AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON AUGUST 15, 1996
AMENDMENT NO. 1
TO
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
MINNESOTA 3841 41-1350192
(State or other (Primary Standard (I.R.S. Employer
jurisdiction of Industrial Identification Number)
incorporation or Classification Code
organization) Number)
1840 BERKSHIRE LANE
MINNEAPOLIS, MINNESOTA 55441
(612) 553-1102
|
(Address, including zip code, and telephone number, including area code, of
registrant's principal executive offices)
COPIES TO:
J. ANDREW HERRING JOEL I. PAPERNIK
AMY E. LANGE SQUADRON, ELLENOFF, PLESENT &
DORSEY & WHITNEY LLP SHEINFELD, LLP
220 SOUTH SIXTH STREET 551 FIFTH AVENUE
MINNEAPOLIS, MINNESOTA 55402-1498 NEW YORK, NEW YORK 10176
(612) 340-2600 (212) 661-6500
---------------
|
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: As soon as
practicable after the effective date of this Registration Statement.
If any of the securities being registered on this Form are to be offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, check the following box: [_]
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following
box and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering: [_]
If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earliest effective registration statement
for the same offering: [_]
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box: [_]
PROPOSED PROPOSED
TITLE OF EACH PROPOSED MAXIMUM MAXIMUM AMOUNT OF
CLASS OF SECURITIES AMOUNT TO BE OFFERING PRICE AGGREGATE REGISTRATION
TO BE REGISTERED REGISTERED (1) PER UNIT (2) OFFERING PRICE (2) FEE
- -----------------------------------------------------------------------------------------
Common Stock, $.01 par
value................. 2,750,000 shares $10.00 $27,500,000 $9,483(3)
- -----------------------------------------------------------------------------------------
Warrants to purchase
Common Stock
to be issued to the
Representatives....... 220,000 warrants $.001 $220 $1
|
(1) Including 330,000 shares of Common Stock issuable upon exercise of an
option which the Underwriters may exercise to cover over-allotments, if
any, and 220,000 shares issuable upon exercise of a Warrant to be issued
to the Representatives in connection with the offering.
(2) Estimated solely for the purposes of calculating the registration fee
pursuant to Rule 457.
(3) Of this amount, $8,725 was paid upon filing the Company's initial registration statement.
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT
SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS
REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH
SECTION 8(a) OF THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT
SHALL BECOME EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID
SECTION 8(a), MAY DETERMINE.
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
+ + +INFORMATION CONTAINED HEREIN IS SUBJECT TO COMPLETION OR AMENDMENT. A + +REGISTRATION STATEMENT RELATING TO THESE SECURITIES HAS BEEN FILED WITH THE + +SECURITIES AND EXCHANGE COMMISSION. THESE SECURITIES MAY NOT BE SOLD NOR MAY + +OFFERS TO BUY BE ACCEPTED PRIOR TO THE TIME THE REGISTRATION STATEMENT + +BECOMES EFFECTIVE. THIS PROSPECTUS SHALL NOT CONSTITUTE AN OFFER TO SELL OR + +THE SOLICITATION OF AN OFFER TO BUY NOR SHALL THERE BE ANY SALE OF THESE + +SECURITIES IN ANY STATE IN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE + +UNLAWFUL PRIOR TO REGISTRATION OR QUALIFICATION UNDER THE SECURITIES LAWS OF + +ANY SUCH STATE. + |
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
SUBJECT TO COMPLETION, DATED AUGUST 15, 1996
2,200,000 SHARES
Medi-Ject [LOGO]
Needle-Free Drug Delivery Systems
COMMON STOCK
All of the 2,200,000 shares of Common Stock offered hereby are being offered by Medi-Ject Corporation ("Medi-Ject" or the "Company").
Prior to this offering, there has been no public market for the Common Stock of the Company. It is currently anticipated that the initial public offering price will be between $8.00 and $10.00 per share. See "Underwriting" for a discussion of the factors to be considered in determining the initial public offering price. The Common Stock has been approved for quotation on the Nasdaq National Market under the symbol "MEDJ."
FOR A DISCUSSION OF CERTAIN MATERIAL FACTORS THAT SHOULD BE CONSIDERED IN CONNECTION WITH AN INVESTMENT IN THE COMMON STOCK, SEE "RISK FACTORS" COMMENCING ON PAGE 6 AND "DILUTION" ON PAGE 16.
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION PASSED UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
UNDERWRITING
PRICE TO DISCOUNTS AND PROCEEDS TO
PUBLIC COMMISSIONS (1) COMPANY (2)
- -----------------------------------------------------------------------------------------------
Per Share . . . . . . . . . . . . . $ $ $
- -----------------------------------------------------------------------------------------------
Total (3) . . . . . . . . . . . . . $ $ $
|
(2) Before deducting offering expenses estimated to be $ payable by the Company.
(3) The Company has granted to the Underwriters a 30-day option to purchase up to 330,000 additional shares of Common Stock solely to cover over- allotments, if any, on the same terms and conditions as the shares offered hereby. If such option is exercised in full, the total Price to Public, Underwriting Discounts and Commissions and Proceeds to Company will be $ , $ and $ , respectively. See "Underwriting."
The shares of Common Stock are offered by the several Underwriters named herein, subject to receipt and acceptance by them and subject to their right to reject any order in whole or in part. It is expected that delivery of such shares will be made at the offices of Rodman & Renshaw, Inc., New York, New York, on or about , 1996.
RODMAN & RENSHAW, INC. R. J. STEICHEN & COMPANY
The date of this Prospectus is , 1996
[Picture of Medi-Jector VI-B system with vial, adapter, and disposable front- end chamber]
FRONT-END
VIAL ADAPTER CHAMBER INJECTOR
The Medi-Jector VI-B system shown above is a hand-held, spring-powered device that injects drugs from a front-end chamber through the skin without a needle as a narrow, high pressure stream of liquid approximately 7/1000ths of an inch in diameter. The Medi-Jector VI-B system is an improved version of the Company's current Medi-Jector VI system which will include the disposable plastic front-end chamber pictured above. The Medi-Jector VI-B system is expected to be commercially introduced in late 1996 or early 1997.
The picture at left shows both the Medi-Jector VI-B system and the Company's future generation pen- like Medi-Jector system. Although the device on the right shows current plans for the pen-like system, the design has not yet been finalized. The actual system, when and if finally developed, could differ from the Company's current plans. There can be no assurance that this system will be commercially introduced, or that the resulting system will have an appearance similar to that depicted.
[Picture of Medi-Jector VI-B system
and pen-like Medi-Jector system, each
held in hand.]
IN CONNECTION WITH THIS OFFERING, THE UNDERWRITERS MAY OVER-ALLOT OR EFFECT TRANSACTIONS WHICH STABILIZE OR MAINTAIN THE MARKET PRICE OF THE COMMON STOCK AT A LEVEL ABOVE THAT WHICH MIGHT OTHERWISE PREVAIL IN THE OPEN MARKET. SUCH TRANSACTIONS MAY BE EFFECTED ON THE NASDAQ NATIONAL MARKET, IN THE OVER-THE- COUNTER MARKET OR OTHERWISE. SUCH STABILIZING, IF COMMENCED, MAY BE DISCONTINUED AT ANY TIME.
Medi-Jector(R) is a registered trademark of the Company. This Prospectus also includes trade names, trademarks and registered trademarks of companies other than the Company.
PROSPECTUS SUMMARY
The following summary is qualified in its entirety by reference to the more detailed information and financial statements and notes appearing elsewhere in this Prospectus. Unless otherwise indicated, all financial and share information set forth in this Prospectus (i) has been adjusted to reflect the conversion of all outstanding Convertible Preferred Stock into Common Stock upon the effectiveness or the closing of this offering, (ii) reflects a 1-for- 1.313 reverse stock split of the Common Stock effected on August 6, 1996, (iii) assumes an initial public offering price of $9.00 per share, the midpoint of the range set forth on the cover page of this Prospectus and (iv) assumes no exercise of the Underwriters' over-allotment option. Unless the context requires otherwise, all references in this Prospectus to "Medi-Ject" or the "Company" refer to Medi-Ject Corporation. This Prospectus contains forward- looking statements that involve risks and uncertainties. The Company's actual results may differ significantly from the results discussed in the forward- looking statements. Factors that might cause such differences include, but are not limited to, those discussed under the heading "Risk Factors," which investors should consider carefully.
THE COMPANY
Medi-Ject Corporation is a drug delivery company focused on developing, manufacturing and marketing needle-free injection systems for the self- administration of a wide range of parenteral (injectable) drugs. The Company's product, the Medi-Jector system, is a hand-held, spring-powered device that injects drugs from a front-end chamber through the skin without a needle as a narrow, high pressure stream of liquid approximately 7/1000ths of an inch in diameter. The Medi-Jector system eliminates the need to pierce the skin with a sharp needle and manipulate a plunger with the needle inserted through the skin. Therefore, many people perceive injections with the Medi-Jector system to be less threatening than injections with a needle. Today's Medi-Jector systems are smaller, easier to use, less expensive and more comfortable than previous needle-free injection systems. The Company believes that the key to widespread market acceptance of its needle-free injection systems depends upon continued improvements in these areas.
The Company believes that individuals who require self-injection will benefit
from the Medi-Jector system because it (i) eliminates the need to pierce
themselves with needles for each injection, which should lead to increased
compliance with a prescribed injection regimen and consequently reduce health
complications, (ii) provides the ability to inject themselves discreetly and
(iii) eliminates the need for sharps disposal of used needles. In addition,
healthcare industry providers and payors may benefit from the decrease in long-
term costs of patient care which may result from improved patient compliance.
Furthermore, pharmaceutical companies may benefit from increased sales and
larger market share as a result of an increased ability to differentiate their
products in the marketplace and improved patient compliance.
The Company has entered into licensing and development agreements with multi- national pharmaceutical and medical device companies covering the design and manufacture of customized injection systems for specific drug therapies. In addition to agreements with pharmaceutical companies, including those with Ferring NV, JCR Pharmaceuticals Co., Ltd., Schwarz Pharma AG and GeneMedicine, Inc., the Company has entered into a strategic alliance with Becton Dickinson and Company ("Becton Dickinson"). The goal of this alliance is the joint development and commercialization of new, less expensive and more user friendly injectors which embody proprietary, advanced technology. The Company will design and manufacture the injectors, and Becton Dickinson will design and manufacture the consumable components for the systems. Becton Dickinson has the right to market the injectors and the consumable components worldwide for use initially with insulin and potentially with other drugs. Medi-Ject and Becton Dickinson will collaborate on the development and manufacture of customized versions of the system and share revenues from sales of injectors and consumables to pharmaceutical companies and any revenue generated from licensing milestone payments, development fees and royalties. See "Business-- Collaborative Agreements."
The Company's focus is on the market for the delivery of self-administered parenteral drugs, the largest, most developed portion of which consists of the delivery of insulin. In the United States, over 3.2 million people inject insulin for the treatment of diabetes, resulting in an estimated 2.3 billion injections annually, and the Company believes that the number of insulin injections will increase with time as the result of new diabetes management approaches which recommend more frequent use. Other parenteral drugs that presently are self-administered and are or may be suitable for injection with the Medi-Jector system include therapies for the treatment of multiple sclerosis, migraine headaches, growth retardation, impotence, female infertility, AIDS and hepatitis. The Company also believes that other existing parenteral drugs will be self-administered in the future and that additional parenteral drugs that are under development will be deemed appropriate for self-administration.
In 1993, the Company hired a new management team with the goal of revitalizing and redefining the Company's strategic direction. Since that time, the Company has focused on entering into collaborative arrangements with pharmaceutical and medical device companies, and has increased its product development efforts to emphasize ease of use and to reduce the cost of its products to make them more competitive in the marketplace. The Company's goal is to establish its needle-free injectors as the drug delivery method of choice for the self-administration of a wide range of parenteral drugs. The Company's strategic plan for accomplishing this goal consists of (i) developing improved proprietary injection systems, (ii) generating an income stream from consumable components, (iii) collaborating with pharmaceutical and medical device manufacturers to leverage off of their marketing capabilities and (iv) focusing on delivery systems for high-priced pharmaceuticals.
The Company's offices are located at 1840 Berkshire Lane, Minneapolis, Minnesota 55441, and its telephone number is (612) 553-1102. The Company was incorporated in Minnesota in 1979.
THE OFFERING
Common Stock Offered by the Company......... 2,200,000 shares
Common Stock to be Outstanding After the
Offering.................................... 6,925,633 shares (1)
Use of Proceeds............................. For capital expenditures, primarily the
improvement
of the Company's manufacturing and assembly
capability; market development activities;
research and development; and working
capital and other general corporate
purposes.
Proposed Nasdaq National Market Symbol...... "MEDJ"
|
(1) Excludes 2,966,810 shares consisting of (i) 481,690 shares issuable upon exercise of outstanding options granted under the Company's 1993 Stock Option Plan and (ii) 2,485,120 shares issuable upon exercise of outstanding options and warrants granted to third parties. The terms of an option to purchase 380,808 shares of Common Stock held by Becton Dickinson (the "Becton Dickinson Option") provide that such option will expire upon the closing of an initial public offering of the Company's Common Stock at a public offering price of not less than $7.88 per share and gross proceeds of not less than $10 million. Becton Dickinson has notified the Company of its intent to exercise the Becton Dickinson Option immediately prior to and contingent upon the closing of this offering in the event the public offering price is at least $7.88 per share. See "Description of Capital Stock" and "Certain Transactions--Becton Dickinson."
SUMMARY FINANCIAL DATA
(IN THOUSANDS, EXCEPT PER SHARE DATA)
SIX MONTHS
ENDED
YEAR ENDED DECEMBER 31, JUNE 30,
--------------------------- ---------------
1993 1994 1995 1995 1996
------- -------- -------- ------ -------
STATEMENT OF OPERATIONS DATA:
Sales........................... $ 1,058 $ 1,518 $ 1,654 $ 831 $ 814
Licensing and product develop-
ment........................... 125 470 921 410 686
------- -------- -------- ------ -------
Revenues....................... 1,183 1,988 2,575 1,241 1,500
------- -------- -------- ------ -------
Cost of sales................... 409 631 1,049 465 502
Research and development........ 146 401 1,195 607 1,093
General and administrative...... 615 868 978 628 672
Sales and marketing............. 485 1,128 1,146 450 467
------- -------- -------- ------ -------
Operating expenses............. 1,655 3,028 4,368 2,150 2,734
------- -------- -------- ------ -------
Net operating loss.............. (472) (1,040) (1,793) (909) (1,233)
Net other income (expense)...... (28) (26) (89) (21) 49
------- -------- -------- ------ -------
Net loss........................ $ (500) $ (1,066) $ (1,882) $ (930) $(1,184)
======= ======== ======== ====== =======
Pro forma net loss per common $ (0.36) $ (0.19)
share (1)...................... ======== =======
Pro forma weighted average com-
mon shares outstanding (1)..... 5,180 6,354
|
AT JUNE 30, 1996
-------------------------
ACTUAL AS ADJUSTED (2)
-------- ---------------
SELECTED BALANCE SHEET DATA:
Cash and cash equivalents............................ $ 2,233 $ 20,148
Working capital...................................... 1,699 19,614
Total assets......................................... 3,705 21,620
Long-term liabilities, less current maturities....... 54 54
Accumulated deficit.................................. (10,486) (10,486)
Total shareholders' equity (3)....................... 2,544 20,459
|
RISK FACTORS
An investment in the shares of Common Stock offered hereby involves a high degree of risk and immediate and substantial dilution. In evaluating an investment in the Common Stock being offered hereby, investors should consider carefully, among other matters, the following risk factors, as well as the other information contained in this Prospectus.
UNCERTAINTY OF MARKET ACCEPTANCE; LIMITED CURRENT MARKET FOR NEEDLE-FREE INJECTION SYSTEMS
The Company's success will depend upon increasing market acceptance of its needle-free injection systems as an alternative to needle injections. During the approximately 15 years since their initial commercial introduction, the Company's needle-free injection systems have had only limited success competing with traditional needles and syringes because, the Company believes, of the size, cost and complexity of use and maintenance of the Company's injectors and the relatively small number of parenteral drugs that have been self-administered. In order to increase market acceptance, the Company believes that it must successfully develop improvements in the design and functionality of future needle-free injection systems that will reduce their cost and increase their appeal to users, thereby making these systems desirable despite their premium cost over traditional disposable needles and syringes. Projected improvements in functionality and design may not adequately address the actual or perceived complexity of using the Company's needle-free injection systems or adequately reduce their cost. In addition, the Company believes that its future success is dependent upon its ability to enter into additional collaborative agreements with drug and medical device manufacturers for the use of its needle-free injection systems with new and existing parenteral drugs. There can be no assurance that the Company will be successful in these efforts or that its needle-free injection systems will ever gain sufficient market acceptance to sustain profitable operations. See "Business--Strategy," "--Target Markets" and "--Products and Technology."
HISTORY OF OPERATING LOSSES; UNCERTAINTY OF FUTURE PROFITABILITY
The Company has had a history of operating losses and, at June 30, 1996, had an accumulated shareholders' deficit of approximately $10.5 million. Net losses for the years ended December 31, 1993, 1994 and 1995 and the six months ended June 30, 1996 were $500,319, $1,066,462, $1,882,459 and $1,184,178, respectively. The Company expects to continue to incur net losses at least through 1997, as it introduces new and improved needle-free injection systems while undertaking research and development, regulatory approval and commercial introduction activities related to new uses for its needle-free injection systems. There can be no assurance that the Company will achieve or sustain profitability in the future. See "Management's Discussion and Analysis of Financial Condition and Results of Operations."
RISKS ASSOCIATED WITH DEVELOPING NEW PRODUCTS
The Company believes that its future success is in part dependent upon the development and commercial introduction of needle-free injection systems that incorporate improvements in design and functionality to reduce their cost and increase their appeal to users. In the United States, Japan and certain European countries, the Company's needle-free Medi-Jector system has been approved only for the injection of insulin and human growth hormone. The Company's future success depends to a significant degree on its ability to obtain regulatory approval for and commercialize the use of its needle-free injection systems for other parenteral drugs. However, the Company has not yet completed research and development work or obtained regulatory approval for such improved systems or for use with any drugs other than insulin and human growth hormone. There can be no assurance that any development work will ultimately be successful or that unforeseen difficulties will not occur in research and development, clinical testing, regulatory submissions and approval, product manufacturing and commercial scale up, marketing, or product distribution related to any such improved systems or new uses. Any such occurrence could materially delay the commercialization of such improved systems or new uses or prevent their market introduction entirely. See "--Need to Comply with Government Regulations" and "Business."
RISKS OF RELATIONSHIP WITH BECTON DICKINSON AND COMPANY
The Company's ability to introduce improved and less expensive needle-free injection systems will depend in part on the success of its collaborative effort with Becton Dickinson to develop a smaller needle-free injector with a disposable, single-use front-end chamber. This effort is governed by the terms of a Development and License Agreement between the Company and Becton Dickinson (the "Becton Dickinson Agreement"), under which the Company is responsible for developing the injector body and Becton Dickinson is responsible for developing the front-end chamber for the system. Until January 1, 1999, Becton Dickinson may terminate the Becton Dickinson Agreement without cause by providing six months' written notice and after January 1, 1999, by providing 12 months' written notice. Since the Company expects that the majority of the funding for its development efforts on the new, smaller injector will be derived from payments to be made by Becton Dickinson under the Becton Dickinson Agreement and since responsibility for developing the front-end chamber lies with Becton Dickinson, any termination of the Becton Dickinson Agreement would adversely affect the timing and the likelihood of ultimate success of these development efforts. In addition, under the Becton Dickinson Agreement, Medi-Ject granted Becton Dickinson the exclusive, worldwide right to sell a proposed new injector for use with insulin and any other injector that is not designed or calibrated for use with a specific drug made by a specific drug company and that is intended to be distributed primarily through pharmacies for non-professional use. Prior to developing a system for use with any specific drug, the Company and Becton Dickinson must mutually agree on whether or not such system will be of the type covered by Becton Dickinson's exclusive sales rights. See "Business--Collaborative Agreements," "--Products and Technology" and "Certain Transactions--Becton Dickinson."
DEPENDENCE ON COLLABORATIVE RELATIONSHIPS
The Company believes that the introduction and broad acceptance of its systems is in part dependent upon the success of its current and any future development and licensing arrangements with pharmaceutical and medical device companies covering the development, manufacture or use of the Medi-Jector system with specific parenteral drug therapies. The Company anticipates, consistent with past practice, that under these arrangements the pharmaceutical or medical device company will assist in the development of systems for such drug therapies and collect or sponsor the collection of the appropriate data for submission for regulatory approval of the use of the Medi-Jector system with the licensed drug therapy. The pharmaceutical or medical device company also will be responsible for distribution and marketing of the systems for these drug therapies either worldwide or in specific territories. The Company currently is a party to seven such agreements. There can be no assurance that the Company will be successful in executing additional agreements with pharmaceutical or medical device companies or that existing or future agreements will result in the sale of the Company's needle- free injection systems. As a result of these arrangements, the Company is dependent upon the development, data collection and marketing efforts of such pharmaceutical and medical device companies. The amount and timing of resources such pharmaceutical and medical device companies devote to these efforts are not within the control of the Company, and such pharmaceutical and medical device companies could make material decisions regarding these efforts that could adversely affect the Company's future financial condition and results of operations. In addition, factors that adversely impact the introduction and level of sales of any drug covered by such licensing arrangements, including competition within the pharmaceutical and medical device industries, the timing of FDA or other approvals and intellectual property litigation (such as that surrounding Bio-Technology General Corporation's human growth hormone, which has delayed the introduction of the use of the Medi-Jector system with human growth hormone in the United States), will also negatively affect the Company's sales of Medi-Jector systems for those uses. See "Business--Target Markets," "--Collaborative Agreements," "-- Products and Technology" and "--Marketing."
LIMITED MANUFACTURING EXPERIENCE; RISKS ASSOCIATED WITH NEW MATERIALS, NEW ASSEMBLY PROCEDURES AND INCREASED PRODUCTION LEVELS
The Company's past assembly, testing and manufacturing experience has related primarily to the assembly of products from machined stainless steel and composite components in limited quantities. The Company's
planned future needle-free injection systems necessitate significant changes and additions to the Company's manufacturing and assembly process to accommodate new plastic components and a new injection power source. These systems must be manufactured in compliance with regulatory requirements, in a timely manner and in sufficient quantities while maintaining quality and acceptable manufacturing costs. In addition, the Company's plans call for significantly increased levels of production and a shift to performing more manufacturing functions internally rather than relying on third-party suppliers, which will require the Company to expand beyond its current facilities. In the course of these changes and additions to its manufacturing and production methods, the Company may encounter difficulties, including problems involving yields, quality control and assurance, product reliability, manufacturing costs, existing and new equipment, component supplies and shortages of personnel, any of which could result in significant delays in production. There can be no assurance that the Company will be able to produce and manufacture successfully the Company's future needle-free injection systems. Any failure to do so would negatively impact the Company's business, financial condition and results of operations. See "Business--Manufacturing."
DEPENDENCE ON THIRD-PARTY DEVELOPMENT EFFORTS
The Company relies heavily on outside consultants for its technology development and engineering work, and the Company's ability to introduce new systems and improvements to its existing systems is dependent on their efforts. There can be no assurance that the Company's current consultants will produce the necessary work product in a timely fashion or at all, or that the Company could find suitable replacements if the services of such consultants were to become unavailable. "Business--Products and Technology."
COMPETITION; RISK OF TECHNOLOGICAL OBSOLESCENCE
The Company's current competition is primarily from traditional hypodermic needles and syringes which are used for the vast majority of injections administered today. In order to make needles and syringes easier and safer to use, certain companies have developed syringes with hidden needles, spring- powered needle injectors and injectors with sheathed needles. In addition to competing with these types of traditional hypodermic needles and syringes, the Company's needle-free injection systems also compete with other needle-free injection devices. Currently, competition in the needle-free injection market is limited to small companies with modest financial and other resources, but the barriers to entry are currently low and additional competitors may enter the needle-free injection systems market, including companies with substantially greater resources and experience than the Company. There can be no assurance that the Company will be able to compete effectively against its current or potential competitors in the needle-free injection market, or that such competitors will not succeed in developing or marketing products that will be more accepted in such market. Competition in this market could also force the Company to reduce the prices of its systems below currently planned levels, thereby adversely affecting the Company's revenues and future profitability.
In general, injection is used only with drugs for which other drug delivery methods are not possible, in particular with biopharmaceutical proteins (drugs derived from living organisms, such as insulin and human growth hormone) that cannot currently be delivered orally, transdermally (through the skin) or pulmonarily (through the lungs). Many companies, both large and small (including Becton Dickinson), are engaged in research and development efforts on novel techniques aimed at delivering such drugs without injection. The successful development and commercial introduction of such a non-injection technique would likely have a material adverse effect on the Company's business, financial condition, results of operations and general prospects. See "Business--Competition."
NEED TO COMPLY WITH GOVERNMENT REGULATIONS
Government regulation in the United States and certain foreign countries is a significant factor in the Company's business. In the United States, the Food and Drug Administration (the "FDA") has principal jurisdiction over products that are used for human injection. Certain clearances are required from the FDA before medical devices, such as the Company's needle-free injection systems and their use with new drug therapies,
can be marketed. The FDA regulatory process in the United States may delay the marketing of new systems for lengthy periods and impose substantial additional costs. Moreover, FDA marketing clearance regulations depend heavily on administrative interpretation, and there can be no assurance that interpretations made by the FDA or other regulatory bodies, with possible retroactive effect, will not adversely affect the Company. There can be no assurance that the Company will be able to obtain clearance of any future Company systems or any expanded uses of current or future Company systems in a timely manner or at all. In addition, even if obtained, FDA clearances are subject to continual review, and if the FDA believes that the Company is not in compliance with applicable requirements, it can institute proceedings to detain or seize the Company's systems, require a recall, suspend production, distribution, marketing and sales, enjoin future violations and assess civil and criminal penalties against the Company, its directors, officers or employees. The FDA may also suspend or withdraw market approval for the Company's systems or require the Company to repair, replace or refund the cost of any system manufactured or distributed by the Company. The Company must also demonstrate compliance with current Good Manufacturing Practices ("GMP") regarding quality control and manufacturing procedures. Compliance with these requirements requires the Company to expend time, resources and effort in the areas of production and quality control for itself and for its contract manufacturers. If violations of the applicable regulations are noted during FDA inspections, the continued marketing of any systems manufactured by the Company may be halted or adversely affected.
Sales of medical devices outside the United States are subject to United States export requirements and foreign regulatory requirements. Legal restrictions on the sale of imported medical devices vary from country to country. The time and requirements to obtain approval by a foreign country may differ substantially from those required for FDA approval. There can be no assurance that the Company will be able to obtain regulatory approvals or clearances for its products in foreign countries. See "Business--Government Regulation" and "--Manufacturing."
FUTURE CAPITAL NEEDS; UNCERTAINTY OF ADDITIONAL FUNDING
The Company anticipates that the proceeds of this offering, together with cash on hand, interest expected to be earned thereon and anticipated revenues will be sufficient to finance the Company's operations at least through 1997, although there can be no assurance that additional capital will not be required sooner. In order to meet its needs beyond this period, the Company may be required to raise additional funds through public or private financings. Such financings may not be available when needed on terms acceptable to the Company or at all. Moreover, any additional equity financings may be dilutive to purchasers in this offering, and any debt financing may involve restrictive covenants. An inability to raise such funds when needed might require the Company to delay, scale back or eliminate some or all of its planned system enhancements, market expansion and research and development activities, and might require the Company to cease operations entirely. In such event, all expenditures to date as well as expenditures from the proceeds of this offering might not be recoverable. See "Use of Proceeds" and "Management's Discussion and Analysis of Financial Condition and Results of Operations--Liquidity and Capital Resources."
DEPENDENCE ON PROPRIETARY TECHNOLOGY RIGHTS
The Company's success will depend in part on its ability to protect its proprietary rights and to operate without infringing on the proprietary rights of third parties. In appropriate circumstances, the Company may apply for patent protection for uses, processes, products and systems that it develops. The Company currently owns two United States patents and one United States design patent and has filed eight United States patent applications, one of which has been recently allowed, one Taiwanese patent application and one Patent Cooperation Treaty application. There can be no assurance that any of the Company's current or future patent applications will result in issued patents, that the scope of any current or future patents will prevent competitors from introducing competitive products or that any of the Company's current or future patents would be held valid or enforceable if challenged. Patenting medical devices involves complex legal and factual questions and there is no consistent policy regarding the breadth of claims which issue pertaining to such technologies; the ultimate scope and validity of patents issued to the Company or to its competitors are thus unknown. In addition,
there can be no assurance that measures taken by the Company to protect its unpatented proprietary rights will be sufficient to protect these rights against third parties. Likewise, there can be no assurance that others will not independently develop or otherwise acquire unpatented technologies or products similar or superior to those of the Company.
There has been substantial litigation regarding patent and other intellectual property rights in the medical device industry and the Company may in the future be required to defend its intellectual property rights against infringement, duplication and discovery by third parties or to defend itself against third-party claims of infringement. Likewise, disputes may arise in the future with respect to ownership of technology developed by consultants or under research or development agreements with pharmaceutical companies, or with respect to the ownership of technology developed by employees who were previously employed by other companies. Any such disputes or related litigation could result in substantial costs to, and a diversion of effort by, the Company. An adverse determination could subject the Company to significant liabilities to third parties, require the Company to seek licenses from or pay royalties to third parties or require the Company to develop appropriate alternative technology. There can be no assurance that any such licenses would be available on acceptable terms or at all, or that the Company could develop alternate technology at an acceptable price or at all. Any of these events could have a material adverse effect on the Company's business, financial condition and results of operations. See "Business--Products and Technology" and "--Patents."
RISKS ASSOCIATED WITH THIRD-PARTY REIMBURSEMENT OF END USERS
Sales of the Company's current and proposed systems in certain markets are dependent in part on the availability of adequate reimbursement from third- party healthcare payors. Currently, insurance companies and other third-party payors reimburse the cost of needle-free injectors on a case-by-case basis and may refuse reimbursement if they do not perceive benefits to their use in a particular case. Third-party payors are increasingly challenging the pricing of medical products and services, and there can be no assurance that such third-party payors will not in the future increasingly reject claims for coverage of the cost of needle-free injections. In addition, there can be no assurance that adequate levels of reimbursement will be available to enable the Company to achieve or maintain market acceptance of its systems or maintain price levels sufficient to realize profitable operations. Furthermore, there is a possibility of increased government control or influence over a broad range of healthcare expenditures in the future. Any such trend could negatively impact the market for the Company's needle-free injection systems.
DEPENDENCE ON SINGLE SOURCE SUPPLIERS
The systems currently sold by the Company contain a number of customized steel components manufactured by third-party suppliers, and the most recently introduced model Medi-Jector system contains certain plastic components the molds for which are located at the facilities of the Company's plastics suppliers. In addition, certain of the Company's planned systems will contain plastic disposable front-end chambers which Becton Dickinson has the exclusive right to manufacture for the Company under the Becton Dickinson Agreement. Regulatory requirements applicable to medical device manufacturing can make substitution of suppliers costly and time-consuming. In the event that the Company could not obtain adequate quantities of these components from its suppliers, there can be no assurance that the Company would be able to access alternative sources of such components within a reasonable period of time, on acceptable terms or at all. In particular, if the Company were required to change suppliers for its current plastic components, it would need either to move the necessary molds or to obtain new molds, either of which would entail significant delay. Similarly, if Becton Dickinson declined to supply the Company with disposable front-end chambers for its proposed systems, while the Company has the right to obtain a license to use Becton Dickinson's technology, it is unlikely that the Company could manufacture such components as inexpensively as Becton Dickinson. The unavailability of adequate quantities, the inability to develop alternative sources, a reduction or interruption in supply or a significant increase in the price of components could have a material adverse effect on the Company's ability to manufacture and market its products. See "Business--Manufacturing."
RISK OF PRODUCT LIABILITY; LIMITATIONS OF INSURANCE COVERAGE
The Company faces an inherent business risk of exposure to product liability claims in the event that an end user is adversely affected by use or misuse of its systems, and the Company has in the past experienced such claims. The Company currently carries a product liability insurance policy with an aggregate limit of $5,000,000. As the result either of adverse claim experience or of medical device or insurance industry trends, however, the Company may in the future have difficulty in obtaining product liability insurance or be forced to pay very high premiums, and there can be no assurance that insurance coverage will continue to be available on commercially reasonable terms or at all. In addition, there can be no assurance that insurance will adequately cover any product liability claim against the Company. A successful product liability or other claim with respect to uninsured liabilities or in excess of insured liabilities could have a material adverse effect on the Company's business, financial condition and operations. See "Business--Liability Insurance."
NO PRIOR PUBLIC MARKET FOR COMMON STOCK
Prior to this offering, there has been no public market for the Common Stock. There can be no assurance that an active trading market in the Common Stock will develop or be sustained upon completion of this offering or that the market price of the Common Stock will not decline below the initial public offering price. The initial public offering price of the Common Stock will be determined by negotiations between the Company and the Representatives of the Underwriters and may not be indicative of the prices that will prevail in the public market. See "Underwriting."
QUARTERLY FLUCTUATIONS IN OPERATING RESULTS
The Company's operating results may vary significantly from quarter to quarter, in part because of changes in consumer buying patterns, aggressive competition, the timing of the recognition of licensing or development fee payments and the timing of, and costs related to, any future system or new drug use introductions. The Company's operating results for any particular quarter are not necessarily indicative of any future results. The uncertainties associated with the introduction of any new system or drug use and with general market trends may limit management's ability to forecast short-term results of operations accurately. Fluctuations caused by variations in quarterly operating results or the Company's failure to meet analysts' projections or public expectations as to results may adversely affect the market price of the Company's Common Stock. See "Management's Discussion and Analysis of Financial Condition and Results of Operations."
POSSIBLE STOCK PRICE VOLATILITY
The trading prices of the Company's Common Stock could be subject to wide
fluctuations in response to events or factors, many of which are beyond the
Company's control. These could include, without limitation (i) quarter to
quarter variations in the Company's operating results, (ii) announcements by
the Company or its competitors regarding the results of regulatory approval
filings, clinical trials or testing, (iii) developments or disputes concerning
proprietary rights, (iv) technological innovations or new commercial products,
(v) material changes in the Company's collaborative arrangements and (vi)
general conditions in the medical technology industry. Moreover, the stock
market has experienced extreme price and volume fluctuations, which have
particularly affected the market prices of many medical technology and device
companies and which have often been unrelated to the operating performance of
such companies.
RELIANCE ON KEY PERSONNEL
The success of the Company is highly dependent, in part, on its ability to attract and retain highly qualified personnel, including senior management and scientific personnel. Competition for such personnel is intense, and there can be no assurance that the Company will be successful in attracting and retaining key personnel in the future. Any failure to do so could adversely affect the Company. See "Business--Employees."
CONTROL BY PRINCIPAL SHAREHOLDERS; ANTI-TAKEOVER PROVISIONS
Upon completion of this offering, certain of the Company's officers, directors and principal shareholders will beneficially own in the aggregate approximately 6,078,841 shares of the Company's outstanding Common
Stock (including shares subject to outstanding options and warrants). If these shareholders vote together as a group, they will be able to substantially influence the business and affairs of the Company, including the election of individuals to the Company's Board of Directors (the "Board of Directors"), and to otherwise affect the outcome of certain actions that require shareholder approval, including the adoption of amendments to the Company's articles of incorporation, and certain mergers, sales of assets and other business acquisitions or dispositions.
Upon completion of this offering, the Company will have authorized 1,000,000 shares of undesignated preferred stock, $.01 par value, which may be issued by the Board of Directors on such terms, and with such rights, preferences and designations, as the Board of Directors may determine without further shareholder action. In addition, upon completion of this offering, the Company's Board of Directors will be classified and directors will serve for staggered terms. Finally, the Company is subject to certain provisions of the Minnesota Business Corporation Act that limit the voting rights of shares acquired in certain acquisitions and restrict certain business combinations. Some or all of the foregoing factors could have the effect of discouraging certain attempts to acquire the Company which could deprive the Company's shareholders of opportunities to sell their shares of Common Stock at prices higher than prevailing market prices. See "Principal Shareholders," "Description of Capital Stock--Preferred Stock" and "--Anti-Takeover Provisions of the Minnesota Business Corporation Act."
POSSIBLE ADVERSE MARKET EFFECT OF SHARES ELIGIBLE FOR FUTURE SALE
Sales of significant amounts of Common Stock in the public market or the perception that such sales will occur could adversely affect the market price of the Common Stock or the future ability of the Company to raise capital through an offering of its equity securities. Of the 6,925,633 shares of Common Stock to be outstanding upon completion of this offering, the 2,200,000 shares offered hereby will be eligible for immediate sale in the public market without restriction unless they are held by "affiliates" of the Company within the meaning of Rule 144 of the Securities Act of 1933, as amended (the "Securities Act"). The remaining 4,725,633 shares of Common Stock will be "restricted securities" as that term is defined in Rule 144 under the Securities Act. Of these, an aggregate of 4,293,378 shares are owned by the Company's directors, officers and certain of its shareholders who, together with the Company, have agreed that they will not sell, directly or indirectly, any Common Stock without the prior consent of Rodman & Renshaw, Inc. for a period of 180 days from the date of this Prospectus. Of the shares not subject to this agreement, 125,008 shares will be eligible for immediate sale without restriction pursuant to Rule 144(k) on the effective date of this offering, 381 shares will be eligible for sale, subject to compliance with the volume limitations and other restrictions of Rule 144, 90 days after the effective date of this offering, and 306,866 shares will become eligible for sale under Rule 144 after the expiration of the two-year holding periods from the dates of acquisition, which end between December 29, 1996 and May 31, 1998. Beginning on the 181st day after the date of this Prospectus, when the agreements not to sell shares expire, an additional 1,850,562 of the shares may become eligible for sale without restriction pursuant to Rule 144(k), an additional 929,757 of the shares will become eligible for sale, subject to compliance with the volume limitations and other restrictions of Rule 144, and the remaining 1,513,059 shares will become eligible for sale under Rule 144 after the expiration of the two-year holding periods from the dates of acquisition, which end between December 29, 1996 and February 28, 1998. In the event the Becton Dickinson Option is exercised, there will be an additional 380,808 shares eligible for resale under Rule 144 beginning two years after the closing of this offering. In addition, certain shareholders and holders of warrants and options, who in the aggregate beneficially own 5,049,440 shares of Common Stock, have the right, subject to certain conditions, to include their shares in future registration statements relating to the Company's securities and to cause the Company to register for public sale certain Common Stock owned by them. See "Certain Transactions--Becton Dickinson," "Shares Eligible for Future Sale" and "Underwriting."
IMMEDIATE AND SUBSTANTIAL DILUTION
Purchasers of the Common Stock offered hereby will experience immediate and substantial dilution in net tangible book value per share of $6.09. Investors may also experience additional dilution as a result of the exercise of outstanding stock options and warrants. See "Dilution."
USE OF PROCEEDS
The net proceeds to the Company from the sale of the 2,200,000 shares of Common Stock offered hereby are estimated to be approximately $17.9 million ($20.7 million if the Underwriters' over-allotment option is exercised in full), after deducting the underwriting discounts and estimated offering expenses and assuming an initial public offering price of $9.00 per share.
The Company anticipates that the net proceeds of this offering will be used to fund approximately (i) $5.0 million of capital expenditures, primarily in connection with the improvement of the Company's manufacturing and assembly capability, (ii) $4.0 million of market development activities, including increased customer service and support for the marketing efforts of pharmaceutical and medical device companies with which the Company has collaborative arrangements and (iii) $4.0 million of research and development dedicated to the development of improved needle-free injector systems.
The balance of the net proceeds will be used for working capital and other general corporate purposes. The Company may also use a portion of the net proceeds to acquire technologies, products or businesses compatible with the Company's existing business, although the Company has no current arrangements, commitments or understandings in this regard. These amounts are estimates, and the amount and timing of the expenditures for these purposes will depend upon numerous factors, including the status of the Company's product development efforts, the nature and timing of future licensing, development or other collaborative agreements, the timing of regulatory approvals, competition, manufacturing activities, market acceptance of the Company's products and other factors. The Company believes that the net proceeds from this offering, combined with cash on hand, interest expected to be earned thereon and anticipated revenues will be sufficient to meet its needs at least through 1997.
Pending the use of the net proceeds, the Company plans to invest the funds in short-term, interest-bearing, investment grade securities.
DIVIDEND POLICY
The Company has not paid any dividends since its inception and for the foreseeable future intends to follow a policy of retaining all of its earnings, if any, to finance the development and continued expansion of its business. There can be no assurance that the Company will ever pay dividends. The payment of dividends, if any, in the future will be at the discretion of the Board of Directors and will depend on the Company's earnings, financial condition, capital requirements and other relevant factors.
CAPITALIZATION
The following table sets forth the capitalization of the Company at June 30, 1996 (i) on a pro forma basis giving effect to the conversion of all outstanding shares of Convertible Preferred Stock into Common Stock and (ii) on a pro forma as adjusted basis to reflect the issuance and sale of the 2,200,000 shares of Common Stock offered hereby at an assumed initial public offering price of $9.00 per share and the application of the estimated net proceeds therefrom.
AT JUNE 30, 1996
----------------------
PRO FORMA
PRO FORMA AS ADJUSTED
--------- -----------
(IN THOUSANDS)
Long-term liabilities, less current maturities........... $ 54 $ 54
Shareholders' equity:
Preferred Stock, undesignated as to series, $.01 par
value, 1,000,000 shares authorized pro forma and pro
forma as adjusted; no shares issued and outstanding pro
forma or pro forma as adjusted......................... -- --
Common Stock, $.01 par value, 17,000,000 shares
authorized; 4,725,633 shares issued and outstanding pro
forma; 6,925,633 shares issued and outstanding, pro
forma as adjusted (1) (2).............................. 47 69
Additional paid-in capital.............................. 12,983 30,876
Accumulated deficit..................................... (10,486) (10,486)
-------- --------
Total shareholders' equity............................. 2,544 20,459
-------- --------
Total capitalization................................. $ 2,598 $ 20,513
======== ========
|
(1) Excludes 2,966,810 shares consisting of (i) 481,690 shares issuable upon
exercise of outstanding options granted under the Company's 1993 Stock
Option Plan and (ii) 2,485,120 shares issuable upon exercise of
outstanding options and warrants granted to third parties. Becton
Dickinson has notified the Company of its intent to exercise the Becton
Dickinson Option to purchase 380,808 shares of Common Stock immediately
prior to and contingent upon the closing of this offering in the event the
public offering price is at least $7.88 per share. See "Description of
Capital Stock" and "Certain Transactions--Becton Dickinson."
(2) Reflects the conversion of all outstanding Convertible Preferred Stock
into Common Stock, described in Note 13 of Notes to Financial Statements.
DILUTION
The Company's pro forma net tangible book value as of June 30, 1996 was $2,226,364, or approximately $0.47 per share. Pro forma net tangible book value per share as of June 30, 1996, represents total assets, less intangible assets and total liabilities, divided by the number of shares outstanding, after giving effect to a subsequent 1-for-1.313 reverse stock split and the conversion of all outstanding shares of Convertible Preferred Stock into Common Stock. Without taking into account any changes in such net tangible book value per share after June 30, 1996, other than to give effect to the sale of the 2,200,000 shares of Common Stock offered hereby at an assumed initial public offering price of $9.00 per share and the receipt of the net proceeds of such sale after deducting underwriting discounts and commissions and estimated expenses payable by the Company, the pro forma net tangible book value as of June 30, 1996 would have been $20,141,364, or $2.91 per share. This represents an immediate increase in net tangible book value of $2.44 per share to existing shareholders and an immediate dilution to new investors of $6.09 per share, or 67.7%. The following table sets forth this per share dilution:
Assumed initial public offering price per share.................... $9.00
Pro forma net tangible book value per share at June 30, 1996....... $0.44
Increase per share attributable to new investors................... 2.44
-----
Pro forma net tangible book value per share at June 30, 1996, as
adjusted.......................................................... 2.91
-----
Dilution in net tangible book value per share to new investors..... $6.09
=====
|
If the Underwriters' over-allotment option is exercised in full, the net tangible book value per share of Common Stock after this offering would be $3.15 per share, which would result in dilution to new investors of $5.85 per share, or 64.9%.
The following table summarizes, as of June 30, 1996, the differences between existing shareholders and new investors with respect to the total number of shares of Common Stock purchased from the Company, the total consideration paid and the average price per share paid (assuming an initial public offering price of $9.00 share).
SHARES PURCHASED TOTAL CONSIDERATION
----------------- ------------------- AVERAGE PRICE
NUMBER PERCENT AMOUNT PERCENT PER SHARE
--------- ------- ----------- ------- -------------
Existing shareholders (1). 4,725,633 68.2% $13,030,342 39.7% $2.76
New investors............. 2,200,000 31.8 19,800,000 60.3 9.00
--------- ----- ----------- -----
Total................... 6,925,633 100.0% $32,830,342 100.0%
========= ===== =========== =====
|
(1) Excludes 2,966,810 shares consisting of (i) 481,690 shares issuable upon exercise of outstanding options granted under the Company's 1993 Stock Option Plan and (ii) 2,485,120 shares issuable upon exercise of outstanding options and warrants granted to third parties. Becton Dickinson has notified the Company of its intent to exercise the Becton Dickinson Option to purchase 380,808 shares of Common Stock immediately prior to and contingent upon the closing of this offering in the event the public offering price is at least $7.88 per share.
SELECTED FINANCIAL DATA
(IN THOUSANDS, EXCEPT PER SHARE DATA)
The following selected financial data of the Company are qualified by reference to and should be read in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of Operations" and the financial statements and notes thereto included elsewhere in this Prospectus. The statement of operations data for the years ended December 31, 1993, 1994 and 1995, and the balance sheet data at December 31, 1994 and 1995 are derived from, and are qualified by reference to, the audited financial statements included elsewhere in this Prospectus and should be read in conjunction with those financial statements and notes thereto. The statement of operations data for the years ended December 31, 1991 and 1992 and the balance sheet data at December 31, 1991, 1992 and 1993 are derived from unaudited financial statements not included herein. The selected financial data as of and for the six months ended June 30, 1995 and 1996 have been derived from unaudited financial statements of the Company which, in the opinion of management, include all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of the financial information set forth therein. The results of operations for the six months ended June 30, 1996 are not necessarily indicative of the results to be expected for the entire year ending December 31, 1996.
SIX MONTHS
ENDED
YEAR ENDED DECEMBER 31, JUNE 30,
---------------------------------------- ---------------
1991 1992 1993 1994 1995 1995 1996
------ ------ ------ ------- ------- ------ -------
STATEMENT OF OPERATIONS
DATA:
Sales ................. $1,067 $1,058 $1,058 $ 1,518 $ 1,654 $ 831 $ 814
Licensing and product
development .......... -- -- 125 470 921 410 686
------ ------ ------ ------- ------- ------ -------
Revenues.............. 1,067 1,058 1,183 1,988 2,575 1,241 1,500
------ ------ ------ ------- ------- ------ -------
Cost of sales.......... 290 356 409 631 1,049 465 502
Research and develop-
ment.................. -- -- 146 401 1,195 607 1,093
General and administra-
tive.................. 480 462 615 868 978 628 672
Sales and marketing.... 345 349 485 1,128 1,146 450 467
------ ------ ------ ------- ------- ------ -------
Operating expenses.... 1,115 1,167 1,655 3,028 4,368 2,150 2,734
------ ------ ------ ------- ------- ------ -------
Net operating loss..... (48) (109) (472) (1,040) (1,793) (909) (1,233)
Net other income (ex-
pense)................ (60) (50) (28) (26) (89) (21) 49
------ ------ ------ ------- ------- ------ -------
Net loss .............. $ (108) $ (159) $ (500) $(1,066) $(1,882) $ (930) $(1,184)
====== ====== ====== ======= ======= ====== =======
Pro forma net loss per
common share
(unaudited) (1)....... $ (0.36) $ (0.19)
======= =======
Pro forma weighted
average common shares
outstanding
(unaudited) (1)....... 5,180 6,354
|
AT DECEMBER 31,
------------------------------------------- AT JUNE 30,
1991 1992 1993 1994 1995 1996
------- ------- ------- ------- ------- -----------
BALANCE SHEET DATA:
Cash and cash equiva-
lents................. $ 170 $ 55 $ 649 $ 646 $ 36 $ 2,233
Working capital (defi-
cit).................. (622) (37) 197 108 (650) 1,699
Total assets........... 373 267 894 1,361 1,240 3,705
Long-term liabilities,
less current maturi-
ties.................. -- 363 190 299 136 54
Accumulated deficit.... (5,694) (5,846) (6,353) (7,419) (9,302) (10,486)
Total shareholders' eq-
uity (deficit)........ (548) (329) 119 252 (74) 2,544
|
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion of the financial condition and results of operations of the Company should be read in conjunction with the Selected Financial Data and the financial statements and notes thereto included elsewhere in this Prospectus. This Prospectus, including the following discussion, contains forward-looking statements that involve risks and uncertainties. The Company's actual results may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such differences include, but are not limited to, those discussed under the heading "Risk Factors."
GENERAL
Medi-Ject Corporation designs, manufactures and markets needle-free injection systems. In 1993, the Company hired a new management team with the goal of revitalizing and redefining the Company's strategic direction. Since that time, product development efforts have increased, emphasizing reductions in the cost of the Company's systems to make them more competitive in the marketplace. In addition, marketing efforts have been focused on increasing sales in the domestic insulin market and on expanding the use of needle-free injection systems for parenteral drugs other than insulin. As part of this effort to encourage broader use of needle-free injection systems, the Company began entering into technology and product license agreements to sell the Medi-Jector system. The licensing and development income from these agreements has been used primarily to fund increased product development efforts. This development effort has resulted in a new generation of the Medi-Jector system, the Medi-Jector VI system, which incorporates molded plastic components rather than tooled steel components and was introduced in July 1995, and an innovative needle-free injection technology that is the subject of eight United States patent applications.
RESULTS OF OPERATIONS
Six Months Ended June 30, 1996 Compared to Six Months Ended June 30, 1995
Revenues increased to approximately $1,500,000 in the first six months of 1996 from approximately $1,241,000 in the first six months of 1995, an increase of approximately 21%. This increase was primarily the result of increased licensing and product development fees. Sales of injectors, parts, supplies and repairs declined to approximately $814,000 in the first six months of 1996 from approximately $831,000 in the first six months of 1995, a decrease of approximately 2%. This decrease resulted from a decrease in the number of injectors sold (1,512 in the first six months of 1995 and 1,363 in the first six months of 1996). The average selling price per injector also decreased from $404 to $389 due to an increase in the number of injectors sold to pharmacies at wholesale prices. The decrease was partially offset by an increase in sales of parts, supplies and repairs. Licensing and product development fees increased to approximately $686,000 in the first six months of 1996 from $410,000 in the first six months of 1995, an increase of 67%. The increase in fee income reflects the execution of the Becton Dickinson Agreement in January 1996. The Company expects that licensing and product development fee income will tend to fluctuate on a quarter to quarter basis, depending on a number of factors, including the timing of the execution of new development and licensing agreements and the timing, nature and size of fee payments to be made under existing and new agreements. In addition, since the Company in general does not recognize project-based fee income until related development work has been performed, quarterly results will fluctuate with the timing of the Company's research and development efforts.
Cost of sales increased to approximately $502,000 in the first six months of 1996 from approximately $465,000 in the first six months of 1995, an increase of approximately 8%. The increase in cost of sales was due to an increase in per unit manufacturing costs and an increase in sales of replacement parts, supplies and repairs. The Company expects that per injector manufacturing costs will decrease as volumes increase.
Research and development expenses increased to approximately $1,093,000 in the first six months of 1996 from approximately $607,000 in the first six months of 1995, an increase of approximately 80%. This increase
was primarily attributable to research and development expenditures related to the Company's collaboration with Becton Dickinson, which is being funded in large part by Becton Dickinson under the Becton Dickinson Agreement.
General and administrative expenses increased to approximately $672,000 in the first six months of 1996 from approximately $628,000 in the first six months of 1995, an increase of approximately 7%. The largest component of this increase was legal expenses related to the negotiation of the Becton Dickinson Agreement.
Sales and marketing expenses increased to approximately $467,000 in the first six months of 1996 from approximately $450,000 in the first six months of 1995, an increase of approximately 4%. This increase was primarily the result of a general increase in spending on domestic sales activities.
The Company had net other income of approximately $49,000 in the first six months of 1996 compared to net other expense of approximately $21,000 in the first six months of 1995. The change was the result of increased cash on hand following the sale of equity securities to Becton Dickinson in January 1996. In addition, the Company realized income of approximately $8,000 in the first six months of 1996 from the sale of certain equipment.
Year Ended December 31, 1995 Compared to Year Ended December 31, 1994
Revenues increased to approximately $2,575,000 in 1995 from approximately $1,988,000 in 1994, an increase of approximately 30%. This increase was primarily the result of a growth in licensing and product development fees. Sales of injectors, parts, supplies and repairs increased to approximately $1,654,000 in 1995 from approximately $1,518,000 in 1994, an increase of approximately 9%. This increase was attributable to an increase in the number of injectors sold, to 3,110 in 1995 from 2,636 in 1994, largely for use with human growth hormone, and an increase of approximately $126,000 in sales of parts, supplies and repairs offset by a decrease in the average unit selling price from $465 in 1994 to $397 in 1995. Licensing and product development fees increased to approximately $921,000 in 1995 from $470,000 in 1994, an increase of approximately 96%. This increase was the result of the additional license and development agreements entered into during 1995 with Bio- Technology General Corporation, JCR Pharmaceuticals Co., Ltd. and GeneMedicine, Inc., and increased revenue earned under license and development agreements executed in prior periods.
Cost of sales increased to approximately $1,049,000 in 1995 from approximately $631,000 in 1994, an increase of approximately 66%. This increase was due in large part to nonrecurring expenses associated with the commercial introduction of the Medi-Jector VI system and the fact that a larger number of units were sold.
Research and development expenses increased to approximately $1,195,000 in 1995 from approximately $401,000 in 1994, an increase of approximately 198%. This increase was the result of an increased number of research and development projects at the Company.
General and administrative expenses increased to approximately $978,000 in 1995 from approximately $868,000 in 1994, an increase of approximately 13%. This increase related primarily to increased salary and employee benefits expenses and expenses relating to a larger support staff.
Sales and marketing expenses increased to approximately $1,146,000 in 1995 from approximately $1,128,000 in 1994, an increase of approximately 2%.
Interest income remained relatively constant at approximately $16,000 in both 1995 and 1994. Interest and other expense increased to approximately $106,000 in 1995 from approximately $42,000 in 1994, an increase of approximately 152%. This increase was largely attributable to a non-cash expense in 1995 relating to certain modifications to the terms of an investor option agreement.
Year Ended December 31, 1994 Compared to Year Ended December 31, 1993
Revenues increased to approximately $1,988,000 in 1994 from approximately $1,183,000 in 1993, an increase of approximately 68%. Sales increased to approximately $1,518,000 in 1994 from approximately $1,058,000 in 1993, an increase of approximately 43%. This increase was the result of an increase in the number of injectors sold to 2,636 in 1994 from 1,399 in 1993, largely because the Company decreased the prices of its systems in the domestic insulin market from an average selling price of $574 in 1993 to $465 in 1994 and began to market its systems in Europe and Japan for use with human growth hormone. Product development and licensing fees increased to $470,000 in 1994 from $125,000 in 1993, an increase of approximately 276%. This increase was the result of the license and development agreement entered into during 1994 with Schwarz Pharma AG, and revenue under the Ferring NV license and development agreement entered into in 1993.
Cost of sales increased to approximately $631,000 in 1994 from approximately $409,000 in 1993, an increase of approximately 54%. This increase was driven primarily by the increase in the number of units produced and sold. The cost to manufacture injectors decreased from 1993 to 1994 as a result of the increased volume.
Research and development expense increased to approximately $401,000 in 1994 from approximately $146,000 in 1993, an increase of approximately 175%. This increase was the result of increased research and development work related to the Medi-Jector VI system (which was introduced in 1995) and to other systems.
General and administrative expenses increased to approximately $868,000 in 1994 from approximately $615,000 in 1993, an increase of approximately 41%. This increase was attributable primarily to the hiring of additional management and support personnel and increased rent expenses.
Sales and marketing expenses increased to approximately $1,128,000 in 1994 from approximately $485,000 in 1993, an increase of approximately 133%. This increase was driven by increased advertising expenditures, the addition of new sales and marketing personnel and an increase generally in marketing-related expenditures.
Interest income increased to approximately $16,000 in 1994 from approximately $3,000 in 1993, an increase of approximately 433%, as a result of higher average cash balances resulting from private equity financings completed during the year. Interest and other expense increased to approximately $42,000 in 1994 from approximately $30,000 in 1993, an increase of approximately 40%, as a result of debt financings completed in 1994.
LIQUIDITY AND CAPITAL RESOURCES
The Company has financed its operations through private sales of equity and debt securities, loans, revenues from product sales and licensing and development fees. From September 1993 through the second quarter of 1996, the Company realized net proceeds of approximately $7.6 million from private sales of its equity securities. Among other things, these funds were used to increase sales and marketing and research and development efforts. In January 1996, the Company received gross proceeds of approximately $3.1 million from a private sale to Becton Dickinson of shares of convertible preferred stock (which will convert into 761,615 shares of Common Stock upon the closing of this offering), options to purchase additional shares of convertible preferred stock (which will convert into an option to purchase 380,808 shares of Common Stock at an exercise price of $4.60 per share) and warrants to purchase additional shares of convertible preferred stock (which will convert into warrants to purchase 1,904,037 shares of Common Stock at $5.91 per share). Becton Dickinson has indicated its intent to exercise its option immediately prior to and contingent upon the closing of this offering in the event the public offering price is at least $7.88 per share. The Company intends to use these funds, together with monthly contract development income from Becton Dickinson and from pharmaceutical company licensees, for the development of the proposed smaller injector and for the addition of new drug therapies. See "Business--Products and Technology" and "Certain Transactions."
The Company's long term capital requirements will depend on numerous factors, including the status of the Company's collaborative arrangements, the progress of the Company's research and development programs and
the receipt of revenues from the sales of the Company's products. Cash and cash equivalents were $2.2 million at June 30, 1996. The Company believes that the net proceeds to the Company from this offering, combined with cash on hand, interest expect to be earned thereon and anticipated revenues, will meet its needs at least through 1997. In order to meet its needs beyond this period, the Company may be required to raise additional funds through public or private financings, including equity financings.
The Company has not generated taxable income through June 30, 1996, and at such date it had an accumulated deficit of approximately $10.5 million.
INCOME TAX LOSS CARRYFORWARDS
At June 30, 1996, the Company had approximately $10.1 million of net operating loss carryforwards that may be available to offset future taxable income for federal income tax purposes. These net operating loss carryforwards begin to expire in 1996. In addition to its net operating loss carryforwards, at June 30, 1996, the Company had approximately $117,000 in research and development tax credit carryforwards which begin to expire in 1997.
Under Section 382 of the Internal Revenue Code of 1986, as amended, and the regulations thereunder, a change in ownership of greater than 50% of a company within a three-year period can result in an annual limitation on such company's ability to utilize net operating loss carryforwards from tax periods prior to the change in ownership. The annual limitation may be increased for any built-in gains recognized within five years of the date of the change in ownership. The Company's January 1996 sale of capital stock to Becton Dickinson resulted in a "change in ownership" of the Company, and future utilization of the Company's net operating loss carryforwards will be limited to approximately $1.1 million per year. If the Company were to undergo a further "change in ownership," this limitation might be changed. As a result of the annual limitation, a portion of the Company's carryforwards may expire before ultimately becoming available to reduce potential federal income tax liabilities. See "Certain Transactions."
BUSINESS
OVERVIEW
Medi-Ject is a drug delivery company focused on developing, manufacturing and marketing needle-free injection systems for the self-administration of a wide range of parenteral (injectable) drugs. The Company's product, the Medi- Jector system, is a hand-held, spring-powered device that injects drugs from a front-end chamber through the skin without a needle as a narrow, high pressure stream of liquid approximately 7/1000ths of an inch in diameter. The Medi- Jector system eliminates the need to pierce the skin with a sharp needle and manipulate a plunger with the needle inserted through the skin. Therefore many people perceive injections with the Medi-Jector system to be less threatening than injections with a needle. Today's Medi-Jector systems are smaller, easier to use, less expensive and more comfortable than previous needle-free injection systems. The Company believes that the key to widespread market acceptance of its needle-free injection systems depends upon continued improvements in these areas.
The Company believes that individuals who require self-injection will benefit from the Medi-Jector system because it (i) eliminates the need to pierce themselves with needles for each injection, which should lead to increased compliance with a prescribed injection regimen and consequently reduce health complications, (ii) provides the ability to inject themselves discreetly and (iii) eliminates the need for sharps disposal of used needles. In addition, healthcare industry providers and payors may benefit from the decrease in long-term costs of patient care which may result from improved patient compliance. Furthermore, pharmaceutical companies may benefit from increased sales and larger market share as a result of an increased ability to differentiate their products in the marketplace and improved patient compliance. Although the single largest indication for self-injection is the administration of insulin for the treatment of diabetes, the number of drugs associated with frequent self-injection is increasing as novel biopharmaceuticals are introduced and individuals previously managed in the hospital are now cared for in the home.
Medi-Ject was a pioneer in the development of portable needle-free injection systems. Prior to the development of portable systems, needle-free injection systems were powered by large air compressors and their use was limited to mass vaccination by the military or school health programs. These injectors were painful in comparison to today's injectors. The Company's first commercial injector was five times as heavy as its current injector, which weighs eight ounces. Acceptance of the Company's needle-free injection systems has gradually expanded as functionality and ease of use have improved and the purchase price has been reduced.
INDUSTRY TRENDS
Historically, with the exception of the self-administration of insulin, parenteral drug administration was limited to hospitals, doctors' offices and clinics. Liquid injectable medicines came packaged in single or multi-dose vials. Healthcare professionals filled disposable syringes with the medication, injected the patient and discarded the used syringe. Advances in pharmacology have resulted in an increasing number of drugs that require frequent injections over long periods of time. These drugs have provided dramatic therapeutic effects for conditions that in the past resisted more conventional medications.
Although the availability of these drugs provides new treatment opportunities, the Company believes that the requirement to inject the drugs has and will continue to hinder their acceptance and reduce patient compliance. The Company believes that most individuals view piercing their skin with a needle as unpleasant. In addition, individuals are often reluctant to use needles in public because needles are frequently associated with illegal drug use and cause fear of accidental needle sticks in others. These and other factors can deter patients from fully complying with their doctor- prescribed injection regimens. The failure to administer all prescribed injections can lead to increased health complications for the patient, decreased drug sales for pharmaceutical companies and increased healthcare costs for payors. In addition, needles require special disposal and therefore must be carried after use until they can be discarded in a special sharps container.
These factors have led pharmaceutical manufacturers to explore many alternative delivery technologies, including novel needle injectors (for example, sheathed and spring-powered needle injectors), transdermal
patches, controlled release oral delivery methods and inhalation devices. In Western Europe, pharmaceutical and medical product companies, including Becton Dickinson, market pen-like needle injection systems. Patients have demonstrated a willingness to pay a premium for these systems over traditional needles and syringes. The Company believes, however, that injection will continue as the major delivery method because many of these drugs are protein biopharmaceuticals which are destroyed in the gastrointestinal tract, do not readily penetrate the skin or are not effectively absorbed through the lungs.
In addition to the increase in the number of drugs requiring self-injection, changes in the frequency of insulin injections for the treatment of diabetes also may contribute to an increase in the number of self-injections. For many years, standard treatment protocol was for insulin to be administered once or twice daily for the treatment of diabetes. However, according to a recent study, tightly controlling the disease by, among other things, administration of insulin as many as four to six times a day, can decrease its debilitating effects. The Company believes that as the benefits of tightly controlling diabetes become more widely known, the number of insulin injections self- administered by individuals with diabetes will increase. The need to increase the number of insulin injections given per day may also lead additional patients to seek an alternative to traditional needles and syringes.
While the Company currently is not pursuing drug applications administered by healthcare professionals, needle-free injection systems may be attractive to hospitals, doctors' offices and clinics, and the Company may explore such applications in the future. The issues raised by accidental needle sticks and disposal of used syringes have led to the development of syringes with sheathed needles and have led hospitals to give injections through intravenous tubing to reduce the number of contaminated needles. The Company believes that needle-free injection systems may be attractive to healthcare professionals as a further means to reduce accidental needle sticks and the burdens of disposing of contaminated needles. Becton Dickinson has the option to distribute Medi-Jector systems to hospitals worldwide.
MARKET OPPORTUNITY
An estimated nine to 12 billion needles and syringes are sold annually worldwide according to industry sources. The Company believes that a significant portion of these are used for the administration of drugs that could be delivered using the Company's Medi-Jector system but that only a small percentage of individuals who self-administer drugs currently use needle-free injection systems.
The Company's focus is on the market for the delivery of self-administered parenteral drugs, the largest, most developed portion of which consists of the delivery of insulin. In the United States, over 3.2 million people inject insulin for the treatment of diabetes, resulting in an estimated 2.3 billion injections annually, and the Company believes that the number of insulin injections will increase with time as the result of new diabetes management approaches which recommend more frequent use. Other parenteral drugs that are presently self-administered and may be suitable for injection with the Medi- Jector system include therapies for the treatment of multiple sclerosis, migraine headaches, growth retardation, impotence, female infertility, AIDS and hepatitis. The Company also believes that other existing parenteral drugs will be self-administered in the future and that additional parenteral drugs that are under development will be deemed appropriate for self-administration.
STRATEGY
The Company's goal is to establish its needle-free injectors as the drug delivery method of choice for the self-administration of a wide range of parenteral drugs. The Company believes that the key to this goal is the development and marketing of a new generation of needle-free injectors that are less expensive and more user friendly than existing needle-free injection systems. The Company's strategic plan for accomplishing this goal consists of:
Developing Proprietary Technologies. To address the need for improved injector systems, the Company initiated a product development program in 1993. The Company believes that the design improvements resulting
from these efforts can reduce production costs and lower sales prices. Central to this program is a new proprietary injection power source, the gas spring. The gas spring injectors will be smaller, operate more intuitively and may give more comfortable injections.
Generating an Income Stream from Consumable Components. In addition to sales of injectors, the Company intends to generate revenue from the ongoing sale of disposable front-end chambers, which soon will replace the current stainless steel chambers.
Collaborating with Pharmaceutical and Medical Device Companies. To achieve more rapid distribution of and capture a portion of the value added by the Company's delivery system, the Company has chosen to pursue licensing and development agreements with pharmaceutical and medical device companies. The Company anticipates that these pharmaceutical and medical device companies will promote and sell the Medi-Jector systems. Using this approach will enable the Company to reduce its marketing expenses and leverage off of the marketing strength and expertise of the other companies.
Focusing on Proprietary Pharmaceuticals. The Company has focused on entering into agreements covering high-priced drugs, largely biopharmaceuticals, which may cost many thousands of dollars per year. The Company believes that pharmaceutical companies that perceive a problem with patient compliance have in many instances demonstrated a willingness to fund the development of alternatives to traditional needle injection. As new injectors become available at reduced costs, the Company will address distribution strategies for less expensive drugs.
PRODUCTS AND TECHNOLOGY
Current Needle-Free Injection Systems
The Company's current Medi-Jector system consists of a coil spring mechanism, a dosage meter, a steel front-end chamber and a plastic adapter. This injector is used by arming the spring mechanism, filling the medication chamber and then setting the pressure level for an optimally effective and comfortable injection. The coil spring is armed by turning the two overlapping tubes in the power pack to shorten the coil spring. The unit is then filled by placing a plastic adapter on a drug vial, turning the power pack body in the opposite direction to pull the medication into the front-end chamber until the proper dosage is displayed in the dosage window and removing the vial and adapter assembly. The pressure is adjusted by again turning the winding grip. An injection is given by holding the Medi-Jector system perpendicular to the skin in a location appropriate for the injection and pressing the trigger button. The most common injection sites are the upper arm, upper thigh, buttocks or the side of the torso. It is recommended that the steel front-end chamber on current models be cleaned after two weeks of use.
Based in part upon the results of focus group studies performed by the Company, it believes that injections using a Medi-Jector system are more comfortable than injections using a needle because there is no need to pierce the skin with a sharp needle and manipulate a plunger with the needle inserted through the skin. In addition, the Company believes injections can be administered more discreetly using a Medi-Jector system than with a needle and syringe. Although both types of injections can be and are performed in public, many people are reluctant to use needles in public because needles are frequently associated with illegal drug use and cause fear of accidental needle sticks in others.
The first lightweight Medi-Jector system, the Medi-Jector EZ system, was introduced by the Company in 1987. Although the Medi-Jector EZ system provided significant advantages over previous needle-free injection systems, it was fabricated from stainless steel parts, which are expensive to manufacture.
In July 1995, the Company introduced the Medi-Jector VI system which replaced the stainless steel body of the Medi-Jector EZ system with a composite plastic body. This change will allow the Company to reduce manufacturing costs as unit volumes increase. The composite body also provides a natural lubricity which
reduces friction and therefore the effort required to arm the coil spring. The Medi-Jector VI system, which is approximately 7 3/4 inches long and weighs approximately eight ounces, also incorporated additional design changes to improve functionality.
New Product Research and Development
The Company continues to improve its existing products while developing new products and technology. Specifically, it is now developing a novel injector power source which it anticipates will form the basis of a new generation of pen-like injectors. In addition, the Company is customizing its injectors in collaboration with pharmaceutical and medical device companies for use with a broader range of parenteral drugs. These development efforts are focused on making Medi-Jector systems more attractive to users by eliminating the periodic cleaning requirements, reducing the size of the system, making the system easier to arm and lowering the cost barrier for new users.
Pen-Like Injectors. The Company believes that a major obstacle to widespread market acceptance of needle-free injection systems has been the lack of a suitably compact and easy to use power source. Although the Company has reduced the size and complexity of its coil spring injectors, the Company believes further reduction in size or improvement in ease of use of systems using a coil spring are not feasible. Other companies have developed and marketed injectors powered by CO/2/ cartridges, but these systems do not provide any advantage in size and are complex and costly to manufacture.
To overcome this obstacle, the Company is developing a novel and proprietary power source, the gas spring. The Company's gas spring is a permanently charged gas cylinder that is smaller than a coil spring with comparable capabilities, allowing the development of smaller systems. A rubber seal surrounds a central rod, preventing the gas from escaping and allowing it to be reused thousands of times. The spring is armed by pushing the rod into the cylinder and compressing the gas in the cylinder. When the rod is released, it springs forward with the energy stored from arming. Medi-Ject built its first prototype gas spring injector in 1994 and filed a patent application shortly after the successful testing of the technology. Use of the Company's proprietary gas spring will allow its needle-free injection systems to be easier to arm and reduced in size (anticipated to be approximately 7 3/4 inches long, seven ounces in weight and 30% smaller in diameter than the Medi- Jector VI system) and may result in more comfortable injections.
Plastic Front-End Chambers. The Company plans to replace the steel front-end chamber of the current Medi-Jector system with a multi-use disposable plastic front-end chamber in its next generation Medi-Jector system, the Medi-Jector VI-B system, which it expects to introduce in late 1996 or early 1997. The Company believes that one of the reasons its needle-free injection systems have not gained widespread market acceptance is the inconvenience of cleaning the systems every two weeks. The disposable front-end chamber will eliminate the need to perform this cleaning process and increase ease of use. In addition, use of this plastic front-end chamber will allow the Company to further reduce the manufacturing costs of the Medi-Jector system.
The Company expects that each front-end chamber will be labeled for use for 14 injections, subject to FDA approval. The Company currently anticipates that the retail selling price of the Medi-Jector VI-B unit (excluding the disposable front-end chamber) will be reduced by 20% to 30% from the price of the current version (which includes the steel front-end chamber). The total annual cost to the end user of disposable front-end chambers and related supplies is anticipated to increase from approximately $50 per year for disposable supplies used with the current system to approximately $200 to $250 per year, depending upon the final cost per unit (based upon an average of two injections per day). Although the total cost to use the Medi-Jector VI-B system over time will be more than with models that do not require disposable front-end chambers, the Company believes that lowering the initial purchase price of a Medi-Jector system will encourage more individuals to make the initial investment in the injector and increase market acceptance.
In addition, the Company plans to introduce a single-use disposable plastic front-end chamber for use with its new generation pen-like injectors. The Company believes that the single-use disposable chamber will be priced competitively but at a premium compared to disposable syringes, and that it will offer users sterility and increased convenience.
The disposable front-end chambers to be used with the Medi-Jector system should not require special disposal. Because a used front-end chamber will not pierce the skin, the risk of cross-infection from discarded front-end chambers is reduced significantly over the risk associated with needles.
Application Specific Systems. In addition to pen-like injectors for insulin, the Company, in collaboration with Becton Dickinson and other pharmaceutical and medical device companies, is in the process of developing customized pen- like needle-free injection systems for specific drug applications. Modified injectors currently are being developed for use in gene therapy, the treatment of erectile dysfunction, and the treatment of multiple sclerosis.
Research and Development Programs. The Company manages four outside product
development programs relating to the further development of (i) the gas
spring, (ii) an electronic dosage display, (iii) an electric arming system and
(iv) the miniaturization of its systems. In addition, over the past year, the
Company has expanded its internal development efforts by hiring additional
technical personnel, purchasing laboratory equipment and dedicating facility
space to internal product development efforts. Product development currently
is the largest single category of Company expenditure, in part supported by
fees under license and development agreements. The Company has expended
approximately $146,000, $401,000, $1,195,000 and $1,093,000 on research and
development efforts during fiscal years 1993, 1994 and 1995 and the six month
period ended June 30, 1996, respectively. Of these amounts, approximately
$125,000, $470,000, $921,000 and $686,000, respectively, were funded by third-
party sponsored development programs and licensing fees.
TARGET MARKETS
The Company intends to target the following markets for use of the Medi- Jector system. To date, the Medi-Jector system has only been approved for use in the United States, Japan and certain European countries for the administration of insulin and human growth hormone.
Insulin
Approximately 3.2 million people take insulin daily for the control of high blood sugar observed in individuals with diabetes according to the National Institutes of Health. Most of these individuals take two injections daily, often combining short acting insulin and long acting insulin. In the United States, the vast majority of insulin users use disposable plastic syringes and needles, while in Western Europe and Japan, in addition to disposable plastic syringes, patients use pen-like injectors that hold small vial cartridges of insulin and use small needles. The management of Type I (insulin dependent) diabetes has been found to be benefitted by a more disciplined approach to glucose management, including, among other things, more frequent injections, which have been proven to reduce long-term complications such as heart disease, strokes, neuropathy (degeneration of the nervous system), kidney failure and loss of vision. As a result, some individuals with diabetes take four to six injections daily. Needle-free injectors have been available to and used by diabetes patients with a serious aversion to needles for many years and for these patients, cost and complexity are not significant barriers to use. The Company believes that another, much larger group of individuals, not seriously averse to needles yet still reluctant to piercing themselves, find it difficult to comply with injection regimens and would benefit from the Company's new, less costly and more user friendly needle-free technology.
Human Growth Hormone
Approximately 52,000 children worldwide receive frequent injections of human growth hormone for the treatment of growth retardation according to industry sources. The disease may be diagnosed as early as age three, with injections administered until bone maturity is reached at age seventeen or beyond. The hormone drug used for the treatment of this condition costs an estimated $20,000 or more at the wholesale level annually. Despite the use of pen-like needle injection systems which are more convenient to use than traditional needles, compliance with the prescribed injection regimen continues to be a problem. A study in Germany found that 36% of children on human growth hormone therapy did not fully comply with the therapy using needle
injections. In addition, a study performed in the Netherlands showed that most children in the study preferred to have their human growth hormone administered using a Medi-Jector system rather than a pen-like needle injector. A small number of pharmaceutical companies currently hold a significant percentage of the worldwide human growth hormone market. The Company believes that its needle-free injector system offers a marketing advantage to the pharmaceutical companies with which it has agreements relating to human growth hormone.
Erectile Dysfunction
Studies estimate the number of men in the United States suffering from impotence at over fifteen million. The causes, earlier thought to be mainly psychogenic, are now thought to be most often a natural result of aging, or a complication of diabetes, urogenital surgery or other physiological causes. Over ten years ago, it was observed that penile injections of vasoactive (blood vessel relaxing) drugs caused temporary erections sufficient to allow satisfactory sexual intercourse. The first drug approved for such use in the United States was the generic drug prostaglandin E/1/. However, the Company believes that use of this drug has been hindered because penile self-injection is difficult and viewed as unpleasant by most men. As a result, drug companies are seeking both local and oral alternative drug delivery methods to avoid the problems of needle injection. The Company believes that its needle-free injection technology may provide an attractive alternative to needles.
Gene Therapy
Gene therapy involves the injection of replacement genes into the body instead of biopharmaceutical protein drugs. In recent years, investigators have been successful in inserting missing genes directly into the body for therapeutic purposes. For example, theoretically, an intramuscular injection of genes of Factor VIII (the blood component necessary for proper clotting) which is missing in individuals with hemophilia, could produce sufficient levels of Factor VIII to prevent excessive bleeding. Gene therapy is also being tested as a more effective method of vaccination. At least one published study suggests that gene delivery with a needle-free injector results in higher blood levels of the protein drug or antibodies to vaccines in animals.
Multiple Sclerosis
Multiple sclerosis is a progressive neurological disease where, most commonly, nerve function loss occurs following an acute episode of peripheral nerve damage. The cause of the disease is obscure, but recent studies have demonstrated that at least three drugs reduce the number of acute episodes. Each of the drugs is a protein or mixture of proteins and requires frequent injections, ranging from daily to weekly. One of these drugs, Betaseron, has been available in the United States for over one year, and the Company believes that many individuals using Betaseron are having difficulty with the prescribed injection regimen due to needle aversion. As a result, the Company believes that administration of these drugs would benefit from needle-free injection systems. Approximately 100,000 individuals in the United States are candidates for treatment with such drugs.
Other Target Markets
The Company has targeted other parenteral drugs that are regularly self- administered. These include narcotic analgesics, the anticoagulant heparin used to prevent blood clots, hormones used in the treatment of female infertility, biopharmaceuticals used to treat hepatitis or to elevate red and white blood cell production following chemotherapy or for the treatment of AIDS.
Although the Company has chosen to focus initially on self-injection opportunities, similar opportunities exist in hospitals, doctors' offices, clinics, nursing homes and hospices. Certain opportunities may address the concern for well being, such as the vaccination of small children, and others may be prompted by the danger of accidental needle sticks in high risk environments, such as the emergency room of the hospital.
COLLABORATIVE AGREEMENTS
The Company's business development efforts are focused on entering into collaborative agreements with pharmaceutical companies. The table below summarizes certain elements of the Company's current agreements.
VOLUME AND
COMPANY MARKET TYPE OF INJECTION
------- ------ --------------------
Becton Dickinson and
Company (1)............. Insulin 0.5 ml subcutaneous
Ferring NV............... Growth Hormone 0.5 ml subcutaneous
(Worldwide except United States,
Canada, Japan and Korea)
JCR Pharmaceuticals Co., 0.5 ml subcutaneous
Ltd..................... Growth Hormone
(Japan)
Bio-Technology General 0.5 ml subcutaneous
Corporation............. Growth Hormone
(United States)
Schwarz Pharma AG........ Prostaglandin E/1/ 1.0 ml intrapenile
(Erectile Dysfunction)
GeneMedicine, Inc........ Gene Therapy 0.5 ml intramuscular
Teva Pharmaceutical 1.0 ml subcutaneous
Industries Ltd.......... Copaxone(R)
(Multiple Sclerosis)
|
Becton Dickinson Agreement
The Company entered into a Development and License Agreement with Becton Dickinson in January 1996. Under the agreement, Becton Dickinson is required to pay to the Company periodic development fees for the development of a pen- sized insulin injector. Becton Dickinson obtained (i) a worldwide license to distribute the new, smaller pen-like injectors for use with insulin and potentially certain other drugs and (ii) the exclusive right to manufacture a disposable front-end chamber for such injector and for injectors to be developed for use in the administration of such other drugs. Medi-Ject retained the right to manufacture the injectors. Both companies have certain rights to share in future revenues generated from injector and disposable front-end chamber sales. In connection with this transaction, Becton Dickinson purchased convertible preferred stock and options and warrants to purchase preferred stock from the Company. See "Certain Transactions--Becton Dickinson."
Ferring Agreement
The Company entered into an agreement with Ferring NV ("Ferring") in December 1993. Pursuant to this agreement, the Company developed and granted Ferring exclusive rights to use, market and distribute a Medi-Jector system to be used in conjunction with human growth hormone worldwide with the exception of the United States, Canada, Japan and Korea. Ferring distributes human growth hormone manufactured by Bio-Technology General Corporation ("Bio- Technology General") in Europe. The Company received an initial development fee at the time the agreement was executed and additional licensing fees are to be paid to the Company by Ferring at the time of regulatory approval of the product in certain countries. The Company has retained its rights as the exclusive manufacturer and supplier of the Medi-Jector system as modified pursuant to this agreement. Ferring first launched the Medi-Jector system in Germany in October 1994, and subsequently in certain other European countries. Ferring has purchased injectors from the Company on a regular basis and has contributed research funding for the modification of the system to meet certain European regulatory requirements. Approximately 400 children are using the Medi-Jector system and have received the Medi-Jector system and training from Ferring without charge. The agreement has a term of ten years from the date the product is introduced in France, Germany, Italy and Spain and may be extended at Ferring's option for additional periods of two years. The agreement may be terminated by Ferring at any time prior to the receipt of all approvals necessary to market the injector in each of these countries.
JCR Agreement
In February 1995, the Company entered into an exclusive license agreement with JCR Pharmaceuticals, Ltd. ("JCR") for the use, marketing and distribution of the Medi-Jector system with human growth hormone in Japan. The Company has retained the exclusive right to manufacture the Medi-Jector system under the agreement. Recently, JCR has entered into the human growth hormone market, after licensing the drug from Bio-Technology General. JCR has distributed approximately 250 injectors for use with human growth hormone. The agreement is for a period of ten years, and may be extended at the option of JCR for additional two year periods.
Bio-Technology General Agreement
The Company entered into an agreement with Bio-Technology General in June 1995. Pursuant to this agreement, the Company developed and granted Bio- Technology General the exclusive rights to use, market and distribute a Medi- Jector system to be used in conjunction with its human growth hormone in the United States in exchange for a licensing fee, research fee payments and ongoing royalty payments. The Company has retained its rights as the exclusive manufacturer and supplier of the Medi-Jector system as modified pursuant to this agreement. The Medi-Jector system was approved for use with the Bio- Technology General human growth hormone by the FDA in April 1996, but the sale of Bio-Technology General human growth hormone in the United States is currently prohibited by a federal injunction issued in late 1995 as a result of an unresolved patent infringement suit brought by Genentech, Inc. Bio- Technology General and Medi-Ject are currently considering various options in connection with the status of this agreement in light of the injunction.
Schwarz Pharma Agreement
The Company entered into an agreement with Schwarz Pharma AG ("Schwarz") in October 1994. Pursuant to this agreement, the Company is to develop and grant Schwarz the exclusive right to use, market and distribute a Medi-Jector system for use in conjunction with prostaglandin of the E series for any human ailment, and any other drug for the treatment of erectile dysfunction. The Company received an initial fee at the time the agreement was executed and additional fees are to be paid at the time of reaching certain milestones in the development. The preliminary design of an injector for this purpose has been completed and human clinical testing is expected to begin in 1996. Data on efficacy, pain and tissue damage will be collected prior to finalizing the design of the injector. Clinical trials of the injector are planned to determine the occurrence of any adverse effects which commonly occur as a result of frequent penile needle usage. The Company has retained its rights as the exclusive manufacturer and supplier of the Medi-Jector system as modified pursuant to this agreement. The agreement may be terminated by either party prior to the first commercial sale of product under the agreement and is otherwise for a period of five years following the first commercial sale or until the expiration of all patent coverage for the covered product, and may be extended for additional three year terms upon mutual agreement of the parties.
GeneMedicine Agreement
The Company entered into an agreement with GeneMedicine, Inc. ("GeneMedicine") in July 1995. GeneMedicine and the Company agreed to collaborate in the development of an injector to deliver gene constructs to muscle and solid tissue in humans. The Company received an initial fee at the time the agreement was executed and additional funds for research support were paid to the Company at regular intervals thereafter. GeneMedicine may secure rights to distribute the injector for certain gene therapies in exchange for licensing fees, and both companies will share in fees and sales revenues generated by licenses to other gene therapy companies. The Company has retained its rights as the exclusive manufacturer and supplier of the Medi- Jector system as modified pursuant to this agreement. The agreement may be terminated by either party upon sixty days' written notice.
Teva Agreement
The Company entered into an agreement with Teva Pharmaceutical Industries Ltd. ("Teva") in May 1996. Teva has obtained a non-exclusive license to distribute a Medi-Jector system to be modified specifically for the
administration of the Teva drug, Copaxone(R), for the treatment of multiple sclerosis. Copaxone(R) is the subject of a currently pending FDA new drug application. Teva has agreed to support the product development work required to modify the injector for Copaxone(R) administration. The Company has retained its rights as the exclusive manufacturer and supplier of the Medi- Jector system as modified pursuant to this agreement. The agreement has an initial term of ten years and will be extended for additional two year terms unless either party notifies the other of its intention to terminate the agreement at least six months prior to the expiration of the current term.
PATENTS
The Company actively seeks, when appropriate, protection for its products and proprietary information by means of United States and foreign patents and trademarks. In addition, the Company relies on trade secrets and confidential contractual agreements to protect certain proprietary information and products. The Company currently holds two United States patents relating to the drug vial adapter and the front-end chamber, one United States design patent relating to the appearance of the Medi-Jector system and has eight United States patent applications pending, one of which has been recently allowed, one Patent Cooperation Treaty application and one Taiwanese patent application relating to the gas spring energy source and aspects of its use.
Much of the Company's technology is being developed on its behalf by independent outside contractors. To protect the rights of its proprietary know-how and technology, Company policy requires all employees and consultants with access to proprietary information to execute confidentiality agreements prohibiting the disclosure of confidential information to anyone outside of the Company. These agreements also require disclosure and assignment to the Company of discoveries and inventions made by such individuals while devoted to Company sponsored activities. Companies with which the Company has entered into development agreements have the right to certain technology developed in connection with such agreements.
The Company has obtained the rights to certain technology and makes milestone payments to the inventors of certain core technology. See "Risk Factors--Dependence on Proprietary Technology Rights."
MANUFACTURING
The Company operates a manufacturing facility in compliance with current GMP established by the FDA. Injector parts are manufactured by third-party suppliers and assembled at the Company's facility in Plymouth, Minnesota. Disposable vial adapters are either assembled at the Company's facility or by third parties. Quality control and final packaging are performed on site. A strong effort has been directed toward reducing component part costs and accelerating assembly procedures, and the Company anticipates a need to invest in automated assembly equipment as volumes increase in the future. Becton Dickinson has the right to manufacture the disposable plastic components of the gas spring systems for the Company in exchange for royalty payments and certain profit sharing arrangements. See "Risk Factors--Dependence on Relationship with Becton Dickinson," "--Dependence on Single Source Suppliers" and "Certain Transactions."
MARKETING
The Company's strategy is to leverage off of the marketing strength, existing distribution systems and expertise of the pharmaceutical and medical device companies with which it collaborates by relying on them to promote and sell its needle-free injection systems together with the products they manufacture. The Company anticipates that under these collaborative arrangements, it will manufacture and supply the needle-free injection technology for specific drug applications to the pharmaceutical company which will market the system for use with its drugs. In some instances pharmaceutical companies may choose to give the injection systems and disposable components to users without charge as an inducement to customers to use their products. Becton Dickinson has informed the Company that it intends to distribute the insulin injection system to be developed under the Becton Dickinson Agreement through an existing distribution system.
The Company currently sells most Medi-Jector systems through a pharmacy distribution system consisting of approximately 3,100 pharmacies and pharmacy distributors. Pharmacies marketing the Company's products display sales literature describing the Medi-Jector system. Often, individuals with diabetes call the Company directly for additional information regarding the product and its uses. The Company's sales personnel explain the need for a doctor's prescription and advise on methods of filing for insurance reimbursement. Additionally, a small national advertising program in lay journals generates additional inquiries. Such inquiries are either referred by the Company to local pharmacies, or may result in mail order sales. The Company also sells a small number of Medi-Jector systems to exclusive distributors outside the United States.
Training is supported by a video and manual that accompany each product purchased. However, approximately 75% of buyers seek additional help over the telephone through the Company's customer service department. The Company employs two nurses to provide training and support for customers through this channel. The customer service 800 number is prominently displayed on each injector. The Company plans, coincident with the introduction of the multi-use disposable front-end chamber, to enlist diabetes nurse educators to promote and train prospective users. This program will involve placing demonstrator injectors in selected clinics with the suggestion that individuals, especially those just beginning insulin therapy, be presented with the choice of needle- free drug delivery.
The most common retail price of an injector (which can be used over a period of several years) is $595, and disposable adapters cost approximately $50 annually. This compares to an annual cost of approximately $140 to use two syringes with needles daily. The Company anticipates that the retail price of future generation Medi-Jector systems will be less than the current retail price, and that additional revenues will be generated by sales of multi-use and single-use disposable plastic front-end chambers when they are introduced.
COMPETITION
Competition in the drug delivery market is intensifying. The Company faces competition from traditional needle syringes, newer pen-like and sheathed needle syringes and other needle-free injection systems as well as alternative drug delivery methods including oral, transdermal and pulmonary delivery systems. The vast majority of injections currently are administered using needles. Because injection is typically only used when other drug delivery methods are not feasible, the Company's needle-free injection systems may be made obsolete by the development or introduction of drugs or drug delivery methods which do not require injection for the treatment of conditions currently targeted by the Company. In addition, because the Company intends to enter into collaborative arrangements with pharmaceutical companies, the Company's competitive position will depend upon the competitive position of the pharmaceutical company with which it collaborates for each drug application.
While competition in the needle-free injection market currently is limited to small companies with modest financial resources, the barriers to entry are not great and the Company anticipates additional competition from companies with greater financial, commercial, personnel and development resources in the future. Two companies, Health-Mor Personal Care Corp. and Vitajet Corporation, currently sell coil spring injectors to the United States insulin market. The products of these companies resemble earlier versions of the Medi-Jector system and sell at prices ranging from $600 to over $800.
Another company, Bioject, Inc., has sold a CO/2/ powered injector since 1993. The injector is designed for and used almost exclusively for vaccinations in doctors' offices or public clinics. Bioject has announced that it has a contract with a pharmaceutical company to develop a self-injection system for use with drugs for the treatment of multiple sclerosis.
Even though the Company expects the needle-free injection market to expand, improvements continue to be made in needle syringes, including syringes with hidden needles and pen-like needle injectors. The Company expects that it will compete with existing needle injection methods as well as new needle injection methods yet to be developed.
GOVERNMENT REGULATION
The Company's products and manufacturing operations are subject to extensive government regulations, both in the United States and abroad. In the United States, the FDA administers the FDA Act and has adopted regulations, including those governing the introduction of new medical devices, the observation of certain standards and practices with respect to the manufacturing and labeling of medical devices, the maintenance of certain records and the reporting of device-related deaths, serious injuries and certain malfunctions to the FDA. Manufacturing facilities and certain Company records are also subject to FDA inspections. The FDA has broad discretion in enforcing the FDA Act and the regulations thereunder, and noncompliance can result in a variety of regulatory steps ranging from warning letters, product detentions, device alerts or field corrections to mandatory recalls, seizures, injunctive actions and civil or criminal actions or penalties.
Drug delivery systems such as the Company's injectors may be approved or cleared for sale as a medical device or may be evaluated as part of the drug approval process in connection with a new drug application ("NDA"). To the extent permitted under the FDA Act and current FDA policy, the Company intends to seek the required approvals and clearance for the use of its new injectors, as modified for use in specific drug applications such as gene therapy, the treatment of erectile dysfunction, and the treatment of multiple sclerosis, under the medical device rather than under the new drug provisions of the FDA Act. There can be no assurance, however, that any of these new injectors will be classified as medical devices.
Products regulated as medical devices may not be commercially distributed in the United States unless they have been cleared or approved by the FDA, unless otherwise exempted. There are two methods for obtaining such clearance or approvals. Certain products qualify for a premarket notification under Section 510(k) of the FDA Act ("510(k) notification") of the manufacturer's intention to commence marketing the product. The manufacturer must, among other things, establish in the 510(k) notification that the product to be marketed is substantially equivalent to another legally marketed product (that is, that it has the same intended use and that it is as safe and effective as a legally marketed device and does not raise questions of safety and effectiveness that are different from those associated with the legally marketed device). Marketing may commence when the FDA issues a letter finding substantial equivalence to such a legally marketed device. The FDA may require, in connection with a 510(k) notification, that it be provided with animal and/or human test results. If a medical device does not qualify for the 510(k) procedure, the manufacturer must file a premarket approval ("PMA") application under Section 515 of the FDA Act. A PMA must show that the device is safe and effective and is generally a much more complex submission than a 510(k) notification, typically requiring more extensive prefiling testing and a longer FDA review process. The Company believes that its Medi-Jector systems regulated as medical devices are eligible for clearance through the 510(k) notification process, although there can be no assurance that the FDA will not require a PMA in the future.
In addition to submission when a device is being introduced into the market for the first time, a 510(k) notification is also required when the manufacturer makes a change or modification to an already marketed device that could significantly affect safety or effectiveness, or where there is a major change or modification in the intended use or in the manufacture of the device. When any change or modification is made in a device or its intended use, the manufacturer is expected to make the initial determination as to whether the change or modification is of a kind that would necessitate the filing of a new 510(k) notification. The FDA's regulations provide only limited guidance in making this determination.
If the FDA concludes that any or all of the Company's new injectors must be handled under the new drug provisions of the FDA Act, substantially greater regulatory requirements and approval times will be imposed. Use of a modified new product with a previously unapproved new drug will be likely to be handled as part of the NDA for the new drug itself. Under these circumstances, the device component will be handled as a drug accessory and will be approved, if ever, only when the NDA itself is approved. The Company's injector may be required to be approved as part of the drug delivery system under a supplemental NDA for use with previously approved drugs. Under these circumstances, the Company's device could be used with the drug only if and when the supplemental NDA is approved for this purpose. It is possible that, for some or even all drugs, the FDA may
take the position that a drug-specific approval must be obtained through a full NDA or supplemental NDA before the device may be labeled for use with that drug. There can be no assurance that those approvals will be obtained in a timely manner or at all.
To the extent that the Company's modified injectors are handled as drug accessories or part of a drug delivery system, rather than as medical devices, they are subject to all of the requirements that apply to new drugs. These include drug GMP requirements, drug adverse reaction reporting requirements, and all of the restrictions that apply to drug labeling and advertising. In general, the drug requirements under the FDA Act are more onerous and strict than medical device requirements. These requirements could have a substantial adverse impact on the profitability of the Company. Similar requirements apply to systems regulated as medical devices.
The Company received 510(k) marketing clearance from the FDA allowing the Company to market the Medi-Jector EZ system in February 1987, the Medi-Jector V system in October 1988 and for the use of the Medi-Jector system to administer Bio-Technology General's human growth hormone in April 1996. The Company determined that a new 510(k) notification was not required in connection with the commercial introduction of the Medi-Jector VI system which incorporates a change to a plastic component body, although there can be no assurance that the FDA will not require a 510(k) notification in the future.
The Company submitted a 510(k) notification regarding the use of plastic front-end chambers with the Medi-Jector VI-B system in July 1996. In addition, the Company expects in the future to submit 510(k) notifications with regard to further device design improvements and uses with additional drug therapies. There can be no assurance that the FDA will grant timely 510(k) clearance for any such system or use, or that the FDA will not require the submission of a PMA with respect to any such system or use.
The FDA Act also regulates the Company's quality control and manufacturing procedures by requiring the Company and its contract manufacturers to demonstrate current GMP compliance. These regulations require, among other things, that (i) the manufacturing process must be regulated and controlled by the use of written procedures and (ii) the ability to produce devices which meet the manufacturer's specifications must be validated by extensive and detailed testing of every aspect of the process. They also require investigation of any deficiencies in the manufacturing process, the products produced or record-keeping. Further, the FDA's interpretation and enforcement of these requirements has been increasingly strict in recent years and seems likely to be even more stringent in the future. The FDA monitors compliance with these requirements by requiring manufacturers to register with the FDA and by conducting periodic FDA inspections of manufacturing facilities. If the inspector observes conditions that might be violative of the GMP, the manufacturer must correct those conditions or explain them satisfactorily. Failure to adhere to GMP requirements would cause the devices produced to be considered in violation of the FDA Act and subject to FDA enforcement action that might include physical removal of the Company's devices from the marketplace.
The FDA's Medical Device Reporting Regulation requires that the Company provide information to the FDA on the occurrence of any death or serious injuries alleged to have been associated with the use of the Company's products, as well as any product malfunction that would likely cause or contribute to a death or serious injury if the malfunction were to recur. In addition, FDA regulations prohibit a device from being marketed for unapproved or uncleared indications. If the FDA believed that the Company was not in compliance with these regulations, it could institute proceedings to detain or seize the Company's devices, issue a recall, seek injunctive relief or assess civil and criminal penalties against the Company or its executive officers, directors or employees.
The Company is subject to the Occupational Safety and Health Act ("OSHA") and other federal, state and local laws and regulations relating to such matters as safe working conditions, manufacturing practices, environmental protection and disposal of hazardous or potentially hazardous substances. There can be no assurance that the Company will not be required to incur significant costs to comply with such laws, regulations or policies in the future, or that such laws, regulations or policies will not increase the costs of producing the Companys devices or otherwise have a material adverse effect upon the Company's ability to do business.
Laws and regulations regarding the manufacture, sale and use of medical devices are subject to change and depend heavily on administrative interpretations. There can be no assurance that future changes in regulations or interpretations made by the FDA, OSHA or other regulatory bodies, will not adversely affect the Company.
Sales of medical devices outside of the United States are subject to foreign legal and regulatory requirements. The Company's Medi-Jector EZ systems have been approved for sale only in certain foreign jurisdictions. Legal restrictions on the sale of imported medical devices vary from country to country. The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA approval, and the requirements may differ. The Company relies upon the companies marketing its injectors in foreign countries to obtain the necessary regulatory approvals for sales of its injectors in those countries. Generally, devices having an effective 510(k) clearance or PMA may be exported without further FDA authorization. FDA authorization is generally required in order to export other medical devices.
The Company is in the process of implementing ISO 9002, a certification showing that the Company's procedures and manufacturing facilities comply with standards for quality assurance and manufacturing process control. Such certification, along with European Medical Device Directive certification would evidence compliance with the requirements enabling the Company to affix the CE Mark to its current products. The CE Mark denotes conformity with European standards for safety and allows certified devices to be placed on the market in all European Union ("EU") countries. After June 1998, medical devices may not be sold in EU countries unless they display the CE Mark. There is no assurance that the Company will obtain the right to affix the CE Mark prior to such time.
PROPERTY
The Company leases approximately 9,000 square feet of office, manufacturing and warehouse space in Plymouth, a suburb of Minneapolis, Minnesota. The lease expiration date is April 1997. The Company believes its facilities will be sufficient to meet its requirements through such time and is exploring options for alternative space.
EMPLOYEES
As of June 30, 1996, the Company employed 30 full-time employees, of whom six were engaged in administration, eight were engaged in sales and marketing, four were engaged in research and development, three were engaged in business development and customer service and nine were engaged in manufacturing. None of the Company's employees are represented by any labor union or other collective bargaining unit. The Company believes that its relations with its employees are good.
LIABILITY INSURANCE
The business of the Company entails the risk of product liability claims. Although the Company has not experienced any material product liability claims to date, any such claims could have a material adverse impact on the Company. The Company maintains product liability insurance with coverage of $1 million per occurrence and an annual aggregate maximum of $5 million. The Company evaluates its insurance requirements on an ongoing basis. There can be no assurance that product liability claims will be covered by such insurance or will not exceed such insurance coverage limits or that such insurance will be available on commercially reasonable terms or at all.
MANAGEMENT
DIRECTORS AND EXECUTIVE OFFICERS
The directors and executive officers of the Company are as follows:
NAME AGE POSITION
---- --- --------
Franklin Pass, M.D...... 60 President, Chief Executive Officer and Chairman
of the Board of Directors
Mark S. Derus........... 40 Vice President, Finance, Chief Financial
Officer and Secretary
Todd Leonard............ 37 Vice President, Sales and Marketing
Peter Sadowski, Ph.D. .. 49 Vice President, Product Development
Fred L. Shapiro, M.D. .. 61 Director
Louis C. Cosentino,
Ph.D. ................. 52 Director
Kenneth Evenstad........ 52 Director
Geoffrey Guy............ 42 Director
Norman A. Jacobs........ 58 Director
Peter Sjostrand......... 49 Director
|
The following is a brief summary of the business experience of each of the executive officers and directors of the Company:
Franklin Pass, M.D., joined the Company as a director and consultant in January 1992, and has served as the Company's President, Chief Executive Officer and Chairman of the Board of Directors since February 1993. From 1990 to 1992, Dr. Pass served as President of International Agricultural Investments, Ltd., an agricultural technology consulting and investment company. Dr. Pass, a physician and scientist, was Director of the Division of Dermatology at Albert Einstein College of Medicine from 1967 to 1973, the Secretary and Treasurer of the American Academy of Dermatology from 1978 to 1981 and the co-founder and Chief Executive Officer of Molecular Genetics, Inc., now named MGI Pharma, Inc., from 1979 to 1986. He is the author of more than 40 published medical and scientific articles. Dr. Pass serves on the board of directors of Ringer Corporation, a producer of lawn and garden care products.
Mark S. Derus joined the Company in December 1993 as Vice President, Finance, Chief Financial Officer and Secretary. Mr. Derus served as a director of the Company from 1992 until he joined the Company as an employee in 1993. From 1986 to December 1993, Mr. Derus was Vice President, Finance of Cherry Tree Investments, Inc., a venture capital company that invests in early stage ventures.
Todd Leonard joined the Company in April 1993 as Vice President, Business Development, and has served as Vice President, Sales and Marketing since April 1996. From 1991 to 1993, Mr. Leonard served as a Senior Licensing Specialist in the Office of Technology Transfer at the National Institutes of Health.
Peter Sadowski, Ph.D., joined the Company in March 1994 as Vice President, Product Development. From October 1992 to February 1994, Dr. Sadowski served as Manager, Product Development for GalaGen, Inc., a biopharmaceutical company. From 1988 to 1992, he was Vice President, Research and Development for American Biosystems, Inc., a medical device company. Dr. Sadowski holds a Ph.D. in microbiology.
Fred L. Shapiro, M.D., joined the Board of Directors in September 1992 and is a member of the Compensation Committee of the Board of Directors. Dr. Shapiro is currently a consultant to Hennepin Faculty Associates, the Hennepin County Medical Center faculty's health maintenance organization in Minneapolis, Minnesota, of which he was President from 1983 to his retirement in 1995. Dr. Shapiro is a nephrologist who has authored or co-authored more than 100 published medical and scientific articles. Dr. Shapiro is also a director and co-founder of Minntech Corporation ("Minntech"), a company that designs and manufactures dialysis equipment.
Louis C. Cosentino, Ph.D., joined the Board of Directors in January 1995 and is a member of the Audit Committee of the Board of Directors. Dr. Cosentino was a co-founder of Minntech in 1975, and has served as its President and Chief Executive Officer since that time. Dr. Cosentino holds a Ph.D. in biomedical engineering and has authored or co-authored nine scientific publications.
Kenneth Evenstad joined the Board of Directors in May 1993. Since 1969 Mr. Evenstad has been the Chairman and Chief Executive Officer of Upsher-Smith Laboratories, Inc., a private pharmaceutical company specializing in branded generic cardiovascular drugs. Mr. Evenstad is trained as a pharmacist.
Geoffrey Guy joined the Board of Directors in November 1993 and is a member of the Compensation Committee of the Board of Directors. Dr. Guy was a co- founder in 1985 of Ethical Holdings plc ("Ethical"), a company that develops new transdermal and oral drug delivery systems and has served as its Chief Executive Officer since that time. Dr. Guy has been Ethical's Chairman of the Board since 1992. Dr. Guy holds a Diploma of Pharmaceutical Medicine from the British Royal College of Physicians.
Norman A. Jacobs joined the Board of Directors in January 1996. Since 1990, Mr. Jacobs has been the President of Becton Dickinson Transdermal Systems, a division of Becton Dickinson, and in 1996 he also became President of Becton Dickinson's Advanced Injection Systems, a recently formed division of Becton Dickinson. Mr. Jacobs serves on the board of directors of Seragen, Inc., a biopharmaceutical company.
Peter Sjostrand joined the Board of Directors in December 1995 and is a member of the Audit and Compensation Committees of the Board of Directors. Dr. Sjostrand is a board member of Pharma Vision, a Swiss investment company. From 1975 to 1993, he served in various capacities with the Astra Group, a Swedish pharmaceutical firm, most recently as deputy board member, Executive Vice President and Chief Financial Officer. Dr. Sjostrand holds a Swedish medical degree. Dr. Sjostrand also serves on the board of directors of S-E Banken Fonder AB, a group of Swedish-based investment funds and Tryggh Hansa, a major insurance company in Sweden.
Under the terms of the Company's Second Amended and Restated Articles of Incorporation which will become effective upon the closing of this offering, the directors will be divided into three classes, with the term of one class expiring each year. As the term of each class expires, the successors to the directors in that class will be elected for a term of three years. The Company believes that classification of the Board of Directors will help to ensure the continuity and stability of the Company's business strategies and policies as determined by the Board of Directors. The terms of Mr. Evenstad and Dr. Cosentino will expire at the Annual Meeting of Shareholders in fiscal 1997, the terms of Drs. Guy and Shapiro will expire at the Annual Meeting of Shareholders in fiscal 1998, and the terms of Drs. Pass and Sjostrand and Mr. Jacobs will expire at the Annual Meeting of Shareholders in fiscal 1999. Vacancies on the Board of Directors and newly created directorships can be filled by vote of the majority of the directors then in office.
Dr. Guy was elected to the Board of Directors as the designee of Ethical under an agreement between Ethical and the Company. The relevant section of the agreement with Ethical will terminate upon the closing of this offering. Mr. Jacobs was elected as the designee of Becton Dickinson under an agreement between Becton Dickinson and the Company. The relevant terms of the agreement with Becton Dickinson provide that, so long as Becton Dickinson controls, directly or indirectly, not less than 5% of the capital stock of the Company, the Company shall use its best efforts to nominate and elect to the Board of Directors a person designated by Becton Dickinson and that the Board of Directors shall consist of at least a majority of members who are not employed by the Company. In the event that a person designated by Becton Dickinson shall not be a member of the Board of Directors, Becton Dickinson shall be entitled to notice of and to attend all meetings of the Board of Directors and its committees and shall receive all information distributed to the directors at the same time as the directors and shall receive the same notice of meetings as the directors. These provisions of the agreement with Becton Dickinson will continue in force following the closing of this offering. Both Dr. Guy and Mr. Jacobs will continue to serve as directors upon completion of this offering.
The Company's executive officers are elected by the Board of Directors and serve until the next election of officers or until their successors are elected or appointed and qualify.
COMMITTEES
The Board of Directors has established an Audit Committee and a Compensation Committee. The Compensation Committee makes recommendations concerning executive salaries and incentive compensation for employees of the Company, subject to ratification by the full Board of Directors, and administers the Company's 1993 Stock Option Plan and the Company's 1996 Stock Option Plan. The Audit Committee reviews the results and scope of the audit and other services provided by the Company's independent auditors, as well as the Company's accounting principles and its system of internal controls, and reports the results of its review to the full Board of Directors and to management.
DIRECTORS' COMPENSATION
The Company has not in the past paid cash directors' fees and does not intend to do so after the closing of this offering. All directors may be reimbursed for expenses actually incurred in attending meetings of the Board of Directors and its committees. In the past, the Board of Directors has made annual discretionary grants of options to purchase shares of Common Stock under the Company's 1993 Stock Option Plan to all members of the Board of Directors. The size of these grants has varied from year to year.
EXECUTIVE COMPENSATION
The following table sets forth the cash and noncash compensation awarded to or earned by the Chief Executive Officer for each of the last three fiscal years. No other executive officer of the Company earned a salary and bonus in excess of $100,000 during 1995.
SUMMARY COMPENSATION TABLE
LONG-TERM
ANNUAL COMPENSATION
COMPENSATION AWARDS
---------------------------------- ------------
SECURITIES
UNDERLYING
NAME AND STOCK ALL OTHER
PRINCIPAL POSITION YEAR SALARY BONUS OTHER (1) OPTIONS COMPENSATION
- ------------------ ---- -------- ------- --------- ------------ ------------
Franklin Pass, M.D. ... 1995 $175,000 $ -- $5,174 45,697 $ --
President, Chief 1994 150,000 20,000 3,879 -- 1,200(2)
Executive Officer and 1993(3) 103,661 -- -- 76,161 --
Chairman of the Board
of Directors
|
(3) Dr. Pass became the Company's President, Chief Executive Officer and Chairman of the Board of Directors in February 1993.
The following table summarizes options granted during the year ended December 31, 1995 to the Chief Executive Officer.
OPTION GRANTS DURING YEAR ENDED DECEMBER 31, 1995
POTENTIAL REALIZABLE
PERCENT VALUE AT ASSUMED
NUMBER OF OF TOTAL ANNUAL RATES OF STOCK
SHARES OPTIONS PRICE APPRECIATION
UNDERLYING GRANTED TO EXERCISE FOR OPTION TERM (2)
OPTIONS EMPLOYEES PRICE EXPIRATION ----------------------
NAME GRANTED (1) IN 1995 PER SHARE DATE 5% 10%
- ---- ----------- ---------- --------- ---------- ---------- -----------
Franklin Pass, M.D...... 45,697 32.1% $3.28 1/1/00 $ 32,301 $ 69,562
|
The following table summarizes the value of options held at December 31, 1995, by the Chief Executive Officer. The Chief Executive Officer did not exercise any options during 1995.
AGGREGATED OPTION VALUES AT DECEMBER 31, 1995
VALUE OF UNEXERCISED
NUMBER OF UNEXERCISED IN-THE-MONEY OPTIONS
OPTIONS AT DECEMBER 31, 1995 AT DECEMBER 31, 1995(1)
NAME EXERCISABLE/UNEXERCISABLE EXERCISABLE/UNEXERCISABLE
- ---- ---------------------------- -------------------------
Franklin Pass, M.D....... 68,595/53,312 $482,097/$364,959
|
EMPLOYMENT AGREEMENT WITH DR. PASS
In January 1995, the Company entered into an employment agreement with Dr. Pass (the "Pass Employment Agreement"). The Pass Employment Agreement provides for a base salary of $175,000 for 1995 and, as to subsequent years, for a base salary to be mutually agreed upon between the Company and Dr. Pass prior to the beginning of each year. For 1996, the parties have agreed that Dr. Pass' base salary is $192,500. The Pass Employment Agreement also contains provisions regarding participation in benefits plans, repayment of expenses, participation in projects and ventures involving the Company and third parties (which is permitted), protection of confidential information and ownership of intellectual property. In addition, the Pass Employment Agreement contains covenants that Dr. Pass will not compete with the Company during the term of his employment and that he will not solicit or interfere with the Company's customers, suppliers or employees during the term of his employment and for a period of two years thereafter. The Pass Employment Agreement had an initial term through December 31, 1995, which term is automatically extended for successive one-year periods unless either party objects by written notice at least 90 days prior to the end of the current term. The Pass Employment Agreement may be terminated prior to the end of the initial term or any extension thereof if Dr. Pass dies; if the Board of Directors of the Company determines that Dr. Pass has become disabled (as defined), has breached the Pass Employment Agreement in any material respect and Dr. Pass has not cured or cannot cure such breach within 30 days after delivery of written notice of such breach or has engaged in willful
and material misconduct; or if Dr. Pass is terminated by the Company, with or without cause, following not less than 90 days' prior written notice.
The Company maintains a $1,000,000 key person life insurance policy on Dr. Pass, payable to the Company.
EMPLOYEE STOCK OPTION PLANS
Under the Company's 1993 Stock Option Plan, as amended (the "1993 Plan"), and the Company's 1996 Stock Option Plan, as amended (the "1996 Plan" and, together with the 1993 Plan, the "Plans"), full- and part-time employees of the Company or of its future subsidiary corporations and directors, consultants and independent contractors of the Company or of its future subsidiary corporations are eligible to receive options to purchase Common Stock. The 1993 Plan is administered by the Compensation Committee and the 1996 Plan is administered by the Board of Directors. The Plans provide for the grant of both incentive stock options intended to qualify for preferential tax treatment under Section 422 of the Internal Revenue Code of 1986, as amended, and nonqualified stock options that do not qualify for such treatment. The exercise price of all incentive stock options granted under the Plans shall be as determined by the Compensation Committee, but shall not be less than 100% of the fair market value of the Common Stock on the date of grant; the exercise price of nonqualified stock options shall be as determined by the Compensation Committee. Only employees are eligible for the grant of incentive stock options.
A total of 495,050 and 500,000 shares of Common Stock have been reserved for issuance under the 1993 Plan and the 1996 Plan, respectively. As of June 30, 1996, the Company had outstanding options to purchase an aggregate of 481,690 shares with a weighted average exercise price of $2.54 per share under the 1993 Plan and no shares under the 1996 Plan.
INDEMNIFICATION OF DIRECTORS AND OFFICERS
The Company's Bylaws and the statutes of the State of Minnesota require the Company to indemnify any director, officer, employee or agent who was or is a party to any threatened, pending or completed action, suit or proceedings, whether civil, criminal, administrative or investigative, against certain liabilities and expenses incurred in connection with the action, suit or proceeding, except where such persons have not acted in good faith or did not reasonably believe that the conduct was in the best interests of the Company.
Insofar as indemnification for liabilities arising under the Securities Act may be available to directors, officers or other persons controlling the Company pursuant to the foregoing provisions, the Company has been informed that in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.
PRINCIPAL SHAREHOLDERS
The following table sets forth certain information regarding beneficial ownership of the Common Stock, as of June 1, 1996, after giving effect to a 1- for-1.313 reverse stock split effected on August 6, 1996, and the conversion of the outstanding shares of Convertible Preferred Stock into Common Stock upon the effectiveness or closing of this offering, before giving effect to the sale by the Company of the 2,200,000 shares of Common Stock hereby and as adjusted to reflect such sale, by (i) each person who is known by the Company to beneficially own more than 5% of the Common Stock, (ii) each of the Company's directors, (iii) the executive officer named in the Summary Compensation Table above and (iv) all directors and executive officers of the Company as a group.
PERCENTAGE OWNED (1)
AMOUNT AND NATURE OF ------------------------------
NAME OF BENEFICIAL OWNER BENEFICIAL OWNERSHIP (1) BEFORE OFFERING AFTER OFFERING
- ------------------------ ------------------------ --------------- --------------
Franklin Pass, M.D. (2). 177,636 3.7% 2.5%
Fred L. Shapiro, M.D.
(3).................... 67,408 1.4 *
Louis C. Cosentino,
Ph.D. (4).............. 15,234 * *
Kenneth Evenstad (5).... 14,092 * *
Peter Sjostrand (6)..... 7,617 * *
Geoffrey Guy (7)........ 7,618 * *
Norman A. Jacobs (8).... -- -- --
Becton Dickinson and
Company (9)............ 3,046,460 43.5 33.1
Ethical Holdings plc
(10)................... 1,224,198 25.9 17.7
Cherry Tree Ventures I
and II (11)............ 820,810 17.3 11.8
Enskilda
Kapitalforvaltning
(12)................... 542,994 11.5 7.8
All executive officers
and directors as a
group (10 persons)
(13)................... 408,597 8.2% 5.7%
|
(2) Includes 68,544 shares of Common Stock issuable to Dr. Pass upon the
exercise of outstanding options.
(3) Includes 14,092 shares of Common Stock issuable to Dr. Shapiro upon the
exercise of outstanding options and 22,851 shares issuable to Dr. Shapiro
upon the exercise of outstanding warrants.
(4) Includes 7,617 shares of Common Stock issuable to Dr. Cosentino upon the
exercise of outstanding options.
(5) Includes 14,092 shares of Common Stock issuable to Mr. Evenstad upon the
exercise of outstanding options.
(6) Dr. Sjostrand is a board member of S-E Banken Fonder AB.
(7) Includes 7,618 shares of Common Stock issuable to Dr. Guy upon the
exercise of outstanding options. Dr. Guy is the Chairman and Chief
Executive Officer and an approximately 11% shareholder of Ethical.
(8) Mr. Jacobs is the President of Becton Dickinson Transdermal Systems and of
Advanced Injection Systems, both of which are divisions of Becton
Dickinson.
(9) Includes 380,808 shares of Common Stock issuable to Becton Dickinson upon
the exercise of outstanding options and 1,904,037 shares of Common Stock
issuable to Becton Dickinson upon the exercise of outstanding warrants.
Becton Dickinson has notified the Company of its intent to exercise its
option to purchase 380,808 shares of Common Stock immediately prior to and
contingent upon the closing of this offering in the event the public
offering price is at least $7.88 per share. The address of Becton
Dickinson is 1 Becton Drive, Franklin Lakes, NJ 07417.
(10) The address of Ethical is Corpus Christi House, 9 West Street,
Godmanchester, Huntingdon, Cambs., PE18 8HG, United Kingdom.
(11) Includes 581,418 shares of Common Stock held of record by Cherry Tree
Ventures II, L.P. ("Cherry Tree I") and 208,926 shares of Common Stock
held of record by Cherry Tree Ventures I, L.P. ("Cherry Tree II"). Also
includes 30,466 shares of Common Stock issuable to Cherry Tree II upon
the exercise of outstanding warrants. Tony Christianson and Gordon
Stofer, the general partners of each of Cherry Tree I and Cherry Tree II,
share voting and investment power with respect to the shares of Common
Stock indicated. The address for Cherry Tree I and Cherry Tree II is 3800
West 80th Street, Suite 1400, Bloomington, MN 55431.
(12) The address of Enskilda is c/o Skandinaviska Enskilda Banken, Jakobsbergsgatan 17, Box 16053, 103 21 Stockholm, Sweden. Enskilda Kapitalforvaltning is a wholly owned subsidiary of S-E Banken Fonder AB.
(13) Includes 242,381 shares of Common Stock issuable to all directors and executive officers as a group upon the exercise of outstanding options and warrants.
CERTAIN TRANSACTIONS
CHERRY TREE II
On April 16 and June 4, 1993, Cherry Tree II loaned the Company an aggregate of $40,000 pursuant to the terms of loan agreements and related 9% Demand Promissory Notes; in partial consideration for these loans, Cherry Tree II received warrants to purchase an aggregate of 30,466 shares of Common Stock at $1.31 per share, which warrants expire on April 16, 1998 and June 3, 1998. The principal amount of these loans was converted into 30,465 shares of Series A Convertible Preferred Stock in November 1993 which was in turn converted into 30,465 shares of Common Stock in January 1996; the Company paid Cherry Tree II an aggregate of $2,017 interest in cash on these loans.
FRED L. SHAPIRO, M.D.
On April 16 and June 4, 1993, Fred L. Shapiro, M.D., a director of the Company, loaned the Company an aggregate of $20,000 pursuant to the terms of loan agreements and related 9% Demand Promissory Notes; in partial consideration for these loans, Dr. Shapiro received warrants to purchase an aggregate of 15,234 shares of Common Stock at $1.31 per share, which warrants expire on April 16, 1998 and June 3, 1998. The Company repaid the principal amount of these loans, together with an aggregate of $747 in interest, on October 9, 1993. On August 29, 1994, Dr. Shapiro loaned the Company $100,000 pursuant to the terms of a promissory note due August 29, 1995, bearing interest at 12% per year; Dr. Shapiro also received a warrant to purchase 7,617 shares of Common Stock at $3.28 per share, which warrant expires on August 31, 1997. In August 1995, the Company and Dr. Shapiro agreed to extend the term of the loan and to amend the terms of the loan to permit Dr. Shapiro to convert the principal amount of the loan into shares of Common Stock. On February 29, 1996, Dr. Shapiro elected to convert the outstanding principal amount of this loan into 30,465 shares of Common Stock. The Company paid Dr. Shapiro an aggregate of $18,000 interest in cash on the loan.
ETHICAL
On September 27, 1993, Ethical and the Company entered into a Preferred Stock Purchase Agreement pursuant to which Ethical purchased 380,808 shares of Series B Convertible Preferred Stock for a price of $1.31 per share. At the same time, the Company and Ethical also entered into (i) an Option Agreement (the "Ethical Option") pursuant to which Ethical obtained the right to purchase 761,615 shares of Series B Convertible Preferred Stock at a price of $1.31 per share (subject to adjustment to $2.62 per share upon the occurrence of certain events) at any time before the first to occur of March 10, 1995, or the effectiveness of a registration statement under the Securities Act registering the Common Stock and (ii) a Technology License and Co-Development Agreement (the "Ethical License Agreement"). In a letter dated December 10, 1993, Ethical and the Company amended the Ethical Option to provide that the $1.31 per share price should in all events remain valid as to 380,808 shares through September 30, 1994. On March 24, 1995, pursuant to the terms of the Ethical Option, the exercise price was adjusted to $2.62 upon the Company raising in excess of $1,000,000 through the sale of additional shares of capital stock at a price of at least $2.62 per share. On September 16, 1994, Ethical and the Company executed a Waiver and Notice of Exercise Agreement pursuant to which (i) the parties agreed to waive a 380,808 share minimum exercise amount provision in the Ethical Option, (ii) the parties agreed to a 152,323 share minimum exercise amount for the Ethical Option, (iii) the parties agreed to extend the $1.31 per share exercise price on 380,808 shares subject to the Ethical Option through October 31, 1994 and (iv) Ethical exercised the Ethical Option as to 152,323 shares of Series B Convertible Preferred Stock for $1.31 per share. On February 10, 1995, in return for a commitment by Ethical to exercise $100,000 worth of the Ethical Option under certain circumstances, the Company and Ethical amended the Ethical Option to extend its term through September 10, 1995. Ethical exercised the Ethical Option as to 76,161 shares of Series B Convertible Preferred Stock in February 1995, at a price of $1.31 per share. Pursuant to an Agreement dated September 1, 1995, between Ethical and the Company, (i) the parties agreed to waive the 380,808 share minimum exercise increment in the Ethical Option, (ii) the Company agreed to extend the Ethical Option through February 29, 1996, provided that Ethical exercise the Ethical Option as to at least 152,323 shares by September 1, 1995, (iii) Ethical exercised the Ethical Option as to 152,323 shares of Series B Convertible Preferred Stock for $1.64 per share (with the
Company agreeing to such price) and (iv) the parties agreed that the Company would have the unilateral right to terminate the Ethical License Agreement at any time. In January 1996, the Company terminated the Ethical License Agreement.
On December 22, 1995, Ethical and the Company entered into a Loan Agreement (the "Ethical Loan") pursuant to which the Company borrowed $312,500 from Ethical in three installments in December 1995 and January 1996; amounts outstanding under the Ethical Loan bore interest at the rate of 10% per year. In connection with the Ethical Loan, the Company and Ethical again amended the Ethical Option to reduce the per share exercise price on 190,404 of the shares of Series B Convertible Preferred Stock subject to the Ethical Option from $2.62 to $1.64 and to extend the term of the Ethical Option through the later of February 29, 1996, or the repayment date of the Ethical Loan. On February 28, 1996, the Company issued 190,404 shares of Series B Convertible Preferred Stock to Ethical at a price of $1.64 per share in repayment of all principal amounts advanced under the Ethical Loan and paid $1,301 interest in cash. On the same date, Ethical exercised the remainder of the Ethical Option and purchased 190,404 shares of Series B Convertible Preferred Stock for $2.62 per share.
As the result of certain anti-dilution protections applicable to the Series B Convertible Preferred Stock sold to Ethical, these shares will convert upon the effectiveness of this offering into 1,224,198 shares of Common Stock.
ENSKILDA
On December 28, 1993, the Company and Enskilda entered into a Preferred Stock Purchase Agreement pursuant to which Enskilda purchased 57,121 shares of Series B Convertible Preferred Stock at a purchase price of $1.31 per share. At the same time, the Company and Enskilda orally agreed that Enskilda should be allowed to purchase an additional 399,848 shares of Series B Convertible Preferred Stock. On February 1, 1994, the Company and Enskilda entered into a Preferred Stock Agreement pursuant to which Enskilda purchased 399,848 shares of Non-Voting Series B Convertible Preferred Stock for $1.31 per share. On December 29, 1994, Enskilda purchased 30,465 shares of Series B Convertible Preferred Stock for $3.28 per share as part of a private placement of such shares. On May 31, 1995, Enskilda purchased 22,848 shares of Series B Convertible Preferred Stock for $3.28 per share as part of a private placement of such shares.
As the result of certain anti-dilution protections applicable to the Series B Convertible Preferred Stock sold to Enskilda, these shares will convert upon the effectiveness of this offering into 542,992 shares of Common Stock.
BECTON DICKINSON
On January 25, 1996, the Company and Becton Dickinson entered into a Preferred Stock, Option and Warrant Purchase Agreement pursuant to which Becton Dickinson purchased 761,615 shares of Series C Convertible Preferred Stock for $3.94 per share. Becton Dickinson also received, for no additional consideration, an option (the "Becton Dickinson Option") to purchase 380,808 shares of Series D Convertible Preferred Stock at $4.60 per share and purchased, for $125,000, a warrant (the "Becton Dickinson Warrant") to purchase 1,904,037 shares of Series E Convertible Preferred Stock at $5.91 per share. Under its terms, the Becton Dickinson Option will expire on the date on which the Company completes this offering provided that the public offering price per share is at least $7.88 and gross proceeds equal or exceed $10 million. Becton Dickinson has notified the Company of its intent to exercise the Becton Dickinson Option immediately prior to and contingent upon the closing of this offering provided that the public offering price is at least $7.88 per share. All shares of Series C convert 1-for-1 into, and the Becton Dickinson Option and the Becton Dickinson Warrant will become exercisable for, shares of Common Stock upon the closing of this offering.
At the same time, the Company and Becton Dickinson entered into a Development and License Agreement relating to the further development of the Company's needle-free injection systems and Becton Dickinson's development of certain disposables for use with the Company's systems. The terms of the Development and
License Agreement include the grant to Becton Dickinson during the term of the agreement of an exclusive, worldwide license to (i) sell and use certain of the Company's needle-free injection systems that are not designed or calibrated for use with a specific drug made by a specific drug company and that are intended to be distributed primarily through pharmacies for non- professional use and (ii) make, have made, use, sell and import single- or multiple-use disposable front-end chambers or other related drug-containing or drug-contacting components for use with certain of the Company's needle-free injection systems. These exclusive rights with respect to the injectors will continue for a period of at least five years from the date of FDA marketing clearance of each such injector, and for a longer period if Becton Dickinson meets certain minimum sales goals set in the Becton Dickinson Agreement. During such period, the Company will not have the right to sell any such injector independently. In addition to the systems to be sold by Becton Dickinson, the Company and Becton Dickinson expect to enter into agreements with third-party pharmaceutical companies, including development, supply and license agreements, governing the development and commercial sale of needle- free injection systems for use only with such third-party pharmaceutical company's version of a specific drug.
DESCRIPTION OF CAPITAL STOCK
Upon completion of this offering the authorized capital stock of the Company will consist of 17,000,000 shares of Common Stock, $.01 par value, and 1,000,000 shares of preferred stock, $.01 par value, that are undesignated as to terms and preferences. As of June 30, 1996, there were 4,725,633 shares of Common Stock outstanding, which were held of record by approximately 91 shareholders, and no shares of undesignated preferred stock outstanding.
COMMON STOCK
The holders of Common Stock are entitled to one vote for each share held of record on all matters submitted to a vote of shareholders. There is no cumulative voting for the election of directors so that the holders of more than 50% of the outstanding Common Stock can elect all directors. Subject to preferences that may be applicable 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 of the Company out of funds legally available therefor and in liquidation proceedings. Holders of Common Stock have no preemptive or subscription rights and there are no redemption rights with respect to such shares. The outstanding shares of Common Stock are, and the shares of Common Stock offered hereby will be, validly issued, fully paid and nonassessable.
PREFERRED STOCK
All of the Company's outstanding Convertible Preferred Stock will be converted into Common Stock upon the effectiveness or the closing of this offering pursuant to its terms. Immediately after the conversion of the Convertible Preferred Stock into Common Stock, there will be no Convertible Preferred Stock outstanding and the Company will have authorized 1,000,000 shares of preferred stock that is undesignated as to terms and preferences. Under Minnesota law and the Company's Second Amended and Restated Articles of Incorporation to be effective upon the closing of this offering, the Board of Directors is authorized, without further shareholder action, to issue preferred stock in one or more classes or series and to fix the voting rights, liquidation preferences, dividend rights, repurchase rights, conversion rights, redemption rights and terms, including sinking fund provisions, and certain other rights and preferences, of the preferred stock. Accordingly, although it has no current intention of doing so, the Board of Directors of the Company may, without shareholder approval, issue shares of a class or series of preferred stock with voting and conversion rights which could adversely affect the voting power and the dividend and other rights of the holders of Common Stock. In addition, the existence of undesignated preferred stock may have the effect of discouraging, delaying, deferring or preventing an attempt, through acquisition of a substantial number of shares of Common Stock, to acquire control of the Company with a view to effecting a merger, sale or exchange of assets or a similar transaction. The anti-takeover effects of the undesignated preferred stock may deny shareholders the receipt of a premium on their Common Stock and may also have a depressive effect on the market price of the Common Stock.
WARRANTS AND OPTIONS
As of June 30, 1996, the Company had outstanding options to purchase 481,690 shares of Common Stock that had been issued to employees, directors and consultants to the Company pursuant to the 1993 Stock Option Plan with a weighted average exercise price of $2.54 per share. Such options expire between October 1997 and January 2006. As of June 30, 1996, the Company also had outstanding warrants and options to purchase a total of 2,485,120 shares of Common Stock that have been granted to third parties outside of the 1993 Stock Option Plan with a weighted average exercise price of $5.35 per share. Such third-party warrants and options are all currently exercisable and expire on dates ranging from February 1997 to January 2006. All agreements embodying such outstanding third-party warrants and options provide for anti-dilution adjustments in the event of certain mergers, consolidations, reorganizations, recapitalizations, stock dividends, stock splits or other changes in the corporate structure of the Company. Becton Dickinson has notified the Company of its intent to exercise the Becton Dickinson Option for 380,808 shares of Common Stock immediately prior to and contingent upon the closing of this offering in the event the public offering price is at least $7.88 per share. Holders of third-party warrants and options to purchase approximately 2,287,893 shares of Common Stock are entitled to certain rights to cause the Company to register the sale of such shares under the Securities Act. See "Shares Eligible for Future Sale."
ANTI-TAKEOVER PROVISIONS OF THE MINNESOTA BUSINESS CORPORATION ACT
Certain provisions of Minnesota law described below could have an anti- takeover effect. These provisions are intended to provide management flexibility, to enhance the likelihood of continuity and stability in the composition of the Board of Directors and in the policies formulated by the Board of Directors and to discourage an unsolicited takeover of the Company if the Board of Directors determines that such a takeover is not in the best interests of the Company and its shareholders. However, these provisions could have the effect of discouraging certain attempts to acquire the Company, which could deprive the Company's shareholders of opportunities to sell their shares of Common Stock at prices higher than prevailing market prices.
Section 302A.671 of the Minnesota Business Corporation Act (the "MBCA") provides that, unless the acquisition of certain new percentages of voting control of the Company (in excess of 20%, 33 1/3% or 50%) by an existing shareholder or other person is approved by a majority of the disinterested shareholders of the Company, the shares acquired above such new percentage level of voting control will not be entitled to voting rights. The Company is required to hold a special shareholders' meeting to vote on any such acquisition within 55 days after the delivery to the Company by the acquirer of an information statement describing, among other things, the acquirer and any plans of the acquirer to liquidate or dissolve the Company and copies of definitive financing agreements for any financing of the acquisition not to be provided by funds of the acquirer. If any acquirer does not submit an information statement to the Company within ten days after acquiring shares representing a new threshold percentage of voting control of the Company, or if the disinterested shareholders vote not to approve such an acquisition, the Company may redeem the shares so acquired by the acquirer at their market value. Section 302A.671 generally does not apply to a cash offer to purchase all shares of voting stock of the issuing corporation if such offer has been approved by a majority vote of disinterested board members of the issuing corporation.
Section 302A.673 of the MBCA restricts certain transactions between the Company and a shareholder who becomes the beneficial holder of 10% or more of the Company's outstanding voting stock (an "interested shareholder") unless a majority of the disinterested directors of the Company have approved, prior to the date on which the shareholder acquired a 10% interest, either the business combination transaction suggested by such a shareholder or the acquisition of shares that made such a shareholder a statutory interested shareholder. If such prior approval is not obtained, the statute imposes a four-year prohibition from the statutory interested shareholder's share acquisition date on mergers, sales of substantial assets, loans, substantial issuances of stock and various other transactions involving the Company and the statutory interested shareholder or its affiliates.
TRANSFER AGENT AND REGISTRAR
The Transfer Agent and Registrar with respect to the Common Stock will be Norwest Bank, Minnesota, N.A.
SHARES ELIGIBLE FOR FUTURE SALE
Future sales of shares by current shareholders could adversely affect the price of the Company's Common Stock.
Upon completion of this offering, the Company will have outstanding an aggregate of 6,925,633 shares of Common Stock, assuming the issuance of the 2,200,000 shares of Common Stock offered hereby. Of the total outstanding shares of Common Stock, the 2,200,000 shares offered hereby will be freely tradeable without restriction or further registration under the Securities Act, unless held by "affiliates" of the Company, as that term is defined in Rule 144 under the Securities Act (whose sales would be subject to certain volume limitations and other restrictions described below).
The remaining 4,725,633 shares of Common Stock will be "restricted securities" as that term is defined in Rule 144 under the Securities Act. Of these, an aggregate of 4,293,378 shares are owned by the Company's directors, officers and certain of the Company's shareholders who, together with the Company, have agreed that they will not sell, directly or indirectly, any Common Stock without the prior consent of Rodman & Renshaw, Inc. for a period of 180 days from the date of this Prospectus. Of the shares not subject to this agreement, 125,008 shares will be eligible for immediate sale without restriction pursuant to Rule 144(k) on the effective date of this offering, 381 shares will be eligible for sale, subject to compliance with the volume limitations and other restrictions of Rule 144, 90 days after the effective date of this offering, and 306,866 shares will become eligible for sale under Rule 144 after the expiration of the two-year holding periods from the dates of acquisition, which end between December 29, 1996 and May 31, 1998. Beginning on the 181st day after the date of this Prospectus, when the agreements not to sell shares expire, an additional 929,757 of the shares may become eligible for sale without restriction pursuant to Rule 144(k), an additional 1,850,562 of the shares will become eligible for sale, subject to compliance with the volume limitations and other restrictions of Rule 144, and the remaining 1,513,059 shares will become eligible for sale under Rule 144 after the expiration of the two-year holding periods from the dates of acquisition, which end between December 29, 1996 and February 28, 1998.
In general, under Rule 144, as currently in effect, if at least two years have elapsed from the date that shares of Common Stock were acquired from the Company or an affiliate of the Company, then the holder is entitled to sell in "brokers' transactions" or to market makers, within any three-month period commencing 90 days after the date of this Prospectus, a number of shares that does not exceed the greater of (i) one percent of the then outstanding shares of Common Stock (69,256 shares immediately after this offering) or (ii) generally, the average weekly trading volume in the Common Stock during the four calendar weeks preceding the filing of a Form 144 with respect to such sale, subject to certain other limitations and restrictions. In addition, a person who is not deemed to have been an affiliate of the Company at any time during the three months preceding a sale, and who has beneficially owned the shares proposed to be sold for at least three years, would be entitled to sell such shares under Rule 144(k) without regard to the requirements described above.
The Company intends to file registration statements under the Securities Act, covering 495,050 and 500,000 shares of Common Stock reserved for issuance under, respectively, the 1993 Stock Option Plan and the 1996 Stock Option Plan. Such registration statements are expected to be filed soon after the date of this Prospectus and will automatically become effective upon filing. Accordingly, shares issued under such registration statements upon the exercise of options will be available for resale in the open market subject to the agreements not to sell described above. See "Management--Stock Option Plans."
In addition, after this offering, the holders of 2,761,547 shares of Common Stock and warrants and options to purchase 2,287,893 shares of Common Stock (together, the "Registrable Securities") will be entitled to certain rights to cause the Company to register the sale of such shares under the Securities Act. After this offering, if the Company proposes to register any of its securities under the Securities Act for its own account, holders of Registrable Securities will be entitled to notice of such registration and will be entitled to include Registrable Securities therein, subject to certain conditions and exceptions, including the right of the underwriters of any such offering to limit the number of shares that may be included in such registration. Certain of the holders
of Registrable Securities have the right to require the Company to prepare and file a registration statement under the Securities Act at its expense, and the Company is required to use its best efforts to effect such registration, subject to certain conditions and limitations; provided, however, that with respect to certain of the Registrable Securities, the Company shall not be required to obtain the effectiveness of any such registration statement until six months after the date of this Prospectus. Furthermore, the Company's obligation to effect such shareholder-initiated registrations is limited in number with respect to certain of the Registrable Securities. Registration of such shares would result in such shares becoming freely tradeable without restriction under the Securities Act (except for shares purchased by affiliates of the Company) immediately upon the effectiveness of such registration. All but 3,048 of these shares are subject to the agreements not to sell described above.
The Company can make no prediction as to the effect, if any, that sales of shares of Common Stock or the availability of Common Stock for sale will have on the market price prevailing from time to time. Nevertheless, sales of substantial amounts of the Common Stock in the public markets or the perception that such sales will occur could adversely affect the market price or the future ability to raise capital through an offering of its equity securities.
UNDERWRITING
The Underwriters below, for whom Rodman & Renshaw, Inc. ("Rodman") and R. J. Steichen & Company are acting as representatives (the "Representatives"), have severally agreed, subject to the terms and conditions contained in the Underwriting Agreement, to purchase from the Company, the number of shares of Common Stock set forth opposite their names below.
UNDERWRITER NUMBER OF SHARES
----------- ----------------
Rodman & Renshaw, Inc...............................................
R. J. Steichen & Company............................................
---------
Total........................................................... 2,200,000
=========
|
The Underwriting Agreement provides that the obligations of the several Underwriters thereunder are subject to approval of certain legal matters by counsel and to various other considerations. The nature of obligations is such that they are committed to purchase and pay for all of the above shares of Common Stock offered hereby if any are purchased.
The Underwriters, through the Representatives, have advised the Company that they propose to offer the Common Stock initially at the public offering price set forth on the cover page of this Prospectus; that the Underwriters may allow to selected dealers a concession of $ per share and that such dealers may reallow a concession of $ per share to certain other dealers. After the public offering, the offering price and other selling terms may be changed by the Underwriters. The Common Stock has been approved for quotation on the Nasdaq National Market. The Representatives have advised the Company that they do not intend to confirm sales to any account over which they exercise discretionary authority.
The Company has granted to the Underwriters a 30-day over-allotment option to purchase up to an aggregate of 330,000 additional shares of Common Stock, exercisable at the public offering price less the underwriting discount. If the Underwriters exercise such over-allotment option, then each of the Underwriters will have a firm commitment, subject to certain conditions, to purchase approximately the same percentage thereof as the number of shares of Common Stock to be purchased by it as shown in the above table, bears to the 2,200,000 shares of Common Stock offered hereby. The Underwriters may exercise such option only to cover over-allotments made in connection with the sale of the shares of Common Stock offered hereby.
In connection with this offering, the Company has agreed to issue and sell to the Representatives, for nominal consideration, warrants to purchase a number of shares of Common Stock equal to 10% of the shares of Common Stock sold in this offering, exclusive of any shares of Common Stock sold pursuant to the Underwriters' over-allotment option (the "Representatives' Warrants"). The Representatives' Warrants will be initially exercisable at a price per share equal to 120% of the public offering price, commencing one year from the date of this Prospectus, and will continue to be exercisable for a period of four years after such date. The Representatives' Warrants are restricted from sale, transfer, assignment or hypothecation for a period of 12 months from the effective date of this offering, except to officers, partners or successors of the Representatives. The exercise price of the Representatives' Warrants and the number of shares of Common Stock issuable upon exercise thereof are subject to adjustment under certain circumstances. The Representatives' Warrants grant to the holders thereof certain rights regarding the registration of the Common Stock issuable upon exercise of the Representatives' Warrants.
The officers, directors and certain shareholders of the Company, who will beneficially own 4,293,378 shares of Common Stock after the offering, have agreed that they will not publicly sell or dispose of any shares of Common Stock for a period of 180 days after the date on which the Registration Statement is declared effective by the Commission, without the prior written consent of Rodman. See "Shares Eligible for Future Sale."
The Company has agreed to indemnify the Underwriters against certain liabilities, losses and expenses, including liabilities under the Securities Act, or to contribute to payments the Underwriters may be required to make in respect thereof.
Prior to this offering, there has been no public market for the Common Stock. Consequently, the initial public offering price has been determined through negotiations between the Company and the Representatives. Among the factors considered in determining the initial public offering price were prevailing market and economic conditions, estimates of the business potential and prospects of the Company, the present state of the Company's business operations, an assessment of the Company's management and the consideration of the above factors in relation to the market valuation of companies in related businesses.
LEGAL MATTERS
The validity of the shares of Common Stock offered hereby will be passed upon for the Company by Dorsey & Whitney LLP, Minneapolis, Minnesota. Certain legal matters in connection with the sale of the Common Stock offered hereby will be passed on for the Underwriters by Squadron, Ellenoff, Plesent & Sheinfeld, LLP, New York, New York.
EXPERTS
The financial statements as of December 31, 1994 and 1995, and for each of the years in the three-year period ended December 31, 1995, included in this Prospectus have been audited by KPMG Peat Marwick LLP, independent auditors, as set forth in their report thereon appearing elsewhere herein and in the Registration Statement, and are included in reliance upon such report given upon the authority of such firm as experts in accounting and auditing.
On December 29, 1995, on the recommendation of the Audit Committee and with the approval of the Board of Directors, the Company engaged KPMG Peat Marwick LLP to audit the consolidated financial statements of the Company for the year ended December 31, 1995. KPMG Peat Marwick LLP has also conducted a reaudit of the financial statements as of December 31, 1994, and for each of the years in the two-year period ended December 31, 1994. There were no disagreements between the Company and Stirtz Bernards Boyden Surdel & Larter Professional Association ("Stirtz Bernards"), the Company's prior accountants, (whether resolved to the satisfaction of Stirtz Bernards or not) on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure. The audit opinion of Stirtz Bernards for the years ended December 31, 1993 and 1994 did not contain an adverse opinion or disclaimer of opinion, nor were they qualified as to uncertainty, audit scope, or accounting principles.
ADDITIONAL INFORMATION
The Company has filed with the SEC in Washington, D.C. a Registration Statement on Form S-1, including amendments thereto, with respect to the shares of Common Stock offered hereby has been filed with the SEC. This Prospectus does not contain all of the information set forth in the Registration Statement and the exhibits and schedules thereto. For further information pertaining to the Company and the shares of Common Stock offered hereby, reference is made to the Registration Statement, including the exhibits, financial statements and schedules filed therewith. Statements contained in this Prospectus as to the contents of any contract or any other document are not necessarily complete, and in each instance, reference is made to the copy of such contract or document filed as an exhibit to the Registration Statement, each such statement being qualified in all respects by such reference.
The Registration Statement, including the exhibits and schedules thereto, may be inspected, without charge, and copies may be obtained, at prescribed rates, at the public reference facilities of the SEC maintained at Room 1024, 450 Fifth Street, N.W., Washington, D.C. 20549 and at the SEC's regional offices at 7 World Trade Center, New York, New York 10048 and 500 West Madison Street, Suite 1400, Chicago, Illinois 60661. Copies of the Registration Statement may also be obtained by mail at prescribed rates, from the Public Reference Section of the SEC at 450 Fifth Street, N.W., Washington, D.C. 20549.
The Company intends to furnish its shareholders with annual reports containing financial statements audited by its independent public accountants and quarterly reports containing unaudited financial information for the first three quarters of each fiscal year.
MEDI-JECT CORPORATION
INDEX TO FINANCIAL STATEMENTS
PAGE
----
Independent Auditors' Report.............................................. F-2
Balance Sheets as of December 31, 1994 and 1995 and June 30, 1996
(unaudited) and Pro forma Shareholders' Equity as of June 30, 1996
(unaudited).............................................................. F-3
Statements of Operations for the Years Ended December 31, 1993, 1994 and
1995 and the Six Months Ended June 30, 1995 and 1996 (unaudited)......... F-4
Statements of Shareholders' Equity (Deficit) for the Years Ended December
31, 1993, 1994 and 1995 and the Six Months Ended June 30, 1996
(unaudited).............................................................. F-5
Statements of Cash Flows for the Years Ended December 31, 1993, 1994 and
1995 and the Six Months Ended June 30, 1995 and 1996 (unaudited)......... F-6
Notes to Financial Statements............................................. F-7
|
INDEPENDENT AUDITORS' REPORT
To the Shareholders and Board of Directors Medi-Ject Corporation:
We have audited the accompanying balance sheets of Medi-Ject Corporation (the Company) as of December 31, 1994 and 1995, and the related statements of operations, shareholders' equity (deficit), and cash flows for each of the years in the three-year period ended December 31, 1995. 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 generally accepted auditing standards. 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 Medi-Ject Corporation as of December 31, 1994 and 1995, and the results of its operations and its cash flows for each of the years in the three-year period ended December 31, 1995, in conformity with generally accepted accounting principles.
KPMG Peat Marwick LLP
Minneapolis, Minnesota
June 7, 1996, except as to Note 13(a)
which is as of August 6, 1996
MEDI-JECT CORPORATION
BALANCE SHEETS
DECEMBER 31, PRO FORMA
---------------------- JUNE 30, JUNE 30,
1994 1995 1996 1996
---------- ---------- ----------- -----------
(UNAUDITED) (UNAUDITED)
ASSETS
Current assets:
Cash and cash equivalents... $ 645,667 $ 35,817 $ 2,232,660
Accounts receivable, less
allowance for doubtful ac-
counts of $1,501 for 1994,
$4,125 for 1995, and $4,000
for June 30, 1996.......... 89,303 176,240 128,218
Inventories................. 170,861 280,229 334,535
Prepaid expenses............ 12,318 35,508 110,941
---------- ---------- -----------
918,149 527,794 2,806,354
---------- ---------- -----------
Equipment, furniture and fix-
tures....................... 907,248 1,027,462 1,144,619
Less accumulated deprecia-
tion........................ (464,654) (550,436) (563,685)
---------- ---------- -----------
442,594 477,026 580,934
---------- ---------- -----------
Patent rights................ 0 235,288 317,901
---------- ---------- -----------
$1,360,743 $1,240,108 $ 3,705,189
========== ========== ===========
LIABILITIES AND SHAREHOLDERS'
EQUITY (DEFICIT)
Current liabilities:
Accounts payable............ $ 160,018 $ 243,281 $ 235,951
Accrued expenses............ 291,039 398,232 248,630
Deferred revenue............ 110,000 148,563 457,024
Capital lease obligations--
current maturities......... 42,455 45,534 42,350
Notes payable--current matu-
rities..................... 206,324 342,457 123,454
---------- ---------- -----------
809,836 1,178,067 1,107,409
---------- ---------- -----------
Long-term liabilities:
Capital leases, less current
maturities................. 85,326 40,109 20,214
Notes payable, less current
maturities................. 213,554 96,097 33,301
---------- ---------- -----------
298,880 136,206 53,515
---------- ---------- -----------
Shareholders' equity (defi-
cit):
Series C convertible pre-
ferred stock: $.01 par; au-
thorized 761,615 shares: 0;
0; and 761,615 issued and
outstanding at December 31,
1994, 1995, and June 30,
1996, respectively......... -- -- 7,616 $ --
Series B convertible pre-
ferred stock: $.01 par; au-
thorized 3,046,459 shares:
1,488,958; 2,090,633; and
2,471,484 issued and out-
standing at December 31,
1994, 1995 and June 30,
1996, respectively......... 14,890 20,906 24,714 --
Series A convertible pre-
ferred stock: $.01 par; au-
thorized 1,218,584 shares:
1,103,867; 1,103,867; and 0
issued and outstanding at
December 31, 1994, 1995 and
June 30, 1996, respective-
ly......................... 11,039 11,039 -- --
Common stock: $.01 par; au-
thorized 7,616,147 shares:
217,722; 218,864;
1,353,785; and 4,725,633
issued and outstanding at
December 31, 1994, 1995,
June 30, 1996, and June 30,
1996 pro forma, respec-
tively .................... 2,177 2,189 13,538 47,256
Additional paid-in capital.. 7,643,361 9,193,600 12,984,474 12,983,086
Accumulated deficit......... (7,419,440) (9,301,899) (10,486,077) (10,486,077)
---------- ---------- ----------- -----------
Total shareholders' equity
(deficit).................. 252,027 (74,165) 2,544,265 2,544,265
---------- ---------- ----------- -----------
$1,360,743 $1,240,108 $ 3,705,189 $ 3,705,189
========== ========== =========== ===========
|
See accompanying notes to financial statements.
MEDI-JECT CORPORATION
STATEMENTS OF OPERATIONS
SIX MONTHS ENDED
YEAR ENDED DECEMBER 31, JUNE 30,
------------------------------------ -----------------------
1993 1994 1995 1995 1996
---------- ----------- ----------- ---------- -----------
(UNAUDITED)
Revenues:
Sales.................. $1,057,703 $ 1,517,660 $ 1,653,869 $ 831,130 $ 814,244
Licensing and product
development........... 125,000 470,000 920,937 410,000 686,038
---------- ----------- ----------- ---------- -----------
1,182,703 1,987,660 2,574,806 1,241,130 1,500,282
---------- ----------- ----------- ---------- -----------
Operating expenses:
Cost of sales.......... 409,247 630,628 1,048,937 465,277 501,718
Research and develop-
ment.................. 146,061 401,382 1,195,435 606,613 1,093,087
General and administra-
tive.................. 615,035 867,616 977,579 628,046 672,079
Sales and marketing.... 484,939 1,128,232 1,145,894 450,173 466,880
---------- ----------- ----------- ---------- -----------
1,655,282 3,027,858 4,367,845 2,150,109 2,733,764
---------- ----------- ----------- ---------- -----------
Net operating loss...... (472,579) (1,040,198) (1,793,039) (908,979) (1,233,482)
---------- ----------- ----------- ---------- -----------
Other income (expense):
Interest and other in-
come.................. 2,538 15,916 16,486 10,824 69,485
Interest and other ex-
pense................. (30,278) (42,180) (105,906) (31,506) (20,181)
---------- ----------- ----------- ---------- -----------
(27,740) (26,264) (89,420) (20,682) 49,304
---------- ----------- ----------- ---------- -----------
Net loss................ $ (500,319) $(1,066,462) $(1,882,459) $ (929,661) $(1,184,178)
========== =========== =========== ========== ===========
Pro forma per share data
(unaudited) (Note 1):
Net loss per common
share................. $ (0.36) $ (0.19)
=========== ===========
Weighted average common
shares outstanding.... 5,180,186 6,353,706
|
See accompanying notes to financial statements.
MEDI-JECT CORPORATION
STATEMENTS OF SHAREHOLDERS' EQUITY (DEFICIT)
CONVERTIBLE PREFERRED STOCK
------------------------------------------------------
SERIES C SERIES B SERIES A COMMON STOCK ADDITIONAL
-------------- ------------------ -------------------- ------------------ PAID-IN ACCUMULATED
SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT CAPITAL DEFICIT
------- ------ --------- -------- ---------- -------- --------- ------- ----------- ------------
Balance, December
31, 1992......... -- $ -- -- $ -- 1,073,402 $ 10,734 229,216 $ 2,292 $ 5,511,019 $ (5,852,659)
Common stock:
Stock incentive
awards expired.. -- -- -- -- -- -- (97,696) (977) 977 --
Shares issued as
compensation.... -- -- -- -- -- -- 46,078 461 2,467 --
Series A:
Conversion of
notes payable... -- -- -- 30,465 305 -- -- 39,695 --
Series B:
Shares issued
for cash........ -- -- 761,615 7,616 -- -- -- -- 992,385 --
Offering costs.. -- -- -- -- -- -- -- -- (95,274) --
Net loss........ -- -- -- -- -- -- -- -- -- (500,319)
------- ------ --------- -------- ---------- -------- --------- ------- ----------- ------------
Balance, December
31, 1993......... -- -- 761,615 7,616 1,103,867 11,039 177,598 1,776 6,451,269 (6,352,978)
Common stock:
Shares issued as
compensation.... -- -- -- -- -- -- 37,310 373 2,029 --
Shares issued
for cash........ -- -- -- -- -- -- 2,814 28 200 --
Series B:
Exercise of
stock options... -- -- 552,171 5,522 -- -- -- -- 719,478 --
Shares issued
for cash........ -- -- 175,172 1,752 -- -- -- -- 548,248 --
Offering costs.. -- -- -- -- -- -- -- -- (77,863) --
Net loss........ -- -- -- -- -- -- -- -- -- (1,066,462)
------- ------ --------- -------- ---------- -------- --------- ------- ----------- ------------
Balance, December
31, 1994......... -- -- 1,488,958 14,890 1,103,867 11,039 217,722 2,177 7,643,361 (7,419,440)
Common stock:
Exercise of
stock options... -- -- -- -- -- -- 1,142 12 1,548 --
Series B:
Exercise of
stock options... -- -- 228,483 2,284 -- -- -- -- 347,716 --
Shares issued
for cash........ -- -- 373,192 3,732 -- -- -- -- 1,221,268 --
Offering costs.. -- -- -- -- -- -- -- -- (65,383) --
Amendments to
investor option
agreement....... -- -- -- -- -- -- -- -- 45,090 --
Net loss........ -- -- -- -- -- -- -- -- -- (1,882,459)
------- ------ --------- -------- ---------- -------- --------- ------- ----------- ------------
Balance, December
31, 1995......... -- -- 2,090,633 20,906 1,103,867 11,039 218,864 2,189 9,193,600 (9,301,899)
Conversion of
Series A to com-
mon stock (1)... -- -- -- -- (1,103,867) (11,039) 1,103,867 11,039 -- --
Conversion of
note payable
(1)............. -- -- -- -- -- -- 30,465 305 99,695 --
Shares issued
for reverse
stock split (1). -- -- 43 -- -- -- 589 5 (5) --
Series B: (1)
Exercise of
stock options
and conversion
of
note payable.... -- -- 380,808 3,808 -- -- -- -- 809,822 --
Series C: (1)
Shares issued
for cash........ 761,615 7,616 -- -- -- -- -- -- 2,992,384 --
Offering costs.. -- -- -- -- -- -- -- -- (236,022) --
Series E: (1)
Warrant issued
for cash........ -- -- -- -- -- -- -- -- 125,000 --
Net loss (1).... -- -- -- -- -- -- -- -- -- (1,184,178)
------- ------ --------- -------- ---------- -------- --------- ------- ----------- ------------
Balance, June 30,
1996 (1)......... 761,615 $7,616 2,471,484 $ 24,714 -- $ -- 1,353,785 $13,538 $12,984,474 $(10,486,077)
======= ====== ========= ======== ========== ======== ========= ======= =========== ============
TOTAL
------------
Balance, December
31, 1992......... $ (328,614)
Common stock:
Stock incentive
awards expired.. --
Shares issued as
compensation.... 2,928
Series A:
Conversion of
notes payable... 40,000
Series B:
Shares issued
for cash........ 1,000,001
Offering costs.. (95,274)
Net loss........ (500,319)
------------
Balance, December
31, 1993......... 118,722
Common stock:
Shares issued as
compensation.... 2,402
Shares issued
for cash........ 228
Series B:
Exercise of
stock options... 725,000
Shares issued
for cash........ 550,000
Offering costs.. (77,863)
Net loss........ (1,066,462)
------------
Balance, December
31, 1994......... 252,027
Common stock:
Exercise of
stock options... 1,560
Series B:
Exercise of
stock options... 350,000
Shares issued
for cash........ 1,225,000
Offering costs.. (65,383)
Amendments to
investor option
agreement....... 45,090
Net loss........ (1,882,459)
------------
Balance, December
31, 1995......... (74,165)
Conversion of
Series A to com-
mon stock (1)... --
Conversion of
note payable
(1)............. 100,000
Shares issued
for reverse
stock split (1). --
Series B: (1)
Exercise of
stock options
and conversion
of
note payable.... 813,630
Series C: (1)
Shares issued
for cash........ 3,000,000
Offering costs.. (236,022)
Series E: (1)
Warrant issued
for cash........ 125,000
Net loss (1).... (1,184,178)
------------
Balance, June 30,
1996 (1)......... $ 2,544,265
============
|
See accompanying notes to financial statements.
MEDI-JECT CORPORATION
STATEMENTS OF CASH FLOWS
SIX MONTHS
YEAR ENDED DECEMBER 31, ENDED JUNE 30,
------------------------------------ ------------------------
1993 1994 1995 1995 1996
---------- ----------- ----------- ----------- -----------
(UNAUDITED)
Cash flows from
operating activities:
Net loss............... $ (500,319) $(1,066,462) $(1,882,459) $ (929,661) $(1,184,178)
Adjustments to reconcile
net loss to net cash
used in operating
activities:
Depreciation........... 26,324 36,945 85,960 25,422 69,881
Shares issued as
compensation.......... 2,928 2,402 -- -- --
Amendments to investor
option agreement...... -- -- 45,090 -- --
Changes in operating
assets and
liabilities:
Accounts receivable.... (15,455) (20,639) (86,937) (4,539) 48,022
Inventories............ 15,006 (121,547) (109,368) (145,274) (54,306)
Prepaid expenses....... 7,121 3,542 (23,190) (31,028) (75,433)
Accounts payable....... 42,524 16,854 83,263 (49,197) (7,330)
Deferred revenue....... 43,750 66,250 38,563 (35,000) 308,461
Accrued expenses....... 73,907 90,026 107,193 125,042 (149,602)
---------- ----------- ----------- ----------- -----------
Net cash used in
operating activities... (304,214) (992,629) (1,741,885) (1,044,235) (1,044,485)
---------- ----------- ----------- ----------- -----------
Cash flows from
investing activities:
Purchases of equipment,
furniture and
fixtures.............. (39,096) (256,622) (120,392) (64,862) (173,789)
Purchase of patent
rights................ -- -- (235,288) (125,853) (82,613)
---------- ----------- ----------- ----------- -----------
Net cash used in
investing activities.. (39,096) (256,622) (355,680) (190,715) (256,402)
---------- ----------- ----------- ----------- -----------
Cash flows from
financing activities:
Principal payments on
capital lease
obligations........... (7,194) (26,729) (42,138) (20,225) (23,079)
Proceeds from issuance
of common stock....... -- 228 1,560 1,560 101,130
Proceeds from issuance
of convertible
preferred stock....... 1,000,001 1,275,000 1,575,000 980,000 3,812,500
Warrants issued........ -- -- -- -- 125,000
Proceeds from issuance
of notes payable...... 40,000 100,000 125,000 -- 187,500
Principal payments on
notes payable......... -- (24,967) (106,324) (52,507) (469,299)
Offering costs......... (95,274) (77,863) (65,383) (45,571) (236,022)
---------- ----------- ----------- ----------- -----------
Net cash provided by
financing activities... 937,533 1,245,669 1,487,715 863,257 3,497,730
---------- ----------- ----------- ----------- -----------
Net increase (decrease)
in cash and cash
equivalents............ 594,223 (3,582) (609,850) (371,693) 2,196,843
Cash and cash
equivalents:
Beginning of period.... 55,026 649,249 645,667 645,667 35,817
---------- ----------- ----------- ----------- -----------
End of period.......... $ 649,249 $ 645,667 $ 35,817 $ 273,974 $ 2,232,660
========== =========== =========== =========== ===========
|
See accompanying notes to financial statements.
MEDI-JECT CORPORATION
NOTES TO FINANCIAL STATEMENTS
DECEMBER 31, 1995
(UNAUDITED AS TO JUNE 30, 1996 DATA)
1. DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Business
The Company is primarily a manufacturer/distributor of needle-free injection devices and disposables for the injection of insulin and human growth hormone. Products are sold throughout the United States, Europe, the Middle East, and Asia.
Interim Financial Information
The financial information presented for the six months ended June 30, 1996 is unaudited. In the opinion of management, this unaudited financial information contains all adjustments (which consist only of normal, recurring adjustments) necessary for a fair presentation. Operating results for the six months ended June 30, 1996 are not necessarily indicative of results that may be expected for the full year.
Pro Forma Net Loss Per Share
Pro forma net loss per share is computed by dividing the net loss attributable to common shareholders by the weighted average number of shares of common stock and common stock equivalents outstanding, after applying the treasury stock method and after giving effect to the reverse stock split and the automatic conversion of all outstanding shares of convertible preferred stock in accordance with the Company's initial public offering (see Note 13).
Pursuant to certain requirements of the Securities and Exchange Commission, common stock equivalents include the impact of the issuance of stock, options and warrants (see Note 8) within one year prior to the date of the initial filing of the Company's initial public offering ("IPO") (see Note 13) at exercise prices less than the assumed initial public offering price of $9.00 per share, whether or not the effects are antidilutive.
Cash Equivalents
The Company considers highly liquid debt instruments with remaining maturities of ninety days or less at time of purchase to be cash equivalents.
Inventories
Inventories are stated at the lower of cost or market. Cost is determined on a first-in, first-out basis.
Equipment, Furniture, and Fixtures
Equipment, furniture, and fixtures are stated at cost and are depreciated using the straight-line method over their estimated useful lives.
Sales Recognition
Sales and related costs are recognized upon shipment of product to customers. Sales are recorded net of provisions for returns and discounts.
MEDI-JECT CORPORATION
NOTES TO FINANCIAL STATEMENTS--(CONTINUED)
DECEMBER 31, 1995
(UNAUDITED AS TO JUNE 30, 1996 DATA)
Licensing and Product Development Revenue Recognition
Licensing and product development revenue is recognized when underlying performance criteria for payment have been met and the Company has an unconditional right to such payment. Depending on a license or product development agreement's terms, recognition criteria may be satisfied upon achievement of milestones, passage of time, or product sales by the licensee. Payments received by the Company in excess of amounts earned are classified as deferred revenue.
Product Warranty
The Company recognizes the estimated cost of warranty obligations to its customers at the time the products are shipped.
Research and Development
Company sponsored research and development expenses related to both present and future products are expensed as incurred.
Income Taxes
Deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between the financial carrying amounts of existing assets and liabilities and their respective tax bases.
Concentration of Credit Risk
Financial instruments that may subject the Company to concentration of credit risk consist principally of accounts receivable. This risk is mitigated by the large number of individual customers and long-standing credit relationships with the Company's major distributors.
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 liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from these estimates.
New Accounting Pronouncements
For 1996, the Company is required to adopt Statement of Financial Accounting Standards No. 121, Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to be Disposed of, and SFAS No. 123, Accounting for Stock- Based Compensation. SFAS No. 121 prescribes accounting and reporting standards when circumstances indicate that the carrying amount of an asset may not be recoverable. Initial application of SFAS No. 121 is not expected to result in recognition of a cumulative effect of a change in accounting principle by the Company. SFAS No. 123 prescribes accounting and reporting standards for all stock-based compensation plans. Since the Company intends to elect continued recognition of certain stock-based compensation using the intrinsic value method prescribed under Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees, no effect on the Company's expense recognition is expected.
MEDI-JECT CORPORATION
NOTES TO FINANCIAL STATEMENTS--(CONTINUED)
DECEMBER 31, 1995
(UNAUDITED AS TO JUNE 30, 1996 DATA)
2. INVENTORIES:
Inventories consist of the following:
DECEMBER 31,
----------------- JUNE 30,
1994 1995 1996
-------- -------- -----------
(UNAUDITED)
Raw material................................... $119,316 $145,603 $178,026
Work-in-process................................ 45,878 80,663 76,208
Finished goods................................. 5,667 53,963 80,301
-------- -------- --------
$170,861 $280,229 $334,535
======== ======== ========
|
3. EQUIPMENT, FURNITURE AND FIXTURES
Equipment, furniture and fixtures consisted of the following:
DECEMBER 31,
------------------- JUNE 30, USEFUL
1994 1995 1996 LIVES
-------- ---------- ----------- ----------
(UNAUDITED)
Office equipment.................. $222,350 $ 262,847 $ 376,489 3-5 years
Production equipment.............. 674,862 753,319 756,834 3-10 years
Displays.......................... 10,036 11,296 11,296 3-5 years
-------- ---------- ----------
$907,248 $1,027,462 $1,144,619
======== ========== ==========
|
4. ACCRUED EXPENSES
Accrued expenses consisted of the following:
DECEMBER 31,
----------------- JUNE 30,
1994 1995 1996
-------- -------- -----------
(UNAUDITED)
Accrued product warranty and returns........... $ 95,438 $ 71,620 $ 71,620
Payroll........................................ 18,795 29,787 23,706
Accrued patent rights obligation............... -- 96,500 --
Other.......................................... 176,806 200,325 153,304
-------- -------- --------
$291,039 $398,232 $248,630
======== ======== ========
|
MEDI-JECT CORPORATION
NOTES TO FINANCIAL STATEMENTS--(CONTINUED)
DECEMBER 31, 1995
(UNAUDITED AS TO JUNE 30, 1996 DATA)
5. NOTES PAYABLE
Notes payable consisted of the following:
DECEMBER 31,
-------------------- JUNE 30,
1994 1995 1996
--------- --------- -----------
(UNAUDITED)
Unsecured notes payable, interest at 10%.. $ -- $ 125,000 $ --
Notes payable, due in aggregate monthly
payments of $11,127 including interest at
10% through October 1997. Notes are
secured by all assets of the Company..... 319,878 213,554 156,755
Unsecured note payable to shareholder/
director, with interest at 12% payable
monthly. Principal is due August 1996.
Convertible into 30,465 shares of common
stock.................................... 100,000 100,000 --
--------- --------- ---------
419,878 438,554 156,755
Current maturities........................ (206,324) (342,457) (123,454)
--------- --------- ---------
Notes payable, less current maturities.... $ 213,554 $ 96,097 $ 33,301
========= ========= =========
Aggregate future maturities are as fol-
lows:
1996..................................... $ 342,457
1997..................................... 96,097
---------
$ 438,554
=========
|
6. LEASES
The Company has a noncancelable operating lease for its office and manufacturing facility that expires in April 1997. This lease requires the Company to pay all executory costs such as maintenance and insurance.
Rent expense incurred for the years ended December 31, 1993, 1994, and 1995 was $57,924, $102,306, and $107,616, respectively.
The Company is also obligated under noncancelable leases classified as capital leases. The leases call for aggregate monthly payments of $5,301 with various expiration dates through September 1999. Equipment, furniture, and fixtures include $163,506 and $326,186 of cost and $25,791 and $221,341 of accumulated amortization as of December 31, 1994 and 1995, respectively, related to these leases.
Future minimum lease payments are as follow as of December 31, 1995:
CAPITAL OPERATING
LEASES LEASES
-------- ---------
1996..................................................... $ 57,034 $76,729
1997..................................................... 35,220 --
1998..................................................... 7,070 --
1999..................................................... 1,901 --
-------- -------
$101,225 $76,729
=======
Less amount representing interest (at rates ranging from
12% to 20.9%)............................................. 15,582
--------
Present value of minimum capital lease payments......... 85,643
Less current maturities.................................. 45,534
--------
Obligations under capital leases less current maturi-
ties................................................... $ 40,109
========
|
MEDI-JECT CORPORATION
NOTES TO FINANCIAL STATEMENTS--(CONTINUED)
DECEMBER 31, 1995
(UNAUDITED AS TO JUNE 30, 1996 DATA)
7. INCOME TAXES
The Company incurred losses for both book and tax purposes in each of the three years in the period ended December 31, 1995 and, accordingly, no income taxes were provided. Effective tax rates differ from statutory federal income tax rates in the years ended December 31, 1995, 1994, and 1993 as follows:
1993 1994 1995
----- ----- -----
Statutory federal income
tax rate............... (34.0)% (34.0)% (34.0)%
Valuation allowance in-
crease................. 36.0 36.0 36.0
State income taxes, net
of federal benefit..... (2.0) (2.0) (2.0)
----- ----- -----
0.0% 0.0% 0.0%
===== ===== =====
|
Deferred taxes as of December 31, 1995 and 1994 consist of the following:
1994 1995
----------- -----------
Deferred tax assets:
Inventory reserve................................. $ 65,100 $ 72,100
Net operating loss carryforward................... 2,462,000 3,123,600
Research credit carryforward...................... 117,000 117,000
Other............................................. 34,900 27,300
----------- -----------
2,679,000 3,340,000
Less valuation allowance........................... (2,679,000) (3,340,000)
----------- -----------
$ 0 $ 0
=========== ===========
|
At December 31, 1995, the Company had net operating loss carryforwards ("NOL") of approximately $9,000,000 for federal income tax purposes, which begin to expire in 1996. Additionally, the Company had research credit carryforwards of approximately $117,000, which begin to expire in 1997.
Pursuant to the Tax Reform Act of 1986, use of the Company's NOL will be limited because of a cumulative "change of ownership" of more than 50%. This ownership change occurred as a result of the sale of 1,000,000 shares of Series C convertible preferred stock on January 25, 1996 (see Note 12).
8. SHAREHOLDERS' EQUITY
Series A Convertible Preferred Stock
The Series A convertible preferred stock carries voting rights, has no dividend preference over the Company's common stock and a liquidation preference of $0.641. Each Series A share is convertible into one share of common stock at the option of the holder and is, under certain circumstances, automatically converted to common stock (see Note 12).
Series B Convertible Preferred Stock
The Series B convertible preferred stock, which carries voting rights, has dividend preference over Series A convertible preferred and common stock and a liquidation preference of $1.31. Each Series B share is convertible into one share of common stock, subject to certain anti-dilution adjustments.
MEDI-JECT CORPORATION
NOTES TO FINANCIAL STATEMENTS--(CONTINUED)
DECEMBER 31, 1995
(UNAUDITED AS TO JUNE 30, 1996 DATA)
In January 1994, the Board of Directors established a new Series B non- voting convertible preferred stock and authorized 761,615 shares for this class of stock. The Series B non-voting ranks on par with the Series B voting convertible preferred stock, with regard to dividends and liquidation preference, and is convertible at the option of the holder into common stock.
In October 1994, the Board of Directors established a new Series B, Class II, voting convertible preferred stock and authorized 304,646 shares for this class of stock. The Series B-II has a liquidation preference of $3.28 per share, and otherwise ranks on par with the Series B voting convertible preferred stock.
In April 1995, the Board of Directors established a new Series B, Class III, voting convertible preferred stock and authorized 152,323 shares for this class of stock. The Series B-III has a liquidation preference of $3.28 per share, and otherwise ranks on par with the Series B voting convertible preferred stock.
In August 1995, the Board of Directors established a new Series B, Class IV, voting convertible preferred stock and authorized 761,162 shares for this class of stock. The Series B-IV has a liquidation preference of $3.28 per share, and otherwise ranks on par with the Series B voting convertible preferred stock.
At December 31, 1995, the total number of shares authorized for all classes of stock was 13,404,420 shares: 7,616,147 common shares; 1,218,584 Series A preferred shares; 2,284,844 Series B preferred shares; 761,615 nonvoting Series B preferred shares; and 1,523,230 preferred shares undesignated as to class.
Stock Options and Warrants
The Company has issued options and warrants for common stock to various lenders and others. These options and warrants have exercise prices ranging from $0.79 to $3.28 per share, are fully exercisable, and expire from August 1996 to December 2003.
The Company also has stock options outstanding for 380,808 shares of its Series B convertible preferred stock issued in connection with a 1993 stock purchase agreement. This option agreement, as amended, expired on February 29, 1996. The exercise price is $1.64 per share for 190,404 shares and $2.63 for the remaining 190,404 shares. Amendments during 1995 to the Series B preferred option agreement resulted in the recognition of $45,090 in expense. This expense was associated with decreases in the exercise price of certain options in exchange for a short-term credit facility, and the cancellation of a technology license and co-development agreement (see Note 12).
Under the terms of the Company's 1993 Stock Option Plan, incentive stock options and nonqualified options may be granted to officers, directors, employees, and consultants. Under this plan, 495,050 shares of common stock have been reserved. At December 31, 1995, 87,891 shares remain available for grant.
Stock options granted under the 1993 Stock Option Plan become exercisable over varying periods and expire up to ten years from date of grant. The option price for incentive stock options cannot be less than fair market value on the date of the grant. The option price for nonqualified stock options may be set by the Board of Directors.
MEDI-JECT CORPORATION
NOTES TO FINANCIAL STATEMENTS--(CONTINUED)
DECEMBER 31, 1995
(UNAUDITED AS TO JUNE 30, 1996 DATA)
Stock option and warrant activity for the three years ended December 31, 1995 and the six months ended June 30, 1996 is summarized as follows:
NUMBER EXERCISE PRICE
OF SHARES PER SHARE
--------- --------------
Outstanding at December 31, 1992...................... 4,570 $26.26-32.83
Granted............................................. 1,038,712 0.79-2.63
Exercised........................................... -- --
Canceled............................................ -- --
--------- ------------
Outstanding at December 31, 1993...................... 1,043,282 0.79-32.83
Granted............................................. 124,995 1.31-1.64
Exercised........................................... (152,323) 1.31
Canceled............................................ (7,236) 0.79-32.83
--------- ------------
Outstanding at December 31, 1994...................... 1,008,718 0.79-1.64
Granted............................................. 214,776 1.31-3.28
Exercised........................................... (229,627) 1.31-1.64
Canceled............................................ (2,057) 3.28
--------- ------------
Outstanding at December 31, 1995...................... 991,810 0.79-3.28
Granted (unaudited)................................. 2,372,677 3.94-5.91
Exercised (unaudited)............................... (380,808) 1.64-2.63
Canceled (unaudited)................................ (16,869) 1.31-2.63
--------- ------------
Outstanding at June 30, 1996 (unaudited).............. 2,966,810 $ 0.79-5.91
========= ============
|
As of December 31, 1995 and June 30, 1996 options and warrants for 823,119 and 2,809,071 (unaudited) shares, respectively, were exercisable.
9. EMPLOYEE SAVINGS PLAN
The Company has an employee savings plan that covers all employees who have met minimum age and service requirements. Under the plan, eligible employees may contribute up to 15% of their compensation into the plan. The Company, at the discretion of the Board of Directors, may contribute elective amounts to the plan, allocated in proportion to employee contributions to the plan, employee's salary, or both. No elective contributions have been made for the years ended December 31, 1993, 1994, and 1995.
10. SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
During 1994, the Company entered into capital lease obligations for equipment of $111,571.
Cash paid for interest during the years ended December 31, 1993, 1994, 1995 and the six months ended June 30, 1996 was $7,119, $67,785, $62,515 and $20,182 (unaudited), respectively.
On January 25, 1996 and February 29, 1996, notes payable of $312,500 and $100,000, respectively, were converted into 190,404 shares of Series B Preferred Stock and 30,465 shares of Common Stock, respectively.
11. SALES
The Company had a foreign customer, a distributor of the Company's products, who accounted for approximately 0%, 5%, and 18% of sales for the years ended December 31, 1993, 1994, and 1995, respectively.
MEDI-JECT CORPORATION
NOTES TO FINANCIAL STATEMENTS--(CONTINUED)
DECEMBER 31, 1995
(UNAUDITED AS TO JUNE 30, 1996 DATA)
Foreign sales by geography were as follows:
1993 1994 1995
-------- -------- --------
Europe............................................... $ 20,877 $ 14,960 $301,277
Other................................................ 127,629 146,649 319,379
-------- -------- --------
Total.............................................. $148,506 $161,609 $620,656
======== ======== ========
|
Other consists mainly of sales to Asia and South America.
12. SUBSEQUENT EVENTS
On January 25, 1996, the Company sold 761,615 shares of Series C Junior convertible preferred stock to Becton Dickinson and Company ("Becton Dickinson") for $3,000,000. In addition, the Company granted Becton Dickinson an option to purchase 380,808 shares of Series D Junior preferred stock with an exercise price of $4.60. These options expire on the tenth anniversary of the agreement or on the first anniversary of an IPO of the Company's stock if the per share price is less than $7.88 but more than $6.57, or on the IPO date if the per share price is greater than or equal to $7.88. Warrants for 1,904,037 shares of Series E Junior convertible preferred stock were also granted at an exercise price of $5.91 for initial consideration of $125,000. These warrants expire on the tenth anniversary of the agreement or on the seventh anniversary following an IPO if the per share price is greater than or equal to $7.88.
In connection with the above transaction the Company entered into a licensing agreement with Becton Dickinson, which provides Becton Dickinson exclusive worldwide rights to certain Medi-Ject technology. In exchange for granting this exclusive right, the Company will receive $100,000 per month for 24 months beginning January 1996 to develop the technology.
On January 25, 1996, the Company converted an unsecured note payable totaling $312,500 (of which $125,000 is outstanding at year end) into 190,404 shares of Series B convertible preferred stock. In addition, the holder of the debt purchased an additional 190,404 shares of Series B convertible preferred stock for proceeds of $500,000 in connection with a stock option exercise.
On January 31, 1996, the Company converted its Series A convertible preferred stock into common stock. Automatic conversion into common stock of the Series A was precipitated by the Company's net worth exceeding $1.0 million.
On February 29, 1996 an unsecured note payable to a shareholder totaling $100,000, which is outstanding at year end, was converted to 30,465 shares of common stock.
13. ITEMS SUBSEQUENT TO DATE OF AUDITORS' REPORT
(a) Reverse Stock Split
In connection with the Company's IPO, the Board of Directors and shareholders approved a 1-for-1.313 reverse stock split of its common stock, effective August 6, 1996. The effect of the stock split has been retroactively reflected in the accompanying financial statements and notes thereto.
MEDI-JECT CORPORATION
NOTES TO FINANCIAL STATEMENTS--(CONCLUDED)
DECEMBER 31, 1995
(UNAUDITED AS TO JUNE 30, 1996 DATA)
(b) Initial Public Offering (unaudited)
The Company is in the process of preparing for an IPO of up to 2,530,000 shares of its common stock. Simultaneously with the effective or closing date of this offering, all outstanding shares of preferred stock (consisting of 2,471,484 shares Series B, and 761,615 shares Series C) will be automatically converted into an aggregate of 3,371,848 shares of common stock. Included in the Series B conversion are 138,749 additional shares related to an antidilution adjustment (see Note 8). The conversion of the Company's preferred stock to common stock, as described herein, has been reflected in the pro forma shareholders' equity column of the balance sheet at June 30, 1996.
[ART WORK]
Medi-Jector(R) System Operation
[Drawing of Medi-Jector system held in
hands with arrow showing direction of
winding.]
NO DEALER, SALESPERSON OR ANY OTHER PERSON HAS BEEN AUTHORIZED TO GIVE ANY IN- FORMATION OR TO MAKE ANY REPRESENTATION IN CONNECTION WITH THIS OFFERING OTHER THAN THOSE CONTAINED IN THIS PROSPECTUS AND, IF GIVEN OR MADE, SUCH INFORMATION OR REPRESENTATION MUST NOT BE RELIED UPON AS HAVING BEEN AUTHORIZED BY THE COM- PANY OR ANY OF THE UNDERWRITERS. THIS PROSPECTUS DOES NOT CONSTITUTE AN OFFER TO SELL OR SOLICITATION OF ANY OFFER TO BUY BY ANYONE IN ANY JURISDICTION IN WHICH SUCH OFFER TO SELL OR SOLICITATION IS NOT AUTHORIZED, OR IN WHICH THE PERSON MAKING SUCH OFFER OR SOLICITATION IS NOT QUALIFIED TO DO SO, OR TO ANY PERSON TO WHOM IT IS UNLAWFUL TO MAKE SUCH OFFER OR SOLICITATION. NEITHER THE DELIVERY OF THIS PROSPECTUS NOR ANY SALE MADE HEREUNDER SHALL UNDER ANY CIRCUM- STANCES CREATE ANY IMPLICATION THAT THE INFORMATION CONTAINED HEREIN IS CORRECT AS OF ANY TIME SUBSEQUENT TO THE DATE HEREOF.
UNTIL , 1996 ALL DEALERS EFFECTING TRANSACTIONS IN THE REGISTERED SECURI- TIES, WHETHER OR NOT PARTICIPATING IN THIS DISTRIBUTION, MAY BE REQUIRED TO DE- LIVER A PROSPECTUS. THIS IS IN ADDITION TO THE OBLIGATION OF DEALERS TO DELIVER A PROSPECTUS WHEN ACTING AS UNDERWRITERS AND WITH RESPECT TO THEIR UNSOLD AL- LOTMENTS OR SUBSCRIPTIONS.
TABLE OF CONTENTS
PAGE
----
Prospectus Summary........................................................ 3
Risk Factors.............................................................. 6
Use of Proceeds........................................................... 13
Dividend Policy........................................................... 13
Capitalization............................................................ 14
Dilution.................................................................. 15
Selected Financial Data................................................... 16
Management's Discussion and Analysis of Financial Condition and Results of
Operations............................................................... 17
Business.................................................................. 21
Management................................................................ 34
Principal Shareholders.................................................... 39
Certain Transactions...................................................... 40
Description of Capital Stock.............................................. 42
Shares Eligible for Future Sale........................................... 44
Underwriting.............................................................. 46
Legal Matters............................................................. 47
Experts................................................................... 47
Additional Information.................................................... 47
Index to Financial Statements............................................. F-1
|
Medi-Ject [LOGO] Needle-Free Drug Delivery Systems
2,200,000 SHARES
COMMON STOCK
RODMAN & RENSHAW, INC.
R. J. STEICHEN & COMPANY
, 1996
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 13. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following fees and expenses will be paid by the Company in connection with the issuance and distribution of the securities registered hereby and do not include underwriting commissions and discounts. All such expenses, except for the SEC, NASD and Nasdaq fees, are estimated.
SEC registration fee............................................... $ 9,484
NASD filing fee.................................................... 3,030
Nasdaq Stock Market listing fee.................................... 35,639
Legal fees and expenses............................................ 125,000
Accounting fees and expenses....................................... 45,000
Blue Sky fees and expenses......................................... 15,000
Transfer Agent's and Registrar's fees.............................. 5,000
Printing and engraving expenses.................................... 70,000
Directors' and Officers' Insurance................................. 60,000
Miscellaneous...................................................... 31,847
--------
Total........................................................ $400,000
========
|
ITEM 14. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Section 302A.521 of the Minnesota Statutes provides that a corporation shall
indemnify any person made or threatened to be made a party to a proceeding by
reason of the former or present official capacity of such person against
judgments, penalties, fines (including, without limitation, excise taxes
assessed against such person with respect to any employee benefit plan),
settlements and reasonable expenses, including attorneys' fees and
disbursements, incurred by such person in connection with the proceeding, if,
with respect to the acts or omissions of such person complained of in the
proceeding, such person (1) has not been indemnified therefor by another
organization or employee benefit plan for the same judgments, penalties or
fines; (2) acted in good faith; (3) received no improper personal benefit and
Section 302A.255 (with respect to director conflicts of interest), if
applicable, has been satisfied; (4) in the case of a criminal proceeding, had
no reasonable cause to believe the conduct was unlawful; and (5) in the case
of acts or omissions in such person's official capacity for the corporation,
reasonably believed that the conduct was in the best interests of the
corporation, or in the case of acts or omissions in such person's official
capacity for other affiliated organizations, reasonably believed that the
conduct was not opposed to the best interests of the corporation. Section
302A.521 also requires payment by a corporation, upon written request, of
reasonable expenses in advance of final disposition of the proceeding in
certain instances. A decision as to required indemnification is made by a
disinterested majority of the Board of Directors present at a meeting at which
a disinterested quorum is present, or by a designated committee of the Board,
by special legal counsel, by the shareholders or by a court.
Provisions regarding indemnification of officers and directors of the Company to the extent permitted by Section 302A.521 of the Minnesota Statutes are contained in the Company's Second Amended and Restated Bylaws as they will be amended immediately upon closing of the offering (Exhibit 3.4 hereto), which are incorporated herein by reference.
Under Section 7 of the Underwriting Agreement to be filed as Exhibit 1.1 hereto, the Underwriters have agreed to indemnify, under certain conditions, the Company, its directors, certain of its officers and persons who control the Company within the meaning of the Securities Act of 1933, as amended, against certain liabilities.
ITEM 15. RECENT SALES OF UNREGISTERED SECURITIES
The information set forth below (i) gives effect to a 1-for-1.313 reverse split of the Company's capital stock effected on August 6, 1996, and (ii) does not give effect to the automatic conversion of all shares of Convertible Preferred Stock into shares of Common Stock prior to or upon the closing of the offering.
II-1
Since June 1, 1993, the Company has issued and sold the following securities that were not registered under the Securities Act of 1933, as amended (the "Securities Act"):
In June 1993, the Company issued warrants to purchase an aggregate of 53,315 shares of Common Stock at a price of $1.31 per share to three accredited investors including two existing securityholders, which warrants were issued in connection with the issuance of 9% Demand Promissory Notes in the aggregate original principal amount of $80,000.
In September 1993, the Company sold 380,808 shares of Series B Convertible Preferred Stock to Ethical Holdings plc, an accredited investor, at a per share price of $1.31. In connection with this sale, the Company also issued to Ethical Holdings plc an option to purchase 761,615 shares of Series B Convertible Preferred Stock at a price of $1.31 per share (subject to adjustment to $2.62 per share upon the occurrence of certain events).
In November 1993, the Company issued 381 shares of Common Stock to Lois Jovanovic Peterson, M.D., a former consultant to the Company, in consideration of a release and waiver of the Company under a consulting agreement.
In November 1993, the Company sold to Grayson & Associates a warrant to purchase 19,041 shares of Common Stock at a price of $1.31 per share, which warrant was sold in consideration of services rendered in connection with the private placement of shares of Series B Convertible Preferred Stock.
In November 1993, the Company sold 30,465 shares of Series A Convertible Preferred Stock to Cherry Tree Ventures II, L.P., an accredited investor, in consideration of conversion of 9% Demand Promissory Notes in the aggregate principal amount of $40,000.
In November 1993, the Company sold to Physical Sciences, Inc. a warrant to purchase 33,000 shares of Common Stock at a price of $0.79 per share, which warrant was issued in consideration of engineering services rendered.
In November and December 1993, the Company sold an aggregate of 380,808 shares of Series B Convertible Preferred Stock to six accredited investors at a price of $1.31 per share, including 38,081 shares sold in consideration of conversion of a 9% Demand Promissory Note in the principal amount of $50,000.
In February 1994, the Company sold an aggregate of 399,848 shares of Non- Voting Series B Convertible Preferred Stock to Enskilda Kapitalforvaltning, an accredited investor and existing shareholder, for $1.31 per share.
In February 1994, the Company sold to Nordberg Capital, Inc. a warrant to purchase 22,849 shares of Common Stock at a price of $1.31 per share, which warrant was sold in consideration of services rendered in connection with the private placement of shares of Series B Convertible Preferred Stock.
In February 1994, the Company sold to Martha Russell a warrant to purchase 1,905 shares of Common Stock at a price of $1.31 per share, which warrant was sold in consideration of grant-writing services rendered.
In June 1994, the Company sold 15,233 shares of Non-Voting Series B Convertible Preferred Stock to Joseph Card, an accredited investor, for $1.64 per share.
In August 1994, the Company sold to Physical Sciences, Inc. a warrant to purchase 20,314 shares of Common Stock at a price of $1.64 per share, which warrant was issued in consideration of engineering services rendered.
In August 1994, the Company sold a warrant to purchase 7,617 shares of Common Stock at a price of $3.28 per share to Fred L. Shapiro, M.D., a director of the Company, which warrant was issued in connection with a $100,000 loan from Dr. Shapiro to the Company.
II-2
In September 1994, the Company sold 152,323 shares of Series B Convertible Preferred Stock to Ethical Holdings plc, an accredited investor and existing shareholder, at a price of $1.31 per share upon a partial exercise of the stock option described above.
In November 1994, the Company sold 2,806 shares of Common Stock to Calvert Social Ventures Partners, L.P., an accredited investor, at a price of $0.081 per share upon the exercise of certain preemptive rights triggered by the issuance during 1994 of stock grants as compensation to employees of the Company. In connection with this sale, the Company also issued warrants to purchase (a) 1,842 shares of Common Stock at a price of $1.31 per share, which warrant was issued in consideration of $24.18, (b) 567 shares of Common stock at a price of $3.28 per share, which warrant was issued in consideration of $7.44, and (c) 1,512 shares of Common Stock at a price of $1.64 per share, which warrant was issued in consideration of $19.84.
From December 1994 through March 1995, the Company sold an aggregate of 304,665 shares of Series B Convertible Preferred Stock (Class II) to 23 accredited investors, including certain existing shareholders and a director, at a price of $3.28 per share. In connection with this offering, the Company issued warrants to purchase an aggregate of 3,048 shares of Common Stock at a price of $3.28 per share to Delphi Financial Corp. in consideration of its services as placement agent. (On March 24, 1995, such warrants were transferred to Robert Fullerton and Michael Trautner, principals of Delphi Financial Corp.)
In January 1995, the Company sold 762 shares of Common Stock to John L. Brooks, an employee, at a price of $1.31 per share upon exercise of an incentive stock option.
In February 1995, the Company sold 381 shares of Common Stock to Deborah A. Close, an employee, at a price of $1.31 per share upon exercise of an incentive stock option.
In February 1995, the Company sold 76,161 shares of Series B Convertible Preferred Stock to Ethical Holdings plc, an accredited investor and existing shareholder, at a price of $1.31 per share upon a partial exercise of the stock option described above.
In February 1995, the Company sold to Nordberg Capital, Inc. a warrant to purchase 4,570 shares of Common Stock at a price of $3.28 per share, which warrant was sold in consideration of $60 and services rendered in connection with the private placement of shares of Series B Convertible Preferred Stock (Class II).
In April 1995, the Company sold to Perry Silverman a warrant to purchase 229 shares of Common Stock at a price of $3.28 per share, which warrant was sold in consideration of $3.00 and services rendered in connection with the private placement of shares of Series B Convertible Preferred Stock (Class II).
From May 1995 through August 1995, the Company sold an aggregate of 152,335 shares of Series B Convertible Preferred Stock (Class III) to 16 accredited investors, including existing shareholders, at a price of $3.28 per share.
In September 1995, the Company sold an aggregate of 76,170 shares of Series B Convertible Preferred Stock (Class IV) to 11 accredited investors, at a price of $3.28 per share.
In September 1995, the Company sold 152,323 shares of Series B Convertible Preferred Stock to Ethical Holdings plc, an accredited investor and existing shareholder, at a price of $1.64 per share upon a partial exercise of the stock option described above.
In January 1996, the Company sold 761,615 shares of Series C Junior Convertible Preferred Stock to Becton Dickinson and Company, an accredited investor, at a price of $3.94 per share. In connection with this sale, the Company granted Becton Dickinson and Company an option to purchase 380,808 shares of Series D Junior Convertible Preferred Stock at a price of $4.60 per share and the Company sold Becton Dickinson and Company a warrant to purchase 1,904,037 shares of Series E Junior Convertible Preferred Stock at a price of $5.91 per share for a warrant purchase price of $125,000.
II-3
In February 1996, the Company sold 30,465 shares of Common Stock to Fred L. Shapiro, M.D., a director of the Company, in consideration of conversion of a loan in the principal amount of $100,000.
In February 1996, the Company sold 380,808 shares of Series B Convertible Preferred Stock to Ethical Holdings plc, an accredited investor and existing shareholder, 190,404 of which shares had a per share price of $1.64 and were issued in consideration of conversion of all principal amounts advanced under a $312,500 loan from Ethical to the Company and 190,404 of which shares were sold at a price of $2.62 per share; all such shares represented the final partial exercise of the stock option described above.
In May 1996, the Company sold to William Anderson, an employee, 381 shares of Common Stock at a price of $1.31 per share and 191 shares of Common Stock at a price of $3.28 per share upon exercise of incentive stock options.
The shares sold to employees upon the exercise of stock options were issued pursuant to Rule 701 under the Securities Act. The other sales of capital stock and of warrants and options to purchase capital stock have been made by the Company in reliance upon Section 4(2) of the Securities Act and Rule 506 thereunder. The Company has relied upon such exemption because it believed that each of the purchasers had such knowledge and experience in financial and business matters that it, he or she, as the case may be, was capable of evaluating the merits and risks of the prospective investment. With respect to all of such sales, the Company imprinted a legend on the certificates representing such securities restricting their transfer.
ITEM 16. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) Exhibits
NUMBER DESCRIPTION
------ -----------
*1.1 Underwriting Agreement.
*1.2 Form of Representative's Warrant
3.1(a) Amended and Restated Articles of Incorporation of the Company.
3.2(a) Amended Bylaws of the Company.
3.3 Second Amended and Restated Articles of Incorporation of the
Company (as proposed to be effective upon completion of the
offering).
3.4 Second Amended and Restated Bylaws of the Company (as proposed to
be effective upon completion of the offering).
4.1 Form of Certificate for Common Stock.
4.2(a) Stock Warrant, dated January 25, 1996, issued to Becton Dickinson
and Company.
4.3(a) Stock Option, dated January 25, 1996, issued to Becton Dickinson
and Company.
4.4(a) Warrant, dated March 24, 1995, issued to Robert Fullerton.
4.5(a) Warrant, dated March 24, 1995, issued to Michael Trautner.
4.6(a) Preferred Stock, Option and Warrant Purchase Agreement, dated
January 25, 1996, between the Company and Becton Dickinson and
Company (filed herewith as Exhibit 10.7).
5.1 Opinion of Dorsey & Whitney LLP.
10.1(a) Office/Warehouse/Showroom Lease, dated January 2, 1995, including
amendments thereto.
10.2(a) Promissory Note, dated August 29, 1994, issued to Fred Shapiro.
10.3(a) Security Agreement, dated September 30, 1994, by and between the
Company and Kelsey Lake Limited Partnership and Kerry Lake
Company, a Limited Partnership.
|
II-4
NUMBER DESCRIPTION
------ -----------
10.4(a) Promissory Note, dated September 30, 1994, issued to Kelsey Lake
Limited Partnership.
10.5(a) Promissory Note, dated September 30, 1994, issued to Kerry Lake
Company, a Limited Partnership.
10.6(a) Loan Agreement, dated as of December 22, 1995, by and between
Ethical Holdings, plc and the Company, including the related
Promissory Note, dated December 22, 1995, issued to Ethical
Holdings, plc.
10.7(a) Preferred Stock, Option and Warrant Purchase Agreement, dated
January 25, 1996, between the Company and Becton Dickinson and
Company.
10.8(a) Employment Agreement, dated as of January 3, 1995, between the
Company and Franklin Pass, M.D.
10.9(a) Employment Agreement, dated as of January 3, 1995, between the
Company and Mark Derus.
10.10(a) Employment Agreement, dated as of January 3, 1995, between the
Company and Todd Leonard.
10.11(a) Employment Agreement, dated as of January 3, 1995, between the
Company and Peter Sadowski.
10.12(a) 1993 Stock Option Plan.
10.13(a) Form of incentive stock option agreement for use with 1993 Stock
Option Plan.
10.14(a) Form of nonqualified stock option agreement for use with 1993
Stock Option Plan.
10.15 1996 Stock Option Plan, with form of stock option agreement.
10.16(a) Preferred Stock Purchase Agreement between Enskilda
Kapitalforvaltning and the Company, dated February 1, 1994,
relating to the Company's Non-Voting Series B Convertible
Preferred Stock.
10.17(a) Preferred Stock Purchase Agreement between Enskilda
Kapitalforvaltning and the Company, dated December 28, 1993,
relating to the Company's Series B Convertible Preferred Stock.
10.18(a) Preferred Stock Purchase Agreement between Calvert Social Venture
Partners, L.P. and the Company, dated November 29, 1993,
relating to the Company's Series B Convertible Preferred Stock.
10.19(a) Form of Preferred Stock Purchase Agreement relating to the
Company's Series B Convertible Preferred Stock.
+10.20 Development and License Agreement between Becton Dickinson and
Company and the Company, effective January 1, 1996.
11.1 Statement Regarding Computation of Earnings Per Share.
16.1(a) Letter Regarding Change in Certifying Accountant.
23.1 Consent of KPMG Peat Marwick LLP.
23.2 Consent of Dorsey & Whitney LLP (included in Exhibit 5.1).
24.1(a) Powers of Attorney (included on signature page).
27.1 Financial Data Schedule.
|
(a) Previously filed.
II-5
ITEM 17. UNDERTAKINGS
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 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.
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-6
SIGNATURES
PURSUANT TO THE REQUIREMENTS OF THE SECURITIES ACT OF 1933, THE REGISTRANT HAS DULY CAUSED THIS AMENDMENT NO. 1 TO THE REGISTRATION STATEMENT ON FORM S-1 TO BE SIGNED ON ITS BEHALF BY THE UNDERSIGNED, THEREUNTO DULY AUTHORIZED, IN THE CITY OF MINNEAPOLIS, STATE OF MINNESOTA, ON AUGUST 15, 1996.
Medi-Ject Corporation
/s/ Franklin Pass, M.D.
By: _________________________________
FRANKLIN PASS, M.D. PRESIDENT AND
CHIEF EXECUTIVE OFFICER
|
PURSUANT TO THE REQUIREMENTS OF THE SECURITIES ACT OF 1933, THIS AMENDMENT NO. 1 TO THE REGISTRATION STATEMENT ON FORM S-1 HAS BEEN SIGNED BY THE FOLLOWING PERSONS IN THE CAPACITIES INDICATED ON AUGUST 15, 1996.
SIGNATURE TITLE
President, Chief Executive Officer and
/s/ Franklin Pass, M.D. Director (principal executive
- ------------------------------------- officer)
FRANKLIN PASS, M.D.
Vice President of Finance, Chief
/s/ Mark Derus Financial Officer (principal
- ------------------------------------- financial and accounting officer)
MARK DERUS
* Director
- -------------------------------------
LOUIS COSENTINO
* Director
- -------------------------------------
KENNETH EVENSTAD
* Director
- -------------------------------------
GEOFFREY GUY
* Director
- -------------------------------------
NORMAN JACOBS
* Director
- -------------------------------------
FRED SHAPIRO, M.D.
* Director
- -------------------------------------
PETER SJOSTRAND
/s/ Franklin Pass, M.D.
*By: ________________________________
FRANKLIN PASS, M.D.,
ATTORNEY-IN-FACT
|
II-7
SECOND AMENDED AND RESTATED ARTICLES OF INCORPORATION
OF
MEDI-JECT CORPORATION
The following Second Amended and Restated Articles of Incorporation shall supersede and take the place of the existing Amended and Restated Articles of Incorporation and all amendments thereto:
The name of the corporation is Medi-Ject Corporation
The address of the registered office of the corporation is 1840 Berkshire Lane, Minneapolis, Minnesota 55441.
1. Authorized Shares.
The total number of shares of capital stock which the corporation is authorized to issue shall be 18,000,000 shares, consisting of 17,000,000 shares of common stock, par value $.01 per share ("Common Stock"), and 1,000,000 shares of preferred stock, par value $.01 per share ("Preferred Stock").
2. Common Stock.
All shares of Common Stock shall be voting shares and shall be entitled to one vote per share. Subject to any preferential rights of holders of Preferred Stock, holders of Common Stock shall be entitled to receive their pro rata share, based upon the number of shares of Common Stock held by them, of such dividends or other distributions as may be declared by the board of directors from time to time and of any distribution of the assets of the corporation upon its liquidation, dissolution or winding up, whether voluntary or involuntary.
3. Preferred Stock.
The board of directors of the corporation is hereby authorized to provide, by resolution or resolutions adopted by such board, for the issuance of Preferred Stock from time to time in one or more classes and/or series, to establish the designation and number of shares of each such class or series, and to fix the relative rights and preferences of the shares of each such class or series, all to the full extent permitted by the Minnesota Business Corporation Act, Section 302A.401, or
any successor provision. Without limiting the generality of the foregoing, the board of directors is authorized to provide that shares of a class or series of Preferred Stock:
(a) are entitled to cumulative, partially cumulative or noncumulative dividends or other distributions payable in cash, capital stock or indebtedness of the corporation or other property, at such times and in such amounts as are set forth in the board resolutions establishing such class or series or as are determined in a manner specified in such resolutions;
(b) are entitled to a preference with respect to payment of dividends over one or more other classes and/or series of capital stock of the corporation;
(c) are entitled to a preference with respect to any distribution of assets of the corporation upon its liquidation, dissolution or winding up over one or more other classes and/or series of capital stock of the corporation in such amount as is set forth in the board resolutions establishing such class or series or as is determined in a manner specified in such resolutions;
(d) are redeemable or exchangeable at the option of the corporation and/or on a mandatory basis for cash, capital stock or indebtedness of the corporation or other property, at such times or upon the occurrence of such events, and at such prices, as are set forth in the board resolutions establishing such class or series or as are determined in a manner specified in such resolutions;
(e) are entitled to the benefits of such sinking fund, if any, as is required to be established by the corporation for the redemption and/or purchase of such shares by the board resolutions establishing such class or series;
(f) are convertible at the option of the holders thereof into shares of any other class or series of capital stock of the corporation, at such times or upon the occurrence of such events, and upon such terms, as are set forth in the board resolutions establishing such class or series or as are determined in a manner specified in such resolutions;
(g) are exchangeable at the option of the holders thereof for cash, capital stock or indebtedness of the corporation or other property, at such times or upon the occurrence of such events, and at such prices, as are set forth in the board resolutions establishing such class or series or as are determined in a manner specified in such resolutions;
(h) are entitled to such voting rights, if any, as are specified in the board resolutions establishing such class or series (including, without limiting the generality of the foregoing, the right to elect one or more directors voting alone as a single class or series or together with one or more other classes and/or series of Preferred Stock, if so specified by such board resolutions) at all times or upon the occurrence of specified events; and
(i) are subject to restrictions on the issuance of additional shares of Preferred Stock of such class or series or of any other class or series, or on the reissuance of shares of Preferred Stock of such class or series or of any other class or series, or on increases or decreases in the number of authorized shares of Preferred Stock of such class or series or of any other class or series.
Without limiting the generality of the foregoing authorizations, any of the rights and preferences of a class or series of Preferred Stock may be made dependent upon facts ascertainable outside the board resolutions establishing such class or series, and may incorporate by reference some or all of the terms of any agreements, contracts or other arrangements entered into by the corporation in connection with the issuance of such class or series, all to the full extent permitted by the Minnesota Business Corporation Act. Unless otherwise specified in the board resolutions establishing a class or series of Preferred Stock, holders of a class or series of Preferred Stock shall not be entitled to cumulate their votes in any election of directors in which they are entitled to vote and shall not be entitled to any preemptive rights to acquire shares of any class or series of capital stock of the corporation.
There shall be no cumulative voting by the shareholders of the corporation.
The shareholders of the corporation shall not have any preemptive rights to subscribe for or acquire securities or rights to purchase securities of any class, kind or series of the corporation.
An action required or permitted to be taken at a meeting of the board of directors of the corporation may be taken by a written action signed, or counterparts of a written action signed in the aggregate, by all of the directors unless the action need not be approved by the shareholders of the corporation, in which case the
action may be taken by a written action signed, or counterparts of a written action signed in the aggregate, by the number of directors that would be required to take the same action at a meeting of the board of directors of the corporation at which all of the directors were present.
To the fullest extent permitted by the Minnesota Business Corporation Act as the same exists or may hereafter be amended, a director of this corporation shall not be liable to this corporation or its shareholders for monetary damages for breach of fiduciary duty as a director.
1. Removal. Any or all directors may be removed from office at any time, with or without cause, buy only by the affirmative vote of the holders of at least 70% of the voting power of all of the shares of this corporation entitled to vote in the election of directors; provided, however, that any director appointed by the board of directors to fill a vacancy may also be removed from office at any time, with or without cause, by the affirmative vote of a majority of the remaining directors if the shareholders have not elected such director in the interim between the time of appointment to fill such vacancy and the time of removal. In the event that the board of directors or any one or more of the directors are so removed, new directors may be appointed or elected at the same meeting at which the removal occurs.
2. Number. The number of directors of the corporation shall be fixed from time to time by either (i) the board of directors pursuant to a resolution adopted by a majority of the entire board of directors or (ii) the affirmative vote of the holders of at least 70% of the voting power of all shares of this corporation entitled to vote generally in the election of directors. No decrease in the number of directors shall shorten the term of any incumbent director.
3. Amendment. The affirmative vote of the holders of at least 70% of the voting power of all of the shares of this corporation entitled to vote generally in the election of directors shall be required to alter, amend, adopt any provision inconsistent with or repeal this Article 8 or alter, amend, adopt any provision inconsistent with or repeal any Bylaw of this corporation fixing a quorum for meetings of shareholders, prescribing procedures for removing directors of filling vacancies in the board of directors or fixing the number of directors or their classifications, qualifications or terms of office.
SECOND AMENDED AND RESTATED BYLAWS
OF
MEDI-JECT CORPORATION
ARTICLE I.
OFFICES, CORPORATE SEAL
Section 1.01. Registered Office. The registered office of the corporation in Minnesota shall be that set forth in the articles of incorporation or in the most recent amendment of the articles of incorporation or resolution of the directors filed with the secretary of state of Minnesota changing the registered office.
Section 1.02. Other Offices. The corporation may have such other offices, within or without the state of Minnesota, as the directors shall, from time to time, determine.
Section 1.03. Corporate Seal. The corporation shall have no seal.
ARTICLE II.
MEETINGS OF SHAREHOLDERS
Section 2.01. Place and Time of Meetings. Except as provided otherwise by the Minnesota Business Corporation Act, meetings of the shareholders may be held at any place, within or without the state of Minnesota, as may from time to time be designated by the directors.
Section 2.02. Regular Meetings.
(a) A regular meeting of the shareholders shall be held on such date as the board of directors shall by resolution establish.
(b) At a regular meeting, the shareholders, voting as provided in the articles of incorporation and these Bylaws, shall elect qualified successors for directors who serve for an indefinite term or whose terms have expired or are due to expire within six months after the date of the meeting and shall transact such other business as may properly come before them.
(c) To be properly brought before a regular meeting of shareholders, business must be either (1) specified in the notice of the meeting, (2) directed to be brought before the meeting by the board of directors or (3) proposed by a shareholder in the manner herein provided. For business to be properly brought before a regular meeting by a shareholder, the shareholder must give written notice to the Secretary of the corporation so as to be received at the principal executive offices of the
corporation not later than the close of business on the 15th day following the day on which the notice of the regular meeting was mailed to shareholders; provided, however, that such notice must be received no later than 48 hours prior to the regular meeting. Such notice shall set forth (1) a brief description of the business desired to be brought before the regular meeting and the reasons for conducting such business, (2) the name and record address of the shareholder proposing such business, (3) the class and number of shares of the corporation beneficially owned by the shareholder and (4) any material interest of the shareholder in such business.
Section 2.03. Special Meetings. Special meetings of the shareholders may be held at any time and for any purpose and may be called by the Chief Executive Officer, the Chief Financial Officer, two or more directors or by a shareholder or shareholders holding 10% or more of the voting power of all shares entitled to vote, except that a special meeting for the purpose of considering any action to directly or indirectly facilitate or affect a business combination, including any action to change or otherwise affect the composition of the board of directors for that purpose, must be called by 25% or more of the voting power of all shares entitled to vote. A shareholder or shareholders holding the requisite percentage of the voting power of all shares entitled to vote may demand a special meeting of the shareholders by written notice of demand given to the Chief Executive Officer or Chief Financial Officer of the corporation and containing the purposes of the meeting. Within 30 days after receipt of demand by one of those officers, the board of directors shall cause a special meeting of shareholders to be called and held on notice no later than 90 days after receipt of the demand, at the expense of the corporation. Special meetings shall be held on the date and at the time and place fixed by the Chief Executive Officer or the board of directors, except that a special meeting called by or at demand of a shareholder or shareholders shall be held in the county where the principal executive office is located. The business transacted at a special meeting shall be limited to the purposes as stated in the notice of the meeting.
Section 2.04. Quorum, Adjourned Meetings. The holders of a majority of the shares entitled to vote shall constitute a quorum for the transaction of business at any regular or special meeting. In case a quorum shall not be present at a meeting, the meeting may be adjourned from time to time without notice other than announcement at the time of adjournment of the date, time and place of the adjourned meeting. If a quorum is present, a meeting may be adjourned from time to time without notice other than announcement at the time of adjournment of the date, time and place of the adjourned meeting. At adjourned meetings at which a quorum is present, any business may be transacted which might have been transacted at the meeting as originally noticed. If a quorum is present when a meeting is convened, the shareholders present may continue to transact business until adjournment notwithstanding the withdrawal of enough shareholders originally present to leave less than a quorum.
Section 2.05. Voting. At each meeting of the shareholders, every shareholder having the right to vote shall be entitled to vote either in person or by proxy. Each shareholder, unless the articles of incorporation or statutes provide otherwise, shall have one vote for each share having voting power registered in such shareholder's name on the books of the corporation. Jointly owned shares may be voted by any joint owner unless the corporation receives written notice from any one of them denying the authority of that person to vote those shares. Upon the demand of any shareholder, the vote upon any question before the meeting shall be by ballot. All questions shall be decided by a majority vote of the number of shares entitled to vote and represented at the meeting at the time of the vote except if otherwise required by statute, the articles of incorporation, or these Bylaws.
Section 2.06. Record Date. The board of directors may fix a date, not exceeding 60 days preceding the date of any meeting of shareholders, as a record date for the determination of the shareholders entitled to notice of, and to vote at, such meeting, notwithstanding any transfer of shares on the books of the corporation after any record date so fixed. If the board of directors fails to fix a record date for determination of the shareholders entitled to notice of, and to vote at, any meeting of shareholders, the record date shall be the 20th day preceding the date of such meeting.
Section 2.07. Notice of Meetings. There shall be mailed to each shareholder, shown by the books of the corporation to be a holder of record of voting shares, at such shareholder's address as shown by the books of the corporation, a notice setting out the date, time and place of each regular meeting and each special meeting, except where the meeting is an adjourned meeting and the date, time and place of the meeting were announced at the time of adjournment, which notice shall be mailed at least fifteen days prior thereto. Every notice of any special meeting called pursuant to section 2.03 hereof shall state the purpose or purposes for which the meeting has been called, and the business transacted at all special meetings shall be confined to the purposes stated in the notice.
Section 2.08. Waiver of Notice. Notice of any regular or special meeting may be waived by any shareholder either before, at or after such meeting orally or in writing signed by such shareholder or a representative entitled to vote the shares of such shareholder. A shareholder, by the shareholder's attendance at any meeting of shareholders, shall be deemed to have waived notice of such meeting, except where the shareholder objects at the beginning of the meeting to the transaction of business because the meeting is not lawfully called or convened, or objects before a vote on an item of business because the item may not lawfully be considered at that meeting and does not participate in the consideration of the item at that meeting.
Section 2.09. Conduct of Meetings. The presiding officer at each meeting of shareholders shall conclusively determine the order of business, all matters of procedure and whether or not a proposal is proper business to be transacted at the meeting and has been properly brought before the meeting. Following completion of the business of the meeting as determined by the presiding officer, the presiding officer shall have the exclusive authority and power to adjourn the meeting.
Section 2.10. Nomination of Directors. Only persons nominated in accordance with the following procedures shall be eligible for election by shareholders as directors. Nominations of persons for election as directors may be made at a meeting of shareholders called for the purpose of electing directors (a) by or at the direction of the board of directors or (b) by any shareholder in the manner herein provided. For a nomination to be properly made by a shareholder, the shareholder must give written notice to the Secretary of the corporation so as to be received at the principal executive offices of the corporation not later than the close of business on the fifteenth day following the day on which the notice of the meeting of shareholders was mailed to shareholders. Such notice shall set forth (a) as to each person the shareholder proposes to nominate (1) the name, age, business address and residence address of the person, (2) the principal occupation or employment of the person, (3) the class and number of shares of the corporation's capital stock beneficially owned by the person and (4) any other information required to be disclosed in solicitations of proxies for election of directors pursuant to Regulation 14A under the Securities Exchange Act of 1934; and (b) as to the shareholder giving the notice (1) the name and record address of the shareholder and (2) the class and number of shares of the corporation beneficially owned by the shareholder.
ARTICLE III.
DIRECTORS
Section 3.01. General Powers. The business and affairs of the corporation shall be managed by or under the authority of the board of directors, except as otherwise permitted by statute.
Section 3.02. Number, Qualification and Term of Office. The number of members of the board of directors shall be seven as of the effective date of these Bylaws and, thereafter, shall be fixed from time to time by the board of directors or by the affirmative vote of the holders of not less than 70% of the outstanding shares of the capital stock of the corporation entitled to vote generally in the election of directors, voting together as a single class. The directors shall be divided into three classes, as nearly equal in number as reasonably possible, with the term of office of the first class to expire initially at the 1997 annual meeting of shareholders, the term of office of the second class to expire initially at the 1998 annual meeting of
shareholders and the term of office of the third class to expire initially at the 1999 annual meeting of shareholders. At each annual meeting of shareholders following such initial classification and election, directors elected to succeed those directors whose terms expire shall be elected for a term of office to expire at the third succeeding annual meeting of shareholders after their election. Directors need not be shareholders.
Section 3.03. Board Meetings. Meetings of the board of directors may be held from time to time at such time and place within or without the state of Minnesota as may be designated in the notice of such meeting.
Section 3.04. Calling Meetings; Notice. Meetings of the board of directors may be called by the Chairman of the Board and/or the Chief Executive Officer by giving at least five days' written notice or 48 hours' telephonic notice, or by any other director by giving at least five days' notice, of the date, time and place thereof to each director by mail, telephone, telegram or in person. If the day or date, time and place of a meeting of the board of directors has been announced at a previous meeting of the board, no notice is required. Notice of an adjourned meeting of the board of directors need not be given other than by announcement at the meeting at which adjournment is taken.
Section 3.05. Waiver of Notice. Notice of any meeting of the board of directors may be waived by any director either before, at, or after such meeting orally or in a writing signed by such director. A director, by the director's attendance at any meeting of the board of directors, shall be deemed to have waived notice of such meeting, except where the director objects at the beginning of the meeting to the transaction of business because the meeting is not lawfully called or convened and does not participate thereafter in the meeting.
Section 3.06. Quorum. A majority of the directors holding office immediately prior to a meeting of the board of directors shall constitute a quorum for the transaction of business at such meeting.
Section 3.07. Absent Directors. A director may give advance written consent or opposition to a proposal to be acted on at a meeting of the board of directors. If such director is not present at the meeting, consent or opposition to a proposal does not constitute presence for purposes of determining the existence of a quorum, but consent or opposition shall be counted as a vote in favor of or against the proposal and shall be entered in the minutes or other record of action at the meeting, if the proposal acted on at the meeting is substantially the same or has substantially the same effect as the proposal to which the director has consented or objected.
Section 3.08. Conference Communications. Any or all directors may participate in any meeting of the board of directors, or of any duly constituted committee thereof, by any means of communication through which the directors may simultaneously hear each other during such meeting. For the purposes of establishing a quorum and taking any action at the meeting, such directors participating pursuant to this section 3.08 shall be deemed present in person at the meeting; and the place of the meeting shall be the place of origination of the conference telephone conversation or other comparable communication technique.
Section 3.09. Vacancies; Newly Created Directorships. Vacancies on the board of directors of this corporation occurring by reason of death, resignation, removal or disqualification shall be filled for the unexpired term by a majority of the remaining directors of the board although less than a quorum; newly created directorships resulting from an increase in the authorized number of directors by action of the board of directors as permitted by section 3.02 may be filled by a majority vote of the directors serving at the time of such increase; and each director elected pursuant to this section 3.09 shall be a director until such director's successor is elected by the shareholders at their next regular or special meeting at which a vote is held with respect to the class for which such director has been chosen.
Section 3.10. Removal. Any or all of the directors may be removed from office at any time, with or without cause, by the affirmative vote of the shareholders holding at least 70% of the shares entitled to vote at an election of directors. A director named by the board of directors to fill a vacancy may be removed from office at any time, with or without cause, by the affirmative vote of the remaining directors if the shareholders have not elected directors in the interim between the time of the appointment to fill such vacancy and the time of the removal. In the event that the entire board or any one or more directors be so removed, new directors may be elected at the same meeting.
Section 3.11. Committees. A resolution approved by the affirmative vote of a majority of the board of directors may establish committees having the authority of the board in the management of the business of the corporation to the extent provided in the resolution. A committee shall consist of one or more persons, who need not be directors, appointed by affirmative vote of a majority of the directors present. Committees are subject to the direction and control of, and vacancies in the membership thereof shall be filled by, the board of directors. A majority of the members of the committee present at a meeting is a quorum for the transaction of business.
Section 3.12. Written Action. Any action which might be taken at a
meeting of the board of directors, or any duly constituted committee thereof,
may be taken without a meeting if done in writing and signed by all of the
directors or
committee members, unless the articles provide otherwise and the action need not be approved by the shareholders.
Section 3.13. Compensation. Directors who are not salaried officers of this corporation shall receive such fixed sum per meeting attended or such fixed annual sum as shall be determined, from time to time, by resolution of the board of directors. The board of directors may, by resolution, provide that all directors shall receive their expenses, if any, of attendance at meetings of the board of directors or any committee thereof. Nothing herein contained shall be construed to preclude any director from serving this corporation in any other capacity and receiving proper compensation therefor.
ARTICLE IV.
OFFICERS
Section 4.01. Number and Designation. The corporation shall have one or more natural persons exercising the functions of the offices of Chief Executive Officer and Chief Financial Officer. The board of directors shall annually elect or appoint such other officers or agents as it deems necessary for the operation and management of the corporation, with such powers, rights, duties, and responsibilities as may be determined by the board of directors, including, without limitation, Chairman of the Board, a President, one or more Vice Presidents, a Secretary, a Treasurer and such assistant officers or other officers as may from time to time be elected or appointed by the board of directors. Each such officer shall have the powers, rights, duties and responsibilities set forth in these Bylaws unless otherwise determined by the board of directors. Any number of offices may be held by the same person. Each officer shall serve in the position for which he or she was elected or appointed by the board of directors until the next occurring annual meeting of shareholders held pursuant to the provisions of Article II of these Bylaws.
Section 4.02. Chief Executive Officer. Unless provided otherwise by a resolution adopted by the board of directors, the Chief Executive Officer: (a) shall have general active management of the business of the corporation; (b) shall, when present, preside at all meetings of the shareholders; (c) shall see that all orders and resolutions of the board of directors are carried into effect; (d) shall sign and deliver in the name of the corporation any deeds, mortgages, bonds, contracts or other instruments pertaining to the business of the corporation, except in cases in which the authority to sign and deliver is required by law to be exercised by another person or is expressly delegated by these Bylaws or the board of directors to some other officer or agent of the corporation; and (e) shall perform such other duties as from time to time may be assigned by the board of directors.
Section 4.03. Chief Financial Officer. Unless provided otherwise by a resolution adopted by the board of directors, the Chief Financial Officer: (a) shall cause to be kept accurate financial records for the corporation; (b) shall cause to be deposited all monies, drafts and checks in the name of and to the credit of the corporation in such banks and depositories as the board of directors shall designate from time to time; (c) shall cause to be endorsed for deposit all notes, checks and drafts received by the corporation as ordered by the board of directors, making proper vouchers therefor; (d) shall cause to be disbursed corporate funds and shall cause to be issued checks and drafts in the name of the corporation, as ordered by the board of directors; (e) shall render to the Chief Executive Officer and the board of directors, whenever requested, an account of all the transactions as Chief Financial Officer and of the financial condition of the corporation; and (f) shall perform such other duties as may be prescribed by the board of directors or the Chief Executive Officer from time to time.
Section 4.04. Chairman of the Board. The Chairman of the Board, if one is elected, shall preside at all meetings of the directors and shall have such other duties as may be prescribed, from time to time, by the board of directors.
Section 4.05. President. Unless otherwise determined by the board of directors, the President shall be the Chief Executive Officer of the corporation. If an officer other than the President is designated Chief Executive Officer, the President shall perform such duties as may from time to time be assigned by the board of directors.
Section 4.06. Vice President. Each Vice President shall perform such duties as may be prescribed from time to time by these Bylaws or by the board of directors.
Section 4.07. Secretary. Unless provided otherwise by a resolution adopted by the board of directors, the Secretary: (a) shall attend all meetings of the shareholders and board of directors, and shall record all the proceedings of such meetings in the minute book of the corporation; (b) shall give proper notice of meetings of shareholders and board of directors and other notices required by law or these Bylaws; and (c) shall perform such other duties as from time to time may be assigned by the board of directors.
Section 4.08. Treasurer. Unless otherwise determined by the board of directors, the Treasurer shall be the Chief Financial Officer of the corporation. If an officer other than the Treasurer is designated Chief Financial Officer, the Treasurer shall perform such duties as may from time to time be assigned by the board of directors.
Section 4.09. Authority and Duties. 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 determined from time to time by the board of directors. Unless prohibited by a resolution of the board of directors, an officer elected or appointed by the board of directors may, without specific approval of the board of directors, delegate some or all of the duties and powers of an office to other persons.
Section 4.10. Removal and Vacancies. The board of directors may remove any officer from office at any time, with or without cause, by a resolution approved by the affirmative vote of a majority of the directors present. Such removal, however, shall be without prejudice to the contract rights of the person so removed. A vacancy in an office of the corporation by reason of death, resignation, removal, disqualification, or otherwise may, or in the case of a vacancy in the office of the Chief Executive Officer or Chief Financial Officer shall, be filled for the unexpired term by the board of directors.
Section 4.11. Compensation. The officers of this corporation shall receive such compensation for their services as may be determined by or in accordance with resolutions of the board of directors or by one or more committees to the extent so authorized from time to time by the board of directors.
ARTICLE V.
SHARES AND THEIR TRANSFER
Section 5.01 Certificates for Shares. All shares of the corporation shall be certificated shares. Each holder of shares of the corporation shall be entitled to a certificate for shares in such form as the board of directors may, from time to time, approve. Certificates shall be signed by an authorized representative of the corporation's transfer agent. A certificate representing shares of this corporation shall contain on its face the information required by the Minnesota Business Corporation Act, section 302A.417. A certificate representing shares issued by this corporation shall set forth upon the face or back of the certificate, or shall state that the corporation will furnish to any shareholder upon request and without charge, a full statement of the designations, preferences, limitations and relative rights of the shares of each class or series authorized to be issued, so far as they have been determined, and the authority of the board to determine relative rights and preferences of subsequent classes or series.
Section 5.02. Issuance of Shares. The board of directors is authorized to cause to be issued shares of the corporation up to the full amount authorized by the articles of incorporation in such amounts as may be determined by the board of directors and as may be permitted by law. Shares may be issued for any consideration, including, without limitation, in consideration of cash or other
property, tangible or intangible, received or to be received by the corporation under a written agreement or of services rendered or to be rendered to the corporation under a written agreement. At the time of approval of the issuance of shares, the board of directors shall state, by resolution, its determination of the fair value to the corporation in monetary terms of any consideration other than cash for which shares are to be issued.
Section 5.03. Transfer of Shares. Transfer of shares on the books of the corporation may be authorized only by the shareholder named in the certificate, or the shareholder's legal representative, or the shareholder's duly authorized attorney-in-fact, and upon surrender of the certificate or the certificates for such shares. The corporation may treat as the absolute owner of shares of the corporation, the person or persons in whose name shares are registered on the books of the corporation.
Section 5.04. Loss of Certificates. Except as otherwise provided by the Minnesota Business Corporation Act, section 302A.419, any shareholder claiming a certificate for shares to be lost, stolen, or destroyed shall make an affidavit of that fact in such form as the board of directors and/or the corporation's transfer agent shall require and shall, if the board of directors and/or the corporation's transfer agent so requires, give the corporation and/or the corporation's transfer agent a bond of indemnity in form, in an amount, and with one or more sureties satisfactory to the board of directors and/or the corporation's transfer agent, to indemnify the corporation and/or the corporation's transfer agent against any claim which may be made against it on account of the reissue of such certificate, whereupon a new certificate may be issued in the same tenor and for the same number of shares as the one alleged to have been lost, stolen or destroyed.
ARTICLE VI.
DISTRIBUTIONS, RECORD DATE
Section 6.01. Distributions. Subject to the provisions of the articles of incorporation, of these Bylaws, and of law, the board of directors may authorize and cause the corporation to make distributions whenever, and in such amounts or forms as, in its opinion, are deemed advisable.
Section 6.02. Record Date. Subject to any provisions of the articles of incorporation, the board of directors may fix a date not exceeding 120 days preceding the date fixed for the payment of any distribution as the record date for the determination of the shareholders entitled to receive payment of the distribution and, in such case, only shareholders of record on the date so fixed shall be entitled to receive payment of such distribution notwithstanding any transfer of shares on the books of the corporation after the record date.
ARTICLE VII.
BOOKS AND RECORDS, FISCAL YEAR
Section 7.01. Share Register. The board of directors of the corporation shall cause to be kept at its principal executive office, or at another place or places within the United States determined by the board:
(1) a share register not more than one year old, containing the names and addresses of the shareholders and the number and classes of shares held by each shareholder; and
(2) a record of the dates on which certificates or transaction statements representing shares were issued.
Section 7.02. Other Books and Records. The board of directors shall cause to be kept at its principal executive office, or, if its principal executive office is not in Minnesota, shall make available at its Minnesota registered office within ten days after receipt by an officer of the corporation of a written demand for them made by a shareholder or other person authorized by the Minnesota Business Corporation Act, section 302A.461, originals or copies of:
(1) records of all proceedings of shareholders for the last three years;
(2) records of all proceedings of the board for the last three years;
(3) its articles and all amendments currently in effect;
(4) its Bylaws and all amendments currently in effect;
(5) financial statements required by the Minnesota Business Corporation Act, section 302A.463 and the financial statements for the most recent interim period prepared in the course of the operation of the corporation for distribution to the shareholders or to a governmental agency as a matter of public record;
(6) reports made to shareholders generally within the last three years;
(7) a statement of the names and usual business addresses of its directors and principal officers; and
(8) any shareholder voting or control agreements of which the corporation is aware.
Section 7.03. Fiscal Year. The fiscal year of the corporation shall be determined by the board of directors.
ARTICLE VIII.
LOANS, GUARANTEES, SURETYSHIP
Section 8.01. The corporation may lend money to, guarantee an obligation of, become a surety for, or otherwise financially assist a person if the transaction, or a class of transactions to which the transaction belongs, is approved by the affirmative vote of a majority of the directors present, and:
(1) is in the usual and regular course of business of the corporation;
(2) is with, or for the benefit of, a related corporation, an organization in which the corporation has a financial interest, an organization with which the corporation has a business relationship, or an organization to which the corporation has the power to make donations;
(3) is with, or for the benefit of, an officer or other employee of the corporation or a subsidiary, including an officer or employee who is a director of the corporation or a subsidiary, and may reasonably be expected, in the judgment of the board, to benefit the corporation; or
(4) has been approved by (a) the holders of two-thirds of the voting power of the shares entitled to vote which are owned by persons other than the interested person or persons, or (b) the unanimous affirmative vote of the holders of all outstanding shares whether or not entitled to vote.
Such loan, guarantee, surety contract or other financial assistance may be with or without interest, and may be unsecured, or may be secured in the manner as a majority of the directors present approve, including, without limitation, a pledge of or other security interest in shares of the corporation. Nothing in this section shall be deemed to deny, limit or restrict the powers of guaranty, surety or warranty of the corporation at common law or under a statute of the state of Minnesota.
ARTICLE IX.
INDEMNIFICATION OF CERTAIN PERSONS
Section 9.01. The corporation shall indemnify all officers and directors of the corporation, for such expenses and liabilities, including the advancement of reimbursement of expenses, in such manner, under such circumstances and to such
extent as permitted by Minnesota Business Corporation Act section 302A.521, as now enacted or hereafter amended.
ARTICLE X.
AMENDMENTS
Section 10.01. Except as otherwise provided in this Article X, these Bylaws may be amended or altered by a vote of the majority of the whole board of directors at any meeting. Such authority of the board of directors is subject to the power of the shareholders, exercisable in the manner provided in the Minnesota Business Corporation Act, section 302A.181, subd. 3, to adopt, amend, or repeal Bylaws adopted, amended, or repealed by the board of directors. The board of directors shall not in any case adopt, amend or repeal a bylaw fixing a quorum for meetings of shareholders, prescribing procedures for removing directors or filling vacancies in the board of directors, or fixing the number of directors or their classifications, qualifications or terms of office, but the board of directors may adopt or amend a bylaw to increase the number of directors. Notwithstanding anything contained in these Bylaws to the contrary, the affirmative vote of the holders of at least 70% of the voting power of all of the shares of the corporation entitled to vote generally in the election of directors shall be required to alter, amend, adopt any provision inconsistent with or repeal any bylaw of this corporation fixing a quorum for meetings of shareholders, prescribing procedures for removing directors or filling vacancies in the board of directors, or fixing the number of directors or their classifications, qualifications or terms of office.
ARTICLE XI.
SECURITIES OF OTHER CORPORATIONS
Section 11.01. Voting Securities Held by the Corporation. Unless otherwise ordered by the board of directors, the Chief Executive Officer shall have full power and authority on behalf of the corporation (a) to attend any meeting of security holders of other corporations in which the corporation may hold securities and to vote such securities on behalf of this corporation; (b) to execute any proxy for such meeting on behalf of the corporation; or (c) to execute a written action in lieu of a meeting of such other corporation on behalf of this corporation. At such meeting, the Chief Executive Officer shall possess and may exercise any and all rights and powers incident to the ownership of such securities that the corporation possesses. The board of directors may, from time to time, grant such power and authority to one or more other persons and may remove such power and authority from the Chief Executive Officer or any other person or persons.
Section 11.02. Purchase and Sale of Securities. Unless otherwise ordered by the board of directors, the Chief Executive Officer shall have full power and authority on behalf of the corporation to purchase, sell, transfer or encumber any and all securities of any other corporation owned by the corporation, and may execute and deliver such documents as may be necessary to effectuate such purchase, sale, transfer or encumbrance. The board of directors may, from time to time, confer like powers upon any other person or persons.
Effective Date of Bylaws: July 25, 1996
Exhibit 4.1
Form of Common Stock Certificate
INCORPORATED UNDER THE LAWS OF THE STATE OF MINNESOTA
NUMBER SHARES
MEDI-JECT CORPORATION
This Certifies that ________________________ is the owner and registered holder of ___________________ Shares of fully paid and nonassessable shares of Common Stock, $.01 par value, of Medi-Ject Corporation
transferable only on the books of the corporation by the holder hereof in person or by duly authorized attorney upon surrender of this certificate properly endorsed.
In witness whereof, the said corporation has caused this certificate to be signed by its duly authorized officers and to be sealed with the seal of the corporation this ___day of _____________, 19__.
The issuer of the securities represented by this certificate will furnish to any shareholder upon request and without charge, a full statement of the designations, preferences, limitations and relative rights of the shares of each class or series authorized to be issued by such issuer, so far as they have been determined, and the authority of the board of directors of such issuer to determine the relative rights and preferences of subsequent classes or series.
For Value Received ___________________ hereby sell, assign and transfer unto _____________________________________________________ Shares represented by the within Certificate, and do hereby irrevocably constitute and appoint
____________________________________________________Attorney to transfer the said shares on the Books of the within named Corporation with full power of substitution in the premises.
Dated __________________, 19___
IN PRESENCE OF ____________________________________________
NOTICE: THE SIGNATURE TO THIS ASSIGNMENT MUST CORRESPOND WITH THE NAME AS WRITTEN UPON THE FACE OF THIS CERTIFICATE IN EVERY PARTICULAR, WITHOUT ALTERNATION OR ENLARGEMENT OR ANY CHANGE WHATEVER.
[Dorsey & Whitney LLP Letterhead]
Medi-Ject Corporation
1840 Berkshire Lane
Minneapolis, Minnesota 55441
Re: Registration Statement on Form S-1
Ladies and Gentlemen:
We have acted as counsel to Medi-Ject Corporation, a Minnesota corporation (the "Company"), in connection with a Registration Statement on Form S-1 (the "Registration Statement") relating to the sale by the Company of warrants (the "Representatives' Warrants") to purchase 220,000 shares of the Company's common stock, $.01 par value (the "Common Stock"), to be issued to the representatives of the several underwriters and up to 2,750,000 shares (the "Shares") of Common Stock (including 330,000 Shares to be subject to the Underwriter's over-allotment option and 220,000 Shares to be issued upon exercise of the Representatives' Warrants).
We have examined such documents and have reviewed such questions of law as we have considered necessary and appropriate for the purposes of our opinions set forth below. In rendering our opinions set forth below, we have assumed the authenticity of all documents submitted to us as originals, the genuineness of all signatures and the conformity to authentic originals of all documents submitted to us as copies. We have also assumed the legal capacity for all purposes relevant hereto of all natural persons and, with respect to all parties to agreements or instruments relevant hereto other than the Company, that such parties had the requisite power and authority (corporate or otherwise) to execute, deliver and perform such agreements or instruments, that such agreements or instruments have been duly authorized by all requisite action (corporate or otherwise), executed and delivered by such parties and that such agreements or instruments are the valid, binding and enforceable obligations of such parties. As to questions of fact material to our opinions, we have relied upon certificates of officers of the Company and of public officials. We also have assumed that the Shares will be issued and sold as described in the Registration Statement.
Medi-Ject Corporation
August 12, 1996
Based on the foregoing, we are of the opinion that the Shares to be sold by the Company pursuant to the Registration Statement and the Representatives' Warrants have been duly authorized by all requisite corporate action and, upon issuance, delivery and payment therefor as described in the Registration Statement or in accordance with the terms of the Representatives' Warrants, as appropriate, will be validly issued, fully paid and nonassessable.
We hereby consent to the filing of this opinion as an exhibit to the Registration Statement, and to the reference to our firm under the heading "Legal Matters" in the Prospectus constituting part of the Registration Statement.
Dated: August 12, 1996
Very truly yours,
/s/ Dorsey & Whitney LLP
JAH
|
MEDI-JECT CORPORATION
1996 INCENTIVE AND STOCK OPTION PLAN
SECTION 1. PURPOSE.
The purpose of this 1996 Incentive and Stock Option Plan (the "Plan") is to promote the interests of Medi-Ject Corporation (the "Company") and its shareholders by aiding the Company in attracting and retaining employees and directors capable of contributing to the growth and success of, and providing strategic direction to, the Company, and by offering such employees and directors an opportunity to acquire a proprietary interest in the Company, thereby providing them with incentives to put forth maximum efforts for the success of the Company's business and aligning the interests of such employees and directors with those of the Company's shareholders.
SECTION 2. DEFINITIONS.
As used in the Plan, the following terms shall have the meanings set forth below:
(a) "Affiliate" shall mean (i) any entity that, directly or indirectly through one or more intermediaries, is controlled by the Company and (ii) any entity in which the Company has a significant equity interest, in each case as determined by the Board of Directors.
(b) "Award" shall mean any Option granted under the Plan.
(c) "Award Agreement" shall mean any written agreement, contract or other instrument or document evidencing any Award granted under the Plan.
(d) "Code" shall mean the Internal Revenue Code of 1986, as amended from time to time, and any regulations promulgated thereunder.
(e) "Committee" shall mean a committee of the Board of Directors of the Company to whom the powers and duties of such Board of Directors under the Plan may be delegated pursuant to Section 3(b) hereof, which shall consist of members appointed from time to time by the Board of Directors and shall be composed solely of two or more directors, each of whom is an "outside director" within the meaning of Section 162(m) of the Code to the extent required by such Section.
(f) "Company" shall mean Medi-Ject Corporation, a Minnesota corporation, and any successor corporation.
(g) "Eligible Person" shall mean any employee, officer, director, consultant or independent contractor providing services to the Company or any Affiliate.
(h) "Exchange Act" shall mean the Securities and Exchange Act of 1934, as amended.
(i) "Fair Market Value" shall mean, with respect to any property (including, without limitation, any Shares or other securities), the fair market value of such property determined by such methods or procedures as the Board of Directors shall establish in good faith from time to time. Where there is a public market for the Shares, the fair market value per Share on a given date shall be the closing price of a Share in the over-the-counter market on such date, as reported in The Wall Street Journal (or, if not so reported, as otherwise reported by The Nasdaq Stock Market ("Nasdaq")) or, in the event the Shares are traded on the Nasdaq National Market ("NMS") or listed on a stock exchange, the fair market value per Share shall be the closing price on such system or exchange on such date, as reported in The Wall Street Journal; if such market or exchange is not open for trading on such date, the Fair Market Value shall be determined as of the day closest to such date when such market or exchange is open for trading.
(j) "Incentive Stock Option" shall mean an option granted under Section 6(a) of the Plan that is intended to meet the requirements of Section 422 of the Code or any successor provision.
(k) "Non-Qualified Stock Option" shall mean an option granted under
Section 6(a) of the Plan that is not intended to be an Incentive Stock Option.
(l) "Option" shall mean an Incentive Stock Option or a Non-Qualified Stock Option.
(m) "Participant" shall mean an Eligible Person whom the Board of Directors designates to receive an Award under the Plan.
(n) "Person" shall mean any individual, corporation, partnership, association or trust.
(o) "Rule 16b-3" shall mean Rule 16b-3 promulgated by the Securities and Exchange Commission under the Exchange Act or any successor rule or regulation.
(p) "Shares" shall mean shares of Common Stock, $.01 par value, of the Company or such other securities or property as may become subject to Awards pursuant to an adjustment made under Section 4(c) of the Plan.
SECTION 3. ADMINISTRATION.
(a) Administration by the Board of Directors. The Plan shall be
administered by the Board of Directors of the Company, with or without the
advice of a committee. Subject to the express provisions of the Plan and to
applicable law, the Board of Directors shall have full power and authority to:
(i) designate Participants; (ii) determine the type or types of Awards to be
granted to each Participant under the Plan; (iii) determine the number of Shares
to be covered by each Award; (iv) determine the terms and conditions of any
Award or Award Agreement; (v) amend the terms and conditions of any Award or
Award Agreement and accelerate the exercisability of Options; (vi) interpret and
administer the Plan and any instrument or agreement relating to, or Award made
under, the Plan; (vii) establish, amend, suspend or waive such rules and
regulations and appoint such agents as it shall deem appropriate for the proper
administration of the Plan; and (viii) make any other determination and take any
other action that the Board of Directors deems necessary or desirable for the
administration of the Plan. Unless otherwise expressly provided in the Plan, all
designations, determinations, interpretations and other decisions under or with
respect to the Plan or any Award shall be within the sole discretion of the
Board of Directors, may be made at any time and shall be final, conclusive and
binding upon any Participant, any holder or beneficiary of any Award and any
employee of the Company or any Affiliate.
(b) Delegation to Committee. Notwithstanding anything to the contrary contained herein, the Board of Directors may, at any time and from time to time, delegate its powers and duties hereunder to a Committee solely for purposes of complying with Section 162(m) of the Code.
(c) References to Board of Directors. Unless stated to the contrary, as used herein, references to the Board of Directors shall mean the Committee to whom the Board of Directors has delegated its powers and duties in the event such powers and duties have been so delegated.
SECTION 4. SHARES AVAILABLE FOR AWARDS.
(a) Shares Available. Subject to adjustment as provided in Section 4(c), the aggregate number of Shares which may be issued under all Awards under the Plan shall be 500,000. Shares to be issued under the Plan shall be authorized but previously unissued Shares. If any Shares covered by an Award or to which an Award relates are not purchased or are forfeited, or if an Award otherwise terminates without delivery of any Shares, then the number of Shares counted against the aggregate number of Shares available under the Plan with respect to such Award, to the extent of any such forfeiture or termination, shall again be available for granting Awards under the Plan.
(b) Accounting for Awards. For purposes of this Section 4, if an Award entitles the holder thereof to purchase Shares, the number of Shares covered by such Award shall be counted on the date of grant of such Award against the aggregate number of Shares available for granting Awards under the Plan.
(c) Adjustments. In the event that the Board of Directors shall determine that any dividend or other distribution (whether in the form of cash, Shares, other securities or other property), recapitalization, stock split, reverse stock split, reorganization, merger, consolidation, split-up, spin-off, combination, repurchase or exchange of Shares or other securities of the Company, issuance of warrants or other rights to purchase Shares or other securities of the Company or other similar corporate transaction or event affects the Shares such that an adjustment is determined by the Board of Directors to be appropriate in order to prevent dilution or enlargement of the benefits or potential benefits intended to be made available under the Plan, then the Board of Directors shall, in such manner as it may deem equitable, adjust any or all of (i) the number and type of Shares (or other securities or other property) which thereafter may be made the subject of Awards, (ii) the number and type of Shares (or other securities or other property) subject to outstanding Awards and (iii) the purchase or exercise price with respect to any Award; provided, however, that the number of Shares covered by any Award or to which such Award relates shall always be a whole number.
SECTION 5. ELIGIBILITY.
Any Eligible Person, including any Eligible Person who is an officer or director of the Company or any Affiliate, shall be eligible to be designated a Participant. In determining which Eligible Persons shall receive an Award and the terms of any Award, the Board of Directors may take into account the nature of the services rendered by the respective Eligible Persons, their present and potential contributions to the success of the Company or such other factors as the Board of Directors, in its discretion, shall deem relevant. Notwithstanding the foregoing, an Incentive Stock Option may only be granted to full or part- time employees (which term as used herein includes, without limitation, officers and directors who are also employees), and an Incentive Stock Option shall not be granted to an employee of an Affiliate unless such Affiliate is also a "subsidiary corporation" of the Company within the meaning of Section 424(f) of the Code or any successor provision.
SECTION 6. AWARDS.
(a) Options. The Board of Directors is hereby authorized to grant Options to Participants with the following terms and conditions and with such additional terms and conditions not inconsistent with the provisions of the Plan as the Board of Directors shall determine:
(i) Exercise Price. The purchase price per Share purchasable under an Option shall be determined by the Board of Directors; provided, however, that the purchase price per Share purchasable under an Incentive Stock Option shall not be less than 100% of the Fair Market Value of a Share on the date of grant of such Option.
(ii) Option Term. The term of each Option shall be fixed by the Board of Directors; provided, however, that the term of an Incentive Stock Option may not extend more than ten years from the date of grant of such Incentive Stock Option.
(iii) Time and Method of Exercise. The Board of Directors shall determine the time or times at which an Option may be exercised in whole or in part and the method or methods by which, and the form or forms (including, without limitation, cash, previously owned Shares, Shares issuable upon exercise of the Award or any combination thereof, having a Fair Market Value on the exercise date equal to the relevant exercise price) in which, payment of the exercise price with respect thereto may be made or deemed to have been made.
(iv) Certain Options to be Treated as Non-Qualified Stock Options. If the aggregate Fair Market Value of all Shares subject to Incentive Stock Options granted to a Participant under all plans of the Company and its parent and subsidiary corporations (as described in Section 422(d) of the Code) that are exercisable for the first time during any calendar year exceeds $100,000 at the time an Option is granted to such Participant, then such Option shall be treated as an Option that does not qualify as an Incentive Stock Option.
(v) Ten Percent Shareholder Rule. Notwithstanding any other provision in the Plan, if at the time an Option is otherwise to be granted pursuant to the Plan to a Participant who owns, directly or indirectly (within the meaning of Section 424(d) of the Code), Common Stock of the Company possessing more than 10% of the total combined voting power of all classes of stock of the Company or its parent or any subsidiary, then any Incentive Stock Option to be granted to such Participant pursuant to the Plan shall satisfy the requirements of Section 422(c)(5) of the Code, and the exercise price of such Option shall be not less than 110% of the Fair Market Value of the Shares covered, and such Option by its terms shall not be exercisable after the expiration of five years from the date such Option is granted.
(vi) Option Limitations Under the Plan. No Eligible Person who is an employee of the Company at the time of grant may be granted any Option, the value of which is based solely on an increase in the value of the Shares after the date of grant of such Option, covering more than 500,000 Shares in the aggregate in any calendar year. The foregoing annual limitation specifically
includes the grant of any Option representing "qualified performance-based compensation" within the meaning of Section 162(m) of the Code to the extent required by such Section.
(b) General.
(i) No Cash Consideration for Awards. Awards shall be granted for no cash consideration or for such minimal cash consideration as may be required by applicable law.
(ii) Grant of Additional Awards. An Eligible Person who has been granted an Award under this Plan may be granted additional Awards under the Plan if the Board of Directors shall so determine.
(iii) Limits on Transfer of Awards. No Award and no right under any such Award shall be transferable by a Participant otherwise than by will or by the laws of descent and distribution. No Award or right under any such Award may be pledged, alienated, attached or otherwise encumbered, and any purported pledge, alienation, attachment or encumbrance thereof shall be void and unenforceable against the Company or any Affiliate.
(iv) Term of Awards. The term of each Award shall be for such period as may be determined by the Board of Directors and the Board of Directors shall be under no duty to provide terms of like duration for Awards granted under the Plan.
(v) Restrictions; Securities Exchange Listing. All certificates for Shares or other securities delivered under the Plan pursuant to any Award or the exercise thereof shall be subject to such stop transfer orders and other restrictions as the Board of Directors may deem advisable under the Plan or the rules, regulations and other requirements of the Securities and Exchange Commission and any applicable federal or state securities laws, and the Board of Directors may cause a legend or legends to be placed on any such certificates to make appropriate reference to such restrictions. If the Shares or other securities are quoted on Nasdaq, traded on NMS or listed on a stock exchange, the Company shall not be required to deliver any Shares or other securities covered by an Award unless and until such Shares or other securities have been admitted for quotation or trading on NMS or such stock exchange.
SECTION 7. INCOME TAX WITHHOLDING.
In order to comply with all applicable federal or state income tax laws or regulations, the Company may take such action as it deems appropriate to ensure that all applicable federal or state payroll, withholding, income or other taxes, all of which are and shall remain the sole and absolute responsibility of a Participant, are
withheld or collected from such Participant. In order to assist a Participant in paying all or a portion of the federal and state taxes to be withheld or collected upon exercise of an Award, the Board of Directors, in its discretion and subject to such additional terms and conditions as it may adopt, may permit the Participant to satisfy such tax obligation by (i) electing to have the Company withhold a portion of the Shares otherwise to be delivered upon exercise of such Award with a Fair Market Value equal to the amount of such taxes or (ii) delivering to the Company Shares other than Shares issuable upon exercise of such Award with a Fair Market Value equal to the amount of such taxes. The election, if any, must be made on or before the date that the amount of tax to be withheld is determined.
SECTION 8. GENERAL PROVISIONS.
(a) No Rights to Awards. No Eligible Person, Participant or other Person shall have any claim to be granted any Award under the Plan, and there is no obligation for uniformity of treatment of Eligible Persons, Participants or holders or beneficiaries of Awards under the Plan. The terms and conditions of Awards need not be the same with respect to any Participant or with respect to different Participants.
(b) Award Agreements. No Participant will have rights under an Award granted to such Participant unless and until an Award Agreement shall have been duly executed on behalf of the Company and, if requested by the Company, signed by the Participant.
(c) No Limit on Other Compensation Arrangements. Nothing contained in the Plan shall prevent the Company or any Affiliate from adopting or continuing in effect other or additional compensation arrangements, and such arrangements may be either generally applicable or applicable only in specific cases.
(d) No Right to Employment. The grant of an Award shall not be construed as giving a Participant the right to be retained as an employee or director of the Company or any Affiliate, nor will it affect in any way the right of the Company or an Affiliate to terminate such employment or directorship at any time, with or without cause. In addition, the Company or an Affiliate may at any time dismiss a Participant from employment or directorship free from any liability or any claim under the Plan, except as otherwise expressly provided in the Plan or in any Award Agreement.
(e) Governing Law. The validity, construction and effect of the Plan or of any Award, and any rules and regulations relating to the Plan or any Award, shall be determined in accordance with the laws of the State of Minnesota.
(f) Severability. If any provision of the Plan or any Award is or becomes or is deemed to be invalid, illegal or unenforceable in any jurisdiction or would
disqualify the Plan or any Award under any law deemed applicable by the Board of Directors, such provision shall be construed or deemed amended to conform to applicable law, or if it cannot be so construed or deemed amended without, in the determination of the Board of Directors, materially altering the purpose or intent of the Plan or the Award, such provision shall be stricken as to such jurisdiction or Award, and the remainder of the Plan or any such Award shall remain in full force and effect.
(g) No Trust or Fund Created. Neither the Plan nor any Award shall create or be construed to create a trust or separate fund of any kind or a fiduciary relationship between the Company or any Affiliate and a Participant or any other Person. To the extent that any Person acquires a right to receive payments from the Company or any Affiliate pursuant to an Award, such right shall be no greater than the right of any unsecured general creditor of the Company or any Affiliate.
(h) No Fractional Shares. No fractional Shares shall be issued or delivered pursuant to the Plan or any Award, and the Board of Directors shall determine whether cash shall be paid in lieu of any fractional Shares or whether such fractional Shares or any rights thereto shall be canceled, terminated or otherwise eliminated.
(i) Headings. Headings are given to the Sections and subsections of the Plan solely as a convenience to facilitate reference. Such headings shall not be deemed in any way material or relevant to the construction or interpretation of the Plan or any provision thereof.
(j) Other Benefits. No compensation or benefit awarded to or realized by any Participant under the Plan shall be included for the purpose of computing such Participant's compensation under any compensation-based retirement, disability, or similar plan of the Company unless required by law or otherwise provided by such other plan.
SECTION 9. AMENDMENT AND TERMINATION; ADJUSTMENTS.
Except to the extent prohibited by applicable law and unless otherwise expressly provided in an Award Agreement or in the Plan:
(a) Amendments to the Plan. The Board of Directors of the Company may amend, alter, suspend, discontinue or terminate the Plan; provided, however, that, notwithstanding any other provision of the Plan or any Award Agreement, without the approval of the shareholders of the Company, no such amendment, alteration, suspension, discontinuation or termination shall be made that, absent such approval, would:
(i) violate the rules or regulations of Nasdaq, NMS or any stock exchange that are applicable to the Company; or
(ii) cause the Company to be unable, under the Code, to grant Incentive Stock Options under the Plan.
(b) Amendments to Awards. The Board of Directors may waive any conditions or rights of the Company under any outstanding Award, prospectively or retroactively. The Board of Directors may not amend, alter, suspend, discontinue or terminate any outstanding Award, prospectively or retroactively, without the consent of the Participant or holder or beneficiary thereof, except as otherwise provided herein or in the Award Agreement.
(c) Correction of Defects, Omissions and Inconsistencies. The Board of Directors may correct any defect, supply any omission or reconcile any inconsistency in the Plan or any Award in the manner and to the extent it shall deem desirable to carry the Plan into effect.
SECTION 10. EFFECTIVE DATE; TERM.
(a) Effective Date. The Plan shall be effective as of July 10, 1996 (the "Effective Date"); provided, however, that if the Company's shareholders do not approve the Plan at the next meeting of Shareholders, the Plan shall be null and void and all Awards granted prior to the date of such Special Meeting shall be of no force or effect.
(b) Term. Awards shall be granted under the Plan only during a 10-year period beginning on the Effective Date. Unless otherwise expressly provided in the Plan or in an applicable Award Agreement, however, any Award theretofore granted may extend beyond the end of such 10-year period, and the authority of the Board of Directors provided for hereunder, shall extend beyond the termination of the Plan.
FORM OF
MEDI-JECT CORPORATION
EMPLOYEE INCENTIVE STOCK OPTION AGREEMENT
This Employee Incentive Stock Option Agreement (the "Agreement") is made and entered into effective as of _____________, _____, by and between Medi-Ject Corporation, a Minnesota corporation (the "Company"), and _____________________ ("Optionee").
WHEREAS, the Company has adopted the Medi-Ject Corporation 1996 Stock Option Plan (the "Plan"), which permits the issuance of stock options for the purchase of shares of the Common Stock, $.01 par value, of the Company (the "Common Stock"), and the Company wishes to grant this stock option to Optionee pursuant to the Plan. (Capitalized terms used herein but not otherwise defined herein have the meanings assigned to them in the Plan.)
NOW, THEREFORE, in consideration of the premises and the mutual covenants contained in this Agreement, and for other good and valuable consideration, the adequacy and receipt of which are hereby acknowledged, the Company and Optionee do hereby agree as follows:
SECTION 1. GRANT OF OPTION.
The Company hereby grants Optionee, as of the date of this Agreement, the
right and option (hereinafter called the "Option") to purchase all or any part
of an aggregate of ________ shares of the Common Stock at the price of $_____
per share and subject to all of the terms and conditions of this Agreement and
of the Plan. It is understood and agreed that such price is not less than 100%
of the Fair Market Value of each such share on the date of this Agreement. The
Option is intended to be an Incentive Stock Option governed by the provisions of
Section 422 of the Internal Revenue Code of 1986, as amended (the "Code").
SECTION 2. DURATION AND EXERCISABILITY.
(a) The Option may not be exercised by Optionee except as set forth below, and the Option shall in all events terminate ten years from the date hereof. Subject to the other terms and conditions set forth herein, the Option shall vest and may be exercised by Optionee in cumulative installments as follows:
Cumulative percentage
On or after each of of shares as to which the
the following dates Option is exercisable
------------------- -------------------------
|
(b) During the lifetime of Optionee, the Option shall be exercisable only by Optionee. The Option shall not be assignable or transferable by Optionee, otherwise than by will or the laws of descent or distribution or pursuant to a qualified domestic relations order as defined by the Code or Title 1 of the Employee Retirement Income Security Act of 1974, as amended, or the rules thereunder.
(c) Optionee understands that to the extent that the aggregate fair market value (determined as of the date hereof) of the Common Stock with respect to which all Incentive Stock Options (within the meaning of Section 422 of the Code) are exercisable for the first time by Optionee during any calendar year exceeds $100,000, such options shall be treated as options that do not qualify as Incentive Stock Options.
SECTION 3. EFFECT OF TERMINATION OF EMPLOYMENT.
(a) In the event that Optionee shall cease to be employed by the Company or its Affiliates for any reason other than Optionee's gross and willful misconduct or Optionee's death or disability, Optionee shall have the right to exercise the Option at any time within three months after such termination of employment to the extent of the full number of shares Optionee was entitled to purchase under the Option on the date of termination, subject to the condition that the Option shall not be exercisable after the expiration of its term.
(b) In the event that Optionee shall cease to be employed by the Company or its Affiliates by reason of Optionee's gross and willful misconduct during the
course of employment (as reasonably determined by the Company), the Option shall terminate as of the date of the misconduct.
(c) If Optionee shall die while in the employ of the Company or its Affiliates or within three months after termination of employment for any reason other than gross and willful misconduct, or if Optionee shall become disabled within the meaning of Section 22(e)(3) of the Code while in the employ of the Company or its Affiliates and Optionee shall not have fully exercised the Option, the Option may be exercised at any time within twelve months after Optionee's death or disability by the legal representative or, if applicable, guardian of Optionee, or by any person to whom the Option is transferred by will or the applicable laws of descent or distribution, to the extent of the full number of shares Optionee was entitled to purchase under the Option on the date of death (or termination of employment, if earlier) or disability and subject to the condition that the Option shall not be exercisable after the expiration of its term.
SECTION 4. MANNER OF EXERCISE.
(a) The Option may only be exercised by Optionee or other proper party by delivery, within the Option period, of written notice to the Company at its principal office. The notice shall state the number of shares as to which the Option is being exercised. The Company will verify the appropriateness of the election and determine the amounts of compensation and related withholding tax.
(b) The exercise amount and applicable taxes must be tendered by the Optionee or other proper party prior to the issuance of shares covered by the notice of exercise. Payment shall be made to the Company in cash (including bank check, certified check, personal check, or money order), or, at the discretion of the Committee and as specified by the Committee, (i) by delivering certificates for Common Stock already owned by the Optionee or other proper party having a Fair Market Value as of the date of exercise equal to the full purchase price of the shares as to which the Option is exercised, (ii) by delivering written 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, (iii) by delivering the Optionee's or other proper party's promissory note, which shall provide for interest at a rate not less than the minimum rate required to avoid the imputation of income, original issue discount or a below-market-rate loan pursuant to Sections 483, 1274 or 7872 of the Code or any successor provisions thereto, (iv) by delivery (including by facsimile) to the Company or its designated agent of an executed irrevocable option exercise form together with irrevocable instructions to a broker-dealer to sell a sufficient portion of the shares as to which the Option is exercised and deliver the sale proceeds directly to the Company to pay
for the exercise price, (v) any combination of the foregoing methods of payment or (vi) such other consideration and method of payment for the issuance of shares as may be permitted under applicable laws. The Optionee's or other proper party's promissory note shall be a full recourse liability of the Optionee or other proper party and may, at the discretion of the Committee, be secured by a pledge of the shares being purchased.
(c) The exercise of the Option is contingent upon receipt from Optionee (or other proper person exercising the Option) of a representation that, at the time of such exercise, it is Optionee's intention to acquire the shares being purchased for investment and not with a view to the distribution or sale thereof within the meaning of the Securities Act of 1933, as amended (the "Securities Act"); provided, however, that the receipt of such representation shall not be required upon exercise of the Option in the event that, at the time of such exercise, the shares subject to the Option shall have been properly registered under the Securities Act and all applicable state securities laws. Such representation shall be in writing and in such form as the Company may reasonably request. The certificate representing the shares so issued for investment shall be imprinted with an appropriate legend setting forth all applicable restrictions on the transferability of such shares.
SECTION 5. MISCELLANEOUS.
(a) The Option is issued pursuant to the Plan and is subject to all of the terms and conditions thereof. Optionee acknowledges receipt of a copy of the Plan and represents to the Company that he or she is familiar with the provisions thereof.
(b) Nothing in this Agreement shall confer on Optionee any right to continue in the employ of the Company or any Affiliate of the Company or affect, in any way, the right of the Company or any Affiliate of the Company to terminate Optionee's employment at any time.
(c) Until Optionee or any other proper party has been issued the shares as to which this Option has been exercised, he or she shall possess no rights as a shareholder with respect to such shares.
(d) The exercise of all or any part of the Option shall only be effective at such time as the sale of the Common Stock pursuant to such exercise will not violate any federal or state securities laws.
(e) If there shall be any change in the Common Stock subject to the Option through merger, consolidation, reorganization, recapitalization, stock dividend, stock split or other change in the corporate structure of the Company, appropriate
adjustments shall be made in accordance with the Plan in the number of shares and the price per share of the shares subject to the Option in order to prevent dilution or enlargement of the option rights granted hereunder.
(f) The Company shall at all times during the term of the Option reserve and keep available such number of shares of the Common Stock as will be sufficient to satisfy the requirements of this Agreement.
(g) If Optionee shall dispose of any of the shares of Common Stock acquired upon exercise of the Option within two years from the date hereof or within one year after exercise of the Option, then, in order to provide the Company with the opportunity to claim the benefit of any income tax deduction which may be available to it under the circumstances, Optionee shall promptly notify the Company of the dates of acquisition and disposition of such shares, the number of shares so disposed of, and the consideration, if any, received for such shares. In order to comply with all applicable federal and state income tax laws and regulations, the Company may take such action as it deems appropriate to ensure that, if necessary, all applicable federal or state payroll, withholding, income or other taxes are withheld or collected from Optionee.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed effective as of the date first set forth above.
Medi-Ject Corporation
Optionee
DEVELOPMENT AND LICENSE AGREEMENT
This Agreement is made by and between BECTON, DICKINSON AND COMPANY, a New Jersey corporation ("BECTON"), and MEDI-JECT CORPORATION, a Minnesota corporation ("MEDI-JECT").
Whereas, MEDI-JECT has experience in and has committed significant resources to designing and developing needleless injection devices and systems, including disposables, suitable for the delivery of various drugs;
Whereas, BECTON has experience in marketing and selling drug delivery devices and systems, including disposables;
Whereas, MEDI-JECT and BECTON entered into a Confidentiality Agreement, dated February 1, 1995, for the purpose of sharing information in order to evaluate a possible business relationship;
Whereas, the parties have completed their evaluation and now desire to proceed with a development and licensing agreement sufficient to permit MEDI- JECT to develop needleless injection devices and BECTON to develop disposables, to be followed by separate supply agreements;
Now, therefore, in consideration of the premises and promises contained herein, the parties agree as follows.
ARTICLE I - DEFINITIONS
1.1 "AFFILIATE" shall mean any corporation or other business entity controlled by or in common control of a party. "Control" as used herein means the ownership directly or indirectly of fifty percent (50%) or the maximum interest
permitted by local law of the voting stock of a corporation or a fifty percent (50%) or greater interest in the income of such corporation or other business entity or the ability otherwise of a party to secure that the affairs of such corporation or other business entity are managed in accordance with its wishes.
1.2 "BECTON" shall include all of the divisions, subsidiaries and AFFILIATES of Becton, Dickinson and Company.
1.3 "BECTON PROPERTY" shall mean (a) all INTELLECTUAL PROPERTY owned by or licensed to (with right of sublicense) BECTON prior to the EFFECTIVE DATE relating to DISPOSABLES, and (b) all INTELLECTUAL PROPERTY made, conceived, created, developed or reduced to practice (by employees or agents of BECTON or MEDI-JECT or jointly by employees or agents of both parties) during the course of the OPEN DEVELOPMENT PROGRAM or a CLOSED DEVELOPMENT PROGRAM and covering DISPOSABLES (including without limitation the manufacture, use or sale thereof), excluding PROGRAM DISPOSABLE PROPERTY.
1.4 "CLOSED ARCHITECTURE SYSTEM" shall mean any NEEDLELESS INJECTOR and DISPOSABLE (a) each of which is designed or calibrated for use with a specific drug, (b) which are designed to be used together as an integrated unit, and (c) which are intended to be sold to and distributed by or on behalf of a third party pharmaceutical company. The parties will develop and commercialize CLOSED ARCHITECTURE SYSTEMS as set forth in Article III.
1.5 "CLOSED DEVELOPMENT PROGRAM" shall mean each and every development program for the development and commercialization of one or more CLOSED ARCHITECTURE SYSTEMS pursuant to Paragraph 3.3.
1.6 "COST OF GOODS SOLD" shall mean (***).
1.7 "DISPOSABLE" shall mean a single-use or multiple-use disposable drug chamber (either user-filled or pre-fillable) or other related drug-containing or drug-contacting component (e.g., vial adapter) for use with a NEEDLELESS INJECTOR.
1.8 "EFFECTIVE DATE" shall mean January 1, 1996.
1.9 "INTELLECTUAL PROPERTY" shall mean and include all patentable and unpatentable inventions, ideas, discoveries, improvements, design rights, works of authorship, trade secrets, know-how and any equivalents thereof.
1.10 "LICENSED PATENTS" shall mean those United States and foreign patents and/or patent applications within the MEDI-JECT PROPERTY, BECTON PROPERTY, PROGRAM DISPOSABLE PROPERTY or PROGRAM SYSTEM PROPERTY, including any continuations, continuations-in-part, divisions, extensions, substitutions, reissues or re-examinations thereof.
1.11 "MEDI-JECT" shall include all of the divisions, subsidiaries and AFFILIATES of Medi-Ject Corporation.
1.12 "MEDI-JECT PROPERTY" shall mean (a) all INTELLECTUAL PROPERTY owned by or licensed to (with right of sublicense) MEDI-JECT prior to the EFFECTIVE DATE relating to NEEDLELESS INJECTORS and/or DISPOSABLES
for OPEN ARCHITECTURE SYSTEMS or CLOSED ARCHITECTURE SYSTEMS and (b) all INTELLECTUAL PROPERTY made, conceived, created, developed or reduced to practice (by employees or agents of BECTON or MEDI-JECT or jointly by employees or agents of both parties) during the course of the OPEN DEVELOPMENT PROGRAM or a CLOSED DEVELOPMENT PROGRAM and covering NEEDLELESS INJECTORS (including without limitation the manufacture, use or sale thereof).
1.13 "MJ-6" shall mean the needleless injector system previously developed by MEDI-JECT as of the EFFECTIVE DATE for use in connection with the delivery of insulin, human growth hormone and those other drugs listed on Exhibit C hereto, including enhancements thereto (e.g. disposables) but excluding any needleless injector system having a size materially smaller than that of the MJ-6.
1.14 "NEEDLELESS INJECTOR" shall mean (a) a reusable device for needleless, transdermal injection of parenteral drugs which is (i) designed for use with a DISPOSABLE and (ii) self-powered or powered by means of any external energy source and, if applicable, (b) any reusable external energy source and related ancillary components. The parties agree that the term NEEDLELESS INJECTOR excludes the MJ-6.
1.15 "NET SALES" shall mean the price at which ROYALTY-BEARING DISPOSABLES are sold by BECTON or MEDI-JECT, its respective AFFILIATES or sublicensees to a purchaser (other than BECTON OR MEDI-JECT, its respective AFFILIATES or sublicensees), (***). The parties recognize that only one royalty shall be payable with respect to any ROYALTY-BEARING DISPOSABLE regardless of the
number of VALID CLAIMS under the applicable LICENSED PATENTS that may cover the manufacture, sale or use of such DISPOSABLE.
1.16 "OPEN ARCHITECTURE SYSTEM" shall mean a NEEDLELESS INJECTOR and DISPOSABLE (a) which are not designed or calibrated for use with a specific drug made by a specific drug company and (b) which are intended to be distributed primarily through pharmacies for uses other than (***). Initially, the parties will develop an OPEN ARCHITECTURE SYSTEM for insulin; the parties may develop additional OPEN ARCHITECTURE SYSTEMS for other drugs as set forth in Article III.
1.17 "OPEN DEVELOPMENT PROGRAM" shall mean the joint program under which:
(i) MEDI-JECT, using PROGRAMS FUNDS paid by BECTON and on behalf of BECTON,
shall undertake to develop a NEEDLELESS INJECTOR for an OPEN ARCHITECTURE
SYSTEM, including specifications, timetables, milestones, reports and
deliverables, as set forth in Exhibit A hereto; (ii) BECTON, using its own
funds, shall undertake to develop a DISPOSABLE for use with such NEEDLELESS
INJECTOR for an OPEN ARCHITECTURE SYSTEM, including the specifications,
timetables, milestones reports and deliverables, also as set forth in Exhibit A
hereto; and (iii) MEDI-JECT and BECTON shall work together to integrate the
NEEDLELESS INJECTOR and DISPOSABLE so developed into an OPEN ARCHITECTURE
SYSTEM.
1.18 (***).
1.19 (***).
1.20 "PROGRAM DISPOSABLE PROPERTY" shall mean all INTELLECTUAL PROPERTY made, conceived, created, developed or reduced to practice (by employees or agents of BECTON or MEDI-JECT or jointly by employees or agents of both parties) during the course of the OPEN DEVELOPMENT PROGRAM or a CLOSED DEVELOPMENT PROGRAM and covering DISPOSABLES (including without limitation the manufacture, use or sale thereof) solely for use in connection with NEEDLELESS INJECTORS.
1.21 "PROGRAM FUNDS" shall mean the monies paid by BECTON to MEDI-JECT pursuant to Paragraph 2.4 to fund MEDI-JECT's portion of the OPEN DEVELOPMENT PROGRAM.
1.22 "PROGRAM SYSTEM PROPERTY" shall mean all INTELLECTUAL PROPERTY made, conceived, created, developed or reduced to practice (by employees or agents of BECTON or MEDI-JECT or jointly by employees or agents of both parties) during the course of the OPEN DEVELOPMENT PROGRAM or a CLOSED DEVELOPMENT PROGRAM and covering NEEDLELESS INJECTORS and DISPOSABLES (including without limitation the manufacture, use or sale thereof) as integral parts of an OPEN ARCHITECTURE SYSTEM or CLOSED ARCHITECTURE SYSTEM.
1.23 "ROYALTY-BEARING DISPOSABLE" shall mean:
(a) with respect to Paragraphs 3.3, 7.2, 12.4(b) and (c) any DISPOSABLE, (i) the manufacture, use or sale of such is covered, in the country where the DISPOSABLE is manufactured or sold, by (***), a claim of a pending
patent application within the LICENSED PATENTS, or (***), a VALID CLAIM of any LICENSED PATENT or any third party technology acquired jointly pursuant to Paragraph 6.3; provided that such pending patent application or such LICENSED PATENT, as applicable, names as the sole inventor(s) or as joint inventors, employees of MEDI-JECT; or (ii) which is manufactured or sold in any country in which the FDA or applicable regulatory authority requires the use of such DISPOSABLE with a NEEDLELESS INJECTOR covered by any of the LICENSED PATENTS; or
(b) with respect to Paragraphs 3.5, 4.4, 5.5, 12.2 and 12.5 of this Agreement and Paragraph 8 of Exhibit B, any DISPOSABLE, (i) the manufacture, use or sale of such is covered, in the country where the DISPOSABLE is manufactured or sold, by (***), a claim of a pending patent application within the LICENSED PATENTS, or (***), a LICENSED PATENT of any LICENSED PATENT or any third party technology acquired jointly pursuant to Paragraph 6.3; provided that such pending patent application or such LICENSED PATENT, as applicable, names as the sole inventor(s) or joint inventors, employees of BECTON, or (ii) which is manufactured or sold in any country in which the FDA or applicable regulatory authority requires the use of such DISPOSABLE with a NEEDLELESS INJECTOR covered by any of the LICENSED PATENTS.
1.24 "SUPPLY AGREEMENT" shall mean an agreement to be entered into between BECTON and MEDI-JECT under which MEDI-JECT shall supply to BECTON NEEDLELESS INJECTORS for OPEN ARCHITECTURE SYSTEMS, which
agreement shall include the terms set forth in Exhibit B below and such other terms and conditions as are customary in such agreements and as the parties shall mutually agree.
1.25 "STOCK PURCHASE AGREEMENTS" shall mean the PREFERRED STOCK PURCHASE AGREEMENT, WARRANT, and OPTION AGREEMENT between BECTON and MEDI-JECT of even date herewith under which BECTON acquired equity and other interests in MEDI- JECT.
1.26 "VALID CLAIM" shall mean at least one claim of an issued or granted LICENSED PATENT so long as such claim shall not have been cancelled or shall not have been held invalid or not infringed in an unappealed or unappealable decision rendered by a tribunal of competent jurisdiction.
ARTICLE II - OPEN DEVELOPMENT PROGRAM
2.1 MEDI-JECT and BECTON each shall use reasonably diligent efforts to carry out their respective parts of the OPEN DEVELOPMENT PROGRAM as set forth in Exhibit A. MEDI-JECT shall use PROGRAM FUNDS solely to carry out the OPEN DEVELOPMENT PROGRAM and for no other purpose. MEDI-JECT shall use reasonably diligent efforts to assure that it is the owner of all MEDI-JECT PROPERTY. BECTON shall use reasonably diligent efforts to assure that it is the owner of all BECTON PROPERTY.
2.2 MEDI-JECT warrants that the design, manufacture, sale and use of a NEEDLELESS INJECTOR as part of the OPEN DEVELOPMENT SYSTEM shall not
knowingly infringe the valid INTELLECTUAL PROPERTY of others. MEDI-JECT agrees to notify BECTON if it becomes aware of such an infringement before incorporating a feature covered by such rights into NEEDLELESS INJECTOR so developed, and agrees to notify the Executive Committee (***).
2.3 BECTON warrants that the design, manufacture, sale and use of a DISPOSABLE shall not knowingly infringe the valid INTELLECTUAL PROPERTY of others. BECTON agrees to notify MEDI-JECT if it becomes aware of such an infringement before incorporating a feature covered by such rights into the DISPOSABLE, and agrees to notify the Executive Committee (***).
2.4 Unless earlier terminated under Article XII, as partial consideration for MEDI-JECT's performing the development of NEEDLELESS INJECTORS for OPEN ARCHITECTURE SYSTEMS, BECTON shall provide PROGRAM FUNDS to MEDI-JECT in an amount not to exceed Two Million Four Hundred Thousand Dollars ($2,400,000), in exchange for such rights granted to BECTON under Article IV. The PROGRAM FUNDS shall be paid in twenty-four equal monthly installments of $100,000, with the first such monthly installment payable on the EFFECTIVE DATE and the remaining monthly installments being due on or before the fifth day of each month commencing February 1996. The initial term of the OPEN DEVELOPMENT PROGRAM shall be two (2) years from the EFFECTIVE DATE. Any extension of the OPEN DEVELOPMENT PROGRAM beyond December 1997 and/or modifications in the scope, direction and efforts of the parties under it after that date, shall be determined by the representatives of the parties comprising the Executive
Committee which also shall set the amount and timing of any additional PROGRAM FUNDS to be spent as of January 1998, all of which shall be set forth in a writing amending this Agreement and Exhibit A in order to be effective. The PROGRAM FUNDS shall be allocated to the OPEN DEVELOPMENT PROGRAM and such other development projects as the Executive Committee may determine, but in no event shall such PROGRAM FUNDS be refundable to BECTON.
ARTICLE III - COMMERCIALIZATION EFFORTS
3.1 (a) (***).
(b) (***).
(c) The parties acknowledge that their respective rights and
|
obligations with respect to (***) are not subject to Paragraphs 3.1, 6.3 or 6.4.
3.2 OPEN ARCHITECTURE SYSTEMS for drugs other than insulin shall be developed under modifications of the OPEN DEVELOPMENT PROGRAM determined in accordance with the provisions of Paragraph 2.4 above. MEDI-JECT shall have the exclusive right to manufacture and supply NEEDLELESS INJECTORS for OPEN ARCHITECTURE SYSTEMS, for BECTON'S worldwide sales of such OPEN ARCHITECTURE SYSTEMS. Such manufacture and supply of NEEDLELESS INJECTORS for each OPEN ARCHITECTURE SYSTEM (e.g., initially insulin, and thereafter, such other drugs as the parties may designate pursuant to Paragraph 2.4) shall be pursuant to a SUPPLY AGREEMENT to be executed by the parties; each such
SUPPLY AGREEMENT shall include the terms set forth in Exhibit B and such other customary and reasonable terms as the parties may then agree.
3.3 Development of CLOSED ARCHITECTURE SYSTEMS shall be carried out as follows: MEDI-JECT and BECTON shall develop and establish a joint plan for the development, marketing and sale of CLOSED ARCHITECTURE SYSTEMS on behalf of one or more drug companies ("PLAN"). The PLAN shall be completed and submitted to the Executive Committee for approval by it by and on behalf of the parties, no later than (***). It is understood that the PLAN would include provisions to (i) jointly market to and then establish contracts ("Contracts") with individual drug companies to develop a CLOSED ARCHITECTURE SYSTEM for a particular company's drug, and (ii) assist each drug company which entered into such a Contract or Contracts ("Drug Company") to obtain regulatory clearance for the SYSTEM so developed. Each such arrangement with a Drug Company entered into under the PLAN also shall provide that: (i) unless otherwise agreed to with a Drug Company, MEDI-JECT would exclusively supply NEEDLELESS INJECTORS, and BECTON would exclusively supply DISPOSABLES (paying a royalty to MEDI-JECT on NET SALES of ROYALTY-BEARING DISPOSABLES pursuant to Paragraph 7.2 below); (ii) MEDI-JECT and BECTON would enter into a CLOSED DEVELOPMENT PROGRAM with the Drug Company (***); (iii) MEDI-JECT and BECTON would grant licenses to each other consistent with the terms of Article IV below; and (iv) (***).
3.4 In the event that the purchase price paid for one or more of the NEEDLELESS INJECTORS for CLOSED ARCHITECTURE SYSTEMS pursuant to any Contract contemplated in Paragraph 3.3 (***). The Executive Committee will discuss in good faith whether it is desirable for BECTON and MEDI-JECT to contract jointly with the Drug Company. In any event, neither party shall have the right or authority to enter into a Contract alone or to bind the other to a Contract without having first obtained the prior express written approval to do so.
3.5 If BECTON determines, in good faith, that it is not commercially feasible for it to manufacture DISPOSABLES for a particular CLOSED ARCHITECTURE SYSTEM, then it shall grant to MEDI-JECT, and it hereby does, the exclusive worldwide right and license under the BECTON PROPERTY, to make, have made, use, sell and import such DISPOSABLES for such particular CLOSED ARCHITECTURE SYSTEM only, together with the right to grant sublicenses under the terms and conditions of this Agreement. Such license shall be subject to a (***) royalty on NET SALES of such ROYALTY-BEARING DISPOSABLES, provided, however, that the manufacture, use or sale of such DISPOSABLE is covered, in the country whether the DISPOSABLE is manufactured or sold, by a VALID CLAIM under such BECTON PROPERTY.
agree that except as expressly provided in this Section 3.6, development and commercialization of the MJ-6 is outside of the scope of this Agreement.
ARTICLE IV - GRANT
4.1 MEDI-JECT hereby grants to BECTON an exclusive, world-wide right and license under MEDI-JECT PROPERTY, PROGRAM DISPOSABLE PROPERTY and PROGRAM SYSTEM PROPERTY, during the term of this Agreement, (i) to sell and use NEEDLELESS INJECTORS for OPEN ARCHITECTURE SYSTEMS and (ii) to make, have made, use, sell and import DISPOSABLES for use with OPEN ARCHITECTURE SYSTEMS and CLOSED ARCHITECTURE SYSTEMS, together with the right to grant sublicenses under the terms and conditions of this Agreement.
4.2 BECTON hereby grants to MEDI-JECT an exclusive, world-wide right and license under the BECTON PROPERTY, during the term of this Agreement, to make and have made NEEDLELESS INJECTORS as part of OPEN ARCHITECTURE SYSTEMS, CLOSED ARCHITECTURE SYSTEMS or (***), together with the right to grant sublicenses under the terms and conditions of this Agreement.
SUPPLY AGREEMENT or any CONTRACT, or with respect to MEDI-JECT's exercise of any of its licenses hereunder.
4.4 MEDI-JECT also shall have the right to convert BECTON's rights under Paragraph 4.1 to non-exclusive if either BECTON fails (***). In the event MEDI- JECT converts BECTON's license rights to non-exclusive due to a failure to (***), MEDI-JECT shall have the non-exclusive, world-wide right (with right of sublicense) under the BECTON PROPERTY to make, have made, use and sell such DISPOSABLES for use with OPEN ARCHITECTURE SYSTEMS, CLOSED ARCHITECTURE SYSTEMS or (***), and to the extent that such DISPOSABLES are ROYALTY-BEARING DISPOSABLES, MEDI-JECT shall pay a (***) royalty on NET SALES of such ROYALTY- BEARING DISPOSABLES.
ARTICLE V - (***) RIGHTS
5.1 In the course of this Agreement, MEDI-JECT shall be free to work on and develop one or more (***). In the course of this work, MEDI-JECT shall be free to incorporate and use MEDI-JECT PROPERTY, BECTON PROPERTY, PROGRAM DISPOSABLE PROPERTY and PROGRAM SYSTEM PROPERTY in any such (***) developed. No PROGRAM FUNDS, however, shall be spent on the development of a device for such use.
5.2 In the event the efforts of MEDI-JECT to develop such a (***) are successful, MEDI-JECT hereby grants to BECTON a right of first refusal to evaluate
and negotiate for rights to such SYSTEM, including the exclusive right to sell and use such SYSTEM, subject to the following conditions:
A. MEDI-JECT shall notify BECTON in writing of the completed development of prototypes for a (***) and shall provide BECTON with such information and data as may be necessary to allow BECTON to evaluate the prototype of the new device, including at least two (2) functional models of such a device;
B. BECTON shall have (***) after receiving such notification and functional models from MEDI-JECT to evaluate the new device, including the right to conduct focus groups, market research and/or preliminary clinical studies, with BECTON agreeing to share the results of its evaluation with MEDI-JECT; and
C. If BECTON desires to exercise its right of first refusal, it shall do so in writing not later than (***) after receiving such notification and models from MEDI-JECT. Failure to provide such notice in a timely manner shall result in a forfeiture of such right of first refusal as to the (***) so noticed.
5.4 So long as BECTON shall have the rights of first refusal granted to it under this Article, MEDI-JECT shall not mortgage, grant, assign, license or otherwise convey any right, title or interest in any INTELLECTUAL PROPERTY in, or any rights or interest to sell, distribute or otherwise provide, (***) to any third party.
5.5 If the parties are unable to agree on the terms and conditions of an agreement within a period of (***) after receiving the notice and models provided for under Paragraph 5.2(A), MEDI-JECT shall be (***); it being understood that any such rights granted to a third party to such (***) shall in no way conflict with or diminish the rights granted to BECTON under of this Agreement, including but not limited to those set forth in Article IV. (***).
ARTICLE VI - EXECUTIVE COMMITTEE
ARCHITECTURE SYSTEM should be developed for a particular drug, class of drugs, or drugs for a particular indication, as set forth in Paragraph 3.1 above; (iv) to set forth in writing the PLAN, as defined in Paragraph 3.3 above, for the development of CLOSED ARCHITECTURE SYSTEMS; (v) to appoint persons to such committees to carry out any projects and programs as the Executive Committee shall deem appropriate and (vi) to attempt to resolve any and all disputes as may arise under or relate to this Agreement.
6.2 The Executive Committee shall meet at such times and places as are mutually agreed upon, preferably at each other's principal place of business on an alternating basis, but in any event not less than quarterly. Each party shall bear its own costs in attending Executive Committee meetings. Each party shall have the right to replace its members of the Executive Committee on notice to the other party. Persons not members of the Executive Committee may be invited to attend Committee meetings in the discretion of the Executive Committee. Decisions of the Executive Committee shall be by majority.
6.3 In the event that either party becomes aware of the availability of any third party INTELLECTUAL PROPERTY relating to NEEDLELESS INJECTORS or DISPOSABLES (other than such INTELLECTUAL PROPERTY required pursuant to Paragraph 2.2 and 2.3), either alone or in conjunction with the sale of that third party's business or assets, the parties shall bring such information to the attention of the Executive Committee. (***).
6.4 During the term of this Agreement, in the event that either party becomes aware of the availability of any third party INTELLECTUAL PROPERTY relating to needleless, transdermal injection of parenteral drugs other than as provided in Paragraph 6.3, either alone or in conjunction with the sale of that third party's business or assets, the parties shall bring such information to the attention of the Executive Committee. Although the Executive Committee may discuss whether it would be desirable for the parties to acquire such INTELLECTUAL PROPERTY as provided in Paragraph 6.3, each party shall be free to acquire and use such INTELLECTUAL PROPERTY independently from, and without limitation or encumbrance under, this Agreement.
ARTICLE VII -- COMMERCIALIZATION AND ROYALTIES
7.1 (***).
7.2 BECTON shall pay to MEDI-JECT the following royalties on NET SALES of ROYALTY-BEARING DISPOSABLES with the applicable royalty rate to be determined by annual worldwide NET SALES of ROYALTY-BEARING DISPOSABLES:
Annual Worldwide Sales Revenue Royalty
------------------------------ -------
(***) (***)
7.3 (***).
|
7.4 Each party owing royalties or any other payment hereunder or any SUPPLY AGREEMENT (the "paying party") shall keep complete and accurate records of the NET SALES and COST OF GOODS SOLD of DISPOSABLES and/or NEEDLELESS INJECTORS, as applicable, and all data necessary for the computation of payment or other calculation made hereunder or thereunder. However, the paying party shall have no duty of trust or other fiduciary relationship with the other party (the "receiving party") regarding the maintenance of the books of account or the calculation and reporting of royalties and other calculations and payments hereunder.
7.5 Royalty payments hereunder, when due, shall be made on or before the last business day of May, August, November and February of each year for the sales of the ROYALTY-BEARING DISPOSABLES and/or NEEDLELESS INJECTORS, as the case may be, during the preceding quarterly periods ending on the last day of March, June, September and December, respectively. Such payments shall be accompanied by a statement showing the NET SALES and such other particulars as are necessary for an account of the payments to be made pursuant to this Agreement. Payment of the amount due shall accompany such statement, which shall be deemed to be true and correct unless objected to and audited in accordance with Paragraph 7.7 below.
7.6 All royalties and other payments hereunder or under any SUPPLY AGREEMENT shall be payable by the paying party to the receiving party in United States dollars by a check or checks drawn to the order of the receiving party. To the extent sales may have been made by the paying party in a foreign country, such royalty payments shall be made in United States dollars on the basis of conversion, from the currency of such foreign country, in the case of BECTON, at the rate recited in the report entitled "Rates of Exchange" issued monthly by BECTON's International Finance Department which provides spot exchange rates for each foreign country where sales were made, or in the case of MEDI-JECT, according to its then standard procedures for such conversions, which standard procedures shall utilize a publicly available bank exchange rate or other published exchange rate (e.g., The Wall Street Journal), on the last business day of the calendar quarter when the sales occurred, and shall be paid at the time and in the manner set forth above, provided, however, that royalties based on sales in any foreign country shall be payable to the receiving party only after deducting for exchange and all other charges due foreign governments, including withholding taxes, arising from the origin and transmittal of such royalties, and further provided that the foregoing is subject to the right of the paying party to make payment of royalties in any country where the currency is blocked and where legal conversion of the currency billed cannot be made into United States dollars by depositing such royalty payments in the
receiving party's name in a bank designated by the receiving party within such country.
7.7 The receiving party, at its own expense, shall have the right for a period of (***) after receiving any report from the paying party to nominate an independent Certified Public Accountant ("CPA") reasonably acceptable to the paying party, who shall have access to the paying party's records during reasonable business hours for the purpose of verifying the payments or other calculations made under this Agreement, but this right may not be exercised more than once in any calendar year, and the CPA shall disclose to the receiving party only information relating to the accuracy of the payment report or other calculations and the payments made in accordance with this Agreement. The failure of the receiving party to request verification of any payment report during said (***) period shall be considered acceptance of the accuracy of such report and the paying party shall have no obligation to maintain any records pertaining such report beyond said (***) period.
ARTICLE VIII - CONFIDENTIALITY OBLIGATIONS
8.1 Subject to the rights and licenses granted herein, any information, report, document or other materials (including, but not limited to, laboratory notebooks, schematics, specifications, circuits, diagrams, specimens, samples, prototypes, models and data regardless of how stored) disclosed or provided to the
other party during this Agreement which is of a trade secret, confidential,
proprietary or like undisclosed nature or is identified as such ("CONFIDENTIAL
INFORMATION"), shall be retained by the receiving party in confidence for the
term of this Agreement and a five (5) year period thereafter and shall not be
used except in connection with performance under this Agreement; provided,
however, nothing in this Agreement shall in any way restrict the right of a
receiving party to use, disclose, or otherwise deal with any information which
(i) was already known to the receiving party at the time of disclosure as
evidenced by written documents in the receiving party's possession prior to
disclosure; or (ii) was generally available to the public or becomes publicly
known through no wrongful act of the receiving party; or (iii) was received by
the receiving party from a third-party who had a legal right to provide it; or
(iv) was developed independently of knowledge of CONFIDENTIAL INFORMATION
received by the receiving party from the disclosing party.
8.2 Upon termination or expiration of this Agreement or within thirty (30) days following a written request made at any time by a disclosing party, the receiving party shall return all CONFIDENTIAL INFORMATION, including all writings, models and the like supplied by the disclosing party, except that one copy of same may be retained for archival purposes.
8.3 The receiving party agrees to exercise the same care and safeguards with respect to CONFIDENTIAL INFORMATION disclosed by the disclosing party as
used to maintain the confidentiality of its own information of like character, but in no event less than a reasonable degree of care.
8.4 Nothing contained herein shall be construed, either expressly or implicitly, to grant to the receiving party any rights to the CONFIDENTIAL INFORMATION, including technology or license under any INTELLECTUAL PROPERTY now or hereinafter in existence, except as specifically provided herein.
ARTICLE IX - INTELLECTUAL PROPERTY
9.1 Each party shall promptly disclose, in writing, to the other party all INTELLECTUAL PROPERTY made, developed, created, conceived or reduced to practice by any person(s), including any employee, agent or representative of the party as part of the OPEN DEVELOPMENT PROGRAM or CLOSED DEVELOPMENT PROGRAM, and all rights, title and interest to such INTELLECTUAL PROPERTY, shall be owned exclusively by and vest entirely in the parties, subject to the rights and licenses granted under this Agreement, as follows:
(a) MEDI-JECT shall own all MEDI-JECT PROPERTY, PROGRAM DISPOSABLE PROPERTY and PROGRAM SYSTEM PROPERTY; and
(b) BECTON shall own all BECTON PROPERTY.
9.2 MEDI-JECT shall diligently file and prosecute patent applications covering, and shall maintain all LICENSED PATENTS granted under, MEDI-JECT PROPERTY in the United States and Patent Cooperation Treaty Countries. MEDI-
JECT shall keep BECTON currently informed of the filing and progress of all material aspects of the prosecution of all such applications and of the issuance of patents, and shall consult with BECTON concerning any decisions which would affect the scope of any issued claims and other prosecutorial details, including the potential abandonment of any application. MEDI-JECT shall promptly inform BECTON of any additions, deletions or changes in the status of such LICENSED PATENTS. All actions taken by MEDI-JECT pursuant to this Paragraph 9.2 shall be at its own expense.
9.3 BECTON shall diligently file and prosecute patent applications covering, and shall maintain all LICENSED PATENTS granted under, BECTON PROPERTY and PROGRAM DISPOSABLE PROPERTY material to DISPOSABLES. BECTON shall keep MEDI-JECT currently informed of the filing and progress of all material aspects of the prosecution of all such applications and of the issuance of patents, and shall consult with MEDI-JECT concerning any decisions which would affect the scope of any issued claims and other prosecutorial details, including the potential abandonment of any application. BECTON shall promptly inform MEDI- JECT of any additions, deletions or changes in the status of such LICENSED PATENTS. All actions taken by BECTON pursuant to this Paragraph 9.3 shall be at its own expense.
9.4 The parties shall mutually agree, through the Executive Committee, on whether and in which countries to file and prosecute patent applications covering,
and to maintain LICENSED PATENTS granted under, PROGRAM SYSTEM PROPERTY. All such joint filings shall be made by counsel reasonably acceptable to the parties. Each party shall have the opportunity to review and comment on any such filings prior to submission and to discuss the strategy for the preparation, filing, prosecution, maintenance and defense of any patent applications covering the PROGRAM SYSTEM PROPERTY and any LICENSED PATENTS granted thereon. The parties shall share equally any out-of-pocket costs and expenses incurred with respect to such actions.
9.5 OPEN ARCHITECTURE SYSTEMS shall bear such trademarks and trade names as BECTON may choose, and BECTON shall be the owner of all right, title and interest in any such trademarks and trade names so used (with BECTON being responsible to obtaining at its cost all registrations worldwide for such trademarks and trade names). BECTON shall be responsible for and shall own all copyrights in any labels, marketing materials, publications and other written documentation created for use in connection with the distribution, marketing and sale of OPEN ARCHITECTURE SYSTEMS.
9.6 Upon request, each party shall execute and deliver to the other party all descriptions, applications, assignments and other documents and instruments necessary or proper to carry out the provisions of this Agreement without further compensation; and the parties shall cooperate with and assist each other or their nominees in all reasonable ways and at all reasonable times, including, but not
limited to, testifying in all legal proceedings, signing all lawful papers and in general performing all lawful acts reasonable, necessary or proper, to aid the other party in obtaining, maintaining, defending and enforcing all lawful patent, copyright, trade secret, know-how and the like in the United States and elsewhere.
9.7 (***).
ARTICLE X - PATENT LITIGATION
10.1 BECTON and MEDI-JECT shall promptly notify the other as soon as either becomes aware of any infringement, actual or threatened, of any of the INTELLECTUAL PROPERTY licensed hereunder, including those with respect to the LICENSED PATENTS.
10.2 (***).
10.3 (***).
10.4 (***).
ARTICLE XI - REGULATORY MATTERS
11.1 Upon finalization of any OPEN DEVELOPMENT SYSTEM developed hereunder, MEDI-JECT and BECTON shall jointly conduct (or cause to be conducted) such clinical trials as may be necessary or deemed advisable to obtain clearance to market and sell such SYSTEMS in such countries in the world as the parties may agree upon. MEDI-JECT and BECTON shall jointly design the content, claims and
timing of all trials conducted, and shall provide each other access to all data and documentation collected or prepared in support of such trials and access to all communications and filings sent to or received from any regulatory agency. The costs of such trials shall be borne equally by the parties; provided, however, BECTON shall contribute, without charge, an amount of DISPOSABLES sufficient to conduct such trials, and MEDI-JECT shall contribute, without charge, an amount of NEEDLELESS INJECTORS sufficient to conduct such trials. Each party agrees to use reasonably diligent efforts to file for and obtain regulatory approval for such OPEN DEVELOPMENT SYSTEMS in such agreed countries.
11.2 Clinical trials for each CLOSED DEVELOPMENT SYSTEM, developed pursuant to a CLOSED DEVELOPMENT PROGRAM shall be handled in accordance with terms of each Contract associated therewith.
ARTICLE XII - TERMINATION
12.1 Unless sooner terminated, this Agreement and the rights and licenses granted hereunder shall continue in effect until the later of (a) the end of (***) years after conclusion of the initial OPEN DEVELOPMENT PROGRAM or (b) the life of the last to expire of the LICENSED PATENTS.
12.2 For a period of three (3) years following the EFFECTIVE DATE or prior to MEDI-JECT receiving FDA approval for an OPEN ARCHITECTURE SYSTEM, whichever is shorter, BECTON shall have the right to terminate this Agreement,
without cause, on six (6) months advance written notice. Thereafter, BECTON shall have the right to terminate this Agreement, without cause, on twelve (12) months advance written notice. If BECTON terminates this Agreement without cause and if any DISPOSABLES for OPEN or CLOSED ARCHITECTURE SYSTEMS have been developed hereunder as of the date of such termination, BECTON shall negotiate in good faith, terms and conditions reasonably necessary to enable MEDI-JECT to arrange an alternative source of such DISPOSABLES, including upon MEDI-JECT's request, the continued supply of such DISPOSABLES by BECTON for a period of time not to exceed (***), and BECTON shall grant to MEDI-JECT, and hereby does grant (effective only upon such termination pursuant to this Paragraph 12.2), a non- exclusive license (with right of sublicense) under BECTON PROPERTY, PROGRAM DISPOSABLE PROPERTY and PROGRAM SYSTEM PROPERTY to make, have made, use, sell and import such DISPOSABLES for use with OPEN ARCHITECTURE SYSTEMS, CLOSED ARCHITECTURE SYSTEMS or (***), and to the extent that such DISPOSABLES are ROYALTY-BEARING DISPOSABLES, MEDI-JECT shall pay a (***) royalty on NET SALES of such ROYALTY-BEARING DISPOSABLES.
12.3 In the event of any breach of a material term of this Agreement by either party, including non-performance under the OPEN DEVELOPMENT PROGRAM, and such breach cannot be cured or otherwise addressed by action of the Executive Committee, the non-breaching party shall have the right to terminate this
Agreement on sixty (60) days written notice, in addition to any other legal or equitable remedies available to such non-breaching party.
12.4 (***).
12.5 (***).
12.6 Upon any termination or expiration of this Agreement, the parties shall retain their respective ownership rights under the BECTON PROPERTY, MEDI- JECT PROPERTY, PROGRAM DISPOSABLE PROPERTY or PROGRAM SYSTEM PROPERTY, subject to the provisions of Paragraphs 3.5, 4.3, 4.4, 5.5, 9.7, 12.2, 12.4 or 12.5, to the extent that such provisions are in effect as of, or as a result of, such termination.
12.7 (***).
12.8 All rights and licenses granted under or pursuant to this Agreement are, and shall otherwise be deemed to be, for the purposes of Paragraph 365(n) of the Bankruptcy Code, licenses of rights to "intellectual property" as defined under Paragraph 101(52) of the Bankruptcy Code. The parties agree that each party, as a licensee hereunder, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code.
12.9 Termination of this Agreement for any reason shall not affect the rights or obligations of any party accrued prior to termination. In addition, upon any termination of this Agreement, each party shall be entitled to any rights and remedies such party may have at law and in equity. Termination or expiration of
this Agreement shall not relieve the parties of their respective rights and obligations under Article VIII [Confidentiality], Article IX [Intellectual Property], and with respect to any royalties owing after such termination, Article VII [Commercialization and Royalties]. Termination of this Agreement shall not terminate the parties' respective rights and licenses under Paragraph 3.5, 4.3, 4.4, 5.3, 9.7, 12.2, 12.4 or 12.5 to the extent that such rights and licenses are in effect as of or as a result of such termination.
12.10 Termination of any OPEN DEVELOPMENT PROGRAM or CLOSED DEVELOPMENT PROGRAM shall not affect the continuation of any other OPEN DEVELOPMENT PROGRAM or CLOSED DEVELOPMENT PROGRAM hereunder or the continuation of this Agreement.
ARTICLE XIII - MISCELLANEOUS
13.1 Each party represents and warrants to the other party that it is duly authorized to enter into this Agreement and become bound by all of its terms and conditions, and further represents and warrants that nothing in this Agreement will contravene or conflict with any Article of Incorporation, by-law, rule, regulation, order, statute, agreement or other writing by which it may be bound or held accountable.
13.2 Nothing in this Agreement shall be deemed or construed as creating any agency or partnership between or among the parties. The parties shall not
conduct their activities hereunder in such manner as to make it appear to third parties that they have formed a partnership. No person not a party to this Agreement, including any employees or agents or any party to this Agreement, shall have or acquire any rights by reason of the parties having entered into this Agreement.
13.3 This Agreement and any of its individual terms shall be amended, modified, waived, superseded or canceled only by a writing duly authorized and signed by both parties. The delay or failure of any party at any time or times to require performance of any term shall in no manner affect that party's rights at a later time to enforce the same.
13.4 This Agreement, including Exhibits A-C, which are hereby incorporated herein by reference, contains the entire understanding of the parties with respect to the subject matter hereof and supersedes all prior and contemporaneous understandings, negotiations and agreements whether written or oral.
13.5 This Agreement shall be binding upon and inure to the benefit of the parties and their respective legal representatives, successors and permitted assigns. This Agreement shall not be assigned by either party without the prior written consent of the other party, unless such assignment is to a wholly-owned subsidiary of a party in which case only written notice need be provided.
13.6 This Agreement may be executed in two or more counterparts, each of
which shall be deemed an original.
13.7 Any notice permitted or required under this Agreement shall be deemed
given upon receipt when hand-delivered or sent by United States Postal Service
Express Mail when addressed to:
If to BECTON: President
Becton Dickinson Advanced Injection Systems
1 Becton Drive
Franklin Lakes, New Jersey 07417-1880
with a copy to: General Counsel
Becton Dickinson and Company
1 Becton Drive
Franklin Lakes, New Jersey 07417-1880
If to MEDI-JECT: President
MEDI-JECT Corporation
1840 Berkshire Lane
Minneapolis, Minnesota 55441
with a copy to: J. Andrew Herring, Esq.
Dorsey & Whitney P.L.L.P.
220 South Sixth Street
Minneapolis, Minnesota 55402
|
13.8 This Agreement (and any SUPPLY AGREEMENTS executed hereunder) shall be governed by and construed in accordance with Minnesota law (excluding its choice of law rules). The parties agree to submit any disputes arising hereunder or thereunder first to the Executive Committee. If the Executive Committee is unable to resolve such dispute, the parties shall submit such dispute to non- binding mediation, to be performed over a period not to exceed five days by a
professional mediation service reasonably acceptable to the parties. If the dispute is not resolved by such mediation, the parties may exercise their rights to any legal or equitable remedy available; provided, however that the exclusive jurisdiction and venue for any such disputes shall be the state and federal courts located in (a) Minneapolis, Minnesota, if BECTON brings suit against MEDI-JECT or (b) Bergen County, New Jersey, if MEDI-JECT brings suit against BECTON.
13.9 If any term or condition of this Agreement is or is found to be invalid or unenforceable in any country or countries, the remaining terms and conditions shall remain in full force and effect, and the parties agree to amend or construe the invalid or unenforceable terms or conditions of this Agreement in such manner so as to render them valid and enforceable giving due regard to the intent of the parties. In the event that cannot be done and the invalid or unenforceable term or condition is material to this Agreement, the parties agree to renegotiate the entire Agreement with respect to that country.
13.10 If the parties determine that a filing or notification with the European Economic Commission is necessary or useful to affect the intent of this Agreement within the European Economic Community, the parties shall cooperate, at their own expense, in the preparation and filing of such documents.
Having intended to become bound by the terms and conditions of this Agreement, the parties acknowledge entering into this Agreement as evidenced by their duly authorized signatures set forth below.
MEDI-JECT CORPORATION BECTON, DICKINSON AND
COMPANY
BY: /s/ Franklin Pass BY: /s/ Raymond P. Ohlmuller
------------------------- --------------------------
ITS: President and CEO ITS: Vice President and Secretary
------------------------ ----------------------------
|
EXHIBIT A
(***)
EXHIBIT B
SUPPLY AGREEMENT TERMS
1. Terms defined in the DEVELOPMENT AND LICENSE AGREEMENT shall be incorporated by reference in each SUPPLY AGREEMENT.
2. MEDI-JECT shall manufacture and supply NEEDLELESS INJECTORS to BECTON and BECTON shall manufacture and supply for itself DISPOSABLES.
3. Assuming MEDI-JECT meets the cost targets set forth in Exhibit A, BECTON will pay a transfer price to MEDI-JECT on NEEDLELESS INJECTORS FOR OPEN ARCHITECTURE SYSTEMS, sold to it by MEDI-JECT equal to (***).
4. The term of each SUPPLY AGREEMENT shall be the later of (a) (***) years from the first commercial sale of the applicable OPEN ARCHITECTURE SYSTEM or (b) the life of the last to expire of the LICENSED PATENTS covering such OPEN ARCHITECTURE SYSTEM.
5. Each SUPPLY AGREEMENT shall include customary and reasonable provisions relating to ordering, delivery, shipment, inspection and payment. The parties shall mutually negotiate and agree in good faith on the quantity of NEEDLELESS INJECTORS to be supplied to BECTON during the first year of each SUPPLY AGREEMENT. In addition, thereafter, BECTON shall submit to MEDI-JECT, on a quarterly basis, rolling annual forecasts, prepared in good faith, of its reasonably anticipated orders for NEEDLELESS INJECTORS for the applicable OPEN ARCHITECTURE SYSTEM. In addition, in order to permit MEDI-JECT to plan its
manufacturing needs appropriately, the parties shall negotiate in good faith the terms of the initial purchase order (i.e. quantity and delivery date) of NEEDLELESS INJECTORS for each OPEN ARCHITECTURE SYSTEM.
6. (a) If, for any reason, MEDI-JECT cannot meet BECTON's reasonable requirements (whether by virtue of quantities ordered or other reason) for such NEEDLELESS INJECTORS, subject to the terms of this Paragraph 6, MEDI-JECT shall designate a third party to manufacture such NEEDLELESS INJECTORS on its behalf for supply to BECTON; with such third party manufacturer to be acceptable to BECTON, which acceptance shall not be unreasonably withheld. The term of such third party manufacturing arrangement shall be mutually agreed by MEDI-JECT and such third party and MEDI-JECT shall be entitled to recommence manufacture of such NEEDLELESS INJECTORS upon a showing, reasonably acceptable to BECTON, of its ability to provide a consistent supply of such NEEDLELESS INJECTOR as necessary to meet BECTON's reasonably anticipated requirements therefor.
(b) (***).
(c) Notwithstanding the foregoing, BECTON shall not be entitled to invoke the provisions of this Paragraph 6, unless such unfilled quantities are within the forecast required by Paragraph 5 above, and such failure lasts for a period of more than (***). In addition, upon (***) written notice to BECTON and a showing, reasonably acceptable to BECTON, of its ability to provide a consistent supply of such NEEDLELESS INJECTOR as necessary to meet BECTON's reasonably anticipated requirements therefor, MEDI-JECT will have the option to:
(1) allow BECTON to continue to manufacture such NEEDLELESS INJECTORS on a non-exclusive basis until such time as (***); in which case MEDI-JECT shall also be entitled to supply NEEDLELESS INJECTORS to BECTON; or
(2) reimburse BECTON for (***) and, upon the expiration of such notice period, BECTON shall no longer be entitled to manufacture such NEEDLELESS INJECTORS hereunder.
7. Termination of any SUPPLY AGREEMENT shall not result in termination of the DEVELOPMENT AND LICENSE AGREEMENT.
8. If BECTON terminates any SUPPLY AGREEMENT without cause, BECTON shall negotiate, in good faith, terms and conditions reasonably necessary to enable MEDI-JECT to arrange an alternative source of the DISPOSABLES subject to such SUPPLY AGREEMENT, including upon MEDI-JECT's request the continued supply of such DISPOSABLES by BECTON for a period of time (***), and BECTON shall grant to MEDI-JECT, and hereby does grant (effective only upon such termination), a non- exclusive license under BECTON PROPERTY, PROGRAM DISPOSABLE PROPERTY and PROGRAM SYSTEM PROPERTY to make, have made, use, sell and import such DISPOSABLES for use in OPEN ARCHITECTURE SYSTEMS, CLOSED ARCHITECTURE SYSTEMS or (***), and to the extent that such DISPOSABLES are ROYALTY-BEARING DISPOSABLES, MEDI-JECT shall pay a (***) royalty on NET SALES of such ROYALTY-BEARING DISPOSABLES.
9. MEDI-JECT shall indemnify, defend and hold harmless BECTON, its directors, officers, employees and agents, against any judgments, fees, expenses, liability, costs, awards or damages arising from or incidental to any product liability or other suit, claim, demand or action (including infringement of the INTELLECTUAL PROPERTY rights of others) brought as a consequence of the sale and/or use of NEEDLELESS INJECTORS for OPEN ARCHITECTURE SYSTEMS sold to BECTON hereunder, whether BECTON, either jointly or severally, is named as a party defendant in such action.
10. BECTON shall indemnify, defend and hold harmless MEDI-JECT, its directors, officers, employees and agents, against any judgments, fees, expenses, liability costs, awards or damages arising from or incidental to any product liability or other suit, claim, demand or action (including infringement of the INTELLECTUAL PROPERTY rights of others) brought as a consequence of the sale and/or use of DISPOSABLES sold by BECTON hereunder whether MEDI-JECT, either jointly or severally, is named as a party defendant in such action.
11. In the event an action is brought against either or both MEDI-JECT and BECTON alleging infringement of the INTELLECTUAL PROPERTY rights of another by the sale and/or use of NEEDLELESS INJECTORS for OPEN ARCHITECTURE SYSTEMS, (***).
12. MEDI-JECT and BECTON shall each warrant to the other that it shall comply with all documentation and other requirements, rules and regulations of the Food and Drug Administration ("FDA") necessary to permit production of NEEDLELESS INJECTORS and DISPOSABLES, respectively, under FDA's Good Manufacturing Practices, and shall comply with all requirements, rules and regulations of any other agency or body having regulatory authority over the manufacture, distribution or sale of OPEN ARCHITECTURE SYSTEMS, and MEDI-JECT and BECTON shall each further warrant to the other it shall obtain IS 9002 certification for their manufacturing facilities and operations prior to commercial production of NEEDLELESS INJECTORS or DISPOSABLES, respectively, hereunder.
EXHIBIT C
Third Party Agreements
(***)
Ferring (hGH) (MJ-6)
JCR (hGH) (MJ-6)
Gene Medicine (gene therapy) (MJ-6)
BioTechnology General (hGH) (MJ-6)
Schwarz Pharma (PGE\\1\\) (CAS)
(***)
EXHIBIT 11.1
MEDI-JECT CORPORATION
Computation of Earnings per Share
(Not Covered by Independent Auditors' Report)
12 months ended 6 months ended
December 31, June 30,
1995 1996
--------------- --------------
Net Loss (1,882,459) (1,184,178)
Pro Forma Per Share Data:
Shares of common stock and
common stock equivalents:
Number of common shares
outstanding 3,552,113 4,725,633
Effect of outstanding stock options 903,796 903,796
Effect of incremental shares 724,277 724,277
--------------- --------------
5,180,186 6,353,706
=============== ==============
Pro Forma Net loss per Common share (0.36) (0.19)
|
Note: Shares outstanding and the effect of stock options and warrants and the incremental effect of shares issued below the IPO price within the past 12
months were calculated pursuant to the rules of Staff Accounting Bulletin 4:D.
Exhibit 23.1
Consent of Independent Auditors
The Board of Directors
Medi-Ject Corporation
We consent to the use of our report included herein and to the reference to our firm under the heading "Experts" in the prospectus.
/s/KPMG Peat Marwick LLP
------------------------
Minneapolis, Minnesota
August 15, 1996
|
| ARTICLE 5 |
| This schedule contains summary financial information extracted from audited and unaudited financial statements contained in the Registration Statement No. 33- 6661 and is qualified in its entirety by reference to such financial statements. |
| PERIOD TYPE | YEAR | 6 MOS |
| FISCAL YEAR END | DEC 31 1995 | JUN 30 1996 |
| PERIOD START | JAN 01 1995 | JAN 01 1996 |
| PERIOD END | DEC 31 1995 | JUN 30 1996 |
| CASH | 35,817 | 2,232,660 |
| SECURITIES | 0 | 0 |
| RECEIVABLES | 180,365 | 132,218 |
| ALLOWANCES | 4,125 | 4,000 |
| INVENTORY | 280,229 | 334,535 |
| CURRENT ASSETS | 527,794 | 2,806,354 |
| PP&E | 1,027,462 | 1,144,619 |
| DEPRECIATION | 550,436 | 563,685 |
| TOTAL ASSETS | 1,240,108 | 3,705,189 |
| CURRENT LIABILITIES | 1,178,067 | 1,107,409 |
| BONDS | 136,206 | 53,515 |
| COMMON | 2,189 | 13,538 |
| PREFERRED MANDATORY | 0 | 0 |
| PREFERRED | 31,945 | 32,330 |
| OTHER SE | (108,299) | 2,498,397 |
| TOTAL LIABILITY AND EQUITY | 1,240,108 | 3,705,189 |
| SALES | 1,653,869 | 814,244 |
| TOTAL REVENUES | 2,574,806 1 | 1,500,282 1 |
| CGS | 1,048,937 | 501,718 |
| TOTAL COSTS | 4,367,845 | 2,733,764 |
| OTHER EXPENSES | 45,090 | 0 |
| LOSS PROVISION | 0 | 0 |
| INTEREST EXPENSE | 60,816 | 20,181 |
| INCOME PRETAX | (1,882,459) | (1,184,178) |
| INCOME TAX | 0 | 0 |
| INCOME CONTINUING | (1,882,459) | (1,184,178) |
| DISCONTINUED | 0 | 0 |
| EXTRAORDINARY | 0 | 0 |
| CHANGES | 0 | 0 |
| NET INCOME | (1,882,459) | (1,184,178) |
| EPS PRIMARY | (.36) | (.19) |
| EPS DILUTED | (.36) | (.19) |
| 1 | Excludes interest income of 16,486 for the year ended 12 31 95 and 69,485 for the 6 months ended 6-30-96. |