") of its intent to initiate development activities or grant such license in a specific country or countries which shall identify such country or countries and shall describe in detail the formulation proposed to be licensed; and (iii) Schwarz shall provide CIMA a notice within forty-five (45) days of its receipt of the License Notice that either: A) Schwarz does not intend to market the Product in such country or countries, in which case CIMA shall be free to initiate development activities and/or license the formulation described in the License Notice to a third party; or B) Schwarz does intend to market the Product in such country or countries, in which case this Agreement shall be amended to include such country or countries in the Territory and to allow CIMA to perform any necessary development work. Schwarz shall have one (1) year from the date of its notice to CIMA to demonstrate significant progress towards bringing the Product to market in such country or countries. If Schwarz fails to demonstrate significant progress within one (1) year or fails thereafter to demonstrate continued activities to market the Product in such country or countries, Schwarz's license to the Product in that country or countries will terminate in thirty (30) days after re-notification by CIMA that Schwarz is not in compliance with this Section 2.1(d)(iii). 2.2 Sublicenses. Schwarz shall have the right to extend the licenses granted pursuant to this Section 2 in whole or in part to any Affiliate of Schwarz, provided that Schwarz is not then in default with respect to any of its obligations to CIMA under this Agreement. All the terms and provisions of this Agreement shall apply to the Affiliate to which this license has been extended to the same extent as they apply to Schwarz, and the operations of the Affiliate shall be deemed to be the operations of Schwarz and Schwarz shall account therefor and be responsible for the performance of such Affiliate of all of its obligations hereunder. In addition, Schwarz shall have the right to extend the licenses granted pursuant to this Section 2 in whole or in part to Persons who are not Affiliates of Schwarz with the prior written consent of CIMA, which consent shall not unreasonably be withheld or delayed. 2.3 Marketing, Distribution and Sale. After each Launch, Schwarz shall use its commercially reasonable efforts to market, distribute and sell the launched Product in the Territory. Such efforts shall be consistent with industry norms, given the product profile, product potential and the state of the market at Launch. - 6 - SECTION 3 PRODUCT DEVELOPMENT 3.1 Obligations of CIMA. CIMA shall be responsible for the satisfactory performance of each of the development activities set forth on Schedule 3.1 at least by the times set forth on Schedule 3.1. 3.2 Obligations of Schwarz Schwarz shall, in a timely fashion, supply CIMA or cause CIMA to be supplied with sufficient quantities of API for CIMA to perform the development activities described on Schedule 3.1 and the supply activities described in Sections 5.1 and 5.5. 3.3 License of Schwarz Technology. Schwarz hereby grants to CIMA a non-exclusive license under the Schwarz Technology so that CIMA may carry out its obligations under Section 3.1. Such license may not be sublicensed without the prior written consent of Schwarz 3.4 Additional Products. Schwarz may, with the prior written consent of CIMA, such consent not to be unreasonably withheld, supplement Schedule 3.1 after the date hereof by adding additional products thereto in order to increase the number of Products subject to this Agreement or to replace any Product previously terminated under Section 11.1 (c) or (d), in which case each such additional product(s) shall be deemed a "Product" within the meaning hereof, provided that any Product added pursuant to this Section 3.4 shall be subject to terms, including development schedules, comparable to then existing Products. This Agreement shall be amended as necessary to accommodate such additional or replacement Products and terms related thereto. 3.5 Regulatory Matters. All Product, other than Prototypes, supplied to Schwarz shall be produced under cGMP and in accordance with the Specifications. CIMA shall furnish Schwarz with a Certificate of Analysis with a cGMP statement to demonstrate that each shipment of Product has been manufactured under cGMP and other FDA guidelines and in accordance with the Specifications. In addition, Schwarz reserves the right, at its own expense, to audit the facility of CIMA, including its processes, records and other facets of the operation as may be necessary to assure that all applicable regulations have been complied with, and the Specifications have been met. CIMA shall permit duly authorized representatives of Schwarz to audit all manufacturing and processing operations at reasonable times with a prior appointment. The right to audit shall commence with the effective date of this Agreement. These audits will be conducted to assure compliance with all pertinent acts, regulations, and guidelines promulgated by the FDA and other regulatory authorities, as well as standards then in effect in the regulatory environment. Such audits will be permitted during normal business hours and will be performed with a minimum of disruption. - 7 - SECTION 4 ROYALTY, COST OF GOODS AND MILESTONE PAYMENTS 4.1 Royalty and Milestone Payments. (a) Schwarz shall make royalty payments to CIMA, at the times, in the amounts and subject to the conditions set forth on Schedule 4.1(a). (b) Schwarz shall make Milestone Payments and Development Fee Payments to CIMA as set forth on Schedule 4.1(b). (c) In the event of (i) any patent infringement of the CIMA Technology that has a materially adverse effect on any Product, and/or (ii) the occurrence of an interruption in the supply of any Product for a period of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] or more, then, in each case, the obligation of Schwarz to make any payments pursuant to Sections 4.1(a) or 4.1(b) or Schedules 4.1(a) or 4.1(b) shall, in each case, terminate with respect to such Product(s) and be deemed waived by CIMA and shall be promptly renegotiated in good faith by Schwarz and CIMA. Any renegotiated obligations pursuant to this Section 4.1(c) shall be retroactively effective to the date the applicable event described above occurred. 4.2 Records and Audit. (a) Schwarz and its Affiliates shall keep full, true and accurate books of account containing all particulars that may be necessary for the purpose of showing the amounts payable to CIMA hereunder. Such books of account shall be kept at Schwarz's principal place of business or the principal place of business of the appropriate Affiliate of Schwarz to which this Agreement relates. Such books and the supporting data shall be open, at all reasonable times and upon reasonable notice during the term of this Agreement and for 2 years after its termination, to the inspection by a firm of certified public accountants selected by CIMA and reasonably acceptable to Schwarz, for the limited purpose of verifying Schwarz's royalty statements; provided, however, that such examination shall not take place more often than once each Year and shall not cover more than the preceding 3 Years, with no right to audit any period previously audited. Except as otherwise provided in this Section, the cost of any such examination shall be paid by CIMA. In the event that any such inspection reveals a deficiency in excess of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the reported royalty for the period covered by the inspection, Schwarz shall promptly pay CIMA the deficiency, plus interest at the rate of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] per annum, and shall reimburse CIMA for the fees and expenses paid to such accountants in connection with their less than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the reported royalty for the period covered by the inspection, Schwarz - 8 - shall promptly pay CIMA the deficiency, plus interest at the rate of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] per annum. The parties agree that neither party shall be required to retain books and records with respect to the above other than books and records relating to the current Year and the immediately preceding 3 Years. (b) CIMA shall keep full, true and accurate books and records that may be necessary for the purpose of determining the actual Costs of Goods incurred by CIMA as contemplated hereunder. Such books and records shall be kept at CIMA's principal place of business. Such books and records and the supporting data shall be open, at all reasonable times and upon reasonable notice during the term of this Agreement and for 2 years after its termination, to inspection by a firm of certified public accountants selected by Schwarz and reasonably acceptable to CIMA, for the limited purpose of verifying CIMA's Costs of Goods; provided, however, that such examination shall not take place more often than once each Year and shall not cover more than the preceding 3 Years, with no right to audit any period previously audited. Except as otherwise provided in this Section, the cost of any such examination shall be paid by Schwarz In the event that any such inspection reveals a discrepancy between CIMA's actual Costs of Goods and that invoiced to Schwarz, in favor of CIMA, in excess of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the reported Costs of Goods for the period covered by the inspection, CIMA shall promptly pay Schwarz the amount of such discrepancy, plus interest at the rate of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] per annum, and shall reimburse Schwarz for the fees and expenses paid to such accountants in connection with their inspection. In the event that any such inspection reveals a discrepancy between CIMA's actual Costs of Goods and that invoiced to Schwarz, in favor of CIMA, that is less than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the reported Cost of Goods for the period covered by the inspection, CIMA shall promptly pay Schwarz the amount of such discrepancy, plus interest at the rate of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] per annum. The parties agree that neither party shall be required to retain books and records with respect to the above other than books and records relating to the current Year and the immediately preceding 3 Years. 4.3 Quarterly Reports of Royalties. In any Year, Schwarz shall, within sixty (60) days after the end of each Quarter, deliver to CIMA true and accurate reports, certified by an authorized official of Schwarz, setting forth the actual Annual Net Sales and total royalties due under Section 4.1(a) for such Year. If no royalties are due, Schwarz shall so report. 4.4 Annual Reports of Costs of Goods. CIMA shall, not later than 60 days prior to the Launch of each Product and, thereafter, not later than 60 days after January 1 of each Year, deliver to Schwarz true and accurate reports, certified by an authorized official of CIMA, setting forth in reasonable detail the information necessary to calculate the Cost of Goods for each Product in accordance with Schedule 5.3. Product delivered to Schwarz between January 1 and February 28 each year shall be invoiced to Schwarz at the price applicable to Product delivered - 9 - to Schwarz during the immediately preceding calendar year. Then on or about February 28 of each year CIMA shall transmit to Schwarz 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 increase or decrease, and setting forth the applicable additional charges or credits. 4.5 Sales and Marketing Estimates. Schwarz shall provide CIMA with a non-binding estimate of its Annual Net Sales by quarter for each Product [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] prior to the Launch of each Product. Thereafter, prior to September 30th in any year following the Launch of such Product, Schwarz shall provide CIMA with non-binding estimate of its Annual Net Sales of such Product by quarter for the following year. SECTION 5 SUPPLY OF PRODUCT 5.1 Supply of Product. (a) For the term of this Agreement, or for as long as CIMA manufactures any of the Products hereunder, whichever is shorter, Schwarz agrees to purchase from CIMA and CIMA agrees to supply Schwarz with all of Schwarz's requirements for the Products, Product samples and Product placebos for their subsequent use, sale, lease or transfer by Schwarz (b) Schwarz agrees to initiate purchases of the Products, Product samples and Product placebos hereunder by issuing CIMA binding purchase orders not less than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] prior to the required shipping date set forth therein. CIMA agrees to accept any order issued in accordance with this Section 5.1(b) and to meet the delivery dates specified thereon. All purchase orders hereunder shall be on Schwarz's standard purchase order form (a copy of which is attached as Schedule 5.1(b) hereto and which shall not, for purposes of this Agreement only, be modified in any material respect without CIMA's prior written consent, such consent not to be unreasonably withheld or delayed) and shall be directed to CIMA at the address set forth below. The terms and conditions of purchase enumerated on the reverse side of such standard purchase order form shall prevail over any inconsistent or conflicting language as may exist on invoices, confirmation or order acknowledgment forms of CIMA, provided, however, that in the event any terms thereof are in conflict, or are inconsistent with any terms of this Agreement, the terms and conditions hereof shall prevail. No Product delivered by CIMA shall have a shelf life that is more than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] less than the maximum shelf life of such Product (other than batches that were under investigation and batches for validation which shall have not more than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND - 10 - EXCHANGE COMMISSION.***] less than the maximum shelf life of such Product upon delivery to Schwarz). (c) Purchase order quantities shall be in full batch sizes that are mutually agreed by the parties. (d) Schwarz shall cause the amount of API that CIMA requires to perform its obligations pursuant to Schedule 3.1 and Sections 5.1 and 5.5 to be provided at no charge to CIMA [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] prior to date of tablet manufacture, as well as [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of safety stock. API must conform to Schwarz's then current raw materials specifications. CIMA shall not be accountable for production or shipment delays due to lack of API. (e) EXCEPT AS SPECIFICALLY PROVIDED HEREIN, INCLUDING, WITHOUT LIMITATION, SECTION 7.8, THE PRODUCT WILL BE SUPPLIED BY CIMA WITH NO WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABLILITY OR FITNESS FOR A PARTICULAR PURPOSE. 5.2 Identification. Schwarz may market the Products under its name, with its packaging and logo; Schwarz will, however, identify CIMA as the supplier in a fair manner, reasonably acceptable to CIMA. CIMA will bear all the costs of labeling the Product so as to appropriately display the Schwarz name provided Schwarz supplies all the appropriate graphics, designs, logos and related and appropriate artwork at least a reasonable amount of time in advance of any Product being manufactured. Schwarz shall reimburse CIMA for any reasonable and documented costs incurred by CIMA in making changes to the packaging required to manufacture the Products in accordance with changes to the PDMA or other applicable law or changes required by Schwarz, including, but not limited to plate and die charges due to label changes and product identification requirements, and for any packaging components rendered obsolete by the changes. In addition, CIMA shall pay for all initial one-time set-up charges incurred by CIMA in respect of packaging each Product. Schwarz may use CIMA's name and derivations thereof in promoting, marketing and selling the Products in the Territory; provided, however, that the particular formulation of any reference to CIMA's name in any Promotional Material shall be subject to CIMA's review and consent; and provided, further, that once the formulation of any such reference has been reviewed and consented to by CIMA, any subsequent reference to CIMA's name using such formulation shall not be subject to the further review or consent of CIMA. All samples shall be clearly marked "for sample use only" or some similar phrasing suggested by Schwarz 5.3 Trade, Sample and Placebo Product Price. CIMA shall supply Products, Product samples and Product placebos to Schwarz at the price set forth on Schedule 5.3. - 11 - 5.4 Forecasts, Delivery and Quality. (a) Schwarz shall provide CIMA with 12-month non-binding forecasts within 15 days after the end of each Quarter. Such forecasts shall be revised and extended in each succeeding Quarter. (b) Delivery of the Products, Product samples and Product placebos shall be in accordance with the means of transportation, destination and dates set forth in Schwarz's purchase order. Delivery shall be EXW (Incoterms 2000) CIMA and CIMA shall load Products on to collecting vehicle at CIMA's risk. (c) All deliveries of the Products hereunder shall include a Certificate of Analysis provided by the quality control manager of CIMA attesting to the fact that such Products (i) have been manufactured by a process which complies with cGMP and (ii) are of quality which is in accordance with criteria established in the Specifications and all FDA requirements. (d) The Products, Product samples and Product placebos supplied hereunder shall have been manufactured by a process which complies with the quality assurance addendum set forth on Schedule 5.4(d). 5.5 Rejection and Replacement. (a) In the event Schwarz determines that any Products, Product samples or Product placebos as manufactured and/or packaged by CIMA is Defective, then, within [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] after delivery of such Products, Product samples or Product placebos to Schwarz [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], Schwarz shall provide to CIMA a written notice of rejection, specifying in reasonable detail the manner in which the Products are Defective (the "Notice of Rejection"). If no written Notice of Rejection is given to CIMA by Schwarz within such [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] period, such Products, Product samples or Product placebos shall be deemed to have been accepted by Schwarz, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. (b) Upon receipt of a Notice of Rejection from Schwarz and in order to minimize any hardship to Schwarz's customers, CIMA shall use its reasonable best efforts to promptly supply to Schwarz a quantity of replacement Products, Product samples or Product placebos meeting the Specifications equal to the size of the lot or lots which Schwarz claims was Defective so that such replacement Products shall be received by Schwarz within 30 days following CIMA's receipt of Schwarz's Notice of Rejection. If CIMA agrees with Schwarz that such Product is Defective then CIMA shall either replace the Defective Product at no cost to Schwarz, or refund or credit, as designated by Schwarz, the price paid for such Product plus any applicable delivery charges, including, without limitation, shipping, insurance and taxes, and any reasonable and - 12 - documented out-of-pocket expense that Schwarz may have incurred, within thirty (30) days after written notice from Schwarz If CIMA disagrees with Schwarz as to whether such Product is Defective, the parties shall cooperate to have the Product in dispute analyzed by an independent testing laboratory of recognized repute jointly selected by Schwarz and CIMA. If the Product is determined by such laboratory to meet the Specifications, then Schwarz shall bear the cost of the independent laboratory testing and pay for the 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 Defective Product within thirty (30) days after the date of such determination, at no cost to Schwarz, or refund or credit, as designated by Schwarz, the price paid for such Product plus any applicable delivery charges, including, without limitation, shipping, insurance and taxes, and any reasonable and documented out-of-pocket expense that Schwarz may have incurred, within thirty (30) days after written notice from Schwarz If CIMA is unable to replace any such Product within thirty (30) days (or at any time that CIMA fails to deliver the replacement Product at an agreed upon date), Schwarz shall have the right, at its sole discretion, to extend the timeframe for delivery of replacement Product to a mutually agreed upon date, or, in the alternative, to require CIMA to reimburse Schwarz for the price paid for such Product plus any applicable delivery charges, including, without limitation, shipping, insurance and taxes and any reasonable and documented out-of-pocket expense Schwarz may have incurred. Such reimbursement shall be made within thirty (30) days of such notice. 5.6 Invoice and Payment. Upon shipment of any Products, Product samples or Product placebos, CIMA shall be entitled to submit invoices therefor to Schwarz, and Schwarz agrees to remit payment within thirty (30) days from CIMA's invoice date. 5.7 Supply Disruption; Alternate Manufacturing Site. (a) CIMA shall use its best efforts to supply Schwarz with the Products in a timely manner in accordance with the orders and forecasts received by CIMA pursuant to Sections 5.1(b) and 5.4(a), respectively. In any consecutive [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] period, should CIMA fail to supply Schwarz with a Product ordered for such [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] period pursuant to Section 5.1(b) (other than for reason of Force Majeure), Schwarz shall have the right to require CIMA to transfer the manufacture of such Product(s) to Schwarz's Seymour facility or other designated Schwarz facility. Should CIMA cure its failure to supply any Product so transferred, CIMA shall have the right to resume the manufacture of such Product and Schwarz and CIMA shall transfer the manufacture of such Product back to CIMA within a commercially reasonable amount of time. (b) CIMA shall, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] establish a second manufacturing plant as an alternate FDA-approved manufacturing site for the Products however, the second manufacturing plant is not required to contain a bottling capability - 13 - 5.8 CIMA's Obligation to Continue Manufacture. If this Agreement terminates or expires through no breach of Schwarz, CIMA shall reasonably cooperate with Schwarz in transferring the manufacture of the Products to Schwarz, its Affiliate or, subject to confidentiality obligations consistent with Section 9.4, a third-party appointed by Schwarz, the parties shall develop a timing and payment schedule for the transfer of the manufacture of the Products and CIMA shall continue to supply the Products to Schwarz pursuant to the terms of this Agreement until [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] from the date this Agreement is terminated or expires pursuant to Section 11.1. SECTION 6 CONDITIONS PRECEDENT TO THE CLOSING; CLOSING DATE 6.1 Conditions Precedent to Schwarz's Obligations. Subject to waiver as set forth in Section 12.3, all obligations of Schwarz to close the transactions contemplated under this Agreement are subject to the fulfillment or satisfaction of each of the following conditions precedent: (a) Representations and Warranties True as of the Closing Date. The representations and warranties of CIMA contained in this Agreement or in any schedule, certificate or document delivered by CIMA to Schwarz pursuant to the provisions hereof shall have been true on the date hereof and shall be true on the Closing Date with the same effect as though such representations and warranties were made as of such date. (b) Compliance with this Agreement. CIMA shall have performed and complied with all agreements and conditions required by this Agreement to be performed or complied with by it prior to or by the Closing Date. (c) Closing Certificate. Schwarz shall have received a certificate from CIMA, executed by an officer of CIMA, certifying in such detail as Schwarz may reasonably request that the conditions specified in Sections 6.1(a) and 6.1(b), above, have been fulfilled and certifying that CIMA has obtained all consents and approvals required hereunder. (d) No Threatened or Pending Litigation. On the Closing Date, no suit, action or other proceeding, or injunction or final judgment relating thereto, shall, to the best of CIMA's knowledge, be threatened or be pending before any court or governmental or regulatory official, body or authority in which it is sought to restrain or prohibit or to obtain damages or other relief in connection with this Agreement or the consummation of the transactions contemplated hereby, and no investigation that might result in any such suit, action or proceeding shall be pending or, to the best of CIMA's knowledge, threatened. - 14 - 6.2 Conditions Precedent to CIMA's Obligations. Subject to waiver as set forth in Section 12.3, all obligations of CIMA to close the transactions contemplated under this Agreement are subject to the fulfillment or satisfaction of each of the following conditions precedent: (a) Representations and Warranties True as of the Closing Date. The representations and warranties of Schwarz contained in this Agreement or in any schedule, certificate or document delivered by Schwarz to CIMA pursuant to the provisions hereof shall have been true on the date hereof and shall be true on the Closing Date with the same effect as though such representations and warranties were made as of such date. (b) Compliance with this Agreement. Schwarz shall have performed and complied with all agreements and conditions required by this Agreement to be performed or complied with by it prior to or by the Closing Date. (c) Closing Certificate. CIMA shall have received a certificate from Schwarz, executed by an officer of Schwarz, certifying in such detail as CIMA may reasonably request that the conditions specified in Sections 6.2(a) and 6.2(b), above, have been fulfilled and certifying that Schwarz has obtained all consents and approvals required hereunder. (d) No Threatened or Pending Litigation. On the Closing Date, no suit, action or other proceeding, or injunction or final judgment relating thereto, shall, to the best of Schwarz's knowledge, be threatened or be pending before any court or governmental or regulatory official, body or authority in which it is sought to restrain or prohibit or to obtain damages or other relief in connection with this Agreement or the consummation of the transactions contemplated hereby, and no investigation that might result in any such suit, action or proceeding shall be pending or, to the best of Schwarz's knowledge, threatened. 6.3 Closing Date. (a) Subject to Section 6.3(b), below, the closing of the transactions contemplated by this Agreement shall take place at 10:00 a.m., local time, on December 18, 2001, or on such other date as may be mutually agreed upon in writing by the parties (the "Closing Date"), at the offices of Mayer, Brown & Platt, 1675 Broadway, New York, New York 10019. (b) Each party hereby agrees to use its best efforts to consummate the transactions contemplated herein, as modified, on or before December 18, 2001; provided, however, that if the parties are unable to close the transactions contemplated hereby by January 31, 2002, or such later date as shall be mutually agreed to in writing by CIMA and Schwarz, then all of the rights and obligations of the parties under this Agreement shall terminate without liability. - 15 - SECTION 7 REPRESENTATIONS AND WARRANTIES OF CIMA CIMA hereby represents and warrants to Schwarz that: 7.1 Organization, Power and Authority. CIMA is a corporation duly organized and validly existing under the laws of the State of Delaware. CIMA has all necessary corporate power and authority to enter into, and be bound by the terms and conditions of, this Agreement, and to license the Licensed Assets and the CIMA Trademarks to Schwarz pursuant hereto. 7.2 Due Authority; No Breach. The execution, delivery and performance by CIMA of this Agreement and each agreement or instrument contemplated by this Agreement, and the performance of the transactions contemplated hereby and thereby, have been duly authorized by all necessary corporate action by CIMA. This Agreement is, and each agreement or instrument contemplated by this Agreement, when executed and delivered by CIMA in accordance with the provisions hereof, will be (assuming the due execution and delivery hereof and thereof by Schwarz) the legal, valid and binding obligation of CIMA, in each case enforceable against CIMA in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, moratorium, reorganization, or similar laws from time to time in effect which affect the enforcement of creditors' rights generally and by legal and equitable limitations on the availability of specific performance and other equitable remedies against CIMA. All persons who have executed this Agreement on behalf of CIMA, or who will execute on behalf of CIMA any agreement or instrument contemplated by this Agreement, have been duly authorized to do so by all necessary corporate action. Neither the execution and delivery of this Agreement or any such other agreement or instrument by CIMA, nor the performance of the obligations contemplated hereby or thereby, will (i) conflict with or result in any violation of or constitute a breach of any of the terms or provisions of, or result in the acceleration of any obligation under, or constitute a default under any provision of the articles of incorporation or by-laws of CIMA or any material contract or any other material obligation to which CIMA is a party or to which it is subject or bound, or (ii) violate any judgment, order, injunction, decree or award of any court, administrative agency, arbitrator or governmental body against, or affecting or binding upon, CIMA or upon the securities, property or business of CIMA, or (iii) constitute a violation by CIMA of any applicable law or regulation of any jurisdiction as such law or regulation relates to CIMA, or to the property or business of CIMA except for such conflict, acceleration, default, breach or violation that is not reasonably likely to have a material adverse effect on CIMA's ability to perform its obligations under this Agreement or under any agreement or instrument contemplated hereby. 7.3 Intellectual Property. CIMA is the lawful owner of the Licensed Assets and CIMA Trademarks, CIMA can license the Licensed Assets and CIMA Trademarks without the consent of any third party in the Territory, there is no pending or overtly threatened claim against CIMA asserting that any of the Licensed Assets or CIMA Trademarks infringes or violates the rights of third parties in the Territory or that Schwarz, by practicing under the Licensed Assets and CIMA Trademarks in performing the Activities, would violate any of the intellectual property rights of any third party in the Territory, and nothing has come to the attention of CIMA which has, or reasonably should have, led CIMA to believe that any of the Licensed Assets and CIMA Trademarks infringes or violates the right of third parties in the Territory. CIMA has not given any notice to any third parties asserting infringement by such third parties upon any of the Licensed Assets and - 16 - CIMA Trademarks. CIMA is not aware of and has not received any communications challenging the ownership, validity or effectiveness of any of the Licensed Assets and CIMA Trademarks. CIMA has not granted any right to any third party relating to the Activities which would violate the terms of or conflict with the rights granted to Schwarz pursuant to this Agreement. 7.4 Technology Rights. The CIMA Technology, to the best of CIMA's knowledge, when combined with the Schwarz Technology, includes all the technology, patents, know-how, trade secrets and other intellectual property necessary to manufacture the Products. 7.5 Litigation. There are no pending or, to the best of CIMA's knowledge, threatened judicial, administrative or arbitral actions, claims, suits or proceedings pending as of the date hereof against CIMA relating to the Activities, the Licensed Assets or the CIMA Trademarks which, either individually or together with any other, would have a material adverse effect on the Activities, the Licensed Assets, the CIMA Trademarks or the ability of CIMA to perform its obligations under this Agreement or any agreement or instrument contemplated hereby. There are no pending, and CIMA does not presently contemplate bringing, any actions or suits relating to the Activities, the Licensed Assets or the CIMA Trademarks against others. 7.6 Governmental Approval. No consent, approval, waiver, order or authorization of, or registration, declaration or filing with, any governmental authority is required in connection with the execution, delivery and performance of this Agreement, or any agreement or instrument contemplated by this Agreement, by CIMA or the performance by CIMA of its obligations contemplated hereby and thereby. 7.7 Brokerage. No broker, finder or similar agent has been employed by or on behalf of CIMA, and no Person with which CIMA has had any dealings or communications of any kind is entitled to any brokerage commission, finder's fee or any similar compensation, in connection with this Agreement or the transactions contemplated hereby. 7.8 Supply. All finished Products supplied by CIMA under Section 5 shall (i) have been manufactured by a process which complies with cGMP and the Quality Assurance Addendum set forth on Schedule 5.4(d) and (ii) be of a quality which is in accordance with criteria established by the specifications established by the Specifications and all FDA requirements. SECTION 8 REPRESENTATIONS AND WARRANTIES OF SCHWARZ Schwarz represents and warrants to CIMA that: 8.1 Organization, Power and Authority. Schwarz is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware. Schwarz has all - 17 - necessary corporate power and authority to enter into, and be bound by the terms and conditions of, this Agreement, to license the Licensed Assets, the Patents and the CIMA Technology from CIMA, and to license the Schwarz Technology to CIMA pursuant hereto. 8.2 Due Authority; No Breach. The execution, delivery and performance by Schwarz of this Agreement, and each agreement or instrument contemplated by this Agreement, and the performance of the transactions contemplated hereby and thereby, have been duly authorized by all necessary corporate action by Schwarz This Agreement is, and each agreement or instrument contemplated by this Agreement, when executed and delivered by Schwarz in accordance with the provisions hereof, will be (assuming due execution and delivery hereof and thereof by CIMA) the legal, valid and binding obligation of Schwarz, in each case enforceable against Schwarz in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, moratorium, reorganization, or similar laws from time to time in effect which affect the enforcement of creditors' rights generally and by legal and equitable limitations on the availability of specific performance and other equitable remedies against Schwarz All persons who have executed this Agreement on behalf of Schwarz, or who will execute on behalf of Schwarz any agreement or instrument contemplated by this Agreement, have been duly authorized to do so by all necessary corporate action. Neither the execution and delivery of this Agreement by Schwarz, or any such other agreement or instrument by Schwarz, nor the performance of the obligations contemplated hereby and thereby, will (i) conflict with or result in any violation of or constitute a breach of any of the terms or provisions of, or result in the acceleration of any obligation under, or constitute a default under any provision of its articles of incorporation or by-laws or any material contract or any other material obligation to which Schwarz is a party or to which it is subject or bound, or (ii) violate any judgment, order, injunction, decree or award of any court, administrative agency, arbitrator or government body against, or affecting or binding upon, Schwarz or upon the securities, property or business of Schwarz, or (iii) constitute a violation by Schwarz of any applicable law or regulation of any jurisdiction as such law or regulation relates to Schwarz or to the property or business of Schwarz, except for such conflict, acceleration, default, breach or violation that is not reasonably likely to have a material adverse effect on Schwarz's ability to perform its obligations under this Agreement or any agreement or instrument contemplated hereby. 8.3 Brokerage. No broker, finder or similar agent has been employed by or on behalf of Schwarz and no Person with which Schwarz has had any dealings or communications of any kind is entitled to any brokerage commission, finder's fee or any similar compensation, in connection with this Agreement or the transactions contemplated hereby. 8.4 Litigation. There are no pending or, to the best of Schwarz's knowledge, threatened judicial, administrative or arbitral actions, claims, suits or proceedings pending as of the date hereof against Schwarz which, either individually or together with any other, will have a material adverse effect on the ability of Schwarz to perform its obligations under this Agreement or any agreement or instrument contemplated hereby or affect adversely the grant to CIMA of the non-exclusive license of the Schwarz Technology pursuant to Section 3.3. 8.5 Governmental Approval. No consent, approval, waiver, order or authorization of, or registration, declaration or filing with, any governmental authority is required in connection with the execution, delivery and performance of this Agreement, or any agreement or instrument - 18 - contemplated by this Agreement, by Schwarz or the performance by Schwarz of its obligations contemplated hereby and thereby. SECTION 9 ADDITIONAL COVENANTS AND AGREEMENTS OF THE PARTIES 9.1 Governmental Filings. CIMA and Schwarz each agree to prepare and file whatever filings, listings, requests or applications are required to be filed with any governmental authority in connection with this Agreement or the Products and to cooperate with one another as reasonably necessary to accomplish the foregoing. 9.2 Compliance with Law. Schwarz and CIMA shall each comply with all federal, state and local laws and regulations applicable to developing, approving, manufacturing, marketing and selling the Products in the Territory, the Licensed Assets, the Patents and the Technology or the performance of their respective obligations hereunder. CIMA and Schwarz each shall keep all records and reports required to be kept by applicable laws and regulations, and each shall make its facilities available at reasonable times during business hours for inspection by representatives of governmental agencies. CIMA and Schwarz each shall notify the other within forty-eight (48) hours of receipt of any notice or any other indication whatsoever of any FDA or other governmental agency inspection, investigation or other inquiry, or other material notice or communication of any type, involving any Product. Schwarz and CIMA shall cooperate with each other during any such inspection, investigation or other inquiry including, but not limited to, allowing upon request a representative of the other to be present during the applicable portions of any such inspection, investigation or other inquiry and providing copies of all relevant documents. Schwarz and CIMA shall discuss any written response to observations or notifications received in connection with any such inspection, investigation or other inquiry and each shall give the other an opportunity to comment upon any proposed response before it is made. In the event of disagreement concerning the form or content of such response, however, CIMA shall be responsible for deciding the appropriate form and content of any response with respect to any of its cited activities and Schwarz shall be responsible for deciding the appropriate form and content of any response with respect to any of its cited activities. 9.3 Recall. Schwarz and CIMA shall consult with one another as to all decisions concerning recall or withdrawal of any Product from the market, including, but not limited to, determining whether or not to make any such recall or withdrawal, the timing and scope thereof, and the means of conducting any recall or withdrawal. The party requesting any recall or withdrawal must receive the prior written consent of the other party, such consent not to be unreasonably withheld, prior to initiating such recall or withdrawal. No consent shall be necessary if the recall or withdrawal is requested by the FDA or other governmental authority. CIMA shall bear the costs (including but not limited to, shipping and product credits) for any recall or withdrawal primarily due to CIMA's failure to comply with this Agreement. The costs for any other recall or withdrawal shall be the responsibility of Schwarz. - 19 - 9.4 Confidentiality. Schwarz shall treat as confidential the Licensed Assets, the Patents, the CIMA Technology, and all other information of CIMA of which Schwarz becomes aware in connection with this Agreement (collectively, "CIMA Proprietary Information"). Schwarz shall neither disclose CIMA Proprietary Information to any third party nor use CIMA Proprietary Information for any purpose other than as set forth in this Agreement. CIMA shall treat as confidential the Schwarz Technology and all other information of Schwarz of which CIMA becomes aware in connection with this Agreement (collectively, "Schwarz Proprietary Information"). CIMA shall neither disclose Schwarz Proprietary Information to any third party nor use Schwarz Proprietary Information for any purpose other than as set forth in this Agreement. Nothing contained herein will in any way restrict or impair either party's (the "Using Party's") right to use, disclose or otherwise deal with any Proprietary Information of the other party which: (a) at the time of disclosure is known to the public or thereafter becomes known to the public by publication or otherwise through no fault of the Using Party; (b) the Using Party can establish was in its possession prior to the time of the disclosure and was not obtained directly or indirectly from the other party; (c) is independently made available as a matter of right to the Using Party by a third party who is not thereby in violation of a confidential relationship with the other party; (d) is developed by the Using Party independently of the Proprietary Information received from the other party and the Using Party can establish such development; or (e) is information required to be disclosed by legal or regulatory process; provided, in each case the Using Party timely informs the other party and uses reasonable efforts to limit the disclosure and maintain confidentiality to the extent possible and permits the other party to intervene and contest or attempt to limit the disclosure. 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 applicable 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. Schwarz shall obtain no right or license of any kind under the CIMA Proprietary Information except as set forth in this Agreement. CIMA shall obtain no right or license of any kind under the Schwarz Proprietary Information except as set forth in this Agreement. 9.5 Expenses. CIMA and Schwarz shall each bear their own direct and indirect expenses incurred in connection with the negotiation and preparation of this Agreement and, except as set forth in this Agreement, the performance of the obligations contemplated hereby. - 20 - 9.6 Reasonable Efforts. CIMA and Schwarz each hereby agrees to use all reasonable efforts to take, or cause to be taken, all actions and to do, or cause to be done all things necessary or proper to make effective the transactions contemplated by this Agreement, including such actions as may be reasonably necessary to obtain approvals and consents of governmental Persons and other Persons. 9.7 Publicity. Each of the parties agrees that no publicity release or announcement concerning the transactions contemplated hereby shall be issued without the advance written consent of the other, except as such release or announcement may be required by law, in which case the party making the release or announcement shall, before making any such release or announcement, afford the other party a reasonable opportunity to review and comment upon such release or announcement. 9.8 Cooperation. If either party shall become engaged in or participate in any investigation, claim, litigation or other proceeding with any third party, including the FDA, relating in any way to the Products or any of the Licensed Assets, the Patents or the Technology, the other party shall cooperate in all reasonable respects with such party in connection therewith, including, without limitation, using its reasonable efforts to make available to the other such employees who may be helpful with respect to such investigation, claim, litigation or other proceeding, provided that, for purposes of this provision, reasonable efforts to make available any employee shall be deemed to mean providing a party with reasonable access to any such employee at no cost for a period of time not to exceed 24 hours (e.g., three 8-hour business days). Thereafter, any such employee shall be made available for such time and upon such terms and conditions (including, but not limited to, compensation) as the parties may mutually agree. 9.9 Competition; No Sale for Resale. (a) CIMA agrees that, commencing on the Closing Date and continuing for the period ending [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] after the term of this Agreement, it shall not directly or indirectly, develop or manufacture for sale within the Territory any Product described on Schedule 3.1 on the date hereof or engage in the marketing, selling or distributing of any such Product in the Territory except as contemplated by this Agreement. It is further understood that the remedies at law are inadequate in the case of any breach of this covenant and that Schwarz shall be entitled to equitable relief, including the remedy of specific performance, with respect to any breach of such covenant. (b) Neither Schwarz nor any sublicensee of Schwarz shall knowingly directly or indirectly sell any Product to anyone in the Territory for subsequent distribution or resale outside the Territory and each shall take all reasonable precautions to prevent such distribution or resale outside the Territory. Neither CIMA nor any of its Affiliates shall knowingly directly or indirectly sell any Product to anyone in the Territory or outside the Territory for subsequent distribution or resale in the Territory and each shall take all reasonable precautions to prevent such distribution or resale in the Territory. - 21 - 9.10 Conflicting Rights. CIMA shall not grant any right to any third party relating to the Activities which would violate the terms of or conflict with the rights granted to Schwarz pursuant to this Agreement. 9.11 Patent and Trademark Maintenance. (a) CIMA shall be solely responsible for filing, prosecuting, and maintaining all of the CIMA Patents, and CIMA shall pay the costs associated therewith. CIMA shall file, prosecute, and maintain all CIMA Patents so as to fully continue the benefits under the licenses granted to Schwarz hereunder. CIMA may, however, discontinue prosecuting and maintaining any CIMA Patent if (i) CIMA has a valid business reason to do so, and (ii) obtains the prior written approval of Schwarz, such approval not to be unreasonably withheld or delayed. (b) CIMA shall be solely responsible for filing, prosecuting, and maintaining all CIMA Trademarks, and CIMA shall pay the costs associated therewith. All registrations, variations, logos, goodwill and other rights under or acquired through use of the CIMA Trademarks shall accrue and belong to CIMA. Except as provided herein, Schwarz shall have no rights to use the CIMA Trademarks. Schwarz will not use in its business, in or outside of the Territory, any other mark or name which is similar to or nearly resembles any of the CIMA Trademarks in use by CIMA to indicate the source and origin of the CIMA Technology as to be likely to cause deception or confusion. Schwarz recognizes that CIMA is the owner of all CIMA Trademarks used in commerce to indicate the source of the CIMA Technology and agrees that the CIMA Trademarks shall remain vested in CIMA both during the term of this Agreement and thereafter. Schwarz shall not contest the validity of the CIMA Trademarks or CIMA's ownership of the CIMA Trademarks. Use of the CIMA Trademarks by Schwarz in conjunction with the manufacture, use, and sale of the Product and all goodwill related thereto shall inure to the benefit of CIMA for purposes of building the longevity and extent of use of the CIMA Trademarks. (c) Schwarz shall be solely responsible for filing, prosecuting, and maintaining all trademarks it develops or owns for the Products (the "Schwarz Trademarks"), and Schwarz shall pay the costs associated therewith. All registrations, variations, logos, goodwill and other rights under or acquired through use of the Schwarz Trademarks shall accrue and belong to Schwarz CIMA shall have no rights to use the Schwarz Trademarks, including, without limitation, in connection with any product subsequently developed by CIMA. CIMA will not use in its business, in or outside of the Territory, any other mark or name which is similar to or nearly resembles the Schwarz Trademarks in use by Schwarz in a manner that is likely to cause deception or confusion. CIMA recognizes that Schwarz is the owner of all of the Schwarz Trademarks used in commerce to indicate the source of the Product and agrees that the Schwarz Trademarks shall remain vested in Schwarz both during the term of this Agreement and thereafter. CIMA shall not contest the validity of the Schwarz Trademarks or Schwarz's ownership of the Schwarz Trademarks. Use of the Schwarz Trademarks by Schwarz in conjunction with the manufacture, use, and sale of the Product and all goodwill related thereto shall - 22 - inure to the benefit of Schwarz for purposes of building the longevity and extent of use of the Schwarz Trademarks. (d) Schwarz and CIMA agree that, where applicable, all packaging of the Products shall identify (i) the number of the CIMA Patents and CIMA as the owner thereof and (ii) Schwarz as the owner of the Schwarz Trademarks. (e) Any improvements to the CIMA Technology (whether or not patentable) shall be owned solely by CIMA. (f) Any improvements to the Schwarz Technology (whether or not patentable) shall be owned solely by Schwarz (g) Schwarz shall have full ownership rights to the Products with the exception of any improvements to the CIMA Technology as contemplated by Section 9.11(e). (h) Any provisions in this Agreement to the contrary notwithstanding, Schwarz acknowledges that, for all purposes, CIMA is the owner of the CIMA Technology and CIMA acknowledges that, for all purposes, Schwarz is the owner of the Schwarz Technology. 9.12 Infringement; Enforcement of Proprietary Rights. (a) Infringement of Patent Rights. Each party shall promptly notify the other of any alleged infringement by third parties of any CIMA Patent and provide any information available to that party relating to such alleged infringement. CIMA shall have the responsibility to investigate such alleged infringement and act diligently, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], to end any infringement of such rights that materially affect Schwarz's rights pursuant to this Agreement, including, but not limited to, bringing suit against such third party infringer. In the event that CIMA does not bring suit against such third party infringer, Schwarz may, at its own expense, bring suit against such third party infringer on CIMA's behalf. (b) Procedures. No settlement, consent judgment or other voluntary final disposition of any suit contemplated by Section 9.12(a) may be entered into without the consent of each party, which consent shall not be unreasonably withheld or delayed. Any recovery of damages in any such suit shall be retained by the party bearing the costs of such suit. In the event of any infringement suit against a third party brought by either party pursuant to this Section 9.12, the party not bringing such suit shall cooperate in all respects, execute any documents reasonably necessary to permit the other party to prosecute such suit, and to the extent reasonable shall make available its employees and relevant records to provide evidence for such suit. (c) Infringement of Third Party Rights. If, during the term of this Agreement, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED - 23 - SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Schwarz's marketing or selling of the Product hereunder infringes on a third party patent based upon claims that dominate claims in the CIMA Patents, within [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] after notice by Schwarz, CIMA shall use its reasonable best efforts to procure for Schwarz the right to exercise all rights licensed under this Agreement without any additional payment therefor by Schwarz 9.13 Supply of Products. CIMA shall maintain sufficient capacity throughout the term of this Agreement to meet the requirements of Schwarz for the supply of Products hereunder. 9.14 Liability Insurance. At and after each Launch, CIMA shall use its best efforts to obtain and carry in full force and effect product liability insurance in respect of the applicable Product in the amount of $1,000,000 per occurrence and in the aggregate and policies of $10,000,000 of excess coverage in the aggregate. At and after each Launch, Schwarz shall use its best efforts to obtain and carry in full force and effect product liability insurance in respect of the applicable Product in the amount of $1,000,000 per occurrence and in the aggregate and policies of $10,000,000 of excess coverage in the aggregate. 9.15 Referral of Orders and Inquiries. CIMA shall refer all Persons sending orders or making inquiries regarding the Products within the Territory to Schwarz and shall promptly notify Schwarz of the name of each such Person and the nature of the inquiry of such Person. 9.16 Deemed Breach of Covenant. Neither CIMA nor Schwarz shall be deemed to be in breach of any covenant contained in this Section 9 if such party's deemed breach is the result of any action or inaction on the part of the other party. SECTION 10 INDEMNIFICATION 10.1 Indemnification. (a) CIMA shall indemnify, defend and hold Schwarz (and its directors, officers, employees, and Affiliates) harmless from and against any and all Damages incurred or suffered by Schwarz (and its directors, officers, employees, and Affiliates) as a consequence of: (i) any breach of any representation or warranty made by CIMA in this Agreement or any agreement, instrument or document delivered by CIMA pursuant to the terms of this Agreement; (ii) any failure to perform duly and punctually any covenant, agreement or undertaking on the part of CIMA contained in this Agreement; - 24 - (iii) any act or omission of CIMA with respect to the operation of CIMA's business, or the handling, manufacturing or development of the Products by CIMA; or (iv) the infringement of the Licensed Assets, the Patent or the Technology of any patent, trademark, copyright, trade secret or other intellectual property right of any person other than CIMA or Schwarz (b) Schwarz shall indemnify, defend and hold CIMA (and its directors, officers, employees, and Affiliates) harmless from and against any and all Damages incurred or suffered by CIMA (and its directors, officers, employees, and Affiliates) as a consequence of: (i) any breach of any representation or warranty made by Schwarz in this Agreement or any agreement, instrument or document delivered by Schwarz pursuant to the terms of this Agreement; (ii) any failure to perform duly and punctually any covenant, agreement or undertaking on the part of Schwarz contained in this Agreement; or (iii) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of Schwarz with respect to the operation of Schwarz's business or the handling, marketing or sale of the Products by Schwarz, including Schwarz's supply of API hereunder. 10.2 Notice and Opportunity To Defend. Promptly after receipt by a party hereto of notice of any claim which could give rise to a right to indemnification pursuant to Section 10.1. such party (the "Indemnified Party") shall give the other party (the "Indemnifying Party") written notice describing the claim in reasonable detail. The failure of an Indemnified Party to give notice in the manner provided herein shall not relieve the Indemnifying Party of its obligations under this Section, except to the extent that such failure to give notice materially prejudices the Indemnifying Party's ability to defend such claim. The Indemnifying Party shall have the right, at its option, to compromise or defend, at its own expense and by its own counsel, any such matter involving the asserted liability of the party seeking such indemnification. If the Indemnifying Party shall undertake to compromise or defend any such asserted liability, it shall promptly (and in any event not less than 10 days after receipt of the Indemnified Party's original notice) notify the Indemnified Party in writing of its intention to do so, and the Indemnified Party agrees to cooperate fully with the Indemnifying Party and its counsel in the compromise or defense against any such asserted liability. All reasonable costs and expenses incurred in connection with such cooperation shall be borne by the Indemnifying Party. If the Indemnifying Party elects not to compromise or defend the asserted liability, fails to notify the Indemnified Party of its election to compromise or defend as herein provided, fails to admit its obligation to indemnify under this Agreement with respect to the claim, or, if in the reasonable opinion of the Indemnified Party, the claim could result in the Indemnified Party becoming subject to injunctive relief or relief other than the payment of money damages that could materially adversely affect the ongoing business of the Indemnified Party in any manner, the Indemnified Party shall have the right, at its option, to pay, compromise or defend such asserted liability by its own counsel - 25 - and its reasonable costs and expenses shall be included as part of the indemnification obligation of the Indemnifying Party hereunder. Notwithstanding the foregoing, neither the Indemnifying Party nor the Indemnified Party may settle or compromise any claim over the objection of the other; provided, however, that consent to settlement or compromise shall not be unreasonably withheld. In any event, the Indemnified Party and the Indemnifying Party may participate, at their own expense, in the defense of such asserted liability. If the Indemnifying Party chooses to defend any claim, the Indemnified Party shall make available to the Indemnifying Party any books, records or other documents within its control that are necessary or appropriate for such defense. Notwithstanding anything to the contrary in this Section 10.2, (i) the party conducting the defense of a claim shall (A) keep the other party informed on a reasonable and timely basis as to the status of the defense of such claim (but only to the extent such other party is not participating jointly in the defense of such claim), and (B) conduct the defense of such claim in a prudent manner, and (ii) the Indemnifying Party shall not cease to defend, settle or otherwise dispose of any claim without the prior written consent of the Indemnified Party (which consent shall not be unreasonably withheld). 10.3 Indemnification Payment Obligation. No Indemnifying Party will have any obligations under Sections 10.1(a) or 10.1(b) until the cumulative aggregate amount of Damages incurred or suffered by the Indemnified Party which the Indemnifying Party is otherwise subject to under this Agreement exceeds [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] at which time the entire cumulative aggregate amount of such Damages shall be covered. The provisions of this Section 10.3 shall not limit or otherwise affect the obligations of any Indemnifying Party under any other Section of this Agreement. 10.4 Indemnification Payment Adjustments. The amount of any Damages for which indemnification is provided under this Section 10 shall be reduced to take account of any net tax benefit and shall be increased to take account of any net tax detriment arising from the incurrence or payment of any such Damages or from the receipt of any such indemnification payment and shall be reduced by the insurance proceeds received and any other amount recovered, if any, by the Indemnified Party with respect to any Damages; provided, however, that an Indemnified Party shall not be subject to an obligation to pursue an insurance claim relating to any Damages for which indemnification is sought hereunder. If any Indemnified Party shall have received any payment pursuant to this Section 10 with respect to any Damages and shall subsequently have received insurance proceeds or other amounts with respect to such Damages, then such Indemnified Party shall pay to the Indemnifying Party an amount equal to the difference (if any) between (i) the sum of the amount of those insurance proceeds or other amounts received and the amount of the payment by such Indemnifying Party pursuant to this Section 10 with respect to such Damages and (ii) the amount necessary to fully and completely indemnify and hold harmless such Indemnified Party from and against such Damages; provided, however, in no event will such Indemnified Party have any obligation pursuant to this sentence to pay to such Indemnifying Party an amount greater than the amount of the payment by such Indemnifying Party pursuant to this Section 10 with respect to such Damages. 10.5 Indemnification Payment. Upon the final determination of liability and the amount of the indemnification payment under this Section 10, the appropriate party shall pay to - 26 - the other, as the case may be, within 10 business days after such determination, the amount of any claim for indemnification made hereunder. 10.6 Survival. The provisions of Section 10 shall survive any termination of this Agreement. Each Indemnified Party's rights under Section 10 shall not be deemed to have been waived or otherwise affected by such Indemnified Party's waiver of the breach of any representation, warranty, agreement or covenant contained in or made pursuant this Agreement, unless such waiver expressly and in writing also waives any or all of the Indemnified Party's right under Section 10. SECTION 11 TERMINATION 11.1 Termination. The term of this Agreement shall begin upon the Closing Date and, unless sooner terminated as hereinafter provided, shall end with respect to each Product upon the expiration of the last CIMA Patent applicable to such Product to expire or, if later, the expiration of any other patent resulting from the development process contemplated hereby. Notwithstanding the foregoing, this Agreement may be terminated as follows: (a) Termination for Insolvency. If either Schwarz or CIMA (i) makes a general assignment for the benefit of creditors or becomes insolvent; (ii) files an insolvency petition in bankruptcy; (iii) petitions for or acquiesces in the appointment of any receiver, trustee or similar officer to liquidate or conserve its business or any substantial part of its assets; (iv) commences under the laws of any jurisdiction any proceeding involving its insolvency, bankruptcy, reorganization, adjustment of debt, dissolution, liquidation or any other similar proceeding for the release of financially distressed debtors; or (v) becomes a party to any proceeding or action of the type described above in (iii) or (iv) and such proceeding or action remains undismissed or unstayed for a period of more than 60 days, then the other party may by written notice terminate this Agreement in its entirety with immediate effect. (b) Termination for Default. Schwarz and CIMA each shall have the right to terminate this Agreement for default upon the other's failure to comply in any material respect with the terms and conditions of this Agreement. At least ninety (90) days prior to any such termination for default, the party seeking to so terminate shall give the other written notice of its intention to terminate this Agreement in accordance with the provisions of this Section 11.1(b), which notice shall set forth the default(s) which form the basis for such termination. If the defaulting party fails to correct such default(s) within ninety (90) days after receipt of notification, then such party immediately may terminate this Agreement. This Section 11.1(b) shall not be exclusive and shall not be in lieu of any other remedies available to a party hereto for any default hereunder on the part of the other party. (c) Unilateral Termination by Schwarz Prior to Launch. Prior to the Launch of any Product, Schwarz will have the right to unilaterally terminate this Agreement - 27 - either in its entirety or with respect to one or more specific Products at any time and in its sole discretion upon the delivery of written notice to CIMA. Any provision herein notwithstanding, in the event that Schwarz terminates this Agreement pursuant to this Section 11.1(c), Schwarz's sole obligation under this Agreement shall be to reimburse CIMA for the costs and expenses actually incurred by CIMA (i) in performing the development activities set forth on Schedule 4.1(b) hereto in respect of such terminated Product(s) prior to CIMA's receipt of such notice of termination and (ii) in connection with the orderly close out of such development activities; provided, however, that Schwarz's reimbursement obligations pursuant to this Section 11.1(c) in respect of any terminated Product(s) shall exclude the costs and expenses incurred by CIMA in connection with any Development Phase for which Schwarz has made a Development Fee Payment and shall in no event exceed the Development Fee Payment associated with the Development Phase on which CIMA is then working, as set forth on Schedule 4.1(b). (d) Unilateral Termination by Schwarz After Launch. Following the Launch of any Product, Schwarz will have the right to unilaterally terminate this Agreement either in its entirety or with respect to one or more specific Products and in its sole discretion upon the delivery of written notice to CIMA. Termination of the Agreement either in its entirety or with respect to one or more specific Products will be effective with respect to such Product or Products one hundred eighty (180) days following such written notice to CIMA. (e) Continuing Obligations. Termination of this Agreement for any reason shall not relieve the parties of any obligation accruing prior thereto with respect to any Product and any ongoing obligations hereunder with respect to the remaining Products and shall be without prejudice to the rights and remedies of either party with respect to any antecedent breach of the provisions of this Agreement. Without limiting the generality of the foregoing, no termination of this Agreement, whether by lapse of time or otherwise, shall serve to terminate the obligations of the parties hereto under Sections 5.8, 9.3, 9.4, 9.5, 9.7, 9.9(a), 10, 11.1(c), 11.1(d), 11.1(e) and 12 hereof, and such obligations shall survive any such termination. SECTION 12 MISCELLANEOUS 12.1 Successors and Assigns. This Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors and permitted assigns; provided, however, that neither CIMA nor Schwarz may assign any of its rights, duties or obligations hereunder without the prior written consent of the other, which consent shall not be unreasonably withheld, except that no prior written consent shall be required in the event that a third party acquires substantially all of the assets or outstanding shares of, or merges with, Schwarz or CIMA, as the case may be. - 28 - 12.2 Notices. All notices or other communications required or permitted to be given hereunder shall be in writing and shall be deemed to have been duly given if delivered by hand or facsimile and confirmed in writing, or mailed first class, postage prepaid, by registered or certified mail, return receipt requested (mailed notices and notices sent by facsimile shall be deemed to have been given on the date received) as follows: If to CIMA, as follows: CIMA LABS INC 10000 Valley View Road Eden Prairie, MN 55344 Facsimile: 952-947-8770 Attention: Chief Executive Officer If to Schwarz, as follows: Schwarz Pharma, Inc. 6140 West Executive Drive Mequon, Wisconsin 53092 Facsimile: 262-242-1641 Attention: General Counsel with a copy to: Mayer, Brown & Platt 1675 Broadway New York, New York 10019 Facsimile: 212-262-1910 Attention: Philip O. Brandes or in any case to such other address or addresses as hereafter shall be furnished as provided in this Section 12.2 by any party hereto to the other party. 12.3 Waiver; Remedies. Any term or provision of this Agreement may be waived at any time by the party entitled to the benefit thereof by a written instrument executed by such party. No delay on the part of CIMA or Schwarz in exercising any right, power or privilege hereunder shall operate as a waiver thereof, nor shall any waiver on the part of either CIMA or Schwarz of any right, power or privilege hereunder operate as a waiver of any other right, power or privilege hereunder nor shall any single or partial exercise of any right, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, power or privilege hereunder. The indemnification provided in Section 10 shall be the sole remedy available for any Damages arising out of or in connection with this Agreement except for any rights or remedies which the parties hereto may otherwise have in equity. 12.4 Survival of Representations. Each of the representations and warranties made in this Agreement shall continue for the term of this Agreement and shall thereafter be extinguished. - 29 - 12.5 Independent Contractors. The parties hereto are independent contractors and nothing contained in this Agreement shall be deemed to create the relationship of partners, joint venturers, or of principal and agent, franchisor and franchisee, or of any association or relationship between the parties other than as expressly provided in this Agreement. Schwarz acknowledges that it does not have, and Schwarz shall not make representations to any third party, either directly or indirectly, indicating that Schwarz has any authority to act for or on behalf of CIMA or to obligate CIMA in any way whatsoever. CIMA acknowledges that it does not have, and it shall not make any representations to any third party, either directly or indirectly, indicating that it has any authority to act for or on behalf of Schwarz or to obligate Schwarz in any way whatsoever. 12.6 Entire Agreement. This Agreement constitutes the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior agreements including, without limitation the Feasibility Agreement entered by CIMA and Schwarz on November 30, 2001, or understandings of the parties relating thereto. 12.7 Amendment. This Agreement may be modified or amended only by written agreement of the parties hereto. 12.8 Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original but all of which together shall constitute a single instrument. 12.9 Governing Law. This Agreement shall be governed and construed in accordance with the laws of the State of New York excluding any choice of law rules which may direct the application of the law of another state. 12.10 Arbitration. Any dispute, controversy or claim arising out of or in connection with this Agreement shall be determined and settled by arbitration in New York, New York, pursuant to the Rules of Arbitration then in effect of the American Arbitration Association. Any award rendered shall be final and conclusive upon the parties and a judgment thereon may be entered in a court having competent jurisdiction. Any arbitration hereunder shall be (i) submitted to an arbitration tribunal comprised of three (3) independent members knowledgeable in the pharmaceutical industry, one of whom shall be selected by Schwarz, one of whom shall be selected by CIMA, and one of whom shall be selected by the other two arbitrators; (ii) allow for the parties to request discovery pursuant to the rules then in effect under the Federal Rules of Civil Procedure for a period not to exceed 90 days; and (iii) require the award to be accompanied by findings of fact and a statement of reasons for the decision. Each party shall bear its own costs and expenses, including attorney's fees incurred in any dispute which is determined and/or settled by arbitration pursuant to this Section. Except where clearly prevented by the area in dispute, both parties agree to continue performing their respective obligations under this Agreement while the dispute is being resolved. Arbitration shall not prevent any party from seeking injunctive relief where such remedy is an appropriate form of remedy under the circumstances. 12.11 Captions. All section titles or captions contained in this Agreement, in any Schedule referred to herein or in any Exhibit annexed hereto, and the table of contents, if any, to - 30 - this Agreement are for convenience only, shall not be deemed a part of this Agreement and shall not affect the meaning or interpretation of this Agreement. 12.12 No Third-Party Rights. No provision of this Agreement shall be deemed or construed in any way to result in the creation of any rights or obligation in any Person not a party or not affiliated with a party to this Agreement. 12.13 Severability. If any provision of this Agreement is found or declared to be invalid or unenforceable by any court or other competent authority having jurisdiction, such finding or declaration shall not invalidate any other provision hereof, and this Agreement shall thereafter continue in full force and effect. 12.14 Attachments. All Schedules, Exhibits and other attachments to this Agreement are by this reference incorporated herein and made a part of this Agreement. 12.15 Force Majeure. In the event that a party is prevented from carrying out its obligations under this Agreement by an event of Force Majeure, then such party's performance of its obligations under this Agreement shall be excused during the period of such event and for a subsequent reasonable period of recovery. 12.16 Consents. Where this Agreement requires the consent of any party and specifies that such consent is not to be unreasonably withheld, the determination of whether such consent may be withheld shall be based upon the facts and circumstances of the business of the party whose consent is requested, it being understood that it is reasonable to withhold the requested consent if granting the requested consent would have an adverse impact on such party's business activities. - 31 - IN WITNESS WHEREOF, the parties have caused this Agreement to be duly executed and delivered on the day and year first above written. CIMA LABS INC. By: /s/ John Hontz ----------------------------------- Name: John Hontz Title: Chief Operating Officer SCHWARZ PHARMA, INC. By: /s/ Ron Stratton ------------------------------------ Name: Ron Stratton, Ph.D. Title: President and COO - 32 - Schedule 3.1 to Master Development License and Supply Agreement Master Development Schedule [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Schedule 4.1(a) to Master Development, License and Supply Agreement Royalty Rates In any Year, Schwarz shall pay to CIMA a royalty in the amount of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the Annual Net Sales, if any, actually recorded during such Year. Schwarz shall pay the royalty payment due in respect of any Quarter (a "Quarterly Installment") by remitting a check, together with the report required by Section 4.3, to CIMA within 60 days after the end of each Quarter during such Year. For purposes of determining the royalty payment pursuant to this Schedule 4.1(a) the amount of each Quarterly Installment shall be calculated based on actual Net Sales recorded during such Quarter. Schedule 4.1(b) to Master Development, License and Supply Agreement Development Fee And Milestone Payments (a) Subject to paragraph (b) of this Schedule 4.1(b), Schwarz shall pay to CIMA any of the milestone payments set forth below (each a "Milestone Payment") promptly after CIMA demonstrates the Satisfactory Completion (as defined below) of the research and development phases (each a "Development Phase") set forth opposite such Milestone Payment: [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] (b) Promptly after the completion of each Development Phase, CIMA shall notify Schwarz of such completion and shall provide Schwarz sufficient written materials (a "Development Phase Notice") to allow Schwarz to evaluate whether or not such Development Phase has been Satisfactorily Completed. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] (c) In addition to the Milestone Payments described above, in connection with each Product, Schwarz shall pay CIMA an amount equal to (i) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] in the event the actual Completion Date for such Product precedes the target Completion Date therefor set forth on Schedule 3.1 by at least [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] or (ii) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] in the event the actual Completion Date for such Product precedes the target Completion Date therefor set forth on Schedule 3.1 by at least [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. (d) Schwarz shall also pay to CIMA the development fee payments set forth below (each a "Development Fee Payment") within thirty (30) days of CIMA's invoice for development work performed in accordance with this Agreement during the applicable Quarter. - -------------------------------------------------------------------------------- TIME PERIOD DEVELOPMENT FEE - -------------------------------------------------------------------------------- [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] - -------------------------------------------------------------------------------- Quarter ending December 31, 2001 $500,000 - -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] - -------------------------------------------------------------------------------- Schedule 5.1(b) to Master Development License and Supply Agreement Schwarz Purchase Order [See Attached] ================================================================================ SCHWARZ SCHWARZ PHARMA MANUFACTURING, INC. PURCHASE ORDER NO. PHARMA 1101 C AVENUE WEST PURCHASE ORDER DATE PO BOX 328 SEYMOUR, IN 47274 812-523-3457 PAGE ------------------------------ ------------------------------ VENDOR: SHIP TO: ------------------------------ ------------------------------
ORIGINAL COPY - -------------------------------------------------------------------------------- SHIP VIA TAXABLE TERMS DESCRIPTION FOB DESCRIPTION - -------------------------------------------------------------------------------- RESOURCE NUMBER RESOURCE DESCRIPTION QUANTITY UM UNIT PRICE AMOUNT ================================================================================
THE TERMS AND CONDITIONS ON THE REVERSE SIDE ARE PART OF THIS PURCHASE ORDER. BY:__________________________ TERMS AND CONDITIONS 1. Definitions. (a) Buyer means Schwarz Pharma Manufacturing, Inc. (b) Seller means any person, firm, or corporation to whom this Purchase Order is directed. 2. Terms: This Purchase Order constitutes any order to buy goods, equipment, material, supplies, or services according to the description and other terms set forth on its face and reverse side. No additional or different terms offered by the Seller shall be or become part of this order, nor shall this order be modified without the express written approval of Buyer. 3. Shipping Instructions: All shipments must contain packing lists giving descriptions of material, quantity and purchase order number. If shipment is not made F.O.B. destination, the original bill of lading must be furnished with invoices. Buyer's count will be accepted as final on all shipments not accompanied by packing lists. 4. Risk of Loss: The risk of loss from any casualty to the goods regardless of the cause, shall be on Seller until the goods have been received, inspected and accepted by the company. 5. Delays in Delivery: Time is of the essence. If Seller for any reason does not comply with the buyer's delivery schedule, Buyer in addition to remedies provided by law, at its option may either approve and revise delivery schedule or, may terminate the order without liability on account thereof. 6. Warranty: Seller expressly warrants that all goods, equipment, material, supplies or services covered by this order will conform to the specification, drawings, samples or other description furnished or specified by the Buyer, shall be of good material and workmanship and free from defects. 7. Rejections: If any of the goods, equipment, material or supplies are found within a reasonable time after delivery to the Buyer to be defective in material or workmanship or otherwise not in conformity with the requirements of the order, Buyer, in addition to any other rights which it may have under warranties or otherwise, shall have the right to reject and return such goods at Seller's expense, such goods not to be replaced without suitable written authorization from Buyer. 8. Patent Infringements: Seller shall pay costs and damages finally awarded in any suit against the Buyer or its vendees to the extent based upon a finding that the design or construction of articles as furnished infringes a United States Patent (except infringement occurring as a result of incorporating a design or modification at the request of Buyer); provided the Buyer promptly notifies Seller of any charge of such infringement and the Seller is given the right at its expense to settle such charge and to defend or control the defense of any suit based upon such charge, this paragraph sets forth the Seller's exclusive liability with respect to patents. 9. Compliance with Laws: Seller shall comply with all applicable State, Federal and local laws, rules and regulations. 10a. Termination: The Buyer may terminate work on this order for its own convenience in whole or in part by written or telegraphic notice at any time. In the event, any claim arising out of such termination shall be settled by negotiation on the basis of the Seller's costs and commitments properly incurred or made, with due allowance for salvage value. 10b. If the Seller ceases to conduct its operations in the normal course of business including liability to meet its obligations as they mature of if any proceeding under the bankruptcy or insolvency laws is brought by or against the Seller, a receiver for the Seller is appointed or applied for or an assignment for the benefit of Creditors is made by the Seller, Buyer may terminate order without liability except for the deliveries previously made or for goods covered by the order then completed and subsequently delivered in accordance with the terms of the order. 11. Nondiscrimination in Employment. Seller will not discriminate against any employee or applicant for employment because of race, religion, color, sex, age, or national origin. 12. Non-Waiver. Any waiver of strict compliance with the provisions of this order shall not be deemed a waiver of the Buyer's rights to insist upon strict compliance thereafter. 13. Subcontracting. In the event the Seller subcontracts all or any part of this order, Seller remains completely responsible for price, delivery and quality. Schedule 5.3 to Master Development, License and Supply Agreement Cost of Goods [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Schedule 5.4(d) to Master Development License and Supply Agreement Quality Assurance Addendum [To be mutually agreed by parties on or prior to each Launch] SCHWARZ PHARMA, INC. 6140 West Executive Drive Mequon, Wisconsin 53092 March 1, 2002 CIMA LABS INC. 10000 Valley View Road Eden Prairie, Minnesota 55344 Attention: Chief Executive Officer Ladies and Gentlemen: Reference is made to the Master Development, License and Supply Agreement, dated as of December 18, 2001 (as amended, restated or otherwise modified from time to time, the "License Agreement"), by and between CIMA LABS INC., a Delaware corporation ("CIMA") and Schwarz Pharma, Inc., a Delaware corporation ("Schwarz"). Capitalized terms that are used but not defined in this letter agreement (this "Letter Agreement") shall have the meanings given them in the License Agreement. For good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, each of the undersigned hereby agrees to modify the License Agreement as follows: 1. In order to (i) memorialize the final agreement of the parties regarding the Milestone Payments applicable to Product #3 ([***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]) and Product #2 ([***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]) and (ii) replace certain of the Products, as contemplated by Section 3.4 of the License Agreement, (a) Schedule 3.1 of the License Agreement is hereby amended by replacing the Products numbered 5, 6 and 7 in the table therein with the following (the "Replacement Products") and by replacing the relevant portions of the table in Schedule 3.1 that relate to the Products numbered 5, 6 and 7 with the information set forth below: [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Schwarz and CIMA hereby agree that each of the Replacement Products shall be deemed to be a Product under and as defined in the License Agreement. (b) Schedule 4.1(b) of the License Agreement is hereby amended such that the table included in paragraph (a) therein shall be deleted in its entirety and replaced with the table set forth in Exhibit A hereto. 2. Schwarz and CIMA further agree that, anything to the contrary herein or in the License Agreement notwithstanding, with respect to Product #7 ([***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]) only, the date after which the Development Phase relating to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], as contemplated by paragraph (b) of Schedule 4.1(b) of the License Agreement, shall be [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] after deadline therefor. In addition, should CIMA determine, in its reasonable discretion, that a [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] is not suitable and a [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] is required for the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] referred to in this paragraph 2 shall be extended to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. 3. Schwarz and CIMA further agree that, anything to the contrary herein or in the License Agreement notwithstanding, Product #5 ([***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]) will be developed to be packaged in bottles and blisters; provided, however, that if, for technical or stability reasons, bottles are not suitable, such Product may be developed to be packaged in blisters only. 4. Schwarz and CIMA further agree that, anything to the contrary herein or in the License Agreement notwithstanding, with respect to Product # 6 ([***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]) only, CIMA will perform an initial formulation feasibility study ([***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]) and provide a report its findings to Schwarz no later than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. At the time of such report, should either party not want to proceed with the development of such Product, Schwarz will pay CIMA [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. If such Product is canceled, Schwarz may replace Product #6 with a new -2- Product in accordance with the License Agreement. Any such replacement Product will be assigned a Completion Date to be agreed upon by the parties. 5. Section 12 of the License Agreement is hereby, mutatis mutandis, incorporated by reference as though specifically set forth herein. 6. This Letter Agreement is binding and enforceable against CIMA and Schwarz notwithstanding any provision to the contrary in the License Agreement, and, in the event of a conflict between this Letter Agreement and the License Agreement, the terms of this Letter Agreement shall control. 7. Each of the undersigned hereby ratifies the License Agreement, as modified by this License Agreement, and agrees that the License Agreement, as modified hereby, shall continue in full force and effect. [Signatures next page] -3- IN WITNESS WHEREOF, this Agreement is entered into by the duly authorized representatives of CIMA and Schwarz as of the date first set forth above. SCHWARZ PHARMA, INC. By: /s/ Klaus Veitinger ----------------------------- Name: Klaus Veitinger Title: CEO ACKNOWLEDGED AND AGREED: CIMA LABS INC. By: /s/ John M. Siebert ----------------------------- Name: John M. Siebert Title: President & CEO CC: Mayer, Brown, Rowe & Maw 1675 Broadway New York, New York 10019 Attention: Philip O. Brandes -4- EXHIBIT A [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] SCHWARZ PHARMA, INC. 6140 West Executive Drive Mequon, Wisconsin 53092 October 24, 2002 CIMA LABS INC. 10000 Valley View Road Eden Prairie, Minnesota 55344 Attention: Chief Executive Officer Ladies and Gentlemen: Reference is made to the Master Development, License and Supply Agreement, dated as of December 18, 2001 (as amended, restated or otherwise modified from time to time, the "License Agreement"), by and between CIMA LABS INC., a Delaware corporation ("CIMA") and Schwarz Pharma, Inc., a Delaware corporation ("Schwarz"). Capitalized terms that are used but not defined in this letter agreement (this "Letter Agreement") shall have the meanings given them in the License Agreement. For good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, each of the undersigned hereby agrees to modify the License Agreement as follows: 3. In order to memorialize (a) the replacement of the Product numbered 7 with the pharmaceutical product [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] (the "Replacement Product"), (b) the agreement of the parties regarding changes to the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the Products numbered 4 and 5, and (c) the actual delivery dates of certain API, Schedule 3.1 of the License Agreement is hereby deleted in its entirety and replaced with Exhibit A hereto. Schwarz and CIMA agree that the Replacement Product shall be deemed to be a Product under and within the meaning of the License Agreement. 4. Schedule 4.1(b) to the License Agreement is hereby amended as follows: (a) In order to memorialize (i) the final agreement of the parties regarding the Milestone Payments applicable to Product #1 ([***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]), Product #4 ([***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]), Product #5 ([***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]) and Product #6 ([***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]), (ii) the agreement of the parties regarding certain additional amounts that shall be payable to CIMA in respect of the Milestone [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], as set forth in the table included in paragraph (a) therein (the "Milestone Table") and (iii) the estimated Milestone Payments applicable to the Replacement Product, Schedule 4.1(b) to the License Agreement is amended such that the Milestone Table shall be deleted in its entirety and replaced with the table set forth in Exhibit B hereto. (b) In order to memorialize the agreement of the parties regarding an increase in the Development Fee Payments in respect of the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], Schedule 4.1(b) to the License Agreement is amended such that the table included in paragraph (d) therein shall be deleted in its entirety and replaced with the table set forth in Exhibit C hereto. 5. Anything to the contrary herein or in the License Agreement notwithstanding, the parties agree that the development activities described on the Development Schedule and the payments to be made by Schwarz in respect of such development activities contemplate CIMA conducting up to an aggregate total of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] stability study pulls (the "Expected Stability Work"). In the event that such development activities require more than the Expected Stability Work, the parties shall negotiate in good faith additional compensation to be paid to CIMA on a per-pull basis. 6. Anything to the contrary in the License Agreement notwithstanding, Schwarz and CIMA hereby agree that Schwarz will pay CIMA the sum of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] promptly upon receipt of CIMA's invoice therefore, which amount shall satisfy in full Schwarz's obligations to CIMA in respect of CIMA's development efforts in connection with the pharmaceutical product [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] pursuant to the License Agreement. 5. In order to memorialize certain agreements of the parties regarding modifications to Schwarz's obligations to supply API, the License Agreement is hereby amended as follows: (a) Section 1 of the License Agreement is amended by adding the following defined term thereto: "'Provide' shall have the meaning given in Section 3.2 hereof." (b) Section 3.2 of the License Agreement is deleted in its entirety and replaced with the following: "3.2 Supply of API. (a) The parties shall be responsible for Providing API as follows: (i) CIMA shall be responsible for Providing all API consisting of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] and all API that is classified as a "controlled substance" by the United States Drug Enforcement Agency ("DEA API"); provided, however, that CIMA shall notify Schwarz, at least forty-eight (48) hours prior to any order, of the quantity of such API that CIMA proposes to order. If Schwarz notifies CIMA within such forty-eight (48) hour period that Schwarz disagrees with the amount of API that CIMA proposes to order, CIMA shall postpone such order until such time as the parties shall agree upon the appropriate amount of such API. (ii) Schwarz shall be responsible for Providing all API not required to be provided by CIMA pursuant to clause (i), above. (b) The parties shall each be responsible for the costs of Providing API incurred by them; provided, however, that within thirty (30) days from CIMA invoice date therefor, Schwarz shall, except as set forth in Section 3.2(e), below, (i) reimburse CIMA for the purchase price (excluding any costs described in Section 3.2(b)(iv), below) of any API purchased by CIMA; (ii) pay CIMA a sourcing fee equal to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the aggregate purchase price of any API consisting of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] purchased by CIMA as contemplated hereby; (iii) pay CIMA a sourcing fee in respect of any DEA API equal to (A) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the aggregate purchase price of such DEA API, until such aggregate purchase price reaches [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES -3- AND EXCHANGE COMMISSION.***] in any Year and (B) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the aggregate purchase price of such DEA API, to the extent that such aggregate purchase price exceeds [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] in any Year; and (iv) reimburse CIMA for [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] which CIMA incurs in connection with Providing API in accordance with Section 3.2(a)(i). (c) As used herein, "Provide" means that the applicable party shall be responsible, in respect of the API which it is responsible for Providing, for ordering, receiving and testing such API, paying supplier invoices therefor, releasing such API for use, auditing suppliers thereof for cGMP compliance and keeping Schwarz's Regulatory Affairs department apprised of the status of the Drug Master Files in respect of such API. (d) CIMA shall, promptly following the end of each Quarter, furnish to Schwarz a written report of the total amount of each type of API in CIMA's inventory as of the final day of such Quarter, as reflected on CIMA's books and records. (e) Schwarz agrees and acknowledges that it shall be responsible to CIMA for the amounts described in this Section 3.2 that CIMA incurs in respect of any API that is used, lost, destroyed or otherwise consumed in connection with the development activities described on the Development Schedule. In the event, however, that any API is lost, stolen, destroyed, or otherwise consumed at CIMA's facilities other than in connection with such development activities ("Lost API"), CIMA agrees to (i) file and pursue a claim for the value of such Lost API under its applicable insurance policy and (ii) promptly remit to Schwarz any proceeds received from its insurers in respect of such Lost API." (c) Section 12.3 of the License Agreement is amended by deleting the last sentence thereof and replacing the same with the following: "Except as set forth in Section 3.2(e), the indemnification provided in Section 10 shall be the sole remedy available for any Damages arising out of or in connection with this Agreement except for any rights or remedies which the parties hereto may otherwise have in equity." (d) Section 5.1(d) of the License Agreement is deleted in its entirety and replaced with the following: -4- "(d) The parties shall be responsible for Providing, in accordance with Section 3.2 and with Schwarz's forecasts provided in accordance with Section 5.4, quantities of API sufficient for (i) for CIMA to perform its obligations pursuant to Schedule 3.1 and Sections 5.1 and 5.5 at least [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] prior to the date of tablet manufacture and (ii) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of safety stock. All API not Provided by Schwarz must conform to Schwarz's then current raw materials specifications. CIMA shall not be accountable for any production or shipment delays due to lack of any API that Schwarz is required to Provide pursuant to Section 3.2." 6. The parties hereby agree that, anything to the contrary in the License Agreement notwithstanding, any Products that are contemplated in the License Agreement as being packaged using "CIMA Standard" packaging and/or "CIMA Standard" tablet size, may, at Schwarz's sole option, be packaged using child resistant packaging ("CR Packaging") and/or utilize non-standard tablet size tooling ("Off-Size Tooling"). In accordance with such agreement, in the event that Schwarz elects to have any Products packaged in CR Packaging and/or utilize Off-Size Tooling, the parties further agree as follows: (a) CIMA shall be solely responsible for the development of CR Packaging and/or Off-Size Tooling for each applicable Product in accordance with specifications to be provided by Schwarz; provided, however, that Schwarz shall reimburse CIMA, on a Quarterly basis and, within thirty (30) days after receipt of invoices from CIMA, for all costs incurred by CIMA in connection with any design and testing activities in respect of the CR Packaging that are conducted by third parties and which are approved in advance by Schwarz. (b) CIMA shall be responsible, subject to Schwarz's approval, not to unreasonably be withheld, for the purchase of any equipment needed for CR Packaging and Off-Size Tooling that is not then owned or leased by CIMA. The aggregate purchase price (the "Equipment Costs") of the equipment to be purchased by CIMA in order to perform its obligations under this paragraph 6 (the "Optional Equipment") [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. Such Equipment Costs shall be included, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] cost included in the calculation of the Cost of Goods of each Product in accordance with Schedule 5.3 of the License Agreement; provided, however, that the portion of the Equipment Cost allocable to Schwarz during any Year shall be determined [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] for the Product(s) requiring CR Packaging or Off-Size Tooling, as applicable, in accordance with [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND -5- EXCHANGE COMMISSION.***] for such Year and; provided further, that Schwarz shall not be responsible, during any Year, for any Equipment Costs to the extent that the Optional Equipment is used for products other than Products, determined [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] in accordance with [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] during such Year. In the event that Schwarz cancels all Products requiring CR Packaging or Off-Size Tooling in accordance with the terms of the License Agreement, within [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the cancellation of the last such Product requiring such packaging, Schwarz shall pay to CIMA the amount of the Equipment Costs related to the CR Packaging or the Off-Size Tooling, as applicable, that have not theretofore been reimbursed by Schwarz or a third party. 7. The parties hereby agree that Schwarz shall have the right, exercisable by delivering written notice to CIMA at any time on or prior to the date that is [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] after the date of this Letter Agreement, to initiate negotiations with CIMA for the development and supply of the pharmaceutical product [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] (the "Option Product") in accordance with this paragraph 7. Upon Schwarz's exercise of such option, the parties shall negotiate in good faith the specific terms applicable to the Option Product, which terms shall thereupon be memorialized in a formal license and supply agreement (the "New Agreement"); provided, however that the terms of the New Agreement shall be similar to the terms of the License Agreement. The foregoing notwithstanding, CIMA shall be obligated to commence development of the Option Product no later than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] from the later of (i) the effective date of the New Agreement and (ii) CIMA's receipt of the active ingredient required for the Option Product. 8. Section 12 of the License Agreement is hereby, mutatis mutandis, incorporated by reference as though specifically set forth herein. 9. This Letter Agreement is binding and enforceable against CIMA and Schwarz notwithstanding any provision to the contrary in the License Agreement, and, in the event of a conflict between this Letter Agreement and the License Agreement, the terms of this Letter Agreement shall control. 10. Each of the undersigned hereby ratifies the License Agreement, as modified by this Letter Agreement, and agrees that the License Agreement, as modified hereby, shall continue in full force and effect. [Signatures next page] -6- IN WITNESS WHEREOF, this Agreement is entered into by the duly authorized representatives of CIMA and Schwarz as of the date first set forth above. SCHWARZ PHARMA, INC. By: /s/ Klaus Veitinger -------------------------- Name: Klaus Veitinger Title: CEO ACKNOWLEDGED AND AGREED: CIMA LABS INC. By: /s/ John M. Siebert ---------------------------- Name: John M. Siebert Title: President & CEO CC: Mayer, Brown, Rowe & Maw 1675 Broadway New York, New York 10019 Attention: Philip O. Brandes -7- Exhibit A Master Development Schedule [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] EXHIBIT B [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Exhibit C
- -------------------------------------------------------------------------------- TIME PERIOD DEVELOPMENT FEE - -------------------------------------------------------------------------------- [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] - -------------------------------------------------------------------------------- Quarter ending December 31, 2001 $500,000 - -------------------------------------------------------------------------------- [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] - --------------------------------------------------------------------------------
SCHWARZ PHARMA, INC. 6140 West Executive Drive Mequon, Wisconsin 53092 February 18, 2003 CIMA LABS INC. 10000 Valley View Road Eden Prairie, Minnesota 55344 Attention: Chief Executive Officer Ladies and Gentlemen: Reference is made to the Master Development, License and Supply Agreement, dated as of December 18, 2001 (as amended, restated or otherwise modified from time to time, the "License Agreement"), by and between CIMA LABS INC., a Delaware corporation ("CIMA") and Schwarz Pharma, Inc., a Delaware corporation ("Schwarz"). Capitalized terms that are used but not defined in this letter agreement (this "Letter Agreement") shall have the meanings given them in the License Agreement. For good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, each of the undersigned hereby agrees to modify the License Agreement as follows: 7. In order to memorialize the agreement of the parties regarding changes to the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the Products numbered 1, 4, 5 and 6 and the final determination of the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of Product number 7, the table set forth on Schedule 3.1 of the License Agreement is hereby deleted in its entirety and replaced with Exhibit A hereto. 8. In order to memorialize the agreement of the parties that [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], Schedule 4.1(b) to the License Agreement is hereby amended by deleting the definition of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] and replacing such definition with the following: [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] 9. The parties hereby agree that, anything to the contrary in the License Agreement notwithstanding, in addition to blisters and [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] bottles, CIMA will develop Product # 5 ([***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]) for packaging in [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] bottles. In consideration of the costs associated with such additional development work, Schwarz shall pay to CIMA a supplemental development fee equal to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] upon execution of this Letter Agreement. 10. Whereas, the parties have mutually determined that the development activities heretofore completed in respect of Product # 1 ([***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]) have been unsuccessful, the parties hereby agree that such Product shall be redeveloped in accordance with the Master Development Schedule contemplated therefore in the License Agreement; provided, however, that anything to the contrary in the License Agreement notwithstanding, the parties hereby agree that (a) as part of the development activities in respect of the New Formulation (as defined below), CIMA shall prepare two batches of each strength of the New Formulation for filing with the FDA, each of which batches shall be packaged in both CIMA standard blisters and [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] bottles, (b) notwithstanding the Milestone Payments that Schwarz has heretofore made to CIMA pursuant to Schedule 4.1(b) of the License Agreement in respect of Product #1, but in lieu of any other Milestone Payments that Schwarz may be required to make in respect of Product #1 pursuant to the License Agreement, Schwarz shall make the following Milestone Payments to CIMA in accordance with the License Agreement and this Letter Agreement with respect to the development of the New Formulation:
- ----------------------------------------------------- Milestone Development Phase Payment - ----------------------------------------------------- [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], and - -----------------------------------------------------
(c) CIMA shall not be eligible to receive the payment referred to in Section (c)(ii) on Schedule 4.1(b) of the License Agreement in respect of the New Formulation. For purposes hereof, Product #1 ([***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]), redeveloped as contemplated in this paragraph 4 shall be referred to herein as the "New Formulation". The parties agree and acknowledge that the New -2- Formulation shall for all purposes be Product # 1 and a Product within the meaning of the License Agreement. 11. Section 12 of the License Agreement is hereby, mutatis mutandis, incorporated by reference as though specifically set forth herein. 12. This Letter Agreement is binding and enforceable against CIMA and Schwarz notwithstanding any provision to the contrary in the License Agreement, and, in the event of a conflict between this Letter Agreement and the License Agreement, the terms of this Letter Agreement shall control. 13. Each of the undersigned hereby ratifies the License Agreement, as modified by this Letter Agreement, and agrees that the License Agreement, as modified hereby, shall continue in full force and effect. [Signatures next page] -3- IN WITNESS WHEREOF, this Agreement is entered into by the duly authorized representatives of CIMA and Schwarz as of the date first set forth above. SCHWARZ PHARMA, INC. By: /s/ Ron Stratton ---------------------------------- Name: Ron Stratton Title: President & COO ACKNOWLEDGED AND AGREED: CIMA LABS INC. By: /s/ John M. Siebert ------------------------------ Name: John M. Siebert Title: President & CEO CC: Mayer, Brown, Rowe & Maw 1675 Broadway New York, New York 10019 Attention: Philip O. Brandes -4- Exhibit A [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
EX-10.29 4 c75663exv10w29.txt EX-10.29 DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT EXHIBIT 10.29 DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT by and between CIMA LABS INC. and ALAMO PHARMACEUTICALS, LLC dated as of March 2, 2001 DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT This DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT ("this Agreement"), dated and effective as of March 2, 2001 (the "Effective Date"), is by and between CIMA LABS INC., a Delaware corporation ("CIMA"), and ALAMO PHARMACEUTICALS, LLC, a California Limited Liability Company ("Alamo"). W I T N E S S E T H WHEREAS, CIMA is engaged, among other things, in the business of research, development, manufacturing and commercialization of pharmaceutical products through its proprietary drug delivery technologies; WHEREAS, Alamo is engaged, among other things, in the business of developing, marketing and selling of pharmaceutical products; WHEREAS, subject to the terms and conditions set forth in this Agreement, CIMA and Alamo wish to collaborate in the development, registration, marketing and sale of a certain prescription product; and WHEREAS, subject to the terms and conditions set forth in this Agreement, CIMA wishes to license to Alamo and Alamo wishes to license from CIMA rights to CIMA's DuraSolv(TM) technology for use with such prescription product. NOW, THEREFORE, the parties hereto, intending to be legally bound, hereby agree as follows: SECTION 1 DEFINITIONS For purposes of this Agreement, the following terms shall have the meanings set forth below: "Activities" shall mean the development, manufacturing, marketing, selling and distributing of the Product in the Territory as contemplated by this Agreement. "Affiliates" shall mean, with respect to any Person, any Persons directly or indirectly controlling, controlled by, or under common control with, such other Person. For purposes hereof, the term "controlled" (including the terms "controlled by" and "under common control with"), as used with respect to any Person, shall mean the direct or indirect ability or power to direct or cause the direction of management policies of such Person or otherwise direct the affairs of such Person, whether through ownership of voting securities or otherwise. "Alamo" shall have the meaning given in the preamble and shall include its Affiliates. "Alamo Trademarks" shall have the meaning given in Section 9.11(d). "Annual Net Sales" shall mean, for any Calendar Year, the Net Sales for such Year. "Active Pharmaceutical Ingredient (API) "shall mean the active ingredient [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. "cGMP" shall mean the then-current standards for the manufacture of pharmaceuticals, as set forth in the United States Federal Food, Drug and Cosmetics Act and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good manufacturing 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 cGMP. "CIMA" shall have the meaning given in the preamble and shall include its Affiliates. "CIMA Intellectual Property" shall mean, collectively, 1) the CIMA Patents, 2) the CIMA Technology and 3) the CIMA Trademarks. "CIMA Patents" shall mean United States Patent No. 6,024,981 (entitled "Rapidly Dissolving Robust Dosage Form") and any patents, patent applications, and foreign counterparts or equivalents relating thereto, including any extension, reissue, renewal, reexamination, divisional, continuation or continuation-in-part of such patents or patent applications. "CIMA Technology" shall mean all of CIMA's Patents, trade secrets, technology, know-how and all other information necessary for the manufacture of the Product including, without limitation that related to CIMA's DuraSolv(TM) technology. "CIMA Trademarks" shall mean the CIMA(R) (logo), CIMA LABS INC.(R), DuraSolv(TM), and Meltabs(R) trademarks. "Damages" shall mean any and all actions, costs, losses, claims, liabilities, fines, penalties, demands, damages and expenses, court costs, and reasonable fees and disbursements of counsel, consultants and expert witnesses incurred by a party hereto -2- (including interest which may be imposed in connection therewith), but shall not include incidental, consequential, special or punitive damages. "Defective" shall mean, as to the Product, Product samples or Product placebos, as the case may be, the failure of such to strictly conform to the Specifications, this Agreement and all applicable law, including, without limitation, all FDA regulatory filings and regulations. "Development Schedule" shall mean the schedule of development activities set forth on Schedule B hereto. "DuraSolv(TM)" shall mean CIMA's orally disintegrating tablet formulations as described in the CIMA Patents "FDA" shall mean the United States Food and Drug Administration. "Force Majeure" shall mean acts of God, explosion, fire, flood, tornadoes, thunderstorms, earthquake or tremor, war whether declared or not, civil strife, riots or embargo, or changes in applicable laws, regulations or orders by any government, governmental agency or instrumentality, or other similar circumstances beyond the control of each party, in each case having the effect of preventing or prohibiting a party from performing its obligations hereunder. "GAAP" shall mean generally accepted accounting principles in the United States as in effect from time to time. "Indemnified Party" shall have the meaning given in Section 10.2 hereof. "Indemnifying Party" shall have the meaning given in Section 10.2 hereof. "Launch" shall mean the date of first commercial shipment of the Product by Alamo or its sublicensees to any unaffiliated third party. "Licensed Assets" shall have the meaning set forth in Section 2.1 hereof. "Net Sales" means the gross invoice price for Product sold by Alamo or its 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 of 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 -3- the billing amount) which are included in any 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 Alamo and its sublicensees and subdistributors maintained in accordance with U.S. GAAP consistently applied, and such amounts shall be calculated using the same accounting principles used for other Alamo products. Sales between or among Alamo, 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 and subdistributors. Where (i) Product is sold by Alamo, its Affiliates or their respective 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 Alamo's average Net Sales price for the applicable quantity of to the Product at that time. "PDMA" shall mean the Prescription Drug Marketing Act of 1987, as amended from time to time, together with any rules or regulations promulgated thereunder. "Person" shall mean a natural person, a corporation, a partnership, a trust, a joint venture, a limited liability company, any governmental authority or any other entity or organization. "Product" shall mean a pharmaceutical product containing [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] or such other amounts as may be requested by Alamo, as the case may be, of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] formulated in DuraSolv(TM). "Quarter" shall mean, as the case may be, the three months ending on March 31, June 30, September 30 or December 31 in any Year. "Specifications" shall mean, at any time, the specifications for the Product that are included in the Technical Agreement Addendum set forth on Schedule F. "Territory" shall mean the world. "Year" shall mean a calendar year during the term of this Agreement. -4- SECTION 2 GRANT OF LICENSES; LICENSE OPTION 2.1 Grant of Licenses. (a) CIMA hereby grants to Alamo an exclusive license for the term of this Agreement under the following assets to market, distribute and sell the Product in the Territory (such assets are referred to herein collectively as the "Licensed Assets"): (i) all current and future regulatory filings, approvals, registrations and governmental authorizations that relate to the Product in the Territory; and (ii) the CIMA Intellectual Property. (b) The license to Alamo will be exclusive in that CIMA will not grant any licenses of the Licensed Assets to any other Person with respect to the Product during the term of this Agreement, except as provided in Section 2.1(c). (c) In the event that Product is not commercially available in any country of the Territory [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] from the date of Launch of the Product in the United States, CIMA and Alamo agrees as follows: (i) CIMA shall be entitled to solicit interest of third parties in making the Product commercially available in any such country or countries; (ii) prior to granting a license to a third party for Product, CIMA shall provide Alamo a notice of its intent to grant such license ("License Notice") in a specific country or countries and shall identify such country or countries in the License Notice; (iii) Subject to the provisions of clauses (iv) and (v) below, Alamo shall provide CIMA a notice within forty-five (45) days of the License Notice that either: A) Alamo does not intend to market the Product in such country or countries, in which case Alamo's license to that country or countries shall terminate and CIMA shall be free to license the Product to such third party; or B) Alamo does intend to market the Product in such country or -5- countries, in which case Alamo shall have [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] from the date of its notice to CIMA to demonstrate significant progress in developing the Product to market in such country or countries. If Alamo fails to demonstrate significant progress within [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] or fails thereafter to demonstrate continued active development in such country or countries, Alamo's license to the Product in that country or countries will terminate in 30 days after re-notification by CIMA that they desire to solicit interested third parties in such country or countries and with written agreement by Alamo, such agreement shall not be unreasonably withheld. (iv) In the event that CIMA licenses the product to a third party under this Section 2.1(c), Alamo shall be entitled to receive reimbursement of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of its out-of-pocket cost for developing the Product (as determined in accordance with sub paragraph (v) below, including amounts paid to CIMA) and [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of any royalties received by CIMA from sales of the Product under such license to a third party, provided that Alamo cooperates with CIMA and such third party in obtaining regulatory approval for the Product, including providing access to any clinical data available to Alamo and any patent or other licenses necessary to commercialize the Product in any country or countries covered under the license from CIMA. (v) CIMA and Alamo shall negotiate in good faith the total amount of Alamo's out-of-pocket cost for developing the Product and a schedule for reimbursement of such costs. The reimbursement schedule shall be based on the scope of the license or licenses granted by CIMA to the third party or parties and the potential market for the Product in the country or countries. -6- 2.2 Sublicenses. Alamo shall have the right to extend the licenses granted pursuant to this Section 2 in whole or in part to any Affiliate of Alamo, provided that Alamo is not then in material default with respect to any of its obligations to CIMA under this Agreement. All the terms and provisions of this Agreement shall apply to the Affiliate to which this license has been extended to the same extent as they apply to Alamo, and the operations of the Affiliate shall be deemed to be the operations of Alamo. In addition, Alamo shall have the right to extend the licenses granted pursuant to this Section 2 in whole or in part to Persons who are not Affiliates of Alamo with the prior written consent of CIMA, such consent not to be unreasonably withheld or delayed. 2.3 Developments, Marketing, Distribution and Sale. After the Launch, Alamo shall use its commercially reasonable efforts to market, distribute and sell the Product in the Territory. Such efforts shall be consistent with industry norms, given the product profile, product potential and the state of the market, in each case, as existing from time to time. 2.4 Minimum Annual Royalties. Alamo shall endeavor to meet or exceed the minimum annual royalty targets set forth on Schedule A hereto. Any provision in this Agreement to the contrary notwithstanding, in the event that CIMA has performed all of its obligations hereunder and Alamo fails to pay the minimum annual royalty amounts set forth on Schedule A hereto for any Year following the Year in which the Product is Launched, then the royalty rate which Alamo pays to CIMA for such Year shall be modified as noted in Schedule C. SECTION 3 PRODUCT DEVELOPMENT 3.1 Obligations of CIMA. CIMA shall be responsible for the successful performance of each of the development activities set forth on Schedule B within the respective time periods set forth on Schedule B. 3.2 Obligations of Alamo. Alamo shall upon execution hereof pay CIMA [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] which represents the sum of both [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the Phase I cost and [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the Phase II cost as set forth on the Development Schedule included as Schedule B and Alamo shall, in a timely fashion following successful performance by CIMA of each Phase I and Phase II development activity set forth on Schedule B, pay CIMA the balance of the development fees set forth in -7- Schedule B with respect to such development activity for Phase II. Prior to the commencement of the development activities in each of Phases III, IV, V and VII, Alamo shall pay CIMA [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the development fees for such phase and shall, in a timely fashion following successful performance of the development activity or activities for each such phase, pay CIMA the balance of the development fees set forth in Schedule B with respect to such development activity or activities for such phase. Alamo shall also reimburse CIMA for CIMA's certified out-of-pocket costs plus [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] (net of any rebates, credits or refunds) for the acquisition of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] necessary for CIMA to perform the development activities described on Schedule B and the supply activities described in Sections 5.1 and 5.5. 3.3 Regulatory Matters. CIMA represents and warrants that all Product supplied to Alamo shall be produced under cGMP and in accordance with the Specifications. CIMA shall furnish Alamo with a Certificate of Analysis with a cGMP statement to demonstrate that each shipment of Product has been manufactured under cGMP and other FDA guidelines and that the Specifications have been met. In addition, Alamo may, at its own expense, audit the facilities of CIMA, including its processes, records and other facets of the operation as may be necessary to assure that all applicable regulations have been complied with, and the Specifications have been met. CIMA shall permit duly authorized representatives of Alamo to audit all manufacturing and processing operations related to this Agreement at reasonable times with a prior appointment. The right to audit shall commence with the Effective Date. These audits will be conducted to assure compliance with all pertinent acts, regulations, and guidelines promulgated by the FDA and other regulatory authorities, as well as standards then in effect in the regulatory environment. Such audits will be permitted during normal business hours and will be performed with a minimum of disruption. Alamo's exercise or failure to exercise any of its rights to audit CIMA's facilities and/or records pursuant to this Section 3.3 shall in no way alter or affect CIMA's obligations under this Agreement. SECTION 4 ROYALTY AND MILESTONE PAYMENTS 4.1 Royalty, and Milestone Payments. (a) Subject to CIMA's supply of Product in accordance with Section 5 hereof, Alamo shall make royalty payments to CIMA in the amounts set forth on Schedule C. -8- (b) Alamo shall make milestone payments to CIMA as set forth on Schedule D upon successful completion of each milestone listed therein. (c) On the Effective Date, Alamo shall pay the License Payment set forth on Schedule D hereto, which License Payment shall be refundable on a pro-rata basis if Alamo terminates this Agreement prior to the second anniversary date hereof by reason of CIMA's failure to successfully complete any of the development activities for which it is responsible under the Development Schedule. In such event, Alamo shall be entitled to a refund of, and CIMA shall promptly pay to Alamo, an amount equal to the product obtained by multiplying the License Payment by a fraction, the numerator of which shall be the number of calendar days remaining between the date of termination and the second anniversary of this Agreement and the denominator of which shall be 730. 4.2 Records and Audit. Alamo and its Affiliates shall keep full, true and accurate books of account containing all particulars that may be necessary for the purpose of showing the amounts payable to CIMA hereunder. Such books of account shall be kept at Alamo's principal place of business or the principal place of business of the appropriate Affiliate of Alamo to which this Agreement relates. Such books and the supporting data shall be open, at all reasonable times and upon reasonable notice during the term of this Agreement and for two (2) years after its termination, to the inspection by a firm of certified public accountants selected by CIMA and reasonably acceptable to Alamo, for the limited purpose of verifying Alamo's royalty statements; provided, however, that such examination shall not take place more often than once each Year, shall not cover more than the preceding two (2) Years, with no right to audit any period previously audited and shall not occur during the 90-day period following the end of Alamo's fiscal Year. Except as otherwise provided in this Section, the cost of any such examination shall be paid by CIMA. In the event that any such inspection reveals a deficiency in excess of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the reported royalty for the period covered by the inspection, Alamo shall promptly pay CIMA the deficiency, plus interest at the rate of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] per annum (which interest shall accrue from the date any such deficiency payment is due), and shall reimburse CIMA for the reasonable fees and expenses paid to such accountants in connection with their inspection for such period. In the event that any such inspection reveals a deficiency that is less than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the reported royalty for the period covered by the inspection, Alamo shall promptly pay CIMA the deficiency, plus interest at the rate of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] per -9- annum (which interest shall accrue from the date any such deficiency payment is due). In the event that any such inspection reveals an overpayment, CIMA shall promptly pay Alamo the overpayment. The parties agree that neither party shall be required to retain books and records with respect to the above other than books and records relating to the current Year and the immediately preceding two (2) Years. 4.3 Quarterly Reports and Payment of Royalties. In any Year following Launch of the Product, Alamo shall, within sixty (60) days after the end of the first, second and third Quarter, deliver to CIMA reports, certified by an authorized official of Alamo, setting forth the Net Sales and total royalties due under Section 4.1(a) for such Quarter. Alamo shall pay such royalties within sixty-five (65) days after the end of each Quarter by wire transfer, at CIMA's cost, or such other method as CIMA may designate. In any Year following Launch of the Product, Alamo shall, within forty-five (45) days after the end of the fourth (4th) Quarter, deliver to CIMA reports, certified by an authorized official of Alamo, setting forth the Net Sales and total royalties due under Section 4.1(a). Alamo shall pay such royalties within sixty-five (65) days after the end of the fourth (4th) Quarter by wire transfer, at CIMA's cost, or such other method as CIMA may designate. If no royalties are due, Alamo shall so report. SECTION 5 SUPPLY OF PRODUCT 5.1 Supply of Product. (a) Subject to Section 5.7, for the term of this Agreement, Alamo agrees to purchase from CIMA and CIMA agrees to supply Alamo with all of Alamo's requirements for the Product, Product samples and Product placebos for their subsequent use, sale, offer for sale, lease or transfer by Alamo. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall be responsible for procurement of all API necessary for the satisfaction of its obligations under this Agreement. (b) Alamo agrees to initiate purchases of the Product, Product samples and Product placebos hereunder by issuing CIMA binding purchase orders not less than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] prior to the required shipping date set forth therein. CIMA agrees to accept any order issued in accordance with this Section 5.1(b) and to meet the delivery dates specified therein. All purchase orders hereunder shall be on Alamo's standard purchase order form (a copy of which is attached as Schedule E hereto and which shall not, for purposes of this Agreement -10- only, be modified in any material respect without CIMA's prior written consent, such consent not to be unreasonably withheld or delayed) and shall be directed to CIMA at the address set forth below. The terms and conditions of purchase enumerated on the reverse side of such standard purchase order form shall prevail over any inconsistent or conflicting language as may exist on invoices, confirmation or order acknowledgment forms of CIMA, provided, however, that in the event any terms thereof are in conflict, or are inconsistent with any terms of this Agreement, the terms and conditions hereof shall prevail. No Product delivered by CIMA shall have a shelf life that is more than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] less than the maximum shelf life of such product; and, in any case, all Product delivered by CIMA shall have at least [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of shelf life remaining upon delivery to Alamo (other than batches that were under investigation and batches for validation which shall have at least [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of shelf life remaining upon delivery to Alamo). (c) Purchase order quantities shall be equivalent to the batch size of the Product, Product samples or Product placebos which shall be determined during the development activities, approximately [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] tablets for the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] dose, and [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] tablets for the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] dose, in the aggregate for any single purchase order, unless otherwise mutually agreed by the parties. The delivery quantity of tablets for trade shall not exceed a total of 4 batches in any one calendar month, unless otherwise agreed to by the Parties. (d) Purchase orders shall clearly state that the order is for tablets for sale, tablets for samples or placebos, as well as the shipping destination and address. Alamo agrees that the maximum quantity of tablets for samples shall not exceed [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] percent of the quantity of trade tablets in any year, unless otherwise agreed to by the Parties. 5.2 Identification. Alamo may market the Product under its name, with its packaging and logo; Alamo will, however, identify CIMA as the supplier in a fair manner, reasonably acceptable to CIMA. Alamo may use CIMA's name and derivations thereof in -11- promoting, marketing and selling the Product in the Territory; provided, however, that the particular formulation of any reference to CIMA's name in any promotional material shall be subject to CIMA's review and consent; and provided, further, that once the formulation of any such reference has been reviewed and consented to by CIMA, any subsequent reference to CIMA's name using such formulation shall not be subject to the further review or consent of CIMA. All samples shall be clearly marked "for sample use only" or some similar phrasing suggested by Alamo. CIMA shall design and develop labels for the bulk tablet containers and Alamo shall review and approve such labels. Such approval shall not be unreasonably withheld. 5.3 Trade and Sample Product Price. CIMA shall supply Product, Product samples and Product placebos to Alamo at the price set forth on Schedule G, subject to adjustment as set forth therein. 5.4 Forecasts, Delivery and Quality. (a) Alamo shall provide CIMA with 12-month non-binding forecasts within [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] after the end of each Quarter. Such forecasts shall be revised and extended in each succeeding Quarter. (b) Delivery of the Product, Product samples and Product placebos shall be in accordance with the means of transportation, destination and dates set forth in Alamo's purchase order, and shipped in full batch sized quantities. CIMA shall arrange for the transportation and insurance of the Product, Product samples and Product placebos and shall ensure that the transporter maintains the Product, Product samples and Product placebos in accordance with the labeling of such Product, Product samples and Product placebos. Delivery shall be F.O.B. destination, freight prepaid (delivered) and insured and Alamo shall reimburse CIMA for the cost of transportation and insurance of the Product, Product samples and Product placebos. Title and risk of loss to all Product, Product samples or Product placebos shall pass to Alamo upon delivery of the Product, Product samples or Product placebos to Alamo or its designated agent. (c) All deliveries of the Product hereunder shall include a Certificate of Analysis provided by the quality assurance manager of CIMA attesting to the fact that the Product (i) has been manufactured by a process which complies with cGMP and (ii) are of quality which is in accordance with criteria established in the Specifications and all FDA requirements. (d) The Product, Product samples and Product placebos supplied hereunder shall have been manufactured by a process which complies with the Technical Agreement Addendum set forth on Schedule F. -12- 5.5 Rejection, Replacement and Arbitration. (a) In the event that Alamo determines that any Product, Product samples or Product placebos as manufactured and/or packaged by CIMA is Defective, then: i) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] from shipment of Product, Product samples or Product placebos to Alamo or to Alamo's designated agent for final packaging; or ii) in the event that such Product, Product samples or Product placebos is Defective [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], Alamo shall provide to CIMA a written notice of rejection, specifying in reasonable detail the manner in which the Product is Defective (the "Notice of Rejection"). If no written Notice of Rejection is given to CIMA by Alamo within the period specified in clauses (i) and (ii), such Product, Product samples or Product placebos shall be deemed to have been accepted by Alamo, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. (b) Upon receipt of a Notice of Rejection from Alamo and in order to minimize any hardship to Alamo's customers, CIMA shall use reasonable commercial efforts to promptly supply to Alamo a quantity of replacement Product, Product samples or Product placebos meeting the Specifications equal to the size of the lot which Alamo claims was Defective so that such replacement Product shall be received by Alamo within [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] following CIMA's receipt of Alamo's Notice of Rejection. In the event that such Defective Product, Defective Product samples or Defective Product placebos are due to: i) faulty manufacture; faulty release; faulty primary packaging or labeling of the relevant batch(es) of the Product; or ii) improper shipping to Alamo's designated agent for final packaging, which fact shall be established on the basis of the corresponding sealed samples retained by CIMA and/or Alamo's designated agent for final packaging, utilizing an outside independent laboratory if necessary, the cost of which is borne by both parties and whose findings shall be binding or on the basis of process deviation documentation provided to Alamo, CIMA shall replace such batches free of charge, otherwise Alamo shall promptly pay CIMA for all such Product, Product samples or Product placebos, including any Defective Product. 5.6 Invoices and Payment. Upon CIMA's shipment to Alamo or its designated agent of any Product, Product samples, or Product placebos CIMA shall be entitled to submit an invoice to Alamo, and Alamo agrees to remit payment with respect to such invoice within [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] from -13- receipt of both such invoice and the shipment to which such invoice relates, unless within such [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] period Alamo sends notice of rejection to CIMA; provided, that payment of any invoice pursuant to this Section 5.6 shall not constitute or be deemed to constitute acceptance of any Product, Product samples or Product placebos or in any way limit Alamo's rights to inspect and/or reject any of the foregoing pursuant to Section 5.5 hereof . Within [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of delivery of the Product, Product samples, or Product placebos Alamo or its designated agent shall acknowledge the delivery of Product, Product samples, or Product placebos and shall notify CIMA's shipping department of any obvious shipping damage; provided, that failure to provided any such notice shall not constitute a waiver or in any way limit Alamo's rights under Section 5.5 with respect to such shipment. There will be a [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], of invoice price, penalty per month, for each month a payment is past due. Such penalty shall not exceed [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] per annum. 5.7 Supply Disruption; Alternate Manufacturing Site. (a) CIMA shall supply Alamo with the Product, Product samples and Product placebos in a timely manner in accordance with the orders and forecasts received by CIMA pursuant to Sections 5.1(b) and 5.4(a), respectively. In any consecutive [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] period, should CIMA fail to supply Alamo with substantially all of the Product, Product samples or Product placebos ordered for such [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] period pursuant to Section 5.1(b), Alamo shall have the right to require CIMA to transfer the manufacture of the Product to another manufacturing facility designated by Alamo and approved by CIMA, such approval not to be unreasonably withheld, which manufacturing facility agrees to be bound by Section 9.4 hereof. CIMA will assume all costs of, take all actions and grant all rights (on a royalty-free, exclusive, worldwide basis with the right to grant sub-licenses) with respect to CIMA Technology as shall be necessary to effect such transfer. Should CIMA cure its failure to supply within [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the end of such [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] period, CIMA shall have the right to resume the manufacture of the Product and Alamo and CIMA shall, at CIMA's expense, transfer the manufacture of the Product back to CIMA -14- within a commercially reasonable amount of time and all rights granted under the sublicense shall terminate. (b) If at any time following the Launch CIMA shall not have a second manufacturing facility, capable of supplying the Product in accordance with the terms of this Agreement, CIMA and Alamo shall, as soon as practicable following the date of Launch, qualify a manufacturing plant designated by Alamo as an alternate FDA approved manufacturing and packaging site for the Product. The costs of obtaining such approval shall be [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. 5.8 CIMA's Obligation to Continue Manufacture. If this Agreement terminates or expires through no breach of Alamo, CIMA shall reasonably cooperate with Alamo in transferring the manufacture of the Product to Alamo, its Affiliate or a third-party appointed by Alamo (which manufacturing facility agrees to be bound by Section 9.4 hereof) and CIMA shall, if requested by Alamo, continue to supply the Product to Alamo pursuant to the terms of this Agreement until [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] from the date this Agreement is terminated or expires pursuant to Section 11.1. 5.9 EXCEPT AS SPECIFICALLY PROVIDED HEREIN, THE PRODUCT WILL BE SUPPLIED BY CIMA WITH NO WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. SECTION 6 [RESERVED] SECTION 7 REPRESENTATIONS AND WARRANTIES OF CIMA CIMA hereby represents and warrants to Alamo that: 7.1 Organization, Power and Authority. CIMA is a corporation duly organized and validly existing under the laws of the State of Delaware. CIMA has all necessary corporate power and authority to enter into, and be bound by the terms and conditions of, this Agreement, and to license the Licensed Assets to Alamo pursuant hereto. -15- 7.2 Due Authority; No Breach. The execution, delivery and performance by CIMA of this Agreement and each agreement or instrument contemplated by this Agreement, and the performance of the transactions contemplated hereby and thereby, have been duly authorized by all necessary corporate action by CIMA. This Agreement is, and each agreement or instrument contemplated by this Agreement, when executed and delivered by CIMA in accordance with the provisions hereof, will be (assuming the due execution and delivery hereof and thereof by Alamo) the legal, valid and binding obligation of CIMA, in each case enforceable against CIMA in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, moratorium, reorganization, or similar laws from time to time in effect which affect the enforcement of creditors' rights generally and by legal and equitable limitations on the availability of specific performance and other equitable remedies against CIMA. All persons who have executed this Agreement on behalf of CIMA, or who will execute on behalf of CIMA any agreement or instrument contemplated by this Agreement, have been duly authorized to do so by all necessary corporate action. Neither the execution and delivery of this Agreement or any such other agreement or instrument by CIMA, nor the performance of the obligations contemplated hereby and thereby, will (i) conflict with or result in any violation of or constitute a breach of any of the terms or provisions of, or result in the acceleration of any obligation under, or constitute a default under any provision of the articles of incorporation or by-laws of CIMA or any material contract or any other material obligation to which CIMA is a party or to which it is subject or bound, or (ii) violate any judgment, order, injunction, decree or award of any court, administrative agency, arbitrator or governmental body against, or affecting or binding upon, CIMA or upon the securities, property or business of CIMA, or (iii) constitute a violation by CIMA of any applicable law or regulation of any jurisdiction as such law or regulation relates to CIMA, or to the property or business of CIMA except for such conflict, acceleration, default, breach or violation that is not reasonably likely to have a material adverse effect on CIMA's ability to perform its obligations under this Agreement or under any agreement or instrument contemplated hereby. 7.3 Intellectual Property. CIMA is the lawful owner of the Licensed Assets, CIMA can license the Licensed Assets without the consent of any third party, there is no pending or overtly threatened claim against CIMA asserting that any of the Licensed Assets infringes or violates the rights of third parties or that Alamo, by practicing under the Licensed Assets in performing the Activities, would violate any of the intellectual property rights of any third party, and nothing has come to the attention of CIMA which has, or reasonably should have, led CIMA to believe that any of the Licensed Assets infringes or violates the right of third parties. CIMA has not given any notice to any third parties asserting infringement by such third parties upon any of the Licensed Assets. CIMA is not aware of and has not received any communications challenging the ownership, validity, enforceability or effectiveness of any of the Licensed Assets. CIMA has not granted any right to any third party relating to the Activities which would violate the terms of or conflict with the rights granted to Alamo pursuant to this Agreement. -16- 7.4 [RESERVED] 7.5 Litigation. There are no pending or, to the best of CIMA's knowledge, threatened judicial, administrative or arbitral actions, claims, suits or proceedings pending as of the date hereof against CIMA relating to the Activities, or the Licensed Assets which, either individually or together with any other, would have a material adverse effect on the Activities, the Licensed Assets, or the ability of CIMA to perform its obligations under this Agreement or any agreement or instrument contemplated hereby. There are no pending, and CIMA does not presently contemplate bringing, any actions or suits relating to the Activities, or the Licensed Assets against others. 7.6 Governmental Approval. No consent, approval, waiver, order or authorization of, or registration, declaration or filing with, any governmental authority is required in connection with the execution, delivery and performance of this Agreement, or any agreement or instrument contemplated by this Agreement, by CIMA or the performance by CIMA of its obligations contemplated hereby and thereby. 7.7 Brokerage. No broker, finder or similar agent has been employed by or on behalf of CIMA, and no Person with which CIMA has had any dealings or communications of any kind is entitled to any brokerage commission, finder's fee or any similar compensation, in connection with this Agreement or the transactions contemplated hereby. SECTION 8 REPRESENTATIONS AND WARRANTIES OF ALAMO Alamo represents and warrants to CIMA that: 8.1 Organization, Power and Authority. Alamo is a limited liability company duly organized, validly existing and in good standing under the laws of the State of California . Alamo has all necessary power and authority to enter into, and be bound by the terms and conditions of, this Agreement and to license the Licensed Assets. 8.2 Due Authority; No Breach. The execution, delivery and performance by Alamo of this Agreement, and each agreement or instrument contemplated by this Agreement, and the performance of the transactions contemplated hereby and thereby, have been duly authorized by all necessary action by Alamo. This Agreement is, and each agreement or instrument contemplated by this Agreement, when executed and delivered by Alamo in accordance with the provisions hereof, will be (assuming due execution and delivery hereof and thereof by CIMA) the legal, valid and binding obligation of Alamo, in each case enforceable against Alamo in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, moratorium, -17- reorganization, or similar laws from time to time in effect which affect the enforcement of creditor's rights generally and by legal and equitable limitations on the availability of specific performance and other equitable remedies against Alamo. All persons who have executed this Agreement on behalf of Alamo, or who will execute on behalf of Alamo any agreement or instrument contemplated by this Agreement, have been duly authorized to do so by all necessary action. Neither the execution and delivery of this Agreement by Alamo, or any such other agreement or instrument by Alamo, nor the performance of the obligations contemplated hereby and thereby, will (i) conflict with or result in any violation of or constitute a breach of any of the terms or provisions of, or result in the acceleration of any obligation under, or constitute a default under any provision of its articles of organization or other governing documents or any material contract or any other material obligation to which Alamo is a party or to which it is subject or bound, or (ii) violate any judgment, order, injunction, decree or award of any court, administrative agency, arbitrator or government body against, or affecting or binding upon, Alamo or upon the securities, property or business of Alamo, or (iii) constitute a violation by Alamo of any applicable law or regulation of any jurisdiction as such law or regulation relates to Alamo or to the property or business of Alamo, except for such conflict, acceleration, default, breach or violation that is not reasonably likely to have a material adverse effect on Alamo's ability to perform its obligations under this Agreement or any agreement or instrument contemplated hereby. 8.3 Brokerage. No broker, finder or similar agent has been employed by or on behalf of Alamo and no Person with which Alamo has had any dealings or communications of any kind is entitled to any brokerage commission, finder's fee or any similar compensation, in connection with this Agreement or the transactions contemplated hereby. 8.4 Litigation. There are no pending or, to the best of Alamo's knowledge, threatened judicial, administrative or arbitral actions, claims, suits or proceedings pending as of the date hereof against Alamo which, either individually or together with any other, will have a material adverse effect on the ability of Alamo to perform its obligations under this Agreement or any agreement or instrument contemplated hereby. 8.5 Governmental Approval. No consent, approval, waiver, order or authorization of, or registration, declaration or filing with, any governmental authority is required in connection with the execution, delivery and performance of this Agreement, or any agreement or instrument contemplated by this Agreement, by Alamo or the performance by Alamo of its obligations contemplated hereby and thereby. SECTION 9 ADDITIONAL COVENANTS AND AGREEMENTS OF THE PARTIES 9.1 Governmental Filings. CIMA and Alamo each agree to prepare and file whatever filings, listings, requests or applications are required to be filed with any -18- governmental authority in connection with this Agreement or the Product and to cooperate with one another as reasonably necessary to accomplish the foregoing. 9.2 Compliance with Law. Alamo and CIMA shall each comply with all federal, state and local laws and regulations applicable to developing, approving, manufacturing, marketing and selling the Product in the Territory and the Licensed Assets or the performance of their respective obligations hereunder. CIMA and Alamo each shall keep all records and reports required to be kept by applicable laws and regulations, and each shall make its facilities available at reasonable times during business hours for inspection by representatives of governmental agencies. CIMA and Alamo each shall notify the other within forty-eight (48) hours of receipt of any notice or any other indication what so ever of any FDA or other governmental agency inspection, investigation or other inquiry, or other material notice or communication of any type, involving the Product. Alamo and CIMA shall cooperate with each other during any such inspection, investigation or other inquiry including, but not limited to, allowing upon request a representative of the other to be present during the applicable portions of any such inspection, investigation or other inquiry and providing copies of all relevant documents. Alamo and CIMA shall discuss any written response to observations or notifications received in connection with any such inspection, investigation or other inquiry and each shall give the other an opportunity to comment upon any proposed response before it is made. In the event of disagreement concerning the form or content of such response, however, CIMA shall be responsible for deciding the appropriate form and content of any response with respect to any of its cited activities and Alamo shall be responsible for deciding the appropriate form and content of any response with respect to any of its cited activities. 9.3 Recall. Alamo and CIMA shall consult with one another as to all decisions concerning recall or withdrawal of the Product from the market, including, but not limited to, determining whether or not to make any such recall or withdrawal, the timing and scope thereof, and the means of conducting any recall or withdrawal. The party requesting any recall or withdrawal must receive the prior written consent of the other party, such consent not to be unreasonably withheld, prior to initiating such recall or withdrawal. No consent shall be necessary if the recall or withdrawal is requested by the FDA or other governmental authority. CIMA shall bear the costs (including but not limited to, shipping and product credits) for any recall or withdrawal due to CIMA's failure to comply with this Agreement, including Product failure relating to CIMA's cGMP or CIMA's failure to meet the Specifications . The costs for any other recall or withdrawal shall be the responsibility of Alamo. 9.4 Confidentiality. Alamo shall treat as confidential the Licensed Assets and all other information of CIMA of which Alamo becomes aware in connection with this Agreement (collectively, "CIMA Proprietary Information"). Alamo shall neither disclose CIMA Proprietary Information to any third party nor use CIMA Proprietary Information for any purpose other than as set forth in this Agreement. CIMA shall treat as confidential all -19- other information of Alamo of which CIMA became aware of prior to the Effective Date or becomes aware in connection with this Agreement (collectively, "Alamo Proprietary Information"). CIMA shall neither disclose Alamo Proprietary Information to any third party nor use Alamo Proprietary Information for any purpose other than as set forth in this Agreement. Nothing contained herein will in any way restrict or impair either party's (the "Using Party's") right to use, disclose or otherwise deal with any Proprietary Information of the other party which: (a) at the time of disclosure is known to the public or thereafter becomes known to the public by publication or otherwise through no fault of the Using Party; (b) the Using Party can establish was in its possession prior to the time of the disclosure and was not obtained directly or indirectly from the other party; (c) is independently made available to the Using Party by a third party who is not thereby in violation of a confidential relationship with the other party known to the Using Party; (d) is developed by the Using Party independently of the Proprietary Information received from the other party and the Using Party can establish such development; or (e) is information required to be disclosed by legal or regulatory process; provided, in each case the Using Party timely informs the other party and uses reasonable efforts to limit the disclosure and maintain confidentiality to the extent possible and permits the other party to intervene and contest or attempt to limit the disclosure. Alamo shall obtain no right or license of any kind under the CIMA Proprietary Information except as set forth in this Agreement. CIMA shall obtain no right or license of any kind under the Alamo Proprietary Information except as set forth in this Agreement. 9.5 Expenses. CIMA and Alamo shall each bear their own direct and indirect expenses incurred in connection with the negotiation and preparation of this Agreement and, except as set forth in this Agreement, the performance of the obligations contemplated hereby. 9.6 Reasonable Efforts. CIMA and Alamo each hereby agrees to use all reasonable efforts to take, or cause to be taken, all actions and to do, or cause to be done all things necessary or proper to make effective the transactions contemplated by this -20- Agreement, including such actions as may be reasonably necessary to obtain approvals and consents of governmental Persons and other Persons. 9.7 Publicity. Except as expressly contemplated hereby, the parties agree that no publicity release or announcement concerning the transactions contemplated hereby shall be issued without the advance written consent of the other, which consent shall not be unreasonably withheld or delayed, except as such release or announcement may be required by law, including but not limited to the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, in which case the party making the release or announcement shall, before making any such release or announcement, afford the other party a reasonable opportunity to review and comment upon such release or announcement; provided, that the party making the release or announcement or otherwise disclosing this Agreement to any governmental agency in accordance with the foregoing exception shall use its best efforts to obtain confidential treatment of the terms hereof to the fullest extent permitted by applicable law. 9.8 Cooperation. If either party shall become engaged in or participate in any investigation, claim, litigation or other proceeding with any third party, including the FDA, relating in any way to the Product or any of the Licensed Assets the other party shall cooperate in all reasonable respects with such party in connection therewith, including, without limitation, using its reasonable efforts to make available to the other such employees who may be helpful with respect to such investigation, claim, litigation or other proceeding, provided that, for purposes of this provision, reasonable efforts to make available any employee shall be deemed to mean providing a party with reasonable access to any such employee at no cost for a period of time not to exceed 24 hours (e.g., three 8-hour business days). Thereafter, any such employee shall be made available for such time and upon such terms and conditions (including, but not limited to, compensation) as the parties may mutually agree. 9.9 Competition; No Sale for Resale. Neither Alamo nor any sub-licensee of Alamo shall knowingly sell any Product to anyone in the Territory for subsequent distribution or resale outside the Territory and each shall take all reasonable precautions to prevent such distribution or resale outside the Territory. Except as provided in 2.1(c), CIMA shall not knowingly sell any Product to anyone in the Territory or outside the Territory for subsequent distribution or resale in the Territory and CIMA shall take all reasonable precautions to prevent such distribution or resale in the Territory. 9.10 Conflicting Rights. CIMA shall not grant any right to any third party relating to the Activities which would violate the terms of or conflict with the rights granted to Alamo pursuant to this Agreement. -21- 9.11 Patent and Trademark Maintenance. (a) CIMA hereby represents and warrants that, to the best of its knowledge, the CIMA Technology, when used with the Active Pharmaceutical Ingredient, includes all the technology, patents, know-how, trade secrets and other intellectual property necessary to manufacture the Product. Any improvement (whether or not patentable) in the technology used in manufacturing the Product shall be owned by the Party who discovers or invents such improvement. (b) CIMA shall be solely responsible for filing, prosecuting, and maintaining all of the CIMA Patents, and CIMA shall pay the costs associated therewith. CIMA shall file, prosecute, and maintain all CIMA Patents so as to fully continue the benefits under the licenses granted to Alamo hereunder. CIMA may, however, discontinue prosecuting or maintaining any CIMA Patent if (i) CIMA has a valid business reason to do so, and (ii) CIMA notifies Alamo of this decision in which event, Alamo shall have the right, but not the obligation, to prosecute or maintain any such patent, with the full cooperation of CIMA, in Alamo's name and at Alamo's expense. (c) CIMA shall be solely responsible for filing, prosecuting, and maintaining all CIMA Trademarks, and CIMA shall pay the costs associated therewith. All registrations, variations, logos, goodwill and other rights under or acquired through use of the CIMA Trademarks shall accrue and belong to CIMA. Except as provided herein, Alamo shall have no rights to use the CIMA Trademarks. Alamo will not use in its business, in or outside of the Territory, any other mark or name which is similar to or nearly resembles any of the CIMA Trademarks in use by CIMA to indicate the source and origin of the CIMA Technology as to be likely to cause deception or confusion. Alamo recognizes that CIMA is the owner of all CIMA Trademarks used in commerce to indicate the source of the CIMA Technology and agrees that the CIMA Trademarks shall remain vested in CIMA both during the term of this Agreement and thereafter. Alamo shall not contest the validity of the CIMA Trademarks or CIMA's ownership of the CIMA Trademarks. Use of the CIMA Trademarks by Alamo in conjunction with the manufacture, use, and sale of the Product and all goodwill related thereto shall inure to the benefit of CIMA for purposes of building the longevity and extent of use of the CIMA Trademarks. (d) Alamo shall be solely responsible for filing, prosecuting, and maintaining all trademarks it develops or owns for the Product (the "Alamo Trademarks"), and Alamo shall pay the costs associated therewith. All registrations, variations, logos, goodwill and other rights under or acquired through use of the Alamo Trademarks shall accrue and belong to Alamo. CIMA shall have no rights to use the Alamo Trademarks. CIMA will not use in its business, in or outside of the Territory, any other mark or name which is similar to or nearly resembles the Alamo -22- Trademarks in use by Alamo in a manner that is likely to cause deception or confusion. CIMA recognizes that Alamo is the owner of all of the Alamo Trademarks used in commerce to indicate the source of the Product and agrees that the Alamo Trademarks shall remain vested in Alamo both during the term of this Agreement and thereafter. CIMA shall not contest the validity of the Alamo Trademarks or Alamo's ownership of the Alamo Trademarks. Use of the Alamo Trademarks by Alamo in conjunction with the manufacture, use, and sale of the Product and all goodwill related thereto shall inure to the benefit of Alamo for purposes of building the longevity and extent of use of the Alamo Trademarks. (e) Alamo and CIMA agree that, where applicable and appropriate, all packaging of the Product shall identify (i) the number of the CIMA Patents and CIMA as the owner thereof and (ii) Alamo as the owner of the Alamo Trademarks. (f) Any provisions in this Agreement to the contrary notwithstanding, Alamo acknowledges that, for all purposes, CIMA is the owner of the CIMA Technology. 9.12 Infringement; Enforcement of Proprietary Rights. (a) Infringement of Patent Rights. Each party shall promptly notify the other of any alleged infringement by third parties of any CIMA Patent and provide any information available to that party relating to such alleged infringement. (i) Within a reasonable time (not to exceed 30 days) following such notification, the parties shall meet to discuss a desirable response to such infringement and enter into good faith negotiations to determine an agreed upon course of action to end such infringement and the appropriate allocation of any costs or recoveries associated therewith. (ii) If the parties are unable to agree upon the course of action or the appropriate allocation of any costs associated therewith, CIMA [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] such alleged infringement and [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] any infringement of such rights that materially affect Alamo's rights pursuant to this Agreement, including, but not limited to, bringing suit against such third party infringer. In the event that CIMA does not bring suit against such third party infringer, Alamo may bring suit against such third party infringer on CIMA's behalf and Alamo [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE -23- SECURITIES AND EXCHANGE COMMISSION.***] in bringing such suit [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] to CIMA under this agreement. (b) Procedures. No settlement, consent judgment or other voluntary final disposition of any suit contemplated by Section 9.12(a) may be entered into without the consent of each party, which consent shall not be unreasonably withheld or delayed. Unless otherwise agreed by the parties, to the extent that any suit contemplated by Section 9.12(a) is directly related to the Product, any recovery of Damages to the extent related to the Product (net of the respective out-of-pocket legal fees and associated costs) in any such suit shall be allocated among the parties hereto assuming that such Damages constitute Net Sales by Alamo hereunder. In the event of any infringement suit against a third party brought by either party pursuant to this Section 9.12, the party not bringing such suit shall cooperate in all respects, execute any documents reasonably necessary to permit the other party to prosecute such suit, and to the extent reasonable, shall make available its employees and relevant records to provide evidence for such suit. 9.13 Referral of Orders and Inquiries. Except as provided in 2.1(c), CIMA shall refer all Persons sending orders or making inquiries regarding the Product within the Territory to Alamo and shall promptly notify Alamo of the name of each such Person and the nature of the inquiry of such Person. SECTION 10 INDEMNIFICATION 10.1 Indemnification. (a) CIMA shall indemnify, defend and hold Alamo (and its directors, officers, employees, and Affiliates) harmless from and against any and all Damages incurred or suffered by Alamo (and its directors, officers, employees, and Affiliates) as a consequence of: (i) any breach of any representation, warranty or covenant made by CIMA in this Agreement or any agreement, instrument or document delivered by CIMA pursuant to the terms of this Agreement; (ii) any failure to perform to perform duly and punctually any covenant, agreement or undertaking on the part of Alamo contained in this Agreement; or -24- (iii) any act or omission of CIMA with respect to the operation of CIMA's business, or handling, manufacturing, or use of the Product by CIMA; or (iv) any claim or demand that the manufacture, use, sale or offer for sale of the Product by reason of CIMA Technology infringes any United States or foreign patent. (b) Alamo shall indemnify, defend and hold CIMA (and its directors, officers, employees, and Affiliates) harmless from and against any and all Damages incurred or suffered by CIMA (and its directors, officers, employees, and Affiliates) as a consequence of: (i) any breach of any representation, warranty or covenant made by Alamo in this Agreement or any agreement, instrument or document delivered by Alamo pursuant to the terms of this Agreement; (ii) any failure to perform to perform duly and punctually any covenant, agreement or undertaking on the part of Alamo contained in this Agreement; or (iii) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of Alamo with respect to the operation of Alamo's business or the handling, manufacturing, sale, consumption or use of the Product by Alamo. 10.2 Notice and Opportunity To Defend. Promptly after receipt by a party hereto of notice of any claim which could give rise to a right to indemnification pursuant to Section 10.1. such party (the "Indemnified Party") shall give the other party (the "Indemnifying Party") written notice describing the claim in reasonable detail. The failure of an Indemnified Party to give notice in the manner provided herein shall not relieve the Indemnifying Party of its obligations under this Section, except to the extent that such failure to give notice materially prejudices the Indemnifying Party's ability to defend such claim. The Indemnifying Party shall have the right, at its option, to compromise or defend, at its own expense and by its own counsel, any such matter involving the asserted liability of the party seeking such indemnification. If the Indemnifying Party shall undertake to compromise or defend any such asserted liability, it shall promptly (and in any event not less than 10 days after receipt of the Indemnified Party's original notice) notify the Indemnified Party in writing of its intention to do so, and the Indemnified Party agrees to cooperate fully with the Indemnifying Party and its counsel in the compromise or defense against any such asserted liability. All reasonable costs and expenses incurred in connection with such cooperation shall be borne by the Indemnifying Party, as incurred by the Indemnified Party. -25- If the Indemnifying Party elects not to compromise or defend the asserted liability, fails to notify the Indemnified Party of its election to compromise or defend as herein provided, fails to admit its obligation to indemnify under this Agreement with respect to the claim, or, if in the reasonable opinion of the Indemnified Party, the claim could result in the Indemnified Party becoming subject to injunctive relief or relief other than the payment of money damages that could materially adversely affect the ongoing business of the Indemnified Party in any manner, the Indemnified Party shall have the right, at its option, to pay, compromise or defend such asserted liability by its own counsel and its reasonable costs and expenses shall be included as part of the indemnification obligation of the Indemnifying Party hereunder. Notwithstanding the foregoing, neither the Indemnifying Party nor the Indemnified Party may settle or compromise any claim over the objection of the other. In any event, the Indemnified Party and the Indemnifying Party may participate, at their own expense, in the defense of such asserted liability. If the Indemnifying Party chooses to defend any claim, the Indemnified Party shall make available to the Indemnifying Party any books, records or other documents within its control that are necessary or appropriate for such defense. Notwithstanding anything to the contrary in this Section 10.2, (i) the party conducting the defense of a claim shall (A) keep the other party informed on a reasonable and timely basis as to the status of the defense of such claim (but only to the extent such other party is not participating jointly in the defense of such claim), and (B) conduct the defense of such claim in a prudent manner, and (ii) the Indemnifying Party shall not cease to defend, settle or otherwise dispose of any claim without the prior written consent of the Indemnified Party (which consent shall not be unreasonably withheld). Upon the final determination of liability and the amount of the indemnification payment under this Section 10, the appropriate party shall pay to the other, as the case may be, within 10 business days after such determination, the amount of any claim for indemnification made hereunder. 10.3 Survival. The provisions of Section 10 shall survive any termination of this Agreement. Each Indemnified Party's rights under Section 10 shall not be deemed to have been waived or otherwise affected by such Indemnified Party's waiver of the breach of any representation, warranty, agreement or covenant contained in or made pursuant this Agreement, unless such waiver expressly and in writing also waives any or all of the Indemnified Party's right under Section 10. 10.4 Insurance. Alamo shall maintain throughout the term of this Agreement comprehensive general liability insurance, including product liability insurance underwritten by an insurance company reasonably acceptable to CIMA. This insurance coverage shall provide protection of not less than ten ($10) million, combined single limit for personal injury and property damage (on a per occurrence basis) with CIMA named as an additional insured. Such liability insurance shall be maintained on an occurrence basis to provide such protection after expiration or termination of the policy itself and/or this Agreement. Alamo shall furnish to CIMA certificates issued by the insurance company setting forth the amount of the liability insurance and a provision that CIMA shall receive thirty (30) days written notice prior to termination, reduction or modification of coverage. -26- SECTION 11 TERMINATION 11.1 Termination. The term of this Agreement shall begin upon the Effective Date and, unless sooner terminated as hereinafter provided, shall end upon the expiration of the last CIMA Patent to expire or, if later, the expiration of any other patent resulting from the development process contemplated hereby. Upon expirationof this Agreement, CIMA will, if requested by Alamo, grant Alamo on a royalty free basis a license to continue to use the CIMA Intellectual Property formerly covered by the CIMA Patents for the manufacture of Product and, should Alamo desire to have CIMA continue the manufacture of Product beyond the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] period provided for in Section 5.8, CIMA agrees to enter into good faith negotiations with Alamo to discuss terms of manufacture. Notwithstanding the foregoing, this Agreement may be terminated as follows: (a) Termination for Insolvency. If either Alamo or CIMA (i) makes a general assignment for the benefit of creditors or becomes insolvent; (ii) files an insolvency petition in bankruptcy; (iii) petitions for or acquiesces in the appointment of any receiver, trustee or similar officer to liquidate or conserve its business or any substantial part of its assets; (iv) commences under the laws of any jurisdiction any proceeding involving its insolvency, bankruptcy, reorganization, adjustment of debt, dissolution, liquidation or any other similar proceeding for the release of financially distressed debtors; or (v) becomes a party to any proceeding or action of the type described above in (iii) or (iv) and such proceeding or action remains undismissed or unstayed for a period of more than 60 days, then the other party may by written notice terminate this Agreement in its entirety with immediate effect. (b) Termination for Default. In addition to Alamo's rights under Section 4.1(c), Alamo and CIMA each shall have the right to terminate this Agreement for default upon the other's failure to comply in any material respect with the terms and conditions of this Agreement. At least 60 days prior to any such termination for default, the party seeking to so terminate shall give the other written notice of its intention to terminate this Agreement in accordance with the provisions of this Section 11.1(b), which notice shall set forth the default(s) which form the basis for such termination. If the defaulting party fails to correct such default(s) within 60 days after receipt of notification, then such party immediately may terminate this Agreement. Notwithstanding the foregoing, if Alamo fails to pay any invoice for development fees payable pursuant to Section 3.2 above with respect to one of the development activities set forth on the Development Schedule within 45 days after receipt of such invoice following the successful completion of such development -27- activity, CIMA shall have the right to terminate this Agreement by delivering written notice of such election to terminate and this Agreement shall terminate on the thirtieth (30th) day following the receipt of such notice by Alamo, unless prior to such thirtieth (30th) day Alamo shall have cured such failure to pay or shall have delivered to CIMA written notice that it disputes that such development activity has been successfully completed. This Section 11.1(b) shall not be exclusive and shall not be in lieu of any other remedies available to a party hereto for any default hereunder on the part of the other party. (c) Continuing Obligations. Termination of this Agreement for any reason shall not relieve the parties of any obligation accruing prior thereto with respect to the Product and any ongoing obligations hereunder with respect to the remaining Product and shall be without prejudice to the rights and remedies of either party with respect to any antecedent breach of the provisions of this Agreement. Without limiting the generality of the foregoing, no termination of this Agreement, whether by lapse of time or otherwise, shall serve to terminate the obligations of the parties hereto under Sections 9.3, 9.4, 9.6, 9.8, 10, 11.1(c) and 12 hereof, and such obligations shall survive any such termination. SECTION 12 MISCELLANEOUS 12.1 Successors and Assigns. This Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors and permitted assigns; provided, however, that neither CIMA nor Alamo may assign any of its rights, duties or obligations hereunder without the prior written consent of the other, except that no prior written consent shall be required in the event that a third party acquires substantially all of the assets or outstanding shares of, or merges with, Alamo or CIMA, as the case may be. 12.2 Notices. All notices or other communications required or permitted to be given hereunder shall be in writing and shall be deemed to have been duly given if delivered by hand or facsimile and confirmed in writing, or mailed first class, postage prepaid, by registered or certified mail, return receipt requested (mailed notices and notices sent by facsimile shall be deemed to have been given on the date received) as follows: If to CIMA, as follows: CIMA LABS INC. 10000 Valley View Road Eden Prairie, MN 55344 Facsimile: (952)947-8770 Attention: President and CEO -28- If to Alamo, as follows: Alamo Pharmaceuticals, LLC 8501 Wilshire Blvd., Suite 318 Beverly Hills, CA 90211 Facsimile: (310) 854-0739 Attention: Chief Financial Officer with a copy to: Milbank, Tweed, Hadley & McCloy LLP 601 S. Figueroa Street Los Angeles, CA 90017 Facsimile: (213) 629-5063 Attention: Kenneth J. Baronsky or in any case to such other address or addresses as hereafter shall be furnished as provided in this Section 12.2 by any party hereto to the other party. 12.3 Waiver; Remedies. Any term or provision of this Agreement may be waived at any time by the party entitled to the benefit thereof by a written instrument executed by such party. No delay on the part of CIMA or Alamo in exercising any right, power or privilege hereunder shall operate as a waiver thereof, nor shall any waiver on the part of either CIMA or Alamo of any right, power or privilege hereunder operate as a waiver of any other right, power or privilege hereunder nor shall any single or partial exercise of any right, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, power or privilege hereunder. 12.4 Survival of Representations. Each of the representations and warranties made in this Agreement shall survive the term of this Agreement. 12.5 Independent Contractors. The parties hereto are independent contractors and nothing contained in this Agreement shall be deemed to create the relationship of partners, joint venturers, or of principal and agent, franchiser and franchisee, or of any association or relationship between the parties other than as expressly provided in this Agreement. Alamo acknowledges that it does not have, and Alamo shall not make representations to any third party, either directly or indirectly, indicating that Alamo has any authority to act for or on behalf of CIMA or to obligate CIMA in any way whatsoever. CIMA acknowledges that it does not have, and it shall not make any representations to any third party, either directly or indirectly, indicating that it has any authority to act for or on behalf of Alamo or to obligate Alamo in any way whatsoever. -29- 12.6 Entire Agreement. This Agreement constitutes the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior agreements or understandings of the parties relating thereto. 12.7 Amendment. This Agreement may be modified or amended only by written agreement of the parties hereto. 12.8 Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original but all of which together shall constitute a single instrument. 12.9 Governing Law. This Agreement shall be governed and construed in accordance with the laws of the State of New York excluding any choice of law rules which may direct the application of the law of another state. 12.10 Dispute Resolution. To the extent a dispute arises with respect to a term or provision of this Agreement which is not subject to a specific time period or remedy, the Parties will use all reasonable efforts to resolve in an amicable fashion any dispute, claim or controversy that may arise relating to the terms or performance of this Agreement. If the Parties are unable to resolve such dispute within thirty (30) days after initial notice, either party, by notice to the other, have such dispute referred to a senior officer of each company. Such officers shall attempt to resolve the dispute by good faith negotiation within thirty (30) days after receipt of such notice. 12.11 Captions. All section titles or captions contained in this Agreement, in any Schedule referred to herein or in any Exhibit annexed hereto, and the table of contents, if any, to this Agreement are for convenience only, shall not be deemed a part of this Agreement and shall not affect the meaning or interpretation of this Agreement. 12.12 No Third-Party Rights. No provision of this Agreement shall be deemed or construed in any way to result in the creation of any rights or obligation in any Person not a party or not affiliated with a party to this Agreement. 12.13 Severability. If any provision of this Agreement is found or declared to be invalid or unenforceable by any court or other competent authority having jurisdiction, such finding or declaration shall not invalidate any other provision hereof, and this Agreement shall thereafter continue in full force and effect. 12.14 Attachments. All Schedules, Exhibits and other attachments to this Agreement are by this reference incorporated herein and made a part of this Agreement. -30- 12.15 Force Majeure. In the event that a party is prevented from carrying out its obligations under this Agreement by an event of Force Majeure, then such party's performance of its obligations under this Agreement shall be excused during the period of such event and for a subsequent reasonable period of recovery. -31- IN WITNESS WHEREOF, the parties have caused this Agreement to be duly executed and delivered on the day and year first above written. CIMA LABS INC. By: /s/ John Siebert --------------------------------- Name: John Siebert Ph.D. Title: President and CEO ALAMO PHARMACEUTICALS, LLC By: /s/ Robert L. Sevy --------------------------------- Name: Robert L. Sevy Title: Chief Financial Officer Schedule A to Development, License and Supply Agreement Minimum Annual Royalty Targets Pursuant to Section 4.1(c), Alamo shall endeavor to meet or exceed the minimum annual royalty targets set forth below. References to Years below are to full calendar years commencing at least six (6) months after the date on which the Product is launched. Minimum Annual Royalty Targets
- ---------------------------------------------------------------- YEAR MINIMUM ROYALTY TARGETS - ---------------------------------------------------------------- 1 $[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] - ---------------------------------------------------------------- 2 $[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] - ---------------------------------------------------------------- 3 $[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] - ---------------------------------------------------------------- 4 $[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] - ---------------------------------------------------------------- 5 $[***CONFIDENTIAL TREATMENT REQUESTED, and thereafter PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] - ----------------------------------------------------------------
Schedule B to Development, License and Supply Agreement Development Schedule
- ------------------------------------------------------- ACTIVITY DURATION COST Phase - -------------------------------------------------------
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Schedule C to Development, License and Supply Agreement Royalty Rates Pursuant to Section 4.3, Alamo shall pay to CIMA a percentage of Annual Net Sales, if any, actually recorded during such Year, as indicated on the following schedule. If Alamo does not meet the Minimum Annual Royalty Target set forth in Schedule A for any Year, then the royalty rate paid for such Year shall be that rate noted in Tier 2
- -------------------------------------------------------------------- TIER ROYALTY RATE - -------------------------------------------------------------------- Tier 1 [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of Net Sales - -------------------------------------------------------------------- Tier 2 [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of Net Sales - --------------------------------------------------------------------
Schedule D to Development, License and Supply Agreement License and Milestone Payments Pursuant to Section 4.1, Alamo shall pay CIMA the License Payment of $[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] upon the Effective Date and the milestone payments set forth below (each a "Milestone Payment") within thirty (30) days of successful completion of each research and development milestones. MILESTONE ACTIVITY MILESTONE PAYMENT [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Schedule E to Development, License and Supply Agreement Alamo Purchase Order [See Attached] Schedule F to Development, License and Supply Agreement Technical Agreement Addendum CIMA will be accountable for all aspects of the Product research and development and manufacturing other than (i) the design and conduct of clinical trials, (ii) the assembly and filing of the regulatory documents and (iii) the final packaging and sales of Product. Specifications will be mutually agreed by both parties on or prior to the final regulatory filing. To the extent that a more detailed allocation of pharmaceutical responsibility is required in connection with the final packaging and/or marketing of the product in any jurisdiction in the Territory, the Parties shall amend this Schedule F as necessary. Schedule G to Development, License and Supply Agreement Cost of Goods Pursuant to Sections 5.1, 5.3 and 5.6, Alamo shall pay to CIMA the amounts indicated on the following schedule in respect of CIMA's manufacturing obligations hereunder. TRADE and SAMPLES (cost per tablet)
- --------------------------------------------------------------- POTENCY TOTAL COST(1)(2)(3) PACKAGING - ---------------------------------------------------------------
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] 1) The cost per tablet does not include the cost of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], as noted in Section 3.2. 2) Per tablet costs may be reviewed annually. Any increase in cost will reflect documented increase in raw material(s) and be subject to Alamo's acceptance, but increases shall not exceed the PPI increase for that year. 3) Final cost per tablet will be determined upon completion of formulation development and shall not exceed the costs noted in this table PLACEBOS (cost per tablet)
- --------------------------------------------------------------- PLACEBO TOTAL COST* PACKAGING TYPE - ---------------------------------------------------------------
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] TABLE OF CONTENTS
SCHEDULES Schedule A Minimum Annual Royalty Targets Schedule B Development Schedule Schedule C Royalty Rates Schedule D License and Milestone Payments Schedule E Alamo Purchase Order Schedule F Technical Agreement Addendum Schedule G Cost Of Goods
i AMENDMENT #1 TO DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT Whereas, CIMA LABS INC. (CIMA) and Alamo Pharmaceuticals Inc. (Alamo) have entered into a Development License and Supply Agreement dated March 2, 2001 (DLSA) regarding the development, licensing and supply of a pharmaceutical product containing [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] and CIMA's DuraSolv(TM) technology; Whereas, CIMA has been conducting research according to Schedule B of the DLSA and such research has indicated that CIMA's DuraSolv technology [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]; and Whereas, CIMA and Alamo have decided to utilize CIMA's OraSolv(R) technology to develop a pharmaceutical product containing [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] and that certain changes to the DLSA will therefore be required; Therefore, for good and valid consideration, the Parties agree as follows: 1) Schedule G of the DLSA is hereby replaced by Schedule G-1 of this Amendment; 2) Schedule B of the DLSA is hereby replaced by Schedule B-1 of this Amendment 3) Schedule D of the DLSA is hereby replaced by Schedule D-1 of this Amendment; 4) In the definition of "CIMA Patents" replace "United States Patent No. 6,024,981 (entitled "Rapidly Dissolving Robust Dosage Form")" with "United States Patent No. 5,178,878 (entitled "Effervescent Dosage Form with Microparticles")"; 5) In the definition of "CIMA Technology" replace "DuraSolv(TM)" with "OraSolv(R)"; 6) In the definition of "CIMA Trademarks" replace "DuraSolv(TM)" with "OraSolv(R)"; 7) In the definition of "DuraSolv(TM)" replace "DuraSolv(TM)" with "OraSolv(R)"; and 8) In the definition of "Product" replace "DuraSolv(TM)" with "OraSolv(R)". 9) In all other respects, the terms and conditions of the Development License and Supply Agreement dated March 2, 2001 shall remain in full force and effect. Capitalized terms in this Amendment shall have the same meaning as in the Development License and Supply Agreement. CIMA LABS INC. Alamo Pharmaceuticals, LLC By: /s/ John M. Siebert By: /s/ Greg Wichmann ------------------------------- ------------------------------- (Signature) (Signature) John M. Siebert Greg Wichmann ------------------------------- ------------------------------- (Print or Type Name) (Print or Type Name) Title: President & CEO Title: Director ------------------------ ------------------------ Date: 4 January 2002 Date: 15 January 2002 ------------------------- ------------------------- SCHEDULE B-1 Development Schedule
- --------------------------------------------------------------------------- ACTIVITY DURATION COST PHASE - ---------------------------------------------------------------------------
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] SCHEDULE G-1 TRADE AND SAMPLES (COST PER TABLET)
- ------------------------------------------------------------------------ POTENCY TOTAL COST(1)(2)(3) PACKAGING - ------------------------------------------------------------------------
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] (1) The cost per tablet does not include the cost of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], as noted in Section 3.2. (2) Per tablet costs may be reviewed annually. Any increase in cost will reflect documented increase in raw material(s) and be subject to Alamo's acceptance, but increases shall not exceed the PPI increase for that year. (3) Final cost per tablet will be determined upon completion of formulation development and shall not exceed the costs noted in this table. Placebos (cost per tablet)
- --------------------------------------------------------------- POTENCY TOTAL COST PACKAGING - ---------------------------------------------------------------
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] SCHEDULE D-1 Pursuant to Section 4.1, Alamo shall pay CIMA the License Payment of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] upon the Effective Date and the milestone payments set forth below (each a "Milestone Payment") with in thirty (30) days of successful completion of each research and development milestones. Milestone Activity Milestone Payment [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] * 1/10th scale batches will be manufactured using equipment that is identical in design and principle to full-scale equipment per regulatory requirements
EX-10.30 5 c75663exv10w30.txt EX-10.30 FIRST AMENDMENT TO EMPLOYMENT AGREEMENT EXHIBIT 10.30 FIRST AMENDMENT TO EMPLOYMENT AGREEMENT THIS FIRST AMENDMENT TO EMPLOYMENT AGREEMENT (this "First Amendment") is entered into as of December 31, 2002, by and between CIMA LABS INC., a Delaware corporation (the "Company"), and John Hontz, Ph.D., an individual resident of Minnesota ("Employee"). WHEREAS, the Company and Employee entered into an Employment Agreement dated effective as of August 23, 2000 (the "Original Agreement"); and WHEREAS, the Company and Employee desire to amend certain of the terms of the Original Agreement as set forth in this First Amendment. NOW, THEREFORE, in consideration of the premises and of the mutual covenants and agreements contained herein, the parties do hereby agree as follows: 1. Extension of Term of Original Agreement. As approved by the Company's Board of Directors on December 17, 2002, Section 1 of the Original Agreement will be amended in its entirety to read as follows: 1. EMPLOYMENT AND TERM. Subject to the terms and conditions herein provided, the Company hereby continues employment of the Employee, and the Employee hereby accepts continued employment by the Company, for a term beginning on September 1, 2000 and continuing thereafter for five (5) years until September 1, 2005, unless earlier terminated in accordance with Section 11. 2. Increase In Certain Payments Upon Termination of Employment. As approved by the Company's Board of Directors on December 17, 2002, Sections 12(c), 12(d) and 12(e) of the Original Agreement will be amended in their entirety to read as follows: 12. PAYMENTS ON TERMINATION. (c) Termination By the Company Without Cause. Upon termination by the Company during the term for any reason other than Cause (not including termination due to death, disability, or upon expiration of the term set forth in Section 1), the Company will continue to pay Employee at the rate of his then current annual Base Salary for a period of twenty-four (24) months after the Termination Date. (d) Other Terminations. Upon termination of Employee's employment by the Company for Cause, by the Employee for other than Good Reason, or upon expiration of the term as set forth in Section 1, the Company will pay Employee his Base Salary earned through the Termination Date. (e) Termination after Change in Control. In the event of termination of Employee's employment by the Company as a result of a Change in Control of the Company or by Employee for Good Reason, and in lieu of payment under any other provision of Section 12 of this Agreement, the Company will continue to pay Employee at the rate of his then current annual Base Salary for a period of twenty-four (24) months after the Termination Date. The amount of payment to be made by the Company to the Employee pursuant to this Section 12(e) shall be reduced by 50% of any gross compensation earned by the Employee in connection with any employment or self-employment of the Employee during the compensation period pursuant to this Section 12(e). Employee shall promptly notify the Company of any such employment or self-employment and disclose to the Company his gross earnings therefrom. Except as otherwise provided in the last sentence of this paragraph, if the payments owed to the Employee pursuant to this Section 12(e) and any other benefits to which the Employee shall become entitled, either alone or together with other payments or benefits in the nature of compensation to the Employee which would constitute a "parachute payment" as defined in Section 280G of the Internal Revenue Code of 1986, as amended (the "Code"), such payments or other benefits shall be reduced (but not below zero) to the largest aggregate amount as will result in no portion thereof being subject to the excise tax imposed under Section 4999 of the Code. The Employee in good faith shall determine the amount of any reduction to be made pursuant to this paragraph. Notwithstanding the foregoing, this Section 12(e) shall not apply (and no reduction shall be made to the payments or other benefits otherwise available to the Employee) if the Company determines that (i) the Employee's net after-tax position without the imposition of such reduction would be greater than (ii) the Employee's net after-tax position with the imposition of such reduction. 3. Miscellaneous. All capitalized terms not otherwise defined herein shall take the meanings ascribed to such terms in the Original Agreement. Other than as expressly amended in this First Amendment, the Original Agreement shall continue in full force and effect, as so amended by this First Amendment. IN WITNESS WHEREOF, the parties to this Agreement have executed and delivered this First Amendment on the date first above written. CIMA LABS INC. EMPLOYEE By: /s/ John M. Siebert /s/ John Hontz ----------------------- --------------------------- John M. Siebert, Ph.D. John Hontz, Ph.D. Its President and CEO 2 EX-10.31 6 c75663exv10w31.txt EX-10.31 LETTER AGREEMENT WITH DAVID FESTE EXHIBIT 10.31 February 27, 2003 David Feste 5145 Russell Ave S Minneapolis, MN 55410 Dear Dave: This letter will confirm our discussions and agreements regarding the transition and termination of your employment with CIMA LABS INC. (the "Company"). 1. Employment. Your employment with the Company will end by mutual agreement effective June 30, 2003 (the "Separation Date"). Your status as Chief Financial Officer of the Company ("CFO") will end effective March 31, 2003. You will continue to perform the responsibilities of CFO from now through March 31, 2003. Thereafter until the Separation Date, you will perform such transition duties consistent with your former position as CFO as may be requested by the Company. Such transition duties requested by the Company will not exceed eight days per month and will be performed by you at times mutually agreed upon with the Company. Between now and the Separation Date, the Company may terminate your employment only for "cause," as defined in the Employment Agreement between you and the Company, dated as of January 26, 2001 (the "Employment Agreement"). In the event of termination by the Company for "cause," the Company shall have no further obligation to you under this letter agreement except to pay your base salary and benefits accrued through the date of termination. 2. Compensation. While you are so employed by the Company, you will continue to receive base salary at your current annual rate of $203,970 and those benefits as set forth in Section 3(c), (d), (e), and (g) of the Employment Agreement. Except as provided in paragraph 3(c) of this letter agreement below, you will not be eligible for any incentive bonus for calendar year 2003. 3. Severance Pay. If you sign the enclosed Release By David Feste (the "Release") within 21 days following the Separation Date and do not rescind the Release within 15 days after signing it, and subject to your complying with all terms of this letter agreement, the Company will provide you with the following benefits: a. The Company will pay you severance pay equal to your final base salary at the annual rate of $203,970 for a period of six months. Thereafter, if you have not obtained other employment by December 31, 2003, then the Company will continue to pay you severance pay at the same rate until the earlier of (i) March 31, 2004 and (ii) the date you obtain other employment. Such severance pay will subject to normal tax withholdings and will be paid by the Company in accordance with its regular payroll schedule. You agree to diligently seek employment following the Separation Date and to promptly report any employment to the Company in writing within three (3) days of acceptance of such employment. b. If following the Separation Date you elect to continue your group medical and dental insurance in accordance with the terms of the applicable plans and laws, the Company will continue to pay its portion of the monthly premiums for such coverage up to nine (9) months following the Separation Date as if you were still employed by the Company. Your continued coverages will be at the same level as in effect as of the Separation Date and dependent coverages may be added in connection with a qualifying event in accordance with the applicable plans and laws. The portion of the premiums that shall be paid by the Company if dependent coverage is added will also be that portion that the Company would pay if you were still an employee of the Company. The Company's obligation to make such premium payments shall commence after the rescission period has expired and shall cease immediately if you become eligible for other health or dental (as applicable) insurance benefits through a new employer. The Company shall deduct your contributions for the monthly premiums from the severance pay described in paragraph 3(a) above of this letter agreement. You agree to notify the Company in writing within three (3) days of your acceptance of any employment that provides health or dental insurance benefits. c. The Company will pay you a prorated annual bonus for calendar year 2003, in the amount of $25,496.25, less normal tax withholdings. Such bonus payment will be paid at the same time as annual bonus payments are paid to other management employees of the Company for calendar year 2003, but in no event later than March 31, 2004. 4. Stock Options. You currently have options to purchase shares of the Common Stock of the Company in accordance with the following schedule, assuming your continued employment with the Company through the Separation Date:
Amount Date of Exercise Number of Exercisable as of Grant Price Shares Granted 6/30/03 - ----------- -------- -------------- ----------------- 2/28/00 $18.6875 50,000 25,000 5/16/00 $15.00 86,000 57,333 12/31/00 $66.00 75,000 50,000
You agree and acknowledge that all of your options to purchase the Company's Common Stock are listed above and will lapse and cease to be outstanding 90 days following the Separation Date, unless previously exercised in accordance with the terms of the applicable option agreement and the Equity Incentive Plan (and subject to adjustment if your employment terminates before the Separation Date). 5. Press Release. The Company will not issue a press release announcing your departure from the Company without your advance approval of the text of such release. Such approval will not be unreasonably withheld by you. 6. Your Obligations. You shall continue to be obligated to comply with each of the terms of Sections 5, 6, 7, and 8 of the Employment Agreement, provided, however, that the second sentence of Section 7 of the Employment Agreement shall be amended to state as follows: The Employee therefore agrees that for a period of one (1) year from the date of termination of his employment with the Company, the Employee -2- shall not operate, join, control, be employed by, or participate in ownership, management, operation, or control of, or be connected in any manner as an independent contractor, consultant, or otherwise, with any person or organization engaged in the design, development, manufacture, distribution, marketing or selling of pharmaceutical products using fast-dissolve drug delivery technologies within the United States. 7. Company Obligations. The sole obligations of the Company will be its obligations as set forth in this letter agreement, except as otherwise provided by law. This letter agreement represents the entire agreement between you and the Company and supersedes all prior negotiations, discussions, communications and agreements. 8. Governing Law. All matters relating to the interpretation, construction, application, validity and enforcement of this letter agreement shall be governed by the laws of the State of Minnesota. * * * * * This letter agreement is intended to state all the terms of the conclusion of your employment by the Company. Please indicate your acceptance of all such terms by signing both copies of this letter agreement and returning one copy to the undersigned. Sincerely, CIMA LABS INC. /s/Steven Ratoff Steven Ratoff Member, Board of Directors On this 27th day of February, 2003, I, David A. Feste, hereby accept and agree to the terms of the above letter agreement and further acknowledge that I have 21 days after the Separation Date to decide whether to sign the enclosed Release. I also hereby specifically confirm (a) that I am being advised by the Company to seek independent advice from legal counsel of my own selection in connection with this letter agreement and the Release (and that I have had adequate opportunity to do so); and (b) that I have not relied to any extent on any statement or other communication from any shareholder, director, officer, employee, attorney or agent of the Company in connection herewith. /s/David A. Feste 2/27/03 - ----------------------------------------- ------- David A. Feste Dated -3- RELEASE BY DAVID A. FESTE DEFINITIONS. I intend all words used in this Release to have their plain meanings in ordinary English. Specific terms that I use in this Release have the following meanings: A. I, me, and my include both me and anyone who has or obtains any legal rights or claims through me. B. CIMA means CIMA LABS INC., any company related to CIMA LABS INC. in the present or past (including without limitation, its predecessors, parents, subsidiaries, affiliates, joint venture partners, and divisions), and any successors of CIMA LABS INC. C. Company means CIMA; the present and past officers, directors, committees, shareholders, and employees of CIMA; any company providing insurance to CIMA in the present or past; the present and past fiduciaries of any employee benefit plan sponsored or maintained by CIMA (other than multiemployer plans); the attorneys for CIMA; and anyone who acted on behalf of CIMA or on instructions from CIMA. D. Letter Agreement means the letter agreement from CIMA dated February __, 2003 and accepted by me, including all of the documents attached to the Letter Agreement. E. My Claims mean all of my rights that I now have to any relief of any kind from the Company, including without limitation: 1. all claims arising out of or relating to my employment with CIMA or the termination of that employment; 2. all claims arising out of or relating to the statements, actions, or omissions of the Company; 3. all claims for any alleged unlawful discrimination, harassment, retaliation or reprisal, or other alleged unlawful practices arising under any federal, state, or local statute, ordinance, or regulation, including without limitation, claims under Title VII of the Civil Rights Act of 1964, the Age Discrimination in Employment Act, the Americans with Disabilities Act, 42 U.S.C. ss. 1981, the Employee Retirement Income Security Act, the Equal Pay Act, the Worker Adjustment and Retraining Notification Act, the Minnesota Human Rights Act, the Fair Credit Reporting Act, and workers' compensation non-interference or non-retaliation statutes (such as Minn. Stat. Section 176.82); 4. all claims for alleged wrongful discharge; breach of contract; breach of implied contract; failure to keep any promise; breach of a covenant of -1- good faith and fair dealing; breach of fiduciary duty; estoppel; my activities, if any, as a "whistleblower"; defamation; infliction of emotional distress; fraud; misrepresentation; negligence; harassment; retaliation or reprisal; constructive discharge; assault; battery; false imprisonment; invasion of privacy; interference with contractual or business relationships; any other wrongful employment practices; and violation of any other principle of common law; 5. all claims for compensation of any kind, including without limitation, bonuses, commissions, stock-based compensation or stock options, vacation pay, and expense reimbursements; 6. all claims for back pay, front pay, reinstatement, other equitable relief, compensatory damages, damages for alleged personal injury, liquidated damages, and punitive damages; and 7. all claims for attorneys' fees, costs, and interest. However, My Claims do not include any claims that the law does not allow to be waived, any claims that may arise after the date on which I sign this Release, any claims for indemnification under the charter documents of the Company or under any applicable state or federal statute, or any claims for breach of the Letter Agreement. AGREEMENT TO RELEASE MY CLAIMS. I will receive consideration from CIMA as set forth in the Letter Agreement if I sign and do not rescind this Release as provided below. I understand and acknowledge that that consideration is in addition to anything of value that I would be entitled to receive from CIMA if I did not sign this Release or if I rescinded this Release. In exchange for that consideration I give up and release all of My Claims. I will not make any demands or claims against the Company for compensation or damages relating to My Claims. The consideration that I am receiving is a fair compromise for the release of My Claims. ADDITIONAL AGREEMENTS AND UNDERSTANDINGS. Even though CIMA will provide consideration for me to settle and release My Claims, the Company does not admit that it is responsible or legally obligated to me. In fact, the Company denies that it is responsible or legally obligated to me for My Claims, denies that it engaged in any unlawful or improper conduct toward me, and denies that it treated me unfairly. ADVICE TO CONSULT WITH AN ATTORNEY. I understand and acknowledge that I am hereby being advised by the Company to consult with an attorney prior to signing this Release and I have done so. My decision whether to sign this Release is my own voluntary decision made with full knowledge that the Company has advised me to consult with an attorney. PERIOD TO CONSIDER THE RELEASE. I understand that I have 21 days following my last day of employment with the Company to consider whether I wish to sign this -2- Release before the end of the 21-day period, it will be my voluntary decision to do so because I have decided that I do not need any additional time to decide whether to sign this Release. MY RIGHT TO RESCIND THIS RELEASE. I understand that I may rescind this Release at any time within 15 days after I sign it, not counting the day upon which I sign it. This Release will not become effective or enforceable unless and until the 15-day rescission period has expired without my rescinding it. PROCEDURE FOR ACCEPTING OR RESCINDING THE RELEASE. To accept the terms of this Release, I must deliver the Release, after I have signed and dated it, to CIMA by hand or by mail within the 21-day period that I have to consider this Release. To rescind my acceptance, I must deliver a written, signed statement that I rescind my acceptance to CIMA by hand or by mail within the 15-day rescission period. All deliveries must be made to CIMA at the following address: Ronald Gay CIMA LABS INC. 10000 Valley View Road Eden Prairie, MN 55344 If I choose to deliver my acceptance or the rescission of my acceptance by mail, it must be (1) postmarked within the period stated above; and (2) properly addressed to CIMA at the address stated above. INTERPRETATION OF THE RELEASE. This Release should be interpreted as broadly as possible to achieve my intention to resolve all of My Claims against the Company. If this Release is held by a court to be inadequate to release a particular claim encompassed within My Claims, this Release will remain in full force and effect with respect to all the rest of My Claims. MY REPRESENTATIONS. I am legally able and entitled to receive the consideration being provided to me in settlement of My Claims. I have not been involved in any personal bankruptcy or other insolvency proceedings at any time since I began my employment with CIMA. No child support orders, garnishment orders, or other orders requiring that money owed to me by CIMA be paid to any other person are now in effect. I have read this Release carefully. I understand all of its terms. In signing this Release, I have not relied on any statements or explanations made by the Company except as specifically set forth in the Letter Agreement. I am voluntarily releasing My Claims against the Company. I intend this Release and the Letter Agreement to be legally binding. Dated: _____________________________ _________________________________ David A. Feste -3-
EX-10.32 7 c75663exv10w32.txt EX10.32 EMPLOYMENT AGREEMENT - JAMES C HAWLEY EXHIBIT 10.32 CIMA LABS INC. EMPLOYMENT AGREEMENT THIS EMPLOYMENT AGREEMENT (this "Agreement") is entered into on February 19, 2003 by and between Cima Labs Inc., a Delaware corporation (the "Company"), and James C. Hawley, a resident of Minnesota ("Executive"). A. The Company develops and manufactures prescription and over-the-counter pharmaceutical products using fast-dissolve drug delivery technologies for sale around the world. B. Executive is an experienced business manager. C. The Company desires to hire Executive as its Vice President, Chief Financial Officer and Secretary, and Executive desires to be employed by the Company, subject to the terms and conditions set forth in this Agreement. NOW, THEREFORE, in consideration of the foregoing premises and the respective agreements of the Company and Executive set forth below, the Company and Executive, intending to be legally bound, agree as follows: 1. Employment. Effective as of March 17, 2003, the Company shall employ Executive, and Executive shall accept such employment and perform services for the Company, upon the terms and conditions set forth in this Agreement. 2. Term of Employment. The term of Executive's employment with the Company shall be for the period commencing on March 17, 2003 and continuing until terminated in accordance with Section 9 hereof. 3. Position and Duties. (a) Employment with the Company. During the term of Executive's employment with the Company, Executive shall report to the President and Chief Executive Officer of the Company and shall perform such duties and responsibilities as the Company shall assign to him from time to time consistent with his position. Effective as of April 1, 2003 and subject to approval of the Board of Directors of the Company (the "Board"), Executive shall be an executive officer of the Company and Executive's title shall be "Vice President, Chief Financial Officer and Secretary". (b) Performance of Duties and Responsibilities. Executive shall serve the Company faithfully and to the best of his ability and shall devote his full working time, attention and efforts to the business of the Company during his employment with the Company. Executive hereby represents and confirms that he is under no contractual or legal commitments that would prevent him from fulfilling his duties and responsibilities as set forth in this Agreement. During his employment with the Company, Executive may participate in charitable activities and personal investment activities to a reasonable extent, and, subject to prior Board approval, may serve on boards of directors of other companies, so long as such activities do not interfere with the performance of his duties and responsibilities hereunder. 4. Compensation. (a) Base Salary. While Executive is employed by the Company hereunder, the Company shall pay to Executive an annual base salary at the rate of $200,000, less deductions and withholdings, which base salary shall be paid in accordance with the Company's normal payroll policies and procedures. Annual performance and salary reviews will be conducted in accordance with Company policy and practice. (b) Incentive Bonus. For each full calendar year that Executive is employed by the Company hereunder, Executive shall be eligible for an incentive bonus award of up to 50% of Executive's base salary, based on achievement of objectives established by the Company. For calendar year 2003, Executive shall be eligible for an incentive bonus award of up to $100,000. (c) Stock Options. Subject to approval by the Board and the terms of a definitive stock option agreement to be entered into by the Company and Executive, the Company shall grant Executive a stock option to purchase 50,000 shares of common stock of the Company. (d) Employee Benefits. While Executive is employed by the Company hereunder, Executive shall be entitled to participate in all employee benefit plans and programs of the Company to the extent that Executive meets the eligibility requirements for each individual plan or program. The Company provides no assurance as to the adoption or continuance of any particular employee benefit plan or program, and Executive's participation in any such plan or program shall be subject to the provisions, rules and regulations applicable thereto. (e) Expenses. While Executive is employed by the Company hereunder, the Company shall reimburse Executive for all reasonable and necessary out-of-pocket business, travel and entertainment expenses incurred by him in the performance of his duties and responsibilities hereunder, subject to the Company's normal policies and procedures for expense verification and documentation. (f) Vacation/Paid Time Off. While Executive is employed by the Company hereunder, Executive shall accrue paid time off each year in accordance with the Company's policies and practices in effect from time to time; provided, however, that Executive shall accrue paid time off each pay period at a rate of four weeks per year. Paid time off shall be taken at such times so as not to unduly disrupt the operations of the Company. 2 5. Confidential Information. Except as permitted in writing by the Company's Board, during the term of Executive's employment with the Company and at all times thereafter, Executive shall not divulge, furnish or make accessible to anyone or use in any way other than in the ordinary course of the business of the Company, any confidential, proprietary or secret knowledge or information of the Company that Executive has acquired or shall acquire during his employment with the Company, whether developed by himself or by others, concerning (i) any trade secrets, (ii) any confidential, proprietary or secret designs, processes, formulae, plans, devices or material (whether or not patented or patentable) directly or indirectly useful in any aspect of the business of the Company, (iii) any customer or supplier lists of the Company, (iv) any confidential, proprietary or secret development or research work of the Company, (v) any strategic or other business, marketing or sales plans of the Company, (vi) any financial data or plans respecting the Company, or (vii) any other confidential or proprietary information or secret aspects of the business of the Company. Executive acknowledges that the above-described knowledge and information constitutes a unique and valuable asset of the Company and represents a substantial investment of time and expense by the Company, and that any disclosure or other use of such knowledge or information other than for the sole benefit of the Company would be wrongful and would cause irreparable harm to the Company. During the term of Executive's employment with the Company, Executive shall refrain from any acts or omissions that would reduce the value of such knowledge or information to the Company. The foregoing obligations of confidentiality shall not apply to any knowledge or information that (i) is now or subsequently becomes generally publicly known in the form in which it was obtained from the Company, (ii) is independently made available to Executive in good faith by a third party who has not violated a confidential relationship with the Company, or (iii) is required to be disclosed by legal process, other than as a direct or indirect result of the breach of this Agreement by Executive. 6. Ventures. If, during the term of Executive's employment with the Company, Executive is engaged in or associated with the planning or implementing of any project, program or venture involving the Company and a third party or parties, all rights in such project, program or venture shall belong to the Company. Except as approved in writing by the Board, Executive shall not be entitled to any interest in any such project, program or venture or to any commission, finder's fee or other compensation in connection therewith, other than the compensation to be paid to Executive by the Company as provided herein. Executive shall have no interest, direct or indirect, in any customer or supplier that conducts business with the Company, unless such interest has been disclosed in writing to and approved by the Board before such customer or supplier seeks to do business with the Company. Ownership by Executive, as a passive investment, of less than 2.5% of the outstanding shares of capital stock of any corporation listed on a national securities exchange or publicly traded in the over-the-counter market shall not constitute a breach of this Section 6. 7. Noncompetition Covenant. (a) Agreement Not to Compete. During the term of Executive's employment with the Company and for a period of twelve (12) consecutive months from the date of the termination of such employment, whether such termination is with or without Cause (as defined 3 below), or whether such termination is at the instance of Executive or the Company, Executive shall not, directly or indirectly, throughout North America, engage in any business that the Company has engaged in during the term of Executive's employment with the Company, or any part of such business, including without limitation the design, development, manufacture, distribution, marketing or selling of pharmaceutical products using fast-dissolve drug delivery technologies, in any manner or capacity, including without limitation as a proprietor, principal, agent, partner, officer, director, stockholder, employee, member of any association, consultant or otherwise. Ownership by Executive, as a passive investment, of less than 2.5% of the outstanding shares of capital stock of any corporation listed on a national securities exchange or publicly traded in the over-the-counter market shall not constitute a breach of this Section 7(a). (b) Agreement Not to Hire. During the term of Executive's employment with the Company and for a period of twelve (12) consecutive months from the date of the termination of such employment, whether such termination is with or without Cause (as defined below), or whether such termination is at the instance of Executive or the Company, Executive shall not, directly or indirectly, hire, engage or solicit any person who is then an employee of the Company or who was an employee of the Company at the time of Executive's termination of employment, in any manner or capacity, including without limitation as a proprietor, principal, agent, partner, officer, director, stockholder, employee, member of any association, consultant or otherwise. (c) Agreement Not to Solicit. During the term of Executive's employment with the Company and for a period of twelve (12) consecutive months from the date of the termination of such employment, whether such termination is with or without Cause (as defined below), or whether such termination is at the instance of Executive or the Company, Executive shall not, directly or indirectly, solicit, request, advise or induce any current or potential customer, supplier or other business contact of the Company on behalf of any entity competing with the Company or to cancel, curtail or otherwise change its relationship with the Company, in any manner or capacity, including without limitation as a proprietor, principal, agent, partner, officer, director, stockholder, employee, member of any association, consultant or otherwise. A "current customer" is defined as a customer of the Company as of the Termination Date (as defined below). A "potential customer" is an entity with which the Company has had significant and substantive discussions within one year prior to, or is having significant and substantive discussions as of, the Termination Date. (d) Acknowledgment. Executive hereby acknowledges that the provisions of this Section 7 are reasonable and necessary to protect the legitimate interests of the Company and that any violation of this Section 7 by Executive shall cause substantial and irreparable harm to the Company to such an extent that monetary damages alone would be an inadequate remedy therefor. Therefore, in the event that Executive violates any provision of this Section 7, the Company shall be entitled to an injunction, in addition to all the other remedies it may have, restraining Executive from violating or continuing to violate such provision. (e) Blue Pencil Doctrine. If the duration of, the scope of or any business activity covered by any provision of this Section 7 is in excess of what is valid and enforceable under applicable law, such provision shall be construed to cover only that duration, scope or 4 activity that is valid and enforceable. Executive hereby acknowledges that this Section 7 shall be given the construction which renders its provisions valid and enforceable to the maximum extent, not exceeding its express terms, possible under applicable law. 8. Patents, Copyrights and Related Matters. (a) Disclosure and Assignment. Executive shall immediately disclose to the Company any and all improvements, inventions, ideas, and discoveries that Executive may conceive and/or reduce to practice individually or jointly or commonly with others while he is employed with the Company with respect to (i) any methods, processes or apparatus concerned with the development, use or production of any type of products, goods or services sold or used by the Company, and (ii) any type of products, goods or services sold or used by the Company. Executive also shall immediately assign, transfer and set over to the Company his entire right, title and interest in and to any and all of such inventions as are specified in this Section 8(a), and in and to any and all applications for letters patent that may be filed on such inventions, and in and to any and all letters patent that may issue, or be issued, upon such applications. In connection therewith and for no additional compensation therefor, but at no expense to Executive, Executive shall sign any and all instruments deemed necessary by the Company for: (i) the filing and prosecution of any applications for letters patent of the United States or of any foreign country that the Company may desire to file upon such inventions as are specified in this Section 8(a); (ii) the filing and prosecution of any divisional, continuation, continuation-in-part or reissue applications that the Company may desire to file upon such applications for letters patent; and (iii) the reviving, re-examining or renewing of any of such applications for letters patent. This Section 8(a) shall not apply to any invention for which no equipment, supplies, facilities, confidential, proprietary or secret knowledge or information, or other trade secret information of the Company was used and that was developed entirely on Executive's own time, and (i) that does not relate (A) directly to the business of the Company, or (B) to the Company's actual or demonstrably anticipated research or development, or (ii) that does not result from any work performed by Executive for the Company. (b) Copyrightable Material. All right, title and interest in all copyrightable material that Executive shall conceive or originate individually or jointly or commonly with others, and that arise during the term of his employment with the Company and out of the performance of his duties and responsibilities under this Agreement, shall be the property of the Company and are hereby assigned by Executive to the Company, along with ownership of any and all copyrights in the copyrightable material. Upon request and without further compensation 5 therefor, but at no expense to Executive, Executive shall execute any and all papers and perform all other acts necessary to assist the Company to obtain and register copyrights on such materials in any and all countries. Where applicable, works of authorship created by Executive for the Company in performing his duties and responsibilities hereunder shall be considered "works made for hire," as defined in the U.S. Copyright Act. (c) Know-How and Trade Secrets. All know-how and trade secret information conceived or originated by Executive that arises during the term of his employment with the Company and out of the performance of his duties and responsibilities hereunder or any related material or information shall be the property of the Company, and all rights therein are hereby assigned by Executive to the Company. 9. Termination of Employment. (a) The Executive's employment with the Company shall terminate immediately upon: (i) Executive's receipt of written notice from the Company of the termination of his employment; (ii) Executive's abandonment of his employment or his resignation; or (iii) Executive's death or Disability (as defined below). (b) The date upon which Executive's termination of employment with the Company occurs shall be the "Termination Date." 10. Payments upon Termination of Employment. (a) If Executive's employment with the Company is terminated by the Company for any reason other than for Cause (as defined below) or by Executive for Good Reason (as defined below): (i) (A) if the Termination Date occurs within the first six (6) months of Executive's employment with the Company, the Company shall pay to Executive as severance pay an amount equal to his current base salary for a period of six (6) consecutive months after the Termination Date; or (B) if the Termination Date occurs after six (6) months of Executive's employment with the Company, the Company shall pay to Executive as severance pay an amount equal to his current base salary for a period of twelve (12) consecutive months after the Termination Date; and 6 (ii) if Executive elects to continue his group health insurance coverage with the Company following the termination of his employment with the Company, and if Executive pays the remaining portion of the health insurance premium, the Company will continue to pay its portion of the monthly premiums as if Executive were still employed and at the same level of coverage that was in effect as of the Termination Date for the same period as Executive is receiving severance pay under Section 10(a)(i) above; and (iii) the Company shall pay to Executive a pro rata portion (based on the number of full calendar months of employment during the calendar year in which the Termination Date occurs) of any incentive bonus that would have been payable to him for such year pursuant to Section 4(b) hereof as if Executive had been in the employ of the Company for the full calendar year. Any amount payable to Executive as severance pay shall be subject to deductions and withholdings and shall be paid to Executive by the Company in accordance with the Company regular payroll schedule commencing on the first normal payroll date of the Company following the expiration of all applicable rescission provided by law and continuing thereafter. Any amount payable to Executive as incentive bonus hereunder shall be paid to Executive by the Company in the same manner and at the same time that incentive bonus payments are made to current employees of the Company, but no earlier than the first normal payroll date of the Company following the expiration of all applicable rescission periods provided by law. The Company shall be entitled to deduct from any severance pay otherwise payable to Executive hereunder any amount received by Executive after the Termination Date under any short-term or long-term disability insurance plan or program provided to him by the Company. In addition, the Company shall be entitled to cease making severance payments to Executive if Executive obtains other employment after the Termination Date and to cease making payments for the cost of the continuation of his group health insurance coverage with the Company after the Termination Date if Executive becomes eligible for comparable group health insurance coverage from any other employer. For purposes of mitigation and reduction of the Company's financial obligations to Executive under this Section 10(a), Executive shall within three days promptly and fully disclose to the Company in writing: (i) the fact of any employment with any other employer, (ii) the amount of any such disability insurance payments, or (iii) the fact that he has become eligible for comparable group health insurance coverage from any other employer, and Executive shall be liable to repay any amounts to the Company that should have been so mitigated or reduced but for Executive's failure or unwillingness to make such disclosures. (b) If Executive's employment with the Company is terminated by reason of: (i) Executive's resignation or abandonment of his employment, 7 (ii) termination of Executive's employment by the Company for Cause (as defined below), or (iii) Executive's death or Disability, the Company shall pay to Executive or his beneficiary or his estate, as the case may be, his base salary through the Termination Date. (c) "Cause" hereunder shall mean: (i) an act or acts of dishonesty undertaken by Executive and intended to result in substantial gain or substantial personal enrichment of Executive at the expense of the Company; (ii) unlawful conduct or gross misconduct that is willful and deliberate on Executive's part and that, in either event, is materially injurious to the Company; (iii) the conviction of Executive of a felony; (iv) material failure of Executive to perform his duties and responsibilities hereunder or to satisfy his obligations as an officer or employee of the Company, which failure has not been cured by Executive within 30 days after written notice thereof to Executive from the Company specifying such material failure; or (v) material breach of any terms and conditions of this Agreement by Executive not caused by the Company. (d) "Disability" hereunder shall mean the inability of Executive to perform on a full-time basis the duties and responsibilities of his employment with the Company by reason of his illness or other physical or mental impairment or condition, if such inability continues for an uninterrupted period of 90 calendar days or more during any 360-day period. A period of inability shall be "uninterrupted" unless and until Executive returns to full-time work for a continuous period of at least 30 days. (e) "Good Reason" hereunder shall mean (i) any action by the Company that results in a substantial diminution in Executive's responsibilities as Chief Financial Officer of the Company (after such appointment as contemplated by Section 3(a) of this Agreement), other than for Cause or on account of Disability; or (ii) a material reduction in Executive's base salary. 8 (f) In the event of termination of Executive's employment, the sole obligation of the Company shall be its obligation to make the payments called for by Section 10(a) or Section 10(b) hereof, as the case may be, and the Company shall have no other obligation to Executive or to his beneficiary or his estate, except as otherwise provided by law, under the terms of any other applicable agreement between Executive and the Company or under the terms of any employee benefit plans or programs then maintained by the Company in which Executive participates. (g) Notwithstanding the foregoing provisions of this Section 10, the Company shall not be obligated to make any payments to Executive under Section 10(a) hereof unless Executive shall have signed a release of claims in favor of the Company in a form to be prescribed by the Company, all applicable consideration periods and rescission periods provided by law shall have expired and Executive is in strict compliance with the terms of this Agreement as of the dates of the payments. 11. Return of Records and Property. Upon termination of his employment with the Company, Executive shall promptly deliver to the Company any and all Company records and any and all Company property in his possession or under his control, including without limitation manuals, books, blank forms, documents, letters, memoranda, notes, notebooks, reports, printouts, computer disks, computer tapes, source codes, data, tables or calculations and all copies thereof, documents that in whole or in part contain any trade secrets or confidential, proprietary or other secret information of the Company and all copies thereof, and keys, access cards, access codes, passwords, credit cards, personal computers, telephones and other electronic equipment belonging to the Company. 12. Remedies. (a) Remedies. Executive acknowledges that it would be difficult to fully compensate the Company for monetary damages resulting from any breach by him of the provisions of Sections 5, 7, 8 and 11 hereof. Accordingly, in the event of any actual or threatened breach of any such provisions, the Company shall, in addition to any other remedies it may have, be entitled to injunctive and other equitable relief to enforce such provisions, and such relief may be granted without the necessity of proving actual monetary damages. (b) Arbitration. Except for disputes arising under Sections 5, 7 or 8 hereof, all disputes involving the interpretation, construction, application or alleged breach of this Agreement and all disputes relating to Executive's employment with the Company or the termination of such employment shall be submitted to final and binding arbitration in Minneapolis, Minnesota. The arbitrator shall be selected and the arbitration shall be conducted pursuant to the then most recent Employment Dispute Resolution Rules of the American Arbitration Association. The decision of the arbitrator shall be final and binding, and any court of competent jurisdiction may enter judgment upon the award. All fees and expenses of the arbitrator shall be paid by the Company. The arbitrator shall have jurisdiction and authority to interpret and apply the provisions of this Agreement and relevant federal, state and local laws, 9 rules and regulations insofar as necessary to the determination of the dispute and to remedy any breaches of the Agreement and/or violations of applicable laws, but shall not have jurisdiction or authority to alter in any way the provisions of this Agreement. The arbitrator shall have the authority to award attorneys' fees and costs to the prevailing party. The parties hereby agree that this arbitration provision shall be in lieu of any requirement that either party exhaust such party's administrative remedies under federal, state or local law. (c) Jurisdiction and Venue. Executive and the Company consent to jurisdiction of the courts of the State of Minnesota and/or the federal district courts, District of Minnesota, for the purpose of resolving all issues of law, equity, or fact arising out of or in connection with Sections 5, 7 or 8 of this Agreement. Any action involving claims of a breach of such Sections shall be brought in such courts. Each party consents to personal jurisdiction over such party in the state and/or federal courts of Minnesota and hereby waives any defense of lack of personal jurisdiction. Venue, for the purpose of all such suits, shall be in Hennepin County, State of Minnesota. 13. Miscellaneous. (a) Governing Law. All matters relating to the interpretation, construction, application, validity and enforcement of this Agreement shall be governed by the laws of the State of Minnesota without giving effect to any choice or conflict of law provision or rule, whether of the State of Minnesota or any other jurisdiction, that would cause the application of laws of any jurisdiction other than the State of Minnesota. (b) Entire Agreement. Except for the stock option agreement referred to in Section 4(c) hereof, this Agreement contains the entire agreement of the parties relating to the subject matter of this Agreement and supersedes all prior agreements and understandings with respect to such subject matter, and the parties hereto have made no agreements, representations or warranties relating to the subject matter of this Agreement that are not set forth herein. (c) Amendments. No amendment or modification of this Agreement shall be deemed effective unless made in writing and signed by the parties hereto. (d) No Waiver. No term or condition of this Agreement shall be deemed to have been waived, except by a statement in writing signed by the party against whom enforcement of the waiver is sought. Any written waiver shall not be deemed a continuing waiver unless specifically stated, shall operate only as to the specific term or condition waived and shall not constitute a waiver of such term or condition for the future or as to any act other than that specifically waived. (e) Assignment. This Agreement shall not be assignable, in whole or in party, by either party without the written consent of the other party, except that the Company may, without the consent of Executive, assign its rights and obligations under this Agreement to any corporation or other business entity (i) with which the Company may merge or consolidate, (ii) to which the Company may sell or transfer all or substantially all of its assets or capital stock, or 10 (iii) of which 50% or more of the capital stock or the voting control is owned, directly or indirectly, by the Company. After assignment by the Company under clause (i) or (ii) of the preceding sentence, the Company shall be discharged from all further liability hereunder and such assignee shall thereafter be deemed to be the "Company" for purposes of all terms and conditions of this Agreement, including this Section 13. (f) Counterparts. This Agreement may be executed in any number of counterparts, and such counterparts executed and delivered, each as an original, shall constitute but one and the same instrument. (g) Severability. Subject to Section 7(e) hereof, to the extent that any portion of any provision of this Agreement shall be invalid or unenforceable, it shall be considered deleted herefrom and the remainder of such provision and of this Agreement shall be unaffected and shall continue in full force and effect. (h) Captions and Headings. The captions and paragraph headings used in this Agreement are for convenience of reference only and shall not affect the construction or interpretation of this Agreement or any of the provisions hereof. IN WITNESS WHEREOF, Executive and the Company have executed this Agreement as of the date set forth in the first paragraph. CIMA LABS INC. By /s/Steven Ratoff ---------------- Its Member of the Board of Directors /s/James C. Hawley ------------------ JAMES C. HAWLEY 11 EX-23.1 8 c75663exv23w1.txt EX-23.1 CONSENT OF ERNST & YOUNG LLP EXHIBIT 23.1 Consent of Independent Auditors We consent to the reference to our firm under the caption, Selected Financial Data, and to the incorporation by reference in the Registration Statements (Form S-8 No. 333-42354, Form S-8 No. 333-32233, Form S-8 No. 333-05741, Form S-8 No. 333-59791, Form S-8 No. 333-82794, Form S-8 No. 333-82790, Form S-8 No. 333-62954 and Form S-8 No. 333-63026) pertaining to certain stock option and employee stock purchase plans of the Company, of our report dated February 14, 2003, with respect to the financial statements and schedule of CIMA LABS INC. included in the Annual Report (Form 10-K) for the year ended December 31, 2002. Minneapolis, Minnesota /s/ Ernst & Young LLP March 24, 2003 EX-24.1 9 c75663exv24w1.txt EX-24.1 POWERS OF ATTORNEY EXHIBIT 24.1 POWER OF ATTORNEY KNOW ALL PERSONS BY THESE PRESENT, that each person whose signature appears below hereby constitutes and appoints John M. Siebert, John Hontz and David A. Feste and each of them, his true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution for him and in his name, place and stead, in any and all capacities, to sign the Annual Report on Form 10-K of CIMA LABS INC. for the twelve months ended December 31, 2002, and all amendments to such Annual Report on Form 10-K and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite or necessary to be done in and about the premises, as fully to all intents and purposes he might or could do in person, hereby ratifying and confirming all said attorneys-in-fact and agents or any of them, or their or his substitutes, may lawfully do or cause to be done by virtue hereof.
Signature Date --------- ---- /s/John M. Siebert February 10, 2003 - ---------------------------------------------------- John M. Siebert President & Chief Executive Officer (Principal Executive Officer) and Director /s/John F. Chappell January 11, 2003 - ---------------------------------------------------- John F. Chappell Director /s/Steven D. Cosler January 11, 2003 - ---------------------------------------------------- Steven D. Cosler Director /s/Terrence W. Glarner January 11, 2003 - ---------------------------------------------------- Terrence W. Glarner Director /s/Steven B. Ratoff January 11, 2003 - ---------------------------------------------------- Steven B. Ratoff Director /s/Joseph R. Robinson January 13, 2003 - ---------------------------------------------------- Joseph R. Robinson Director
AA
EX-99.1 10 c75663exv99w1.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 Annual Report of CIMA LABS INC. (the "Company") on Form 10-K for the period ending December 31, 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: 3/28/2003 /s/ John M. Siebert -------------------------------------- John M. Siebert, President and Chief Executive Officer (Principal Executive Officer) A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request. EX-99.2 11 c75663exv99w2.txt EX-99.2 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 Annual Report of CIMA LABS INC. (the "Company") on Form 10-K for the period ending December 31, 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: 3/28/2003 /s/ David A. Feste ------------------------------- David A. Feste, Chief Financial Officer (Principal Financial Officer) A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request. -----END PRIVACY-ENHANCED MESSAGE-----