Delaware 2834 94-3297098 (Primary Standard (I.R.S. Employer (State or Other Industrial Identification Number) Jurisdiction of Classification Code Incorporation or Number) Organization) ---------------- 10240 Bubb Road Cupertino, CA 95014 (408) 777-1417 |
Mark B. Weeks Gregory M. Gallo Stephen B. Thau Joe C. Sorenson Ughetta T. Manzone Sally J. Rau Venture Law Group Bradley J. Gersich A Professional Corporation Gray Cary Ware & Freidenrich LLP 2800 Sand Hill Road 400 Hamilton Avenue Menlo Park, CA 94025 Palo Alto, CA 94301 ---------------- |
CALCULATION OF REGISTRATION FEE
-------------------------------------------------------------------------------- -------------------------------------------------------------------------------- Proposed Title of Each Class of Maximum Aggregate Amount of Securities to be Registered Offering Price(1) Registration Fee -------------------------------------------------------------------------------- Common Stock, par value $0.0001............. $115,000,000 $30,360 -------------------------------------------------------------------------------- -------------------------------------------------------------------------------- |
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+The information in this prospectus is not complete and may be changed. We may +
+not sell these securities until the registration statement filed with the + +Securities and Exchange Commission is effective. This prospectus is not an + +offer to sell these securities and we are not soliciting offers to buy these + +securities in any state where the offer or sale is not permitted. + |
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PROSPECTUS (Subject to Completion)
Issued April 20, 2000
[ ] Shares
[LOGO OF DURECT CORPORATION]
DURECT Corporation
COMMON STOCK
DURECT Corporation is offering shares of its common stock. This is our initial public offering and no public market exists for our shares. We anticipate that the initial public offering price will be between $ and $ per share.
We have applied to list our common stock for quotation on the Nasdaq National Market under the symbol "DRRX."
Investing in our common stock involves risks. See "Risk Factors" beginning on page 5.
PRICE $ A SHARE
Price Underwriting to Discounts and Proceeds to Public Commissions DURECT ------ ------------- ----------- Per Share ..................................... $ $ $ Total ......................................... $ $ $ |
DURECT has granted the underwriters the right to purchase up to an additional shares of common stock to cover over-allotments.
The Securities and Exchange Commission and state securities regulators have not approved or disapproved these securities, or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
Morgan Stanley & Co. Incorporated expects to deliver the shares of common stock to purchasers on , 2000.
MORGAN STANLEY DEAN WITTER
CHASE H&Q
CIBC WORLD MARKETS
, 2000
[COLOR ARTWORK]
Upper right hand corner: Text "Targeted drug delivery for chronic disease therapy."
Right side of page: The following images and words are presented from top to bottom: (1) An image of chemistry equipment with the word "Chemistry" underneath and an arrow pointing to the center of the page; and (2) an image of gears with the word "Engineering" underneath and an arrow pointing to the center of the page.
Center of page: Two images of the DUROS drug delivery system, one above the other. The bottom image also includes a catheter connected to the DUROS drug delivery system. Four arrows start near the center, each pointing to one of the images at the left side of the page described below.
Left side of page: The following images and text are presented from top to
bottom: (1) an image of a molecule with the words "The right drug" underneath;
(2) an image of a graph showing curves representing drug concentration in the
body over a period of time, with the words "The Right Amount" underneath; (3)
an image of a person with arrows pointing to locations where pharmaceutical
systems may be located, with the words "The Right Place" underneath; and (4)
an image of an hourglass with the words "The Right Time" underneath.
TABLE OF CONTENTS
Page ---- Prospectus Summary....................................................... 1 Risk Factors............................................................. 5 Use of Proceeds.......................................................... 19 Dividend Policy.......................................................... 19 Capitalization........................................................... 20 Dilution................................................................. 21 Selected Financial and Operating Data.................................... 22 Management's Discussion and Analysis of Financial Condition and Results of Operations........................................................... 23 Business................................................................. 28 Management............................................................... 43 Certain Transactions..................................................... 56 Principal Stockholders................................................... 57 Description of Capital Stock............................................. 60 Shares Eligible for Future Sale.......................................... 64 Underwriting............................................................. 66 Legal Matters............................................................ 68 Experts.................................................................. 68 Where You Can Find More Information...................................... 69 Index to Consolidated Financial Statements............................... F-1 |
You should rely only on the information contained in this prospectus. We have not authorized anyone to provide you with information different from that contained in this prospectus. We are offering to sell, and seeking offers to buy, shares of common stock only in jurisdictions where offers and sales are permitted. The information contained in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of the prospectus or of any sale of the common stock.
Until , 2000 (25 days after the date of this prospectus) all dealers that buy, sell or trade our common stock, whether or not participating in this offering, may be required to deliver a prospectus. This delivery requirement is in addition to the dealers' obligation to deliver a prospectus when acting as underwriters and with respect to their allotments or subscriptions.
For investors outside the United States: Neither we nor any of the underwriters have done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. You are required to inform yourselves about and to observe any restrictions relating to this offering and the distribution of this prospectus.
PROSPECTUS SUMMARY
You should read the following summary together with the more detailed information regarding our company and the common stock being sold in this offering and our consolidated financial statements and notes thereto appearing elsewhere in this prospectus.
DURECT Corporation
We are pioneering the treatment of chronic diseases and conditions by developing and commercializing pharmaceutical systems to deliver the right drug to the right place in the right amount at the right time. Our pharmaceutical systems combine engineering innovations and delivery technology from the medical device and drug delivery industries with our proprietary pharmaceutical and biotechnology drug formulations. By integrating these technologies, we are able to control the rate and duration of drug administration as well as target the delivery of the drug to its intended site of action, allowing our pharmaceutical systems to meet the special challenges associated with treating chronic diseases or conditions. Our pharmaceutical systems can enable new drug therapies or optimize existing therapies based on a broad range of compounds, including small molecule pharmaceuticals as well as biotechnology molecules such as proteins, peptides and genes. Our initial portfolio of products combine the DUROS technology, a proven and patented drug delivery platform licensed for specified fields of use from ALZA Corporation, with drugs for which medical data on efficacy and safety are available.
According to the Centers for Disease Control, cardiovascular disease, cancer, neurodegenerative diseases, diabetes, arthritis, epilepsy and other chronic diseases claimed the lives of more that 1.7 million Americans in 1999. The Centers for Disease Control also estimates that the major chronic diseases are responsible for approximately 70% of all deaths in the U.S., and medical care costs for these conditions totaled more than $400 billion annually. Currently, more than 60% of total health care spending in the U.S. is devoted to the treatment of chronic diseases. Demographic trends suggest that, as the U.S. population ages, the incidence of chronic disease and cost of treating it as a proportion of total health care spending will increase. While the pharmaceutical, biotechnology, drug delivery and medical device industries have increased overall life expectancy and improved patient quality of life, many chronic debilitating diseases continue to be inadequately treated with current drugs or medical devices.
Our pharmaceutical systems are suitable for providing long-term drug therapy because they store highly concentrated, stabilized drugs in a small volume and can protect the drug from degradation by the body. This, in combination with our ability to deliver precise, accurate and continuous doses of a drug, allows us to extend the therapeutic value of a wide variety of drugs, including those which would otherwise be ineffective, too unstable, too potent or cause adverse side effects. Delivering the drug directly to the intended site of action can also improve efficacy while minimizing unwanted side effects elsewhere in the body, which often limit the long-term use of many drugs. Our pharmaceutical systems can thus provide better therapy for chronic diseases or conditions by replacing multiple injection therapy or oral dosing, improving drug efficacy, reducing side effects and ensuring dosing compliance. Our pharmaceutical systems can improve patients' quality of life by eliminating more repetitive treatments, reducing dependence on caregivers and allowing them to lead more independent lives.
We are currently developing pharmaceutical systems based on the DUROS technology, coupled with proprietary catheter and drug formulation technology, to address a variety of therapeutic areas, including chronic pain, central nervous system disorders, cardiovascular diseases and inner ear disorders. The DUROS is a miniature drug-dispensing pump that releases minute quantities of concentrated drug formulations in a continuous, consistent flow for as long as one year using an osmotic engine. The miniature pump, made out of titanium, can be as small as a wooden matchstick and can be implanted under the skin. The potential of the DUROS technology as a platform for providing drug therapy was recently demonstrated by the Food and Drug Administration's approval in March 2000 of ALZA's Viadur (leuprolide acetate implant), a one-year
implant for the palliative treatment of prostate cancer, the first approved product to incorporate the DUROS implant technology. By leveraging this proven platform technology, we believe we can reduce our development risk and more rapidly introduce new products to the market. Beyond the DUROS technology, we intend to develop other technologies consistent with our objective of delivering the right drug to the right place in the right amount at the right time.
Our lead product is for the treatment of chronic pain and combines the DUROS technology with a proprietary formulation of sufentanil, a potent opioid currently used in hospitals as an anesthetic. We completed an initial Phase I trial in November 1999 using an external pump to test the safety of continuous chronic infusion of the drug. We intend to commence a pharmacokinetic study and a Phase II human clinical trial in late 2000. This product is aimed at the approximately $1 billion market for the treatment of chronic pain and will compete with oral opioids, analgesic patches and external and implantable infusion pumps. Our second product in development is designed to target delivery of hydromorphone, an opioid approved for use as an analgesic, via a catheter to the intended site of action in the central nervous system. We are designing this product to treat end-stage cancer pain and will be conducting preclinical studies in mid-2000. We are also researching and developing pharmaceutical systems based on the DUROS technology in a variety of other therapeutic areas, including central nervous system disorders, cardiovascular disease and inner ear disorders.
Our objective is to develop and commercialize pharmaceutical systems that address significant medical needs and improve patients' quality of life. To achieve this objective, our strategy includes the following key elements:
. Focus on chronic debilitating medical conditions;
. Minimize product development risk and speed time-to-market;
. Enable the development of pharmaceutical systems based on biotechnology and other new compounds; and
. Expand our technology platforms.
DURECT Corporation's executive offices are located at 10240 Bubb Road, Cupertino, CA 95104, (408) 777-1417. IntraEAR, Round Window (mu)-Cath, Round Window e-Cath and ALZET are trademarks of DURECT Corporation. DUROS is a registered trademark of ALZA Corporation, and Viadur is a trademark of ALZA Corporation. Each other trademark, trade name or service mark of any other company appearing in this prospectus is the property of its holders.
THE OFFERING
Common stock offered............................... shares Common stock to be outstanding after the offering.. shares Use of proceeds.................................... For research, development, manufacture and commercialization of existing and future products and general corporate purposes, including working capital and capital expenditures. See "Use of Proceeds." Proposed Nasdaq National Market symbol............. DRRX |
The number of shares does not take into account:
. 738,350 shares of our common stock subject to options outstanding under our stock plans at March 31, 2000;
. 1,265,650 shares reserved for issuance under our 2000 stock plan;
. 150,000 shares reserved for issuance under our 2000 employee stock purchase plan;
. 300,000 shares reserved under our 2000 directors stock option plan;
. a warrant to purchase 31,395 shares of our common stock issued in January 1999; and
. a warrant to purchase 1,000,000 shares of our common stock issued in April 2000.
Except as otherwise indicated, information in this prospectus is based on the following assumptions:
. The conversion of all outstanding shares of preferred stock into common stock on a one-for-one basis upon the closing of this offering;
. No exercise of the underwriters' over-allotment option; and
. The filing of our amended and restated certificate of incorporation upon the closing of this offering.
SUMMARY FINANCIAL DATA
In the following summary financial data, the statement of operations data for the period from inception (February 6, 1998), to December 31, 1998, the year ended December 31, 1999 and the period from inception (February 6, 1998) to December 31, 1999 are derived from and qualified in their entirety by our consolidated financial statements. See "Management's Discussion and Analysis of Financial Condition and Results of Operations."
Period from Period from inception inception (February 6, Fiscal Year (February 6, 1998) to Ended 1998) to December 31, December 31, December 31, 1998 1999 1999 ------------ ------------ ------------ Statement of Operations Data: (in thousands, except per share data) Revenue, net............................ $ -- $ 86 $ 86 Research and development expenses....... 709 6,363 7,072 Loss from operations.................... (1,443) (9,359) (10,802) Net loss applicable to common stockholders........................... (1,322) (9,310) (10,632) Basic and diluted net loss per common share.................................. (0.36) (1.76) Shares used in computing basic and diluted net loss per common share...... 3,655 5,291 Pro forma basic and diluted net loss per common share (unaudited)............... (0.37) Shares used in computing pro forma basic and diluted net loss per common share (unaudited)............................ 23,771 |
See Note 1 of the notes to financial statements for the determination of the number of shares used in computing net loss per share and pro forma net loss per share amounts.
The actual column in the following table presents actual summary balance sheet data as of December 31, 1999. The pro forma balance sheet data below reflects the sale of 3,571,429 shares of our stock in March 2000 for net proceeds of approximately $24.8 million. The pro forma as adjusted balance sheet data below also reflects the receipt of the net proceeds from the sale of shares of common stock offered by us at an assumed initial public offering price of $ per share, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. The pro forma and pro forma as adjusted columns below do not reflect the issuance of 1,000,000 shares of our common stock in April 2000.
December 31, 1999 ---------------------------------- Pro Pro Forma Actual Forma As Adjusted -------------- ------- ----------- (in thousands) (unaudited) Balance Sheet Data: Cash, cash equivalents and investments...... $18,933 $43,683 Working capital............................. 15,921 40,671 Total assets................................ 22,463 47,213 Equipment loan, net of current portion...... 189 189 189 Stockholders' equity........................ 20,728 45,478 |
RISK FACTORS
An investment in our shares is extremely risky. You should carefully consider the following risks, in addition to the other information presented in this prospectus, before deciding to buy our common stock. If any of the following risks actually occur, as well as other risks not mentioned here, our business and prospects could be seriously harmed, the price of our common stock could decline and you could lose all or part of your investment.
Risks Related to Our Business
We have not completed development of any of our pharmaceutical systems, and we cannot be certain that our pharmaceutical systems will be able to be commercialized
To be profitable, we must successfully research, develop, obtain regulatory approval for, manufacture, introduce, market and distribute our pharmaceutical systems under development. For each pharmaceutical system that we intend to commercialize, we must successfully meet a number of critical developmental milestones for each disease or medical condition that we target, including:
. selecting and developing drug delivery platform technology to deliver the proper dose of drug over the desired period of time;
. selecting and developing catheter technology, if appropriate, to deliver the drug to a specific location within the body;
. determining the appropriate drug dosage for use in the pharmaceutical system;
. developing drug compound formulations that will be safe, effective and compatible with the system; and
. demonstrating the drug formulation will be stable for commercially reasonable time periods.
The time frame necessary to achieve these developmental milestones for any individual product is long and uncertain, and we may not successfully complete these milestones for any of our products in development. For our lead product, DUROS sufentanil, we have not yet determined the drug dosages we intend to use for commercialization. We may not be able to develop dosages that will be safe and effective or compatible with the pharmaceutical system for a commercially reasonable treatment and storage period.
Development of pharmaceutical systems is costly and requires significant investment. In addition, we may choose to license either additional drug delivery platform technology or rights to particular drugs for use in our pharmaceutical systems. The license fees for these technologies or rights would increase the costs of our pharmaceutical systems.
We must conduct and satisfactorily complete clinical trials for our pharmaceutical systems
Before we can obtain government approval to sell any of our pharmaceutical
systems, we must demonstrate through preclinical (animal) studies and clinical
(human) trials that each system is safe and effective for human use for each
targeted disease. We have completed an initial Phase I clinical trial for our
lead product, DUROS sufentanil, using an external pump to test the safety of
continuous chronic infusion of the drug, and we plan to begin pharmacokinetic
studies and Phase II human clinical trials for this product in late 2000. We
plan to continue extensive and costly clinical trials to assess the safety and
effectiveness of DUROS sufentanil and our other potential products. We may not
be permitted to begin or continue our planned clinical trials for our potential
products or, if our trials are permitted, our potential products may not prove
to be safe or produce their intended effects.
The length of our clinical trials depends upon, among other factors, the rate of trial site and patient enrollment. We may fail to obtain adequate levels of patient enrollment in our clinical trials. Delays in planned patient enrollment may result in increased costs, delays or termination of clinical trials, which could have a material adverse effect on us. In addition, even if we enroll the number of patients we expect in the time frame we expect, our clinical trials may not provide the data necessary for their successful completion.
Additionally, we may fail to effectively oversee and monitor these clinical trials, which would result in increased costs or delays of our clinical trials. Even if these clinical trials are completed, we may fail to complete and submit a new drug application as scheduled. Even if we are able to submit a new drug application as scheduled, the Food and Drug Administration may not clear our application in a timely manner or may deny the application entirely.
Data already obtained from preclinical studies and clinical trials of our pharmaceutical systems do not necessarily predict the results that will be obtained from later preclinical studies and clinical trials. Moreover, preclinical and clinical data such as ours is susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials, even after promising results in earlier trials. The failure to adequately demonstrate the safety and effectiveness of a product under development could delay or prevent regulatory clearance of the potential product, resulting in delays to the commercialization of our products, and could materially harm our business. Our clinical trials may not demonstrate the sufficient levels of safety and efficacy necessary to obtain the requisite regulatory approvals for our products, and thus our products may not be approved for marketing.
Our agreement with ALZA limits our fields of operation for our DUROS-based pharmaceutical systems, requires us to spend significant funds on product development and gives ALZA a first right to distribute selected products for us
In April 1998, we entered into a development and commercialization agreement with ALZA Corporation, which was amended and restated in April 1999 and April 2000. This agreement gives us exclusive rights to develop, commercialize and manufacture products using ALZA's DUROS technology to deliver by catheter:
. drugs to the central nervous system to treat select nervous system disorders;
. drugs to the middle and inner ear;
. drugs to the pericardial sac of the heart; and
. select drugs into vascular grafts.
We also have the right to use the DUROS technology to deliver systemically and by catheter:
. sufentanil to treat chronic pain; and
. select cancer antigens.
We may not develop, manufacture or commercialize DUROS-based pharmaceutical systems outside of these specific fields without ALZA's prior approval. In addition, if we develop or commercialize any drug delivery technology for use in a manner similar to the DUROS technology in a field covered in our license agreement with ALZA, then we may lose our exclusive rights to use the DUROS technology in such field as well as the right to develop new products using DUROS technology in such field. Furthermore, to maintain our rights under this license agreement, we must spend at least $58.0 million to develop products in some or all of these fields through 2004. In order to maintain commercialization rights for our products in the U.S. and any foreign countries, we must diligently develop our products, procure required regulatory approvals and commercialize the products in these countries. If we fail to meet the various diligence requirements, we may:
. lose our rights to develop, commercialize and manufacture some of our DUROS-based pharmaceutical systems;
. lose rights for products in some or all countries, including the U.S.; or
. lose rights in some fields of use.
These rights would revert to ALZA, which could then develop DUROS-based pharmaceutical products in such countries or fields of use itself or license others to do so.
Our agreement with ALZA gives us the right to develop and manufacture the DUROS pump component of our pharmaceutical systems in the fields described above. In the event of a change in our corporate control, including an acquisition of us, our right to manufacture and develop the DUROS pump would terminate and ALZA would have the right to manufacture and develop DUROS systems for us so long as ALZA can meet our specification and supply requirements following such change in control.
Under the ALZA agreement, we must pay ALZA royalties on sales of DUROS- based pharmaceutical systems we commercialize. In addition, ALZA has an exclusive option to distribute our DUROS sufentanil product in the U.S. and Canada and any DUROS-based pharmaceutical system we develop to deliver non- proprietary cancer antigens worldwide. ALZA's option to acquire distribution rights limit our ability to negotiate with other distributors for these products and may result in lower payments to us than if these rights were subject to competitive negotiations.
Failure to obtain product approvals or comply with ongoing governmental regulations could delay or limit introduction of our new products and result in failure to achieve anticipated revenues
The manufacture and marketing of our products and our research and development activities are subject to extensive regulation for safety, efficacy and quality by numerous government authorities in the United States and abroad. Before receiving FDA clearance to market a product, we will have to demonstrate that the product is safe and effective on the patient population and for the diseases that will be treated. Clinical trials, manufacturing and marketing of products are subject to the rigorous testing and approval process of the FDA and equivalent foreign regulatory authorities. The Federal Food, Drug and Cosmetic Act and other federal, state and foreign statutes and regulations govern and influence the testing, manufacture, labeling, advertising, distribution and promotion of drugs and medical devices. As a result, clinical trials and regulatory approval can take a number of years to accomplish and require the expenditure of substantial resources. Data obtained from clinical trials are susceptible to varying interpretations, which could delay, limit or prevent regulatory clearances. As of the date of this prospectus, we have completed an initial Phase I clinical trial for our DUROS sufentanil product using an external pump to test the safety of continuous chronic infusion of the drug, but we have not begun Phase II or Phase III trials of any products. If we fail to obtain timely clearance or approval for our products, we will not be able to market and sell our products, which will limit our ability to generate revenue. See "Business-- Government Regulation."
In addition, we may encounter delays or rejections based upon additional government regulation from future legislation or administrative action or changes in FDA policy during the period of product development, clinical trials and FDA regulatory review. We may encounter similar delays in foreign countries. Sales of our products outside the U.S. are subject to foreign regulatory approvals that vary from country to country. The time required to obtain approvals from foreign countries may be shorter or longer than that required for FDA approval, and requirements for foreign licensing may differ from FDA requirements. We may be unable to obtain requisite approvals from the FDA and foreign regulatory authorities, and even if obtained, such approvals may not be on a timely basis, or they may not cover the clinical uses that we specify.
Marketing or promoting a drug for an unapproved use is subject to very strict controls. Furthermore, clearance may entail ongoing requirements for post-marketing studies. The manufacture and marketing of drugs are subject to continuing FDA and foreign regulatory review and requirements that we update our regulatory filings. Later discovery of previously unknown problems with a product, manufacturer or facility, or our failure to update regulatory files, may result in restrictions, including withdrawal of the product from the market. Any of the following events, if they were to occur, could delay or preclude us from further developing, marketing or realizing full commercial use of our products, which in turn would materially harm our business, financial condition and results of operations:
. failure to obtain or maintain requisite governmental approvals;
. failure to obtain approvals for clinically intended uses of our products under development; or
. identification of serious and unanticipated adverse side effects in our products under development.
Manufacturers of drugs also must comply with the applicable FDA good manufacturing practice regulations, which include production design controls, testing, quality control and quality assurance requirements as well as the corresponding maintenance of records and documentation. Compliance with current good manufacturing practices regulations is difficult and costly. Manufacturing facilities are subject to ongoing periodic inspection by the FDA and corresponding state agencies, including unannounced inspections, and must be licensed before they can be used for the commercial manufacture of our products. We or our present or future suppliers may be unable to comply with the applicable good manufacturing practice regulations and other FDA regulatory requirements. We have not been subject to a good manufacturing regulation inspection by the FDA or any state agency relating to our pharmaceutical systems. If we do not achieve compliance for the products we manufacture, the FDA may withdraw marketing clearance or require product recall, which may cause interruptions or delays in the manufacture and sale of our products.
Our limited operating history makes evaluating our stock difficult
You can only evaluate our business based on a limited operating history. We were incorporated in February 1998 and have engaged primarily in research and development, licensing technology, raising capital and recruiting scientific and management personnel. This short history may not be adequate to enable you to fully assess our ability to successfully develop our products, achieve market acceptance of our products and respond to competition.
Acceptance of our products in the marketplace is uncertain, and failure to achieve market acceptance will delay our ability to generate or grow revenues
Our future financial performance will depend upon the successful introduction and customer acceptance of our future products, including DUROS sufentanil. Even if approved for marketing, our products may not achieve market acceptance. The degree of market acceptance will depend upon a number of factors, including:
. the receipt of regulatory clearance of marketing claims for the uses that we are developing;
. the establishment and demonstration in the medical community of the safety and clinical efficacy of our products and their potential advantages over existing therapeutic products, including oral medication, transdermal drug delivery products such as drug patches, or external or implantable drug delivery products; and
. pricing and reimbursement policies of government and third-party payors such as insurance companies, health maintenance organizations and other health plan administrators.
Physicians, patients, payors or the medical community in general may be unwilling to accept, utilize or recommend any of our products. If we are unable to obtain regulatory approval, commercialize and market our future products when planned and achieve market acceptance, we will not achieve anticipated revenues.
We have a history of operating losses, expect to continue to have losses in the future and may never achieve or maintain profitability
We have incurred significant operating losses since our inception in 1998 and, as of December 31, 1999, had an accumulated deficit of approximately $10.6 million. We expect to continue to incur significant operating losses over the next several years as we continue to incur increasing costs for research and development, clinical trials and manufacturing. Our ability to achieve profitability depends upon our ability, alone or with others, to successfully complete the development of our proposed products, obtain the required regulatory clearances and manufacture and market our proposed products. To date, we have not generated significant revenue from the commercial sale of our products and do not expect to receive significant revenue in the near future. All revenues to date are from the sale of products we acquired in October 1999 in connection with the acquisition of substantially all of the assets of IntraEAR, Inc. and the ALZET product we acquired in April 2000 from ALZA. We do not expect these revenues to increase significantly in future periods. We do not anticipate commercialization and marketing of our products in development in the near future, and therefore do not expect to generate sufficient revenues to cover expenses or achieve profitability in the near future.
We do not control ALZA's ability to develop and commercialize DUROS technology outside of fields licensed to us, and problems encountered by ALZA could result in negative publicity, loss of sales and delays in market acceptance of our DUROS-based pharmaceutical systems
ALZA retains complete rights to the DUROS technology for fields outside the specific fields licensed to us. Accordingly, ALZA may develop and commercialize DUROS-based products or license others to do so, so long as there is no conflict with the rights granted to us. ALZA recently received FDA approval to market its first DUROS-based product, Viadur (leuprolide acetate implants) for the palliative treatment of advanced prostate cancer. If ALZA fails to commercialize this product successfully, or encounters problems associated with this product, negative publicity could be created about all DUROS-based products, which could result in harm to our reputation and cause reduced sales of our products. In addition, if any third-party that may be licensed by ALZA fails to develop and commercialize DUROS-based products successfully, the success of all DUROS-based systems could be impeded, including ours, resulting in delay or loss of revenue or damage to our reputation, any one of which could harm our business.
We do not own the trademark "DUROS" and any competitive advantage we derive from the name may be impaired by third-party use
ALZA owns the trademark "DUROS." Because ALZA is also developing and marketing DUROS-based systems, and may license third parties to do so, there may be confusion in the market between ALZA, its potential licensees and us, and this confusion could impair the competitive advantage, if any, we derive from use of the DUROS name. In addition, any actions taken by ALZA or its potential licensees that negatively impact the trademark "DUROS" could negatively impact our reputation and result in reduced sales of our DUROS- based pharmaceutical systems.
We may be sued by third parties which claim that our products infringe on their intellectual property rights, particularly because there is substantial uncertainty about the validity and breadth of medical patents
We may be exposed to future litigation by third parties based on claims that our products infringe the intellectual property rights of others or that we have misappropriated the trade secrets of others. This risk is exacerbated by the fact that the validity and breadth of claims covered in medical technology patents and the breadth and scope of trade secret protection involve complex legal and factual questions for which important legal principles are unresolved. Any litigation or claims against us, whether or not valid, could result in substantial costs, could place a significant strain on our financial resources and could harm our reputation. In addition, intellectual property litigation or claims could force us to do one or more of the following:
. cease selling, incorporating or using any of our products that incorporate the challenged intellectual property, which would adversely affect our revenue;
. obtain a license from the holder of the infringed intellectual property right, which license may be costly or may not be available on reasonable terms, if at all; or
. redesign our products, which would be costly and time-consuming.
If we are unable to adequately protect or enforce our intellectual property rights or secure rights to third-party patents, we may lose valuable assets, experience reduced market share or incur costly litigation to protect our rights
Our success will depend in part on our ability to obtain patents, maintain trade secret protection and operate without infringing the proprietary rights of others. We currently hold four issued or allowed U.S. patents and one issued or allowed foreign patent. In addition, we have 11 pending U.S. patent applications and have filed six corresponding patent applications under the Patent Cooperation Treaty, five of which are currently pending in Europe, Australia and Canada. To maintain the license rights to ALZA intellectual property granted to us under
our development and commercialization agreement with ALZA, we must meet annual minimum development spending requirements and develop a minimum number of products. If we do not meet these diligence requirements, we may lose rights to one or more of our licensed fields. Also, under our agreement with ALZA, we must assign any intellectual property rights relating to the DUROS technology to ALZA. In addition, ALZA retains the right to enforce and defend against infringement actions relating to DUROS technology, and if ALZA exercises these rights, it will be entitled to the proceeds of these infringement actions.
The patent positions of pharmaceutical companies, including ours, are uncertain and involve complex legal and factual questions. In addition, the coverage claimed in a patent application can be significantly reduced before the patent is issued. Consequently, our patent applications or those of ALZA may not issue into patents, and any issued patents may not provide protection against competitive technologies or may be held invalid if challenged or circumvented. Our competitors may also independently develop products similar to ours or design around or otherwise circumvent patents issued to us or licensed by us. In addition, the laws of some foreign countries may not protect our proprietary rights to the same extent as U.S. law.
We also rely upon trade secrets, technical know-how and continuing technological innovation to develop and maintain our competitive position. We require our employees, consultants, advisors and collaborators to execute appropriate confidentiality and assignment-of-inventions agreements with us. These agreements typically provide that all materials and confidential information developed or made known to the individual during the course of the individual's relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances, and that all inventions arising out of the individual's relationship with us shall be our exclusive property. These agreements may be breached, and in some instances, we may not have an appropriate remedy available for breach of the agreements. Furthermore, our competitors may independently develop substantially equivalent proprietary information and techniques, reverse engineer our information and techniques, or otherwise gain access to our proprietary technology. We may be unable to meaningfully protect our rights in trade secrets, technical know-how and other non-patented technology.
We may have to resort to litigation to protect our intellectual property rights, or to determine their scope, validity or enforceability. Enforcing or defending our proprietary rights is expensive, could cause diversion of our resources and may not prove successful. Any failure to enforce or protect our rights could cause us to lose the ability to exclude others from using our technology to develop or sell competing products.
We rely heavily on third parties and do not control critical steps in the manufacturing and testing of our products
We currently depend heavily and will depend heavily in the future on third parties for support in manufacturing and clinical testing. We have an agreement with Chesapeake Biological Labs, Inc. for the final manufacturing steps of our DUROS sufentanil product to deliver product quantities that we expect we will need for Phase II clinical trials of this product. The steps to be performed by Chesapeake include filling the DUROS system with the sufentanil drug formulation in a sterile environment, sterilization and final product testing. Manufacturing DUROS sufentanil, including the manufacturing steps performed by Chesapeake, is a complex process, and Chesapeake may not be able to provide sufficient quantities of DUROS sufentanil within an acceptable time frame. Failure by Chesapeake to do so could delay clinical trials of our products and result in delays in regulatory approval and commercialization of our products, either of which would materially harm our business.
We have a master services agreement with Quintiles, Inc. under which we may engage Quintiles to provide services related to clinical trials for our pharmaceutical systems, at terms to be agreed to and specified in subsequent work orders. We may be unable to negotiate the terms of these work orders with Quintiles. If we are unable to agree to terms, we will need to establish commercial relationships with a different third party, or perform these services ourselves, either of which could materially delay the development and approval of our products and increase our expenses. If we do negotiate work orders with Quintiles, Quintiles may be unable to manage these trials to completion in the time periods or at the costs we expect. Failure of Quintiles to do so could materially harm our business, financial condition and results of operations.
Key components of our DUROS-based pharmaceutical systems are provided by sole or limited numbers of suppliers, and supply shortages or loss of these suppliers could result in interruptions in supply or increased costs
Certain components used in our DUROS-based pharmaceutical systems are currently purchased from a single or a limited number of outside sources. The reliance on a sole or limited number of suppliers could result in:
. delays associated with redesigning a product due to a failure to obtain a single source component;
. an inability to obtain an adequate supply of required components; and
. reduced control over pricing, quality and timely delivery.
We do not have long-term agreements with any of our suppliers, and therefore the supply of a particular component could be terminated at any time without penalty to the supplier. Any interruption in the supply of single source components could cause us to seek alternative sources of supply or manufacture these components internally. If the supply of any components for our pharmaceutical systems is interrupted, components from alternative suppliers may not be available in sufficient volumes within required timeframes, if at all, to meet our needs. This could delay our ability to complete clinical trials and obtain approval for commercialization and marketing of our products, causing us to lose sales, incur additional costs and delay new product introductions and could harm our reputation.
We have limited manufacturing experience and may not be able to manufacture sufficient quantities of our products at an acceptable cost
We must manufacture our products in clinical and commercial quantities, either directly or through third parties, in compliance with regulatory requirements and at an acceptable cost. We do not own manufacturing facilities necessary to provide clinical and commercial quantities of our products. We currently manufacture sub-assemblies of our DUROS-based pharmaceutical systems and rely on Chesapeake Biological Labs, Inc. to complete the final manufacturing steps of these products. See "Risk Factors--We rely heavily on third parties and do not control critical steps in the manufacturing and testing of our products." Under our agreement with ALZA, we cannot subcontract the manufacture of subassemblies of the DUROS system.
Prior to obtaining regulatory approval of our products under development, we intend to build a manufacturing facility that will enable us to manufacture commercial quantities of our DUROS-based pharmaceutical systems, as well as to manufacture additional products in development on a pilot scale and our own clinical trial supplies. The manufacture of our DUROS-based pharmaceutical systems is a complex process, and any facility that we build must comply with federal and state good manufacturing practices regulations. DURECT has no experience building facilities, and we may not be able to build a facility prior to clinical approval of our products or at currently anticipated costs. If we build a facility, we will be subject to government audits to determine compliance with good manufacturing practices regulations, and we may be unable to obtain and maintain certifications for complying with these regulations. If we fail to build a manufacturing facility before regulatory approval of our products or at currently anticipated costs, or fail to obtain and maintain certification for compliance with good manufacturing practices regulation, we could experience a delay in the commercial sale of our DUROS-based pharmaceutical systems.
In April 2000, we acquired the ALZET product and related assets from ALZA. We intend to manufacture the ALZET product at a leased facility. We have limited experience manufacturing this product, and we may not be able to successfully or consistently manufacture this product at an acceptable cost, if at all.
We lack marketing, sales and distribution experience for pharmaceutical systems and we may not be able to sell our products if we do not enter into relationships with third parties or develop a direct sales organization
We have yet to establish marketing, sales or distribution capabilities for our pharmaceutical systems. We intend to enter into agreements with third parties to sell our products or to develop our own sales and marketing
force. We may be unable to establish or maintain third-party relationships on a commercially reasonable basis, if at all. In addition, these third parties may have similar or more established relationships with our competitors.
If we do not enter into relationships with third parties for the sales and marketing of our products, we will need to develop our own sales and marketing capabilities. DURECT has only limited experience in developing, training or managing a sales force. If we choose to establish a direct sales force, we will incur substantial additional expenses in developing, training and managing such an organization. We may be unable to build a sales force, the cost of establishing such a sales force may exceed our product revenues, or our direct marketing and sales efforts may be unsuccessful. In addition, we compete with many other companies that currently have extensive and well- funded marketing and sales operations. Our marketing and sales efforts may be unable to compete successfully against these other companies. We may be unable to establish a sufficient sales and marketing organization on a timely basis, if at all.
We may be unable to engage qualified distributors. Even if engaged, these distributors may:
. fail to satisfy financial or contractual obligations to us;
. fail to adequately market our products;
. cease operations with little or no notice to us; or
. offer, design, manufacture or promote competing product lines.
If we fail to develop sales, marketing and distribution channels, we would experience delays in product sales and incur increased costs, which would harm our financial results.
If we are unable to train physicians to use our pharmaceutical systems to treat patients' diseases or medical conditions, we may incur delays in market acceptance of our products
Broad use of our pharmaceutical systems will require extensive training of numerous physicians. The time required to begin and complete training of physicians could delay introduction of our products and adversely affect market acceptance of our products. We may be unable to rapidly train physicians in numbers sufficient to generate adequate demand for our pharmaceutical systems. Any delay in training would materially delay the demand for our systems. In addition, we may expend significant funds towards such training before any orders are placed for our products.
We may have difficulty raising needed capital in the future
Our business currently does not generate sufficient revenues to meet our capital requirements and we do not expect that it will do so in the near future. We have expended and will continue to expend substantial funds to complete the research, development and clinical testing of our products. We will require additional funds for these purposes, to establish additional clinical- and commercial-scale manufacturing arrangements and to provide for the marketing and distribution of our products. Additional funds may not be available on acceptable terms, if at all. If adequate funds are unavailable from operations or additional sources of financing, we may have to delay, reduce the scope of or eliminate one or more of our research or development programs which would materially harm our business, financial condition and results of operations.
We believe that the net proceeds of this offering, together with our cash, cash equivalents and investments, will be adequate to satisfy our capital needs for at least the next 18 months. However, our actual capital requirements will depend on many factors, including:
. continued progress and cost of our research and development programs;
. progress with preclinical studies and clinical trials;
. the time and costs involved in obtaining regulatory clearance;
. costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims;
. costs of developing sales, marketing and distribution channels and our ability to sell our products;
. costs involved in establishing manufacturing capabilities for commercial quantities of our products;
. competing technological and market developments;
. market acceptance or our products; and
. costs for recruiting and retaining employees and consultants.
We may consume available resources more rapidly than currently anticipated, resulting in the need for additional funding. We may seek to raise any necessary additional funds through equity or debt financings, collaborative arrangements with corporate partners or other sources, which may be dilutive to existing stockholders. In addition, in the event that additional funds are obtained through arrangements with collaborative partners or other sources, we may have to relinquish rights to some of our technologies, product candidates or products under development that we would otherwise seek to develop or commercialize ourselves. If adequate funds are not available, we may be required to significantly reduce or refocus our product development efforts, or relinquish to ALZA rights to develop DUROS products in certain fields, resulting in loss of sales, increased costs, and reduced revenues.
We may acquire technologies and businesses which may be difficult to integrate, disrupt our business, dilute stockholder value or divert management attention
We may acquire technologies, products or businesses to broaden the scope of our existing and planned product lines and technologies. For example, in October 1999, we acquired substantially all of the assets of IntraEAR, Inc. and in April 2000 we acquired the ALZET product and related assets from ALZA. These and other acquisitions expose us to:
. the risks associated with the assimilation of new technologies, operations, sites and personnel;
. the diversion of resources from our existing business and technologies;
. the inability to generate revenues to offset associated acquisition costs;
. the requirement to maintain uniform standards, controls, and procedures; and
. the impairment of relationships with employees and customers as a result of any integration of new management personnel.
Acquisitions may also result in the issuance of dilutive equity securities, the incurrence or assumption of debt or additional expenses associated with the amortization of acquired intangible assets or potential businesses. Past acquisitions, such as our acquisitions of IntraEAR and ALZET, as well future acquisitions, may not generate any additional revenue or provide any benefit to our business.
We depend upon key personnel who may terminate their employment with us at any time, and we need to hire additional qualified personnel
Our success will depend to a significant degree upon the continued services of key management, technical, and scientific personnel, including Felix Theeuwes, our Chairman and Chief Scientific Officer and James E. Brown, our President and Chief Executive Officer. In addition, our success will depend on our ability to attract and retain other highly skilled personnel. Competition for qualified personnel is intense, and the process of hiring and integrating such qualified personnel is often lengthy. We may be unable to recruit such personnel on a timely basis, if at all. Our management and other employees may voluntarily terminate their employment with us at any time. The loss of the services of key personnel, or the inability to attract and retain additional qualified personnel, could result in delays to product development or approval, loss of sales and diversion of management resources.
We may not successfully manage our growth
Our success will depend on the expansion of our operations and the effective management of growth, which will place a significant strain on our management and on our administrative, operational and financial resources.
To manage such growth, we must expand our facilities, augment our operational, financial and management systems and hire and train additional qualified personnel. If we are unable to manage growth effectively our business would be harmed.
Risks Related to Our Industry
The market for our products is new, rapidly changing and competitive, and new products or technologies developed by others could impair our ability to grow our business and remain competitive
The pharmaceutical industry is subject to rapid and substantial technological change. Developments by others may render our products under development or technologies noncompetitive or obsolete, or we may be unable to keep pace with technological developments or other market factors. Technological competition in the industry from pharmaceutical and biotechnology companies, universities, governmental entities and others diversifying into the field is intense and is expected to increase. Many of these entities have significantly greater research and development capabilities than we do, as well as substantially more marketing, manufacturing, financial and managerial resources. These entities represent significant competition for us. Acquisitions of, or investments in, competing pharmaceutical or biotechnology companies by large corporations could increase such competitors' financial, marketing, manufacturing and other resources.
We are a new enterprise and are engaged in the development of novel therapeutic technologies. As a result, our resources are limited and we may experience technical challenges inherent in such novel technologies. Competitors have developed or are in the process of developing technologies that are, or in the future may be, the basis for competitive products. Some of these products may have an entirely different approach or means of accomplishing similar therapeutic effects than our products. Our competitors may develop products that are safer, more effective or less costly than our products and, therefore, present a serious competitive threat to our product offerings.
The widespread acceptance of therapies that are alternatives to ours may limit market acceptance of our products even if commercialized. Chronic pain can also be treated by oral medication, transdermal drug delivery systems, such as drug patches, or with other implantable drug delivery devices. These treatments are widely accepted in the medical community and have a long history of use. The established use of these competitive products may limit the potential for our products to receive widespread acceptance if commercialized.
If users of our products are unable to obtain adequate reimbursement from third-party payors, or if new restrictive legislation is adopted, market acceptance of our products may be limited and we may not achieve anticipated revenues
The continuing efforts of government and insurance companies, health maintenance organizations and other payors of healthcare costs to contain or reduce costs of health care may affect our future revenues and profitability, and the future revenues and profitability of our potential customers, suppliers and collaborative partners and the availability of capital. For example, in certain foreign markets, pricing or profitability of prescription pharmaceuticals is subject to government control. In the United States, given recent federal and state government initiatives directed at lowering the total cost of health care, the U.S. Congress and state legislatures will likely continue to focus on health care reform, the cost of prescription pharmaceuticals and on the reform of the Medicare and Medicaid systems. While we cannot predict whether any such legislative or regulatory proposals will be adopted, the announcement or adoption of such proposals could materially harm our business, financial condition and results of operations.
Our ability to commercialize our products successfully will depend in part on the extent to which appropriate reimbursement levels for the cost of our products and related treatment are obtained by governmental authorities, private health insurers and other organizations, such as HMOs. Third-party payors are increasingly challenging the prices charged for medical products and services. Also, the trend toward managed health care in
the United States and the concurrent growth of organizations such as HMOs, which could control or significantly influence the purchase of health care services and products, as well as legislative proposals to reform health care or reduce government insurance programs, may all result in lower prices for or rejection of our products. The cost containment measures that health care payors and providers are instituting and the effect of any health care reform could materially harm our ability to operate profitably.
We could be exposed to significant product liability claims which could be time consuming and costly to defend, divert management attention and adversely impact our ability to obtain and maintain insurance coverage
The testing, manufacture, marketing and sale of our products involve an inherent risk that product liability claims will be asserted against us. Although we are insured against such risks up to a $5,000,000 annual aggregate limit in connection with clinical trials and commercial sales of our products, our present product liability insurance may be inadequate and may not fully cover the costs of any claim or any ultimate damages we might be required to pay. Product liability claims or other claims related to our products, regardless of their outcome, could require us to spend significant time and money in litigation or to pay significant damages. Any successful product liability claim may prevent us from obtaining adequate product liability insurance in the future on commercially desirable or reasonable terms. In addition, product liability coverage may cease to be available in sufficient amounts or at an acceptable cost. An inability to obtain sufficient insurance coverage at an acceptable cost or otherwise to protect against potential product liability claims could prevent or inhibit the commercialization of our pharmaceutical systems. A product liability claim could also significantly harm our reputation and delay market acceptance of our products.
Our business involves environmental risks and risks related to handling controlled substances
In connection with our research and development activities and our manufacture of materials and products, we are subject to federal, state and local laws, rules, regulations and policies governing the use, generation, manufacture, storage, air emission, effluent discharge, handling and disposal of certain materials, biological specimens and wastes. Although we believe that we have complied with the applicable laws, regulations and policies in all material respects and have not been required to correct any material noncompliance, we may be required to incur significant costs to comply with environmental and health and safety regulations in the future. Our research and development involves the controlled use of hazardous materials, including but not limited to certain hazardous chemicals and narcotics. Although we believe that our safety procedures for storing, handling and disposing of such materials comply with the standards prescribed by state and federal regulations, we cannot completely eliminate the risk of accidental contamination or injury from these materials. In the event of such an occurrence, we could be held liable for any damages that result and any such liability could exceed our resources.
Risks Related to this Offering
Our stock price will fluctuate after this offering, and your investment in our stock could decline in value
After this offering, an active trading market in our stock might not develop or continue. If you purchase shares of our common stock in the offering, you will pay a price that was not established in a competitive market. Rather, you will pay a price that we negotiated with the representatives of the underwriters based upon an assessment of the valuation of our stock. The public market may not agree with or accept this valuation, in which case you may not be able to sell your shares at or above the initial offering price. See "Underwriters." The market price of our common stock may fluctuate significantly in response to factors which are beyond our control.
In addition, the stock market in general has recently experienced extreme price and volume fluctuations. In addition, the market prices of securities of technology and pharmaceutical companies have been extremely volatile, and have experienced fluctuations that often have been unrelated or disproportionate to the operating performance of these companies. These broad market fluctuations could result in extreme fluctuations in the price of our common stock, which could cause a decline in the value of your shares.
Future sales of our common stock may depress our stock price
As many as 23,863,617 shares of our common stock can be sold in the public market 180 days after the offering. If substantial amounts of our common stock were to be sold in the public market following this offering, the market price of our common stock could fall. In addition, these sales could create the perception to the public of difficulties or problems in our business. As a result, these sales also might make it more difficult for us to sell equity or equity-related securities in the future at a time and price that we deem appropriate. For a more detailed discussion of shares eligible for sale after the offering, see "Shares Eligible for Future Sale."
We have broad discretion to use the offering proceeds, and the investment of these proceeds may not yield a favorable return
Our management has broad discretion over how these proceeds are used and could spend most of these proceeds in ways with which our stockholders may not agree. The proceeds may be invested in ways that do not yield favorable returns. See "Use of Proceeds" for more information about how we plan to use our proceeds from this offering.
Executive officers, directors and entities affiliated with them will continue to have substantial control over us after the offering, which could delay or prevent a change in our corporate control favored by our other stockholders
After this offering, our directors, executive officers and principal stockholders, together with their affiliates, will beneficially own, in the aggregate, approximately % of our outstanding common stock following the completion of this offering, % if the overallotment option is exercised in full. In particular, our executive officers will control approximately % of our common stock after this offering, % if the overallotment option is exercised in full. The interests of these stockholders may differ from the interests of other stockholders. As a result, these stockholders, if acting together, would have the ability to exercise control over all corporate actions requiring stockholder approval irrespective of how our other stockholders may vote, including:
. the election of directors;
. the amendment of charter documents;
. the approval of certain mergers and other significant corporate transactions, including a sale of substantially all of our assets; or
. the defeat of any non-negotiated takeover attempt that might otherwise benefit the public stockholders.
Our certificate of incorporation, our bylaws and Delaware law contain provisions that could discourage another company from acquiring us
Provisions of Delaware law, our certificate of incorporation and by-laws may discourage, delay or prevent a merger or acquisition that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares. These provisions include:
. authorizing the issuance of "blank check" preferred stock without any need for action by stockholders;
. providing for a classified board of directors with staggered terms;
. requiring supermajority stockholder voting to effect certain amendments to our certificate of incorporation and by-laws;
. eliminating the ability of stockholders to call special meetings of stockholders;
. prohibiting stockholder action by written consent; and
. establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on by stockholders at stockholder meetings.
See "Management--Board Composition" and "Description of Capital Stock-- Delaware Anti-Takeover Law and Provisions of our Certificate of Incorporation and Bylaws."
Purchasers in this offering will experience immediate and substantial dilution of their investment
We expect that the initial public offering price per share will significantly exceed the net tangible book value per share of the outstanding common stock. Accordingly, purchasers of common stock in this offering will suffer immediate and substantial dilution of their investment. In the past, we have issued options to acquire common stock at prices below the initial public offering price. To the extent these outstanding options are ultimately exercised, there will be further dilution to investors in this offering.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Some of the statements under "Prospectus Summary," "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations," "Business," and elsewhere in this prospectus are forward-looking statements. These statements involve known and unknown risks, uncertainties, and other factors that may cause our or our industry's actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by forward-looking statements. Such factors include, among other things, those listed under "Risk Factors" and elsewhere in this prospectus.
In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential," or "continue" or the negative of these terms or other comparable terminology. You should read statements that contain these words carefully, because they discuss our expectations about our future operating results or our future financial condition or state other "forward-looking" information. There may be events in the future that we are not able to accurately predict or control. Before you invest in our common stock, you should be aware that the occurrence of any of the events described in these risk factors and elsewhere in this prospectus could substantially harm our business, results of operations and financial condition, and that upon the occurrence of any of these events, the trading price of our common stock could decline and you could lose all or part of your investment.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, growth rates, levels of activity, performance, or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of these statements. We are under no duty to update any of the forward-looking statements after the date of this prospectus to conform these statements to actual results.
USE OF PROCEEDS
The net proceeds from the sale of the shares of common stock in this offering are estimated to be approximately $ million, based upon an assumed initial public offering price of $ per share and after deducting |
estimated underwriting discounts and commissions and our estimated offering expenses. If the underwriters' over-allotment option is exercised in full, the net proceeds would be approximately $ million.
We currently intend to use the net proceeds from this offering to fund the research, development, manufacture and commercialization of existing and future products and for general corporate purposes, including working capital and capital expenditures. We may use a portion of the net proceeds to fund, acquire or invest in complementary businesses or technologies, although we have no present commitments with respect to any acquisition or investment. The amount of cash that we actually expend for any of the described purposes will vary significantly based on a number of factors, including the progress of our research and development programs and clinical trials, the establishment of collaborative relationships, the cost and pace of establishing and expanding our manufacturing capabilities, the development of sales and marketing activities if undertaken by us and competing technological and market developments. Our management will have significant discretion in applying the net proceeds of this offering. Pending the uses described above, we will invest the net proceeds in investment-grade, interest-bearing securities.
DIVIDEND POLICY
We have never declared or paid any cash dividends on our common stock or other securities and do not intend to pay any cash dividends with respect to our common stock in the foreseeable future. We intend to retain any earnings for use in the operation of our business and to fund future growth. The terms of our credit agreement prohibit the payment of dividends on our stock (except for dividends payable solely in stock) without prior written consent.
CAPITALIZATION
The following table sets forth our total capitalization as of December 31, 1999 on an actual basis, on a pro forma basis to reflect the sale of 3,571,429 shares of our Series C preferred stock in March 2000 for net proceeds of approximately $24.8 million, the issuance of 1,000,000 shares of our common stock in April 2000, and the conversion of all outstanding shares of preferred stock into 27,502,660 shares of common stock upon the completion of this offering, and on a pro forma as adjusted basis to reflect the application by us of the estimated net proceeds from the sale of the shares of common stock in this offering at the initial public offering price of $ per share after deducting estimated underwriting discounts and commissions and our estimated offering expenses.
You should read this table in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of Operations" and the consolidated financial statements and related notes to the financial statements.
December 31, 1999 ------------------------------------ Pro Forma Actual Pro Forma As Adjusted -------- -------------- ----------- (in thousands) (unaudited) Equipment Loan, noncurrent portion........ $ 189 $ 189 $ 189 -------- -------- -------- Stockholders' equity: Preferred stock, $0.0001 par value; 24,242 shares authorized, 23,931 shares issued and outstanding, actual; shares authorized, no shares issued and outstanding pro forma; shares authorized, no shares issued or outstanding, pro forma as adjusted..... 2 -- -- Common stock, $0.0001 par value: 41,542 shares authorized, 8,502 shares issued and outstanding actual; shares authorized, 37,005 shares issued and outstanding pro forma; shares authorized, shares issued and outstanding, pro forma as adjusted..... 1 3 Additional paid-in capital................ 34,642 66,392 Notes receivable from stockholders........ (33) (33) (33) Deferred stock compensation............... (3,252) (3,252) (3,252) Deficit accumulated during the development stage.................................... (10,632) (10,632) (10,632) -------- -------- -------- Total stockholders' equity.............. 20,728 52,478 -------- -------- -------- Total capitalization.................. $ 22,463 $ 52,667 $ ======== ======== ======== |
The number of shares of common stock shown as outstanding in the table above excludes the following:
. 1,605,000 shares of common stock issuable upon the exercise of options outstanding December 31, 1999 with a weighted-average exercise price of $0.23 per share;
. 296,500 shares reserved for issuance under our 1998 Stock Option Plan at December 31, 1999;
. 31,395 shares of common stock issuable upon the exercise of a warrant outstanding at December 31, 1999, with an exercise price of $2.15 per share; and
. 1,000,000 shares of common stock issuable upon the exercise of a warrant issued in April 2000 with an exercise price equal to the price at which our common stock is sold in this offering.
DILUTION
Our pro forma net tangible book value as of December 31, 1999 was approximately $44.1 million, or $1.22 per share of common stock. Pro forma net tangible book value per share represents our pro forma stockholders' equity less intangible assets divided by the pro forma number of shares of common stock outstanding after giving effect to the sale of 3,571,429 shares of our Series C preferred stock in March 2000 for net proceeds of approximately $24.8 million and the conversion of all outstanding shares of preferred stock into 27,502,660 shares of common stock. Pro forma net tangible book value per share does not reflect the issuance of 1,000,000 shares of our common stock in April 2000 and the issuance of a warrant to purchase 1,000,000 shares of our common stock in April 2000. Dilution per share represents the difference between the amount per share paid by purchasers of shares of common stock in this offering and the pro forma net tangible book value per share of common stock immediately after completion of this offering. After giving effect to the sale of shares of common stock offered by us, at an assumed initial public offering price of $ per share and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us, and the application of the estimated net proceeds, our pro forma net tangible book value at December 31, 1999 would have been $ million, or $ per share. This represents an immediate increase in pro forma net tangible book value to existing stockholders of $ per share and an immediately dilution to new investors of $ per share. The following table illustrates the per share dilution:
Assumed initial public offering price per share..................... $ ----- Pro forma net tangible book value per share as of December 31, 1999............................................................. ---- Increase per share attributable to new investors.................. ---- Pro forma net tangible book value per share after this offering..... ----- Dilution per share to new public investors.......................... $ ===== |
The following table sets forth as of December 31, 1999, on the pro forma basis described above, the number of shares of common stock purchased from us, the total consideration paid and the average price per share paid by existing stockholders and by the new investors purchasing shares of common stock in this offering, before deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us:
Shares Purchased Total Consideration ------------------ ------------------- Average Price Number Percent Amount Percent Per Share ---------- ------- ----------- ------- ------------- Existing stockholders..... 36,004,660 % $55,988,000 % $1.56 New public investors...... ---------- ----- ----------- ------- ----- Totals.................. 100.0% $ 100.0% ========== ===== =========== ======= ===== |
The above discussion and tables assume no exercise of any options or warrants to purchase our capital stock. As of March 31, 2000, there were options outstanding to purchase a total of 738,350 shares of common stock, with a weighted average exercise price of $0.45 per share, and a warrant to purchase a total of 31,395 shares of common stock, with an exercise price of $2.15 per share. In addition, in April 2000 we issued to ALZA a warrant to purchase a total of 1,000,000 shares of our common stock, with an exercise price equal to the price per share at which our common stock is sold in this offering. To the extent that any of the outstanding options or warrants are exercised, there will be further dilution to new public investors.
SELECTED FINANCIAL AND OPERATING DATA
The following selected financial and operating data should be read in conjunction with and are qualified by reference to "Management's Discussion and Analysis of Financial Condition and Results of Operations" and our financial statements and related notes, which are included elsewhere in this prospectus. The statement of operations data for the period from inception (February 6, 1998) to December 31, 1998, the year ended December 31, 1999 and the period from inception (February 6, 1998) to December 31, 1999 and the balance sheet data at December 31, 1999 are derived from, and are qualified by reference to, the audited financial statements included elsewhere in this prospectus. Historical operating results are not necessarily indicative of results in the future, and the results for interim periods are not necessarily indicative of the results that may be expected for the entire year. See Note 1 of notes to financial statements for an explanation of the determination of the shares used in computing net loss per share and pro forma net loss per share amounts.
Period from Period from inception inception (February 6, 1998) (February 6, 1998) to Fiscal Year Ended to December 31, 1998 December 31, 1999 December 31, 1999 ------------------ ----------------- ------------------- (in thousands, except per share data) Consolidated Statement of Operations Data: Revenue, net............ $ -- $ 86 $ 86 Costs of goods sold..... -- 39 39 ------- ------- -------- Gross margin............ -- 47 47 ------- ------- -------- Operating costs and expenses: Research and development.......... 466 5,181 5,647 Research and development to related party........ 243 1,182 1,425 Selling, general and administrative....... 585 2,178 2,763 Stock-based compensation......... 149 865 1,014 ------- ------- -------- Total operating expenses........... 1,443 9,406 10,849 ------- ------- -------- Loss from operations......... (1,443) (9,359) (10,802) Interest income......... 121 678 799 Interest expense........ -- (27) (27) ------- ------- -------- Net loss............ (1,322) (8,708) (10,030) Accretion of cumulative dividend on Series B convertible preferred stock.................. -- 602 602 Net loss applicable to common stockholders.... $(1,322) $(9,310) $(10,632) ======= ======= ======== Basic and diluted net loss per common share.. $ (0.36) $ (1.76) Shares used in computing basic and diluted net loss per common share.. 3,655 5,291 Pro forma basic and diluted net loss per common share (unaudited)............ $ (0.37) Shares used in computing pro forma basic and diluted net loss per common share (unaudited)............ 23,771 As of December 31, ------------------------------------ 1998 1999 ------------------ ----------------- Balance Sheet Data: Cash, cash equivalents and investments........ $ 7,975 $18,933 Working capital......... 7,664 15,921 Total assets............ 8,283 22,463 Equipment loan, net of current portion........ 83 189 Stockholders' equity.... 7,749 20,728 |
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 in conjunction with "Selected Financial Data" and our financial statements and related notes appearing elsewhere in this prospectus. 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 a result of certain factors, including, but not limited to, those set forth under "Risk Factors" and elsewhere in this prospectus.
Overview
DURECT Corporation is pioneering the treatment of chronic diseases and conditions by developing and commercializing pharmaceutical systems to deliver the right drug to the right place in the right amount at the right time. These capabilities can enable new drug therapies or optimize existing therapies based on a broad range of compounds, including small molecule pharmaceuticals as well as biotechnology molecules such as proteins, peptides and genes.
From our inception in February 1998 through December 31, 1998, we were engaged in negotiating a licensing agreement with ALZA Corporation to gain specified rights to use its DUROS system, raising capital, recruiting scientific and management personnel and commencing research and development activities. In late 1998, we filed an investigational new drug application relating to our first product, DUROS sufentanil, a DUROS-based pharmaceutical system for the treatment of chronic pain. In 1999, we began a Phase I clinical trial for DUROS sufentanil using an external pump to test the safety of continuous chronic infusion of this drug, initiated the development of a spinal hydromorphone product, and initiated the research and development of other products based on the DUROS system. Through December 31, 1999, we financed operations primarily through the sale of private equity securities, resulting in net proceeds of approximately $28.2 million.
We have incurred significant net losses and negative cash flows from operations since our inception. As of December 31, 1999, we had an accumulated deficit of $10.6 million.
Our expenses have primarily been the result of research and development activities, and general and administrative costs associated with our operations. We expect our research and development expenses to increase in the future as we expand clinical trials and research and development activities. To support these activities, we also expect to expand our infrastructure. We do not anticipate revenues from our pharmaceutical systems, should they be approved, for at least several years. We also expect to incur substantial non- cash expenses relating to stock-based compensation. As a result of these factors, we expect to incur significant losses and negative cash flow for the foreseeable future.
In October 1999, we acquired substantially all of the assets of IntraEAR, Inc, a developer and marketer of catheters that permit controlled fluid delivery to the round window membrane of the ear for the treatment of ear disorders. The total purchase price consisted of 325,023 shares of Series B-1 preferred stock and $320,000 in cash. The acquisition was accounted for using the purchase method of accounting. As a result of this acquisition, we recorded approximately $1.5 million of intangible assets, which will be amortized over 2 to 6 years. From the time of the acquisition through December 31, 1999, our sales of catheters resulted in revenues of $86,000. We do not anticipate that revenues derived from catheter sales will increase significantly in the near future. In the future, we may research and develop products that incorporate technology acquired from IntraEAR.
In April 2000, we acquired from ALZA the ALZET product and assets used primarily in the manufacture, sale and distribution of this product. This acquisition provides us with an ongoing business making and selling this product worldwide. The total purchase price consisted of approximately $8.2 million in cash, including approximately $3.2 million of inventory, of which $2.4 million is to be paid over twelve months. The acquisition will be accounted for using the purchase method.
In April 2000, we amended our development and commercialization agreement with ALZA. The amendments included a reduction in product royalties and upfront payments to ALZA by us under the agreement. In addition, ALZA's option to distribute the DUROS sufentanil product was amended to cover only the U.S. and Canada instead of worldwide. As consideration, ALZA received 1,000,000 shares of our common stock and a warrant to purchase 1,000,000 shares of our common stock at an exercise price equal to the price at which our common stock is sold in this offering.
Limited Operating History
We have a limited history of operations and anticipate that our quarterly results of operations will fluctuate for the foreseeable future. We believe that period-to-period comparisons of our operating results should not be relied upon as predictive of future performance. Our prospects must be considered in light of the risks, expenses and difficulties encountered by companies at an early stage of development, particularly companies in new and rapidly evolving markets such as pharmaceuticals, drug delivery, and biotechnology. To address these risks, we must, among other things, obtain regulatory approval for and commercialize our products, which may not occur. We may not be successful in addressing these risks and difficulties. We may require additional funds to complete the development of our products and to fund operating losses to be incurred in the next several years.
Results of Operations
Year ended December 31, 1999 compared to the period from inception (February 6, 1998) to December 31, 1998
Revenue. Following the acquisition of substantially all of the assets of IntraEAR, Inc. on October 1, 1999, we began selling catheters that permit controlled fluid delivery to the inner ear for the treatment of ear disorders. Since this acquisition, we have derived revenues from these products of approximately $86,000. In the near future, we do not anticipate that revenues derived from these products will increase significantly.
Research and Development. Research and development expenses consist of salaries and related expenses for research and development personnel, contract research and development services, supplies and a portion of overhead operating expenses. Research and development expenses increased to approximately $6.4 million in 1999 from approximately $709,000 in 1998. The increase was attributable to increases in contract research and development services, research and development personnel and clinical activity for our Phase I trial relating to DUROS sufentanil. In 1999, research and development activities were initiated in other product areas. We expect research and development expenses to increase significantly as we enter Phase II clinical trials for DUROS sufentanil, continue to hire research and development personnel, and develop other products.
In addition, we expect research and development expenses to continue to increase in order to meet minimum product funding requirements under our license agreement with ALZA. To maintain our rights under this agreement, we must spend minimum amounts each year on product development, with the amount and duration of funding in each field varying over time. For our two products currently in development, we are required to fund each in the amount of at least $3 million per year until the time of commercialization. Funding requirements to maintain rights to additional products begin in 2001. The future minimum annual product funding requirements for all fields of use are as follows:
(in thousands) Year ended December 31, -------------- 2000.................................................... $ 6,000 2001.................................................... 8,000 2002.................................................... 13,000 2003.................................................... 14,000 2004*................................................... 17,000 ------- Total minimum funding required.......................... $58,000 ======= |
Selling, General and Administrative. Selling, general and administrative expenses consist primarily of salaries and related expenses for administrative, finance, sales and executive personnel, legal, accounting and other professional fees and overhead operating expenses. Selling, general and administrative expenses increased to approximately $2.2 million in 1999 from approximately $585,000 in 1998. The increase was primarily due to an increase in selling, general and administrative personnel and infrastructure to support our growth and other related expenses. We expect general and administrative expenses to continue to increase as we increase the number of personnel and related resources required to support our growth.
Stock-Based Compensation. Stock-based compensation expense was $149,000 for the period from inception (February 1998) to December 31, 1998, and $865,000 for the year ending December 31, 1999. This compensation related to the following: research and development expenses of $46,000 in 1998 and $485,000 in 1999, and selling, general and administrative expenses of $103,000 in 1998 and $380,000 in 1999. The remaining deferred stock compensation at December 31, 1999 was $3.3 million, which will be amortized as follows: $1.7 million for the year ending December 31, 2000, $907,000 for the year ending December 31, 2001, $454,000 for the year ending December 31, 2002, and $154,000 for the year ending December 31, 2003. Termination of option holders could cause stock-based compensation in future years to be less than indicated. Between January 1 and March 31, 2000, we granted options to purchase approximately 530,850 shares of common stock to our employees at exercise prices of from $0.35 to $1.00 per share. We anticipate that we will record additional deferred stock compensation related to these grants.
Other Income (Expense). Interest income increased to approximately $678,000 in 1999 from approximately $121,000 in 1998. The increase in interest income was primarily attributable to higher average outstanding balance of cash and investments resulting from the sale of convertible preferred stock in July 1999. Interest expense was approximately $27,000 in 1999 as we initiated payments on debt obligations under an equipment loan. We expect interest income to increase because of higher cash and investment balances resulting from our sale of Series C preferred stock in March 2000 and our sale of common stock in this offering.
Income Taxes
We had federal and state net operating loss carryforwards of approximately $1.1 million at December 31, 1998 and approximately $9.2 million at December 31, 1999. The net operating losses and credit carryforwards will expire at various dates beginning in 2006 through 2019, if not utilized. Financial Accounting Standards Board Statement No. 109 provides for the recognition of deferred tax assets if realization of such assets is more likely than not. Based upon available data, which includes our historical operating performance and the reported cumulative net losses in prior years, we have provided a full valuation allowance against our net deferred tax assets as the future realization of the tax benefit is not sufficiently assured. We intend to evaluate the realization of the deferred tax assets on a quarterly basis.
The net operating loss carryforwards are subject to review by the Internal Revenue Service. Ownership changes, as defined in the Internal Revenue Code, may limit the amount of these tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of annual limitation is determined based on our value immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years.
Liquidity and Capital Resources
Since our inception, we have financed our operations primarily from the sale of our convertible preferred stock. From inception through December 31, 1999, we raised approximately $28.2 million, net of issuance costs, through convertible preferred stock financings. At December 31, 1998, we had cash, cash equivalents and short-term investments totaling $8.0 million compared to $16.6 million at December 31, 1999.
Working capital at December 31, 1998 was approximately $7.7 million compared to $15.9 million at December 31, 1999. The increase was primarily attributable to the sale of convertible preferred stock. This was
partially offset by operating losses of $9.4 million and increases in accounts payable, accruals and other current liabilities of $1.0 million.
We used approximately $885,000 of cash for operations in 1998 compared to $7.3 million in 1999. Cash used for operations in 1998 was primarily driven by operating losses, offset by accrued liabilities and amortization of deferred compensation. Cash used for operations during 1999 was primarily driven by operating losses, offset by increases in accounts payable, amortization of deferred compensation and accrued liabilities. We have used approximately $8.2 million for operations since our inception.
We used approximately $62,000 in 1998 for investing activities compared to approximately $16.2 million in 1999. In 1998, we invested in equipment. In 1999, we invested $1.1 million in equipment and leasehold improvements, and $15.1 million in investments. We have used approximately $16.2 million for investing activities since our inception.
We received approximately $8.9 million of cash from financing activities in 1998 compared to $19.3 million in 1999. In both years, cash received from financing activities was primarily the result of the sale of convertible preferred stock. We have received approximately $28.2 million of cash from financing activities since our inception through December 31, 1999.
We anticipate that cash used in operating and investing activities will increase significantly in the future as we research, develop, and manufacture our products, and meet our product funding requirements under our agreement with ALZA.
In January 2000, we received $750,000 under an equipment loan, and had $1.5 million of equipment financing available for investment in our manufacturing and other equipment. In March 2000, we received approximately $24.8 million from the sale of convertible preferred stock, net of issuance costs.
We believe that our existing cash balances together with the net proceeds of this offering will be sufficient to finance our planned operations and capital expenditures through at least 18 months. We may consume available resources more rapidly than currently anticipated, resulting in the need for additional funding. Accordingly, we may be required to raise additional capital through a variety of sources, including:
. the public equity market;
. private equity financing;
. collaborative arrangements; and
. public or private debt.
There can be no assurance that additional capital will be available on favorable terms, if at all. If adequate funds are not available, we may be required to significantly reduce or refocus our operations or to obtain funds through arrangements that may require us to relinquish rights to certain of our products, technologies or potential markets, either of which could have a material adverse effect on our business, financial condition and results of operations. To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of such securities would result in ownership dilution to our existing stockholders.
Disclosure About Market Risk
Our exposure to market risk is principally confined to our cash and investments that have maturities of less than two years. We maintain a non- trading investment portfolio of investment grade, liquid debt securities that limits the amount of credit exposure to any issue, issuer or type of instrument. The securities in our investment portfolio are not leveraged, are classified as available for sale and are therefore subject to interest rate risk. We do not use derivative instruments to hedge interest rate exposure. Due to the nature of our investments, we believe there is no material risk exposure.
Recent Accounting Pronouncements
In June 1998, the FASB issued Statement of Financial Accounting Standards
No. 133, Accounting for Derivative Instruments and Hedging Activities, or SFAS
133. SFAS 133 requires us to recognize all derivatives on the balance sheet at
fair value. Derivatives that are not hedges must be adjusted to fair value
through net income. If the derivative is a hedge, depending on the nature of
the hedge, changes in the fair value of the derivative are either offset
against the change in fair value of assets, liabilities, or firm commitments
through earnings or recognized in the other comprehensive income until the
hedged item is recognized in earnings. The ineffective portion of the
derivative's change in fair value will be immediately recognized in earnings.
SFAS 133 is effective for our fiscal year ending December 31, 2001. We do not
currently hold any derivatives and do not expect this pronouncement to
materially impact the results of operations.
In December 1999, the SEC issued Staff Accounting Bulletin No. 101, Revenue Recognition in Financial Statements, or SAB 101. SAB 101 summarizes certain areas of the Staff's views in applying generally accepted accounting principles to revenue in financial statements and specifically addresses revenue recognition for non-refundable technology access fees. We believe that our current revenue recognition principles comply with SAB 101, and thus the adoption had no effect on results of operations.
BUSINESS
Overview
We are pioneering the treatment of chronic diseases and conditions by developing and commercializing pharmaceutical systems to deliver the right drug to the right place in the right amount at the right time. Our pharmaceutical systems combine engineering innovations and delivery technology from the medical device and drug delivery industries with our proprietary pharmaceutical and biotechnology drug formulations. By integrating these technologies, we are able to control the rate and duration of drug administration as well as target the delivery of the drug to its intended site of action, allowing our pharmaceutical systems to meet the special challenges associated with treating chronic diseases or conditions. Our pharmaceutical systems can enable new drug therapies or optimize existing therapies based on a broad range of compounds, including small molecule pharmaceuticals as well as biotechnology molecules such as proteins, peptides and genes. Our initial portfolio of products combine the DUROS technology, a proven and patented drug delivery platform licensed for specified fields of use from ALZA Corporation, with drugs for which data on medical efficacy and safety are available.
Our pharmaceutical systems are suitable for providing long-term drug therapy because they store highly concentrated, stabilized drugs in a small volume and can protect the drug from degradation by the body. This, in combination with our ability to continuously deliver precise and accurate doses of a drug, allows us to extend the therapeutic value of a wide variety of drugs, including those which would otherwise be ineffective, too unstable, too potent or cause adverse side effects. Delivering the drug directly to the intended site of action can also improve efficacy while minimizing unwanted side effects elsewhere in the body, which often limit the long-term use of many drugs. Our pharmaceutical systems can thus provide better therapy for chronic diseases or conditions by replacing multiple injection therapy or oral dosing, improving drug efficacy, reducing side effects and ensuring dosing compliance. Our pharmaceutical systems can improve patients' quality of life by eliminating more repetitive treatments, reducing dependence on caregivers and allowing them to lead more independent lives.
We are currently developing pharmaceutical systems based on the DUROS technology in a variety of therapeutic areas, including chronic pain, central nervous system disorders, cardiovascular diseases and inner ear disorders. The DUROS technology is a miniature drug-dispensing pump that releases minute quantities of concentrated drug formulations in a continuous, consistent flow over months or years using an osmotic engine. The miniature pump, made out of titanium, can be as small as a wooden matchstick and can be implanted under the skin. Beyond the DUROS technology, we intend to develop other technologies consistent with our objective of delivering the right drug to the right place in the right amount at the right time.
Our lead product is for the treatment of chronic pain and combines the DUROS technology with a proprietary formulation of sufentanil, a potent opioid currently used in hospitals as an anesthetic. We completed an initial Phase I trial in November 1999 using an external pump to test the safety of continuous chronic infusion of the drug. We intend to commence a pharmacokinetic study and a Phase II human clinical trial in late 2000. This product is aimed at the approximately $1 billion market for the treatment of chronic pain and will compete with oral opioids, analgesic patches and external and implantable infusion pumps. We are also researching and developing pharmaceutical systems based on the DUROS technology in a variety of other therapeutic areas, including central nervous system disorders, cardiovascular disease and inner ear disorders.
Our second product in development is designed to target the delivery of hydromorphone via a catheter directly to its intended site of action in the central nervous system for the treatment of end-stage cancer pain. Hydromorphone is an opioid approved for use as an analgesic. We will be conducting pre-clinical studies for this product in mid-2000.
Industry Background
Chronic Diseases and Conditions
Although the pharmaceutical, biotechnology and medical device industries have played key roles in increasing life expectancy and improving health, many chronic, debilitating diseases continue to be inadequately
addressed with current drugs or medical devices. Cardiovascular disease, cancer, neurodegenerative diseases, diabetes, arthritis, epilepsy and other chronic diseases claim the lives of millions of Americans each year. These illnesses are prolonged, are rarely cured completely, and pose a significant societal burden in mortality, morbidity and cost. The Centers for Disease Control estimates that the major chronic diseases are responsible for approximately 70% of all deaths in the U.S., and medical care costs for these conditions totaled more than $400 billion annually. Currently, more than 60% of total health care spending in the U.S. is devoted to the treatment of chronic diseases. Demographic trends suggest that, as the U.S. population ages, the cost of treating chronic disease as a proportion of total health care spending will increase.
Current Approaches to Treatment
Drugs are available to treat many chronic diseases, but harmful side effects can limit prolonged treatment. In addition, patients with chronic diseases commonly take multiple medications, often several times a day, for the remainder of their lives. If patients fail to take drugs as prescribed, they often do not receive the intended benefits or may experience side effects which are harmful or decrease quality of life. These problems become more common as the number of drugs being taken increases, the regimen of dosing becomes more complicated, or the patient ages or becomes cognitively impaired. It is estimated that only half of prescribed medicines are taken correctly.
The Pharmaceutical Industry. The pharmaceutical industry has traditionally focused on the chemical structure of small molecules to create drugs that can treat diseases and medical conditions. The ability to use these molecules as drugs is based on their potency, safety and efficacy. Therapeutic outcome and ultimately the suitability of a molecule as a drug depends to a large extent on how it gets into the body, distributes throughout the body, reacts with its intended site of action and is eliminated from the body. However, small molecules act at locations throughout the body and are often accompanied by unwanted side effects.
Most drugs require a minimum level in blood and tissues to have significant therapeutic effects. Above a maximum level, however, the drug becomes toxic or has some unwanted side effects. These two levels define the therapeutic range of the drug. With oral dosing and injections, typically a large quantity of drug is administered to the patient at one time, which results in high blood levels of drug immediately after dosing. Because of these high levels, the patient can be over-medicated during the period immediately following dosing, resulting in wasted drug and possible side effects. Due to distribution processes and drug clearance, the blood level of drug falls as time elapses from the last dose. For some duration, the patient is within the desired therapeutic range of blood levels. Eventually, the blood level of drug falls sufficiently such that the patient becomes under-medicated and experiences little or no drug effect until the next dose is administered.
[Insert Injection-Infusion Graph Here]
When drugs are administered orally, transdermally or by injection, they are absorbed into the systemic circulation and distributed throughout the body. Because the drug is dispersed throughout the body, relatively large quantities are necessary to create the desired effect at the intended site of action. In addition, systemic administration of drugs in this fashion may result in unwanted side effects, because the drug has access to many tissues and organs in the body other than the intended site of action.
The Biotechnology Industry. Over the past twenty years, the biotechnology revolution and the expanding field of genomics have led to the discovery of huge numbers of proteins and genes. Tremendous resources have been committed in the hope of developing drug therapies that would better mimic the body's own processes and allow for greater therapeutic specificity than is possible with small molecule drugs. Unfortunately, this huge effort has led to only a limited number of therapeutic products. The proteins and genes identified by the biotechnology industry are large, complex, intricate molecules, and many are unsuitable as drugs. If these molecules are given orally, they are often digested before they can have an effect; if given by injection, they may be destroyed by the body's natural processes before they can reach their intended sites of action. The body's natural elimination processes require frequent, high dose injections that may result in unwanted side effects. As a result, the development of biotechnology molecules for the treatment of human diseases has been limited.
The Drug Delivery Industry. In the last thirty years, a multibillion dollar drug delivery industry has developed on the basis that medicine can be improved by delivering drugs to patients in a precise, controlled fashion. Several commercially successful oral controlled release products, transdermal controlled release patches, and injectable depot formulations have been developed. These products demonstrate that the delivery system can be as important to the ultimate therapeutic value of a pharmaceutical product as the drug itself. However, to date, most drug delivery products deliver drug systemically and do not target delivery to the intended site of action. In addition, drug delivery products are generally limited in duration and therefore may be less desirable for treating chronic diseases.
The Medical Device Industry. Advances in the field of medical device technology have dramatically improved device miniaturization and sophistication and allowed minimally invasive surgical access to remote locations within the body. For example, a coronary bypass patient can be treated with a stent in a procedure with a relatively short recovery, rather than with major surgery. Most devices, however, apply only mechanical solutions, rather than addressing chemical or biological mechanisms of disease.
The DURECT Solution: Pharmaceutical Systems
We are pioneering the treatment of chronic diseases and conditions by developing and commercializing pharmaceutical systems that will deliver the right drug to the right place in the right amount at the right time. By integrating chemistry and engineering advancements, we can achieve what drugs or devices alone cannot. Our pharmaceutical systems enable optimized therapy for a given disease or patient population by controlling the rate and duration of drug administration as well as targeting the delivery of the drug to its intended site of action.
. The Right Drug: By precisely controlling the dosage and targeting delivery to a specific site, we can expand the therapeutic use of compounds that otherwise would be too potent to be administered systemically, do not remain in the body long enough to be effective, or have significant side effects when administered systemically. This flexibility allows us to work with a variety of drug candidates including small molecules, proteins, peptides or genes.
. The Right Place: We draw on innovations in the medical device industry to enhance our products. With precise placement of proprietary microcatheters, we can design our pharmaceutical systems to deliver drugs directly to the intended site of action. This can ensure that the drug reaches the target tissue in effective concentrations, eliminates many side effects caused by delivery of drug to unintended sites in the body, and may reduce the total amount of drug administered to the body.
. The Right Amount: Our pharmaceutical systems can automatically deliver drug dosages continuously within the desired therapeutic range for the duration of the treatment period, for up to one year, without the fluctuations in drug levels associated with pills or injections.
[REPEAT GRAPH AND ADD INFUSION LINE]
This can reduce side effects, eliminate gaps in drug therapy, conveniently ensure accurate dosing and patient compliance, and may reduce the total amount of drug administered to the body.
. The Right Time: Our pharmaceutical systems technology allows drugs to be delivered automatically without intervention of the patient or care- giver. In addition to reducing the cost of care, continuous drug therapy frees the patient from repeated treatment or hospitalization, improving convenience and quality of life. Our systems are well-suited for treating chronic, debilitating diseases such as chronic pain, cancer, heart disease, and neurodegenerative diseases that last for months or years. We believe that it is more effective to treat chronic diseases with continuous, long-term therapy than with alternatives such as multiple injections that create short-term effects. Because our pharmaceutical systems are designed to operate automatically, patient compliance is assured.
DURECT Pharmaceutical Systems Technology
The technological foundation of our initial products is the DUROS implant technology, coupled with proprietary catheter and drug formulation technology. The DUROS system is a miniature drug-dispensing pump made out of titanium which can be as small as a wooden matchstick. We have licensed the DUROS technology for specified fields of use from ALZA. The potential of the DUROS technology as a platform for providing drug therapy was recently demonstrated by the Food and Drug Administration's approval in March 2000 of ALZA's Viadur (leuprolide acetate implant), a once-yearly implant for the palliative treatment of prostate cancer, the first approved product to incorporate the DUROS implant technology. By leveraging this proven technology, we believe we can reduce our development risk and more rapidly introduce new products to the market.
[INSERT CROSS SECTION OF DUROS PUMP]
Most of the volume of the DUROS system will contain our proprietary drug formulation. The DUROS pump operates like a miniature syringe. Through osmosis, water from the body is slowly drawn through a semi-permeable membrane into the pump by salt residing in the engine compartment. This water fills the engine compartment and slowly and continuously pushes a piston to dispense minute amounts of drug formulation from the drug reservoir. The osmotic engine does not require batteries, switches or other electromechanical parts in order to operate. The amount of drug delivered by the system is regulated by the semi-permeable membrane's control of the rate of body water entering the engine compartment and the concentration of the drug formulation.
The DUROS system has performance characteristics that cannot be matched by drug delivery pumps on the market today. First, the engine can generate sufficient pressure to deliver highly concentrated and viscous formulations. Second, the system can be engineered to deliver a drug formulation at the desired dosing rate with a high degree of precision, to less than 1/100th of a drop per day on a continuous basis. The titanium shell of the DUROS system protects the drug formulation from degradation by enzymes and clearance processes within the body. As a result, the DUROS system can store drugs for up to one year as they are being released into the body.
The DUROS system can be used for therapies requiring systemic or site- specific administration of drug. To deliver drugs systemically, the DUROS system is placed just under the skin, for example in the upper arm, in an outpatient procedure that is completed in just a few minutes using local anesthetic. Removal or replacement of the product is also a simple, quick procedure completed in the doctor's office.
To deliver drug to a specific site, we are developing proprietary miniaturized catheter technology that can be attached to the DUROS system to direct the flow of drug directly to the target organ, tissue or synthetic medical structure, such as a graft. Site specific delivery enables a therapeutic concentration of a drug to be present at the desired target without exposing the entire body of the patient to a similar dose. The precision, size and performance characteristics of the DUROS system will allow for continuous site-specific delivery to a variety of precise locations within the body.
By concentrating drug in proprietary formulations, we can store enough drug in our pharmaceutical systems to dose a patient for extended periods of time, for up to one year. Our proprietary formulations of traditional small molecule drugs are much more concentrated than those currently available on the market. Concentrated formulations allow our pharmaceutical systems to be significantly smaller than alternative drug delivery systems available today. We also believe that we can keep these formulations chemically and physically stable for extended periods of time at body temperature. Our formulation expertise, combined with the protection provided by the reservoir of the DUROS system, may allow for the stable storage and delivery of proteins, peptides, and other large molecule agents in a long-term continuous fashion, thus enabling the full therapeutic potential of a wide range of biotechnology compounds.
DURECT Strategy
Our objective is to develop and commercialize pharmaceutical systems that address significant medical needs and improve patients' quality of life. To achieve this objective, our strategy includes the following key elements:
Focus on Chronic Debilitating Medical Conditions. Many of the diseases that present the greatest challenges to medicine are chronic, debilitating diseases such as chronic pain, central nervous system disorders, cardiovascular disorders, cancer, degenerative neurological diseases and ear disorders. Our initial efforts will focus on using the versatile DUROS platform technology to develop products that address these diseases.
Minimize Product Development Risk and Speed Time-to-Market. Initially, we intend to minimize product development risk and speed time-to-market by using the proven DUROS platform to administer drugs for which medical data on efficacy and safety are available. This strategy reduces much of the development risk that is inherent in traditional pharmaceutical product discovery. We anticipate that we can expand the medical usefulness of existing well-characterized drugs in several ways:
. expand uses or create new uses for existing drugs with clear safety profiles;
. create new uses for drugs which were previously thought to be too potent to be used safely; and
. enhance drug performance by minimizing side effects.
We anticipate that our products can be more rapidly developed at lower cost than comparable products that are developed purely based on chemical solutions to the problems of efficacy, side effects, stability and delivery
of the active agent. This allows us to use potent agents that would otherwise not be available as therapies to treat chronic diseases. It also allows us to innovate more rapidly in the development of products and to respond to market feedback by optimizing our existing products or developing line extensions that address new market needs.
Enable the Development of Pharmaceutical Systems Based on Biotechnology and Other New Compounds. We believe there is a significant opportunity for pharmaceutical systems to add value to therapeutic medicine by administering biotechnology products, such as proteins, peptides and genes. We believe our technology will improve the specificity, potency, convenience and cost- effectiveness of proteins, genes and other newly discovered drugs. Our systems can enable these compounds to be effectively administered, thus allowing them to become viable medicines. We can address the stability and storage needs of these compounds through our advanced formulation technology and package them in a suitable pharmaceutical system for optimum delivery. Through continuous administration, the DUROS system may eliminate the need for multiple injections of these drugs. In addition, through the use of our proprietary miniature catheter technology, proteins and genes can be delivered to specific tissues for extended periods of time, thus ensuring that large molecule agents are present at the desired site of action and minimizing the potential for adverse side effects elsewhere in the body.
Expand Our Technology Platforms. In addition to the DUROS technology, we will continue to develop, license and acquire other technologies consistent with our objective of delivering the right drug to the right place in the right amount at the right time. For example, in our October 1999 acquisition of IntraEAR, we acquired proprietary products and intellectual property that allow for continuous delivery of fluids to treat inner and middle ear disorders. We have and expect to continue to license or acquire technology from others that will complement our core capabilities.
Product Development Programs
Our pharmaceutical systems are designed to provide improved treatment efficacy with a high level of precision and quality. Our development efforts are focused on the application of our pharmaceutical systems technologies to potential products in the broad areas of focus set forth in the following table:
Delivery Areas of Focus Drug Method Indications Status -------------- --------------- ------------- ----------------------- ------------------- . Chronic Pain . Sufentanil . Systemic . Opioid-Responsive . Initial Phase I Chronic Malignant completed; and Non-Malignant Phase II to Pain commence late 2000 . Central . Hydromorphone . Targeted . Cancer Pain . Preclinical Stage Nervous System . Others . Others in Development . Research Stage Disorders . Ear Disorders . Gentamycin . Targeted . Meniere's Disease . Preclinical Stage . Others . Others in Development . Research Stage . Cardiovascular . Various . Targeted . Various . Research Stage Diseases . Vascular Graft . Various . Targeted . Various . Research Stage . Cancer . Various . Targeted or . Various . Research Stage Immunotherapy Systemic |
Chronic Pain
Market Opportunity. Chronic pain, defined as pain lasting 6 months or longer, is a significant problem associated with chronic diseases, including cancer and various neurological and skeletal disorders. Chronic nonmalignant pain affects as many as 34 million Americans annually. In addition, the National Cancer Institute estimates that 8.4 million Americans alive today have a history of cancer. About 1.2 million new cancer cases are expected to be diagnosed in 2000, and about 50%-70% of cancer patients experience chronic pain during the course of the disease. Sales of opioids for the treatment of chronic malignant and nonmalignant pain are approximately $1 billion. With our lead product, DUROS sufentanil, we intend to target patients with chronic pain that is stable and opioid responsive and results from a variety of causes. Sufentanil is an off-patent, highly potent opioid that is currently used in hospitals as an anesthetic. This product will provide an alternative to current therapies for the treatment of chronic pain, as well as ensuring improved patient compliance and convenience.
Development Strategy. We are developing a subcutaneous, implantable DUROS- based system that delivers sufentanil systemically at a constant rate for 3 months. We will develop a family of dosage strengths, tailored to meet market needs. An initial Phase I trial using an external pump to test the safety of continuous chronic infusion of the drug was completed in 1999. Pharmacokinetic and Phase II human clinical trials are planned to commence in late 2000. These trials are designed to develop data in support of dose selection for later trials and commercial use as well as data to guide physicians in converting patients from previous therapies to the DUROS sufentanil implant.
Central Nervous System Disorders
Market Opportunity. Millions of people suffer from chronic diseases and disorders of the central nervous system, including brain and spinal cord tumors, epilepsy, spasticity, spinal meningitis, Parkinson's disease, multiple sclerosis and back disorders. Opportunities exist to apply our pharmaceutical systems for treatment of these disorders. The first central nervous system disorder we will address is end-stage cancer pain. Roughly 550,000 people in the U.S. will die from cancer and cancer-related complications this year. It is estimated that over half of terminal cancer patients experience severe, chronic pain. Infusion of opiates into the spinal fluid has become accepted medical therapy in patients who find high dose oral or transdermal opioids ineffective or who experience side effects that make systemic therapy unacceptable. This method of delivery increases analgesic potency and reduces side effects. However, patients with cancer pain are often not treated with this therapeutic regimen because currently available implantable spinal infusion pumps are only approved for patients with life expectancies of three months or more. Furthermore, external infusion pumps are inconvenient and expose a patient to a risk of infection. A need exists for a minimally invasive, spinal infusion device that has improved cost benefit for end-stage cancer patients with chronic pain.
Development Strategy. Our strategy is to develop an infusion system that can deliver hydromorphone into the spinal fluid via a catheter. This product will be considerably smaller and less invasive than currently available spinal infusion pumps. Hydromorphone is an opioid that has been approved for treatment of pain. Pre-clinical prototypes of this device are currently being designed and tested. We anticipate that initial clinical trials with this device will begin in 2001 and will focus on determining its safety, efficacy and tolerability in cancer patients with 3 months or less to live.
Middle and Inner Ear Disorders
Market Opportunity. Inner ear disorders, including tinnitus, hearing loss and Meniere's disease impact the lives of millions of people worldwide. Opportunities may exist to treat these inner ear disorders through continuous low dose application of drug. For example, Meniere's disease is a debilitating inner ear disorder characterized by vertigo, tinnitus, fluctuating hearing loss and aural pressure. In the U.S., it is estimated that Meniere's disease afflicts at least 3 million people with 100,000 new cases being diagnosed each year. Current first line treatments include vestibular suppressants, diet modifications and diuretics. We estimate that about
30 percent of patients receive second line treatments such as large doses of gentamycin or surgery that can destroy inner ear function. These destructive treatments can result in permanent loss of hearing and impair balance. We are researching treatments which therapeutically rather than destructively treat Meniere's disease while minimizing risk of hearing loss and preserving balance function.
Development Strategy. In October 1999, we acquired substantially all of the assets of IntraEAR, Inc. This acquisition provided us with an extensive intellectual property portfolio related to devices and methods for the delivery of fluids to the round window niche of the middle ear. We are researching pharmaceutical systems that include this proprietary catheter technology to treat intractable inner ear disorders such as Meniere's disease, hearing loss and tinnitus.
Ongoing Research
We plan to devote substantial resources to developing multiple products based on our pharmaceutical systems technology in one or more of the areas of focus in the above table or others. For example, we are currently engaged in research on treating chronic cardiovascular diseases and other central nervous system disorders.
Ear Catheter Business
Our acquisition in October 1999 of substantially all of the assets of IntraEAR, Inc. provided us with catheter technology and products that had previously received 510K marketing clearance from the FDA and European CE Mark approval. We currently market these catheters through a direct sales force in the U.S. and through a network of 13 distributors outside the U.S.
The Round Window ^-Cath and Round Window e-Cath products are dual- and triple-lumen micro-catheters of proprietary design which allow controlled fluid delivery to the round window membrane for treatment of ear disorders. These catheters feature a proprietary tip which is designed to allow the surgeon to secure it in the round window niche of the middle ear. When attached to a commercially available, external infusion pump, such as those manufactured by Disetronic Medical Systems, a variety of therapeutic fluids can be continuously delivered to the round window membrane to potentially treat ear disorders including Meniere's disease, hearing loss and tinnitus. These catheters can be left in place for up to 29 days and can be connected to a syringe or pump for continuous delivery. The dual-lumen design allows the treating physician to add and remove fluid or flush the device without a build-up of air or fluid pressure. The e-Cath design incorporates an additional electrode to allow physicians to record electrical signals related to activities in the ear.
ALZET Business
In April 2000, we acquired from ALZA the ALZET product and assets used primarily in the manufacture, sale and distribution of this product. This acquisition provides us with an ongoing business making and selling this product worldwide. We currently market the ALZET product through a direct sales force in the U.S. and through a network of 10 distributors outside the U.S.
The ALZET product is a miniature, implantable osmotic pump used for experimental research in mice, rats and other laboratory animals. These pumps are not approved for use in humans, nor are they intended for such use. ALZET pumps continuously deliver drugs, hormones and other test agents at controlled rates from one day to four weeks without the need for external connections, frequent handling or repeated dosing. In laboratory research, these infusion pumps can be used for systemic administration when implanted under the skin or in the body. They can be attached to a catheter for intravenous, intracerebral, or intra-arterial infusion or for targeted delivery, where the effects of a drug or test agent are localized in a particular tissue or organ.
We believe that the ALZET business provides us with innovative design and application opportunities for potential new products.
Marketing and Sales
In general, we intend to establish strategic distribution and marketing alliances for our products. We recognize that pharmaceutical companies have established sales organizations in markets we are targeting. We plan to leverage these sales organizations to achieve greater market penetration for our products than we could on our own. Because our first products use proven drugs with a proven technology platform, we have the flexibility to enter into these alliances at a later stage of clinical development when the product development risk is diminished in order to retain greater economic participation. We may also establish our own sales force when strategically or economically advantageous.
We have established a small sales force in the U.S. to market our approved catheters for delivering fluids to the inner ear. In addition, we sell our catheters through 13 distributors outside the U.S. We market and sell our ALZET product in the U.S. through a direct sales force, and we have a network of ten distributors for this product outside of the U.S.
ALZA has an option to exclusively market and distribute DUROS sufentanil in the U.S. and Canada on terms to be negotiated by the parties at arms-length. Depending on when ALZA exercises its option, it may be required to pay for all or part of the clinical and development costs for this product. Should ALZA decide not to exercise its option, we will market and distribute DUROS sufentanil in the U.S. and Canada ourselves or through a third party.
Manufacturing
The process for manufacturing our pharmaceutical systems is technically complex, requires special skill in aseptic processing, and must be performed in a qualified facility. For our lead product, we subcontract to third-parties the manufacture of components of the DUROS system, which we then assemble. We have entered into a contract with Chesapeake Biological Labs, Inc. to finish and fill the DUROS system for Phase II clinical testing of DUROS sufentanil. We plan to construct a flexible manufacturing facility to produce materials for Phase III clinical testing and market launch of DUROS sufentanil and to serve as a pilot facility for additional products under development. In addition, we are evaluating alternative strategies to meet our long-term commercial manufacturing needs.
For the manufacture of our ear catheter products, we have a supply agreement with a third party manufacturer of disposable medical products. Under this agreement, renewable annually, the third party has responsibility for all manufacturing and packaging of finished goods and some regulatory responsibilities. We manufacture our ALZET product in a leased facility located in Vacaville, California.
Development and Commercialization Agreement with ALZA Corporation
On April 21, 1998, we entered into a Development and Commercialization Agreement with ALZA Corporation, which was amended and restated on April 28, 1999 and April 14, 2000. Pursuant to this agreement, ALZA granted to us exclusive, world-wide rights under ALZA intellectual property, including patents, trade secrets and know-how, to develop and commercialize products using the DUROS drug delivery technology in the fields of the delivery of drugs by catheter (except for the sufentanil product) to the central nervous system to treat selected central nervous system disorders, the delivery of drugs by catheter to the middle and inner ear, the delivery of drugs by catheter into the pericardial sac of the heart, the delivery of selected drugs by catheter into vascular grafts and the delivery of selected cancer antigens. To maintain the rights granted to us in our licensed fields, we must meet annual minimum development spending requirements and develop a minimum number of products. We must also diligently procure required regulatory approvals and commercialize the products in each country in order to maintain commercialization rights for such product in that country.
Under this agreement, we initiate product development by sending ALZA a written notice containing a description of the proposed product and proposed target dates for key milestones. These target dates are subject
to ALZA's reasonable approval and may be adjusted from time to time by mutual agreement. We have the right to subcontract to third parties product development activities including development of components of the DUROS system, provided that design of the DUROS system and other development activities relating to the DUROS system must be performed by ourselves or ALZA unless ALZA permits us to subcontract out such development. We also have the right to partner with third parties to commercialize our products on a product-by-product basis, provided that ALZA has options to distribute our DUROS sufentanil product in the U.S. and Canada and our cancer antigen products which do not incorporate proprietary molecules owned by a third party throughout the world. We have the right to subcontract manufacturing activities relating to our products other than the assemblage of the components of the DUROS system itself. See "Risk Factor--Our agreement with ALZA limits our field of operation for our DUROS-based pharmaceutical systems, requires us to spend significant funds on product development and gives ALZA a first right to distribute selected products for us."
In consideration for the rights granted to us under this agreement, ALZA received 5,600,000 shares of our Series A-1 Preferred Stock pursuant to a Series A-1 and Series A-2 Preferred Stock Purchase Agreement dated as of June 19, 1998. As additional consideration, ALZA is entitled to receive a royalty on the net sales of products for so long as we sell the product and a percentage of any up-front license fees, milestone or any special fees, payments or other consideration we receive, excluding research and development funding. In connection with an amendment to the agreement made in April 2000, ALZA received 1,000,000 shares of our common stock and a warrant to purchase 1,000,000 shares of our common stock at an exercise price equal to the price at which we sell our common stock in this offering. The amendments to our development and commercialization agreement with ALZA include a reduction in product royalties and up front payments payable to ALZA by us under the agreement. In addition, ALZA's option to distribute the DUROS sufentanil product was amended in geographic scope to cover only the U.S. and Canada, instead of worldwide.
Under this agreement, we may engage ALZA to provide certain consulting and development services agreed upon by the respective companies on a fee for services basis.
The term of this agreement is for so long as we are obligated to make product payments to ALZA. The agreement is assignable by either party to an acquiror of all or substantially all of such party's business.
Patents, Licenses and Proprietary Rights
Our success depends in part on our ability to obtain patents, to protect trade secrets, to operate without infringing upon the proprietary rights of others and to prevent others from infringing on our proprietary rights. Our policy is to seek to protect our proprietary position by, among other methods, filing U.S. and foreign patent applications related to our proprietary technology, inventions and improvements that are important to the development of our business. As of February 29, 2000, we held four issued or allowed U.S. patents and one issued or allowed foreign patent. Our patents expire at various dates starting in the year 2012. In addition, we have 11 pending U.S. patent applications and have filed six corresponding patent applications under the Patent Cooperation Treaty, five of which are currently pending in Europe, Australia and Canada. In addition, we have licensed from ALZA a portfolio of pending, issued and future patents to permit us to develop and commercialize products under our agreement with ALZA.
Proprietary rights relating to our planned and potential products will be protected from unauthorized use by third parties only to the extent that they are covered by valid and enforceable patents or are effectively maintained as trade secrets. Patents owned by or licensed to us may not afford protection against competitors, and our pending patent applications now or hereafter filed by or licensed to us may not result in patents being issued. In addition, the laws of certain foreign countries may not protect our intellectual property rights to the same extent as do the laws of the U.S. The patent positions of biopharmaceutical companies involve complex legal and factual questions and, therefore, their enforceability cannot be predicted with certainty. Our patents or patent applications, or those licensed to us, if issued, may be challenged, invalidated or circumvented, and the rights granted thereunder may not provide proprietary protection or competitive advantages to us against competitors with similar technology. Furthermore, our competitors may independently develop similar technologies or
duplicate any technology developed by us. Because of the extensive time required for development, testing and regulatory review of a potential product, it is possible that, before any of our products can be commercialized, any related patent may expire or remain in existence for only a short period following commercialization, thus reducing any advantage of the patent, which could adversely affect our ability to protect future product development and, consequently, our operating results and financial position.
Because patent applications in the U.S. are maintained in secrecy until patents issue and since publication of discoveries in the scientific or patent literature often lag behind actual discoveries, we cannot be certain that we were the first to make the inventions covered by each of our issued or pending patent applications or that we were the first to file for protection of inventions set forth in such patent applications. Our planned or potential products may be covered by third-party patents or other intellectual property rights, in which case we would need to obtain a license to continue developing or marketing these products.
Any required licenses may not be available to us on acceptable terms, if at all. If we do not obtain any required licenses, we could encounter delays in product introductions while we attempt to design around these patents, or could find that the development, manufacture or sale of products requiring such licenses is foreclosed. Litigation may be necessary to defend against or assert such claims of infringement, to enforce patents issued to us, to protect trade secrets or know-how owned by us, or to determine the scope and validity of the proprietary rights of others. In addition, interference proceedings declared by the U.S. Patent and Trademark Office may be necessary to determine the priority of inventions with respect to our patent applications. Litigation or interference proceedings could result in substantial costs to and diversion of effort by us, and could have a material adverse effect on our business, financial condition and results of operations. These efforts by us may not be successful.
We may rely, in certain circumstances, on trade secrets to protect our technology. However, trade secrets are difficult to protect. We seek to protect our proprietary technology and processes, in part, by confidentiality agreements with our employees and certain contractors. There can be no assurance that these agreements will not be breached, that we will have adequate remedies for any breach, or that our trade secrets will not otherwise become known or be independently discovered by competitors. To the extent that our employees, consultants or contractors use intellectual property owned by others in their work for us, disputes may also arise as to the rights in related or resulting know-how and inventions.
Government Regulation
The FDA and comparable regulatory agencies in state and local jurisdictions and in foreign countries impose substantial requirements upon the clinical development, manufacture and marketing of pharmaceutical products. These agencies and other federal, state and local entities regulate research and development activities and the testing, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion of our products. We believe that our initial products will be regulated as drugs by the FDA rather than as biologics or devices, whereas later products may be regulated as combination products with a device designation for all or some of the final product components.
The process required by the FDA under the new drug provisions of the Federal Food, Drug and Cosmetics Act before our initial products may be marketed in the U.S. generally involves the following:
. preclinical laboratory and animal tests;
. submission of an IND application which must become effective before clinical trials may begin;
. adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed pharmaceutical in our intended use; and
. FDA approval of a new drug application.
The testing and approval process requires substantial time, effort, and financial resources and we cannot be certain that any approval will be granted on a timely basis, if at all.
Preclinical tests include laboratory evaluation of the product, its chemistry, formulation and stability, as well as animal studies to assess the potential safety and efficacy of the product. We then submit the results of the preclinical tests, together with manufacturing information and analytical data, to the FDA as part of an IND, which must become effective before we may begin human clinical trials. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the trials as outlined in the IND and imposes a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can begin. Our submission of an IND may not result in FDA authorization to commence clinical trials. Further, an independent Institutional Review Board at each medical center proposing to conduct the clinical trials must review and approve any clinical study.
Human clinical trials are typically conducted in three sequential phases which may overlap:
. PHASE I: The drug is initially introduced into healthy human subjects or patients and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion.
. PHASE II: Involves studies in a limited patient population to identify possible adverse effects and safety risks, to determine the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.
. PHASE III: When Phase II evaluations demonstrate that a dosage range of the product is effective and has an acceptable safety profile, Phase III trials are undertaken to further evaluate dosage, clinical efficacy and to further test for safety in an expanded patient population, often at geographically dispersed clinical study sites.
In the case of products for severe diseases, such as chronic pain, or life- threatening diseases such as cancer, the initial human testing is often conducted in patients with disease rather than in healthy volunteers. Since these patients already have the target disease or condition, these studies may provide initial evidence of efficacy traditionally obtained in Phase II trials and thus these trials are frequently referred to as Phase I/II trials. We cannot be certain that we will successfully complete Phase I, Phase II or Phase III testing of our product candidates within any specific time period, if at all. Furthermore, the FDA or the Institutional Review Board or the sponsor may suspend clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.
The results of product development, preclinical studies and clinical studies are submitted to the FDA as part of a new drug application for approval of the marketing and commercial shipment of the product. The FDA may deny a new drug application if the applicable regulatory criteria are not satisfied or may require additional clinical data. Even if such data is submitted, the FDA may ultimately decide that the new drug application does not satisfy the criteria for approval. Once issued, the FDA may withdraw product approval if compliance with regulatory standards is not maintained or if safety problems occur after the product reaches the market. In addition, the FDA requires surveillance programs to monitor approved products which have been commercialized, and the agency has the power to require changes in labeling or to prevent further marketing of a product based on the results of these post-marketing programs.
In addition to the drug approval requirements applicable to our initial product for the treatment of chronic pain through the Center for Drug Evaluation and Research (CDER), the FDA may require an intercenter consultation review by the Center for Devices and Radiological Health (CDRH). This request for consultation may be based on the device-like nature of a number of aspects of the DUROS technology.
Satisfaction of the above FDA requirements or similar requirements of state, local and foreign regulatory agencies typically takes several years and the actual time required may vary substantially, based upon the type, complexity and novelty of the pharmaceutical product. Government regulation may delay or prevent marketing of potential products for a considerable period of time and impose costly procedures upon our activities. We cannot be certain that the FDA or any other regulatory agency will grant approval for any of our products under
development on a timely basis, if at all. Success in preclinical or early stage clinical trials does not assure success in later stage clinical trials. Data obtained from preclinical and clinical activities is not always conclusive and may be susceptible to varying interpretations which could delay, limit or prevent regulatory approval. Even if a product receives regulatory approval, the approval may be significantly limited to specific indications. Further, even after regulatory approval is obtained, later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market. Delays in obtaining, or failures to obtain regulatory approvals would have a material adverse effect on our business. Marketing our products abroad will require similar regulatory approvals and is subject to similar risks. In addition, we cannot predict what adverse governmental regulations may arise from future U.S. or foreign governmental action.
Any products manufactured or distributed by us pursuant to FDA clearances or approvals are subject to pervasive and continuing regulation by the FDA, including record-keeping requirements and reporting of adverse experiences with the drug. Drug manufacturers and their subcontractors are required to register their establishments with the FDA and state agencies, and are subject to periodic unannounced inspections by the FDA and state agencies for compliance with good manufacturing practices, which impose procedural and documentation requirements upon us and our third party manufacturers. We cannot be certain that we or our present or future suppliers will be able to comply with the GMP regulations and other FDA regulatory requirements.
The FDA regulates drug labeling and promotion activities. The FDA has actively enforced regulations prohibiting the marketing of products for unapproved uses. Under the FDA Modernization Act of 1997, the FDA will permit the promotion of a drug for an unapproved use in certain circumstances, but subject to very stringent requirements. We and our products are also subject to a variety of state laws and regulations in those states or localities where our products are or will be marketed. Any applicable state or local regulations may hinder our ability to market our products in those states or localities. We are also subject to numerous federal, state and local laws relating to such matters as safe working conditions, manufacturing practices, environmental protection, fire hazard control, and disposal of hazardous or potentially hazardous substances. We may incur significant costs to comply with such laws and regulations now or in the future.
The FDA's policies may change and additional government regulations may be enacted which could prevent or delay regulatory approval of our potential products. Moreover, increased attention to the containment of health care costs in the U.S. and in foreign markets could result in new government regulations that could have a material adverse effect on our business. We cannot predict the likelihood, nature or extent of adverse governmental regulation that might arise from future legislative or administrative action, either in the U.S. or abroad.
Competition
We may face competition from other companies in numerous industries including pharmaceuticals, medical devices and drug delivery. Our DUROS sufentanil product will compete with oral opioids, transdermal opioid patches, and implantable and external infusion pumps which can be used for infusion of opioids. Products of these types are marketed by Purdue Pharma, Knoll, Janssen, Medtronic, AstraZeneca, Arrow International, Tricumed and others. Our spinal hydromorphone product will compete with implantable and external infusion pumps marketed by Medtronic, Arrow International, Tricumed, Abbott, Deltec and others. Numerous companies are applying significant resources and expertise to the problems of drug delivery and several of these are focusing or may focus on delivery of drugs to the intended site of action, including Alkermes, Genetronics, The Liposome Company, Focal, Matrix Pharmaceuticals and others. Although we have exclusivity with respect to our license of the DUROS technology in specific fields of therapy, ALZA is also a potential competitor with technologies other than DUROS.
Some of these competitors may be addressing the same therapeutic areas or indications as us. Our current and potential competitors may succeed in obtaining patent protection or commercializing products before us. Any
products we develop using our pharmaceutical systems technologies will compete in highly competitive markets. Many of our potential competitors in these markets have greater development, financial, manufacturing, marketing, and sales resources than we do and we cannot be certain that they will not succeed in developing products or technologies which will render our technologies and products obsolete or noncompetitive. In addition, many of those potential competitors have significantly greater experience than we do in their respective fields.
Employees
As of March 31, 2000, we had 41 full-time employees, including 26 in research, development and manufacturing and 15 in sales, general and administrative. From time to time, we also employ independent contractors to support our engineering and support and administrative organizations. None of our employees are represented by a collective bargaining unit and we have never experienced a work stoppage. We consider our relations with our employees to be good.
Facilities
We are headquartered in Cupertino, California, where we lease approximately 30,000 square feet of space under a lease expiring in January 2004 with options to extend for up to an additional ten years. This facility contains both office and laboratory space. We sublease approximately 11,000 square feet of this space under a sublease that terminates in March 2001. We are also in the process of assuming a lease for approximately 7,800 square feet of space in Vacaville, California. This facility contains manufacturing space for the ALZET product. Our lease of this facility expires in March 2001 with an option to extend for one year. We believe that our existing and planned facilities are adequate to meet our current and foreseeable requirements or that suitable additional or substitute space will be available as needed.
Legal Proceedings
We are not a party to any material legal proceedings.
Scientific and Medical Advisors
We have recruited and will continue to recruit leading researchers and physicians in our fields of interest to serve as scientific and medical advisors for each of our products under development. The scientific advisory board advises our management on strategic issues related to our scientific development program. In return for their services, these advisors may receive compensation in the form of cash and/or option grants for the purchase of common stock. Listed in alphabetical order, the following individuals serve as scientific advisors for our lead product in the field of pain treatment:
Stuart L. DuPen, M.D.
Stuart DuPen, M.D. is an anesthesiologist specializing in pain management. He is board certified in anesthesiology and pain management, with over twenty years of experience. His interests include management of neuropathic pain syndromes associated with both cancer and non-cancer sources. He lectures widely on epidural analgesia in cancer pain management. He is the principal investigator on two National Cancer Institute studies designed to enhance education of doctors and nurses about pain, and to improve pain relief outcomes. Dr. DuPen participated in our Phase I trial for DUROS sufentanil.
Elliot S. Krames, M.D.
Elliot Krames, M.D., is a board-certified anesthesiologist who has been practicing pain medicine solely for the past 20 years. He is a pioneer and one of the leading experts in the field of intraspinal analgesia. He is a world- renowned leader and educator in the fields of neuromodulation for pain control. He has written extensively on implantable technologies for pain management and has conducted national and international symposia on this
topic. For the past 10 years, Dr. Krames has been the Medical Director of the Pacific Pain Treatment Centers in the San Francisco Bay Area, an organization of pain clinics dedicated to interdisciplinary pain medicine. He is co-founder of the National Pain Foundation, a founding member of the American Neuromodulation Society and he participates on the Boards of the International and American Neuromodulation Societies, World Institutes of Pain, and the American Academy of Pain Medicine. Dr. Krames is the Chairman of the Combined Worldwide Pain Conference of the International and American Neuromodulation Societies, the World Institutes of Pain and the World Society of Pain Clinicians that will take place July 15-21, 2000 in San Francisco. In addition, he is Editor-in-Chief of Neuromodulation, the Journal of the International Neuromodulation Society.
Dwight E. Moulin, M.D.
Dwight Moulin, M.D., is an Associate Professor, Division of Neurology, Department of Clinical Neurological Sciences at the University of Western Ontario, Canada. He is also an associate professor in the department of Oncology and an Honorary Lecturer in the Department of Medicine at the University of Western Ontario. In addition, Dr. Moulin is a Consultant Neurologist at St. Joseph's Health Center, Head of the Division of Neurology at the Victoria Campus of the London Health Sciences Centre as well as Attending Neurologist at the Victoria Campus and University Campus of the London Health Sciences Centre. He has published widely in the field of chronic pain, and has been very active in clinical trials in chronic pain, including trials for controlled and sustained release opioids.
Russell K. Portenoy, M.D.
Russell K. Portenoy, M.D., is chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center and Professor of Neurology at the Albert Einstein College of Medicine. Dr. Portenoy received his medical degree from the University of Maryland School of Medicine. He completed a residency in neurology at the Albert Einstein College of Medicine and a fellowship in pain management at Memorial Sloan-Kettering Cancer Center. Dr. Portenoy has been very active as both a researcher and an educator. He has published extensively on topics related to pain and analgesics, treatments for symptoms other than pain, symptom assessment and quality of life. He is the immediate past president of the American Pain Society, and the recipient of that society's Wilbert E. Fordyce Clinical Investigator Award and the Distinguished Service Award. Dr. Portenoy also is Secretary of the International Association for the Study of Pain and a Trustee of the American Board of Hospice and Palliative Medicine. Dr. Portenoy is Editor-in-Chief of an international, peer-reviewed medical journal, The Journal of Pain and Symptom Management. He is also Associate Editor for cancer pain for the journal Pain, and serves on several other editorial boards.
Peter Staats, M.D.
Peter S. Staats, M.D., is currently Chief of the Division of Pain Medicine in the Department of Anesthesiology and Critical Care Medicine at the Johns Hopkins Hospital, where he is also the Director of the Anesthesia Pain Medicine Clinic. His academic posts at the Johns Hopkins University School of Medicine include Associate Professorships in the Department of Anesthesiology and Critical Care Medicine and the Department of Oncology. Prior to joining the medical and teaching staff at Johns Hopkins in 1994, Dr. Staats received his medical residency training in anesthesiology and critical care medicine at the Johns Hopkins University School of Medicine and was subsequently awarded a fellowship in Pain Medicine. Dr. Staats has lectured throughout the world and has written over a hundred articles, book chapters and abstracts on the management of chronic pain.
MANAGEMENT
The directors and executive officers of DURECT Corporation and their ages as of March 31, 2000 are as follows:
Name Age Position ---- --- -------- Felix Theeuwes, D.S.C. .......... 62 Chairman, Chief Scientific Officer and Director James E. Brown, D.V.M. .......... 43 President, Chief Executive Officer and Director Thomas A. Schreck................ 42 Chief Financial Officer and Director Edward M. Gillis................. 38 Vice President, Engineering Randolph M. Johnson, Ph.D. ...... 49 Vice President, Pharmacology and Toxicology, Director of CNS Programs Jean I Liu....................... 31 Vice President, Legal & General Counsel Judy A. Magruder................. 41 Vice President, Regulatory & Development Timothy S. Nelson................ 36 Vice President, Business and Commercial Development Scott M. Wheelwright, Ph.D. ..... 45 Vice President, Manufacturing James R. Butler(2)............... 59 Director John L. Doyle(2)................. 68 Director Douglas A. Lee(1)................ 35 Director Matthew V. McPherron(1)(2)....... 35 Director Albert L. Zesiger(1)............. 70 Director |
Felix Theeuwes, D.S.C. co-founded DURECT in February 1998 and has served as our Chairman, Chief Scientific Officer and a Director since July 1998. He is also currently a consultant to ALZA Corporation, a pharmaceutical and drug delivery company which is an affiliate of us. Prior to that, Dr. Theeuwes held various positions at ALZA Corporation, including President of New Ventures from August 1997 to August 1998, President of ALZA Research and Development from 1995 to August of 1997, President of ALZA Technology Institute from 1994 to April 1995 and Chief Scientist from 1982 to June 1997. Dr. Theeuwes is also a director of Genetronics, a medical device company, and several private companies. Dr. Theeuwes holds a D.Sc. degree in Physics from the University of Leuven (Louvain), Belgium. He also served as a post-doctoral fellow and visiting research assistant professor in the Department of Chemistry at the University of Kansas and has completed the Stanford Executive Program.
James E. Brown, D.V.M. co-founded DURECT in February 1998 and has served as our President, Chief Executive Officer and a Director since June 1998. He previously worked at ALZA Corporation as Vice President of Biopharmaceutical and Implant Research and Development from June 1995 to June 1998. Prior to that, Dr. Brown held various positions at Syntex Corporation, a pharmaceutical company, including Director of Business Development from May 1994 to May 1995, Director of Joint Ventures for Discovery Research from April 1992 to May 1995, and held a number of positions including Program Director for Syntex Research and Development from October 1985 to March 1992. Dr. Brown holds a B.A. from San Jose State University and a D.V.M. (Doctor of Veterinary Medicine) from the University of California, Davis where he also conducted post-graduate work in pharmacology and toxicology.
Thomas A. Schreck co-founded DURECT in February 1998 and served as Chief Executive Officer, Chief Financial Officer and President from February 1998 to June 1998. Since June 1998, he has served as our Chief Financial Officer and a Director. Prior to founding DURECT, he founded and was President of Schreck Merchant Group, Inc., an investment bank specializing in private placements and mergers and acquisitions, from June 1994 to February 1998. Mr. Schreck also founded and served as Risk Manager to Genesis Merchant Group/Portola Capital Partners, L.P., a convertible arbitrage fund, from 1993 to 1994. He also served as a Manager of the Convertible Securities Department at Montgomery Securities, from 1988 to 1991. Mr. Schreck received a B.A. from Williams College.
Edward M. Gillis has served as our Vice President of Engineering since March 2000. Prior to that, Mr. Gillis served as our Executive Director of Engineering from April 1999 to March 2000. Prior to that he served as our Director of Engineering from October 1998 to April 1999. From March 1997 to October 1998, Mr. Gillis served as the Director of Pilot Manufacturing and Process Engineering at EndoTex Interventional Systems, a private medical device company. From July 1993 to March 1997, Mr. Gillis served as Director of Catheter Ablation Product Development and Manufacturing Engineering Manager at Cardiac Pathways Corporation, a medical device company. Mr. Gillis holds a B.S. in Biological Sciences and an M.S. in Plastics Engineering from the University of Lowell.
Randolph M. Johnson, Ph.D. has served as our Vice President and Director of Toxicology and Pharmacology and Director of CNS (Central Nervous System) Programs since September 1998. From July 1995 to September 1998, Dr. Johnson held various positions at Roche Bioscience, a pharmaceutical company. From July 1995 to October 1997 Dr. Johnson served as the Department Head of Neurobiology, Center for Biological Research and from October 1997 to September 1998, as the Department Head of Molecular & Cellular Biochemistry, Center for Biological Research. From January to June 1995, Dr. Johnson served as the Director of Preclinical Development at Syntex Development Research, a pharmaceutical company. Dr. Johnson received a B.S. in Zoology from California State University, Long Beach, an M.A. in Biology-Physiology from California State University, Long Beach and a Ph.D. in Biomedical Science-Pharmacology from the University of South Carolina School of Medicine. In addition, he was a Postdoctoral Research Associate in the Department of Pharmacology at the University of Virginia School of Medicine.
Jean I Liu has served as our Vice President of Legal and General Counsel since February 1999. Previously, from October 1998, Ms. Liu served as our Vice President of Legal. Prior to that, Ms. Liu worked as an attorney at Venture Law Group, a law firm, from May 1997 to October 1998. Ms. Liu worked as an attorney at Pillsbury Madison & Sutro LLP, a law firm, from September 1993 to May 1997. Ms. Liu received a B.S. in Cellular & Molecular Biology from University of Michigan, an M.S. in Biology from Stanford University and a J.D. from Columbia University School of Law.
Judy A. Magruder has served as our Vice President of Regulatory and Development since February 2000. From March 1999 to February 2000, Ms. Magruder served as our Executive Director of Regulatory and Product Development. Prior to that, Ms. Magruder served as Director of Product Development at Vascular Therapeutics, Inc., a private pharmaceuticals company, from January 1998 to March 1999. Ms. Magruder held various positions at ALZA Corporation, including Head of Program Management, Implant Development and a Research Scientist from February 1996 to January 1998, Product Development Manager/Program Manager as well as Research Scientist from January 1991 to February 1996, and Chemist from May 1984 to April 1989. Ms. Magruder received a B.S. in Animal Science from the University of California, Davis and an M.B.A. from Santa Clara University.
Timothy S. Nelson has served as our Vice President of Business and Commercial Development since September 1998. Previously, Mr. Nelson held various positions at Medtronic, Inc., a medical device company, including Business Director of Neurological Division, Europe, Middle East and Africa from June 1996 to September 1998, and Manager of Drug Delivery Ventures and Business Development from August 1992 to June 1996. Mr. Nelson holds a Bachelor of Chemical Engineering degree from the University of Minnesota and a Master of Management degree with Distinction from the J.L. Kellogg Graduate School of Management, Northwestern University.
Scott M. Wheelwright, Ph.D. has served as our Vice President of Manufacturing since February 2000. Previously, Dr. Wheelwright was the Vice President of Development and Manufacturing at Calydon, Inc., a privately held biotechnology company developing cancer therapeutics, from March 1998 to February 2000. From October 1992 to March 1998, he served as Senior Director of Process Development, Manufacturing and Engineering at Scios Inc., a biotechnology company. Dr. Wheelwright holds a B.S. in Chemical Engineering from the University of Utah, a Ph.D. in Chemical Engineering from the University of California, Berkeley, and conducted post-doctoral research at the Max Planck Institute for Biophysics in Frankfurt, Germany.
James R. Butler has served as a Director since July 1999. Mr. Butler is currently an employee of ALZA where he holds two positions. Mr. Butler joined ALZA in July 1993 as Vice President of Sales and Marketing and in January 2000, Mr. Butler became the Group Vice President of ALZA International. Mr. Butler is also a director of Aronex Pharmaceuticals, a pharmaceutical company. Mr. Butler holds a B.A. in Business Administration from the University of Florida.
John L. Doyle has served as a Director since February 2000. Mr. Doyle is currently an independent consultant. In 1957, he joined Hewlett-Packard, a computer company, where from 1957 to 1991 he served in several manufacturing and general management positions, including the Vice President of Personnel from 1976 to 1980, Vice President of Research and Development from 1980 to 1984, Executive Vice President of the Computer Sector from 1984 to 1988, and of Business Development until his retirement in 1991. Mr. Doyle studied naval architecture at Glasgow University and holds a B.S. in Mechanical Engineering as well as an M.S. in Electrical Engineering and Business from Stanford University. Mr. Doyle is also a director of Analog Devices Inc., a semiconductor company, Dupont Photomasks Inc., a manufacturer of semiconductor manufacturing equipment, and Xilinx Inc., a semiconductor company.
Douglas A. Lee has served as a Director since June 1998. Since February 2000, he has been Senior Vice President of Business Development for drspock.com, Inc., a health care internet company. From September 1997, until joining drspock.com, Mr. Lee served as Managing Director of Premier Medical Partner Fund L.P, a health care venture capital fund. From October 1995 to February 1997, Mr. Lee worked at Guidant Corporation, a medical device company, where he was Vice President and Chief Financial Officer of its new ventures and corporate business development group. From March 1994 to April 1995, Mr. Lee was Vice President and Chief Financial Officer to Genelabs Technologies, Inc., a biotechnology company. Mr. Lee is also a Director of Atrionix, Inc., a private medical device company. Mr. Lee received a B.S. from the University of California, Berkeley and an M.B.A. from the University of Chicago.
Matthew V. McPherron has served as a Director since July 1999. Since June 1998, Mr. McPherron has been a Director of Brookside Capital Partners Fund, L.P. Previously, Mr. McPherron served as the President and Chief Operating Officer of US Carelink, a health care internet company from September 1997 to March 1998. From August 1993 to September 1997, Mr. McPherron served in a number of roles at Medtronic, Inc., most recently as the Global Marketing Manager for Pain Therapy. Mr. McPherron holds a B.S. from the University of Kansas and an M.B.A. from the Harvard Graduate School of Business Administration.
Albert L. Zesiger has served as a Director since 1998. Mr. Zesiger is a Founding Principal of Zesiger Capital Group, LLC, an investment advisory firm, which Mr. Zesiger co-founded in October 1995. In 1968, Mr. Zesiger founded BEA Associates, Inc., an investment advisory firm, which in 1995 became wholly- owned by CS Holdings, the holding company for Credit Suisse Bank and CS First Boston. Mr. Zesiger also serves on the Board of Directors of Eos Biotechnology, Inc., Hayes Medical Inc., Praecis Pharmaceuticals Inc., and ViroLogic Inc. Mr. Zesiger holds a B.S. in Engineering from the Massachusetts Institute of Technology and an M.B.A. from the Harvard Graduate School of Business Administration.
Board Composition
Directors are elected annually at our annual meeting of stockholders, and serve for the term for which they are elected and until their successors are duly elected and qualified. Our bylaws currently provide for a board of directors comprised of eight directors.
Board Compensation
None of the directors is paid any fee or other cash compensation for acting as a director. Our officers are appointed by the board of directors and serve at its discretion. Directors who are our employees are eligible to participate in our 1998 stock option plan and in our 2000 stock plan and, beginning upon the effectiveness of the registration statement used in this offering, they will also be eligible to participate in our 2000 employee stock
option plan. Mr. Butler acquired 15,000 shares of our common stock at a purchase price of $.20 per share upon exercise of an option granted under the 1998 stock option plan. These shares our subject to our right of repurchase in the event of a termination of Mr. Butler's services to us, which repurchase right lapses at a rate of 1/3 of the shares on each anniversary of the date of the grant. Mr. Doyle was granted an option to purchase 15,000 shares of common stock under the 2000 stock plan at an exercise price of $.35 per share in February 2000 and 1/3 of the shares vest on each anniversary of the date of grant. Mr. Lee acquired 15,000 shares of our common stock at a purchase price of $.20 per share upon exercise of an option granted under the 1998 stock option plan. These shares are subject to our right of repurchase in the event of a termination of Mr. Lee's services to us, which repurchase right lapses at the rate of 1/3 of the shares on each anniversary of the date of grant. Upon the effectiveness of the registration statement used in this offering, directors who are not our employees will be eligible to participate in our 2000 directors' stock option plan. See "Employee Benefit Plans."
We have entered into indemnification agreements with each member of the board of directors and our executive officers providing for the indemnification of such person to the fullest extent authorized, permitted or allowed by law.
Board Committees
The board of directors has a compensation committee that reviews and recommends the compensation arrangements for our management. The members of the compensation committee are James R. Butler, John L. Doyle, and Matthew V. McPherron.
The board of directors has an audit committee that reviews our annual audit and meets with our independent auditors to review our internal controls and financial management practices. The board's audit committee currently consists of Douglas A. Lee, Matthew V. McPherron and Albert L. Zesiger. The functions of the audit committee are to make recommendations to the board of directors regarding the selection of independent auditors, review the results and scope of the audit and other services provided by our independent auditors and review and evaluate our audit and control functions.
Compensation Committee Interlocks and Insider Participation
The members of the compensation committee of our board of directors are currently James R. Butler, John L. Doyle, and Matthew V. McPherron. Neither Mr. Butler, Mr. Doyle, nor Mr. McPherron has at any time been an officer or employee of DURECT or any of our subsidiaries. The Chief Executive Officer, President and Chief Scientific Officer are entitled to be non-voting participants in each meeting of the compensation committee and are excused from any discussion that relates to their own compensation.
Limitation on Liability and Indemnification Matters
Our certificate of incorporation and bylaws limit or eliminate the personal liability of our directors for monetary damages for breach of the directors' fiduciary duty of care. The duty of care generally requires that, when acting on behalf of the corporation, directors exercise an informed business judgment based on all material information reasonably available to them. Consequently, our directors or officers will not be personally liable to us or our stockholders for monetary damages for breach of their fiduciary duty as a director, except for:
. any breach of the director's duty of loyalty to us or our stockholders;
. acts or omissions not in good faith or that involve intentional misconduct or a knowing violation of law;
. unlawful payments of dividends or unlawful stock repurchases, redemptions or other distributions; and
. any transaction from which the director derived an improper personal benefit.
These provisions are permitted under Delaware law.
Our certificate of incorporation also provides that we will indemnify, to the fullest extent permitted by law, any person made or threatened to be made a party to any action or proceeding by reason of the fact that he or she is or was one of our directors or officers or serves or served at any other enterprise as a director, officer or employee at our request.
Our bylaws provide that we will, to the maximum extent and in the manner permitted by Delaware law, indemnify each of the following persons against expenses, including attorneys' fees, judgments, fines, settlements, and other amounts incurred in connection with any proceeding arising by reason of the fact that he or she is or was our agent:
. one of our current or past directors or officers;
. a current or past director or officer of another enterprise who served at our request; or
. a current or past director or officer of a corporation that was our predecessor corporation or of another enterprise at the request of a predecessor corporation.
We have entered into indemnification agreements with each of our directors and executive officers to give them additional contractual assurances regarding the scope of the indemnification described above and to provide additional procedural protections. These agreements, among other things, indemnify our directors and executive officers for certain expenses, including attorneys' fees, judgments, fines, penalties and settlement amounts incurred by them in any action or proceeding arising out of their services to us, our subsidiaries or any other enterprise to which they provide services at our request. In addition, we have directors' and officers' insurance providing indemnification for our directors, officers and certain employees for certain liabilities. We believe that these indemnification provisions and agreements are necessary to attract and retain qualified directors and officers.
The limited liability and indemnification provisions in our certificate of incorporation and bylaws may discourage stockholders from bringing a lawsuit against directors for breach of their fiduciary duty and may reduce the likelihood of derivative litigation against directors and officers, even though a derivative action, if successful, might otherwise benefit us and our stockholders. Furthermore, a stockholder's investment in us may be adversely affected to the extent we pay the costs of settlement and damage awards against our directors and officers under these indemnification provisions.
Executive Compensation
The following table provides certain summary information concerning the compensation earned for services rendered to us during the fiscal year ended December 31, 1999 by our Chief Executive Officer and our four other most highly compensated executive officers who earned more than $100,000 in 1999 and were serving as executive officers at the end of 1999, whom we refer to collectively as the named executive officers.
Summary Compensation Table
Long-Term Annual Compensation Compensation ---------------------------------- ------------ Securities Name and Principal Other Annual Underlying All Other Position Year Salary($) Bonus($) Compensation($) Options(#) Compensation($) ------------------ ---- --------- -------- --------------- ------------ --------------- James E. Brown, D.V.M... 1999 225,000 -- -- -- -- President, Chief Executive Officer and Director Felix Theeuwes, D.R.S... 1999 177,564 -- -- -- -- Chairman, Chief Scientific Officer Thomas A. Schreck(1).... 1999 200,000 -- -- -- -- Chief Financial Officer and Director Timothy S. Nelson....... 1999 165,000 -- -- 88,500 24,543(2) Vice President, Business & Commercial Development Randolph M. Johnson, Ph.D................... 1999 160,000 -- -- 20,000 -- Vice President, Pharmacology & Toxicology, Director of CNS Programs |
(2) Mr. Nelson receives $24,543 per year for three years, beginning in 1999, for a housing allowance.
Option Grants During Year Ended December 31, 1999
The following table sets forth certain information for the year ended December 31, 1999 with respect to grants of stock options to each of the named executive officers. All options granted by us in 1999 were granted under our 1998 stock option plan. These options have a term of 10 years. See "Employee Benefit Plans" for a description of the material terms of these options. We granted options to purchase common stock and issued shares of common stock pursuant to restricted stock purchase agreements equal to a total of 934,500 shares during 1999. Options were granted at an exercise price equal to the fair market value of our common stock, as determined in good faith by our board of directors. Potential realizable values are net of exercise price before taxes, and are based on the assumption that our common stock appreciates at the annual rate shown, compounded annually, from the date of grant until the expiration of the ten-year term. These numbers are calculated based on Securities and Exchange Commission requirements and do not reflect our projection or estimate of future stock price growth. Unless the market price of the common stock appreciates over the option term, no value will be realized from the option grants made to executive officers. Actual gains, if any, on stock option exercises will be dependent on the future performance of our common stock. The assigned 5% and 10% rates of stock appreciation are based on the fair market value of our common stock at December 31, 1999.
Individual Grants --------------------------------------------- Potential Realizable Value At Assumed Number Of Percent Of Annual Rates of Stock Securities Total Options Price Appreciation Underlying Granted To Exercise for Option Term Options Employees In Price Expiration --------------------- Name Granted(#) Fiscal Year ($/Share) Date 5% 10% ---- ---------- ------------- --------- ---------- ---------- ---------- James E. Brown.......... -- -- -- -- -- -- Felix Theeuwes.......... -- -- -- -- -- -- Thomas A. Schreck....... -- -- -- -- -- -- Timothy S. Nelson....... 88,500 9.5% $0.35 (1) $ 19,480 $ 49,366 Randolph M. Johnson..... 20,000 2.1% $0.35 12/9/2009 $ 4,402 $ 11,156 |
Aggregated Option Exercises in Last Fiscal year and 1999 Year-End Option Values
The following table sets forth information with respect to the named executive officers concerning exercisable and unexercisable options held as of December 31, 1999. The value of in-the-money options is based on an assumed offering price of $ per share and net of the option exercise price.
Number of Securities Underlying Unexercised Value of Unexercised Shares Options at In-the-Money Options at Acquired on Value December 31, 1999 December 31, 1999 Name Exercise(#) Realized($) Exercisable Unexercisable Exercisable Unexercisable ---- ----------- ----------- ------------------------- ------------------------- James E. Brown.......... 0 -- --/-- Felix Theeuwes.......... 0 -- --/-- Thomas A. Schreck....... 0 -- --/-- Timothy S. Nelson....... 0 -- 302,500/0 Randolph M. Johnson..... 0 -- 170,000/0 |
Options shown above were granted under the 1998 stock option plan and vest at a rate of 25% of the shares on each twelve month anniversary of the vesting commencement date. Notwithstanding the foregoing, all options are immediately exercisable; however, the underlying shares are subject to our right of repurchase at the original purchase price. Such repurchase right will lapse with respect to 25% of the shares on each twelve month anniversary of the vesting commencement date.
Employment Agreements
We have entered into an employment agreement with James E. Brown, our Chief Executive Officer and President, for a term of three years starting on June 19, 1998. The agreement acknowledges that for the first twelve months of employment Dr. Brown would perform services for ALZA Corporation, but after that period, he became a full time employee of DURECT. The agreement also provides that Dr. Brown will be paid an annual salary of $225,000 and makes him eligible for any salary, stock option, bonus and other benefits we offer. In the event of involuntary termination, Dr. Brown is entitled to his regular monthly salary for the remainder of the original term of the employment agreement, any bonus payable, and continued health insurance benefits. In the event of termination for cause, Dr. Brown is entitled to his accrued unpaid salary and vacation. In the event of termination by reason of death or disability, Dr. Brown or his estate is entitled to all salary and unpaid vacation accrued and any other benefits payable under our then existing benefit plans. In the event of a constructive termination, Dr. Brown is entitled to a lump sum payment of the salary we would have paid him during the twelve-month period following his termination, as well as continuing health insurance benefits for the twelve-month period following his termination.
We have entered into an employment agreement with Felix Theeuwes, our Chairman and Chief Scientific Officer, for a term of three years starting on June 19, 1998. His duties also include arranging funding and participating in overall management of the company. The agreement acknowledges that for the first twelve months of employment Dr. Theeuwes would perform services for ALZA Corporation, but after that period, he became a full time employee of DURECT. The agreement also provides that Dr. Theeuwes will be paid an annual salary of $250,000 to be reduced by an amount to reflect his time and work for ALZA Corporation and makes him eligible for any salary, stock option, bonus and other benefits we may offer. In the event of involuntary termination, Dr. Theeuwes is entitled to his regular monthly salary for the remainder of the original term of the employment agreement, any bonus payable, and continued health insurance benefits. In the event of termination for cause, Dr. Theeuwes is entitled to his accrued unpaid salary and vacation. In the event of termination by reason of death or disability, Dr. Theeuwes or his estate is entitled to all salary and unpaid vacation accrued and any other benefits payable under our then existing benefit plans. In the event of a constructive termination, Dr. Theeuwes is entitled to a lump sum payment of the salary we would have paid him during the twelve-month period following his termination, as well as continuing health insurance benefits for the twelve- month period following his termination.
We have entered into an employment agreement with Thomas A. Schreck, the Chief Financial Officer for a term of three years starting June 19, 1998. The agreement acknowledges the financial relationship with Schreck Merchant Group Inc., of which Mr. Schreck is a principal, for financial services. The agreement also provides for an annual salary of $100,000 for Mr. Schreck for the first two years of the term and an increase in his annual salary to $200,000 effective on June 19, 2000. The agreement also makes him eligible for any salary, stock option, bonus and other benefits we may offer. In the event of involuntary termination, Mr. Schreck is entitled to his regular monthly salary for the remainder of the original term of the employment agreement, any bonus payable, and continued health insurance benefits. In the event of termination for cause, Mr. Schreck is entitled to accrued unpaid salary and vacation. In the event of termination by reason of death or disability, Mr. Schreck or his estate is entitled to all salary and unpaid vacation accrued and any other benefits payable under our then existing benefit plans. In the event of a constructive termination, Mr. Schreck is entitled to a lump sum payment of the salary we would have paid him during the twelve-month period following his termination, as well as continuing health insurance benefits for the twelve-month period following his termination.
We have entered into change of control agreements with Randolph M. Johnson and Timothy S. Nelson. These agreements provide that, in the event of a change in our control, one half of the unvested portion of any stock option or restricted stock held by Dr. Johnson and Mr. Nelson on the effective date of the change of control is automatically accelerated so as to become completely vested as of the effective date, unless such acceleration would make us ineligible for "pooling of interests" accounting treatment in a transaction. In addition, in the event of a termination without cause within the twelve months following the change in our control, the number
of shares which would have vested in the second twelve month period following the change of control is automatically accelerated so as to become completely vested as of the effective date of the termination unless the acceleration would make us ineligible for "pooling of interests" accounting treatment in the change in control transaction.
Employee Benefit Plans
2000 Stock Plan.
Adoption and Reserved Shares. Our 2000 stock plan was adopted by our board of directors and approved by our stockholders in March 2000. It provides for the grant of incentive stock options to employees and nonstatutory stock options and stock purchase rights to employees and consultants, including nonemployee directors. As of March 31, 2000, 1,796,500 shares were reserved for issuance under the 2000 stock plan of which 1,265,650 remain available for future grants. In addition, the 2000 stock plan was amended in April 2000 to provide for an automatic annual increase to the shares reserved under the plan (an "evergreen" provision) on the first day of each of our fiscal years beginning in 2001 and ending in 2010 in an amount equal to the lesser of:
. 2,250,000 shares;
. 5% of our outstanding common stock on the last day of the immediately preceding fiscal year; or
. a lesser number of shares as determined by the board of directors.
Purposes of the 2000 Stock Plan. The purposes of the 2000 stock plan are to attract and retain the best available personnel, to provide additional incentives to our employees and consultants and to promote the success of our business.
Eligible Persons and Types of Options. The 2000 stock plan provides for the granting to employees, including officers and directors, of incentive stock options within the meaning of Section 422 of the Internal Revenue Code of 1986, as amended. The 2000 stock plan also provides for the granting to employees and consultants, including non-employee directors, of nonstatutory stock options and stock purchase rights.
Administration. The 2000 stock plan may be administered by the board of directors or a committee of the board, each known as the administrator. The administrator determines the terms of options and stock purchase rights granted under the 2000 stock plan, including the number of shares subject to the award, the exercise or purchase price, the term and the vesting and exercisability of the award and other conditions to which the award is subject. In no event, however, may an individual employee receive awards for more than 1,500,000 shares under the 2000 stock plan in any fiscal year. Decisions of the administrator are final and binding on all 2000 stock plan participants.
Exercise Price. The exercise price of all incentive stock options granted under the 2000 stock plan must be at least equal to the fair market value of our common stock on the date of grant. The exercise price of any incentive stock option granted to a person who owns stock representing more than 10% of the total combined voting power of all classes of our outstanding capital stock or the stock of our parent or subsidiary corporations must equal at least 110% of the fair market value of the common stock on the date of grant. Before this offering, the exercise of nonstatutory stock options and stock purchase rights granted under the 2000 stock plan must have been at least equal to 85% of the fair market value of our common stock on the date of grant. After the date of this offering, the exercise price of nonstatutory stock options and the purchase price of stock purchase rights will no longer be subject to these limitations. However, incentive stock options and stock purchase rights granted to our Chief Executive Officer and our four other most highly compensated officers will be at least 100% of the fair market value of the common stock on the date of grant if the award is intended to qualify as performance based compensation under Section 162(m) of the Internal Revenue Code. Payment of the exercise price may be made in cash or other consideration as determined by the administrator.
Other Option Terms. The administrator determines the term of options, which may not exceed 10 years, or 5 years in the case of an incentive stock option granted to an employee who owns stock representing more
than 10% of the total voting power of our outstanding capital stock or a parent or subsidiary's stock. Generally, an option may not be transferred by the option holder other than by will or the laws of descent or distribution and may be exercised during the lifetime of the option holder only by such option holder. However, the administrator may in its discretion provide for the limited transferability of nonstatutory stock options granted under the 2000 stock plan under specified circumstances. The administrator determines when options become exercisable. Options granted under the 2000 stock plan are generally subject to vesting at a rate of 25% of the shares granted on each of the first, second, third and fourth anniversaries of the date of grant. Stock purchased pursuant to stock purchase rights granted under the 2000 stock plan is generally subject to a repurchase right at the purchaser's original purchase price. This repurchase right will lapse according to the terms of the stock purchase right determined by the administrator and is exercisable by us upon termination of the purchaser's employment or consulting relationship with us, for any reason, including death or disability. Stock options under the 2000 stock plan generally remain exercisable for a period of three months following termination of the optionee's employment or consulting relationship with us (with longer periods applying in the event such termination occurs as a result of death or disability).
Change of Control. In a merger, reorganization or similar transaction involving us, each outstanding option shall be assumed by the successor corporation or an equivalent option substituted for it, with appropriate adjustments made to both the price and number of shares subject to each option. If the successor corporation does not assume the options or substitute new options, then the outstanding options will be fully vested and exercisable immediately prior to the effective date of the transaction. Outstanding repurchase rights will terminate on the effective date of the transaction unless assigned to the successor corporation. Outstanding options will adjust in the event of a stock split, stock dividend or other similar change in our capital structure.
Amendment and Termination. The administrator has the authority to amend or terminate the 2000 stock plan as long this action does not adversely affect any outstanding option and provided that stockholder approval shall be obtained as required by applicable law. The 2000 stock plan will terminate in March 2010 unless the board of directors terminates it earlier.
1998 Stock Option Plan.
Adoption and Initial Reserve. Our 1998 stock option plan was originally adopted by our board of directors and approved by our stockholders in March 1998. As of March 31, 2000, an aggregate of 1,703,500 shares was reserved for issuance under the 1998 stock option plan, 418,500 shares of common stock were issuable upon exercise of outstanding options granted under the 1998 stock option plan at a weighted average exercise price of $0.24, 1,222,750 shares of common stock have been issued upon exercise of options at purchase prices ranging between $0.10 and $0.35, and no shares of common stock remained available for future issuance under the 1998 stock option plan. In connection with the adoption of the 2000 stock plan, the board of directors determined that no further grants would be made under the 1998 stock option plan.
Option Terms. The terms of the options under the 1998 stock option plan are generally the same as those that may be issued under the 2000 stock plan, except for the following features. Only options could be granted under the 1998 stock option plan. Nonstatutory stock options granted under the 1998 stock option plan are nontransferable in all cases and must be granted with an exercise price of at least 85% of the fair market value of the common stock on the date of grant. The 1998 stock option plan does not impose a limitation on the number of shares subject to options that may be issued to any individual employee.
Change of Control. In a merger, reorganization or similar transaction involving us, each outstanding option shall be assumed by the successor corporation or an equivalent option substituted for it, with appropriate adjustments made to both the price and number of shares subject to each option. If the successor corporation does not assume the options or substitute new options, then the outstanding options will be fully vested and exercisable immediately prior to the effective date of the transaction. Outstanding options will adjust in the event of a stock split, stock dividend or other similar change in our capital structure.
2000 Employee Stock Purchase Plan.
Adoption and Reserved Shares. Our 2000 employee stock purchase plan was adopted by the board of directors in April 2000 and will be submitted to our stockholders for approval before completion of this offering. A total of 150,000 shares of common stock has been reserved for issuance under the purchase plan, none of which have been issued as of the date of this offering. The number of shares reserved for issuance under the purchase plan will be subject to an automatic annual increase on the first day of each of our fiscal years beginning in 2001 and ending in 2010 in an amount equal to the lesser of:
. 225,000 shares;
. 0.5% of our outstanding common stock on the last day of the immediately preceding fiscal year; or
. a lesser number of shares as determined by the board of directors.
The purchase plan becomes effective on the date of this offering. Unless terminated earlier by our board of directors, the purchase plan will terminate in 2010.
Offering Periods. The purchase plan, which is intended to qualify under
Section 423 of the Code, will be implemented by a series of overlapping
offering periods of approximately 24 months' duration, with new offering
periods, other than the first offering period, beginning on August 1 and
February 1 of each year and ending on July 31 and January 31, respectively,
two years later. Each offering period will consist of four consecutive
purchase periods of approximately six months' duration. The initial offering
period is expected to begin on the date of this offering and end on July 31,
2002; the initial purchase period is expected to end on January 31, 2001.
Administration. The purchase plan will be administered by the board of directors or by a committee appointed by the board.
Plan Terms. Our employees, including our officers, or employees of any majority-owned subsidiary designated by the board of directors, are eligible to participate in the purchase plan if they are employed by us or any such subsidiary for at least 20 hours per week and more than five months per year. The purchase plan permits eligible employees to purchase common stock through payroll deductions, which may not exceed 20% of an employee's base salary, at a price equal to the lower of 85% of the fair market value of our common stock at the beginning of each offering period or at the end of each purchase period. Employees may end their participation in an offering at any time during an offering period, and participation ends automatically on termination of employment with us. An employee cannot be granted an option under the purchase plan if immediately after the grant the employee would own stock or hold outstanding options to purchase stock equaling 5% or more of the total voting power or value of all classes of our stock or stock of our subsidiaries, or if the option would permit an employee's rights to purchase stock under the purchase plan to accrue at a rate that exceeds $25,000 of the fair market value of the stock for each calendar year in which an option is outstanding. In addition, no employee may purchase more than 2,000 shares of common stock under the purchase plan in any one purchase period.
Change of Control. The purchase plan provides that in the event of our merger with or into another corporation or a sale of all or substantially all of our assets, each right to purchase stock under the purchase plan will be assumed or an equivalent right substituted by the successor corporation. However, if the successor corporation refuses to assume each purchase right or to substitute an equivalent right, our board of directors will shorten any ongoing offering period so that employees' rights to purchase stock under the purchase plan are exercisable before the effective date of the transaction. Outstanding options will adjust in the event of a stock split, stock dividend or other similar change in our capital structure.
Amendment and Termination. The board of directors has the power to amend or terminate the purchase plan as long as the action does not adversely affect any outstanding rights to purchase stock under the plan. However, our board of directors may amend or terminate the purchase plan or an offering period even if it would adversely affect outstanding options to avoid our incurring adverse accounting charges or if the board of directors
determines that termination of the plan or offering period is in our best interests and the best interests of our stockholders. We must obtain stockholder approval for any amendment to the purchase plan to the extent required by applicable law.
2000 Directors' Stock Option Plan.
Adoption and Initial Reserve. The 2000 directors' stock option plan was adopted by the board of directors in April 2000 and will be submitted to our stockholders for approval before completion of this offering. A total of 300,000 shares of common stock has been reserved for issuance under the directors' plan. No shares have been issued under the directors' plan. The directors' plan becomes effective on the date of this offering.
Eligible Persons and Administration. The directors' plan provides for the grant of nonstatutory stock options to our nonemployee directors. The directors' plan is designed to work automatically without administration. However, to the extent administration is necessary, it will be performed by the board of directors.
Option Terms. The directors' plan provides that each person who becomes one of our nonemployee directors after the effective date of this offering will be granted a nonstatutory stock option to purchase 20,000 shares of common stock on the date on which the optionee first becomes a nonemployee director of ours. On the date of our annual stockholder meeting each year, each of our nonemployee directors will be granted an option to purchase 5,000 shares of common stock if, on such date, the director has served on our board of directors for at least six months. The directors' plan sets neither a maximum nor a minimum number of shares for which options may be granted to any one nonemployee director. The directors' plan specifies the number of shares that may be included in any grant and the method of making a grant.
The directors' plan provides that each option granted to a new director shall vest at the rate of 33 1/3% per year and each annual option granted to a director shall vest in full at the end of one year. No option granted under the directors' plan is transferable by the option holder other than by will or the laws of descent or distribution or pursuant to a qualified domestic relations order, and each option is exercisable, during the lifetime of the option holder, only by that option holder. If a nonemployee director ceases to serve as a director for any reason other than death or disability, he or she may, but only within 90 days after the date he or she ceases to be a director of DURECT, exercise vested options granted under the directors' plan. If the director does not exercise the option which the director was entitled to exercise within this 90-day period, the option shall terminate. The exercise price of all stock options granted under the directors' plan shall be equal to the fair market value of a share of our common stock on the date of grant of the option. Options granted under the directors' plan have a term of ten years. Outstanding options will adjust in the event of a stock split, stock dividend or other similar change in our capital structure.
Change of Control. If we sell all or substantially all of our assets or merge with another company or conduct another similar transaction, whether or not options are assumed, substituted for or terminated in connection with the transaction, the vesting of each outstanding option shall accelerate in full such that each option holder shall have the right to exercise his or her option as to all of the optioned stock, including shares as to which the option would not otherwise be exercisable, immediately prior to consummation of the transaction.
Amendment and Termination. The board of directors may amend or terminate the directors' plan. However, no action may adversely affect any outstanding option and we must obtain stockholder approval for any amendment to the extent required by applicable law. If not terminated earlier, the directors' plan will terminate in April 2010.
Limitation of Liability and Indemnification Matters
As permitted by the Delaware General Corporation Law, we have included in our restated certificate of incorporation a provision eliminating the personal liability of our officers and directors for monetary damages for breach or alleged breach of their fiduciary duties as officers or directors, respectively, subject to certain
exceptions. In addition, our bylaws provide that we are required to indemnify our officers and directors under certain circumstances and we are required to advance expenses to our officers and directors as incurred in connection with proceedings against them for which they may be indemnified. We have entered into indemnification agreements with our officers and directors containing provisions that are in some respects broader than the specific indemnification provisions contained in the Delaware Law. The indemnification agreements require us, among other things, to indemnify our officers and directors against certain liabilities that may arise by reason of their status or service as officers and directors (other than liabilities arising from willful misconduct of a culpable nature), to advance their expenses incurred as a result of any proceeding against them as to which they could be indemnified, and to obtain directors' and officers' insurance if available on reasonable terms. We have also obtained directors' and officers' liability insurance.
At present, we are not aware of any pending or threatened litigation or proceeding involving any of our directors, officers, employees or agents in which indemnification would be required or permitted. We are not aware of any threatened litigation or proceeding that might result in a claim for such indemnification. We believe that our charter provisions and indemnification agreements are necessary to attract and retain qualified persons as directors and officers.
CERTAIN TRANSACTIONS
Private Placements of Securities
In June 1998, we sold 5,600,000 shares of our Series A-1 preferred stock to ALZA Corporation in consideration of the execution and delivery of our Development and Commercialization Agreement, dated April 21, 1998 with ALZA Corporation. This agreement is for the development, manufacture and marketing of pharmaceutical products utilizing proprietary technology of ALZA relating to the DUROS system for controlled delivery of drugs in select fields.
In June 1998, we sold 5,636,000 shares of our Series A-2 preferred stock for $1.00 per share and in December 1998, we sold 3,005,867 shares of our Series A-2 preferred stock for $1.25 per share. The purchasers of the Series A-2 preferred stock included among others, Premier Medical Partner Fund L.P., State of Oregon PERS/ZCG, James R. Butler, a director of DURECT, Albert L. Zesiger, a director of DURECT, Barrie Ramsay Zesiger, the spouse of Albert L. Zesiger, and the Zesiger Capital Group LLC, whose principal is Albert L. Zesiger.
In July 1999, we sold an aggregate of 9,364,341 shares of our Series B preferred stock for $2.15 per share. The purchasers of the Series B preferred stock included, among others, Brookside Capital Partners Fund, L.P., Morgan Guaranty Trust Company of New York, as Trustee for the Co-Mingled Pension Trust Fund and the Multi-Market Special Investment Trust Fund, Morgan Guaranty Trust Company of New York, as Agent and Investment Manager of The Alfred P. Sloan Foundation, and Premier Medical Partners Fund L.P.
In October 1999, we sold 325,023 shares of our Series B-1 preferred stock to IntraEAR, Inc. in consideration of the execution and delivery of the Asset Purchase Agreement, dated September 24, 1999 between IntraEAR, Inc. and DURECT.
In March 2000, we sold an aggregate of 3,571,429 shares of our Series C preferred stock for $7.00 per share. The purchasers of the Series C preferred stock included, among others, Biotech Growth S.A. (funds controlled by BB Biotech), Brookside Capital Partners Fund, L.P., and the Zesiger Capital Group LLC, whose principal, Albert L. Zesiger, is also a director of DURECT.
In April 2000, we amended our development and commercialization agreement with ALZA. The amendments included a reduction in product royalties and upfront payments to ALZA by us under the agreement. In addition, ALZA's option to distribute the DUROS sufentanil product was amended to cover only the U.S. and Canada instead of worldwide. As consideration, ALZA received 1,000,000 shares of our common stock and a warrant to purchase 1,000,000 shares of our common stock at an exercise price equal to the price at which our common stock is sold in this offering.
The following members of our board of directors are affiliated with certain private investors that participated in the foregoing transactions:
. Albert L. Zesiger, principal of the Zesiger Capital Group LLC.
. Matthew V. McPherron, a director of Brookside Capital Partners, L.P.
. Douglas A. Lee, a former managing director of Premier Medical Partner Fund L.P.
. James R. Butler, an employee of ALZA Corporation.
Other Transactions
In June and December 1998, we paid the Schreck Merchant Group, Inc., a financial services company controlled by Mr. Schreck, an investment banking fee of $279,000 in the aggregate. Mr. Schreck is our Chief Financial Officer and one of our directors.
In April 2000, we acquired from ALZA the ALZET product and assets used primarily in the manufacture, sale and distribution of this product. This acquisition provides us with an ongoing business making and selling this product worldwide. The total purchase price consisted of approximately $8.2 million in cash, including approximately $3.2 million of inventory, of which $2.4 million is to be paid over twelve months.
Since inception, from time to time we have issued and sold shares of our common stock and granted options to purchase common stock to our employees, directors and consultants.
PRINCIPAL STOCKHOLDERS
The following table presents information concerning the beneficial ownership of the shares of our common stock as of April 15, 2000 and as adjusted to reflect the sale of the shares of common stock in this offering by:
. each person who is known by us to beneficially own more than 5% of our common stock;
. each of our directors;
. each of the named executive officers; and
. all of our directors and executive officers of as a group.
The number and percentage of shares beneficially owned are based on 38,336,410 shares of common stock outstanding as of April 15, 2000, assuming conversion of all outstanding shares of preferred stock into common stock. Beneficial ownership is determined under the rules and regulations of the Securities and Exchange Commission. Shares of common stock subject to options or warrants that are currently exercisable or exercisable within 60 days of April 15, 2000 are deemed to be outstanding and beneficially owned by the person holding the options or warrants for the purpose of computing the number of shares beneficially owned and the percentage ownership of that person, but are not deemed to be outstanding for the purpose of computing the percentage ownership of any other person. Except as indicated in the footnotes to this table, and subject to applicable community property laws, these persons have sole voting and investment power with respect to all shares of our common stock shown as beneficially owned by them. Percentage ownership figures after the offering do not include shares that may be purchased by each person in the offering.
Percentage of Shares Beneficially Owned ------------------------ Number of Shares Before After Beneficially Owned Offering Offering ------------------ ---------- ---------- ALZA Corporation.............. 6,600,000 17.2% 1900 Charleston Road Mountain View, CA 94043 Brookside Capital Partners(1) 3,845,514 10.0 ............................. Two Copley Place Boston, MA 02116 Morgan Trust(2)............... 2,325,583 6.1 522 Fifth Avenue New York, NY 10036 State of Oregon PERS/ZCG(3)... 2,208,000 5.8 c/o Zesiger Capital Group LLC 320 Park Avenue New York, NY 10022 Biotech Growth S.A.(4)........ 2,142,857 5.6 Swiss Bank Tower Obarie Street Panama 1 Republic of Panama Premier Medical Partner Fund 1,931,316 5.0 L.P.(5)...................... 12225 El Camino Real San Diego, CA 92130 Albert L. Zesiger(6).......... 6,075,000 15.8 Matthew V. McPherron(1)....... 3,845,514 10.0 Felix Theeuwes, Ph.D.(7)...... 2,884,430 7.5 Thomas A. Schreck(8).......... 2,846,568 7.4 James E. Brown, D.V.M.(9)..... 2,800,000 7.3 Randolph M. Johnson, Ph.D.(10).................... 60,500 * Timothy S. Nelson(11)......... 347,000 * Douglas A. Lee(5)............. 1,931,316 5.0 James R. Butler............... 15,000 * John L. Doyle................. * * All executive officers and directors as a group (13 persons)(12)................. 21,206,828 55.3 |
consultant's consulting relationship with us. Also includes an aggregate of 626,750 shares which are subject to repurchase by us at the original purchase price in the event of the termination of individual employees' employment with us, which repurchase right terminates with respect to each employee at the rate of 1/4 of the employee's shares on each annual anniversary of such employee's original option grant date. Also includes an aggregate of 1,559,880 shares which are subject to repurchase by us at the original purchase price in the event of termination of employment with us, which repurchase right terminates with respect to each employee over time.
DESCRIPTION OF CAPITAL STOCK
Upon the completion of this offering, our authorized capital stock will consist of shares of common stock, $0.0001 par value, and 10,000,000 shares of undesignated preferred stock, $0.0001 par value. Upon completion of this offering, there will be outstanding shares of common stock outstanding, no outstanding shares of preferred stock, options to purchase shares of common stock and outstanding warrants to purchase 1,031,395 shares of common stock.
Common Stock
As of March 31, 2000, there were 37,336,410 shares of common stock outstanding (as adjusted to reflect the conversion of all outstanding shares of Series A-1 preferred stock, Series A-2 preferred stock, Series B preferred stock, Series B-1 preferred stock and Series C preferred stock into common stock upon the completion of this offering, held of record by 169 stockholders. In addition, options to purchase an aggregate of 738,350 shares of common stock were outstanding.
The holders of common stock are entitled to one vote for each share held of record on all matters submitted to a vote of the stockholders. Subject to preferential rights with respect to any outstanding preferred stock, holders of common stock are entitled to receive ratably such dividends as may be declared by the board of directors out of funds legally available therefor. See "Dividend Policy." In the event of our liquidation, dissolution or winding up, the holders of common stock are entitled to share ratably in all assets remaining after payment of liabilities and satisfaction of preferential rights of any outstanding preferred stock. The common stock has no preemptive or conversion rights or other subscription rights. There are no sinking fund provisions applicable to the common stock. The outstanding shares of common stock are, and the shares of common stock to be issued upon completion of this offering will be, fully paid and non-assessable.
Preferred Stock
Upon the closing of the offering, all outstanding shares of preferred stock will be converted into 27,502,660 shares of common stock and automatically retired. Thereafter, the board of directors is authorized to issue preferred stock in one or more series and to fix the rights, preferences, privileges and restrictions thereof, including dividend rights, dividend rates, conversion rights, voting rights, terms of redemption, redemption prices, liquidation preferences and the number of shares constituting any series or the designation of such series, without further vote or action by the stockholders.
The issuance of preferred stock may have the effect of delaying, deferring or preventing a change in our control without further action by the stockholders. The issuance of preferred stock with voting and conversion rights may adversely affect the voting power of the holders of common stock, including voting rights, of the holders of common stock. In certain circumstances, such issuance could have the effect of decreasing the market price of the common stock. As of the closing of the offering, no shares of preferred stock will be outstanding and we currently have no plans to issue any shares of preferred stock.
Options
As of March 31, 2000, options to purchase a total of 738,350 shares of common stock were outstanding with a weighted-average exercise price of $0.45 per share. Up to 1,265,650 additional shares of common stock may be subject to options granted in the future under the 2000 stock plan. See "Employee Benefit Plans--2000 stock plan."
Warrants
As of April 15, 2000, we had an outstanding warrant for the purchase of 31,395 shares of Series B-1 preferred stock at an exercise price of $2.15. This warrant expires on December 16, 2006. We also had an outstanding warrant for the purchase of 1,000,000 shares of common stock at an exercise price equal to the price per share at which our common stock sold in this offering. This warrant expires four years from the date of this offering.
Registration Rights
The holders of 35,363,295 shares of common stock and common stock issuable upon conversion of Series A-1, A-2, B, B-1 and C preferred stock or their transferees are entitled to certain rights with respect to the registration of such shares under the Securities Act. These rights are provided under the terms of an agreement between us and the holders of the registrable securities. Pursuant to the agreement, on the written demand of holders of more than 40% of the then outstanding registrable securities, we shall use our best efforts to register these shares and those of any other stockholders who, by prompt notice, request registration, subject to certain cutbacks in participation made by the managing underwriter. We are not required to effect more than three demand registrations on Form S-1 at any time and more than two demand registrations on Form S-3 in any twelve-month period. These holders are also entitled to unlimited piggyback registration rights, subject to certain cutbacks in participation made by the managing underwriter. All offering expenses in connection with the registration will be borne by us, excluding underwriting discounts and commissions.
At any time after six months following the effective date of this offering, the holders of at least 40% of the registrable securities then outstanding may require us to file a registration statement covering registrable securities if an aggregate offering price, net of underwriting discounts and commissions, would exceed $10.0 million. In addition, beginning 180 days after this offering, holders of registrable securities may require, up to two times a year, that we register their shares for public resale on Form S-3 or any successor form, provided we can use Form S-3 or any such successor form, and provided that the holders of registrable securities propose to sell securities with an anticipated aggregate offering price of not less than $2.0 million, net of underwriting discounts and commissions. Furthermore, in the event we elect to register any of our shares of common stock or other securities for purposes of effecting any public offering, the holders of registrable securities are entitled to include their registrable securities in the registration, subject to our right to reduce the number of shares proposed to be registered in view of market conditions. All expenses in connection with any registration, other than underwriting discounts and commissions, will be borne by us. Registration rights, other than the right to require us to register shares on Form S-3 or any successor form, will terminate at such time as our shares are publicly traded and the holder is entitled to sell all of its shares in any three-month period under Rule 144 of the Securities Act. If our stockholders with registration rights cause a large number of securities to be registered and sold in the public market, those sales could have an adverse effect on the market price for our common stock. If we were to initiate a registration and include registrable securities because of the exercise of registration rights, the inclusion of registrable securities could have an adverse effect on our ability to raise capital.
Effect of Certain Certificate of Incorporation and Bylaw Provisions
In April 2000, our board of directors and stockholders approved certain amendments to our certificate of incorporation and bylaws to provide, among other things, that our directors will be elected without the application of cumulative voting. This provision shall become effective at the first meeting of stockholders following the annual meeting of stockholders when we shall have had at least 800 stockholders. These amendments also provide that, after the closing of the offering contemplated by this prospectus, any action required or permitted to be taken by our stockholders may be taken only at a duly called annual or special meeting of the stockholders. The bylaws also establish procedures, including advance notice procedures with regard to the nomination, other than by or at the direction of the board of directors, of candidates for election as directors. See "Description of Capital Stock-- Common Stock."
The foregoing provisions could have the effect of making it more difficult for a third party to effect a change in the control of our board of directors. In addition, these provisions could have the effect of making it more difficult for a third party to acquire, or of discouraging a third party from attempting to acquire, a majority of our outstanding voting stock.
Certain Anti-Takeover Effects of Provisions of Our Certificate of Incorporation and Bylaws and Of Delaware Law
General. Certain provisions of Delaware law and our certificate of incorporation and bylaws could have the effect of making it more difficult for a third party to acquire, or of discouraging a third party from acquiring, control of us. Such provisions could limit the price that certain investors might be willing to pay in the future for shares of our common stock. These provisions of Delaware law and the certificate of incorporation and bylaws may also have the effect of discouraging or preventing certain types of transactions involving an actual or threatened change in our control, including unsolicited takeover attempts, even though such a transaction may offer our stockholders the opportunity to sell their stock at a price above the prevailing market price.
Delaware Takeover Statute. Following consummation of this offering, we will be subject to the "business combination" provisions of Section 203 of the Delaware General Corporation Law. In general, those provisions prohibit a publicly-held Delaware corporation from engaging in various "business combination" transactions with any interested stockholder for a period of three years after the date of the transaction in which the person became an interested stockholder, unless:
. the transaction is approved by the board of directors prior to the date the interested stockholder obtained interested stockholder status;
. upon consummation of the transaction that resulted in the stockholder's becoming an interested stockholder, the stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the number of shares outstanding those shares owned by (a) persons who are directors and also officers and (b) employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or
. on or subsequent to the date the business combination is approved by the board of directors and authorized at an annual or special meeting of stockholders by the affirmative vote of at least 66 2/3% of the outstanding voting stock that is not owned by the interested stockholder. A "business combination" is defined to include mergers, asset sales and other transactions resulting in financial benefit to a stockholder. In general, an "interested stockholder" is a person who, together with affiliates and associates, owns, or within three years, did own, 15% or more of a corporation's voting stock.
The statute could prohibit or delay mergers or other takeover or change in control attempts with respect to us and, accordingly, may discourage attempts to acquire us.
Certificate of Incorporation and Bylaws. Our certificate of incorporation provides that any action to be taken by our stockholders must be effected at an annual or special stockholder meeting and may not be taken by written consent. Our bylaws provide that special meetings of our stockholders may be called by the board of directors, the Chairman of the board or by our President. Our bylaws also require advance written notice by a stockholder of a proposal or director nomination that such stockholder desires to present at an annual or special stockholders meeting. No business other than that stated in the notice may be transacted at any special meeting. These provisions will delay consideration of a stockholder proposal until the next annual meeting unless a special meeting is called by the board of directors.
Our bylaws provide that the authorized number of directors may be changed by an amendment to the bylaws adopted by the board of directors or by the stockholders. Vacancies on the board of directors may be filled either by holders of a majority our voting stock or a majority of directors in office, although less than a quorum. Our certificate of incorporation also provides for a staggered board of directors. Under a staggered board of directors, each director is designated to one of three categories. Each year the directors' positions in one of the three categories are subject to election so that it would take three years to replace the entire board, absent resignation or premature expiration of a director's term, which may have the effect of deterring a hostile takeover or delaying or preventing changes in our control or management.
Limitations on Liability and Indemnification of Officers and Directors
Our certificate of incorporation limits the liability of directors to the fullest extent permitted by the Delaware law. In addition, the certificate of incorporation and bylaws provide that we will indemnify our directors and officers to the fullest extent permitted by Delaware law. We have entered into separate indemnification agreements with its directors and executive officers that provide these persons indemnification protection in the event the certificate of incorporation is subsequently amended.
Transfer Agent and Registrar
Equiserve has been appointed as transfer agent and registrar for our common stock.
Listing
We have applied for quotation of our common stock on the Nasdaq National Market under the symbol "DRRX."
SHARES ELIGIBLE FOR FUTURE SALE
Prior to this offering, there has been no public market for our common stock. Future sales of substantial amounts of common stock in the public market, or the perception that such sales may occur, could adversely affect prevailing market prices.
Upon consummation of the offering, we will have an aggregate of shares of common stock outstanding, based on the number of shares of common stock outstanding as of April 15, 2000, assuming that the underwriters do not exercise their over-allotment option and none of the outstanding options and warrants are exercised. Of the shares outstanding after the offering, only the shares sold in this offering will be freely tradable without restriction under the Securities Act, except for any shares that may be purchased by our "affiliates." Shares purchased by our affiliates will be subject to the volume and other limitations of Rule 144 of the Securities Act, or "Rule 144" described below. As defined in Rule 144, an "affiliate" of an issuer is a person who, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with the issuer. Upon the expiration of certain contractual "lock-up" restrictions described below, 23,863,617 shares will be eligible for sale 180 days after the date of this prospectus, with 14,029,867 of these shares subject to the volume and other limitations of Rule 144. The remaining 14,472,793 shares will become eligible for sale at various times after that date. All of these remaining shares will be subject to the volume and other limitations of Rule 144.
Each of our directors and officers and certain of our other stockholders have agreed with Morgan Stanley & Co. Incorporated, for a period of 180 days after the date of this prospectus, not to:
. offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, lend, or otherwise transfer or dispose of, directly or indirectly, any shares of common stock or any securities convertible into or exercisable or exchangeable for common stock; or
. enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the common stock, whether any such transaction described above is to be settled by delivery of common stock or other securities, in cash or otherwise.
Morgan Stanley & Co. Incorporated may choose to release some of these shares from such restrictions prior to the expiration of the 180-day period "lock-up" period, although it has no current intention of doing so.
Under Rule 144 as currently in effect, beginning 90 days after the date of this prospectus, a person who has beneficially owned restricted shares of common stock for at least one year, including the holding period of any prior owner who is not an affiliate, would be entitled to sell a number of the shares within any three-month period equal to the greater of 1% of the then outstanding shares of the common stock or the average weekly reported volume of trading of the common stock on the Nasdaq National Market during the four calendar weeks preceding such sale. Immediately after the offering, 1% of our outstanding shares of common stock would equal approximately shares. Under Rule 144, restricted shares are subject to manner of sale and notice requirements and requirements as to the availability of current public information concerning us. Under Rule 144(k), a person who is not deemed to have been an affiliate at any time during the 90 days preceding a sale, and who has beneficially owned the shares proposed to be sold for at least two years, including the holding period of any prior owner who is not an affiliate, is entitled to sell such shares without regard to the volume or other limitations of Rule 144 just described.
The holders of approximately 35,363,295 shares of common stock are also entitled to certain rights with respect to registration of their shares of common stock for offer or sale to the public. If the holders, by exercising their registration rights, cause a large number of shares to be registered and sold in the public market, the sales could have a material adverse effect on the market price for our common stock.
Immediately after this offering, there will be options to purchase approximately 738,350 shares of common stock outstanding, based on the number of options outstanding as of March 31, 2000. Subject to the provisions of the lock-up agreements described above, holders of these options may rely on the resale provisions of Rule 701 under the Securities Act. Rule 701 permits non- affiliates to sell their shares without having to comply with the volume, holding period or other limitations of Rule 144 and permits affiliates to sell their shares without having to comply with the holding period limitation of Rule 144, in each case beginning 90 days after the consummation of this offering. In addition, shortly after this offering, we intend to file a registration statement on Form S-8 covering the 1,585,500 shares of common stock reserved for issuance under the 2000 Stock Plan based upon the number of options outstanding as of March 31, 2000. Shares of common stock registered under any registration statement will, subject to Rule 144 volume limitations applicable to affiliates, be available for sale in the open market, unless the shares are subject to vesting restrictions with us or the lock-up agreements described above.
UNDERWRITING
Under the terms and subject to the conditions contained in an underwriting agreement dated the date hereof, or the "underwriting agreement," the underwriters named below have severally agreed to purchase, and we have agreed to sell to them, severally, the respective number of shares of common stock set forth opposite the names of such underwriters below:
Number of Name Shares ---- --------- Morgan Stanley & Co. Incorporated............................ Chase Securities Inc. ....................................... CIBC World Markets Corp. .................................... --- Total.................................................... --- |
The underwriters are collectively referred to as the "underwriters." The underwriting agreement provides that the obligations of the several underwriters to pay for and accept delivery of the shares of common stock offered hereby are subject to the approval of certain legal matters by their counsel and to certain other conditions. The underwriters are obligated to take and pay for all of the shares of common stock offered by this prospectus if any shares are taken. However, the underwriters are not required to take the shares covered by the underwriters' over-allotment option described below.
The underwriters initially propose to offer part of the shares of common stock directly to the public at the public offering price set forth on the cover page hereof and part to certain dealers at a price that represents a concession not in excess of $ a share under the public offering price. Any underwriter may allow, and such dealers may reallow, a concession not in excess of $ a share to other underwriters or to certain other dealers. After the initial offering of the shares of common stock, the offering price and other selling terms may from time to time be varied by the representatives.
We have granted to the underwriters an option, exercisable for 30 days from the date of this prospectus, to purchase up to an aggregate of additional shares of common stock at the public offering price set forth on the cover page hereof, less underwriting discounts and commissions. The underwriters may exercise such option solely for the purpose of covering over- allotments, if any, made in connection with the offering of the shares of common stock offered hereby. To the extent such option is exercised, each U.S. underwriter will become obligated, subject to certain conditions, to purchase approximately the same percentage of such additional shares of common stock as the number set forth next to such U.S. underwriter's name in the preceding table bears to the total number of shares of common stock set forth next to the names of all underwriters in the preceding table.
The underwriters have informed us that they do not intend sales to discretionary accounts to exceed five percent of the total number of shares of common stock offered by them.
We have requested that the underwriters reserve up to shares of common stock to be offered at the public offering price to employees, friends and families of employees, service providers, employees of customers and others in the U.S. These people will agree to hold their shares for at least 180 days after the date of this prospectus. This directed share program will be administered by Morgan Stanley & Co. Incorporated. The number of shares of common stock available for sale to the general public will be reduced to the extent such individuals purchase such reserved shares. Any reserved shares which are not so purchased will be offered by the underwriters to the general public on the same basis as the other shares offered hereby.
Each of our directors, officers and certain of our other stockholders has agreed that, without the prior written consent of Morgan Stanley & Co. Incorporated on behalf of the underwriters, it will not, during the period ending 180 days after the date of this prospectus:
. offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, lend or otherwise transfer or dispose of, directly or indirectly, any shares of common stock or any securities convertible into or exercisable or exchangeable for common stock or
. enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the common stock,
whether any such transaction described above is to be settled by delivery of common stock or such other securities, in cash or otherwise.
The restrictions described above do not apply to:
. the sale of shares to the underwriters,
. the issuance by us of shares of common stock upon the exercise of an option or a warrant or the conversion of a security outstanding on the date of this prospectus of which the underwriters have been advised in writing, provided that purchasers enter into similar "lock-up" agreements, or
. transactions by any person other than us relating to shares of common stock or other securities acquired in open market transactions after the completion of the offering of the shares.
In order to facilitate the offering of the common stock, the underwriters may engage in transactions that stabilize, maintain or otherwise affect the price of the common stock. Specifically, the underwriters may over-allot in connection with the offering, creating a short position in the common stock for their own account. In addition, to cover over-allotments or to stabilize the price of the common stock, the underwriters may bid for, and purchase, shares of common stock in the open market. Finally, the underwriting syndicate may reclaim selling concessions allowed to an underwriter or a dealer for distributing the common stock in the offering if the syndicate repurchases previously distributed common stock in transactions to cover syndicate short positions, in stabilization transactions or otherwise. Any of these activities may stabilize or maintain the market price of the common stock above independent market levels. The underwriters are not required to engage in these activities, and may end any of these activities at any time.
We and the underwriters have agreed to indemnify each other against certain liabilities, including liabilities under the Securities Act.
Entities affiliated with Chase H&Q purchased an aggregate of 309,471 shares of our preferred stock for an aggregate amount of approximately $551,332 million. These shares will convert into 309,471 shares of common stock upon the completion of this offering.
Certain of the underwriters from time to time perform various investment banking services for us, for which such underwriters receive customary compensation.
Pricing of the Offering
Prior to this offering, there has been no public market for the common stock. The initial public offering price will be determined by negotiations between us and the underwriters. Among the factors will be considered in determining the initial public offering price will be our future prospects and our industry in general, sales, earnings and certain of our other financial and operating information in recent periods, and the price-earnings ratios, price-sales ratios, market prices of securities and certain financial and operating information of companies engaged in activities similar to ours. The estimated initial public offering price range set forth on the cover page of this preliminary prospectus is subject to change as a result of market conditions and other factors.
LEGAL MATTERS
The validity of the common stock offered hereby will be passed upon for DURECT by Venture Law Group, A Professional Corporation, Menlo Park, California. Mark B. Weeks, a director of Venture Law Group, is our Secretary. Certain legal matters in connection with this offering will be passed upon for the underwriters by Gray Cary Ware & Freidenrich LLP, Palo Alto, California. Mr. Weeks, employees of Venture Law Group and an investment partnership affiliated with Venture Law Group own a total of 23,256 shares of our Series B preferred stock.
EXPERTS
Ernst & Young LLP, independent auditors, have audited our financial statements at December 31, 1998 and 1999 and for the period from inception (February 6, 1998) to December 31, 1998, the year ended December 31, 1999 and the period from inception (February 6, 1998) to December 31, 1999, as set forth in their report. We have included our financial statements in the prospectus and elsewhere in the registration statement in reliance on Ernst & Young LLP's report, given on their authority as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the Securities and Exchange Commission a registration statement on Form S-1 under the Securities Act, and the rules and regulations promulgated thereunder, with respect to the common stock offered hereby. This prospectus, which constitutes a part of the registration statement, does not contain all of the information set forth in the registration statement and the exhibits thereto. Statements contained in this prospectus as to the contents of any contract or other document that is filed as an exhibit to the registration statement are not necessarily complete and each such statement is qualified in all respects by reference to the full text of such contract or document. For further information with respect to us and the common stock, reference is hereby made to the registration statement and the exhibits thereto, which may be inspected and copied at the principal office of the Commission, 450 Fifth Street, N.W., Washington, D.C. 20549, and at the regional offices of the Commission located at Seven World Trade Center, Suite 1300, New York, New York 10048 and Citicorp Center, 500 West Madison Street, Suite 1400, Chicago, Illinois 60661, and copies of all or any part thereof may be obtained at prescribed rates from the Commission's Public Reference Section at such addresses. Also, the Commission maintains a World Wide Web site on the Internet at http://www.sec.gov that contains reports, proxy and information statements and other information regarding registrants that file electronically with the Commission.
Upon completion of this offering, we will become subject to the information and periodic reporting requirements of the Exchange Act and, in accordance therewith, will file periodic reports, proxy and information statements and other information with the Commission. Such periodic reports, proxy and information statements and other information will be available for inspection and copying at the regional offices, public reference facilities and Web site of the Commission referred to above.
DURECT CORPORATION
(a development stage company)
INDEX TO FINANCIAL STATEMENTS
Page ---- Report of Independent Auditors............................................. F-2 Balance Sheets............................................................. F-3 Statements of Operations................................................... F-4 Statement of Stockholders' Equity.......................................... F-5 Statements of Cash Flows................................................... F-6 Notes to Financial Statements.............................................. F-7 |
REPORT OF INDEPENDENT AUDITORS
The Board of Directors and Stockholders
DURECT Corporation
We have audited the accompanying balance sheets of DURECT Corporation (a development stage company) as of December 31, 1998 and 1999, and the related statements of operations, stockholders' equity, and cash flows for the period from inception (February 6, 1998) to December 31, 1998, the year ended December 31, 1999, and the period from inception (February 6, 1998) to December 31, 1999. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements 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 DURECT Corporation (a development stage company) at December 31, 1998 and 1999, and the results of its operations and its cash flows for the period from inception (February 6, 1998) to December 31, 1998, the year ended December 31, 1999, and the period from inception (February 6, 1998) to December 31, 1999, in conformity with accounting principles generally accepted in the United States.
/s/ Ernst & Young LLP Palo Alto, California February 9, 2000 |
DURECT CORPORATION
(a development stage company)
BALANCE SHEETS
(in thousands, except per share amounts)
Pro forma December 31, stockholders' equity ----------------- at December 31, 1998 1999 1999 ------- -------- -------------------- (Unaudited) Assets Current assets: Cash and cash equivalents............ $ 7,975 $ 3,863 Short-term investments............... -- 12,735 Accounts receivable, net of allowance of $0 and $5 at December 31, 1998 and 1999, respectively.............. -- 97 Inventory............................ -- 188 Prepaid expenses and other current assets.............................. 140 584 ------- -------- Total current assets................... 8,115 17,467 Property and equipment, net............ 168 1,271 Intangible assets, net................. -- 1,390 Long-term investments.................. -- 2,335 ------- -------- Total assets........................... $ 8,283 $ 22,463 ======= ======== Liabilities and stockholders' equity Current liabilities: Accounts payable..................... $ 53 $ 483 Accrued liabilities.................. 155 429 Accrued liabilities to related party............................... 203 321 Contract research liability.......... 12 180 Equipment loan, current portion...... 28 133 ------- -------- Total current liabilities.............. 451 1,546 Equipment loan, noncurrent portion..... 83 189 Commitments Stockholders' equity: Preferred stock, issuable in series-- $0.0001 par value, 14,800 and 24,242 shares authorized at December 31, 1998 and 1999, respectively; 14,143 and 23,931 shares issued and outstanding in December 31, 1998 and 1999, respectively; aggregate liquidation preference of $9,394 and $30,226 at December 31, 1998 and 1999, respectively; pro forma shares authorized, no shares issued and outstanding..................... 1 2 $ -- Common stock, $0.0001 par value: 25,200 and 41,542 shares authorized at December 31, 1998 and 1999 respectively; 8,400 and 8,502 shares issued and outstanding at December 31, 1998 and 1999, respectively; pro forma shares authorized, shares issued and outstanding....... 1 1 3 Additional paid-in capital........... 9,626 34,642 34,642 Notes receivable from stockholders... (36) (33) (33) Deferred compensation................ (521) (3,252) (3,252) Deficit accumulated during the development stage................... (1,322) (10,632) (10,632) ------- -------- -------- Stockholders' equity................... 7,749 20,728 $ 20,728 ------- -------- ======== Total liabilities and stockholders' equity................................. $ 8,283 $ 22,463 ======= ======== |
The accompanying notes are an integral part of these statements.
DURECT CORPORATION
(a development stage company)
STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Period from Period from inception inception (February 6, (February 6, 1998) to Year ended 1998) to December 31, December 31, December 31, 1998 1999 1999 ------------ ------------ ------------ Revenue, net........................... $ -- $ 86 $ 86 Cost of goods sold..................... -- 39 39 ------- ------- -------- Gross margin........................... -- 47 47 ------- ------- -------- Operating expenses: Research and development............. 466 5,181 5,647 Research and development to related party............................... 243 1,182 1,425 Selling, general and administrative.. 585 2,178 2,763 Stock-based compensation(1).......... 149 865 1,014 ------- ------- -------- Total operating expenses............... 1,443 9,406 10,849 ------- ------- -------- Loss from operations................... (1,443) (9,359) (10,802) Other income (expense): Interest income...................... 121 678 799 Interest expense..................... -- (27) (27) ------- ------- -------- Net other income....................... 121 651 772 ------- ------- -------- Net loss............................... $(1,322) $(8,708) $(10,030) Accretion of cumulative dividends on Series B convertible preferred stock.. -- 602 602 ------- ------- -------- Net loss attributable to common stockholders.......................... $(1,322) $(9,310) $(10,632) ======= ======= ======== Net loss per common share, basic and diluted............................... $ (0.36) $ (1.76) ======= ======= Shares used in computing basic and diluted net loss per share............ 3,655 5,291 ======= ======= Pro forma net loss per share, basic and diluted (unaudited)................... $ (0.37) ======= Shares used in computing pro forma net loss per share........................ 23,771 ======= -------- Research and development............... $ 46 $ 485 $ 531 Selling, general and administrative.... 103 380 483 ------- ------- -------- $ 149 $ 865 $ 1,014 ======= ======= ======== |
(1) Stock-based compensation related to the following:
The accompanying notes are an integral part of these statements.
DURECT CORPORATION
(a development stage company)
STATEMENT OF STOCKHOLDERS' EQUITY
For the period from inception (February 6, 1998) to December 31, 1999
(in thousands, except per share amounts)
Convertible Deficit Preferred Notes Accumulated Stock Common Stock Additional Receivable During the Total ------------- ------------- Paid-In From Deferred Development Stockholders' Shares Amount Shares Amount Capital Stockholders Compensation Stage Equity ------ ------ ------ ------ ---------- ------------ ------------ ----------- ------------- Issuance of common stock to founders at $0.0036 per share for cash in April 1998.... -- $ -- 8,400 $ 1 $ 29 $ -- $ -- $ -- $ 30 Issuance of Series A-1 convertible preferred stock in June 1998 for license rights........ 5,600 -- -- -- -- -- -- -- -- Issuance of Series A-2 convertible preferred stock at $1.00 per share in June 1998 for cash, net of issuance costs of $277......... 5,636 1 -- -- 5,359 -- -- -- 5,360 Issuance of Series A-2 convertible preferred stock at $1.25 per share in December 1998 for cash, net of issuance costs of $66................... 2,907 -- -- -- 3,568 (36) -- -- 3,532 Deferred compensation related to stock options............... 670 (521) 149 Net loss............... -- -- -- -- -- -- (1,322) (1,322) ------ ----- ----- --- ------- ---- ------- -------- ------- Balance at December 31, 1998................... 14,143 1 8,400 1 9,626 (36) (521) (1,322) 7,749 Issuance of common stock upon exercise of stock options for notes receivable and cash at $0.35 per share................. -- -- 102 -- 34 (33) -- -- 1 Repayment of notes receivable............ -- -- -- -- -- 36 -- -- 36 Issuance of Series A-2 convertible preferred stock at $1.25 per share in May 1999 for cash, net of issuance costs of $21.......... 99 -- -- -- 103 -- -- -- 103 Issuance of Series B convertible preferred stock at $2.15 per share in July 1999 for cash, net of issuance costs of $880......... 9,364 1 -- -- 19,251 -- -- -- 19,252 Issuance of Series B-1 convertible preferred stock at $4.40 per share in October 1999 in connection with the acquisition of IntraEar.............. 325 -- -- -- 1,430 -- -- -- 1,430 Deferred compensation related to stock options............... -- -- -- -- 3,596 -- (2,731) -- 865 Accretion of cumulative dividends on Series B convertible preferred stock -- -- -- -- 602 -- -- (602) -- Net loss............... -- -- -- -- -- -- (8,708) (8,708) ------ ----- ----- --- ------- ---- ------- -------- ------- Balance at December 31, 1999................... 23,931 $ 2 8,502 $ 1 $34,642 $(33) $(3,252) $(10,632) $20,728 ====== ===== ===== === ======= ==== ======= ======== ======= |
The accompanying notes are an integral part of these statements.
DURECT CORPORATION
(a development stage company)
STATEMENTS OF CASH FLOWS
(in thousands)
Period from Period from inception inception (February 6, (February 6, 1998) to Year ended 1998) to December 31, December 31, December 31, 1998 1999 1999 ------------ ------------ ------------ Cash flows from operating activities Net loss............................... $(1,322) $ (8,708) $(10,030) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization........ 5 311 311 Amortization of deferred compensation........................ 149 865 1,014 Changes in assets and liabilities: Accounts receivable................ -- (97) (97) Inventory.......................... -- (188) (188) Prepaid expenses and other assets.. (140) (444) (584) Accounts payable................... 53 430 483 Accrued liabilities................ 155 274 429 Accrued liabilities to related party............................. 203 118 321 Contract research liability........ 12 168 180 ------- -------- -------- Total adjustments.................... 437 1,437 1,874 ------- -------- -------- Net cash and cash equivalents used in operating activities................ (885) (7,271) (8,156) Cash flows from investing activities Purchase of equipment.................. (62) (1,016) (1,078) Purchase of investments................ -- (15,070) (15,070) Payment for acquisition of IntraEar, net................................... -- (69) (69) ------- -------- -------- Net cash and cash equivalents used in investing activities................ (62) (16,155) (16,217) ------- -------- -------- Cash flows from financing activities Payments on equipment loan............. -- (78) (78) Net proceeds from issuances of common stock................................. 30 1 31 Net proceeds from notes receivable from stockholders.......................... -- 36 36 Net proceeds from issuances of convertible preferred stock........... 8,892 19,355 28,247 ------- -------- -------- Net cash and cash equivalents provided by financing activities.... 8,922 19,314 28,236 ------- -------- -------- Net increase (decrease) in cash and cash equivalents...................... 7,975 (4,112) 3,863 Cash and cash equivalents at beginning of periods/year....................... -- 7,975 -- ------- -------- -------- Cash and cash equivalents at end of periods/year.......................... $ 7,975 $ 3,863 $ 3,863 ======= ======== ======== Supplemental disclosure of cash flow information Equipment financed through an equipment loan.................................. $ 111 $ 289 $ 400 ======= ======== ======== Cash paid during the year for interest.............................. $ -- $ 27 $ 27 ======= ======== ======== Notes receivable issued in connection with exercise of stock options $ 36 $ 33 $ 33 ======= ======== ======== Issuance of Series B-1 convertible preferred stock for assets acquired in acquisition of IntraEar............... $ -- $ 1,430 $ 1,430 ======= ======== ======== |
The accompanying notes are an integral part of these statements.
DURECT CORPORATION
(a development stage company)
NOTES TO FINANCIAL STATEMENTS
1. Summary of Significant Accounting Policies
Nature of Operations and Basis of Presentation
DURECT Corporation (the "Company") was incorporated in the state of Delaware on February 6, 1998. The Company is a pharmaceutical company developing therapies for chronic disorders that require continuous drug dosing. The Company's lead product is for the treatment of chronic pain.
The Company's activities in 1998 consisted principally of raising capital, arranging for facilities, acquiring equipment and licensing rights, recruiting managerial and technical personnel, and commencing research and development efforts. In 1999, the Company expanded its research and development activities, acquired licensing rights, raised capital, and continued to recruit managerial and technical personnel. Accordingly, the Company is classified as a development stage enterprise as of December 31, 1999.
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 reported amounts of assets and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reported period. Actual results could differ materially from those estimates.
Cash Equivalents and Marketable Securities
The Company considers all highly liquid investments with maturities of 90 days or less from the date of purchase to be cash equivalents. Investments with maturities of greater than 90 days but less than one year are classified as short-term investments. Management determines the appropriate classification of its cash equivalents and investment securities at the time of purchase and reevaluates such determination as of each balance sheet date. Management has classified the Company's cash equivalents and marketable securities as available-for-sale securities in the accompanying financial statements. Available-for-sale securities are carried at fair value, with unrealized gains and losses reported in a separate component of stockholders' equity, when material. Realized gains and losses are included in interest income. The cost of securities sold is based on the specific identification method.
The Company invests its excess cash in debt instruments of financial institutions and corporations, and money market funds with high credit ratings. The Company has established guidelines regarding diversification of its investments and their maturities with the objectives of maintaining safety and liquidity, while maximizing yield.
Concentrations of Credit Risk
Financial instruments that potentially subject the Company to credit risk consist principally of interest-bearing investments and trade receivables. The Company maintains cash and cash equivalents and investments with various major financial institutions. The Company performs periodic evaluations of the relative credit standing of these financial institutions and limits the amount of credit exposure with any one institution.
Hospitals and other health-care providers account for a substantial portion of the trade receivables; collateral for these receivables is generally not required by the Company. The risk associated with this concentration is limited due to the large number of accounts and their geographic dispersion. The Company monitors the creditworthiness of its customers to which it grants credit terms in the normal course of business. The Company is exposed to credit-related losses in the event of nonperformance by counterparties to financial instruments, but management believes credit risk exposure to such contracts is limited by periodically reviewing the
DURECT CORPORATION
(a development stage company)
NOTES TO FINANCIAL STATEMENTS--(Continued)
creditworthiness of the counterparties to the transactions. As of December 31, 1999, the Company has not experienced significant credit losses.
The Company maintains cash, cash equivalents and investments with various financial institutions. The Company performs periodic evaluations of the relative credit quality of its investments.
Inventories
Inventories are stated at the lower of cost or market, with cost determined on a first-in, first-out basis. At December 31, 1999, inventories consisted of finished goods.
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation, which is computed using the straight-line method over the estimated useful lives of the assets, which range from three to five years. Leasehold improvements are amortized using the straight-line method over the estimated useful lives of the assets or terms of the related leases, whichever are shorter.
Acquisition of IntraEAR
On October 1, 1999, the Company acquired substantially all of the assets of IntraEAR, Inc. ("IntraEAR") for a total cost of approximately $1,797,000 (consisting of $320,000 in cash, 325,023 shares of Series B-1 convertible preferred stock, and transaction costs of approximately $46,000). IntraEAR developed and commercialized products aimed at the treatment of inner-ear disorders. The purchase price was allocated to the tangible and identifiable intangible assets acquired on the basis of their fair values, as follows:
Tangible assets............................................... $ 297,000 Patents....................................................... 368,000 Developed technology.......................................... 75,000 Other intangibles............................................. 154,000 Goodwill...................................................... 903,000 ---------- Total purchase price........................................ $1,797,000 ========== |
The acquisition of IntraEAR has been accounted for as a purchase, with the result of IntraEAR's operations included in the Company's results of operations from the date of acquisition.
Intangible assets represent the excess of total acquisition cost of IntraEAR over the fair value of identifiable net assets of businesses acquired. Intangible assets are amortized using the straight-line method over their estimated useful lives over periods ranging from two to six years. Management periodically reviews the carrying amount of goodwill and other intangible assets to assess their continued recoverability. Accumulated amortization of patents, developed technology and other intangibles totaled $69,000 at December 31, 1999.
Impairment of Long-Lived Assets
In accordance with the provisions of Statement of Financial Accounting Standards No. 121, "Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to be Disposed Of" ("SFAS 121"), the Company reviews long- lived assets, including property and equipment, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Under SFAS 121, an impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition is less than the carrying amount. Impairment, if any, is assessed using discounted cash flows. Through December 31, 1999, there have been no such losses.
DURECT CORPORATION
(a development stage company)
NOTES TO FINANCIAL STATEMENTS--(Continued)
Stock-Based Compensation
The Company accounts for stock-based employee compensation arrangements in accordance with the provisions and related interpretations of Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees," and has elected to follow the "disclosure only" alternative prescribed by Financial Accounting Standards Board's Statement of Financial Accounting Standards No. 123, "Accounting for Stock-Based Compensation" ("SFAS 123"). Under APB No. 25, stock-based compensation is based on the difference, if any, on the date of grant, between the fair value of the Company's stock and the exercise price. Unearned compensation is amortized and expensed over the vesting period of the respective options. The Company accounts for stock options issued to nonemployees in accordance with the provisions of SFAS 123 and Emerging Issues Task Force 96-18, "Accounting for Equity Instruments that are Issued to other than Employees for Acquiring, or in Conjunction with Selling, Goods or Services." The fair value of options granted to non- employees is periodically remeasured as the underlying options vest.
Revenue Recognition
Revenue from the sale of products is primarily recognized at the time product is shipped to customers, provided no continuing obligation exists. The Company maintains consigned inventory at customer locations for certain products. For these products, revenue is recognized at the time the Company is notified that the device has been used. The Company provides credit, in the normal course of business, to its customers. The Company also maintains an allowance for doubtful customer accounts and charges actual losses when incurred to this allowance.
Research and Development Expenses
Research and development costs are expensed as incurred. Research and development costs paid to third parties under sponsored research agreements are recognized as the related services are performed, generally ratably over the period of service. Purchased research and development is recognized in purchase business combinations for the portion of the purchase price allocated to the appraised value of in-process technologies. The portion assigned to in- process technologies excludes the value of core and developed technologies, which are recorded as intangible assets.
Comprehensive Loss
The Company has adopted Statement of Financial Accounting Standards No. 130, "Reporting Comprehensive Income," which establishes standards for reporting comprehensive loss and its components in the financial statements. To date, the Company's comprehensive loss has equaled its net loss.
Segment Reporting
Effective January 1, 1999, the Company adopted the provisions of Statement of Financial Accounting Standards No. 131, "Disclosures about Segments of an Enterprise and Related Information" ("SFAS 131"). SFAS 131 establishes standards for the way companies report information about operating segments in annual financial statements. It also establishes standards for related disclosures about products and services, geographic areas and major customers. The Company has determined that it did not have any separately reportable business segments during any of the periods from inception to December 31, 1999.
Net Loss Per Share
Basic net loss per share and diluted net loss per share are computed in conformity with Statement of Financial Accounting Standards No. 128, "Earnings Per Share" ("SFAS 128"). In accordance with SFAS 128,
DURECT CORPORATION
(a development stage company)
NOTES TO FINANCIAL STATEMENTS--(Continued)
basic net loss per share excludes dilutive common stock equivalents and is calculated as net loss divided by the weighted-average number of common shares outstanding. Diluted net loss per share is computed using the weighted-average number of common shares outstanding and dilutive common stock equivalents outstanding during the period. Common equivalent shares from common stock issued to founders, investors, and employees that are subject to repurchases (using the treasury stock method) are excluded from the calculation of net loss per share as their effect is antidilutive. Pursuant to the Securities and Exchange Commission Staff Accounting Bulletin No. 98, common stock and convertible preferred stock issued or granted for nominal consideration prior to the anticipated effective date of the initial public offering must be included in the calculation of basic and diluted net loss per share as if they had been outstanding for all periods presented. Through December 31, 1999, the Company had not had any issuances or grants for nominal consideration.
Pro forma basic and diluted pro forma net loss per share has been computed as described above and also gives effect, under SEC guidance, to the conversion of the convertible preferred stock (using the if-converted method) as though it had happened on the original date of issuance. The following table presents the calculations of basic and diluted and pro forma basic and diluted net loss per share (in thousands, except per share amounts):
Period from inception (February 6, 1998) Year ended to December 31, December 31, 1998 1999 ------------------ ------------ Net loss.................................... $(1,322) $(8,708) Less: accumulated dividend on Series B preferred stock.......................... -- 602 ------- ------- Net loss available to common stockholders... $(1,322) $(9,310) ======= ======= Basic and diluted weighted average shares: Weighted-average shares of common stock outstanding.............................. 8,400 8,407 Less: weighted-average shares subject to repurchase............................... (4,745) (3,116) ------- ------- Weighted-average shares used in computing basic and diluted net loss per share..... 3,655 5,291 ======= ======= Basic and diluted net loss per share........ $ (0.36) $ (1.76) ======= ======= Pro forma: Net loss.................................. $(1,322) $(8,708) ======= ======= Shares used above......................... 3,655 5,291 Pro forma adjustment to reflect weighted effect of assumed conversion of convertible preferred stock.............. 8,080 18,480 ------- ------- Shares used in computing pro forma basic and diluted net loss per share (unaudited).............................. 11,735 23,771 ======= ======= Pro forma basic and diluted net loss per share (unaudited).......................... $ (0.11) $ (0.37) ======= ======= |
Unaudited Pro Forma Balance Sheet
If the initial public offering discussed in Note 11 is consummated, all of the convertible preferred stock outstanding will automatically be converted into common stock upon the closing of the offering. The conversion
DURECT CORPORATION
(a development stage company)
NOTES TO FINANCIAL STATEMENTS--(Continued)
of the convertible preferred stock that was outstanding as of December 31, 1999 has been reflected in the accompanying unaudited pro forma balance sheet.
Recent Accounting Pronouncements
In June 1998, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 133, "Accounting for Derivative Instruments and Hedging Activities" ("SFAS 133"). SFAS 133 requires the Company to recognize all derivatives on the balance sheet at fair value. Derivatives that are not hedges must be adjusted to fair value through net income. If the derivative is a hedge, depending on the nature of the hedge, changes in the fair value of the derivative are either offset against the change in fair value of assets, liabilities, or firm commitments through earnings or recognized in other comprehensive income until the hedged item is recognized in earnings. The ineffective portion of the derivative's change in fair value will be immediately recognized in earnings. SFAS 133 is effective for the Company's year ending December 31, 2001. The Company does not currently hold any derivatives and does not expect the adoption of SFAS 133 to materially impact the results of its operations.
In December 1999, the Securities and Exchange Commission issued Staff Accounting Bulletin No. 101 ("SAB 101"). SAB 101 summarizes certain areas of the Staff's views in applying generally accepted accounting principles to revenue recognition in financial statements. The Company believes that its current revenue recognition principles comply with SAB 101.
2. Agreements with ALZA and Others
In April 1998, the Company entered into a development and commercialization agreement with ALZA Corporation ("ALZA") for certain product development rights, patent rights, and other know-how relating to the DUROS system. The Company issued 5,600,000 shares of Series A-1 preferred stock to ALZA in connection with this agreement and is required to pay ALZA a royalty on the net sales of products and a percentage of up front license fees, milestone payments, or any other payments or consideration received by the Company, excluding research and development funding. Under the terms of this agreement, the Company is required to meet annual minimum development spending requirements and develop a minimum number of products.
As provided for in the license agreement, the Company may pursue a number of products in specified fields of use using the DUROS technology. However, to maintain its rights under the agreement, the Company must commit to a minimum annual level of product development funding with the amount and duration of such funding in each field varying over time.
The future minimum annual product development funding required under the ALZA agreement for all fields of use is as follows (in thousands):
Year ended December 31, 2000.......................................................... $ 6,000 2001.......................................................... 8,000 2002.......................................................... 13,000 2003.......................................................... 14,000 2004.......................................................... 17,000 ------- Total minimum funding required.................................. $58,000 ======= |
The agreement may be terminated by the Company, by providing ninety days written notice to ALZA, or when the Company ceases to have royalty payment obligations to ALZA (at least 20 years).
DURECT CORPORATION
(a development stage company)
NOTES TO FINANCIAL STATEMENTS--(Continued)
In the period from inception (February 6, 1998) to December 31, 1998, the year ended December 31, 1999, and the period from inception (February 6, 1998) to December 31, 1999, the Company incurred development expenses of $243,000, $1,182,000, and $1,425,000, respectively, for work performed by ALZA, of which $40,000, $861,000, and $901,000 was paid during the period from inception (February 6, 1998) to December 31, 1998, the year ended December 31, 1999, and the period from inception (February 6, 1998) to December 31, 1999, respectively. At December 31, 1998 and 1999, $203,000 and $321,000, respectively, were included in accrued liabilities.
In 1998 and 1999, the Company entered into several contract research agreements with numerous consultants, clinics and hospitals focused on the general research and clinical study support. Total contract research expenses recognized under research and development expenses for the period from inception (February 6, 1998) to December 31, 1998, the year ended December 31, 1999, and the period from inception (February 6, 1998) to December 31, 1999 was approximately $39,000, $1,028,000, and $1,067,000, respectively. The Company has the right to terminate these agreements at any time upon 30 days' written notice.
3. Financial Instruments
The following methods and assumptions were used by the Company in estimating its fair value disclosures for financial instruments:
The following is a summary of available-for-sale securities as of December 31, 1999:
Amortized Cost and Estimated Fair Value ------------------ (In thousands) Money market fund..................................... $ 82 Commercial paper...................................... 18,783 ------- $18,865 ======= Reported as: Cash equivalents.................................... $ 3,795 Short-term marketable securities.................... 12,735 Long-term marketable securities..................... 2,335 ------- $18,865 ======= As of December 31, 1999, the difference between the fair value and the amortized cost of available-for-sale securities was immaterial. The following is a summary of the cost and estimated fair value of available-for-sale securities at December 31, 1999, by contractual maturity: Cost and Estimated Fair Value ------------------ Mature in one year or less............................ $12,735 Mature after one year through two years............... 2,335 ------- Total............................................... $15,070 ======= |
DURECT CORPORATION
(a development stage company)
NOTES TO FINANCIAL STATEMENTS--(Continued)
4. Property and Equipment
Property and equipment consist of the following:
December 31, -------------- 1998 1999 ------ ------- (In thousands) Equipment.................................................. $ 120 $ 1,161 Leasehold improvement...................................... 12 155 Construction-in-progress................................... 41 162 ----- ------- 173 1,478 Less accumulated depreciation.............................. (5) (207) ----- ------- Equipment, net............................................. $ 168 $ 1,271 ===== ======= |
At December 31, 1998 and 1999, equipment financed under an equipment loan totaled approximately $111,000 and $289,000, respectively. Accumulated depreciation for this equipment was $5,000 and $102,000 as of December 31, 1998 and 1999, respectively.
5. Equipment Loan
In October 1998, the Company financed the purchase of certain equipment through a bank loan. The loan was renewed in April 1999 and the amount of the loan was increased to $400,000 from $250,000 in June 1999, with an interest rate increase to 1.25% plus the bank's base rate from 0.5% plus the bank's base rate, respectively. This loan is repayable in equal monthly installments over three years (payments commence April 1999). This equipment loan is secured by substantially all of the Company's assets.
Payment on equipment loan is due as follows (in thousands):
December 31, --------------- 1998 1999 ------- ------- (In thousands) 1999..................................................... $ 28 $ -- 2000..................................................... 41 133 2001..................................................... 42 133 2002..................................................... -- 56 ------- ------- $111 $ 322 ======= ======= |
The carrying value of the Company's equipment loan approximates its fair value. The fair value of the Company's equipment loan is estimated using a discounted cash flow analysis based on the company's current incremental borrowing rates for similar types of borrowing arrangements.
6. Commitments
The Company leases its office and research facility under a noncancelable operating lease which expires in January 2004, with two options to extend the lease for 5 years each. The Company is required to pay certain maintenance expenses in addition to monthly rent. Rent expense is recognized on a straight-line basis over the
DURECT CORPORATION
(a development stage company)
NOTES TO FINANCIAL STATEMENTS--(Continued)
lease term which has scheduled rental payment increases. Rent expense under this operating lease was $80,000, $313,000, and $393,000 for the period from inception (February 6, 1998) to December 31, 1998, the year ended December 31, 1999, and the period from inception (February 6, 1998) to December 31, 1999, respectively.
Future minimum lease payments under this noncancelable lease are as follows (in thousands):
Operating Leases --------- Year ended December 31, 2000........................................................ $ 613 2001......................................................... 775 2002......................................................... 798 2003......................................................... 806 2004 and thereafter.......................................... 34 ------ Total minimum payments required................................ $3,127 ====== |
Future minimum rentals have been reduced by minimum sublease rental income of $184,000 due in the future under noncancelable subleases. The Company subleases office space to a third party. Rental income under this lease was $0, $360,000, and $360,000 for the period from inception (February 6, 1998) to December 31, 1998, the year ended December 31, 1999, and the period from inception (February 6, 1998) to December 31, 1999, respectively.
At December 31, 1999, the Company had outstanding commitments to purchase laboratory equipment totaling approximately $368,000.
7. Stockholders' Equity
Preferred Stock
Convertible preferred stock is issuable in series, with rights and preferences designated by series. The shares outstanding are as follows:
December 31, 1998 December 31, 1999 ---------------------------------- ------------------------------------ Shares Shares Issued Shares Issued and Liquidation Shares and Liquidation Authorized Outstanding Preference Authorized Outstanding Preference ---------- ----------- ----------- ---------- ------------- ----------- Series A-1.............. 5,600 5,600 $ -- 5,600 5,600 $ -- Series A-2.............. 9,200 8,543 9,286 8,642 8,642 9,394 Series B................ -- -- -- 9,378 9,364 20,133 Series B-1.............. -- -- -- 450 325 699 Undesignated............ -- -- -- 172 -- -- ------ ------ ------ ------ ------ ------- 14,800 14,143 $9,286 24,242 23,931 $30,226 ====== ====== ====== ====== ====== ======= |
All series of preferred stock are convertible at any time at the stockholders' option into common stock on a one-for-one basis, subject to adjustment for certain dilutive events. Conversion is automatic upon at the earlier of (i) the closing of an underwritten public offering with aggregate offering proceeds in excess of $25,000,000 (as adjusted for stock splits, stock dividends, recapitalization, or similar events) or (ii) upon agreement of the majority of holders of all outstanding shares of preferred stock voting together as a single class.
DURECT CORPORATION
(a development stage company)
NOTES TO FINANCIAL STATEMENTS--(Continued)
Holders of Series A-1, A-2, and B-1 convertible preferred stock are entitled to noncumulative dividends of $0.05, $0.05, and $0.13975, respectively, if and when declared by the board of directors. These dividends are to be paid in advance of any distributions to common stockholders. No dividends have been declared through December 31, 1999.
Holders of Series B convertible preferred stock are entitled to receive cumulative dividends at the rate of $0.13975 per share per annum on each outstanding share of Series B convertible preferred stock, payable quarterly when, as, and if declared by the board of directors. Such dividends shall accrue on each share from July 16, 1999, and shall accrue on a day-to-day basis whether or not declared. Accumulation of dividends on the Series B convertible preferred stock bear no interest. As of December 31, 1999, the accrued dividend payable is $602,000. Cumulative dividends with respect to Series B convertible preferred stock which are accrued and/or in arrears shall be forgiven upon conversion of such shares to common stock.
In the event of a liquidation or winding up of the Company, holders of Series A-2, B, and B-1 convertible preferred stock shall have a liquidation preference of $1.087, $2.15, and $2.15, respectively, per share, together with any declared but unpaid dividends, over holders of Series A-1 convertible preferred stock and common shares. After payments have been made to the Series A-2, B and B-1 stockholders, the remaining assets of the Company legally available for distribution, if any, shall be distributed ratably to the holders of common stock and Series A-1 preferred stock pro rata based on the number of shares of common stock that are or would be held by each on an as- converted basis.
Preferred stockholders are entitled to the number of votes they would have upon conversion of their preferred shares into common stock.
Common Stock
As of December 31, 1999, the Company's founders owned 8,400,000 shares of common stock.
The founders' common stock is subject to the Company's right of repurchase upon termination of their employment at the original issue price, and to the extent the Company elects not to exercise its right of repurchase, the remaining founders and certain stockholders may exercise the repurchase right.
Initially 66- 2/3% of the founders shares were subject to repurchase, but such repurchase rights lapse over time at the rate of 1.85% for each completed month of employment (until all shares are released from the repurchase option).
As of December 31, 1999, an aggregate of 2,181,480 shares of the founders' stock remained subject to repurchase.
As of December 31, 1999, shares of common stock reserved for future issuance consisted of the following:
December 31, 1999 ------------ Series A-1, A-2, B, and B-1 convertible preferred stock...... 23,931,231 Stock options outstanding.................................... 1,605,000 Stock options available for grant............................ 296,500 ---------- 25,832,731 ========== |
DURECT CORPORATION
(a development stage company)
NOTES TO FINANCIAL STATEMENTS--(Continued)
1998 Incentive Stock Plan
In March 1998, the Company adopted the DURECT Corporation Stock Option Plan (the "Stock Plan") under which incentive stock options and nonstatutory stock options may be granted to employees, directors of, or consultants to, the Company and its affiliates.
Options granted under the Stock Plan expire no later than ten years from the date of grant. Options may be granted with different vesting terms from time to time but not to exceed five years from the date of grant.
The option price of an Incentive Stock Option granted to an employee or of a Nonstatutory Stock Option granted to any person who owns stock representing more than 10% of the total combined voting power of all classes of stock of the Company (or any Parent or Subsidiary) shall be no less than 110% of the fair market value per share on the date of grant. The option price of an incentive stock option granted to any other employee shall be no less than 100% of the fair market value per share on the date of grant. The option price of a Nonstatutory Stock Option that is granted to any other person shall be no less than 85% of the fair market value per share on the date of grant.
Activity under the Stock Plan through December 31, 1999 is as follows:
Weighted- Shares Average Available Number of Exercise for Grant Shares Price --------- --------- --------- Shares authorized............................. 1,000,000 -- -- Options granted............................... (804,000) 804,000 $0.10 Options exercised............................. -- -- -- Options canceled.............................. -- -- -- Balance at December 31, 1998.................... 196,000 804,000 $0.10 --------- --------- Shares authorized............................. 1,000,000 -- -- Options granted............................... (934,500) 934,500 $0.35 Options exercised............................. -- (98,500) $0.35 Options canceled.............................. 35,000 (35,000) $0.35 --------- --------- Balance at December 31, 1999.................... 296,500 1,605,000 $0.23 ========= ========= |
The Company recorded deferred compensation in connection with certain stock option grants, net of forfeitures, of $3,596,000 in 1999 and $670,000 in 1998. The Company amortized deferred compensation of $865,000 in 1999 and $149,000 in 1998. The remaining unamortized deferred compensation of $3,252,000 at December 31, 1999 will be recognized as compensation expense over the vesting term of the related options.
The weighted-average grant-date fair value of options granted was $0.02 in 1998 and $0.12 in 1999.
The following table summarizes the information about stock options outstanding at December 31, 1999:
Weighted- Average Weighted- Weighted- Range of Number of Remaining Average Number of Average Exercise Options Contractual Exercise Options Exercise Price Outstanding Life Price Exercisable Price -------- ----------- ----------- --------- ----------- --------- (In years) $0.10 774,000 8.70 $0.10 774,000 $0.10 $0.20 30,000 8.95 $0.20 30,000 $0.20 $0.35 801,000 9.34 $0.35 801,000 $0.35 --------- --------- $0.10-$0.35 1,605,000 9.03 $0.23 1,605,000 $0.23 ========= ========= |
DURECT CORPORATION
(a development stage company)
NOTES TO FINANCIAL STATEMENTS--(Continued)
As of December 31, 1999, outstanding options to purchase an aggregate of 211,000 shares of common stock were vested and exercisable at a weighted- average exercise price per share of $0.10.
The Company has elected to follow APB 25 and related interpretations in accounting for its employee stock-based compensation plans. Because the exercise price of the employee stock options equals the market price of the underlying stock on the date of grant, no compensation expense is generally recognized. Pro forma information regarding net loss has been determined as if the Company accounted for its employee stock options under the fair value method prescribed by SFAS 123. The resulting effect on pro forma net loss disclosed is not likely to be representative of the effects on net loss on a pro forma basis in future years, due to additional grants and years of vesting in subsequent years. The fair value of each option granted through the period from inception (February 6, 1998) to December 31, 1998 and for the year ended December 31, 1999 were estimated on the date of grant using the minimum value method, with the following weighted-average assumptions:
Period from inception (February 6, 1998) to Year ended December 31, December 31, 1998 1999 ------------ ------------ Risk-free interest rate........................ 4.5% 6.00% Expected dividend yield........................ -- -- Expected life of option 5 years 5 years |
For the purposes of pro forma disclosures, the estimated fair value of the options is amortized to expense over the options' vesting period, and results in a pro forma net loss that is not materially different from actual net loss for all periods presented.
8. Income Taxes
No provision for income taxes has been recorded due to operating losses with no current tax benefit.
As of December 31, 1998 and 1999, the Company had federal and state net operating loss carryforwards of approximately $1,100,000 and $9,200,000, respectively. The net operating losses and credit carryforwards will expire at various dates beginning in 2006 through 2019, if not utilized.
Utilization of the net operating losses may be subject to a substantial annual limitation due to federal and state ownership change limitations. The annual limitation may result in the expiration of net operating losses before utilization.
Deferred tax assets and liabilities reflect the net tax effects of net operating loss and credit carryforwards and of temporary differences between the carrying amounts of assets and liabilities for financial reporting and the amounts used for income tax purposes. Significant components of the Company's deferred tax assets are as follows (in thousands):
December 31, -------------- 1998 1999 ----- ------- Deferred tax assets: Net operating loss carryforwards......................... $ 550 $ 3,600 Other individually immaterial items...................... -- (100) ----- ------- Total deferred tax assets.................................. 550 3,500 Valuation allowance for deferred tax assets................ (550) (3,500) ----- ------- Net deferred tax assets.................................... $ -- $ -- ===== ======= |
DURECT CORPORATION
(a development stage company)
NOTES TO FINANCIAL STATEMENTS--(Continued)
The Company has provided a full valuation allowance against the net deferred tax assets at December 31, 1998 and 1999 because the future realization of such assets is uncertain.
9. Related Party Transactions
In connection with the Series A-2 preferred stock financing, the Company incurred $279,000 of advisory fees from a company controlled by an executive officer of the Company for the period from inception (February 6, 1998) to December 31, 1998.
10. Subsequent Event
Term Loan and Capital Lease Line
In January 2000, the Company obtained a term loan and capital lease line with one financial institution on January 26, 2000 for $750,000 and $1,500,000, respectively. In connection with this borrowing, the Company issued warrants to purchase 31,395 shares of Series B-1 preferred stock at $2.15 per share. Both the term loan and capital lease line are secured by all equipment and other property acquired through these borrowings.
11. Subsequent Events (unaudited)
Amended Articles of Incorporation
In March 2000, the board of directors authorized an amendment to the Company's articles of incorporation to increase the authorized stock of the Company to 77,641,436 shares, consisting of 50,000,000 shares of common stock and 27,641,436 shares of preferred stock.
Series C Financing
In March 2000, the Company completed a private placement of 3,571,429 shares of Series C convertible preferred stock at $7.00 per share, resulting in net cash proceeds of approximately $24.8 million. Holders of Series C preferred stock are entitled to annual noncumulative dividends of $0.35 per share when and if declared by the board of directors. In the event of voluntary or involuntary liquidation of DURECT, holders of Series C preferred stock are entitled to a liquidation preference of $7.00 per share plus all declared and unpaid dividends. Holders of Series C preferred stock are entitled to one vote for each share of common stock into which the preferred stock is convertible, currently on a one-for-one basis. Each share of Series C preferred stock will be automatically converted into one share of common stock upon the closing of a firm commitment underwritten initial public offering of DURECT common stock with a per share price of at least $7.00 per share with gross proceeds of at least $25 million.
2000 Stock Option Plan
In March 2000, the Company's Board of Directors adopted the Durect Corporation 2000 Stock Option Plan which will be submitted to the Company's stockholders for approval before completion of the Company's proposed initial public offering. Under the 2000 Stock Option Plan, incentive stock options and nonstatutory stock options and stock purchase rights may be granted to employees and consultants, including nonemployee directors. A total of 1,796,000 shares of common stock have been reserved for issuance under this plan.
DURECT CORPORATION
(a development stage company)
NOTES TO FINANCIAL STATEMENTS--(Continued)
2000 Employee Stock Purchase Plan
The Company's Board of Directors adopted the 2000 Employee Stock Purchase Plan which will be submitted to the Company's stockholders for approval before completion of this offering. A total of 150,000 shares of common stock have been reserved for issuance under the purchase plan. This purchase plan will be implemented by a series of overlapping offering periods of approximately 24 months' duration, with new offering periods, other than the first offering period, beginning on August 1 and February 1 of each year and ending July 31 and January 31, respectively, two years later. The purchase plan allows eligible employees to purchase common stock through payroll deductions at a price equal to the lower of 85% of the fair market value of DURECT's common stock at the beginning of each offering period or at the end of each purchase period. The initial offering period will commence on the effectiveness of the initial public offering.
2000 Directors' Stock Option Plan
In March 2000, the Board of Directors adopted the 2000 Directors' Stock Option Plan. A total of 300,000 shares of common stock have been reserved for issuance under this plan. The directors' plan provides that each person who becomes a nonemployee director of DURECT after the effective date of this offering will be granted a nonstatutory stock option to purchase 20,000 shares of common stock on the date on which the optionee first becomes a nonemployee director of DURECT. This plan also provides that each option granted to a new director shall vest at the rate of 33 1/3% per year and each annual option shall vest in full at the end of one year. No shares have been issued under the directors' plan.
Initial Public Offering
In April 2000, the board of directors authorized the Company to file a registration statement with the SEC for an initial public offering of the Company's common stock.
Arrangements with Alza
In April 2000, ALZA and DURECT amended and restated their development and commercialization agreement by entering into the Second Amended and Restated Development and Commercialization Agreement. These amendments include a reduction in product royalties and upfront payments in certain instances payable to ALZA by DURECT under the Agreement. In addition, ALZA's option to distribute the DUROS sufentanil product was amended in geographic scope to cover only the U.S. and Canada instead of worldwide. As consideration for these amendments, ALZA received 1,000,000 shares of the Company's common stock and subject to conditions on exercise, a warrant to purchase 1,000,000 shares of common stock at an exercise price equal to the price at which the Company sells its common stock in its proposed initial public offering.
In April 2000, the Company acquired from ALZA Corporation the ALZET product and certain assets used primarily in the manufacture, sale and distribution of this product. This acquisition provides the Company with an ongoing business making and selling this product worldwide. The total purchase price consisted of approximately $8.2 million in cash, including approximately $3.2 million in inventory, $2.4 million of which will be paid over twelve months. The acquisition will be accounted for using the purchase method of accounting.
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 13. Other Expenses of Issuance and Distribution
The following table sets forth the costs and expenses, other than underwriting discounts and commissions, payable by the Company in connection with the sale of common stock being registered. All amounts are estimates except the SEC registration fee and the NASD filing fee and the Nasdaq National Market listing fee.
Amount to be Paid ---------- SEC registration fee............................................. $ 30,600 NASD filing fee.................................................. 12,000 Nasdaq National Market listing fee............................... 95,000 Printing and engraving expenses.................................. 200,000 Legal fees and expenses.......................................... 400,000 Accounting fees and expenses..................................... 300,000 Blue Sky qualification fees and expenses......................... 10,000 Transfer Agent and Registrar fees................................ 2,000 Miscellaneous fees and expenses.................................. 60,400 Total.......................................................... $1,200,000 |
Item 14. Indemnification of Directors and Officers
Section 145 of the Delaware General Corporation Law (the "Delaware Law") authorizes a court to award, or a corporation's Board of Directors to grant, indemnity to directors and officers in terms sufficiently broad to permit such indemnification under certain circumstances for liabilities (including reimbursement for expenses incurred) arising under the Securities Act of 1933, as amended (the "Securities Act"). Article VII of the Company's Certificate of Incorporation (Exhibit 3.2 hereto) and Article VI of the Company's Bylaws (Exhibit 3.3 hereto) provide for indemnification of the Company's directors, officers, employees and other agents to the maximum extent permitted by Delaware Law. In addition, the Company has entered into Indemnification Agreements (Exhibit 10.1 hereto) with its officers and directors. The Underwriting Agreement (Exhibit 1.1) also provides for cross-indemnification among the Company and the Underwriters with respect to certain matters, including matters arising under the Securities Act.
Item 15. Recent Sales of Unregistered Securities
(a) Since inception, we have sold and issued the following unregistered securities:
(1) From inception to March 31, 2000, we issued options to purchase an aggregate of 1,738,500 shares of common stock under the 1998 stock plan at exercise prices of $0.10 to $0.35 per share, of which options to purchase 1,222,750 shares have been exercised.
(2) From inception to March 31, 2000, we issued options to purchase an aggregate of 530,850 shares of common stock under our 2000 stock option plan at exercise prices of $0.35 to $1.00 per share, of which options to purchase 211,000 shares have been exercised.
(3) On June 19, 1998, we issued and sold 5,600,000 shares of Series A-1 preferred stock to ALZA Corporation, a principal stockholder of DURECT, in consideration of the executed and delivered Commercialization and Development Agreement with ALZA.
(4) On June 19, 1998, we issued and sold 5,636,000 shares of Series A-2 preferred stock to 43 private investors at a price of $1.00 per share for a total price of $5,636,000.
(5) On December 18, 1998, we sold 3,005,867 shares of our Series A-2 preferred stock to 43 private investors at a price of $1.25 per share for a total price of $3,757,334.
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(6) On July 19, 1999, we sold 9,364,341 shares of our Series B preferred stock to 56 private investors at a price of $2.15 per share for a total price of $20,133,333.
(7) On October 1, 1999, we sold 325,023 shares of our Series B-1 preferred stock to IntraEAR in consideration of the executed and delivered Asset Purchase Agreement.
(8) On December 31, 1999, in connection with a loan, we issued a warrant to Silicon Valley Bank to purchase 31,395 shares of our Series B-1 preferred stock.
(9) On March 28, 2000, we sold 3,571,429 shares of our Series C preferred stock to 12 private investors at a price of $7.00 per share for a total purchase price of $25,000,003.
(10) On April 14, 2000, in connection with an amendment to our development and commercialization agreement, we issued to ALZA Corporation 1,000,000 shares of our common stock and a warrant to purchase 1,000,000 shares of our common stock.
There were no underwriters employed in connection with any of the transactions set forth in Item 15.
For additional information concerning these equity investment transactions, please see the section entitled "Certain Transactions" in the prospectus.
The issuances described in Items 15(a)(3) thru 15(a)(10) were deemed exempt from registration under the Securities Act in reliance on Section 4(2) of the Securities Act as transactions by an issuer not involving a public offering. Certain issuances described in Items 15(a)(1) and 15(a)(2) were deemed exempt from registration under the Securities Act in reliance on Rule 701 promulgated thereunder as transactions pursuant to compensatory benefit plans and contracts relating to compensation. The recipients of securities in each such transaction represented their intention to acquire the securities for investment only and not with a view to or for sale in connection with any distribution thereof and appropriate legends were affixed to the share certificates and other instruments issued in such transactions. All recipients either received adequate information about us or had access, through employment or other relationships, to such information.
Item 16. Exhibits and Financial Statement Schedules
(a) Exhibits
Number Description ------ ----------- 1.1 Form of Underwriting Agreement. 3.1 Amended and Restated Certificate of Incorporation of the Company. 3.2 Amendment to Amended and Restated Certificate of Incorporation of the Company. 3.3 Amended and Restated Certificate of Incorporation of the Company (proposed). 3.4 Amended and Restated Bylaws of the Company. 3.5 Amended and Restated Bylaws of the Company (proposed). 3.6 Certificate of Designation of Rights, Preferences and Privileges of Series B-1 Preferred Stock. 3.7 Certificate of Designation of Rights, Preferences and Privileges of Series C Preferred Stock. 4.1* Specimen Stock Certificate. 4.2 Second Amended and Restated Investors' Rights Agreement. 5.1 Form of Opinion of Venture Law Group regarding the legality of the common stock being registered. 10.1 Form of Indemnification Agreement between the Company and each of its Officers and Directors. 10.2 1998 Stock Option Plan. 10.3 2000 Stock Plan. 10.4 2000 Employee Stock Purchase Plan. 10.5 2000 Directors' Stock Option Plan. |
II-2
Number Description ------ ----------- 10.6** Second Amended and Restated Development and Commercialization Agreement between the Company and ALZA Corporation effective April 28, 1999. 10.7** Product Acquisition Agreement between the Company and ALZA Corporation dated as of April 14, 2000. 10.8 Amended and Restated Loan and Security Agreement between the Company and Silicon Valley Bank dated as of October 28, 1998. 10.9** Manufacturing and Supply Agreement between Neuro-Biometrix, Inc. and Novel Biomedical, Inc. dated as of November 24, 1997. 10.10** Master Services Agreement between the Company and Quintiles, Inc. dated as of November 1, 1999. 10.11 Modified Net Single Tenant Lease Agreement between the Company and DeAnza Enterprises, Ltd. dated as of February 18, 1999. 10.12 Sublease Amendment between the Company and Ciena Corporation dated as of November 29, 1999 and Sublease Agreement between Company and Lightera Networks, Inc. dated as of March 10, 1999. 10.13** Project Proposal between the Company and Chesapeake Biological Laboratories, Inc. dated as of October 11, 1999. 10.14 Employment Agreement with James E. Brown. 10.15 Employment Agreement with Felix Theeuwes. 10.16 Employment Agreement with Thomas A. Schreck. 10.17 Common Stock Purchase Agreement between the Company and ALZA Corporation dated April 14, 2000. 10.18 Warrant issued to ALZA Corporation dated April 14, 2000. 10.19 Amended and Restated Market Stand-off Agreement between the Company and ALZA Corporation dated as of April 14, 2000. 10.20* Asset Purchase Agreement between the Company and IntraEAR, Inc. dated as of September 24, 1999. 10.21 Warrant issued to Silicon Valley Bank dated December 16, 1999. 10.22* Amendment to Second Amended and Restated Investors' Rights Agreement dated as of April 14, 2000. 23.1 Consent of Ernst & Young LLP, Independent Auditors. 23.2 Consent of Attorneys (included in Exhibit 5.1). 24.1 Power of Attorney (see II-5). 27.1 Financial Data Schedule. |
(b) Financial Statement Schedules
Schedules not listed above have been omitted because the information required to be set forth therein is not applicable or is shown in the financial statements or notes thereto.
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Item 17. Undertakings
The undersigned registrant hereby undertakes to provide to the underwriters at the closing specified in the underwriting agreements certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act, and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer, or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.
The undersigned registrant hereby undertakes that:
(1) For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.
(2) For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the Offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
II-4
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the city of Palo Alto, State of California on April 20, 2000.
Durect Corporation
/s/ James E. Brown By: _________________________________ James E. Brown President and Chief Executive Officer |
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints, jointly and severally, James Brown and Felix Theeuwes as his or her attorney-in-fact, with full power of substitution, for him or her in any and all capacities, to sign any and all amendments to this Registration Statement (including post-effective amendments), and any and all Registration Statements filed pursuant to Rule 462 under the Securities Act of 1933, as amended, in connection with or related to the Offering contemplated by this Registration Statement and its amendments, if any, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming our signatures as they may be signed by our said attorney to any and all amendments to said Registration Statement.
Pursuant to the requirements of the Securities Act of 1933, this Registration Statement has been signed by the following persons in the capacities and on the dates indicated:
Signature Title Date --------- ----- ---- /s/ James E. Brown President, Chief Executive April 20, 2000 ______________________________________ Officer and Director James E. Brown /s/ Felix Theeuwes Chairman, Chief Scientific April 20, 2000 ______________________________________ Officer Felix Theeuwes /s/ Thomas A. Schreck Chief Financial Officer, April 20, 2000 ______________________________________ Director Thomas A. Schreck /s/ James R. Butler Director April 20, 2000 ______________________________________ James R. Butler /s/ Douglas A. Lee Director April 20, 2000 ______________________________________ Douglas A. Lee /s/ Albert L. Zesiger Director April 20, 2000 ______________________________________ Albert L. Zesiger /s/ Matthew V. McPherron Director April 20, 2000 ______________________________________ Matthew V. McPherron /s/ John L. Doyle Director April 20, 2000 ______________________________________ John L. Doyle |
II-5
EXHIBIT INDEX
Number Description ------ ----------- 1.1 Form of Underwriting Agreement. 3.1 Amended and Restated Certificate of Incorporation of the Company. 3.2 Amendment to Amended and Restated Certificate of Incorporation of the Company. 3.3 Amended and Restated Certificate of Incorporation of the Company (proposed). 3.4 Amended and Restated Bylaws of the Company. 3.5 Amended and Restated Bylaws of the Company (proposed). 3.6 Certificate of Designation of Rights, Preferences and Privileges of Series B-1 Preferred Stock. 3.7 Certificate of Designation of Rights, Preferences and Privileges of Series C Preferred Stock. 4.1* Specimen Stock Certificate. 4.2 Second Amended and Restated Investors' Rights Agreement. 5.1 Form of Opinion of Venture Law Group regarding the legality of the common stock being registered. 10.1 Form of Indemnification Agreement between the Company and each of its Officers and Directors. 10.2 1998 Stock Option Plan. 10.3 2000 Stock Plan. 10.4 2000 Employee Stock Purchase Plan. 10.5 2000 Directors' Stock Option Plan. 10.6** Second Amended and Restated Development and Commercialization Agreement between the Company and ALZA Corporation effective April 28, 1999. 10.7** Product Acquisition Agreement between the Company and ALZA Corporation dated as of April 14, 2000. 10.8 Amended and Restated Loan and Security Agreement between the Company and Silicon Valley Bank dated as of October 28, 1998. 10.9** Manufacturing and Supply Agreement between Neuro-Biometrix, Inc. and Novel Biomedical, Inc. dated as of November 24, 1997. 10.10** Master Services Agreement between the Company and Quintiles, Inc. dated as of November 1, 1999. 10.11 Modified Net Single Tenant Lease Agreement between the Company and DeAnza Enterprises, Ltd. dated as of February 18, 1999. 10.12 Sublease Amendment between the Company and Ciena Corporation dated as of November 29, 1999 and Sublease Agreement between Company and Lightera Networks, Inc. dated as of March 10, 1999. 10.13** Project Proposal between the Company and Chesapeake Biological Laboratories, Inc. dated as of October 11, 1999. 10.14 Employment Agreement with James E. Brown. |
Number Description ------ ----------- 10.15 Employment Agreement with Felix Theeuwes. 10.16 Employment Agreement with Thomas A. Schreck. 10.17 Common Stock Purchase Agreement between the Company and ALZA Corporation dated April 14, 2000. 10.18 Warrant issued to ALZA Corporation dated April 14, 2000. 10.19 Amended and Restated Market Stand-off Agreement between the Company and ALZA Corporation dated as of April 14, 2000. 10.20* Asset Purchase Agreement between the Company and IntraEAR, Inc. dated as of September 24, 1999. 10.21 Warrant issued to Silicon Valley Bank dated December 16, 1999. 10.22* Amendment to Second Amended and Restated Investors' Rights Agreement dated as of April 14, 2000. 23.1 Consent of Ernst & Young LLP, Independent Auditors. 23.2 Consent of Attorneys (included in Exhibit 5.1). 24.1 Power of Attorney (see II-5). 27.1 Financial Data Schedule. |
** Confidential treatment requested as to certain portions of this Exhibit.
EXHIBIT 1.1
_______________Shares
DURECT CORPORATION
Common Stock, Par Value $0.0001 per share
UNDERWRITING AGREEMENT
_______________, 2000
_____________, 2000
Morgan Stanley & Co. Incorporated
Chase H&Q
CIBC World Markets Corp.
c/o Morgan Stanley & Co. Incorporated
1585 Broadway
New York, New York 10036
Dear Sirs and Mesdames:
Durect Corporation, a Delaware corporation (the "Company"), proposes to issue and sell to the several Underwriters named in Schedule I hereto (the "Underwriters") an aggregate of _______________ shares of its Common Stock, par value $0.0001 per share (the "Firm Shares").
The Company also proposes to issue and sell to the several Underwriters not more than an additional __________ shares of its Common Stock, par value $0.0001 per share (the "Additional Shares") if and to the extent that you, as managers of the offering, shall have determined to exercise, on behalf of the Underwriters, the right to purchase such shares of common stock granted to the Underwriters in Section 2 hereof. The Firm Shares and the Additional Shares are hereinafter collectively referred to as the "Shares". The shares of Common Stock, par value $0.0001 per share of the Company to be outstanding after giving effect to the sales contemplated hereby are hereinafter referred to as the "Common Stock".
The Company has filed with the Securities and Exchange Commission (the "Commission") a registration statement relating to the Shares. The registration statement as amended at the time it becomes effective, including the information (if any) deemed to be part of the registration statement at the time of effectiveness pursuant to Rule 430A under the Securities Act of 1933, as amended (the "Securities Act"), is hereinafter referred to as the "Registration Statement"; the prospectus in the form first used to confirm sales of Shares is hereinafter referred to as the "Prospectus". If the Company has filed an abbreviated registration statement to register additional shares of Common Stock pursuant to Rule 462(b) under the Securities Act (the "Rule 462 Registration Statement"), then any reference herein to the term "Registration Statement" shall be deemed to include such Rule 462 Registration Statement.
Morgan Stanley & Co. Incorporated ("Morgan Stanley") has agreed to reserve a portion of the Shares to be purchased by it under this Agreement for sale to the Company's directors, officers, employees and business associates and other parties related to the Company (collectively, "Participants"), as set forth in the Prospectus under the heading "Underwriters" (the "Directed Share Program"). The Shares to be sold by Morgan Stanley and its affiliates pursuant to the Directed Share Program are referred to hereinafter as the "Directed Shares." Any Directed Shares not orally confirmed for purchase by any Participants by the end of the business day on which this Agreement is executed will be offered to the public by the Underwriters as set forth in the Prospectus.
1. Representations and Warranties. The Company represents and warrants to and agrees with each of the Underwriters that:
(a) The Registration Statement has become effective; no stop order suspending the effectiveness of the Registration Statement is in effect, and no proceedings for such purpose are pending before or threatened by the Commission.
(b) (i) The Registration Statement, when it became effective, did not contain and, as amended or supplemented, if applicable, will not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading, (ii) the Registration Statement and the Prospectus comply and, as amended or supplemented, if applicable, will comply in all material respects with the Securities Act and the applicable rules and regulations of the Commission thereunder and (iii) the Prospectus does not contain and, as amended or supplemented, if applicable, will not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading, except that the representations and warranties set forth in this paragraph do not apply to statements or omissions in the Registration Statement or the Prospectus based upon information relating to any Underwriter furnished to the Company in writing by such Underwriter through you expressly for use therein.
(c) The Company has been duly incorporated, is validly existing as a corporation in good standing under the laws of the jurisdiction of its incorporation, has the corporate power and authority to own its property and to conduct its business as described in the Prospectus and is duly qualified to transact business and is in good standing in each jurisdiction in which the conduct of its business or its ownership or leasing of property requires such qualification, except to the extent that the failure to be so qualified or be in good standing would not have a material adverse effect on the Company and its subsidiaries, taken as a whole.
(d) Each subsidiary of the Company has been duly incorporated, is validly existing as a corporation in good standing under the laws of the jurisdiction of its incorporation, has the corporate power and authority to own its property and to conduct its business as described in the Prospectus and is duly qualified to transact business and is in good standing in each jurisdiction in which the conduct of its business or its ownership or leasing of property requires such qualification, except to the extent that the failure to be so qualified or be in good standing would not have a material adverse effect on the Company and its subsidiaries, taken as a whole; all of the issued shares of capital stock of each subsidiary of the Company have been duly and validly authorized and issued, are fully paid and non-assessable and are owned directly by the Company, free and clear of all liens, encumbrances, equities or claims.
(e) This Agreement has been duly authorized, executed and delivered by the Company.
(f) The authorized capital stock of the Company conforms as to legal matters to the description thereof contained in the Prospectus.
(g) The shares of Common Stock outstanding prior to the issuance of the Shares have been duly authorized and are validly issued, fully paid and non-assessable.
(h) The Shares have been duly authorized and, when issued and delivered in accordance with the terms of this Agreement, will be validly issued, fully paid and non-assessable, and the issuance of such Shares will not be subject to any preemptive or similar rights.
(i) The execution and delivery by the Company of, and the performance by the Company of its obligations under, this Agreement will not contravene any provision of applicable law or the certificate of incorporation or by- laws of the Company or any agreement or other instrument binding upon the Company or any of its subsidiaries that is material to the Company and its subsidiaries, taken as a whole, or any judgment, order or decree of any governmental body, agency or court having jurisdiction over the Company or any subsidiary, and no consent, approval, authorization or order of, or qualification with, any governmental body or agency is required for the performance by the Company of its obligations under this Agreement, except such as may be required by the securities or Blue Sky laws of the various states in connection with the offer and sale of the Shares.
(j) There has not occurred any material adverse change, or any development involving a prospective material adverse change, in the condition, financial or otherwise, or in the earnings, business or operations of the Company and its subsidiaries, taken as a whole, from that set forth in the Prospectus (exclusive of any amendments or supplements thereto subsequent to the date of this Agreement).
(k) There are no legal or governmental proceedings pending or threatened to which the Company or any of its subsidiaries is a party or to which any of the properties of the Company or any of its subsidiaries is subject that are required to be described in the Registration Statement or the Prospectus and are not so described or any statutes, regulations, contracts or other documents that are required to be described in the Registration Statement or the Prospectus or to be filed as exhibits to the Registration Statement that are not described or filed as required.
(l) Each preliminary prospectus filed as part of the registration statement as originally filed or as part of any amendment thereto, or filed pursuant to Rule 424 under the Securities Act, complied when so filed in all material respects with the Securities Act and the applicable rules and regulations of the Commission thereunder.
(m) The Company is not and, after giving effect to the offering and sale of the Shares and the application of the proceeds thereof as described in the Prospectus, will not be required to register as an "investment company" as such term is defined in the Investment Company Act of 1940, as amended.
(n) The Company and its subsidiaries (i) are in compliance with any and all applicable foreign, federal, state and local laws and regulations relating to the protection
of human health and safety, the environment or hazardous or toxic
substances or wastes, pollutants or contaminants ("Environmental Laws"),
(ii) have received all permits, licenses or other approvals required of
them under applicable Environmental Laws to conduct their respective
businesses and (iii) are in compliance with all terms and conditions of any
such permit, license or approval, except where such noncompliance with
Environmental Laws, failure to receive required permits, licenses or other
approvals or failure to comply with the terms and conditions of such
permits, licenses or approvals would not, singly or in the aggregate, have
a material adverse effect on the Company and its subsidiaries, taken as a
whole.
(o) There are no costs or liabilities associated with Environmental Laws (including, without limitation, any capital or operating expenditures required for clean-up, closure of properties or compliance with Environmental Laws or any permit, license or approval, any related constraints on operating activities and any potential liabilities to third parties) which would, singly or in the aggregate, have a material adverse effect on the Company and its subsidiaries, taken as a whole.
(p) There are no contracts, agreements or understandings between the Company and any person granting such person the right to require the Company to file a registration statement under the Securities Act with respect to any securities of the Company or to require the Company to include such securities with the Shares registered pursuant to the Registration Statement.
(q) The Company has complied with all provisions of Section 517.075, Florida Statutes relating to doing business with the Government of Cuba or with any person or affiliate located in Cuba.
(r) Subsequent to the respective dates as of which information is given in the Registration Statement and the Prospectus, (1) the Company and its subsidiaries have not incurred any material liability or obligation, direct or contingent, nor entered into any material transaction not in the ordinary course of business; (2) the Company has not purchased any of its outstanding capital stock, nor declared, paid or otherwise made any dividend or distribution of any kind on its capital stock other than ordinary and customary dividends; and (3) there has not been any material change in the capital stock, short-term debt or long-term debt of the Company and its subsidiaries, except in each case as described in the Prospectus.
(s) The Company and its subsidiaries have good and marketable title in fee simple to all real property and good and marketable title to all personal property owned by them which is material to the business of the Company and its subsidiaries, in each case free and clear of all liens, encumbrances and defects except such as are described in the Prospectus or such as do not materially affect the value of such property and do not interfere with the use made and proposed to be made of such property by the Company and its subsidiaries; and any real property and buildings held under lease by the Company and its subsidiaries are held by them under valid, subsisting and enforceable leases with such exceptions as are not material and do not interfere with the use made and proposed
to be made of such property and buildings by the Company and its subsidiaries, in each case except as described in the Prospectus.
(t) The Company and its subsidiaries own or possess, or can acquire on reasonable terms, all material patents, patent rights, licenses, inventions, copyrights, know-how (including trade secrets and other unpatented and/or unpatentable proprietary or confidential information, systems or procedures), trademarks, service marks and trade names currently employed by them in connection with the business now operated by them, and neither the Company nor any of its subsidiaries has received any notice of infringement of or conflict with asserted rights of others with respect to any of the foregoing which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would have a material adverse affect on the Company and its subsidiaries, taken as a whole.
(u) No material labor dispute with the employees of the Company or any of its subsidiaries exists, except as described in the Prospectus, or, to the knowledge of the Company, is imminent; and the Company is not aware of any existing, threatened or imminent labor disturbance by the employees of any of its principal suppliers, manufacturers or contractors that could have a material adverse effect on the Company and its subsidiaries, taken as a whole.
(v) The Company and its subsidiaries are insured by the insurers of recognized financial responsibility against such losses and risks and in such amounts as are prudent and customary in the businesses in which they are engaged; neither the Company nor any of its subsidiaries has been refused any insurance coverage sought or applied for; and neither the Company nor any of its subsidiaries has any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business at a cost that would not have a material adverse effect on the Company and its subsidiaries, taken as a whole, except as described in the Prospectus.
(w) The Company and its subsidiaries possess all certificates, authorizations and permits issued by the appropriate federal, state or foreign regulatory authorities necessary to conduct their respective businesses, and neither the Company nor any of its subsidiaries has received any notice of proceedings relating to the revocation or modification of any such certificate, authorization or permit which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would have a material adverse effect on the Company and its subsidiaries, taken as a whole, except as described the Prospectus
(x) The Company and each of its subsidiaries maintain a system of internal accounting controls sufficient to provide reasonable assurance that (1) transactions are executed in accordance with management's general or specific authorizations; (2) transactions are recorded as necessary to permit preparation of financial statements in conformity with generally accepted accounting principles and to maintain asset accountability; (3) access to assets is permitted only in accordance with management's general or specific authorization; and (4) the recorded accountability for assets is
compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences.
(y) Ernst & Young LLP are independent public accountants with respect to the Company and its subsidiaries as required by the Securities Act.
(z) The consolidated financial statements included in the Registration Statement and the Prospectus (and any amendment or supplement thereto, together with related schedules and notes, present fairly the consolidated financial position, results of operations and changes in financial position of the Company and its subsidiaries on the basis stated therein at the respective dates or for the respective periods to which they apply; such statements and related schedules and notes have been prepared in accordance with generally accepted accounting principles consistently applied throughout the periods involved, except as disclosed therein; the supporting schedules, if any, included in the Registration Statement present fairly in accordance with generally accepted accounting principles the information required to be stated therein; and the other financial and statistical information and data set forth in the Registration Statement and the Prospectus (and any amendment or supplement thereto) are, in all material respects, accurately presented and prepared on a basis consistent with such financial statements and the books and records of the Company.
(aa) The Common Stock has been approved for listing on the Nasdaq National Market.
(bb) Except for the Shares and approximately _________ shares of Common Stock currently outstanding, all outstanding shares of Common Stock, and all securities convertible into or exercisable or exchangeable for Common Stock, are subject to valid and binding agreements (collectively, the "Lock-up Agreements") that restrict the holders thereof from selling, making any short sale of, granting any option for the purchase of, or otherwise transferring or disposing of, any of such shares of Common Stock, or any such securities convertible into or exercisable or exchangeable for Common Stock, for a period of 180 days after the date of the Prospectus without the prior written consent of Morgan Stanley & Co. Incorporated or the Company.
(cc) There are no contracts, agreements or understandings between the Company and any person granting such person the right to require the Company to file a registration statement under the Securities Act with respect to any securities of the Company or to require the Company to include such securities with the Shares registered pursuant to the Registration Statement other than as described in the Registration Statement and as have been waived in writing in connection with the offering contemplated hereby.
(dd) The Registration Statement, the Prospectus and any preliminary prospectus comply, and any amendments or supplements thereto will comply, with any applicable laws or regulations of foreign jurisdictions in which the Prospectus or any preliminary prospectus, as amended or supplemented, if applicable, are distributed in connection with the Directed Share Program.
(ee) No consent, approval, authorization or order of, or qualification with, any governmental body or agency, other than those obtained, is required in connection with the offering of the Directed Shares in any jurisdiction where the Directed Shares are being offered.
(ff) The Company has not offered, or caused Morgan Stanley or its affiliates to offer, Shares to any person pursuant to the Directed Share Program with the intent to unlawfully influence (i) a customer or supplier of the Company to alter the customer's or supplier's level or type of business with the Company, or (ii) a trade journalist or publication to write or publish favorable information about the Company or its products.
2. Agreements to Sell and Purchase. The Company hereby agrees to sell to the several Underwriters, and each Underwriter, upon the basis of the representations and warranties herein contained, but subject to the conditions hereinafter stated, agrees, severally and not jointly, to purchase from the Company the respective numbers of Firm Shares set forth in Schedule I hereto opposite its names at U.S.$_____ a share (the "Purchase Price").
On the basis of the representations and warranties contained in this Agreement, and subject to its terms and conditions, the Company agrees to sell to the Underwriters the Additional Shares, and the Underwriters shall have a one-time right to purchase, severally and not jointly, up to __________ Additional Shares at the Purchase Price. If you, on behalf of the Underwriters, elect to exercise such option, you shall so notify the Company in writing not later than 30 days after the date of this Agreement, which notice shall specify the number of Additional Shares to be purchased by the Underwriters and the date on which such shares are to be purchased. Such date may be the same as the Closing Date (as defined below) but not earlier than the Closing Date nor later than ten business days after the date of such notice. Additional Shares may be purchased as provided in Section 4 hereof solely for the purpose of covering over-allotments made in connection with the offering of the Firm Shares. If any Additional Shares are to be purchased, each Underwriter agrees, severally and not jointly, to purchase the number of Additional Shares (subject to such adjustments to eliminate fractional shares as you may determine) that bears the same proportion to the total number of Additional Shares to be purchased as the number of Firm Shares set forth in Schedule I hereto opposite the name of such Underwriter bears to the total number of Firm Shares.
The Company hereby agrees that, without the prior written consent of Morgan
Stanley & Co. Incorporated on behalf of the Underwriters, it will not, during
the period ending 180 days after the date of the Prospectus, (i) offer, pledge,
sell, contract to sell, sell any option or contract to purchase, purchase any
option or contract to sell, grant any option, right or warrant to purchase,
lend, or otherwise transfer or dispose of, directly or indirectly, any shares of
Common Stock or any securities convertible into or exercisable or exchangeable
for Common Stock or (ii) enter into any swap or other arrangement that transfers
to another, in whole or in part, any of the economic consequences of ownership
of the Common Stock, whether any such transaction described in clause (i) or
(ii) above is to be settled by delivery of Common Stock or such other
securities, in cash or otherwise. The foregoing sentence shall not apply to (A)
the Shares to be sold hereunder or (B) the issuance by the Company of shares of
Common Stock upon the exercise of an option or warrant or the conversion of a
security outstanding on the date hereof of which the Underwriters have been
advised in writing.
3. Terms of Public Offering. The Company is advised by you that the Underwriters propose to make a public offering of their respective portions of the Shares as soon after the Registration Statement and this Agreement have become effective as in your judgment is advisable. The Company is further advised by you that the Shares are to be offered to the public initially at U.S.$_____ a share (the "Public Offering Price") and to certain dealers selected by you at a price that represents a concession not in excess of U.S.$____ a share under the Public Offering Price, and that any Underwriter may allow, and such dealers may reallow, a concession, not in excess of U.S.$____ a share, to any Underwriter or to certain other dealers.
4. Payment and Delivery. Payment for the Firm Shares shall be made to the Company in Federal or other funds immediately available in New York City against delivery of such Firm Shares for the respective accounts of the several Underwriters at 10:00 a.m., New York City time, on ____________, 2000, or at such other time on the same or such other date, not later than _________, 2000, as shall be designated in writing by you. The time and date of such payment are hereinafter referred to as the "Closing Date".
Payment for any Additional Shares shall be made to the Company in Federal
or other funds immediately available in New York City against delivery of such
Additional Shares for the respective accounts of the several Underwriters at
10:00 a.m., New York City time, on the date specified in the notice described in
Section 2 or at such other time on the same or on such other date, in any event
not later than ___________, 2000, as shall be designated in writing by the U.S.
Representatives. The time and date of such payment are hereinafter referred to
as the "Option Closing Date".
Certificates for the Firm Shares and Additional Shares shall be in definitive form and registered in such names and in such denominations as you shall request in writing not later than one full business day prior to the Closing Date or the Option Closing Date, as the case may be. The certificates evidencing the Firm Shares and Additional Shares shall be delivered to you on the Closing Date or the Option Closing Date, as the case may be, for the respective accounts of the several Underwriters, with any transfer taxes payable in connection with the transfer of the Shares to the Underwriters duly paid, against payment of the Purchase Price therefor.
5. Conditions to the Underwriters' Obligations. The obligations of the Company to sell the Shares to the Underwriters and the several obligations of the Underwriters to purchase and pay for the Shares on the Closing Date are subject to the condition that the Registration Statement shall have become effective not later than 3:00 p.m. (New York City time) on the date hereof.
The several obligations of the Underwriters are subject to the following further conditions:
(a) Subsequent to the execution and delivery of this Agreement and prior to the Closing Date:
(i) there shall not have occurred any downgrading, nor shall any notice have been given of any intended or potential downgrading or of any review for a possible change that does not indicate the direction of the possible change, in
the rating accorded any of the Company's securities by any "nationally recognized statistical rating organization," as such term is defined for purposes of Rule 436(g)(2) under the Securities Act; and
(ii) there shall not have occurred any change, or any development involving a prospective change, in the condition, financial or otherwise, or in the earnings, business or operations of the Company and its subsidiaries, taken as a whole, from that set forth in the Prospectus (exclusive of any amendments or supplements thereto subsequent to the date of this Agreement) that, in your judgment, is material and adverse and that makes it, in your judgment, impracticable to market the Shares on the terms and in the manner contemplated in the Prospectus.
(b) The Underwriters shall have received on the Closing Date a certificate, dated the Closing Date and signed by an executive officer of the Company, to the effect set forth in Section 5(a)(i) above and to the effect that the representations and warranties of the Company contained in this Agreement are true and correct as of the Closing Date and that the Company has complied with all of the agreements and satisfied all of the conditions on its part to be performed or satisfied hereunder on or before the Closing Date.
The officer signing and delivering such certificate may rely upon the best of his or her knowledge as to proceedings threatened.
(c) The Underwriters shall have received on the Closing Date an opinion of Venture Law Group, outside counsel for the Company, dated the Closing Date, to the effect that:
(i) the Company has been duly incorporated, is validly existing as a corporation in good standing under the laws of the jurisdiction of its incorporation, has the corporate power and authority to own its property and to conduct its business as described in the Prospectus and is duly qualified to transact business and is in good standing in each jurisdiction in which the conduct of its business or its ownership or leasing of property requires such qualification, except to the extent that the failure to be so qualified or be in good standing would not have a material adverse effect on the Company and its subsidiaries, taken as a whole;
(ii) each subsidiary of the Company has been duly incorporated, is validly existing as a corporation in good standing under the laws of the jurisdiction of its incorporation, has the corporate power and authority to own its property and to conduct its business as described in the Prospectus and is duly qualified to transact business and is in good standing in each jurisdiction in which the conduct of its business or its ownership or leasing of property requires such qualification, except to the extent that the failure to be so qualified or be in good standing would not have a material adverse effect on the Company and its subsidiaries, taken as a whole;
(iii) the authorized capital stock of the Company conforms as to legal matters to the description thereof contained in the Prospectus;
(iv) the shares of Common Stock outstanding prior to the issuance of the Shares have been duly authorized and are validly issued, fully paid and non-assessable;
(v) all of the issued shares of capital stock of each subsidiary of the Company have been duly and validly authorized and issued, are fully paid and non-assessable and are owned directly by the Company, free and clear of all liens, encumbrances, equities or claims;
(vi) the Shares have been duly authorized and, when issued and delivered in accordance with the terms of this Agreement, will be validly issued, fully paid and non-assessable, and the issuance of such Shares will not be subject to any preemptive or similar rights;
(vii) this Agreement has been duly authorized, executed and delivered by the Company;
(viii) the execution and delivery by the Company of, and the performance by the Company of its obligations under, this Agreement will not contravene any provision of applicable law or the certificate of incorporation or by-laws of the Company or, to the best of such counsel's knowledge, any agreement or other instrument binding upon the Company or any of its subsidiaries that is material to the Company and its subsidiaries, taken as a whole, or, to the best of such counsel's knowledge, any judgment, order or decree of any governmental body, agency or court having jurisdiction over the Company or any subsidiary, and no consent, approval, authorization or order of, or qualification with, any governmental body or agency is required for the performance by the Company of its obligations under this Agreement, except such as may be required by the securities or Blue Sky laws of the various states in connection with the offer and sale of the Shares by the Underwriters;
(ix) the statements (A) in the Prospectus under the captions "Risk Factors - We rely heavily on third parties and do not control critical steps in the manufacturing and testing of our products," "Management - Employment Agreements", "Management - Employee Benefit Plans," "Certain Transactions," "Description of Capital Stock", "Shares Eligible for Future Sale" and "Underwriters" and (B) in the Registration Statement in Items 14 and 15, in each case insofar as such statements constitute summaries of the legal matters, documents or proceedings referred to therein, fairly present the information called for with respect to such legal matters, documents and proceedings and fairly summarize the matters referred to therein;
(x) after due inquiry, such counsel does not know of any legal or governmental proceedings pending or threatened to which the Company or any of
its subsidiaries is a party or to which any of the properties of the Company or any of its subsidiaries is subject that are required to be described in the Registration Statement or the Prospectus and are not so described or of any statutes, regulations, contracts or other documents that are required to be described in the Registration Statement or the Prospectus or to be filed as exhibits to the Registration Statement that are not described or filed as required;
(xi) the Company is not and, after giving effect to the offering and sale of the Shares and the application of the proceeds thereof as described in the Prospectus, will not be required to register as an "investment company" as such term is defined in the Investment Company Act of 1940, as amended;
(xii) the Company and its subsidiaries (A) are in compliance with any and all applicable Environmental Laws, (B) have received all permits, licenses or other approvals required of them under applicable Environmental Laws to conduct their respective businesses and (C) are in compliance with all terms and conditions of any such permit, license or approval, except where such noncompliance with Environmental Laws, failure to receive required permits, licenses or other approvals or failure to comply with the terms and conditions of such permits, licenses or approvals would not, singly or in the aggregate, have a material adverse effect on the Company and its subsidiaries, taken as a whole; and
(xiii) such counsel (A) is of the opinion that the Registration Statement and Prospectus (except for financial statements and schedules and other financial and statistical data included therein as to which such counsel need not express any opinion) comply as to form in all material respects with the Securities Act and the applicable rules and regulations of the Commission thereunder, (B) has no reason to believe that (except for financial statements and schedules and other financial and statistical data as to which such counsel need not express any belief) the Registration Statement and the prospectus included therein at the time the Registration Statement became effective contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary to make the statements therein not misleading and (C) has no reason to believe that (except for financial statements and schedules and other financial and statistical data as to which such counsel need not express any belief) the Prospectus contains any untrue statement of a material fact or omits to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading.
(d) The Underwriters shall have received on the Closing Date an opinion of Bozicevic, Field & Francis LLP, patent counsel to the Company, dated the Closing Date, with respect to certain patent matters, to the effect that:
(i) The Company owns or has valid licenses to use all patents, licenses, inventions and rights described in the Prospectus as being owned or licensed by it, and such counsel is not aware of any claim to the contrary or any
challenge by any other person to the rights of the Company with respect to the foregoing other than those identified in the Prospectus;
(ii) Such counsel is not aware of any legal actions, claims or proceedings pending or threatened against the Company, its manufacturers, suppliers or customers other than those identified in the Prospectus alleging that the Company is infringing or otherwise violating any patents, licenses or inventions owned by others;
(iii) Such counsel has reviewed the descriptions of intellectual property under the captions "Risk Factors - Our agreement with ALZA limits our fields of operation for our DUROS-based pharmaceutical systems, requires us to spend significant funds on product development and gives ALZA a first right to distribute selected products for us," "Business - Development and Commercialization Agreement with ALZA Corporation" and "- Patents, Licenses and Proprietary Rights" in the Registration Statement and Prospectus, and, to the extent they constitute matters of law or legal conclusions, these descriptions are accurate and fairly and completely present the patent situation of the Company or that such descriptions contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made therein, in light of the circumstances under which they were made, not misleading, including without limitation, any undisclosed material issue with respect to the subsequent validity or enforceability of such patent or patent issuing from any such pending patent application.
(iv) With respect to the patent protection on the Company's
technology for each patent or patent application described in the
Prospectus as being owned by the Company, such counsel is aware of
nothing that causes such counsel to believe that, as of the date the
Registration Statement became effective and as of the date of such
opinion, the description of patents and patent applications under the
captions "Risk Factors--If we are unable to adequately protect or
enforce our intellectual property rights or secure rights to third-
party patents, we may lose valuable assets, experience reduced market
share or incur costly litigation to protect our rights," and "Business
- Intellectual Property" in the Registration Statement and Prospectus
contain any untrue statement of a material fact or omit to state a
material fact necessary to make the statements made therein, in light
of the circumstances under which they were made, not misleading,
including without limitation, any undisclosed material issue with
respect to the subsequent validity or enforceability of such patent or
patent issuing from any such pending patent application.
(e) The Underwriters shall have received on the Closing Date an opinion of ________________________, Food and Drug Administration ("FDA") counsel to the Company, dated the closing date, with respect to certain FDA matters, to the effect that:
(i) The statements in the Prospectus under the captions "Risk Factors - We must conduct and satisfactorily complete clinical trials for our
pharmaceutical systems," "- Failure to obtain product approvals or
comply with ongoing governmental regulations could delay or limit
introduction of our new products and result in failure to achieve
anticipated revenues," "Business - Durect Pharmaceutical Systems
Technology," "- Product Development Programs," and "-Government
Regulation," insofar as such statements constitute legal conclusions
under the Federal Food, Drug, and Cosmetic Act ("FDC Act"), the Public
Health Service Act ("PHS Act") or the FDA regulations (such matters
(a) and (b) collectively, the "FDA Regulatory Matters"), regulations
or summaries of FDA Regulatory Matters, have been reviewed by such
counsel and fairly present and summarize, in all material respects,
the matters referred to therein.
(ii) Such counsel knows of no material action, suit, claim or proceeding relating to FDA Regulatory Matters which is pending or threatened against the Company or any of its officers or directors, nor is such counsel aware of any material violation of the FDC Act, the PHS Act or FDA regulations by the Company.
(iv) The FDA has not placed a clinical hold on any Company clinical trial, and/or placed any conditions on the continuation of a Company clinical trial, and the Company has not voluntarily or involuntarily, on a temporary or permanent basis, suspended or terminated a clinical trial.
(v) To such counsel's knowledge, no Adverse Event has occurred during a clinical trial that would require the Company to report such event to the FDA.
(f) The Underwriters shall have received on the Closing Date an
opinion of Gray Cary Ware & Freidenrich LLP, counsel for the Underwriters,
dated the Closing Date, covering the matters referred to in Sections
5(c)(vi), 5(c)(vii), 5(c)(ix) (but only as to the statements in the
Prospectus under "Description of Capital Stock" and "Underwriters") and
5(c)(xiii) above.
With respect to Section 5(c)(xiii) above, Venture Law Group and Gray Cary Ware & Freidenrich LLP may state that their opinion and belief are based upon their participation in the preparation of the Registration Statement and Prospectus and any amendments or supplements thereto and review and discussion of the contents thereof, but are without independent check or verification, except as specified.
The opinions of Venture Law Group, Bozicevic, Field & Francis LLP and _____________ described in Sections 5(c), 5(d) and 5(e) above shall be rendered to the Underwriters at the request of the Company and shall so state therein.
(g) The Underwriters shall have received, on each of the date hereof and the Closing Date, a letter dated the date hereof or the Closing Date, as the case may be, in form and substance satisfactory to the Underwriters, from Ernst & Young LLP, independent public accountants, containing statements and information of the type ordinarily included in accountants' "comfort letters" to underwriters with respect to the financial statements and certain financial information contained in the Registration Statement and the Prospectus; provided that the letter delivered on the Closing Date shall use a "cut-off date" not earlier than the date hereof.
(h) The "lock-up" agreements, each substantially in the form of Exhibit A hereto, between you and certain shareholders, officers and directors of the Company relating to sales and certain other dispositions of shares of Common Stock or certain other securities, delivered to you on or before the date hereof, shall be in full force and effect on the Closing Date.
The several obligations of the Underwriters to purchase Additional Shares hereunder are subject to the delivery to the Representatives on the Option Closing Date of such documents as they may reasonably request with respect to the good standing of the Company, the due authorization and issuance of the Additional Shares and other matters related to the issuance of the Additional Shares.
6. Covenants of the Company. In further consideration of the agreements of the Underwriters herein contained, the Company covenants with each Underwriter as follows:
(a) To furnish to you, without charge, four signed copies of the
Registration Statement (including exhibits thereto) and for delivery to
each other Underwriter a conformed copy of the Registration Statement
(without exhibits thereto) and to furnish to you in New York City, without
charge, prior to 10:00 a.m. New York City time on the business day next
succeeding the date of this Agreement and during the period mentioned in
Section 6(c) below, as many copies of the Prospectus and any supplements
and amendments thereto or to the Registration Statement as you may
reasonably request.
(b) Before amending or supplementing the Registration Statement or the Prospectus, to furnish to you a copy of each such proposed amendment or supplement and not to file any such proposed amendment or supplement to which you reasonably object, and to file with the Commission within the applicable period specified in Rule 424(b) under the Securities Act any prospectus required to be filed pursuant to such Rule.
(c) If, during such period after the first date of the public offering of the Shares as in the opinion of counsel for the Underwriters the Prospectus is required by law to be delivered in connection with sales by an Underwriter or dealer, any event shall occur or condition exist as a result of which it is necessary to amend or supplement the Prospectus in order to make the statements therein, in the light of the circumstances when
the Prospectus is delivered to a purchaser, not misleading, or if, in the opinion of counsel for the Underwriters, it is necessary to amend or supplement the Prospectus to comply with applicable law, forthwith to prepare, file with the Commission and furnish, at its own expense, to the Underwriters and to the dealers (whose names and addresses you will furnish to the Company) to which Shares may have been sold by you on behalf of the Underwriters and to any other dealers upon request, either amendments or supplements to the Prospectus so that the statements in the Prospectus as so amended or supplemented will not, in the light of the circumstances when the Prospectus is delivered to a purchaser, be misleading or so that the Prospectus, as amended or supplemented, will comply with law.
(d) To endeavor to qualify the Shares for offer and sale under the securities or Blue Sky laws of such jurisdictions as you shall reasonably request.
(e) To make generally available to the Company's security holders and to you as soon as practicable an earning statement covering the twelve- month period ending June 30, 2001 that satisfies the provisions of Section 11(a) of the Securities Act and the rules and regulations of the Commission thereunder.
(f) The Company will apply the proceeds from the sale of the Shares as set forth under "Use of Proceeds" in the Prospectus.
(g) The Company will use its best efforts to obtain and maintain in effect the quotation of the Shares on the Nasdaq National Market and will take all necessary steps to cause the Shares to be included on the Nasdaq National Market as promptly as practicable and to maintain such inclusion for a period of three years after the date hereof or until such earlier date as the Shares shall be listed for regular trading privileges on another national securities exchange approved by you.
(h) The Company will comply with all registration, filing and reporting requirements of the Exchange Act which may from time to time be applicable to the Company.
(i) The Company will comply with all provisions of all undertakings contained in the Registration Statement.
(j) Prior to the Closing Date, the Company will not, directly or indirectly, issue any press release or other communication and will not hold any press conference with respect to the Company, or its financial condition, results of operations, business, properties, assets, or prospects or this offering, without your prior written consent.
(k) Whether or not the transactions contemplated in this Agreement are consummated or this Agreement is terminated, to pay or cause to be paid all expenses incident to the performance of its obligations under this Agreement, including: (i) the fees, disbursements and expenses of the Company's counsel and the Company's accountants in connection with the registration and delivery of the Shares under the Securities Act and all other fees or expenses in connection with the preparation and filing of the Registration Statement, any preliminary prospectus, the Prospectus and
amendments and supplements to any of the foregoing, including all printing
costs associated therewith, and the mailing and delivering of copies
thereof to the Underwriters and dealers, in the quantities hereinabove
specified, (ii) all costs and expenses related to the transfer and delivery
of the Shares to the Underwriters, including any transfer or other taxes
payable thereon, (iii) the cost of printing or producing any Blue Sky or
Legal Investment memorandum in connection with the offer and sale of the
Shares under state securities laws and all expenses in connection with the
qualification of the Shares for offer and sale under state securities laws
as provided in Section 6(d) hereof, including filing fees and the
reasonable fees and disbursements of counsel for the Underwriters in
connection with such qualification and in connection with the Blue Sky or
Legal Investment memorandum, (iv) all filing fees and the reasonable fees
and disbursements of counsel to the Underwriters incurred in connection
with the review and qualification of the offering of the Shares by the
National Association of Securities Dealers, Inc., (v) all fees and expenses
in connection with the preparation and filing of the registration statement
on Form 8-A relating to the Common Stock and all costs and expenses
incident to listing the Shares on the Nasdaq National Market, (vi) the cost
of printing certificates representing the Shares, (vii) the costs and
charges of any transfer agent, registrar or depositary, (viii) the costs
and expenses of the Company relating to investor presentations on any "road
show" undertaken in connection with the marketing of the offering of the
Shares, including, without limitation, expenses associated with the
production of road show slides and graphics, fees and expenses of any
consultants engaged in connection with the road show presentations with the
prior approval of the Company, travel and lodging expenses of the
representatives and officers of the Company and any such consultants, and
the cost of any aircraft chartered in connection with the road show, and
(ix) all other costs and expenses incident to the performance of the
obligations of the Company hereunder for which provision is not otherwise
made in this Section. It is understood, however, that except as provided in
this Section, Section 7 entitled "Indemnity and Contribution", and the last
paragraph of Section 10 below, the Underwriters will pay all of their costs
and expenses, including fees and disbursements of their counsel, stock
transfer taxes payable on resale of any of the Shares by them and any
advertising expenses connected with any offers they may make.
7. Indemnity and Contribution.
(a) The Company agrees to indemnify and hold harmless each Underwriter and each person, if any, who controls any Underwriter within the meaning of either Section 15 of the Securities Act or Section 20 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), from and against any and all losses, claims, damages and liabilities (including, without limitation, any legal or other expenses reasonably incurred in connection with defending or investigating any such action or claim) caused by any untrue statement or alleged untrue statement of a material fact contained in the Registration Statement or any amendment thereof, any preliminary prospectus or the Prospectus (as amended or supplemented if the Company shall have furnished any amendments or supplements thereto), or caused by any omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, except insofar as such losses, claims, damages or liabilities are caused by any such untrue statement or omission or alleged untrue
statement or omission based upon information relating to any Underwriter furnished to the Company in writing by such Underwriter through you expressly for use therein.
(b) Each Underwriter agrees, severally and not jointly, to indemnify and hold harmless the Company, its directors, its officers who sign the Registration Statement and each person, if any, who controls the Company within the meaning of either Section 15 of the Securities Act or Section 20 of the Exchange Act to the same extent as the foregoing indemnity from the Company to such Underwriter, but only with reference to information relating to such Underwriter furnished to the Company in writing by such Underwriter through you expressly for use in the Registration Statement, any preliminary prospectus, the Prospectus or any amendments or supplements thereto.
(c) In case any proceeding (including any governmental investigation)
shall be instituted involving any person in respect of which indemnity may
be sought pursuant to Section 7(a) or 7(b), such person (the "indemnified
party") shall promptly notify the person against whom such indemnity may be
sought (the "indemnifying party") in writing and the indemnifying party,
upon request of the indemnified party, shall retain counsel reasonably
satisfactory to the indemnified party to represent the indemnified party
and any others the indemnifying party may designate in such proceeding and
shall pay the fees and disbursements of such counsel related to such
proceeding. In any such proceeding, any indemnified party shall have the
right to retain its own counsel, but the fees and expenses of such counsel
shall be at the expense of such indemnified party unless (i) the
indemnifying party and the indemnified party shall have mutually agreed to
the retention of such counsel or (ii) the named parties to any such
proceeding (including any impleaded parties) include both the indemnifying
party and the indemnified party and representation of both parties by the
same counsel would be inappropriate due to actual or potential differing
interests between them. It is understood that the indemnifying party shall
not, in respect of the legal expenses of any indemnified party in
connection with any proceeding or related proceedings in the same
jurisdiction, be liable for the fees and expenses of more than one separate
firm (in addition to any local counsel) for all such indemnified parties
and that all such fees and expenses shall be reimbursed as they are
incurred. Such firm shall be designated in writing by Morgan Stanley & Co.
Incorporated, in the case of parties indemnified pursuant to Section 7(a),
and by the Company, in the case of parties indemnified pursuant to Section
7(b). The indemnifying party shall not be liable for any settlement of any
proceeding effected without its written consent, but if settled with such
consent or if there be a final judgment for the plaintiff, the indemnifying
party agrees to indemnify the indemnified party from and against any loss
or liability by reason of such settlement or judgment. Notwithstanding the
foregoing sentence, if at any time an indemnified party shall have
requested an indemnifying party to reimburse the indemnified party for fees
and expenses of counsel as contemplated by the second and third sentences
of this paragraph, the indemnifying party agrees that it shall be liable
for any settlement of any proceeding effected without its written consent
if (i) such settlement is entered into more than 30 days after receipt by
such indemnifying party of the aforesaid request and (ii) such indemnifying
party shall not have reimbursed the indemnified party in accordance with
such request prior to the date of such settlement. No indemnifying party
shall, without the prior written consent of the indemnified party, effect
any settlement of any pending or threatened proceeding in
respect of which any indemnified party is or could have been a party and indemnity could have been sought hereunder by such indemnified party, unless such settlement includes an unconditional release of such indemnified party from all liability on claims that are the subject matter of such proceeding.
(d) To the extent the indemnification provided for in Section 7(a) or 7(b) is unavailable to an indemnified party or insufficient in respect of any losses, claims, damages or liabilities referred to therein, then each indemnifying party under such paragraph, in lieu of indemnifying such indemnified party thereunder, shall contribute to the amount paid or payable by such indemnified party as a result of such losses, claims, damages or liabilities (i) in such proportion as is appropriate to reflect the relative benefits received by the Company on the one hand and the Underwriters on the other hand from the offering of the Shares or (ii) if the allocation provided by clause 7(d)(i) above is not permitted by applicable law, in such proportion as is appropriate to reflect not only the relative benefits referred to in clause 7(d)(i) above but also the relative fault of the Company on the one hand and of the Underwriters on the other hand in connection with the statements or omissions that resulted in such losses, claims, damages or liabilities, as well as any other relevant equitable considerations. The relative benefits received by the Company on the one hand and the Underwriters on the other hand in connection with the offering of the Shares shall be deemed to be in the same respective proportions as the net proceeds from the offering of the Shares (before deducting expenses) received by the Company and the total underwriting discounts and commissions received by the Underwriters, in each case as set forth in the table on the cover of the Prospectus, bear to the aggregate Public Offering Price of the Shares. The relative fault of the Company on the one hand and the Underwriters on the other hand shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission or alleged omission to state a material fact relates to information supplied by the Company or by the Underwriters and the parties' relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission. The Underwriters' respective obligations to contribute pursuant to this Section 7 are several in proportion to the respective number of Shares they have purchased hereunder, and not joint.
(e) The Company and the Underwriters agree that it would not be just or equitable if contribution pursuant to this Section 7 were determined by pro rata allocation (even if the Underwriters were treated as one entity for such purpose) or by any other method of allocation that does not take account of the equitable considerations referred to in Section 7(d). The amount paid or payable by an indemnified party as a result of the losses, claims, damages and liabilities referred to in the immediately preceding paragraph shall be deemed to include, subject to the limitations set forth above, any legal or other expenses reasonably incurred by such indemnified party in connection with investigating or defending any such action or claim. Notwithstanding the provisions of this Section 7, no Underwriter shall be required to contribute any amount in excess of the amount by which the total price at which the Shares underwritten by it and distributed to the public were offered to the public exceeds the amount of any damages that such Underwriter has otherwise been required to pay by reason of such untrue or alleged untrue statement or omission or alleged omission. No person guilty of fraudulent
misrepresentation (within the meaning of Section 11(f) of the Securities
Act) shall be entitled to contribution from any person who was not guilty
of such fraudulent misrepresentation. The remedies provided for in this
Section 7 are not exclusive and shall not limit any rights or remedies
which may otherwise be available to any indemnified party at law or in
equity.
(f) The indemnity and contribution provisions contained in this
Section 7 and the representations, warranties and other statements of the
Company contained in this Agreement shall remain operative and in full
force and effect regardless of (i) any termination of this Agreement, (ii)
any investigation made by or on behalf of any Underwriter or any person
controlling any Underwriter or by or on behalf of the Company, its officers
or directors or any person controlling the Company and (iii) acceptance of
and payment for any of the Shares.
8. Directed Share Program Indemnification.
(a) The Company agrees to indemnify and hold harmless Morgan Stanley and its affiliates and each person, if any, who controls Morgan Stanley or its affiliates within the meaning of either Section 15 of the Securities Act or Section 20 of the Exchange Act ("Morgan Stanley Entities"), from and against any and all losses, claims, damages and liabilities (including, without limitation, any legal or other expenses reasonably incurred in connection with defending or investigating any such action or claim) (i) caused by any untrue statement or alleged untrue statement of a material fact contained in any material prepared by or with the consent of the Company for distribution to Participants in connection with the Directed Share Program, or caused by any omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading; (ii) caused by the failure of any Participant to pay for and accept delivery of Directed Shares that the Participant has agreed to purchase; or (iii) related to, arising out of, or in connection with the Directed Share Program other than losses, claims, damages or liabilities (or expenses relating thereto) that are finally judicially determined to have resulted from the bad faith or gross negligence of Morgan Stanley Entities.
(b) In case any proceeding (including any governmental investigation) shall be instituted involving any Morgan Stanley Entity in respect of which indemnity may be sought pursuant to Section 7(a), the Morgan Stanley Entity seeking indemnity shall promptly notify the Company in writing and the Company, upon request of the Morgan Stanley Entity, shall retain counsel reasonably satisfactory to the Morgan Stanley Entity to represent the Morgan Stanley Entity and any other the Company may designate in such proceeding and shall pay the fees and disbursements of such counsel related to such proceeding. In any such proceeding, any Morgan Stanley Entity shall have the right to retain its own counsel, but the fees and expenses of such counsel shall be at the expense of such Morgan Stanley Entity unless (I) the Company shall have agreed to the retention of such counsel or (ii) the named parties to any such proceeding (including any impleaded parties) include both the Company and the Morgan Stanley Entity and representation of both parties by the same counsel would be inappropriate due to actual or potential differing interests between them. The Company shall not, in respect of the legal
expenses of the Morgan Stanley Entities in connection with any proceeding or related proceedings the same jurisdiction, be liable for the fees and expenses of more than one separate firm (in addition to any local counsel) for all Morgan Stanley Entities. Any such firm for the Morgan Stanley Entities shall be designated in writing by Morgan Stanley. The Company shall not be liable for any settlement of any proceeding effected without its written consent, but if settled with such consent or if there be a final judgment for the plaintiff, the Company agrees to indemnify the Morgan Stanley Entities from and against any loss or liability by reason of such settlement or judgment. Notwithstanding the foregoing sentence, if at any time a Morgan Stanley Entity shall have requested the Company to reimburse it for fees and expenses of counsel as contemplated by the second and third sentences of this paragraph, the Company agrees that it shall be liable for any settlement of any proceeding effected without its written consent if (i) such settlement is entered into more than 30 days after receipt by the Company of the aforesaid request and (ii) the Company shall not have reimbursed the Morgan Stanley Entity in accordance with such request prior to the date of such settlement. The Company shall not, without the prior written consent of Morgan Stanley, effect any settlement of any pending or threatened proceeding in respect of which any Morgan Stanley Entity is or could have been a party and indemnity could have been sought hereunder by such Morgan Stanley Entity, unless such settlement includes an unconditional release of the Morgan Stanley Entities from all liability on claims that are the subject matter of such proceeding.
(c) To the extent the indemnification provided for in Section 7(a) is unavailable to a Morgan Stanley Entity or insufficient in respect of any losses, claims, damages or liabilities referred to therein, then the Company, in lieu of indemnifying the Morgan Stanley Entity thereunder, shall contribute to the amount paid or payable by the Morgan Stanley Entity as a result of such losses, claims, damages or liabilities (i) in such proportion as is appropriate to reflect the relative benefits received by the Company on the one hand and the Morgan Stanley Entities on the other hand from the offering of the Directed Shares or (ii) if the allocation provided by clause 7(c)(i) above is not permitted by applicable law, in such proportion as is appropriate to reflect not only the relative benefits referred to in clause 7(c)(i) above but also the relative fault of the Company on the one hand and of the Morgan Stanley Entities on the other hand in connection with the statements or omissions that resulted in such losses, claims, damages or liabilities, as well as any other relevant equitable considerations. The relative benefits received by the Company on the one hand and of the Morgan Stanley Entities on the other hand in connection with the offering of the Directed Shares shall be deemed to be in the same respective proportions as the net proceeds from the offering of the Directed Shares (before deducting expenses) and the total underwriting discounts and commissions received by the Morgan Stanley Entities for the Directed Shares, bear to the aggregate Public Offering Price of the Shares. If the loss, claim, damage or liability is caused by an untrue or alleged untrue statement of a material fact, the relative fault of the Company on the one hand and the Morgan Stanley Entities on the other hand shall be determined by reference to, among other things, whether the untrue or alleged untrue statement or the omission or alleged omission relates to information supplied by the Company or by the Morgan Stanley Entities and the parties' relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission.
(d) The Company and the Morgan Stanley Entities agree that it would not be just or equitable if contribution pursuant to this Section 8 were determined by pro rata allocation (even if the Morgan Stanley Entities were treated as one entity for such purpose) or by any other method of allocation that does not take account of the equitable considerations referred to in Section 8(c). The amount paid or payable by the Morgan Stanley Entities as a result of the losses, claims, damages and liabilities referred to in the immediately preceding paragraph shall be deemed to include, subject to the limitations set forth above, any legal or other expenses reasonably incurred by the Morgan Stanley Entities in connection with investigating or defending any such action or claim. Notwithstanding the provisions of this Section 8, no Morgan Stanley Entity shall be required to contribute any amount in excess of the amount by which the total price at which the Directed Shares distributed to the public were offered to the public exceeds the amount of any damages that such Morgan Stanley Entity has otherwise been required to pay by reason of such untrue or alleged untrue statement or omission or alleged omission. The remedies provided for in this Section 8 are not exclusive and shall not limit any rights or remedies which may otherwise be available to any Morgan Stanley Entity at law or in equity.
(e) The indemnity and contribution provisions contained in this
Section 8 shall remain operative and in full force and effect regardless of
(i) any termination of this Agreement, (ii) any investigation made by or on
behalf of any Morgan Stanley Entity or the Company, its officers or
directors or any person controlling the Company and (iii) acceptance of and
payment for any of the Directed Shares.
9. Termination. This Agreement shall be subject to termination by notice given by you to the Company, if (a) after the execution and delivery of this Agreement and prior to the Closing Date (i) trading generally shall have been suspended or materially limited on or by, as the case may be, any of the New York Stock Exchange, the American Stock Exchange, the National Association of Securities Dealers, Inc., the Chicago Board of Options Exchange, the Chicago Mercantile Exchange or the Chicago Board of Trade, (ii) trading of any securities of the Company shall have been suspended on any exchange or in any over-the-counter market, (iii) a general moratorium on commercial banking activities in New York shall have been declared by either Federal or New York State authorities or (iv) there shall have occurred any outbreak or escalation of hostilities or any change in financial markets or any calamity or crisis that, in your judgment, is material and adverse and (b) in the case of any of the events specified in clauses 9(a)(i) through 9(a)(iv), such event, singly or together with any other such event, makes it, in your judgment, impracticable to market the Shares on the terms and in the manner contemplated in the Prospectus.
10. Effectiveness; Defaulting Underwriters. This Agreement shall become effective upon the execution and delivery hereof by the parties hereto.
If, on the Closing Date or the Option Closing Date, as the case may be, any one or more of the Underwriters shall fail or refuse to purchase Shares that it has or they have agreed to purchase hereunder on such date, and the aggregate number of Shares which such defaulting Underwriter or Underwriters agreed but failed or refused to purchase is not more than one-tenth of the aggregate number of the Shares to be purchased on such date, the other Underwriters shall
be obligated severally in the proportions that the number of Firm Shares set forth opposite their respective names in Schedule I or Schedule II bears to the aggregate number of Firm Shares set forth opposite the names of all such non- defaulting Underwriters, or in such other proportions as you may specify, to purchase the Shares which such defaulting Underwriter or Underwriters agreed but failed or refused to purchase on such date; provided that in no event shall the number of Shares that any Underwriter has agreed to purchase pursuant to this Agreement be increased pursuant to this Section 10 by an amount in excess of one-ninth of such number of Shares without the written consent of such Underwriter. If, on the Closing Date, any Underwriter or Underwriters shall fail or refuse to purchase Firm Shares and the aggregate number of Firm Shares with respect to which such default occurs is more than one-tenth of the aggregate number of Firm Shares to be purchased, and arrangements satisfactory to you and the Company for the purchase of such Firm Shares are not made within 36 hours after such default, this Agreement shall terminate without liability on the part of any non-defaulting Underwriter or the Company. In any such case either you or the Company shall have the right to postpone the Closing Date, but in no event for longer than seven days, in order that the required changes, if any, in the Registration Statement and in the Prospectus or in any other documents or arrangements may be effected. If, on the Option Closing Date, any Underwriter or Underwriters shall fail or refuse to purchase Additional Shares and the aggregate number of Additional Shares with respect to which such default occurs is more than one-tenth of the aggregate number of Additional Shares to be purchased, the non-defaulting Underwriters shall have the option to (i) terminate their obligation hereunder to purchase Additional Shares or (ii) purchase not less than the number of Additional Shares that such non-defaulting Underwriters would have been obligated to purchase in the absence of such default. Any action taken under this paragraph shall not relieve any defaulting Underwriter from liability in respect of any default of such Underwriter under this Agreement.
If this Agreement shall be terminated by the Underwriters, or any of them, because of any failure or refusal on the part of the Company to comply with the terms or to fulfill any of the conditions of this Agreement, or if for any reason the Company shall be unable to perform its obligations under this Agreement, the Company will reimburse the Underwriters or such Underwriters as have so terminated this Agreement with respect to themselves, severally, for all out-of-pocket expenses (including the fees and disbursements of their counsel) reasonably incurred by such Underwriters in connection with this Agreement or the offering contemplated hereunder.
11. Counterparts. This Agreement may be signed in two or more counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument.
12. Applicable Law. This Agreement shall be governed by and construed in accordance with the internal laws of the State of New York.
13. Headings. The headings of the sections of this Agreement have been inserted for convenience of reference only and shall not be deemed a part of this Agreement.
Very truly yours,
DURECT CORPORATION
By:__________________________________
Name:
Title:
Accepted as of the date hereof
Morgan Stanley & Co. Incorporated
Chase H&Q
CIBC World Markets
Acting severally on behalf of themselves
and the several Underwriters
named in Schedule I hereto.
By: Morgan Stanley & Co. Incorporated
By:_____________________________________
Name:
Title:
SCHEDULE I
UNDERWRITERS
Number of Firm Underwriter Shares To Be Purchased ----------- ---------------------- Morgan Stanley & Co. Incorporated Chase H&Q |
CIBC World Markets
EXHIBIT A
[FORM OF LOCK-UP LETTER]
EXHIBIT 3.1
AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION
OF
DURECT CORPORATION
The undersigned, James E. Brown and Mark B. Weeks, hereby certify that:
1. They are the duly elected and acting President and Secretary, respectively, of Durect Corporation, a Delaware corporation.
2. The Certificate of Incorporation of this corporation was originally filed with the Secretary of State of Delaware on February 6, 1998 under the name of "Durect Therapeutics Corporation."
3. The Certificate of Incorporation of this corporation shall be amended and restated to read in full as follows:
"ARTICLE I
The name of this corporation is Durect Corporation (the "Corporation").
ARTICLE II
The address of the Corporation's registered office in the State of Delaware is Corporation Service Company, 1013 Centre Road, Wilmington, Delaware 19805, County of New Castle. The name of its registered agent at such address is Corporation Service Company.
ARTICLE III
The purpose of the Corporation is to engage in any lawful act or activity for which corporations may be organized under the Delaware General Corporation Law.
ARTICLE IV
shall be forgiven upon conversion (a "Specified Conversion") of such share to Common Stock pursuant to either Section 4(a) below or Section 4(b) below so long as any conversion pursuant to either section is in connection with a registered offering of the Corporation's Common Stock under the Securities Act (defined below). Cumulative dividends with respect to a share of Series B Preferred Stock which are accrued and/or in arrears shall be paid upon any conversion of such share into Common Stock other than a Specified Conversion either in cash or, at the discretion of the Board of Directors, in Common Stock valued at the fair market value of such Common Stock as determined in good faith by the Board of Directors; provided, however, if the holders of a majority of the then outstanding shares of the Series B Preferred Stock (the "Contesting Holders") notify the Board of Directors of the Corporation within ten (10) days after receiving written notification of such determination of the fair market value that they disagree with such determination, then the fair market value of the Common Stock shall be mutually agreed upon by the Board of Directors and the holders of a majority of the Series B Preferred Stock within thirty (30) days after the receipt of notice by the Board of Directors from the Contesting Holders.
where Y is the amount equal to the excess, if any, of the aggregate consideration to be received in the Non-Approved Merger over $95,000,000. If, upon the occurrence of such event, the assets and funds thus distributed among the holders of the Series A-2 and Series B Preferred Stock shall be insufficient to permit the payment to such holders of the full aforesaid Liquidation Preferences, then, subject to the rights of any series of Preferred Stock that may from time to time come into existence, the entire assets and funds of the Corporation legally available for distribution shall be distributed among the holders of the Series A-2 and Series B Preferred Stock pro rata in proportion to the Liquidation Preference each such holder is otherwise entitled to receive.
(A) Securities not subject to "investment letter" restrictions (e.g., federal or state securities laws restrictions) or other similar restrictions on free marketability:
(1) If traded on a securities exchange or the Nasdaq Stock Market, the value shall be deemed to be the average of the closing prices of the securities on such exchange over the thirty-day period ending three (3) days prior to the closing;
(2) If actively traded over-the- counter, the value shall be deemed to be the average of the closing bid or sale prices (whichever is applicable) over the thirty-day period ending three (3) days prior to the closing; and
(3) If there is no active public market, the value shall be the fair market value thereof, as mutually determined in good faith by the Board of Directors and the holders of at least a majority of all then outstanding shares of Series A-2 and Series B Preferred Stock, voting together as a single class.
(B) The method of valuation of securities subject to investment letter or other restrictions on free marketability (other than restrictions arising solely by virtue of a stockholder's status as an affiliate or former affiliate) shall be to make an appropriate discount from the fair market value determined as above in Section 2(c)(ii)(A) to reflect such restriction on marketability, as mutually determined in good faith by the Board of Directors and the holders of at least a majority of all then outstanding shares of Series A-2 and Series B Preferred Stock, voting together as a single class.
(1) Common Stock issued pursuant to a transaction described in Section 4(d)(ii) hereof,
(2) Not more than 2,000,000 shares of Common Stock issuable or issued prior to, on or after the Purchase Date to employees, consultants or directors of the Corporation directly or pursuant to a stock option plan or restricted stock plan approved by the Board of Directors of the Corporation,
(3) Not more than 500,000 shares of capital stock, or options or warrants to purchase capital stock, issued to financial institutions or lessors in connection with commercial credit arrangements, equipment financings or similar transactions approved by the Board of Directors,
(4) Capital stock or warrants or options to purchase capital stock issued in connection with bona fide acquisitions, mergers, partnering transactions or similar transactions ("Transactions"), the terms of which are approved by the Board of Directors, unless the Director designated by the Series B Preferred Stock reasonably determines in good faith, in his or her capacity as Director of the Corporation, that the value of the assets, consideration or rights received by the Corporation in such Transaction, when taken as a whole, would not contribute to increasing the value of the Corporation so as to justify issuance of such capital stock or warrants or options to purchase capital stock in such Transaction,
(5) Shares of Common Stock issued or issuable upon conversion of the Series A-1, Series A-2 or Series B Preferred Stock, and
(6) Shares of Common Stock issued or issuable in a public offering prior to or in connection with which all outstanding shares of Series A-1, Series A-2 and Series B Preferred Stock will be converted into shares of Common Stock.
allowed, paid or incurred by the Corporation for any underwriting or otherwise in connection with the issuance and sale thereof. In the case of the issuance of the Common Stock for a consideration in whole or in part other than cash, the consideration other than cash shall be deemed to be the fair value thereof as determined in good faith by the Board of Directors; provided, however, if the holders of a majority of the then outstanding shares of the Series A-1 Preferred Stock, Series A-2 Preferred Stock and Series B Preferred Stock (the "Contesting Holders") notify the Board of Directors of the Corporation within ten (10) business days after receiving written notification of such determination of the fair market value that they disagree with such determination, then the fair market value of the consideration shall be mutually agreed upon by the Board of Directors and the holders of a majority of the Series A-1 Preferred Stock, Series A-2 Preferred Stock and Series B Preferred Stock within thirty (30) days after the receipt of notice by the Board of Directors from the Contesting Holders.
(1) The aggregate maximum number of
shares of Common Stock deliverable upon exercise (assuming the satisfaction of
any conditions to exercisability, including without limitation, the passage of
time, but without taking into account potential antidilution adjustments) of
such options to purchase or rights to subscribe for Common Stock shall be deemed
to have been issued at the time such options or rights were issued and for a
consideration equal to the consideration (determined in the manner provided in
Section 4(d)(i)(D)), if any, received by the Corporation upon the issuance of
such options or rights plus the minimum exercise price provided in such options
or rights (without taking into account potential antidilution adjustments) for
the Common Stock covered thereby.
(2) The aggregate maximum number
of shares of Common Stock deliverable upon conversion of or in exchange
(assuming the satisfaction of any conditions to convertibility or
exchangeability, including, without limitation, the passage of time, but without
taking into account potential antidilution adjustments) for any such convertible
or exchangeable securities or upon the exercise of options to purchase or rights
to subscribe for such convertible or exchangeable securities and subsequent
conversion or exchange thereof shall be deemed to have been issued at the time
such securities were issued or such options or rights were issued and for a
consideration equal to the consideration, if any, received by the Corporation
for any such securities and related options or rights (excluding any cash
received on account of accrued interest or accrued dividends), plus the minimum
additional consideration, if any, to be received by the Corporation (without
taking into account potential antidilution adjustments) upon the conversion or
exchange of such securities or the exercise of any related options or rights
(the consideration in each case to be determined in the manner provided in
Section 4(d)(i)(D)).
(3) In the event of any change in the number of shares of Common Stock deliverable or in the consideration payable to the Corporation upon
exercise of such options or rights or upon conversion of or in exchange for such convertible or exchangeable securities, including, but not limited to, a change resulting from the antidilution provisions thereof, the Conversion Price of each of the Series A-1, Series A-2 and Series B Preferred Stock, to the extent in any way affected by or computed using such options, rights or securities, shall be recomputed to reflect such change, but no further adjustment shall be made for the actual issuance of Common Stock or any payment of such consideration upon the exercise of any such options or rights or the conversion or exchange of such securities.
(4) Upon the expiration of any such options or rights, the termination of any such rights to convert or exchange or the expiration of any options or rights related to such convertible or exchangeable securities, the Conversion Price of each of the Series A-1, Series A-2 and Series B Preferred Stock, to the extent in any way affected by or computed using such options, rights or securities or options or rights related to such securities, shall be recomputed to reflect the issuance of only the number of shares of Common Stock (and convertible or exchangeable securities which remain in effect) actually issued upon the exercise of such options or rights, upon the conversion or exchange of such securities or upon the exercise of the options or rights related to such securities.
(5) The number of shares of Common
Stock deemed issued and the consideration deemed paid therefor pursuant to
Sections 4(d)(i)(E)(1) and 4(d)(i)(E)(2) shall be appropriately adjusted to
reflect any change, termination or expiration of the type described in either
Section 4(d)(i)(E)(3) or 4(d)(i)(E)(4).
(i) No fractional shares shall be issued upon the conversion of any share or shares of the Series A-1, Series A-2 or Series B Preferred Stock, and the number of shares of Common Stock to be issued shall be rounded to the nearest whole share with one-half being rounded upward. The number of shares issuable upon such conversion shall be determined
on the basis of the total number of shares of Series A-1, Series A-2 or Series B Preferred Stock the holder is at the time converting into Common Stock and the number of shares of Common Stock issuable upon such aggregate conversion.
(ii) Upon the occurrence of each adjustment
or readjustment of the Conversion Price of Series A-1, Series A-2 or Series B
Preferred Stock pursuant to this Section 4, the Corporation, at its expense,
shall promptly compute such adjustment or readjustment in accordance with the
terms hereof and prepare and furnish to each holder of such Preferred Stock a
certificate setting forth such adjustment or readjustment and showing in detail
the facts upon which such adjustment or readjustment is based. The Corporation
shall, upon the written request at any time of any holder of Series A-1, Series
A-2 or Series B Preferred Stock, furnish or cause to be furnished to such holder
a like certificate setting forth (A) such adjustment and readjustment, (B) the
Conversion Price for such series of Preferred Stock at the time in effect, and
(C) the number of shares of Common Stock and the amount, if any, of other
property which at the time would be received upon the conversion of a share of
such series of Preferred Stock.
(a) Subject to the rights of any series of Preferred Stock that may from time to time come into existence, so long as at least three million five hundred thousand (3,500,000) shares of Series A-1, Series A-2 and Series B Preferred Stock are outstanding (as adjusted for stock splits, stock dividends or recapitalizations), the Corporation shall not without first obtaining the approval (by vote or written consent, as provided by law) of the holders of at least a majority of the then outstanding shares of Series A-1, Series A-2 and Series B Preferred Stock, voting together as a single class:
(i) effect a transaction described in
Section 2(c)(i) above or, except pursuant to the terms of the Amended and
Restated Development and Commercialization Agreement between the Corporation and
Alza Corporation effective April 28, 1999 ("Alza Agreement"), effect, in any
transaction or series of related transactions, an irrevocable sale, transfer,
license or other disposition of: (x) all significant rights associated with the
CNS Field (as defined in the Alza Agreement), (y) all rights associated with
one-third or more of the total number of Durect Fields then in existence (as
defined in the Alza Agreement); or (z) more than 35% of the fair market value of
the consolidated assets of the Corporation;
(ii) increase or decrease (other than by redemption or conversion) the total number of authorized shares of Preferred Stock;
(iii) authorize or issue, or obligate itself to issue, any other equity security, including any other security convertible into or exercisable for any equity security, having a preference over, or being on a parity with, the Series A-1, Series A-2 or Series B Preferred Stock with respect to voting, dividends, conversion or upon liquidation;
(iv) amend the Bylaws or the Certificate of Incorporation to increase or decrease the number of authorized directors above or below eight (8);
option to repurchase such shares at cost upon the occurrence of certain events, such as the termination of employment, or through the exercise of any right of first refusal;
(vi) declare or pay any dividend or other distribution on Common Stock, provided that the Corporation shall not declare or pay any dividend on Common Stock so long as any dividends on Series B Preferred Stock pursuant to Section 1(b) above are accrued or declared and unpaid;
(vii) except for transactions which are contemplated in the Alza Agreement, engage in any transactions with Alza Corporation or its successors or any person or entity who directly or indirectly controls the Corporation or directly or indirectly owns beneficially at least 10% of the outstanding capital stock of the Corporation.
(b) So long as at least two million (2,000,000) shares of Series B Preferred Stock are outstanding (as adjusted for stock splits, stock dividends or recapitalizations), the Corporation shall not without first obtaining the approval (by vote or written consent, as provided by law) of the holders of at least two-thirds of the then outstanding shares of Series B Preferred Stock, voting together as a class: (i) alter or change the rights, preferences or privileges of the shares of Series B Preferred Stock; (ii) amend the Certificate of Incorporation or the Bylaw of the Corporation so as to affect adversely the shares of Series B Preferred Stock; or (iii) authorize or issue, or obligate itself to issue, any other equity security, including any other security convertible into or exercisable for any equity security, having a preference over the Series B Preferred Stock with respect to voting, dividends, conversion or upon liquidation.
the Bylaws of the Corporation, and shall be entitled to vote upon such matters and in such manner as may be provided by law.
ARTICLE V
The Board of Directors of the Corporation is expressly authorized to make, alter or repeal Bylaws of the Corporation.
ARTICLE VI
Elections of directors need not be by written ballot unless otherwise provided in the Bylaws of the Corporation.
ARTICLE VII
(A) To the fullest extent permitted by the Delaware General Corporation Law, as the same exists or as may hereafter be amended, a director of the Corporation shall not be personally liable to the Corporation or its stockholders for monetary damages for breach of fiduciary duty as a director.
(B) The Corporation shall indemnify to the fullest extent permitted by law any person made or threatened to be made a party to an action or proceeding, whether criminal, civil, administrative or investigative, by reason of the fact that he, his testator or intestate is or was a director or officer of the Corporation or any predecessor of the Corporation, or serves or served at any other enterprise as a director or officer at the request of the Corporation or any predecessor to the Corporation.
(C) Neither any amendment nor repeal of this Article VII, nor the adoption of any provision of the Corporation's Certificate of Incorporation inconsistent with this Article VII, shall eliminate or reduce the effect of this Article VII in respect of any matter occurring, or any action or proceeding accruing or arising or that, but for this Article VII, would accrue or arise, prior to such amendment, repeal or adoption of an inconsistent provision."
* * *
The foregoing Amended and Restated Certificate of Incorporation has been duly adopted by this corporation's Board of Directors and stockholders in accordance with the applicable provisions of Sections 228, 242 and 245 of the General Corporation Law of the State of Delaware.
Executed at Cupertino, California, on July 15, 1999.
/s/ James E. Brown ---------------------------- James E. Brown, President /s/ Mark B. Weeks ---------------------------- Mark B. Weeks, Secretary |
Exhibit 3.2
CERTIFICATE OF AMENDMENT OF
AMENDED AND RESTATED CERTIFICATE OF INCORPORATION
OF
DURECT CORPORATION
The undersigned hereby certifies that:
1. He is the duly elected and acting Secretary of Durect Corporation, a Delaware corporation.
2. The Certificate of Incorporation of this corporation was originally filed with the Secretary of State of Delaware of February 6, 1998 under the name of "Durect Therapeutics Corporation."
3. Pursuant to Section 242 of the General Corporation Law of the State of Delaware, this Certificate of Amendment of Amended and Restated Certificate of Incorporation amends Article IV(A) of this corporation's Certificate of Incorporation to read in its entirety as follows:
4. The foregoing Certificate of Amendment has been duly adopted by this corporation's Board of Directors and stockholders in accordance with the applicable provisions of Section 228 and 242 of the General Corporation Law of the State of Delaware.
Executed at Cupertino, California, March 24, 2000.
/s/ Mark B. Weeks ----------------------------- Mark B. Weeks, Secretary |
EXHIBIT 3.3
AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION
OF
DURECT CORPORATION
The undersigned, James E. Brown and Mark B. Weeks, hereby certify that:
1. They are the duly elected and acting President and Secretary, respectively, of Durect Corporation, a Delaware corporation.
2. The Certificate of Incorporation of this corporation was originally filed with the Secretary of State of Delaware on February 6, 1998 under the name "Durect Therapeutics Corporation."
3. The Certificate of Incorporation of this corporation shall be amended and restated to read in full as follows:
"ARTICLE I
The name of this corporation is Durect Corporation (the "Corporation").
ARTICLE II
The address of the Corporation's registered office in the State of Delaware is 1209 Orange Street, Wilmington, County of New Castle. The name of its registered agent at such address is The Corporation Trust Company.
ARTICLE III
The purpose of the Corporation is to engage in any lawful act or activity for which corporations may be organized under the General Corporation Law of Delaware.
ARTICLE IV
(A) The Corporation is authorized to issue two classes of stock to be designated, respectively, "Common Stock" and "Preferred Stock." The total number of shares which the Corporation is authorized to issue is One Hundred and Twenty Million (120,000,000) shares, each with a par value of $0.0001 per share. One Hundred and Ten Million (110,000,000) shares shall be Common Stock and Ten Million (10,000,000) shares shall be Preferred Stock.
(B) The Preferred Stock may be issued from time to time in one or more series. The Board of Directors is hereby authorized, by filing a certificate pursuant to the applicable law of the state of Delaware and within the limitations and restrictions stated in this Certificate of Incorporation, to determine or alter the rights, preferences, privileges and restrictions granted to or imposed upon any wholly unissued series of Preferred Stock and the number of shares constituting any such series and the designation thereof, or any of them; and to increase or decrease the number of shares of any series subsequent to the issuance of shares of that series,
but not below the number of shares of such series then outstanding. In case the number of shares of any series shall be so decreased, the shares constituting such decrease shall resume the status which they had prior to the adoption of the resolution originally fixing the number of shares of such series.
ARTICLE V
The number of directors of the Corporation shall be fixed from time to time by a bylaw or amendment thereof duly adopted by the Board of Directors.
ARTICLE VI
The following paragraph shall become effective only after such time as the
Corporation meets the criteria set forth in Subdivisions (i), (ii) or (iii) of
Section 2115(c) of the California Corporations Code (the "Effective Time").
On or prior to the date on which the Corporation first provides notice of an annual meeting of the stockholders following the Effective Time, the Board of Directors of the Corporation shall divide the directors into three classes, as nearly equal in number as reasonably possible, designated Class I, Class II and Class III, respectively. Directors shall be assigned to each class in accordance with a resolution or resolutions adopted by the Board of Directors. At the first annual meeting of stockholders or any special meeting in lieu thereof following the Effective Time, the terms of the Class I directors shall expire and Class I directors shall be elected for a full term of three years. At the second annual meeting of stockholders or any special meeting in lieu thereof following the Effective Time, the terms of the Class II directors shall expire and Class II directors shall be elected for a full term of three years. At the third annual meeting of stockholders or any special meeting in lieu thereof following the Effective Time, the terms of the Class III directors shall expire and Class III directors shall be elected for a full term of three years. At each succeeding annual meeting of stockholders or special meeting in lieu thereof, directors elected to succeed the directors of the class whose terms expire at such meeting shall be elected for a full term of three years. In addition to the requirements of law and any other provisions hereof (and notwithstanding the fact that approval by a lesser vote may be permitted by law or any other provision hereof), the affirmative vote of the holders of at least 66 2/3 percent of the voting power of the then-outstanding shares of voting stock of the Corporation entitled to vote generally in the election of directors (the "Voting Stock"), voting together as a single class, shall be required to amend, alter, repeal, or adopt any provision inconsistent with this paragraph.
Prior to the Effective Time, the provisions of the preceding paragraph shall not apply, and all directors shall be elected at each annual meeting of stockholders or any special meeting in lieu thereof to hold office until the next annual meeting or special meeting in lieu thereof.
Notwithstanding the foregoing provisions of this Article VI, each director shall serve until his or her successor is duly elected and qualified or until his or her death, resignation, or removal. No decrease in the number of directors constituting the Board of Directors shall shorten the term of any incumbent director.
Any vacancies on the Board of Directors resulting from death, resignation, disqualification, removal, or other causes shall be filled by either (i) the affirmative vote of the holders of a majority of the Voting Stock voting together as a single class; or (ii) by the affirmative vote of a majority of the remaining directors then in office, even though less than a quorum of the Board of Directors. Subject to the rights of any series of Preferred Stock then outstanding, newly created directorships resulting from any increase in the number of directors shall, unless the Board of Directors determines by resolution that any such newly created directorship shall be filled by the stockholders, be filled only by the affirmative vote of the directors then in office, even though less than a quorum of the Board of Directors, or by a sole remaining director. Any director elected in accordance with the preceding sentence shall hold office for the remainder of the full term of the class of directors in which the new directorship was created or the vacancy occurred and until such director's successor shall have been elected and qualified. Any director, or the entire Board of Directors, may be removed from office at any time (i) with cause by the affirmative vote of the holders of at least a majority of the voting power of the then-outstanding shares of the Voting Stock, voting together as a single class; or (ii) without cause by the affirmative vote of the holders of at least 66 2/3% of the voting power of the then-outstanding shares of the Voting Stock, voting together as a single class.
ARTICLE VII
In the election of directors, each holder of shares of any class or series of capital stock of the Corporation shall be entitled to one vote for each share held. No stockholder will be permitted to cumulate votes at any election of directors.
ARTICLE VIII
No action shall be taken by the stockholders of the Corporation other than at an annual or special meeting of the stockholders, upon due notice and in accordance with the provisions of the Bylaws of the Corporation (the "Bylaws"), and no action shall be taken by the stockholders by written consent.
ARTICLE IX
The Corporation reserves the right to amend, alter, change or repeal any provision contained in this Certificate of Incorporation, in the manner now or hereafter prescribed by statute, and all rights conferred upon stockholders herein are granted subject to this reservation.
ARTICLE X
(A) Except as otherwise provided in the Bylaws, the Bylaws may be altered or amended or new Bylaws adopted by the affirmative vote of at least 66 2/3% of the voting power of all of the then-outstanding shares of the voting stock of the Corporation entitled to vote. The Board of Directors of the Corporation is expressly authorized to adopt, amend or repeal Bylaws.
(B) The directors of the Corporation need not be elected by written ballot unless the Bylaws so provide.
(C) Advance notice of stockholder nominations for the election of directors or of business to be brought by the stockholders before any meeting of the stockholders of the Corporation shall be given in the manner provided in the Bylaws.
ARTICLE XI
Meetings of stockholders may be held within or without the State of Delaware, as the Bylaws may provide. The books of the Corporation may be kept (subject to any provision contained in the statutes) outside the State of Delaware at such place or places as may be designated from time to time by the Board of Directors or in the bylaws of the Corporation.
ARTICLE XII
The Corporation shall have perpetual existence.
ARTICLE XIII
(A) To the fullest extent permitted by the General Corporation Law of Delaware, as the same may be amended from time to time, a director of the Corporation shall not be personally liable to the Corporation or its stockholders for monetary damages for breach of fiduciary duty as a director. If the General Corporation Law of Delaware is hereafter amended to authorize, with the approval of a corporation's stockholders, further reductions in the liability of a corporation's directors for breach of fiduciary duty, then a director of the Corporation shall not be liable for any such breach to the fullest extent permitted by the General Corporation Law of Delaware, as so amended.
(B) Any repeal or modification of the foregoing provisions of this Article XIII shall not adversely affect any right or protection of a director of the Corporation with respect to any acts or omissions of such director occurring prior to such repeal or modification.
ARTICLE XIV
(A) To the fullest extent permitted by applicable law, the Corporation is also authorized to provide indemnification of (and advancement of expenses to) such agents (and any other persons to which Delaware law permits the Corporation to provide indemnification) through Bylaw provisions, agreements with such agents or other persons, vote of stockholders or disinterested directors or otherwise, in excess of the indemnification and advancement otherwise permitted by Section 145 of the General Corporation Law of Delaware, subject only to limits created by applicable Delaware law (statutory or non-statutory), with respect to actions for breach of duty to a corporation, its stockholders, and others.
(B) Any repeal or modification of any of the foregoing provisions of this Article XIV shall not adversely affect any right or protection of a director, officer, agent or other person existing at the time of, or increase the liability of any director of the Corporation with respect to any acts or omissions of such director, officer or agent occurring prior to such repeal or modification."
* * *
The foregoing Amended and Restated Certificate of Incorporation has been duly adopted by this Corporation's Board of Directors and stockholders in accordance with the applicable provisions of Section 228, 242 and 245 of the General Corporation Law of the State of Delaware.
Executed at ____________________, on the ____ day of ___________, 2000.
EXHIBIT 3.4
BYLAWS
OF
DURECT THERAPEUTICS CORPORATION
TABLE OF CONTENTS
Page ---- ARTICLE I - CORPORATE OFFICES.................................................................................... 1 1.1 Registered Office................................................................................... 1 1.2 Other Offices....................................................................................... 1 ARTICLE II - MEETINGS OF STOCKHOLDERS............................................................................ 1 2.1 Place Of Meetings................................................................................... 1 2.2 Annual Meeting...................................................................................... 1 2.3 Special Meeting..................................................................................... 1 2.4 Notice Of Stockholders' Meetings.................................................................... 2 2.5 Manner Of Giving Notice; Affidavit Of Notice........................................................ 2 2.6 Quorum.............................................................................................. 2 2.7 Adjourned Meeting; Notice........................................................................... 2 2.8 Conduct Of Business................................................................................. 3 2.9 Voting.............................................................................................. 3 2.10 Waiver Of Notice................................................................................... 3 2.11 Stockholder Action By Written Consent Without A Meeting............................................ 3 2.12 Record Date For Stockholder Notice; Voting; Giving Consents........................................ 4 2.13 Proxies............................................................................................ 4 ARTICLE III - DIRECTORS.......................................................................................... 5 3.1 Powers.............................................................................................. 5 3.2 Number Of Directors................................................................................. 5 3.3 Election, Qualification And Term Of Office Of Directors............................................. 5 3.4 Resignation And Vacancies........................................................................... 5 3.5 Place Of Meetings; Meetings By Telephone............................................................ 6 3.6 Regular Meetings.................................................................................... 6 3.7 Special Meetings; Notice............................................................................ 7 3.8 Quorum.............................................................................................. 7 3.9 Waiver Of Notice.................................................................................... 7 3.10 Board Action By Written Consent Without A Meeting.................................................. 8 3.11 Fees And Compensation Of Directors................................................................. 8 3.12 Approval Of Loans To Officers...................................................................... 8 3.13 Removal Of Directors............................................................................... 8 3.14 Chairman Of The Board Of Directors................................................................. 8 ARTICLE IV - COMMITTEES.......................................................................................... 9 4.1 Committees Of Directors............................................................................. 9 4.2 Committee Minutes................................................................................... 9 4.3 Meetings And Action Of Committees................................................................... 9 |
TABLE OF CONTENTS
(continued)
Page ---- ARTICLE V - OFFICERS............................................................................................. 10 5.1 Officers............................................................................................ 10 5.2 Appointment Of Officers............................................................................. 10 5.3 Subordinate Officers................................................................................ 10 5.4 Removal And Resignation Of Officers................................................................. 10 5.5 Vacancies In Offices................................................................................ 10 5.6 Chief Executive Officer............................................................................. 11 5.7 President........................................................................................... 11 5.8 Vice Presidents..................................................................................... 11 5.9 Secretary........................................................................................... 11 5.10 Chief Financial Officer............................................................................ 12 5.11 Representation Of Shares Of Other Corporations..................................................... 12 5.12 Authority And Duties Of Officers................................................................... 12 ARTICLE VI - INDEMNIFICATION OF DIRECTORS, OFFICERS, EMPLOYEES, AND OTHER AGENTS................................. 13 6.1 Indemnification Of Directors And Officers........................................................... 13 6.2 Indemnification Of Others........................................................................... 13 6.3 Payment Of Expenses In Advance...................................................................... 13 6.4 Indemnity Not Exclusive............................................................................. 13 6.5 Insurance........................................................................................... 14 6.6 Conflicts........................................................................................... 14 ARTICLE VII - RECORDS AND REPORTS................................................................................ 14 7.1 Maintenance And Inspection Of Records............................................................... 14 7.2 Inspection By Directors............................................................................. 15 7.3 Annual Statement To Stockholders.................................................................... 15 ARTICLE VIII - GENERAL MATTERS................................................................................... 15 8.1 Checks.............................................................................................. 15 8.2 Execution Of Corporate Contracts And Instruments.................................................... 15 8.3 Stock Certificates; Partly Paid Shares.............................................................. 15 8.4 Special Designation On Certificates................................................................. 16 8.5 Lost Certificates................................................................................... 16 8.6 Construction; Definitions........................................................................... 17 8.7 Dividends........................................................................................... 17 8.8 Fiscal Year......................................................................................... 17 8.9 Seal................................................................................................ 17 8.10 Transfer Of Stock.................................................................................. 17 |
TABLE OF CONTENTS
(continued)
Page ---- 8.11 Stock Transfer Agreements.......................................................................... 18 8.12 Registered Stockholders............................................................................ 18 ARTICLE IX - AMENDMENTS.......................................................................................... 18 |
BYLAWS
OF
DURECT THERAPEUTICS CORPORATION
ARTICLE I
The registered office of the corporation shall be in the City of Wilmington, County of New Castle, State of Delaware. The name of the registered agent of the corporation at such location is Corporate Service Company.
The Board of Directors may at any time establish other offices at any place or places where the corporation is qualified to do business.
ARTICLE II
Meetings of stockholders shall be held at any place, within or outside the State of Delaware, designated by the Board of Directors. In the absence of any such designation, stockholders' meetings shall be held at the registered office of the corporation.
The annual meeting of stockholders shall be held on such date, time and place, either within or without the State of Delaware, as may be designated by resolution of the Board of Directors each year. At the meeting, directors shall be elected and any other proper business may be transacted.
A special meeting of the stockholders may be called at any time by the Board of Directors, the chairman of the board, the president or by one or more stockholders holding shares in the aggregate entitled to cast not less than ten percent of the votes at that meeting.
If a special meeting is called by any person or persons other than the Board of Directors, the president or the chairman of the board, the request shall be in writing, specifying the time of such meeting and the general nature of the business proposed to be transacted, and
shall be delivered personally or sent by registered mail or by telegraphic or other facsimile transmission to the chairman of the board, the president, any vice president, or the secretary of the corporation. No business may be transacted at such special meeting otherwise than specified in such notice. The officer receiving the request shall cause notice to be promptly given to the stockholders entitled to vote, in accordance with the provisions of Sections 2.4 and 2.5 of this Article II, that a meeting will be held at the time requested by the person or persons calling the meeting, not less than thirty-five (35) nor more than sixty (60) days after the receipt of the request. If the notice is not given within twenty (20) days after the receipt of the request, the person or persons requesting the meeting may give the notice. Nothing contained in this paragraph of this Section 2.3 shall be construed as limiting, fixing, or affecting the time when a meeting of stockholders called by action of the Board of Directors may be held.
All notices of meetings with stockholders shall be in writing and shall be sent or otherwise given in accordance with Section 2.5 of these Bylaws not less than ten (10) nor more than sixty (60) days before the date of the meeting to each stockholder entitled to vote at such meeting. The notice shall specify the place, date, and hour of the meeting, and, in the case of a special meeting, the purpose or purposes for which the meeting is called.
Written notice of any meeting of stockholders, if mailed, is given when deposited in the United States mail, postage prepaid, directed to the stockholder at his address as it appears on the records of the corporation. An affidavit of the secretary or an assistant secretary or of the transfer agent of the corporation that the notice has been given shall, in the absence of fraud, be prima facie evidence of the facts stated therein.
The holders of a majority of the stock issued and outstanding and entitled to vote thereat, present in person or represented by proxy, shall constitute a quorum at all meetings of the stockholders for the transaction of business except as otherwise provided by statute or by the certificate of incorporation. If, however, such quorum is not present or represented at any meeting of the stockholders, then either (a) the chairman of the meeting or (b) the stockholders entitled to vote thereat, present in person or represented by proxy, shall have power to adjourn the meeting from time to time, without notice other than announcement at the meeting, until a quorum is present or represented. At such adjourned meeting at which a quorum is present or represented, any business may be transacted that might have been transacted at the meeting as originally noticed.
When a meeting is adjourned to another time or place, unless these Bylaws otherwise require, notice need not be given of the adjourned meeting if the time and place thereof are announced at the meeting at which the adjournment is taken. At the adjourned meeting the
corporation may transact any business that might have been transacted at the original meeting. If the adjournment is for more than thirty (30) days, or if after the adjournment a new record date is fixed for the adjourned meeting, a notice of the adjourned meeting shall be given to each stockholder of record entitled to vote at the meeting.
The chairman of any meeting of stockholders shall determine the order of business and the procedure at the meeting, including the manner of voting and the conduct of business.
The stockholders entitled to vote at any meeting of stockholders shall be determined in accordance with the provisions of Section 2.12 of these Bylaws, subject to the provisions of Sections 217 and 218 of the General Corporation Law of Delaware (relating to voting rights of fiduciaries, pledgors and joint owners of stock and to voting trusts and other voting agreements).
Except as may be otherwise provided in the certificate of incorporation, each stockholder shall be entitled to one vote for each share of capital stock held by such stockholder.
Whenever notice is required to be given under any provision of the General Corporation Law of Delaware or of the certificate of incorporation or these Bylaws, a written waiver thereof, signed by the person entitled to notice, whether before or after the time stated therein, shall be deemed equivalent to notice. Attendance of a person at a meeting shall constitute a waiver of notice of such meeting, except when the person attends a meeting for the express purpose of objecting, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened. Neither the business to be transacted at, nor the purpose of, any regular or special meeting of the stockholders need be specified in any written waiver of notice unless so required by the certificate of incorporation or these Bylaws.
Unless otherwise provided in the certificate of incorporation, any action required to be taken at any annual or special meeting of stockholders of the corporation, or any action that may be taken at any annual or special meeting of such stockholders, may be taken without a meeting, without prior notice, and without a vote if a consent in writing, setting forth the action so taken, is signed by the holders of outstanding stock having not less than the minimum number of votes that would be necessary to authorize or take such action at a meeting at which all shares entitled to vote thereon were present and voted.
Prompt notice of the taking of the corporate action without a meeting by less than unanimous written consent shall be given to those stockholders who have not consented in
writing. If the action which is consented to is such as would have required the filing of a certificate under any section of the General Corporation Law of Delaware if such action had been voted on by stockholders at a meeting thereof, then the certificate filed under such section shall state, in lieu of any statement required by such section concerning any vote of stockholders, that written notice and written consent have been given as provided in Section 228 of the General Corporation Law of Delaware.
In order that the corporation may determine the stockholders entitled to notice of or to vote at any meeting of stockholders or any adjournment thereof, or entitled to express consent to corporate action in writing without a meeting, or entitled to receive payment of any dividend or other distribution or allotment of any rights, or entitled to exercise any rights in respect of any change, conversion or exchange of stock or for the purpose of any other lawful action, the Board of Directors may fix, in advance, a record date, which shall not be more than sixty (60) nor less than ten (10) days before the date of such meeting, nor more than sixty (60) days prior to any other action.
If the Board of Directors does not so fix a record date:
(a) The record date for determining stockholders entitled to notice of or to vote at a meeting of stockholders shall be at the close of business on the day next preceding the day on which notice is given, or, if notice is waived, at the close of business on the day next preceding the day on which the meeting is held.
(b) The record date for determining stockholders entitled to consent to corporate action in writing without a meeting, when no prior action by the Board of Directors is necessary, shall be the day on which the first written consent is delivered to the corporation.
(c) The record date for determining stockholders for any other purpose shall be at the close of business on the day on which the Board of Directors adopts the resolution relating thereto.
A determination of stockholders of record entitled to notice of or to vote at a meeting of stockholders shall apply to any adjournment of the meeting; provided, however, that the Board of Directors may fix a new record date for the adjourned meeting.
Each stockholder entitled to vote at a meeting of stockholders or to express consent or dissent to corporate action in writing without a meeting may authorize another person or persons to act for such stockholder by a written proxy, signed by the stockholder and filed with the secretary of the corporation, but no such proxy shall be voted or acted upon after three (3) years from its date, unless the proxy provides for a longer period. A proxy shall be deemed signed if the stockholder's name is placed on the proxy (whether by manual signature, typewriting, telegraphic transmission or otherwise) by the stockholder or the stockholder's
attorney-in-fact. The revocability of a proxy that states on its face that it is irrevocable shall be governed by the provisions of Section 212(e) of the General Corporation Law of Delaware.
ARTICLE III
Subject to the provisions of the General Corporation Law of Delaware and any limitations in the certificate of incorporation or these Bylaws relating to action required to be approved by the stockholders or by the outstanding shares, the business and affairs of the corporation shall be managed and all corporate powers shall be exercised by or under the direction of the Board of Directors.
Upon the adoption of these bylaws, the number of directors constituting the entire Board of Directors shall be 3. Thereafter, this number may be changed by a resolution of the Board of Directors or of the stockholders, subject to Section 3.4 of these Bylaws. No reduction of the authorized number of directors shall have the effect of removing any director before such director's term of office expires.
Except as provided in Section 3.4 of these Bylaws, directors shall be elected at each annual meeting of stockholders to hold office until the next annual meeting. Directors need not be stockholders unless so required by the certificate of incorporation or these Bylaws, wherein other qualifications for directors may be prescribed. Each director, including a director elected to fill a vacancy, shall hold office until his or her successor is elected and qualified or until his or her earlier resignation or removal.
Elections of directors need not be by written ballot.
Any director may resign at any time upon written notice to the attention of the Secretary of the corporation. When one or more directors so resigns and the resignation is effective at a future date, a majority of the directors then in office, including those who have so resigned, shall have power to fill such vacancy or vacancies, the vote thereon to take effect when such resignation or resignations shall become effective, and each director so chosen shall hold office as provided in this section in the filling of other vacancies.
Unless otherwise provided in the certificate of incorporation or these Bylaws:
(a) Vacancies and newly created directorships resulting from any increase in the authorized number of directors elected by all of the stockholders having the right to vote as a
single class may be filled by a majority of the directors then in office, although less than a quorum, or by a sole remaining director.
(b) Whenever the holders of any class or classes of stock or series thereof are entitled to elect one or more directors by the provisions of the certificate of incorporation, vacancies and newly created directorships of such class or classes or series may be filled by a majority of the directors elected by such class or classes or series thereof then in office, or by a sole remaining director so elected.
If at any time, by reason of death or resignation or other cause, the corporation should have no directors in office, then any officer or any stockholder or an executor, administrator, trustee or guardian of a stockholder, or other fiduciary entrusted with like responsibility for the person or estate of a stockholder, may call a special meeting of stockholders in accordance with the provisions of the certificate of incorporation or these Bylaws, or may apply to the Court of Chancery for a decree summarily ordering an election as provided in Section 211 of the General Corporation Law of Delaware.
If, at the time of filling any vacancy or any newly created directorship, the directors then in office constitute less than a majority of the whole board (as constituted immediately prior to any such increase), then the Court of Chancery may, upon application of any stockholder or stockholders holding at least ten (10) percent of the total number of the shares at the time outstanding having the right to vote for such directors, summarily order an election to be held to fill any such vacancies or newly created directorships, or to replace the directors chosen by the directors then in office as aforesaid, which election shall be governed by the provisions of Section 211 of the General Corporation Law of Delaware as far as applicable.
The Board of Directors of the corporation may hold meetings, both regular and special, either within or outside the State of Delaware.
Unless otherwise restricted by the certificate of incorporation or these Bylaws, members of the Board of Directors, or any committee designated by the Board of Directors, may participate in a meeting of the Board of Directors, or any committee, by means of conference telephone or similar communications equipment by means of which all persons participating in the meeting can hear each other, and such participation in a meeting shall constitute presence in person at the meeting.
Regular meetings of the Board of Directors may be held without notice at such time and at such place as shall from time to time be determined by the board.
Special meetings of the Board of Directors for any purpose or purposes may be called at any time by the chairman of the board, the president, any vice president, the secretary or any two directors.
Notice of the time and place of special meetings shall be delivered personally or by telephone to each director or sent by first-class mail or telegram, charges prepaid, addressed to each director at that director's address as it is shown on the records of the corporation. If the notice is mailed, it shall be deposited in the United States mail at least four (4) days before the time of the holding of the meeting. If the notice is delivered personally or by telephone or by telegram, it shall be delivered personally or by telephone or to the telegraph company at least forty-eight (48) hours before the time of the holding of the meeting. Any oral notice given personally or by telephone may be communicated either to the director or to a person at the office of the director who the person giving the notice has reason to believe will promptly communicate it to the director. The notice need not specify the purpose or the place of the meeting, if the meeting is to be held at the principal executive office of the corporation.
At all meetings of the Board of Directors, a majority of the authorized number of directors shall constitute a quorum for the transaction of business and the act of a majority of the directors present at any meeting at which there is a quorum shall be the act of the Board of Directors, except as may be otherwise specifically provided by statute or by the certificate of incorporation. If a quorum is not present at any meeting of the Board of Directors, then the directors present thereat may adjourn the meeting from time to time, without notice other than announcement at the meeting, until a quorum is present.
A meeting at which a quorum is initially present may continue to transact business notwithstanding the withdrawal of directors, if any action taken is approved by at least a majority of the required quorum for that meeting.
Whenever notice is required to be given under any provision of the General Corporation Law of Delaware or of the certificate of incorporation or these Bylaws, a written waiver thereof, signed by the person entitled to notice, whether before or after the time stated therein, shall be deemed equivalent to notice. Attendance of a person at a meeting shall constitute a waiver of notice of such meeting, except when the person attends a meeting for the express purpose of objecting, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened. Neither the business to be transacted at, nor the purpose of, any regular or special meeting of the directors, or members of a committee of directors, need be specified in any written waiver of notice unless so required by the certificate of incorporation or these Bylaws.
Unless otherwise restricted by the certificate of incorporation or these Bylaws, any action required or permitted to be taken at any meeting of the Board of Directors, or of any committee thereof, may be taken without a meeting if all members of the board or committee, as the case may be, consent thereto in writing and the writing or writings are filed with the minutes of proceedings of the board or committee. Written consents representing actions taken by the board or committee may be executed by telex, telecopy or other facsimile transmission, and such facsimile shall be valid and binding to the same extent as if it were an original.
Unless otherwise restricted by the certificate of incorporation or these Bylaws, the Board of Directors shall have the authority to fix the compensation of directors. No such compensation shall preclude any director from serving the corporation in any other capacity and receiving compensation therefor.
The corporation may lend money to, or guarantee any obligation of, or otherwise assist any officer or other employee of the corporation or of its subsidiary, including any officer or employee who is a director of the corporation or its subsidiary, whenever, in the judgment of the directors, such loan, guaranty or assistance may reasonably be expected to benefit the corporation. The loan, guaranty or other assistance may be with or without interest and may be unsecured, or secured in such manner as the Board of Directors shall approve, including, without limitation, a pledge of shares of stock of the corporation. Nothing in this section contained shall be deemed to deny, limit or restrict the powers of guaranty or warranty of the corporation at common law or under any statute.
Unless otherwise restricted by statute, by the certificate of incorporation or by these Bylaws, any director or the entire Board of Directors may be removed, with or without cause, by the holders of a majority of the shares then entitled to vote at an election of directors; provided, however, that if the stockholders of the corporation are entitled to cumulative voting, if less than the entire Board of Directors is to be removed, no director may be removed without cause if the votes cast against his removal would be sufficient to elect him if then cumulatively voted at an election of the entire Board of Directors.
No reduction of the authorized number of directors shall have the effect of removing any director prior to the expiration of such director's term of office.
The corporation may also have, at the discretion of the Board of Directors, a chairman of the Board of Directors who shall not be considered an officer of the corporation.
ARTICLE IV
The Board of Directors may designate one or more committees, each committee to consist of one or more of the directors of the corporation. The Board may designate 1 or more directors as alternate members of any committee, who may replace any absent or disqualified member at any meeting of the committee. In the absence or disqualification of a member of a committee, the member or members present at any meeting and not disqualified from voting, whether or not such member or members constitute a quorum, may unanimously appoint another member of the Board of Directors to act at the meeting in the place of any such absent or disqualified member. Any such committee, to the extent provided in the resolution of the Board of Directors, or in these Bylaws, shall have and may exercise all the powers and authority of the Board of Directors in the management of the business and affairs of the corporation, and may authorize the seal of the corporation to be affixed to all papers which may require it; but no such committee shall have the power or authority in reference to the following matters: (i) approving or adopting, or recommending to the stockholders, any action or matter expressly required by this chapter to be submitted to stockholders for approval or (ii) adopting, amending or repealing any Bylaw of the corporation.
Each committee shall keep regular minutes of its meetings and report the same to the Board of Directors when required.
Meetings and actions of committees shall be governed by, and held and
taken in accordance with, the provisions of Section 3.5 (place of meetings and
meetings by telephone), Section 3.6 (regular meetings), Section 3.7 (special
meetings and notice), Section 3.8 (quorum), Section 3.9 (waiver of notice), and
Section 3.10 (action without a meeting) of these Bylaws, with such changes in
the context of such provisions as are necessary to substitute the committee and
its members for the Board of Directors and its members; provided, however, that
the time of regular meetings of committees may be determined either by
resolution of the Board of Directors or by resolution of the committee, that
special meetings of committees may also be called by resolution of the Board of
Directors and that notice of special meetings of committees shall also be given
to all alternate members, who shall have the right to attend all meetings of the
committee. The Board of Directors may adopt rules for the government of any
committee not inconsistent with the provisions of these Bylaws.
ARTICLE V
The officers of the corporation shall be a chief executive officer, a
president, a secretary, and a chief financial officer. The corporation may also
have, at the discretion of the Board of Directors, one or more vice presidents,
one or more assistant secretaries, one or more assistant treasurers, and any
such other officers as may be appointed in accordance with the provisions of
Section 5.3 of these Bylaws. Any number of offices may be held by the same
person.
The officers of the corporation, except such officers as may be appointed in accordance with the provisions of Sections 5.3 or 5.5 of these Bylaws, shall be appointed by the Board of Directors, subject to the rights, if any, of an officer under any contract of employment.
The Board of Directors may appoint, or empower the chief executive officer or the president to appoint, such other officers and agents as the business of the corporation may require, each of whom shall hold office for such period, have such authority, and perform such duties as are provided in these Bylaws or as the Board of Directors may from time to time determine.
Subject to the rights, if any, of an officer under any contract of employment, any officer may be removed, either with or without cause, by an affirmative vote of the majority of the Board of Directors at any regular or special meeting of the board or, except in the case of an officer chosen by the Board of Directors, by any officer upon whom such power of removal may be conferred by the Board of Directors.
Any officer may resign at any time by giving written notice to the attention of the Secretary of the corporation. Any resignation shall take effect at the date of the receipt of that notice or at any later time specified in that notice; and, unless otherwise specified in that notice, the acceptance of the resignation shall not be necessary to make it effective. Any resignation is without prejudice to the rights, if any, of the corporation under any contract to which the officer is a party.
Any vacancy occurring in any office of the corporation shall be filled by the Board of Directors.
Subject to such supervisory powers, if any, as may be given by the Board of Directors to the chairman of the board, if any, the chief executive officer of the corporation shall, subject to the control of the Board of Directors, have general supervision, direction, and control of the business and the officers of the corporation. He or she shall preside at all meetings of the stockholders and, in the absence or nonexistence of a chairman of the board, at all meetings of the Board of Directors and shall have the general powers and duties of management usually vested in the office of chief executive officer of a corporation and shall have such other powers and duties as may be prescribed by the Board of Directors or these bylaws.
Subject to such supervisory powers, if any, as may be given by the Board of Directors to the chairman of the board (if any) or the chief executive officer, the president shall have general supervision, direction, and control of the business and other officers of the corporation. He or she shall have the general powers and duties of management usually vested in the office of president of a corporation and such other powers and duties as may be prescribed by the Board of Directors or these Bylaws.
In the absence or disability of the chief executive officer and president, the vice presidents, if any, in order of their rank as fixed by the Board of Directors or, if not ranked, a vice president designated by the Board of Directors, shall perform all the duties of the president and when so acting shall have all the powers of, and be subject to all the restrictions upon, the president. The vice presidents shall have such other powers and perform such other duties as from time to time may be prescribed for them respectively by the Board of Directors, these Bylaws, the president or the chairman of the board.
The secretary shall keep or cause to be kept, at the principal executive office of the corporation or such other place as the Board of Directors may direct, a book of minutes of all meetings and actions of directors, committees of directors, and stockholders. The minutes shall show the time and place of each meeting, the names of those present at directors' meetings or committee meetings, the number of shares present or represented at stockholders' meetings, and the proceedings thereof.
The secretary shall keep, or cause to be kept, at the principal executive office of the corporation or at the office of the corporation's transfer agent or registrar, as determined by resolution of the Board of Directors, a share register, or a duplicate share register, showing the names of all stockholders and their addresses, the number and classes of shares held by each, the number and date of certificates evidencing such shares, and the number and date of cancellation of every certificate surrendered for cancellation.
The secretary shall give, or cause to be given, notice of all meetings of the stockholders and of the Board of Directors required to be given by law or by these Bylaws. He or she shall keep the seal of the corporation, if one be adopted, in safe custody and shall have such other powers and perform such other duties as may be prescribed by the Board of Directors or by these Bylaws.
The chief financial officer shall keep and maintain, or cause to be kept and maintained, adequate and correct books and records of accounts of the properties and business transactions of the corporation, including accounts of its assets, liabilities, receipts, disbursements, gains, losses, capital retained earnings, and shares. The books of account shall at all reasonable times be open to inspection by any director.
The chief financial officer shall deposit all moneys and other valuables in the name and to the credit of the corporation with such depositories as may be designated by the Board of Directors. He or she shall disburse the funds of the corporation as may be ordered by the Board of Directors, shall render to the president, the chief executive officer, or the directors, upon request, an account of all his or her transactions as chief financial officer and of the financial condition of the corporation, and shall have other powers and perform such other duties as may be prescribed by the Board of Directors or the bylaws.
The chairman of the board, the chief executive officer, the president, any vice president, the chief financial officer, the secretary or assistant secretary of this corporation, or any other person authorized by the Board of Directors or the chief executive officer or the president or a vice president, is authorized to vote, represent, and exercise on behalf of this corporation all rights incident to any and all shares of any other corporation or corporations standing in the name of this corporation. The authority granted herein may be exercised either by such person directly or by any other person authorized to do so by proxy or power of attorney duly executed by the person having such authority.
In addition to the foregoing authority and duties, all officers of the corporation shall respectively have such authority and perform such duties in the management of the business of the corporation as may be designated from time to time by the Board of Directors or the stockholders.
ARTICLE VI
The corporation shall, to the maximum extent and in the manner permitted by the General Corporation Law of Delaware, indemnify each of its directors and officers against expenses (including attorneys' fees), judgments, fines, settlements and other amounts actually and reasonably incurred in connection with any proceeding, arising by reason of the fact that such person is or was an agent of the corporation. For purposes of this Section 6.1, a "director" or "officer" of the corporation includes any person (a) who is or was a director or officer of the corporation, (b) who is or was serving at the request of the corporation as a director or officer of another corporation, partnership, joint venture, trust or other enterprise, or (c) who was a director or officer of a corporation which was a predecessor corporation of the corporation or of another enterprise at the request of such predecessor corporation.
The corporation shall have the power, to the maximum extent and in the manner permitted by the General Corporation Law of Delaware, to indemnify each of its employees and agents (other than directors and officers) against expenses (including attorneys' fees), judgments, fines, settlements and other amounts actually and reasonably incurred in connection with any proceeding, arising by reason of the fact that such person is or was an agent of the corporation. For purposes of this Section 6.2, an "employee" or "agent" of the corporation (other than a director or officer) includes any person (a) who is or was an employee or agent of the corporation, (b) who is or was serving at the request of the corporation as an employee or agent of another corporation, partnership, joint venture, trust or other enterprise, or (c) who was an employee or agent of a corporation which was a predecessor corporation of the corporation or of another enterprise at the request of such predecessor corporation.
Expenses incurred in defending any action or proceeding for which indemnification is required pursuant to Section 6.1 or for which indemnification is permitted pursuant to Section 6.2 following authorization thereof by the Board of Directors shall be paid by the corporation in advance of the final disposition of such action or proceeding upon receipt of an undertaking by or on behalf of the indemnified party to repay such amount if it shall ultimately be determined that the indemnified party is not entitled to be indemnified as authorized in this Article VI.
The indemnification provided by this Article VI shall not be deemed exclusive of any other rights to which those seeking indemnification may be entitled under any bylaw,
agreement, vote of shareholders or disinterested directors or otherwise, both as to action in an official capacity and as to action in another capacity while holding such office, to the extent that such additional rights to indemnification are authorized in the certificate of incorporation
The corporation may purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise against any liability asserted against him or her and incurred by him or her in any such capacity, or arising out of his or her status as such, whether or not the corporation would have the power to indemnify him or her against such liability under the provisions of the General Corporation Law of Delaware.
No indemnification or advance shall be made under this Article VI, except where such indemnification or advance is mandated by law or the order, judgment or decree of any court of competent jurisdiction, in any circumstance where it appears:
(a) That it would be inconsistent with a provision of the certificate of incorporation, these Bylaws, a resolution of the stockholders or an agreement in effect at the time of the accrual of the alleged cause of the action asserted in the proceeding in which the expenses were incurred or other amounts were paid, which prohibits or otherwise limits indemnification; or
(b) That it would be inconsistent with any condition expressly imposed by a court in approving a settlement.
ARTICLE VII
The corporation shall, either at its principal executive offices or at such place or places as designated by the Board of Directors, keep a record of its stockholders listing their names and addresses and the number and class of shares held by each stockholder, a copy of these Bylaws as amended to date, accounting books, and other records.
Any stockholder of record, in person or by attorney or other agent, shall, upon written demand under oath stating the purpose thereof, have the right during the usual hours for business to inspect for any proper purpose the corporation's stock ledger, a list of its stockholders, and its other books and records and to make copies or extracts therefrom. A proper purpose shall mean a purpose reasonably related to such person's interest as a stockholder. In every instance where an attorney or other agent is the person who seeks the right to inspection,
the demand under oath shall be accompanied by a power of attorney or such other writing that authorizes the attorney or other agent to so act on behalf of the stockholder. The demand under oath shall be directed to the corporation at its registered office in Delaware or at its principal place of business.
Any director shall have the right to examine the corporation's stock ledger, a list of its stockholders, and its other books and records for a purpose reasonably related to his or her position as a director. The Court of Chancery is hereby vested with the exclusive jurisdiction to determine whether a director is entitled to the inspection sought. The Court may summarily order the corporation to permit the director to inspect any and all books and records, the stock ledger, and the stock list and to make copies or extracts therefrom. The Court may, in its discretion, prescribe any limitations or conditions with reference to the inspection, or award such other and further relief as the Court may deem just and proper.
The Board of Directors shall present at each annual meeting, and at any special meeting of the stockholders when called for by vote of the stockholders, a full and clear statement of the business and condition of the corporation.
ARTICLE VIII
From time to time, the Board of Directors shall determine by resolution which person or persons may sign or endorse all checks, drafts, other orders for payment of money, notes or other evidences of indebtedness that are issued in the name of or payable to the corporation, and only the persons so authorized shall sign or endorse those instruments.
The Board of Directors, except as otherwise provided in these Bylaws, may authorize any officer or officers, or agent or agents, to enter into any contract or execute any instrument in the name of and on behalf of the corporation; such authority may be general or confined to specific instances. Unless so authorized or ratified by the Board of Directors or within the agency power of an officer, no officer, agent or employee shall have any power or authority to bind the corporation by any contract or engagement or to pledge its credit or to render it liable for any purpose or for any amount.
The shares of a corporation shall be represented by certificates, provided that the Board of Directors of the corporation may provide by resolution or resolutions that some or all of
any or all classes or series of its stock shall be uncertificated shares. Any such resolution shall not apply to shares represented by a certificate until such certificate is surrendered to the corporation. Notwithstanding the adoption of such a resolution by the Board of Directors, every holder of stock represented by certificates and upon request every holder of uncertificated shares shall be entitled to have a certificate signed by, or in the name of the corporation by the chairman or vice-chairman of the Board of Directors, or the president or vice-president, and by the chief financial officer or an assistant treasurer, or the secretary or an assistant secretary of such corporation representing the number of shares registered in certificate form. Any or all of the signatures on the certificate may be a facsimile. In case any officer, transfer agent or registrar who has signed or whose facsimile signature has been placed upon a certificate has ceased to be such officer, transfer agent or registrar before such certificate is issued, it may be issued by the corporation with the same effect as if he or she were such officer, transfer agent or registrar at the date of issue.
The corporation may issue the whole or any part of its shares as partly paid and subject to call for the remainder of the consideration to be paid therefor. Upon the face or back of each stock certificate issued to represent any such partly paid shares, upon the books and records of the corporation in the case of uncertificated partly paid shares, the total amount of the consideration to be paid therefor and the amount paid thereon shall be stated. Upon the declaration of any dividend on fully paid shares, the corporation shall declare a dividend upon partly paid shares of the same class, but only upon the basis of the percentage of the consideration actually paid thereon.
If the corporation is authorized to issue more than one class of stock or more than one series of any class, then the powers, the designations, the preferences, and the relative, participating, optional or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences and/or rights shall be set forth in full or summarized on the face or back of the certificate that the corporation shall issue to represent such class or series of stock; provided, however, that, except as otherwise provided in Section 202 of the General Corporation Law of Delaware, in lieu of the foregoing requirements there may be set forth on the face or back of the certificate that the corporation shall issue to represent such class or series of stock a statement that the corporation will furnish without charge to each stockholder who so requests the powers, the designations, the preferences, and the relative, participating, optional or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences and/or rights.
Except as provided in this Section 8.5, no new certificates for shares shall be issued to replace a previously issued certificate unless the latter is surrendered to the corporation and cancelled at the same time. The corporation may issue a new certificate of stock or uncertificated shares in the place of any certificate previously issued by it, alleged to have been lost, stolen or destroyed, and the corporation may require the owner of the lost, stolen or
destroyed certificate, or the owner's legal representative, to give the corporation a bond sufficient to indemnify it against any claim that may be made against it on account of the alleged loss, theft or destruction of any such certificate or the issuance of such new certificate or uncertificated shares.
Unless the context requires otherwise, the general provisions, rules of construction, and definitions in the Delaware General Corporation Law shall govern the construction of these Bylaws. Without limiting the generality of this provision, the singular number includes the plural, the plural number includes the singular, and the term "person" includes both a corporation and a natural person.
The directors of the corporation, subject to any restrictions contained in (a) the General Corporation Law of Delaware or (b) the certificate of incorporation, may declare and pay dividends upon the shares of its capital stock. Dividends may be paid in cash, in property, or in shares of the corporation's capital stock.
The directors of the corporation may set apart out of any of the funds of the corporation available for dividends a reserve or reserves for any proper purpose and may abolish any such reserve. Such purposes shall include but not be limited to equalizing dividends, repairing or maintaining any property of the corporation, and meeting contingencies.
The fiscal year of the corporation shall be fixed by resolution of the Board of Directors and may be changed by the Board of Directors.
The corporation may adopt a corporate seal, which may be altered at pleasure, and may use the same by causing it or a facsimile thereof, to be impressed or affixed or in any other manner reproduced.
Upon surrender to the corporation or the transfer agent of the corporation of a certificate for shares duly endorsed or accompanied by proper evidence of succession, assignation or authority to transfer, it shall be the duty of the corporation to issue a new certificate to the person entitled thereto, cancel the old certificate, and record the transaction in its books.
The corporation shall have power to enter into and perform any agreement with any number of stockholders of any one or more classes of stock of the corporation to restrict the transfer of shares of stock of the corporation of any one or more classes owned by such stockholders in any manner not prohibited by the General Corporation Law of Delaware.
The corporation shall be entitled to recognize the exclusive right of a person registered on its books as the owner of shares to receive dividends and to vote as such owner, shall be entitled to hold liable for calls and assessments the person registered on its books as the owner of shares, and shall not be bound to recognize any equitable or other claim to or interest in such share or shares on the part of another person, whether or not it shall have express or other notice thereof, except as otherwise provided by the laws of Delaware.
ARTICLE IX
The Bylaws of the corporation may be adopted, amended or repealed by the stockholders entitled to vote; provided, however, that the corporation may, in its certificate of incorporation, confer the power to adopt, amend or repeal Bylaws upon the directors. The fact that such power has been so conferred upon the directors shall not divest the stockholders of the power, nor limit their power to adopt, amend or repeal Bylaws.
CERTIFICATE OF ADOPTION OF BYLAWS
OF
DURECT THERAPEUTICS CORPORATION
The undersigned person appointed in the certificate of incorporation to act as the Incorporator of Durect Therapeutics Corporation hereby adopts the foregoing bylaws as the Bylaws of the corporation.
Executed this 6th day of February, 1998.
/s/ Keith Mosley ---------------- C. Keith Mosley, Incorporator |
The undersigned hereby certifies that the undersigned is the duly elected, qualified, and acting Secretary of Durect Therapeutics Corporation, and that the foregoing Bylaws were adopted as the Bylaws of the corporation on February 6, 1998, by the person appointed in the certificate of incorporation to act as the Incorporator of the corporation.
Executed this 6th day of February 1998.
/s/ Tae Hea Nahm ----------------------- Tae Hea Nahm, Secretary |
CERTIFICATE OF AMENDMENT
OF BYLAWS OF
DURECT THERAPEUTICS CORPORATION
The undersigned, Tae Hea Nahm, hereby certifies that:
2. By action of the Board of Directors of the Company duly pursuant to Action by Unanimous Written Consent effective as of June 3, 1998, certain sections of the Bylaws of the Company were amended to read as set forth on Exhibit A attached hereto.
3. The matters set forth in this certificate are true and correct of my own knowledge.
Dated: June 3, 1998 /s/Tae Hea Nahm ----------------------- Tae Hea Nahm, Secretary |
1. Article III, Section 3.2 of the Bylaws of the Company is amended to read in its entirety as follows:
The number of directors constituting the entire Board of Directors shall be 7. Thereafter, this number may be changed by a resolution of the Board of Directors or of the stockholders, subject to Section 3.4 of these Bylaws. No reduction of the authorized number of directors shall have the effect of removing any director before such director's term of office expires."
2. The first paragraph of Article III, Section 3.4 of the Bylaws of the Company is amended to read in its entirety as follows:
Any director may resign at any time upon written notice to the attention of the Secretary of the corporation. When one or more directors so resigns and the resignation is effective at a future date, except where provided for to the contrary in any voting agreement to which the corporation is a party, a majority of the directors then in office, including those who have so resigned, shall have power to fill such vacancy or vacancies, the vote thereon to take effect when such resignation or resignations shall become effective, and each director so chosen shall hold office as provided in this section in the filling of other vacancies."
3. The first paragraph of Article III, Section 3.13 of the Bylaws of the Company is amended to read in its entirety as follows:
Unless otherwise restricted by statute, by the certificate of incorporation or by these Bylaws, or where provided for to the contrary in any voting agreement to which the corporation is a party, any director or the entire Board of Directors may be removed, with or without cause, by
the holders of a majority of the shares then entitled to vote at an election of directors; provided, however, that if the stockholders of the corporation are entitled to cumulative voting, if less than the entire Board of Directors is to be removed, no director may be removed without cause if the votes cast against his removal would be sufficient to elect him if then cumulatively voted at an election of the entire Board of Directors.
No reduction of the authorized number of directors shall have the effect of removing any director prior to the expiration of such director's term of office."
4. Article IX of the Bylaws of the Company be amended to read in its entirety as follows:
The Bylaws of the corporation may be adopted, amended or repealed by the stockholders entitled to vote; provided, however, that the corporation may, in its certificate of incorporation, confer the power to adopt, amend or repeal Bylaws upon the directors; and further provided that any amendment to Sections 3.4 and Section 3.13 of Article III shall only be effective upon the amendment of any voting agreements to which the corporation is a party if such voting agreements would otherwise be in conflict with such Sections, as amended. The fact that such power has been so conferred upon the directors shall not divest the stockholders of the power, nor limit their power to adopt, amend or repeal Bylaws."
CERTIFICATE OF AMENDMENT
OF BYLAWS OF
DURECT CORPORATION
The undersigned, Mark B. Weeks, hereby certifies that:
"The number of directors of the corporation shall be not less than five
(5) nor more than eight (8) The exact number of directors shall be
eight (8) until changed, within the limits specified above, by a bylaw
amending this Section 3.2, duly adopted by the board of directors or by
the shareholders of the corporation."
3. The matters set forth in this certificate are true and correct of my own knowledge.
Date: July 16, 1999 /s/ Mark Weeks ---------------------------- Mark B. Weeks, Secretary |
EXHIBIT 3.5
BYLAWS
OF
DURECT CORPORATION
(AS AMENDED AND RESTATED EFFECTIVE __________ __, 2000)
TABLE OF CONTENTS
Page ---- ARTICLE I - CORPORATE OFFICES....................................................................... 1 1.1 Registered Office......................................................................... 1 1.2 Other Offices............................................................................. 1 ARTICLE II - MEETINGS OF STOCKHOLDERS............................................................... 1 2.1 Place of Meetings......................................................................... 1 2.2 Annual Meeting............................................................................ 1 2.3 Special Meeting........................................................................... 2 2.4 Notice of Stockholder's Meetings; Affidavit of Notice..................................... 2 2.5 Advance Notice of Stockholder Nominees and Other Stockholder Proposals.................... 3 2.6 Quorum.................................................................................... 4 2.7 Adjourned Meeting; Notice................................................................. 4 2.8 Conduct of Business....................................................................... 4 2.9 Voting.................................................................................... 4 2.10 Waiver of Notice.......................................................................... 5 2.11 Record Date for Stockholder Notice; Voting................................................ 5 2.12 Proxies................................................................................... 5 ARTICLE III - DIRECTORS............................................................................. 6 3.1 Powers.................................................................................... 6 3.2 Number of Directors....................................................................... 6 3.3 Election, Qualification and Term of Office of Directors................................... 6 3.4 Resignation and Vacancies................................................................. 7 3.5 Place of Meetings; Meetings by Telephone.................................................. 8 3.6 Regular Meetings.......................................................................... 8 3.7 Special Meetings; Notice.................................................................. 8 3.8 Quorum.................................................................................... 8 3.9 Waiver of Notice.......................................................................... 9 3.10 Board Action by Written Consent Without a Meeting......................................... 9 3.11 Fees and Compensation of Directors........................................................ 9 3.12 Approval of Loans to Officers............................................................. 9 3.13 Removal of Directors...................................................................... 10 3.14 Chairman of the Board of Directors........................................................ 10 ARTICLE IV - COMMITTEES............................................................................. 10 4.1 Committees of Directors................................................................... 10 4.2 Committee Minutes......................................................................... 11 4.3 Meetings and Action of Committees......................................................... 11 ARTICLE V - OFFICERS................................................................................ 11 5.1 Officers.................................................................................. 11 |
5.2 Appointment of Officers........................................................ 12 5.3 Subordinate Officers........................................................... 12 5.4 Removal and Resignation of Officers............................................ 12 5.5 Vacancies in Offices........................................................... 12 5.6 Chief Executive Officer........................................................ 12 5.7 President...................................................................... 13 5.8 Vice Presidents................................................................ 13 5.9 Secretary...................................................................... 13 5.10 Chief Financial Officer........................................................ 13 5.11 Representation of Shares of Other Corporations................................. 14 5.12 Authority and Duties of Officers............................................... 14 ARTICLE VI - INDEMNIFICATION OF DIRECTORS, OFFICERS, EMPLOYEES, AND OTHER AGENTS......... 14 6.1 Indemnification of Directors and Officers...................................... 14 6.2 Indemnification of Others...................................................... 15 6.3 Payment of Expenses in Advance................................................. 15 6.4 Indemnity Not Exclusive........................................................ 15 6.5 Insurance...................................................................... 15 6.6 Conflicts...................................................................... 16 ARTICLE VII - RECORDS AND REPORTS........................................................ 16 7.1 Maintenance and Inspection of Records.......................................... 16 7.2 Inspection by Directors........................................................ 16 7.3 Annual Statement to Stockholders............................................... 17 ARTICLE VIII - GENERAL MATTERS........................................................... 17 8.1 Checks......................................................................... 17 8.2 Execution of Corporate Contracts And Instruments............................... 17 8.3 Stock Certificates; Partly Paid Shares......................................... 17 8.4 Special Designation on Certificates............................................ 18 8.5 Lost Certificates.............................................................. 18 8.6 Construction; Definitions...................................................... 18 8.7 Dividends...................................................................... 19 8.8 Fiscal Year.................................................................... 19 8.9 Seal........................................................................... 19 8.10 Transfer of Stock.............................................................. 19 8.11 Stock Transfer Agreements...................................................... 19 8.12 Registered Stockholders........................................................ 19 ARTICLE IX............................................................................... 20 |
AMENDED AND RESTARTED
BYLAWS
OFC
DURECT CORPORATION
ARTICLE I
The address of the Corporation's registered office in the State of Delaware is 1209 Orange Street, Wilmington, County of New Castle. The name of its registered agent at such address is The Corporation Trust Company.
The Board of Directors may at any time establish other offices at any place or places where the Corporation is qualified to do business.
ARTICLE II
Meetings of stockholders shall be held at any place, within or outside the State of Delaware, designated by the Board of Directors. In the absence of any such designation, stockholders' meetings shall be held at the registered office of the Corporation.
(a) The annual meeting of stockholders shall be held each year on a date and at a time designated by resolution of the Board of Directors. At the meeting, directors shall be elected and any other proper business may be transacted.
(b) Nominations of persons for election to the Board of Directors of the Corporation and the proposal of business to be transacted by the stockholders may be made at an annual meeting of stockholders (i) pursuant to the Corporation's notice with respect to such meeting, (ii) by or at the direction of the Board of Directors or (iii) by any stockholder of the Corporation who was a stockholder of record at the time of giving of the notice provided for in this Section 2.2, who is entitled to vote at the meeting and who has complied with the notice procedures set forth in this Section 2.2.
(c) For nominations or other business to be properly brought before an annual meeting by a stockholder pursuant to clause (iii) of paragraph (b) of this Section 2.2, the stockholder must have given timely notice thereof in writing to the secretary of the Corporation, as provided in Section 2.5, and such business must be a proper matter for stockholder action under the General Corporation Law of Delaware.
(d) Only such business shall be conducted at an annual meeting of stockholders as shall have been brought before the meeting in accordance with the procedures set forth in these Bylaws. The chairman of the meeting shall determine whether a nomination or any business proposed to be transacted by the stockholders has been properly brought before the meeting and, if any proposed nomination or business has not been properly brought before the meeting, the chairman shall declare that such proposed business or nomination shall not be presented for stockholder action at the meeting.
(e) Nothing in this Section 2.2 shall be deemed to affect any rights of stockholders to request inclusion of proposals in the Corporation's proxy statement pursuant to Rule 14a-8 under the Exchange Act.
(a) A special meeting of the stockholders may be called at any time by the Board of Directors, the chairman of the board or the president.
(b) Nominations of persons for election to the Board of Directors may be made at a special meeting of stockholders, if such election is set forth in the notice of such special meeting. Such nominations may be made either by or at the direction of the Board of Directors, or by any stockholder of record entitled to vote at such special meeting, provided the stockholder follows the notice procedures set forth in Section 2.5.
(a) All notices of meetings of stockholders shall be in writing and shall be sent or otherwise given in accordance with this Section 2.4 of these Bylaws not less than 10 nor more than 60 days before the date of the meeting to each stockholder entitled to vote at such meeting (or such longer or shorter time as is required by Section 2.5 of these Bylaws, if applicable). The notice shall specify the place, date, and hour of the meeting, and, in the case of a special meeting, the purpose or purposes for which the meeting is called. Written notice of any meeting of stockholders, if mailed, is given when deposited in the United States mail, postage prepaid, directed to the stockholder at his address as it appears on the records of the Corporation. An affidavit of the secretary or an assistant secretary or of the transfer agent of the Corporation that the notice has been given shall, in the absence of fraud, be prima facie evidence of the facts stated therein.
(b) If a special meeting is called by stockholders representing the percentage of the total votes outstanding designated in Section 2.3(a), the request shall be in writing, specifying the time of such meeting and the general nature of the business proposed to be
transacted, and shall be delivered personally, or sent by registered mail or by facsimile transmission to the chairman of the board, the president, any vice president, or the secretary of the corporation. No business may be transacted at such special meeting otherwise than specified in such request. The officer receiving the request shall cause notice to be promptly given to the stockholders entitled to vote, in accordance with the provisions of this Section 2.4, that a meeting will be held at the time requested by the person or persons calling the meeting, not less than 35 nor more than 60 days after the receipt of the request. If the notice is not given within 20 days after the receipt of the request, the person or persons requesting the meeting may give the notice. Nothing contained in this Section 2.4(b) shall be construed as limiting, fixing, or affecting the time when a meeting of stockholders called by action of the Board of Directors may be held.
Only persons who are nominated in accordance with the procedures set
forth in this Section 2.5 shall be eligible for election as directors.
Nominations of persons for election to the Board of Directors of the Corporation
may be made at a meeting of stockholders by or at the direction of the Board of
Directors or by any stockholder of the Corporation entitled to vote for the
election of directors at the meeting who complies with the notice procedures set
forth in this Section 2.5. Such nominations, other than those made by or at the
direction of the Board of Directors, shall be made pursuant to timely notice in
writing to the secretary of the Corporation. Stockholders may bring other
business before the annual meeting, provided that timely notice is provided to
the secretary of the Corporation in accordance with this section, and provided
further that such business is a proper matter for stockholder action under the
General Corporation Law of Delaware. To be timely, a stockholder's notice shall
be delivered to or mailed and received at the principal executive offices of the
Corporation not less than 90 days nor more than 120 days prior to the
anniversary date of the prior year's meeting; provided, however, that in the
event that (i) the date of the annual meeting is more than 30 days prior to or
more than 60 days after such anniversary date, and (ii) less than 60 days notice
or prior public disclosure of the date of the meeting is given or made to
stockholders, notice by the stockholder to be timely must be so received not
later than the close of business on the 10/th/ day following the day on which
such notice of the date of the meeting was mailed or such public disclosure was
made. Such stockholder's notice shall set forth (a) as to each person whom the
stockholder proposes to nominate for election or re-election as a directors, (i)
the name, age, business address and residence address of such person, (ii) the
principal occupation or employment of such person, (iii) the class and number of
shares of the Corporation which are beneficially owned by such person and (iv)
any other information relating to such person that is required to be disclosed
in solicitations of proxies for election of directors, or is otherwise required,
in each case pursuant to Regulation 14A under the Securities Exchange Act of
1934 (including, without limitation, such person's written consent to being name
in the proxy statement as a nominee and to serving as a director if elected);
(b) as to any other business that the stockholder proposes to bring before the
meeting, a brief description of such business, the reasons for conducting such
business at the meeting and any material interest in such business of such
stockholder and the beneficial owner, if any, on whose behalf the proposal is
made; and (c) as to the stockholder giving the notice and the beneficial owner,
if any, on whose behalf the proposal is made (i) the name and address of the
stockholder, as they appear on the Corporation's books, and of such beneficial
owner and (ii)
the class and number of shares of the Corporation which are owned of record by such stockholder and beneficially by such beneficial owner. At the request of the Board of Directors any person nominated by the Board of Directors for election as a director shall furnish to the secretary of the Corporation that information required to be set forth in a stockholder's notice of nomination which pertains to the nominee. No person shall be eligible for election as a director of the Corporation unless nominated in accordance with the procedures set forth in this Section 2.5. The chairman of the meeting shall, if the facts warrant, determine and declare to the meeting that a nomination was not made in accordance with the procedures prescribed by the Bylaws, and if he or she should so determine, he or she shall so declare to the meeting and the defective nomination shall be disregarded.
The holders of a majority of the stock issued and outstanding and entitled to vote thereat, present in person or represented by proxy, shall constitute a quorum at all meetings of the stockholders for the transaction of business except as otherwise provided by statute or by the Certificate of Incorporation. If, however, such quorum is not present or represented at any meeting of the stockholders, then either (a) the chairman of the meeting or (b) the stockholders entitled to vote thereat, present in person or represented by proxy, shall have power to adjourn the meeting from time to time, without notice other than announcement at the meeting, until a quorum is present or represented. At such adjourned meeting at which a quorum is present or represented, any business may be transacted that might have been transacted at the meeting as originally noticed.
When a meeting is adjourned to another time or place, unless these Bylaws otherwise require, notice need not be given of the adjourned meeting if the time and place thereof are announced at the meeting at which the adjournment is taken. At the adjourned meeting the Corporation may transact any business that might have been transacted at the original meeting. If the adjournment is for more than 30 days, or if after the adjournment a new record date is fixed for the adjourned meeting, a notice of the adjourned meeting shall be given to each stockholder of record entitled to vote at the meeting.
The chairman of any meeting of stockholders shall determine the order of business and the procedure at the meeting, including the manner of voting and the conduct of business.
(a) The stockholders entitled to vote at any meeting of stockholders shall be determined in accordance with the provisions of Section 2.11 of these Bylaws, subject to the provisions of Sections 217 and 218 of the General Corporation Law of Delaware (relating to
voting rights of fiduciaries, pledgors and joint owners of stock and to voting trusts and other voting agreements).
(b) Except as may be otherwise provided in the Certificate of Incorporation, each stockholder shall be entitled to one vote for each share of capital stock held by such stockholder.
Whenever notice is required to be given under any provision of the General Corporation Law of Delaware or of the Certificate of Incorporation or these Bylaws, a written waiver thereof, signed by the person entitled to notice, whether before or after the time stated therein, shall be deemed equivalent to notice. Attendance of a person at a meeting shall constitute a waiver of notice of such meeting, except when the person attends a meeting for the express purpose of objecting, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened. Neither the business to be transacted at, nor the purpose of, any regular or special meeting of the stockholders need be specified in any written waiver of notice unless so required by the Certificate of Incorporation or these Bylaws.
In order that the Corporation may determine the stockholders entitled to notice of or to vote at any meeting of stockholders or any adjournment thereof or entitled to receive payment of any dividend or other distribution or allotment of any rights, or entitled to exercise any rights in respect of any change, conversion or exchange of stock or for the purpose of any other lawful action, the Board of Directors may fix, in advance, a record date, which shall not be more than 60 nor less than 10 days before the date of such meeting, nor more than 60 days prior to any other action. If the Board of Directors does not so fix a record date:
(a) The record date for determining stockholders entitled to notice of or to vote at a meeting of stockholders shall be at the close of business on the day next preceding the day on which notice is given, or, if notice is waived, at the close of business on the day next preceding the day on which the meeting is held.
(b) The record date for determining stockholders for any other purpose shall be at the close of business on the day on which the Board of Directors adopts the resolution relating thereto.
A determination of stockholders of record entitled to notice of or to vote at a meeting of stockholders shall apply to any adjournment of the meeting; provided, however, that the Board of Directors may fix a new record date for the adjourned meeting.
Each stockholder entitled to vote at a meeting of stockholders may authorize another person or persons to act for such stockholder by a written proxy, signed by the
stockholder and filed with the secretary of the Corporation, but no such proxy shall be voted or acted upon after three years from its date, unless the proxy provides for a longer period. A proxy shall be deemed signed if the stockholder's name is placed on the proxy (whether by manual signature, typewriting, electronic or telegraphic transmission or otherwise) by the stockholder or the stockholder's attorney-in-fact. The revocability of a proxy that states on its face that it is irrevocable shall be governed by the provisions of Section 212(e) of the General Corporation Law of Delaware.
ARTICLE III
Subject to the provisions of the General Corporation Law of Delaware and any limitations in the Certificate of Incorporation or these Bylaws relating to action required to be approved by the stockholders or by the outstanding shares, the business and affairs of the Corporation shall be managed and all corporate powers shall be exercised by or under the direction of the Board of Directors.
The number of directors constituting the entire Board of Directors shall be eight (8).
Thereafter, this number may be changed by a resolution of the Board of Directors or of the stockholders, subject to Section 3.4 of these Bylaws. No reduction of the authorized number of directors shall have the effect of removing any director before such director's term of office expires.
Except as provided in Section 3.4 of these Bylaws, and unless otherwise provided in the Certificate of Incorporation, directors shall be elected at each annual meeting of stockholders to hold office until the next annual meeting. Directors need not be stockholders unless so required by the Certificate of Incorporation or these Bylaws, wherein other qualifications for directors may be prescribed. Each director, including a director elected to fill a vacancy, shall hold office until his or her successor is elected and qualified or until his or her earlier resignation or removal.
Directors need not be stockholders unless so required by the Certificate of Incorporation or these Bylaws, wherein other qualifications for directors may be prescribed.
Each director, including a director elected to fill a vacancy, shall hold office until his or her successor is elected and qualified or until his or her earlier resignation or removal.
Unless otherwise specified in the Certificate of Incorporation, elections of directors need not be by written ballot.
Any director may resign at any time upon written notice to the attention of the secretary of the Corporation. When one or more directors so resigns and the resignation is effective at a future date, a majority of the directors then in office, including those who have so resigned, shall have power to fill such vacancy or vacancies, the vote thereon to take effect when such resignation or resignations shall become effective, and each director so chosen shall hold office as provided in this section in the filling of other vacancies. Unless otherwise provided in the Certificate of Incorporation, and subject to the rights of the holders of any series of Preferred Stock that may then be outstanding, a vacancy created by the removal of a director by the vote of the stockholders or by court order may be filled only by the affirmative vote of a majority of the shares represented and voting at a duly held meeting at which a quorum is present (which shares voting affirmatively also constitute a majority of the quorum. Each director so elected shall hold office until the next annual meeting of the stockholders and until a successor has been elected and qualified.
Unless otherwise provided in the Certificate of Incorporation or these Bylaws:
(a) Vacancies and newly created directorships resulting from any increase in the authorized number of directors elected by all of the stockholders having the right to vote as a single class may be filled by a majority of the directors then in office, although less than a quorum, or by a sole remaining director.
(b) Whenever the holders of any class or classes of stock or series thereof are entitled to elect one or more directors by the provisions of the Certificate of Incorporation, vacancies and newly created directorships of such class or classes or series may be filled by a majority of the directors elected by such class or classes or series thereof then in office, or by a sole remaining director so elected.
If at any time, by reason of death or resignation or other cause, the Corporation should have no directors in office, then any officer or any stockholder or an executor, administrator, trustee or guardian of a stockholder, or other fiduciary entrusted with like responsibility for the person or estate of a stockholder, may call a special meeting of stockholders in accordance with the provisions of the Certificate of Incorporation or these Bylaws, or may apply to the Court of Chancery for a decree summarily ordering an election as provided in Section 211 of the General Corporation Law of Delaware.
If, at the time of filling any vacancy or any newly created directorship, the directors then in office constitute less than a majority of the whole Board of Directors (as constituted immediately prior to any such increase), then the Court of Chancery may, upon application of any stockholder or stockholders holding at least 10% of the total number of the shares at the time outstanding having the right to vote for such directors, summarily order an election to be held to fill any such vacancies or newly created directorships, or to replace the
directors chosen by the directors then in office as aforesaid, which election shall be governed by the provisions of Section 211 of the General Corporation Law of Delaware as far as applicable.
The Board of Directors of the Corporation may hold meetings, both regular and special, either within or outside the State of Delaware. Unless otherwise restricted by the Certificate of Incorporation or these Bylaws, members of the Board of Directors, or any committee designated by the Board of Directors, may participate in a meeting of the Board of Directors, or any committee, by means of conference telephone or similar communications equipment by means of which all persons participating in the meeting can hear each other, and such participation in a meeting shall constitute presence in person at the meeting.
Regular meetings of the Board of Directors may be held without notice at such time and at such place as shall from time to time be determined by the Board of Directors.
Special meetings of the board of directors for any purpose or purposes may be called at any time by the chairman of the board, the president, any vice president, the secretary or any two (2) directors.
Notice of the time and place of special meetings shall be delivered personally or by telephone to each director or sent by first-class mail or telegram, charges prepaid, addressed to each director at that director's address as it is shown on the records of the Corporation. If the notice is mailed, it shall be deposited in the United States mail at least four (4) days before the time of the holding of the meeting. If the notice is delivered personally or by telephone, telecopy, telegram, telex or other similar means of communication, it shall be delivered at least twenty-four (24) hours before the time of the holding of the meeting, or on such shorter notice as the person or persons calling such meeting may deem necessary and appropriate in the circumstances. Any oral notice given personally or by telephone may be communicated either to the director or to a person at the office of the director who the person giving the notice has reason to believe will promptly communicate it to the director. The notice need not specify the purpose of the place of the meeting, if the meeting is to be held at the principal executive office of the Corporation.
At all meetings of the Board of Directors, a majority of the authorized number of directors shall constitute a quorum for the transaction of business and the act of a majority of the directors present at any meeting at which there is a quorum shall be the act of the Board of Directors, except as may be otherwise specifically provided by statute or by the Certificate of Incorporation. If a quorum is not present at any meeting of the Board of Directors, then the
directors present thereat may adjourn the meeting from time to time, without notice other than announcement at the meeting, until a quorum is present.
A meeting at which a quorum is initially present may continue to transact business notwithstanding the withdrawal of directors, if any action taken is approved by at least a majority of the required quorum for that meeting.
Whenever notice is required to be given under any provision of the General Corporation Law of Delaware or of the Certificate of Incorporation or these Bylaws, a written waiver thereof, signed by the person entitled to notice, whether before or after the time stated therein, shall be deemed equivalent to notice. Attendance of a person at a meeting shall constitute a waiver of notice of such meeting, except when the person attends a meeting for the express purpose of objecting, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened. Neither the business to be transacted at, nor the purpose of, any regular or special meeting of the directors, or members of a committee of directors, need be specified in any written waiver of notice unless so required by the Certificate of Incorporation or these Bylaws.
Unless otherwise restricted by the Certificate of Incorporation or these Bylaws, any action required or permitted to be taken at any meeting of the Board of Directors, or of any committee thereof, may be taken without a meeting if all members of the Board of Directors or committee, as the case may be, consent thereto in writing and the writing or writings are filed with the minutes of proceedings of the Board of Directors or committee. Written consents representing actions taken by the board or committee may be executed by telex, telecopy or other facsimile transmission, and such facsimile shall be valid and binding to the same extent as if it were an original.
Unless otherwise restricted by the Certificate of Incorporation or these Bylaws, the Board of Directors shall have the authority to fix the compensation of directors. No such compensation shall preclude any director from serving the Corporation in any other capacity and receiving compensation therefor.
The Corporation may lend money to, or guarantee any obligation of, or otherwise assist any officer or other employee of the Corporation or of its subsidiary, including any officer or employee who is a director of the Corporation or its subsidiary, whenever, in the judgment of the directors, such loan, guaranty or assistance may reasonably be expected to benefit the Corporation. The loan, guaranty or other assistance may be with or without interest and may be unsecured, or secured in such manner as the Board of Directors shall approve, including, without
limitation, a pledge of shares of stock of the Corporation. Nothing in this
Section 3.2 contained shall be deemed to deny, limit or restrict the powers of
guaranty or warranty of the Corporation at common law or under any statute.
Unless otherwise restricted by statute, by the Certificate of Incorporation or by these Bylaws, any director or the entire Board of Directors may be removed, with or without cause, by the holders of a majority of the shares then entitled to vote at an election of directors; provided, however, that if the stockholders of the Corporation are entitled to cumulative voting, if less than the entire Board of Directors is to be removed, no director may be removed without cause if the votes cast against his removal would be sufficient to elect him if then cumulatively voted at an election of the entire Board of Directors.
No reduction of the authorized number of directors shall have the effect of removing any director prior to the expiration of such director's term of office.
The Corporation may also have, at the discretion of the Board of Directors, a Chairman of the Board of Directors who shall not be considered an officer of the Corporation.
ARTICLE IV
The Board of Directors may, by resolution passed by a majority of the whole Board of Directors, designate one or more committees, with each committee to consist of one or more of the directors of the Corporation. The Board of Directors may designate one or more directors as alternate members of any committee, who may replace any absent or disqualified member at any meeting of the committee. In the absence or disqualification of a member of a committee, the member or members thereof present at any meeting and not disqualified from voting, whether or not such member or members constitute a quorum, may unanimously appoint another member of the Board of Directors to act at the meeting in the place of any such absent or disqualified member. Any such committee, to the extent provided in the resolution of the Board of Directors or in the Bylaws of the Corporation, shall have and may exercise all the powers and authority of the Board of Directors in the management of the business and affairs of the Corporation, and may authorize the seal of the Corporation to be affixed to all papers that may require it; but no such committee shall have the power or authority to (a) amend the Certificate of Incorporation (except that a committee may, to the extent authorized in the resolution or resolutions providing for the issuance of shares of stock adopted by the Board of Directors as provided in Section 151(a) of the General Corporation Law of Delaware, fix the designations and any of the preferences or rights of such shares relating to dividends, redemption, dissolution, any distribution of assets of the Corporation or the conversion into, or the exchange of such shares
for, shares of any other class or classes or any other series of the same or any other class or classes of stock of the Corporation or fix the number of shares of any series of stock or authorize the increase or decrease of the shares of any series),(b) adopt an agreement of merger or consolidation under Sections 251 or 252 of the General Corporation Law of Delaware, (c) recommend to the stockholders the sale, lease or exchange of all or substantially all of the Corporation's property and assets, (d) recommend to the stockholders a dissolution of the Corporation or a revocation of a dissolution, or (e) amend the Bylaws of the Corporation; and, unless the board resolution establishing the committee, the Bylaws or the Certificate of Incorporation expressly so provide, no such committee shall have the power or authority to declare a dividend, to authorize the issuance of stock, or to adopt a certificate of ownership and merger pursuant to Section 253 of the General Corporation Law of Delaware.
Each committee shall keep regular minutes of its meetings and report the same to the Board of Directors when required.
Meetings and actions of committees shall be governed by, and held and
taken in accordance with, the provisions of Section 3.5 (place of meetings and
meetings by telephone), Section 3.6 (regular meetings), Section 3.7 (special
meetings and notice), Section 3.8 (quorum), Section 3.9 (waiver of notice), and
Section 3.10 (action without a meeting) of these Bylaws, with such changes in
the context of such provisions as are necessary to substitute the committee and
its members for the Board of Directors and its members; provided, however, that
the time of regular meetings of committees may be determined either by
resolution of the Board of Directors or by resolution of the committee, that
special meetings of committees may also be called by resolution of the Board of
Directors and that notice of special meetings of committees shall also be given
to all alternate members, who shall have the right to attend all meetings of the
committee. The Board of Directors may adopt rules for the government of any
committee not inconsistent with the provisions of these Bylaws.
ARTICLE V
The officers of the Corporation shall be a chief executive officer, a
president, a secretary, and a chief financial officer. The Corporation may also
have, at the discretion of the Board of Directors, one or more vice presidents,
one or more assistant secretaries, one or more assistant treasurers, and any
such other officers as may be appointed in accordance with the provisions of
Section 5.3 of these Bylaws. Any number of offices may be held by the same
person.
The officers of the Corporation, except such officers as may be appointed in accordance with the provisions of Sections 5.3 or 5.5 of these Bylaws, shall be appointed by the Board of Directors, subject to the rights, if any, of an officer under any contract of employment.
The Board of Directors may appoint, or empower the chief executive officer or the president to appoint, such other officers and agents as the business of the Corporation may require, each of whom shall hold office for such period, have such authority, and perform such duties as are provided in these Bylaws or as the Board of Directors may from time to time determine.
Subject to the rights, if any, of an officer under any contract of employment, any officer may be removed, either with or without cause, by an affirmative vote of the majority of the Board of Directors at any regular or special meeting of the Board of Directors or, except in the case of an officer chosen by the Board of Directors, by any officer upon whom such power of removal may be conferred by the Board of Directors.
Any officer may resign at any time by giving written notice to the attention of the secretary of the Corporation. Any resignation shall take effect at the date of the receipt of that notice or at any later time specified in that notice; and, unless otherwise specified in that notice, the acceptance of the resignation shall not be necessary to make it effective. Any resignation is without prejudice to the rights, if any, of the Corporation under any contract to which the officer is a party.
Any vacancy occurring in any office of the Corporation shall be filled by the Board of Directors.
Subject to such supervisory powers, if any, as may be given by the Board of Directors to the chairman of the board, if any, the chief executive officer of the Corporation shall, subject to the control of the Board of Directors, have general supervision, direction, and control of the business and the officers of the Corporation. He or she shall preside at all meetings of the stockholders and, in the absence or nonexistence of a chairman of the board, at all meetings of the Board of Directors and shall have the general powers and duties of management usually vested in the office of chief executive officer of a corporation and shall have such other powers and duties as may be prescribed by the Board of Directors or these Bylaws.
Subject to such supervisory powers, if any, as may be given by the Board of Directors to the chairman of the board (if any) or the chief executive officer, the president shall have general supervision, direction, and control of the business and other officers of the Corporation. He or she shall have the general powers and duties of management usually vested in the office of president of a corporation and such other powers and duties as may be prescribed by the Board of Directors or these Bylaws.
In the absence or disability of the chief executive officer and president, the vice presidents, if any, in order of their rank as fixed by the Board of Directors or, if not ranked, a vice president designated by the Board of Directors, shall perform all the duties of the president and when so acting shall have all the powers of, and be subject to all the restrictions upon, the president. The vice presidents shall have such other powers and perform such other duties as from time to time may be prescribed for them respectively by the Board of Directors, these Bylaws, the president or the chairman of the board.
The secretary shall keep or cause to be kept, at the principal executive office of the Corporation or such other place as the Board of Directors may direct, a book of minutes of all meetings and actions of directors, committees of directors, and stockholders. The minutes shall show the time and place of each meeting, the names of those present at directors' meetings or committee meetings, the number of shares present or represented at stockholders' meetings, and the proceedings thereof.
The secretary shall keep, or cause to be kept, at the principal executive office of the Corporation or at the office of the Corporation's transfer agent or registrar, as determined by resolution of the Board Of Directors, a share register, or a duplicate share register, showing the names of all stockholders and their addresses, the number and classes of shares held by each, the number and date of certificates evidencing such shares, and the number and date of cancellation of every certificate surrendered for cancellation.
The secretary shall give, or cause to be given, notice of all meetings of the stockholders and of the Board of Directors required to be given by law or by these Bylaws. He or she shall keep the seal of the Corporation, if one be adopted, in safe custody and shall have such other powers and perform such other duties as may be prescribed by the Board of Directors or by these Bylaws.
The chief financial officer shall keep and maintain, or cause to be kept and maintained, adequate and correct books and records of accounts of the properties and business transactions of the Corporation, including accounts of its assets, liabilities, receipts,
disbursements, gains, losses, capital retained earnings, and shares. The books of account shall at all reasonable times be open to inspection by any director.
The chief financial officer shall deposit all moneys and other valuables in the name and to the credit of the Corporation with such depositories as may be designated by the Board of Directors. He or she shall disburse the funds of the Corporation as may be ordered by the Board of Directors, shall render to the president, the chief executive officer, or the directors, upon request, an account of all his or her transactions as chief financial officer and of the financial condition of the Corporation, and shall have other powers and perform such other duties as may be prescribed by the Board of Directors or the Bylaws.
The chairman of the board, the chief executive officer, the president, any vice president, the chief financial officer, the secretary or assistant secretary of this Corporation, or any other person authorized by the Board of Directors or the chief executive officer or the president or a vice president, is authorized to vote, represent, and exercise on behalf of this Corporation all rights incident to any and all shares of any other corporation or corporations standing in the name of this Corporation. The authority granted herein may be exercised either by such person directly or by any other person authorized to do so by proxy or power of attorney duly executed by the person having such authority.
In addition to the foregoing authority and duties, all officers of the Corporation shall respectively have such authority and perform such duties in the management of the business of the Corporation as may be designated from time to time by the Board of Directors or the stockholders.
ARTICLE VI
The Corporation shall, to the maximum extent and in the manner permitted by the General Corporation Law of Delaware, indemnify each of its directors and officers against expenses (including attorneys' fees), judgments, fines, settlements and other amounts actually and reasonably incurred in connection with any proceeding, arising by reason of the fact that such person is or was an agent of the Corporation. For purposes of this Section 6.1, a "director" or "officer" of the Corporation includes any person (a) who is or was a director or officer of the Corporation, (b) who is or was serving at the request of the Corporation as a director or officer of another corporation, partnership, joint venture, trust or other enterprise, or (c) who was a director or officer of a Corporation which was a predecessor corporation of the Corporation or of another enterprise at the request of such predecessor corporation.
The Corporation shall have the power, to the maximum extent and in the manner permitted by the General Corporation Law of Delaware, to indemnify each of its employees and agents (other than directors and officers) against expenses (including attorneys' fees), judgments, fines, settlements and other amounts actually and reasonably incurred in connection with any proceeding, arising by reason of the fact that such person is or was an agent of the Corporation. For purposes of this Section 6.2, an "employee" or "agent" of the Corporation (other than a director or officer) includes any person (a) who is or was an employee or agent of the Corporation, (b) who is or was serving at the request of the Corporation as an employee or agent of another corporation, partnership, joint venture, trust or other enterprise, or (c) who was an employee or agent of a corporation which was a predecessor corporation of the Corporation or of another enterprise at the request of such predecessor corporation.
Expenses incurred in defending any action or proceeding for which indemnification is required pursuant to Section 6.1 or for which indemnification is permitted pursuant to Section 6.2 following authorization thereof by the Board of Directors shall be paid by the Corporation in advance of the final disposition of such action or proceeding upon receipt of an undertaking by or on behalf of the indemnified party to repay such amount if it shall ultimately be determined that the indemnified party is not entitled to be indemnified as authorized in this Article VI.
The indemnification provided by this Article VI shall not be deemed exclusive of any other rights to which those seeking indemnification may been titled under any Bylaw, agreement, vote of shareholders or disinterested directors or otherwise, both as to action in an official capacity and as to action in another capacity while holding such office, to the extent that such additional rights to indemnification are authorized in the Certificate of Incorporation.
The Corporation may purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the Corporation, or is or was serving at the request of the Corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise against any liability asserted against him or her and incurred by him or her in any such capacity, or arising out of his or her status as such, whether or not the Corporation would have the power to indemnify him or her against such liability under the provisions of the General Corporation Law of Delaware.
No indemnification or advance shall be made under this Article VI, except where such indemnification or advance is mandated by law or the order, judgment or decree of any court of competent jurisdiction, in any circumstance where it appears:
(a) That it would be inconsistent with a provision of the Certificate of Incorporation, these Bylaws, a resolution of the stockholders or an agreement in effect at the time of the accrual of the alleged cause of the action asserted in the proceeding in which the expenses were incurred or other amounts were paid, which prohibits or otherwise limits indemnification; or
(b) That it would be inconsistent with any condition expressly imposed by a court in approving a settlement.
ARTICLE VII
The Corporation shall, either at its principal executive offices or at such place or places as designated by the Board of Directors, keep a record of its stockholders listing their names and addresses and the number and class of shares held by each stockholder, a copy of these Bylaws as amended to date, accounting books, and other records.
Any stockholder of record, in person or by attorney or other agent, shall, upon written demand under oath stating the purpose thereof, have the right during the usual hours for business to inspect for any proper purpose the Corporation's stock ledger, a list of its stockholders, and its other books and records and to make copies or extracts therefrom. A proper purpose shall mean a purpose reasonably related to such person's interest as a stockholder. In every instance where an attorney or other agent is the person who seeks the right to inspection, the demand under oath shall be accompanied by a power of attorney or such other writing that authorizes the attorney or other agent to so act on behalf of the stockholder. The demand under oath shall be directed to the Corporation at its registered office in Delaware or at its principal place of business.
Any director shall have the right to examine the Corporation's stockledger, a list of its stockholders, and its other books and records for a purpose reasonably related to his or her position as a director. The Court of Chancery is hereby vested with the exclusive jurisdiction to determine whether a director is entitled to the inspection sought. The Court may summarily order the Corporation to permit the director to inspect any and all books and records, the stock ledger, and the stock list and to make copies or extracts therefrom. The Court may, in its
discretion, prescribe any limitations or conditions with reference to the inspection, or award such other and further relief as the Court may deem just and proper.
The Board of Directors shall present at each annual meeting, and at any special meeting of the stockholders when called for by vote of the stockholders, a full and clear statement of the business and condition of the Corporation.
ARTICLE VIII
From time to time, the Board of Directors shall determine by resolution which person or persons may sign or endorse all checks, drafts, other orders for payment of money, notes or other evidences of indebtedness that are issued in the name of or payable to the Corporation, and only the persons so authorized shall sign or endorse those instruments.
The Board of Directors, except as otherwise provided in these Bylaws, may authorize any officer or officers, or agent or agents, to enter into any contract or execute any instrument in the name of and on behalf of the Corporation; such authority may be general or confined to specific instances. Unless so authorized or ratified by the Board of Directors or within the agency power of an officer, no officer, agent or employee shall have any power or authority to bind the Corporation by any contract or engagement or to pledge its credit or to render it liable for any purpose or for any amount.
The shares of the Corporation shall be represented by certificates, provided that the Board of Directors of the Corporation may provide by resolution or resolutions that some or all of any or all classes or series of its stock shall be uncertificated shares. Any such resolution shall not apply to shares represented by a certificate until such certificate is surrendered to the Corporation. Notwithstanding the adoption of such a resolution by the Board of Directors, every holder of stock represented by certificates and upon request every holder of uncertificated shares shall be entitled to have a certificate signed by, or in the name of the Corporation by the chairman or vice-chairman of the Board of Directors, or the chief executive officer or the president or vice- president, and by the chief financial officer or an assistant treasurer, or the secretary or an assistant secretary of the Corporation representing the number of shares registered in certificate form. Any or all of the signatures on the certificate may be a facsimile. In case any officer, transfer agent or registrar who has signed or whose facsimile signature has been placed upon a certificate has ceased to be such officer, transfer agent or registrar before such certificate
is issued, it may be issued by the Corporation with the same effect as if he or she were such officer, transfer agent or registrar at the date of issue.
The Corporation may issue the whole or any part of its shares as partly paid and subject to call for the remainder of the consideration to be paid therefor. Upon the face or back of each stock certificate issued to represent any such partly paid shares, upon the books and records of the Corporation in the case of uncertificated partly paid shares, the total amount of the consideration to be paid therefor and the amount paid thereon shall be stated. Upon the declaration of any dividend on fully paid shares, the Corporation shall declare a dividend upon partly paid shares of the same class, but only upon the basis of the percentage of the consideration actually paid thereon.
If the Corporation is authorized to issue more than one class of stock or more than one series of any class, then the powers, the designations, the preferences, and the relative, participating, optional or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences and/or rights shall be set forth in full or summarized on the face or back of the certificate that the Corporation shall issue to represent such class or series of stock; provided, however, that, except as otherwise provided in Section 202 of the General Corporation Law of Delaware, in lieu of the foregoing requirements there may be set forth on the face or back of the certificate that the Corporation shall issue to represent such class or series of stock a statement that the Corporation will furnish without charge to each stockholder who so requests the powers, the designations, the preferences, and the relative, participating, optional or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences and/or rights.
Except as provided in this Section 8.5, no new certificates for shares shall be issued to replace a previously issued certificate unless the latter is surrendered to the Corporation and canceled at the same time. The Corporation may issue a new certificate of stock or uncertificated shares in the place of any certificate previously issued by it, alleged to have been lost, stolen or destroyed, and the Corporation may require the owner of the lost, stolen or destroyed certificate, or the owner's legal representative, to give the Corporation a bond sufficient to indemnify it against any claim that may be made against it on account of the alleged loss, theft or destruction of any such certificate or the issuance of such new certificate or uncertificated shares.
Unless the context requires otherwise, the general provisions, rules of construction, and definitions in the Delaware General Corporation Law shall govern the construction of these Bylaws. Without limiting the generality of this provision, the singular number includes the plural, the plural number includes the singular, and the term "person" includes both a corporation and a natural person.
The directors of the Corporation, subject to any restrictions contained in (a) the General Corporation Law of Delaware or (b) the Certificate of Incorporation, may declare and pay dividends upon the shares of its capital stock. Dividends may be paid in cash, in property, or in shares of the Corporation's capital stock.
The directors of the Corporation may set apart out of any of the funds of the Corporation available for dividends a reserve or reserves for any proper purpose and may abolish any such reserve. Such purposes shall include but not be limited to equalizing dividends, repairing or maintaining any property of the Corporation, and meeting contingencies.
The fiscal year of the Corporation shall be fixed by resolution of the Board of Directors and may be changed by the Board of Directors.
The Corporation may adopt a corporate seal, which may be altered at pleasure, and may use the same by causing it or a facsimile thereof, to be impressed or affixed or in any other manner reproduced.
Upon surrender to the Corporation or the transfer agent of the Corporation of a certificate for shares duly endorsed or accompanied by proper evidence of succession, assignation or authority to transfer, it shall be the duty of the Corporation to issue a new certificate to the person entitled thereto, cancel the old certificate, and record the transaction in its books.
The Corporation shall have power to enter into and perform any agreement with any number of stockholders of any one or more classes of stock of the Corporation to restrict the transfer of shares of stock of the Corporation of any one or more classes owned by such stockholders in any manner not prohibited by the General Corporation Law of Delaware.
The Corporation shall be entitled to recognize the exclusive right of a person registered on its books as the owner of shares to receive dividends and to vote as such owner, shall be entitled to hold liable for calls and assessments the person registered on its books as the owner of shares, and shall not be bound to recognize any equitable or other claim to or interest in such share or shares on the part of another person, whether or not it shall have express or other notice thereof, except as otherwise provided by the laws of Delaware.
ARTICLE IX
The Bylaws of the Corporation may be adopted, amended or repealed by the stockholders entitled to vote; provided, however, that the Corporation may, in its Certificate of Incorporation, confer the power to adopt, amend or repeal Bylaws upon the directors. The fact that such power has been so conferred upon the directors shall not divest the stockholders of the power, nor limit their power to adopt, amend or repeal Bylaws.
CERTIFICATE OF ADOPTION OF
AMENDED AND RESTATED BYLAWS
OF
DURECT CORPORATION
The undersigned hereby certifies that the undersigned is the duly elected, qualified, and acting Secretary of Durect Corporation (the "Corporation"), and that the foregoing Amended and Restated Bylaws, comprising 20 pages, were adopted the Bylaws of the corporation on March __, 2000 by the Board of Directors of the corporation.
Executed this _____ day of _________________, ___.
Mark B. Weeks, Secretary
EXHIBIT 3.6
CERTIFICATE OF DESIGNATION OF RIGHTS, PREFERENCES
AND PRIVILEGES OF
SERIES B-1 PREFERRED STOCK
OF
DURECT CORPORATION
Pursuant to Section 151 of the General Corporation Law of the State of Delaware
We, James E. Brown and Mark B. Weeks, the Chief Executive Officer and the Secretary, respectively, of Durect Corporation, a Delaware corporation (the
That pursuant to the authority conferred upon the Board of Directors by the Amended and Restated Certificate of Incorporation of the said Corporation (the
"RESOLVED, that pursuant to the authority vested in the Board of Directors of the corporation by the Restated Certificate, the Board of Directors does hereby provide for the issue of a Series of Preferred Stock, $0.0001 par value, of the Corporation, to be designated "Series B-1 Preferred Stock", initially consisting of Four Hundred and Fifty Thousand (450,000) shares, and to the extent that the designations, powers, preferences and relative and other special rights and the qualifications, limitations and restrictions of the Series B-1 Preferred Stock are not stated and expressed in the Restated Certificate, does hereby fix and herein state and express such designations, powers, preferences and relative and other special rights and the qualifications, limitations and restrictions thereof, as follows (all terms used herein which are defined in the Restated Certificate shall be deemed to have the meanings provided therein):
Preferred Stock, payable quarterly when, as and if declared by the Board of Directors; provided, however, that no dividend shall be declared or paid on the shares of Series B-1 Preferred Stock unless dividends have been declared and paid in full to the holders of Series A, Series A-1 and Series B Preferred Stock. Such dividends shall not be cumulative.
(1) Common Stock issued pursuant to a transaction described in Section 5(d)(ii) hereof,
(2) Not more than 2,000,000 shares of Common Stock issuable or issued prior to, on or after the Purchase Date to employees, consultants or directors of the Corporation directly or pursuant to a stock option plan or restricted stock plan approved by the Board of Directors of the Corporation,
(3) Not more than 500,000 shares of capital stock, or options or warrants to purchase capital stock, issued to financial institutions or lessors in connection with commercial credit arrangements, equipment financings or similar transactions approved by the Board of Directors,
(4) Capital stock or warrants or options to purchase capital stock issued in connection with bona fide acquisitions, mergers, partnering transactions or similar transactions ("Transactions"), the terms of which are approved by the Board of Directors, unless the Director designated by the Series B Preferred Stock reasonably
determines in good faith, in his or her capacity as Director of the Corporation, that the value of the assets, consideration or rights received by the Corporation in such Transaction, when taken as a whole, would not contribute to increasing the value of the Corporation so as to justify issuance of such capital stock or warrants or options to purchase capital stock in such Transaction,
(5) Shares of Common Stock issued or issuable upon conversion of the Series A-1, Series A-2, Series B or Series B-1 Preferred Stock, and
(6) Shares of Common Stock issued or issuable in a public offering prior to or in connection with which all outstanding shares of Series A-1, Series A-2, Series B and Series B-1 Preferred Stock will be converted into shares of Common Stock.
(1) The aggregate maximum number of shares of Common
Stock deliverable upon exercise (assuming the satisfaction of any conditions to
exercisability, including without limitation, the passage of time, but without
taking into account potential antidilution adjustments) of such options to
purchase or rights to subscribe for Common Stock shall be deemed to have been
issued at the time such options or rights were issued and for a consideration
equal to the consideration (determined in the manner provided in Section
5(d)(i)(D)), if any, received by the Corporation upon the issuance of such
options or rights plus the minimum exercise price provided in such options or
rights (without taking into account potential antidilution adjustments) for the
Common Stock covered thereby.
(2) The aggregate maximum number of shares of Common Stock deliverable upon conversion of or in exchange (assuming the satisfaction of any conditions to convertibility or exchangeability, including, without limitation, the passage of time, but without taking into account potential antidilution adjustments) for any such convertible or exchangeable securities or upon the exercise of options to purchase or rights to subscribe for such convertible or exchangeable securities and subsequent conversion or exchange thereof shall be deemed to have been issued at the time such securities were issued or such options or rights were issued and for a consideration equal to the consideration, if any, received by the Corporation for any such securities and related options or rights (excluding any cash received on account of accrued interest or accrued dividends), plus the minimum additional consideration, if any, to be received by the Corporation (without taking into account potential antidilution adjustments) upon the conversion or exchange of such securities or the exercise of any related options or rights (the consideration in each case to be determined in the manner provided in Section 5(d)(i)(D)).
(3) In the event of any change in the number of shares of Common Stock deliverable or in the consideration payable to the Corporation upon exercise of such options or rights or upon conversion of or in exchange for such convertible or exchangeable securities, including, but not limited to, a change resulting from the antidilution provisions thereof, the Conversion Price of each of the Series A-1, Series A-2, Series B and Series B-1 Preferred Stock, to the extent in any way affected by or computed using such options, rights or securities, shall be recomputed to reflect such change, but no further adjustment shall be made for the actual issuance of Common Stock or any payment of such consideration upon the exercise of any such options or rights or the conversion or exchange of such securities.
(4) Upon the expiration of any such options or rights, the termination of any such rights to convert or exchange or the expiration of any options or rights related to such convertible or exchangeable securities, the Conversion Price of each of the Series A-1, Series A-2, Series B and Series B-1 Preferred Stock, to the extent in any way affected by or computed using such options, rights or securities or options or rights related to such securities, shall be recomputed to reflect the issuance of only the number of shares of Common Stock (and convertible or exchangeable securities which remain in effect) actually issued upon the exercise of such options or rights, upon the conversion or exchange of such securities or upon the exercise of the options or rights related to such securities.
(5) The number of shares of Common Stock deemed issued and the consideration deemed paid therefor pursuant to Sections 5(d)(i)(E)(1) and 5(d)(i)(E)(2) shall be appropriately adjusted to reflect any change, termination or expiration of the type described in either Section 5(d)(i)(E)(3) or 5(d)(i)(E)(4).
(i) No fractional shares shall be issued upon the conversion of any share or shares of the Series B-1 Preferred Stock, and the number of shares of Common Stock to be issued shall be rounded to the nearest whole share with one-half being rounded upward. The number of shares issuable upon such conversion shall be determined on the basis of the total number of shares of Series B-1 Preferred Stock the holder is at the time converting into Common Stock and the number of shares of Common Stock issuable upon such aggregate conversion.
(ii) Upon the occurrence of each adjustment or readjustment of the Conversion Price of Series B-1 Preferred Stock pursuant to this Section 5, the Corporation, at its expense, shall promptly compute such adjustment or readjustment in accordance with the terms hereof and prepare and furnish to each holder of such Preferred Stock a certificate setting forth such adjustment or readjustment and showing in detail the facts upon which such adjustment or readjustment is based. The Corporation shall, upon the written request at any time of any holder of Series B-1 Preferred Stock, furnish or cause to be furnished to such holder a like certificate setting forth (A) such adjustment and readjustment, (B) the Conversion Price for such series of Preferred Stock at the time in effect, and (C) the number of shares of Common Stock and the amount, if any, of other property which at the time would be received upon the conversion of a share of such series of Preferred Stock.
Preferred Stock, voting together as a class: (i) alter or change the rights, preferences or privileges of the shares of Series B-1 Preferred Stock or (ii) amend the Certificate of Incorporation or the Bylaw of the Corporation so as to affect adversely the shares of Series B-1 Preferred Stock in a manner materially different from any other series of Preferred Stock.
IN WITNESS WHEREOF, we have executed and subscribed this Certificate and do affirm the foregoing as true under the penalties of perjury this 30th day of September, 1999.
/s/ James E. Brown ------------------ James E. Brown Chief Executive Officer ATTEST: /s/ Mark B. Weeks ----------------- Mark B. Weeks, Secretary |
EXHIBIT 3.7
CERTIFICATE OF DESIGNATION OF RIGHTS, PREFERENCES
AND PRIVILEGES OF
SERIES C PREFERRED STOCK
OF
DURECT CORPORATION
Pursuant to Section 151 of the General Corporation Law of the State of Delaware
"RESOLVED, that pursuant to the authority vested in the Board of Directors of the corporation by the Restated Certificate, the Board of Directors does hereby create and provide for the issuance of a series of Preferred Stock, $0.0001 par value, of the Corporation, to be designated "Series C Preferred Stock", initially consisting of three million five hundred seventy one thousand, four hundred twenty nine (3,571,429) shares, and to the extent that the designations, powers, preferences and relative and other special rights and the qualifications, limitations and restrictions of the Series C Preferred Stock are not stated and expressed in the Restated Certificate, does hereby fix and herein state and express such designations, powers, preferences and relative and other special rights and the qualifications, limitations and restrictions thereof, as follows (all terms used herein which are defined in the Restated Certificate shall be deemed to have the meanings provided therein):
for stock splits, stock dividends, reclassification and the like) per annum on each outstanding share of Series C Preferred Stock payable quarterly when, as and if declared by the Board of Directors; provided, however, that dividends declared or paid on the shares of Series C Preferred stock shall be paid on a pari passu basis with the dividends of the Series A-1, Series A-2 and Series B Preferred Stock pro rata in accordance with the then unpaid amounts of the dividends then payable on the respective series of Preferred Stock. To the extent that assets are not legally available for the payment of such dividends on the Series A-1, Series A-2, Series B or Series C Preferred Stock, such dividends shall be paid pro rata as provided in the immediately preceding sentence at such time as assets become legally available for such purpose. The dividends on the Series C Preferred Stock shall not be cumulative.
deemed to have converted such Preferred Stock until immediately prior to the closing of such sale of securities.
(1) Common Stock issued pursuant to a transaction described in Section 5(d)(ii) hereof,
(2) Not more than 3,000,000 shares of Common Stock issuable or issued prior to, on or after the Purchase Date to employees, consultants or directors of the Corporation directly or pursuant to a stock option plan or restricted stock plan approved by the Board of Directors of the Corporation,
(3) Capital stock, or options or warrants to purchase capital stock, issued to financial institutions or lessors in connection with commercial credit arrangements, equipment financings or similar transactions approved by the Board of Directors,
(5) Shares of Common Stock issued or issuable upon conversion of the Series A-1, Series A-2, Series B, Series B-1 or Series C Preferred Stock,
(6) Shares of Common Stock issued or issuable in a public offering prior to or in connection with which all outstanding shares of Series A-1, Series A-2, Series B, Series B-1 and Series C Preferred Stock will be converted into shares of Common Stock, subject to the anti-dilution rights set forth in Sections 5(e) and 5(f) below, and
(7) Capital stock issuable or issued upon exercise or conversion of warrants, options, notes or other rights to acquire securities outstanding as of the date of this Certificate of Designation.
(1) The aggregate maximum number of shares of Common
Stock deliverable upon exercise (assuming the satisfaction of any conditions to
exercisability, including without limitation, the passage of time, but without
taking into account potential antidilution adjustments) of such options to
purchase or rights to subscribe for Common Stock shall be deemed to have been
issued at the time such options or rights were issued and for a consideration
equal to the consideration (determined in the manner provided in Section
5(d)(i)(D)), if any, received by the Corporation upon the issuance of such
options or rights plus the minimum exercise price provided in such options or
rights (without taking into account potential antidilution adjustments) for the
Common Stock covered thereby.
(2) The aggregate maximum number of shares of Common Stock deliverable upon conversion of or in exchange (assuming the satisfaction of any conditions to convertibility or exchangeability, including, without limitation, the passage of time, but without taking into account potential antidilution adjustments) for any such convertible or exchangeable securities or upon the exercise of options to purchase or rights to subscribe for such convertible or exchangeable securities and subsequent conversion or exchange thereof shall be deemed to have been issued at the time such securities were issued or such options or rights were issued and for a consideration equal to the consideration, if any, received by the Corporation for any such securities and related options or rights (excluding any cash received on account of accrued interest or accrued dividends), plus the minimum additional consideration, if any, to be received by the Corporation (without taking into account potential antidilution adjustments) upon the conversion or exchange of such securities or the exercise of any related options or rights (the consideration in each case to be determined in the manner provided in Section 5(d)(i)(D)).
(3) In the event of any change in the number of shares of Common Stock deliverable or in the consideration payable to the Corporation upon exercise of such options or rights or upon conversion of or in exchange for such convertible or exchangeable securities, including, but not limited to, a change resulting from the antidilution
provisions thereof, the Conversion Price of each of the Series A-1, Series A-2, Series B, Series B-1 and Series C Preferred Stock, to the extent in any way affected by or computed using such options, rights or securities, shall be recomputed to reflect such change, but no further adjustment shall be made for the actual issuance of Common Stock or any payment of such consideration upon the exercise of any such options or rights or the conversion or exchange of such securities.
(4) Upon the expiration of any such options or rights, the termination of any such rights to convert or exchange or the expiration of any options or rights related to such convertible or exchangeable securities, the Conversion Price of each of the Series A-1, Series A-2, Series B, Series B-1 and Series C Preferred Stock, to the extent in any way affected by or computed using such options, rights or securities or options or rights related to such securities, shall be recomputed to reflect the issuance of only the number of shares of Common Stock (and convertible or exchangeable securities which remain in effect) actually issued upon the exercise of such options or rights, upon the conversion or exchange of such securities or upon the exercise of the options or rights related to such securities.
(5) The number of shares of Common Stock deemed issued and the consideration deemed paid therefor pursuant to Sections 5(d)(i)(E)(1) and 5(d)(i)(E)(2) shall be appropriately adjusted to reflect any change, termination or expiration of the type described in either Section 5(d)(i)(E)(3) or 5(d)(i)(E)(4).
determination of the holders of Common Stock of the Corporation entitled to receive such distribution.
(i) No fractional shares shall be issued upon the conversion of any share or shares of the Series C Preferred Stock, and the number of shares of Common Stock to be issued shall be rounded to the nearest whole share with one-half being rounded upward. The number of shares issuable upon such conversion shall be determined on the basis of the total number of shares of Series C Preferred Stock the holder is at the time converting into Common Stock and the number of shares of Common Stock issuable upon such aggregate conversion.
(ii) Upon the occurrence of each adjustment or readjustment of the Conversion Price of Series C Preferred Stock pursuant to this Section 5, the Corporation, at its expense, shall promptly compute such adjustment or readjustment in accordance with the terms hereof and prepare and furnish to each holder of such Preferred Stock a certificate setting forth such adjustment or readjustment and showing in detail the facts upon which such adjustment or readjustment is based. The Corporation shall, upon the written request at any time of any holder of Series C Preferred Stock, furnish or cause to be furnished to such holder a like certificate setting forth (A) such adjustment and readjustment, (B) the Conversion Price for such series of Preferred Stock at the time in effect, and (C) the number of shares of Common Stock and the amount, if any, of other property which at the time would be received upon the conversion of a share of such series of Preferred Stock.
the then outstanding shares of Series A-1, Series A-2, Series B and Series C Preferred Stock, voting together as a class:
(a) effect a transaction described in Section 2(c)(i) of the Restated Certificate;
(b) alter, reclassify or change the rights, preferences or privileges of the shares of the Series C Preferred Stock so as to materially and adversely affect such shares in a manner differently than the shares of the Series A-1, Series A-2 and Series B Preferred Stock;
(c) increase or decrease (other than by redemption or conversion) the total number of authorized shares of Preferred Stock;
(d) authorize or issue, or obligate itself to issue, any other equity security, including any other security convertible into or exercisable for any equity security having a preference over, or being on a parity with, the Series A-1, Series A-2, Series B or Series C Preferred Stock;
(f) amend the Bylaws or the Certificate of Incorporation to increase or decrease the number of authorized directors above or below eight (8);
(g) liquidate, dissolve or wind up the Corporation; or
(h) enter into any transactions with any officers, directors or holders of greater than 5% of the outstanding capital stock of the Corporation, unless such transaction is at arms' length and shall have been approved by the Board of Directors.
FURTHER RESOLVED, that the statements contained in the foregoing resolution creating and designating the Series C Preferred Stock and fixing the powers, designations, preferences and relative, optional, participating and other special rights and the qualifications, limitations, restrictions, and other distinguishing characteristics thereof shall, upon the effective
date of said series, be deemed to be included in and be part of the Restated Certificate pursuant to the provisions of Sections 104 and 151 of the General Corporation Law of the State of Delaware.
No shares of Series C Preferred Stock have previously been issued.
IN WITNESS WHEREOF, the undersigned has executed and subscribed this Certificate as the act and deed of the Corporation and does affirm the foregoing as true under the penalties of perjury this 24th day of March, 2000.
/s/ James E. Brown ------------------ James E. Brown Chief Executive Officer ATTEST: /s/ Mark B. Weeks ----------------- Mark B. Weeks, Secretary |
EXHIBIT 4.2
DURECT CORPORATION
SECOND AMENDED AND RESTATED INVESTORS' RIGHTS AGREEMENT
March 28, 2000
TABLE OF CONTENTS
Page A. Amendment of Prior Rights Agreement/Waiver of Right of First Offer....................................2 1. Registration Rights...................................................................................2 1.1 Definitions..................................................................................2 1.2 Request for Registration.....................................................................3 1.3 Company Registration.........................................................................4 1.4 Form S-3 Registration........................................................................5 1.5 Obligations of the Company...................................................................6 1.6 Furnish Information..........................................................................7 1.7 Expenses of Registration.....................................................................7 1.8 Underwriting Requirements....................................................................8 1.9 Delay of Registration........................................................................9 1.10 Indemnification..............................................................................9 1.11 Reports Under Securities Exchange Act of 1934...............................................11 1.12 Assignment of Registration Rights...........................................................12 1.13 Limitations on Subsequent Registration Rights...............................................12 1.14 Market Stand-Off Agreement..................................................................13 1.15 Termination of Registration Rights..........................................................13 2. Covenants of the Company.............................................................................13 2.1 Delivery of Financial Statements............................................................13 2.2 Right of First Offer........................................................................14 2.3 Termination of Covenants....................................................................16 3. Miscellaneous........................................................................................16 3.1 Successors and Assigns......................................................................16 3.2 Amendments and Waivers......................................................................16 3.3 Notices.....................................................................................17 3.4 Severability................................................................................17 3.5 Governing Law...............................................................................17 3.6 Additional Parties..........................................................................17 3.7 Counterparts................................................................................17 3.8 Titles and Subtitles........................................................................17 3.9 Aggregation of Stock........................................................................17 |
DURECT CORPORATION
C. The Company, the Founders, the Series A Holders, the Series B Holders and the Series B-1 Holders each desire to amend and restate the 1999 Rights Agreement to add the Series C Holders as parties to this Agreement and make certain other changes.
The parties hereby agree as follows:
number of shares of Common Stock issuable pursuant to then exercisable or convertible securities which are, Registrable Securities;
(a) If the Company shall receive at any time
after the earlier of (i) March 31, 2003 or (ii) six (6) months after the
effective date of the first registration statement for a public offering of
securities of the Company (other than a registration statement relating either
to the sale of securities to employees of the Company pursuant to a stock
option, stock purchase or similar plan or an SEC Rule 145 transaction), a
written request from the Holders of at least forty percent (40%) of the
Registrable Securities then outstanding that the Company file a registration
statement under the Securities Act covering the registration of at least forty
percent (40%) of the Registrable Securities then outstanding (or a lesser
percent if the anticipated aggregate offering price, net of underwriting
discounts and commissions, would exceed $10,000,000), then the Company shall,
within ten (10) days of the receipt thereof, give written notice of such request
to all Holders and shall, subject to the limitations of subsection 1.2(b), use
its best efforts to effect as soon as practicable, and in any event within 60
days of the receipt of such request, the registration under the Securities Act
of all Registrable Securities which the Holders request to be registered within
twenty (20) days of the mailing of such notice by the Company in accordance with
Section 3.3.
(d) In addition, the Company shall not be obligated to effect, or to take any action to effect, any registration pursuant to this Section 1.2:
(i) After the Company has effected three
(3) registrations pursuant to this Section 1.2 and such registrations have been
declared or ordered effective;
(ii) During the period starting with the date sixty (60) days prior to the Company's good faith estimate of the date of filing of, and ending on a date one hundred eighty (180) days after the effective date of, a registration subject to Section 1.3 hereof; provided that the Company is actively employing in good faith all reasonable efforts to cause such registration statement to become effective; or
(iii) If the Initiating Holders propose to dispose of shares of Registrable Securities that may be immediately registered on Form S-3 pursuant to a request made pursuant to Section 1.4 below.
included in a registration statement covering the sale of the Registrable
Securities), the Company shall, at such time, promptly give each Holder written
notice of such registration. Upon the written request of each Holder given
within fifteen (15) days after notice given by the Company in accordance with
Section 3.3, the Company shall, subject to the provisions of Section 1.8, cause
to be registered under the Securities Act all of the Registrable Securities that
each such Holder has requested to be registered.
(a) promptly give written notice of the proposed registration, and any related qualification or compliance, to all other Holders; and
(c) Subject to the foregoing, the Company shall file a registration statement covering the Registrable Securities and other securities so requested to be registered as soon as practicable after receipt of the request or requests of the Holders. Registrations effected
pursuant to this Section 1.4 shall not be counted as demands for registration or registrations effected pursuant to Sections 1.2.
(a) Prepare and file with the SEC a registration statement with respect to such Registrable Securities and use its best efforts to cause such registration statement to become effective, and, upon the request of the Holders of a majority of the Registrable Securities registered thereunder, keep such registration statement effective for up to one hundred twenty (120) days. The Company shall not be required to file, cause to become effective or maintain the effectiveness of any registration statement that contemplates a distribution of securities on a delayed or continuous basis pursuant to Rule 415 under the Securities Act.
(b) Prepare and file with the SEC such amendments
and supplements to such registration statement and the prospectus used in
connection with such registration statement as may be necessary to comply with
the provisions of the Securities Act with respect to the disposition of all
securities covered by such registration statement for up to one hundred twenty
(120) days.
(c) Furnish to the Holders such numbers of copies of a prospectus, including a preliminary prospectus, in conformity with the requirements of the Securities Act, and such other documents as they may reasonably request in order to facilitate the disposition of Registrable Securities owned by them.
(e) In the event of any underwritten public offering, enter into and perform its obligations under an underwriting agreement, in usual and customary form, with the managing underwriter of such offering. Each Holder participating in such underwriting shall also enter into and perform its obligations under such an agreement.
(f) Notify each Holder of Registrable Securities covered by such registration statement at any time when a prospectus relating thereto is required to be delivered under the Securities Act of the happening of any event as a result of which the prospectus included in such registration statement, as then in effect, includes an untrue statement of a material fact or omits to state a material fact required to be stated therein or necessary to make the statements therein not misleading in the light of the circumstances then existing, such obligation to continue for one hundred twenty (120) days.
(g) Cause all such Registrable Securities registered pursuant hereunder to be listed on each securities exchange on which similar securities issued by the Company are then listed.
(h) Provide a transfer agent and registrar for all Registrable Securities registered hereunder and a CUSIP number for all such Registrable Securities, in each case not later than the effective date of such registration.
(i) Use its best efforts to furnish, at the request
of any Holder requesting registration of Registrable Securities pursuant to this
Section 1, on the date that such Registrable Securities are delivered to the
underwriters for sale in connection with a registration pursuant to this Section
1, if such securities are being sold through underwriters, or, if such
securities are not being sold through underwriters, on the date that the
registration statement with respect to such securities becomes effective, (i) an
opinion, dated such date, of the counsel representing the Company for the
purposes of such registration, in form and substance as is customarily given to
underwriters in an underwritten public offering, addressed to the underwriters,
if any, and to the Holders requesting registration of Registrable Securities and
(ii) a letter dated such date, from the independent certified public accountants
of the Company, in form and substance as is customarily given by independent
certified public accountants to underwriters in an underwritten public offering,
addressed to the underwriters, if any, and to the Holders requesting
registration of Registrable Securities.
pay for any expenses of any registration proceeding begun pursuant to Section 1.2 if the registration request is subsequently withdrawn at the request of the Holders of a majority of the Registrable Securities to be registered (in which case all participating Holders shall bear such expenses), unless the Holders of a majority of the Registrable Securities agree to forfeit their right to one demand registration pursuant to Section 1.2.
which occurs in reliance upon and in conformity with written information furnished expressly for use in connection with such registration by any such Holder, underwriter or controlling person.
(d) If the indemnification provided for in this
Section 1.10 is held by a court of competent jurisdiction to be unavailable to
an indemnified party with respect to any loss, liability, claim, damage or
expense referred to therein, then the indemnifying party, in lieu of
(e) Notwithstanding the foregoing, to the extent that the provisions on indemnification and contribution contained in the underwriting agreement entered into in connection with the underwritten public offering are in conflict with the foregoing provisions, the provisions in the underwriting agreement shall control.
(f) The obligations of the Company and Holders under this Section 1.10 shall survive the completion of any offering of Registrable Securities in a registration statement under this Section 1, and otherwise.
(a) make and keep public information available, as those terms are understood and defined in SEC Rule 144, at all times after ninety (90) days after the effective date of the first registration statement filed by the Company for the offering of its securities to the general public so long as the Company remains subject to the periodic reporting requirements under Sections 13 or 15(d) of the Exchange Act;
(b) take such action, including the voluntary registration of its Common Stock under Section 12 of the Exchange Act, as is necessary to enable the Holders to utilize Form S-3 for the sale of their Registrable Securities, such action to be taken as soon as practicable after the end of the fiscal year in which the first registration statement filed by the Company for the offering of its securities to the general public is declared effective;
(c) file with the SEC in a timely manner all reports and other documents required of the Company under the Securities Act and the Exchange Act; and
(d) furnish to any Holder, so long as the Holder owns any Registrable Securities, forthwith upon request (i) a written statement by the Company that it has complied
with the reporting requirements of SEC Rule 144 (at any time after ninety (90) days after the effective date of the first registration statement filed by the Company), the Securities Act and the Exchange Act (at any time after it has become subject to such reporting requirements), or that it qualifies as a registrant whose securities may be resold pursuant to Form S-3 (at any time after it so qualifies), (ii) a copy of the most recent annual or quarterly report of the Company and such other reports and documents so filed by the Company, and (iii) such other information as may be reasonably requested in availing any Holder of any rule or regulation of the SEC which permits the selling of any such securities without registration or pursuant to such form.
securities in any registration filed under Section 1.2 hereof, unless under the terms of such agreement, such holder or prospective holder may include such securities in any such registration only to the extent that the inclusion of his securities will not reduce the amount of the Registrable Securities of the Holders which is included or (b) to make a demand registration which could result in such registration statement being declared effective prior to the earlier of either of the dates set forth in subsection 1.2(a) or within one hundred twenty (120) days of the effective date of any registration effected pursuant to Section 1.2.
(a) such agreement shall only be applicable to the first such registration statement of the Company which covers Common Stock (or other securities) to be sold on its behalf to the public in an underwritten offering; and
(b) all officers and directors of the Company and all five percent security holders enter into similar agreements.
In order to enforce the foregoing covenant, the Company may impose stop-transfer instructions with respect to the Registrable Securities of each Holder (and the shares or securities of every other person subject to the foregoing restriction) until the end of such period, and each Holder agrees that, if so requested, such Holder will execute an agreement in the form provided by the underwriter containing terms which are essentially consistent with the provisions of this Section 1.14.
Notwithstanding the foregoing, the obligations described in this Section 1.14 shall not apply to a registration relating solely to employee benefit plans on Form S-1 or Form S-8 or similar forms which may be promulgated in the future, or a registration relating solely to an SEC Rule 145 transaction on Form S-4 or similar forms which may be promulgated in the future.
(b) as soon as practicable, but in any event within thirty (30) days after the end of each of the first three (3) quarters of each fiscal year of the Company, an unaudited profit or loss statement, a statement of cash flows for such fiscal quarter and an unaudited balance sheet as of the end of such fiscal quarter;
(c) within thirty (30) days of the end of each month, an unaudited income statement and a statement of cash flows and balance sheet for and as of the end of such month, in reasonable detail;
(d) as soon as practicable, but in any event thirty (30) days prior to the end of each fiscal year, a budget and business plan for the next fiscal year, prepared on a monthly basis, and, as soon as prepared, any other budgets or revised budgets prepared by the Company; and
(e) with respect to the financial statements called for in subsections (b) and (c) of this Section 2.1, an instrument executed by the Chief Financial Officer or President of the Company and certifying that such financials were prepared in accordance with GAAP consistently applied with prior practice for earlier periods (with the exception of footnotes that may be required by GAAP) and fairly present the financial condition of the Company and its results of operation for the period specified, subject to year-end audit adjustment, provided that the foregoing shall not restrict the right of the Company to change its accounting principles consistent with GAAP, if the Board of Directors determines that it is in the best interest of the Company to do so.
Stock issued upon conversion thereof), in which case, such right of first offer must be allocated pro rata among such holders on the basis of the Series A-1, Series A-2, Series B or Series C Preferred Stock (or the Common Stock issued upon conversion thereof) held by such holder.
(b) Within 15 calendar days after delivery of the Notice, the Major Investor may elect to purchase or obtain, at the price and on the terms specified in the Notice, up to that portion of such Shares which equals the proportion that the number of shares of Common Stock issued and held, or issuable upon conversion and exercise of all convertible or exercisable securities then held, by such Major Investor bears to the total number of shares of Common Stock then outstanding (assuming full conversion and exercise of all convertible or exercisable securities).
(c) The Company may, during the 45-day period following the expiration of the period provided in subsection 2.2(b) hereof, offer the remaining unsubscribed portion of the Shares to any person or persons at a price not less than, and upon terms no more favorable to the offeree than those specified in the Notice. If the Company does not enter into an agreement for the sale of the Shares within such period, or if such agreement is not consummated within 60 days of the execution thereof, the right provided hereunder shall be deemed to be revived and such Shares shall not be offered unless first reoffered to the Major Investors in accordance herewith.
(d) The right of first offer in this paragraph 2.2 shall not be applicable (i) to the issuance or sale of Common Stock (or options therefor) to employees, consultants and directors, pursuant to plans or agreements approved by the Board of Directors for the primary purpose of soliciting or retaining their services (including options granted prior to the first issuance of Series C Preferred Stock), (ii) to the issuance of securities in a public offering or after consummation of a Qualified IPO, (iii) to the issuance of securities in connection with a bona fide business acquisition of or by the Company, whether by merger, consolidation, sale of assets, sale or exchange of stock or otherwise, (iv) to the issuance of securities to financial institutions or lessors in connection with commercial credit arrangements, equipment financings, or similar transactions, (v) to the issuance or sale of the Series C Preferred Stock as provided in the Purchase Agreement, (vi) to the issuance of securities in connection with partnering transactions approved by the Board of Directors of the Company, (vii) to the issuance of securities pursuant to a stock split, stock dividend or like transaction, (viii) to the issuance of securities pursuant to currently outstanding options, warrants, notes or other rights to acquire securities of the Company or (ix) to the issuance of Common Stock upon conversion of Preferred Stock.
(a) The covenants set forth in Section 2.2 shall terminate as to each Holder and be of no further force or effect (i) immediately prior to the consummation of a Qualified IPO, or (ii) when the Company (or a secured party receiver or other person or entity legally entitled to act on behalf of the Company) shall sell, convey, or otherwise dispose of all or substantially all of its assets or business or if the Company shall merge into or consolidate with any other corporation or effect any other transaction or series of related transactions and the result thereof is that more than fifty percent (50%) of the combined voting power of the Company is held by persons or entities that were not stockholders immediately prior to such merger, consolidation or other transaction.
(b) The covenants set forth in Section 2.1 shall terminate as to each Holder and be of no further force or effect (i) so long as the Company is subject to the periodic reporting requirements of Sections 13 or 15(d) of the Exchange Act or (ii) when the Company (or a secured party receiver or other person or entity legally entitled to act on behalf of the Company) shall sell, convey, or otherwise dispose of all or substantially all of its assets or business or if the Company shall merge into or consolidate with any other corporation or effect any other transaction or series of related transactions and the result thereof is that more than fifty percent (50%) of the combined voting power of the Company is held by persons or entities that were not stockholders immediately prior to such merger, consolidation or other transaction.
paragraph shall be binding upon each holder of any Registrable Securities then outstanding, each future holder of all such Registrable Securities, and the Company.
[Signature Page Follows]
The parties have executed this Second Amended and Restated Investors' Rights Agreement as of the date first above written.
COMPANY:
DURECT CORPORATION
By: /s/ James E. Brown ------------------ James E. Brown, President |
FOUNDERS:
/s/ Thomas A. Schreck --------------------- Thomas A. Schreck /s/ James E. Brown ------------------ James E. Brown /s/ Felix Theeuwes ------------------ Felix Theeuwes |
INVESTORS:
By: /s/ Anders Hove __________________________ Title:_______________________ |
By: /s/ Anders Hove __________________________ Title:_______________________ |
By: /s/ Domenic Ferrante -------------------- Title: Managing Director ----------------- |
By: /s/ Denis Dionne ------------------ Title: President --------- By: /s/ Jean-Christophe Renond --------------------------- Title: Vice President -------------- |
By: /s/ Alejandro Zaffaroni ----------------------- Title: General & Limited Partner ------------------------- |
SIGNATURE PAGE TO AMENDED AND RESTATED INVESTORS' RIGHTS AGREEMENT
By: /s/ Ronald W. Lennox -------------------- Title: Vice President -------------- |
By: Zesiger Capital Group LLC,
As Attorney-in-Fact
By: /s/ Albert L. Zesiger --------------------- Title: Principal --------- |
Alza Corporation
Atwell & Company - Wells Family LLC
Auer & Co.
Batrus & Company - The Jennifer Altman Foundation
Booth & Company - Elizabeth Heller Mandell Trusts
Roy & Katherine Bukstein, Trustees for Roy & Katherine
Bukstein Trust
Mr. Andrew J. Butler
Mr. James R. Butler
City of Milford Pension and Retirement Fund
City of Stamford Firemen's Pension Fund
Mr. Jim Concidine
Cudd & Company - Helen Hunt
Daly & Company - Dean Witter Foundation
Dengel & Company - Trustees of Amherst College
Goldfarb & Simens Profit Sharing Plan FBO David Goldfarb
Mr. David Halpert
Hambrecht & Quist Employee Venture Fund, L.P.
Hambrecht & Quist LLC
Hare & Company - Norwalk Employees Pension Plan
HBL Charitable Unitrust
Houvis & Co. FBO NFIB Employee Pension Trust
Mr. Jonathan W. Kawaja
Mr. William B. Lazar
Mellon Bank NA custodian for PERSI-Zesiger Capital Public
Employee Retirement System of Idaho
Justine Mary Miner
Luke Ian Miner
Mary Miner, TTEE FBO the Survivors TR Est Under the R& M
Nicola Mary Miner
Ms. Jeanne L. Morency
Morgan (Bahamas) Trust Co. of the Bahamas Ltd. As Trustee
Ms. Nicola Z. Mullen
Murray Capital, LLC
Mr. John Osterweis
Premier Medical Partner Fund, L.P.
Promed Partners, L.P.
Psychology Associates
Mr. Dennis Purcell
Mr. John Rumsey
Westcoast & Company - State of Oregon PERS/ZCG
Mr. Kurt Wheeler
Harold & Grace Willens, JTWROS
Winsal & Company - Roanoke College
Wolfson Investment Partners, L.P.
Zaffaroni Revocable Trust UTD 1/24/86
Ms. A. Carey Zesiger
Mr. Albert L. Zesiger
Ms. Alexa L. Zesiger
Ms. Barrie Ramsay Zesiger
Mr. David Zesiger
Ms. Teresa Alessi
Dean Witter Reynolds Inc. C/F Kenneth Barovsky IRA
Standard Dated 3/7/97
Bost & Company - Mellon Securities Trust Co.
Brookside Capital Partners Fund, L.P.
CFS Group, Inc.
Bank One Trust Co. Trustee Ronald L. Chez IRA A/C
2620804400
CHL Medical Partners, L.P.
Michael Cohen
Teresa M. Corbin
Kathleen A. DaSilva
Eagle Lake Ventures, Inc.
Steve Elms
Eugene Farber
Daniel F. Feldman
Gregory Daniel Frank
FWH Associates
Shelly Guyer
Hambrecht & Quist California
Hambrecht & Q(upsilon)ist Employee Venture Fund, L.P. II
Hambrecht & Quist LLC
Jeffrey G. Heuer
Jonathan Heuer
Zach Hulsey
Vivek Jain
Dean Witter Reynolds Inc. C/F Randolph M. Johnson IRA
Rollover dtd. 11/10/98
Carl Kawaja
Kawaja Foods Ltd.
Leonard Kingsley
Steven J. Krausse
Mr. Reggie O. Lapastora
The Magruder Living Trust
First Trust, Trustee for the benefit of Jerry Edwin Marks
Seth Miller
Morgan (Co-Mingled) Guaranty Trust Company
Morgan (Multi-Market) Guaranty Trust Company
Dallas Nelson
Dorothy Nelson
Gregory Nelson
Timothy S. Nelson
PaineWebber Incorporated, not in its individual capacity but
solely as Custodian of the IRA of Timothy S. Nelson
Zaffaroni Revocable Trust UTD 1/24/86
Biotech Growth S.A.
Medgrowht S.A.
Brookside Capital Partners Fund, L.P.
Sofinov
CHL Medical Partners, L.P.
Zaffaroni Family Partnership, L.P.
Domenic J. Mizio
Hare & Co.
Cudd & Co.
Salvador O. Gutierrez
Peter Looram
Mary Anderson
EXHIBIT 5.1
April ___, 2000
DURECT Corporation
10240 Bubb Rd
Cupertino, CA 95014
Ladies and Gentlemen:
It is our opinion that the Shares, when issued and sold in the manner described in the Registration Statement, will be legally and validly issued, fully paid and nonassessable.
We consent to the use of this opinion as an exhibit to the Registration Statement and further consent to the use of our name wherever it appears in the Registration Statement and in any amendment to it.
Sincerely,
VENTURE LAW GROUP
A Professional Corporation
EXHIBIT 10.1
The Company and Indemnitee recognize the increasing difficulty in obtaining liability insurance for directors, officers and key employees, the significant increases in the cost of such insurance and the general reductions in the coverage of such insurance. The Company and Indemnitee further recognize the substantial increase in corporate litigation in general, subjecting directors, officers and key employees to expensive litigation risks at the same time as the availability and coverage of liability insurance has been severely limited. Indemnitee does not regard the current protection available as adequate under the present circumstances, and Indemnitee and agents of the Company may not be willing to continue to serve as agents of the Company without additional protection. The Company desires to attract and retain the services of highly qualified individuals, such as Indemnitee, and to indemnify its directors, officers and key employees so as to provide them with the maximum protection permitted by law.
In consideration of the mutual promises made in this Agreement, and for other good and valuable consideration, receipt of which is hereby acknowledged, the Company and Indemnitee hereby agree as follows:
reasonably believed to be in or not opposed to the best interests of the Company, or, with respect to any criminal action or proceeding, that Indemnitee had reasonable cause to believe that Indemnitee's conduct was unlawful.
writing as soon as practicable of any claim made against Indemnitee for which indemnification will or could be sought under this Agreement. Notice to the Company shall be directed to the Chief Executive Officer of the Company and shall be given in accordance with the provisions of Section 12(d) below. In addition, Indemnitee shall give the Company such information and cooperation as it may reasonably require and as shall be within Indemnitee's power.
fees of counsel subsequently incurred by Indemnitee with respect to the same proceeding, provided that (i) Indemnitee shall have the right to employ counsel in any such proceeding at Indemnitee's expense; and (ii) if (A) the employment of counsel by Indemnitee has been previously authorized by the Company, (B) Indemnitee shall have reasonably concluded that there may be a conflict of interest between the Company and Indemnitee in the conduct of any such defense or (C) the Company shall not, in fact, have employed counsel to assume the defense of such proceeding, then the fees and expenses of Indemnitee's counsel shall be at the expense of the Company.
liabilities arising under certain federal securities laws, and federal legislation prohibits indemnification for certain ERISA violations. Indemnitee understands and acknowledges that the Company has undertaken or may be required in the future to undertake with the SEC to submit the question of indemnification to a court in certain circumstances for a determination of the Company's right under public policy to indemnify Indemnitee.
name of the Company under this Agreement or to enforce or interpret any of the terms of this Agreement, Indemnitee shall be entitled to be paid all court costs and expenses, including attorneys' fees, incurred by Indemnitee in defense of such action (including with respect to Indemnitee's counterclaims and cross- claims made in such action), unless as a part of such action the court determines that each of Indemnitee's material defenses to such action were made in bad faith or were frivolous.
[Signature Page Follows]
The parties hereto have executed this Agreement as of the day and year set forth on the first page of this Agreement.
DURECT CORPORATION
Address: 10240 Bubb Road Cupertino, CA 95104
AGREED TO AND ACCEPTED:
EXHIBIT 10.2
DURECT CORPORATION
1998 STOCK OPTION PLAN
(as amended on June 10, 1999)
(as further amended on January 31, 2000)
(ii) If the Common Stock is quoted on the Nasdaq System (but not on the National Market thereof) or regularly quoted by a recognized securities dealer but selling prices are not reported, its Fair Market Value shall be the mean between the high bid and low asked prices for the Common Stock for the last market trading day prior to the time of determination, as reported in The Wall Street Journal or such other source as the Administrator deems reliable; or
(iii) In the absence of an established market for the Common Stock, the Fair Market Value thereof shall be determined in good faith by the Administrator.
(i) to determine the Fair Market Value of the Common Stock, in accordance with Section 2(k) of the Plan;
(ii) to select the Consultants and Employees to whom Options and Stock Purchase Rights or any combination thereof may from time to time be granted hereunder;
(iii) to determine whether and to what extent Options and Stock Purchase Rights or any combination thereof are granted hereunder;
(iv) to determine the number of shares of Common Stock to be covered by each such award granted hereunder;
(v) to approve forms of agreement for use under the Plan;
(vi) to determine the terms and conditions, not inconsistent with the terms of the Plan, of any award granted hereunder;
(vii) to determine whether and under what circumstances an Option may be settled in cash under Section 9(f) instead of Common Stock;
(viii) to reduce the exercise price of any Option to the then current Fair Market Value if the Fair Market Value of the Common Stock covered by such Option shall have declined since the date the Option was granted;
(ix) to determine the terms and restrictions applicable to Stock Purchase Rights and the Restricted Stock purchased by exercising such Stock Purchase Rights; and
(x) to construe and interpret the terms of the Plan and awards granted pursuant to the Plan; and
(xi) in order to fulfill the purposes of the Plan and without amending the Plan, to modify grants of Options or Stock Purchase Rights to participants who are foreign nationals or employed outside of the United States in order to recognize differences in local law, tax policies or customs.
notwithstanding such designations, to the extent that the aggregate Fair Market Value of Shares with respect to which Options designated as Incentive Stock Options are exercisable for the first time by any Optionee during any calendar year (under all plans of the Company or any Parent or Subsidiary) exceeds $100,000, such excess Options shall be treated as Nonstatutory Stock Options. For purposes of this Section 5(b), Incentive Stock Options shall be taken into account in the order in which they were granted, and the Fair Market Value of the Shares subject to an Incentive Stock Option shall be determined as of the date of the grant of such Option.
(c) The Plan shall not confer upon the holder of any Option or Stock Purchase Right any right with respect to continuation of employment or consulting relationship with the Company, nor shall it interfere in any way with such holder's right or the Company's right to terminate his or her employment or consulting relationship at any time, with or without cause.
(a) The per share exercise price for the Shares to be issued pursuant to exercise of an Option shall be such price as is determined by the Board and set forth in the applicable agreement, but shall be subject to the following:
(i) In the case of an Incentive Stock Option that is:
(A) granted to an Employee who, at the time of the grant of such Incentive Stock Option, owns stock representing more than 10% of the total combined voting power of all classes of stock of the Company or any Parent or Subsidiary, the per Share exercise price shall be no less than 110% of the Fair Market Value per Share on the date of grant.
(B) granted to any other Employee, the per Share exercise price shall be no less than 100% of the Fair Market Value per Share on the date of grant.
(ii) In the case of a Nonstatutory Stock Option that is:
(A) granted to a person who, at the time of the grant of such Option, owns stock representing more than 10% of the total combined voting power of all classes of stock of the Company or any Parent or Subsidiary, the per Share exercise price shall be no less than 110% of the Fair Market Value per Share on the date of the grant.
(B) granted to any person, the per Share exercise price shall be no less than 85% of the Fair Market Value per Share on the date of grant.
(b) The consideration to be paid for the Shares to be issued upon exercise of an Option, including the method of payment, shall be determined by the Administrator (and, in the case of an Incentive Stock Option, shall be determined at the time of grant) and may consist entirely of (1) cash, (2) check, (3) promissory note (subject to the provisions of Section 153 of the Delaware General Corporation Law), (4) other Shares that (x) in the case of Shares acquired upon exercise of an Option, have been owned by the Optionee for more than six months on the date of surrender or such other period as may be required to avoid a charge to the Company's earnings, and (y) have a Fair Market Value on the date of surrender equal to the aggregate exercise price of the Shares as to which such Option shall be exercised, (5) authorization for the Company to retain from the total number of Shares as to which the Option is exercised that number of Shares having a Fair Market Value on the date of exercise equal to the exercise price for the total number of Shares as to which the Option is exercised, (6) delivery of a properly executed exercise notice together with such other documentation as the Administrator and the broker, if applicable, shall require to effect an exercise of the Option and delivery to the Company of the sale or loan proceeds required to pay the exercise price and any applicable income or employment taxes, (7) delivery of an irrevocable subscription agreement for the Shares that irrevocably obligates the option holder to take and pay for the Shares not more than twelve months after the date of delivery of the subscription agreement, (8) any combination of the foregoing methods of payment, or (9) such other consideration and method of payment for the issuance of Shares to the extent permitted under the Applicable Laws. In making its determination as to the type of consideration to accept, the Administrator shall consider if acceptance of such consideration may be reasonably expected to benefit the Company.
An Option may not be exercised for a fraction of a Share.
An Option shall be deemed to be exercised when written notice of such
exercise has been given to the Company in accordance with the terms of the
Option by the person entitled to exercise the Option and the Company has
received full payment for the Shares with respect to which the Option is
exercised. Full payment may, as authorized by the Board, consist of any
consideration and method of payment allowable under Section 8(b) of the Plan.
Until the issuance (as evidenced by the appropriate entry on the books of the
Company or of a duly authorized transfer agent of the Company) of the stock
certificate evidencing such Shares, no right to vote or receive dividends or any
other rights as a stockholder shall exist with respect to the Optioned Stock,
not withstanding the exercise of the Option. The Company shall issue (or cause
to be issued) such stock certificate promptly upon exercise of the Option. No
adjustment will be made for a dividend or other right for which the record date
is prior to the date the stock certificate is issued, except as provided in
Section 12 of the Plan.
Exercise of an Option in any manner shall result in a decrease in the number of Shares that thereafter may be available, both for purposes of the Plan and for sale under the Option, by the number of Shares as to which the Option is exercised.
(i) Notwithstanding Section 9(b) above, in the event of
termination of an Optionee's Continuous Status as an Employee or Consultant as a
result of his or her total and permanent disability (within the meaning of
Section 22(e)(3) of the Code), such Optionee may, but only within twelve months
from the date of such termination (but in no event later than the expiration
date of the term of such Option as set forth in the Option Agreement), exercise
the Option to the extent otherwise entitled to exercise it at the date of such
termination. To the extent that the Optionee was not entitled to exercise the
Option at the date of termination, or if the Optionee does not exercise such
Option to the extent so entitled within the time specified herein, the Option
shall terminate.
Any surrender by a Reporting Person of previously owned Shares to satisfy tax withholding obligations arising upon exercise of this Option must comply with the applicable provisions of Rule 16b-3.
All elections by an Optionee to have Shares withheld to satisfy tax withholding obligations shall be made in writing in a form acceptable to the Administrator and shall be subject to the following restrictions:
(a) the election must be made on or prior to the applicable Tax Date;
(b) once made, the election shall be irrevocable as to the particular Shares of the Option or Stock Purchase Right as to which the election is made; and
(c) all elections shall be subject to the consent or disapproval of the Administrator.
In the event the election to have Shares withheld is made by an Optionee and the Tax Date is deferred under Section 83 of the Code because no election is filed under Section 83(b) of the Code, the Optionee shall receive the full number of Shares with respect to which the Option or Stock Purchase Right is exercised but such Optionee shall be unconditionally obligated to tender back to the Company the proper number of Shares on the Tax Date.
discontinuation shall be made that would impair the rights of any Optionee under any grant theretofore made, without his or her consent. In addition, to the extent necessary and desirable to comply with Rule 16b-3 or with Section 422 of the Code (or any other applicable law or regulation, including the requirements of any Stock Exchange), the Company shall obtain stockholder approval of any Plan amendment in such a manner and to such a degree as required.
As a condition to the exercise of an Option, the Company may require the person exercising such Option to represent and warrant at the time of any such exercise that the Shares are being purchased only for investment and without any present intention to sell or distribute such Shares if, in the opinion of counsel for the Company, such a representation is required by law.
more Options or Stock Purchase Rights outstanding, and in the case of an individual who acquired Shares pursuant to the Plan, during the period such individual owns such Shares. The Company shall not be required to provide such information if the issuance of Options or Stock Purchase Rights under the Plan is limited to key employees whose duties in connection with the Company assure their access to equivalent information. In addition, at the time of issuance of any securities under the Plan, the Company shall provide to the Optionee or the Purchaser a copy of the Plan and any agreement(s) pursuant to which securities granted under the Plan are issued.
EXHIBIT 10.3
DURECT CORPORATION
2000 STOCK PLAN
(as amended, April 2000)
such leave is for a period of not more than 90 days, unless reemployment upon the expiration of such leave is guaranteed by contract or statute, or unless provided otherwise pursuant to Company policy adopted from time to time; or (iv) in the case of transfers between locations of the Company or between the Company, its Subsidiaries or their respective successors. For purposes of this Plan, a change in status from an Employee to a Consultant or from a Consultant to an Employee will not constitute an interruption of Continuous Status as an Employee or Consultant.
(ii) If the Common Stock is quoted on the Nasdaq System (but not on the National Market thereof) or regularly quoted by a recognized securities dealer but selling prices are not reported, its Fair Market Value shall be the mean between the high bid and low asked prices for the Common Stock for the last market trading day prior to the time of determination, as reported in The Wall Street Journal or such other source as the Administrator deems reliable; or
(iii) In the absence of an established market for the Common Stock, the Fair Market Value thereof shall be determined in good faith by the Administrator.
as a national market system security on an interdealer quotation system by the National Association of Securities Dealers, Inc.
If an Option should expire or become unexercisable for any reason without having been exercised in full, the unpurchased Shares that were subject thereto shall, unless the Plan shall have been terminated, become available for future grant under the Plan. In addition, any Shares of Common Stock which are retained by the Company upon exercise of an Option or Stock Purchase Right in order to satisfy the exercise or purchase price for such Option or Stock Purchase Right or any withholding taxes due with respect to such exercise shall be treated as not issued and shall continue to be available under the Plan. Shares repurchased by the Company pursuant to any repurchase right which the Company may have shall not be available for future grant under the Plan.
to qualify for the exemption set forth in Rule 16b-3 and to qualify as performance-based compensation under Section 162(m) of the Code.
(i) to determine the Fair Market Value of the Common Stock, in accordance with Section 2(m) of the Plan;
(ii) to select the Consultants and Employees to whom Options and Stock Purchase Rights or any combination thereof may from time to time be granted hereunder;
(iii) to determine whether and to what extent Options and Stock Purchase Rights or any combination thereof are granted hereunder;
(iv) to determine the number of shares of Common Stock to be covered by each such award granted hereunder;
(v) to approve forms of agreement for use under the Plan;
(vi) to determine the terms and conditions, not inconsistent with the terms of the Plan, of any award granted hereunder;
(vii) to reduce the exercise price of any Option to the then current Fair Market Value if the Fair Market Value of the Common Stock covered by such Option shall have declined since the date the Option was granted;
(viii) to determine the terms and restrictions applicable to Stock Purchase Rights and the Restricted Stock purchased by exercising such Stock Purchase Rights; and
(ix) to construe and interpret the terms of the Plan and awards granted pursuant to the Plan; and
(x) in order to fulfill the purposes of the Plan and without amending the Plan, to modify grants of Options or Stock Purchase Rights to participants who are foreign
nationals or employed outside of the United States in order to recognize differences in local law, tax policies or customs.
(a) The per share exercise price for the Shares to be issued pursuant to exercise of an Option shall be such price as is determined by the Board and set forth in the applicable agreement, but shall be subject to the following:
(i) In the case of an Incentive Stock Option that is:
(A) granted to an Employee who, at the time of the grant of such Incentive Stock Option, is a Ten Percent Holder, the per Share exercise price shall be no less than 110% of the Fair Market Value per Share on the date of grant.
(B) granted to any other Employee, the per Share exercise price shall be no less than 100% of the Fair Market Value per Share on the date of grant.
(ii) In the case of a Nonstatutory Stock Option that is:
(A) granted prior to the date, if any, on which the Common Stock becomes a Listed Security, to a person who, at the time of the grant of such Option, is a Ten Percent Holder, the per Share exercise price shall be no less than 110% of the Fair Market Value per Share on the date of the grant.
(B) granted, prior to the date, if any on which the Common Stock becomes a Listed Security, to any other person, the per share Exercise Price shall be no less than 85% of the Fair Market Value on the date of grant, if required by the Applicable Laws and, if not so required, shall be such price as it determined by the Administrator; or
(C) granted on or after the date, if any, on which the Common Stock becomes a Listed Security to any person, the per Share exercise price shall be such price as determined by the Administrator; provided, however, that if the person is, at the time of grant of such option, a Named Executive of the Company, the per share exercise price shall be no less than 100% of the Fair Market Value per Share on the date of grant if such Option is intended to qualify as performance-based compensation under Section 162(m) of the Code; or
(iii) Notwithstanding the foregoing, Options may be granted with a per Share exercise price other than as required above pursuant to a merger or other corporate transaction.
(b) The consideration to be paid for the Shares to be issued upon exercise of an Option, including the method of payment, shall be determined by the Administrator (and, in the case of an Incentive Stock Option, shall be determined at the time of grant) and may consist entirely of (1) cash, (2) check, (3) promissory note (subject to the provisions of Section 153 of the Delaware General Corporation Law), (4) other Shares that (x) in the case of Shares acquired
upon exercise of an Option, have been owned by the Optionee for more than six months on the date of surrender or such other period as may be required to avoid a charge to the Company's earnings, and (y) have a Fair Market Value on the date of surrender equal to the aggregate exercise price of the Shares as to which such Option shall be exercised, (5) authorization for the Company to retain from the total number of Shares as to which the Option is exercised that number of Shares having a Fair Market Value on the date of exercise equal to the exercise price for the total number of Shares as to which the Option is exercised, (6) delivery of a properly executed exercise notice together with such other documentation as the Administrator and the broker, if applicable, shall require to effect an exercise of the Option and delivery to the Company of the sale or loan proceeds required to pay the exercise price and any applicable income or employment taxes, (7) delivery of an irrevocable subscription agreement for the Shares that irrevocably obligates the option holder to take and pay for the Shares not more than twelve months after the date of delivery of the subscription agreement, (8) any combination of the foregoing methods of payment, or (9) such other consideration and method of payment for the issuance of Shares to the extent permitted under the Applicable Laws. In making its determination as to the type of consideration to accept, the Administrator shall consider if acceptance of such consideration may be reasonably expected to benefit the Company.
An Option may not be exercised for a fraction of a Share.
An Option shall be deemed to be exercised when written notice of such exercise has been given to the Company in accordance with the terms of the Option by the person entitled to exercise the Option and the Company has received full payment for the Shares with respect to which the Option is exercised. Full payment may, as authorized by the Board, consist of any consideration and method of payment allowable under Section 9(b) of the Plan. Until the issuance (as evidenced by the appropriate entry on the books of the Company or of a duly authorized transfer agent of the Company) of the stock certificate evidencing such Shares, no right to vote or receive dividends or any other rights as a stockholder shall exist with respect to
the Optioned Stock, not withstanding the exercise of the Option. The Company shall issue (or cause to be issued) such stock certificate promptly upon exercise of the Option. No adjustment will be made for a dividend or other right for which the record date is prior to the date the stock certificate is issued, except as provided in Section 13 of the Plan.
Exercise of an Option in any manner shall result in a decrease in the number of Shares that thereafter may be available, both for purposes of the Plan and for sale under the Option, by the number of Shares as to which the Option is exercised.
(i) Notwithstanding Section 10(b) above, in the event of termination of an Optionee's Continuous Status as an Employee or Consultant as a result of his or her total and permanent disability (within the meaning of Section 22(e)(3) of the Code), such Optionee may, but only within twelve months from the date of such termination (but in no event later than the expiration date of the term of such Option as set forth in the Option Agreement), exercise the Option to the extent otherwise entitled to exercise it at the date of such termination. To the extent that the Optionee was not entitled to exercise the Option at the date of termination, or if the Optionee does not exercise such Option to the extent so entitled within the time specified herein, the Option shall terminate.
does not exercise such Option to the extent so entitled within six months from the date of termination, the Option shall terminate.
(a) As a condition of the exercise of an Option granted under the Plan, the Participant (or in the case of the Participant's death, the person exercising the Option) shall make such arrangements as the Administrator may require for the satisfaction of any applicable federal, state, local or foreign withholding tax obligations that may arise in connection with the exercise of Option and the issuance of Shares. The Company shall not be required to issue any Shares under the Plan until such obligations are satisfied.
(b) In the case of an Employee and in the absence of any other arrangement, the Employee shall be deemed to have directed the Company to withhold or collect from his or her compensation an amount sufficient to satisfy such tax obligations from the next payroll payment otherwise payable after the date of an exercise of the Option.
(c) This Section 12(c) shall apply only after the date, if any, upon which the Common Stock becomes a Listed Security. In the case of Participant other than an Employee (or in the case of an Employee where the next payroll payment is not sufficient to satisfy such tax obligations, with respect to any remaining tax obligations), in the absence of any other arrangement and to the extent permitted under the Applicable Laws, the Participant shall be deemed to have elected to have the Company withhold from the Shares to be issued upon exercise of the Option that number of Shares having a Fair Market Value determined as of the applicable Tax Date (as defined below) equal to the minimum statutory amounts required to be withheld. For purposes of this Section 12, the Fair Market Value of the Shares to be withheld
(d) If permitted by the Administrator, in its discretion, a Participant may satisfy his or her tax withholding obligations upon exercise of an Option or Stock Purchase Right by surrendering to the Company Shares that (i) in the case of Shares previously acquired from the Company, have been owned by the Participant for more than six (6) months on the date of surrender, and (ii) have a Fair Market Value determined as of the applicable Tax Date equal to the minimum statutory amounts required to be withheld.
(e) Any election or deemed election by a Participant to have Shares withheld to satisfy tax withholding obligations under Section 12(c) or (d) above shall be irrevocable as to the particular Shares as to which the election is made and shall be subject to the consent or disapproval of the Administrator. Any election by a Participant under Section 12(d) above must be made on or prior to the applicable Tax Date.
(f) In the event an election to have Shares withheld is made by a Participant and the Tax Date is deferred under Section 83 of the Code because no election is filed under Section 83(b) of the Code, the Participant shall receive the full number of Shares with respect to which the Option is exercised but such Participant shall be unconditionally obligated to tender back to the Company the proper number of Shares on the applicable Tax Date.
granting such Incentive Stock Option or the date of commencement of the Optionee's employment relationship with the Company. Notice of the determination shall be given to each Employee or Consultant to whom an Option or Stock Purchase Right is so granted within a reasonable time after the date of such grant.
As a condition to the exercise of an Option, the Company may require the person exercising such Option to represent and warrant at the time of any such exercise that the Shares are being purchased only for investment and without any present intention to sell or distribute such Shares if, in the opinion of counsel for the Company, such a representation is required by law.
adopted. Such stockholder approval shall be obtained in the degree and manner required under the Applicable Laws. All Options and Stock Purchase Rights issued under the Plan shall become void in the event such approval is not obtained.
EXHIBIT 10.4
DURECT CORPORATION
The following constitute the provisions of the 2000 Employee Stock Purchase Plan of Durect Corporation.
the issuance of options to such Subsidiary's Employees pursuant to the Plan would not cause the Company to incur adverse accounting charges.
(a) Any person who is an Employee as of the Offering Date of a given Offering Period shall be eligible to participate in such Offering Period under the Plan, subject to the requirements of Section 5(a) and the limitations imposed by Section 423(b) of the Code.
(b) Any provisions of the Plan to the contrary notwithstanding, no Employee shall be granted an option under the Plan (i) if, immediately after the grant, such Employee (or any other person whose stock would be attributed to such Employee pursuant to Section 424(d) of the Code) would own capital stock of the Company and/or hold outstanding options to purchase stock possessing five percent (5%) or more of the total combined voting power or value of all classes of stock of the Company or of any subsidiary of the Company, or (ii) if such option would permit his or her rights to purchase stock under all employee stock purchase plans (described in Section 423 of the Code) of the Company and its Subsidiaries to accrue at a rate which exceeds Twenty-Five Thousand Dollars ($25,000) of the Fair Market Value (as defined in Section 7(b) below) of such stock (determined at the time such option is granted) for each calendar year in which such option is outstanding at any time.
(a) An eligible Employee may become a participant in the Plan by completing an enrollment agreement on the form provided by the Company and it to the Company prior to
the applicable Offering Date. The enrollment agreement shall set forth the percentage of the participant's Compensation (subject to Section 6(a) below) to be paid as Contributions pursuant to the Plan.
(b) Payroll deductions shall commence on the first full payroll paid following the Offering Date and shall end on the last payroll paid on or prior to the last Purchase Period of the Offering Period to which the enrollment agreement is applicable, unless sooner terminated by the participant as provided in Section 10.
(a) A participant shall elect to have payroll deductions made on each payday during the Offering Period in an amount not less that one percent (1%) and not more than 20 (or such greater percentage as the Board may establish from time to time before an Offering Date) of such participant's Compensation on each payday during an Offering Period; provided that to the extent a participant is participating in more than one Offering Period, the maximum percentage of Compensation that may be contributed under the Plan shall be twenty percent (20%). All payroll deductions made by a participant shall be credited to his or her account under the Plan. A participant may not make any additional payments into such account.
(b) A participant may discontinue his or her participation in the Plan as provided in Section 10, or, on one occasion only during a Purchase Period may increase and on one occasion only during a Purchase Period may decrease the rate of his or her Contributions with respect to the Offering Period, by completing and filing with the Company a new enrollment agreement authorizing a change in the payroll deduction rate. Any change in rate of Contributions pursuant to the preceding sentence shall be effective as of the beginning of the next calendar month following the date of filing of the new enrollment agreement, provided the agreement indicating such change is filed at least ten (10) business days prior to such date and, if not, then as of the beginning of the next succeeding calendar month.
(c) Notwithstanding the foregoing, to the extent necessary to comply with Section 423(b)(8) of the Code and Section 3(b), a participant's payroll deductions may be decreased by the Company to 0% at any time during a Purchase Period. Payroll deductions shall re-commence at the rate provided in such participant's enrollment agreement at the beginning of the first Purchase Period which is scheduled to end in the following calendar year, unless terminated by the participant as provided in Section 10. In addition, a participant's payroll deductions may be decreased by the Company to 0% at any time during a Purchase Period in order to avoid unnecessary payroll contributions as a result of application of the maximum share limit set forth in Section 7(a), in which case payroll deductions shall re-commence at the rate provided in such participant's enrollment agreement at the beginning of the next Purchase Period, unless terminated by the participant as provided in Section 10.
(a) On the Offering Date of each Offering Period, each eligible Employee participating in such Offering Period shall be granted an option to purchase on each Purchase
Date a number of Shares of the Company's Common Stock determined by dividing such Employee's Contributions accumulated prior to such Purchase Date and retained in the participant's account as of the Purchase Date by the applicable Purchase Price; provided however that the maximum number of Shares an Employee may purchase during each Purchase Period shall be 2,000 Shares (subject to any adjustment pursuant to Section 19 below), and provided further that such purchase shall be subject to the limitations set forth in Sections 3(b) and 13.
(a) A participant may withdraw all but not less than all the Contributions credited to his or her account under the Plan at any time prior to each Purchase Date by giving written notice to the Company. All of the participant's Contributions credited to his or her account will be paid to him or her promptly after receipt of his or her notice of withdrawal and
his or her option for the current period will be automatically terminated, and no further Contributions for the purchase of Shares will be made during the Offering Period.
(b) Upon termination of the participant's Continuous Status as an Employee prior to the Purchase Date of an Offering Period for any reason, including retirement or death, the Contributions credited to his or her account will be returned to him or her or, in the case of his or her death, to the person or persons entitled thereto under Section 14, and his or her option will be automatically terminated.
(c) In the event an Employee fails to remain in Continuous Status as an Employee of the Company for at least twenty (20) hours per week during the Offering Period in which the employee is a participant, he or she will be deemed to have elected to withdraw from the Plan and the Contributions credited to his or her account will be returned to him or her and his or her option terminated.
(d) A participant's withdrawal from an offering will not have any effect upon his or her eligibility to participate in a succeeding offering or in any similar plan which may hereafter be adopted by the Company.
(a) Subject to adjustment as provided in Section 19, the maximum number of Shares which shall be made available for sale under the Plan shall be 150,000 Shares, plus an annual increase on the first day of each of the Company's fiscal years beginning in 2001 through 2010 equal to the lesser of (i) 225,000 Shares (before giving effect to a stock split effected in connection with the Company's initial public offering), (ii) one-half of one percent (0.5%) of the Shares outstanding on the last day of the immediately preceding fiscal year, or (iii) such lesser
number of Shares as is determined by the Board. If the Board determines that, on a given Purchase Date, the number of shares with respect to which options are to be exercised may exceed (i) the number of shares of Common Stock that were available for sale under the Plan on the Offering Date of the applicable Offering Period, or (ii) the number of shares available for sale under the Plan on such Purchase Date, the Board may in its sole discretion provide (x) that the Company shall make a pro rata allocation of the Shares of Common Stock available for purchase on such Offering Date or Purchase Date, as applicable, in as uniform a manner as shall be practicable and as it shall determine in its sole discretion to be equitable among all participants exercising options to purchase Common Stock on such Purchase Date, and continue all Offering Periods then in effect, or (y) that the Company shall make a pro rata allocation of the shares available for purchase on such Offering Date or Purchase Date, as applicable, in as uniform a manner as shall be practicable and as it shall determine in its sole discretion to be equitable among all participants exercising options to purchase Common Stock on such Purchase Date, and terminate any or all Offering Periods then in effect pursuant to Section 20 below. The Company may make pro rata allocation of the Shares available on the Offering Date of any applicable Offering Period pursuant to the preceding sentence, notwithstanding any authorization of additional Shares for issuance under the Plan by the Company's stockholders subsequent to such Offering Date.
(b) The participant shall have no interest or voting right in Shares covered by his or her option until such option has been exercised.
(c) Shares to be delivered to a participant under the Plan will be registered in the name of the participant or in the name of the participant and his or her spouse.
(a) A participant may file a written designation of a beneficiary who is to receive any Shares and cash, if any, from the participant's account under the Plan in the event of such participant's death subsequent to the end of a Purchase Period but prior to delivery to him or her of such Shares and cash. In addition, a participant may file a written designation of a beneficiary who is to receive any cash from the participant's account under the Plan in the event of such participant's death prior to the Purchase Date of an Offering Period. If a participant is married and the designated beneficiary is not the spouse, spousal consent shall be required for such designation to be effective.
(b) Such designation of beneficiary may be changed by the participant (and his or her spouse, if any) at any time by written notice. In the event of the death of a participant and in the absence of a beneficiary validly designated under the Plan who is living at the time of such participant's death, the Company shall deliver such Shares and/or cash to the executor or
administrator of the estate of the participant, or if no such executor or administrator has been appointed (to the knowledge of the Company), the Company, in its discretion, may deliver such Shares and/or cash to the spouse or to any one or more dependents or relatives of the participant, or if no spouse, dependent or relative is known to the Company, then to such other person as the Company may designate.
The Board may, if it so determines in the exercise of its sole discretion, also make provision for adjusting the Reserves, as well as the price per Share of Common Stock covered by each outstanding option, in the event that the Company effects one or more reorganizations, recapitalizations, rights offerings or other increases or reductions of Shares of its outstanding Common Stock, and in the event of the Company's being consolidated with or merged into any other corporation.
(a) The Board may at any time and for any reason terminate or amend the Plan. Except as provided in Section 19, no such termination of the Plan may affect options previously granted, provided that the Plan or an Offering Period may be terminated by the Board on a Purchase Date or by the Board's setting a new Purchase Date with respect to an Offering Period and Purchase Period then in progress if the Board determines that termination of the Plan and/or the Offering Period is in the best interests of the Company and the stockholders or if continuation of the Plan and/or the Offering Period would cause the Company to incur adverse accounting charges as a result of a change after the effective date of the Plan in the generally accepted accounting rules applicable to the Plan. Except as provided in Section 19 and in this Section 20, no amendment to the Plan shall make any change in any option previously granted which adversely affects the rights of any participant. In addition, to the extent necessary to
comply with Rule 16b-3 under the Exchange Act, or under Section 423 of the Code (or any successor rule or provision or any applicable law or regulation), the Company shall obtain stockholder approval in such a manner and to such a degree as so required.
(b) Without stockholder consent and without regard to whether any participant rights may be considered to have been adversely affected, the Board (or its committee) shall be entitled to change the Offering Periods and Purchase Periods, limit the frequency and/or number of changes in the amount withheld during an Offering Period, establish the exchange ratio applicable to amounts withheld in a currency other than U.S. dollars, permit payroll withholding in excess of the amount designated by a participant in order to adjust for delays or mistakes in the Company's processing of properly completed withholding elections, establish reasonable waiting and adjustment periods and/or accounting and crediting procedures to ensure that amounts applied toward the purchase of Common Stock for each participant properly correspond with amounts withheld from the participant's Compensation, and establish such other limitations or procedures as the Board (or its committee) determines in its sole discretion advisable which are consistent with the Plan.
As a condition to the exercise of an option, the Company may require the person exercising such option to represent and warrant at the time of any such exercise that the Shares are being purchased only for investment and without any present intention to sell or distribute such Shares if, in the opinion of counsel for the Company, such a representation is required by any of the aforementioned applicable provisions of law.
DURECT CORPORATION
New Election ______ Change of Election ______
2. I elect to have Contributions in the amount of ____% of my Compensation, as those terms are defined in the Plan, applied to this purchase. I understand that this amount must not be less than 1% and not more than 20% of my Compensation during the Offering Period. (Please note that no fractional percentages are permitted).
3. I hereby authorize payroll deductions from each paycheck during the Offering Period at the rate stated in Item 2 of this Enrollment Agreement. I understand that all payroll deductions made by me shall be credited to my account under the Plan and that I may not make any additional payments into such account. I understand that all payments made by me shall be accumulated for the purchase of shares of Common Stock at the applicable purchase price determined in accordance with the Plan. I further understand that, except as otherwise set forth in the Plan, shares will be purchased for me automatically on the Purchase Date of each Offering Period unless I otherwise withdraw from the Plan by giving written notice to the Company for such purpose.
4. I understand that I may discontinue at any time prior to the Purchase Date my participation in the Plan as provided in Section 10 of the Plan. I also understand that I can increase or decrease the rate of my Contributions during an Offering Period by completing and filing with the Company a new Enrollment Agreement with such increase or decrease taking effect as of the beginning of the next following calendar month, if filed at least ten (10) business days prior to the beginning of such month. Further, I may change the rate of deductions for future Offering Periods by filing a new Enrollment Agreement, and any such change will be effective as of the beginning of the next Offering Period. In addition, I acknowledge that, unless I discontinue my participation in the Plan as provided in Section 10 of the Plan, my election will continue to be effective for each successive Offering Period.
5. I have received a copy of the Company's most recent description of the Plan and a copy of the complete "Durect Corporation 2000 Employee Stock Purchase Plan." I understand that my participation in the Plan is in all respects subject to the terms of the Plan.
6. Shares purchased for me under the Plan should be issued in the name(s) of (name of employee or employee and spouse only):
7. In the event of my death, I hereby designate the following as my beneficiary(ies) to receive all payments and shares due to me under the Plan:
NAME: (Please print) _____________________________________ (First) (Middle) (Last) __________________________ _____________________________________ (Relationship) (Address) Social Security #:________ _____________________________________ |
8. I understand that if I dispose of any shares received by me pursuant to the Plan within 2 years after the Offering Date (the first day of the Offering Period during which I purchased such shares) or within 1 year after the Purchase Date, I will be treated for federal income tax purposes as having received ordinary compensation income at the time of such disposition in an amount equal to the excess of the fair market value of the shares on the Purchase Date over the price which I paid for the shares, regardless of whether I disposed of the shares at a price less than their fair market value at the Purchase Date. The remainder of the gain or loss, if any, recognized on such disposition will be treated as capital gain or loss.
9. If I dispose of such shares at any time after expiration of the 2-year and 1-year holding periods, I understand that I will be treated for federal income tax purposes as having received compensation income only to the extent of an amount equal to the lesser of (1) the excess of the fair market value of the shares at the time of such disposition over the purchase price which I paid for the shares under the option, or (2) 15% of the fair market value of the shares on the Offering Date. The remainder of the gain or loss, if any, recognized on such disposition will be treated as capital gain or loss.
10. In connection with the initial public offering of the Company's securities and upon request of the Company or the underwriters managing any underwritten offering of the Company's securities, I agree not to sell, make any short sale of, loan, grant any option for the purchase of, or otherwise dispose of any securities of the Company, however or whenever I acquired them, without the prior written consent of the Company or such underwriters, as the case may be, for such period of time (not to exceed 180 days) from the effective date of such registration as may be requested by the Company or such managing underwriters and to execute an agreement reflecting the foregoing as may be requested by the underwriters at the time of the public offering.
11. I hereby agree to be bound by the terms of the Plan. The effectiveness of this Enrollment Agreement is dependent upon my eligibility to participate in the Plan.
NAME (print):____________________________
SIGNATURE:_______________________________
SOCIAL SECURITY #:_______________________
DATE:____________________________________
SPOUSE'S SIGNATURE (necessary
if beneficiary is not spouse):
DURECT CORPORATION
2000 EMPLOYEE STOCK PURCHASE PLAN
I understand that all Contributions credited to my account will be paid to me within ten (10) business days of receipt by the Company of this Notice of Withdrawal and that my option for the current period will automatically terminate, and that no further Contributions for the purchase of shares can be made by me during the Offering Period.
The undersigned further understands and agrees that he or she shall be eligible to participate in succeeding offering periods only by delivering to the Company a new Enrollment Agreement.
Dated:___________________ ____________________________________ Signature of Employee ____________________________________ Social Security Number |
EXHIBIT 10.5
DURECT CORPORATION, INC.
All options granted hereunder shall be nonstatutory stock options.
If an Option should expire or become unexercisable for any reason without having been exercised in full, the unpurchased Shares which were subject thereto shall, unless the Plan has been terminated, become available for future grant under the Plan. In addition, any Shares of Common Stock that are retained by the Company upon exercise of an Option in order to satisfy the exercise price for such Option, or any withholding taxes due with respect to such exercise, shall be treated as not issued and shall continue to be available under the Plan. If Shares that were acquired upon exercise of an Option are subsequently repurchased by the Company, such Shares shall not in any event be returned to the Plan and shall not become available for future grant under the Plan.
(i) No person shall have any discretion to select which Outside Directors shall be granted Options or to determine the number of Shares to be covered by Options granted to Outside Directors.
(ii) Each Outside Director shall be automatically granted an Option to purchase 20,000 Shares, (the "Initial Option") on the date on which such person first becomes an Outside Director after the effective date of this Plan, whether through election by the shareholders of the Company or appointment by the Board of Directors to fill a vacancy.
(iii) Each Outside Director, including an Outside Director who did not receive an Initial Option grant, shall be automatically granted an Option to purchase 5,000 Shares (the "Annual Option") on the date of each Annual Meeting of the Company's shareholders immediately following which such Outside Director is serving on the Board, provided that, on such date, he or she shall have served on the Board for at least six (6) months prior to the date of such Annual Meeting.
(iv) Notwithstanding the provisions of subsections (ii) and (iii) hereof, in the event that a grant would cause the number of Shares subject to outstanding Options plus the number of Shares previously purchased upon exercise of Options to exceed the Pool, then each such automatic grant shall be for that number of Shares determined by dividing the total number of Shares remaining available for grant by the number of Outside Directors receiving an Option on the automatic grant date. Any further grants shall then be deferred until such time, if any, as additional Shares become available for grant under the Plan through action of the stockholders to increase the number of Shares which may be issued under the Plan or through cancellation or expiration of Options previously granted hereunder.
(v) Notwithstanding the provisions of subsections (ii) and (iii) hereof, any grant of an Option made before the Company has obtained stockholder approval of the Plan in accordance with Section 17 hereof shall be conditioned upon obtaining such stockholder approval of the Plan in accordance with Section 17 hereof.
(vi) The terms of each Initial Option granted hereunder shall be as follows:
(1) each Initial Option shall be exercisable only while the
Outside Director remains a Director of the Company, except as set forth in
Section 9 below;
(2) the exercise price per Share shall be 100% of the fair market value per Share on the date of grant of each Initial Option, determined in accordance with Section 8 hereof;
(3) each Initial Option shall vest and become exercisable at the rate of thirty three and one-third percent (33 1/3%) of the Shares subject to the Initial Option on each of the first, second and third anniversaries of the date of grant of the Initial Option.
(vii) The terms of each Annual Option granted hereunder shall be as follows:
(1) each Annual Option shall be exercisable only while the
Outside Director remains a Director of the Company, except as set forth in
Section 9 below;
(2) the exercise price per Share shall be 100% of the fair market value per Share on the date of grant of each Annual Option, determined in accordance with Section 8 hereof;
(3) each Annual Option shall vest and become exercisable at the rate of one hundred percent (100%) of the Shares subject to the Annual Option on the first anniversary of the date of grant of the Annual Option.
The Plan shall not confer upon any Optionee any right with respect to continuation of service as a Director or nomination to serve as a Director, nor shall it interfere in any way with any rights which the Director or the Company may have to terminate his or her directorship at any time.
to the Company's initial public offering of securities. It shall continue in effect for a term of ten (10) years unless sooner terminated under Section 13 of the Plan.
An Option may not be exercised for a fraction of a Share.
An Option shall be deemed to be exercised when written notice of such exercise has been given to the Company in accordance with the terms of the Option by the person entitled to exercise the Option and full payment for the Shares with respect to which the Option is exercised has been received by the Company. Full payment may consist of any consideration and method of payment allowable under Section 8(c) of the Plan. Until the issuance (as evidenced by the appropriate entry on the books of the Company or of a duly authorized transfer
agent of the Company) of the stock certificate evidencing such Shares, no right to vote or receive dividends or any other rights as a stockholder shall exist with respect to the Optioned Stock, notwithstanding the exercise of the Option. A share certificate for the number of Shares so acquired shall be issued to the Optionee as soon as practicable after exercise of the Option. No adjustment will be made for a dividend or other right for which the record date is prior to the date the stock certificate is issued, except as provided in Section 11 of the Plan.
Exercise of an Option in any manner shall result in a decrease in the number of Shares which thereafter may be available, both for purposes of the Plan and for sale under the Option, by the number of Shares as to which the Option is exercised.
For purposes of this Section 11(b), an Option shall be considered assumed, without limitation, if, at the time of issuance of the stock or other consideration upon such Change of Control, each Optionee would be entitled to receive upon exercise of an Option the same number and kind of shares of stock or the same amount of property, cash or securities as the Optionee would have been entitled to receive upon the occurrence of such transaction if the Optionee had been, immediately prior to such transaction, the holder of the number of Shares of Common Stock covered by the Option at such time (after giving effect to any adjustments in the number of Shares covered by the Option as provided for in this Section 11); provided however that if such consideration received in the transaction was not solely common stock of the successor corporation or its Parent, the Administrator may, with the consent of the successor corporation, provide for the consideration to be received upon exercise of the Option to be solely
common stock of the successor corporation or its Parent equal to the Fair Market Value of the per Share consideration received by holders of Common Stock in the transaction.
As a condition to the exercise of an Option, the Company may require the person exercising such Option to represent and warrant at the time of any such exercise that the Shares are being purchased only for investment and without any present intention to sell or distribute such Shares if, in the opinion of counsel for the Company, such a representation is required by law.
DURECT CORPORATION, INC.
2000 DIRECTORS' STOCK OPTION PLAN
((Optionee))
((Optionee Address 1))
((Optionee Address 2))
Date of Grant ((Grant Date)) Vesting Commencement Date ((Vesting Start Date)) Exercise Price per Share ((Exercise Price)) Total Number of Shares Granted ((Shares Granted)) Total Exercise Price ((Total Exercise Price)) Expiration Date ((Expir Date)) Vesting Schedule: This Option may be exercised, ---------------- in whole or in part, in accordance with the following schedule: [_________ of the Option Shares shall vest and be exercisable on each _____ anniversary of the Vesting Commencement Date.] Termination Period: This Option may be exercised ------------------ for 90 days after termination of Optionee's Continuous Status as a Director, or such longer period as may be applicable upon death or Disability of Optionee as provided in the Plan, but in no event later than the Expiration Date as provided above. |
By your signature and the signature of the Company's representative below, you and the Company agree that this option is granted under and governed by the terms and conditions of the 2000 Directors' Stock Option Plan and the Nonstatutory Stock Option Agreement, all of which are attached and made a part of this document.
OPTIONEE: DURECT CORPORATION, INC. By:__________________________ _____________________________ Signature Title:_______________________ _____________________________ Print Name |
DURECT CORPORATION, INC.
No Shares shall be issued pursuant to the exercise of this Option unless such issuance and exercise complies with all relevant provisions of law and the requirements of any stock exchange or quotation service upon which the Shares are then listed. Assuming such compliance, for income tax purposes the Exercised Shares shall be considered transferred to the Optionee on the date the Option is exercised with respect to such Exercised Shares.
(a) cash;
(b) check;
(c) delivery of a properly executed exercise notice together with such other documentation as the Administrator and the broker, if applicable, shall require to effect an exercise of the Option and delivery to the Company of the sale or loan proceeds required to pay the exercise price; or
(d) surrender of other Shares which (i) in the case of Shares acquired
upon exercise of an option, have been owned by the Optionee for more than six
(6) months on the date of surrender, and (ii) have a Fair Market Value on the
date of surrender equal to the aggregate Exercise Price of the Exercised Shares.
By your signature and the signature of the Company's representative below, you and the Company agree that this Option is granted under and governed by the terms and conditions of the Plan and this Nonstatutory Stock Option Agreement. Optionee has reviewed the Plan and this Nonstatutory Stock Option Agreement in their entirety, has had an opportunity to obtain the advice of counsel prior to executing this Nonstatutory Stock Option Agreement and fully understands all provisions of the Plan and Nonstatutory Stock Option Agreement. Optionee hereby agrees to accept as binding, conclusive and final all decisions or interpretations of the Administrator upon any questions relating to the Plan and Nonstatutory Stock Option Agreement.
DURECT CORPORATION, INC.
_______________________________ By:_________________________________
((Optionee))
Title:______________________________
The undersigned spouse of Optionee has read and hereby approves the terms and conditions of the Plan and this Nonstatutory Stock Option Agreement. In consideration of the Company's granting his or her spouse the right to purchase Shares as set forth in the Plan and this Nonstatutory Stock Option Agreement, the undersigned hereby agrees to be irrevocably bound by the terms and conditions of the Plan and this Nonstatutory Stock Option Agreement and further agrees that any community property interest shall be similarly bound. The undersigned hereby appoints the undersigned's spouse as attorney-in-fact for the undersigned with respect to any amendment or exercise of rights under the Plan or this Nonstatutory Stock Option Agreement.
EXHIBIT A
To: Durect Corporation, Inc. Attn: Stock Option Administrator Subject: Notice of Intention to Exercise Stock Option -------------------------------------------- |
Grant Number: __________________________ Date of Purchase: __________________________ Number of Shares: __________________________ Purchase Price: __________________________ Method of Payment of Purchase Price: __________________________ Social Security No.: __________________________ The shares should be issued as follows: __________________________ Name: __________________________ Address: __________________________ __________________________ __________________________ |
Signed: __________________________
Date: __________________________
CONFIDENTIAL
EXHIBIT 10.6
SECOND AMENDED AND RESTATED
DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
between
ALZA CORPORATION
and
DURECT CORPORATION
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
TABLE OF CONTENTS
PAGE
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
This Second Amended and Restated Development and Commercialization Agreement (the "Agreement") is effective as of April 28, 1999 ("Effective Date") between ALZA Corporation, a Delaware corporation ("ALZA"), and Durect Corporation, a Delaware corporation ("Durect").
A. ALZA and Durect have previously entered into that certain Development and Commercialization Agreement with an effective date of April 21, 1998 and subsequently entered into an Amended and Restated Development and Commercialization Agreement with an effective date of April 28, 1999 (collectively "Previous Agreement") for the development, manufacture and marketing of pharmaceutical products utilizing proprietary technology of ALZA relating to the DUROS(R) System for the controlled delivery of drugs in certain fields, as set forth herein.
B. The parties wish to amend such Previous Agreement and restate their understandings herein.
NOW THEREFORE, in consideration of the mutual covenants and agreements provided herein, the parties hereby agree as follows:
For purposes of this Agreement, the following terms shall have the respective meanings set forth below:
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
common control with, the designated party, but only for so long as the relationship exists. "Control" shall mean ownership of shares of stock having at least 50% of the voting power entitled to vote for the election of directors in the case of a corporation, and at least 50% of the interests in profits in the case of a business entity other than a corporation.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
To provide further clarification, the Durect Fields shall not include applications of any ALZA drug delivery technology other than applications of DUROS(R) Technology as set forth in this Agreement.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
with the Program, and any Technical Information developed by one party using any other Program Information or any of the other party's Confidential Information.
Subterritory A -- [* * *] Subterritory B -- [* * *] Subterritory C -- [* * *] Subterritory D -- [* * *]
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
1.32 "Work Plan" and "Cost Estimate" shall have the meaning set forth
--------- ------------- in Section 2.3. |
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
reasonably necessary, in order to carry out its obligations. In the event Durect desires to initiate development work on a new product, it shall send to ALZA a written notice setting forth a description of the proposed new product and projected target dates for the filing of an IND, start of Phase III and filing of an NDA (each a "Milestone"), which target dates shall be reasonable by industry standards and shall be consistent with the timeline used by Durect for internal planning and presentation to investors. Upon ALZA's written approval of the target dates for the Milestones, which approval shall not be unreasonably withheld, the proposed new product shall be added as a Product Candidate to Schedule 1. From time to time, the parties will review the target dates for the Milestones in good faith and, by mutual written agreement, revise and update the target dates if necessary. Durect shall notify ALZA in writing when a Product Candidate is ready to pass into the clinical development stage as outlined in Exhibit C, in which event it shall be added as a Product to Schedule 2. Subject to the terms and conditions of this Agreement, the addition or deletion of a Product Candidate or Product to Schedule 1 or Schedule 2 shall be determined based on the reasonable, good faith judgment of Durect, provided that any proposed Product Candidate or proposed Product will not be added in the event that: (i) such proposed Product Candidate or proposed Product was within the past 12 months removed by ALZA from the Program pursuant to Section 2.5; or (ii) ALZA determines, reasonably and in good faith, based on medical or technical reasons, that the proposed Product Candidate or proposed Product is not suitable for development because development or Commercialization of such proposed Product or Product Candidate would be likely to be harmful to the reputation of ALZA and/or DUROS Technology, provided, however, that: (a) ALZA's determination pursuant to this clause (iii) shall be subject to review by a mutually acceptable third party expert in the event of disagreement by the parties as to such determination, and (b) ALZA shall not initiate development of such proposed Product Candidate (or proposed Product), pursuant to Section 5.3 or otherwise, for its own account or with a third party for a period of [***] from the date of ALZA's determination without first proposing such proposed Product Candidate (or proposed Product) to Durect for development and providing Durect with a period of [***] in which to accept or reject such proposed Product Candidate (or
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Proposed Product) in writing and diligently initiate development under the terms of this Agreement.
(b) Development work for the System may be performed by Durect or ALZA (to the extent agreed upon in the Work Plans). Durect shall have the right to subcontract to third parties development of System components (but not
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
System design). The subcontracting of all other System development work will be subject to the prior written consent of ALZA. If Durect desires to subcontract out the development of System components as permitted herein to any third party, prior to providing any information relating to Systems to such third party, Durect shall notify ALZA of the identity of such third party, and Durect shall enter into a confidentiality and invention assignment agreement with such third party in a form previously approved by ALZA which expressly makes ALZA a third- party beneficiary of such agreement and permits ALZA to directly enforce its terms. Unless agreed to in writing by ALZA, the rights granted to Durect to perform development work for the System pursuant to this Section 2.3 shall terminate after a change in control of Durect in which Durect becomes controlled by a third party company, in which event ALZA shall have the right to elect to perform all development work relating to the System and ALZA and Durect shall enter into a Work Plan for such System development work which shall provide for the continued diligent performance of such System development work so as to minimize disruption of Product timelines. If ALZA elects not to perform development work relating to the System after such change in control, then Durect shall continue to have the right to perform development work relating to the System as set forth in this Section 2.3. For the purposes of this Section 2.3, "control" shall have the same meaning as set forth in Section 1.1. All other Product development activities may be performed by Durect, ALZA (to the extent agreed upon in Work Plans) or subcontracted to third parties.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Fields in accordance with Exhibit F. If Durect fails to meet the diligence requirements relating to a Durect Field as set forth in Exhibit F, for which such failure continues for [* * *] after-the delivery of written notice thereof by ALZA, then ALZA's sole and exclusive remedy shall be to terminate the restrictions on ALZA provided for in Section 5.3 upon written notice from ALZA solely in the Durect Field in which such requirements were not met (or such Durect Field as is otherwise provided for in Exhibit F under "Consequences for Fields"), in which event such Durect Field shall be deemed to be eliminated from the "Durect Fields" definition, and thereafter no Product Candidates shall be added to Schedule 1 within such Durect Field and no Products shall be added to Schedule 2 for such Durect Field except for those Product Candidates existing at the time of such elimination and for which the screening stage has been or subsequently is successfully completed. Notwithstanding the elimination of any Durect Field hereunder, Durect shall continue to have rights to the Product Candidates and Products already included in Schedules 1 and 2 as of the date that such field is eliminated so long as it continues to meet its obligations for such Product Candidates and/or Products, including those set forth in Exhibit F, provided, however, that if Durect fails to meet such obligations with respect to a Product Candidate or Product and such failure continues for [* * * ] after the delivery of written notice thereof by ALZA, then ALZA may eliminate such Product Candidate or Product from this Agreement and ALZA shall have the rights set forth in Section 11.6.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Territory. ALZA may be delegated certain duties relating to clinical and regulatory activities under the Program on a Product-by-Product basis by mutual agreement as set forth in Work Plans. The CMC Section of any regulatory filing, to the extent it relates to the System, may be maintained by ALZA, in one or more of ALZA's Drug Master Files to the extent permissible under applicable laws and regulations, for which Durect shall have the right of reference for each Product hereunder. Durect shall prepare the CMC Section subject to ALZA's review and decision-making authority under Section 2.6(b).
(b) Notwithstanding the allocation of regulatory responsibilities in this Section 2.6, the representatives of each party shall have the right to review and comment upon all regulatory filings proposed to be made with respect to any Product for each country of the Territory as to which Durect maintains rights hereunder, provided that for any such comments to be considered, the comments shall be provided within [* * *] after the receipt of any draft filings for review. To the extent ALZA performs review of regulatory filings or attends meetings with regulatory agencies as to matters beyond the requirements of its activities under the Program (and not at Durect's request), it shall do so at its cost and expense. Durect shall have the right to make final decisions with regard to any regulatory filings relating to any Product, provided that notwithstanding anything to the contrary herein, due to ALZA's continuing interest in development and production of Systems for multiple applications, ALZA shall have the right to approve regulatory matters relating to the System or its function, manufacture or safety, including manufacturing specifications and the relevant portions of the CMC Section of an NDA or its equivalent. Each party shall with reasonable promptness provide the other party with copies of all correspondence from or to such regulatory authorities concerning each such Product. ALZA shall have the right to participate in any conference or meeting with regulatory authorities with respect to each Product. Durect shall notify ALZA in writing of its receipt of regulatory approval to market the Product in any country of the Territory within [* * *] after receipt of any such approval.
(c) Representatives of each party shall have the right to review and comment on all proposed protocols for any clinical studies to be conducted by
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
either party with respect to any Product, and each party shall make such changes
in such protocols as may be reasonably requested by the other in writing within
[* * *] after receiving the proposed protocols, provided that Durect shall make
final decisions on the protocols and their implementation. To the extent ALZA
conducts review of protocols as to matters beyond the requirements of its
activities in the Program (and not at Durect's request), ALZA shall do so at its
cost and expense.
(d) From time to time during the term of this Agreement, ALZA may wish to include certain patent information in the patent certification of an NDA filed or which may be filed by or on behalf of Durect under this Agreement relating to a Product. If ALZA advises Durect in writing of the patent number and expiration date, or such other information as the FDA may from time to time require, of patents to be included in the NDA patent certification or any amendment thereof, Durect shall include such information in the NDA, or amend the NDA, within the applicable time limits required by law.
(e) Nothing contained in this Section 2.6 or elsewhere in this Agreement is intended to conflict with any applicable regulations and laws relating to procuring and maintaining regulatory approval for the Products in all countries of the Territory where the Products will be developed and Commercialized, and in the event of any conflict with the terms of this Agreement and applicable laws, the applicable laws will control.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
subject to Section 4.1, allow personnel of the other party to consult with its staff at mutually agreeable times, to discuss and review such Confidential Information and Program Information. All Confidential Information and Program Information heretofore or hereafter disclosed by either party to the other relating to the subject matter hereof shall be deemed to have been disclosed pursuant to this Agreement and shall be subject to the provisions of this Agreement including, but not limited to, Section 4.1.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
parties under appropriate terms and conditions including confidentiality provisions substantially equivalent to those in this Agreement for consulting, manufacturing, development, external testing and marketing trials with respect to the Product; (C) published, if and to the extent such publication has been approved in writing by ALZA, to the extent it relates to ALZA Confidential Information, or Durect, to the extent it relates to Durect Confidential Information; or (D) disclosed to the extent required by applicable laws or regulations or as ordered by a court or other regulatory body having competent jurisdiction. In each of the foregoing cases, the recipient will use its reasonable efforts to limit the disclosure and maintain confidentiality to the extent possible.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
[***] and (iii) the rights of ALZA under this Agreement shall not be prejudiced or in any other way reduced or limited by such subcontracting arrangement. Subject to the terms and conditions of this Agreement, ALZA hereby grants to Durect and its Affiliates a license under Intellectual Property Rights covering ALZA Confidential Information (including information owned by ALZA as of April 21, 1998 relating to catheters and mechanisms for docking catheters to the Systems), ALZA Program Information, and the Systems solely to the extent necessary for Durect to Commercialize and Manufacture (subject to Section 5.6 hereof) Products, to perform development activities as contemplated herein, and to otherwise perform its obligations in accordance with this Agreement.
(b) Subject to the terms and conditions of this Agreement, including but not limited to Section 5.3, Durect shall have the exclusive right to Commercialize each Product on Schedule 2: (A) in Subterritories A, B and C for a period of [* * *] from the [* * *] in such Subterritory; (B) in Subterritory D for a period of [* * *] from the [* * *]
(c) Subject to the terms and conditions of this Agreement, Durect shall have an option to extend year-by-year the period of Commercialization rights granted under Section 5.1(a) on a Product-by-Product, Subterritory-by-Subterritory basis (with respect to the Products, Subterritories and countries for which Durect has retained rights), by written notice to ALZA given at least [* * *] prior to the expiration of Durect's rights under Section 5.1(b) for such Product in such Subterritory.
(d) If the option to extend Commercialization rights is
exercised in accordance with Section 5.1(c) for any Product in any Subterritory,
Durect shall commence making payments automatically under the provisions of
Section 6.3 for such
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Product with respect to such Subterritory as the obligations to make Product Payments for such Product in such Subterritory under Section 6.1 expire. In the event that Durect exercises its option to extend its rights described in Section 5.1(c), the Commercialization rights granted under Section 5.1(a) for such Product in such Subterritory shall continue for the extension term(s) and under the conditions set forth in Section 6.3.
[***]
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
for which neither Durect or its Affiliates or Subcontractors are, nor have been for at least the preceding [* * *], diligently seeking regulatory approval to Commercialize the Product in such country (the "Identified Country"). ALZA and Durect shall attempt in good faith, for up to [* * *] from the date of such notice, to seek a mutually acceptable means of Commercializing the Product in such Identified Country, which may include both ALZA and Durect negotiating an agreement with a third party. If after such [* * *] no such means has been agreed upon, then ALZA may, by written notice to Durect, terminate the rights of Durect hereunder to Commercialize such Product in such Identified Country. For each Product with respect to which Durect does not retain Commercialization rights in any particular country ("Terminated Countries"), ALZA shall have the rights to such Product in such Terminated Countries in accordance with Section 11.6.
(A) ALZA may not itself develop or Commercialize, nor grant rights to a third party to develop or Commercialize any product using the System which incorporates Sufentanil so long as Durect and/or a Subcontractor (including ALZA) is diligently developing or Commercializing the non- catheterized Product using Sufentanil as the Drug ("Sufentanil Product") in accordance with the terms of this Agreement.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
(B) In the event ALZA (or a third party to whom ALZA has granted rights) Commercializes a product using the System which incorporates an opioid compound (other than Sufentanil) as the active ingredient, then starting upon the FDA approval for such other product and during such period as Durect and/or a Subcontractor is diligently developing or Commercializing the Sufentanil Product in accordance with the terms of this Agreement, [***]
(C) In the event that ALZA (or a third party to whom ALZA has granted rights) Commercializes the Sufentanil Product as a result of ALZA's exercise of its option right under Section 5.5(a), then if ALZA (or any third party to whom ALZA has granted rights) commences Commercialization of any product using the System which incorporates any opioid other than Sufentanil, then commencing upon the FDA approval of such other product, [* * *] in which event [* * *]
If Durect can reasonably show that a third party contractor of ALZA is
manufacturing or Commercializing products using the System, which products are
being used in the Durect Fields, then ALZA agrees to notify such third party
contractor of Durect's rights in the Durect Fields and, to the extent it has the
legal right to do so, to use its reasonable commercial efforts to stop such
third party from manufacturing or Commercializing such products in the Durect
Fields. However, Durect acknowledges that ALZA may not have the right to limit
uses of products that are not designed for use in a Durect Field. The
obligations of ALZA under Section 5.3 shall continue only for such period as is
covered by specifically agreed-upon diligence requirements as set forth in
Section 2.5 or Exhibit F.
(b) From time to time during the term of this Agreement, Durect and ALZA may, at their discretion, discuss opportunities to add either additional products or additional fields of products to the definition of Durect Fields under this Agreement, by written agreement of the parties; provided that neither party shall be obligated to enter into negotiations or into such an agreement, or to reserve for the other party rights to any additional products or fields until such time as an agreement is
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
made to that effect. In addition, if any such additional Products, or Products
in such additional fields, involves clinical applications in the areas of [* *
*] or delivery of drugs to the [* * *] and subject to the exception provided in
the next sentence below, then ALZA shall have an option to obtain exclusive
Commercialization rights to such Products as set forth in Section 5.5(a). The
foregoing option to ALZA shall not apply to any Product which Durect
Commercializes through a Subcontractor who holds exclusive rights (by ownership
or exclusive license) to a United States patent which: (i) covers the Drug
incorporated into such Product, or the Drug's manufacture or use which but for a
license from the Subcontractor would preclude Durect from the development,
Commercialization or manufacture of such Product incorporating such Drug, and
(ii) will provide at least [***] from the time Durect and the Subcontractor
enter into an agreement for the development and/or Commercialization of such
Product (any such Product shall herein be referred to as "Proprietary Product").
(c) Notwithstanding Section 5.3(a), if ALZA is requested by a third party to develop a product using the System without a catheter, which product is designed for use in the Cancer Antigen Field, then ALZA shall notify Durect in writing of such opportunity. Durect shall notify ALZA within [* * *] after the receipt of such notice from ALZA as to whether or not Durect wishes to pursue such opportunity as a Product under this Agreement with such third party. If Durect and such third party enter into a written agreement providing for the development and Commercialization of the product within [* * *] after Durect's receipt of the notice from ALZA described in the first sentence of this Section 5.3(c), then such product shall be developed as a Product under this Agreement, and if such condition has not been met, then ALZA shall be free to pursue such opportunity using the System without a catheter with such third party; provided, however, that: (A) ALZA may not develop or grant rights to a third party to develop or Commercialize any such product using the System in the Cancer Antigen Field which product incorporates the same Drug as a Product which is then being developed or Commercialized diligently by Durect or a Subcontractor under this
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Agreement in the Cancer Antigen Field; and (B) for a period of [* * *]
("Exclusion Period"), ALZA will refrain from developing or granting rights to a
third party to Commercialize any such product in the Cancer Antigen Field which
product is designed for the same clinical use for which a Product is then being
developed or Commercialized diligently by Durect or a Subcontractor under this
Agreement in the Cancer Antigen Field. Durect may extend such Exclusion Period,
by written notice to ALZA at least [* * *] before expiration of such Exclusion
Period, by up to an additional [* * *] if Durect (i) has met and continues to
meet all of its diligence requirements under Section 2.5 in a timely manner, and
(ii) is [* * *] in the Cancer Antigen Field, but in no event shall any extension
to the Exclusion Period be granted beyond [* * *] Subject to the foregoing,
[* * *]
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
all rights of Durect in such Durect Field shall terminate; provided, however, such deletion of any Durect Field by Durect shall not affect the rights and obligations of the parties with respect to any other Durect Fields not deleted in accordance with this Section 5.4.
(i) enter into an agreement with Durect to develop and Commercialize such Product, in which case the parties shall negotiate in good faith an agreement for the development and Commercialization of such Product, which agreement shall require ALZA to Commercialize such Product with the same degree of diligence as required of Durect under Section 5.2; or
(ii) not obtain Commercialization rights to such Product, in which event Durect shall be entitled to enter into an agreement with a third party to develop and Commercialize such Product; or
(iii) solely with respect to an Option Product, extend the Option Period by increments of [***] until such time as [* * *] and thereafter by increments of [***] until such time [***] (each increment an "Extension Period"), provided that ALZA shall be required to fund development work for such
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Product during each such Extension Period, but provided further that ALZA shall not be required to fund development work on more than [***] in order to extend its options for all Products in such Durect Field. [***]
If ALZA elects to exercise its option to the Sufentanil Product or any other Product subject to this Section 5.5(a) at any time during the Option Period or any Extension Period, and the parties are unable to agree on terms for such Commercialization rights within [***] after such exercise, either party may elect to submit the determination of such terms to special arbitration in accordance with Section 15, provided that judgment must be rendered no later than [***] after the commencement of arbitration (as defined in Section 15). In such arbitration, the arbitrators shall be instructed to make a determination as to the fair market value of the rights granted to the Product in question as between two independent companies negotiating at arms' length and shall determine appropriate terms, including reasonable diligence provisions, taking into account, among other things, evidence presented concerning the terms agreed upon by other parties in arms' length negotiations for products at a similar stage of development and with similar market potential. Upon such decision by the arbitrators, the decision shall become a binding agreement of the parties.
[***]
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
[***]
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
hereto, and ALZA and Durect shall enter into a written supply agreement for such
manufacture and supply to Durect, its Affiliates and Subcontractors which shall
include such provisions for interim supply to ensure uninterrupted supply of
Products (at a price to Durect of ALZA's [* * *] until ALZA is able to fully
meet Durect and its Affiliates and Subcontractor's requirements after such a
change in control. If ALZA elects not to supply Durect and its Affiliates and
Subcontractor's requirements after such a change in control, then Durect shall
continue to have the right to Manufacture Product as set forth in this Section
5.6. For the purposes of this Section 5.6(a), "control" shall have the same
meaning as set forth in Section 1.1.
(b) The parties acknowledge that ALZA has provided Durect with reasonable assistance (including making available scientific, engineering and manufacturing and other personnel) and transferred to Durect appropriate documentation relating to Systems manufacture in accordance with a work plan agreed upon by the Parties. All such materials and information shall remain the sole property of ALZA. At the request of ALZA, Durect shall promptly transfer back to ALZA any and all improvements, documentation or other Technical Information that may be developed by Durect or its subcontractors relating to Manufacture of Systems. To the extent such transfer requires technical assistance from Durect, ALZA shall reimburse Durect for the cost of such assistance as determined in accordance with Exhibit E.
(c) All Manufacturing of Product by Durect hereunder shall be in strict accordance with all applicable laws and regulations, including the "current good manufacturing practices" regulations of the U.S. Food and Drug Administration. If Durect desires to subcontract any part of manufacturing of Systems as permitted herein to any third party, prior to providing any manufacturing information relating to Systems to such third party, Durect shall notify ALZA of the identity of such third party, and Durect shall enter into a confidentiality and invention assignment agreement in a form previously approved by ALZA with such third party which expressly makes ALZA a third-party beneficiary of such agreement and permits ALZA to directly enforce its terms.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
(a) Product Payments on Net Sales of Product due under this
Section 6.1 for any calendar year shall be based on the prior calendar year's
total Net Sales of Product in the Territory, with payment rates for such
calendar year to be the applicable percentages set forth herein. The applicable
payment rate shall be calculated by [* * *] but shall not be [* * *]. During
the first calendar year of Product sales, the payment rate will be [* * *].
Examples: Sales in Year X-1* Payment Rate ($ Million) For Year X** ------------------ ------------ |
[* * * * * *]
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
[* * * * * *]
[* * * * * *]
[* * * * * *]
[* * * * * *]
* Net Sales in the Territory by Durect, its Affiliates and Subcontractors for the prior calendar year. ** The applicable payment rate for the current calendar year.
(b) In addition to Product Payments under Section 6.1(a), Durect shall make payments to ALZA equal to [* * *] with respect to Products after deducting from such consideration: (i) any tax or other government charge (other than income tax) levied on such consideration to the extent borne by Durect, its Affiliates and Subcontractors and (ii) any payments (or portions thereof) that constitute reimbursement of (and are determined based upon) genuine research, development and/or manufacturing costs incurred by Durect, its Affiliates and Subcontractors including but not limited to reimbursement of expenses for reagents, materials, equipment, salaries, testing, clinical trials, insurance and any overhead reasonably attributable to such research, development or manufacture.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Subterritory Minimum Payment Commences With ------------ ------------------------------ A or B* First Minimum Payment Year A or B** Second Minimum Payment Year C Third Minimum Payment Year |
* Whichever of Subterritory A or B in which the Product is first approved in a Major Market Country. ** The other of Subterritory A or B.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
in such country, ALZA and Durect will use all reasonable efforts to oppose the grant of such license or rights and to obtain the highest royalty or payment rate possible if such compulsory license cannot be avoided. In the event that a third party obtains such compulsory license in such country, Durect shall have the benefit of any more favorable payment terms with respect to such Product in such country as is granted under such compulsory license or right, from the date of first commercial sale by the third party of the Product in such country.
(iii) Simultaneously with the execution of this Agreement, Durect is issuing to ALZA warrants to purchase, 1,000,000 shares of Durect Common Stock pursuant to the Warrant Agreement attached hereto as Exhibit J.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Period as to which payments are due. Each payment under this Section 7.2 shall be accompanied by a report setting forth the calculations of the amounts payable to ALZA on a Product-by-Product and Subterritory-by-Subterritory basis.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
and the accuracy of such books of account. Such examination shall be made during
normal business hours at the place of business of the party being audited. The
parties agree that information furnished as a result of any such examination
shall be limited to a written statement by such certified public accountants to
the effect that they have reviewed the books of account of the party being
audited and either (i) the amounts of the payments due or charges made under
this Agreement are in conformity with such books of account and the applicable
provisions of this Agreement or (ii) setting forth any required adjustments. The
fees and expenses of the accountants performing such verification shall be borne
by the party requesting the audit. If any such audit shows any underpayment or
overcharge, a correcting payment or refund shall be made within 30 days after
receipt of the written statement described above. Notwithstanding the foregoing,
if any such audit results in any underpayment or overcharge with respect to any
Payment Computation Period of more than the greater of (i) [[* * *] or (ii) [[*
* *] of the payment or charge actually due, then the party being audited shall
bear all costs of the audit.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
the foregoing, all Program Information relating to the System or its manufacture or to any combination of Systems with other components, active agents, features or processes and any Technical Information developed by Durect (whether or not pursuant to the Program) that relates to DUROS Technology shall be the sole property of ALZA (and shall be included in ALZA Technical Information for purposes of this Agreement). Durect shall promptly disclose to ALZA any such Program Information and Technical Information, and Durect and its personnel and Subcontractors working on the Program shall execute and deliver such assignments, confirmations of assignments, or other written instruments as are necessary to vest in ALZA clear and marketable title to Program Information assigned to ALZA hereunder. In addition to the foregoing, to the extent Durect develops any Technical Information relating to [***] and subject to ALZA abiding by the terms and conditions of the Amended and Restated Market Stand-Off Agreement entered into between Durect and ALZA dated June 19, 1998 and attached hereto as Exhibit H, Durect grants to ALZA a worldwide, royalty free, nonexclusive license, with the right to grant sublicenses, to any such Technical Information.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
(a) The party becoming so aware shall forthwith give written notice to the other ("Notice"). If there is disagreement as to whether the act complained of is in fact an infringement of an ALZA patent, the parties shall refer such issue to a mutually acceptable independent patent counsel. The costs incurred in this regard shall be shared equally.
(b) If, with or without the advice of independent counsel, ALZA desires to litigate such alleged third party infringement, ALZA shall bear all costs thereof and shall be entitled to all recoveries. ALZA shall have the right to join Durect in such suit at ALZA's cost and expense. ALZA shall notify Durect within 90 days after the delivery of Notice by one party to the other above whether it intends to so litigate.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
(c) If ALZA determines not to litigate in accordance with paragraph
(b) above, the parties will promptly confer, and if both parties jointly desire
to litigate such third party infringement, they shall share any costs thereof
and any recovery therein equally, unless otherwise agreed by the parties.
(d) With respect to alleged infringement of such patents, the claims of which are limited to applications of DUROS Technology in the Durect Fields, and which do not include claims for other applications, if no action is taken or agreed to be taken under paragraph (b) or (c) above within 90 days after the Notice and (i) the unit sales volume of the Infringing Product in any country is equal to or exceeds [* * *] of the unit sales volume by Durect and its Affiliates and Subcontractors of the Product that is substantially similar to the Infringing Product in such country, and (ii) the patent counsel described in paragraph (a) above has opined that the act complained of is, or most likely is, an infringement in such country, then Durect may, in its sole discretion, and at its sole cost and expense, bring suit in its name (or, if ALZA is an indispensable party, in the name of and on behalf of ALZA) to restrain such third party infringement in such country, and in such instance, Durect shall be entitled to receive and retain, for its own use and benefit, any recovery awarded in such suit.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Agreement upon [* * *] written notice to the breaching or defaulting party. Failure to pay any amounts due under this Agreement within [* * *] after notice that such amounts are overdue shall be deemed a material breach of this Agreement.
(b) Either party may terminate this Agreement and the rights granted hereunder, effective upon giving written notice of such termination to the other party, if such other party is liquidated or dissolved, or enters into any proceeding, whether voluntary or otherwise, in bankruptcy, reorganization, or arrangement for the appointment of a receiver or trustee to take possession of such other party's assets or any other proceeding under any law for the relief of creditors, or makes an assignment for the benefit of creditors.
11.5 [***]
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
[***]
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
to a specified country or countries). Notwithstanding the foregoing, in the event of the elimination of a Product under this Agreement, if Durect has developed and successfully filed an NDA covering such Product prior to such elimination, then in consideration of the rights granted ALZA respecting such Product ALZA shall pay Durect [* * *] after the obligation to make payments under the preceding sentence has expired, provided that the obligations to pay royalties shall expire for the Territory [* * *] In each case, such payments by ALZA will be subject to adjustments under the same terms as are applicable to Durect's Product Payment obligations under this Agreement.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
such Durect Indemnitee: (i) provides reasonable notice to ALZA of such Loss and permits ALZA to control, in a manner not adverse to such Durect Indemnitee, the defense, settlement, adjustment or compromise of any such Claim using counsel reasonably acceptable to such Durect Indemnitee; and (ii) reasonably cooperates with ALZA in the defense of any such Claim, subject to ALZA's payment of all reasonable costs and expenses associated with such cooperation, and further provided that ALZA shall not be liable for any such costs or expenses incurred without its prior written authorization. ALZA shall not enter into any settlement that affects a Durect Indemnitee's rights or interest without prior written approval by the Durect Indemnitee. The Durect Indemnitee shall have no authority to settle any claim for Losses on behalf of ALZA. The Durect Indemnitee shall have the right to participate, at its own expense, in the defense of any such claim or demand to the extent it so desires.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
waiver is recited in writing and signed by such party. Failure of any party to require, in one or more instances, performance by the other party in strict accordance with the terms and conditions of this Agreement shall not be deemed a waiver or relinquishment of the future performance of any such terms or conditions or of any other terms and conditions of this Agreement. A waiver by either party of any term or condition of this Agreement shall not be deemed or construed to be a waiver of such term or condition for any other term. All rights, remedies, undertakings, obligations and agreements contained in this Agreement shall be cumulative and none of them shall be a limitation of any other remedy, right, undertaking, obligation or agreement of either party. This Agreement may not be amended except in a writing signed by both parties.
If to ALZA: ALZA Corporation 1900 Charleston Rd. Mountain View, CA 94309 |
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Attention: General Counsel
If to Durect: Durect Corporation 10240 Bubb Road Cupertino, CA 95014 Attention: Chief Executive Officer
All notices shall be deemed to be effective five days after the date of mailing or upon receipt if sent by facsimile (but only if followed by certified or registered confirmation). Either party may change the address at which notice is to be received by written notice pursuant to this Section 16.4.
(a) Neither party shall, without the prior written consent of the other party, disclose to third parties, nor originate any publicity, news release or public announcement, written or oral, whether to the public, the press, stockholders or otherwise, referring to the existence or terms of this Agreement, including its existence, the subject matter to which it relates, the performance under it or any of its specific terms and conditions, except such announcements or disclosures as, in the opinion of the counsel for the party making such announcement, are required by law, including United States securities laws, and each party may disclose the existence of this Agreement and the material terms and conditions hereof under circumstances that
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
reasonably ensure the confidentiality thereof to: (i) any government or
regulatory authorities, including without limitation the United States
Securities and Exchange Commission to the extent required by applicable law,
(ii) its legal representatives, advisors and prospective investors, and (iii) to
prospective Subcontractors to the extent required for entering into agreements
with such Subcontractors. If a party decides to make an announcement it believes
to be required by law with respect to this Agreement, it will give the other
party such notice as is reasonably practicable and an opportunity to comment
upon the announcement.
(b) Durect shall submit for review to ALZA, and obtain ALZA's prior written consent for any reference to or description of ALZA or its technology, proprietary rights or products that is to be disseminated to third parties.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Agreement (including the exhibits hereto) is intended to define the full extent of the parties' respective agreements, arrangements and obligations with respect to the subject matter hereof, and each party represents that it is not relying on any such other discussions, conversations, negotiations, correspondence, writings and memoranda in executing and delivering this Agreement or performing its respective obligations hereunder.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the date first written above by their duly authorized representatives.
DURECT CORPORATION ALZA CORPORATION By: /s/ Peter Staple By: /s/ James E. Brown __________________________ __________________________ Title: Executive Vice President Title: Chief Executive Officer __________________________ __________________________ |
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
EXHIBIT A - Specified Anticancer Antigens for Immunization Therapy
------------------------------------------------------------------------------ Name and/or Reference Abbreviation ============================================================================== * * * * * * ============================================================================== * * * * * * ============================================================================== * * * * * * ============================================================================== * * * * * * ============================================================================== * * * * * * ============================================================================== * * * * * * ============================================================================== * * * * * * ============================================================================== * * * * * * ============================================================================== * * * * * * ============================================================================== * * * * * * ============================================================================== * * * * * * ============================================================================== * * * * * * ============================================================================== * * * * * * ============================================================================== * * * * * * ============================================================================== * * * * * * ============================================================================== * * * * * * ============================================================================== * * * * * * ============================================================================== |
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
EXHIBIT B - Manufacturing Process Transfer
[work plan attached]
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
EXHIBIT C - Development Stages
[* * *]
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
EXHIBIT D - Countries of Sub-Territory C [***]
[* * *]
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
EXHIBIT E - Cost Calculation for Purposes of Section 2.3(a)
Development Costs are equal to the sum of (i) research expenses, (ii) general and administrative expenses and (iii) capital asset expenditures.
(i) Research expenses include both direct expenses and indirect expenses.
(a) Direct expenses include direct research salaries (including project management and temporary labor), clinical expenses, supplies and other expenses incurred specifically in connection with the Program.
(b) Indirect expenses include general research management and support costs of the research and product development organization. Indirect expenses are allocated to all projects and billed to clients at a fixed rate* of 160% of direct research salaries.
Examples of items included in direct and indirect expenses are listed on Exhibit E-1
(ii) General and administrative expenses are allocated among the research and product development, manufacturing and marketing organizations. The portion allocated to the research and product development organization is then allocated to all research and development projects and billed to clients at a fixed rate* of 80% of direct research salaries.
Examples of items included in general and administrative expenses are listed on Exhibit E-1.
(iii) Capital asset expenditures are the actual costs of new capital assets acquired specifically for the project.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
EXHIBIT E-1 - Examples of Research Expenses
Direct Expenses
Direct research salaries*
Project clinical expenses and outside services
Project specific supplies
Project travel and related expenses
Miscellaneous project expenses
Regulatory and filing fees and maintenance payments
Indirect Expenses
Research management and indirect salaries*
General research supplies and materials
General research consulting and outside services
Facilities expenses
Telephone and communications
Equipment depreciation, rent, maintenance and services
Research travel and related expenses
Patent and trademark expenses
Miscellaneous indirect research expenses
Corporate management, administrative, and indirect salaries*
Telephone and communications
Equipment depreciation, rent, maintenance and services
Board of directors and corporate consulting
Annual audit, accounting and legal expenses
Facilities expenses
Information services (data processing) expenses
Interest expense
Miscellaneous general and administrative expenses
*Salaries include fringe benefits at a fixed rate of 52% of salaries. This fixed rate will not be changed prior to January 1, 1999 and, if changed on or after January 1, 1999, such changes will be limited to not more than one change per calendar year and shall be a maximum of 10% of the rate in effect at the time of the increase.
EXHIBIT F - Minimum Diligence Obligations
Durect will comply with the following minimum diligence obligations of Durect respecting research and development of Products:
Durect will fund the amounts as described below for the development of Products in the Durect Fields. The first partial "Contract Year" will start on September 1, 1998 and end on December 31, 1998, and each subsequent "Contract Year" will start on January 1 of each subsequent year.
Number of Total development Products being separate costs per Contract developed in Products being Year for each Contract Year Fields identified funded(1) Product ($mm)/(2)//(3)/ ------------------------------------------------------------------------------- (Partial) 1 [* * *] [* * *] [* * *] 2 [* * *] [* * *] [* * *] 3 [* * *] [* * *] [* * *] 4 [* * *] [* * *] [* * *] 5 [* * *] [* * *]/(4)/ [* * *] 6 [* * *] [* * *]/(4)/ [* * *] 7 [* * *] [* * *]/(4)/ [* * *] |
(2) During the year a Product is initiated after Contract Year 1, the "total development cost" for that year can be the year-end spending rate based on at least 3 months' activity.
(3) For each Contract Year for which more than one cost level is given, the lower cost figures apply to the Products in earlier stages of development.
(4) At least [* * *] Products which shall be [[* * *].
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Notwithstanding the table above, Durect shall be deemed to be meeting its
minimum obligations under this Part A with respect to a particular Field (other
than the [* * *]) during Contract Years 5, 6, and 7 if Durect funds at least
[[* * *]] during each such year for development of at least [* * *] Product in
that Field and conducts a research program to determine the feasibility of
other Products in that Field in an amount equal to at least [[* * *]] for each
such year. -
Proof of Principle will be positively established for at least [* * *] Secondary Field in Contract Year 3, for [* * *] Secondary Field by the end of Contract Year 4, and for the [* * *] by the end of Contract Year 5; for each such year in which Durect has not met the foregoing Proof of Principle requirements, ALZA will have the right to [* * *].
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
EXHIBIT G - Manufacturing Costs
"Cost of Manufacturing" shall mean ALZA's standard cost of manufacturing Product, including packaging thereof, determined in accordance with generally accepted accounting procedures and consistent with ALZA's accounting practices on its other products, and including the cost of materials, direct labor and benefits, and allocated overhead, the total expressed as Manufacturing Cost per Unit of Product manufactured.
A. Materials. Includes those items which form an integral and direct part of the Product, or are necessary for its production, as well as cartons, labels, package inserts, shippers, etc.
B. Direct Labor and Benefits. Includes labor and related payroll taxes and employment benefits spent in the actual production of the Product. It is that portion of basic wages, taxes and benefits which can be identified with or charged to a specific product.
C. Overhead. Overhead includes all operating expenses incurred by and in support of all manufacturing cost centers and quality operations. Cost elements included are:
- Direct labor, related payroll taxes and employee benefits
- Depreciation
- Taxes
- Insurance
- Rent
- Repairs and maintenance
- Supplies, scrap and inventory expenses
- Utilities
- Factory administration expenses
- Other similar cost elements of factory overhead
- Allocation of general and administrative overhead allocated to Product manufacturing centers and quality operations.
EXHIBIT H - Amended and Restated Market Stand-Off Agreement
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
EXHIBIT I - Common Stock Purchase Agreement
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
EXHIBIT J - Warrant Agreement
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
SCHEDULE 1 - Product Candidates
**Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
SCHEDULE 2 - Products
EXHIBIT 10.7
PRODUCT ACQUISITION AGREEMENT
PRODUCT ACQUISITION AGREEMENT, dated as of April 14, 2000, by and between DURECT Corporation, a Delaware corporation, and ALZA Corporation, a Delaware corporation.
RECITALS
WHEREAS, Seller manufactures and sells osmotic, miniature, implantable pumps for research use in laboratory animals (the "Business"); and
WHEREAS, Seller desires to sell and cause to be transferred to Buyer (including either existing Affiliates of Buyer or those organized for that purpose), and Buyer (including such Affiliates) desires to purchase and accept the transfer from Seller certain assets and properties of Seller used primarily in the Business, including the Product as defined below, all as hereinafter specifically provided;
NOW, THEREFORE, in consideration of the premises and the respective representations, warranties and agreements herein contained, the parties hereto hereby agree as follows:
ARTICLE I
DEFINITIONS
1.1 Certain Defined Terms. As used in this Agreement, the following terms shall have the following meanings (such definitions to be equally applicable to both the singular and plural forms of the terms defined):
"Accessory Products" means any products or devices including without
limitation those products set forth on Schedule 1 and other products or devices,
e.g., catheters and cannulas, to the extent such products and devices are sold
specifically for use with the Product or an Improvement.
"Action" means any notice of material noncompliance or violation, or any claim, demand, action, suit, audit, assessment or arbitration, or any other request (including any request for information), proceeding or investigation, by or before any Governmental Authority or any nongovernmental arbitration, mediation or other nonjudicial dispute resolution body.
"Affiliate" has the meaning set forth in Rule 12b-2 of the regulations under the Securities Exchange Act of 1934, as amended.
"Agreement" means this Product Acquisition Agreement, including all schedules and exhibits hereto, as it may be further amended from time to time as herein provided.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
"Ancillary Agreements" means the General Support Services Agreement, Coating Services Agreement and New Models Development Agreement attached hereto as Exhibit A, Exhibit B and Exhibit C respectively, each of which is required by this Agreement to be executed and delivered by the parties hereto at or before the Closing.
"Assets" has the meaning specified in Section 2.1.
"Assumed Liabilities" has the meaning specified in Section 3.1.
"Books and Records" means all of the following which are maintained at Seller's facilities in Mountain View, California and the Vacaville Facility which relate solely to the making, using and sale of the Product and Accessory Products: books, records, manuals and other materials, accounting books and records, property records for property, plant and equipment, files, computer tapes, disks and other storage media and records, advertising matter, market research, catalogues, price lists, correspondence, mailing lists, lists of customers and suppliers, distribution lists, photographs, production data (for two years), sales and promotional materials and records, purchasing materials and records, personnel records, credit records, manufacturing and quality control records and procedures, lot records, blueprints, copies of research and development files, data and laboratory books, trademark files and disclosures, media materials and plates, sales order files, and artwork.
"Business" has the meaning specified in the Recitals to this Agreement.
"Buyer" means DURECT Corporation, a Delaware corporation, and, as applicable, Affiliates of Buyer used or formed for the purpose of consummating the transactions contemplated by this Agreement.
"Buyer Indemnified Parties" has the meaning specified in Section 8.2.
"Buyer Loss" has the meaning specified in Section 8.2.
"Closing" means the closing of the transactions contemplated by this Agreement as specified in Section 4.1.
"Contracts" has the meaning specified in subsection 2.1(c).
"Employee" has the meaning specified in Section 5.9.
"Encumbrance" means any interest (including any security interest), pledge, mortgage, lien (including environmental liens), charge, claim (including any adverse claim) or other right of third Persons, whether created by law or in equity, including any such restriction on the use, voting, transfer, receipt of income or other exercise of any attributes of ownership.
"Environmental Laws" means all laws, regulations, ordinances, codes, policies, Governmental Orders and consent decrees, and any judicial or administrative interpretations thereof, of Governmental Authorities, or any common law doctrines, in effect from time to time relating to pollution or protection of the environment, natural resources or protection of health
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
from Hazardous Material exposure, including those relating to emissions, discharges, releases or threatened releases of Hazardous Material into the environment (including ambient air, surface water, groundwater or land), or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport or handling of Hazardous Material.
"Governmental Authority" means any international, national, federal, state, territorial or provincial, municipal or local government, governmental authority, regulatory or administrative agency, governmental commission, department, board, bureau, agency or instrumentality, political subdivision, court, tribunal, official, arbitrator or arbitral body.
"Governmental Order" means any order, writ, rule, judgment, injunction, decree, stipulation, determination, award, citation or notice of violation entered by or with any Governmental Authority
"Hazardous Material" means all substances, materials, chemicals, compounds, pollutants or wastes regulated by, under or pursuant to any Environmental Laws.
"Improvements" means an improved version of the Product which meets all of the following criteria: [ * * * ]
"Inventories" has the meaning specified in subsection 2.1(a).
"Lease" has the meaning specified in subsection 2.1(d).
"Liabilities" means any and all debts, liabilities and obligations of any nature whatsoever, whether accrued or fixed, absolute or contingent, mature or unmatured or determined or determinable, including those arising under any law, rule, regulation, Action, Governmental Order, and those arising under any contract, agreement, commitment or undertaking.
"Material Adverse Effect" means any event(s) with respect to, change(s) in, or effect(s) on, the Product or the Assets or the Business which, individually or in the aggregate, may be adverse to the Business or the results of operations, the condition (financial or otherwise), assets, properties, Liabilities of the Business in a manner that is material to the Business taken as a whole, excluding any effects of a general nature which do not affect the Business uniquely.
"Person" shall include any individual, trustee, firm, corporation, partnership, limited liability company, Governmental Authority or other entity, whether acting in an individual, fiduciary or any other capacity.
"Product" means the ALZET(R) osmotic, implantable pumps for research use in laboratory animals as existing on the Closing Date, as described on Schedule 1.
"Product Trademark" means the ALZET(R) trademark, including all common law rights and applications and registrations therefor, throughout the world.
"Purchase Price" has the meaning specified in Section 2.4.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
"Retained Liabilities" has the meaning specified in Section 3.2.
"Seller" means ALZA Corporation, a Delaware corporation.
"Seller Indemnified Parties" has the meaning specified in Section 8.3.
"Seller Loss" has the meaning specified in Section 8.3.
"Vacaville Facility" means Seller's facility used for the manufacture of Product prior to the Closing located in Vacaville, California.
1.2 Other Defined Terms. In addition to the terms defined in Section 1.1, certain other terms are defined elsewhere in this Agreement and, whenever such terms are used in this Agreement, they shall have their respective defined meanings.
ARTICLE II
PURCHASE AND SALE OF ASSETS
2.1 Purchase of Assets. Upon the terms and subject to the conditions herein set forth, in consideration of the payment of the Purchase Price, Seller hereby sells, conveys, assigns, transfers and delivers to Buyer, and Buyer hereby purchases and acquires from Seller, subject only to the express representations set forth in Article V, all of Seller's rights, title and interests in and to the following (collectively, the "Assets"):
(a) the Product and all raw materials and inventories, including inventories of work in process, stores, supplies and finished goods, which are used solely in the manufacture, use or sale of the Product and Accessory Products as listed on Schedule 2.1(a) (collectively, the "Inventories");
(b) that machinery, manufacturing equipment, laboratory and testing equipment, computers, tools and other tangible personal property, whether owned, leased or subleased, set forth on Schedule 2.1(b) (collectively, the "Fixed Assets");
(c) the contracts listed on Schedule 2.1(c) (collectively, the "Contracts");
(d) subject to the consent by the landlord to the assignment, the lease to the Vacaville Facility described on Schedule 2.1(d) (the "Lease"), together with all of Seller's rights to improvements thereon and fixtures thereto;
(e) (1) the Product Trademark and other trademarks listed on Schedule 2.1(e), including all applications and registrations therefor, and any and all common law trademarks pertaining to the Product or as used with Accessory Products throughout the world and the goodwill associated with the foregoing trademarks; (2) all copyrights, including any common law copyrights and applications therefor throughout the world for Product and Accessory Products related advertising material, and (3) the good will associated with the Product (collectively, the "Intangible Personal Property"); and
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
(f) all Books and Records and the marketing assets as listed in Schedule 2.1(f).
In the event that assets which are used primarily in the manufacture, use or sale of the Product and Accessory Products are inadvertently omitted from the above schedules, then Buyer and Seller shall in good faith, upon mutual agreement, revise the schedules to include such assets.
2.2 License. Seller hereby grants to Buyer a nonexclusive license to Seller's know-how, trade secrets, confidential information, software, technical information, process technology, plans, drawings, analytical and process methods related to the manufacture, testing and packaging of the Product, designs, inventions, research records, procedures, manuals and blue prints in order for Buyer to make, use and sell the Product.
2.3 Product Trademark.
(a) Buyer acknowledges that the Product Trademark is similar to Seller's name and that Seller has a continuing interest in the manner that the Product Trademark is used. Buyer agrees to use the Product Trademark only in connection with the Product, Improvements and Accessory Products and will not without Seller's prior written consent: (a) modify or alter in any way the Product Trademark; (b) transfer the Product Trademark, other than to an Affiliate of Buyer; or (c) authorize any use of the Product Trademark other than in connection with the Product, Improvements or Accessory Products. Buyer further agrees not to use the DUROS(R) trademark, Seller's name or any other trademark of Seller in any manner in association with the Product, Improvements or Accessory Products except as provided in Section 7.8.
(b) Buyer shall notify ALZA in writing of any conflicting uses of, or of any acts of infringement, unfair competition or imitation by others involving the Product Trademark promptly after such matters are brought to Buyer's attention or Buyer obtains knowledge thereof.
2.5 Full Possession. Subject to the terms and conditions of this Agreement, and subject to the Ancillary Agreements, at the Closing, Seller shall put Buyer and its Affiliates into full and actual possession and enjoyment of the Product and the Assets. The sale of the Product and the Assets contemplated hereby shall be effected by instruments of conveyance, transfer and assignment as Buyer may request that are necessary to vest in Buyer all of the rights, title and interests of Seller in the Product and the Assets as provided herein and to put Buyer in full and actual possession, enjoyment and operating control of the Product and the Assets.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
ARTICLE I
ASSUMPTION OF LIABILITIES
3.1 Assumption of Liabilities. Effective as of the Closing, without any further responsibility or Liability of or recourse to Seller or any of Seller's Affiliates, subsidiaries, stockholders, officers, directors, employees, agents, successors or assigns, Buyer hereby absolutely and irrevocably assumes, and shall pay, perform and be liable and responsible for, only the following Liabilities of Seller (collectively, the "Assumed Liabilities"):
(a) all obligations of Seller arising after the Closing Date under the Contracts; and
(b) subject to the assignment of the Lease to Buyer, all obligations of Seller arising after the Closing Date under the Lease.
3.2 Retained Liabilities. Except as provided in Section 3.1, Buyer and its Affiliates shall not assume and shall not be responsible for, and there shall not be transferred to or assumed by Buyer or any of its Affiliates, any Liabilities of Seller or its Affiliates (or any predecessors thereof).
ARTICLE I
CLOSING
4.1 Closing. The consummation of the transactions contemplated by this Agreement and the Ancillary Agreements (the "Closing") shall take place at Seller's principal executive offices located at 1900 Charleston Road, Mountain View, CA, at 2 p.m., local time, on April 14, 2000 or at such other place, time and date as the parties hereby may agree in writing. The consummation of such transactions is herein collectively referred to as the "Closing." The date and time of the Closing are sometimes referred to herein as the "Closing Date."
4.2 Seller's Obligations at Closing. At the Closing, Seller shall deliver or cause to be delivered to Buyer:
(a) All bills of sale and other instruments of conveyance, transfer and assignment, including a trademark assignment in connection with the trademarks assigned in Section 2.1(e) in the form attached as Exhibit D, that are necessary to vest in Buyer all of the rights, title and interests of Seller in the Assets, free and clear of all Encumbrances;
(b) This Agreement and the Ancillary Agreements, duly executed by Seller.
4.3 Buyer's Obligations at Closing. At the Closing, Buyer shall deliver or cause to be delivered to Seller:
(a) The Purchase Price, which shall be delivered to Seller by wire transfer of immediately available funds to an account or accounts designated in writing by Seller;
(b) A California resale certificate pursuant to Sections 6091 et seq of the California Revenue and Taxation Code; and
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
(c) This Agreement and the Ancillary Agreements, duly executed by Buyer or its Affiliates, as the case may be.
ARTICLE I
REPRESENTATIONS AND WARRANTIES OF SELLER
Seller represents and warrants to Buyer as follows:
5.1 Organization, Standing and Power. Seller is a corporation duly organized, validly existing and in good standing under the laws of its jurisdiction of incorporation and has full corporate power and authority to own its assets and properties and to conduct its business as and where it is being conducted, including to own the Assets owned by it and conduct its business as and where it is being conducted by it. Seller is duly qualified or licensed as a foreign corporation to do business, and is in good standing, in each jurisdiction where the character of the properties owned, leased or operated by it or the nature of its business makes such qualification or licensing necessary, except where the failure to be so qualified or licensed would not result in a Material Adverse Effect.
5.2 Authorization.
(a) Seller has full corporate power and authority to enter into this Agreement and the Ancillary Agreements and to consummate the transactions contemplated hereby and thereby. The execution and delivery of this Agreement and the Ancillary Agreements and the consummation of the transactions contemplated hereby and thereby have been duly authorized by all necessary corporate action on the part of Seller. This Agreement has been duly executed and delivered by Seller. This Agreement constitutes, and upon the execution and delivery thereof by Seller each Ancillary Agreement will constitute, a legal, valid and binding obligation of Seller, enforceable against Seller in accordance with its terms, except as the enforceability thereof may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar laws affecting the enforcement of creditors' rights generally and general principles of equity (regardless of whether enforceability is considered in a proceeding at law or in equity).
(b) Except for transfer of Seller's interest in the Lease, no consent, waiver, approval, order or authorization of, notice to, or registration, declaration, designation, qualification or filing with, any Governmental Authority or third Person, domestic or foreign, is or has been or will be required on the part of Seller in connection with the execution and delivery of this Agreement or any Ancillary Agreement or the consummation of the transactions contemplated hereby or thereby, except where the failure to obtain such consent would not result in a Material Adverse Effect.
5.3 Non-Contravention. Neither the execution and delivery of this Agreement or any Ancillary Agreement, nor the consummation of the transactions contemplated hereby or thereby, will violate or conflict with or provide a right of termination to any Person under (a) any provision of the Charter or Bylaws of Seller, (b) any law, rule, regulation or Governmental Order to which Seller or the Product and the Assets are bound or subject or (c) any agreement, indenture, undertaking, permit, license or other instrument to which Seller is a party or by which it or any of
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
its properties may be bound or affected, other than (x) the requirements of any applicable bulk sales or bulk transfer laws or (y) where such violation, conflict or right of termination would not result in a Material Adverse Effect.
5.4 Disclosure. There is no fact (other than matters of a general societal, economic or political nature which do not affect the business of Seller or Buyer uniquely) known to Seller, and there have been no events or transactions or information which have come to the attention of Seller, which might reasonably be expected to have a Material Adverse Effect on the Product or the Assets.
5.5 Real Property.
(a) The Lease is a legal, valid and binding agreement enforceable in accordance with its terms and is in full force and effect. There are no existing material defaults under the Lease by Seller and no event of default on the part of Seller or, to the knowledge of Seller, on the part of any other party thereto has occurred which (whether with or without notice, lapse of time or the happening or occurrence of any other event) would constitute a default thereunder permitting landlord to terminate. Subject to consent by the landlord to assignment of the Lease to Buyer, upon consummation of the transactions contemplated by this Agreement, the Lease will continue in full force and effect without penalty or other adverse consequence and shall be unaffected by such transactions. The Lease has not been amended or otherwise affected by any side letter, interpretation or correspondence relating thereto except for amendments provided to Buyer. Seller has made available to Buyer true and correct copies of the Lease.
5.6 Title to Assets. Seller has good and marketable title to the Product and all of the Assets, free and clear of any Encumbrances.
5.7 Intangible Personal Property.
(a) The execution, delivery and performance of this Agreement, the Ancillary Agreements, and the consummation of the transactions contemplated hereby and thereby will not breach, violate or conflict with any instrument or agreement governing any intellectual property necessary or required for, or used in, the conduct of the Business as presently conducted; and
(b) Seller has not been notified of any claim by a third party that Seller's manufacture or sales of the Product violate any proprietary right of any other party. The Product Trademark is subsisting and Seller has no notice of any claims that a third party has any rights thereto. There are no existing or pending patents held by Seller that would prevent Buyer from manufacturing, using or selling the Product. Seller has not received any notice asserting that the manufacture, use or sale of the Product conflicts with the rights of any other party. Seller is not aware of any material unauthorized use, infringement or misappropriation on the part of any third party of the Assets or the Intangible Personal Property.
5.8 Litigation; Legal Matters. There is no Action pending or, to the knowledge of Seller, threatened against or involving Seller or any of the officers, directors, stockholders, properties, assets or businesses of Seller, whether at law or in equity, or before or by any
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Governmental Authority, nor any Governmental Order against, or the subject of which is, the Product or the Assets.
5.9 Employees; Employee Benefit Plans; Labor.
(a) Schedule 5.9 contains a complete and correct list of all employees of Seller whose employment is primarily devoted to the manufacture or sale of the Product (collectively, the "Employees").
(b) There are no employment agreements or other similar arrangements that pertain to any Employee, except standard secrecy agreements for all employees.
(c) Except to the extent provided in Article X, Buyer will incur no Liability with respect to, or on account of, and Seller will retain any Liability for, and on account of, any employee benefit plan of Seller including, but not limited to, Liabilities Seller may have to such employees under all employee benefit schemes, incentive compensation plans, bonus plans, pension and retirement plans, vacation, profit-sharing plans (including any profit-sharing plan with a cash-or-deferred arrangement) share purchase and option plans, savings and similar plans, medical, dental, travel, accident, life, disability and other insurance and other plans or arrangements, whether written or oral and whether "qualified" or "non-qualified," or to any employee as a result of termination of employment by Seller as contemplated by this Agreement.
(d) No Employee is covered under any collective bargaining agreement. With respect to the use of the Assets: (a) there is no unfair labor practice complaint against Seller pending or, to the knowledge of Seller, threatened before the National Labor Relations Board or any comparable state or local Governmental Authority; (b) there is no labor strike, dispute, slowdown or stoppage actually pending or, to the knowledge of Seller, threatened against or directly affecting Seller; (c) no union representation question exists or negotiations regarding union representation have taken place or are ongoing respecting the employees of any of the Business and no notice or demand for union recognition has been received by Seller; (d) no grievance or any Action arising out of or under collective bargaining agreements is pending and no claims therefor exist; (e) no collective bargaining agreement which is binding on Seller prevents it from relocating or closing any of its operations; (f) Seller has not experienced any work stoppage or other labor difficulty; and (g) there are no pending or, to the knowledge of Seller, threatened unfair employment practice charges or administrative proceedings relating to any past or present employees of the Business.
5.10 Environmental Matters. Except as set forth in Schedule 5.10:
(a) to Seller's knowledge, prior to the Closing, Seller has operated and maintained the Business and the Assets, in compliance with all applicable Environmental Laws and Governmental Orders and the requirements of all Environmental Permits held or required to be held by Seller and Seller has not received a notice of violation or other demand from a third Person alleging that the Business is in violation of any Environmental Law;
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
(b) to Seller's knowledge, no Environmental Permits are necessary or required for any activities currently conducted by or on behalf of the Business except for the permit required for the coating process currently conducted in Seller's Mountain View facility;
(c) to Seller's knowledge, there are no underground storage tanks at the Vacaville Facility containing Hazardous Materials or which formerly contained Hazardous Materials; nor is there, to Seller's knowledge, Hazardous Material in any of the fixtures, structures, soils, groundwater, surface water or air on, under or about or emanating from the Assets or the Vacaville Facility,
(d) to Seller's knowledge, the Vacaville Facility is not listed nor proposed for listing on the U.S. National Priorities List under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, 42 U.S.C. (S)(S) 9601 et seq. or on the Comprehensive Environmental Response Compensation Liability Information System or any foreign or state list of sites requiring investigation, remediation or cleanup;
(e) Seller has provided Buyer with true, accurate and complete copies of any Governmental Orders applicable to the Product, the Vacaville Facility and the Assets, and written reports, if any, of material releases of Hazardous Materials on, under, or emanating from the Vacaville Facility in Seller's possession or reasonable control.
5.11 Contracts and Commitments.
(a) True and complete copies of all Contracts (together with all ancillary documents thereto, including any amendments, consents for alterations and documents regarding variations) set forth in Schedule 2.1(c) have been delivered to Buyer.
(b) With respect to the Contracts, (i) each is a legal, valid and binding obligation of Seller and, to the knowledge of Seller, each other party thereto, and is in full force and effect, and (ii) Seller has not been notified that it is in breach of any such Contract, nor has Seller notified the other party that it is in breach of any such Contract.
5.12 Compliance With Laws. Seller has not been notified of any violation of laws or regulations in connection with its manufacture and sale of Product.
5.13 Inventory. All of the Inventories consist of a quality and quantity usable and salable in the ordinary course of business.
5.14 Brokers and Finders. Neither Seller nor any of its officers, directors or employees has employed any broker or finder or incurred any liability for any brokerage fee, commission or finder's fee in connection with the transactions contemplated by this Agreement.
5.15 Permits. Except as disclosed in Section 5.10(b), to Seller's knowledge, there are no governmental licenses, permits, approvals, license applications and product registrations required for the making, using and selling of the Product.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
5.16 Patents. As of the Closing Date, there are no unexpired patents (or equivalent rights) nor applications pending anywhere in the world which are owned or controlled by Seller which would be infringed by the manufacture, use and sale of the Product.
ARTICLE I
REPRESENTATIONS AND WARRANTIES OF BUYER
Buyer represents and warrants to Seller as follows:
6.1 Organization. Buyer is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware.
6.2 Authorization.
(a) Buyer has full corporate power and authority to enter into this Agreement and the Ancillary Agreements and to consummate the transactions contemplated hereby and thereby. The execution and delivery of this Agreement and the Ancillary Agreements and the consummation of the transactions contemplated hereby and thereby have been duly authorized by all necessary corporate action on the part of Buyer. This Agreement has been duly executed and delivered by Buyer. This Agreement constitutes, and upon the execution and delivery thereof by Buyer, each Ancillary Agreement will constitute, a legal, valid and binding obligation of Buyer, enforceable against Buyer in accordance with its terms, except as the enforceability thereof may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar laws affecting the enforcement of creditors' rights generally and general principles of equity (regardless of whether enforceability is considered in a proceeding at law or in equity).
(b) No consent, waiver, approval, order or authorization of, notice to, or registration, declaration, designation, qualification or filing with, any Governmental Authority or third Person, domestic or foreign, is or has been or will be required on the part of Buyer or any of its Affiliates in connection with the execution and delivery of this Agreement or any Ancillary Agreement or the consummation of the transactions contemplated hereby or thereby.
6.3 Non-Contravention. Neither the execution and delivery of this Agreement or any Ancillary Agreement, nor the consummation of the transactions contemplated hereby or thereby, will violate or conflict with (a) any provision of the charter or bylaws of Buyer or any of its Affiliates, (b) any law, rule, regulation or Governmental Order to which Buyer or any such Affiliate or any of their business or assets are bound or subject or (c) any agreement, indenture, undertaking, permit, license or other instrument to which Buyer or any such Affiliate is a party or by which any of them or any of their properties may be bound or affected.
ARTICLE II
CERTAIN COVENANTS
7.1 Access to Information. To the extent reasonably requested by Buyer, Seller shall provide Buyer with information about the Product and the Business following the Closing.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
7.2 Transition. For the [* * *], Seller will conduct the Business on behalf of Buyer under the General Support Services Agreement.
7.3 Confidentiality. After the Closing Date, each party shall, and shall
cause its representatives, Affiliates and employees: (a) to treat and hold as
confidential (and not to disclose or provide access to any Person to) any
confidential information of the other party disclosed in connection with this
transaction or in performance of this Agreement or the Ancillary Agreements; and
(b) in the event that any of them becomes legally compelled to disclose any such
information: (i) to provide the other party with prompt written notice of such
requirement so that such other party or an Affiliate thereof may seek a
protective order or other remedy or waive compliance with this Section 7.3; (ii
in the event that such protective order or other remedy is not obtained, or such
other party waives compliance with this Section 7.3, to furnish only that
portion of such information which is legally required to be provided and to
exercise its best efforts to obtain assurances that confidential treatment will
be accorded such information; and (iii) to the extent permitted by law, to
promptly furnish (prior to, at, or as soon as practicable following such
required disclosure) to the other party any and all copies (in whatever form or
medium) of all such disclosed information; provided, however, that this sentence
shall not apply to any information which, at the time of disclosure, is
available publicly and was not disclosed in breach of this Agreement, or is
subsequently disclosed to the public, or to Seller or Buyer by a third party.
Each party agrees and acknowledges that remedies at law for any breach of its
obligations under this Section 7.3 may be inadequate and that in addition
thereto the other party (or its Affiliate) shall be entitled to seek equitable
relief, including injunction and specific performance, in the event of any such
breach.
7.4 Bulk Sales Compliance. Buyer will not seek to enforce compliance by Seller with the provisions of any bulk sales or transfers law or similar law of any jurisdiction in respect of the transactions contemplated by this Agreement and the Ancillary Agreements.
7.5 Restrictive Covenants.
(a) Except to perform its obligations under this Agreement or the Ancillary Agreements, for a period of [* * *], Seller will not sell for research use in laboratory animals any products that compete directly with the Product and that work in substantially the same way as the Product, or manufacture any such products for such purpose, nor will Seller grant rights to any third party to do so, or own, directly or indirectly, more than [* * *] in any other entity that engages in such activity. Nothing herein shall be deemed to limit the activities of any entity that is the successor or assignee of all or substantially all of Seller's business.
(b) For a period of [* * *], Seller shall not, without Buyer's written consent, solicit for employment at Seller nor hire any Employee, unless such Employee has ceased to be employed by Buyer or any of its Affiliates for at least [* * *]; provided, however, the restriction in this Section 7.5(b) shall not apply to any Employee who Buyer has terminated at its own initiative.
(c) Seller agrees and acknowledges that remedies at law for any breach of Seller's obligations under this Section 7.5 may be inadequate and that in addition thereto Buyer (or its
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Affiliate) shall be entitled to seek equitable relief, including injunction and specific performance, in the event of any such breach.
7.6 Purchase of Inventory. On the Closing Date, Buyer shall purchase the Inventories from Seller at the per unit standard cost set forth on Schedule 7.6. Buyer shall pay Seller the purchase price for the Inventories in accordance with the following schedule: [* * *]; provided, however, that the purchase price shall be paid in full within [* * *], if such purchase price has not been paid in full by that time.
7.7 Product Discussions. At the request of Seller, Buyer shall participate in periodic discussions with Seller summarizing the type and quantity of products sold in connection with the Business, the identity of all customers of the Business and, to the extent known by Buyer, the purpose for which each such product was ordered.
7.8 Promotional and Marketing Material.The parties acknowledge that Buyer intends to continue to utilize the Product Trademark in the marketing and sale of the Product after the Closing. As soon as practicable after the Closing Date, Buyer shall make such changes to the packaging, product labeling, and promotional and marketing materials in connection with the Business as necessary to reflect (i) Buyer as the manufacturer and seller of the Product and (ii) to include Seller's logo and identify Seller as the developer of the Product; provided, however, that finished Product in the Inventories as of the Closing Date may be sold as currently packaged in the ordinary course of business so long as such packaging is modified to indicate Buyer as the seller of such products.
7.9 Vendors. Upon written request by Buyer, after the Closing Date Seller will provide all reasonable assistance to Buyer in contacting and establishing an ongoing business relationship with vendors of supplies, raw materials and services used by Seller in connection with the manufacture and sale of the Product prior to the Closing Date.
7.10 Exploitation of the Business; Discontinuation of the Business. After
the Closing, Buyer will use its [* * *]. If at any time after the Closing
Date, Buyer discontinues the Business (other than as a result of transferring
the Business to a third party), Seller may, at its sole discretion, obtain from
Buyer (i) all rights, title and interest in the Product and the Assets (to the
extent then existing) at a purchase price to be negotiated by the parties and
(ii) the Product inventory then in Buyer's possession at the standard cost
incurred by Buyer therefor.
7.11 No Action. Seller, on behalf of itself, its assigns, successors and Affiliates, hereby covenants that neither it nor its Affiliates, assigns or successors will institute or bring any Action against Buyer, its assigns, successors or Affiliates alleging that the making, using, selling, offering for sale or importation of the Product and Improvements will infringe any patent or equivalent intellectual property rights anywhere in the world owned or controlled by Seller or any of its Affiliates, provided that such Products and Improvements are sold solely for research use in laboratory animals.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
ARTICLE III
INDEMNIFICATION, LIMITATION OF LIABILITY
AND DISCLAIMER OF WARRANTY
8.1 Survival. All representations and warranties of Seller and Buyer and their Affiliates contained in this Agreement and the Ancillary Agreements (including all schedules and exhibits hereto and thereto and all certificates, documents, instruments and undertakings furnished pursuant to this Agreement and the Ancillary Agreements) shall survive the consummation of the transactions contemplated hereby and thereby. All indemnification obligations of Seller and Buyer in this Agreement or the Ancillary Agreements (including all schedules and exhibits thereto and all certificates, documents, instruments and undertakings furnished pursuant to this Agreement and the Ancillary Agreements) shall survive indefinitely. All covenants, obligations and agreements of Buyer and Seller and their Affiliates contained in this Agreement and the Ancillary Agreements (including all schedules and exhibits hereto and thereto and all certificates, documents, instruments and undertakings furnished pursuant to this Agreement and the Ancillary Agreements) shall survive the consummation of the transactions contemplated hereby and thereby.
8.2 Indemnification by Seller. Seller shall indemnify and hold harmless Buyer, its subsidiaries and Affiliates, any assignee or successor thereof, and each officer, director, employee, agent and representative of each of the foregoing (collectively, the "Buyer Indemnified Parties") from and against, and pay or reimburse the Buyer Indemnified Parties for, any and all losses, Actions, Liabilities, damages, claims, costs and expenses (including reasonable expenses of investigation and legal fees and costs in connection therewith), interest, awards, judgments, penalties and Encumbrances suffered or incurred by any of the Buyer Indemnified Parties (hereinafter a "Buyer Loss") to the extent arising from any Action instituted by a third party against any of the Buyer Indemnified Parties relating to the manufacture, use, sale, distribution, import, export or testing of Products, the operation of the Business or the use, operation, ownership, lease, possession, control, occupancy, maintenance or condition of the Assets, in each case, prior to the Closing.
8.3 Indemnification by Buyer. Buyer shall indemnify and hold harmless Seller, any assignee or successor of Seller, and each officer, director, employee, agent and representative of each of the foregoing (collectively, the "Seller Indemnified Parties") from and against, and pay or reimburse the Seller Indemnified Parties for, any and all losses, Actions, Liabilities, damages, claims, costs and expenses (including reasonable expenses of investigation and legal fees and costs in connection therewith), interest, awards, judgments, penalties and Encumbrances suffered or incurred by any of the Seller Indemnified Parties (hereinafter a "Seller Loss") to the extent arising from any Action instituted by a third party against any of the Seller Indemnified Parties relating to any Assumed Liability or the manufacture, use, sale, distribution, import, export or testing of Products, the operation of the Business or the use, operation, ownership, lease, possession, control, occupancy, maintenance or condition of the Assets, in each case, after the Closing.
8.4 General Indemnification Provisions.
(a) For the purposes of this Section 8.4, the term "Indemnitee" shall refer to the Person or Persons indemnified, or entitled, or claiming to be entitled, to be indemnified, pursuant
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
to the provisions of Section 8.2 or 8.3, as the case may be; the term "Indemnitor" shall refer to the Person having the obligation to indemnify pursuant to such provisions; and "Losses" shall refer to Seller Losses or Buyer Losses, as the case may be.
(b) Within a reasonable time following the determination thereof, an
Indemnitee shall give the Indemnitor written notice of any matter which such
Indemnitee has determined has given rise to a right of indemnification under
this Agreement stating the amount of the Loss, if known, and method of
computation thereof, all with reasonable particularity and containing a
reference to the provisions of this Agreement in respect of which such right of
indemnification is claimed or arises (subject to the last sentence of this
subsection). The obligations and Liabilities of any party under this Article
VIII with respect to Losses arising from claims, assertions, events or
proceedings of any third party (including claims by any assignee or successor of
the Indemnitee or any Governmental Authority), which are subject to the
indemnification provided for in this Article VIII ("Third Party Claims") shall
be governed by and be subject to the following additional terms and conditions:
If any Indemnitee shall receive written notice of any Third Party Claim, the
Indemnitee shall promptly give the Indemnitor written notice of such Third Party
Claim (subject to the last sentence of this subsection) and shall permit the
Indemnitor, at its option, to participate in the defense of such Third Party
Claim by counsel of its own choice and at its expense. If the Indemnitor
acknowledges in writing its obligation to indemnify the Indemnitee hereunder
against any Loss (without limitation) that may result from such Third Party
Claim, then the Indemnitor shall be entitled, at its option, to assume and
control the defense against such Third Party Claim at its expense and through
counsel of its choice if it gives written notice of its intention to do so to
the Indemnitee within 15 calendar days of the receipt of notice of such Third
Party Claim from Indemnitee, unless, in the reasonable opinion of counsel for
the Indemnitee, there is a conflict or a potential conflict of interest between
the Indemnitee and the Indemnitor in such Action, in which event the Indemnitee
shall be entitled to direct the defense with respect to those issues as to which
such conflict exists with separate counsel of its choice reasonably acceptable
to the Indemnitor. The fees and expenses of any such separate counsel shall be
borne by the Indemnitor. In the event that the Indemnitor exercises its right to
undertake the defense against any such Third Party Claim as provided above, the
Indemnitee shall cooperate with the Indemnitor in such defense and make
available to the Indemnitor, at Indemnitor's expense, all witnesses, pertinent
records, materials and information in its possession or under its control
reasonably relating thereto as is required by the Indemnitor. Similarly, in the
event the Indemnitee is, directly or indirectly, conducting the defense against
any Third Party Claim, the Indemnitor shall cooperate with the Indemnitee in
such defense and make available to it all witnesses, pertinent records,
materials and information in its possession or under its control reasonably
relating thereto as is reasonably required by the Indemnitee. No such Third
Party Claim, except the settlement thereof which involves the payment of money
only either by a party other than the Indemnitee or for which the Indemnitee is
totally indemnified (without limitation) by the Indemnitor and the unconditional
release from all related liability of the Indemnitee, may be settled by the
Indemnitor without the written consent of the Indemnitee. In the event that an
Indemnitee reasonably determines, and gives notification to the Indemnitor, that
the failure to resolve a Third Party Claim is having a material adverse effect
on the Indemnitee's ongoing business, and as a result the Indemnitee wishes to
propose a settlement of the Third Party Claim and the third party will
unconditionally release the Indemnitor from any and all Liabilities relating
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
to or arising from such Third Party Claim, then the Indemnitor shall not unreasonably withhold its consent to such settlement. If the Indemnitor does not consent to such settlement, the Indemnitee may settle the Third Party Claim on the terms proposed without discharging the Indemnitor from its liability hereunder with respect to such Third Party Claim. The foregoing notwithstanding, the failure of any Indemnitee to give any notice required to be given hereunder shall not affect such Indemnitee's right to indemnification hereunder except to the extent the Indemnitor from whom such indemnity is sought shall have been actually and materially prejudiced in its ability to defend the claim or action for which such indemnification is sought by reason of such failure.
(c) Payment by an Indemnitee to a third party with respect to a Loss shall not affect such Indemnitee's rights to indemnification pursuant to this Article VIII.
8.5 Limitation on Liability.
(a) EXCEPT FOR THE INDEMNIFICATION OBLIGATIONS SET FORTH IN SECTIONS
8.2 AND 8.3 OR AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, IN NO EVENT
SHALL EITHER PARTY BE LIABLE FOR ANY SPECIAL, INDIRECT, PUNITIVE OR
CONSEQUENTIAL DAMAGES ARISING OUT OF OR RELATING TO THE TRANSACTION CONTEMPLATED
BY THIS AGREEMENT, REGARDLESS OF THE FORM OF THE CLAIM, INCLUDING WITHOUT
LIMITATION CLAIMS FOR INDEMNIFICATION, TORT, BREACH OF CONTRACT, WARRANTY,
REPRESENTATION OR COVENANT OR ANY LOSS OF PROFITS, EVEN IF NOTIFIED OF THE
POSSIBILITY OF SUCH DAMAGES AND WHETHER OR NOT SUCH DAMAGES ARE REASONABLY
FORESEEABLE.
(b) Except for the indemnification obligations set forth in Sections 8.2 and 8.3, Buyer's obligation to pay for the inventory set forth in section 7.6 or as otherwise expressly provided in this Agreement, (i) Seller or Buyer's aggregate liability arising out of or related to the transaction contemplated by this Agreement, regardless of the form of the claim or action, is limited to the amount [* * *], and (ii) neither party shall have any claim against the other for any inaccuracy in any representation or breach of warranty set forth in Articles V and VI unless such party shall have given the other party notice of such claim not later than [* * *] after the Closing Date.
8.6 Disclaimer of Warranty. EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, SELLER MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY WARRANTIES OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND OTHER THAN EXPRESSLY SET FORTH IN THIS AGREEMENT, SPECIFICALLY DISCLAIMS ALL SUCH WARRANTIES.
ARTICLE II
TAX MATTERS
9.1 Taxes Relating to Transactions Contemplated by This Agreement. All sales and use taxes imposed in connection with the transfer of the Assets, whether such taxes are
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
assessed initially against Seller or Buyer or any Affiliate of Buyer, shall be borne and paid by Buyer.
ARTICLE I
EMPLOYEES AND EMPLOYEE BENEFIT PLANS
10.1 Business Employees.
(b) Seller will coordinate with Buyer in communicating with the Employees so offered employment by Buyer.
(c) If the employment of any Employee is terminated by Buyer, other than for cause, at any time within [* * *], Buyer agrees to provide [* * *].
(d) Buyer and Seller acknowledge and agree that the Employees are deemed to be third party beneficiaries of this Article X.
10.2 Modification of Confidentiality and Related Agreements. Seller agrees that disclosure of information relating specifically to manufacture, use or sale of the Product or provision of any services by any Person who becomes an employee of Buyer or its Affiliates in connection with the transactions contemplated hereby (a "New Employee") to Buyer or its Affiliates shall not be a violation of any provision of any trade secret, confidentiality, non-compete or comparable agreements entered into prior to the Closing between Seller, on the one hand, and any New Employee, on the other hand.
ARTICLE II
GENERAL PROVISIONS
11.1 Fees and Expenses. Except as otherwise provided in this Agreement, each party will pay all fees and expenses incurred by it in connection with this Agreement, the Ancillary Agreements and the transactions contemplated hereby and thereby.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
11.2 Notices. All notices and other communications given or made pursuant hereto shall be in writing and shall be deemed to have been duly given or made as of the date delivered or mailed if delivered personally or mailed by registered or certified mail (postage prepaid, return receipt requested), or sent by facsimile transmission, (confirmation received) to the parties at the following addresses and facsimile transmission numbers (or at such other address or number for a party as shall be specified by like notice), except that notices after the giving of which there is a designated period within which to perform an act and notices of changes of address or number shall be effective only upon receipt:
(a) If to Seller
ALZA Corporation
1900 Charleston Road
Mountain View, California 94043
Attention: General Counsel
Telecopy No.: 650-564-7848
Telephone No.: 650-564-5260
(b) if to Buyer:
DURECT Corporation
10240 Bubb Road
Cupertino, California 95014-4166
Attention: General Counsel
Telecopy No.: (408) 777-3577
Telephone No.: (408) 777-1827
with a copy to:
Orrick, Herrington & Sutcliffe LLP
Old Federal Reserve Bank Building
400 Sansome Street
San Francisco, California 94111
Attention: Richard V. Smith, Esq.
Telecopy No.: (415) 773-5759
Telephone No.: (415) 392-1122
11.3 Interpretation; Conflict Between Agreements.
(a) When a reference is made in this Agreement to Sections, subsections, Schedules or Exhibits, such reference shall be to a Section, subsection, Schedule or Exhibit to this Agreement unless otherwise indicated. The words "include," "includes" and "including" when used herein shall be deemed in each case to be followed by the words "without limitation." The word "herein" and similar references mean, except where a specific Section or Article reference is
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
expressly indicated, the entire Agreement rather than any specific Section or Article. The table of contents and the headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement. Except as otherwise expressly provided herein, all monetary amounts referenced in this Agreement shall mean U.S. dollars.
(b) In the event of any inconsistency, conflict or ambiguity as to the rights and obligations of the parties under this Agreement and any Ancillary Agreement, the terms of this Agreement shall control and supersede any such inconsistency, conflict or ambiguity.
11.4 Severability. If any term or other provision of this Agreement is invalid, illegal or incapable of being enforced by any rule of statute, law, regulation, Governmental Order or public policy, all other conditions and provisions of this Agreement shall nevertheless remain in full force and effect so long as the economic or legal substance of the transactions contemplated hereby is not affected in any manner adverse to any party. In such event, any such term or provision shall be modified, amended and limited to the extent necessary to render the same and the remainder of this Agreement valid, enforceable and lawful.
11.5 Assignment. This Agreement may not be assigned by operation of law or otherwise, except that either party (including its Affiliates) may assign its rights and benefits hereunder and under the Ancillary Agreements (provided that the assigning party or its Affiliates, as applicable, shall remain responsible for its obligations hereunder) (a) to any Affiliate of the assigning party, (b) to any Person acquiring all or substantially all of the assets and properties of the assigning party or, (c) in the case of Buyer, to any person acquiring all or substantially all of the assets and properties of the Business, as such Business is then conducted by Buyer and its Affiliates. Subject to the preceding sentence, this Agreement will apply to, be binding in all respects upon and inure to the benefit of the successors and permitted assigns of Buyer and Seller.
11.6 No Third-Party Beneficiaries. Other than as set forth in Section 10.1(d), this Agreement is for the sole benefit of the parties hereto and their permitted assigns and nothing herein expressed or implied shall give or be construed to give to any Person, other than the parties hereto and such assigns, any legal or equitable rights hereunder.
11.7 Amendment, Other Remedies and Waiver.
(a) This Agreement may not be amended or modified except by an instrument in writing signed by Seller and Buyer.
(b) The rights and remedies of the parties to this Agreement are cumulative and not alternative of any other remedy conferred hereby or by law or equity, and the exercise of any remedy will not preclude the exercise of any other.
(c) Neither the failure nor any delay by any party in exercising any right, power or privilege under this Agreement or any Ancillary Agreement will operate as a waiver of such right, power or privilege, and single or partial exercise of any such right, power or privilege will preclude any other or further exercise of such right, power or privilege or the exercise of any
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
other right, power or privilege. To the maximum extent permitted by law, (i) no Action or right arising out of this Agreement or the Ancillary Agreements can be discharged by one party, in whole or in part, by a waiver or renunciation of the Action or right unless in a writing signed by the other party; (ii) no waiver that may be given by a party will be applicable except in the specific instance for which it is given; and (iii) no notice to or demand on one party will be deemed to be a waiver of any obligation of such party or of the right of the party giving such notice or demand to take further action without notice or demand as provided in this Agreement or the documents referred to in this Agreement.
11.8 Further Assurances. Each of Buyer and Seller agrees to (a) cooperate
fully with the other party, and to cause its Affiliates to cooperate fully, (b)
execute and cause such Affiliates to execute such further instruments, documents
and agreements, and (c) give such further written assurances as may be
reasonably requested by Buyer or Seller, as the case may be, to evidence and
reflect the transactions described herein and contemplated hereby and to carry
into effect the intents and purposes of this Agreement. If at any time and from
time to time after the Closing Date (without limitation as to time or otherwise)
Buyer reasonably determines that all of Seller's rights, title and interests in
and to an Asset has failed to be fully transferred and conveyed in accordance
with this Agreement to Buyer or an Affiliate thereof, as the case may be, then
Seller shall cause such Asset to be transferred and conveyed to Buyer or an
Affiliate thereof in accordance with this Agreement as soon as reasonably
practicable after notice from Buyer to Seller. If requested by Buyer, Seller
shall prosecute or otherwise enforce in its own name for the benefit of Buyer
any claims, rights or benefits that are transferred to Buyer and its Affiliates
by this Agreement and that require prosecution or enforcement in the name of
Seller. Any prosecution or enforcement of claims, rights or benefits under this
Section 11.8 shall be solely at Buyer's expense, unless the prosecution or
enforcement is made necessary by a breach of this Agreement by Seller. Following
the Closing Date, Seller shall refer to Buyer and its Affiliates, as
appropriate, as promptly as practicable, any telephone calls, letters, orders,
notices, requests, inquiries and other communications relating to the Assets and
the Business.
11.9 Mutual Drafting. This Agreement is the joint product of Buyer and Seller and each provision hereof has been subject to the mutual consultation, negotiation and agreement of Buyer and Seller and shall not be construed for or against any party hereto.
11.10 Governing Law; Consent to Jurisdiction. This Agreement shall be governed
by, and construed in accordance with, the laws of the State of California
(without giving effect to its choice of law principles). Subject to Section
11.11, each of the parties hereto irrevocably submits to the exclusive
jurisdiction of (a) the Superior Court of the State of California, San Francisco
County, and (b) the United States District Court for the Northern District of
California, for the purposes of any Action arising out of this Agreement, any
Ancillary Agreement or any transaction contemplated hereby or thereby. Each of
the parties hereto agrees to commence any Action relating hereto either in the
United States District Court for the Northern District of California, or if such
Action may not be brought in such court for jurisdictional reasons, in the
Superior Court of the State of California, San Francisco County. Each of the
parties hereto further agrees that service of any process, summons, notice or
document by U.S. registered mail to such party's respective address set forth in
Section 11.2 shall be effective service of process for any Action in
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
California with respect to any matters to which it has submitted to jurisdiction in this Section 11.10. Each of the parties hereto irrevocably and unconditionally waives any objection to the laying of venue of any Action arising out of this Agreement, any Ancillary Agreement or any transaction contemplated hereby or thereby in (i) the Superior Court of the State of California, San Francisco County, or (ii) the United States District Court for the Northern District of California, and hereby further irrevocably and unconditionally waives and agrees not to plead or claim in any such court that any such Action brought in any such court has been brought in an inconvenient forum.
11.11 Dispute Resolution. Any dispute, controversy or claim between the parties relating to, arising out of or in connection with this Agreement or the Ancillary Agreements (or any subsequent agreements or amendments thereto), including as to their existence, enforceability, validity, interpretation, performance, indemnification, breach or damages, including claims in tort, whether arising before or after the termination of this Agreement, shall be settled only by binding arbitration pursuant to the Commercial Arbitration Rules, as then amended and in effect, of the American Arbitration Association (the "Rules"), subject to the following:
(a) The arbitration shall take place in San Francisco County, California, and in no other place.
(b) There shall be one arbitrator, who shall be selected under the normal procedures prescribed in the Rules.
(c) Subject to legal privileges, each party shall be entitled to discovery in accordance with the Federal Rules of Civil Procedure.
(d) The arbitrators shall comply with Section 11.10, provided that the procedural law shall be the U.S. Arbitration Act, as amended, to the extent not inconsistent with the Rules and this Section 11.11.
(e) At the arbitration hearing, each party may make written and oral presentations to the arbitrator, present testimony and written evidence and examine witnesses.
(f) The arbitrators' decision shall be in writing, shall be binding and final and may be entered and enforced in any court of competent jurisdiction.
(g) The arbitrators shall have the authority to grant injunctive relief and order specific performance.
(h) No party shall be eligible to receive, and the arbitrators shall not have the authority to award, exemplary or punitive damages.
(i) Each party to the arbitration shall bear their own attorney's fees and costs, but shall pay one-half of the fees and expenses of the arbitrators and the American Arbitration Association.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
11.12 Counterparts. This Agreement may be executed in one or more counterparts, and by the different parties hereto in separate counterparts, each of which when executed shall be deemed to be an original but all of which taken together shall constitute one and the same agreement.
11.13 Public Announcements. Neither Buyer, Seller nor the representatives of either of them shall issue to the media any news release or other public announcement with respect to this Agreement or the transactions contemplated hereby without the prior written consent of the other party hereto. The foregoing notwithstanding, any such news release or other public announcement may be made if required by applicable law or a securities exchange rule, provided that the party required to make such news release or other public announcement shall confer with the other party concerning the timing and content of such news release or other public announcement before the same is made. Buyer and Seller will consult with each other concerning the means by which employees, customers and suppliers and others having dealings with Seller with respect to the Business will be informed of the transactions contemplated hereby, and Buyer shall be allowed to have present for any such communication a representative of Buyer.
11.14 Entire Agreement. This Agreement, together with all Schedules and Exhibits hereto, and the documents and instruments and other agreements among the parties delivered pursuant hereto, constitute the entire agreement and supersede all prior agreements and undertakings, both written and oral, among Buyer and Seller with respect to the subject matter hereof and are not intended to confer upon any other Person any rights or remedies hereunder, except as otherwise expressly provided herein.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
IN WITNESS WHEREOF, Buyer and Seller have caused this Agreement to be executed as of the date first written above by their respective officers thereunto duly authorized.
DURECT CORPORATION, INC.,
a Delaware corporation
By: /s/ James E. Brown ________________________________ Name: James E. Brown Title: Chief Executive Officer |
ALZA CORPORATION,
a Delaware corporation
By: /s/ Peter Staple ________________________________ Name: Peter Staple Title: Executive Vice President |
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
ATTACHMENTS
EXHIBITS
Exhibit A General Support Services Agreement Exhibit B Coating Services Agreement Exhibit C New Models Development Agreement Exhibit D Form of Trademark Assignment Schedule 1 Product and Accessory Products Schedule 2.1 (a) Inventories Schedule 2.1 (b) Fixed Assets Schedule 2.1 (c) Contracts Schedule 2.1 (d) Lease Schedule 2.1 (e) Trademarks Schedule 2.1 (f) Marketing Materials Schedule 5.9 Employees Schedule 5.10 Environmental Matters Schedule 7.6 Inventory Price List |
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
GENERAL SUPPORT SERVICES AGREEMENT
This GENERAL SUPPORT SERVICES AGREEMENT (this "Agreement"), dated as of April 14, 2000 (the "Effective Date" ), is made by and between ALZA CORPORATION, a Delaware corporation ("Seller"), and DURECT CORPORATION, a Delaware corporation ("Buyer").
R E C I T A L S
A. Seller and Buyer have entered into a Product Acquisition Agreement of even date herewith (the "Acquisition Agreement"), providing for the sale by Seller to Buyer of certain Assets (as defined in the Acquisition Agreement).
B. Buyer desires that Seller render certain services to Buyer on an interim basis to assist in the operation of the Business (as defined in the Acquisition Agreement) of the manufacture and sale of the Product (as defined in the Acquisition Agreement). Seller is willing to perform such services on the terms and subject to the conditions set forth herein.
A G R E E M E N T
In consideration of the premises and the respective covenants and obligations set forth herein the parties agree as follows:
(c) The services provided by Seller to Buyer under subsection 1(a) and 1(b) are individually and collectively referred to hereafter as the "Services".
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
develop its ability to provide to itself the Services and/or obtain alternate sources of supply for the Services as soon as practicable after the Effective Date. Buyer may terminate this Agreement with respect to any item of Service upon [* * *] prior written notice to Seller. Unless this Agreement is renewed by mutual agreement of the parties, this Agreement shall terminate not later than December 31, 2000; provided that, no such termination shall affect the obligations of Buyer to make payments due hereunder.
With respect to Services during the Transition Period, it is intended that [* * *]. Buyer and Seller shall coordinate with each other to account for and -- implement the foregoing provision in a mutually acceptable manner. After the Transition Period [* * *]. Seller's [* * *]. -- 4. Invoicing. Seller shall invoice Buyer for the Services on one or --------- more invoices at such intervals as Seller shall determine, provided that Seller |
will not invoice Buyer more than once per month. All payments shall be due and payable 30 days after the date of the invoice.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
representatives, successors and assigns, from and against any and all claims, liabilities, obligations, losses, deficiencies and damages (except for criminal penalties) or judgments of any kind or nature whatsoever arising from or associated with provision of the Services set forth on Exhibit A, including reasonable fees and expenses of counsel.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
(a) If to Seller
ALZA Corporation
1900 Charleston Road
Mountain View, California 94043Attention: General
CounselTelecopy No.: (650) 564-7848
Telephone No.: (650) 564-5260
(b) if to Buyer:
DURECT Corporation10240 Bubb RoadCupertino,
California 95014-4166Attention: Jean Liu,
Esq.Telecopy No.: (408)777-3577Telephone No.:
(408) 777-1417
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
(a) This Agreement may not be amended or modified except by an instrument in writing signed by Seller and Buyer.
(b) The rights and remedies of the parties to this Agreement are cumulative and not alternative of any other remedy conferred hereby or by law or equity, and the exercise of any remedy will not preclude the exercise of any other.
(c) Neither the failure nor any delay by any party in exercising any right, power or privilege under this Agreement will operate as a waiver of such right, power or privilege, and single or partial exercise of any such right, power or privilege will preclude any other or further exercise of such right, power or privilege or the exercise of any other right, power or privilege. To the maximum extent permitted by law, (i) no Action or right arising out of this Agreement can be discharged by one party, in whole or in part, by a waiver or renunciation of the Action or right unless in a writing signed by the other party; (ii) no waiver that may be given by a party will be applicable except in the specific instance for which it is given; and (iii) no notice to or demand on one party will be deemed to be a waiver of any obligation of such party or of the right of the party giving such notice or demand to take further action without notice or demand as provided in this Agreement or the documents referred to in this Agreement.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first set forth above.
DURECT CORPORATION, ALZA CORPORATION
a Delaware corporation a Delaware corporation By: /s/ James E. Brown By: /s/ Peter Staple _________________________ _________________________ Name: James E. Brown Name: Peter Staple Title: Chief Executive Officer Title: Executive Vice President |
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
EXHIBIT A
Schedule of Services
Services to be Provided:
Payment for Services:
[* * *]
*Materials has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
COATING SERVICES AGREEMENT
This COATING SERVICES AGREEMENT (this "Agreement"), dated as of April 14, 2000 (the "Effective Date"), is made by and between ALZA CORPORATION, a Delaware corporation ("Seller"), and DURECT CORPORATION, a Delaware corporation ("Buyer").
R E C I T A L S
A. Seller and Buyer have entered into a Product Acquisition Agreement of even date herewith (the "Acquisition Agreement"), providing for the sale by Seller to Buyer of certain Assets (as defined in the Acquisition Agreement).
B. Buyer desires that Seller render certain services to Buyer on an interim basis to assist in the operation of the Business (as defined in the Acquisition Agreement) of the manufacture and sale of the Product (as defined in the Acquisition Agreement). Seller is willing to perform such services on the terms and subject to the conditions set forth herein.
A G R E E M E N T
In consideration of the premises and the respective covenants and obligations set forth herein the parties agree as follows:
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
(a) If to Seller
ALZA Corporation
1900 Charleston Road
Mountain View, California 94043
Attention: General Counsel
Telecopy No.: (650) 564-7848
Telephone No.: (650) 564-5260
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
(b) if to Buyer:
DURECT Corporation
10240 Bubb Road
Cupertino, California 95014-4166
Attention: Jean Liu, Esq.
Telecopy No.: (408) 777-3577
Telephone No.: (408) 777-1417
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
(a) This Agreement may not be amended or modified except by an instrument in writing signed by Seller and Buyer.
(b) The rights and remedies of the parties to this Agreement are cumulative and not alternative of any other remedy conferred hereby or by law or equity, and the exercise of any remedy will not preclude the exercise of any other.
(c) Neither the failure nor any delay by any party in exercising any right, power or privilege under this Agreement will operate as a waiver of such right, power or privilege, and single or partial exercise of any such right, power or privilege will preclude any other or further exercise of such right, power or privilege or the exercise of any other right, power or privilege. To the maximum extent permitted by law, (i) no Action or right arising out of this Agreement can be discharged by one party, in whole or in part, by a waiver or renunciation of the Action or right unless in a writing signed by the other party; (ii) no waiver that may be given by a party will be applicable except in the specific instance for which it is given; and (iii) no notice to or demand on one party will be deemed to be a waiver of any obligation of such party or of the right of the party giving such notice or demand to take further action without notice or demand as provided in this Agreement or the documents referred to in this Agreement.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first set forth above.
DURECT CORPORATION, ALZA CORPORATION a Delaware corporation a Delaware corporation By: /s/ James E. Brown By: /s/ Peter Staple ------------------------------- --------------------------------- Name: James E. Brown Name: Peter Staple Title: Chief Executive Officer Title: Executive Vice President |
EXHIBIT A
Schedule of Services
Services to be Provided:
Responsibilities of ALZA in Provision of Services:
Responsibilities of DURECT in Provision of Services:
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
NEW MODELS DEVELOPMENT AGREEMENT
THIS NEW MODELS DEVELOPMENT AGREEMENT ("AGREEMENT") IS ENTERED INTO AS OF
APRIL 14, 2000 BETWEEN ALZA CORPORATION ("ALZA") AND DURECT CORPORATION
("DURECT").
A. ALZA and DURECT are parties to a Product Acquisition Agreement ("Acquisition Agreement") dated the date hereof, whereby DURECT acquired ALZA's right, title and interest in and to the osmotic, miniature, implantable pumps for research use in laboratory animals, sold under the trademark ALZET(R) (the "Product").
B. The parties desire that ALZA continue certain in-process development of two New Models of the Product.
NOW THEREFORE, in consideration of the mutual covenants and agreements provided herein, the parties hereby agree as follows:
2.1 Promptly after execution of this Agreement and approval of a work plan as described in Section 2.2, ALZA will commence the Program activities necessary to continue development of the New Models. In connection with the Program, both parties will make available appropriate scientific, engineering and other
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC. 10
personnel to perform tasks under the Program. The parties will use reasonable commercial efforts to carry out the Program, will participate in periodic conferences to review its status and will cooperate in the prompt preparation and review of, and discussion concerning, work plans and cost estimates and revisions thereto described in Section 2.2.
2.2 ALZA and DURECT agree to cooperate to devise mutually acceptable work plans and cost estimates for the development of the New Models. The parties understand and agree that it is difficult to accurately predict the activities that will be necessary to develop the New Models, or the cost thereof, and significant uncertainties exist in any product development effort. As a result, any such work plan and cost estimate will be diligently reviewed and revised from time to time in order that it remain a faithful best-estimate of work to be done by the parties under the Program and, with regard to ALZA's activities, the Development Costs thereof.
Any inventions and information solely relating to the New Models ("Inventions") and any intellectual property rights therein and thereto will be the property of DURECT, without regard to whether the Inventions are made by employees of DURECT, ALZA or both parties. ALZA shall promptly disclose any such Inventions to DURECT, execute all required instruments to assign ownership of such Inventions to DURECT and cooperate with DURECT to obtain and enforce any patents or other registrations covering such Inventions. This provision will survive the termination of this Agreement for any reason.
4.1 Unless earlier terminated under Section 4.2, this Agreement will remain in effect until completion of the development of the New Models.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC. 11
4.2 DURECT may terminate this Agreement at any time upon not less than 30 days' written notice to ALZA. ALZA may terminate this Agreement upon not less than 30 days' written notice to DURECT, if DURECT fails to pay any amounts due to ALZA under this Agreement within 30 days after the date of invoice, unless DURECT shall have paid such outstanding amounts within 30 days of DURECT's receipt of ALZA's written notice thereof.
4.3 Termination of this Agreement will be without prejudice to ALZA's right to receive payment of all Development Costs incurred prior to the effective date of the termination. After termination of this Agreement by DURECT or termination by ALZA due to a breach of this Agreement by DURECT, DURECT will reimburse ALZA, within 30 days after invoice, for any uncancellable obligations and expenses incurred by ALZA prior to such termination in connection with the Program and all costs incurred by ALZA in terminating the Program.
5.1 This Agreement will be governed by and construed in accordance with the laws of the State of California, excluding any choice of law rules which may direct the application of the laws of another jurisdiction.
5.2 This Agreement will not be amended or modified except in a writing signed by each of the parties hereto.
5.3 All notices, requests and other communications required or permitted to be given hereunder or with respect hereto will be in writing, and may be given by (i) personal delivery, (ii) registered first-class United States mail, postage prepaid by the sender, return receipt requested, (iii) overnight delivery service, charges prepaid by the sender, or (iv) via facsimile and, in each case, addressed to the other party at the address for such party as set forth below, and will be effective upon receipt in the case of (i) (iii) or (iv) above, and five days after mailing in the case of (ii) above.
If to ALZA: ALZA Corporation 1900 Charleston Road Mountain View, CA 94043 Fax #: 650-564-7848 Attention: Senior Vice President and General Counsel |
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC. 12
If to DURECT: DURECT CORPORATION
10240 Bubb Road
Cupertino, CA 95014
Fax #: (408) 777-3577
Attention: General Counsel
Any party may change its address at which notice is to be received by written notice provided pursuant to this Section 5.3.
5.4 Each party will be responsible for assuring that all applicable rules, laws and regulations are met in the performance of its duties hereunder.
5.5 This Agreement, together with the exhibits hereto, sets forth the entire agreement and understanding between the parties with respect to the subject matter hereof, and supersedes all prior agreements and understandings between the parties with respect to the subject matter hereof, whether oral or in writing.
5.6 Neither party will be liable to the other due to the termination of this Agreement as provided herein, whether in loss of good will, anticipated profits or otherwise.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first set forth above.
ALZA CORPORATION DURECT CORPORATION
By: /s/ Peter Staple By: /s/ James E. Brown __________________________ _________________________ Title: Executive Vice President Title: Chief Executive Officer __________________________ _________________________ |
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC. 13
EXHIBIT A
DEVELOPMENT COSTS
Development Costs are equal to the sum of (i) research expenses, (ii) general and administrative expenses and (iii) capital asset expenditures.
(i) Research expenses include both direct expenses and indirect expenses.
(a) Direct expenses include direct research salaries (including project management and temporary labor), clinical expenses, supplies and other expenses incurred specifically in connection with the Program.
(b) Indirect expenses include general research management and support costs of the research and product development organization. Indirect expenses are allocated to all projects and billed to clients at a fixed rate* of 160% of direct research salaries.
Examples of items included in direct and indirect expenses are listed on Exhibit A-1
(ii) General and administrative expenses are allocated among the research and product development, manufacturing and marketing organizations. The portion allocated to the research and product development organization is then allocated to all research and development projects and billed to clients at a fixed rate* of 80% of direct research salaries.
Examples of items included in general and administrative expenses are listed on Exhibit A-1.
(iii) Capital asset expenditures are the actual costs of new capital assets acquired specifically for the project.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC. 1
EXHIBIT A-1
Direct research salaries*
Project clinical expenses and outside services
Project specific supplies
Project travel and related expenses
Miscellaneous project expenses
Regulatory and filing fees and maintenance payments
Research management and indirect salaries*
General research supplies and materials
General research consulting and outside services
Facilities expenses
Telephone and communications
Equipment depreciation, rent, maintenance and services
Research travel and related expenses
Patent and trademark expenses
Miscellaneous indirect research expenses
Corporate management, administrative, and indirect salaries*
Telephone and communications
Equipment depreciation, rent, maintenance and services
Board of directors and corporate consulting
Annual audit, accounting and legal expenses
Facilities expenses
Information services (data processing) expenses
Interest expense
Miscellaneous general and administrative expenses
*Salaries include fringe benefits at a fixed rate of 52% of salaries. This fixed rate will not be changed prior to January 1, 2001 and, if changed on or after January 1, 2001, such changes will be limited to not more than one change per calendar year and shall be a maximum of 10% of the rate in effect at the time of the increase.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
A General Description
------------------------------------------------------------------ Item Part # ------------------------------------------------------------------ [ * * * ] [ * * * ] ------------------------------------------------------------------ [ * * * ] [ * * * ] ------------------------------------------------------------------ [ * * * ] [ * * * ] ------------------------------------------------------------------ [ * * * ] [ * * * ] ------------------------------------------------------------------ [ * * * ] [ * * * ] ------------------------------------------------------------------ [ * * * ] [ * * * ] ------------------------------------------------------------------ [ * * * ] [ * * * ] ------------------------------------------------------------------ [ * * * ] [ * * * ] ------------------------------------------------------------------ [ * * * ] [ * * * ] ------------------------------------------------------------------ [ * * * ] [ * * * ] ------------------------------------------------------------------ [ * * * ] [ * * * ] ------------------------------------------------------------------ [ * * * ] [ * * * ] ------------------------------------------------------------------ [ * * * ] [ * * * ] ------------------------------------------------------------------ [ * * * ] [ * * * ] |
. [ * * * ]
. [ * * * ]
Non-Profiled Document
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
The attached inventory list is subject to confirmation by Seller and Buyer.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Asset No. Description -------- ----------- [[ * * * ] [ * * * ] - |
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
5. Distributorship Agreement between ALZA and [[ * * * ]
6. Distributorship Agreement between ALZA and [[ * * * ]
7. Distributorship Agreement between ALZA and [ * * * ]
8. Distributorship Agreement between ALZA and [[ * * * ]
9. Distributorship Agreement between ALZA and [[ * * * ]
10. Distributorship Agreement between ALZA and [ * * * ]
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Lease between ALZA and Chevron Land and Development Company dated February 1, 1986, as amended October 15, 1990, January 25, 1995, March 27, 1997 and December 1, 1999.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
TRADEMARKS
1. ALZET
------------------------------------------------------------------------------------------------------------ Trademark Name: Country Name Registration No: Reg. Date: Classes: ------------------------------------------------------------------------------------------------------------ ALZET [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------ ALZET [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------ ALZET [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------ ALZET [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------ ALZET [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------ ALZET [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------ ALZET [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------ ALZET [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------ ALZET [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------ ALZET [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------ ALZET [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------ ALZET [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------ ALZET [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------ ALZET [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------ ALZET [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------ ALZET [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------ ALZET [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------ ALZET [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------ ALZET [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------ ALZET [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------ |
2. SPECIAL DELIVERY
------------------------------------------------------------------------------------------------------------------- Country Trademark Name: Owner Name Registration No: Reg. Date: Classes: ------------------------------------------------------------------------------------------------------------------- [***] SPECIAL DELIVERY [***] [***] [***] [***] ------------------------------------------------------------------------------------------------------------------- |
3. ALZAID
------------------------------------------------------------------------------------------------------------------- Country Trademark Name: Owner Registration No: Reg. Date: Classes: ------------------------------------------------------------------------------------------------------------------- [***] ALZAID [***] [***] [***] [***] -------------------------------------------------------------------------------------------------------------------- |
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
[[ * * * ]
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Name Title ---- ----- [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] |
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
The following are exceptions to the representations and warranties of Seller in
Section 5.10:
[ * * * ]
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Part # Price (per Unit) ----- ---------------- [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] [ * * * ] |
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT
DURECT CORPORATION
TABLE OF CONTENTS
Page ---- 1 ACCOUNTING AND OTHER TERMS.............................................. 4 -------------------------- 2 LOAN AND TERMS OF PAYMENT............................................... 4 ------------------------- 2.1 Credit Extensions.................................................. 4 2.2 Interest Rate, Payments............................................ 5 2.3 Fees............................................................... 6 3 CONDITIONS OF LOANS..................................................... 6 ------------------- 3.1 Conditions Precedent to Initial Credit Extension................... 6 3.2 Conditions Precedent to all Credit Extensions...................... 6 4 CREATION OF SECURITY INTEREST........................................... 7 ----------------------------- 4.1 Grant of Security Interest......................................... 7 5 REPRESENTATIONS AND WARRANTIES.......................................... 7 ------------------------------ 5.1 Due Organization and Authorization................................. 7 5.2 Collateral......................................................... 7 5.3 Litigation......................................................... 7 5.4 No Material Adverse Change in Financial Statements................. 7 5.5 Solvency........................................................... 8 5.6 Regulatory Compliance.............................................. 8 5.7 Subsidiaries....................................................... 8 5.8 Full Disclosure.................................................... 8 6 AFFIRMATIVE COVENANTS................................................... 8 --------------------- 6.1 Government Compliance.............................................. 8 6.2 Financial Statements, Reports, Certificates........................ 9 6.3 Inventory; Returns................................................. 9 6.4 Taxes.............................................................. 9 6.5 Insurance.......................................................... 9 6.6 Primary Accounts................................................... 9 6.7 Loss; Destruction; or Damage....................................... 9 6.8 Further Assurances................................................. 10 7 NEGATIVE COVENANTS...................................................... 10 ------------------ 8 EVENTS OF DEFAULT....................................................... 11 ----------------- 8.1 Payment Default.................................................... 11 8.2 Covenant Default................................................... 11 8.3 Material Adverse Change............................................ 11 8.4 Attachment......................................................... 11 8.5 Insolvency......................................................... 11 8.6 Other Agreements................................................... 12 8.7 Judgments.......................................................... 12 8.8 Misrepresentations................................................. 12 9 BANK'S RIGHTS AND REMEDIES.............................................. 12 -------------------------- 9.1 Rights and Remedies................................................ 12 9.2 Power of Attorney.................................................. 12 9.3 Accounts Collection................................................ 13 |
9.4 Bank Expenses...................................................... 13 9.5 Bank's Liability for Collateral.................................... 13 9.6 Remedies Cumulative................................................ 13 9.7 Demand Waiver...................................................... 13 10 NOTICES................................................................. 13 ------- 11 CHOICE OF LAW , VENUE AND JURY TRIAL WAIVER............................. 14 ------------------------------------------- 12 GENERAL PROVISIONS...................................................... 14 ------------------ 12.1 Successors and Assigns............................................ 14 12.2 Indemnification................................................... 14 12.3 Time of Essence................................................... 14 12.4 Severability of Provision......................................... 14 12.5 Amendments in Writing, Integration................................ 14 12.6 Counterparts...................................................... 15 12.7 Survival.......................................................... 15 12.8 Confidentiality................................................... 15 12.9 Effect of Amendment and Restatement............................... 15 12.10 Attorneys' Fees, Costs and Expenses............................... 15 13 DEFINITIONS............................................................. 15 ----------- 13.1 Definitions....................................................... 15 |
This AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT dated December 16, 1999, between SILICON VALLEY BANK ("Bank"), whose address is 3003 Tasman Drive, Santa Clara, California 95054 and DURECT CORPORATION ("Borrower"), whose address is 10240 Bubb Road, Cupertino, California 95014.
RECITALS
A. Bank and Borrower are parties to that certain QuickStart Loan and Security Agreement, dated October 29, 1998, as amended (the "Original Agreement").
B. Borrower and Bank desire in this Agreement to set forth their agreement with respect to an equipment line and term loan and to amend and restate in its entirety without novation the Original Agreement in accordance with the provisions herein. This Agreement shall be construed to impart upon Bank a duty to act reasonably at all times.
AGREEMENT
The parties agree as follows:
Accounting terms not defined in this Agreement will be construed following GAAP. Calculations and determinations must be made following GAAP. The term "financial statements" includes the notes and schedules. The terms "including" and "includes" always mean "including (or includes) without limitation," in this or any Loan Document.
2.1 Credit Extensions.
Borrower will pay Bank the unpaid principal amount of all Credit Extensions and interest on the unpaid principal amount of the Credit Extensions.
2.1.1 Equipment Advances.
(a) Subject to the terms and conditions of this Agreement, Bank agrees to
lend to Borrower, from time to time prior to the Commitment Termination Date,
equipment advances (each an "Equipment Advance" and collectively the "Equipment
Advances") in an aggregate amount not to exceed the Committed Equipment Line.
When repaid, the Equipment Advances may not be re-borrowed. The proceeds of the
Equipment Advances will be used solely to reimburse Borrower for the purchase of
Eligible Equipment purchased prior to September 30, 1999. Each Equipment
Advance shall be considered a promissory note evidencing the amounts due
hereunder for all purposes. Bank's obligation to lend hereunder shall terminate
on the earlier of (i) the occurrence and continuance of an Event of Default, or
(ii) the Commitment Termination Date. For purposes of this Section, the
minimum amount of each Equipment Advance is $750,000 and the maximum number of
Equipment Advances that will be made is 1.
(a) (b) To obtain an Equipment Advance, Borrower will deliver to Bank a completed supplement in substantially the form attached as Exhibit C ("Loan Supplement"), copies of invoices for the Financed Equipment, together with a UCC Financing Statement covering the Equipment described on the Loan Supplement, and such additional information as Bank may request at least five (5) Business Days before the proposed funding date (the "Funding Date"). On each Funding Date, Bank will specify in the Loan Supplement for each Equipment Advance, the Basic Rate, the Loan Factor, and the Payment Dates. If Borrower satisfies the conditions of each Equipment Advance specified herein, Bank will disburse such Equipment Advance by
internal transfer to Borrower's deposit account with Bank. Each Equipment Advance may not exceed 100% of the Original Stated Cost.
(c) Bank's obligation to lend the undisbursed portion of the Committed Equipment Line will terminate if, in Bank's sole discretion, there has been a material adverse change in the general affairs, management, results of operation, condition (financial or otherwise) or the prospects of Borrower, whether or not arising from transactions in the ordinary course of business, or there has been any material adverse deviation by Borrower from the most recent business plan of Borrower presented to and accepted by Bank prior to the execution of this Agreement.
2.1.2 Term Loan.
(a) Bank will continue to make a Term Loan available to Borrower, pursuant to the Original Agreement.
(b) Borrower will continue to pay its Term Loan obligations in a total of 30 equal installments of principal of $11,111.12 plus Interest (the "Term Loan Payment"). Each Term Loan Payment is payable on the 29th of each month during the term of the loan. Borrower's final Term Loan Payment, due on May 29, 2002, includes all outstanding Term Loan principal and accrued interest.
2.2 Interest Rate, Payments.
2.2.1 Equipment Facility.
Principal and Interest Payments On Payment Dates. Borrower will repay the Equipment Advances on the terms provided in the Loan Supplement. Borrower will make payments monthly of principal and accrued interest for each Equipment Advance (collectively, "Scheduled Payments"), beginning one month following the Funding Date with respect to such Equipment Advance and continuing thereafter during the Repayment Period on the same day of each calendar month (each a "Payment Date"), in an amount equal to the Loan Factor multiplied by the Loan Amount for such Equipment Advance as of such Payment Date. All unpaid principal and accrued interest is due and payable in full on the last Payment Date with respect to such Equipment Advance. Payments received after 12:00 noon Pacific time are considered received at the opening of business on the next Business Day. An Equipment Advance may only be prepaid in accordance with Sections 2.2.1(d) and 2.2.1(f).
(b) Interest Rate. Borrower will pay interest on the Payment Dates (as described above) at the per annum rate of interest equal to the Basic Rate determined by Bank as of the Funding Date for each Equipment Advance in accordance with the definition of the Basic Rate. Any amounts outstanding during the continuance of an Event of Default shall bear interest at a per annum rate equal to the Basic Rate plus five percent (5%) or the maximum permitted by law. If any change in the law increases Bank's expenses or decreases its return from the Equipment Advances, Borrower will pay Bank upon request the amount of such increase or decrease.
(c) Final Payment. On the Maturity Date with respect to each Equipment Advance, Borrower will pay, in addition to the unpaid principal and accrued interest and all other amounts due on such date with respect to such Equipment Advance, an amount equal to the Final Payment.
(d) Prepayment Upon an Event of Loss. If any Financed Equipment is subject to an Event of Loss and Borrower is required to or elects to prepay the Equipment Advance with respect to such Financed Equipment pursuant to Section 6.7, then such Equipment Advance shall be prepaid to the extent and in the manner provided in such section.
(e) Mandatory Prepayment Upon an Acceleration. If the Equipment Advances are accelerated following the occurrence of an Event of Default or otherwise (other than following an Event of Loss), then Borrower will immediately pay to Bank (i) all unpaid Scheduled Payments (including principal and interest) with respect to each Equipment Advance, (ii) all remaining Scheduled Payments (including principal and interest unpaid) (iii) all accrued unpaid interest, including the default rate of interest, to the date of the prepayment, (iv) the Final Payment and (v) all other sums, if any, that shall have become due and payable with respect to any Equipment Advance.
2.2.2 Term Loan.
(a) Interest Rate. The Term Loan accrues interest at a per annum rate of 1.25 percentage points above the Prime Rate. After an Event of Default, Obligations accrue interest at 5 percent above the rate effective immediately before the Event of Default. The interest rate increases or decreases when the Prime Rate changes. Interest is computed on a 360 day year for the actual number of days elapsed.
(b) Payments received after 12:00 noon Pacific time are considered received at the opening of business on the next Business Day. When a payment is due on a day that is not a Business Day, the payment is due the next Business Day and additional fees or interest accrue.
2.2.3 Request to Debit Accounts.
Bank may debit any of Borrower's deposit accounts including Account Number 3300076017 for principal and interest payments or any amounts Borrower owes Bank when due. Bank will notify Borrower when it debits Borrower's accounts. These debits are not a set-off.
2.3 Fees.
Borrower will pay:
Bank Expenses. All Bank Expenses (including reasonable attorneys' fees and reasonable expenses) incurred through and after the date of this Agreement, are payable when due.
3.1 Conditions Precedent to Initial Credit Extension.
Bank's obligation to make the initial Credit Extension is subject to the condition precedent that it receive the agreements and documents that it reasonably requires and fees that it requires; provided, however, that fees shall not exceed $5,000.
3.2 Conditions Precedent to all Credit Extensions.
Bank's obligations to make each Credit Extension, including the initial Credit Extension, is subject to the following:
(a) timely receipt of any Payment/Advance Form; and
(b) the representations and warranties in Section 5 must be materially true on the date of the Payment/Advance Form and on the effective date of each Credit Extension and no Event of Default may have occurred and be continuing, or result from the Credit Extension. Each Credit Extension is Borrower's representation and warranty on that date that the representations and warranties of Section 5 remain materially true.
4.1 Grant of Security Interest.
Borrower grants Bank a continuing security interest in all presently existing and later acquired Collateral to secure all Obligations and performance of each of Borrower's duties under the Loan Documents. Except for Permitted Liens, any security interest will be a first priority security interest in the Collateral. Bank may place a "hold" on any deposit account pledged as Collateral. If this Agreement is terminated, Bank's lien and security interest in the Collateral will continue until Borrower fully satisfies its Obligations. Notwithstanding the foregoing, at such time as the Term Loan is paid in full, Bank will release the Negative Pledge Agreement and its interest in all Collateral, except for any and all Equipment (including all attachments, accessories, accessions, replacements, substitutions, additions, and improvements, wherever located) financed by Equipment Advances.
Borrower represents and warrants as follows:
5.1 Due Organization and Authorization.
Borrower and each Subsidiary is duly existing and in good standing in its state of formation and qualified and licensed to do business in, and in good standing in, any state in which the conduct of its business or its ownership of property requires that it be qualified, except where the failure to do so could not reasonably be expected to cause a Material Adverse Change.
The execution, delivery and performance of the Loan Documents have been duly authorized, and do not conflict with Borrower's formation documents, nor constitute an event of default under any material agreement by which Borrower is bound. Borrower is not in default under any agreement to which or by which it is bound in which the default could cause reasonably be expected to cause a Material Adverse Change.
5.2 Collateral.
Borrower has good title to the Collateral, free of Liens except Permitted Liens. All Inventory is in all material respects of good and marketable quality, free from material defects.
5.3 Litigation.
Except as shown in the Schedule, there are no actions or proceedings pending or, to the knowledge of Borrower's Responsible Officers, threatened by or against Borrower or any Subsidiary in which a likely adverse decision could reasonably be expected to cause a Material Adverse Change.
5.4 No Material Adverse Change in Financial Statements.
All consolidated financial statements for Borrower, and any Subsidiary, delivered to Bank fairly present in all material respects Borrower's consolidated financial condition and Borrower's consolidated results of operations. There has not been any material deterioration in Borrower's
consolidated financial condition since the date of the most recent financial statements submitted to Bank.
5.5 Solvency.
The fair salable value of Borrower's assets (including goodwill minus disposition costs) exceeds the fair value of its liabilities; the Borrower is not left with unreasonably small capital after the transactions in this Agreement; and Borrower is able to pay its debts (including trade debts) as they mature.
5.6 Regulatory Compliance.
Borrower is not an "investment company" or a company "controlled" by an "investment company" under the Investment Company Act. Borrower is not engaged as one of its important activities in extending credit for margin stock (under Regulations T and U of the Federal Reserve Board of Governors). Borrower has complied in all material respects with the Federal Fair Labor Standards Act. To its knowledge, Borrower has not violated any laws, ordinances or rules, the violation of which could reasonably be expected to cause a Material Adverse Change. None of Borrower's or any Subsidiary's properties or assets has been used by Borrower or any Subsidiary or, to the best of Borrower's knowledge, by previous Persons, in disposing, producing, storing, treating, or transporting any hazardous substance other than legally. Borrower and each Subsidiary has timely filed all required tax returns and paid, or made adequate provision to pay, all material taxes, except those being contested in good faith with adequate reserves under GAAP. Borrower and each Subsidiary has obtained all consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all government authorities that are necessary to continue its business as currently conducted, except where the failure to do so could not reasonably be expected to cause a Material Adverse Change.
5.7 Subsidiaries.
Borrower does not own any stock, partnership interest or other equity securities except for Permitted Investments.
5.8 Full Disclosure.
No written representation, warranty or other statement of Borrower in any certificate or written statement given to Bank (taken together with all such written certificates and written statements to Bank) contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements contained in the certificates or statements not misleading. It being recognized by Bank that the projections and forecasts provided by Borrower in good faith and based upon reasonable assumptions are not viewed as facts and that actual results during the period or periods covered by such projections and forecasts may differ from the projected and forecasted results.
Borrower will do all of the following:
6.1 Government Compliance.
Borrower will maintain its and all Subsidiaries' legal existence and good standing in its jurisdiction of formation and maintain qualification in each jurisdiction in which the failure to so qualify would reasonably be expected to cause a material adverse effect on Borrower's business or operations. Borrower will comply, and have each Subsidiary comply, with all laws, ordinances and regulations to which it is subject, noncompliance with which could have a material adverse
effect on Borrower's business or operations or would reasonably be expected to cause a Material Adverse Change.
6.2 Financial Statements, Reports, Certificates.
(a) Borrower will deliver to Bank: (i) as soon as available, but no later than 30 days after the last day of each month, a company prepared consolidated balance sheet and income statement covering Borrower's consolidated operations during the period, in a form and certified by a Responsible Officer acceptable to Bank; (ii) as soon as available, but no later than 90 days after the last day of Borrower's fiscal year, audited consolidated financial statements prepared under GAAP, consistently applied, together with an unqualified opinion on the financial statements from an independent certified public accounting firm reasonably acceptable to Bank; (iii) a prompt report of any legal actions pending or threatened against Borrower or any Subsidiary that could result in damages or costs to Borrower or any Subsidiary of $100,000 or more; and (iv) budgets, sales projections, operating plans or other financial information Bank reasonably requests.
(b) Bank has the right to audit Borrower's Collateral at Borrower's expense, but the audits will be conducted no more often than every quarter unless an Event of Default has occurred and is continuing.
6.3 Inventory; Returns.
Borrower will keep all Inventory in good and marketable condition, free from material defects. Returns and allowances between Borrower and its account debtors will follow Borrower's customary practices as they exist at execution of this Agreement. Borrower must promptly notify Bank of all returns, recoveries, disputes and claims, that involve more than $50,000.
6.4 Taxes.
Borrower will make, and cause each Subsidiary to make, timely payment or filing of extensions of all material federal, state, and local taxes or assessments and will deliver to Bank, on demand, appropriate certificates attesting to the payment.
6.5 Insurance.
Borrower will keep its business and the Collateral insured for risks and in amounts, as Bank requests. Insurance policies will be in a form, with companies, and in amounts that are reasonably customary for companies similar to Borrower and Borrower's industry. All property policies will have a lender's loss payable endorsement showing Bank as an additional loss payee and all liability policies will show the Bank as an additional insured and all policies will provide that the insurer must give Bank at least 20 days notice before canceling its policy. At Bank's request, Borrower will deliver certified copies of policies and evidence of all premium payments. Subject to Section 6.7(a) below, so long as no Event of Default has occurred and is continuing, Borrower shall have the option of applying the proceeds of any casualty policy to the replacement or repair of destroyed or damaged property; provided that, after the occurrence and during the continuance of an Event of Default, all proceeds payable under any such casualty policy shall, at the option of Bank, be payable to Bank on account of the Obligations.
6.6 Primary Accounts.
Borrower will maintain its primary depository and operating accounts with Bank.
6.7 Loss; Destruction; or Damage.
Borrower will bear the risk of the Financed Equipment being lost, stolen, destroyed, or damaged. If during the term of this Agreement any item of Financed Equipment is lost, stolen, destroyed, damaged beyond repair, rendered permanently unfit for use, or seized by a governmental authority for any reason for a period equal to at least the remainder of the term of this Agreement (an "Event of Loss"), then in each case, Borrower:
(a) prior to the occurrence of an Event of Default, at Borrower's option, will (i) pay to Bank on account of the Obligations all accrued interest to the date of the prepayment, plus all outstanding principal, plus the Final Payment; or (ii) repair or replace any Financed Equipment subject to an Event of Loss provided the repaired or replaced Financed Equipment is of equal or like value to the Financed Equipment subject to an Event of Loss and provided further that Bank has a first priority perfected security interest in such repaired or replaced Financed Equipment.
(b) during the continuance of an Event of Default, on or before the Payment Date after such Event of Loss for each such item of Financed Equipment subject to such Event of Loss, Borrower will, at Bank's option, pay to Bank an amount equal to the sum of: (i) all accrued and unpaid Scheduled Payments (with respect to such Equipment Advance related to the Event of Loss) due prior to the next such Payment Date, (ii) all Regularly Scheduled Payments (including principal and interest), (iii) the Final Payment plus (iv) all other sums, if any, that shall have become due and payable, including interest at the Default Rate with respect to any past due amounts.
(c) On the date of receipt by Bank of the amount specified above with respect to each such item of Financed Equipment subject to an Event of Loss, this Agreement shall terminate as to such Financed Equipment. If any proceeds of insurance or awards received from governmental authorities are in excess of the amount owed under this Section, Bank shall promptly remit to Borrower the amount in excess of the amount owed to Bank.
6.8 Further Assurances.
Borrower will execute any further instruments and take further action as Bank reasonably requests to perfect or continue Bank's security interest in the Collateral or to effect the purposes of this Agreement.
Borrower will not do any of the following without Bank's prior written consent, which will not be unreasonably withheld:
(i) Enter into any transaction outside the ordinary course of business
except for the sale of capital stock to venture investors, provided that
Borrower promptly delivers written notification to Silicon of any such sale;
(ii) Sell or transfer any Collateral, except in the ordinary course of business;
(iii) pay or declare any dividends on Borrower's stock (except for dividends
payable solely in stock of Borrower); (iv) Redeem, retire, purchase or otherwise
acquire, directly or indirectly, any of Borrower's stock other than the
repurchase of the Borrower's stock upon termination of the employee, consultant
or director's relationship with Borrower pursuant to the repurchase provisions
of the stock purchase agreement with Borrower; provided, however, such payments
shall not exceed $30,000 in any fiscal year and provided further no Event of
Default exists, is continuing or would result from such action; (v) Change its
name or the chief executive office or principal place of business, move or
dispose of any interest in the Collateral, permit any lien or security interest
to attach to the Collateral, or enter into any transaction outside the ordinary
course of Borrower's business; (vi) Become an "investment company" or a company
controlled by an "investment company," under the Investment Company Act of 1940
or undertake as one of its important activities extending credit to purchase or
carry margin stock, or use the proceeds of any Advance for that purpose; fail to
meet the minimum funding requirements of ERISA, permit a Reportable Event or
Prohibited Transaction, as defined in ERISA, to occur; fail to
comply with the Federal Fair Labor Standards Act or violate any other law or regulation, if the violation could have a material adverse effect on Borrower's business or operations or cause a Material Adverse Change, or permit any of its Subsidiaries to do so; (vii) Create, incur, assume, or be liable for any Indebtedness, or permit any Subsidiary to do so, other than Permitted Indebtedness; (viii) Create, incur, or allow any Lien on any of its property, or assign or convey any right to receive income, including the sale of any Accounts, or permit any of its Subsidiaries to do so, except for Permitted Liens, or permit any Collateral not to be subject to the first priority security interest granted here, subject to Permitted Liens.
Any one of the following is an Event of Default:
8.1 Payment Default.
If Borrower fails to pay any of the Obligations within 3 days after their due date. During the additional period the failure to cure the default is not an Event of Default (but no Credit Extension will be made during the cure period);
8.2 Covenant Default.
If Borrower violates any covenant in Section 7 or does not perform or observe any other material term, condition or covenant in this Agreement, any Loan Documents, or in any agreement between Borrower and Bank and as to any default under a term, condition or covenant that can be cured, has not cured the default within 10 days after it occurs, or if the default cannot be cured within 10 days or cannot be cured after Borrower's attempts within 10 day period, and the default may be cured within a reasonable time, then Borrower has an additional period (of not more than 30 days) to attempt to cure the default. During the additional time, the failure to cure the default is not an Event of Default (but no Credit Extensions will be made during the cure period);
8.3 Material Adverse Change.
If there (i) occurs a material impairment in the perfection or priority of the Bank's security interest in the Collateral or in the value of such Collateral (other than normal depreciation) which is not covered by adequate insurance or (ii) is a material impairment of the prospect of repayment of any portion of the Obligations.
8.4 Attachment.
If any material portion of Borrower's assets is attached, seized, levied on, or comes into possession of a trustee or receiver and the attachment, seizure or levy is not removed in 10 days, or if Borrower is enjoined, restrained, or prevented by court order from conducting a material part of its business or if a judgment or other claim becomes a Lien on a material portion of Borrower's assets, or if a notice of lien, levy, or assessment is filed against any of Borrower's assets by any government agency and not paid within 10 days after Borrower receives notice. These are not Events of Default if stayed or if a bond is posted pending contest by Borrower (but no Credit Extensions will be made during the cure period);
8.5 Insolvency.
If Borrower becomes insolvent or if Borrower begins an Insolvency Proceeding or an Insolvency Proceeding is begun against Borrower and not dismissed or stayed within 30 days (but no Credit Extensions will be made before any Insolvency Proceeding is dismissed);
8.6 Other Agreements.
If there is a default in any agreement between Borrower and a third party that gives the third party the right to accelerate any Indebtedness exceeding $100,000 or that could cause a Material Adverse Change or if a default exists or is declared in the Master Lease Agreement between Borrower as Lessee and Bank as Lessor;
8.7 Judgments.
If a money judgment(s) in the aggregate of at least $50,000 is rendered against Borrower and is unsatisfied and unstayed for 10 days (but no Credit Extensions will be made before the judgment is stayed or satisfied); or
8.8 Misrepresentations.
If Borrower or any Person acting for Borrower makes any material misrepresentation or material misstatement now or later in any warranty or representation in this Agreement or in any writing delivered to Bank or to induce Bank to enter this Agreement or any Loan Document.
9.1 Rights and Remedies.
When an Event of Default occurs and continues Bank may, without notice or demand, do any or all of the following:
(a) Declare all Obligations immediately due and payable (but if an Event of Default described in Section 8.5 occurs all Obligations are immediately due and payable without any action by Bank);
(b) Stop advancing money or extending credit for Borrower's benefit under this Agreement or under any other agreement between Borrower and Bank;
(c) Settle or adjust disputes and claims directly with account debtors for amounts, on terms and in any order that Bank considers advisable;
(d) Make any payments and do any acts it considers necessary or reasonable to protect its security interest in the Collateral. Borrower will assemble the Collateral if Bank requires and make it available as Bank designates. Bank may enter premises where the Collateral is located, take and maintain possession of any part of the Collateral, and pay, purchase, contest, or compromise any Lien which appears to be prior or superior to its security interest and pay all expenses incurred. Borrower grants Bank a license to enter and occupy any of its premises, without charge, to exercise any of Bank's rights or remedies;
(e) Apply to the Obligations any (i) balances and deposits of Borrower it holds, or (ii) any amount held by Bank owing to or for the credit or the account of Borrower;
(f) Ship, reclaim, recover, store, finish, maintain, repair, prepare for sale, advertise for sale, and sell the Collateral; and
(g) Dispose of the Collateral according to the Code.
9.2 Power of Attorney.
Effective only when an Event of Default occurs and continues, Borrower irrevocably appoints Bank as its lawful attorney to: (i) endorse Borrower's name on any checks or other
forms of payment or security; (ii) sign Borrower's name on any invoice or bill of lading for any Account or drafts against account debtors, (iii) make, settle, and adjust all claims under Borrower's insurance policies; (iv) settle and adjust disputes and claims about the Accounts directly with account debtors, for amounts and on terms Bank determines reasonable; and (v) transfer the Collateral into the name of Bank or a third party as the Code permits. Bank may exercise the power of attorney to sign Borrower's name on any documents necessary to perfect or continue the perfection of any security interest regardless of whether an Event of Default has occurred. Bank's appointment as Borrower's attorney in fact, and all of Bank's rights and powers, coupled with an interest, are irrevocable until all Obligations have been fully repaid and performed and Bank's obligation to provide Credit Extensions terminates.
9.3 Accounts Collection.
When an Event of Default occurs and continues, Bank may notify any Person owing Borrower money of Bank's security interest in the funds and verify the amount of the Account. Borrower must collect all payments in trust for Bank and, if requested by Bank, immediately deliver the payments to Bank in the form received from the account debtor, with proper endorsements for deposit.
9.4 Bank Expenses.
If Borrower fails to pay any amount or furnish any required proof of payment to third persons, Bank may make all or part of the payment or obtain insurance policies required in Section 6.5, and take any action under the policies Bank deems prudent. Any amounts paid by Bank are Bank Expenses and immediately due and payable, bearing interest at the then applicable rate and secured by the Collateral. No payments by Bank are deemed an agreement to make similar payments in the future or Bank's waiver of any Event of Default.
9.5 Bank's Liability for Collateral.
If Bank complies with reasonable banking practices and Section 9-207 of the Code, it is not liable for: (a) the safekeeping of the Collateral; (b) any loss or damage to the Collateral; (c) any diminution in the value of the Collateral; or (d) any act or default of any carrier, warehouseman, bailee, or other person. Borrower bears all risk of loss, damage or destruction of the Collateral.
9.6 Remedies Cumulative.
Bank's rights and remedies under this Agreement, the Loan Documents, and all other agreements are cumulative. Bank has all rights and remedies provided under the Code, by law, or in equity. Bank's exercise of one right or remedy is not an election, and Bank's waiver of any Event of Default is not a continuing waiver. Bank's delay is not a waiver, election, or acquiescence. No waiver is effective unless signed by Bank and then is only effective for the specific instance and purpose for which it was given.
9.7 Demand Waiver.
Borrower waives demand, notice of default or dishonor, notice of payment and nonpayment, notice of any default, nonpayment at maturity, release, compromise, settlement, extension, or renewal of accounts, documents, instruments, chattel paper, and guarantees held by Bank on which Borrower is liable.
All notices or demands by any party about this Agreement or any other related agreement must be in writing and be personally delivered or sent by an overnight delivery
service, by certified mail, postage prepaid, return receipt requested, or by telefacsimile to the addresses set forth at the beginning of this Agreement. A party may change its notice address by giving the other party written notice.
California law governs the Loan Documents without regard to principles of conflicts of law. Borrower and Bank each submit to the exclusive jurisdiction of the State and Federal courts in Santa Clara County, California.
BORROWER AND BANK EACH WAIVE THEIR RIGHT TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION ARISING OUT OF ANY OF THE LOAN DOCUMENTS OR ANY CONTEMPLATED TRANSACTION, INCLUDING CONTRACT, TORT, BREACH OF DUTY AND ALL OTHER CLAIMS. THIS WAIVER IS A MATERIAL INDUCEMENT FOR BOTH PARTIES TO ENTER INTO THIS AGREEMENT. EACH PARTY HAS REVIEWED THIS WAIVER WITH ITS COUNSEL.
12.1 Successors and Assigns.
This Agreement binds and is for the benefit of the successors and permitted assigns of each party. Borrower may not assign this Agreement or any rights under it without Bank's prior written consent which may be granted or withheld in Bank's discretion. Bank has the right, without the consent of or notice to Borrower, to sell, transfer, negotiate, or grant participation in all or any part of, or any interest in, Bank's obligations, rights and benefits under this Agreement.
12.2 Indemnification.
Borrower will indemnify, defend and hold harmless Bank and its officers, employees, and agents against: (a) all obligations, demands, claims, and liabilities asserted by any other party in connection with the transactions contemplated by the Loan Documents; and (b) all losses or Bank Expenses incurred, or paid by Bank from, following, or consequential to transactions between Bank and Borrower (including reasonable attorneys fees and expenses), except for losses caused by Bank's gross negligence or willful misconduct.
12.3 Time of Essence.
Time is of the essence for the performance of all obligations in this Agreement.
12.4 Severability of Provision.
Each provision of this Agreement is severable from every other provision in determining the enforceability of any provision.
12.5 Amendments in Writing, Integration.
All amendments to this Agreement must be in writing and signed by Borrower and Bank. This Agreement represents the entire agreement about this subject matter, and supersedes prior negotiations or agreements. All prior agreements, understandings, representations, warranties, and negotiations between the parties about the subject matter of this Agreement merge into this Agreement and the Loan Documents.
12.6 Counterparts.
This Agreement may be executed in any number of counterparts and by different parties on separate counterparts, each of which, when executed and delivered, are an original, and all taken together, constitute one Agreement.
12.7 Survival.
All covenants, representations and warranties made in this Agreement continue in full force while any Obligations remain outstanding. The obligations of Borrower in Section 12.2 to indemnify Bank will survive until all statutes of limitations for actions that may be brought against Bank have run.
12.8 Confidentiality.
In handling any confidential information, Bank will exercise the same degree of care that it exercises for its own proprietary information, but disclosure of information may be made (i) to Bank's subsidiaries or affiliates in connection with their business with Borrower, (ii) to prospective transferees or purchasers of any interest in the loans, (iii) as required by law, regulation, subpoena, or other order, (iv) as required in connection with Bank's examination or audit and (v) as Bank considers appropriate exercising remedies under this Agreement. Confidential information does not include information that either: (a) is in the public domain or in Bank's possession when disclosed to Bank, or becomes part of the public domain after disclosure to Bank; or (b) is disclosed to Bank by a third party, if Bank does not know that the third party is prohibited from disclosing the information.
12.9 Effect of Amendment and Restatement.
This Agreement is intended to and does completely amend and restate, without novation, the Original Agreement. All credit extensions or loans outstanding under the Original Agreement are and shall continue to be outstanding under this Agreement. All security interests granted under the Original Agreement are hereby confirmed and ratified and shall continue to secure all Obligations under this Agreement.
12.10 Attorneys' Fees, Costs and Expenses.
In any action or proceeding between Borrower and Bank arising out of the Loan Documents, the prevailing party will be entitled to recover its reasonable attorneys' fees and other reasonable costs and expenses incurred, in addition to any other relief to which it may be entitled.
13.1 Definitions. In this Agreement: "Accounts" are all existing and later arising accounts, contract rights, |
and other obligations owed Borrower in connection with its sale or lease of goods (including licensing software and other technology) or provision of services, all credit insurance, guaranties, other security and all merchandise returned or reclaimed by Borrower and Borrower's Books relating to any of the foregoing.
"Affiliate" of a Person is a Person that owns or controls directly or indirectly the Person, any Person that controls or is controlled by or is under common control with the Person, and each of that Person's senior executive officers, directors, partners and, for any Person that is a limited liability company, that Person's managers and members.
"Bank Expenses" are all audit fees and expenses and reasonable costs and expenses (including reasonable attorneys' fees and expenses) for preparing, negotiating, administering, defending and enforcing the Loan Documents (including appeals or Insolvency Proceedings).
"Basic Rate" is, as of the Funding Date, the per annum rate of interest (based on a year of 360 days) equal to the sum of (a) the U.S. Treasury note yield to maturity for a term equal to the Treasury Note Maturity as quoted in The Wall Street Journal on the day the Loan Supplement is prepared, plus (b) the Loan Margin.
"Borrower's Books" are all Borrower's books and records including ledgers, records regarding Borrower's assets or liabilities, the Collateral, business operations or financial condition and all computer programs or discs or any equipment containing the information.
"Business Day" is any day that is not a Saturday, Sunday or a day on which the Bank is closed.
"Closing Date" is December 31, 1999.
"Code" is the California Uniform Commercial Code.
"Commitment Termination Date" is the Closing Date.
"Committed Equipment Line" is a Credit Extension of up to $750,000.
"Contingent Obligation" is, for any Person, any direct or indirect liability, contingent or not, of that Person for (i) any indebtedness, lease, dividend, letter of credit or other obligation of another such as an obligation directly or indirectly guaranteed, endorsed, co-made, discounted or sold with recourse by that Person, or for which that Person is directly or indirectly liable; (ii) any obligations for undrawn letters of credit for the account of that Person; and (iii) all obligations from any interest rate, currency or commodity swap agreement, interest rate cap or collar agreement, or other agreement or arrangement designated to protect a Person against fluctuation in interest rates, currency exchange rates or commodity prices; but "Contingent Obligation" does not include endorsements in the ordinary course of business. The amount of a Contingent Obligation is the stated or determined amount of the primary obligation for which the Contingent Obligation is made or, if not determinable, the maximum reasonably anticipated liability for it determined by the Person in good faith; but the amount may not exceed the maximum of the obligations under the guarantee or other support arrangement.
"Credit Extension" is each Equipment Advance, Term Loan, or any other extension of credit by Bank for Borrower's benefit.
"Eligible Equipment" is general purpose computer equipment, manufacturing and laboratory equipment, test and laboratory equipment, furnishings that complies with all of Borrower's representations and warranties to Bank and which is acceptable to Bank in all respects. All Equipment financed with the proceeds of Equipment Advances shall be new, provided that Bank, in its sole discretion, may finance used equipment.
"Equipment" is all present and future machinery, equipment, tenant improvements, furniture, fixtures, vehicles, tools, parts and attachments in which Borrower has any interest.
"Equipment Advance" is defined in Section 2.1.1.
"ERISA" is the Employment Retirement Income Security Act of 1974, and its regulations.
"Final Payment" is a payment (in addition to and not a substitution for the regular monthly payments of principal plus accrued interest) due on the Maturity Date for such Equipment Advance equal to the Loan Amount for such Equipment Advance multiplied by the Final Payment Percentage.
"Final Payment Percentage" is, for each Equipment Advance, 10%.
"Financed Equipment" is defined in the Loan Supplement.
"Funding Date" is any date on which an Equipment Advance is made to or on account of Borrower.
"GAAP" is generally accepted accounting principles.
"Indebtedness" is (a) indebtedness for borrowed money or the deferred price of property or services, such as reimbursement and other obligations for surety bonds and letters of credit, (b) obligations evidenced by notes, bonds, debentures or similar instruments, (c) capital lease obligations and (d) Contingent Obligations.
"Insolvency Proceeding" are proceedings by or against any Person under the United States Bankruptcy Code, or any other bankruptcy or insolvency law, including assignments for the benefit of creditors, compositions, extensions generally with its creditors, or proceedings seeking reorganization, arrangement, or other relief.
"Inventory" is present and future inventory in which Borrower has any interest, including merchandise, raw materials, parts, supplies, packing and shipping materials, work in process and finished products intended for sale or lease or to be furnished under a contract of service, of every kind and description now or later owned by or in the custody or possession, actual or constructive, of Borrower, including inventory temporarily out of its custody or possession or in transit and including returns on any accounts or other proceeds (including insurance proceeds) from the sale or disposition of any of the foregoing and any documents of title.
"Investment" is any beneficial ownership of (including stock, partnership interest or other securities) any Person, or any loan, advance or capital contribution to any Person.
"Lien" is a mortgage, lien, deed of trust, charge, pledge, security interest or other encumbrance.
"Loan Amount" is the aggregate amount of the Equipment Advance.
"Loan Documents" are, collectively, this Agreement, any note, or notes or guaranties executed by Borrower or Guarantor, and any other present or future agreement between Borrower and/or for the benefit of Bank in connection with this Agreement, all as amended, extended or restated.
"Loan Factor" is the percentage which results from amortizing the Equipment Advance over the Repayment Period, using the Basic Rate as the interest rate. As an example, based on a treasury note yield of 6.10% for a Treasury Note Maturity as published August 10, 1999, two (2) Loan Factors are derived: (i) the Loan Factor for the first 12 months of the Repayment Period is 1.50%; and (ii) the Loan Factor for the remaining 30 months in the Repayment Period is 3.40%
"Loan Margin" is a negative -303.61 basis points increasing to a positive
+849.24 basis points beginning January 1, 2001.
"Loan Supplement" is attached as Exhibit C
"Material Adverse Change" is defined in Section 8.3.
"Maturity Date" is, with respect to each Equipment Advance, the last day of the Repayment Period for such Equipment Advance, or if earlier, the date of acceleration of such Equipment Advance by Bank following an Event of Default.
"Obligations" are debts, principal, interest, Bank Expenses and other amounts Borrower owes Bank now or later, including cash management services, letters of credit and foreign exchange contracts, if any and including interest accruing after Insolvency Proceedings begin and debts, liabilities, or obligations of Borrower assigned to Bank.
"Original Agreement" has the meaning set forth in recital paragraph A.
"Original Stated Cost" is (i), the original cost to the Borrower of the item of new Equipment net of any and all freight, installation, tax or (ii) the fair market value assigned to such item of used Equipment by mutual agreement of Borrower and Bank at the time of making of the Equipment Advance.
"Permitted Indebtedness" is:
(a) Borrower's indebtedness to Bank under this Agreement or any other Loan Document;
(b) Indebtedness existing on the Closing Date and shown on the Schedule;
(c) Subordinated Debt;
(d) Indebtedness to trade creditors incurred in the ordinary course of business; and
(e) Indebtedness secured by Permitted Liens.
"Permitted Investments" are:
(a) Investments shown on the Schedule and existing on the Closing Date; and
(b) (i) marketable direct obligations issued or unconditionally guaranteed by the United States or its agency or any State maturing within 1 year from its acquisition, (ii) commercial paper maturing no more than 1 year after its creation and having the highest rating from either Standard & Poor's Corporation or Moody's Investors Service, Inc., and (iii) Bank's certificates of deposit issued maturing no more than 1 year after issue.
"Permitted Liens" are:
(a) Liens existing on the Closing Date and shown on the Schedule or arising under this Agreement or other Loan Documents;
(e) Leases or subleases granted in the ordinary course of Borrower's business, including in connection with Borrower's leased premises or leased property;
"Person" is any individual, sole proprietorship, partnership, limited liability company, joint venture, company association, trust, unincorporated organization, association, corporation, institution, public benefit corporation, firm, joint stock company, estate, entity or government agency.
"Prime Rate" is Bank's most recently announced "prime rate," even if it is not Bank's lowest rate.
"Repayment Period" as to the Equipment Advances, is 42 months.
"Responsible Officer" is each of the Chief Executive Officer, the President, the Chief Financial Officer and the Controller of Borrower.
"Schedule" is any attached schedule of exceptions.
"Subordinated Debt" is debt incurred by Borrower subordinated to Borrower's indebtedness owed to Bank and which is reflected in a written agreement in a manner and form acceptable to Bank and approved by Bank in writing.
"Subsidiary" is for any Person, or any other business entity of which more than 50% of the voting stock or other equity interests is owned or controlled, directly or indirectly, by the Person or one or more Affiliates of the Person.
"Term Loan" a loan of $333,333 (originally $400,000 advanced under the Original Agreement).
"Term Loan Maturity Date" is May 29, 2002.
"Total Liabilities" is on any day, obligations that should, under GAAP, be classified as liabilities on Borrower's consolidated balance sheet, including all Indebtedness, and current portion Subordinated Debt allowed to be paid, but excluding all other Subordinated Debt.
"Treasury Note Maturity" is 42 months.
BORROWER:
Durect Corporation
By: /s/ Thomas A. Schreck --------------------- Title: Chief Financial Officer ----------------------- |
BANK:
SILICON VALLEY BANK
By: /s/ Kathryn Lungaro ------------------- Title: Senior Vice President --------------------- |
The Collateral consists of all of Borrower's right, title and interest in and to the following:
All goods and equipment now owned or hereafter acquired, including, without limitation, all machinery, fixtures, vehicles (including motor vehicles and trailers), and any interest in any of the foregoing, and all attachments, accessories, accessions, replacements, substitutions, additions, and improvements to any of the foregoing, wherever located;
All inventory, now owned or hereafter acquired, including, without limitation, all merchandise, raw materials, parts, supplies, packing and shipping materials, work in process and finished products including such inventory as is temporarily out of Borrower's custody or possession or in transit and including any returns upon any accounts or other proceeds, including insurance proceeds, resulting from the sale or disposition of any of the foregoing and any documents of title representing any of the above;
All contract rights and general intangibles now owned or hereafter acquired, including, without limitation, goodwill, trademarks, servicemarks, trade styles, trade names, leases, franchise agreements, blueprints, drawings, purchase orders, customer lists, route lists, infringements, claims, computer programs, computer discs, computer tapes, literature, reports, catalogs, design rights, income tax refunds, payments of insurance and rights to payment of any kind;
All now existing and hereafter arising accounts, contract rights, royalties, license rights and all other forms of obligations owing to Borrower arising out of the sale or lease of goods, the licensing of technology or the rendering of services by Borrower, whether or not earned by performance, and any and all credit insurance, guaranties, and other security therefor, as well as all merchandise returned to or reclaimed by Borrower;
All documents, cash, deposit accounts, securities, securities entitlements, securities accounts, investment property, financial assets, letters of credit, certificates of deposit, instruments and chattel paper now owned or hereafter acquired and Borrower's Books relating to the foregoing; and
All Borrower's Books relating to the foregoing and any and all claims, rights and interests in any of the above and all substitutions for, additions and accessions to and proceeds thereof.
Notwithstanding the foregoing, the Collateral shall not be deemed to include any copyrights, copyright applications, copyright registration and like protection in each work of authorship and derivative work thereof, whether published or unpublished, now owned or hereafter acquired; any patents, patent applications and like protections including without limitation improvements, divisions, continuations, renewals, reissues, extensions and continuations-in- part of the same, trademarks, servicemarks and applications therefor, whether registered or not, and the goodwill of the business of Borrower connected with and symbolized by such trademarks, any trade secret rights, including any rights to unpatented inventions, know-how, operating manuals, license rights and agreements and confidential information, now owned or hereafter acquired; or any claims for damage by way of any past, present and future infringement of any of the foregoing (collectively, the "Intellectual Property"), except that the Collateral shall include the proceeds of all the Intellectual Property that are accounts, (i.e. accounts receivable) of Borrower, or general intangibles consisting of rights to payment, if a judicial authority (including a U.S. Bankruptcy Court) holds that a security interest in the underlying Intellectual Property is necessary to have a security interest in such accounts and general intangibles of Borrower that are proceeds of the Intellectual Property, then the Collateral shall automatically, and effective as of the Closing Date, include the Intellectual Property to the extent necessary to permit perfection of Bank's security interest in such accounts and general intangibles of Borrower that are proceeds of the Intellectual Property.
LOAN PAYMENT/ADVANCE TELEPHONE REQUEST FORM
DEADLINE FOR SAME DAY PROCESSING IS 3:00 P.M., P.S.T.
TO: CENTRAL CLIENT SERVICE DIVISION DATE: __________________________ FAX#: (408) 496-2426 TIME: __________________________ ________________________________________________________________________________ FROM: Durect Corporation ------------------------------------------------------------------------ CLIENT NAME (BORROWER) REQUESTED BY: ----------------------------------------------------------------- AUTHORIZED SIGNER'S NAME |
FROM ACCOUNT # _________________________ TO ACCOUNT # ______________________
REQUESTED TRANSACTION TYPE REQUESTED DOLLAR AMOUNT -------------------------- ----------------------- PRINCIPAL INCREASE (ADVANCE) $ _________________________________________ PRINCIPAL PAYMENT (ONLY) $ _________________________________________ INTEREST PAYMENT (ONLY) $ _________________________________________ PRINCIPAL AND INTEREST (PAYMENT) $ _________________________________________ |
All Borrower's representations and warranties in the Amended and Restated Loan and Security Agreement are true, correct and complete in all material respects on the date of the telephone request for and Advance confirmed by this Borrowing Certificate; but those representations and warranties expressly referring to another date shall be true, correct and complete in all material respects as of that date.
BANK USE ONLY
The following person is authorized to request the loan payment transfer/loan advance on the advance designated account and is known to me.
---------------------------------- ------------------------------------ Authorized Requester Phone # ---------------------------------- ------------------------------------ Received By (Bank) Phone # ---------------------------------- |
Authorized Signature (Bank)
FORM OF LOAN AGREEMENT SUPPLEMENT
LOAN AGREEMENT SUPPLEMENT No. [ ]
LOAN AGREEMENT SUPPLEMENT No. [ ], dated ______________, 199____ ("Supplement"), to the Loan and Security Agreement dated as of ______________, 199____ (the "Loan Agreement) by and between the undersigned ("Borrower"), and Silicon Valley Bank ("Bank").
Capitalized terms used herein but not otherwise defined herein are used with the respective meanings given to such terms in the Loan Agreement.
To secure the prompt payment by Borrower of all amounts from time to time outstanding under the Loan Agreement, and the performance by Borrower of all the terms contained in the Loan Agreement, Borrower grants Bank, a first priority security interest in each item of equipment and other property described in Annex A hereto, which equipment and other property shall be deemed to be additional Financed Equipment and Collateral. The Loan Agreement is hereby incorporated by reference herein and is hereby ratified, approved and confirmed.
Annex A (Equipment Schedule) and Annex B (Loan Terms Schedule) are attached hereto.
The proceeds of the Loan should be transferred to Borrower's account with Bank set forth below:
Bank Name: Silicon Valley Bank Account No.:
Borrower hereby certifies that (a) the foregoing information is true and correct and authorizes Bank to endorse in its respective books and records, the Basic Rate applicable to the Funding Date of the Loan contemplated in this Loan Agreement Supplement and the principal amount set forth in the Loan Terms Schedule; (b) the representations and warranties made by Borrower in the Loan Agreement are true and correct on the date hereof and will be true and correct on such Funding Date. No Event of Default has occurred and is continuing under the Loan Agreement. This Supplement may be executed by Borrower and Bank in separate counterparts, each of which when so executed and delivered shall be an original, but all such counterparts shall together constitute but one and the same instrument.
This Supplement is delivered as of this day and year first above written.
SILICON VALLEY BANK DURECT Corporation ------------------------------------- By: /s/ Kathryn Lungaro By: /s/ Felix Theeuwes ---------------------------- -------------------------------------- Name: Kathryn Lungaro Name: Felix Theewes -------------------------- ------------------------------------ Title: Senior Vice President Title: Chief Scientific Officer & ------------------------- ------------------------------------ Chairman ------------------------------------ |
Annex A - Description of Financed Equipment Annex B - Loan Terms Schedule
The Financed Equipment being financed with the Equipment Advance which this Loan Agreement Supplement is being executed is listed below. Upon the funding of such Equipment Advance, this schedule automatically shall be deemed to be a part of the Collateral.
Description of Equipment: Make Model Serial # Invoice #
LOAN TERMS SCHEDULE #________
Loan Funding Date: ______________, 199__
Original Loan Amount: $______________
Basic Rate: ____________%
Loan Factor: ______________%
Scheduled Payment Dates and Amounts, subject to prepayment as described in
Section 2.2.1(d)*:
______ payment of $_______ due monthly from ______ through ________
______ payment of $_______ due monthly from ______ through ________
One (1) payment of $_______ due ______________
Maturity Date: ______________
Final Payment: An additional amount equal to the Final Payment Percentage multiplied by the Loan Amount then in effect, shall be paid on the Maturity Date with respect to such Loan.
Payment No. Payment Date
1
2
3
4
...
35
...
*/ The amount of each Scheduled Payment will change as the Loan Amount changes.
SILICON VALLEY BANK
PRO FORMA INVOICE FOR LOAN CHARGES
BORROWER: Durect Corporation LOAN OFFICER: Lois Fisher 3 |
DATE: December 16, 1999 Documentation Fee 1,500.00 Legal Fee 500.00 TOTAL FEE DUE $2,000.00 ------------- ========= |
Please indicate the method of payment:
{ } A check for the total amount is attached.
{ } Debit DDA # __________________ for the total amount.
{ } Loan proceeds
Borrower:
By:
(Authorized Signer)
NEGATIVE PLEDGE AGREEMENT
This Negative Pledge Agreement is made as of December 16, 1999 by and between Durect Corporation ("Borrower") and Silicon Valley Bank ("Bank").
In connection with, among other documents, the Loan and Security Agreement (the "Loan Documents") being concurrently executed herewith between Borrower and Bank, Borrower agrees as follows:
1. Borrower shall not sell, transfer, assign, mortgage, pledge, lease, grant a security interest in, or encumber any of Borrower's intellectual property, including, without limitation, the following:
a. Any and all copyright rights, copyright applications, copyright registrations and like protections in each work or authorship and derivative work thereof, whether published or unpublished and whether or not the same also constitutes a trade secret, now or hereafter existing, created, acquired or held;
b. All mask works or similar rights available for the protection of semiconductor chips, now owned or hereafter acquired;
c. Any and all trade secrets, and any and all intellectual property rights in computer software and computer software products now or hereafter existing, created, acquired or held;
d. Any and all design rights which may be available to Borrower now or hereafter existing, created, acquired or held;
e. All patents, patent applications and like protections including, without limitation, improvements, divisions, continuations, renewals, reissues, extensions and continuations-in-part of the same, including without limitation the patents and patent applications;
f. Any trademark and servicemark rights, whether registered or not, applications to register and registrations of the same and like protections, and the entire goodwill of the business of Borrower connected with and symbolized by such trademarks, including without limitation;
g. Any and all claims for damages by way of past, present and future infringements of any of the rights included above, with the right, but not the obligation, to sue for and collect such damages for said use or infringement of the intellectual property rights identified above;
h. All licenses or other rights to use any of the Copyrights, Patents, Trademarks or Mask Works, and all license fees and royalties arising from such use to the extent permitted by such license or rights; and
i. All amendments, extensions, renewals and extensions of any of the Copyrights, Trademarks, Patents, or Mask Works; and
j. All proceeds and products of the foregoing, including without limitation all payments under insurance or any indemnity or warranty payable in respect of any of the foregoing;
2. It shall be an event of default under the Loan Documents between Borrower and Bank if there is a breach of any term of this Negative Pledge Agreement.
3. Capitalized terms used but not otherwise defined herein shall have the same meaning as in the Loan Documents.
BORROWER:
Durect Corporation
By: /s/ Thomas A. Schreck ------------------------------- Name: Thomas A. Schreck --------------------------- Title: Chief Financial Officer -------------------------- |
BANK:
SILICON VALLEY BANK
By: /s/ Kathryn Lungaro ------------------------------ Name: Kathryn Lungaro ---------------------------- Title: Senior Vice President --------------------------- |
CORPORATE BORROWING RESOLUTION
Borrower: Durect Corporation Bank: Silicon Valley Bank 10240 Bubb Road 3003 Tasman Drive Cupertino, CA 95014 Santa Clara, CA 95054-1191 |
I, the Secretary or Assistant Secretary of Durect Corporation ("Borrower"), CERTIFY that Borrower is a corporation existing under the laws of the State of Delaware.
I certify that at a meeting of Borrower's Directors (or by other authorized corporate action) duly held the following resolutions were adopted.
It is resolved that any one of the following officers of Borrower, whose name, title and signature is below:
NAMES POSITIONS ACTUAL SIGNATURES ----- --------- ----------------- Thomas A. Schreck Chief Financial Officer /s/ Thomas A. Schreck ------------------ ----------------------------------- ------------------------- James E. Brown President & Chief Executive Officer /s/ James E. Brown ------------------ ----------------------------------- ------------------------- Felix Theeuwes Chairman & Chief Scientific Officer /s/ Felix Theeuwes ------------------ ----------------------------------- ------------------------- ------------------ ----------------------------------- ------------------------- |
may act for Borrower and:
Borrow Money. Borrow money from Silicon Valley Bank ("Bank").
Execute Loan Documents. Execute any loan documents Bank requires.
Grant Security. Grant Bank a security interest in any of Borrower's assets.
Negotiate Items. Negotiate or discount all drafts, trade acceptances, promissory notes, or other indebtedness in which Borrower has an interest and receive cash or otherwise use the proceeds.
Letters of Credit. Apply for letters of credit from Bank.
Foreign Exchange Contracts. Execute spot or forward foreign exchange contracts.
Issue Warrants. Issue warrants for Borrower's stock.
Further Acts. Designate other individuals to request advances, pay fees and costs and execute other documents or agreements (including documents or agreement that waive Borrowers right to a jury trial) they think necessary to effectuate these Resolutions.
Further resolved that all acts authorized by these Resolutions and performed before they were adopted are ratified. These Resolutions remain in effect and Bank may rely on them until Bank receives written notice of their revocation.
I certify that the persons listed above are Borrower's officers with the titles and signatures shown following their names and that these resolutions have not been modified are currently effective.
CERTIFIED TO AND ATTESTED BY:
X /s/ Mark B. Weeks ----------------------------------------------- *Secretary or Assistant Secretary |
X _______________________________________________________
*NOTE: In case the Secretary or other certifying officer is designated by the
foregoing resolutions as one of the signing officers, this resolution should
also be signed by a second Officer or Director of Borrower.
Exhibit 10.9
MANUFACTURING AND SUPPLY AGREEMENT
This Manufacturing and Supply Agreement ("Agreement") is entered into by and between Neuro-Biometrix, Inc., a Colorado corporation, with its principal place of business at 7995 E. Prentice Ave., Suite 110, Greenwood Village, Colorado 80111 (hereinafter "Neuro-Biometrix") and Novel Biomedical, Inc., a Minnesota corporation with its principal place of business at 13845 Industrial Park Blvd., Plymouth, Minnesota 55441 (hereinafter "Novel").
RECITALS
1. Neuro-Biometrix markets and sells medical devices for use in the middle ear. The two human use devices currently being made by Novel are called the RW(mu)Cath(TM) (Novel Part #90077-5XX) and the RWE-Cath(TM) (Novel Part #90078-5XX) (the "Human Products"). The two animal models are called the Animal RW(mu)Cath(TM) (Novel Part #70012-5XX) and the Animal RWE-Cath (Novel Part #70013-5XX) (the "Animal Products"). The Human Products and the Animal Products are collectively called the ("FINISHED PRODUCTS").
2. Novel is in the business of designing, developing, manufacturing, sterilizing and packaging medical devices.
3. The parties have entered into a confidentiality agreement dated July 9, 1996. The parties entered into a Consulting Agreement dated September 18, 1996. This Consulting Agreement includes two sections (Confidentiality and Inventions/Assignment) which supplement the July 9, 1996 confidentiality agreement. The parties entered a second confidentiality agreement dated August 12, 1997. These three agreements shall be collectively referred to as the "Confidentiality Agreements." The Confidentiality Agreements are hereby incorporated in this Manufacturing and Supply Agreement.
4. The parties desire to enter into an agreement under which Novel will manufacture and supply FINISHED PRODUCTS to Neuro-Biometrix, according to Neuro-Biometrix' specifications which is described in Top Level Novel Drawings (90077-5XX, 90078-5XX, 70012-5XX and 70013-5XX) (hereafter referred to as the "top level drawings"). This Manufacturing and Supply Agreement is not intended to alter or amend the Confidentiality Agreements.
In consideration of the foregoing and of the mutual covenants, promises and conditions set forth below, the parties intending to be bound, agree as follows.
AGREEMENT
ARTICLE 1
NEURO-BIOMETRIX OBLIGATIONS
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
(i.e. the balloon RW(mu)Cath(TM)/RWE-Cath(TM)) may be substituted for FINISHED PRODUCTS, when agreed to by both parties. Firm releases will be authorized by Neuro-Biometrix against the purchase order as indicated in Section B(i) below. The terms and conditions of this Agreement supersede the terms and conditions contained on the Neuro-Biometrix purchase order form. The First Purchase order will cover [***] FINISHED PRODUCTS.
(i) Firm Releases: The first sixty (60) days of the forecast are fixed with respect to both quantity and delivery date. "Delivery date" shall be the date that the Finished Products are received by Neuro-Biometrix. The parties will mutually agree upon delivery dates. Novel is authorized to produce these items and Neuro-Biometrix is committed to purchase them as planned. Neuro- Biometrix may reschedule firm delivery dates with Novel's written agreement when necessary.
(ii) Scheduled Releases: The next sixty (60) days of the forecast are for the procurement of materials. Novel is authorized to purchase materials needed to fill these requirements, subject to minimum order requirements. Upon termination of this Agreement (see Article 3, Section 16), Neuro-Biometrix commits to purchase, at Novel's direct out of pocket cost, [***] all the non-cancelable or non-returnable materials purchased by Novel in reasonable reliance on the Scheduled Releases. No material procurement or capacity scheduling will take place until Neuro-Biometrix has transmitted the 6- month Rolling Forecast to Novel. In the event of a Technology Transfer (See Article 2, Section 9 below), all materials that Neuro-Biometrix is required to purchase under this paragraph shall be used in the production of FINISHED PRODUCTS that Novel is supplying during the transfer or, if reasonable, transferred to the transferee.
(iii) Forecasted Releases: The last sixty (60) days of the forecast contain Neuro-Biometrix' current estimate of the demand for the FINISHED PRODUCTS and is offered only for planning purposes. Neuro-Biometrix makes no commitment except that this is its best estimate at the time of the Forecast. Circumstances may develop during the course of business, which would make it prudent for larger range commitments to Novel's suppliers by Novel. Prior to making such a commitment, the parties must agree in writing to the commitment.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
quantity of each FINISHED PRODUCT shipped, product destination, carrier, bill to and ship to address, and package weight. Novel will insure, at the invoice price, all shipments. Neuro-Biometrix will pay the costs of such insurance. Novel reserves the right to ship a partial order (must be at least [***] of order). Novel also reserves the right to over-ship by a maximum of [***] of order).
---------------------------------------------------------------------------------------- [***] [***] [***] UNITS UNITS UNITS RW(mu)Cath(TM) (Novel Part #90077) $ [***] $ [***] $ [***] ---------------------------------------------------------------------------------------- RWE-Cath(TM) (Novel Part #90078) $ [***] $ [***] $ [***] ---------------------------------------------------------------------------------------- Animal RW(mu)Cath(TM) (Novel Part #70012) $ [***] $ [***] $ [***] ---------------------------------------------------------------------------------------- Animal RWE-Cath(TM) (Novel Part #70013) $ [***] $ [***] $ [***] ---------------------------------------------------------------------------------------- |
If one of the following occur, after this Agreement is signed by both parties, the parties will, in good faith, determine a revised per unit price:
. There is a significant design change to a FINISHED PRODUCT
. There is a significant price increase from one of the suppliers used by Novel for the manufacture of the FINISHED PRODUCTS, and Novel has made reasonable efforts to locate an alternative supplier.
. Neuro-Biometrix makes a special order request, above and beyond the order supplied in Article 1, Paragraph 1 (Purchase Orders) above.
. Neuro-Biometrix requests less than [***] FINISHED PRODUCTS for a particular month.
. Novel determines that the cost of materials is lower than expected
. Neuro-Biometrix pays to upgrade the equipment or staff involved in the production which lowers the unit price, per a mutually agreeable plan and budget.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
ARTICLE 2
NOVEL'S OBLIGATIONS
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
The following list is not exhaustive. It is meant only as an example of some of the documents and records that Novel will maintain and control.
. a Device Master Record for each type of FINISHED PRODUCT, per 21 CFR (S)820.181 (Quality System Regulation);
. a Design History File for each type of FINISHED PRODUCT, per QSR 21 CFR (S)820.30(j) (Quality System Regulation);
. Device History Records for each lot of FINISHED PRODUCTS shipped to Neuro-Biometrix per 21 C.F.R. (S)820.184, (Quality System Regulation)
. Technical Documentation/Quality System Records required by EN 46001/ISO 9001.
. "Technical Documentation" required by the Medical Device Directive (EC
Council Directive 93/42/EEC), as defined by the items listed in Neuro-
Biometrix Standard Operating Procedure Q-l6 (copy attached as Exhibit
B) labeled "Maintained by Turn-key." Any changes to SOP Q-16, that
place additional requirements on Novel will require the approval of
both parties.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Notified Body or Competent Authority determine that Neuro-Biometrix loses its ISO certification or is unable to affix the CE Mark to its products, Novel will remedy the situation at Novel's cost within 60 days. The situation would be "remedied" when Neuro-Biometrix is again able to affix the CE Mark to the RW(mu)Cath and the RWE-Cath, and regains its ISO Certification. If Novel is unable to remedy the situation in 60 days, Neuro-Biometrix can compel Novel to complete a technology transfer, as defined in Article 2, Section 9 (in 90 days or less) at [***] of the costs described in Exhibit C.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
of a technology transfer, in which case the costs will be included in the technology transfer fee. Novel will maintain an inventory of Neuro-Biometrix' tooling, and this inventory list will be updated and provided to Neuro-Biometrix on a semi-annual basis, beginning November 15, 1997, upon Neuro-Biometrix' request.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
ARTICLE
MISCELLANEOUS PROVISIONS
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
assignment without such consent shall be void, except that, Novel may delegate its sterilization responsibilities, but sterilization is still in Novel's "control."
Novel Biomedical, Inc. 13845 Industrial Park Blvd.
Plymouth, MN 55441
Attention: Jon Kagan, President
612-557-0920 (fax)
Neuro-Biometrix, Inc.
7995 E. Prentice Ave., Suite 110
Englewood, CO 80111
Attention: Dan Arenberg, Vice President 303-850-0671 (fax)
Notices shall be considered given on the date mailed or sent, if mailed or sent in accordance with the provisions of the Paragraph above, subject to proof of receipt by telecopy confirmation or return receipt.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
IN WITNESS HEREOF, Neuro-Biometrix, Inc. and Novel Biomedical, Inc. executed this agreement on the respective dates indicated.
NEURO-BIOMETRIX, INC. NOVEL BIOMEDICAL, INC. By: /s/ Daniel K. Arenburg By: /s/ Jonathan Kagar ------------------------------ ------------------------------ Printed: Daniel K. Arenburg Printed: Jonathan Kagar ------------------------- ------------------------- Title: Vice President Title: President --------------------------- --------------------------- Date: November 3, 1997 Date: November 24, 1997 ---------------------------- ---------------------------- |
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Exhibit A
NEURO-BIOMETRIX, INC.
OFFICERS
October 23, 1997
1. I. Kaufman Arenberg, MD, President
2. Daniel Arenberg, Vice President of Operations
3. Michael Arenberg, Vice President of Marketing
4. Christine Lemke, Vice President of Research and Development
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
EXHIBIT B
NEURO-BIOMETRIX, INC.
Standard Operating Procedure
for
Maintaining a Technical File for Compliance with the Medical Device Directive
Procedure No. Q-16
Revision Date: October 23, 1997
Approved: /s/ Daniel K. Arenburg ------------------------------ Training and Distribution Complete (Effective Date) 10/23/97 --------------------------- |
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
TECHNICAL FILE
A. PURPOSE
The purpose of this procedure is to establish the content of a technical file as required by the Medical Device Directive.
B. SCOPE
This procedure applies to products distributed by NBI within the European Union.
C. REFERENCE DOCUMENTS
Medical Device Directive NBI Quality Manual EN 46002
D. DEFINITIONS
Technical File - a compilation of information and data regarding the construction, materials, processing, testing, labeling and packaging of a NBI product distributed in Europe.
E. RESPONSIBILITY
The Quality Department is responsible for the maintenance of the technical file.
F. PROCEDURE
1. The technical file has an index clearly stating the information contained within.
2. The technical file shall reside at NBI and be available for review by a Notified Body or a Competent Authority within the European Union within five (5) working days from the date of request.
3. A copy of the technical file or summaries of the information contained in the technical file may also reside in Europe with the Authorized Representative.
4. Similar products (i.e., product family extensions) may be in the same technical file.
5. The technical file contains the following information:
. Index
. Administrative information
. Product name
. Product classification per MDD
. Name and address of manufacturer
. Name and address of Authorized Representative
. EC Declaration of Conformity
. Power of Attorney Granted to Authorized Representative
. Photographs of the product
. Product description
. Brief product history
. Intended use
. Indications and contraindications
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
. Description of any accessories
. Description of other models in product family
. Labeling
. Instructions for use
. Operator's manual
. Service manual
. Package labels
. Patient information
. Specifications and product performance information (Maintained by
Turn-key)
. Materials list
. Specifications
. Risk analysis
. EN1441
. FMEA
. Complaint history
. Clinical experience
. Essential requirements per Annex 1 of the MDD
. List of standards
. Company procedures (Maintained by Turn-key)
. Work instructions (Maintained by Turn-key)
. Specifications (Maintained by Turn-key)
. Quality steps (Maintained by Turn-key)
. Biocompatibility
. Sterilization
. Cycle description
. Validation report
. Packaging Qualification
. Physical package qualification
. Shelf life information
. Product test data
. Bench testing
. Biostability
. Design qualification testing
. Design qualification plan summary
. Clinical report
. Manufacturing flow diagram (Maintained by Turn-key)
. Include all QA steps
. Bioburden testing
. Pyrogen testing
. Traceability
. Compatibility with other products intended to be connected with
this product.
. Declaration as to the content of a substance (drug) per Annex 1 section 7.4.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
. Summary of other regulatory approvals and registrations.
G. Attachments
None
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
To accomplish a transfer of the technology used by Novel to manufacture the FINISHED PRODUCTS, as that term is defined in the Manufacturing and Supply Agreement ("Supply Agreement") between Novel and Neuro-Biometrix dated November 1, 1997, to Neuro-Biometrix or a third-party designated by Neuro-Biometrix ("Transferee").
A technology transfer will be coordinated by Ricci Smelser, R&D engineer at
Novel, or Mr. Smelser's replacement. The technology transfer team will include:
Mr. Smelser, a manufacturing manager, a documentation specialist, a QA
department representative, assemblers and/or technicians who assemble the
FINISHED PRODUCTS, and other personnel as appropriate (e.g. manufacturing
engineer & equipment department personnel.
A technology Transfer will be "initiated" by Neuro-Biometrix when it informs Novel of the name of the Transferee. Transferee must agree in writing to keep all Novel Confidential Information confidential, not to use it for any products other than the FINISHED PRODUCTS, and take reasonable steps to maintain its confidentiality.
1. Provide Transferee with current revisions of all Novel Component master, Novel Device Master (processes) and SOP documents used in the manufacture of the FINISHED PRODUCTS. Information found in Novel Component masters not related to the FINISHED PRODUCTS may be deleted.
2. Provide Transferee with a copy of the FINISHED PRODUCTS Design History File and Device Master Record. Novel will maintain Device History Records for five years, per the MDD.
3. Construct and calibrate (per Novel standard practice) equipment and fixtures per the options selected by Neuro-Biometrix.
4. Supply FINISHED PRODUCTS as ordered by Neuro-Biometrix, per the Supply Agreement.
5. Train Transferee personnel at Novel (max. 2 people for 10 days each). This training must begin within 14 days of Novel's indication to Neuro-Biometrix that Novel is ready to begin training.
6. Transfer, install and setup all tooling and equipment to Transferee. Novel's ability to supply FINISHED PRODUCTS will end at this point unless tooling is duplicated for 2 site production.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
7. Train Transferee at Transferee's location (5 days max.). This training must begin within 14 days of Novel's indication to Neuro-Biometrix that Novel is ready to begin training.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
September 30, 1999
BY FACSIMILE
Jon Kagan, President
Novel Biomedical, Inc.
13845 Industrial Park Blvd.
Plymouth, MN 55441
Re: Assignment of Manufacturing and Supply Agreement
Dear Mr. Kagan:
This letter is in reference to the Manufacturing and Supply Agreement entered into by and between IntraEAR, Inc., formerly Neuro-Biometrix, Inc. ("IntraEAR") and Novel Biomedical, Inc. ("Novel") effective November 1, 1997 ("Supply Agreement").
Durect Corporation ("Durect") and IntraEAR have executed an Asset Purchase Agreement dated September 24, 1999 ("Asset Purchase Agreement") for the acquisition by Durect of substantially all of the assets and business of IntraEAR ("Acquisition"). Under the Asset Purchase Agreement, IntraEAR has agreed to assign to Durect and Durect has agreed to take assignment of the Supply Agreement subject to Novel's written consent to such assignment.
This letter confirms that Novel consents to IntraEAR's assignment of the Supply Agreement to Durect upon the closing of the Acquisition (currently anticipated to be October 1, 1999) subject to the following conditions:
1. Payment shall have been received by Novel for all outstanding amounts due and payable by IntraEAR under the Supply Agreement as of October 1, 1999;
2. Durect shall assume the obligations for the purchase order in effect as of the date of this letter; and
3. Durect shall render payments under the Agreement within 30 days after the receipt of Novel's invoice. Durect shall be entitled to a reduction of [***] off the amount due for payments made within 10 days of the receipt of Novel's invoice.
This consent by Novel shall be effective upon the receipt by Novel of payment for all outstanding amounts due and payable by IntraEAR under the Supply Agreement as of October 1, 1999.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Please sign below to indicate Novel's acceptance of the foregoing and fax a copy back to my attention at (408) 777-3577.
Please feel free to call me if you have any questions (408) 777-1419. Durect looks forward to working with Novel.
Very truly yours,
James E. Brown Chief Executive Officer
AGREED TO AND ACCEPTED
NOVEL BIOMEDICAL, INC.
By: __________________________
Jon Kagan, President
Dated: ________________________
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
EXHIBIT 10.10
MASTER SERVICES AGREEMENT
This Master Services Agreement ("Agreement") is made between Durect Corporation, which has a place of business at 10240 Bubb Road, Cupertino, California 95014 (hereinafter "Sponsor"), and Quintiles, Inc., a North Carolina corporation having its principal place of business at 1007 Slater Road, Chelsea Place, Durham, North Carolina 27703 (hereinafter "Quintiles"). When signed by both parties, this Agreement will set forth the terms and conditions under which Quintiles agrees to provide certain services to Sponsor as set forth herein.
Recitals:
A. Sponsor is in the business of developing, manufacturing and/or distributing pharmaceutical products, medical devices and/or biotechnology products. Quintiles is in the business of providing clinical trial services, research, and other services for the pharmaceutical, medical device and biotechnology industries.
B. Sponsor and Quintiles desire to enter into this Agreement to provide the terms and conditions upon which Sponsor may engage Quintiles from time-to- time to provide services for individual studies or projects by executing individual Work Orders (as defined below) specifying the details of the services and the related terms and conditions.
Agreement:
1.0 Scope of the Agreement; Work Orders; Nature of Services.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Order"). A sample Work Order is attached hereto as Exhibit A. Each Work Order will include, as appropriate, the scope of work, time line, budget and payment schedule. Each Work Order shall be subject to all of the terms and conditions of this Agreement, in addition to the specific details set forth in the Work Order. To the extent any terms or provisions of a Work Order conflict with the terms and provisions of this Agreement, the terms and provisions of this Agreement shall control, except to the extent that the applicable Work Order expressly and specifically states an intent to supersede the Agreement on a specific matter.
2.0 Payment of Fees and Expenses. Sponsor will pay Quintiles for fees, expenses and pass-through costs in accordance with each Work Order. Sponsor agrees that the budget and payment schedule for each Work Order will be structured in an effort to maintain cash neutrality for Quintiles (with respect to the payment of professional fees, pass-through costs and otherwise). Upon execution of a Work Order, Sponsor shall pay Quintiles an agreed upon percentage of each budget as set forth in such Work Order as an advance against the total compensation value of the budget. Sponsor will draw from these funds in order to pay for services and related costs and expenses consistent with the terms of the Work Order. In developing the payment schedule, the parties, as one of the considerations, will take into account the timing of work performed by Quintiles and payments received from Sponsor. Unless otherwise agreed in a particular Work Order, the following shall apply: (a) Quintiles will invoice Sponsor monthly for the fees, expenses and pass-through costs relating to the Project; and, (b) Sponsor shall pay each invoice within [* * ] of the
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
date of the invoice. If any portion of an invoice is disputed, then Sponsor shall pay the undisputed amounts as set forth in the preceding sentence and the parties shall use good faith efforts to reconcile the disputed amount as soon as practicable. Sponsor shall pay Quintiles interest in an amount equal to [ * **] (or the maximum lesser amount permitted by law) of all undisputed amounts owing hereunder and not paid within thirty (30) days of the date of the invoice.
3.0 Term. This Agreement shall commence on the date of execution and shall continue until terminated by either party in accordance with Section 15 below.
4.0 Change Orders. Any material change in the details of a Work Order or the assumptions upon which the Work Order is based (including, but not limited to, changes in fees, expenses and pass-through costs, an agreed starting date for a Project or suspension of the Project by Sponsor) may require changes in the budget and/or time lines, and shall require a written amendment to the Work Order (a "Change Order"). Each Change Order shall detail the requested changes to the applicable task, responsibility, duty, budget, time line or other matter. The Change Order will become effective upon the execution of the Change Order by both parties, and Quintiles will be given a reasonable period of time within which to implement the changes. Both parties agree to act in good faith and promptly when considering a Change Order requested by the other party. Without limiting the foregoing, Sponsor agrees that it will not unreasonably withhold approval of a Change Order, even if it involves a fixed price contract, if the proposed changes in budgets or time lines result from, among other appropriate reasons, forces outside the reasonable control of Quintiles or changes in the assumptions upon which the initial budget or time lines were based. Quintiles reserves the right to postpone effecting material changes in the Project's scope until such time as the parties agree to and execute the corresponding Change Order. For any Change Order that affects the scope of the regulatory obligations that have been transferred to Quintiles, Quintiles and Sponsor shall execute a corresponding amendment to the Transfer of Obligations Form. Such amendment shall be filed by Sponsor where appropriate, or as required by law or regulation.
5.0 Confidentiality. It is understood that during the course of this Agreement, Quintiles and its employees may be exposed to data and information which is confidential and proprietary to Sponsor. All such data and information (hereinafter "Sponsor Confidential Information") written or verbal, tangible or intangible, made available, disclosed, or otherwise made known to
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Quintiles and its employees as a result of Services under this Agreement shall be considered confidential and shall be considered the sole property of Sponsor. All information regarding Quintiles' pricing and Quintiles' Property (as defined in Section 6.0 below), disclosed by Quintiles to Sponsor in connection with this Agreement is proprietary, confidential information belonging to Quintiles (the "Quintiles Confidential Information", and together with the Sponsor Confidential Information, the "Confidential Information"). The Confidential Information shall be used by the receiving party and its employees only for purposes of performing the receiving party's obligations hereunder. Each party agrees that it will not reveal, publish or otherwise disclose the Confidential Information of the other party to any third party without the prior written consent of the disclosing party. Each party agrees that it will not disclose the terms of this Agreement or any Work Order to any third party without the written consent of the other party, which shall not unreasonably be withheld. These obligations of confidentiality and nondisclosure shall remain in effect for a period of [* * *] after the termination of the applicable Work Order.
The foregoing obligations shall not apply to Confidential Information to the extent that it: (a) is or becomes generally available to the public other than as a result of a disclosure by the receiving party; (b) becomes available to the receiving party on a non-confidential basis from a source which is not prohibited from disclosing such information; (c) was developed independently of any disclosure by the disclosing party or was known to the receiving party prior to its receipt from the disclosing party, as shown by contemporaneous written evidence; or (d) is required by law or regulation to be disclosed.
6.0 Ownership and Inventions. All data and information generated or derived by Quintiles as the result of services performed by Quintiles under this Agreement shall be and remain the exclusive property of Sponsor. Any inventions that may evolve from the data and information described above or as the result of services performed by Quintiles under this Agreement shall belong to Sponsor and Quintiles agrees to assign its rights in all such inventions and/or related patents to Sponsor. Notwithstanding the foregoing, Sponsor acknowledges that Quintiles possesses certain inventions, processes, know-how, trade secrets, improvements, other intellectual properties and other assets, including but not limited to analytical methods, procedures and techniques, procedure manuals, personnel data, financial information, computer technical expertise and software, which have been independently developed by Quintiles and which
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
relate to its business or operations (collectively "Quintiles' Property"). Sponsor and Quintiles agree that any Quintiles' Property or improvements thereto which are used, improved, modified or developed by Quintiles under or during the term of this Agreement are the sole and exclusive property of Quintiles.
At the completion of the Services by Quintiles, all materials, information and all other data owned by Sponsor, regardless of the method of storage or retrieval, shall be delivered to Sponsor in such form as is then currently in the possession of Quintiles, subject to the payment obligations set forth in Paragraph 2 herein. Alternatively, at Sponsor's written request, such materials and data may be retained by Quintiles for Sponsor for a period of [* * ], or disposed of pursuant to the written directions of Sponsor. [ * * * ] Quintiles, however, reserves the right to retain, at its own cost and subject to the confidentiality provisions herein, one copy of all materials provided to Sponsor as the result of the Services, to be used to satisfy regulatory requirements or to resolve disputes regarding the Services. Nothing in this Agreement shall be construed to transfer from Sponsor to Quintiles any FDA or regulatory record- keeping requirements unless such transfer is specifically provided for in the applicable Transfer of Obligations Form.
7.0 Independent Contractor Relationship. For the purposes of this Agreement, the parties hereto are independent contractors and nothing contained in this Agreement shall be construed to place them in the relationship of partners, principal and agent, employer/employee or joint venturers. Neither party shall have the power or right to bind or obligate the other party, nor shall it hold itself out as having such authority.
8.0 Regulatory Compliance; Inspections. Quintiles agrees that its Services will be conducted in compliance with all applicable laws, rules and regulations, including but not limited to the Federal Food, Drug and Cosmetic Act and the regulations promulgated pursuant thereto, and with the standard of care customary in the contract research organization industry. Quintiles certifies that it has not been debarred under the Generic Drug Enforcement Act and that it will not knowingly employ any person or entity that has been so debarred to perform any Services under this Agreement. Sponsor represents and certifies that it will not require Quintiles to perform any assignments or tasks in a manner that would violate any applicable law or regulation. Sponsor further represents that it will cooperate with Quintiles in taking any actions that Quintiles reasonably believes are necessary to comply with the regulatory obligations that have been transferred to Quintiles.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Each party acknowledges that the other party may respond independently to any regulatory correspondence or inquiry in which such party or its affiliates is named. Each party, however, shall: a) notify the other party promptly of any FDA or other governmental or regulatory inspection or inquiry concerning any study or Project of Sponsor in which Quintiles is providing Services, including, but not limited to, inspections of investigational sites or laboratories; b) forward to the other party copies of any correspondence from any regulatory or governmental agency relating to such a study or Project, including, but not limited to, Form FD-483 notices, and FDA refusal to file, rejection or warning letters, even if they do not specifically mention the other party; and, c) obtain the written consent of the other party, which will not unreasonably be withheld, before referring to the other party or any of its affiliates in any regulatory correspondence. Where reasonably practicable, each party will be given the opportunity to have a representative present during an FDA or regulatory inspection. Each party, however, acknowledges that it may not direct the manner in which the other party fulfills its obligations to permit inspection by governmental entities.
Each party agrees that, during an inspection by the FDA or other regulatory authority concerning any study or Project of Sponsor in which Quintiles is providing Services, it will not disclose information and materials that are not required to be disclosed to such agency, without the prior consent of the other party, which shall not unreasonably be withheld. Such information and materials includes, but are not limited to, the following: 1) financial data and pricing data (including, but not limited to, the Budget and Payment sections of the Work Order); 2) sales data (other than shipment data); and, 3) personnel data (other than data as to qualification of technical and professional persons performing functions subject to regulatory requirements).
During the term of this Agreement, Quintiles will permit Sponsor's representatives (unless such representatives are competitors of Quintiles) to examine or audit the work performed hereunder and the facilities at which the work is conducted upon reasonable advance notice during regular business hours to determine that the Project assignment is being conducted in accordance with the agreed task and that the facilities are adequate. Unless the [ * * * ]
9.0 Relationship with Investigators. If a particular Work Order obligates Quintiles to contract with investigators or investigative sites (collectively, "Investigators") then any such contract shall be on a form mutually acceptable to Quintiles and
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Sponsor. If an Investigator requests any material changes to such form, Quintiles shall submit the proposed change to Sponsor, and Sponsor shall promptly review, comment on and/or approve such proposed changes. If Sponsor approves a form Investigator Agreement, or any changes to the form, that differ from the terms of this Agreement or a Work Order (including, but not limited to, allowing an Investigator to publish results or data that Quintiles is prohibited from revealing), then Quintiles shall have no liability for any such approved provisions or changes. The parties acknowledge and agree that Investigators shall not be considered the employees, agents, or subcontractors of Quintiles or Sponsor, and that Investigators shall exercise their own independent medical judgment. Quintiles' responsibilities with respect to Investigators shall be limited to those responsibilities specifically set forth in this Agreement and the applicable Work Order.
If Quintiles will be paying Investigators on behalf of Sponsor, the parties will agree in the applicable Work Orders as to a schedule of amounts to be paid to Investigators. Sponsor acknowledges and agrees Quintiles will only pay Investigators from advances or pre-payments received from Sponsor for Investigators' services, and that Quintiles will not make payments to Investigators prior to receipt of sufficient funds from Sponsor. Sponsor acknowledges and agrees that Quintiles will not be responsible for delays in a study or Project to the extent that such delays are caused by Sponsor's failure to make adequate pre-payment for Investigators' services. Sponsor further acknowledges and agrees that payments for Investigators' services are pass- through payments to third parties and are separate from payments for Quintiles' Services. Sponsor agrees that it will not withhold Investigator payments except to the extent that it has reasonable questions about the services performed by a particular Investigator.
10.0 Conflict of Agreements. Quintiles represents to Sponsor that it is not a party to any agreement which would prevent it from fulfilling its obligations under this Agreement and that during the term of this Agreement, Quintiles agrees that it will not enter into any agreement to provide services which would in any way prevent it from providing the services contemplated under this Agreement. Sponsor agrees that it will not enter into an agreement with a third party that would alter or affect the regulatory obligations delegated to Quintiles in any study or Project without the written consent of Quintiles, which will not be unreasonably withheld.
11.0 Publication. Project results may not be published or referred to, in whole or in part, by Quintiles or its affiliates
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
without the prior expressed written consent of Sponsor. Neither party will use the other party's name in connection with any publication or promotion without the other party's prior, written consent.
12.0 Limitation of Liability. Neither party, nor its affiliates, nor any of its or their respective directors, officers, employees or agents shall have any liability of any type (including, but not limited to, contract, negligence, and tort liability), for any special, incidental, indirect or consequential damages, including, but not limited to the loss of opportunity, loss of use, or loss of revenue or profit, in connection with or arising out of this Agreement, any Work Order, or the Services contemplated hereunder, even if such damages may have been foreseeable to such party. In addition, in no event shall the collective, aggregate liability (including, but not limited to, contract, negligence and tort liability) of Quintiles and its affiliates and its and their respective directors, officers, employees and agents under this Agreement or any Work Order hereunder exceed the amount of fees actually received by Quintiles from Sponsor for the assignment or task from which such liability arose.
13.0 Indemnification. Sponsor shall indemnify, defend and hold harmless Quintiles and its affiliates, and its and their directors, officers, employees and agents (each, a "Quintiles Indemnified Party"), from and against any and all losses, damages, liabilities, reasonable attorney fees, court costs, and expenses (collectively "Losses") resulting or arising from any third-party claims, actions, proceedings, investigations or litigation relating to or arising from or in connection with this Agreement, any Work Order, or the Services contemplated herein (including, without limitation, any Losses arising from or in connection with any study, test, device, product or potential product to which this Agreement or any Work Order relates), except to the extent such Losses are determined to have resulted solely from the negligence or intentional misconduct of the Quintiles Indemnified Party seeking indemnity hereunder, in which event Quintiles shall indemnify, defend and hold harmless Sponsor and its Affiliates, and its and their directors, officers, employees, and agents ("Durect Indemnified Parties") from and against any such Losses.
14.0 Indemnification Procedure. Each Indemnified Party shall give the indemnifying party prompt notice of any such claim or lawsuit (including a copy thereof) served upon it and shall fully cooperate with the Indemnifying Party and its legal representatives in the investigation of any matter the subject of indemnification. The Indemnified Party shall not unreasonably
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
withhold its approval of the settlement of any claim, liability, or action covered by this Indemnification provision.
15.0 Termination. This Agreement or any Work Orders may be terminated without
cause by Sponsor or by Quintiles at any time during the term of the Agreement on
[ * * * ] prior written notice to Quintiles or Sponsor, as appropriate. Either
party may terminate this Agreement or any Work Order for material breach upon
[ * * * ] written notice specifying the nature of the breach, if such breach has
not been substantially cured within the [ * * * ] period. In the event that
Quintiles or Sponsor determines, in its sole discretion, that the continued
performance of the Services contemplated by this Agreement would constitute a
potential or actual violation of regulatory or scientific standards of
integrity, such Party may terminate this Agreement or the applicable Work Order,
by giving written notice stating the effective date (which may be less than
[ * * * ] from the notice date) of such termination. Any written termination
notice shall identify the specific Work Order or Work Orders that are being
terminated.
In the event this Agreement or any Work Order is terminated, Sponsor shall pay Quintiles for all Services performed in accordance with the applicable Work Order(s) hereunder, and reimburse Quintiles for all costs and expenses incurred in performing those Services. If payments in a terminated Work Order are milestone-based, and the Work Order is terminated after costs have been incurred by Quintiles toward achieving a milestone, but that milestone has not yet been completed, Sponsor will pay Quintiles' standard fees for actual work performed toward that milestone up to the date of termination. In the event this Agreement is terminated and Quintiles is determined to have breached this Agreement, Sponsor may deduct from its payment obligations amounts directly related to the damages suffered by Sponsor as a result of such breach. Upon receipt of a termination notice, Quintiles shall cease performing any work not necessary for the orderly close out of the affected Project or for the fulfillment of regulatory requirements. Sponsor shall pay for all actual costs, including time spent by Quintiles personnel (which shall be billed at Quintiles' standard rates in effect as of the date of the termination notice), incurred to complete activities associated with the termination and close out of affected Projects, including the fulfillment of any regulatory requirements.
Upon the termination of this Agreement or any Work Order, Quintiles shall deliver to Sponsor all data and materials provided by Sponsor to Quintiles for the conduct of Services under the impacted Project(s). All statistical data, all
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
statistical reports, all data entries and any other documentation produced as the result of Services performed by Quintiles under the impacted Project(s) shall be delivered to Sponsor upon payment to Quintiles for all Services completed in accordance with the applicable Work Order.
16.0 Relationship with Affiliates; Request for Personnel. Sponsor agrees that Quintiles may use the Services of its corporate affiliates to fulfill Quintiles' obligations under this Agreement and any Work Order. Any affiliate so used shall be subject to all of the terms and conditions applicable to Quintiles under this Agreement or any Work Order, and entitled to all rights and protections afforded Quintiles under this Agreement and any Work Order. Quintiles agrees that Sponsor's affiliates may use the services of Quintiles (and its affiliates) under this Agreement. In such event, such Sponsor's affiliates shall be bound by all the terms and conditions of this Agreement and any Work Order and entitled to all rights and protections afforded Sponsor under this Agreement and any Work Order. Any such affiliate of Sponsor or Quintiles may execute a Work Order directly. The term "affiliate" shall mean all entities controlling, controlled by or under common control with Sponsor or Quintiles, as the case may be. The term "control" shall mean the ability to vote fifty percent (50%) or more of the voting securities of any entity or otherwise having the ability to influence and direct the polices and direction of an entity. In addition, Quintiles shall use its reasonable efforts to accommodate Sponsor's requests for specific personnel to be assigned to specific tasks and/or projects.
17.0 Cooperation; Sponsor Delays; Disclosure of Hazards. Sponsor shall forward to Quintiles in a timely manner all data and information in Sponsor's possession or control necessary for Quintiles to conduct the Services. Quintiles shall not be liable to Sponsor nor be deemed to have breached this Agreement or any Work Order for errors, delays or other consequences arising from Sponsor's failure to timely provide documents, materials or information or to otherwise cooperate with Quintiles in order for Quintiles to timely and properly perform its obligations. Sponsor acknowledges that, if it materially delays or suspends performance of the Services, then the personnel and/or resources originally allocated to the Project may be re-allocated, and Quintiles will not be responsible for delays due to required re-staffing or re-allocation of resources. Sponsor shall provide Quintiles with all information available to it regarding known or potential hazards associated with the use of any substances supplied to Quintiles by Sponsor and Sponsor shall comply with all current legislation and regulations concerning the shipment of substances by the land, sea or air.
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
18.0 Force Majeure. In the event either party shall be delayed or hindered in or prevented from the performance of any act required, hereunder by reasons of strike, lockouts, labor troubles, inability to procure materials or services, failure of power or restrictive government or judicial orders, or decrees, riots, insurrection, war, Acts of God, inclement weather or other reason or cause beyond that party's control, then performance of such act (except for the payment of money owed) shall be excused for the period of such delay.
19.0 Notices and Deliveries. Any notice required or permitted to be given hereunder by either party hereunder shall be in writing and shall be deemed given on the date received if delivered personally or by a reputable overnight delivery service, or three days after the date postmarked if sent by registered or certified mail, return receipt requested, postage prepaid to the following addresses:
If to Quintiles: If to Sponsor: Paula Brown Stafford Jean Liu Executive Vice President Vice President and General Counsel Quintiles, Inc. Durect Corporation 1007 Slater Road 10240 Bubb Road Chelsea Place Cupertino, California 95104 Durham, North Carolina 27703 With a copy to: Quintiles Transnational Legal Department P.O. Box 13979 Research Triangle Park, North Carolina 27709-3979 Attention: John Russell |
If Sponsor delivers, ships, or mails materials or documents to Quintiles, or requests that Quintiles deliver, ship, or mail materials or documents to Sponsor or to third parties, then the expense and risk of loss for such deliveries, shipments, or mailings shall be borne by Sponsor. Quintiles disclaims any liability for the actions or omissions of third-party delivery services or carriers.
20.0 Insurance. Each party will maintain, for the duration of this Agreement, insurance in an amount reasonably adequate to
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
cover its obligations hereunder, and, upon request, each party will provide to the other party a certificate of insurance showing that such insurance is in place.
21.0 Foreign Currency Exchange. For all Work Orders in which Quintiles will earn fees or incur expenses in excess of one million U.S. Dollars in a currency differing from the invoice and payment currency, a foreign currency exchange provision will be included in the Work Order.
22.0 [ * * * ]. Where services in a Work Order are provided by Quintiles
[ * * *].
23.0 Assignment. Except as stated above in Section 16, neither party may assign any of its rights or obligations under this Agreement to any party without the express, written consent of the other party.
24.0 Enforceability. This Agreement shall be construed, governed, interpreted, and applied in accordance with the laws of the State of New York, exclusive of its conflict of law provisions. The failure to enforce any right or provision herein shall not constitute a waiver of that right or provision. If any provisions herein are found to be unenforceable on the grounds that they are overly broad or in conflict with applicable laws, it is the intent of the parties that such provisions be replaced, reformed or narrowed so that their original business purpose can be accomplished to the extent permitted by law, and that the remaining provisions shall not in any way be affected or impaired thereby.
25.0 Survival. The rights and obligations of Sponsor and Quintiles, which by intent or meaning have validity beyond such termination (including, but not limited to, rights with respect to product-related inventions, confidentiality, discoveries and improvements, indemnification and liability limitations) shall survive the termination of this Agreement or any Work Order.
26.0 Arbitration. Any controversy or claim arising out of or relating to this Agreement or the breach thereof shall be settled by arbitration administered by the American Arbitration Association ("AAA") under its Commercial Arbitration Rules, and judgment on the award rendered by the arbitrator shall be binding and may be entered in any court having jurisdiction thereof. Such arbitration shall be filed and conducted at the office of the AAA closest to the Quintiles office having responsibility for the Project if filed for by Sponsor and the AAA office in Santa Clara County, California, if filed for by Quintiles, and shall be
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
conducted in English by one arbitrator mutually acceptable to the parties selected in accordance with AAA Rules.
27.0 Entire Agreement and Modification. This Agreement contains the entire understandings of the parties with respect to the subject matter herein, and supersedes all previous agreements (oral and written), negotiations and discussions. Any modifications to the provisions herein must be in writing and signed by the parties.
IN WITNESS WHEREOF, this Agreement has been executed by the parties hereto through their duly authorized officers on the date(s) set forth below.
ACKNOWLEDGED, ACCEPTED AND AGREED TO:
Quintiles, Inc. Durect Corporation By: /s/ Paula Brown Stafford By: /s/ James E. Brown Print Name: Paula Brown Stafford Print Name: James E. Brown Title: Executive Vice President Title: President and Chief Executive Officer Date: October 19, 1999 Date: November 1, 1999 |
FEDERAL ID # 56-1323952
EXHIBIT A
SAMPLE WORK ORDER
WORK ORDER
This Work Order ("Work Order") is between Durect Corporation ("Sponsor") and Quintiles ____________ ("Quintiles") and relates to the Master Services Agreement dated the ___ day of _________, 19__, (the "Master Agreement"). Pursuant to the Master Agreement, Quintiles has agreed to perform certain services in
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
accordance with written work orders, such as this one, entered into from time- to-time describing such services.
The parties hereby agree as follows:
1. Work Order. This document constitutes a "Work Order" under the Master Agreement and this Work Order and the services contemplated herein are subject to the terms and provisions of the Master Agreement.
2. Services and Payment of Fees and Expenses. The specific services contemplated by this Work Order (the "Services") and the related payment terms and obligations are set forth on the following attachments, which are incorporated herein by reference:
SCOPE OF WORK ATTACHMENT 1 PROJECT BUDGET ATTACHMENT 2 TIMELINE ATTACHMENT 3 PAYMENT SCHEDULE ATTACHMENT 4 TRANSFER OF OBLIGATIONS ATTACHMENT 5 |
3. Term. The term of this Work Order shall commence on the date of execution and shall continue until the services described in Attachment 1 are completed, unless this Work Order is terminated in accordance with the Master Agreement.
4. Affiliates and Subcontractors. Sponsor agrees that Quintiles may use the services of its corporate affiliates to fulfill Quintiles' obligations under this Work Order. Any such affiliates shall be bound by all the terms and conditions of, and be entitled to all rights and protections afforded under, the Master Agreement and this Work Order. Any subcontractors or consultants (other than Quintiles' affiliates) that will be used by Quintiles in performing the Services are listed below:
5. Amendments. No modification, amendment, or waiver of this Work Order shall be effective unless in writing and duly executed and delivered by each party to the other.
ACKNOWLEDGED, ACCEPTED AND AGREED TO:
Quintiles ____________ Durect Corporation
By: By:
Title: Title:
Date: Date:
* Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
EXHIBIT 10.11
MODIFIED NET SINGLE TENANT
LEASE AGREEMENT
THIS LEASE, dated February 18, 1999, is entered into by and between DE ANZA ENTERPRISES, LTD., Joint Venture of HOVER FAMILY TRUST 25%, SARAH T. BEHEL, JULIA G. HOVER SMOOT, DAVID H. HOVER & TERESA KOROL each as to 6.25% and JOHNSON FAMILY TRUST as to 50%, all as tenants in common, whose address is 101 CHURCH STREET, #12, LOS GATOS, CALIFORNIA (hereinafter referred to as "Landlord") and DURECT CORPORATION, a Delaware Corporation, whose address is 10240 Bubb Road, Cupertino, CA 95014 (hereinafter referred to as "Tenant"), and shall be effective on the date set forth below.
As used in this Lease:
A. Landlord hereby leases to Tenant, and Tenant hereby leases from Landlord, upon the terms, conditions and covenants hereinafter set forth, those certain Premises (hereinafter referred to as the "Premises"), consisting of that certain real property, as shown in the Official Records of Santa Clara County, recorded at Book 245 Page(s) 55 Maps, on October 17, 1968, together with all buildings and, improvements thereon and appurtenances thereto, consisting of one (1) building on approximately 74,448 square feet and containing a total building are of 30,149 square feet, commonly known as 10240 Bubb Road in the City of Cupertino, California, all as more particularly shown on Exhibit "A" attached hereto and made a part hereof.
B. There terms "Premises" shall mean all areas and facilities at the same address including, without limitation, parking areas, access and perimeter roads, sidewalks, landscaped area, trash disposal facilities, and similar area facilities.
A. The term of this Lease shall be a period of Five (5) years and -0- months, commencing on the Effective Date, as that term is defined in that certain Termination Agreement Regarding Norian Master Lease and Durect Sublease entered by and between Norian Corporation, Tenant and Landlord dated February 18, 1999, unless sooner terminated as provided herein, terminating on the end of the sixtieth full calendar month after the Commencement Date.
Tenant agrees that if Landlord, for any reasons whatsoever, is unable to deliver possession of the Premises on the commencement date set out in the foregoing Subparagraph A, Landlord shall not be liable to Tenant for any loss or damage therefrom, nor shall this Lease be void or voidable; but in such event the commencement, termination and all other dates of this Lease shall be extended to conform to the time of Landlord's tender of possession of the
Premises to Tenant, and Tenant shall not be obligated to pay rent or other sums due Landlord until possession of the Premises is tendered to Tenant.
A. Tenant shall pay in lawful money of the United States to Landlord for each month of the term of this Lease, rent in the amount set forth below in advance on the first day of each calendar month, except as otherwise provided herein, without abatement, deduction, offset, prior notice or demand and also increasing as scheduled.
Month Rate sq. ft. ----- ------------ 01-12 $2.10 13-24 $2.17 25-36 $2.19 37-48 $2.21 49-60 $2.23 |
B. Landlord hereby acknowledges receipt of Tenant's payment of Rent for period first month of the Lease term in the amount of $63,312.90, Prorated Real Property Taxes from February 1, 1999 to June 30, 1999 in the amount of $5,942.45 and Security Deposit of $75,000.00.
C. If the Commencement Date is not the first (1st) day of a month, or if the termination date is not the last day of a month, a prorated monthly installment based on a thirty (30) day month shall be paid at the then current rate for the fractional month during which the leases commence or terminates.
Tenant acknowledges that late payment by Tenant to Landlord of rent and other charges provided for under this Lease will cause Landlord to incur costs not contemplated by this Lease, the exact amount of such cost being extremely difficult and impracticable to fix. Such costs include, without limitation, processing and accounting charges, and late charges that may be imposed on Landlord by the terms of any encumbrance and notes secured by any encumbrance covering the Premises or late charges and penalties by virtue of late payment of taxes due on the Premises. Therefore, if any installment of rent or any other charge due from Tenant is not received by Landlord in five (5) days of the date due, Tenant shall pay to Landlord an additional sum of $1,000.00 as a late charge for every month that the rent or other charge remains unpaid. The parties agree that this late charge represents a fair and reasonable estimate of the cost that Landlord will incur by reason of the late payment by Tenant. Acceptance of any late charge shall not constitute a waiver of Tenant's default with respect to the overdue amount, nor prevent Landlord from exercising any of the rights and remedies available to Landlord.
Tenant has deposited with Landlord the sum of SEVENTY FIVE THOUSAND AND NO/100 DOLLARS ($75,000.00) as a security for the full and faithful performance of ever portion of this Lease to be performed by Tenant. If Tenant defaults (beyond any applicable cure period) with respect to any provision of this Lease, including but not limited to the provisions relating to the payment of rent and other sums due or the repair of damage to the Premises caused by Tenant, Landlord may use, apply, or retain all or any part of this security deposit for the payment of any rent or any other sum in default, the repair of such damage to the Premises or the payment of any amount which Landlord may spend or become obligated to spend by reason of Tenant's default or to compensate Landlord for any other loss or damage which Landlord may suffer by reasons of Tenant's default to the full extent permitted by law. If any portion of said deposit is so used or applied, Tenant shall within ten (10) days after written demand therefor, deposit cash with Landlord in the amount sufficient to restore the security deposit to its original amount, and Tenant's failure to do so shall be a material breach of this Lease. Landlord shall not be required to keep this security deposit separate from its general funds, and Tenant shall not be entitled to interest on such deposit. If Tenant shall fully and faithfully perform every provision of this Lease to be performed by it, the security deposit or any balance thereof shall be returned to Tenant within thirty (30) days of termination of the Lease term except for amounts that Landlord has deducted therefrom that are needed by Landlord to cure defaults of Tenant under this Lease or compensate Landlord for damages for which Tenant is liable pursuant to this Lease.
If Tenant remains in possession of all or any part of the Premises after the expiration of the term hereof, with or without the expressed or implied consent of Landlord, such tenancy shall be month-to-month only and shall not constitute a renewal or extension for any further term. In such event, rent shall be increased to any amount equal to one hundred twenty-five percent (125%) of the rent paid during the last month of the Lease term, and any other sums due hereunder shall be payable in the amount and at the time specified in this Lease, and such month-to-month tenancy shall be subject to every other term, condition, covenant and agreement contained herein.
None by Landlord.
Except as provided below, by taking possession of the Premises, Tenant accepts and acknowledges the Premises as being in good and sanitary order, condition and repair and accepts them in their then-existing condition providing the building and improvements shall comply with all applicable laws, codes, and ordinances. Notwithstanding the foregoing, however, Landlord hereby acknowledges that Landlord shall be responsible for repairing the air conditioning support structure on the roof of the Premises. Landlord hereby agrees to cooperate with Tenant in order to cause the air conditioning support system on the roof to be properly repaired at the same time
as Tenant undertakes to replace the roof membrane. Should it be established by a
structural engineer prior to the replacement of the roof membrane that the roof
structure requires repair, Landlord hereby agrees to cooperate with Tenant in
order to cause repairs to the roof structure as may be required to be made at
the same time as Tenant undertakes to replace the roof membrane pursuant to
Section 17 of this Lease. Landlord shall be solely responsible for the costs of
upgrading the air conditioning support system and for the repairs necessary to
the roof structure and Tenant shall be solely responsible for the costs of
replacing the roof membrane.
Notwithstanding the foregoing or anything to the contrary contained in this
Lease, Landlord shall also be obligated to deliver the Premises in broom clean
condition, free of debris, with all building and other improvements in existence
as of the date of the execution of this Lease by Tenant except as related to the
laboratory construction commenced by Tenant as subtenant to Norian Corporation.
Tenant acknowledges that neither Landlord nor its agent(s) has made any
representation or warranty as to the suitability or fitness of the Premises for
the conduct of Tenant's business or for any other purpose, nor has Landlord
agreed to undertake any modification, alteration or improvement to the Premises
except as expressly provided in this Lease. Except as provided above, the
taking of possession of the Premises by Tenant shall conclusively establish that
the Premises were at such time in satisfactory condition unless within thirty
(30) days after such date Tenant shall give Landlord written notice specifying
in reasonable detail the respects in which the Premises were not in satisfactory
condition. Landlord also hereby assigns to Tenant all warranties with respect
to the Premises which would reduce Tenant's maintenance obligations hereunder
and shall cooperate with Tenant to enforce all such warranties.
A. Tenant shall use the Premises solely for office, R & D, manufacturing, warehousing , the development of pharmaceuticals and drug delivery systems and other legal purposes and shall not use the Premises for any other purpose without obtaining the prior written consent of the Landlord which consent shall not be unreasonably withheld.
B. Tenant shall not use the Premises or suffer or permit anything to be done in or about the Premises which will in any way conflict with any law, statute, zoning ordinance, regulation or requirement of duly constituted public authorities now in force or which may hereafter be in force, or Board of Fire Underwriters requirements or other similar body now or hereafter constituted relating to or affecting the condition, use or occupancy of the Premises. Tenant shall not commit any public or private nuisance or any other act or things which might or would disturb the quiet enjoyment of any occupant of nearby property. Tenant shall not place loads upon the floors, walls, or ceilings in excess of the maximum designed load or which endanger the structure, place any harmful liquids in the drainage systems unless Tenant installs proper neutralizers; dump or store waste materials or refuse or allow such to remain in, or about any part of the Premises outside of the building proper and Tenant shall not store or permit to be stored or otherwise place any materials of any nature whatsoever outside the building proper. Tenant may store materials provided they are properly and attractively screened, in compliance with all applicable city ordinances and approved, in writing, by Landlord.
Landlord covenants that it has the right to make this Lease and that Tenant, upon performing the terms, conditions, and covenants of this Lease, shall have quiet and peaceful possession of the Premises and against any person claiming the same by, through or under Landlord.
A. Tenant shall not make or permit any alterations, additions or improvements in, on or about the Premises, except for non-structural alterations not exceeding Ten Thousand Dollars ($10,000.00) in cost, without the prior written consent of Landlord which consent shall not be unreasonably withheld. All alterations, additions or improvements shall be installed at Tenant's sole expense in compliance with all applicable laws and by a licensed contractor approved in writing by Landlord. Any such alterations, additions or improvements including but not limited to heating, lighting, electrical, air conditioning, partitioning, drapery and carpentry installations made by Tenant which become an integral part of the Premises or are affixed to the Premises so that it cannot be removed without material damage to the Premises shall be and become the property of Landlord upon installation and shall not be deemed trade fixtures; provided, however, that Landlord may as a condition of its giving consent require that Tenant, at Tenant's sole expense agree to remove nay or all alterations, additions or improvements installed by Tenant and repair any damage to the Premises caused by such removal and prior to the termination of the Lease.
B. Tenant shall give Landlord at least (20) twenty days' prior written notice of the date of commencement of any construction of alterations, additions or improvements in, on or about the Premises and Landlord shall have the right at any time to post notice of non-responsibility or similar notices on the Premises in connection therewith.
C. Tenant shall submit drawings and specifications to Landlord for Landlord's approval, and no work shall be commenced until Landlord has approved such drawings and specifications and the contracts, contractors, performance and payment bonds and the sureties thereon; provided however, that an such approvals by Landlord shall not be unreasonably denied or delayed and no performance or payment bonds shall be required on projects costing less than One Hundred Thousand Dollars ($100,000.00).
On or before the expiration or earlier termination of the term of this Lease, Tenant shall surrender the Premises to Landlord in their condition existing as of the commencement of the term of this Lease, normal wear and tear expected, acts of God, casualties, condemnation, Hazardous Materials, (other than those released or emitted by Tenant in or about the Premises), and interior improvements which Landlord states in writing may be surrendered at the termination of the Lease, with all interior walls repainted or repaired, if marked or damaged, all carpets shampooed and cleaned, all floors cleaned and waxed, all to the reasonable satisfaction of Landlord. Tenant shall remove all of Tenant's personal property and trade fixtures from the
Premises, and all such property not so removed shall be deemed abandoned by Tenant. If Landlord so elects, Tenant, prior to the termination hereof, shall remove at its expense any and all fixtures and improvements installed by it which would otherwise remain a part of the realty and restore the Premises to their condition as of the commencement of this Lease. If Tenant fails to remove any trade fixtures, equipment, or improvements, the removal of which is required by Landlord, and such failure continues after the termination of the Lease, Landlord may retain such property and all rights of Tenant with respect to it shall cease, or Landlord may place such property in public storage for Tenant's account. Tenant shall be liable to Landlord for the costs of removal of any such trade fixtures, improvements or equipment of or installed by Tenant, the transportation and storage costs of same, the cost of returning the Premises to their condition as of the commencement of the term of this Lease, together with interest at fifteen (15%) per annum, but in no event to exceed the maximum rate allowed by law on all such expenses from the date of expenditure by Landlord. If the Premises are not so surrendered at the termination of this Lease, Tenant shall indemnify Landlord against all loss or liability resulting from delay by Tenant in so surrendering the Premises, including, without limitation, any clams made by any succeeding tenants, attorneys' fees and other costs incurred.
Notwithstanding anything to the contrary contained in this lease, Landlord and Tenant each hereby waive any and all rights of recovery against the other or against the officers, employees, agents and representatives of the other on account of loss or damage occasioned to such waiving party for its property or the property of others under its control to the extent that such loss or damage is insured against under any property insurance policies which either may have in force at the time of the loss or damage. Tenant and Landlord shall, upon obtaining policies of property insurance required hereunder give notice to the insurance carrier that the foregoing mutual waiver or subrogation is containing in this lease and Tenant and Landlord shall cause each insurance policy obtained by them to provide that the insurance company waives all right of recovery by way of subrogation against either Landlord or Tenant in connection with any damage covered by such policy.
A. As used in this Lease, the term "Real Property Tax" shall include any
form of assessment, license fee, rent tax, levy, penalty or tax (other than net
income or franchise taxes) imposed by any authority having the direct or
indirect power to tax including without limitation any city, county, state or
federal government or any improvement or other district or division thereof,
whether such tax is (i) determined by the area of the Premises or any part
thereof or the rent and other sums payable hereunder by Tenant, including
without limitation, any gross income or excise tax levied by any of the
foregoing authorities with respect to receipt of such rent or other sums, or
(ii) upon or with respect to any legal or equitable interest of Landlord in the
Premises or any part thereof, or (iii) upon this transaction or any document to
which Tenant is a part creating or transferring any interest in the Premises, or
(iv) taxes of every kind and nature levied or assessed in lieu of, in
substitution for, or in addition to, existing or additional taxes on the
Premises whether or not now customary or within the contemplation of the
parties.
B. On or before April 1 and December 1 of each calendar year during the term of this lease, Tenant shall pay to Landlord, all Real Property Taxes as set forth on the county tax assessor's tax statement for the Premises. Landlord shall give Tenant at last fifteen (15) days prior written notice of the amount so due. Upon Landlord's receipt of said tax payment, Landlord shall pay said taxes, and in the event that Tenant shall fail to pay said taxes on or before April 10 and December 10, respectively, Tenant shall pay to Landlord any penalty incurred by said delinquency. Tenant shall pay any Real Property Tax not included within the county tax assessor's tax statement within ten (10) days after being billed for the same by Landlord. In the event this Lease or any extension thereof shall expire on a date earlier than the end of a fiscal tax year, Landlord shall prepare a statement setting forth the Real Property Taxes to the date of such expiration and the parties shall adjust the Tenant's obligation to pay the Real Property Taxes to the date of the expiration of termination of this Lease.
C. Anything to the contrary notwithstanding contained herein, Tenant shall pay any increases in Real Property taxes resulting from any and all improvements of any kind whatsoever placed in, on or about the Premises for the benefit of, at the request of, or by Tenant.
Tenant's liability to pay any Real Property Tax increase pursuant to this Paragraph 15 shall be pro-rated on the basis of 365-day year to account for any fractional portion of a fiscal tax year included at the commencement or expiration of the term of the Lease. With respect to any assessment which may be levied against or upon the Premises, or which under the laws then in force may be evidenced by improvements or other bonds or may be paid in annual installments, only the amount of such annual installment (with appropriate proration for any partial year) and interest due thereon shall be included within the computation of the annual taxes and assessments levied against the Premises.
D. Tenant shall pay prior to delinquency all taxes assessed against and levied upon trade fixtures, furnishings, equipment and all other personal property of Tenants contained in, on or about the Premises or elsewhere. When possible Tenant shall cause said trade fixtures, furnishings, equipment and all other personal property to the assessed and billed separately from the real or personal property of Landlord.
E. Failure of Tenant to pay any of the charges required to be paid under this Paragraph 15 shall constitute a default under the terms hereof the like manner as failure to pay rental when due.
F. Notwithstanding anything to the contrary contained herein, Tenant
shall not be required to pay any portion of any tax or assessment expense or any
increase therein (i) levied on Landlord's rental income, unless such tax or
assessment expense is imposed in lieu of real property taxes; (ii) in excess of
the amount which would be payable if such tax or assessment expense were paid in
installments over the longest possible term; (iii) imposed on land and
improvements other than the Premises; (iv) attributable to Landlord's net
inheritance, gift, transfer, estate or state taxes, or any penalties resulting
from Landlord's failure to pay any taxes or assessments in a timely fashion; or
(v) resulting from a change of ownership or transfer of any or all of the
Premises. Additionally, Tenant shall have the right, by appropriate
proceedings, to
protest or contest any assessment, reassessment or allocation of property taxes or any change therein or any application of any Law to the Premises or Tenant's use thereof. Landlord shall notify Tenant in writing of any change in property taxes within sufficient time to allow Tenant to review and, if it so desires, to contest or protest such change. In the contest or proceedings, Tenant may act in its own name and/or the name of Landlord and Landlord will, at Tenant's request and expense, cooperate with Tenant in any way Tenant may reasonably require in connection with such contest. If Tenant does not pay the property taxes when due which are the subject of such protest or contest, Tenant shall post a bond in lieu thereof in an amount reasonably determined by Landlord but not less than one hundred twenty-five percent (125%) of the amount demanded by the taxing authorities which holds Landlord and the Premises harmless from any damage arising out of the contest and ensuring the payment of any judgment that may be rendered. With respect to any contest of property taxes or law, Tenant shall hold Landlord and the Premises harmless from any damage arising out of such protest or contest and shall pay any judgment that may be rendered for which Tenant would otherwise be liable under the lease without such contest or protest. Any contest conducted by Tenant under the paragraph shall be at Tenant's expense and if interest or late charges become payable as a result of such contest or protest, Tenant shall pay the same. Tenant shall receive the benefit of all refunds of property taxes received with respect to the Lease term.
Tenant shall be responsible for and shall pay promptly, as the same become due and payable, all charges for water, sewer rental, gas, electricity, telephone, refuse pickup, janitorial services and all other utilities, materials and services furnished directly to or used by Tenant in, on or about the Premises during the term of the Lease, together with any taxes thereon. Landlord shall not be liable in damages or otherwise for any failure or interruption of any utility services or other services furnished to the Premises, except that resulting from the negligence or willful misconduct of Landlord and its agents, employees or contractors, and no such failure or interruption shall entitle Tenant to terminate this Lease or withhold rent or other sums hereunder.
Landlord shall keep in good order, condition and repair the structural parts of the building which structural parts include only the foundation, exterior walls (excluding the interior of all walls and the exterior and interior of all windows, doors, plate glass, showcases and interior ceiling), roof structure not the membrane and subflooring of the Premises, except for any damage thereto caused by negligent of Tenant or of Tenant's agents, employees or invitees, or by reason of the failure of Tenant to perform or comply with any terms, conditions or covenants in this Lease, or caused by alterations, additions or improvements made by Tenant or Tenant's agents, employees or contractors. It is an express condition precedent to all obligations of Landlord to repair and maintain that Tenant shall have notified Landlord in writing of the need for such repair of maintenance.
A. Tenant shall at all times clean, keep and maintain in good order, condition and repair the Premises and every part thereof, including without limitation all plumbing and sewage facilities within the Premises, fixtures, interior walls, floors, ceilings, windows, roofing membrane, doors, entrances, plate glass, showcases, skylights, all electrical facilities and equipment, including without limitation lighting fixtures, lamps, fans and any exhaust equipment and systems, and automatic fire extinguisher equipment within the Premises, electrical motors and all other appliances and equipment of every kind and nature located in, upon or about the Premises, except as otherwise provided hereunder. All glass, both interior and exterior is at the sole risk of Tenant, and any broken glass shall promptly be replaced by Tenant at Tenant's expense with glass of the same kind, size and quality. Tenant shall obtain heating, ventilating and air conditioning systems preventive maintenance contract with quarterly service, which shall be subject to the reasonable approval of Landlord and paid for by Tenant, which shall provide for and include without limitation replacement of filters, oiling and lubricating of machinery, parts replacements, adjustment of drive belts, or changes and other preventive maintenance; provided, however, that the Tenant shall have the benefit of all warranties available to landlord regarding the equipment in said systems. Tenant agrees to assign to Landlord any warranties obtained by Tenant for the roof membrane upon the termination of the Lease. Tenant waives the provisions of Section 1941 and 1942 of the California Civil Code and any similar or successor law regarding Tenant's right to make repairs and deduct the expenses of such repairs from the rent due under this Lease.
B. Unless the same is caused by the negligence or willful misconduct of Landlord or any of its agents, employees or contractors, Landlord shall not be liable to Tenant or to any other person for any damage occasioned by a failure in any utility system or by the bursting or leaking of any vessel or pipe in or about the Premises, or for any damage occasioned by water coming into the Premises or arising from the acts of neglect of occupants of adjacent property, or the public.
C. Notwithstanding anything to the contrary contained in this lease, in the event of the failure of the HVAC equipment and it is not reasonably economical to repair the same, then Landlord shall replace the failed equipment as follows: (i) the replacement shall be made with improvements, materials and/or equipment which are of a type and quality equal to or better than the items that are being replaced, and (ii) such replacements shall be made at its sole expense, but the cost thereof shall be amortized and Tenant shall pay additional rent on account of such amortization in accordance with the following procedures: the cost of such replacement shall be amortized on a straight line basis for ten (10) years with interest on the unamortized balance at either (a) if Landlord borrows the needed funds, the then prevailing market rate Landlord would pay if it borrowed funds to perform such replacement work from a Institutional Lender (as defined below), or (v) if Landlord does not borrow such funds, the annual rate of ten percent (10%) or the maximum rate allowed by Law, whichever is less. Landlord shall inform Tenant of the monthly amortized payment required to amortize such cost and shall also provide Tenant with the information upon which such determination is made. As additional rent, Tenant shall pay an amount equal to such monthly amortization payment for each month after such
replacement is completed until the first to occur of (i) the expiration of the term of the Lease, or (ii) the end of the term over which such costs were amortized. The amount of such additional rent that Tenant is to pay shall be due at the same time rent is due.
D. Tenant shall at all times clean, keep and maintain in good order, condition and repair, the parking and landscaping areas associated with the Premises including without limitation, fences, landscape irrigation systems parking lot and striping.
Tenant shall, at its own expense, provide, install and maintain in good condition all trade fixtures and equipment required in the conduct of its business in the Premises. All fixtures and improvements other than Tenant's trade fixtures and equipment which are installed or constructed upon or attached to the Premises by either Landlord or Tenant shall become a part of the reality and belong to Landlord. If Tenant is not then in default, Tenant may, at the termination of this Leases or at any other time, remove from the Premises all trade fixtures, equipment and other personal property not permanently affixed to the Premises. Upon such removal, Tenant shall restore the Premises to its original condition at the time of occupancy, normal wear and tear expected.
Tenant hereby indemnifies and agrees to hold Landlord free and harmless from all liens, claims and demands arising out of any work performed or materials supplied in, on or about the Premises by or on behalf of Tenant, its agents, employees or contractors. Tenant shall cause any such lien imposed to be released of record by payment or posting of proper bond within twenty (20) days after imposition of the lien or upon written request by Landlord.
Tenant shall permit Landlord and its agents to enter the Premises at all reasonable times upon not less than twenty-four (24) hours prior written notice, (except in case of emergency), to inspect the same, to post notices of non responsibility and similar notices and "For Sale" signs, to submit the Premises to prospective purchasers, to make necessary alterations, additions, improvements, or repairs to discharge alterations, additions, improvements or repairs, to discharge Tenant's obligation hereunder when Tenant has failed to do so within a reasonable time after written notice from Landlord, and at any reasonable time within one hundred and eight (180) days prior to the expiration of this Lease or any extension thereof, to place upon the Leased Premises ordinary "For Lease" signs and to submit the Premises to prospective Tenants. The above rights are subject to reasonable security regulations of Tenant. Any such entry by Landlord and Landlord's agents shall not repair Tenant's operations more than reasonably necessary.
Landlord shall provide a sign location on the Premises which may be used by Tenant ("Designated Location"). In addition, Landlord hereby agrees to allow Tenant to install one or more additional signs on or about the Premises at locations other than the Designated Location ("Addition Signs") so long as such signs comply with all applicable laws including all applicable zoning laws and Tenant agrees to remove any such Additional Signs on termination of the Lease. The costs of installing and maintaining the signs shall be Tenant's obligation.
A. Tenant hereby agrees to indemnify and hold harmless Landlord, its subsidiaries, directors, officers, agents, and employees from and against any and all damage, loss, liability or expense including, but not limited to, attorneys' fees and legal costs suffered by same directly or by reason of any claim, suit or judgment brought by or in favor of any person or persons for damage, loss or expense due to, but not limited to, bodily injury, including death resulting anytime therefrom, and property damage sustained by such person or persons which arises out of, is occasioned by or in any way attributable to the use or occupancy of the demised Premises and adjacent areas by the Tenant, the acts or omissions of the Tenant, its agents, employees or any contractors brought onto said Premises by the Tenant, except to the extent caused by the negligence or willful misconduct of Landlord or its agents, employees or contractors. Tenant agrees that the obligations assumed herein shall survive this Lease.
B. Tenant hereby agrees to maintain in full force and effect at all times during the term of this lease, at its own expense, for the protection of Tenant and Landlord, as their interest may appear, policies of insurance issued by a responsible carrier or carriers acceptable to Landlord which afford the following coverages:
1. Employers' Liability__Not less than $1,000,000
2. Commercial General Liability Insurance, Including Blanket Contractual Liability, Broad Form Property Damage, Personal Injury, Completed Operations Products Liability, Fire Damage and Legal LiabilityNot less than $2,000,000
3. "All Risk" Property, Fire, Extended Coverage, and Special Extended Insurance including without limitation, vandalism, malicious mischief, inflation endorsement, sprinkler leakage endorsement on the Premises, including without limitation, the Improvements and all equipment, trade fixtures, inventory, fixtures and personal property located on or installed in the Premises. Such insurance shall be in the full amount of the replacement cost of the aggregate of the foregoing as the same may from time to time increase as a result of inflation or otherwise.
4. Rent Insurance covering those risks referred to in B(3) in an amount equal to all rents (and any sums payable under the lease) for a period of at least twelve (12) months commencing with the date of loss.
5. Boiler and Machinery Insurance including, but not limited to, steam pipes, return pipes, condensation return pipes and other pressure vessels and HVAC, in an amount satisfactory to Landlord.
6. Earthquake insurance with deductibles approved by Landlord not less than $200,000.
C. Tenant may, with the written consent of Landlord, elect to have reasonable deductibles in connection with Items B(3), B(4) and B(5). Landlord shall have no obligation to pay for repairs within the deductible amount except as provided in B(6).
D. Tenant shall deliver to Landlord at least thirty (30) days prior to the time such insurance is first required to be carried by Tenant, and thereafter at least thirty (30) days prior to expiration of such policy, Certificates of Insurance of copies of the policy evidencing the above coverage with limits not less than those specified above. Such Certificates, with the exception of Workers Compensation, shall name Landlord, as described herein and its agents and employees as additional insured. Further, all Certificates shall expressly provide that no less than thirty (30) days prior written notice shall be given Landlord in the event of a material alteration or to or cancellation of the coverages evidenced by such Certificates.
E. Upon demand, Tenant shall provide Landlord, at Tenant's expense, with such increased amount of existing insurance, and such other insurance with respect to increase in risk due to any change in use of the Premises by Tenant hereafter, as Landlord may reasonably require to afford Landlord adequate protection for said risks.
F. If, on account of the failure of Tenant to comply with the foregoing provisions, Landlord is adjudge a co-insurer by its insurance carrier, then any loss or damage Landlord shall sustain by reason thereof shall be borne by Tenant and shall be immediately paid by Tenant upon receipt of a bill thereof and evidence of such loss.
G. Landlord makes no representation that the limits of liability specified to be carried by Tenant under the terms of this Lease are adequate to protect Tenant against Tenant's undertaking under this Article, and in the event Tenant believes that any such insurance coverage called for under this Lease is insufficient Tenant shall provide, at its own expense, such additional increase as Tenant deems adequate.
H. All such insurance shall be in a form reasonably satisfactory to Landlord and shall be carried with companies that have a general policy holder's rating not less than "A" and a financial rating of not less than Class "X" in the most current edition of Best's Insurance Reports, shall provide that such policies shall not be subject to cancellation or change except after at least thirty (30) days' prior written notice to Landlord, and the policy or policies, or duly executed certificates for them, together with satisfactory evidence of payment of the premium
thereon shall be deposited with Landlord prior to the time Tenant enters into possession of the Premises, and upon renewal of such policies, not less than thirty (30) days prior to the expiration of the term of such coverage. If Tenant fails to procure and maintain the insurance required hereunder, Landlord may, but shall not be required to, order such insurance and Tenant shall pay the cost and expense of same upon demand, plus interest at fifteen percent (15%) per annum, but in no event to exceed maximum rate allowed by law.
A. If the Premises are damaged or destroyed, Landlord shall repair the Premises to their prior condition unless it has the option to terminate this Lease as provided herein and it elects to so terminate. Landlord shall have the option to terminate this Lease in the event any of the following occur:
1. The building(s) which is located on the Premises is destroyed or damaged by fire or other casualty required to be insured against by Tenant pursuant to Paragraph 23(B)(1), then in force to the extent of fifty percent (50%) or more of the replacement cost thereof. Notwithstanding the foregoing, however, in the event Landlord elects to terminate the Lease due to the fact that the Premises is destroyed to the extent of 50% or more of the replacement costs thereof, Tenant shall have the election to cause this Lease to continue in full force and effect by agreeing to pay for all of the costs necessary to repair or replace the Premises to the extent such costs exceed the insurance proceeds. Tenant shall make such election within thirty (30) days following Landlord's election to terminate this Lease. In the event Tenant makes the election to pay such additional expenses in order to avoid the termination of this Lease, the parties shall cooperate and work together in good faith in order to enable the Premises to be rebuilt as quickly as reasonably possible following any such damage and destruction. Tenant also agrees to pay Landlord's reasonable costs and expenses associated with assisting Tenant in reconstruction.
2. The building(s) which is located on the Premises is damaged or destroyed by an uninsured casualty and the cost to repair such damage will exceed 5% of the replacement cost of the building; provided, however, that in the event Landlord elects to terminate the Lease as a result of any such uninsured casualty, Tenant shall have the election to cause this Lease to continue in full force and effect by agreeing to pay for all of the costs necessary to repair or replace the Premises to the extent there are no insurance proceeds available. Durect shall make such election within thirty (30) days following Landlord's election to terminate this Lease. In the event Tenant makes the election to pay such additional expenses in order to avoid the termination of this Lease, the parties shall cooperate and work together in good faith in order to enable the Premises to be rebuilt as quickly as reasonably possible following any such damage and destruction. Tenant also agrees to pay Landlord's reasonable costs and expenses associated with assisting Tenant in reconstruction.
3. If one of the above events occurs, Landlord may terminate this Lease by giving Tenant written notice of its election to terminate within thirty (30) days after such damage or destruction, in which event this Lease shall terminate as of the date Tenant receives such notice unless Tenant has elected to pay for all costs necessary to replace the Premises to the extent such costs exceed the insurance proceeds as provided above. If any of the above events occurs and Landlord elects not to terminate the Lease, Landlord and Tenant shall work together in good faith so as to commence the repair or replacement of the Premises and all of Tenant's fixtures and other property and improvements within ninety (90) days following the date of such damage and destruction in accordance with the terms hereof, and shall thereafter cooperate with each other in good faith in order to prosecute the same diligently to completion in which event this Lease will continue in full force and effect. Landlord shall not be responsible for any costs in replacement or repair of Tenant's trade fixtures and other property and improvements. Notwithstanding the foregoing or anything to the contrary contained in this Lease, if the Premises are condemned or damaged by any peril and the Landlord does not elect to terminate the Lease or is not entitled to terminate the Lease pursuant to its terms, then Tenant shall have the option to terminate the Lease if the Premises are condemned or damaged by any peril and the Landlord does not elect to terminate the Lease or is not entitled to terminate the Lease pursuant to its terms, then Tenant shall have the option to terminate the Lease if the Premises cannot be or are not in fact, fully restored by Landlord to their prior condition within two hundred seventy days (270) days after the condemnation or damage.
All insurance proceeds for the Premises that shall be payable under all risk, property fire and extended coverage and extended insurance provided for in paragraph 23 shall be payable to Landlord and Tenant, as their interests shall appear, and the parties hereby agree to cooperate in good faith with each other to cause such insurance proceeds to be used to repair the Premises and all of Tenant's fixtures and other property. In the event the Lease is terminated as a result of any damage or destruction, such insurance proceeds shall be payable to the parties as their interests may appear. Landlord shall not be liable to tenant for any shortfall in insurance proceeds.
B. In the event of any damage or destruction to the Premises which does not result in a termination of this Lease, and if rent loss proceeds are not available, the rent and other sums payable hereunder shall be temporarily abated proportionately with the degree to which Tenant's use of the Premises is impaired by such damage or destruction commencing from the date of such damage or destruction and continuing during the period required by Landlord to complete its repair and restoration of the Premises. Provided Landlord complies with its obligations under this Section 24, Tenant shall not be entitled to any compensation of damages from Landlord for loss of the use of the Premises, damage to Tenant's personal property or any inconvenience occasioned by such damage, repair or restoration. Tenant hereby waives the provisions of Section 1932, Subdivision 2, and Section 1933, Subdivision 4, of the California Civil Code, and the provisions of any similar law hereinafter enacted.
A. If title to all of the Premises or so much thereof be taken for any public or quasi-public use under any statute or by right of eminent domain, or by private purchase in lieu thereof, so that a reasonable amount of reconstruction of the Premises will not result in the Premises being reasonably suitable for Tenant's continued occupancy for the uses and purposes permitted by this Lease, this Lease shall terminate as of the date that possession of the Premises or part thereof be taken.
B. If any part of the Premises shall be so taken and the remaining part thereof (after reconstruction of the then existing building in which the Premises are located) is reasonably suitable for Tenant's continued occupancy for the purposes and uses permitted by this Lease, this Lease shall, as to the part taken, terminate as of the date that possession of such part of the Premises be so taken and the rental and other sums payable hereunder shall be reduced in the same proportion that the floor areas of the portion of the Premises so taken (less any addition thereto by reason of any reconstruction) bears to the original floor area of the Premises, and Landlord shall, at is own cost and expense, make all necessary repairs or alterations to the building in which the Premises are located so as to make the portion of the building not taken a complete architectural unit and the remaining Premises a complete unit. A proportionate part of the rental and other sums payable hereunder shall be temporarily abated during such restoration to the extent there is a substantial interference with Tenant's business. Each party thereto waives the provisions of Section 1265.130, California Code of Civil Procedure allowing either party to petition the Superior Court to terminate this Lease in the event of a partial taking of the Premises.
C. No award for any partial or entire taking shall be apportioned, and Tenant hereby assigns to Landlord its interest in any award which may be made in such taking or condemnation, together with any and all rights of Tenant now or hereafter arising in or to the same or part thereof; provided, however, that nothing contained herein shall be deemed to give Landlord any interest in or require Tenant to assign Landlord any award made to Tenant for the taking of personal property belonging to Tenant, for the interruption of Tenant's business for its moving cost, or for the loss of good will. No temporary taking of the Premises, defined as a taking for less than 180 days, shall terminate this Lease or give Tenant any right to any abatement of rent hereunder. Any award made to Tenant by reason of such temporary taking shall belong entirely to Tenant and Landlord shall not be entitled to share instruments that may be required to effectuate the provisions of this paragraph.
Any excess of the monies paid to Tenant under the sublease ("Excess Rent") over the rental required to be paid by Tenant hereunder shall be paid to Landlord and Tenant, in equal shares after deducting reasonably direct sublease expenses. Any such Excess Rent to be paid to Landlord pursuant hereto shall be payable to Landlord as and with the monthly rent payable to Landlord hereunder pursuant to the terms of Article 4 above.
A. Upon an "Event of Default" (as defined herein), Landlord shall have the following remedies, in addition to all other rights and remedies provided by law or otherwise provided in this Lease, to which Landlord may resort cumulatively or in the alternative:
1. Landlord can continue this Lease in full force and effect, and the Lease will continue in effect as long as Landlord does not terminate Tenant's right to possession, and Landlord shall have the right to collect rent when due. During the period Tenant is in default, Landlord can enter the Premises and rent them, or any part of them, to third parties for Tenant's account. Tenant shall be liable immediately to Landlord to all costs Landlord incurs in reletting the Premises, including, without limitation, broker's commissions, expenses of remodeling the Premises required by the reletting and like cost. Such reletting cannot be for a period shorter or longer than the remaining term of this lease. Tenant shall pay to Landlord the rent and other sums due under this Lease on the dates the rent is due, less the rent and other sums Landlord receives from any reletting. No act by Landlord allowed by this paragraph shall terminate this Lease unless Landlord notifies Tenant in writing that Landlord elects to terminate this Lease.
2. Landlord can terminate Tenant's right to possession of the Premises at any time. No act by Landlord other than giving written notice to Tenant shall terminate this Lease. Acts of maintenance, efforts to relet the Premises or the appointment of a receiver on Landlord's
interest under this Lease shall not constitute a termination of Tenant's right to possession. On termination, Landlord has the right to remove all personal property of Tenant and store same at Tenant's cost and to recover from Tenant as damages:
a. The worth at the time of award of unpaid rent and other sums due and payable which had been earned at the time of termination; plus
b. The worth at the time of award of the amount by which the unpaid rent and other sums due and payable which would have been payable after termination until the time of award exceeds the amount of such rental loss that Tenant proves could have been reasonably avoided; plus
c. The worth at the time of award of the amount by which the unpaid rent and other sums due and payable for the balance of the term after the time of award exceeds the amount of such rental loss the Tenant proves could be reasonably avoided; plus
d. Any other amount necessary to compensate Landlord for all the detriment proximately caused by Tenant's failure to perform Tenant's obligation under this Lease, or which in the ordinary course of things would be likely to result therefrom, including but not limited to any cost of expenses incurred by Landlord (i) in retaking possession of the Premises, including reasonable attorneys' fees and costs therefore, (ii) maintaining or preserving the Premises after such a new tenant, including repairs or alterations to the Premises for such reletting, (iii) leasing commissions, or (iv) any other cost necessary or appropriate to relet the Premises.
The "worth at the time of award" of the amounts referred to in Subparagraphs 2a and 2b of this Paragraph is computed by allowing interest at the rate of fifteen percent (15%) per annum, but in no event to exceed the maximum rate allowed by law, on the unpaid rent and other sums due and payable from the termination date through the date of award, The "worth at the time of award" of the amount referred to in Subparagraph 2c of this Paragraph is computed by discounting such amount at the discount rate of the Federal Reserve Bank of San Francisco at the time of award plus one percent (1%).
B. At the option of Landlord, a breach of this Lease shall exist if any of the following events (severally "Event of Default" and collectively "Events of Default") shall occur:
1. Tenant shall have failed to pay rent, real property insurance,
building maintenance expenses, real estate taxes or any other sum required to be
aid hereunder when due and such failure shall not have been cured within ten
(10) days after Tenant's receipt of written notice of delinquency; provided,
however, that Landlord shall not be required to provide two (2) such notices for
a similar default in any twelve (12) month period of the lease. Tenant may cure
said default at any time prior to a termination of this Lease by Landlord or a
re-entry by Landlord by paying all rents and other expenses or charges then due.
2. Tenant shall have failed to perform any term, covenant or condition of this Lease, except those requiring the payment of money, and Tenant shall have failed to cure such breach within thirty (30) days after written notice from Landlord if such breach could reasonably
be cured within said 30-day period. In the event any such breach could not reasonably be cured within said 30-day period, then Tenant shall not be in default under the terms of this Lease unless Tenant fails to commence to cure such breach within such 30-day period or fails to diligently prosecute such cure thereafter until completion, or
3. Tenant shall have assigned its assets for the benefit of its creditors, or
4. The sequestration or attachment of or execution on any substantial part of the property of Tenant or on any property essential to the conduct of Tenant's business shall have occurred, and Tenant shall have failed to obtain a return or release of such property within thirty (30) days thereafter, or prior to sale pursuant to such sequestration, attachment or levy, whichever is earlier; or
5. Tenant shall have abandoned or vacated the Premises without paying rent.
6. A court shall have made or entered any decree or order which is not rescinded within sixty (60) days of its issuance and Tenant is not otherwise in default:
a. other than under the bankruptcy laws of the United States or
b. appointing a receiver, trust or assignee of Tenant in bankruptcy or insolvency or for its property; or
c. directing the winding up or liquidation of Tenant and such decree or order shall have continued for a period of thirty (30) days.
C. The waiver by either party of any breach of any term, covenant or condition herein contained shall not be deemed to be a waiver of such term, covenant or condition or any subsequent breach of the same or any other term, covenant or condition herein contained. The subsequent acceptance of rent hereunder by Landlord shall not be deemed to be a waiver of any preceding breach by Tenant of any term, covenant or condition of this Lease, other than the failure of Tenant to pay the particular rental or other sum accepted, regardless of Landlord's knowledge of such preceding breach at the time of acceptance of such payment. No covenant, term or condition of this Lease shall be deemed to have been waived by Landlord or Tenant unless such waiver be in writing signed by such party.
This Lease is subject and subordinate to all mortgages and deeds of trust which now affect the Premises and to all renewals, modifications, consolidations, replacements, and extension thereof and Landlord shall have the right to cause this Lease to be and become and remain subject and subordinate to mortgages or deeds of trust which may hereafter be executed covering the Premises or any renewals, modifications, consolidations, replacements or extensions thereof, for the full amount of all advances made or to be made thereunder and without regard to the time or character of such advances, together with interest thereon and subject to all the terms and provisions thereof, provided only that any such subordination to any existing or future
mortgage or deed of trust shall at all times be expressly subject to the
condition that the holder of any such mortgage or deed of trust agree that in
the event of the foreclosure of any such mortgage or deed of trust, Tenant's
leasehold interest in the Premises shall not be disturbed so long as Tenant is
not in default beyond any applicable cure period. Additionally, the holder of
any such mortgage or deed of trust shall agree to enter into a new lease with
Tenant upon the same terms and conditions as this Lease with respect to the
Premises in the event such holder acquires title to the Premises. Within ten
(10) days after Landlord's written request therefor, Tenant shall execute any
and all documents reasonably required by Landlord or the Holder (or Holders) of
the mortgage or deed of trust required to effectuate such subordination
attornment and non-disturbance agreement to make this Lease prior to any lien of
any mortgage, or deed of trust, as the case may be, so long as such documents
provide that the holder or holders of such mortgage or deed of trust will not
disturb Tenant's leasehold interest in the Premises following foreclosure so
long as Tenant is not in default beyond any applicable cure period.
Notwithstanding anything to the contrary set forth in this paragraph, Tenant
hereby attorns and agrees to attorn to any person, firm or corporation
purchasing or otherwise acquiring the Premises at any sale or other proceeding
or pursuant to the exercise of any other rights, powers or remedies under such
mortgage or deeds of trust as if such person, firm or corporation had been named
as Landlord herein, it being intended hereby that Tenant's right to quiet
possession of the Premises shall not be disturbed if Tenant is not in default
and so long as Tenant shall pay the rent and observe and perform all of the
provisions of this Lease, unless this Lease is otherwise terminated, pursuant to
its terms. If acceptable to Landlord's lender and in an acceptable form, this
Lease may be prior to the mortgage.
Landlord shall, within thirty (30) days of the execution of this Lease by the parties, provide a written acknowledgement to Tenant from the holder or holders of any mortgage or deed of trust encumbering the Premises which (i) provides that this Lease shall not be terminated so long as Tenant is not in default under any applicable cure period under this Lease and (ii) recognizes all of Tenant's rights hereunder.
Any notice or demand required or desired to be given under this Lease, except inspection requests, shall be in writing and shall be personally served or in lieu of personal service may e given by mail in which latter event such notice shall be deemed to have been given when three (3) business days have elapsed from the time when such notice was deposited in the United States mail, certified and postage prepaid, addressed to the party to be served. At the date of execution of this Lease, the addresses of Landlord and Tenant are as first above set forth; provided that from and after the date the term of this Lease commences the address of Tenant shall be the address of the Premises. Either party may change its address by giving notice of same in accordance with this paragraph.
In the event either party shall bring any action or legal proceeding for damages for an alleged breach of any provision of this Lease, to recover rent, or other sums due, to terminate the
tenancy of the Premises or to enforce, protect or establish any term, condition or covenant of this Lese or right of either party, the prevailing party shall be entitled to recover as a part of such action or proceedings, or in a separate action brought for that purpose, reasonable attorneys' fees and court costs as may be fixed by the court or jury.
Tenant shall within fifteen (15) days following request by Landlord:
A. Execute and deliver to Landlord any document, including estoppel certificates as prepared by Landlord (i) certifying that this Lease is unmodified and in full force and effect or, if modified, stating the nature of such modification and certifying that this Lease, as so modified, is in full force and effect and the date to which the rent and other charges are paid in advance, if any, and (ii) acknowledging that there are not, to Tenant's knowledge, any uncured defaults on the part of Landlord hereunder, or if there are uncured defaults on the part of Landlord, stating the nature of such uncured defaults, and (iii) evidencing the status of the Lease as may be reasonably required either by a lender making a loan to Landlord to be secured by deed of trust or mortgage covering the Premises or a purchaser of the Premises from Landlord; and
B. In connection with any refinancing or sale of the Premises by
Landlord, to deliver to Landlord the current financial statements of Tenant with
an opinion of a certified public accountant, if available, including a balance
sheet and profit and loss statement for the most recent prior year, all prepared
in accordance with generally accepted accounting principles consistently
applied. Tenant's failure to deliver an estoppel certificate within fifteen
(15) days after the delivery of Landlord's request therefor shall be conclusive
upon Tenant (i) that his Lease is in full force and effect, without modification
except as may be represented by Landlord, (ii) that there are now no uncured
defaults in Landlord's performance, and (iii) that no rent has been paid in
advance.
In the event of any conveyance of the Premises and assignment by Landlord of this Lease, Landlord shall be and is hereby entirely freed and relieved of all liability under any and all of its covenants and obligations contained in or derived from this Lease first arising and occurring after the consummation of such conveyance assignment so long as Landlord's successor agrees and covenants to assume all of Landlord's obligations under this Lease occurring after the consummation of such conveyance assignment.
A. The captions used in this Lease are for the purpose of convenience only and shall not be constructed to limit or extend the meaning of any part of this Lease.
B. Any executed copy of this Lease Agreement shall be deemed an original for all purposes.
C. Time is of the essence for the performance of each term, condition and covenant of this Agreement.
D. In case any one or more of the provisions contained herein, except for the payment of rent, shall for any reason be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision of this Lease, but this Lease shall be construed as if such invalid, illegal or unenforceable provision had not been contained herein. This Lease shall be construed and enforced in accordance with the laws of the State of California.
E. The language in all parts of this Lease shall in all cases be construed as a whole according to its fair meaning and not strictly for or against either Landlord or Tenant. When the content of this Lease requires the neuter gender, it includes the masculine, the feminine, a partnership or cooperation or joint venture, and the singular includes the plural.
F. The covenants and agreements contained in this Lease shall be binding on the parties hereto and on their respective successors and assigns (to the extent this Lease is assignable).
G. The waiver of Landlord of any breach of any term, condition or covenant of this Lease shall not be deemed to be a waiver of such provision or any subsequent breach of the same or nay other term, condition or covenant of this Lease.
If Tenant shall at any time be in default (beyond any applicable cure period) of its obligations to make any payment or perform any other act on its part to be made or performed under this Lease, Landlord may, but shall not be obligated to and without waiving or releasing Tenant from any obligation of Tenant under this Lease, make such payment or perform such other act to the extent Landlord may deem desirable, and in connection therewith, pay expenses and employ counsel. All sums so paid by Landlord and all penalties, interest and costs in connection therewith shall be due and payable by Tenant on the next day after any such payment by Landlord, together with interest thereon at the rate of fifteen percent (15%) per annum, but in no event to exceed the maximum rate allowed by law, from such date to the date of payment thereof by Tenant to Landlord plus collection costs and attorneys' fees. Landlord shall have the same rights and remedies for the non-payment thereof as in the case of default in the payment of rent.
A. At the expiration of the original five (5) year term hereof, and if
Tenant is not in default of any of the terms and conditions of this Lease,
Tenant shall have an option to extend this Lease for one additional term of five
(5) years (herein referred to as the "First Renewal Term"). The option to
extend the Lease for the First Renewal Term shall be exercised by giving
Landlord written notice of Tenant's intention to do so at least one hundred
eighty (180) days prior to the expiration of the present term. Such First
Renewal Term shall be upon all the terms
and conditions hereof, except that the monthly rental for the new term shall be ninety-five percent (95%) of the then current fair market rental value of the Premises. In determining the then fair market rental value, the value of any tenant improvements in the Premises which were paid for by Tenant or any subtenant shall not be taken into account except for those improvements which Landlord has agreed to in writing need not be removed by Tenant upon the termination of this Lease. The parties acknowledge that the value of the laboratory improvements which construction was commenced by Tenant as subtenant to Norian Corporation prior to the Commencement Date shall not be taken into account when determining the fair market rental value of the Premises for the First Renewal Term.
At the expiration of the First Renewal Term and if Tenant is not in default of any of the terms and conditions of this Lease, Tenant shall have a second option to extend this Lease for one additional term of five (5) years (herein the "Second Renewal Term"). This option to extend the term of this Lease for the Second Renewal Term shall be exercised by giving Landlord written notice of Tenant's election to do so at least one hundred eighty (180) days prior to the expiration of the First Renewal Term. Such Second Renewal Term shall be upon all the terms and conditions hereof except that the monthly rental for the Second Renewal Term shall be an amount equal to ninety-five percent (95%) of the then current fair market rental value of the Premises. In determining the then fair market rental value, the value of any tenant improvements in the Premises which were paid for by Tenant or any subtenant shall not be taken into account except for those improvements which Landlord has agreed to in writing need not be removed by Tenant upon the termination of this Lease. The parties acknowledge that the value of the laboratory improvements which construction was commenced by Tenant as subtenant to Norian Corporation prior to the Commencement Date shall not be taken into account when determining the fair market rental value of the Premises for the Second Renewal Term.
B. In the event Landlord and Tenant cannot agree upon the sum which is ninety-five percent 95% of the then current fair market rental value of the Premises within fifteen (15) days after the expiration of the first five (5) year term or the First Renewal Term, the parties shall have the fair market rental value of the Premises determined by the appraisal procedure set forth below.
Each party shall, within, appoint one (1) representative who shall be an MAI real estate appraiser with at least five (5) years full-time commercial appraisal experience in Santa Clara County to act as an appraiser. The two (2) appraisers within thirty (30) days from the expiration of the fifteen (15) day period shall submit their determination in writing signed by both appraisers to each party.
If the two (2) appraisers cannot agree upon the fair market rental value of the Premises within said thirty (30) days, they shall appoint a third appraiser who is similarly qualified. If the two (2) appraisers cannot agree on a third appraiser within fifteen (15) days from the date they were to have submitted their appraisal to Landlord and Tenant, either of the parties to this Lease, by giving five (5) days notice to the other party, can apply to the presiding judge of the Santa Clara County Superior Court for the selection of a third appraiser who meets the qualifications stated above.
Within thirty (30) days after the selection of the third appraiser, a majority of the appraisers shall set the fair market value of the Premises. If a majority of the appraisers are unable to set the fair market rental value within the stipulated time, three (3) appraisals shall be added together and their total divided by three; the resulting quotient shall be the fair market rental value.
If, however, the low appraisal and/or the high appraisal are more than ten percent (10%) lower and/or higher than the middle appraisal, the low and/or high appraisal shall be disregarded. If only one (1) appraisal is disregarded, the remaining two 92) appraisals shall be added together and their total divided by two (2); the resulting quotient shall be the fair market rental value of the Premises. If both the low appraisal and the high appraisal are disregarded as stated in this paragraph, the middle appraisal shall be the fair market rental value of the Premises.
In appraising the Premises as provided for in this paragraph, the appraisers shall take into consideration the fair market rental value of the space which is comparable in quality and nature to the Premises; provided, however, in determining the fair market rental value, the value of any tenant improvements in the Premises which were paid for by Tenant or any subtenant shall not be taken into account except for those improvements which Landlord has agreed to in writing need not be removed by Tenant upon the termination of this Lease. The parties acknowledge that the value of the laboratory improvements which construction was commenced by Tenant as subtenant to Norian Corporation prior to the Commencement Date shall not be taken into account when determining the fair market rental value of the Premises for either the First Renewal Term or the Second Renewal Term. If feasible, comparable space within the adjacent business park shall be the basis of the appraisers' determination of fair market rental value of the Premises. In no event shall the new fair market rental value be less than the rent last payable under the terms of the Lease.
If Tenant objects to the fair market rental that is finally determined pursuant to the appraisal process set forth above, Tenant shall have the right to elect not to extend the term of the lease so long as such determination is made in writing to Landlord within fifteen (15) days from the date of the final determination of the renewal term rent. If Tenant fails to so notify Landlord of its election to terminate the Lease, it shall be deemed that the Lease shall continue in effect and the rent payable shall be the final determination on the appraisers.
Landlord and Tenant shall each pay for the cost of the appraiser appointed by them and they shall each pay one-half of the cost of the third appraiser in the event it is necessary to appoint a third appraiser.
In the event Landlord or Tenant fails to appoint an appraiser within the time specified, the determination of the appointed appraiser shall be final and binding on both parties.
In the event the third appraiser fails to present a fair market rent within the thirty (30) day period, then by mutual consent of Landlord and Tenant (1) the time period shall be extended or (2) if Landlord or Tenant do not wish to extend the period, a new third appraiser shall be selected by Landlord's and Tenant's appraisers and a new thirty (30) day period shall begin.
This Lease and the Exhibits and Addenda, if any, attached hereto is the entire Agreement between the Parties, and there are no agreements or representations between the Parties except as expressed herein. Except as otherwise provided herein, no subsequent changes or additions to this Lease shall be binding unless in writing and signed by the Parrots hereto.
No claim the Tenant may have against the Landlord for any reason shall be offset against the Rents due from Tenant to Landlord.
Tenant, at its sole cost and expense, shall be responsible for full compliance with the Americans with Disabilities Act of 1990, as amended, including, without limitation, Title III thereof and the regulations promulgated thereunder (collectively ADA), with regard to the leased premises and Tenant's business conducted therein. Notwithstanding anything to the contrary contained herein, Tenant shall not be required to construct or pay the cost of complying with any Laws, including, without limitation, the ADA, requiring the construction of structural or other improvements to the Premises unless such compliance is necessitated by new legislation becoming effective during the Lease term or because of Tenant's particular use of the Premises or any improvements to the Premises made by Tenant.
Tenant shall not permit or conduct any activity on the Premises which would violate or cause Landlord to be in violation of applicable laws, statutes, ordinances, rules, regulations, policies, orders and determinations of any governmental authority pertaining to health or the environmental (collectively the "Applicable Law"), including, but not limited to, the Comprehensive Environmental Response Compensation and Liability Act of 1980, as amended, the Resource Conversion and recovery Act of 1967, as amended, and State Laws, as amended, nor which would cause the presence of any substance or the existence of any condition, or the threatened release of any substance in, on, or under the surface of the Premises, or occurrence of any event in which any substance has been disposed of or released on, in or from the Premises in any manner not permitted under Applicable Law such that Applicable Law would require (i) a report or other notice of such condition or event to any federal, state or local governmental agency or (ii) remodel, treatment, or other procedures or remedial action with respect to such condition or event in order to bring the Premises into compliance with all Applicable Law or (iii) contribution by any current or former owner or operator of the Premises toward removal, treatment or other procedures or remedial action required by or that may be brought under Applicable Law with respect to the Premises or any other site or location affected by such condition or event.
To the best knowledge of Landlord, (i) no Hazardous Material is present on the Premises or the soil, surface water or ground water thereof, and no action, proceeding or claim is pending
or threatened regarding the Premises concerning any Hazardous Material or pursuant to any Applicable Law. Under no circumstance shall Tenant be liable for any losses, costs, claims, liabilities and damages (including attorneys' and consultants' fees) of every type and nature, directly or indirectly arising out of or in connection with any Hazardous material present at any time on or about the Premises, or the soil, air improvements, ground water or surface water thereof, or the violation of any law, orders or regulations, relating to any such Hazardous Material except to the extent that any of the foregoing actually results from the release or emission of Hazardous Material on or about the Premises during the Lease term by Tenant or its agents or employees in violation of Applicable Laws. As used herein, "Hazardous Material" shall mean any material which is now or hereafter regulated by any governmental authority or which poses a hazard to the environment or human life. Tenant acknowledges receipt of Earthmetrics (1990) report showing presence of underground storage tank, but shall not be responsible for such removal if compelled by government action.
Tenant agrees not to commit nor suffer any waste to the leased premises. Tenant will not use or permit the use of the leased premises in any manner which would result, or would with the passage of time result in the creation of any easement or prescriptive right.
Tenant covenants that it will maintain its corporate existence and that it will not during the term hereof sell, transfer or assign all or substantially all of its assets, or merge into or consolidate with any other corporation unless the surviving corporation shall have a new worth at lest equal to the net worth of Tenant immediately prior to such merger or consolidation and unless such surviving corporation shall execute and deliver to Landlord and to any mortgagees of the leased premises written assumption of the obligations of Tenant under this Lease.
At Tenant's request, Landlord shall execute in recordable form, a " Memorandum of Lease" referencing the Lease and setting forth the true and legal description and assessor's parcel number of the Premises in a form reasonably acceptable to Tenant, and which Memorandum of Lease shall be recorded in the Official Records of Santa Clara County, California.
Each of the parties executing this Lease hereby represent that (i) they have the authority to do so and (ii) all requisite approvals from any other parties, if necessary, have been obtained.
Landlord hereby represents to Tenant that Landlord owns the Premises free and clear of all exceptions to title other than those exceptions to title set forth in that Preliminary Report No.
69720012 issued by Commonwealth Land Title Insurance Company attached hereto as Exhibit B.
Landlord further represents to Tenant that to the best of Landlord's knowledge, no claims, lawsuits or other actions have been filed or made against Landlord with regard to its ownership and operation of the Premises except Superior Court action #CV 762983 entitled De Anza et al. v. Johnson Family Trust et al. Landlord hereby agrees to indemnify, defend (with counsel reasonably acceptable to Tenant), protect and hold harmless Tenant and its officers, employees, agents and assigns from and against all claims, demands, losses, costs (including attorney's fees and costs) or liabilities arising from or relating to the foregoing civil action.
Landlord has not received any notice from any city, county or other public agency that the Premises or any portion thereof may be the subject of any taking or condemnation action.
SIGNATURE PAGE
In witness whereof, the undersigned have executed this document of 29 pages this ___ day of February, 1999.
DURECT CORPORATION DE ANZA ENTERPRISES, LTD. By: /s/ Thomas A. Schreck By: /s/ Wade H. Hover ----------------------- -------------------------- Chief Financial Officer Wade H. Hover, Manager By: /s/ Joseph C. Johnson --------------------------- Joseph C. Johnson |
EXHIBIT 10.12
November 24, 1999
James Griffin
V.P. Manufacturing
Ciena Corporation/Core Switching Division
10201 Bubb Road
Cupertino, CA 95014
Re: Sublease Amendment
Dear Jim:
This Letter Agreement is entered into between Durect Corporation ("Sublessor") and Ciena Corporation ("Sublessee") for the purpose of amending the Sublease Agreement between Sublessor and Sublessee dated March 10, 1999 ("Sublease") to include additional space as part of the Subleased Premises for a specified duration during the Term of the Sublease.
Ciena and Durect hereby agree that effective as of November 29, 1999 until March 31, 2000:
a. The Subleased Premises as defined in Section 2 of the Sublease shall include all of the space designated as Area W1 on Exhibit B of the Sublease (a copy of which is attached hereto for convenience of reference) which is deemed to contain 3,655 rentable square feet ("Additional Space").
b. The Base Monthly Rent as defined in Section 4 A of the Sublease shall be $34,128.60.
c. Sublessee's Pro Rata Share as defined in Section 4 B for the purposes of computing Additional Rent shall be forty-nine percent (49%).
d. Sublessor and Sublessee acknowledge that Sublessee intends to provide heating and/or air conditioning to the Additional Space, whereas Sublessor will continue to use the space designated as Area W2 on Exhibit B of the Sublease for warehouse and storage use and will not be providing air conditioning or heating to such space. Therefore, with respect to the allocation of Utilities in Section 8 A of the Sublease, Sublessee's share shall be fifty-nine percent (59%).
e. This terms of this Letter Agreement shall terminate on March 31, 2000 in which event Sublessee shall surrender the Additional Space in accordance with the terms of Section 20 of the Sublease.
f. Except as specifically provided herein, all other terms of the Sublease shall remain unaltered.
If the foregoing is acceptable, please sign below where indicated to acknowledge acceptance of this Letter Agreement by Sublessee.
Very truly yours,
/s/ Thomas A. Schreck --------------------- Thomas A. Schreck Chief Financial Officer |
APPROVED AND ACCEPTED:
Ciena Corporation:
By /s/ Jim Griffin --------------- Title Vice President, Manufacturing ----------------------------- |
ACKNOWLEDGED AND CONSENT GRANTED:
Provided that this Sublease Agreement does not modify or change in anyway the
Excess Rents due DeAnza as described in letter dated July 13, 1999
De Anza Enterprises, Ltd.
By /s/ Wade H. Hover ------------------------ Title Manager --------------------- |
THIS SUBLEASE ("Sublease") is dated for reference purposes as of March 10, 1999, and is made by and between Durect Corporation, a Delaware corporation ("Sublessor"), and Lightera Networks, Inc., a Delaware corporation ("Sublessee"). Sublessor and Sublessee hereby agree as follows:
the Subleased Premises upon such terms or such other terms as are mutually acceptable to Sublessor and Sublessee, then Sublessor and Sublessee shall execute a sublease upon such terms within twenty (20) days after Sublessee's receipt of Sublessor's Offer Notice. If Sublessee does not deliver its notice of intent to sublease the Subleased Premises within said ten (10)-day period, or if Sublessor and Sublessee do not enter into a fully executed sublease within said twenty (20)-day period, then this right of first offer to sublease shall lapse and be of no further force or effect; in such event, Sublessor shall have the right to sublease the Subleased Premises to a third party on any other terms more or less favorable than those offered herein to Sublessee. This right of first offer is personal to Sublessee and is not transferable.
Sublessee, and not Sublessor, shall be responsible for (i) the prompt and timely payment of any personal property taxes or assessments levied against Sublessee's personal property improvements, alterations or trade fixtures located within the Subleased Premises, (ii) any telephone service provided to the Subleased Premises during the Term, and (iii) any permit, license, governmental fees or charges arising out of Sublessee's specific use and operation of the Subleased Premises.
Upon the execution of the Lease by Sublessee, Sublessee shall pay to Sublessor Base Month Rent for the month of March, 1999 in the amount of $13,409.30 in immediately available funds.
A. The parties acknowledge and agree that Sublessee is subleasing the
Subleased Premises on an "as is" basis, and that Sublessor has made no
representations or warranties, express or implied, with respect to the Subleased
Premises, whatsoever, including, without limitation, any representation or
warranty as to the suitability of the Subleased Premises for Sublessee's
intended use, provided, however, Sublessor hereby agrees that the roof membrane
on the Master Premises shall be replaced at no cost to Sublessee within twelve
(12) months following the Commencement Date. Sublessee shall, at its sole cost
and expense, keep and maintain in good condition, repair and replace, the
Subleased Premises and every part thereof (including, without limitation,
improvements constructed by or for the benefit of Sublessee); provided, however,
that Sublessee shall not be required to perform (i) any repair, maintenance or
improvements to the heating, ventilating, air conditioning, electrical, water,
sewer, and plumbing systems which do not exclusively serve the Subleased
Premises, it being understood that Sublessor shall be responsible for the repair
and maintenance of any building systems which serve the entire Master Premises
(except as otherwise set forth in the Master Lease) and Sublessee shall be
responsible for the repair and maintenance of any building systems which
exclusively serve the Subleased Premises, or (ii) any maintenance or repair
obligations to the Subleased Premises which are required to be performed by
Sublessor under this Sublease or Master Lessor under the Master Lease. If any
repair, maintenance or improvements are (i) required to be performed by
Sublessor under the Master Lease and not required to be performed by Sublessee
hereunder, or (ii) required to be paid for by Sublessor under the Master Lease
(including, without limitation, the cost of repairs set forth in Section 18.C of
the Master Lease and the cost of any maintenance contracts required to be
carried by Sublessor under the Master Lease), Sublessee shall reimburse
Sublessor
for Sublessee's pro rata share of costs incurred by Sublessor to perform or to pay for the foregoing (collectively "Maintenance Expenses") within twenty (20) days after receiving an invoice therefor from Sublessor; provided, however, that Sublessee shall have no obligation to reimburse Sublessor for any Maintenance Expenses applicable to building equipment or systems exclusively serving any portion of the Master Premises other than the Subleased Premises and Shared Space. Notwithstanding anything to the contrary contained in this Sublease, Sublessor shall have no obligation to perform any repairs or any other obligation of Master Lessor required to be performed by Master Lessor under the terms of the Master Lease (including, without limitation Master Lessor's obligations under Articles 17, 24 and 25 of the Master Lease and Master Lessor's obligation to comply with laws) and Sublessee shall look solely to Master Lessor for performance of said obligations; provided, however, Sublessor shall request performance of the same in writing from Master Lessor promptly after being requested to do so by Sublessee, and shall use Sublessor's reasonable good faith efforts (provided Sublessee pays all costs incurred by Sublessor in connection therewith, unless the matter at issue also affects the portion of the Master Premises retained for the exclusive use of Sublessor, in which event Sublessee shall only be required to pay an equitable share of such costs as reasonably determined by Sublessor) to obtain Master Lessor's performance.
B. Notwithstanding anything to the contrary contained in this
Sublease, (i) there shall be no abatement of Rent or liability of Sublessor on
account of any (a) injury or interference with Sublessee's business (including
loss of profits) with respect to any improvements, alterations or repairs made
by Sublessor to the Subleased Premises or Master Premises or any part thereof or
(b) the cessation of any utilities supplied to the Subleased Premises or the
limitation, curtailment, rationing or restrictions required by and governmental
authority on the use of water, electricity, or any other form of energy serving
the Subleased Premises, and (ii) Sublessor shall not be responsible for repairs
required by an accident, fire or other peril, or for damage caused to any part
of the Subleased Premises or Master Premises by any act, negligence or omission
of Sublessee or its agents, contractors, employees or invitees. It is an
express condition precedent to all obligations of Sublessor to repair and
maintain the Subleased Premises that Sublessee shall have notified Sublessor of
the need for such repairs and maintenance, whereupon Sublessor shall promptly
commence and diligently prosecute its repair obligations. Sublessee hereby
waives the benefits of any statute which would afford Sublessee the right to
make repairs at Sublessor's expense including but not limited to Sections 1941
and 1942 of the Civil Code of California, or to terminate this Sublease because
of Sublessor's failure to keep the Subleased Premises or Master Premises in good
order, condition and repair.
A. The parties acknowledge that other than the Subleased Premises to be occupied by Sublessee hereunder, the Shared Space, and that portion of the Master Premises occupied by Sublessor consisting of 10,421 square feet (as shown on Exhibit B hereto), the remaining portion of the Master Premises ("Area W1" and "Area W2" as shown on Exhibit B hereto) shall be used solely for warehouse and storage use, and therefore solely with regard to allocation of the cost of Utilities, Sublessee's share shall be fifty-one percent (51%) of the costs incurred by Sublessor for all Utilities set forth in Article 16 of the Master Lease, which amount shall be payable by Sublessee to Sublessor as Additional Rent. Sublessor agrees that heating and air conditioning shall not be provided to Area W1 and Area W2 without prior written notice to Sublessee. In the event Sublessor desires to: (a) change the use of Area W1 or Area W2 to any other use other than warehouse and storage use or (b) provide heating or air conditioning to Area W1 or W2, then Sublessor shall provide prior written notice to Sublessee, in which event Sublessor and Sublessee shall agree to an equitable allocation of the cost of Utilities.
B. Sublessor shall provide air conditioning to the Subleased Premises consistent with the normal capacity (as opposed to maximum capacity) of the current air conditioning system in the Master Premises Monday through Friday 8:00 a.m. to 6:00 p.m. and Saturday from 8:00 a.m. to 12:00 p.m., Sundays
and holidays excepted. Should Tenant use such services in excess of the foregoing or at hours other than those listed above, Sublessor reserves the right to charge Sublessee for such excess use as Additional Rent and may charge Sublessee as Additional Rent Sublessor's actual costs (as reasonably determined by Sublessor) in providing such excess services. Sublessor shall provide to the Subleased Premises electric power consistent with normal office use for lighting and small office machines such as desktop computers, copiers and fax machines. In addition to Sublessee's Pro Rata Share of utilities set forth hereinabove, Sublessee shall pay to Sublessor the cost of excessive electricity consumed by Sublessee as determined by meter, or if not metered, as otherwise reasonably estimated by Sublessor, plus any actual reasonable accounting expenses incurred by Sublessor in connection with said determination. Sublessor may cause the Subleased Premises to be separately metered at Sublessee's expense, including without limitation, the cost of installing, maintaining, repairing and replacing such meters. Notwithstanding anything to the contrary contained herein, Sublessee shall have no obligation to pay for all or any portion of any excessive utility usage by Sublessor.
A. Sublessee shall indemnify, defend with counsel reasonably
acceptable to Sublessor, protect and hold Sublessor harmless from and against
any and all claims, liabilities, judgments, causes of action, damages, costs and
expenses (including, without limitation, reasonable attorneys' and experts'
fees), to the extent caused by or arising in connection with: (i) the use or
occupancy by Sublessee or its agents, employees, contractors or invitees of the
Subleased Premises or the condition of the Subleased Premises; (ii) the
negligence or willful misconduct of Sublessee or its agents, employees,
contractors or invitees, except to the extent caused by the negligence or
willful misconduct of Sublessor or its authorized employees, agents or
contractors; (iii) a breach of Sublessee's obligations under this Sublease; and
(iv) a breach (through no fault of Sublessor) of Sublessee's obligations under
the Master Lease to the extent such obligations are incorporated herein by this
Sublease. Sublessee's indemnification of Sublessor shall survive termination of
this Sublease.
B. Sublessor shall indemnify, defend with counsel reasonably acceptable to Sublessee, protect and hold Sublessor harmless from and against any and all claims, liabilities, judgments, causes of action, damages, costs and expenses (including, without limitation, reasonable attorneys' and experts' fees), to the extent caused by or arising in connection with: (i) the negligence or willful misconduct of Sublessor or its agents, employees, contractors or invitees; or (ii) a breach (through no fault of Sublessee) of Sublessor's obligations as "Tenant" under the Master Lease to the extent such obligations are not incorporated herein as obligations of Sublessee under this Sublease. Sublessor's indemnification of Sublessee shall survive termination of this Sublease.
A. If Sublessee fails to pay any sum of money to Sublessor, or fails to perform any other act on its part to be performed hereunder, then Sublessor may, but shall not be obligated to, after passage of any applicable notice and cure periods, make such payment or perform such act. All such sums paid, and all reasonable costs and expenses of performing any such act, shall be deemed Additional Rent payable by Sublessee to Sublessor within ten (10) days after receipt of demand, together with interest thereon at the rate set forth in Article 34 of the Master Lease (the "Interest Rate") from the date of the expenditure until repaid.
B. If Sublessor is in default (beyond the applicable notice and cure period) of any of its monetary obligations under the Master Lease, then Sublessee may, at its option, cure such default, and Sublessee shall be entitled to collect promptly from Sublessor, Sublessee's reasonable expenses in so doing; provided, however, that (i) Master Lessor accepts such performance by Sublessee on behalf of Sublessor, (ii) if Sublessor notifies Sublessee that it disputes any amount demanded by Master Lessor, Sublessee shall not make any such payment to Master Lessor unless Master Lessor has provided a three-day notice to pay such
amount or forfeit the Master Lease, and (iii) Sublessee shall have provided Sublessor with at least two (2) business days' written notice of such intention to cure, and Sublessor shall not cure such default within two (2) business days after receiving such notice. Additionally, if Sublessor fails to perform any of its repair and maintenance obligations hereunder within a reasonable time, but in no event later than thirty (30) days after Sublessor's receipt of written notice from Sublessee (or such longer period of time if such default cannot reasonably be cured within said thirty (30)-day period, provided Sublessor commences such cure within said thirty (30)-day period and thereafter diligently prosecutes such cure to completion), Sublessee may perform such repair and maintenance work. If Sublessee so performs such repair and maintenance work, the full amount of the reasonable and actual cost and expense incurred by Sublessee shall be owed by Sublessor to Sublessee, and Sublessor shall within ten (10) days after its receipt of written demand from Sublessee pay to Sublessee the full amount thereof, it being understood, however, that Sublessee may enforce its right to such reimbursement by legal action, if necessary, but in no event shall Sublessee be entitled to offset or otherwise deduct such amounts from Rent.
B. Sublessee shall not use, store, keep, handle, manufacture, transport, release, discharge, emit or dispose of any Hazardous Materials (as defined in the Master Lease) in, on, under, about, to or from the Subleased Premises without the prior written consent of Sublessor; provided, however, that Sublessee may, without Sublessor's consent, use, in compliance with all applicable laws, normal types and quantities of Hazardous Materials typically used in connection with general purpose offices (such as
copier toner, janitorial supplies and the like). Without limiting the generality of the foregoing, Sublessee, at its sole cost, shall comply with all laws relating to Hazardous Materials. Sublessee shall indemnify, defend with counsel reasonably acceptable to Sublessor and hold Sublessor harmless from and against all claims, actions, suits, proceedings, judgments, losses, costs, personal injuries, damages, liabilities, deficiencies, fines, penalties, damages, reasonable attorneys' fee and consultants' fees, investigations, detoxifications, remediations, removals, and expenses of every type and nature, to the extent caused by the use, storage, handling, manufacture, transportation, release, discharge, emission or disposal of Hazardous Materials on or about the Subleased Premises or Master Premises by Sublessee or its agents, employees, contractors or invitees. Sublessor shall indemnify, defend with counsel reasonably acceptable to Sublessee and hold Sublessee harmless from and against all claims, actions, suits, proceedings, judgments, losses, costs, personal injuries, damages, liabilities, deficiencies, fines, penalties, damages, reasonable attorneys' fee and consultants' fees, investigations, detoxifications, remediations, removals, and expenses of every type and nature, to the extent caused by the use, storage, handling, manufacture, transportation, release, discharge, emission or disposal of Hazardous Materials on or about the Subleased Premises or Master Premises by Sublessor or its agents, employees, contractors or invitees.
C. Sublessee shall not, without the prior written consent of Sublessor, store any materials, supplies, finished or unfinished products or articles of any nature on any area of the Master Premises (including outside the building) except on the Subleased Premises. Sublessor shall not, without the prior written consent of Sublessee, store any materials, supplies, finished or unfinished products or articles of any nature on the Subleased Premises. Sublessee shall not do or permit anything to be done in, on or about the Subleased Premises which would (i) injure the Subleased Premises, or (ii) vibrate, shake, overload, or impair the efficient operation of the Subleased Premises or any portion of the Master Premises or the sprinkler systems, heating, ventilating or air conditioning equipment, or utilities systems located therein. Sublessee shall comply with all reasonable rules and regulations promulgated from time to time by Sublessor or Master Lessor.
The obligations of Sublessor and Sublessee under this Paragraph 12 shall survive the expiration or earlier termination of the Term.
caused by or results from any risk insured against under any property insurance policy carried by any of such parties or any risk which would normally be covered by so called "all risk" extended coverage property insurance, without regard to the negligence or willful misconduct of the party so released. Each party shall use reasonable efforts to cause each insurance policy obtained by it to provide that the insurer waives all right of recovery against the other party and its agents and employees in connection with any damage or injury covered by the policy, and each party shall notify the other party if it is unable to obtain a waiver of subrogation. Sublessor shall not be liable to Sublessee, nor shall Sublessee be entitled to terminate this Sublease or to abate Rent for any reason, including, without limitation, (i) failure or interruption of any utility system or service; or (ii) failure of Master Lessor to maintain the Subleased Premises or the Master Premises as may be required under the Master Lease. The obligations of Sublessor and Sublessee shall not constitute the personal obligations of the officers, directors, trustees, partners, joint venturers, members, owners, stockholders or other principals or representatives of their respective business entity. To the extent that rent is abated with respect to the Subleased Premises under the Master Lease, Sublessee's rental obligations hereunder shall be abated.
A. Sublessee fails to pay any Rent when due, when such failure continues for five (5) days after written notice from Sublessor to Sublessee that any such sum is due; or
B. Sublessee fails to perform any term, covenant or condition of this Sublease (except those requiring payment of Rent) and fails to cure such breach within fifteen (15) days after delivery of a written notice specifying the nature of the breach; provided, however, that if more than fifteen (15) days are reasonably required to remedy the failure, then Sublessee shall not be in default if Sublessee commences the cure within the fifteen (15) day period and thereafter completes the cure within thirty (30) days after the date of the notice; or
C. Sublessee makes a general assignment of its assets for the benefit of its creditors, including attachment of, execution on, or the appointment of a custodian or receiver with respect to a substantial part of Sublessee's property or any property essential to the conduct of its business; or
D. Sublessee abandons the Subleased Premises; or
E. A petition is filed by or against Sublessee under the bankruptcy laws of the United States or any other debtors' relief law or statute, unless such petition is dismissed within sixty (60) days after filing; or
F. A court directs the winding up or liquidation of Sublessee; or
G. A substantial part of Sublessee's property or any property essential to the conduct of its business is attached or executed upon and not released from the attachment or execution within sixty (60) days; or
H. A custodian or receiver is appointed for a substantial part of Sublessee's property or any property essential to the conduct of its business and not discharged within sixty (60) days; or
I. Sublessee commits any other act or omission which constitutes a default under the Master Lease, which has not been cured after delivery of written notice and passage of the applicable grace period provided in the Master Lease as modified, if at all, by the provisions of this Sublease.
Sublessor's reasonable good faith efforts (provided Sublessee pays all costs incurred by Sublessor in connection therewith, unless the matter at issue also affects the portion of the Master Premises which is not part of the Subleased Premises, in which event Sublessee shall only be required to pay an equitable share of such costs as reasonably determined by Sublessor) to obtain Master Lessor's performance; (v) with respect to any obligation of Sublessee to be performed under this Sublease, wherever the Master Lease grants to "Tenant" a specified number of days to perform its obligations under the Master Lease, except as otherwise provided herein, Sublessee shall have three (3) fewer days to perform the obligation, including, without limitation, curing any defaults (provided, however, that if any cure period provides for three (3) days or less to perform, Sublessee shall have one (1) business day to perform); (vi) with respect to any approval required to be obtained from the "Landlord" under the Master Lease, such consent must be obtained from both Master Lessor and Sublessor, and the approval of Sublessor may be withheld if Master Lessor's consent is not obtained; (vii) in any case where the "Landlord" reserves or is granted the right to manage, supervise, control, repair, alter, regulate the use of, enter or use the Premises or any areas beneath, above or adjacent thereto, such reservation or grant of right of entry shall be deemed to be for the benefit of both Master Lessor and Sublessor; (viii) in any case where "Tenant" is to indemnify, release or waive claims against "Landlord", such indemnity, release or waiver shall be deemed to run from Sublessee to both Master Lessor and Sublessor; (ix) in any case where "Tenant" is to execute and deliver certain documents or notices to "Landlord", such obligation shall be deemed to run from Sublessee to both Master Lessor and Sublessor; (x) the following modifications shall be made to the Master Lease as incorporated herein:
(a) the following provisions of the Master Lease are not incorporated herein: Sections 1, 2, 3, 4, 6, 9, 26(I), 28 (last paragraph), 29 (except with respect to Master Lessor), 30, 35 and 42 and Exhibit "B".
(b) references to "Landlord" in the following provisions shall
mean "Master Lessor" only: Sections 17, 18.C, 24.A (first, third, fifth and
seventh references to "Landlord" only), 24.B, 24.C (first reference), 25.B, and
39 (first sentence of second paragraph).
(c) the reference to $10,000 in Section 12.A shall be replaced by $3,000;
(d) any right to abate rent provided to Sublessee through incorporation of the provisions of the Master Lease shall not exceed the rent actually abated under the Master Lease with respect to the Subleased Premises.
IN WITNESS WHEREOF, the parties have executed this Sublease as of the day and year first above written.
SUBLESSOR: SUBLESSEE: DURECT CORPORATION, a Delaware LIGHTERA NETWORKS, INC., a Delaware corporation corporation By: /s/ Thomas A. Schreck By: /s/ David E. Chambers ------------------------- -------------------------------- Name: Thomas A. Schreck Name: David E. Chambers ------------------------ ------------------------------ |
Its: Chief Financial Officer Its: Vice President of Engineering & ----------------------- ------------------------------- Manufacturing ------------- Address: 10240 Bubb Road Address: 10201 Bubb Road Cupertino, CA 95014 Cupertino, CA 95014 |
CONSENT TO SUBLEASE
Master Lessor hereby acknowledges receipt of a copy of this Sublease, and consents to the terms and conditions of this Sublease. Master Lessor represents and warrants that the Master Lease is in full force and effect and has not been modified, and to Master Lessor's knowledge, there exists under the Master Lease no default or event of default by either Master Lessor or Sublessor, nor has there occurred any event which, with the giving of notice or the passage of time or both, could constitute such a default or event of default. By this consent, Master Lessor shall not be deemed in any way to have entered into the Sublease or to have consented to any further assignment or sublease.
MASTER LESSOR:
DE ANZA ENTERPRISES, LTD.
By: /s/ Julia Hoover-Smoot ----------------------------------- Print Name: Julia Hoover-Smoot --------------------------- Title: Attorney -------------------------------- Dated: March 18, 1999 -------------------------------- |
MASTER LEASE
(Attached)
------------------------------------------------------------------------------------------- Description Count Tag # ------------------------------------------------------------------------------------------- Gray Metal File Cabinet - 4 drawer 36 00153-54, 00205-08, 00215, 00220-21, 00228, 00235, 00269, 00275-80, 00290, 00295, 00325, 00327-31, 00339-40, 00350-51, 00362, 00367, 00371-74 ------------------------------------------------------------------------------------------- Dark Blue Metal File Cabinet - 2 drawer 1 00199 ------------------------------------------------------------------------------------------- Blond Wood Top File Cabinet - 2 drawer 1 00211 ------------------------------------------------------------------------------------------- Gray/Blond Wood Top Storage Cabinets 3 00222-00224 ------------------------------------------------------------------------------------------- Burgundy High Back Swivel Office Chairs 41 00158-59, 00177, 00230-31, 00236, 00241-47, 00250-66, 00273, 00284, 00294, 00300, 00303,00310, 00313, 00317, 00324, 00341, 00347, 00354, 00358-59, 00368, 00378-, 00382, 00386-87, 00390, 00393-94 ------------------------------------------------------------------------------------------- Green Office Guest Chairs 3 001160-62 ------------------------------------------------------------------------------------------- Burgundy Office Guest Chairs 52 00163-76, 00178-97, 00267-68, 00285-86, 00292-93, 00301-02, 00342-43, 00348-49, 00360-61, 00369-70, 00391-92 ------------------------------------------------------------------------------------------- Gray Metal 5 Shelf Bookshelf 1 00326 ------------------------------------------------------------------------------------------- Gray Metal 4 Shelf Bookshelf 8 00203-04, 00219, ------------------------------------------------------------------------------------------- |
------------------------------------------------------------------------------------------- 00229, 00272, 00335, 00363, 00375 ------------------------------------------------------------------------------------------- Furniture Inventory ------------------------------------------------------------------------------------------- Description Count Tag # ------------------------------------------------------------------------------------------- Gray Metal 3 Shelf Bookshelf 1 00296 ------------------------------------------------------------------------------------------- Gray Metal 2 Shelf Bookshelf 2 00237, 00291 ------------------------------------------------------------------------------------------- Black Lobby Coffee Table 1 00238 ------------------------------------------------------------------------------------------- Lobby Ashtray Canister 1 00239 ------------------------------------------------------------------------------------------- Large Oval Blond Wood Conference Table 1 00240 ------------------------------------------------------------------------------------------- Small Oval Blond Wood Conference Table 2 00248-49 ------------------------------------------------------------------------------------------- Blond Wood Top Round Table 1 00157 ------------------------------------------------------------------------------------------- Gray Round Tables 2 00156, 00198 ------------------------------------------------------------------------------------------- Gray Rectangular Table 1 00274 ------------------------------------------------------------------------------------------- |
Acknowledged by: Durect Corp: By:___________________________ Dated:_____________________________ Lightera Networks, Inc.: By:___________________________ Dated:_____________________________ |
CONFIDENTIAL TREATMENT REQUESTED
Exhibit 10. 13
Quote 1090 - Revised 10/27/99, 12/22/99, 1/17/00, 2/11/00 and 2/16/00
To
Durect Corporation
CBL Approval Page
Two signatures are required.
Tom Rice: _________________________________________ Chief Executive Officer John Botek: _________________________________________ Chief Operating Officer Narlin Beaty: _________________________________________ Chief Operating Officer Henry Clark: _________________________________________ Director of Client Relations |
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
CONFIDENTIAL TREATMENT REQUESTED
PROJECT PROPOSAL
TO: Barbara Laidlaw FROM: Charles Proby Durect Corporation Chesapeake Biological Labs., Inc. 10240 Bubb Road 1111 S. Paca Street Cupertino, CA 95014 Baltimore, MD 21230 Issue Date: October 11, 1999 Quotation No.: 1090 - Revised 10/27/99 ---------- ------------- Revised 12/22/99 Revised 1/17/00 Revised 2/11/00 Revised 2/16/00 Subject: Duros(R) Sufentanil ------- Duration: This quote is valid for 60 days from issue date. -------- Schedule: See CBL Scheduling Policy. -------- |
CHESAPEAKE BIOLOGICAL LABORATORIES, INC. will provide materials and perform work as described in the Scope of Work. This quotation consists of the following sections.
1. Scope of Work
A. Project Description
B. Process Diagram
C. Development and Validation Work
2. Project Price or Budget
3. CBL Scheduling Policy
4. Cancellation and Postponement Policy
5. Terms and Conditions
DURECT CORPORATION will provide the following:
1. Pre-released active pharmaceutical ingredient, label text, MSDS, Certificate of Analysis and all
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
documentation necessary for release.
2. Approval by signature of the batch record.
3. Any necessary approvals for the use of the product.
4. Perform all additional testing necessary for release of the product not
performed by CBL.SCOPE OF WORK
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
SCOPE OF WORK
PRODUCT NAME: Duros(R) Sufentanil (Schedule II)
PRODUCT USE: Narcotic Analgesic
EXPECTED BATCH SIZE: ~500, 20 cc vials
Targeted fill date: See attached CBL Scheduling Policy.
General Project Description:
This project will consist of component receipt and control, formulation, filtration, aseptic filling, inspection, testing, stability, labeling and packaging.
NOTE: DEA Schedule II; Respiratory protection required when handling drug substance.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
IQ/OQ/PQ of Custom Filling Equipment
Client will provide process and analytical equipment required for any novel
manufacturing methods. CBL will perform installation qualification (IQ),
operational qualification (OQ) and performance qualification (PQ) as required by
CBL SOP5211 and others. A portion of the PQ will be the evaluation of
modifications which might be necessary to use the equipment in the clean room in
such a way as to eliminate the chance of particulate or microbiological
contamination during operation. The cost estimate assumes that relatively
straightforward engineering solutions for clean room use of the equipment will
be found. To minimize timing delays, CBL engineering staff will participate in
final stages of equipment qualification at Client facility prior to shipment of
equipment to CBL.
[* * *]
Fill Process Development
This refers to the aseptic design for operations within the clean area. It involves the arrangement of support equipment and sequence of assembly and preparation operations. Whenever more than the usual filling equipment is going to be located within class 100 space, and additional time will be devoted to that compounding/processing activity, then it is especially important, that thorough consideration be given to possible generation of particulates. Engineering Technical Services has the responsibility to design both the physical and temporal operations, including preparation of a bill of materials necessary to assure a smooth operation, without delays for unanticipated sterile parts. Fill process development will include the filling of pumps with formulation or a suitable surrogate. These pumps could be evaluated for performance to ensure that the filling process is functioning correctly.
Aseptic Process Validation (media fills)
Three media fill processes will be performed in the class 100 area simulating the entire process up to and including the actual filling of vials. Each fill requires NLT 14 days for incubation to determine sterility. The purpose of these fills is to demonstrate aseptic operations within the clean environment.
Assay Validation ([* * *] Sufentanil - Customer to supply).
Assays will be validated according compendial methods of the US Pharmacopeia 23 <1225>. Typical analytical parameters will be considered in the validation of all assays. In particular, CBL will consider accuracy, precision, specificity, limit of detection, limit of quantitation, linearity and range. All of these parameters are not necessarily suitable to every analytical test. In addition to the analytical parameters CBL will also consider ruggedness and robustness. Clearly different test methods require different validation schemes. Category I includes analytical methods for quantitation of major components of bulk drug substances or active ingredients. Category II includes analytical methods for determination of impurities in bulk drug substances. Category III is for analytical methods used in the determination of performance characteristics. CBL will generate a validation protocol consistent with USP 23 <1225>. Data will be collected and reviewed and a final validation report written.
Bacteriostasis/Fungistasis (for Product)
B/F is required in order to establish the potential of the formulation to interfere with sterility assays. B/F testing can be performed on developmental batches as long as they are prepared with material equivalent to that intended for clinical use and have the same formulation as will the GMP batches.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Enhancement/Inhibition (for Product)
E/I evaluates the potential for interference by the formulation with the assay used to measure endotoxin. A preliminary E/I determination will be required to allow quantitation of endotoxin in developmental batches. Full validation of E/I is required once preparation of GMP batches begins. Validation involves performing E/I on three consecutive batches.
Cleaning Recovery Study
This product will use product-dedicated equipment only. Contract manufacturers must be able to assure themselves, their clients, and the FDA that no significant chance exists for cross contamination to occur among products sharing equipment which may conceivably contact product. CBL requires demonstration that products are easily removed from glass or stainless steel surfaces (as appropriate) by the routine cleaning methods called for in CBL cleaning procedures. The cleaning study involves spotting product onto a stainless steel coupon or tray and simulating the method for cleaning the equipment. Recovery of the product from a stainless steel surface and evaluation of cleaning are monitored by TOC (Total Organic Carbon) analysis which, while lacking the specificity of methods such as HPLC, compensates by virtue of its sensitivity. The cleaning study is expected to demonstrate removal of product from the steel or glass surface. While a negative result is not expected, such a result would require additional evaluation of the data obtained and close consultation with the Client regarding the ability of CBL to proceed.
Specifically, for swab recovery, data must be developed to demonstrate the following:
a) The swab does recover the material of interest.
b) The amount of material recovered on the swab can be detected using a
validated and appropriate analytical method.
c) The quantity of material detected on the swab can be correlated to the mass
of residual on the surface being cleaned.
d) The correlation described above is strong and covers the range of interest.
Filling Machine Fill Volume Qualification
CBL will perform a fill volume study with the actual product (or placebo) to assure machine process capability. This study will set the target volume for the fill using volume specifications or label data for the product. Typically, a minimum alert level is set at +/- 3 sigma from the target weight for the fill volume. The specification is then set slightly outside of those alert levels.
No fill volume qualification will be performed due to the unique filling machine used for this process. The filling process for this product utilizes a fill level check performed on each unit by a machine vision system.
[* * *] Point 1: [* * *] Point 9: [* * *] Point 2: [* *] Point 10: [* * *] Point 3: [* *] Point 11: [* * *] Point 4: [* *] Point 12: [* * *] Point 5: [* *] Point 13: [* * *] Point 6: [* *] Point 14: [* * *] Point 7: [* *] Point 15: [* * *] Point 8: [* * *] |
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
[* * *]. The following document outlines [* * * ] is based on that described in
[* * *]
The following assumptions are made with regard to [* * *]:
> [* * *] in this study.
> [* * *] is included in the program.
> [* * *] will be developed separately.
> [* * *] and is not included in the program herein.
--------------------------------------------------------------------------------------------- Activity ** ** ** ** ** ** --------------------------------------------------------------------------------------------- [* * * ] ** ** ** ** ** ** ** ** ** ** ------ --------------------------------------------------------------------------------------------- [* * * ] ** ** ** ** ** ** ** ** ** ** --------------------------------------------------------------------------------------------- [* * * ] ** ** ** ** ** ** ** ** ** ** --------------------------------------------------------------------------------------------- [* * * ] ** ** ** ** ** ** ** ** ** ** --------------------------------------------------------------------------------------------- [* * * ] ** ** ** ** ** ** --------------------------------------------------------------------------------------------- [* * * ] ** ** ** ** ** ** ** ** ** ** --------------------------------------------------------------------------------------------- |
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
DURECT
Nbb 10/4/99
[Flow chart describing product supply, product manufacture and product testing omitted pursuant to request for confidential treatment]
[* * *]
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
---------------------------------------------------------------------------------------------------- Activity Deliverable Estimated Price ---------------------------------------------------------------------------------------------------- IQ/OQ/PQ Custom Filling Equipment/(7)/ Report [* * *] ---------------------------------------------------------------------------------------------------- Fill Process Development Report [* * *] ---------------------------------------------------------------------------------------------------- Aseptic Process Validation (media fills) Report [* * *] ---------------------------------------------------------------------------------------------------- Assay Validation/Testing [* * *] Report [* * *] Report [* * *] ---------------------------------------------------------------------------------------------------- Bacteriostasis/Fungistasis Report [* * *] ---------------------------------------------------------------------------------------------------- Enhancement/Inhibition1 Report [* * *] ---------------------------------------------------------------------------------------------------- Cleaning Recovery Study Report [* * *] ---------------------------------------------------------------------------------------------------- Total Development/Validation Package [* * *] ---------------------------------------------------------------------------------------------------- Fill Finish (3 lots at [* * /2/] Final Product [* * *] ---------------------------------------------------------------------------------------------------- Stability (excluding "release rate assay") Report [* * *] Pump Release Rate Assay/4/ [* * *] Maximum price at 12 months [* * *] ---------------------------------------------------------------------------------------------------- Finished Product Pump Release Rate Assay/6/ QC Batch [* * *] Maximum estimate for 15 timepoints x 3 lots Record [* * *] ---------------------------------------------------------------------------------------------------- Project Management and Initiation Fee/3/ NA [* * *] ---------------------------------------------------------------------------------------------------- TOTAL [* * *] ---------------------------------------------------------------------------------------------------- |
/1/These studies must be performed three times and will be invoiced each
time, once for each of the first three lots produced at CBL. Price
represents the total cost.
/2/Each lot will run for[* * * ]are produced, whichever comes first.
/3/Project Management Fee to remain fixed independent of the number of
fills.
/4/[* * *]
/5/[* * *]
/6/Other finished product testing is included in the filling price.
/7/[* * *]
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Terms: Purchase Order for Quote 1090 is to be issued for the Total of[* * *] ----- . The Project Management and Initiation Fee must accompany the Purchase Order. . [* * *] of the Fill/Finish Price will be invoiced at completion of QC testing by CBL, or at product shipment, [* * *]. . [* * *] of the Fill/Finish Price will be invoiced at shipment of completed batch record, [* * *]. . The Pump Release Rate Assay will be invoiced with each time point, [* * *]. . Qualification/Validation Studies will be invoiced with each report, [* * *]. . Stability will be invoiced with each time point, [* * *]. . The prices set forth in the Project Budget are firm quotes and shall be applicable unless the activities or services contemplated in this Quote 1090 are changed by mutual agreement of CBL and Client. FOB Sellers Dock, freight collect. Cancellation and Postponement and Terms and Conditions policies will apply. |
The opportunity to work with Durect Corporation on this project is appreciated.
Sincerely,
Charles Proby
Director, Sales
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
CBL SCHEDULING POLICY
In order for CBL to maintain a smooth manufacturing schedule, and offer maximum flexibility to our Clients without punitive fees, CBL adheres to this policy. This policy allows our project managers to provide each Client with an estimated filling date for the purposes of completing a timeline. However, CBL's manufacturing schedule will be set by the manufacturing division and only those projects, which have achieved the following milestones will be put on the schedule.
! Receipt of purchase order and requisite prepayment.
! All required validations/qualifications have been performed and
approved.
! Production batch record signed by all parties.
! All equipment and preparation items in-house and available for use.
! Components, excipients, and/or active ingredients have been received and
released.
Every effort will be made to schedule product fills as soon as practicable after achieving the above, events. After CBL and Durect have agreed to a filling date, then CBL will fill no later than five working days after the scheduled date. We recognize that some products have sensitive active ingredients that must be chilled, filled and lyophilized within a short time window. Once on the manufacturing schedule, the Client will be notified of the actual fill date and charged for any postponement or cancellation caused by the Client.
CBL will work closely with you to ensure that your requirements are met. Should scheduling changes be necessary, you will be notified immediately by your project manager.
Effective: January 17, 2000
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
CANCELLATION AND POSTPONEMENT POLICY
1. Clean room and lyophilizer dates will not be assigned without a valid purchase order.
2. All purchase orders must be accompanied by the Project Management and Initiation Fee.
3. If a fill lot is CANCELED, the fee schedule in effect at the time of the cancellation will apply. The current fee schedule is:
Notification Prior to Fill Day Fee ---------------------------------------------------------- >60 days [* * *] ---------------------------------------------------------- 30 - 60 days [* * *] ---------------------------------------------------------- 15- 29 days [* * *] ---------------------------------------------------------- 8 - 14 days [* * *] ---------------------------------------------------------- <8 days [* * *] ---------------------------------------------------------- |
4. If a fill lot is POSTPONED, the fee schedule in effect at the time of the postponement will apply. The current fee schedule is:
Notification Prior to Fill Day Fee ---------------------------------------------------------- >60 days [* * *] ---------------------------------------------------------- 30 - 60 days [* * *] ---------------------------------------------------------- 21 - 29 days [* * *] ---------------------------------------------------------- 15 - 20 days [* * *] ---------------------------------------------------------- 8 - 14 days [* * *] ---------------------------------------------------------- <8 days [* * *] ---------------------------------------------------------- |
5. A postponement of a fill lot of greater than 60 days will be considered a cancellation of such lot. A new quote and purchase order will be required to renew the order.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Completion of this appendix signifies Durect, Inc. acceptance of CBL proposal No. 1090, dated October 11, 1999, revised February 16, 2000, including the terms and conditions listed on the reverse side of this form. These terms and conditions will take precedence over any specified in the customer's documentation.
Appendix 1 must be fully completed before CBL will schedule services and allocate resources. If Appendix 1 is incomplete when submitted (i.e., missing the Purchase Order No., Accounts Payable contact information, required payment or approval signature, etc.), delays in scheduling will result.
All invoicing is to be sent directly to:
Accounts Payable Optional additional Addressee: Name: _____________________ Name: _________________________ Telephone No.: ____________ Address: ______________________ Address: __________________ _______________________________ ___________________________ _______________________________ ___________________________ _______________________________ |
Preferred Initial Payment Method [X]: [_] Check Enclosed [_] Wire Transfer
Any modifications of this Proposal must be made with an approved Change Order and are subject to the same terms and conditions as this Proposal.
Durect, Inc._______________ Chesapeake Biological Laboratories, Inc. ---------------------------------------- Client /s/ James E. Brown /s/ Thomas P. Rice ___________________________ __________________________________ Signature Signature Chief Executive Officer President __________________________ ---------------------------------- Title Title James E. Brown Thomas P. Rice __________________________ ---------------------------------- Name (type or print) Name (type or print) ___________________________ __________________________________ Date Date |
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Please send this completed Proposal Acceptance Sheet via fax (410-843-4414) and mail the original and required payment to:
Henry P. Clark, Director of Client Relations Chesapeake Biological Laboratories, Inc. 1111 South Paca Street Baltimore, Maryland 21230
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
CHESAPEAKE BIOLOGICAL LABORATORIES, INC.
Terms and Conditions Precedent to the Acceptance of a Purchase Order
1. CBL will be responsible for dutifully performing instructions according to a batch record, which has been jointly agreed to by the Customer and CBL. The customer acknowledges that the work to be performed by CBL is experimental in nature and portions of the work may not have been fully validated within generally accepted standards of the pharmaceutical industry. As such, CBL will not be responsible for unexpected results that can be attributed to a process or procedure either supplied by, or requested by the Customer, that has not been fully validated provided that CBL has performed all procedures in accordance with instructions provided by Customer and that the instructions conform to applicable CBL procedures and cGMP's.
2. All documentation and submissions to regulatory authorities in support of the Customer's product are the responsibility of the Customer. No documentation will be provided by CBL except as specifically contracted between the Customer and CBL.
3. CBL makes no representation or warranties regarding the suitability of the Customer's product for any purpose whatsoever, or for the efficacy of such product.
4. The Customer is solely responsible for providing complete and accurate scientific data to CBL regarding Customer's product and Customer's requirements for formulation, fill and finish of Customer's product.
5. In accepting its obligations under the terms of the Purchase Order, CBL has relied upon the accuracy, completeness and correctness of the data and information provided by the Customer in developing the project, any associated time line and the estimated or fixed cost for the project. It is understood by the Customer that additional charges may be billed to the Customer in the event that any data or information provided by the customer proves to be incorrect, incomplete or in error and as a result requires more effort by CBL than anticipated in the original project proposal.
6. The Customer warrants to CBL that all substances delivered by Customer to CBL will be free of hazardous or toxic material and that no specific safe handling instructions are applicable to any such substance or materials, except as disclosed to CBL in writing by Customer in sufficient time for review by CBL and prior to delivery to CBL.
7. The Customer represents and warrants to CBL that all finished product delivered by CBL to Customer will be held and/or used or disposed of by Customer in a safe and responsible manner, and in accordance with all applicable laws, rules and regulations.
8. Prepayment fees (not including Commencement/Project initiation fees), where applicable, are refundable less charges under CBL's Cancellation and Postponement Policy and/or the expenses incurred by CBL prior to the cancellation or postponement. Other payments including Commencement/Project Initiation fees are non-refundable.
9. CBL hereby represents and warrants to customer that the services and goods rendered shall be provided in accordance with this Proposal and applicable Good Laboratory Practice and current Good Manufacturing Practice, and the products will conform to applicable specifications provided by Customer. In the event that the foregoing warranty is not met, CBL shall at Customer's option re-perform the non-conforming services immediately or refund to Customer the applicable purchase price. The Customer acknowledges and agrees that CBL's monetary liability to Customer is limited to the value of the amounts invoiced by CBL and that CBL's obligations to Customer are limited to performance by CBL of services (formulation, sterilization, fill and finish) in accordance with the master batch record and applicable Good Manufacturing Practices (GMP's).
10. The arrangement between CBL and Customer is one of service provider and Customer. No joint venture, partnership or agency is to be created or deemed as between CBL and Customer.
11. Except for the matters for which CBL is required to indemnify Customer as set forth in Paragraph 12, the Customer agrees to indemnify and hold CBL and its employees and agents harmless from any claim or liability, including attorney's fees, incurred or made against CBL arising out of or relating to any breach of any representation or warranty made by Customer hereunder, or otherwise, including, without limitation, any claim or liability asserted by any organization, clinic, patient or any other group or participant in any clinical trial of Customer's product.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
12. CBL shall indemnify and hold harmless Customer, its officers, agents, employees and affiliates from any claim or liability, including attorney's fee, incurred or made against any of them arising out of or relating to any breach of any representation of warranty made by CBL to customer hereunder or CBL's negligence or willful misconduct.
13. CBL will acquire no rights of any kind with respect to the product, active agent, methods developed by or exclusively for Customer as work product as part of this Proposal, materials, compounds, formulations, methodology or procedures provided by Customer under the terms hereunder. All such rights shall be owned exclusively by Customer or its nominee and CBL agrees to execute any required assignments as necessary in order for Customer or its nominee to attain full and marketable title to any such rights.
14. CBL agrees to maintain in confidence all information provided by customer to CBL hereunder in accordance with the Confidentiality Agreement dated September 2, 1999.
Appendix 2 Quality Agreement Supplier: Chesapeake Biological Laboratories, Inc. Client: Durect Corporation Supplier Quote: Quote 1090, Duros(R) Sufentanil |
1. All activities specified in the Quote listed above, which could potentially affect the quality of the Duros(R) Sufentanil product must be performed in compliance with Code of Federal Regulation 21 Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packaging, or Holding of Drugs: General and Part 211-Current Good Manufacturing Practices for Finished Pharmaceuticals, any applicable Food and Drug Guidance to Industry document and recognized industry standard.
2. All validation protocols including but not limited to facility validation, equipment qualification, analytical method validation, cleaning validation and stability protocols generated as part of the above quote will be submitted to Durect Corporation for review and approval, prior to implementation.
3. All activities performed in compliance with a CBL approved procedure will indicate the procedure number.
4. Durect Corporation retains the right to perform a compliance audit of CBL's facility, processes and systems to evaluate the level of compliance to CFR 21, 210 & 211, prior to initiation of the activities specified in this Quote. Furthermore, Durect Corporation retains the right to have a man in the plant all times during the execution of the activities specified in this Quote.
5. CBL will submit validation report for each validation activity required as
part of the activities specified in this Quote. The report will include
among others:
. A summary of the data generated in support of each validation activity,
. A list of all suspect or non-conforming data identified and considered
acceptable upon investigation,
. A list of all un-planned deviations,
. Results of any investigations performed as a result of deviations or suspect
analytical data and corrective action taken.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
6. Validation reports which are for the facility or general use can be reviewed at CBL. Copies of all CBL procedures used as a basis for any of the Durect specific GMP activities performed as a part of this quote will be made available to Durect for retention in their files. General SOP's or SOP's serving multiple clients can be reviewed at CBL.
7. All documents generated in support of products manufactured for Durect will be retained for a minimum of 3 years, or one year after the expiration date and will be made available to Durect at their request for retention in their files.
8. A preliminary copy of the production batch record, less the QC section will be provided to Durect five (5) working days after the completion of finished product sterility testing.
9. A copy of the completed Batch Record will be submitted to Durect within ten working days from completion of the last processing step (completion of finished product testing).
10. Durect will be notified in writing of any changes agreed upon requirements prior to implementation of said changes.
11. Durect will be notified in writing of any verified out of specification results within 48 hours of verification. No product-re-testing will be performed without Durect's approval.
12. Durect retains the right to perform a document audit, at CBL's facility, of all GMP documentation generated in support of this project prior to release of clinical supplies.
*Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC.
Completion of this appendix signifies Durect, Inc. acceptance of CBL proposal No. 1090, dated October 11, 1999, revised February 16, 2000, including the terms and conditions listed on the reverse side of this form. These terms and conditions will take precedence over any specified in the customer's documentation.
Appendix 1 must be fully completed before CBL will schedule services and allocate resources. If Appendix 1 is incomplete when submitted (i.e., missing the Purchase Order No., Accounts Payable contact information, required payment or approval signature, etc.), delays in scheduling will result.
All invoicing is to be sent directly to:
Accounts Payable Optional additional Addressee: Name: /s/ Surabhi Desai Name: /s/ Scott Wheelwright -------------------------- ---------------------------- Telephone No.: 408-346-1056 Address: Durect Corporation ----------------- ------------------------- Address: Durect Corporation 10240 Bubb Rd. ----------------------- --------------------------------- 10240 Bubb Rd. Cupertino, CA 95014 ------------------------------- --------------------------------- Cupertino, CA 95014 ------------------------------- |
Preferred Initial Payment Method (X): [_] Check Enclosed [_] Wire Transfer
Any modifications of this Proposal must be made with an approved Change Order and are subject to the same terms and conditions as this Proposal.
Durect, Inc. Chesapeake Biological Laboratories, Inc. ----------------------- ---------------------------------------- Client /s/ James E. Brown /s/ Thomas P. Rice ----------------------- ------------------------------------- Signature Signature CEO President ----------------------- ------------------------------------- Title Title James E. Brown Thomas P. Rice ----------------------- ------------------------------------- Name (type or print) Name (type or print) 2-17-00 2/16/00 ----------------------- ------------------------------------- Date Date |
Please send this completed Proposal Acceptance Sheet via fax (410-843-4414) and mail the original and required payment to:
Henry P. Clark, Director of Client Relations Chesapeake Biological Laboratories, Inc. 1111 South Paca Street
Baltimore, Maryland 21230
EXHIBIT 10.14
DURECT THERAPEUTICS CORPORATION
employment, to the extent such policies, procedures and practices do not conflict with the terms of this Agreement.
(i) This Agreement may be terminated by the Company following the Company's reasonable determination in good faith that it is terminating Employee for good cause related to Employee's performance;
(ii) This Agreement may be terminated by Employee following a change in Employee's status such that a Constructive Termination has occurred. Constructive Termination shall be deemed to occur if (A)(1) there is a material adverse change in Employee's position causing such position to be of materially reduced stature or responsibility, or (2) Employee's refusal to relocate to a facility or location more than 50 miles from the Company's current location; and (B) within the 30-day period immediately following such material change or reduction Employee elects to terminate employment;
(iii) This Agreement may be terminated without cause by the Company following a reasonable determination by the Company's Board of Directors that such termination would be in the reasonable best interests of the Company ("Termination Without Cause"); or
(iv) Following Employee's death or Disability (as defined in
Section 7 below).
accrued as of the date of Employee's termination of employment and Employee's benefits will be continued under the Company's then existing benefit plans and policies in accordance with such plans and policies in effect on the date of termination and in accordance with applicable law.
AND HAS READ AND UNDERSTOOD ALL OF THE TERMS AND PROVISIONS OF THIS AGREEMENT. THIS AGREEMENT SHALL NOT BE CONSTRUED AGAINST ANY PARTY BY REASON OF THE DRAFTING OR PREPARATION HEREOF.
[Signature Page Follows]
The parties have executed this Agreement the date first written above.
DURECT THERAPEUTICS CORPORATION
By: /s/ Thomas A. Schreck ------------------------------------- Title: President ------------------------------------- |
Address: ___________________________________
EMPLOYEE
Signature: /s/ James E. Brown -------------------------------- Address: ___________________________________ |
CONFIDENTIAL INFORMATION AND
INVENTION ASSIGNMENT AGREEMENT
DURECT CORPORATION
CONFIDENTIAL INFORMATION AND
INVENTION ASSIGNMENT AGREEMENT
maintain the confidentiality of such information and to use it only for certain limited purposes. I agree to hold all such confidential or proprietary information in the strictest confidence and not to disclose it to any person, firm or corporation or to use it except as necessary in carrying out my work for the Company consistent with the Company's agreement with such third party.
force and effect as if originally executed by me. I hereby waive and irrevocably quitclaim to the Company any and all claims, of any nature whatsoever, which I now or hereafter have for infringement of any and all proprietary rights assigned to the Company.
[Signature Page Follows]
The parties have executed this Agreement on the respective dates set forth below:
COMPANY: EMPLOYEE: DURECT JAMES E. BROWN, an Individual: CORPORATION /s/ Thomas A. Schreck /s/ James E. Brown ------------------------------- -------------------------------- Signature By: ___________________________ ________________________________ Printed Name Title: ________________________ Date: _________________________ Date: __________________________ Address: ______________________ Address: _______________________ _______________________________ _______________________ |
LIST OF PRIOR INVENTIONS
AND ORIGINAL WORKS OF AUTHORSHIP
EXCLUDED FROM SECTION 4
Identifying Number Title Date or Brief Description ----------------------- ---------------------- -------------------- |
EXHIBIT 10.15
DURECT THERAPEUTICS CORPORATION
comply with and be bound by the Company's operating policies, procedures and practices from time to time in effect during the term of Employee's employment, to the extent such policies, procedures and practices do not conflict with the terms of this Agreement.
(i) This Agreement may be terminated by the Company following the Company's reasonable determination in good faith that it is terminating Employee for good cause related to Employee's performance;
(ii) This Agreement may be terminated by Employee following a change in Employee's status such that a Constructive Termination has occurred. Constructive Termination shall be deemed to occur if (A)(1) there is a material adverse change in Employee's position causing such position to be of materially reduced stature or responsibility, or (2) Employee's refusal to relocate to a facility or location more than 50 miles from the Company's current location; and (B) within the 30-day period immediately following such material change or reduction Employee elects to terminate employment;
(iii) This Agreement may be terminated without cause by the Company following a reasonable determination by the Company's Board of Directors that such termination would be in the reasonable best interests of the Company ("Termination Without Cause"); or
(iv) Following Employee's death or Disability (as defined in
Section 7 below).
bonus payable under Section 4(c). Health insurance benefits with the same coverage provided to Employee prior to the termination (e.g. medical, dental, optical, mental health) and in all other respects significantly comparable to those in place immediately prior to the termination will be provided at the Company's cost over the Severance Period.
Agreement and agrees to continue to abide by the terms of the Confidentiality Agreement and further agrees that the provisions of the Confidentiality Agreement shall survive any termination of this Agreement or of Employee's employment relationship with the Company.
rendered by the arbitrator may be entered in any court having jurisdiction thereof. Notwithstanding the foregoing, the parties may apply to any court of competent jurisdiction for preliminary or interim equitable relief, or to compel arbitration in accordance with this paragraph, without breach of this arbitration provision. This Section 12(g) shall not apply to the Confidentiality Agreement.
[Signature Page Follows]
The parties have executed this Agreement the date first written above.
DURECT THERAPEUTICS CORPORATION
By: /s/ Thomas A. Schreck --------------------------------- Title: President --------------------------------- |
EMPLOYEE
Signature: /s/ Felix Theeuwes ----------------------------- Address: ________________________________ ________________________________ ________________________________ |
CONFIDENTIAL INFORMATION AND
INVENTION ASSIGNMENT AGREEMENT
DURECT CORPORATION
CONFIDENTIAL INFORMATION AND
INVENTION ASSIGNMENT AGREEMENT
its duly authorized officers and agents as my agent and attorney in fact, to act for and in my behalf and stead to execute and file any such applications and to do all other lawfully permitted acts to further the application for, prosecution, issuance, maintenance or transfer of letters patent or copyright registrations thereon with the same legal force and effect as if originally executed by me. I hereby waive and irrevocably quitclaim to the Company any and all claims, of any nature whatsoever, which I now or hereafter have for infringement of any and all proprietary rights assigned to the Company.
commencement of my Relationship with the Company. I have not entered into, and I agree I will not enter into, any oral or written agreement in conflict with any of the provisions of this Agreement.
[Signature Page Follows]
The parties have executed this Agreement on the respective dates set forth below:
COMPANY: EMPLOYEE: DURECT FELIX THEEUWES, an Individual: CORPORATION /s/ Thomas A. Schreck /s/ Felix Theeuwes ------------------------------- --------------------------------- Signature Signature By: ___________________________ _________________________________ Printed Name Title: ________________________ Date: _________________________ Date: ___________________________ Address: ______________________ Address: ________________________ _______________________________ __________________________ |
LIST OF PRIOR INVENTIONS
AND ORIGINAL WORKS OF AUTHORSHIP
EXCLUDED FROM SECTION 4
Identifying Number Title Date or Brief Description ----------- ---------- -------------------- |
EXHIBIT 10.16
DURECT THERAPEUTICS CORPORATION
(i) This Agreement may be terminated by the Company following the Company's reasonable determination in good faith that it is terminating Employee for good cause related to Employee's performance;
(ii) This Agreement may be terminated by Employee following a change in Employee's status such that a Constructive Termination has occurred. Constructive Termination shall be deemed to occur if (A)(1) there is a material adverse change in Employee's position causing such position to be of materially reduced stature or responsibility, or (2) Employee's refusal to relocate to a facility or location more than 50 miles from the Company's current location; and (B) within the 30-day period immediately following such material change or reduction Employee elects to terminate employment.
(iv) Following Employee's death or Disability (as defined in
Section 7 below).
bonus payable under Section 4(c). Health insurance benefits with the same coverage provided to Employee prior to the termination (e.g. medical, dental, optical, mental health) and in all other respects significantly comparable to those in place immediately prior to the termination will be provided at the Company's cost over the Severance Period.
Agreement and agrees to continue to abide by the terms of the Confidentiality Agreement and further agrees that the provisions of the Confidentiality Agreement shall survive any termination of this Agreement or of Employee's employment relationship with the Company.
or in any other manner), nor, except as otherwise provided in this Agreement, shall any such payment be reduced by any earnings that Employee may receive from any other source.
[Signature Page Follows]
The parties have executed this Agreement the date first written above.
DURECT THERAPEUTICS CORPORATION
By: /s/ Thomas A. Schreck ------------------------------------- Title: President ------------------------------------- |
Address: ____________________________________
EMPLOYEE
Signature: /s/ Thomas A. Schreck ---------------------------------- Address: ____________________________________ |
CONFIDENTIAL INFORMATION AND
INVENTION ASSIGNMENT AGREEMENT
DURECT CORPORATION
CONFIDENTIAL INFORMATION AND
INVENTION ASSIGNMENT AGREEMENT
to use, any inventions, confidential or proprietary information or material belonging to any previous employer or any other party.
The records will be available to and remain the sole property of the Company at all times. I agree not to remove such records from the Company's place of business except as expressly permitted by Company policy which may, from time to time, be revised at the sole election of the Company for the purpose of furthering the Company's business.
[Signature Page Follows]
The parties have executed this Agreement on the respective dates set forth below:
COMPANY: EMPLOYEE: DURECT THOMAS A. SCHRECK, an Individual: CORPORATION /s/ Thomas A. Schreck /s/ Thomas A. Schreck --------------------------------- ----------------------------------- Signature Signature By: _____________________________ ___________________________________ Printed Name Title: __________________________ Date: ___________________________ Date: _____________________________ Address: ________________________ Address: __________________________ _________________________________ ___________________________ |
LIST OF PRIOR INVENTIONS
AND ORIGINAL WORKS OF AUTHORSHIP
EXCLUDED FROM SECTION 4
Identifying Number Title Date or Brief Description ------------------------ -------------- -------------------- |
___ No inventions or improvements
___ Additional Sheets Attached
Signature of Employee/Consultant:_________________________
Print Name of Employee/Consultant:________________________
Date:_____________________________________________________
(a) Any provision in an employment agreement which provides that an employee shall assign, or offer to assign, any of his or her rights in an invention to his or her employer shall not apply to an invention that the employee developed entirely on his or her own time without using the employer's equipment, supplies, facilities, or trade secret information except for those inventions that either:
(1) Relate at the time of conception or reduction to practice of the invention to the employer's business, or actual or demonstrably anticipated research or development of the employer; or
(2) Result from any work performed by the employee for the employer.
(b) To the extent a provision in an employment agreement purports to require an employee to assign an invention otherwise excluded from being required to be assigned under subdivision (a), the provision is against the public policy of this state and is unenforceable.
TERMINATION CERTIFICATION
I further certify that I have complied with all the terms of the Company's Confidential Information and Invention Assignment Agreement signed by me, including the reporting of any inventions and original works of authorship (as defined therein), conceived or made by me (solely or jointly with others) covered by that agreement.
I further agree that, in compliance with the Confidential Information and Invention Assignment Agreement, I will preserve as confidential all trade secrets, confidential knowledge, data or other proprietary information relating to products, processes, know-how, designs, formulas, developmental or experimental work, computer programs, data bases, other original works of authorship, customer lists, business plans, financial information or other subject matter pertaining to any business of the Company or any of its employees, clients, consultants or licensees.
I further agree that for twenty-four (24) months from the date of this Certificate, I shall not either directly or indirectly solicit, induce, recruit or encourage any of the Company's employees or consultants to terminate their relationship with the Company, or take away such employees or consultants, or attempt to solicit, induce, recruit, encourage or take away employees or consultants of the Company, either for myself or for any other person or entity. Further, for a period of twenty-four (24) months from the date of this Certificate, I shall not solicit any licensor to or customer of the Company or licensee of the Company's products, in each case, that are known to me, with respect to any business, products or services that are competitive to the products or services offered by the Company or under development as of the date of termination of my Relationship with the Company.
EXHIBIT 10.17
DURECT CORPORATION
------- --------- 1. Issuance of Stock. Subject to the terms and conditions of this ----------------- |
(b) Purchaser understands that it is responsible for the payment of all taxes on the receipt of the Shares, including but not limited to federal and state income taxes, local taxes and FICA, if any. Purchaser agrees to indemnify the Company with respect to any obligations or expenses related to such taxes.
(a) Purchaser is aware of the Company's business affairs and financial condition and has acquired sufficient information about the Company to reach an informed and knowledgeable decision to acquire the Shares. Purchaser is purchasing the Shares for investment for its own account only and not with a view to, or for resale in connection with, any "distribution" thereof within the meaning of the Securities Act. Purchaser does not have any present intention to transfer the Shares to any other person or entity.
(b) Purchaser understands that the Shares have not been registered under the Securities Act by reason of a specific exemption therefrom, which exemption depends upon, among other things, the bona fide nature of Purchaser's investment intent as expressed herein.
(c) Purchaser understands that the Shares are "restricted securities" under applicable U.S. federal and state securities laws and that, pursuant to these laws, Purchaser must hold the Shares indefinitely unless they are registered with the Securities and Exchange Commission and qualified by state authorities, or an exemption from such registration and qualification requirements is available. Purchaser acknowledges that the Company has no obligation to register or qualify the Shares for resale. Purchaser further acknowledges that if an exemption from registration or qualification is available, it may be conditioned on various requirements including, but not limited to, the time and manner of sale, the holding period for the Shares, and requirements relating to the Company which are outside of Purchaser's control, and which the Company is under no obligation and may not be able to satisfy.
(d) Purchaser understands that Purchaser may suffer adverse tax consequences as a result of Purchaser's purchase or disposition of the Shares. Purchaser represents that Purchaser has consulted any tax consultants Purchaser deems advisable in connection the purchase or disposition of the Shares and that Purchaser is not relying on the Company for any tax advice.
(i) THE SHARES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AND HAVE BEEN ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE OR DISTRIBUTION THEREOF. NO SUCH SALE OR DISTRIBUTION MAY BE EFFECTED WITHOUT AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR AN OPINION OF COUNSEL IN A FORM SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED UNDER THE SECURITIES ACT OF 1933.
(ii) any other legend required by federal or state securities laws.
such provision, then (i) such provision shall be excluded from this Agreement,
(ii) the balance of the Agreement shall be interpreted as if such provision were
so excluded and (iii) the balance of the Agreement shall be enforceable in
accordance with its terms.
The parties have executed this Agreement as of the date first set forth above.
DURECT CORPORATION
By: /s/ James E. Brown ________________________________ Title: Chief Executive Officer _____________________________ |
Address: ___________________________
PURCHASER:
ALZA CORPORATION
By: /s/ Peter Staple ________________________________ Title: Executive Vice President _____________________________ |
Address: ___________________________
EXHIBIT 10.18
Warrant No. CS-1 Number of Shares: 1,000,000 Date of Issuance: April 14, 2000 (subject to adjustment)
DURECT CORPORATION
Where X = The number of shares of Common Stock to be issued to the Registered Holder. Y = The number of shares of Common Stock purchasable under this Warrant (at the date of such calculation). A = The fair market value of one share of Common Stock (at the date of such calculation). B = The Purchase Price (as adjusted to the date of such calculation). |
(ii) For purposes of this Section 1(d), the fair market value of one share of Common Stock on the date of calculation shall mean:
(A) if the exercise is in connection with an initial public offering of the Company's Common Stock, and if the Company's Registration Statement relating to such public offering has been declared effective by the Securities and Exchange Commission, then the
fair market value per share of Common Stock shall be the initial "Price to Public" specified in the final prospectus with respect to the offering;
(B) if this Warrant is exercised after, and not in connection with, the Company's initial public offering, and if the Company's Common Stock is traded on a securities exchange or The Nasdaq Stock Market or actively traded over-the-counter:
(1) if the Company's Common Stock is traded on a securities exchange or The Nasdaq Stock Market, the fair market value shall be deemed to be the average of the closing prices over a thirty (30) day period ending three days before date of calculation, or since the shares were first traded on such exchange, if less than thirty three (33) days; or
(2) if the Company's Common Stock is actively traded over-the-counter, the fair market value shall be deemed to be the average of the closing bid or sales price (whichever is applicable) over the thirty (30) day period ending three days before the date of calculation, or since the shares were first traded on such exchange, if less than thirty three (33) days; or
(C) if neither (A) nor (B) is applicable, the fair market value shall be at the highest price per share which the Company could obtain on the date of calculation from a willing buyer (not a current employee or director) for shares of Common Stock sold by the Company, from authorized but unissued shares, as reasonably determined in good faith by the Board of Directors, unless the Company is at such time subject to a transaction as described in Section 1(a)(iii) above, in which case the fair market value per share of Common Stock shall be deemed to be the value of the consideration per share received by the holders of such stock pursuant to such transaction.
(i) a certificate or certificates for the number of shares of Warrant Stock to which such Registered Holder shall be entitled, and
(ii) in case such exercise is in part only, a new warrant or
warrants (dated the date hereof) and in the same form as this warrant, calling
in the aggregate on the face or faces thereof for the number of shares of
Warrant Stock equal (without giving effect to any adjustment therein) to the
number of such shares called for on the face of this Warrant minus the number of
such shares purchased by the Registered Holder upon such exercise as provided in
Section 1(b) above.
Stock shall be paid in respect of Common Stock, the Purchase Price in effect
immediately prior to such subdivision or at the record date of such dividend
shall simultaneously with the effectiveness of such subdivision or immediately
after the record date of such dividend be proportionately reduced. If
outstanding shares of Common Stock shall be combined into a smaller number of
shares, the Purchase Price in effect immediately prior to such combination
shall, simultaneously with the effectiveness of such combination, be
proportionately increased. When any adjustment is required to be made in the
Purchase Price, the number of shares of Warrant Stock purchasable upon the
exercise of this Warrant shall be changed to the number determined by dividing
(i) an amount equal to the number of shares issuable upon the exercise of this
Warrant immediately prior to such adjustment, multiplied by the Purchase Price
in effect immediately prior to such adjustment, by (ii) the Purchase Price in
effect immediately after such adjustment.
(a) the Company shall take a record of the holders of its Common Stock (or other stock or securities at the time deliverable upon the exercise of this Warrant) for the purpose of entitling or enabling them to receive any dividend or other distribution, or to receive any right to subscribe for or purchase any shares of stock of any class or any other securities, or to receive any other right, to subscribe for or purchase any shares of stock of any class or any other securities, or to receive any other right, or
(b) of any capital reorganization of the Company, any reclassification of the capital stock of the Company, any consolidation or merger of the Company, any consolidation or merger of the Company with or into another corporation (other than a consolidation or merger in which the Company is the surviving entity), or any transfer of all or substantially all of the assets of the Company, or
(c) of the voluntary or involuntary dissolution, liquidation or winding-up of the Company,
then, and in each such case, the Company will mail or cause to be mailed to the Registered Holder of this Warrant a notice specifying, as the case may be, (i) the date on which a record is to be taken for the purpose of such dividend, distribution or right, and stating the amount and character of such dividend, distribution or right, or (ii) the effective date on which such reorganization, reclassification, consolidation, merger, transfer, dissolution, liquidation or winding-up is to take place, and the time, if any is to be fixed, as of which the holders of record of Common Stock (or such other stock or securities at the time deliverable upon such reorganization, reclassification, consolidation, merger, transfer, dissolution, liquidation or winding-up) are to be determined. Such notice shall be mailed at least ten (10) days prior to the record date or effective date for the event specified in such notice.
shares of Common Stock issuable upon exercise of this Warrant as "Registrable Securities" as defined in Section 1.1(b) of said agreement so that such shares of Common Stock shall have the same registration rights under the Rights Agreement as with respect to shares of the Company's Series A-1 Preferred Stock held by the Registered Holder. If such amendment is not completed within 30 days after the date of this Warrant, then the Warrant Stock shall not be subject to the Amended and Restated Market Stand-Off Agreement dated June 19, 1998.
DURECT CORPORATION
By: /s/ James E. Brown _____________________________________ James E. Brown, President |
Address: 10240 Bubb Road Cupertino, CA 95014
To: DURECT CORPORATION Dated:
The undersigned, pursuant to the provisions set forth in the attached
Warrant No. CS-1, hereby irrevocably elects to (a) purchase _____ shares of the
Common Stock covered by such Warrant and herewith makes payment of $ _________,
representing the full purchase price for such shares at the price per share
provided for in such Warrant, or (b) exercise such Warrant for _______ shares
purchasable under the Warrant pursuant to the Net Issue Exercise provisions of
Section 1(c) of such Warrant.
The undersigned acknowledges that:
A. The Warrant Stock to be acquired by the undersigned will be acquired for investment for the undersigned's own account, not as a nominee or agent, and not with a view to the resale or distribution of any part thereof, and that the undersigned has no present intention of selling, granting any participation in, or otherwise distributing the same. By executing this form, the undersigned further represents that the undersigned does not presently have any contract, undertaking, agreement or arrangement with any person to sell, transfer or grant participations to such person or to any third person, with respect to any of the Warrant Stock. The undersigned has not been formed for the specific purpose of acquiring the Warrant Stock.
B. The undersigned understands that the Warrant Stock has not been, and will not be, registered under the Securities Act, by reason of a specific exemption from the registration provisions of the Securities Act which depends upon, among other things, the bona fide nature of the investment intent and the accuracy of the undersigned's representations as expressed herein. The undersigned understands that the Warrant Stock is "restricted securities" under applicable U.S. federal and state securities laws and that, pursuant to these laws, the undersigned must hold the Warrant Stock indefinitely unless they are registered with the Securities and Exchange Commission and qualified by state authorities, or an exemption from such registration and qualification requirements is available. Except as set forth in the Second Amended and Restated Investors' Rights Agreement dated March 28, 2000, as amended, the undersigned acknowledges that the Company has no obligation to register or qualify the Warrant Stock for resale. The undersigned further acknowledges that if an exemption from registration or qualification is available, it may be conditioned on various requirements including, but not limited to, the time and manner of sale, the holding period for the Warrant Stock, and on requirements relating to the Company which are outside of the undersigned's control, and which the Company is under no obligation and may not be able to satisfy.
C. The undersigned understands that the Warrant Stock and any securities issued in respect of or exchange for the Warrant Stock, may bear one or all of the following legends:
(a) "THE SHARES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AND HAVE BEEN
ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE OR DISTRIBUTION THEREOF. NO SUCH SALE OR DISTRIBUTION MAY BE EFFECTED WITHOUT AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR AN OPINION OF COUNSEL IN A FORM SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED UNDER THE SECURITIES ACT OF 1933."
(b) Any legend required by the Blue Sky laws of any state to the extent such laws are applicable to the shares represented by the certificate so legended.
D. The undersigned is an accredited investor as defined in Rule 501(a) of Regulation D promulgated under the Securities Act.
E. The undersigned further acknowledges that it has reviewed the market standoff provisions set forth in Section 1.14 of the Second Amended and Restated Investors' Rights Agreement dated March 28, 2000 among the Company and certain holders of the Company's securities and agrees to be bound by such provisions. In addition to the foregoing restrictions, and subject to Section 12 of the Warrant, the undersigned further agrees that the Warrant Stock is also subject to the terms of that certain Amended and Restated Market Stand-Off Agreement entered into by and between the Company and Purchaser dated June 19, 1998, and for the purposes of such agreement, the undersigned shall be deemed to hold the Warrant Stock as of the date of the Warrant.
Signature: ______________________
Name (print): ___________________
Title (if applic.): _____________
Company (if applic.): ___________
EXHIBIT B
ASSIGNMENT FORM
FOR VALUE RECEIVED, _________________________________________ hereby sells, assigns and transfers all of the rights of the undersigned under the attached Warrant with respect to the number of shares of Common Stock covered thereby set forth below, to:
EXHIBIT 10.19
AMENDED AND RESTATED MARKET STAND-OFF AGREEMENT
B. In consideration for a worldwide, royalty free, nonexclusive license, with the right to grant sublicenses, to any Technical Information (as defined in the DUROS Agreement) that Durect develops relating to a means of connecting or "docking" a catheter to a System (as defined in the DUROS Agreement) granted to ALZA pursuant to the last sentence of Section 8.1 of the DUROS Agreement (the "Docking License"), ALZA is willing to agree to certain restrictions on the transferability of any securities of Durect that ALZA currently owns or expects to own.
C. The parties wish to set forth the terms of such restriction and to enter into this Agreement.
NOW, THEREFORE, the parties hereby agree as follows:
To the extent necessary in order to enforce the foregoing covenant, Durect may impose stop-transfer instructions with respect to the securities held by ALZA until the end of the Lock-Up Period. Durect shall provide appropriate releases to such stop transfer instructions for transactions in compliance with this Agreement within two business days of ALZA's request therefor.
[Signature Page Follows]
IN WITNESS WHEREOF, the parties hereto have hereby caused this Agreement to be executed as of the date first written above by their duly authorized representatives.
ALZA CORPORATION DURECT CORPORATION By: /s/ Peter Staples By: /s/ James E. Brown -------------------------------- ------------------------------------ Title: Executive Vice President Title: Chief Executive Officer ----------------------------- --------------------------------- |
SIGNATURE PAGE TO MARKET STAND-OFF AGREEMENT
THIS WARRANT AND THE SHARES ISSUABLE HEREUNDER HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, AND MAY NOT BE SOLD, PLEDGED, OR OTHERWISE TRANSFERRED WITHOUT AN EFFECTIVE REGISTRATION THEREOF UNDER SUCH ACT OR PURSUANT TO RULE 144 OR AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE CORPORATION AND ITS COUNSEL, THAT SUCH REGISTRATION IS NOT REQUIRED.
WARRANT TO PURCHASE STOCK
Corporation: Durect Corporation, a Delaware corporation
Number of Shares: 31,395
Class of Stock: Series B-1 Preferred
Initial Exercise Price: $2.15
Issue Date: December 16, 1999
Expiration Date: December 16, 2006
THIS WARRANT CERTIFIES THAT, for the agreed upon value of $1.00 and for other good and valuable consideration, SILICON VALLEY BANK ("Holder") is entitled to purchase the number of fully paid and nonassessable shares of the class of securities (the "Shares") of the corporation (the "Company") at the initial exercise price per Share (the "Warrant Price") all as set forth above and as adjusted pursuant to Article 2 of this Warrant, subject to the provisions and upon the terms and conditions set forth in this Warrant.
(a) The initial Warrant Price referenced on the first page of this Warrant is not greater than (i) the price per share at which shares of the Company's Series B Preferred Stock were last issued in an arms-length transaction in which at least $500,000 of such Series B Preferred Stock was sold.
(b) All Shares which may be issued upon the exercise of the purchase right represented by this Warrant, and all securities, if any, issuable upon conversion of the Shares, shall, upon issuance, be duly authorized, validly issued, fully paid and nonassessable, and free of any liens and encumbrances except for restrictions on transfer provided for herein or under applicable federal and state securities laws.
(c) The Capitalization Table attached to this Warrant is true and complete as of the Issue Date.
THIS SECURITY HAS NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, AND MAY NOT BE SOLD, PLEDGED OR OTHERWISE TRANSFERRED WITHOUT AN EFFECTIVE REGISTRATION THEREOF UNDER SUCH ACT OR PURSUANT TO RULE 144 OR AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE CORPORATION AND ITS COUNSEL THAT SUCH REGISTRATION IS NOT REQUIRED.
the case may be, in writing by the Company or such holder from time to time. All notices to be provided under this Warrant shall be sent to the following address:
Silicon Valley Bank
Attn: Treasury Department
3003 Tasman Drive
Santa Clara, CA 95054
"COMPANY"
By: /s/ James E. Brown --------------------------- Name: President --------------------------- (Print) Title: Chairman of the Board, President or Vice President By: /s/ Thomas A. Schreck --------------------------- Name: Chief Financial Officer --------------------------- (Print) Title: Chief Financial Officer, Secretary, Assistant Treasurer or Assistant Secretary |
APPENDIX 1
1. The undersigned hereby elects to purchase _____________ shares of the Common/Preferred Series ___ [Strike one] Stock of ______________. pursuant to the terms of the attached Warrant, and tenders herewith payment of the purchase price of such shares in full.
2. The undersigned hereby elects to convert the attached Warrant into Shares/cash [strike one] in the manner specified in the Warrant. This conversion is exercised with respect to _____________________ of the Shares covered by the Warrant.
[Strike paragraph that does not apply.]
3. Please issue a certificate or certificates representing said shares in the name of the undersigned or in such other name as is specified below:
4. The undersigned represents it is acquiring the shares solely for its own account and not as a nominee for any other party and not with a view toward the resale or distribution thereof except in compliance with applicable securities laws.
APPENDIX 2
_____________________, ___
(Name of Holder)
(Address of Holder)
Attn: Chief Financial Officer
Dear : ______________________
This is to advise you that the Warrant issued to you described below will expire on _________________________, 19___.
Issuer:
Issue Date:
Class of Security Issuable:
Exercise Price per Share:
Number of Shares Issuable:
Procedure for Exercise:
Please contact [name of contact person at (phone number)] with any questions you may have concerning exercise of the Warrant. This is your only notice of pending expiration.
In the event of the issuance (a "Diluting Issuance") by the Company, after the Issue Date of the Warrant, of securities at a price per share less than the Warrant Price, then the number of shares of common stock issuable upon conversion of the Shares shall be adjusted in accordance with those provisions (the "Provisions") of the Company's Certificate of Designation of Rights, Preferences and Privileges which apply to Diluting Issuances.
The Company agrees that the Provisions, as in effect on the Issue Date, shall be deemed to remain in full force and effect during the term of the Warrant notwithstanding any subsequent amendment, waiver or termination thereof by the Company's shareholders.
Under no circumstances shall the aggregate Warrant Price payable by the Holder upon exercise of the Warrant increase as a result of any adjustment
arising from a Diluting Issuance.
EXHIBIT 23.1
CONSENT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS
We consent to the reference to our firm under the caption "Experts" and to the use of our report dated February 9, 2000, in the Registration Statement (Form S-1) and related Prospectus of Durect Corporation for the registration of shares of its common stock.
/s/ ERNST & YOUNG LLP Palo Alto, California April 19, 2000 |
ARTICLE 5 |
MULTIPLIER: 1,000 |
PERIOD TYPE | YEAR | YEAR |
FISCAL YEAR END | DEC 31 1998 | DEC 31 1999 |
PERIOD START | FEB 06 1998 | JAN 01 1999 |
PERIOD END | DEC 31 1998 | DEC 31 1999 |
CASH | 7,975 | 3,863 |
SECURITIES | 0 | 15,070 |
RECEIVABLES | 0 | 102 |
ALLOWANCES | 0 | 5 |
INVENTORY | 0 | 188 |
CURRENT ASSETS | 8,115 | 17,467 |
PP&E | 173 | 1,478 |
DEPRECIATION | 5 | 207 |
TOTAL ASSETS | 8,283 | 22,463 |
CURRENT LIABILITIES | 451 | 1,546 |
BONDS | 0 | 0 |
PREFERRED MANDATORY | 0 | 0 |
PREFERRED | 1 | 2 |
COMMON | 1 | 1 |
OTHER SE | 7,747 | 20,725 |
TOTAL LIABILITY AND EQUITY | 8,283 | 22,463 |
SALES | 0 | 86 |
TOTAL REVENUES | 0 | 86 |
CGS | 0 | 39 |
TOTAL COSTS | 0 | 39 |
OTHER EXPENSES | 1,443 | 0 |
LOSS PROVISION | 0 | 0 |
INTEREST EXPENSE | 0 | 27 |
INCOME PRETAX | (1,322) | (8,708) |
INCOME TAX | 0 | 0 |
INCOME CONTINUING | (1,322) | (8,708) |
DISCONTINUED | 0 | 0 |
EXTRAORDINARY | 0 | 0 |
CHANGES | 0 | 0 |
NET INCOME | (1,322) | (8,708) |
EPS BASIC | (0.36) | (1.76) |
EPS DILUTED | (0.36) | (1.76) |