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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-KSB
(Mark One)
X ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the fiscal year ended July 31, 1998
OR
_ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
_ EXCHANGE ACT OF 1934 [NO FEE REQUIRED]
For the transition period from to
Commission file No. 000-23399
FLEMINGTON PHARMACEUTICAL CORPORATION
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(Exact name of registrant as specified in its charter)
New Jersey 22-2407152
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(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
43 Emery Avenue, Flemington, New Jersey 08822
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (908) 782-3431
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Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, par value $.01 per share
Redeemable Class A Common Stock Purchase Warrants expiring
November 18, 2002.
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes X No
--- ---
Check if there is no disclosure of delinquent filings pursuant to Item
405 of Regulation S-K contained herein, and no disclosure will be contained, to
the best of registrant's knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this Form 10-KSB or any
amendment to this Form 10-KSB. [X].
State the issuer's revenues for its most recent fiscal year: $871,000.
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The aggregate market value of the voting and non-voting common equity
of the registrant held by non-affiliates of the registrant at October 21, 1998
was approximately $5,475,000 based upon the closing sale price of $2.4375 for
the Registrant's Common Stock, $.01 par value, as reported by the National
Association of Securities Dealers OTC Bulletin Board on October 21, 1998.
As of October 21, 1998 the Registrant had 3,877,300 shares of Common
Stock, $.01 par value, outstanding.
DOCUMENTS INCORPORATED BY REFERENCE:
Certain information contained in the Proxy Statement for the Annual Meeting of
Stockholders of Registrant to be held November 23, 1998 is incorporated by
reference into Part III hereof.
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FLEMINGTON PHARMACEUTICAL CORPORATION
Annual Report on Form 10-KSB
For the Fiscal Year Ended July 31, 1998
TABLE OF CONTENTS
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Page
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PART I
Item 1. Business 4
Item 2. Properties 31
Item 3. Legal Proceedings 31
Item 4. Submission of Matters to Vote of Security Holders 31
PART II
Item 5. Market for the Registrant's Common Stock and Related Security
Holder Matters 32
Item 6. Management's Discussion and Analysis of Financial Condition
and Results of Operations 33
Item 7. Financial Statements 37
Item 8. Changes in and Disagreements with Accountants on Accounting
and Financial Disclosure 37
PART III
Item 9. Directors and Executive Officers of the Registrant 37
Item 10. Executive Compensation 37
Item 11. Security Ownership of Certain Beneficial Owners and
Management 38
Item 12. Certain Relationships and Related Transactions 38
PART IV
Item 13. Exhibit List and Reports on Form 8-K 38
FINANCIAL STATEMENTS
Report of Independent Auditors F-2
Balance Sheet F-3
Statements of Operations F-4
Statements of Cash Flows F-5
Statements of Changes in Stockholders' Equity F-6
Notes to Financial Statements F-7
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PART I
ITEM 1. BUSINESS.
General
Flemington Pharmaceutical Corporation, a New Jersey corporation (the
"Company"), is engaged in consulting activities and the development of novel
application drug delivery systems for presently marketed prescription and
over-the-counter ("OTC") drugs. The Company's patent-pending delivery systems
are lingual sprays and soft gelatin bite capsules, enabling drug absorption
through the oral mucosa and more rapid absorption into the bloodstream than
presently available oral delivery systems. The Company's proprietary oral dosage
delivery systems enhance and greatly accelerate the onset of the therapeutic
benefits which the drugs are intended to produce. The Company refers to its
delivery systems as Immediate-Immediate Release (I2RTM) because its delivery
systems are designed to provide therapeutic benefits within minutes of
administration. The Company's development efforts for its novel drug delivery
systems are concentrated on drugs which are already available and proven in the
marketplace. In addition to increasing bioavailability by avoiding metabolism by
the liver before entry into the bloodstream, the Company believes that its
proprietary delivery systems offer the following significant advantages: (i)
improved drug safety profile by reducing the required dosage, including possible
reduction of side-effects; (ii) improved dosage reliability; (iii) allowing
medication to be taken without water; and (iv) improved patient convenience and
compliance.
The Company has initially identified approximately 50 presently
marketed drugs that meet the Company's criteria for its drug delivery systems.
The Company will concentrate its product development activities on those
pharmaceuticals with significant prescription or OTC sales. The Company believes
that applying a novel application delivery system to existing drugs involves
less cost, time and risk than developing and commercializing a new chemical
entity. The Company believes that there is significant opportunity to combine
its delivery systems with existing pharmaceuticals to expand the market for an
existing drug, differentiate a product from a generic or brand name competition,
and possibly create new markets.
In light of the material expense and delays associated with
independently developing and obtaining approval of pharmaceutical products, the
Company will continue to seek to develop such products through collaborative
arrangements with major pharmaceutical companies, which will fund that
development. The Company is presently a party to one such development agreement
with a pharmaceutical company. In addition, in select instances where the
Company identifies opportunities where there exist multiple customers for a
single product, the Company may develop and seek approvals for products
independently.
Since its inception in 1982, the Company has been a consultant to the
pharmaceutical industry, focusing on product development activities of various
European pharmaceutical companies, and since 1992 has used its consulting
revenues to fund its own product development activities. The Company's recent
focus on developing its own products evolved naturally out of
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its consulting experience for other pharmaceutical companies. Substantially all
of the Company's revenues have been derived from its consulting activities. In
1998, the Company changed the name under which it performs its consulting
activities from Pharmaconsult to FPC Consulting. The Company's principal
business address is 43 Emery Avenue, Flemington, New Jersey, 08822, and its
telephone number is (908) 782-3431.
Forward Looking Statements
When used in this report, the words "may," "will," "expect,"
"anticipate," "continue," "estimate," "project," "intend" and similar
expressions are intended to identify forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934 regarding events, conditions and financial
trends that may affect the Company's future plans of operations, business
strategy, operating results and financial position. Current stockholders and
prospective investors are cautioned that any forward-looking statements are not
guarantees of future performance and are subject to risks and uncertainties and
that actual results may differ materially from those included within the
forward-looking statements as a result of various factors. Such factors are
described under the headings "Business-Certain Considerations", "Management's
Discussion and Analysis of Financial Condition and Results of Operations" and
the Financial Statements and Notes thereto.
Recent Developments
Initial Public Offering
On November 25, 1997, the closing was held for the Company's initial
public offering (the "Public Offering") which was made pursuant to a
Registration Statement filed with the Securities and Exchange Commission (the
"Commission") and declared effective on November 19, 1997 (the "Effective
Date"). Pursuant to the Public Offering, the Company sold an aggregate of
680,000 units (the "Units"). The Public Offering was underwritten on a firm
commitment basis by Monroe Parker Securities, Inc. of Purchase, New York, which
acted as the representative (the "Representative") of the several underwriters
(the "Underwriters"). Each Unit consisted of one (1) share of Common Stock and
one (1) Redeemable Class A Common Stock Purchase Warrant ("Class A Warrant").
Each Class A Warrant entitles the holder to purchase one (1) share of Common
Stock at an exercise price of $5.80 per share, subject to adjustment. The Class
A Warrants expire on November 18, 2002 and are subject to redemption under
certain conditions commencing May 19, 1999. In connection with the Public
Offering, the Underwriters received an option (the "Underwriters' Option") to
purchase an aggregate of 68,000 Units at an exercise price of $9.74 for the four
year period commencing November 19, 1998. Pursuant to the Public Offering, the
Company received gross offering proceeds of approximately $4,012,000. Following
the Effective Date, the Company's Units, Common Stock and Class A Warrants
commenced trading on the National Association of Securities Dealers' OTC
Bulletin Board under the symbols FLEMU, FLEM and FLEMW, respectively. See "Item
5 - Market for the Registrant's Common Stock and Related Securityholder
Matters."
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Bridge Financing Conversion
In November 1997, immediately following consummation of the Public
Offering, two principal shareholders who held the Company's 7% convertible notes
agreed to convert the principal of such indebtedness into shares of Common Stock
of the Company. Pursuant to these agreements (collectively the "Conversion
Agreements"), an aggregate of 600,000 shares of Common Stock were issued in
respect of $300,000 aggregate principal amount of notes.
Status of Underwriter
The Representative ceased market making activities in the Company's
securities in late December 1997, and on January 5, 1998, was the subject of a
complaint issued by the National Association of Securities Dealers, Inc.
("NASD") for alleged violations of the NASD's rules in 1994 and 1995. The
Representative's registration with the Commission was terminated on April 28,
1998. These alleged violations have no connection with the Company or its
securities. Such developments which occurred subsequent to the effective date of
the Registration Statement were reflected in press releases issued by the
Company promptly after the facts were known to the Company. Such developments
were also reflected in prospectus stickers which were affixed to prospectuses
delivered during the 90 day prospectus delivery period following the Public
Offering. In October 1998, the New York attorney general's office announced the
indictment of the Representative and twelve (12) principals and brokers from the
firm on charges that they defrauded investors in the sale and trading of several
small stocks. The Representative's actions leading to the indictment were wholly
unrelated to the Company. The Company reserves the right to object to certain
agreements with the Representative which impact the Company's securities due to
the Representative's current status.
Registration of Non-Plan and Plan Options
In December 1997, the Company filed with the Commission a Registration
Statement on Form S-8 under the Securities Act of 1933 (the "Securities Act")
for the registration of 1,600,000 shares of Common Stock underlying the
Company's 1992 Stock Option Plan, the Company's 1997 Stock Option Plan and
certain executive non-plan options.
Option Grants to Directors
On March 24, 1998, the Company granted 50,000 stock options each to two
of the Company's officer shareholders at an exercise price of $1.10 (110% of the
closing sale price on that date). Additionally, the Company granted 25,000 stock
options each to the Company's four outside directors at an exercise price of
$1.00 (100% of the closing sale price on that date).
Amendment to Consulting Agreement
On May 1, 1997, the Company entered into a consulting agreement with
Saggi Capital Corp., a public relations consultant (the "Consultant") pursuant
to which the Consultant received a
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nonqualified stock option under the 1997 Stock Option Plan to purchase an
aggregate of 200,000 shares of Common Stock. On March 25, 1998, the Company
amended its consulting agreement pursuant to which the Consultant agreed to
expand the scope and duration of the services provided. As a consequence, the
nonqualified stock option was restated and amended and the consultant
surrendered 200,000 unexercised stock options having an exercise price of $5.80
per share in exchange for receiving 200,000 stock options having an exercise
price of $1.00 per share plus 120,000 stock options having an exercise price of
$2.00 per share. These options are exercisable for a period of 5 years following
the date of the grant. For the year ended July 31, 1998, the Company recorded a
$36,000 increase to paid-in-capital in connection with the amended consulting
agreement.
Loan to Chief Executive Officer
In April 1998, the Company made a $60,000 loan to its president and CEO
in exchange for a 7% demand promissory note (the "Executive Note"). Accrued
interest is to be paid quarterly. As of September 1, 1998, all interest payments
on the Executive Note were current.
Employment Agreements
In May 1998, the Company entered into employment agreements with Donald
P. Cox, Ph.D., as Vice President for Regulatory Affairs and Kenneth E. Cleaver,
Ph.D., as Vice President for Product Development at annual salaries of $125,000
and $100,000 respectively. The term of each agreement is three (3) years. As
additional consideration, the Company granted each officer 100,000 ten (10) year
stock options having an exercise price of $1.75 per share. One third of the
options vest in each of the years 1999, 2000 and 2001. In September 1998, the
Company issued to Dr. Cox options to purchase 100,000 shares of Common Stock
under the 1998 Stock Option Plan for future services.
Acquisition of Goldmark Biologicals
On July 29, 1998, the Company acquired substantially all of the
business assets and certain of the liabilities of Goldmark Biologicals
("Goldmark"), a sole proprietorship operated by Dr. Donald P. Cox, the Company's
Vice President for Regulatory Affairs. Prior to the acquisition, Goldmark was
engaged in the distribution of laboratory reagents, a business which the Company
intends to continue. As consideration for the acquisition, the Company made a
cash payment to Dr. Cox in the amount of $50,000.
Agreement with Novartis
The Company and Novartis, one of the world's largest pharmaceutical
companies ("Novartis") were parties to a letter agreement for the development of
an oral spray version of Clemastine, an antihistamine product, pursuant to which
the Company conducted a pilot bioavailability study of the spray version
product. Subsequent to the initial study, the Company
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reformulated the product at the request of Novartis for OTC application. In
October 1998, Novartis gave the Company oral notification that it did not intend
to pursue their development arrangement with the Company. The Company is
presently evaluating its strategy with respect to this product.
Development Agreements
In November 1996, the Company entered into an Agreement with Altana
Inc. ("Altana"), a U.S. subsidiary of Altana GmbH, under which the Company
agreed to prepare for Altana an Abbreviated New Drug Application ("ANDA") for
the Company's patent-pending lingual spray for treatment of angina. Under the
terms of the Agreement, Altana will, upon approval of the product by the FDA,
market the product in the U.S., and source all of its related product
requirements from the Company. The Company was paid a consulting fee for
preparation of the ANDA and will receive additional fees from Altana upon
acceptance by the FDA of the ANDA as filed and upon FDA approval. In March,
1998, the FDA refused to accept the ANDA for filing, however, the Company is
informed that Altana is requesting a meeting with the FDA to discuss the merits
of the FDA's rejection of the filing. There can be no assurance, however, that
the FDA will ultimately accept the ANDA for filing, or that, if accepted, the
FDA will approve the application. Moreover, there is no assurance that the
Company will continue to pursue bringing the product to market if the ANDA is
not accepted for filing by the FDA.
In February 1998, the Company entered into two joint development
agreements with CLL Pharmaceuticals, of Nice, France ("CLL") and Nace Resources,
Inc. of Highland Park, Illinois ("Nace") for the development of various products
using the Company's delivery technologies. Under the terms of such agreements,
the Company, CLL and Nace, respectively, will conduct a series of pilot studies
(at the parties' joint expense) to validate the efficacy of the various products
being tested. If the Company and its partners are satisfied with the results of
a particular pilot study, the parties will seek a license to fund further trials
to support applications with the FDA and foreign regulatory agencies. Under such
agreements, the Company will conduct the clinical trials and file all approval
applications, and the Company and its partners will share equally in the profits
(if any) arising from such arrangements. The first products identified for
development studies are progesterone and estradiol for CLL and Nace,
respectively. The Company intends to initiate the pilot studies in early 1999.
In August 1998, the Company entered into a development agreement with
Intracellular Health, Inc. of Cranford, New Jersey ("ICH") for the development
and marketing of a soft gelatin capsule neutraceutical product containing a
mixture of dietary supplements primarily intended for the nutritional management
of both the prevention and treatment of complications of diabetes. The Company
and ICH each has a separate patent application pending for the product on which
the agreement is based. ICH is currently conducting a clinical trial to assess
the efficacy of this product, and the Company expects such study to be completed
in early 1999. If the results of such study are satisfactory, the Company and
ICH will seek a partner to fund the marketing and distribution of the product
which would be manufactured by the Company.
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1998 Annual Meeting of Stockholders
The Company will hold the 1998 Annual Meeting of Stockholders ("Annual
Meeting") on Monday, November 23, l998 for the following purposes: (i) to elect
six (6) Directors to the Board of Directors to serve until the 1999 Annual
Meeting of Shareholders or until their successors have been duly elected or
appointed and qualified; (ii) to vote upon the adoption of the Company's 1998
Stock Option Plan; (iii) to vote on a proposal to (a) change the state of
incorporation of the Company from New Jersey to Delaware and (b) increase the
Company's authorized shares of Common Stock from 10,000,000 to 50,000,000
shares; (iv) to ratify the appointment of Wiss & Company, LLP as the Company's
independent certified public accountants for the fiscal year ending July 31,
1999; and (v) to consider and take action upon such other business as may
properly come before the Annual Meeting. The Board of Directors fixed the close
of business on September 30, 1998, as the record date for determining the
shareholders entitled to notice of, and to vote at, the Annual Meeting.
Business Strategy
The Company's strategy is to concentrate its product development
activities primarily on those pharmaceuticals for which there already are
significant prescription and OTC sales, where the use of the Company's
innovative delivery systems will greatly enhance speed of onset of therapeutic
effect, reduce side effects through a reduction of the amount of active drug
substance required to produce a given therapeutic effect, and improve patient
convenience or compliance.
The Company has initially identified approximately 50 presently
marketed drugs that meet the Company's criteria for its drug delivery systems.
The Company will concentrate its product development activities on those
pharmaceuticals with significant prescription or OTC sales. The Company believes
that applying a novel application delivery system to existing drugs involves
less cost, time and risk than developing and commercializing a new chemical
entity. The Company believes that there is significant opportunity to combine
its delivery systems with existing pharmaceuticals to expand the market for an
existing drug, differentiate a product from a generic or brand name competition,
and possibly create new markets.
In light of the material expense and delays associated with
independently developing and obtaining approval of pharmaceutical products, the
Company will continue to seek to develop such products through collaborative
arrangements with major pharmaceutical companies, which will fund that
development. The Company is presently a party to such a development agreement
with Altana. In addition, in select instances where the Company identifies
opportunities where there exist multiple customers for a single product, the
Company may develop and seek approvals for products independently.
Patent Pending Delivery Systems
The Company has patent applications pending for two oral dosage
delivery systems, the Lingual (Oral) Spray and the Soft Gelatin Bite Capsule,
for which FDA approval is not a prerequisite for patent approval. The expected
year of marketability will vary depending upon the specific drug product with
which the delivery system will be utilized. Each individual use of the delivery
system will require registration and/or approval with the FDA prior to
marketability,
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and the amount of regulatory oversight required by the FDA will also depend on
the specific type of drug product for which the delivery system is implemented.
The following are descriptions of the two oral dosage delivery systems for which
patent applications are pending:
Lingual (Oral) Spray. The Company's aerosol and pump spray formulations
release the drug in the form of a fine mist into the mouth for immediate
absorption into the bloodstream via the mucosal membranes. The Company believes
that this delivery system offers certain advantages, including improving the
safety profile of certain drugs by lowering the required dosage, improving dose
reliability, and allowing medication to be taken without water. Drug absorption
through the mucosal membranes of the mouth is rapid and minimizes the first-pass
metabolism effect (i.e., total or partial inactivation of a drug as it passes
through the gastrointestinal tract and liver).
Soft Gelatin Bite Capsule. The Company's soft gelatin bite capsule
formulation consists of a seamless gelatin shell surrounding a core substance
(usually a liquid solution). When crushed or chewed, the soft gelatin bite
capsule releases medication into the mouth, thereby allowing absorption through
the oral mucosa. The portion of the dose that is eventually swallowed is
introduced to the stomach in a solution ready for immediate absorption, thereby
maximizing absorption from the gastrointestinal tract into the bloodstream. The
result is rapid onset of the desired therapeutic effect.
Proposed Products
The Company's proposed products described below are subjected to
laboratory testing and stability studies and tested for therapeutic comparison
to the originators' products by qualified laboratories and clinics. To the
extent that two drug products with the same active ingredients are substantially
identical in terms of their rate and extent of absorption in the human body
(bioavailability), they are considered bioequivalent. If the accumulated data
demonstrates bioequivalency, submission is then made to the FDA (through the
filing of an ANDA) for its review and approval to manufacture and market. If the
accumulated data demonstrates that there are differences in the two drugs' rate
and extent of absorption into the human body, or if it is intended to make
additional or different claims regarding therapeutic effect for the newly
developed product, submission is made to the FDA via a NDA for its review and
approval under Section 505(b)(2) of the FDC Act. An NDA submitted under this
section of the FDC Act is generally less complex than an ordinary NDA and is
usually acted upon by FDA in a shorter period of time. It is the Company's
expectation that the majority of its products in development will require the
filing of this shorter version of an NDA because the products are known chemical
entities, but the Company or its licensees will be making new claims as to
therapeutic effects or lessened side effects, or both.
The Company estimates that development of new formulations of
pharmaceutical products, including formulation, testing and obtaining FDA
approval, generally takes three to five years for the ANDA process. Development
of products requiring additional clinical studies under Section 505(b)(2) NDAs,
such as the Company anticipates for the majority of its product development,
including FDA approval, may take four to seven years. There can be no assurance
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that the Company's determinations will prove to be accurate or that
pre-marketing approval relating to its proposed products will be obtained on a
timely basis, or at all. See "Government Regulation."
The Company's initial proposed products fall into the following
therapeutic classes:
o Delayed Contact Allergy Ointments
During the development of the lingual sprays and bite capsules the
Company discovered that certain formulations containing antihistamines could be
used topically for the relief of the symptoms of delayed contact allergies such
as poison ivy and poison oak. The Company applied for patent protection on this
product, and signed an option agreement with Altana to develop an NDA if the
results of a pilot double-blind clinical study confirm the results of the early
open-labeled studies. The option agreement requires the Company to prepare and
file the NDA by the end of 2000, the associated expenses of which will be borne
by Altana.
o Estradiol Lingual Spray
Several new "non-estrogen" products have recently been introduced to
treat osteoporosis without the associated side effects of estrogens. Due to the
non-estrogen nature of these products, the Company believes that patients often
experience "hot-flashes" and find it difficult to maintain the required dosage
regimen. The lingual spray is intended to relieve the "hot-flashes" within
minutes, which, the Company believes, will allow such patients to maintain the
required dosage regimen more easily.
The Company is conducting preformulation development of this product,
and is in the process of developing capability to manufacture and package
supplies for stability and clinical studies. The first product expected to be
developed in this facility is an estradiol lingual spray. The preformulation
development is complete and as soon as the manufacturing area is completed,
clinical supplies of the product will be manufactured and placed on stability
studies. The pilot clinical study is planned for early 1999 at the completion of
the first month stability testing.
o Progesterone Lingual Spray
This product is being developed as part of the agreement with CLL and
is intended to treat the symptoms of progesterone deficiency. The preformulation
work is ongoing, which is being carried out by CLL and stability and clinical
supplies are to be manufactured in early 1999. The pilot clinical study is
planned for mid 1999. If the results of this pilot clinical study support the
concept of fast relief of the symptoms associated with progesterone deficiency
CLL and the Company will seek development partners to finance the further work
associate with filing an NDA and bringing this product to market.
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o Neutraceutical Bite Capsule
In conjunction with ICH, the Company has developed a soft gelatin bite
capsule containing magnesium and other components for use by diabetics. ICH
presently has a clinical study ongoing to determine if the product has the
desired effect. If the results of the clinical study are favorable, ICH and the
Company will search out development partners to finance any further work
associate with the marketing of this product. The product will be registered for
drug listing with the FDA, however, FDA approval is not required before
marketing.
o Sleep Inducers (Diphenhydramine)
The Company is developing its formulation for Diphenhydramine, a sleep
inducing agent. The Company intends to conduct initial pilot clinical studies,
including bioequivalency studies, and thereafter approach pharmaceutical
companies with a proposed product. The earliest time that the Company could
reasonably expect to have a commercially saleable product in this category is
early 2003.
o Cardiovascular (Nitroglycerin)
The Company's Nitroglycerin product has been formulated and stability
testing has been completed. This product is subject to a license agreement with
Altana. See " -- Recent Developments."
Marketing and Distribution
The Company intends, generally, to license products developed with its
technology to drug companies already selling such drug substances under their
own brand names, or to market its products to pharmaceutical wholesalers, drug
distributors, drugstore chains, hospitals, United States governmental agencies,
health maintenance organizations and other drug companies. It is anticipated
that promotion of the Company's proposed products will be characterized by an
emphasis on their distinguishing characteristics, such as dosage form and
packaging, as well as possible therapeutic advantages of such products. The
Company will seek to position its proposed products as alternatives or as line
extensions to brand-name products. The Company believes that to the extent that
the Company's formulated products are patent-protected, such formulations may
offer brand-name manufacturers the opportunity to expand their product lines.
Alternatively, products which are not patented may be offered to brand-name
manufacturers as substitute products after patent protection on existing
products expire.
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Inasmuch as the Company does not have the financial or other resources
to undertake extensive marketing activities, the Company generally intends to
seek to enter into marketing arrangements, including possible joint ventures or
license or distribution arrangements, with third parties. The Company believes
that such third-party arrangements will permit the Company to maximize the
promotion and distribution of its products while minimizing the Company's direct
marketing and distribution costs. Other than the Company's aforementioned
agreements for the Company's proposed lingual spray products for angina, the
Company has not entered into any agreements or arrangements with respect to the
marketing of its proposed products and there can be no assurance that it will do
so in the future. There can be no assurance that the Company's proposed products
can be successfully marketed.
Strategies relating to marketing of the Company's other proposed
formulated products have not yet been determined; these will be formulated in
advance of anticipated completion of development activities relating to the
particular formulated product. Although the Company currently distributes its
Goldmark line of products including laboratory reagents, the Company has no
experience in marketing or distribution of its proposed proprietary products.
Manufacturing
The Company has entered into agreements with each of Rapid Spray GmbH &
Co. KG ("Rapid Spray") of Laupheim, Germany and SCA-Lohnherstellungs AG
("Swisscaps") of Kirchberg, Switzerland, European pharmaceutical manufacturers,
regarding the manufacture of certain of the Company's products in spray and
gelatin bite capsule dosage forms, respectively (the "Joint Development
Agreements"). Rapid Spray has agreed to manufacture the nitroglycerin and
antihistimine products. As for other spray products, the Company is establishing
a facility to create such products for initial clinical supply. If any of such
products are pursued, the Company will seek manufacturing partners for those
products not manufactured by Rapid Spray or Swisscaps. There can be no
assurance, however, that a suitable manufacturing partner can be identified.
Under the Joint Development Agreements the Company is responsible, among other
things, to conduct any necessary clinical trials and take all action necessary
to comply with the regulatory approval process. The Company will purchase all of
its clinical and commercial requirements for its proposed products from such
manufacturers, at a price to be negotiated by the parties.
In addition to protection afforded by patents for which the Company has
applications pending, each of the Joint Development Agreements provides that the
Company retain exclusive rights to market its proposed products in the United
States, Europe and Japan. Each of the Joint Development Agreements also contains
certain minimum purchase requirements for the Company. It is anticipated that
the Company will arrange with third-party suppliers for supplies of active and
inactive pharmaceutical ingredients and packaging materials used in the
manufacture of the Company's proposed products. It is the Company's present
intent to seek to enter into similar manufacturing arrangements for other
products to be developed by it in the future.
The Joint Development Agreements provide for the manufacture of the
Company's
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products at prices to be mutually agreed upon and require re-negotiation of
certain terms relating to per unit cost on an annual basis. The manufacture of
the Company's pharmaceutical products will be subject to current Good
Manufacturing Processes ("cGMP") prescribed by the FDA, and pre-approval
inspections by the FDA and foreign authorities prior to the commercial
manufacture of any such products. See "Government Regulation" and "Raw Materials
and Suppliers."
In addition to those products manufactured by Rapid Spray and
Swisscaps, the Company anticipates that certain of its other proposed products
will be manufactured by other contract manufacturers. In addition, the raw
materials necessary for the manufacture of the Company's products will, in all
likelihood, be purchased by the Company from suppliers in the United States,
Europe and Japan and delivered to its manufacturers' facilities by such
suppliers. Accordingly, the Company and its manufacturers may be subject to
various import duties applicable to both finished products and raw materials and
may be affected by various other import and export restrictions as well as other
developments impacting upon international trade. These international trade
factors will, under certain circumstances, have an impact both on the
manufacturing cost (which will, in turn, have an impact on the cost to the
Company of the manufactured product) and the wholesale and retail prices of the
products to be manufactured abroad. To the extent that transactions relating to
the foreign manufacture of the Company's proposed products and purchase of raw
materials involve currencies other than United States dollars (i.e., Swiss
francs and German marks), the operating results of the Company will be affected
by fluctuations in foreign currency exchange rates.
Raw Materials and Suppliers
The Company believes that the active ingredients used in the
manufacture of its proposed pharmaceutical products are presently available from
numerous suppliers located in the United States, Europe and Japan. Generally,
certain raw materials, including inactive ingredients, are available from a
limited number of suppliers and certain packaging materials intended for use in
connection with the Company's lingual spray products are only available from
sole source suppliers. Further, the Company's Goldmark line of laboratory
reagents is available only from a single source supplier and no additional
sources of supply are known.
Although the Company believes that it will not encounter difficulties
in obtaining the inactive ingredients or packaging materials necessary for the
manufacture of its products, there can be no assurance that the Company or its
manufacturers will be able to enter into satisfactory agreements or arrangements
for the purchase of commercial quantities of such materials. The failure to
enter into agreements or otherwise arrange for adequate or timely supplies of
principal raw materials and the possible inability to secure alternative sources
of raw material supplies could have a material adverse effect on the ability to
manufacture formulated products.
Development and regulatory approval of the Company's pharmaceutical
products are dependent upon the Company's ability to procure active ingredients
and certain packaging materials from FDA-approved sources. Since the FDA
approval process requires manufacturers to specify their proposed suppliers of
active ingredients and certain packaging materials in their applications, FDA
approval of a supplemental application to use a new supplier would be
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required if active ingredients or such packaging materials were no longer
available from the specified supplier, which could result in manufacturing
delays. Accordingly, the Company will seek to locate alternative FDA approved
suppliers.
Research and Development
During fiscal 1998, 1997 and 1996, respectively, the Company spent
$290,000, $171,000 and $172,000 on product research and development. Such
figures include salary and associated payroll expenses. In future periods, the
Company intends to continue to spend significant, and greatly increasing
amounts, to develop its products.
Government Regulation
The development, manufacture and commercialization of pharmaceutical
products are generally subject to extensive regulation by various federal and
state governmental entities. The FDA, which is the principal United States
regulatory authority, has the power to seize adulterated or misbranded products
and unapproved new drugs, to request their recall from the market, to enjoin
further manufacture or sale, to publicize certain facts concerning a product and
to initiate criminal proceedings. As a result of federal statutes and FDA
regulations, pursuant to which new pharmaceuticals are required to undergo
extensive and rigorous testing, obtaining pre-market regulatory approval
requires extensive time and expenditures.
Under the FDC Act, a new drug may not be commercialized or otherwise
distributed in the United States without the prior approval of the FDA. The FDA
approval process relating to a new drug differs, depending on the nature of the
particular drug for which approval is sought. With respect to any drug product
with active ingredients not previously approved by the FDA, a prospective drug
manufacturer is required to submit a NDA, including complete reports of
pre-clinical, clinical and laboratory studies to prove such product's safety and
efficacy. The NDA process generally requires, before the submission of the NDA,
submission of an IND pursuant to which permission is sought to begin preliminary
clinical testing of the new drug. An NDA based on published safety and efficacy
studies conducted by others may also be required to be submitted for a drug
product with a previously approved active ingredient, if the method of delivery,
strength or dosage is changed. Alternatively, a drug having the same active
ingredients as a drug previously approved by the FDA may be eligible to be
submitted under an ANDA, which is significantly less stringent than the NDA
approval process.
While the ANDA process requires a manufacturer to establish
bioequivalence to the previously approved drug, it permits the manufacturer to
rely on the safety and efficacy studies contained in the NDA for the previously
approved drug.
The NDA approval process generally requires between four to seven years
from NDA submission to pre-marketing approval. By contrast, the ANDA process
permits an expedited FDA review pursuant to which pre-marketing regulatory
approval can generally be obtained in three to five years. The ANDA process is
available for drugs with the same active ingredients, dosage form, strength and
method of delivery as a product which has previously received FDA
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approval pursuant to the NDA process. Manufacturing information, including a
review of chemical and physical data, stability data, facilities and processes,
must also be evaluated by FDA before approval.
The Company believes that products developed in lingual spray and soft
gelatin bite capsule delivery systems (dosage forms) usually will require
submission of an NDA.
The Company estimates that the development of new formulations of
pharmaceutical products, including formulation, testing and obtaining FDA
approval, generally takes three to five years for the ANDA process and four to
seven years for the NDA process. There can be no assurance that the Company's
determinations will prove to be accurate or that pre-marketing approval relating
to its proposed products will be obtained on a timely basis, or at all. The FDA
application procedure has become more rigorous and costly and the FDA currently
performs pre-approval and periodic inspections of each finished dosage form and
each active ingredient.
The manufacture of the Company's pharmaceutical products will be
subject to cGMP prescribed by the FDA, pre-approval inspection by the FDA and
foreign authorities prior to the commercial manufacture of such products and
periodic cGMP compliance inspection by the FDA. The Company's European
manufacturers will be required to be in compliance with cGMP with respect to the
manufacture of the Company's products. There can be no assurance that the
Company's manufacturers will be deemed to be in compliance with cGMP with
respect to any particular product. To the extent that the Company's
manufacturers are deemed not to be in compliance with cGMP, there can be no
assurance that the Company will be able to enter into other suitable
manufacturing arrangements with third parties which are in compliance with cGMP.
Competition
The markets which the Company intends to enter are characterized by
intense competition. The Company will be competing against established
pharmaceutical companies which currently market products which are equivalent or
functionally similar to those the Company intends to market. Prices of drug
products are significantly affected by competitive factors and tend to decline
as competition increases. In addition, numerous companies are developing or may,
in the future, engage in the development of products competitive with the
Company's proposed products. The Company expects that technological developments
will occur at a rapid rate and that competition is likely to intensify as
enhanced delivery system technologies gain greater acceptance. Additionally, the
markets for formulated products which the Company has targeted for development
are intensely competitive, involving numerous competitors and products. The
Company will seek to enhance its competitive position by focusing its efforts on
its novel dosage forms.
Patents and Protection of Proprietary Information
The Company has applied for United States and foreign patent protection
for the delivery systems which are the primary focus of its development
activities as well as the delayed contact
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allergy topical formulations. There can be no assurance, however, that its
patent applications will be granted, or, if granted, will provide any adequate
protection to the Company. The Company also intends to rely on whatever
protection the law affords to trade secrets, including unpatented know-how.
Other companies, however, may independently develop equivalent or superior
technologies or processes and may obtain patent or similar rights with respect
thereto.
Although the Company believes that its technology has been developed
independently and does not infringe on the patents of others, there can be no
assurance that the technology does not and will not infringe on the patents of
others. In the event of infringement, the Company or its European manufacturers
could, under certain circumstances, be required to modify the infringing process
or obtain a license. There can be no assurance that the Company or its European
manufacturers would be able to do either of those things in a timely manner or
at all, and failure to do so could have a material adverse effect on the Company
and its business. In addition, there can be no assurance that the Company will
have the financial or other resources necessary to enforce or defend a patent
infringement or proprietary rights violation action. If any of the products
developed by the Company infringe upon the patent or proprietary rights of
others, the Company could, under certain circumstances, be enjoined or become
liable for damages, which would have a material adverse effect on the Company.
The Company also relies on confidentiality and nondisclosure
arrangements with its licensees and potential development candidates. There can
be no assurance that other companies will not acquire information which the
Company considers to be proprietary. Moreover, there can be no assurance that
other companies will not independently develop know-how comparable to or
superior to that of the Company.
Buccal Nonpolar Spray or Capsule. On April, 12, 1996 the Company filed
an application with the United States Patent and Trademark Office ("PTO") for
protection of this subject matter. On September 1, 1998 the PTO allowed the
claims directed to sprays, but rejected the claims directed to the capsules. In
October 1998 the Company dropped the capsule claims from this application, to
pursue allowance and issuance of a patent directed to the spray claims. The
Company is considering either abandoning or re-filing the claims directed to the
capsule in a continuing application. In October 1998, the Company filed a patent
application in Canada for the buccal nonpolar spray claims.
On February 21, 1997, the Company filed an application under the Patent
Cooperation Treaty ("PCT") for the above-subject matter. The International
Preliminary Examination Authority has issued an opinion in which the PCT
examiner determined that the subject matter of the invention while novel, is not
inventive for obviousness. This opinion, with which the Company disagrees, is
not dispositive, however, it may be highly persuasive in subsequent proceedings
in the European and individual national patent offices should the Company decide
to proceed in these jurisdictions. The Company's right to pursue this claim with
the PCT expired on October 12, 1998. The Company has made individual filings for
patent protection in Canada and Europe.
Buccal Polar Spray or Capsule. On April 12, 1996, the Company filed an
application in
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the PTO directed to the buccal polar spray or capsule. The PTO initially allowed
the claims to the above subject matter. In view of references found in the
counterpart PCT application (see below) which the Company, by law, was obliged
to report to the PTO, the PTO withdrew the Notice of Allowance and subsequently
rejected all claims in the application. At this time, the Company is evaluating
whether to appeal the rejection, refile the application with substantially
narrowed claims, or abandon the application in its entirety. The decision in
this matter must be made no later than February 25, 1999.
On February 21, 1997 the Company filed a PCT application directed to
the foregoing subject matter. The situation with respect to this subject matter
is the same as that of the counterpart PCT application directed to buccal
nonpolar spray or capsule discussed above. The Company has made individual
filings for patent protection in Canada and Europe.
Buccal Nonpolar Spray for Nitroglycerin. On April 12, 1996, the Company
filed an application in the PTO directed to the above subject matter. On August
5, 1998 the PTO allowed claims to the above subject matter, and a patent will
issue in early 1999.
On February 21, 1997 the Company filed a PCT application directed to
the above subject matter. The situation with respect to this application is the
same as that for the PCT application directed to buccal nonpolar sprays and
capsules.
General Comment with Respect to the Foregoing PCT Applications
The Company is interested in obtaining patent protection in Europe and
Canada. It is to be expected that the same examiner who examined these
applications as a PCT examiner will be the examiner who will handle these
applications in the European "National" Phase. Hence, the Company anticipates
that in the case of the European applications, it may be necessary to appeal to
the Board of Appeals in Munich. At the present time, it is not possible to
accurately predict the expenses involved in pursuing the foregoing applications.
However, expenses may exceed $100,000 (in the aggregate for all three
applications) before a final disposition is obtained. The Company expects this
process to take between two and four years.
Buccal/Polar/Nonpolar Sprays or Capsule (Different Medicaments as
Above). An application was filed with the PCT on October 1, 1997 designating a
large number of possible countries including the United States. This application
differs from the first two applications above in that it utilizes different
ingredients. The search phase has been initiated and a partial search report has
been received. Further search results are expected, after which the Company will
decide whether to proceed to the examination phase.
Antihistamine Syrup and Ointment. On November 10, 1997 the Company
filed an application with the U.S. PTO for protection of its antihistamine syrup
and ointments. A technology to be utilized in the company's proposed poison ivy
product. In October 1998, the PTO rejected the application for this product, and
the Company is currently evaluating whether to further pursue this claim.
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Product Liability
The Company may be exposed to potential product liability claims by
consumers. With the exception of the Goldmark products, the Company does not
presently maintain product liability insurance coverage. Although the Company
will seek to obtain product liability insurance prior to the commercialization
of any products, there can be no assurance that the Company will obtain such
insurance or, if obtained, that any such insurance will be sufficient to cover
all possible liabilities. In the event of a successful suit against the Company,
insufficiency of insurance coverage could have a material adverse effect on the
Company. In addition, certain food and drug retailers require minimum product
liability insurance coverage as a condition precedent to purchasing or accepting
products for retail distribution. Failure to satisfy such insurance requirements
could impede the ability of the Company or its distributors to achieve broad
retail distribution of its proposed products, which would have a material
adverse effect upon the business and financial condition of the Company.
Customer Dependence
Since inception, substantially all of the Company's revenues have been
derived from consulting activities primarily in connection with product
development for various pharmaceutical companies. Among other things, the
Company works with its European clients to obtain regulatory approvals for new
drug formulations in the United States. For the year ended July 31, 1998,
consulting activities relating to the Company's three (3) largest clients
accounted for approximately 25%, 21% and 21% respectively, of the Company's
revenue. For the year ended July 31, 1997, consulting activities relating to the
Company's two largest clients accounted for approximately 24% and 23%
respectively, of the Company's revenue. For the year ended July 31, 1996
consulting activities relating to the Company's three largest clients accounted
for approximately 60%, 14% and 10% respectively, of the Company's revenue. The
contract with the Company's largest customer for fiscal 1996, was non-recurring
in nature.
Employees
The Company currently has nine (9) full-time employees, five (5) of
whom are executive officers of the Company, and four (4) of whom are engaged in
administrative functions. The success of the Company will be dependent in part,
upon its ability to hire and retain additional qualified sales and distribution
personnel, however, there can be no assurance that the Company will be able to
hire or retain such necessary personnel.
Certain Considerations
This Form 10-KSB, other documents of the Company and statements made by
members of management of the Company, in each case, may contain forward-looking
statements which involve risks and uncertainties. The Company's actual results
may differ significantly from the results discussed in such forward-looking
statements. Factors that might cause such a difference include the following:
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Accumulated Deficit and Operating Losses; Anticipated Continuing
Losses; Limited Working Capital. The Company had an accumulated deficit at July
31, 1998 of approximately $1,868,000. The Company incurred operating losses in
three of the last five fiscal years ended July 31 including a net loss of
approximately $708,000 for the year ended July 31, 1998. Because the Company
increased its product development activities, the Company anticipates that it
will incur substantial operating expenses in connection with continued
development, testing and approval of its proposed products, and expects these
expenses will result in continuing and, perhaps, significant operating losses
until such time, if ever, that the Company is able to achieve adequate product
sales levels.
Dependence on Principal Clients. To date, substantially all of the
Company's revenues have been derived from consulting services rendered to a
limited number of clients, the loss of certain of which would have an adverse
effect on the Company. For the year ended July 31, 1998, consulting activities
relating to the Company's three (3) largest clients, with which the Company has
written agreements, accounted for approximately 25%, 21% and 21%, respectively,
of the Company's revenues. There can be no assurance that the Company's clients
will continue to seek consulting services from the Company or that the Company
will continue to provide consulting services to the industry. See "-- - Customer
Dependence."
Evolving Nature of Business; Entry into Product-Based Business.
Although the Company has received revenue from its own product development
activities, these revenues are insignificant as compared to the Company's
revenues from product development consultation work done for its clients. The
nature of the Company's revenue received from its own product development
consists of payments by major pharmaceutical companies for research and
bioavailability studies, pilot clinical trials, and similar milestone-related
payments. The Company expects to continue its consulting activities despite
increasing its product development activities. The future growth and
profitability of the Company will, however, be partially dependent upon the
Company's ability to successfully complete the development of, obtain regulatory
approvals for, and license out or market, its own proposed products.
Accordingly, the Company's prospects must be considered in light of the risks,
expenses and difficulties frequently encountered in connection with the
establishment of a new business in a highly competitive industry, characterized
by frequent new product introductions. The Company anticipates that it will
incur substantial operating expenses in connection with the development, testing
and approval of its proposed products and expects these expenses to result in
continuing and, perhaps, significant operating losses until such time, if ever,
that the Company is able to achieve adequate levels of sales or license
revenues. There can be no assurance that the Company will be able significantly
to increase revenues or achieve profitable operations.
Significant Capital Requirements for Product Development and
Commercialization. The Company has a significant capital requirement necessary
to fund planned expenditures in connection with the research, development,
testing and approval of its proposed products. The Company anticipates, based on
its current proposed plans and assumptions relating to its operations (including
the timetable of, and costs associated with, new product development), that the
proceeds of the Public Offering and projected cash flow from operations will be
sufficient to
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<PAGE>
satisfy its contemplated cash requirements for approximately 18 months from the
date hereof. If the Company's plans change, its assumptions change or prove to
be inaccurate, or if the projected cash flows prove to be insufficient to fund
operations due to unanticipated expenses, technical problems or difficulties or
otherwise, the Company could be required to seek additional financing sooner
than currently anticipated. The Company has no current arrangements with respect
to, or sources of, additional financing, and there can be no assurance that
additional financing will be available to the Company on acceptable terms, if at
all. Pursuant to the Underwriting Agreement, until November 2002 (thirty-six
months from the closing of the Public Offering), the Company may not offer,
sell, issue or transfer its capital stock without the prior written consent of
the Representative. There exist certain exceptions to this prohibition. The
Company reserves the right to challenge certain contractual obligations with the
Representative due to the Representative's current status. In view of the
Company's very limited resources, its anticipated expenses and the competitive
environment in which the Company operates, any inability to obtain additional
financing could severely limit the Company's ability to complete development and
commercialization of its proposed products. See "MANAGEMENT'S DISCUSSION AND
ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS."
No Commercially Available Products. The Company's principal efforts are
the development of, and obtaining regulatory approvals for, its proposed
products. The Company anticipates that marketing activities for its proprietary
products, whether by the Company or one or more licensees will not begin until
2001 at the earliest. Accordingly, it is not anticipated that the Company will
generate any revenues from royalties or sales of proprietary products until
regulatory approvals are obtained and marketing activities begin. There can be
no assurance that any of the Company's proposed proprietary products will prove
to be commercially viable, or if viable, that they will reach the marketplace on
the timetables desired by the Company. The failure or the delay of these
products to achieve commercial viability would have a material adverse effect on
the Company. See "- Proposed Products" and " - Government Regulation."
Product Development and Acceptance Risks. The development of the
Company's proposed products has not been completed and the Company will be
required to devote considerable effort and expenditures to complete such
development. Satisfactory completion of development, testing, government
approval and sufficient production levels of such products must be obtained
before the proposed products will become available for commercial sale. The
Company does not anticipate generating material revenue from product sales until
perhaps 2000 or thereafter. Other potential products remain in the conceptual or
very early development stage and remain subject to all the risks inherent in the
development of pharmaceutical products, including unanticipated development
problems, and possible lack of funds to undertake or continue development. These
factors could result in abandonment or substantial change in the development of
a specific formulated product. There can be no assurance that any of the
Company's proposed products will be successfully developed, be developed on a
timely basis or be commercially accepted once developed. The inability to
successfully complete development, or a determination by the Company, for
financial or other reasons, not to undertake to complete development of any
product, particularly in instances in which the Company has made significant
capital expenditures, could have a material adverse effect on the Company. See
"- - Proposed Products."
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Lack of Direct Consumer Marketing Experience; Dependence on Joint
Marketing Arrangements. The Company has no experience in marketing or
distribution at the consumer level of its proposed proprietary products.
Moreover, the Company does not have the financial or other resources to
undertake extensive marketing and advertising activities. Accordingly, the
Company intends generally to rely on marketing arrangements, including possible
joint ventures or license or distribution arrangements with third parties. The
Company has not entered into any significant agreements or arrangements with
respect to the marketing of its proposed products, and there can be no assurance
that it will do so in the future or that any such products can be successfully
marketed. The Company's strategy to rely on third party marketing arrangements
could adversely affect its profit margins. See " - Marketing and Distribution."
Dependence on Contract Manufacturing. The Company has agreements with
respect to the manufacture of its initially proposed products with its European
contract manufacturers. Under these agreements the Company is responsible to
obtain required regulatory approvals, begin commercialization within three
months after FDA marketing approval, pay royalties under certain circumstances,
and satisfy certain minimum purchase requirements. Additionally, these
agreements provide for negotiation and annual re-negotiation of terms relating
to per item cost. There can be no assurance that such terms can be negotiated on
terms satisfactory to the Company or that failure to negotiate such terms will
not result in the termination of any such agreement. The failure of the Company
to satisfy its obligations under any of these agreements could result in
modification or termination of such agreement. There can be no assurance that
the Company will have the ability to satisfy all of its obligations under these
agreements, and failure to do so could require the Company to obtain alternative
manufacturing arrangements, which could have an material adverse effect on the
Company. The Company's dependence upon third parties for the manufacture of its
products could have an adverse effect on the Company's profit margins and its
ability to deliver its products on a timely and competitive basis.
Compliance with Good Manufacturing Practices. The Company currently
intends to rely on third-party arrangements for the manufacture of its proposed
products. The manufacture of the Company's pharmaceutical products will be
subject to current Good Manufacturing Practices ("cGMP") prescribed by the FDA,
pre-approval inspections by the FDA or foreign authorities, or both, before
commercial manufacture of any such products and periodic cGMP compliance
inspections thereafter by the FDA. There can be no assurance that the Company's
European manufacturers will be able to comply with cGMP or satisfy pre- or
post-approval inspections in connection with the manufacture of the Company's
proposed products. The Company's gelatin capsule manufacturer
SCA-Lohnherstellungs AG ("Swisscaps") successfully completed an FDA pre-approval
inspection in connection with the approval of the Company's Abbreviated New Drug
Application ("ANDA") for Nifedipine. Because Rapid Spray GmbH & Co., KG. ("Rapid
Spray"), the Company's other manufacturer, is not currently manufacturing a
product covered by an FDA application, Rapid Spray has not yet been inspected by
the FDA. Failure or delay by any such manufacturer to comply with cGMP or
satisfy pre- or post-approval inspections would have a material adverse effect
on the Company. See "-- Manufacturing."
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Foreign Manufacturing and Related Risks. The Company anticipates that
its initially proposed products will be manufactured by its European
manufacturers at facilities in Germany and Switzerland. The Company intends to
import completed manufactured products into the United States. In addition, the
raw materials necessary for the manufacture of the Company's products will, in
all likelihood, be purchased by the Company from suppliers in the United States
or Europe and delivered to its manufacturers' facilities by such suppliers.
Accordingly, the Company and its manufacturers may be subject to various import
duties applicable to both finished products and raw materials and may be
affected by various other import and export restrictions as well as other
developments impacting upon international trade. These international trade
factors will, under certain circumstances, have an impact both on the
manufacturing cost (which will, in turn, have an impact on the cost to the
Company of the manufactured product) and the wholesale and retail prices of the
products to be manufactured abroad. To the extent that transactions relating to
the foreign manufacture of the Company's proposed products and purchase of raw
materials involve currencies other than United States dollars, the operating
results of the Company will be affected by fluctuations in foreign currency
exchange rates. See "- - Manufacturing."
Supplier Dependence. The Company believes that the active ingredients
used in the manufacture of its proposed pharmaceutical products are presently
available from numerous suppliers located in the United States, Europe and
Japan. The Company believes that certain raw materials, including inactive
ingredients, are available from a limited number of suppliers and that certain
packaging materials intended for use in connection with its spray products
currently are available only from sole source suppliers. Although the Company
does not believe it will encounter difficulties in obtaining the inactive
ingredients or packaging materials necessary for the manufacture of its
products, there can be no assurance that the Company will be able to enter into
satisfactory agreements or arrangements for the purchase of commercial
quantities of such materials. The Company has written supply agreements with
Dynamit Nobel for certain raw materials and with Rapid Spray for the
nitroglycerin lingual spray product. With respect to other suppliers, the
Company operates primarily on a purchase order basis beyond which there is no
contract memorializing the Company's purchasing arrangements. The failure to
enter into agreements or otherwise arrange for adequate or timely supplies of
principal raw materials and the possible inability to secure alternative sources
of raw material supplies could have a material adverse effect on the Company's
ability to arrange for the manufacture of formulated products. In addition,
development and regulatory approval of the Company's products are dependent upon
the Company's ability to procure active ingredients and certain packaging
materials from FDA-approved sources. Since the FDA approval process requires
manufacturers to specify their proposed suppliers of active ingredients and
certain packaging materials in their applications, FDA approval of a
supplemental application to use a new supplier would be required if active
ingredients or such packaging materials were no longer available from the
originally specified supplier, which could result in manufacturing delays. See
"- - Raw Materials and Suppliers."
Competition. The markets which the Company intends to enter are
characterized by intense competition. The Company or its licensees may be
competing against established pharmaceutical companies which currently market
products which are equivalent or functionally
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<PAGE>
similar to those the Company intends to market. Prices of drug products are
significantly affected by competitive factors and tend to decline as competition
increases. In addition, numerous companies are developing or may, in the future,
engage in the development of products competitive with the Company's proposed
products. The Company expects that technological developments will occur at a
rapid rate and that competition is likely to intensify as enhanced dosage from
technologies gain greater acceptance. Additionally, the markets for formulated
products which the Company has targeted for development are intensely
competitive, involving numerous competitors and products. Most of the Company's
prospective competitors possess substantially greater financial, technical and
other resources than the Company. Moreover, many of these companies possess
greater marketing capabilities than the Company, including the resources
necessary to enable them to implement extensive advertising campaigns. There can
be no assurance that the Company will have the ability to compete successfully.
See "- - Competition."
Absence of Product Liability Insurance Coverage. The Company may be
exposed to potential product liability claims by consumers. The Company
presently maintains product liability insurance coverage on the Goldmark line of
products only. Although the Company will seek to obtain product liability
insurance before the commercialization of any proprietary products, there can be
no assurance that the Company will be able to obtain such insurance or, if
obtained, that any such insurance will be sufficient to cover all possible
liabilities to which the Company may be exposed. In the event of a successful
suit against the Company, insufficiency of insurance coverage could have a
material adverse effect on the Company. In addition, certain food and drug
retailers require minimum product liability insurance coverage as a condition
precedent to purchasing or accepting products for retail distribution. Failure
to satisfy such insurance requirements could impede the ability of the Company
or its distributors to achieve broad retail distribution of its proposed
products, which could have a material adverse effect on the Company. None of the
Company's European manufacturers have made any representations as to the safety
or efficacy of the products covered by their agreements or as to any products
which may be marketed or used under rights granted under any such agreements,
other than compliance with cGMP and product specifications. See "- Product
Liability."
Extensive Government Regulation. The development, manufacture and
commercialization of pharmaceutical products is generally subject to extensive
regulation by various federal and state governmental entities. The FDA, which is
the principal United States regulatory authority, has the power to seize
adulterated or misbranded products and unapproved new drugs, to request their
recall from the market, to enjoin further manufacture or sale, to publicize
certain facts concerning a product and to initiate criminal proceedings. As a
result of federal statutes and FDA regulations, pursuant to which new
pharmaceuticals are required to undergo extensive and rigorous testing,
obtaining pre-market regulatory approval requires extensive time and
expenditures. Under the Federal Food, Drug and Cosmetic Act (the "FDC Act"), a
new drug may not be commercialized or otherwise distributed in the United States
without the prior approval of the FDA. The FDA approval processes relating to
new drugs differ, depending on the nature of the particular drug for which
approval is sought. With respect to any drug product with active ingredients not
previously approved by the FDA, a prospective drug manufacturer is required to
submit a new drug application ("NDA"), including complete
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<PAGE>
reports of pre-clinical, clinical and laboratory studies to prove such product's
safety and efficacy. The NDA process generally requires, before the submission
of the NDA, submission of an IND pursuant to which permission is sought to begin
preliminary clinical testing of the new drug. An NDA, based on published safety
and efficacy studies conducted by others, may also be required to be submitted
for a drug product with a previously approved active ingredient if the method of
delivery, strength or dosage form is changed. Alternatively, a drug having the
same active ingredient as a drug previously approved by the FDA may be eligible
to be submitted under an ANDA, which is significantly less stringent than the
NDA approval process. While the ANDA process requires a manufacturer to
establish bioequivalence to the previously approved drug, it permits the
manufacturer to rely on the safety and efficacy studies contained in the DNA for
the previously approved drug. The Company believes that some of its drug
products developed in capsule form will be substantially similar to products
which have previously obtained FDA approval and, accordingly, that approvals for
such products can be obtained by submitting an ANDA. The Company, however, may
be required, before submitting an ANDA, to submit a suitability petition, the
purpose of which is to permit the FDA to evaluate whether a change in strength,
dosage form or method of delivery is significant enough to require clinical
trials and, therefore, an NDA filing. There can be no assurance that the FDA
will not require the Company to conduct clinical trials for such products and
otherwise comply with the NDA approval process. The Company believes that
products developed in spray dosage form will require submission of an NDA. The
Company estimates that the development of new formulations of pharmaceutical
products, including formulation, testing and obtaining FDA approval, generally
takes three to five years for the ANDA process and four to seven years for the
NDA process. There can be no assurance that the Company's determinations will
prove to be accurate or that pre-marketing approval relating to its proposed
products will be obtained on a timely basis, or at all. The failure by the
Company to obtain necessary regulatory approvals, whether on a timely basis, or
at all, would have a material adverse effect on the Company.
Patents and Protection of Proprietary Information. The Company holds a
United States patent covering its formulation for Nifedipine gelatin capsules,
which the Company believes is not material to its operations. The Company has
applied for United States and foreign patent protection for its proposed lingual
sprays and soft gelatin drug delivery processes. To the extent possible, the
Company intends to seek formulation patent protection or other proprietary
rights for those products utilizing the Company's oral dosage formulations.
There can be no assurance, however, that patents relating to such formulated
products or processes will in fact be granted or, if granted, will provide any
proprietary rights adequately protecting the Company. Other companies may
independently develop equivalent or superior technologies or processes and may
obtain patent or similar rights with respect thereto. Although the Company
believes that its technology has been independently developed and does not
infringe on the patents of others, there can be no assurance that the technology
does not and will not infringe on the patents of others. If a process covered by
a United States patent is utilized in the manufacture of a product in a foreign
country, the further manufacture, use or sale of such products in the United
States may constitute an infringement of the United States patent. In the event
of infringement, the Company or its European manufacturers could, under certain
circumstances, be required to modify the infringing process or obtain a license.
There can be no assurance that the Company or the European manufacturers will be
able to do so in a timely manner or upon acceptable terms
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and conditions or at all. The failure to do any of the foregoing could have a
material adverse effect on the Company. In addition, there can be no assurance
that the Company will have the financial or other resources necessary to enforce
or defend a patent infringement or proprietary rights violation action. If any
of the products developed by the Company infringes upon the patent or
proprietary rights of others, the Company could, under certain circumstances, be
enjoined or become liable for damages, which would have a material adverse
effect on the Company. See "- - Patents and Protection of Proprietary
Information."
Dependence on Existing Management. The success of the Company is
substantially dependent on the efforts and abilities of its founder Harry A.
Dugger, III, Ph.D., the Company's Chairman, John J. Moroney, Vice Presidents
Kenneth E. Cleaver, Ph.D. and Donald P. Cox, Ph.D., and the Company's Chief
Financial Officer, Donald Deitman. Mr. Moroney is not required to devote full
time to the Company. Decisions concerning the Company's business and its
management are and will continue to be made or significantly influenced by these
individuals. The Company has entered into employment agreements with Mr. Moroney
and Drs. Dugger, Cox and Cleaver. See "MANAGEMENT - Employment Agreements." The
loss or interruption of their continued services would have a materially adverse
effect on the Company's business operations and prospects. Additionally, the
Company's operations may be materially adversely affected if it is unable to
obtain and retain qualified sales and distribution personnel. The Company
purchased a Key Man life insurance policy on Dr. Dugger effective subsequent to
the Public Offering. See "- Marketing and Distribution" and "DIRECTORS AND
OFFICERS."
Control by Current Stockholders, Officers and Directors. Management and
affiliates of the Company currently beneficially own (including shares they have
the right to acquire) approximately 58.8% of the outstanding Common Stock. These
persons are and will continue to be able to exercise control over the election
of the Company's directors and the appointment of officers, increase the
authorized capital, dissolve, merge or engage the Company in other fundamental
corporate transactions. Certain change in control provisions found in the
employment agreements of Dr. Dugger and Mr. Moroney may have the effect of
discouraging, delaying or preventing a change in control of the Company.
Dividend Policy. The Company has never declared or paid a dividend on
its Common Stock, and management expects that a substantial portion of the
Company's future earnings will be retained for expansion or development of the
Company's business. The decision to pay dividends, if any, in the future is
within the discretion of the Board of Directors and will depend upon the
Company's earnings, capital requirements, financial condition and other relevant
factors such as contractual obligations. Management, therefore, does not
contemplate that the Company will pay dividends on the Common Stock in the
foreseeable future.
Limited Public Market. There has been a very limited public market for
the Units, the Common Stock and Warrants. Although the Units, Common Stock and
Warrants have been approved for inclusion on the OTC Bulletin Board, the
securities have been thinly traded, and there can be no assurance that a more
fluid trading market for the securities will develop or that, if developed, it
will be sustained. The OTC Bulletin Board is an unorganized, inter-dealer,
over-
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the-counter market which provides significantly less liquidity than the Nasdaq
Stock market, and quotes for stocks included on the OTC Bulletin Board are not
listed in the financial sections of newspapers as are those for the Nasdaq Stock
Market. Therefore, prices for securities traded solely on the OTC Bulletin Board
may be difficult to obtain and purchasers of the Units may be unable to resell
the securities offered hereby at or near their original offering price or at any
price. See "Possible Adverse Effect of "Penny Stock" Rules in Liquidity for the
Company's Securities."
Outstanding Options and Warrants. The Company has reserved up to
3,216,000 shares of its Common Stock for issuance upon exercise of stock options
and warrants. Of the reserved shares, a total of 1,500,000 shares have been
reserved and evenly divided among each of the Company's 1992, 1997 and 1998
Stock Option Plans, of which options to purchase an aggregate of 500,000,
500,000 and 100,000 shares have been issued under the respective Plans. Another
800,000 shares are reserved for issuance and available for the options granted
pursuant to the terms of the employment agreements of Mr. Moroney, and Drs.
Dugger, Cox and Cleaver. Further, shares of Common Stock are reserved for
issuance to cover warrants to purchase an aggregate of 100,000 shares of Common
Stock issued to Creative Technologies, Inc. in December 1996. In connection with
the Public Offering, the Company issued 680,000 Class A common stock purchase
warrants (the "Class A Warrants"). Also in connection with the Public Offering,
the Company issued to the Underwriters an option to purchase 68,000 Units
exercisable at $9.74 (165% of the respective public offering price of the Units)
which expire in November, 2001 (the "Underwriters' Options").
The Company agreed with the Underwriters, under certain circumstances,
to register the Shares and the Warrants subject to the Underwriters' Options for
distribution to the public. Exercise of these registration rights could involve
a substantial expense to the Company and could prove a hindrance to future
financings. Exercise of the Underwriters' Options, the Class A Warrants, the
outstanding warrants and stock options, and those which may be granted under the
Stock Option Plans (collectively, the "Convertible Securities"), will reduce the
percentage of Common Stock held by the public stockholders. Further, the terms
on which the Company could obtain additional capital during the life of the
Convertible Securities may be adversely affected, and it should be expected that
the holders of the Convertible Securities would exercise them at a time when the
Company would be able to obtain equity capital on terms more favorable than
those provided for by such Convertible Securities.
Potential Adverse Effect of Redemption of Warrants. The Warrants may be
redeemed by the Company commencing May 1999 (eighteen months from the date of
the Public Offering), or earlier with the consent of the Representative, at a
redemption price of $.10 per Warrant upon not less then thirty days prior
written notice provided the last sale price of the Common Stock on the NASD OTC
Bulletin Board, Nasdaq (or another national securities exchange) for twenty
consecutive trading days ending within three days of the notice of redemption,
equals or exceeds 200% of the current Warrant exercise price, subject to
adjustment. Redemption of the Warrants could force the holders thereof to
exercise the Warrants and pay the exercise price at a time when it may be
disadvantageous for the holders to do so, to sell the Warrants at the then
current market price when they might otherwise wish to hold the Warrants, or to
accept the redemption price,
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<PAGE>
which is likely to be substantially less than the market value of the Warrants
at the time of redemption.
Possible Resales Under Rule 144. Of the 3,877,300 shares of Common
Stock held by the Company's present stockholders, 3,197,300 shares of Common
Stock have not been registered under the Securities Act of 1933, as amended (the
"Act"). Under certain circumstances, the unregistered shares may be available
for public sale by means of ordinary brokerage transactions in the open market
pursuant to Rule 144, promulgated under the Act, subject to certain limitations.
In general, under Rule 144, a person (or persons whose shares are aggregated)
who has satisfied a one-year holding period may, under certain circumstances,
sell within any three-month period a number of securities which does not exceed
the greater of 1% of the then outstanding shares of Common Stock or the average
weekly trading volume of the class during the four calendar weeks prior to such
sale. Rule 144 also permits, under certain circumstances, the sale of
securities, without any limitation, by a person who is not an affiliate of the
Company and who has satisfied a two-year holding period. Of the unregistered
shares, (i) 38,700 shares have entered the public market pursuant to Rule 144,
(ii) 1,997,300 shares have been held by present stockholders for more than two
years, and (iii) 1,161,300 shares have been held by present stockholders for
more than one year but less than two years.
The Company has reserved up to 3,216,000 shares of its Common Stock for
issuance upon exercise of various stock options and warrants, of which 1,600,000
shares were registered under a Registration Statement on Form S-8 under the Act.
Although certain of the Company's principal stockholders, as well as all of its
officers and directors have executed lock-up agreements in which they agreed not
to publicly offer, sell or otherwise dispose of directly or indirectly, any of
the Company's securities owned by them, until November 2000 without the prior
written consent of the Representative, any substantial sale of Common Stock
pursuant to Rule 144 may have an adverse effect on the market price of the
Shares or the component securities. Notwithstanding the foregoing, the Company
reserves the right to contest the validity of any release of a lock-up agreement
by the Representative.
Possible Adverse Effect of "Penny Stock" Rules on Liquidity for the
Company's Securities. Commission regulations define a "penny stock" to be any
equity security that is not traded on a national securities exchange or Nasdaq
and that has a market price (as therein defined) of less than $5.00 per share,
subject to certain exceptions. For any transaction involving a penny stock,
unless exempt, the rules require delivery prior to any transaction in a penny
stock, of a disclosure schedule prepared by the Commission relating to the penny
stock market. Disclosure is also required to be made about commissions payable
to both the broker-dealer and the registered representative and current
quotations for the securities. Finally, monthly statements are required to be
sent disclosing recent price information for the penny stock held in the account
and information on the limited market in penny stocks.
The Company currently has an exemption from the penny stock rules. If
the Company no longer holds such an exemption and the Company's Common Stock
continues to trade on the OTC Bulletin Board at less than $5.00 per share, the
Company's securities may become subject to Rule 15g-9 under the Exchange Act
that imposes additional sales practice requirements on
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broker-dealers who sell such securities to persons other than established
customers and accredited investors (generally, such investors have assets in
excess of $1,000,000 or an individual annual income exceeding $200,000, or,
together with the investor's spouse, a joint income of $300,000). For
transactions covered by these rules, the broker-dealer must make a special
suitability determination for the purchase of such securities and have received
the purchaser's written consent to the transaction prior to the purchase.
Additionally, for any transaction involving a penny stock, unless exempt, the
rules require, among other things, the delivery, prior to the transaction, of a
risk disclosure document mandated by the Commission relating to the penny stock
market and the risks associated therewith. The broker-dealer must also disclose
the commission payable to both the broker-dealer and the registered
representative, current quotations for the securities and, if the broker-dealer
is the sole market-maker, the broker-dealer must disclose this fact and the
broker-dealer's presumed control over the market. Finally, monthly statements
must be sent disclosing recent price information for the penny stock held in the
account and information on the limited market in penny stocks. Consequently,
such rule may adversely affect the ability of broker-dealers to sell the
Company's securities and may adversely affect the ability of purchasers in this
offering to sell in the secondary market any of the securities acquired hereby.
There can be no assurance that the Company's securities will continue
to qualify for exemption from these restrictions. Even though the Company's
securities are currently exempt from such restrictions, it would remain subject
to Section 15(b)(6) of the Exchange Act, which gives the Commission the
authority to prohibit any person that is engaged in unlawful conduct while
participating in a distribution of a penny stock from associating with a
broker-dealer or participating in a distribution of a penny stock, if the
Commission finds that such a restriction would be in the public interest. If the
Company's securities were subject to rules on penny stocks, the market liquidity
for the Company's securities could be severely adversely affected. In such
event, the regulations on penny stocks could limit the ability of broker-dealers
to sell the Company's securities and thus the ability of purchasers of the
Company's securities to sell their securities in the secondary market.
Future Unspecified Acquisitions. Although there are no such
transactions contemplated at this time, the Company may, in the future, expand
its business, in part, through the acquisition of compatible products or
businesses. In attempting to locate and consummate such acquisitions, the
Company may compete with other prospective purchasers of the acquisition
candidate, some of which may have greater resources than the Company. There can
be no assurance that suitable acquisition candidates could be identified and
acquired on terms favorable to the Company, or that the acquired product lines
or operations could be profitably operated or integrated into the Company's
operations. In addition, any internally generated growth experienced by the
Company could place significant demands on the Company's management, thereby
restricting or limiting its available time and opportunity to identify and
evaluate potential acquisition candidates. The target entity of any such
acquisition will not be subject to shareholder review and the Company's decision
to pursue such transactions is not subject to shareholder approval.
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<PAGE>
Limitation on Directors' Liabilities under New Jersey Law. Pursuant to
the Company's Certificate of Incorporation and under New Jersey law, directors
of the Company are not liable to the Company or its stockholders for monetary
damages for breach of fiduciary duty, except for liability in connection with a
breach of duty of loyalty, for acts or omissions not in good faith or which
involve intentional misconduct or a knowing violation of law, for dividend
payments or stock repurchases illegal under New Jersey law or any transaction in
which a director has derived an improper personal benefit. In the event the
Company reincorporates under the laws of the State of Delaware (as it proposes
to do upon obtaining approval of the shareholders), New Jersey Law may no longer
be operable as it relates to the above.
Indemnification of Directors under New Jersey Law. Pursuant to both the
Company's Certificate of Incorporation and New Jersey law, the Company's
officers and directors are indemnified by the Company for monetary damages for
breach of fiduciary duty, except for liability which arises in connection with
(i) a breach of duty or loyalty, (ii) acts or omissions not made in good faith
or which involve intentional misconduct or a knowing violation of law, (iii) for
dividend payments or stock repurchases illegal under New Jersey law, or (iv) any
transaction in which the officer or director derived an improper personal
benefit. The Company's Certificate of Incorporation does not have any effect on
the availability of equitable remedies (such as an injunction or rescissions)
for breach of fiduciary duty. However, as a practical matter, equitable remedies
may not be available in particular circumstances. In the event the Company
reincorporates under the laws of the State of Delaware (as it proposes to do
upon approval of the shareholders), New Jersey Law may no longer be operable as
it relates to the above. The Company maintains director and officer liability
coverage.
Authorization and Discretionary Issuance of Preferred Stock. The
Company's Certificate of Incorporation authorizes the issuance of "blank check"
preferred stock with such designations, rights and preferences as may be
determined from time to time by the Board of Directors. Accordingly, the Board
of Directors is empowered, without stockholder approval, to issue preferred
stock with dividends, liquidation, conversion, voting or other rights which
could adversely affect the relative voting power or other rights of the holders
of the Company's Common Stock. In the event of issuance, the preferred stock
could be used, under certain circumstances, as a method of discouraging,
delaying or preventing a change in control of the Company, which could have the
effect of discouraging bids for the Company and thereby
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<PAGE>
prevent stockholders from receiving the maximum value for their shares. Although
the Company has no present intention to issue any shares of its preferred stock,
there can be no assurance that the Company will not do so in the future. In the
event the Company relocates under the Laws of the State of Delaware (as it
proposes to do upon approval of the Company's shareholders) the rights,
preferences and designations of the preferred stock will be substantially
identical to those of the present.
Pursuant to the terms of the Underwriting Agreement, the Company may
not, except with respect to certain qualifying acquisitions, issue capital stock
until November 2000 without prior written consent of the Representative.
Notwithstanding the foregoing, the Company reserves the right to contest its
obligations under agreements with the Representative due to the Representative's
current status.
ITEM 2. PROPERTIES
The Company's executive offices are located at 43 Emery Avenue,
Flemington, New Jersey. The facility, constituting approximately 4,300 square
feet is occupied under two separate month to month tenancies. Should these
tenancies be terminated for any reason, there is ample comparable space
available in the area for the Company to occupy. Since the manufacture of the
Company's products are conducted by outside vendors, the Company does not own or
lease any production or manufacturing facilities. The Company believes the
current Flemington facilities will adequately serve its needs for the
foreseeable future.
ITEM 3. LEGAL PROCEEDINGS
There are no material legal proceedings involving the Company.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
During the fourth quarter of the fiscal year covered by this report, no
matters were submitted to a vote of security holders, though the solicitation of
proxies or otherwise.
ITEM 4A
The non-director executive officers of the Company and their positions
with the Company are as follows:
Donald Deitman, Chief Financial Officer. Mr. Deitman joined the Company in 1998.
From 1988 until joining the Company, Mr. Deitman was employed as a business
consultant implementing multi-module MRP II software systems. From 1982 to 1988,
Mr. Deitman was corporate controller for FCS Industries, Inc. of Flemington, New
Jersey. From 1975 to 1982, he was manager of materials and systems for the
Walworth Company operations located in Linden and Elizabeth, NJ and from 1966 to
1975, he was employed by Ortho Pharmaceuticals, Inc. and Ortho Diagnostics, Inc.
Mr. Deitman received a BS in Accounting from Rutgers University in 1972.
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Kenneth E. Cleaver, Ph.D., Vice President, Regulatory Affairs. Dr. Cleaver
joined the Company in 1998. From 1992 until joining the Company, Dr. Cleaver
founded and served as the President of Medical Development Quality Associates of
Flemington, New Jersey, a consulting firm which assisted various members of the
pharmaceutical industry in the development, marketing and maintenance of medical
products. From 1984 to 1992, Dr. Cleaver held various positions in which he
consulted in the areas of clinical research, quality assurance and regulatory
affairs. From 1976 to 1984, he was employed by Janssen Pharmaceutical, Inc. of
Piscataway, New Jersey. Dr. Cleaver received a BS in Chemistry from Albright
College in 1968, and an MA in Organic Chemistry and a Ph.D. in Pharmaceutics
from Temple University in 1975 and 1984, respectively.
Donald P. Cox, Ph. D., Vice President, Product Development. Dr. Cox joined the
Company in 1998. In 1989, Dr. Cox founded D.P. Cox Associates, a biotechnology
consulting firm, and Goldmark Biologicals, a distributor of colloidal gold
reagents. From 1979 to 1989, Dr. Cox was a Director of Technical
Services/Operations with Janssen Pharmaceutical, Inc. of Piscataway, New Jersey.
Dr. Cox received a BS in Biology from Eureka College in 1964, an MS and Ph.D. in
Bacteriology from the University of Wisconsin in 1967 and 1970, respectively, an
MBA from Temple University in 1989, and conducted a Postdoctoral Fellowship at
Cornell University from 1970 to 1973.
PART II
ITEM 5. MARKET FOR COMMON STOCK AND RELATED
SECURITYHOLDER MATTERS
(a) Market Information. Since the November 1997 closing of the
Public Offering, the Company's Common Stock has traded in the over-the-counter
market on the National Association of Securities Dealers, Inc. OTC Bulletin
Board System ("OTCBB") under the symbol "FLEM". The following table sets forth
the range of high and low closing bid quotations of the Common Stock as reported
by the OTCBB for each fiscal quarter for the past two fiscal years or such
shorter period that there has been a public trading market. High and low bid
quotations represent prices between dealers without adjustment for retail
mark-ups, mark-downs or commissions and may not necessarily represent actual
transactions.
<TABLE>
<CAPTION>
Bid Prices
----------
High Low
---- ---
<S> <C> <C>
FISCAL 1997
Second Quarter (November 26, 1997 through January 31, 1998) 7.75 1.00
Third Quarter (February 1, 1998 through April 30, 1998) 1.938 .875
Fourth Quarter (May 1, 1998 through July 31, 1998) 1.938 1.313
FISCAL 1998
First Quarter (August 1, 1998 through October 21, 1988) 3.375 1.438
</TABLE>
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The closing bid price of the Company's Common Stock as
reported by the OTCBB was $2.4375 on October 21, 1998.
(b) Holders. As of October 21, 1998 there were approximately
50 record holders of the Company's Common Stock.
(c) Dividends. The Company has never declared or paid a
dividend on its Common Stock, and management expects that all or a substantial
portion of the Company's future earnings will be retained for expansion or
development of the Company's business. The decision to pay dividends, if any, in
the future is within the discretion of the Board of Directors and will depend
upon the Company's earnings, capital requirements, financial condition and other
relevant factors such as contractual obligations. Management does not anticipate
that the Company will pay dividends on the Common Stock in the foreseeable
future. Moreover, there can be no assurance that dividends can or will ever be
paid.
ITEM 6. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
General
Since its inception, substantially all of the Company's revenues have
been derived from consulting activities, primarily in connection with product
development for various pharmaceutical companies. The Company has had a history
of recurring losses from operations, giving rise to an accumulated deficit at
July 31, 1998 of approximately $1,868,000. Although substantially all of the
Company's revenues to date have been derived from its consulting business, the
future growth and profitability of the Company will be principally dependent
upon its ability to successfully develop its products and to enter into license
agreements with drug companies who will market and distribute the final
products. The Company's revenues from consulting declined during the two years
ended July 31, 1998 and may continue to decline in the future as the Company
shifts its emphasis away from product development consulting for its clients and
towards development of its own products.
For the reasons stated above, the Company believes that its results of
operations for the periods ended July 31, 1998 are not necessarily indicative of
the Company's future results of operations. The Company anticipates that it will
incur substantial operating expenses in connection with the joint development,
testing and approval of its proposed delivery systems, and expects these
expenses will result in continuing and significant operating losses until such
time, if ever, that the Company is able to achieve adequate sales levels.
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Results of Operations
Fiscal Year 1998 Compared to Fiscal Year 1997
Revenues for the fiscal year ended July 31, 1998 ("fiscal 1998")
decreased approximately $62,000 or 7% to $871,000 from $933,000 for the fiscal
year ended July 31, 1997 ("fiscal 1997"). The revenue decrease in fiscal 1998
was primarily attributable to the completion of clinical studies in progress
from July 31, 1997 and no new studies beginning during fiscal 1998.
Total costs and expenses for fiscal 1998 increased approximately
$235,000 or 17% to approximately $1,579,000 from $1,344,000 for fiscal 1997.
This increase includes an approximate $119,000 increase in product development
costs and an approximate $119,000 increase in consulting fees and commissions.
The consulting fees and commissions related to client studies, business
development and financial public relations. In addition, the Company had an
approximate $160,000 increase in salaries offset with an approximate $200,000
decrease in operating expenses primarily related to costs of clinical studies.
Fiscal Year 1997 Compared to Fiscal Year 1996
Revenues (excluding the non-recurring item discussed below) for the
fiscal year ended July 31, 1997 decreased approximately $500,000 or 35% to
$933,000 from $1,433,000 for the fiscal year ended July 31, 1996 ("fiscal
1996"). In fiscal 1996, the Company incurred a non-recurring consulting fee of
$2,070,000 and associated expenses of $1,606,000.
The revenue decrease in fiscal 1997 was primarily attributable to
delays in commencement of follow-on clinical studies. Follow-on clinical studies
are requested by clients when results of pilot clinical studies (which precede
follow-on studies) confirm clients expectations as to whether a particular
product formation achieves the desired result sought by the client. Because the
results of five pilot clinical studies conducted during fiscal 1997 did not
confirm such results, those clients determined to reformulate their products and
suspend further studies until such time as the client completes reformulation.
No contracts are in place for these follow-on studies. It has been the Company's
experience, and is standard industry practice, that clients in such
circumstances revise their action plans and return to the Company (which
conducted the initial studies) to pursue newly formulated initial clinical
studies, and if confirming results are achieved, the Company typically conducts
the follow-on studies. For those reasons, the Company expects that revenues from
consulting activities in fiscal 1998 will likely exceed consulting revenues in
fiscal 1997.
Costs and expenses for fiscal 1997 (excluding expenses associated with
the 1996 non-recurring consulting fee) decreased approximately $59,000 or 4% to
approximately $1,344,000 from $1,403,000 for fiscal 1996. In fiscal 1997 the
Company incurred a $47,000 expense associated with seeking sources of financing.
The decrease was primarily attributable to reductions in operating expenses of
$84,000, partially offset by increases in selling, general and administrative
expenses of $27,000.
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The net loss for fiscal 1997 was $411,000 compared to income of
$494,000 for fiscal 1996. This change is attributable primarily to reduced
revenues without a corresponding reduction in expenses.
Liquidity and Capital Resources
From its inception, the Company's principal sources of capital have
been provided by consulting revenues and private placements, as well as loans
and capital contributions from the Company's principal stockholders. At July 31,
1998 the Company had working capital of approximately $2,221,000 as compared to
a working capital deficit of $39,000 at July 31, 1997 representing a net
increase in working capital of approximately $2,260,000. In November 1997, the
Company successfully closed an offering of its securities ("Public Offering").
The Public Offering provided for the sale of 675,000 units, each unit consisting
of one share of common stock, par value $.01 per share and one redeemable Class
A common stock purchase warrant with an exercise price of $5.80 per share,
subject to adjustment. As part of the offering, the underwriter exercised part
of its over allotment option to purchase an additional 5,000 units. As a result
of the offering, the Company received proceeds, net of offering costs and
underwriting discounts, of approximately $3,013,000.
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Net cash used in operating activities was approximately $1,073,000 for
the 1998 Period compared to net cash used in operating activities of
approximately $97,000 for the 1997 Period. Net cash used in operating activities
for the 1998 period was primarily attributable to the net loss of $708,000 and
the completion of studies in progress from July 31, 1997. For the 1998 Period,
$93,000 was used for investing activities and $3,090,000 was provided by
financing activities. Therefore, notwithstanding a $708,000 net loss and
$411,000 net loss for the 1998 and 1997 Periods, respectively, total cash flow
for the 1998 period increased approximately $2,632,000 as compared to $513,000
increase for the 1997 Period. The Company, upon the completion of the Public
Offering in November 1997, incurred salary obligations of $200,000 and $150,000
per annum to its two executive officers.
Although there can be no assurance, the Company believes that
the current cash levels together with revenues from operations, will be
sufficient to satisfy its cash requirements for at least the next eighteen (18)
months. No assurance can be given that future unforeseen events will not
adversely affect the Company's ability to implement its expansion plan,
requiring it to seek additional financing, which may not be available on terms
acceptable to the Company, if at all.
Inflation
The Company does not believe that inflation has had a material effect
on its results of operations during the past three fiscal years. There can be no
assurance that the Company's business will not be affected by inflation in the
future.
Year 2000 Issue ("Y2K")
Many existing computer programs use only two digits to identify a year
in the date field. These programs were designed and developed without
considering the impact of the upcoming change in the century. If not corrected
many computer applications could fail or create erroneous results by or at the
Year 2000. The Year 2000 issue affects virtually all companies and
organizations. Although the Company feels that the Year 2000 issue will not have
a significant impact on its internal operations, there can be no assurance that
the Company's suppliers, creditors, customers and financial service
organizations may not be adversely affected by the Year 2000 issue and as a
result, there can be no assurance as to the impact of the Year 2000 issue on the
Company. The Company intends to correspond to the aforementioned organizations
to determine their Y2K readiness and compliance. In the event the Company
determines that any of its suppliers, creditors, customers or financial services
organizations are not Y2K compliant, the Company will seek to develop
relationships with alternative Y2K compliant sources.
New Accounting Pronouncements
See Note 1 to the Financial Statements for a discussion of New
Accounting Pronouncements affecting the Company.
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<PAGE>
ITEM 7. FINANCIAL STATEMENTS
The response to this item is included as a separate section of this
report commencing on page F-1.
ITEM 8. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON
ACCOUNTING AND FINANCIAL DISCLOSURE
Not Applicable.
PART III
ITEM 9. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
See the information under the caption "Election of Directors" contained
in the Proxy Statement for the Annual Meeting of Stockholders of Registrant to
be held on November 23, 1998, which information is incorporated hereby by
reference. See also the information with respect to non-director executive
offices of Registrant under Item 4a of Part I hereof, which information is
incorporated by reference.
ITEM 10. EXECUTIVE COMPENSATION
See the information under the caption "Executive Compensation"
contained in the Proxy Statement for the Annual Meeting of Stockholders of
Registrant to be held on November 23, 1998, which information is incorporated
herein by reference.
37
<PAGE>
ITEM 11. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND
MANAGEMENT
See the information under the caption "Security Ownership of Management
and Certain Beneficial Owners" contained in the Proxy Statement for the Annual
Meeting of Stockholders of Registrant to be held on November 23, 1998, which
information is incorporated herein by reference.
ITEM 12. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
See the information under the caption "Certain Transactions" contained
in the Proxy Statement for the Annual Meeting of Stockholders of Registrant to
be held on November 23, 1998, which information is incorporated herein by
reference.
PART IV
ITEM 13. EXHIBITS, LIST AND REPORTS ON FORM 8-K
List of Exhibits
The exhibits that are filed with this report or that are
incorporated herein by reference are set forth in the Exhibit Index appearing on
page E-1 hereof.
(b) Reports on Form 8-K
No reports on Form 8-K were filed during the last
quarter of fiscal 1998.
38
<PAGE>
INDEPENDENT AUDITORS' REPORT
To the Board of Directors and Stockholders of
Flemington Pharmaceutical Corporation
We have audited the balance sheet of Flemington Pharmaceutical Corporation as of
July 31, 1998 and the related statements of operations, changes in stockholders'
equity and cash flows for each of the two years in the period then ended. 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 Flemington Pharmaceutical
Corporation at July 31, 1998, and the results of its operations and its cash
flows for each of the two years in the period then ended in conformity with
generally accepted accounting principles.
WISS & COMPANY, LLP
Livingston, New Jersey
October 19, 1998
<PAGE>
FLEMINGTON PHARMACEUTICAL CORPORATION
BALANCE SHEET
JULY 31, 1998
<TABLE>
<S> <C> <C>
ASSETS
CURRENT ASSETS:
Cash ...................................................................... $ 2,141,000
Accounts receivable - trade, less allowance for doubtful
accounts of $40,000 .................................................... 146,000
Prepaid expenses and other current assets ................................. 36,000
-----------
Total Current Assets ............................................ $ 2,323,000
FURNITURE, FIXTURES, AND EQUIPMENT, LESS
ACCUMULATED DEPRECIATION OF $45,000 ......................................... 37,000
DEMAND NOTE RECEIVABLE, SHAREHOLDER ......................................... 60,000
OTHER ASSETS ................................................................ 86,000
-----------
$ 2,506,000
===========
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable-trade .................................................... $ 79,000
Accrued expenses and other current liabilities ............................ 23,000
-----------
Total Current Liabilities .............................................. $ 102,000
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY :
Preferred stock, $.01 per value:
Authorized 1,000,000 shares, none issued
Common stock $.01 par value:
Authorized - 10,000,000 shares
Issued and outstanding - 3,877,300 shares ........................ 39,000
Additional paid-in capital ............................................... 4,233,000
Accumulated Deficit ...................................................... (1,868,000)
-----------
Total Stockholders' Equity ....................................... 2,404,000
-----------
$ 2,506,000
===========
</TABLE>
See accompanying notes to financial statements.
2
<PAGE>
FLEMINGTON PHARMACEUTICAL CORPORATION
STATEMENTS OF OPERATIONS
Year Ended
July 31,
-----------------------
1998 1997
---------- ----------
REVENUES:
Operating revenues .............................. $ 774,000 $ 915,000
Interest Income ................................. 97,000 18,000
---------- ----------
871,000 933,000
---------- ----------
COST AND EXPENSES:
Operating expenses ............................... 535,000 735,000
Product development .............................. 290,000 171,000
Selling, general and
administrative expenses ........................ 747,000 437,000
Interest expense ................................. 7,000 1,000
---------- ----------
1,579,000 1,344,000
---------- ----------
NET LOSS ........................................... ( 708,000) ( 411,000)
PRO FORMA ADJUSTMENT:
Officers' salary ................................ 67,000 200,000
---------- ----------
PRO FORMA NET LOSS ................................. ($ 775,000) ($ 611,000)
---------- ----------
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
3,491,637 2,597,300
========== ==========
BASIC AND DILUTED LOSS
PER COMMON SHARE:
Net Loss ......................................... ( $.20) ( $.16)
========== ==========
Pro forma net loss ............................... ( $.22) ( $.24)
========== ==========
See accompanying notes to financial statements.
3
<PAGE>
FLEMINGTON PHARMACEUTICAL CORPORATION
STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIENCY)
<TABLE>
<CAPTION>
Common Stock
----------------------------
Additional Stockholders'
Par Paid-in Accumulated Equity
Shares Value Capital Deficit (Deficiency)
----------- ----------- ----------- ----------- -----------
<S> <C> <C> <C> <C> <C>
BALANCE, JULY 31, 1996 ............ 2,597,300 $ 26,000 $ 850,000 $ (749,000) $ 127,000
YEAR ENDED JULY 31, 1997
Options issued for services ..... -- -- 47,000 -- 47,000
Net loss ........................ -- -- -- (411,000) (411,000)
----------- ----------- ----------- ----------- -----------
BALANCE, JULY 31, 1997 ............ 2,597,300 26,000 897,000 (1,160,000) (237,000)
----------- ----------- ----------- ----------- -----------
YEAR ENDED JULY 31, 1998
Issuance of Common Stock: --
In Connection with Initial Public
Offering, net of offering costs 680,000 7,000 3,006,000 -- 3,013,000
Upon Conversion of
Stockholder Note 600,000 6,000 294,000 -- 300,000
Options issued for services -- -- 36,000 -- 36,000
Net Loss -- -- -- (708,000) (708,000)
----------- ----------- ----------- ----------- -----------
BALANCE, JULY 31, 1998 3,877,300 $ 39,000 $ 4,233,000 $(1,868,000) $ 2,404,000
=========== =========== =========== =========== ===========
</TABLE>
See accompanying notes to financial statements.
4
<PAGE>
FLEMINGTON PHARMACEUTICAL CORPORATION
STATEMENTS OF CASH FLOWS
<TABLE>
<CAPTION>
Year Ended
July 31,
-----------------------------
1998 1997
----------- -----------
<S> <C> <C>
CASH FLOW FROM OPERATING ACTIVITIES:
Net loss ($ 708,000) ($ 411,000)
Adjustments to reconcile net loss to net cash
flows from operating activities:
Provisions for losses on accounts receivable -- 20,000
Options issued for services 7,000 47,000
Depreciation and amortization 11,000 6,000
Changes in operating assets and liabilities:
Accounts receivable 92,000 116,000
Prepaid expenses and other current assets (30,000) 4,000
Costs and estimated earnings in excess of billings on
uncompleted contracts 12,000 6,000
Other Assets (47,000) 18,000
Accounts payable - trade (137,000) (52,000)
Billings in excess of costs and estimated earnings
on uncompleted contracts (277,000) 105,000
Accrued expenses and other current liabilities 4,000 44,000
----------- -----------
Net cash flows from operating activities (1,073,000) (97,000)
----------- -----------
CASH FLOWS FROM INVESTING ACTIVITIES -
Purchase of property and equipment (33,000) (9,000)
Demand note receivable - shareholder (60,000) --
----------- -----------
Net cash flows from investing activities (93,000) (9,000)
----------- -----------
CASH FLOWS FROM FINANCING ACTIVITIES -
Deferred offering costs -- (77,000)
Proceeds of loans from stockholders -- 300,000
Repayments of stockholder loans -- (15,000)
Initial public offering 3,090,000 --
----------- -----------
Net cash flows from financing activities 3,090,000 208,000
----------- -----------
NET CHANGE IN CASH 1,924,000 102,000
CASH, BEGINNING OF YEAR 217,000 115,000
----------- -----------
CASH, END OF YEAR $ 2,141,000 $ 217,000
=========== ===========
SUPPLEMENTAL CASH FLOW INFORMATION:
Interest paid $ 7,000 $ --
----------- -----------
Income taxes paid $ -- $ --
=========== ===========
NON CASH FINANCING ACTIVITIES:
Conversion of Stockholder Note
Payable into Common Stock $ 300,000 $ --
=========== ===========
Reclassification of deferred offering costs into paid in capital $ 77,000 $ --
=========== ===========
Options issued for future services $ 29,000 $ --
=========== ===========
</TABLE>
See accompanying notes to financial statements
5
<PAGE>
FLEMINGTON PHARMACEUTICAL CORPORATION
NOTES TO FINANCIAL STATEMENTS
Note 1 - Nature of the Business and Summary of Significant Accounting Policies:
Nature of the Business - Flemington Pharmaceutical Corporation (the
"Company") is engaged in domestic and international consulting
activities and the development of novel pharmaceutical products
combining presently marketed drugs with innovative patent-pending oral
dosage delivery systems of the Company, designed to enhance and
accelerate the onset of the therapeutic benefits which the drugs are
intended to produce. Management intends to develop the products in
collaboration with pharmaceutical companies having significant existing
sales of the pharmaceutical compounds being incorporated into the
Company's dosage delivery systems, thereby creating a more effective,
and more attractive product.
The Company has not materially commercialized any of its proposed
products and, accordingly, has not generated any material revenue from
product sales. Since inception, substantially all of the Company's
revenue has been derived from providing consulting services to the
pharmaceutical industry. To date, the Company's drug development
activities have been largely funded through cash flow generated by the
initial public offering of its securities in November 1997 and its
consulting services.
Revenues and Costs - Revenues from contract clinical research are
recognized on the percentage-of-completion method. Completion is
measured by the relationship of total contract costs incurred to total
estimated contract costs for each study. Provisions for estimated
losses on uncompleted contracts are made in the period in which such
losses are determined.
Contract costs normally consist of fees paid to outside clinics for
studies and an allocable portion of the Company's operating expenses.
General and administrative costs pertaining to contracts are charged to
expense as incurred. At July 31, 1998, the Company had no outstanding
contracts in process.
Financial Instruments - Financial instruments include cash, accounts
receivable, loans to stockholders, accounts payable, and accrued
expenses. The amounts reported for financial instruments are considered
to be reasonable approximations of their fair values, based on market
information available to management.
Furniture, Fixtures and Equipment - Furniture, fixtures and equipment
are stated at cost. The Company provides for depreciation using
accelerated methods, based upon estimated useful lives of 5 to 7 years
for furniture, fixtures and equipment.
Income Taxes - Deferred income taxes result primarily from net
operating losses and the differences resulting from reporting on the
cash basis of accounting for tax reporting purposes. As a result of
these temporary differences, the Company has recorded a deferred tax
asset with an offsetting valuation allowance for the same amount.
Defined Contribution Retirement Plans - The Company had a 401(K)
retirement plan covering substantially all employees. Company
contributions are at the discretion of the Board of Directors. The
Company made no contributions for the years ended July 31, 1998 and
1997 and the plan was terminated during fiscal July 31, 1998. In
September 1998, the Company adopted a new retirement plan providing for
contributions at management's discretion.
6
<PAGE>
Stock Compensation - Statement of Financial Accounting Standards
("SFAS") No. 123, "Accounting" for Stock-Based Compensation," requires
companies to measure employee stock compensation plans based on the
fair value method of accounting. However, the statement allows the
alternative of continued use of Accounting Principles Board (APB)
Opinion No. 25, "Accounting for Stock Issued to Employees," with pro
forma disclosure of net income and earnings per share determined as if
the fair value based method had been applied in measuring compensation
cost. The Company has determined it will continue to apply APB Opinion
No. 25 in accounting for its stock options plans. The Company recorded
a $36,000 and $47,000 charge in accordance with SFAS No. 123 for the
years ended July 31, 1998 and 1997, respectively, for options which
have been granted, to one of its consultants under an agreement which
was executed in May 1997 and amended in March 1998 (See Stock Options
Footnote Disclosure). No other compensation costs have been recorded
during the years ended July 31, 1998 and 1997 related to options,
warrants or any other equity instrument.
Risk Concentrations:
(a) Major Customers - During the year ended July 31, 1998, the
Company had revenue from three customers located in France,
the United Arab Emirates and Germany approximating 25%, 21%
and 21%, respectively, of the Company's total revenue.
During the year ended July 31, 1997, the Company had revenue
from two customers located in Germany and France approximating
24% and 23%, respectively, of the Company's total revenue.
(b) Accounts Receivable - At July 31, 1998, the Company had
unsecured accounts receivable from one customer located in the
United Arab Emirates and two customers located in Germany,
approximating 36%, 25% and 14%, respectively, of the Company's
total accounts receivable. At July 31, 1997, the Company had
unsecured accounts receivable from three customers located in
France, Germany and the United Arab Emirates approximating
37%, 36% and 13%, respectively, of the Company's total
accounts receivable.
The Company has long-standing relationships with its principal
customers and feels that credit risk associated with these
customers is limited. With regard to new customers, the
Company receives customer referrals through long standing
relationships.
(c) Significant Employees - All of the Company's consulting and
study reporting activities are performed by major stockholders
of the Company. As a result, the Company is completely
dependent upon these stockholders to continue with these
revenue activities.
(d) Supplier Dependence - The Company believes that certain raw
materials, including inactive ingredients, are available only
from a limited number of suppliers internationally and that
certain packaging materials intended for use in connection
with its spray products currently are available from limited
supply sources. The Company does not believe it will encounter
difficulties in obtaining inactive ingredients or packaging
materials necessary for the manufacture of its products.
However, there can be no assurance that the Company will be
able to enter into satisfactory purchasing agreements or
arrangements, thereby, causing a potential significant adverse
effect on the Company's ability to arrange for the manufacture
of formulated products.
7
<PAGE>
(e) Bank Concentrations - The Company maintains certain of its
cash balances in financial institutions, which are insured by
the FDIC up to $100,000 for each institution. At July 31,
1998, the Company has uninsured bank balances for these
accounts totaling approximately $2,000,000.
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 disclosures 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 those estimates.
Pro forma Adjustments - Officers' salaries are determined pursuant to
employment agreements which became effective in November 1997 upon the
consummation of initial public offering of the Company's securities. As
a result, officers' salaries have varied during the periods presented.
Accordingly, the pro forma effects of such changes have been reported
on the face of the statements of operations.
Net Income or (Loss) Per Share - The Company calculates earnings per
share in accordance with Statement of Financial Accounting Standard
(SFAS) No. 128, "Earnings Per Share" which was issued in February 1997
and is effective for periods ending after December 15, 1997. SFAS No.
128 replaces the presentation of primary and fully diluted earnings per
share with basic and diluted earnings per share. The Company uses the
weighted-average number of common shares outstanding during each period
to compute basic earnings per common share. Diluted earnings per share
are computed using the weighted-average number of common shares and
dilutive potential common shares outstanding. Dilutive potential common
shares are additional common shares assumed to be exercised.
New Accounting Pronouncements - In June 1997, the Board issued SFAS No.
130, Reporting Comprehensive Income, which establishes standards for
reporting and displaying comprehensive income and its components as
part of a full set of financial statements, and SFAS No. 131,
Disclosures about Segments of an Enterprise and Related Information. In
February 1998, the Board issued SFAS No. 132, Employers' Disclosures
about Pension and Other Postretirement Benefits. The aforementioned
pronouncements were all effective for years beginning after December
15, 1997.
In addition, the Board issued SFAS No. 133 Accounting for Derivative
Instruments and Hedging Activities in June 1998 for years beginning
after June 15, 1999. The Company does not expect that any of the
previously mentioned pronouncements will significantly impact its
financial statements.
8
<PAGE>
Note 2 - Stockholders' equity:
Initial Public Offering - In November 1997, the Company successfully
closed an offering of its securities ["Public Offering" or "Offering"].
The Offering provided for the sale of 675,000 units at a per unit price
of $5.90, each unit consisting of one share of common stock, par value
$.01 per share and one redeemable Class A common stock purchase warrant
with an exercise price of $5.80 per share, subject to adjustment. As
part of the Offering, the underwriter exercised part of its over
allotment option to purchase an additional 5,000 units. As a result of
the Offering, the Company received proceeds, net of offering costs and
underwriting discounts, of approximately $3,013,000.
Bridge Financing - In July 1997, the Company borrowed an aggregate of
$300,000, at an interest rate of 7% per annum, from two of its officer
shareholders, who financed this loan with proceeds realized upon the
private sale of 600,000 shares of their common stock in the Company.
The loan, which was evidenced by certain notes and was due to mature in
October 1998, was converted into an aggregate of 600,000 shares of the
Company's common stock upon the consummation of the Public Offering in
November 1997 in accordance with the terms of the notes.
Preferred Stock - The Company's Certificate of Incorporation authorizes
the issuance of up to 1,000,000 shares of Preferred Stock. None of such
Preferred Stock has been designated or issued to date. The Board is
authorized to issue shares of Preferred Stock from time to time in one
or more series and to establish and designate any such series and to
fix the number of shares and the relative conversion rights, voting,
terms of redemption and liquidation.
Status of Underwriter - Monroe Parker Securities, Inc., the
representative of several underwriters involved in underwriting the
Company's Public Offering ceased market making activities in the
Company's securities in late December 1997, and on January 5, 1998 was
the subject of a complaint issued by the NASD for alleged violations of
the NASD's rules in 1994 and 1995. In October 1998, the New York
attorney general's office announced the indictment of Monroe Parker
Securities, Inc. and twelve (12) principals and brokers from the firm
on charges that they have defrauded investors in the sale and trading
of securities. These alleged violations have no connection with the
Company's securities.
Note 3 - Related Party Transactions:
Legal Fees - The Company has incurred legal fees with an officer and
director of the Company. These fees approximated $71,000 and $53,000
for the years ended July 31, 1998 and 1997, respectively.
Consulting Fees - During the year ended July 31, 1998, the Company
incurred consulting fees for product development with one of its
stockholder directors approximating $60,000.
Stockholder's Note Receivable - In April 1998, the Company loaned
$60,000 to its President. The note is due on demand with interest at 7%
due quarterly. Interest approximated $1,000 for the year ended July 31,
1998.
Note 4 - Commitments and Contingencies:
Employment Agreements - The Company entered into separate employment
agreements with its President and Chairman of the Board of Directors
for a base annual salary of $200,000 and $150,000, respectively. Each
agreement has a base term of three years, which became effective in
November 1997 upon the completion of the public offering. The
agreements are thereafter renewable for additional one-year periods,
unless the Company gives notice to the contrary.
9
<PAGE>
Pursuant to these agreements, options were issued to these officers to
purchase a total of 600,000 shares, exercisable within a ten-year
period of the date of issue at an exercise price upon the consummation
of the public offering of $1.84 per share.
In May 1998, the Company entered into 3-year employment contracts with
a Vice President for Research and Development and a Vice President for
Product Development at annual salaries of $125,000 and $100,000,
respectively. In addition, the Company granted each officer 100,000 ten
(10) year stock options with an exercise price of $1.75 as
consideration for employment contracts. One third of the options vest
in each of the years 1999, 2000 and 2001.
Consulting Agreement - In December 1996, the Company entered into
agreement with a consulting company, (the "Consultant"), for assistance
in finding suitable business opportunities. The agreement provides for
the Company to pay a fee to the Consultant of 10% of the consideration
received by the Company from projects identified in the agreement, net
of expenses. The agreement also provides for the Company to pay a 5%
fee for equity transactions arranged by the Consultant. In addition to
the above, the Company issued a warrant to the Consultant to purchase
up to 100,000 shares of the Company's common stock at $2.50 per share,
with vesting of 20,000 shares upon completion of each successful
project. No warrants were earned through July 31, 1998 pursuant to this
agreement.
Public Relations Consultant - In May, 1997, the Company entered into an
agreement with a consultant to enhance its entree into the public
market and to secure an underwriter for the Company. In connection with
that agreement, the Company issued an option to the public relations
consultant to purchase an aggregate of 200,000 shares of the Company's
common stock (See Stock Options Disclosure).
In March 1998, the Company and the public relations consultant amended
the agreement to continue services though April 1999. As a result of
this extension, the original option issued in May 1997 was surrendered
and options were issued to purchase 200,000 shares with exercise prices
of $1.00 and 120,000 shares with an exercise price of $2.00, all
expiring five years from the date of grant.
Leases - The Company rents office space on a month to month basis. Rent
expense for the Company's totaled approximately $27,000 and $19,000 for
the years ended July 31, 1998 and 1997, respectively.
Government Regulation - The development, manufacture and
commercialization of pharmaceuticals are subject to extensive
regulation by various federal and state government entities.
Note 5 Income Taxes:
No provision for current and deferred income taxes is required for the
years ended July 31, 1998 and 1997.
10
<PAGE>
The significant components of the Company's net deferred tax asset are
summarized as follows:
<TABLE>
<CAPTION>
July 31
---------------------------
1998 1997
---------- ---------
<S> <C> <C>
Differences between the cash basis of accounting
for income tax reporting and the accrual basis
for financial reporting purposes $ ( 32,000) $ 103,000
Non-employee compensation pursuant to SFAS 123 33,000 19,000
Net operating loss carryforwards............................... 758,000 347,000
759,000 469,000
Valuation allowance (759,000) (469,000)
---------- ---------
Net deferred tax asset.................................$ - -
========== =========
</TABLE>
A valuation allowance is provided when it is more likely than not that
some portion of the deferred tax asset will not be realized. The
Company has determined, based on the Company's prior history of
recurring losses, that a full valuation allowance is appropriate at
July 31, 1998 and 1997.
At July 31, 1998, the Company has federal and state net operating loss
carryforwards for financial reporting and income tax purposes of
approximately $1,902,000 and $1,854,000, respectively, which can be
used to offset current and future taxable income through the year 2018.
Note 6 Stock Options:
At July 31, 1998, the Company had three plans to allow for the issuance
of stock options and other awards, the 1992 Stock Option Plan (the
"1992 Plan"), the 1997 Stock Option Plan (the "1997 Plan") and the
1998 Stock Option Plan (the "1998 Plan").
The 1992 Plan - In May 1992, the Company adopted the 1992 Plan under
which 500,000 shares of common stock were reserved for issuance either
as incentive stock options ("ISO's") under the Internal Revenue Code or
as non-qualified options. ISOs may be granted to employees and officers
of the Company and non-qualified may be granted to consultants,
directors, employees and officers of the Company. Options to purchase
Company's common stock could not be granted at a price less than the
fair market value of the common stock at the date of grant and will
expire not more than ten years from the date of grant. ISOs granted to
a 10% or more stockholder could not be for less than 110% of fair
market value or for a term of more than 5 years.
11
<PAGE>
Information on option activity for the 1992 Plan for the years ended
July 31, 1998 and 1997 is as follows:
<TABLE>
<CAPTION>
July 31,
----------------------------------------------
1998 (c) 1997 (c)
---- ----
<S> <C> <C> <C> <C>
Balance - beginning of year ..... 482,000 $1.76 -- $--
Options granted (a):
To 10% or more shareholders (b) -- -- 400,000 1.84
To others ..................... 20,000 2.00 84,500 1.67
Options cancelled ............... (2,000) 1.67 (2,500) 1.67
-------- ----- -------- -----
Balance - end of year ........... 500,000 1.78 482,000 1.76
======== ===== ======== =====
Options exercisable - end of year 500,000 1.78 482,000 1.76
======== ===== ======== =====
</TABLE>
(a) The weighted average fair value option granted during 1998 and
1997 was .30 and $.67 per option, respectively.
(b) Includes 54,348 incentive stock and 145,652 non-qualified
options, issued to the President of the Company and 200,000
non-qualified options issued to its Chairman of the Board, for
a total of 400,000 options.
(c) Represents weighted average exercise price.
1997 Plan - In January 1997, the Company's Board of Directors adopted
the 1997 Plan, providing for the issuance of options to employees,
officers and under certain circumstances, directors of and consultants
of the Company. Options granted under the plan may be either incentive
stock options as defined in the Internal Revenue Code or non-qualified
stock options. The total number of shares of common stock reserved and
under the plan is 500,000 shares.
Information on option activity of the 1997 Plan for the years ended
July 31, 1998, and 1997 is as follows:
<TABLE>
<CAPTION>
July 31,
--------------------------------------------------
1998 (e) 1997 (e)
---- ----
<S> <C> <C> <C> <C>
Balance - beginning of year ..... 200,000 $5.80 -- $--
Options granted :
To 10% or more shareholders (b) 100,000 1.10 -- --
To others ..................... 400,000 (c) 1.25 200,000(a) 5.80
Options cancelled ............... (200,000)(a) 5.80 -- --
-------- ----- ------- -----
Balance - end of year ........... 500,000 $1.22 200,000 5.80
======== ===== ======= =====
Options exercisable - end of year 500,000 $1.22 200,000 5.80
======== ===== ======= =====
</TABLE>
(a) Represents options issued to a consultant in May 1997,
expiring April 2002 (See Public Relations Consulting
Agreement).
(b) Represents 50,000 ISOs each issued to the President of the
Company and to its Chairman of the Board for total options to
purchase 100,000 shares.
(c) Represents 25,000 non-qualified stock options (NQSO) each
issued to four directors of the Company and 300,000 NQSOs to a
consultant (See Public Relations Consulting Agreement) for a
total of 400,000 NQSOs.
(d) The weighted average fair value of options issued in 1998 and
1997 was $.67 and $.24 per option, respectively.
(e) Represents weighted average exercise price.
1998 Plan - In June 1998, the Company's Board of Directors adopted the
1998 Plan, providing for the issuance of options to employees, officers
and under certain circumstances, directors of and consultants of the
Company. Options granted under the plan may be either incentive stock
options as defined in the Internal Revenue Code or non-qualified stock
options. The total number of shares of common stock reserved and under
the plan shall be 500,000 shares. No options have been issued under the
1998 Plan as of July 31, 1998.
12
<PAGE>
The Company uses the Intrinsic value method of accounting to measure
compensation expense. If the fair value method had been used to measure
compensation expense, net loss would have increased by approximately
$630,000 or $.18 per share to $1,338,000 or $.38 per share for the year
ended July 31, 1998 and $324,000 or $.12 per share to $735,000 or $.28
per share for the year ended July 31, 1997.
The fair value of options granted in 1998 were estimated at the date of
grant using a Black-Scholes option model with the following
weighted-average assumptions, respectively: risk-free interest rates of
5.0%, yield of 0.0%, volatility factors of the expected market price of
the Company's Common Stock of 10% to 128% and a weighted-average
expected life of the options of five (5) to ten (10) years.
The fair value of options granted in 1997 were estimated at the date of
grant using a Black-Scholes option model with the following
weighted-average assumptions, respectively: risk-free interest rates of
5.0%, yield of 0.0%, volatility factors of the expected market price of
the Company's Common Stock of 10% and a weighted-average expected life
of the options of ten (10) years.
The Black-Scholes option valuation model was developed for use in
estimating the fair value of traded options, which have no vesting
restrictions and are fully transferable. In addition, option valuation
models require input of highly subjective assumptions including the
expected stock price volatility. When the Company shares were not
traded publicly, the employee stock options had characteristics
significantly different from those of publicly traded options. Because
changes in the subjective input assumptions can materially affect fair
value estimate, in management's opinion, the existing models do not
necessarily provide a reliable single estimate of the fair value of its
employee stock options.
Other Non-plan Options and Warrants - At July 31, 1998 there were
outstanding the following classes and numbers of instruments
exercisable for Common Stock:
A. 680,000 Class A Warrants, issued in connection with the Public
Offering, exercisable until November 2002, to purchase a like number of
shares of Common Stock at an exercise price of $5.80 per share.
B. 68,000 units, issued to the Underwriter in connection with the
Public Offering, exercisable until November 2002, to purchase 68,000
units, each consisting of one share of Common Stock and one Class A
Warrant at an exercise price of $9.74 per unit. Each Class A Warrant
included in the units is exercisable on the same terms as is described
above in paragraph A.
C. 800,000 stock options, not issued under any of the plans, as follows
(See also Note 4 -Commitments and Contingencies):
o 300,000 options each issued to the Company's President and
Chairman of the Board of Directors having an exercise price of
$1.84 per share, issued in connection with their respective
employment agreements in June 1997, exercisable until November
2007.
o 100,000 options each issued to the Company's Vice President
for Research and Development and Vice President for Product
Development in May 1998 in connection with their respective
employment agreements, having an exercise price of $1.75 per
share, exercisable until May 2008.
D. 100,000 warrants issued to a consulting company as disclosed under
the "Consulting Agreements" section of "Commitments and Contingencies".
13
<PAGE>
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the Company has duly caused this Report to be signed on
its behalf by the undersigned, thereunto duly authorized.
FLEMINGTON PHARMACEUTICAL CORPORATION
Date: October 28, 1998 By: /s/ Harry A. Dugger, III
-------------------------------
Harry A. Dugger, III, President
Pursuant to the requirements of the Securities Exchange Act of 1934,
this Report is signed below by the following persons on behalf of the Company
and in the capacities and on the dates indicated.
<TABLE>
<CAPTION>
<S> <C> <C>
Signatures Title Date
---------- ----- ----
/s/ Harry A. Dugger, III President and Chief Executive Officer (Principal October 28, 1998
- -------------------------- Executive Officer)
Harry A. Dugger, III
/s/ Donald Deitman Chief Financial Officer October 28, 1998
- ------------------- (Principal Financial Officer)
Donald Deitman
/s/ John J. Moroney Chairman of the Board and Director October 28, 1998
- -------------------
John J. Moroney
/s/ Robert F. Schaul Secretary and Director October 28, 1998
- --------------------
Robert F. Schaul
/s/ Jean Mare Maurette Director October 28, 1998
- --------------------------
Jean Mare Maurette
/s/ Jack J. Kornreich Director October 28, 1998
- -------------------------
Jack J. Kornreich
/s/ John R. Toedtman Director October 28, 1998
- -------------------------
John R. Toedtman
</TABLE>
39
<PAGE>
<TABLE>
<CAPTION>
- ----------------- -------------------------------------------------- -----------------------------------------
<S> <C> <C>
Incorporated Documents SEC Exhibit Reference
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
2.1 Agreement of Merger dated as of October 29, 1998 As filed with the Registrant's
Preliminary Proxy Statement on October
20, 1998,
File No. 000-23399
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
3.1 Certificate of Incorporation of the Registrant, As filed with the Registrant's Form
as amended SB-2, on August 8, 1997, File No.
333-33201
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
3.2 Bylaws of the Registrant, as amended As filed with the Registrant's Form
SB-2, on August 8, 1997, File No.
333-33201
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
4.1 Form of Warrant Agreement As filed with the Registrant's Form
SB-2, on October 31, 1997, File No.
333-33201
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
4.3 Form of Class A Warrant Certificate As filed with the Registrant's Form
SB-2, on October 31, 1997, File No.
333-33201
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
4.4 Form of Underwriters' Option Agreement As filed with the Registrant's Form
SB-2, on October 31, 1997, File No.
333-33201
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
10.1 Employment Agreement with Harry A. Dugger, III, As filed with the Registrant's Form
Ph.D. SB-2, on August 8, 1997, File No.
333-33201
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
10.2 Employment Agreement with John J. Moroney As filed with the Registrant's Form
SB-2, on October 3, 1997, File No.
333-33201
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
10.3 Agreement dated December 7, 1996 between the As filed with the Registrant's Form
Registrant and Altana, Inc. SB-2, on August 8, 1997, File No.
333-33201
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
10.4 Registrant's 1992 Stock Option Plan As filed with the Registrant's Form
SB-2, on August 8, 1997, File No.
333-33201
- ----------------- -------------------------------------------------- -----------------------------------------
</TABLE>
40
<PAGE>
<TABLE>
<S> <C> <C>
- ----------------- -------------------------------------------------- -----------------------------------------
10.5 Form of Option Agreement under the 1992 Stock As filed with the Registrant's Form
Option Plan SB-2, on October 3, 1997, File No.
333-33201
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
10.6 Registrant's 1997 Stock Option Plan As filed with the Registrant's Form
SB-2, on August 8, 1997, File No.
333-33201
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
10.7 Form of Option Agreement under the 1997 Stock As filed with the Registrant's Form
Option Plan SB-2, on October 3, 1997, File No.
333-33201
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
10.8 Agreement with Rapid Spray (Clemastine) dated As filed with the Registrant's Form
June 2, 1992 SB-2, on August 8, 1997, File No.
333-33201
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
10.9 Agreement with Rapid Spray (Nitroglycerin) dated As filed with the Registrant's Form
June 2, 1992 SB-2, on August 8, 1997, File No.
333-33201
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
10.10 Agreement with Creative Technologies, Inc. dated As filed with the Registrant's Form
December 26, 1996 SB-2, on October 3, 1997, File No.
333-33201
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
10.11 Registrant's 1998 Stock Option Plan As filed with the Registrant's
Preliminary Proxy Statement on October
20, 1998,
File No. 000-23399
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
Filed herewith
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
10.12 Employment Agreement with Donald P. Cox, Ph.D.
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
10.13 Employment Agreement with Kenneth Cleaver, Ph.D.
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
10.14 Amendment to Consulting Agreement with Saggi
Capital Corp. dated March 25, 1998
- ----------------- -------------------------------------------------- -----------------------------------------
</TABLE>
41
<PAGE>
<TABLE>
<S> <C> <C>
- ----------------- -------------------------------------------------- -----------------------------------------
11.1 Computation of earnings per share
- ----------------- -------------------------------------------------- -----------------------------------------
- ----------------- -------------------------------------------------- -----------------------------------------
27.1 Financial Data Schedule for fiscal year ended
July 31, 1998
- ----------------- -------------------------------------------------- -----------------------------------------
</TABLE>
42
<PAGE>
EXHIBIT 10.12
EMPLOYMENT AGREEMENT
EMPLOYMENT AGREEMENT (the "Agreement") dated April _______,
1998, between FLEMINGTON PHARMACEUTICAL CORPORATION, a New Jersey corporation
(the "Corporation"), 43 Emery Avenue, Flemington, New Jersey 08822 and Donald P.
Cox, Ph.D., 437 Lock Street, Phillipsburg, New Jersey 08865 (the "Executive").
W I T N E S S E T H
WHEREAS, the Corporation desires to employ Executive as the
Corporation's Vice President - Regulatory Affairs to engage in such activities
and to render such services under the terms and conditions hereof and has
authorized and approved the execution of this Agreement; and
WHEREAS, Executive desires to be employed by the Corporation under the
terms and conditions hereinafter provided;
NOW, THEREFORE, in consideration of the mutual covenants and
undertakings herein contained, the parties agree as follows:
1. Employment, Duties and Acceptance.
1.1 Services. During employment hereunder, Executive shall be
Vice President - Regulatory Affairs of the Corporation, shall have the powers
and duties normally held by a corporate officer holding such a position and
shall report directly to the President of the Corporation. Executive shall
devote Executive's entire business time, attention, knowledge and skills
faithfully, diligently and to the best of Executive's ability in furtherance of
the business and activities of the Corporation (the "Services"). The principal
place of performance by Executive of services hereunder shall be at the
principal offices of the Corporation or such other place as the Board may
designate.
1.2 Acceptance. Executive hereby accepts such employment and
agrees to render the Services.
2. Term of Employment.
2.1 Term. The Executive's employment under this Agreement (the
"Term") shall begin as of the Effective Date (as hereinafter defined) and shall
continue for a term of three (3) years, unless sooner terminated pursuant to
Sections 5 or 9 of this Agreement. Notwithstanding anything to the contrary
contained herein, the provisions of this Agreement governing Protection of
Confidential Information shall continue in effect as specified in Section 10
hereof and survive the expiration or termination hereof.
<PAGE>
2.2 Effective Date. The effective date of this Agreement (the
"Effective Date") shall be May 1, 1998.
3. Base Salary and Expense Reimbursement.
3.1 Base Salary. The Corporation shall pay Executive a salary
(the "Base Salary") at the rate of $125,000 per year. Payment shall be made
monthly, on the last day of each calendar month.
3.2 Expense Reimbursement. All travel and other expenses
reasonably incurred by Executive incidental to the rendering of Services to the
Corporation hereunder shall be paid by the Corporation or reimbursed to
Executive upon receipt and approval of expense reports on Corporation forms
supported by appropriate documentation. From time to time, Executive shall
submit, and obtain approval for, proposed expense budgets. All unbudgeted
expenses in excess of $1,000.00 (individually, or collectively if in connection
with a single, related subject or project within a given month) shall require
advance approval.
3.3 Bonuses. In addition, Executive shall be entitled to such
other cash bonuses and other compensation in the form of stock, stock options or
other property or rights as may from time to time be awarded by the Board in
connection with Executive's employment.
4. Stock Options.
In connection with this Agreement, the Corporation hereby grants the
Executive stock options (outside of the Corporation's stock option plans) to
purchase 100,000 shares of the Corporation's common stock, at an exercise price
equivalent to the market price of the Corporation's stock as of the Date on
which this Agreement is signed, (the "Nonplan Options"). The Nonplan Options
shall vest in, and become exercisable by, the Executive as follows: (a) 33,000
Options on April 30, 1999; (b) 33,000 Options on April 30, 2000; and (c) 34,000
Options on April 30, 2001. The Nonplan Options may be exercised by the Executive
at any time, following vesting, during the ten (10) years following the date of
grant, provided the Executive is an employee of the Corporation at the time of
exercise. Notwithstanding anything contained herein to the contrary, the terms
and conditions set forth in the Nonplan Options document shall control the terms
and conditions on which the Nonplan Options shall vest, continue in force and
may be exercised.
5. Severance.
5.1 Termination for Good Reason. If Executive's employment
hereunder shall be terminated for Good Reason (as defined in Section 9.4 hereof)
at any time prior to the end of the Term, Executive shall be entitled to receive
from the Corporation any unpaid accrued Base Salary earned through the date of
termination.
2
<PAGE>
5.2 Executive's Termination without Good Reason. If the
Executive terminates employment without Good Reason (as defined in Section 9.4
hereof) at any time prior to the end of the Term, Executive shall be entitled to
receive from the Corporation payment of any unpaid accrued Base Salary earned
through the date of termination. All other obligations of the Corporation
hereunder shall terminate on the date of termination and the Executive's
termination without Good Reason shall act as a waiver of all claims to
compensation which might otherwise have accrued after the date of termination.
6. Additional Benefits.
During Executive's employment, the Corporation shall cause Executive to
be covered by all the Corporation's employee benefit plans, in effect from time
to time, for which Executive is eligible, including without limitation, any
retirement plan or group insurance. The Corporation does not presently have any
group life insurance or group long-term disability insurance program; however,
the Corporation is in the process of exploring the implementation of such
programs. Upon implementation, it is the Corporation's present expectation that
the Executive will be covered by group life insurance in an amount equal to at
least one year's Base Salary and group long-term disability insurance. In
addition, to facilitate Executive's travel on Corporation business, during
employment the Corporation shall furnish Executive, without cost to Executive,
but in accordance with any applicable IRS requirements and limitations, a
Corporation owned or leased, and Corporation insured, automobile chosen by the
Corporation. Notwithstanding the foregoing, Executive recognizes that each year
the Corporation must report to the IRS an amount of income to be charged to
Executive as taxable income representing the fair value of Executive's personal
use of such automobile. In addition, the Corporation shall pay or reimburse all
reasonable expenses of maintaining and operating such automobile.
7. Vacation.
Executive shall be entitled to such holidays as are in effect for all
of the Corporation's employees, and to sick leave in accordance with Corporation
policy as in effect from time to time. In addition, Executive shall be entitled
to four weeks vacation days (twenty business days) per year. It is not
anticipated that the Executive will use more than ten (10) vacation days during
the remainder of the 1998 calendar year. The timing of the taking of vacation is
left to the discretion of Executive, provided the same is not inconsistent with
the reasonable business requirements of the Corporation. Vacation days not used
by Executive during a given year may be accumulated and carried forward to
future years.
8. Indemnification.
As provided in the Corporation's By-Laws, and only to the extent
provided therein, the Corporation shall indemnify Executive and hold Executive
harmless against any and all expenses reasonably incurred by him in connection
with or arising out of (a) the defense of any action, suit or proceeding to
which Executive is a named party, or (b) any claim asserted or threatened
against Executive, provided, in either case, the matter has arisen because of or
3
<PAGE>
in connection with Executive's being or having been an employee or officer of
the Corporation, whether or not he continues to be such at the time the expenses
indemnified against are incurred, except insofar as (a) such indemnification may
be prohibited by law, (b) the expenses were incurred in connection with a matter
where the Corporation is or was in an adversarial position to Executive and the
Corporation prevailed against Executive in such matter, or (c) the expenses were
incurred in connection with a matter arising out a material breach by Executive
of this Agreement or of Executive's obligations to the Corporation.
9. Termination.
9.1 Death. If Executive dies during the Term of this
Agreement, Executive's employment hereunder shall terminate upon his death and
all obligations of the Corporation hereunder shall terminate on such date,
except that Executive's estate or his designated beneficiary shall be entitled
to payment of any unpaid accrued Base Salary through the date of his death.
9.2 Disability. If Executive shall be unable to perform a
significant part of his duties and responsibilities in connection with the
conduct of the business and affairs of the Corporation and such inability lasts
for a period of at least 180 consecutive days by reason of Executive's physical
or mental disability, whether by reason of injury, illness or similar cause,
Executive shall be deemed disabled, and the Corporation any time thereafter may
terminate Executive's employment hereunder by reason of the disability. During
such 180 day period, the Base Salary and other benefits payable to Executive
hereunder shall not be suspended or diminished, except to the extent equivalent
to the extent of any Corporation-provided disability insurance in effect. Upon
delivery to Executive of notice to terminate, all obligations of the Corporation
hereunder shall terminate, except that Executive shall be entitled to payment of
any unpaid accrued Base Salary through the date of termination. The obligations
of Executive under Section 10 hereof shall continue notwithstanding termination
of Executive's employment pursuant to this Section 9.2.
9.3 Termination For Cause. The Corporation may at any time
during the Term, with 30 days prior written notice, terminate this Agreement and
discharge Executive for Cause, whereupon the Corporation's obligation to pay
compensation or other amounts payable hereunder to or for the benefit of
Executive shall terminate on the date of such discharge. As used herein the term
"Cause" shall be deemed to mean and include: (i) a material breach by Executive
of this Agreement including without limitation a breach by Executive of the
obligations set forth in Section 10 hereof; (ii) excessive absenteeism,
alcoholism or drug abuse; (iii) substantial neglect or inattention by Executive
of or to his duties hereunder; (iv) willful violation of specific and lawful
written or oral direction from the President or Board of Directors of the
Corporation provided such direction is not inconsistent with the Executive's
duties and responsibilities; or (v) fraud, criminal conduct or embezzlement. The
following shall be deemed a material breach for the purposes of Subsection (i)
hereof: (a) the Executive's conviction for, or a plea of nolo contendere to, a
felony or a crime involving moral turpitude (which, through lapse of time or
otherwise, is not subject to appeal); (b) willful misconduct as an employee of
the Corporation; or (c) willful or reckless disregard of his responsibilities
under this Agreement. The obligations of the Executive under Section 10 shall
continue notwithstanding termination of the Executive's employment pursuant to
this Section 9.3.
4
<PAGE>
9.4 Termination by Executive. The Executive shall have the
right to terminate this Agreement for Good Reason, as hereinafter defined. Good
Reason shall mean any of the following: (i) the assignment to the Executive of
duties inconsistent with the Executive's position, duties, responsibilities,
titles or offices as described herein; (ii) any material reduction by the
Corporation of the Executive's duties and responsibilities; or (iii) any
reduction by the Corporation of the Executive's compensation or benefits payable
hereunder (it being understood that a reduction of benefits applicable to all
employees of the Corporation, including the Executive, shall not be deemed a
reduction of the Executive's compensation package for purposes of this
definition).
5
<PAGE>
10. Confidentiality; Non-Competition.
10.1 Confidentiality. The Corporation and Executive
acknowledge that the services to be performed by Executive under this Agreement
are unique and extraordinary, and, as a result of Executive's employment
hereunder, Executive will be in possession of confidential information and trade
secrets relating to the business and affairs of both the Corporation and its
clients. Executive agrees that Executive will not, other than in the ordinary
course of business and subject to receipt of an appropriate Confidentiality
Agreement, during or after any term of employment, directly or indirectly use or
disclose to any person, firm or corporation any confidential information
regarding the clients, customers, business practices, products, research
programs of the Corporation or its clients acquired by Executive during
Executive's employment, unless Executive has obtained the Corporation's advance
written consent specifically authorizing Executive's disclosure or use thereof.
10.2 Non-Competition. Executive agrees that, for a period
beginning with the Effective Date of this Agreement and ending twelve months
after the date of termination of employment by the Company, Executive will not,
either individually or in conjunction with any person, firm, association,
syndicate, company or corporation, directly or indirectly (as principal, agent,
employee, director, officer, shareholder, partner, independent contractor,
individual proprietor, or as an investor who has made advances, loans or
contributions to capital, or in any other manner whatsoever) compete with
company in the business then conducted by the Corporation. Executive also agrees
that, during such period, Executive will not solicit or encourage any persons
who, during such period, were employees of Company to (i) terminate such
persons' employment with Company; or (ii) become affiliated with any person,
firm, association, syndicate, company or corporation which is in a business
similar to that of the Company and in which Executive, either directly or
indirectly, has an interest. If Company directs Executive to cease and desist a
proposed post-termination course of conduct, on the grounds that he is proposing
to compete with the Company's business, during this one-year post-termination
period, Company shall compensate Executive by paying him his base Salary during
the period he is prevented from pursuing such activity. Executive agrees that he
will use his best efforts to transfer all of the business previously conducted
by him under the name Medical Development Quality Associates to the Corporation.
10.3 Anti-Raiding. Executive agrees that during the term of
his employment hereunder, and, thereafter for a period of one (1) year,
Executive will not, as principal, agent, employee, employer, consultant,
director or partner of any person, firm, corporation or business entity other
that the Corporation, or in any individual or representative capacity
whatsoever, directly or indirectly, without the prior express written consent of
the Corporation approach, counsel or attempt to induce any person who is then in
the employ of the Corporation to leave the employ of the Corporation or employ
or attempt to employ any such person or persons who at any time during the
preceding six months was in the employ of the Corporation.
6
<PAGE>
10.4 Injunction. Executive acknowledges and agrees that,
because of the special nature of his services, any breach or threatened breach
of any of the above provisions of this Section 10 hereof will cause the
Corporation irreparable injury and incalculable harm and, therefore, the
Corporation will have "no adequate remedies at law". Executive, therefore,
agrees in advance that Corporation shall be entitled to injunctive and other
equitable relief for such breach or threatened breach and that resort by the
Corporation to such injunctive or other equitable relief shall not be deemed to
waive or to limit in any respect any right or remedy which the Corporation may
have with respect to such breach or threatened breach. The Executive agrees that
in such action, if the Corporation makes a prima facie showing that Executive
has violated or apparently intends to violate any of the provisions of this
Section 10, the Corporation need not prove either damage or irreparable injury
in order to obtain injunctive relief. The Corporation and Executive agree that
any such action for injunctive or equitable relief shall be heard in a state or
federal court situated in New Jersey and each of the parties hereto agrees to
accept service of process by registered mail and to otherwise consent to the
jurisdiction of such courts.
10.5 No Indemnification. The provisions of Section 8, above,
do not apply to any expenses incurred by Executive in defending against any
claim made pursuant to this Section 10.
10.6 Severability. If any provision contained within this
Section 10 is found to be unenforceable by reason of the extent, duration or
scope thereof, or otherwise, then such restriction shall be enforced to the
maximum extent permitted by law, and Executive agrees that such extent, duration
or scope may be modified in any proceeding brought to enforce such restriction.
11. Arbitration.
Except with respect to any proceeding brought under Section 10 hereof,
any controversy, claim, or dispute between the parties, directly or indirectly,
concerning this Employment Agreement or the breach hereof, or the subject matter
hereof, including questions concerning the scope and applicability of this
arbitration clause, shall be finally settled by arbitration in the State of New
Jersey pursuant to the rules then applying of the American Arbitration
Association. The arbitrators shall consist of one representative selected by the
Corporation, one representative selected by the Executive and one representative
selected by the first two arbitrators. The parties agree to expedite the
arbitration proceeding in every way, so that the arbitration proceeding shall be
begun within thirty (30) days after request therefore is made, and shall
continue thereafter, without interruption, and that the decision of the
arbitrators shall be handed down within thirty (30) days after the hearings in
the arbitration proceedings are closed. The arbitrators shall have the right and
authority to assess the cost of the arbitration proceedings and to determine how
their decision or determination as to each issue or matter in dispute may be
implemented or enforced. The decision in writing of any two of the arbitrators
shall be binding and conclusive on all of the parties to this Agreement. Should
either the Corporation or the Executive fail to appoint an arbitrator as
required by this Section 11 within thirty (30) days after receiving written
notice from the other party to do so, the arbitrator appointed by the other
party shall act for all of the parties and his decision in writing shall be
binding and conclusive on all of the parties to this Employment Agreement. Any
decision or award of the arbitrators shall be final and conclusive on the
7
<PAGE>
parties to this Agreement; judgment upon such decision or award may be entered
in any competent Federal or state court located in the United States of America;
and the application may be made to such court for confirmation of such decision
or award for any order of enforcement and for any other legal remedies that may
be necessary to effectuate such decision or award.
12. Notices.
All notices, requests, consents and other communications required or
permitted to be given hereunder, shall be in writing and shall be deemed to have
been duly given if delivered personally or sent by prepaid telegram, telecopy or
mailed first-class, postage prepaid, by registered or certified mail (notices
sent by telegram or mailed shall be deemed to have been given on the date sent),
to the parties at their respective addresses hereinabove set forth or to such
other address as either party shall designate by notice in writing to the other
in accordance herewith. Copies of all notices shall be sent to Robert F. Schaul,
Esq., 57 Dutch Lane, Ringoes, New Jersey 08551.
13. General.
13.1 Governing Law. This Agreement shall be governed by and
construed and enforced in accordance with the local laws of the State of New
Jersey applicable to agreements made and to be performed entirely in New Jersey.
13.2 Captions. The section headings contained herein are for
reference purposes only and shall not in any way affect the meaning or
interpretation of this Agreement.
13.3 Entire Agreement. This Agreement sets forth the entire
agreement and understanding of the parties relating to the subject matter
hereof, and supersedes all prior agreements, arrangements and understandings,
written or oral, relating to the subject matter hereof. No representation,
promise or inducement has been made by either party that is not embodied in this
Agreement, and neither party shall be bound by or liable for any alleged
representation, promise or inducement not so set forth.
13.4 Severability. If any of the provisions of this Agreement shall
be unlawful, void, or for any reason, unenforceable, such provision shall be
deemed severable from, and shall in no way affect the validity or enforceability
of, the remaining portions of this Agreement.
13.5 Waiver. The waiver by any party hereto of a breach of any
provision of this Agreement by any other party shall not operate or be construed
as a waiver of any subsequent breach of the same provision or any other
provision hereof.
13.6 Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original, but all of which taken
together shall constitute one and the same Agreement.
8
<PAGE>
13.7 Assignability. This Agreement, and Executive's rights and
obligations hereunder, may not be assigned by Executive. The Corporation,
however, may assign its rights, together with its obligations, hereunder to any
of its successors or assigns, whether by merger, consolidation or acquisition of
all or substantially all of its business or assets.
13.8 Amendment. This Agreement may be amended, modified,
superseded, canceled, renewed or extended and the terms or covenants hereof may
be waived, only by a written instrument executed by both of the parties hereto,
or in the case of a waiver, by the party waiving compliance. No superseding
instrument, amendment, modification, cancellation, renewal or extension hereof
shall require the consent or approval of any person other than the parties
hereto. The failure of either party at any time or times to require performance
of any provision hereof shall in no matter affect the right at a later time to
enforce the same. No waiver by either party of the breach of any term or
covenant contained in this Agreement, whether by conduct or otherwise, in any
one or more instances, shall be deemed to be, or construed as, a further or
continuing waiver of any such breach, or a waiver of the breach of any other
term or covenant contained in this Agreement.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
date first above written.
ATTEST: FLEMINGTON PHARMACEUTICAL
CORPORATION.
By:___________________________ By:_______________________________
Robert F. Schaul, Secretary Harry A. Dugger III, Ph.D.
President
WITNESS:
______________________________ __________________________________
Donald P. Cox, Ph.D.
9
<PAGE>
EXHIBIT 10.13
EMPLOYMENT AGREEMENT
EMPLOYMENT AGREEMENT (the "Agreement") dated April _______,
1998, between FLEMINGTON PHARMACEUTICAL CORPORATION, a New Jersey corporation
(the "Corporation"), 43 Emery Avenue, Flemington, New Jersey 08822 and Kenneth
E. Cleaver, Ph.D., 8201 Constance, Lenexa, Kansas 66215-5802 (the "Executive").
W I T N E S S E T H
WHEREAS, the Corporation desires to employ Executive as the
Corporation's Vice President - Product Development to engage in such activities
and to render such services under the terms and conditions hereof and has
authorized and approved the execution of this Agreement; and
WHEREAS, Executive desires to be employed by the Corporation under the
terms and conditions hereinafter provided;
NOW, THEREFORE, in consideration of the mutual covenants and
undertakings herein contained, the parties agree as follows:
1. Employment, Duties and Acceptance.
1.1 Services. During employment hereunder, Executive shall be Vice
President - Product Development of the Corporation, shall have the powers and
duties normally held by a corporate officer holding such a position and shall
report directly to the President of the Corporation. Executive shall devote
Executive's business time, attention, knowledge and skills faithfully,
diligently and to the best of Executive's ability in furtherance of the business
and activities of the Corporation (the "Services"). The principal place of
performance by Executive of services hereunder shall be at the principal offices
of the Corporation or such other place as the Board may designate.
1.2 Acceptance. Executive hereby accepts such employment and agrees
to render the Services.
2. Term of Employment.
2.1 Term. The Executive's employment under this Agreement (the
"Term") shall begin as of the Effective Date (as hereinafter defined) and shall
continue for a term of three (3) years, unless sooner terminated pursuant to
Sections 5 or 9 of this Agreement. Notwithstanding anything to the contrary
contained herein, the provisions of this Agreement governing Protection of
Confidential Information shall continue in effect as specified in Section 10
hereof and survive the expiration or termination hereof.
<PAGE>
2.2 Effective Date. The effective date of this Agreement (the
"Effective Date") shall be May 1, 1998.
3. Base Salary and Expense Reimbursement.
3.1 Base Salary. The Corporation shall pay Executive a salary (the
"Base Salary") at the rate of $100,000 per year. Payment shall be made monthly,
on the last day of each calendar month.
3.2 Expense Reimbursement. All travel and other expenses reasonably
incurred by Executive incidental to the rendering of Services to the Corporation
hereunder shall be paid by the Corporation or reimbursed to Executive upon
receipt and approval of expense reports on Corporation forms supported by
appropriate documentation. From time to time, Executive shall submit, and obtain
approval for, proposed expense budgets. All unbudgeted expenses in excess of
$1,000.00 (individually, or collectively if in connection with a single, related
subject or project within a given month) shall require advance approval.
3.3 Bonuses. In addition, Executive shall be entitled to such other
cash bonuses and other compensation in the form of stock, stock options or other
property or rights as may from time to time be awarded by the Board in
connection with Executive's employment.
3.4 Moving Expenses. The Corporation shall reimburse Executive for
his reasonable expenses incurred in relocating himself and his family from
Kansas to the New Jersey area. The Executive shall provide the Corporation with
appropriate documentation for expenses sought to be reimbursed hereunder.
Reimbursable expenses hereunder shall not exceed $7,500.00
4. Stock Options.
In connection with this Agreement, the Corporation hereby grants the
Executive stock options (outside of the Corporation's stock option plans) to
purchase 100,000 shares of the Corporation's common stock, at an exercise price
equivalent to the market price of the Corporation's stock as of the Date on
which this Agreement is signed, (the "Nonplan Options"). The Nonplan Options
shall vest in, and become exercisable by, the Executive as follows: (a) 33,000
Options on April 30, 1999; (b) 33,000 Options on April 30, 2000; and (c) 34,000
Options on April 30, 2001. The Nonplan Options may be exercised by the Executive
at any time, following vesting, during the ten (10) years following the date of
grant, provided the Executive is an employee of the Corporation at the time of
exercise. Notwithstanding anything contained herein to the contrary, the terms
and conditions set forth in the Nonplan Options document shall control the terms
and conditions on which the Nonplan Options shall vest, continue in force and
may be exercised.
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<PAGE>
5. Severance.
5.1 Termination for Good Reason. If Executive's employment hereunder
shall be terminated for Good Reason (as defined in Section 9.4 hereof) at any
time prior to the end of the Term, Executive shall be entitled to receive from
the Corporation any unpaid accrued Base Salary earned through the date of
termination.
5.2 Executive's Termination without Good Reason. If the Executive
terminates employment without Good Reason (as defined in Section 9.4 hereof) at
any time prior to the end of the Term, Executive shall be entitled to receive
from the Corporation payment of any unpaid accrued Base Salary earned through
the date of termination. All other obligations of the Corporation hereunder
shall terminate on the date of termination and the Executive's termination
without Good Reason shall act as a waiver of all claims to compensation which
might otherwise have accrued after the date of termination.
6. Additional Benefits.
During Executive's employment, the Corporation shall cause Executive to
be covered by all the Corporation's employee benefit plans, in effect from time
to time, for which Executive is eligible, including without limitation, any
retirement plan or group insurance. The Corporation does not presently have any
group life insurance or group long-term disability insurance program; however,
the Corporation is in the process of exploring the implementation of such
programs. Upon implementation, it is the Corporation's present expectation that
the Executive will be covered by group life insurance in an amount equal to at
least one year's Base Salary and group long-term disability insurance. In
addition, to facilitate Executive's travel on Corporation business, during
employment the Corporation shall furnish Executive, without cost to Executive,
but in accordance with any applicable IRS requirements and limitations, a
Corporation owned or leased, and Corporation insured, automobile chosen by the
Corporation. Notwithstanding the foregoing, Executive recognizes that each year
the Corporation must report to the IRS an amount of income to be charged to
Executive as taxable income representing the fair value of Executive's personal
use of such automobile. In addition, the Corporation shall pay or reimburse all
reasonable expenses of maintaining and operating such automobile.
7. Vacation.
Executive shall be entitled to such holidays as are in effect for all
of the Corporation's employees, and to sick leave in accordance with Corporation
policy as in effect from time to time. In addition, Executive shall be entitled
to four weeks vacation days (twenty business days) per year. It is not
anticipated that the Executive will use more than ten (10) vacation days during
the remainder of the 1998 calendar year. The timing of the taking of vacation is
left to the discretion of Executive, provided the same is not inconsistent with
the reasonable business requirements of the Corporation. Vacation days not used
by Executive during a given year may be accumulated and carried forward to
future years.
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<PAGE>
8. Indemnification.
As provided in the Corporation's By-Laws, and only to the extent
provided therein, the Corporation shall indemnify Executive and hold Executive
harmless against any and all expenses reasonably incurred by him in connection
with or arising out of (a) the defense of any action, suit or proceeding to
which Executive is a named party, or (b) any claim asserted or threatened
against Executive, provided, in either case, the matter has arisen because of or
in connection with Executive's being or having been an employee or officer of
the Corporation, whether or not he continues to be such at the time the expenses
indemnified against are incurred, except insofar as (a) such indemnification may
be prohibited by law, (b) the expenses were incurred in connection with a matter
where the Corporation is or was in an adversarial position to Executive and the
Corporation prevailed against Executive in such matter, or (c) the expenses were
incurred in connection with a matter arising out a material breach by Executive
of this Agreement or of Executive's obligations to the Corporation.
9. Termination.
9.1 Death. If Executive dies during the Term of this Agreement,
Executive's employment hereunder shall terminate upon his death and all
obligations of the Corporation hereunder shall terminate on such date, except
that Executive's estate or his designated beneficiary shall be entitled to
payment of any unpaid accrued Base Salary through the date of his death.
9.2 Disability. If Executive shall be unable to perform a
significant part of his duties and responsibilities in connection with the
conduct of the business and affairs of the Corporation and such inability lasts
for a period of at least 180 consecutive days by reason of Executive's physical
or mental disability, whether by reason of injury, illness or similar cause,
Executive shall be deemed disabled, and the Corporation any time thereafter may
terminate Executive's employment hereunder by reason of the disability. During
such 180 day period, the Base Salary and other benefits payable to Executive
hereunder shall not be suspended or diminished, except to the extent equivalent
to the extent of any Corporation-provided disability insurance in effect. Upon
delivery to Executive of notice to terminate, all obligations of the Corporation
hereunder shall terminate, except that Executive shall be entitled to payment of
any unpaid accrued Base Salary through the date of termination. The obligations
of Executive under Section 10 hereof shall continue notwithstanding termination
of Executive's employment pursuant to this Section 9.2.
9.3 Termination For Cause. The Corporation may at any time during
the Term, with 30 days prior written notice, terminate this Agreement and
discharge Executive for Cause, whereupon the Corporation's obligation to pay
compensation or other amounts payable hereunder to or for the benefit of
Executive shall terminate on the date of such discharge. As used herein the term
"Cause" shall be deemed to mean and include: (i) a material breach by Executive
of this Agreement including without limitation a breach by Executive of the
obligations set forth in Section 10 hereof; (ii) excessive absenteeism,
alcoholism or drug abuse; (iii) substantial neglect or inattention by Executive
of or to his duties hereunder; (iv) willful violation of specific and lawful
written or oral direction from the President or Board of Directors of the
Corporation provided such direction is not inconsistent with the Executive's
4
<PAGE>
duties and responsibilities; or (v) fraud, criminal conduct or embezzlement. The
following shall be deemed a material breach for the purposes of Subsection (i)
hereof: (a) the Executive's conviction for, or a plea of nolo contendere to, a
felony or a crime involving moral turpitude (which, through lapse of time or
otherwise, is not subject to appeal); (b) willful misconduct as an employee of
the Corporation; or (c) willful or reckless disregard of his responsibilities
under this Agreement. The obligations of the Executive under Section 10 shall
continue notwithstanding termination of the Executive's employment pursuant to
this Section 9.3.
9.4 Termination by Executive. The Executive shall have the right to
terminate this Agreement for Good Reason, as hereinafter defined. Good Reason
shall mean any of the following: (i) the assignment to the Executive of duties
inconsistent with the Executive's position, duties, responsibilities, titles or
offices as described herein; (ii) any material reduction by the Corporation of
the Executive's duties and responsibilities; or (iii) any reduction by the
Corporation of the Executive's compensation or benefits payable hereunder (it
being understood that a reduction of benefits applicable to all employees of the
Corporation, including the Executive, shall not be deemed a reduction of the
Executive's compensation package for purposes of this definition).
10. Confidentiality; Non-Competition.
10.1 Confidentiality. The Corporation and Executive acknowledge that
the services to be performed by Executive under this Agreement are unique and
extraordinary, and, as a result of Executive's employment hereunder, Executive
will be in possession of confidential information and trade secrets relating to
the business and affairs of both the Corporation and its clients. Executive
agrees that Executive will not, other than in the ordinary course of business
and subject to receipt of an appropriate Confidentiality Agreement, during or
after any term of employment, directly or indirectly use or disclose to any
person, firm or corporation any confidential information regarding the clients,
customers, business practices, products, research programs of the Corporation or
its clients acquired by Executive during Executive's employment, unless
Executive has obtained the Corporation's advance written consent specifically
authorizing Executive's disclosure or use thereof.
10.2 Non-Competition. Executive agrees that, for a period beginning
with the Effective Date of this Agreement and ending twelve months after the
date of termination of employment by the Company, Executive will not, either
individually or in conjunction with any person, firm, association, syndicate,
company or corporation, directly or indirectly (as principal, agent, employee,
director, officer, shareholder, partner, independent contractor, individual
proprietor, or as an investor who has made advances, loans or contributions to
capital, or in any other manner whatsoever) compete with company in the business
then conducted by the Corporation. Executive also agrees that, during such
period, Executive will not solicit or encourage any persons who, during such
period, were employees of Company to (i) terminate such persons' employment with
Company; or (ii) become affiliated with any person, firm, association,
syndicate, company or corporation which is in a business similar to that of the
Company and in which Executive, either directly or indirectly, has an interest.
If Company directs Executive to cease and desist a proposed post-termination
5
<PAGE>
course of conduct, on the grounds that he is proposing to compete with the
Company's business, during this one-year post-termination period, Company shall
compensate Executive by paying him his base Salary during the period he is
prevented from pursuing such activity. Executive agrees that he will use his
best efforts to transfer all of the business previously conducted by him under
the name Medical Development Quality Associates to the Corporation.
10.3 Anti-Raiding. Executive agrees that during the term of his
employment hereunder, and, thereafter for a period of one (1) year, Executive
will not, as principal, agent, employee, employer, consultant, director or
partner of any person, firm, corporation or business entity other that the
Corporation, or in any individual or representative capacity whatsoever,
directly or indirectly, without the prior express written consent of the
Corporation approach, counsel or attempt to induce any person who is then in the
employ of the Corporation to leave the employ of the Corporation or employ or
attempt to employ any such person or persons who at any time during the
preceding six months was in the employ of the Corporation.
10.4 Injunction. Executive acknowledges and agrees that, because of
the special nature of his services, any breach or threatened breach of any of
the above provisions of this Section 10 hereof will cause the Corporation
irreparable injury and incalculable harm and, therefore, the Corporation will
have "no adequate remedies at law". Executive, therefore, agrees in advance that
Corporation shall be entitled to injunctive and other equitable relief for such
breach or threatened breach and that resort by the Corporation to such
injunctive or other equitable relief shall not be deemed to waive or to limit in
any respect any right or remedy which the Corporation may have with respect to
such breach or threatened breach. The Executive agrees that in such action, if
the Corporation makes a prima facie showing that Executive has violated or
apparently intends to violate any of the provisions of this Section 10, the
Corporation need not prove either damage or irreparable injury in order to
obtain injunctive relief. The Corporation and Executive agree that any such
action for injunctive or equitable relief shall be heard in a state or federal
court situated in New Jersey and each of the parties hereto agrees to accept
service of process by registered mail and to otherwise consent to the
jurisdiction of such courts.
10.5 No Indemnification. The provisions of Section 8, above, do not
apply to any expenses incurred by Executive in defending against any claim made
pursuant to this Section 10.
10.6 Severability. If any provision contained within this Section 10
is found to be unenforceable by reason of the extent, duration or scope thereof,
or otherwise, then such restriction shall be enforced to the maximum extent
permitted by law, and Executive agrees that such extent, duration or scope may
be modified in any proceeding brought to enforce such restriction.
11. Arbitration.
Except with respect to any proceeding brought under Section 10 hereof,
any controversy, claim, or dispute between the parties, directly or indirectly,
concerning this Employment Agreement or the breach hereof, or the subject matter
6
<PAGE>
hereof, including questions concerning the scope and applicability of this
arbitration clause, shall be finally settled by arbitration in the State of New
Jersey pursuant to the rules then applying of the American Arbitration
Association. The arbitrators shall consist of one representative selected by the
Corporation, one representative selected by the Executive and one representative
selected by the first two arbitrators. The parties agree to expedite the
arbitration proceeding in every way, so that the arbitration proceeding shall be
begun within thirty (30) days after request therefore is made, and shall
continue thereafter, without interruption, and that the decision of the
arbitrators shall be handed down within thirty (30) days after the hearings in
the arbitration proceedings are closed. The arbitrators shall have the right and
authority to assess the cost of the arbitration proceedings and to determine how
their decision or determination as to each issue or matter in dispute may be
implemented or enforced. The decision in writing of any two of the arbitrators
shall be binding and conclusive on all of the parties to this Agreement. Should
either the Corporation or the Executive fail to appoint an arbitrator as
required by this Section 11 within thirty (30) days after receiving written
notice from the other party to do so, the arbitrator appointed by the other
party shall act for all of the parties and his decision in writing shall be
binding and conclusive on all of the parties to this Employment Agreement. Any
decision or award of the arbitrators shall be final and conclusive on the
parties to this Agreement; judgment upon such decision or award may be entered
in any competent Federal or state court located in the United States of America;
and the application may be made to such court for confirmation of such decision
or award for any order of enforcement and for any other legal remedies that may
be necessary to effectuate such decision or award.
12. Notices.
All notices, requests, consents and other communications required or
permitted to be given hereunder, shall be in writing and shall be deemed to have
been duly given if delivered personally or sent by prepaid telegram, telecopy or
mailed first-class, postage prepaid, by registered or certified mail (notices
sent by telegram or mailed shall be deemed to have been given on the date sent),
to the parties at their respective addresses hereinabove set forth or to such
other address as either party shall designate by notice in writing to the other
in accordance herewith. Copies of all notices shall be sent to Robert F. Schaul,
Esq., 57 Dutch Lane, Ringoes, New Jersey 08551.
13. General.
13.1 Governing Law. This Agreement shall be governed by and
construed and enforced in accordance with the local laws of the State of New
Jersey applicable to agreements made and to be performed entirely in New Jersey.
13.2 Captions. The section headings contained herein are for
reference purposes only and shall not in any way affect the meaning or
interpretation of this Agreement.
13.3 Entire Agreement. This Agreement sets forth the entire
agreement and understanding of the parties relating to the subject matter
hereof, and supersedes all prior agreements, arrangements and understandings,
written or oral, relating to the subject matter hereof. No representation,
promise or inducement has been made by either party that is not embodied in this
Agreement, and neither party shall be bound by or liable for any alleged
representation, promise or inducement not so set forth.
7
<PAGE>
13.4 Severability. If any of the provisions of this Agreement shall
be unlawful, void, or for any reason, unenforceable, such provision shall be
deemed severable from, and shall in no way affect the validity or enforceability
of, the remaining portions of this Agreement.
13.5 Waiver. The waiver by any party hereto of a breach of any
provision of this Agreement by any other party shall not operate or be construed
as a waiver of any subsequent breach of the same provision or any other
provision hereof.
13.6 Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original, but all of which taken
together shall constitute one and the same Agreement.
13.7 Assignability. This Agreement, and Executive's rights and
obligations hereunder, may not be assigned by Executive. The Corporation,
however, may assign its rights, together with its obligations, hereunder to any
of its successors or assigns, whether by merger, consolidation or acquisition of
all or substantially all of its business or assets.
13.8 Amendment. This Agreement may be amended, modified, superseded,
canceled, renewed or extended and the terms or covenants hereof may be waived,
only by a written instrument executed by both of the parties hereto, or in the
case of a waiver, by the party waiving compliance. No superseding instrument,
amendment, modification, cancellation, renewal or extension hereof shall require
the consent or approval of any person other than the parties hereto. The failure
of either party at any time or times to require performance of any provision
hereof shall in no matter affect the right at a later time to enforce the same.
No waiver by either party of the breach of any term or covenant contained in
this Agreement, whether by conduct or otherwise, in any one or more instances,
shall be deemed to be, or construed as, a further or continuing waiver of any
such breach, or a waiver of the breach of any other term or covenant contained
in this Agreement.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
date first above written.
ATTEST: FLEMINGTON PHARMACEUTICAL
CORPORATION.
By:____________________________ By:______________________________
Robert F. Schaul, Secretary Harry A. Dugger III, Ph.D.
President
WITNESS:
_______________________________ __________________________________
Kenneth E. Cleaver, Ph.D.
8
<PAGE>
EXHIBIT 10.14
FIRST AMENDMENT TO CONSULTING AGREEMENT
First Amendment to Consulting Agreement is dated as of this ____ day of
March 1998, between FLEMINGTON PHARMACEUTICAL CORPORATION, a New Jersey
corporation, whose address is 43 Emery Avenue, Flemington, New Jersey 08822 (the
"Company") and SAGGI CAPITAL CORP. ("Consultant") whose address is RR 1, Box
132, Millerton, New York 12564.
WITNESSESTH:
WHEREAS, on May 1, 1997, the Company and Consultant entered into a
certain Consulting Agreement (the "Original Agreement"); and
WHEREAS, Company has proposed an amendment to the Original Agreement in
order to extend the term and modify the compensation terms thereof; and the
parties have agreed that the Original Agreement shall be modified in accordance
with the terms hereof; and
WHEREAS, pursuant to Section 3(b) of the Original Agreement, the
Company issued to Consultant a nonqualified stock option (the "Option") under
the Company's 1997 Stock Option Plan (the "1997 Plan") to purchase an aggregate
of 200,000 shares of the Company's Common Stock; and
WHEREAS, the Consultant, has not exercised any of the 200,000 shares of
Common Stock under the Option, and immediately prior to the execution of this
Agreement, had the right to exercise all shares pursuant to the Option.
NOW, THEREFORE, in consideration of the mutual promises contained
below, and for other good and valuable consideration, the receipt and
sufficiency of which both parties acknowledge, the parties agree as follows:
1. The Consultant shall surrender to the Company the entire Option to
purchase 200,000 shares of the Company's Common Stock.
2. The Company shall issue to the Consultant a new option to purchase
200,000 shares of Common Stock under the 1997 Plan on the terms and conditions
set forth in the Amended Stock Option Agreement of this date.
3. The Company shall issue to the Consultant new options to purchase
100,000 shares of Common Stock under the 1997 Plan; and options to purchase
20,000 shares of Common Stock under the Company's 1992 Stock Option Plan.
<PAGE>
4. Section 4 of the Original Agreement shall be amended such that the
Consultant shall continue providing services to the Company until the earlier of
(i) April 30, 1999; or (ii) such time as this Agreement may be earlier
terminated pursuant to the terms of the Original Agreement. In addition to the
services of the Consultant to the Company otherwise provided for in Section 1 of
the Original Agreement, the Consultant shall assist the Company in obtaining a
new market-maker for its publicly traded securities and shall assist the Company
in identifying additional sources of capital.
5. All other terms of the Original Agreement not amended by the terms
hereof shall remain in full force and effect.
6. This Amendment to the Original Agreement shall be effective as of
the date first written above.
IN WITNESS WHEREOF, the parties have signed this Amendment as of the
effective date shown above.
Attest: FLEMINGTON PHARMACEUTICAL
CORPORATION
By:___________________________ By:__________________________________
Harry A. Dugger, President
SAGGI CAPITAL CORP.
______________________________ By:___________________________________
Sharon Will, President
-2-
<PAGE>
EXHIBIT 11
FLEMINGTON PHARMACEUTICAL CORPORATION
EARNINGS PER SHARE COMPUTATION
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
YEAR ENDED
JULY 31, 1998
-------------------------
BASIC
-------------------------
Weighted average shares outstanding 3,491,637
Dilutive effect of stock performance plans (1) --
-------------------------
Total 3,491,637
Net loss (708)
-------------------------
Earnings per share (.20)
-------------------------
YEAR ENDED
JULY 31, 1997
-------------------------
BASIC
-------------------------
Weighted average shares outstanding 2,597,300
Dilutive effect of stock performance plans (1) --
-------------------------
Total 2,597,300
Net loss (411)
-------------------------
Earnings per share (.16)
-------------------------
(1) Since the company has reported a loss for each period, no potential
shares from stock performance plans have been presented, as their
effect would be anti-dilutive.
<TABLE> <S> <C>
<ARTICLE> 5
<S> <C>
<PERIOD-TYPE> YEAR
<FISCAL-YEAR-END> JUL-31-1998
<PERIOD-END> JUL-31-1998
<CASH> 2,141
<SECURITIES> 0
<RECEIVABLES> 186
<ALLOWANCES> 40
<INVENTORY> 0
<CURRENT-ASSETS> 2,323
<PP&E> 37
<DEPRECIATION> 0
<TOTAL-ASSETS> 2,506
<CURRENT-LIABILITIES> 102
<BONDS> 0
0
0
<COMMON> 39
<OTHER-SE> 2,365
<TOTAL-LIABILITY-AND-EQUITY> 2,506
<SALES> 774
<TOTAL-REVENUES> 871
<CGS> 0
<TOTAL-COSTS> 1,579
<OTHER-EXPENSES> 0
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> (708)
<INCOME-TAX> 0
<INCOME-CONTINUING> (708)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (708)
<EPS-PRIMARY> (.20)
<EPS-DILUTED> (.20)
</TABLE>
