ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
No matters were submitted to a vote of security holders during the quarter
ended December 31, 2001.
8
PART II
ITEM 5. MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
The Company's Common Stock is traded on the NASDAQ National Market under
the symbol AKRN. On March 7, 2002, there were approximately 615 holders of
record of the Company's Common Stock. This number does not include shareholders
for which shares are held in a 'nominee' or 'street' name. The closing price of
the Company's Common Stock on March 7, 2002 was $3.94 per share.
High and low bid prices per NASDAQ for the periods indicated were:
HIGH LOW
------ -----
Year Ended December 31, 2001:
1st Quarter............................................... $ 6.25 $1.97
2nd Quarter............................................... 3.25 1.03
3rd Quarter............................................... 4.23 2.79
4th Quarter............................................... 4.74 2.76
Year Ended December 31, 2000:
1st Quarter............................................... $13.56 $4.00
2nd Quarter............................................... 9.88 5.50
3rd Quarter............................................... 12.63 5.00
4th Quarter............................................... 11.00 2.16
The Company did not pay cash dividends in 2001, 2000 or 1999 and does not
expect to pay dividends on our common stock in the foreseeable future. Moreover,
the Company is currently prohibited by its credit agreement with The Northern
Trust Company from making any dividend payment.
9
ITEM 6. SELECTED CONSOLIDATED FINANCIAL DATA
The following table sets forth selected consolidated financial information
for the Company for the years ended December 31, 2001, 2000, 1999, 1998 and
1997. The results for 2001 and 2000 are unaudited. See "Item 8, Statement in
Lieu of Independent Auditors' Report."
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
Management's discussion and analysis of financial condition and results of
operations should be read in conjunction with the accompanying consolidated
financial statements. The results for 2001 and 2000 are unaudited. See "Item 8,
Statement in Lieu of Independent Auditors' Report."
10
RESULTS OF OPERATIONS
The Company's revenues are derived from sales of diagnostic and therapeutic
pharmaceuticals and surgical instruments by the ophthalmic segment, from sales
of diagnostic and therapeutic pharmaceuticals by the injectable segment and from
contract services revenue. The following table sets forth the percentage
relationships that certain items from the Company's Consolidated Statements of
Income bear to revenues for the years ended December 31, 2001, 2000 and 1999.
YEARS ENDED DECEMBER 31,
------------------------------
2001 2000 1999
---- ---- ----
Revenues
Ophthalmic................................................ 41% 42% 50%
Injectable................................................ 23 38 35
Contract Services......................................... 36 20 15
--- --- ---
Total revenues.............................................. 100% 100% 100%
Gross profit................................................ 17% 43% 52%
Selling, general and administrative expenses................ 75 26 26
Amortization of intangibles................................. 4 2 3
Research and development expenses........................... 6 6 4
--- --- ---
Operating income (loss)..................................... (68) 9 19
Net income (loss)........................................... (46)% 3% 10%
SIGNIFICANT ACCOUNTING POLICIES
The Company accrues an estimate of the difference between the gross sales
price of certain products sold to wholesalers and the expected resale prices of
such products under contractual arrangements with third parties such as
hospitals and group purchasing organizations at the time of sale to the
wholesaler. Similarly, the Company records an allowance for rebates related to
contracts and other programs with wholesalers. These allowances are reflected as
a reduction of account receivable balances. The Company evaluates the allowance
balances against actual chargebacks and rebates processed by wholesalers. Actual
chargebacks and rebates processed can vary materially from period to period. The
Company has an increasing number of contracts and other programs with
wholesalers, each incorporating various numbers and types of chargebacks and
rebates. The recorded allowance amount reflects the Company's current estimate
of the chargeback and rebate amounts wholesalers have earned under these various
contracts and programs.
In May 2001, the Company completed an analysis of its March 31, 2001
allowance for chargebacks and rebates and determined that an increase from the
allowance of $3,296,000 at December 31, 2000 was necessary. In performing such
analysis, the Company utilized recently obtained reports of wholesaler's
inventory information, which had not been previously obtained or utilized. Based
on the wholesaler's March 31, 2001 inventories and historical chargeback and
rebate activity, the Company recorded an allowance of $6,961,000, which resulted
in an expense of $12,000,000 for the three months ended March 31, 2001.
During the quarter ended June 30, 2001, the Company further refined its
estimates of the chargeback and rebate liability determining that an additional
$2,250,000 provision needed to be recorded. This additional increase to the
allowance was necessary to reflect the continuing shift of sales to customers
who purchase their products through group purchasing organizations and buying
groups. The Company had previously seen a much greater level of list price
business than is occurring in the current business environment.
The Company records an allowance for estimated product returns. This
allowance is reflected as a reduction of account receivable balances. The
Company evaluates the allowance balance against actual returns processed. Actual
returns processed can vary materially from period to period.
Based on the wholesaler's inventory information, the Company increased its
allowance for potential product returns to $2,232,000 at March 31, 2001 from
$232,000 at December 31, 2000. The provision for the
11
three months ended March 31, 2001 was $2,559,000. The allowance for potential
product returns was $548,000 at December 31, 2001.
The Company records an allowance for doubtful accounts, which reflects
trade receivable balances owed to the Company that are believed to be
uncollectible. This allowance is reflected as a reduction of account receivable
balances. The expense related to doubtful accounts is reflected in SG&A
expenses.
Based upon its recent unsuccessful efforts to collect past due balances,
the Company updated its analysis of potentially uncollectible trade receivable
balances and recorded a total bad debt provision for the year of $12,000,000.
The Company recorded $7,520,000 and $4,610,00 in the first and second quarter of
2001, respectively and reduced the allowance $130,000 in the fourth quarter of
2001. As a result, and after the effect of balances written off, the allowance
for doubtful accounts increased to $3,706,000 at December 31, 2001 from $801,000
at December 31, 2000.
The Company records an allowance for discounts and allowances, which
reflects discounts and allowances available to certain customers based on agreed
upon terms of sale. This allowance is reflected as a reduction of account
receivable balances. The Company evaluates the allowance balance against actual
discounts taken.
The Company records an estimate for slow-moving and obsolete inventory
based upon recent historical sales by unit. The Company evaluates the potential
sales of its products over their remaining lives and estimates the amount that
may expire before being sold.
In the fourth quarter of 2000, the Company increased this reserve by
$2,700,000 to account for slow moving and obsolete inventory primarily related
to products purchased from third parties in 1998 and 1999 for which the original
sales forecast overestimated actual demand.
In the first quarter of 2001, based on sales trends and forecasted sales
activity by product, the Company increased its allowance for inventory
obsolescence to $4,583,000. The provision for the three months ended March 31,
2001 was $1,500,000. The allowance for inventory obsolescence was $1,845,000 at
December 31, 2001.
All other increases to the allowances for chargebacks and rebates, returns,
doubtful accounts, discounts and allowances and inventory obsolescence occurred
as part of the normal recording of product sales.
COMPARISON OF TWELVE MONTHS ENDED DECEMBER 31, 2001 AND 2000
Revenues decreased 36.9% for the year ended December 31, 2001 compared to
the prior year. Ophthalmic segment revenues decreased 38.2%, primarily
reflecting the decline in sales in the antibiotic, glaucoma and artificial tear
product lines. The remaining decline in ophthalmic revenues reflects the effect
of increases to the allowance for chargebacks and rebates discussed in Note K to
the Consolidated Financial Statements. The allowances for chargebacks and
rebates and returns are recorded as reductions to gross sales in computing net
sales. Ophthalmic net sales were also negatively impacted by price competition
for some of the Company's higher volume product lines. The reduction in sales
was due to both declines in unit price as well as volume. Injectable segment
revenues decreased 60.9%, primarily due to the increases in the allowances for
chargebacks and rebates and returns, discussed in Note K to the Consolidated
Financial Statements and a sharp reduction in anesthesia and antidote product
sales. The sharp reduction is attributable to excessive wholesaler inventories
that were reduced during the year without compensating purchases made by the
wholesalers. Contract services revenues increased 10.6% compared to the same
period in 2000, primarily due to price increases necessary to cover increasing
production costs.
Consolidated gross profit decreased 75.4% for the year, with gross margins
decreasing from 43.1% to 16.8%. This reflects the effects of the aforementioned
decline in net sales, as well as an increase in the reserve for slow-moving,
unsaleable and obsolete inventory items (See Note K). In addition, the Company
incurred unfavorable manufacturing variances at both the Somerset, NJ facility
and its Decatur, IL facility, which eroded the gross margin percentage. These
variances were the result of reduced activity in the plant, primarily caused by
the previously discussed reduction in sales that resulted from the wholesaler
inventories being reduced without compensating purchases. Management anticipates
that manufacturing variances will decrease
12
in the future as a result of the restructuring program (See Note S) implemented
during 2001. The Company is actively looking into increasing its manufacturing
activity at its Somerset facility either through additional product approvals or
increasing its third-party manufacturing business.
Selling, general and administrative expenses ("SG&A") increased 81.2% for
the year as compared to 2000. The increase primarily reflects a provision for
bad debts of $12,000,000. The provision for bad debts in 2000 was $607,000. SG&A
expenses also increased due to asset impairment charges of $2,132,000 and
restructuring-related charges of $1,117,000 primarily severance and lease costs.
Without these charges, SG&A would have decreased 6.4%, reflecting the results of
the cost cutting and restructuring efforts employed during the year.
Amortization of intangibles decreased 1.6% for the year, reflecting the
exhaustion of certain product intangibles.
Research and Development expenses ("R&D") decreased 37.1%, primarily
reflecting a scaling back of research and development activities. The Company is
focusing on strategic product niches in which it believes it will be able to add
value, primarily in the areas of controlled substances and ophthalmics.
Interest expense increased 47.8% compared to 2000, reflecting higher
interest rates on higher average outstanding debt balances (See Note G)
partially offset by capitalized interest related to the lyophilized
pharmaceuticals manufacturing line expansion.
Net loss for 2001 was $19,611,000, or $1.01 per share, compared to net
income of $2,187,000, or $0.11 per share, for the prior year.
COMPARISON OF TWELVE MONTHS ENDED DECEMBER 31, 2000 AND 1999
Revenues increased 3.6% for the year ended December 31, 2000 compared to
the prior year. Ophthalmic segment revenues decreased 13.1%, primarily due to
sharply reduced sales in generic therapeutic pharmaceuticals for glaucoma and
allergies. The reduction in sales was due to both declines in unit price as well
as volume. Injectable segment revenues increased 20.3%, primarily due to sales
of acquired anesthesia products. Injectable segment sales also benefited from
favorable unit prices due to a continuing shortage of certain distributed
products and increased contract-manufacturing activity. In both segments,
wholesaler-discounting programs unfavorably impacted unit prices. These
discounts take the form of chargebacks and rebates. Chargebacks and rebates are
discussed further in Note K to the Consolidated Financial Statements. This
charge is reflected as a reduction in net sales, primarily ophthalmic.
Consolidated gross profit decreased 13.9% for the year, with gross margins
decreasing from 51.8% to 43.1%. Pricing pressure on ophthalmic generic
pharmaceuticals as well as the disproportionate increase in contract
manufacturing revenues caused the decrease in gross margins. Contract
manufacturing activity commands significantly lower margins than sales of the
Company's other product lines. Margins in 2000 were also reduced by a $4.0
million ($2.7 million in the fourth quarter) increase in the reserve for
slow-moving and obsolete inventory. This increase was primarily related to
products purchased from third parties in 1998 and 1999 for which the original
sales forecast overestimated demand.
Selling, general and administrative expenses ("SG&A") increased 4.0%,
reflecting routine escalations in rental and other contracts, routine
compensation increases, and the increase in leased space in the Buffalo Grove
facility.
Amortization of intangibles decreased 19.1% for the year, reflecting a
patent expiration in the 2nd quarter of 1999.
Research and Development expenses ("R&D") increased 50.6%, primarily
reflecting costs associated with Piroxicam clinical trials and beginning stage
development of the Company's age-related macular degeneration product.
Interest expense increased 24.9%, reflecting higher interest rates on
higher average outstanding debt balances partially offset by capitalized
interest related to major capital projects in 2000.
13
Net income for 2000 was $2,187,000, or $0.11 per diluted share, compared to
$6,670,000, or $0.36 per diluted share, for the prior year. The decrease in
earnings resulted from the above mentioned items.
FINANCIAL CONDITION AND LIQUIDITY
As of December 31, 2001, the Company had cash and cash equivalents of
$5,355,000. The net working capital balance at December 31, 2001 was
$(24,357,000) versus $26,355,000 at December 31, 2000 resulting primarily from
decreases in receivables and inventory and reclassification of the Company's
senior debt obligation as a current liability.
During the year ended December 31, 2001, the Company used $654,000 in cash
for operations. Investing activities, which include the purchase of
product-related intangible assets as well as equipment required $4,126,000 in
cash. Fixed asset purchases related to the lyophilized (freeze-dried)
pharmaceuticals manufacturing line expansion accounted for $2,566,000 of the
$4,126,000 cash used in investing activities and the Company expects to spend an
additional $2,500,000 for such expansion during 2002. Financing activities
provided $9,328,000 in cash primarily through the issuance of $5,000,000
subordinated convertible debentures and a $3,250,000 promissory note.
In 1997 the Company entered into a $15 million revolving credit
arrangement, increased to $25 million in 1998, and subsequently increased to $45
million in 1999, subject to certain financial covenants and certain liens on the
Company's fixed assets. The credit agreement, as amended effective January 1,
2002, requires the Company to maintain certain financial covenants. These
covenants include minimum levels of cash receipts, limitations on capital
expenditures, a $750,000 per quarter limitation on product returns and required
amortization of the loan principal. The agreement also prohibits the Company
from declaring any cash dividends on its common stock and identifies certain
conditions in which the principal and interest on the credit agreement would
become immediately due and payable. These conditions include: (a) an action by
the FDA which results in a partial or total suspension of production or shipment
of products, (b) failure to invite the FDA in for re-inspection of the Decatur
manufacturing facilities by June 1, 2002, (c) failure to make a written
response, within 10 days, to the FDA, with a copy to the lender, to any written
communication received from the FDA after January 1, 2002 that raises any
deficiencies, (d) imposition of fines against the Company in an aggregate amount
greater than $250,000, (e) a cessation in public trading of Akorn stock other
than a cessation of trading generally in the United States securities market,
(f) restatement of or adjustment to the operating results of the Company in an
amount greater than $27,000,000, (g) failure to enter into an engagement letter
with an investment banker for the underwriting of an offering of equity
securities by June 15, 2002, (h) failure to not be party to an engagement letter
at any time after June 15, 2002 or (i) experience any material adverse action
taken by the FDA, the SEC, the DEA or any other Governmental Authority based on
an alleged failure to comply with laws or regulations. Management believes it
will be able to comply with the covenants during 2002. In the event that the
Company is not in compliance with the covenants during 2002 and does not
negotiate amended covenants and/or obtain a waiver thereto, then the debt
holder, at its option, may demand immediate payment of all outstanding amounts
due it. The amended credit agreement requires a minimum payment of $5.6 million,
which relates to an estimated federal tax refund, with the balance of $39.2
million due June 30, 2002. The estimated $5.6 million tax refund must be
remitted within three days of receipt from the Internal Revenue Service. The
Company is also obligated to remit any additional federal tax refunds received
above the estimated $5.6 million. The current credit facility matures on June
30, 2002 at which point the Company will need to re-negotiate or obtain new
financing. Management believes that additional long-term financing will be
needed to finance product development or acquisitions. There are no guarantees
that such financing will be available or available at an acceptable cost. See
Note G to Consolidated Financial Statement for a description of this
indebtedness and other indebtedness of the Company.
On July 12, 2001 the Company entered into a $5,000,000 subordinated debt
transaction with the John N. Kapoor Trust dtd. 9/20/89 (the "Trust"), the sole
trustee and sole beneficiary of which is Dr. John N. Kapoor, the Company's
current CEO and Chairman of the Board of Directors. The transaction is evidenced
by a Convertible Bridge Loan and Warrant Agreement (the "Trust Agreement") in
which the Trust agreed to provide two separate tranches of funding in the
amounts of $3,000,000 ("Tranche A" which was received on
14
July 13) and $2,000,000 ("Tranche B" which was received on August 16). As part
of the consideration provided to the Trust for the subordinated debt, the
Company issued the Trust two warrants which allow the Trust to purchase
1,000,000 shares of common stock at a price of $2.85 per share and another
667,000 shares of common stock at a price of $2.25 per share. The exercise price
for each warrant represented a 25% premium over the share price at the time of
the Trust's commitment to provide the subordinated debt.
Under the terms of the Trust Agreement, the subordinated debt will bear
interest at prime plus 3%, which is the same rate the Company pays on its senior
debt. Interest will not be paid to the Trust, but will instead accrue as
required by the terms of a subordination agreement which was entered into
between the Trust and the Company's senior lenders. The convertible feature of
the Trust Agreement, as amended, allows for conversion of the subordinated debt
plus interest into common stock of the Company, at a price of $2.28 per share of
common stock for Tranche A and $1.80 per share of common stock for Tranche B.
The Company, in accordance with Accounting Principles Board ("APB") Opinion
No. 14, recorded the subordinated debt transaction such that the convertible
debt and warrants have been assigned independent values. The fair value of the
warrants was estimated on the date of grant using the Black-Scholes option
pricing model with the following assumptions: (i) dividend yield of 0%, (ii)
expected volatility of 79%, (iii) risk free rate of 4.75%, and (iv) expected
life of 5 years. As a result, the Company assigned a value of $1,516,000 to the
warrants and recorded this amount as additional paid in capital. The remaining
$3,484,000 was recorded as long-term debt. The resultant bond discount,
equivalent to the value assigned to the warrants, will be amortized and charged
to interest expense over the life of the subordinated debt.
In December 2001, the Company entered into a $3,250,000 five-year loan with
NeoPharm, Inc. ("NeoPharm") to fund Akorn's efforts to complete its
lyophilization facility located in Decatur, Illinois. Under the terms of the
Promissory Note, dated December 20, 2001, interest will accrue at the initial
rate of 3.6% and will be reset quarterly based upon NeoPharm's average return on
its cash and readily tradable long and short-term securities during the previous
calendar quarter. The principal and accrued interest is due and payable on or
before maturity on December 20, 2006. The note provides that Akorn will use the
proceeds of the loan solely to validate and complete the lyophilization facility
located in Decatur, Illinois and to address the issues set forth in the Form 483
and warning letter received from the FDA. The Promissory Note is subordinated to
Akorn's senior debt owed to The Northern Trust Company but is senior to Akorn's
subordinated debt owed to the Trust. The note was executed in conjunction with a
Processing Agreement that provides NeoPharm, Inc. with the option of securing at
least 15% of the capacity of Akorn's lyophilization facility each year. Dr. John
N. Kapoor, the Company's chairman and chief executive officer is also chairman
of NeoPharm and holds a substantial stock position in that company as well as in
the Company.
Commensurate with the completion of the Promissory Note between the Company
and NeoPharm, the Company entered into an agreement with the Trust, which
amended the Trust Agreement. The amendment extended the Trust Agreement to
terminate concurrently with the Promissory Note on December 20, 2006. The
amendment also made it possible for the Trust to convert the interest accrued on
the $3,000,000 tranche into common stock of the Company. Previously, the Trust
could only convert the interest accrued on the $2,000,000 tranche. The change
related to the convertibility of the interest accrued on the $3,000,000 tranche
requires that shareholder approval be received by August 31, 2002.
15
SELECTED QUARTERLY DATA
In Thousands, Except Per Share Amounts
(Unaudited)
A small number of wholesale drug distributors accounts for a large portion
of the Company's revenues. In 2001, sales to five wholesale drug distributors
accounted for 42% of total gross sales and approximately 47% of gross trade
receivables as of December 31, 2001. The loss of one or more of these customers,
a change in purchasing patterns, an increase in returns of the Company's
products, delays in purchasing products and delays in payment for products by
one or more distributors could have a material negative impact on the Company's
revenue and results of operations and may lead to a violation of debt covenants.
At December 31, 2001, the Company had total outstanding indebtedness of
$53,933,000, or 71% of total capitalization. This significant debt load could
limit the Company's operating flexibility as a result of restrictive covenants
placed on the Company by its lenders. Further, the current debt levels could
require usage of a large portion of the cash flow from operations for debt
payments that would reduce the availability of cash flow to fund operations,
product acquisitions, expansion of the Company's sales force, facilities
improvements and research and development activities. On several past occasions,
the Company has been out of compliance with a number of the financial and other
covenants contained in the documents, which govern its debt. To date, the
Company has been able to either renegotiate the terms of such covenants or
obtain waivers of such non-compliance. See "Financial Condition and Liquidity".
No assurance can be given, however, that, if the Company was to fail to comply
in the future with its existing covenants that the Company's lenders would be
willing to either further negotiate the terms of such covenants or waive the
Company's compliance with the covenants. Under the terms of the Company's loan
documents, the Company's lenders would have the right to declare a default under
the loan documents and to thereupon pursue any and all of the remedies available
to them under the loan documents, including, but not limited to, foreclosure on
substantially all of the Company's assets. While the Company believes that it
will be able to fully satisfy all of the terms and conditions set forth in its
loan documents, future events could make such performance more difficult or
impossible.
The Company may need additional funds to operate and grow its business. The
Company may seek additional funds through public and private financing,
including equity and debt offerings. Adequate funds through the financial
markets or from other sources, may not be available when needed or on terms
favorable to the Company or its stockholders. Insufficient funds could cause the
Company to delay, scale back, or
16
abandon some or all of its product acquisition, licensing opportunities,
marketing, product development, research and development and manufacturing
opportunities.
The Company is party to a License Agreement with The Johns Hopkins
University, Applied Physics Laboratory ("JHU/APL") effective April 26, 2000, and
amended effective July 15, 2001 (See Note C). A dispute (see "Legal
Proceedings") has arisen between the Company and JHU/APL concerning the License
Agreement. The Company has an intangible asset valued at $2,084,500 recorded as
a result of the License Agreement, as amended. Unsuccessful resolution of the
dispute could result in a revaluation of this intangible asset.
Government Regulation
Federal and state statutes and government agencies regulate virtually all
aspects of the Company's business. The development, testing, manufacturing,
processing, quality, safety, efficacy, packaging, labeling, record-keeping,
distribution, storage and advertising of the Company's products, and disposal of
waste products arising from such activities, are subject to regulation by one or
more federal agencies. These agencies include the Food and Drug Administration
("FDA"), the Drug Enforcement Agency ("DEA"), the Federal Trade Commission
("FTC"), the Consumer Product Safety Commission, the Occupational Safety and
Health Administration ("OSHA") and the U.S. Environmental Protection Agency
("EPA"). Similar state and local agencies also regulate these activities.
Failure to comply with applicable statutes and government regulations could have
a material adverse effect on the Company's business, financial condition and
results of operations.
All pharmaceutical manufacturers, including the Company, are subject to
regulation by the FDA under the authority of the Federal Food, Drug, and
Cosmetic Act ("FDC Act"). Under the FDC Act, the federal government has
extensive administrative and judicial enforcement powers over the activities of
pharmaceutical manufacturers to ensure compliance with FDA regulations. Those
powers include, but are not limited to, the authority to initiate court action
to seize unapproved or non-complying products, to enjoin non-complying
activities, to halt manufacturing operations that are not in compliance with
current good manufacturing practices ("cGMP"), to recall products which present
a health risk, and to seek civil monetary and criminal penalties. Other
enforcement activities include refusal to approve product applications or the
withdrawal of previously approved applications. Any such enforcement activities,
including the restriction or prohibition on sales of products marketed by the
Company or the halting of manufacturing operations of the Company, could have a
material adverse effect on the Company's business, financial condition and
results of operations. In addition, product recalls may be issued at the
discretion of the Company, the FDA or other government agencies having
regulatory authority for pharmaceutical product sales. Recalls may occur due to
disputed labeling claims, manufacturing issues, quality defects or other
reasons. No assurance can be given that recalls of the Company's pharmaceutical
products will not occur in the future. Any product recall could have a material
adverse effect on the Company's business, financial condition and results of
operations. Further, product recalls, in certain circumstances, could constitute
an event of default under the provision of the Company's senior debt.
All "new drugs" must be the subject of an FDA-approved new drug application
("NDA") before they may be marketed in the United States. Certain prescription
drugs are not currently required to be the subject of an approved NDA but,
rather, may be marketed pursuant to an FDA regulatory enforcement policy
permitting continued marketing of those drugs until the FDA determines whether
they are safe and effective. All generic equivalents to previously approved
drugs or new dosage forms of existing drugs must be the subject of an
FDA-approved abbreviated new drug application ("ANDA") before they may be
marketed in the United States. The FDA has the authority to withdraw existing
NDA and ANDA approvals and to review the regulatory status of products marketed
under the enforcement policy. The FDA may require an approved NDA or ANDA for
any drug product marketed under the enforcement policy if new information
reveals questions about the drug's safety or efficacy. All drugs must be
manufactured in conformity with cGMP and drugs subject to an approved NDA or
ANDA must be manufactured, processed, packaged, held, and labeled in accordance
with information contained in the NDA or ANDA.
17
The Company and its third-party manufacturers are subject to periodic
inspection by the FDA to assure such compliance. The FDA imposes additional
stringent requirements on the manufacture of sterile pharmaceutical products to
ensure the sterilization processes and related control procedures consistently
produce a sterile product. Additional sterile manufacturing requirements include
the submission for expert review of detailed documentation for sterilization
process validation in drug applications beyond those required for general
manufacturing process validation. Various sterilization process requirements are
the subject of detailed FDA guidelines, including requirements for the
maintenance of microbiological control and quality stability. Pharmaceutical
products must be distributed, sampled and promoted in accordance with FDA
requirements. The FDA also regulates drug labeling and the advertising of
prescription drugs. A finding by a governmental agency or court that the Company
is not in compliance could have a material adverse effect on the Company's
business, financial condition and results of operations.
During 2000, the Company received a warning letter as a result of a routine
inspection of its Decatur manufacturing facilities. This letter focused on
general documentation and cleaning validation issues. The Company was
re-inspected in late 2001 and the FDA issued a Form 483 documenting their
findings. The Company responded to these findings on January 4, 2002 and is
awaiting a response from the FDA. The warning letter prevents the FDA from
issuing any approval for new products manufactured at the Decatur facility. The
warning letter does not inhibit the Company's ability to continue manufacturing
products that are currently approved. The warning letter does not impact the
operations at the Somerset facility.
While the Company believes that all of its current pharmaceuticals are
lawfully marketed in the United States under current FDA enforcement policies or
have received the requisite agency approvals for manufacture and sale, such
marketing authority is subject to withdrawal by the FDA. In addition,
modifications or enhancements of approved products are in many circumstances
subject to additional FDA approvals which may or may not be granted and which
may be subject to a lengthy application process. Any change in the FDA's
enforcement policy or any decision by the FDA to require an approved NDA or ANDA
for a Company product not currently subject to the approved NDA or ANDA
requirements or any delay in the FDA approving an NDA or ANDA for a Company
product could have a material adverse effect on the Company's business,
financial condition and results of operations.
A number of products marketed by the Company are "grandfathered" drugs that
are permitted to be manufactured and marketed without FDA-issued ANDAs or NDAs
on the basis of their having been marketed prior to enactment of relevant
sections of the FDC Act. The regulatory status of these products is subject to
change and/or challenge by the FDA, which could establish new standards and
limitations for manufacturing and marketing such products, or challenge the
evidence of prior manufacturing and marketing upon which grandfathering status
is based. The Company is not aware of any current efforts by the FDA to change
the status of any of its "grandfathered" products, but there can be no assurance
that such initiatives will not occur in the future. Any such change in the
status of the Company's "grandfathered" products could have a material adverse
effect on the Company's business, financial condition and results of operations.
The Company also manufactures and sells drugs which are "controlled
substances" as defined in the federal Controlled Substances Act and similar
state laws, which establishes, among other things, certain licensing, security
and record keeping requirements administered by the DEA and similar state
agencies, as well as quotas for the manufacture, purchase and sale of controlled
substances. The DEA could limit or reduce the amount of controlled substances
which the Company is permitted to manufacture and market. The Company has not
experienced sanctions or fines for non-compliance with the foregoing
regulations, but no assurance can be given that any such sanctions or fines
would not have a material adverse effect on the Company's business, financial
condition and results of operations.
On March 6, 2002, the Company received a letter from the United States
Attorney's Office, Central District of Illinois, Springfield, Illinois, advising
the Company that the United States Drug Enforcement Administration had referred
a matter to that office for a possible civil legal action for alleged violations
of the Comprehensive Drug Abuse Prevention Control Act of 1970, 21 U.S.C. sec.
801, et. seq. and regulations promulgated under the Act. The Company is
cooperating fully with the government and anticipates that any action under this
matter will not have a material impact on its financial statements.
18
The Company cannot determine what effect changes in regulations or statutes
or legal interpretation, when and if promulgated or enacted, may have on its
business in the future. Changes could, among other things, require changes to
manufacturing methods, expanded or different labeling, the recall, replacement
or discontinuation of certain products, additional record keeping and expanded
documentation of the properties of certain products and scientific
substantiation. Such changes or new legislation could have a material adverse
effect on the Company's business, financial condition and results of operations.
Dependence on Development of Pharmaceutical Products and Manufacturing
Capabilities
The Company's strategy for growth is dependent upon its ability to develop
products that can be promoted through current marketing and distributions
channels and, when appropriate, the enhancement of such marketing and
distribution channels. The Company currently has 17 ANDAs in various stages of
development and anticipates filing two NDAs at some point in the future. See
"Item 1. Description of Business -- Research and Development." The Company may
not meet its anticipated time schedule for the filing of ANDAs and NDAs or may
decide not to pursue ANDAs or NDAs that it has submitted or anticipates
submitting. The internal development of new pharmaceutical products by the
Company is dependent upon the research and development capabilities of the
Company's personnel and its infrastructure. There can be no assurance that the
Company will successfully develop new pharmaceutical products or, if developed,
successfully integrate new products into its existing product lines. In
addition, there can be no assurance that the Company will receive all necessary
approvals from the FDA or that such approvals will not involve delays, which
adversely affect the marketing and sale of the Company's products. Until such
time as the Company receives clearance from the Form 483 and warning letter
received from the FDA, the Company will not receive approval from the FDA to
manufacture any new NDA products at its Decatur facility. The Company's failure
to develop new products or receive FDA approval of ANDAs or NDAs, or address the
issues raised in the Form 483 and warning letter received from the FDA, could
have a material adverse effect on the Company's business, financial condition
and results of operations. Another part of the Company's growth strategy is to
develop the capability to manufacture lyophilized (freeze-dried) pharmaceutical
products. While the Company has devoted resources to developing these
capabilities, it may not be successful in developing these capabilities, or the
Company may not realize the anticipated benefits from developing these
capabilities.
Generic Substitution
The Company's branded pharmaceutical products are subject to competition
from generic equivalents and alternative therapies. Generic pharmaceuticals are
the chemical and therapeutic equivalents of brand-name pharmaceuticals and
represent an increasing proportion of pharmaceuticals dispensed in the United
States. There is no proprietary protection for most of the branded
pharmaceutical products sold by the Company and generic and other substitutes
for most of its branded pharmaceutical products are sold by other pharmaceutical
companies. In addition, governmental and cost-containment pressures regarding
the dispensing of generic equivalents will likely result in generic substitution
and competition generally for the Company's branded pharmaceutical products.
Although the Company attempts to mitigate the effect of this substitution
through, among other things, creation of strong brand-name recognition and
product-line extensions for its branded pharmaceutical products, there can be no
assurance that the Company will be successful in these efforts. Increased
competition in the sale of generic pharmaceutical products could have a material
adverse effect on the Company's business, financial condition and results of
operations. Generic substitution is regulated by the federal and state
governments, as is reimbursement for generic drug dispensing. There can be no
assurance that substitution will be permitted for newly approved generic drugs
or that such products will be subject to government reimbursement.
Dependence on Generic and Off-Patent Pharmaceutical Products
The success of the Company depends, in part, on its ability to anticipate
which branded pharmaceuticals are about to come off patent and thus permit the
Company to develop, manufacture and market equivalent generic pharmaceutical
products. Generic pharmaceuticals must meet the same quality standards as
branded
19
pharmaceuticals, even though these equivalent pharmaceuticals are sold at prices
that are significantly lower than that of branded pharmaceuticals. In addition,
generic products that third parties develop may render the Company's generic
products noncompetitive or obsolete. Although the Company has successfully
brought generic pharmaceutical products to market in a timely manner in the
past, there can be no assurance that the Company will be able to consistently
bring these products to market quickly and efficiently in the future. An
increase in competition in the sale of generic pharmaceutical products or the
Company's failure to bring such products to market before its competitors could
have a material adverse effect on the Company's business, financial condition
and results of operations.
Risks and Expense of Legal Proceedings
The Company is currently involved in several pending or threatened legal
actions with both private parties and certain government agencies. See "Legal
Proceedings". While the Company believes that its positions in these various
matters are meritorious, to the extent that the Company's personnel must spend
time and the Company must expend resources to pursue or contest these various
matters, or any additional matters that may be asserted from the time to time in
the future, this represents time and money that is not available for other
actions that the Company might otherwise pursue which could be beneficial to the
Company's future. In addition, to the extent that the Company is unsuccessful in
any legal proceedings, the consequences could have a negative impact on the
Company or its operations. These consequences could include, but not be limited
to, fines, penalties, injunctions, the loss of patent or other rights, the need
to write down or off the value of assets (which could negatively impact the
Company's earnings) and a wide variety of other potential remedies or actions
that could be taken against the Company. While the Company will continue to
vigorously pursue its rights in all such matters, no assurance can be given that
the Company will be successful in any of these proceedings or, even if
successful, that the Company would be able to recoup any of the moneys expended
in pursuing such matters.
Competition; Uncertainty of Technological Change
The Company competes with other pharmaceutical companies, including major
pharmaceutical companies with financial resources substantially greater than
those of the Company, in developing, acquiring, manufacturing and marketing
pharmaceutical products. The selling prices of pharmaceutical products typically
decline as competition increases. Further, other products now in use, under
development or acquired by other pharmaceutical companies, may be more effective
or offered at lower prices than the Company's current or future products. The
industry is characterized by rapid technological change that may render the
Company's products obsolete, and competitors may develop their products more
rapidly than the Company. Competitors may also be able to complete the
regulatory process sooner, and therefore, may begin to market their products in
advance of the Company's products. The Company believes that competition in
sales of its products is based primarily on price, service, availability and
product efficacy. There can be no assurance that: (i) the Company will be able
to develop or acquire commercially attractive pharmaceutical products; (ii)
additional competitors will not enter the market; or (iii) competition from
other pharmaceutical companies will not have a material adverse effect on the
Company's business, financial condition and results of operations.
Dependence on Supply of Raw Materials and Components
The Company requires a supply of quality raw materials and components to
manufacture and package pharmaceutical products for itself and for third parties
with which it has contracted. The principal components of the Company's products
are active and inactive pharmaceutical ingredients and certain packaging
materials. Many of these components are available from only a single source and,
in the case of many of the Company's ANDAs and NDAs, only one supplier of raw
materials has been identified. Because FDA approval of drugs requires
manufacturers to specify their proposed suppliers of active ingredients and
certain packaging materials in their applications, FDA approval of any new
supplier would be required if active ingredients or such packaging materials
were no longer available from the specified supplier. The qualification of a new
supplier could delay the Company's development and marketing efforts. If for any
reason the Company is unable to obtain sufficient quantities of any of the raw
materials or components required to
20
produce and package its products, it may not be able to manufacture its products
as planned, which could have a material adverse effect on the Company's
business, financial condition and results of operations.
Dependence on Third-Party Manufacturers
The Company derives a significant portion of its revenues from the sale of
products manufactured by third parties, including its competitors in some
instances. There can be no assurance that the Company's dependence on third
parties for the manufacture of such products will not adversely affect the
Company's profit margins or its ability to develop and deliver its products on a
timely and competitive basis. If for any reason the Company is unable to obtain
or retain third-party manufacturers on commercially acceptable terms, it may not
be able to distribute certain of its products as planned. No assurance can be
made that the manufacturers utilized by the Company will be able to provide the
Company with sufficient quantities of its products or that the products supplied
to the Company will meet the Company's specifications. Any delays or
difficulties with third-party manufacturers could adversely affect the marketing
and distribution of certain of the Company's products, which could have a
material adverse effect on the Company's business, financial condition and
results of operations.
Product Liability
The Company faces exposure to product liability claims in the event that
the use of its technologies or products or those it licenses from third parties
is alleged to have resulted in adverse effects in users thereof. Receipt of
regulatory approval for commercial sale of such products does not mitigate such
product liability risks. While the Company has taken, and will continue to take,
what it believes are appropriate precautions, there can be no assurance that it
will avoid significant product liability exposure. In addition, future product
labeling may include disclosure of additional adverse effects, precautions and
contraindications, which may adversely impact sales of such products. The
Company currently has product liability insurance in the amount of $10.0 million
for aggregate annual claims with a $50,000 deductible per incident and a
$250,000 aggregate annual deductible. However, there can be no assurance that
such insurance coverage will be sufficient to fully cover potential claims.
Additionally, there can be no assurance that adequate insurance coverage will be
available in the future at acceptable costs, if at all, or that a product
liability claim would not have a material adverse effect on the Company's
business, financial condition and results of operations.
Acquisition and Licensing of Pharmaceutical Products
The Company may purchase or license pharmaceutical product lines of other
pharmaceutical or biotechnology companies. Other companies, including those with
substantially greater financial, marketing and other resources, compete with the
Company for the right to acquire or license such products. Were the Company to
elect to pursue this strategy, its success would depend, in part, on its ability
to identify potential products that meet the Company's criteria, including
possessing a recognizable brand name or being complementary to the Company's
existing product lines. There can be no assurance that the Company would have
success in identifying potential product acquisitions or licensing opportunities
or that, if identified, it would complete such product acquisitions or obtain
such licenses on acceptable terms or that it would obtain the necessary
financing, or that it could successfully integrate any acquired or licensed
products into its existing product lines. The inability to complete acquisitions
of, or obtain licenses for, pharmaceutical products could have a material
adverse effect on the Company's business, financial condition and results of
operations. Furthermore, there can be no assurance that the Company, once it has
obtained rights to a pharmaceutical product and committed to payment terms, will
be able to generate sales sufficient to create a profit or otherwise avoid a
loss. Any inability to generate such sufficient sales or any subsequent
reduction of sales could have a material adverse effect on the Company's
business, financial condition and result of operations.
Patents and Proprietary Rights
The patent position of competitors in the pharmaceutical industry generally
is highly uncertain, involves complex legal and factual questions, and is the
subject of much litigation. There can be no assurance that any patent
applications relating to the Company's potential products or processes will
result in patents being
21
issued, or that the resulting patents, if any, will provide protection against
competitors who: (i) successfully challenge the Company's patents; (ii) obtain
patents that may have an adverse effect on the Company's ability to conduct
business; or (iii) are able to circumvent the Company's patent position. It is
possible that other parties have conducted or are conducting research and could
make discoveries of pharmaceutical formulations or processes that would precede
any discoveries made by the Company, which could prevent the Company from
obtaining patent protection for these discoveries or marketing products
developed therefrom. Consequently, there can be no assurance that others will
not independently develop pharmaceutical products similar to or obsoleting those
that the Company is planning to develop, or duplicate any of the Company's
products. The inability of the Company to obtain patents for its products and
processes or the ability of competitors to circumvent or obsolete the Company's
patents could have a material adverse effect on the Company's business,
financial condition and results of operations.
Exercise of Warrants, Conversion of Subordinated Debt, May have Dilutive
Effect
Under terms of a $5,000,000 subordinated debt transaction, which the
Company entered into with the John N. Kapoor trust dtd. 9/20/89 (the "Trust"),
the sole trustee and sole beneficiary of which is Dr. John N. Kapoor, the
Company's current CEO and Chairman of the Board of Directors, the Trust agreed
to provide the Company with $5,000,000 of subordinated debt in two separate
tranches of $3,000,000 ("Tranche A") and $2,000,000 ("Tranche B"). In return for
providing the subordinated debt, the Trust was granted Warrants to purchase
1,000,000 shares of common stock, at a purchase price of $2.85 per share for
Tranche A and 667,000 shares of common stock, at a purchase price of $2.25 per
share, for Tranche B. In addition, Tranche A, plus the interest on Tranche A, is
convertible into common stock of the Company at a price of $2.28 per share, and
Tranche B, plus the interest on Tranche B, is convertible into common stock of
the Company at a price of $1.80 per share. If the price per share of the
Company's common stock at the time of exercise of the Warrants or conversion of
the subordinated debt is in excess of the various Warrant exercise or conversion
prices, exercise of the Warrants and conversion of the subordinated debt would
have a dilutive effect on the Company's common stock. The amount of such
dilution, however, cannot currently be determined as it would depend on the
amount disparity between the stock price and the price at which the warrants
were exercised or the subordinated debt was converted at the time of exercise or
conversion.
Need to Attract and Retain Key Personnel in Highly Competitive Marketplace
The Company's performance depends, to a large extent, on the continued
service of its key research and development personnel, other technical
employees, managers and sales personnel and its ability to continue to attract
and retain such personnel. Competition for such personnel is intense,
particularly for highly motivated and experienced research and development and
other technical personnel. The Company is facing increasing competition from
companies with greater financial resources for such personnel. There can be no
assurance that the Company will be able to attract and retain sufficient numbers
of highly-skilled personnel in the future, and the inability to do so could have
a material adverse effect on the Company's business, operating results and
financial condition and results of operations.
Dependence on Key Executive Officers
The Company's success will depend, in part, on its ability to attract and
retain key executive officers. The inability to find or the loss of one or more
of the Company's key executive officers could have a material adverse effect on
the Company's business, financial condition and results of operations.
Quarterly Fluctuation of Results; Possible Volatility of Stock Price
The Company's results of operations may vary from quarter to quarter due to
a variety of factors including the timing of the development and marketing of
new pharmaceutical products, the failure to develop such products, delays in
obtaining government approvals, including FDA approval of NDAs or ANDAs for
Company products, expenditures to comply with governmental requirements for
manufacturing facilities, expenditures incurred to acquire and promote
pharmaceutical products, changes in the Company's customer base, a customer's
termination of a substantial account, the availability and cost of raw
materials, interruptions
22
in supply by third-party manufacturers, the introduction of new products or
technological innovations by the Company's competitors, loss of key personnel,
changes in the mix of products sold by the Company, changes in sales and
marketing expenditures, competitive pricing pressures and the Company's ability
to meet its financial covenants. There can be no assurance that the Company will
be successful in maintaining or improving its profitability or avoiding losses
in any future period. Such fluctuations may result in volatility in the price of
the Company's Common Stock.
Relationships with Other Entities; Conflicts of Interest
Mr. John N. Kapoor, Ph.D., the Company's Chairman of the Board and Chief
Executive Officer is affiliated with EJ Financial Enterprises, Inc., a health
care consulting investment company ("EJ Financial"). EJ Financial is involved in
the management of health care companies in various fields, and Dr. Kapoor is
involved in various capacities with the management and operation of these
companies. The John N. Kapoor Trust, the beneficiary and sole trustee of which
is Dr. Kapoor, is a principal shareholder of each of these companies. As a
result, Dr. Kapoor does not devote his full time to the business of the Company.
Although such companies do not currently compete directly with the Company,
certain companies with which EJ Financial is involved are in the pharmaceutical
business. Discoveries made by one or more of these companies could render the
Company's products less competitive or obsolete. In addition, one of these
companies, NeoPharm, Inc. of which Dr. Kapoor is Chairman and a major
stockholder, recently entered into a loan agreement with the Company. Further,
Dr. Kapoor has loaned the Company $5,000,000 with the result that he has become
a major creditor of the Company as well as a major stockholder. See "Financial
Condition and Liquidity". Potential conflicts of interest could have a material
adverse effect on the Company's business, financial condition and results of
operations.
RECENT ACCOUNTING PRONOUNCEMENTS
In June 1998, the Financial Accounting Standards Board ("FASB") issued
Statement of Financial Accounting Standards ("SFAS") No. 133, "Accounting for
Derivatives Instruments and Hedging Activities." SFAS 133 establishes accounting
and reporting standards for derivative instruments, including certain derivative
instruments embedded in other contracts, and for hedging activities. SFAS No.
133, as amended by SFAS No. 137 and No. 138, was effective for the Company's
fiscal 2001 financial statements and was adopted by the Company on January 1,
2001. Adoption of these standards did not have a material effect on the
Company's financial position or results of operations.
In July 2001, the FASB approved three statements, SFAS 141, "Business
Combinations," SFAS 142, "Goodwill and Other Intangible Assets," and SFAS 143,
"Accounting for Asset Retirement Obligations."
SFAS 141 supercedes APB Opinion No. 16, "Business Combinations," and
eliminates the pooling-of-interests method of accounting for business
combinations, thus requiring all business combinations be accounted for using
the purchase method. In addition, in applying the purchase method, SFAS 141
changes the criteria for recognizing intangible assets apart from goodwill. The
following criteria is to be considered in determining the recognition of the
intangible assets: (1) the intangible asset arises from contractual or other
legal rights, or (2) the intangible asset is separable or dividable from the
acquired entity and capable of being sold, transferred, licensed, rented, or
exchanged. The requirements of SFAS 141 are effective for all business
combinations completed after June 30, 2001. The adoption of this new standard
did not have a material impact on the Company's financial statements.
SFAS 142 supercedes APB Opinion No. 17, "Intangible Assets," and requires
goodwill and other intangible assets that have an indefinite useful life to no
longer be amortized; however, these assets must be reviewed at least annually
for impairment. The Company has adopted SFAS 142 as of January 1, 2002. The
Company is currently evaluating the impact of this new standard on the Company's
financial statements.
SFAS 143 requires entities to record the fair value of a liability for an
asset retirement obligation in the period in which it is incurred. When the
liability is initially recorded, the entity capitalizes a cost by increasing the
carrying amount of the related long-lived asset. Over time, the liability is
accreted to its present value each period, and the capitalized cost is
depreciated over the useful life of the related asset. Upon settlement of the
23
liability, an entity either settles the obligation for its recorded amount or
incurs a gain or loss upon settlement. The Company has adopted SFAS 143 as of
January 1, 2002. The adoption of this new standard did not have a material
impact on the Company's financial statements.
In August 2001, the FASB issued SFAS 144 "Accounting for the Impairment or
Disposal of Long-Lived Assets." This statement addresses financial accounting
and reporting for the impairment or disposal of long-lived assets. This
statement supercedes SFAS No. 121, "Accounting for the Impairment of Long-Lived
Assets and for Long-Lived Assets to be Disposed Of." This statement also
supercedes the accounting and reporting provisions of APB Opinion No. 30,
"Reporting the Results of Operations -- Reporting the Effects of Disposal of a
Segment of a Business and Extraordinary, Unusual and Infrequently Occurring
Events and Transactions," for the disposal of a segment of a business (as
previously defined in that Opinion). SFAS No. 144 is effective January 1, 2002.
The adoption of this new standard did not have a material impact on the
Company's financial statements.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The Company is subject to market risk associated with changes in interest
rates. The Company's interest rate exposure involves three debt instruments. The
credit agreement with The Northern Trust Company and the subordinated
convertible debentures issued to the John N. Kapoor Trust bear the same interest
rate, which fluctuates at Prime plus 300 basis points. The promissory note
issued to NeoPharm, Inc. ("NeoPharm") bears interest at an initial rate of 3.6%
and will be reset quarterly based upon NeoPharm's average return on its cash and
readily tradable long and short-term securities during the previous calendar
quarter. All of the Company's remaining long-term debt is at fixed interest
rates. The Company believes that reasonably possible near-term changes in
interest rates would not have a material effect on the Company's financial
position, results of operations and cash flows.
The Company's financial instruments consist mainly of cash, accounts
receivable, accounts payable and debt. The carrying amounts of these
instruments, except debt, approximate fair value due to their short-term nature.
The estimated fair value of the Company's debt instruments is based upon rates
currently available to the Company for debt with similar terms and remaining
maturities.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The following financial statements are included in Part II, Item 8 of this
Form 10-K.
Statement in Lieu of Independent Auditors' Report........... 25
Consolidated Balance Sheets as of December 31, 2001 and
2000...................................................... 26
Consolidated Statements of Operations for the years ended
December 31, 2001, 2000 and 1999.......................... 27
Consolidated Statements of Shareholders' Equity for the
years ended December 31, 2001, 2000 and 1999.............. 28
Consolidated Statements of Cash Flow for the years ended
December 31, 2001, 2000 and 1999.......................... 29
Notes to Consolidated Financial Statements.................. 30
24
STATEMENT IN LIEU OF INDEPENDENT AUDITORS' REPORT
The SEC has informed the Company of a proposed enforcement action (See
"Item 3. Legal Proceedings"), which has alleged the Company's accounts
receivable were overstated as of December 31, 2000. If the enforcement action is
ultimately brought to bear, it is possible that the Company would have to
restate its 2000 and 2001 financial statements. Because of this uncertainty,
Deloitte & Touche LLP, the Company's auditors, are unwilling to give an opinion
on the Company's consolidated financial statements and notes thereto for
December 31, 2001 and 2000 and the years then ended until this matter is
resolved, and as a result these financial statements and notes are unaudited.
However, management believes that, subject to the resolution of the
above-mentioned matter, the unaudited consolidated financial statements and
notes to consolidated financial statements as of these dates and for these
periods contain all the information and necessary adjustments for a fair
presentation of these financial statements and footnotes. Because the proposed
enforcement action relates to matters in a prior fiscal year, it is not
anticipated that these proceedings will have any material impact on the
Company's Consolidated Balance Sheet as of December 31, 2001 or on the Company's
2002 or future operating results.
25
AKORN, INC.
CONSOLIDATED BALANCE SHEETS
(DOLLARS IN THOUSANDS, EXCEPT PAR VALUE DATA)
(UNAUDITED)
DECEMBER 31,
------------------
2001 2000
------- -------
ASSETS
CURRENT ASSETS
Cash and cash equivalents................................. $ 5,355 $ 807
Trade accounts receivable (less allowance for
uncollectibles of $3,706 and $801 at December 31, 2001
and 2000, respectively)................................ 5,902 24,144
Inventory................................................. 8,135 14,058
Deferred income taxes..................................... 2,069 2,016
Income taxes recoverable.................................. 6,540 --
Prepaid expenses and other assets......................... 579 1,098
------- -------
TOTAL CURRENT ASSETS................................... 28,580 42,123
OTHER ASSETS
Intangibles, net.......................................... 18,485 20,342
Deferred income taxes..................................... 3,765 --
Other..................................................... 113 22
------- -------
TOTAL OTHER ASSETS..................................... 22,363 20,364
PROPERTY, PLANT AND EQUIPMENT, NET.......................... 33,518 34,031
------- -------
TOTAL ASSETS........................................... $84,461 $96,518
======= =======
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES
Current installments of long-term debt.................... $45,072 $ 7,753
Trade accounts payable.................................... 3,035 5,900
Income taxes payable...................................... -- 556
Accrued compensation...................................... 760 854
Accrued expenses and other liabilities.................... 4,070 705
------- -------
TOTAL CURRENT LIABILITIES.............................. 52,937 15,768
Long-term debt.............................................. 8,861 39,089
Other long-term liabilities................................. 205 --
Deferred income taxes....................................... -- 1,829
------- -------
TOTAL LIABILITIES...................................... 62,003 56,686
======= =======
COMMITMENTS AND CONTINGENCIES (Notes C, H and N)
SHAREHOLDERS' EQUITY
Preferred stock, $1.00 par value -- authorized 5,000,000
shares; none issued Common stock, no par
value -- authorized 40,000,000 shares; issued and
outstanding 19,465,815 and 19,247,299 shares at
December 31, 2001 and 2000, respectively............... 24,884 22,647
Retained (deficit) earnings............................... (2,426) 17,185
------- -------
TOTAL SHAREHOLDERS' EQUITY............................. 22,458 39,832
------- -------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY.................. $84,461 $96,518
======= =======
See notes to consolidated financial statements.
26
AKORN, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
(UNAUDITED)
YEARS ENDED DECEMBER 31,
------------------------------
2001 2000 1999
-------- ------- -------
Revenues.................................................... $ 42,248 $66,927 $64,632
Cost of sales............................................... 35,147 38,090 31,155
-------- ------- -------
GROSS PROFIT.............................................. 7,101 28,837 33,477
Selling, general and administrative expenses................ 31,525 17,397 16,733
Amortization of intangibles................................. 1,494 1,519 1,878
Research and development expenses........................... 2,598 4,132 2,744
-------- ------- -------
35,617 23,048 21,355
-------- ------- -------
OPERATING INCOME (LOSS)................................... (28,516) 5,789 12,122
Interest and other income (expense):
Interest income........................................... -- -- 31
Interest expense.......................................... (3,547) (2,400) (1,921)
(Loss) gain on sale of fixed assets....................... (78) -- 275
Other (expense) income, net............................... (84) 117 132
-------- ------- -------
(3,709) (2,283) (1,483)
-------- ------- -------
INCOME (LOSS) BEFORE INCOME TAXES........................... (32,225) 3,506 10,639
Income tax (benefit) provision.............................. (12,614) 1,319 3,969
-------- ------- -------
NET INCOME (LOSS)......................................... $(19,611) $ 2,187 $ 6,670
======== ======= =======
NET INCOME (LOSS) PER SHARE:
BASIC.................................................. $ (1.01) $ 0.11 $ 0.37
======== ======= =======
DILUTED................................................ $ (1.01) $ 0.11 $ 0.36
======== ======= =======
WEIGHTED AVERAGE SHARES OUTSTANDING:
BASIC.................................................. 19,337 19,030 18,269
======== ======= =======
DILUTED................................................ 19,337 19,721 18,573
======== ======= =======
See notes to consolidated financial statements.
27
AKORN, INC.
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY
(IN THOUSANDS)
(UNAUDITED)
COMMON STOCK
---------------------- RETAINED
SHARES EARNINGS/ TREASURY
OUTSTANDING AMOUNT (DEFICIT) STOCK TOTAL
----------- ------- --------- -------- --------
Balances at January 1, 1999................. 18,122 $17,952 $ 8,328 $ -- $ 26,280
Net income.................................. -- -- 6,670 -- 6,670
Treasury stock received in lieu of cash..... (9) -- -- (35) (35)
Exercise of stock options................... 476 1,228 -- -- 1,228
Management bonus paid in stock.............. 27 109 -- -- 109
Treasury stock reissued..................... 9 (6) -- 35 29
Employee stock purchase plan................ 26 109 -- -- 109
------ ------- -------- ---- --------
Balances at December 31, 1999............... 18,651 19,392 14,998 -- 34,390
Net income.................................. -- -- 2,187 -- 2,187
Exercise of stock options................... 576 3,105 -- -- 3,105
Employee stock purchase plan................ 20 150 -- -- 150
------ ------- -------- ---- --------
Balances at December 31, 2000............... 19,247 22,647 17,185 -- 39,832
Net loss.................................... -- -- (19,611) -- (19,611)
Warrants issued in connection with
convertible debentures.................... -- 1,516 -- -- 1,516
Exercise of stock options................... 175 583 -- -- 583
Employee stock purchase plan................ 44 138 -- -- 138
------ ------- -------- ---- --------
Balances at December 31, 2001............... 19,466 $24,884 $ (2,426) $ -- $ 22,458
====== ======= ======== ==== ========
See notes to consolidated financial statements.
28
AKORN, INC.
CONSOLIDATED STATEMENTS OF CASH FLOW
(DOLLARS IN THOUSANDS)
(UNAUDITED)
YEARS ENDED DECEMBER 31,
------------------------------
2001 2000 1999
-------- -------- --------
OPERATING ACTIVITIES
Net income (loss)........................................... $(19,611) $ 2,187 $ 6,670
Adjustments to reconcile net income (loss) to net cash
(used in) provided by operating activities:
Depreciation and amortization.......................... 4,286 3,539 3,161
Impairment of long-lived assets........................ 2,132 -- --
Loss (gain) on disposal of fixed assets................ 78 -- (245)
Stock bonus............................................ -- -- 109
Deferred income taxes.................................. (5,647) (756) 763
Other.................................................. -- -- (6)
Changes in operating assets and liabilities:
Accounts receivable.................................. 18,242 (6,449) (6,992)
Income taxes recoverable............................. (6,540) -- --
Inventory, prepaid expenses and other assets......... 6,351 2,173 (5,213)
Trade accounts payable, accrued expenses and other
liabilities....................................... 611 718 1,750
Income taxes payable................................. (556) (1,050) 134
-------- -------- --------
NET CASH (USED IN) PROVIDED BY OPERATING ACTIVITIES......... (654) 362 131
INVESTING ACTIVITIES
Purchases of property, plant and equipment.................. (3,626) (15,239) (6,157)
Proceeds from disposal of fixed assets...................... -- -- 629
Purchase of product intangibles and product licensing
fees...................................................... (500) (2,449) (705)
-------- -------- --------
NET CASH USED IN INVESTING ACTIVITIES....................... (4,126) (17,688) (6,233)
FINANCING ACTIVITIES
Proceeds from exercise of stock options..................... 721 3,255 1,337
Repayments of long-term debt................................ (1,153) (22,206) (22,584)
Proceeds from issuance of long-term debt.................... 8,034 37,100 26,800
Proceeds from issuance of stock warrants.................... 1,516 -- --
Amortization of bond discount............................... 210 -- --
Principal payments under capital lease obligations.......... -- (41) (162)
-------- -------- --------
NET CASH PROVIDED BY FINANCING ACTIVITIES................... 9,328 18,108 5,391
-------- -------- --------
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS............ 4,548 782 (711)
CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR.............. 807 25 736
-------- -------- --------
CASH AND CASH EQUIVALENTS AT END OF YEAR.................... $ 5,355 $ 807 $ 25
======== ======== ========
See notes to consolidated financial statements.
29
AKORN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE A -- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Consolidation: The accompanying consolidated financial statements include
the accounts of Akorn, Inc. and its wholly owned subsidiary, Akorn (New Jersey),
Inc. (collectively, the "Company"). Intercompany transactions and balances have
been eliminated in consolidation. During 2000, the Company dissolved the
inactive subsidiaries Compass Vision, Inc., Spectrum Scientific Pharmaceuticals,
Inc. and Walnut Pharmaceuticals, Inc. The dissolution of these subsidiaries did
not have a material impact on the balances and activities of the Company.
Use of Estimates: The preparation of financial statements in conformity
with generally accepted accounting principles requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenues and expenses
during the reporting period. Actual results could differ materially from those
estimates. Significant estimates and assumptions relate to the allowance for
uncollectibles, the allowance for chargebacks and rebates, the reserve for
slow-moving and obsolete inventory, the reserve for returned goods, the carrying
value of intangible assets and the carrying value of deferred tax assets.
Revenue Recognition: The Company recognizes sales upon the shipment of
goods, provided that all obligations of the Company have been fulfilled and
collection of the related receivable is probable. Provision is made at the time
of sale for estimated product returns. Royalty revenue is recognized when earned
and is based on net sales figures that often include deductions for costs of
unsaleable returns.
Cash Equivalents: The Company considers all highly liquid investments with
a maturity of three months or less, when purchased, to be cash equivalents.
Inventory: Inventory is stated at the lower of cost (average cost method)
or market (see Note E). Provision is made for slow-moving, unsalable or obsolete
items.
Intangibles: Intangibles consist primarily of product licensing and other
such costs that are capitalized and amortized on the straight-line method over
the lives of the related license periods or the estimated life of the acquired
product, which range from 17 months to 18 years. Accumulated amortization at
December 31, 2001 and 2000 was $7,132,000 and $5,954,000, respectively. The
Company annually assesses the impairment of intangibles based on several
factors, including estimated fair market value and anticipated cash flows.
Property, Plant and Equipment: Property, plant and equipment is stated at
cost, less accumulated depreciation. Depreciation is provided using the
straight-line method in amounts considered sufficient to amortize the cost of
the assets to operations over their estimated service lives. The average
estimated service lives of buildings, leasehold improvements, furniture and
equipment, and automobiles are approximately 30, 10, 8, and 5 years,
respectively.
Allowance for Chargebacks and Rebates: The Company accrues an estimate of
the difference between the gross sales price of certain products sold to
wholesalers and the expected resale prices of such products under contractual
arrangements with third parties, such as hospitals and group purchasing
organizations at the time of sale. As part of the Company's sales terms to
wholesale customers, it agrees to reimburse wholesalers for such differentials
between wholesale prices and contract prices. Because this allowance relates to
amounts not yet collected from the wholesalers, this allowance is recorded as a
reduction of the account receivable balance. Similarly, the Company records an
allowance for rebates related to contracts and other programs with wholesalers.
The balance for these allowances was $4,190,000 and $3,296,000 as of December
31, 2001 and 2000, respectively.
Income Taxes: The Company files a consolidated federal income tax return
with its subsidiary. Deferred income taxes are provided in the financial
statements to account for the tax effects of temporary differences
30
NOTE A -- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES -- (CONTINUED)
resulting from reporting revenues and expenses for income tax purposes in
periods different from those used for financial reporting purposes. The Company
records a valuation allowance to reduce the deferred tax assets to the amount
that is more likely than not to be realized.
Fair Value of Financial Instruments: The Company's financial instruments
include cash, accounts receivable, accounts payable and term debt. The fair
values of cash, accounts receivable and accounts payable approximate fair value
because of the short maturity of these instruments. The carrying amounts of the
Company's bank borrowings under its credit facility approximate fair value
because the interest rates are reset periodically to reflect current market
rates.
Net Income Per Common Share: Basic net income per common share is based
upon weighted average common shares outstanding. Diluted net income per common
share is based upon the weighted average number of common shares outstanding,
including the dilutive effect of stock options, warrants and convertible debt
using the treasury stock method.
The following table shows basic and diluted earnings per share computations
for the years ended December 31, 2001, 2000 and 1999 (in thousands, except per
share information):
YEARS ENDED DECEMBER 31,
------------------------------
2001 2000 1999
-------- ------- -------
Net income (loss) per share -- basic:
Net income (loss)......................................... $(19,611) $ 2,187 $ 6,670
Weighted average number of shares outstanding............. 19,337 19,030 18,269
Net income (loss) per share -- basic........................ $ (1.01) $ 0.11 $ 0.37
======== ======= =======
Net income (loss) per share -- diluted:
Net income (loss)......................................... $(19,611) $ 2,187 $ 6,670
Net income (loss) adjustment for interest on convertible
debt................................................... -- -- --
-------- ------- -------
Net income (loss), as adjusted............................ $(19,611) $ 2,187 $ 6,670
======== ======= =======
Weighted average number of shares outstanding............. 19,337 19,030 18,269
Additional shares assuming conversion of convertible debt
and convertible interest on debt(1).................... -- -- --
Additional shares assuming conversion of warrants(2)...... -- -- --
Additional shares assuming conversion of options(3)....... -- 691 304
-------- ------- -------
Weighted average number of shares outstanding, as
adjusted............................................... 19,337 19,721 18,573
======== ======= =======
Net income (loss) per share -- diluted...................... $ (1.01) $ 0.11 $ 0.36
======== ======= =======
(1) For fiscal 2001, debt and interest convertible into 2,519 shares of common
stock was excluded from the computation of diluted earnings per share, as
the inclusion of such shares would be antidilutive.
(2) For fiscal 2001, warrants to purchase 1,667 shares of common stock were
excluded from the computation of diluted earnings per share, as the
inclusion of such shares would be antidilutive.
(3) For fiscal 2001 and 2000, options to purchase 3,226 and 145 shares of common
stock, respectively, were excluded from the computation of diluted earnings
per share as the inclusion of such shares would be antidilutive.
NOTE B -- NONCASH TRANSACTIONS
In July 2001, the Company amended a license agreement with The Johns
Hopkins University Applied Physics Laboratory (See Note C). As part of that
amendment, the Company delivered research and development equipment in lieu of a
$100,000 payment. The Company recorded a gain of $51,000 upon transference of
the equipment.
31
NOTE B -- NONCASH TRANSACTIONS -- (CONTINUED)
In August 1999, a former employee exercised options for 23,352 shares of
the Company's common stock. The individual tendered approximately 8,800 shares
of the Company's outstanding stock as consideration for the option exercise,
which was recorded as treasury stock. The net effect of this transaction was to
increase common stock and paid in capital by $35,028 and increase treasury stock
by $35,028.
NOTE C -- PRODUCT AND OTHER ACQUISITIONS
In April 2000, the Company entered into a worldwide license agreement with
The Johns Hopkins University Applied Physics Laboratory. This license provides
the Company exclusive rights to two patents covering the methodology and
instrumentation for a method of treating age-related macular degeneration. Upon
signing the agreement, the Company made an initial payment under the agreement
of $1,484,500. In July 2001, this license agreement was amended such that the
Company relinquished the international rights to the two patents in exchange for
a reduced financial obligation. The Company retained the exclusive rights in the
U.S. Future payments of $600,000 were required under terms of the amendment. As
of December 31, 2001, $300,000 remains due under the terms of the agreement and
was payable on or before March 31, 2002. The Company did not make the remaining
$300,000 payment on or before March 31,2002 and is currently attempting to
negotiate a resolution to a dispute that has arisen over the license agreement.
See Note T for further discussion.
In March 1999, the Company purchased the Paredrine NDA and trade name from
Pharmics for $62,500 in cash. The acquisition cost has been allocated to
intangibles and will be amortized over 15 years.
In February 1999, the Company paid $400,000 to Eastman Kodak to license IC
Green raw material manufacturing processes. The acquisition cost has been
allocated to intangibles and will be amortized over 15 years.
NOTE D -- ALLOWANCE FOR UNCOLLECTIBLES
The activity in the allowance for uncollectibles for the periods indicated
is as follows (in thousands):
YEARS ENDED DECEMBER 31,
------------------------
2001 2000 1999
------- ---- -----
Balance at beginning of year................................ $ 801 $226 $ 425
Provision for bad debts..................................... 12,000 607 161
Specific reversal of doubtful account....................... -- -- (300)
Accounts written off........................................ (9,095) (32) (60)
------- ---- -----
Balance at end of year...................................... $ 3,706 $801 $ 226
======= ==== =====
NOTE E -- INVENTORY
The components of inventory are as follows (in thousands):
DECEMBER 31,
-----------------
2001 2000
------ -------
Finished goods.............................................. $2,906 $ 5,014
Work in process............................................. 1,082 3,644
Raw materials and supplies.................................. 4,147 5,400
------ -------
$8,135 $14,058
====== =======
Inventory at December 31, 2001 and 2000 is reported net of reserves for
slow-moving, unsalable and obsolete items of $1,845,000 and $3,171,000,
respectively.
32
NOTE F -- PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment consists of the following (in thousands):
Construction in progress represents capital expenditures principally
related to the Company's lyophilization project that will enable the Company to
perform processes in-house, which are currently being performed by a
sub-contractor.
NOTE G -- FINANCING ARRANGEMENTS
The Company's long-term debt consists of (in thousands):
DECEMBER 31,
------------------
2001 2000
------- -------
Credit Agreement with The Northern Trust Company............ $44,800 $44,400
Subordinated convertible debentures......................... 5,000 --
Mortgages payable secured by real property located in
Decatur, Illinois......................................... 2,189 2,442
Promissory note to NeoPharm, Inc............................ 3,250 --
------- -------
55,239 46,842
Less unamortized discount on subordinated convertible
debentures................................................ 1,306 --
Less current portion........................................ 45,072 7,753
------- -------
Long-term debt.............................................. $ 8,861 $39,089
======= =======
Maturities of debt are as follows (in thousands):
Year ending December 31:
2002........................................................ 45,072
2003........................................................ 293
2004........................................................ 316
2005........................................................ 340
2006........................................................ 8,616
Thereafter.................................................. 602
-------
Total............................................. $55,239
=======
33
NOTE G -- FINANCING ARRANGEMENTS -- (CONTINUED)
In December 1997, the Company entered into a $15,000,000 revolving credit
agreement with The Northern Trust Company, which was increased to $25,000,000 on
June 30, 1998 and to $45,000,000 on December 28, 1999. This Amended and Restated
Credit Agreement (the "Credit Agreement") is secured by substantially all of the
assets of the Company and its subsidiaries and contains a number or restrictive
covenants. The covenants include, among other things, minimum levels of net
worth, net income and monthly EBITDA and a minimum borrowing base (as defined)
and a limitation on capital expenditures. There were outstanding borrowings of
$44,800,000 and $44,400,000 at December 31, 2001 and 2000, respectively. The
interest rate as of December 31, 2001 was 7.75%.
On April 16, 2001 the revolving credit agreement was amended (the "2001
Amendment") and included, among other things, extension of the term of the
agreement, establishment of a payment schedule, revision of the method by which
the interest rate will be determined, and the amendment and addition of certain
covenants. The 2001 Amendment also required the Company to obtain subordinated
debt of $3 million by May 15, 2001 and waived certain covenant violations
through March 31, 2001. The 2001 Amendment required payments throughout 2001
totaling $7.5 million, with the balance of $37.5 million due January 1, 2002.
The method used to calculate interest was changed to the prime rate plus 300
basis points. Previously, the interest rate was computed at the federal funds
rate or LIBOR plus an applicable percentage, depending on certain financial
ratios.
On July 12, 2001 the Company entered into a Forbearance Agreement (the
"Agreement") with its senior lenders under which the lenders agreed to forbear
from taking action against the Company to enforce their rights under the
currently existing Amended and Restated Credit Agreement until January 2, 2002.
As part of the Agreement, the Company acknowledged the existence of certain
events of default. These events included a default on a $1.3 million principal
payment, failure to timely make monthly interest payments due on May 31, 2001
and June 30, 2001 (these interest payments were subsequently made on July 27,
2001) and failure to receive $3.0 million of cash proceeds of subordinated debt
by May 15, 2001 (these proceeds were subsequently received on July 13, 2001).
The Company received two extensions, which extended the Agreement to
February 1, 2002 and March 15, 2002, respectively. Both of these extensions
carried the same reporting requirements and covenants while establishing new
cash receipts covenants for the months of January and February in 2002.
On April 12, 2002, in lieu of further extending the Agreement, the Company
entered into an amendment to the Credit Agreement (the "2002 Amendment"),
effective January 1, 2002. The 2002 Amendment included, among other things,
extension of the term of the agreement, establishment of a payment schedule and
the amendment and addition of certain covenants. The new covenants include
minimum levels of cash receipts, limitations on capital expenditures, a $750,000
per quarter limitation on product returns and required amortization of the loan
principal. The agreement also prohibits the Company from declaring any cash
dividends on its common stock and identifies certain conditions in which the
principal and interest on the credit agreement would become immediately due and
payable. These conditions include: (a) an action by the FDA which results in a
partial or total suspension of production or shipment of products, (b) failure
to invite the FDA in for re-inspection of the Decatur manufacturing facilities
by June 1, 2002, (c) failure to make a written response, within 10 days, to the
FDA, with a copy to the lender, to any written communication received from the
FDA after January 1, 2002 that raises any deficiencies, (d) imposition of fines
against the Company in an aggregate amount greater than $250,000, (e) a
cessation in public trading of Akorn stock other than a cessation of trading
generally in the United States securities market, (f) restatement of or
adjustment to the operating results of the Company in an amount greater than
$27,000,000, (g) failure to enter into an engagement letter with an investment
banker for the underwriting of an offering of equity securities by June 15,
2002, (h) failure to not be party to an engagement letter at any time after June
15, 2002 or (i) experience any material adverse action taken by the FDA, the
SEC, the DEA or any other Governmental Authority based on an alleged failure to
comply with laws or regulations. Management believes it will be able to comply
with the covenants during 2002. In the event that the Company is not in
compliance with the covenants during 2002 and does not negotiate amended
covenants and/or obtain a waiver thereto,
34
NOTE G -- FINANCING ARRANGEMENTS -- (CONTINUED)
then the debt holder, at its option, may demand immediate payment of all
outstanding amounts due it. The amended credit agreement requires a minimum
payment of $5.6 million, which relates to an estimated federal tax refund, with
the balance of $39.2 million due June 30, 2002. The estimated $5.6 million tax
refund must be remitted within three days of receipt from the Internal Revenue
Service. The Company is also obligated to remit any additional federal tax
refunds received above the estimated $5.6 million. The current credit facility
matures on June 30, 2002.
On July 12, 2001 as required under the terms of the Agreement, the Company
entered into a $5,000,000 subordinated debt transaction with the John N. Kapoor
Trust dtd. 9/20/89 (the "Trust"), the sole trustee and sole beneficiary of which
is Dr. John N. Kapoor, the Company's current CEO and Chairman of the Board of
Directors. The transaction is evidenced by a Convertible Bridge Loan and Warrant
Agreement (the "Trust Agreement") in which the Trust agreed to provide two
separate tranches of funding in the amounts of $3,000,000 ("Tranche A" which was
received on July 13) and $2,000,000 ("Tranche B" which was received on August
16). As part of the consideration provided to the Trust for the subordinated
debt, the Company issued the Trust two warrants which allow the Trust to
purchase 1,000,000 shares of common stock at a price of $2.85 per share and
another 667,000 shares of common stock at a price of $2.25 per share. The
exercise price for each warrant represented a 25% premium over the share price
at the time of the Trust's commitment to provide the subordinated debt.
Under the terms of the Trust Agreement, the subordinated debt will bear
interest at prime plus 3%, which is the same rate the Company pays on its senior
debt. Interest will not be paid to the Trust, but will instead accrue as
required by the terms of a subordination agreement which was entered into
between the Trust and the Company's senior lenders. The convertible feature of
the Trust Agreement, as amended, allows for conversion of the subordinated debt
plus interest into common stock of the Company, at a price of $2.28 per share of
common stock for Tranche A and $1.80 per share of common stock for Tranche B.
The Company, in accordance with Accounting Principles Board ("APB") Opinion
No. 14, recorded the subordinated debt transaction such that the convertible
debt and warrants have been assigned independent values. The fair value of the
warrants was estimated on the date of grant using the Black-Scholes option
pricing model with the following assumptions: (i) dividend yield of 0%, (ii)
expected volatility of 79%, (iii) risk free rate of 4.75%, and (iv) expected
life of 5 years. As a result, the Company assigned a value of $1,516,000 to the
warrants and recorded this amount as additional paid in capital. The remaining
$3,484,000 was recorded as long-term debt. The resultant bond discount,
equivalent to the value assigned to the warrants, will be amortized and charged
to interest expense over the life of the subordinated debt.
As of December 31, 2001, there was no available credit under the Amended
and Restated Credit Agreement. Future working capital needs will be highly
dependent upon the Company's ability to improve gross margins, control expenses
and collect its past due receivables. Management believes that existing cash,
cash flow from operations and the subordinated debt proceeds will be sufficient
to meet the cash needs of the business for the next twelve months, but that
additional funding will be needed to refund the current bank debt. If available
funds, cash generated from operations and subordinated debt proceeds are
insufficient to meet immediate liquidity requirements, further financing and/or
reductions of existing operations will be required. There are no guarantees that
such financing will be available or available on acceptable terms. Further, such
additional financing may require the granting of rights, preferences or
privileges senior to those rights of the common stock and existing stockholders
may experience substantial dilution of their ownership interests. The Company
will need to refinance or extend the maturity of the bank credit agreement, as
it does not anticipate sufficient cash to make the June 30, 2002 scheduled
payment.
In December 2001, the Company entered into a $3,250,000 five-year loan with
NeoPharm, Inc. ("NeoPharm") to fund Akorn's efforts to complete its
lyophilization facility located in Decatur, Illinois. Under the terms of the
Promissory Note, dated December 20, 2001, interest will accrue at the initial
rate of 3.6% and will be reset quarterly based upon NeoPharm's average return on
its cash and readily tradable long and short-term securities during the previous
calendar quarter. The principal and accrued interest is due and
35
NOTE G -- FINANCING ARRANGEMENTS -- (CONTINUED)
payable on or before maturity on December 20, 2006. The note provides that Akorn
will use the proceeds of the loan solely to validate and complete the
lyophilization facility located in Decatur, Illinois. The Promissory Note is
subordinated to Akorn's senior debt owed to The Northern Trust Company but is
senior to Akorn's subordinated debt owed to the Trust. The note was executed in
conjunction with a Processing Agreement that provides NeoPharm, Inc. with the
option of securing at least 15% of the capacity of Akorn's lyophilization
facility each year. Dr. John N. Kapoor, the Company's chairman and chief
executive officer is also chairman of NeoPharm and holds a substantial stock
position in that company as well as in the Company.
Commensurate with the completion of the Promissory Note between the Company
and NeoPharm, the Company entered into an agreement with the Trust, which
amended the Trust Agreement. The amendment extended the Trust Agreement to
terminate concurrently with the Promissory Note on December 20, 2006. The
amendment also made it possible for the Trust to convert the interest accrued on
the $3,000,000 tranche into common stock of the Company. Previously, the Trust
could only convert the interest accrued on the $2,000,000 tranche. The change
related to the convertibility of the interest accrued on the $3,000,000 tranche
requires that shareholder approval be received by August 31, 2002.
In June 1998, the Company entered into a $3,000,000 mortgage agreement with
Standard Mortgage Investors, LLC of which there were outstanding borrowings of
$2,189,000 and $2,442,000 at December 31, 2001 and 2000, respectively. The
principal balance is paid over 10 years, with the final payment due in June
2007. The mortgage note bears an interest rate of 7.375% and is secured by the
real property located in Decatur, Illinois.
The fair value of the debt obligations approximated the recorded value as
of December 31, 2001. The promissory note between the Company and NeoPharm, Inc.
earns interest at a rate that is lower than the Company's current borrowing rate
with its senior lenders. Accordingly, the computed fair value of the debt, which
the Company estimates to be approximately $2,650,000 would be lower than the
current carrying value of $3,250,000. However, the Company believes that
settlement at any computed fair value less than the current carrying value would
not be possible nor prudent due to the nature of the agreement and the purposes
for which the debt was secured. The Company is currently using the proceeds of
the debt to complete the lyophilization facility at its Decatur location as well
as address other necessary capital expenditures.
NOTE H -- LEASING ARRANGEMENTS
The Company leased certain equipment under capital leasing arrangements
that expired in 2000. Property, plant and equipment includes the following
amounts relating to such capital leases (in thousands):
DECEMBER 31,
---------------
2001 2000
---- -----
Furniture and equipment..................................... $-- $ 806
Less accumulated depreciation............................... -- (806)
--- -----
$-- $ --
=== =====
Depreciation expense provided on these assets was $109,000 and $157,000 for
the years ended December 31, 2000 and 1999, respectively.
The Company leases real and personal property in the normal course of
business under various operating leases, including non-cancelable and
month-to-month agreements. Payments under these leases were $1,841,000,
$1,159,000 and $906,000 for the years ended December 31, 2001, 2000 and 1999,
respectively.
36
NOTE H -- LEASING ARRANGEMENTS -- (CONTINUED)
The following is a schedule, by year, of future minimum rental payments
required under non-cancelable operating leases (in thousands):
Years ended December 31,
2002........................................................ $1,749
2003........................................................ 1,219
2004........................................................ 1,149
2005........................................................ 1,145
2006........................................................ 1,129
2007........................................................ 1,127
2008........................................................ 331
------
Total Minimum Payments Required............................. $7,849
======
The Company currently sub-lets portions of its leased space. Rental income
under these sub-leases was $56,000, $227,000 and $211,000 in 2001, 2000 and
1999, respectively.
NOTE I -- STOCK OPTIONS AND EMPLOYEE STOCK PURCHASE PLAN
Under the 1988 Incentive Compensation Program (the "Incentive Program") any
officer or key employee of the Company is eligible to receive options as
designated by the Company's Board of Directors. As of December 31, 2001,
6,500,000 shares of the Company's Common Stock are reserved for issuance under
the Incentive Program. The exercise price of the options granted under the
Incentive Program may not be less than 50 percent of the fair market value of
the shares subject to the option on the date of grant, as determined by the
Board of Directors. All options granted under the Incentive Program during the
years ended December 31, 2001, 2000 and 1999 have exercise prices equivalent to
the market value of the Company's Common Stock on the date of grant. Options
granted under the Incentive Program generally vest over a period of three years
and expire within a period of five years.
Under the 1991 Stock Option Plan for Directors (the "Directors' Plan")
persons elected as directors of the Company are granted nonqualified options at
the fair market value of the shares subject to option on the date of the grant.
As of December 31, 2001, 500,000 shares of the Company's Common Stock are
reserved for issuance under the Directors' Plan. Options granted under the
Directors' Plan vest immediately and expire five years from the date of grant.
A summary of the status of the Company's stock options as of December 31,
2001, 2000 and 1999 and changes during the years ended December 31, 2001, 2000
and 1999 is presented below (shares in thousands):
YEARS ENDED DECEMBER 31,
--------------------------------------------------------------
2001 2000 1999
------------------ ------------------ ------------------
WEIGHTED WEIGHTED WEIGHTED
AVERAGE AVERAGE AVERAGE
EXERCISE EXERCISE EXERCISE
SHARES PRICE SHARES PRICE SHARES PRICE
------ -------- ------ -------- ------ --------
Outstanding at beginning of period.......... 1,827 $4.78 1,901 $3.64 1,952 $3.16
Granted..................................... 2,039 $3.05 644 $6.80 777 $4.53
Exercised................................... (175) $2.48 (576) $3.14 (478) $2.71
Expired/Canceled............................ (465) $5.40 (142) $5.30 (350) $4.19
----- ----- -----
Outstanding at end of period................ 3,226 $3.72 1,827 $4.78 1,901 $3.64
===== ===== =====
Options exercisable at end of period........ 1,735 $3.92 1,054 $4.08 1,088 $3.19
Options available for future grant.......... 1,660 1,234 1,736
Weighted average fair value of options
granted during the period................. $2.02 $5.17 $2.37
37
NOTE I -- STOCK OPTIONS AND EMPLOYEE STOCK PURCHASE PLAN -- (CONTINUED)
The fair value of each option granted during the year ended December 31,
2001 is estimated on the date of grant using the Black-Scholes option pricing
model with the following assumptions: (i) dividend yield of 0%, (ii) expected
volatility of 79%, (iii) risk-free interest rate of 4.4% and (iv) expected life
of 5 years.
The fair value of each option granted during the year ended December 31,
2000 is estimated on the date of grant using the Black-Scholes option pricing
model with the following assumptions: (i) dividend yield of 0%, (ii) expected
volatility of 98%, (iii) risk-free interest rate of 5.0% and (iv) expected life
of 5 years.
The fair value of each option granted during the year ended December 31,
1999 is estimated on the date of grant using the Black-Scholes option pricing
model with the following assumptions: (i) dividend yield of 0%, (ii) expected
volatility of 51%, (iii) risk-free interest rate of 6.5% and (iv) expected life
of 5 years.
The following table summarizes information about stock options outstanding
at December 31, 2001 (shares in thousands):
OPTIONS OUTSTANDING OPTIONS EXERCISABLE
------------------------------------------------------ ----------------------------------
NUMBER NUMBER
OUTSTANDING WEIGHTED AVERAGE EXERCISABLE AT
DECEMBER 31, REMAINING WEIGHTED AVERAGE DECEMBER 31, WEIGHTED AVERAGE
RANGE OF EXERCISE PRICES 2001 CONTRACTUAL LIFE EXERCISE PRICE 2001 EXERCISE PRICE
------------------------ -------------- ---------------- ---------------- -------------- ----------------
$1.74 -- $2.05......... 216 3.9 years $ 2.01 200 $ 2.03
$2.13 -- $2.19......... 173 0.5 years $ 2.14 173 $ 2.14
$2.25 -- $2.60......... 1,085 4.2 years $ 2.30 309 $ 2.30
$2.81 -- $2.99......... 64 2.7 years $ 2.91 38 $ 2.85
$3.00 -- $4.00......... 337 4.3 years $ 3.42 132 $ 3.56
$4.06 -- $4.82......... 367 1.9 years $ 4.19 299 $ 4.17
$5.00 -- $5.57......... 568 2.9 years $ 5.16 334 $ 5.13
$6.06 -- $6.25......... 301 3.1 years $ 6.24 173 $ 6.25
$7.71 -- $8.38......... 55 2.7 years $ 7.99 37 $ 8.10
$9.31 -- $9.50......... 50 3.3 years $ 9.46 35 $ 9.45
$10.06 -- $11.88....... 10 3.7 years $10.97 5 $10.97
----- -----
3,226 1,735
===== =====
The Company applies APB Opinion No. 25 and related interpretations in
accounting for its plans. Accordingly, no compensation expense has been
recognized for its stock option plans.
Had compensation cost for the Company's stock-based compensation plans been
determined based on Statement of Financial Accounting Standards ("SFAS") No.
123, the Company's net income and net income per share for the years ended
December 31, 2001, 2000 and 1999 would have been the pro forma amounts indicated
below (in thousands, except per share amounts):
YEARS ENDED DECEMBER 31,
-----------------------------------------------------------------------
2001 2000 1999
--------------------- --------------------- ---------------------
AS AS AS
REPORTED PRO FORMA REPORTED PRO FORMA REPORTED PRO FORMA
-------- --------- -------- --------- -------- ---------
Net income (loss)................... $(19,611) $(21,365) $2,187 $ 421 $6,670 $5,939
======== ======== ====== ===== ====== ======
Net income (loss) per
share -- diluted.................. $ (1.01) $ (1.10) $ 0.11 $0.02 $ 0.36 $ 0.32
======== ======== ====== ===== ====== ======
The Akorn, Inc. Employee Stock Purchase Plan permits eligible employees to
acquire shares of the Company's common stock through payroll deductions not
exceeding 15% of base wages, at a 15% discount from market price. A maximum of
1,000,000 shares of the Company's common stock may be acquired under the terms
of the Plan. Purchases of shares issued from treasury stock approximated 7,000
shares during the year ended December 31, 1999. New shares issued under the plan
approximated 44,000 in 2001, 20,000 in 2000, and 26,000 in 1999.
38
NOTE J -- INCOME TAXES
The income tax provision (benefit) consisted of the following (in
thousands):
Income tax expense (benefit) differs from the "expected" tax expense
(benefit) computed by applying the U.S. Federal corporate income tax rate of 34%
to income before income taxes as follows (in thousands):
YEARS ENDED DECEMBER 31,
----------------------------
2001 2000 1999
-------- ------ ------
Computed "expected" tax expense (benefit)................... $(10,956) $1,192 $3,618
Change in income taxes resulting from:
State income taxes, net of federal income tax benefits.... (1,597) 177 510
Other, net................................................ (61) (50) (159)
-------- ------ ------
Income tax expense (benefit)................................ $(12,614) $1,319 $3,969
======== ====== ======
Deferred tax assets (liabilities) at December 31, 2001 and 2000 include (in
thousands):
DECEMBER 31, DECEMBER 31,
2001 2000
------------ ------------
Other accrued expenses...................................... $ 2,537 $ 1,688
Intangible assets, net...................................... 510 545
Property, plant and equipment, net.......................... (2,593) (2,332)
Net operating loss carry forwards........................... 5,052 --
Other, net.................................................. 328 286
------- -------
$ 5,834 $ 187
======= =======
The deferred taxes are classified in the accompanying balance sheets as
follows (in thousands):
Management concluded that it was more likely than not that all of the net
deferred tax assets will be realized through future taxable earnings.
Accordingly, no valuation allowance is recorded.
39
NOTE K -- CHANGES IN ACCOUNTING ESTIMATES
The Company accrues an estimate of the difference between the gross sales
price of certain products sold to wholesalers and the expected resale prices of
such products under contractual arrangements with third parties such as
hospitals and group purchasing organizations at the time of sale to the
wholesaler. Similarly, the Company records an allowance for rebates related to
contracts and other programs with wholesalers. These allowances are reflected as
a reduction of account receivable balances. The Company evaluates the allowance
balances against actual chargebacks and rebates processed by wholesalers. Actual
chargebacks and rebates processed can vary materially from period to period. The
Company has an increasing number of contracts and other programs with
wholesalers, each incorporating various numbers and types of chargebacks and
rebates. The recorded allowance amount reflects the Company's current estimate
of the chargeback and rebate amounts wholesalers have earned under these various
contracts and programs.
In May 2001, the Company completed an analysis of its March 31, 2001
allowance for chargebacks and rebates and determined that an increase from the
allowance of $3,296,000 at December 31, 2000 was necessary. In performing such
analysis, the Company utilized recently obtained reports of wholesaler's
inventory information, which had not been previously obtained or utilized. Based
on the wholesaler's March 31, 2001 inventories and historical chargeback and
rebate activity, the Company recorded an allowance of $6,961,000, which resulted
in an expense of $12,000,000 for the three months ended March 31, 2001.
During the quarter ended June 30, 2001, the Company further refined its
estimates of the chargeback and rebate liability determining that an additional
$2,250,000 provision needed to be recorded. This additional increase to the
allowance was necessary to reflect the continuing shift of sales to customers
who purchase their products through group purchasing organizations and buying
groups. The Company had previously seen a much greater level of list price
business than is occurring in the current business environment.
The Company records an allowance for estimated product returns. This
allowance is reflected as a reduction of account receivable balances. The
Company evaluates the allowance balance against actual returns processed. Actual
returns processed can vary materially from period to period.
Based on the wholesaler's inventory information, the Company increased its
allowance for potential product returns to $2,232,000 at March 31, 2001 from
$232,000 at December 31, 2000. The provision for the three months ended March
31, 2001 was $2,559,000. The allowance for potential product returns was
$548,000 at December 31, 2001.
The Company records an allowance for doubtful accounts, which reflects
trade receivable balances owed to the Company that are believed to be
uncollectible. This allowance is reflected as a reduction of account receivable
balances. The expense related to doubtful accounts is reflected in SG&A
expenses.
Based upon its recent unsuccessful efforts to collect past due balances,
the Company updated its analysis of potentially uncollectible trade receivable
balances and recorded a total bad debt provision for the year of $12,000,000.
The Company recorded $7,520,000 and $4,610,00 in the first and second quarter of
2001, respectively and reduced the allowance $130,000 in the fourth quarter of
2001. As a result, and after the effect of balances written off, the allowance
for doubtful accounts increased to $3,706,000 at December 31, 2001 from $801,000
at December 31, 2000.
The Company records an allowance for discounts and allowances, which
reflects discounts and allowances available to certain customers based on agreed
upon terms of sale. This allowance is reflected as a reduction of account
receivable balances. The Company evaluates the allowance balance against actual
discounts taken.
The Company records an estimate for slow-moving and obsolete inventory
based upon recent historical sales by unit. The Company evaluates the potential
sales of its products over their remaining lives and estimates the amount that
may expire before being sold.
In the fourth quarter of 2000, the Company increased this reserve by
$2,700,000 to account for slow moving and obsolete inventory primarily related
to products purchased from third parties in 1998 and 1999 for which the original
sales forecast overestimated actual demand.
40
NOTE K -- CHANGES IN ACCOUNTING ESTIMATES -- (CONTINUED)
In the first quarter of 2001, based on sales trends and forecasted sales
activity by product, the Company increased its allowance for inventory
obsolescence to $4,583,000. The provision for the three months ended March 31,
2001 was $1,500,000. The allowance for inventory obsolescence was $1,845,000 at
December 31, 2001.
All other increases to the allowances for chargebacks and rebates, returns,
doubtful accounts, discounts and allowances and inventory obsolescence occurred
as part of the normal recording of product sales.
NOTE L -- RETIREMENT PLAN
All employees who have attained the age of 21 are eligible for
participation in the Company's 401(k) Plan. The plan-related expense recognized
for the years ended December 31, 2001, 2000 and 1999 totaled $234,000, $285,000
and $220,000, respectively. The employer's matching contribution is a percentage
of the amount contributed by each employee and is funded on a current basis.
NOTE M -- INDUSTRY SEGMENT INFORMATION
The Company classifies its operations into three business segments,
ophthalmic, injectable and contract services. The ophthalmic segment
manufactures, markets and distributes diagnostic and therapeutic pharmaceuticals
and surgical instruments and related supplies. The injectable segment
manufactures, markets and distributes injectable pharmaceuticals, primarily in
niche markets. Selected financial information by industry segment is presented
below (in thousands):
YEARS ENDED DECEMBER 31,
------------------------------
2001 2000 1999
-------- ------- -------
Revenues
Ophthalmic.................................................. $ 17,443 $28,221 $32,467
Injectable.................................................. 9,859 25,196 22,736
Contract services........................................... 14,946 13,510 9,429
-------- ------- -------
Total revenues....................................... $ 42,248 $66,927 $64,632
======== ======= =======
Gross profit
Ophthalmic.................................................. $ (245) $ 9,251 $16,873
Injectable.................................................. 2,936 16,287 13,346
Contract services........................................... 4,410 3,299 3,258
-------- ------- -------
Total gross profit................................... 7,101 28,837 33,477
Operating expenses.......................................... 35,617 23,048 21,355
-------- ------- -------
Total operating income (loss)........................ (28,516) 5,789 12,122
Interest and other (expense), net........................... (3,709) (2,283) (1,483)
-------- ------- -------
Income (loss) before income taxes........................... $(32,225) $ 3,506 $10,639
======== ======= =======
The Company does not identify assets by segment for internal purposes.
NOTE N -- COMMITMENTS AND CONTINGENCIES
The Company is a party in legal proceedings and potential claims arising in
the ordinary course of its business. See Note G -- Financing Arrangements and
Note T -- Subsequent Events. Despite the inherent uncertainties of litigation,
management of the Company at this time does not believe that such proceedings
will have a material adverse impact on the consolidated financial position,
results of operations, or cash flows of the Company.
41
NOTE O -- SUPPLEMENTAL CASH FLOW INFORMATION (IN THOUSANDS)
YEARS ENDED DECEMBER 31,
--------------------------
2001 2000 1999
------ ------ ------
Interest and taxes paid:
Interest (net of amounts capitalized)..................... $3,308 $2,596 $1,245
Income taxes.............................................. 38 1,625 2,860
Noncash investing and financing activities:
Treasury stock received for exercise of stock options..... -- -- 35
Intangible asset received in exchange for research
equipment.............................................. 100 -- --
NOTE P -- RECENT ACCOUNTING PRONOUNCEMENTS
In June 1998, the Financial Accounting Standards Board ("FASB") issued
Statement of Financial Accounting Standards ("SFAS") No. 133, "Accounting for
Derivatives Instruments and Hedging Activities." SFAS 133 establishes accounting
and reporting standards for derivative instruments, including certain derivative
instruments embedded in other contracts, and for hedging activities. SFAS No.
133, as amended by SFAS No. 137 and No. 138, was effective for the Company's
fiscal 2001 financial statements and was adopted by the Company on January 1,
2001. Adoption of these standards did not have a material effect on the
Company's financial position or results of operations.
In July 2001, the FASB approved three statements, SFAS 141, "Business
Combinations," SFAS 142, "Goodwill and Other Intangible Assets," and SFAS 143,
"Accounting for Asset Retirement Obligations."
SFAS 141 supercedes APB Opinion No. 16, "Business Combinations," and
eliminates the pooling-of-interests method of accounting for business
combinations, thus requiring all business combinations be accounted for using
the purchase method. In addition, in applying the purchase method, SFAS 141
changes the criteria for recognizing intangible assets apart from goodwill. The
following criteria is to be considered in determining the recognition of the
intangible assets: (1) the intangible asset arises from contractual or other
legal rights, or (2) the intangible asset is separable or dividable from the
acquired entity and capable of being sold, transferred, licensed, rented, or
exchanged. The requirements of SFAS 141 are effective for all business
combinations completed after June 30, 2001. The adoption of this new standard
did not have a material impact on the Company's financial statements.
SFAS 142 supercedes APB Opinion No. 17, "Intangible Assets," and requires
goodwill and other intangible assets that have an indefinite useful life to no
longer be amortized; however, these assets must be reviewed at least annually
for impairment. The Company has adopted SFAS 142 as of January 1, 2002. The
Company is currently evaluating the impact of this new standard on the Company's
financial statements.
SFAS 143 requires entities to record the fair value of a liability for an
asset retirement obligation in the period in which it is incurred. When the
liability is initially recorded, the entity capitalizes a cost by increasing the
carrying amount of the related long-lived asset. Over time, the liability is
accreted to its present value each period, and the capitalized cost is
depreciated over the useful life of the related asset. Upon settlement of the
liability, an entity either settles the obligation for its recorded amount or
incurs a gain or loss upon settlement. The Company has adopted SFAS 143 as of
January 1, 2002. The adoption of this new standard did not have a material
impact on the Company's financial statements.
In August 2001 the FASB issued SFAS 144 "Accounting for the Impairment or
Disposal of Long-Lived Assets." This statement addresses financial accounting
and reporting for the impairment or disposal of long-lived assets. This
statement supercedes SFAS No. 121, "Accounting for the Impairment of Long-Lived
Assets and for Long-Lived Assets to be Disposed Of." This statement also
supercedes the accounting and reporting provisions of APB Opinion No. 30,
"Reporting the Results of Operations -- Reporting the Effects of Disposal of a
Segment of a Business and Extraordinary, Unusual and Infrequently Occurring
Events and Transactions," for the disposal of a segment of a business (as
previously defined in that Opinion). SFAS No. 144 is effective January 1, 2002.
The adoption of this new standard did not have a material impact on the
Company's financial statements.
42
NOTE Q -- CUSTOMER CONCENTRATION
No single customer accounted for more than 10% of the Company's revenues
during 2001 or 1999. During 2000, the Company realized approximately 12% of its
revenues from one customer. This customer is a distributor of the Company's
products as well as a distributor of a broad range of health care products for
many companies in the health care sector. This customer is not the end user of
the Company's products. If sales to this customer were to diminish or cease, the
Company believes that the end users of its products would find no difficulty
obtaining the Company's products either directly from the Company or from
another distributor. The account receivable balance for this customer was
approximately 22% of gross trade receivables at December 31, 2000.
NOTE R -- DISCONTINUED PRODUCTS
In May 2001, the Company decided to no longer sell one of its products due
to uncertainty of product availability from a third-party manufacturer, rising
manufacturing costs and delays in obtaining FDA approval to manufacture the
product in-house. The Company recorded an asset impairment charge of $1,170,000
related to manufacturing equipment specific to the product and an asset
impairment charge of $140,000 related to the remaining balance of the product
acquisition intangible asset during the first quarter of 2001.
In November 2001, the Company decided to no longer sell one of its products
due to unavailability of raw material at a competitive price and declining
market share. The Company recorded an asset impairment charge of $725,000
related to the remaining balance of the product acquisition intangible asset
during the fourth quarter of 2001.
NOTE S -- RESTRUCTURING CHARGES
During 2001, the Company adopted a restructuring program with aggressive
actions to properly size its operations to current business conditions. These
actions were designed to reduce costs and improve operating efficiencies. The
program included, among other items, severance of employees, plant-closing costs
related to the Company's San Clemente, CA sales office and rent for unused
facilities under lease in San Clemente and Lincolnshire, IL. The restructuring,
affecting all three business segments, reduced the Company's workforce by 50
employees, representing 12.5% of the total workforce. Activities previously
executed in San Clemente have been relocated to the Company's headquarters.
The restructuring program costs are included in selling, general and
administrative expenses in the accompanying consolidated statement of income and
resulted in a charge to operations of approximately $1,117,000 consisting of
severance costs of $398,000, lease costs of $625,000 and other costs of $94,000.
At December 31, 2001, the amount remaining in the accruals for the
restructuring program was approximately $528,000. Approximately $315,000 of the
restructuring accrual will be paid by June 30, 2002 and the remainder will be
paid over the lease term, which expires in April 2003.
NOTE T -- SUBSEQUENT EVENTS
On January 25, 2002, the Company and Novadaq Technologies, Inc. ("Novadaq")
reached a settlement of a dispute involving the two companies. Under terms of a
revised agreement, Novadaq will assume all costs associated with development of
certain devices and procedures for use in fluorescene angiography. The Company,
in consideration of foregoing any share of future net profits, will obtain an
equity ownership interest in Novadaq and the right to be the exclusive supplier
of ICG for use in Novadaq's diagnostic procedures. In addition, Antonio R. Pera,
Akorn's President and Chief Operating Officer, was named to Novadaq's Board of
Directors. In conjunction with the revised agreement, Novadaq and the Company
have agreed to withdraw from arbitration proceedings that were currently in
process at the time.
On March 21, the Company announced that it had been notified by the U.S.
Patent and trademark Office that U.S. patent number 6,352,663 titled Methods for
diagnosing and treating abnormal vasculature using fluorescent dye angiography
and dye enhanced photocoagulation had been issued to the Company. This was one
of the three U.S. patents on file as of December 31, 2001.
43
NOTE T -- SUBSEQUENT EVENTS -- (CONTINUED)
After the close of business on March 27, 2002, the Company received a
letter informing it that the staff of the Securities and Exchange Commission's
regional office in Denver, Colorado, plans to recommend to the Commission that
it bring an enforcement action for injunctive relief against the Company. Based
on the letter, the Company believes the recommended action would concern the
Company's alleged misstatement, in quarterly and annual Securities and Exchange
Commission filing and earnings press releases, of its income for fiscal year
2000 by allegedly failing to reserve for doubtful accounts receivable and
overstating its accounts receivable balance. The Company has also learned that
certain of its former officers, as well as a current employee have received
similar notifications. The Company disagrees with the staff's proposed
recommendation and allegations; it has been invited to submit its views as to
why an enforcement action should not be brought, and intends to do so. Because
the proposed enforcement action relates to matters in a prior fiscal year, it is
not anticipated that these proceedings will have any material impact on the
Company's Consolidated Balance Sheet as of December 31, 2001 or on the Company's
2002 or future operating results.
The Company is party to a License Agreement with The Johns Hopkins
University, Applied Physics Laboratory ("JHU/APL") effective April 26, 2000, and
amended effective July 15, 2001 (See Note C). Pursuant to the License Agreement,
the Company licensed two patents from JHU/APL for the development and
commercialization of a diagnosis and treatment for age-related macular
degeneration ("AMD") using Indocyanine Green ("ICG"). A dispute has arisen
between the Company and JHU/APL concerning the License Agreement. Specifically,
JHU/APL has challenged the Company's performance under the License Agreement and
alleged that the Company is in breach of the License Agreement. The Company's
has denied JHU/APL's allegations and contends that it has performed in
accordance with the terms of the License Agreement. As a result of the dispute,
on March 29, 2002, the Company commenced a lawsuit in the U.S. District Court
for the Northern District of Illinois, seeking declaratory and other relief
against JHU/APL. On Monday, April 1, 2002, the Company and JHU/APL agreed,
through counsel, to attempt to negotiate a resolution to the present dispute. If
negotiations prove unsuccessful, the Company and JHU/APL will seek to mediate
the dispute. Failing that, the litigation would proceed forward. The Company has
an intangible asset valued at $2,084,500 recorded as a result of the License
Agreement, as amended. Unsuccessful resolution of the dispute could result in a
revaluation of this intangible asset.
On March 6, 2002, the Company received a letter from the United States
Attorney's Office, Central District of Illinois, Springfield, Illinois, advising
the Company that the United States Drug Enforcement Administration had referred
a matter to that office for a possible civil legal action for alleged violations
of the Comprehensive Drug Abuse Prevention Control Act of 1970, 21 U.S.C. sec.
801, et. seq. and regulations promulgated under the Act. The Company is
cooperating fully with the government and anticipates that any action under this
matter will not have a material impact on its financial statements.
44
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
None.
PART III
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
The information relating to our directors that is required by this item is
incorporated by reference from the information under the caption "Election of
Directors" contained in our definitive proxy statement (the "Proxy Statement"),
which will be filed with the Securities and Exchange Commission in connection
with our Annual Meeting of Shareholders.
EXECUTIVE OFFICERS OF THE REGISTRANT
The following table sets forth the executive officers of the Company as of
March 15, 2002. Each officer serves as such at the pleasure of the Board of
Directors.
NAME AGE POSITION WITH THE COMPANY
---- --- -------------------------
John N. Kapoor, Ph.D. .................... 58 Chief Executive Officer
Antonio R. Pera........................... 44 President and Chief Operating Officer
Ben J. Pothast............................ 40 Vice President, Chief Financial Officer, Secretary
and Treasurer
John N. Kapoor, Ph.D. Dr. Kapoor has served as Chief Executive Officer of
the Company since March 2001. Dr. Kapoor has served as Chairman of the Board of
the Company since May 1995 and from December 1991 to January 1993. Dr. Kapoor
also served as acting Chairman of the Board of the Company from April 1993 to
May 1995 and Chief Executive Officer of the Company from May 1996 to November
1998. Dr. Kapoor serves as Chairman of the Board of Option Care, Inc. (an
infusion services and supplies company) and was Chief Executive Officer of
Option Care, Inc. from August 1993 to April 1996. Dr. Kapoor is the president of
E.J. Financial Enterprises, Inc., (a health care consulting and investment
company), has served as Chairman of the Board of NeoPharm, Inc. (a specialty
pharmaceutical company) since July 1990 and is a director of First Horizon
Pharmaceutical Corporation (a distributor of pharmaceuticals).
Antonio R. Pera. Mr. Pera has served as President and Chief Operating
Officer of the Company since June 2001. Mr. Pera is also a director of the
Company. From September 1992 to June 2001, he was Vice President and General
Manager of the Bedford Laboratories Division of Ben Venue Laboratories, Inc. (a
manufacturer of injectable drugs), and a subsidiary of Boehringer-Ingelheim
Corporation. Mr. Pera held various positions from March 1989 through September
1992 with Anaquest (Ohmeda, Inc.) (a manufacturer of inhalation anesthetics).
From July 1985 to March 1989, Mr. Pera held several positions with Lyphomed,
Inc. (a parenteral products and injectable drug manufacturer) including two
years as General Manager of the AccuPharma Division of that Company. Mr. Pera is
also a director of Novadaq Technologies, Inc., a privately held research
company.
Ben J. Pothast. Mr. Pothast has served as Vice President, Chief Financial
Officer, Secretary and Treasurer of the Company since September 2001. From 1998
to 2001, he was Director of Financial Planning and Analysis of Moore North
America (a business form printing company). From 1995 to 1998, Mr. Pothast was
Director of Business Planning and Corporate Finance of GATX Corporation (a
transportation and logistics company). From 1990 to 1995, he was Manager of
Financial Reporting and Analysis for The Perseco Company (a packaging and
logistics company). Mr. Pothast began his career at the public accounting firm
of Ernst & Young.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this item is incorporated by reference to the
information under the caption "Executive Compensation" contained in the Proxy
Statement.
45
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The information required by this item is incorporated by reference to the
information under the caption "Security Ownership of Certain Beneficial Owners
and Management" contained in the Proxy Statement.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
The information required by this item is incorporated by reference to the
information under the caption "Certain Relationships and Transactions" contained
in the Proxy Statement.
PART IV
ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K
(a).2. Financial Statement Schedule. The following Financial Statement
Schedule is filed with this Annual Report on Form 10-K on the page
indicated:
Description Page
---------------------------------------------------
II. Valuation and Qualifying Accounts 48
(a).3. Exhibits
Those exhibits marked with an asterisk (*) refer to exhibits filed
herewith. The other exhibits are incorporated herein by reference, as indicated
in the following list.
(2.0) Agreement and Plan of Merger among Akorn, Inc., Taylor, and
Pasadena Research Laboratories, Inc. dated May 7, 1996,
incorporated by reference to the Company's report on Form
10-K for the fiscal year ended June 30, 1996.
(3.1) Restated Articles of Incorporation of the Company dated
September 6, 1991, incorporated by reference to Exhibit 3.1
to the Company's report on Form 10-K for the fiscal year
ended June 30, 1991.
(3.2) Articles of Amendment to Articles of Incorporation of the
company dated February 28, 1997, incorporated by reference
to Exhibit 3.2 to the Company's report on Form 10-K for the
transition period from July 1, 1996 to December 31, 1996.
(3.3) Current Composite of By-laws of the Company, incorporated by
reference to Exhibit 3.3 to the Company's report on Form
10-K for the transition period from July 1, 1996 to December
31, 1996.
(4.1) Specimen Common Stock Certificate, incorporated by reference
to Exhibit 4.1 to the Company's report on Form 10-K for the
fiscal year ended June 30, 1988.
(10.1) Consulting Agreement dated November 15, 1990 by and between
E. J. Financial Enterprises, Inc., a Delaware corporation,
and the Company, incorporated by reference to Exhibit 10.24
to the Company's report on Form 10-K for the fiscal year
ended June 30, 1991.
(10.2) Amendment No. 1 to the Amended and Restated Akorn, Inc. 1988
Incentive Compensation Program, incorporated by reference to
Exhibit 10.33 to the Company's report on Form 10-K for the
fiscal year ended June 30, 1992.
(10.3) 1991 Akorn, Inc. Stock Option Plan for Directors,
incorporated by reference to Exhibit 4.3 to the Company's
registration statement on Form S-8, registration number
33-44785.
(10.4) Common Stock Purchase Warrant dated September 3, 1992,
issued by the Company to the John N. Kapoor Trust dated
September 20, 1989, incorporated by reference to Exhibit No.
7 to Amendment No. 3 to Schedule 13D, dated September 10,
1992, filed by John N. Kapoor and the John N. Kapoor Trust
dated September 20, 1989.
46
(10.5) Amended and Restated Credit Agreement dated September 15, 1999 among the Company, Akorn (New Jersey),
Inc. and The Northern Trust Company (the "Credit Agreement"), incorporated by reference to Exhibit 10.5
to the Company's report on Form 10-K for the fiscal year ended December 31, 1999.
(10.6) Amendment No. 1 to the Credit Agreement dated December 28, 1999, incorporated by reference to Exhibit
10.6 to the Company's report on Form 10-K for the fiscal year ended December 31, 1999.
(10.7) Amendment No. 2 to the Credit Agreement dated February 15, 2001, incorporated by reference to Exhibit
10.1 to the Company's report on Form 8-K filed on April 17, 2001.
(10.8) Amendment No. 3 to the Credit Agreement dated April 16, 2001, incorporated by reference to Exhibit 10.2
to the Company's report on Form 8-K filed on April 17, 2001.
(10.9) Promissory Note among the Company, Akorn (New Jersey), Inc. and The Northern Trust Company dated April
16, 2001, incorporated by reference to Exhibit 10.3 to the Company's report on Form 8-K filed on April
17, 2001.
(10.10) Letter of Commitment to the Company from John. N. Kapoor, incorporated by reference to Exhibit 10.3 to
the Company's report on Form 8-K filed on April 17, 2001.
(10.11) Promissory Note among the Company, Akorn (New Jersey), Inc. and The Northern Trust Company dated April
16, 2001, incorporated by reference to Exhibit 10.3 to the Company's report on Form 8-K filed on April
17, 2001.
(10.12) Convertible Bridge Loan and Warrant Agreement dated as of July 12, 2001, by and between Akorn, Inc. and
the John N. Kapoor Trust dtd. 9/20/89, incorporated by reference to Exhibit 10.1 to the Company's
report on Form 8-K filed on July 26, 2001.
(10.13) The Tranche A Common Stock Purchase Warrant, dated July 12, 2001, incorporated by reference to Exhibit
10.2 to the Company's report on Form 8-K filed on July 26, 2001.
(10.14) The Tranche B Common Stock Purchase Warrant, dated July 12, 2001, incorporated by reference to Exhibit
10.3 to the Company's report on Form 8-K filed on July 26, 2001.
(10.15) Registration Rights Agreement dated July 12, 2001, by and between Akorn, Inc. and the John N. Kapoor
Trust dtd. 9/20/89, incorporated by reference to Exhibit 10.4 to the Company's report on Form 8-K filed
on July 26, 2001.
(10.16) Forbearance Agreement by and among Akorn, Inc., Akorn (New Jersey), Inc. and The Northern Trust
Company, dated as of July 12, 2001, incorporated by reference to Exhibit 10.5 to the Company's report
on Form 8-K filed on July 26, 2001.
(10.17) *Promissory Note among the Company, Akorn (New Jersey), Inc. and NeoPharm, Inc. dated December 20,
2001.
(10.18) *Processing Agreement dated December 20, 2001, by and between Akorn, Inc. and NeoPharm, Inc.
(10.19) *Subordination, Standby and Intercreditor Agreement dated December 20, 2001, by and between NeoPharm,
Inc. and The Northern Trust Company.
(10.20) *Subordination and Intercreditor Agreement dated December 20, 2001, by and between NeoPharm, Inc. and
the John N. Kapoor trust dtd. 9/20/89.
(10.21) *Waiver Letter dated December 20, 2001 by and between the Company, Akorn (New Jersey), Inc. and The
Northern Trust Company.
(10.22) *Supply Agreement dated January 4, 2002, by and between Akorn, Inc. and Novadaq Technologies, Inc.
(21.1) *Subsidiaries of the Company.
(b) Reports on Form 8-K.
There was no Form 8-K filed during the fourth quarter of 2001.
47
AKORN, INC.
VALUATION AND QUALIFYING ACCOUNTS
YEARS ENDED DECEMBER 31, 2001, 2000 AND 1999
ADDITIONS
BALANCE AT CHARGED TO BALANCE
BEGINNING COSTS AND AT END
DESCRIPTION OF PERIOD EXPENSES DEDUCTIONS OF PERIOD
----------- ---------- ---------- ---------- ---------
Allowance for doubtful accounts
1999..................................... $ 425,000 $ 161,000 $ (360,000) $ 226,000
2000..................................... 226,000 607,000 (32,000) 801,000
2001..................................... 801,000 12,000,000 (9,095,000) 3,706,000
Allowance for returns
1999..................................... $ -- $ 205,000 $ (205,000) $ --
2000..................................... -- 1,159,000 (927,000) 232,000
2001..................................... 232,000 4,103,000 (3,787,000) 548,000
Allowance for discounts and allowances
1999..................................... $ -- $ -- $ -- $ --
2000..................................... -- -- -- --
2001..................................... -- 886,000 (743,000) 143,000
Allowance for chargebacks and rebates
1999..................................... $1,549,000 $23,793,000 $(22,168,000) $3,174,000
2000..................................... 3,174,000 29,558,000 (29,436,000) 3,296,000
2001..................................... 3,296,000 28,655,000 (27,761,000) 4,190,000
Allowance for inventory obsolescence
1999..................................... $ 572,000 $ 611,000 $ (1,049,000) $ 134,000
2000..................................... 134,000 3,983,000 (946,000) 3,171,000
2001..................................... 3,171,000 1,830,000 (3,156,000) 1,845,000
48
SIGNATURES
In accordance with Section 13 or 15(d) of the Securities Exchange Act of
1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
AKORN, INC.
By: /s/ JOHN N. KAPOOR
------------------------------------
John N. Kapoor
Chief Executive Officer
Date: April 16, 2002
In accordance with the Securities Exchange Act of 1934, this report has
been signed below by the following persons on behalf of the Registrant, and in
the capacities and on the dates indicated.
SIGNATURE TITLE DATE
--------- ----- ----
Chief Executive Officer and Director April 16, 2002
--------------------------------------------- (Principal Executive Officer)
John N. Kapoor, Ph.D.
President, Chief Operating Officer and April 16, 2002
--------------------------------------------- Director
Antonio R. Pera
Chief Financial Officer April 16, 2002
--------------------------------------------- (Principal Financial Officer and
Ben J. Pothast Principal Accounting Officer)
Director April 16, 2002
---------------------------------------------
Jerry N. Ellis
Director April 16, 2002
---------------------------------------------
Daniel E. Bruhl, M.D.
Director April 16, 2002
---------------------------------------------
Doyle S. Gaw
49
Exhibit 10.17
THIS NOTE HAS NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 OR ANY STATE
SECURITIES LAWS. THIS NOTE MAY NOT BE SOLD, TRANSFERRED, ASSIGNED, OFFERED,
PLEDGED OR OTHERWISE DISTRIBUTED UNLESS REGISTERED UNDER THE SECURITIES ACT OF
1933 AND APPLICABLE STATE SECURITIES LAWS OR SUCH SALE, TRANSFER, ASSIGNMENT,
OFFER, PLEDGE OR OTHER DISTRIBUTION FOR VALUE IS EXEMPT FROM THE REGISTRATION
REQUIREMENTS OF SUCH ACT AND SUCH LAWS.
PROMISSORY NOTE
$3,250,000.00 December 20, 2001
Buffalo Grove, Illinois
FOR VALUE RECEIVED, AKORN, INC., a Louisiana corporation ("Borrower"),
promises to pay to the order of NEOPHARM, INC., a Delaware corporation
("NeoPharm," together with any person or entity to whom all or any portion of
this Note may be transferred being hereinafter referred to as "Lender"), at its
principal offices located at 150 Field Drive, Suite 195, Lake Forest, Illinois
60045, or at such other place as Lender may direct, the principal sum of THREE
MILLION TWO HUNDRED FIFTY THOUSAND AND 00/100 DOLLARS ($3,250,000.00), and to
pay interest thereon in accordance with the terms hereof, on December 20, 2006
(the "Maturity Date").
This Promissory Note (this "Note") has been executed in connection with
(a) that certain Processing Agreement, of even date herewith (the "Processing
Agreement"), between Lender and Borrower; and (b) that certain Subordination and
Intercreditor Agreement, of even date herewith (the "Subordination Agreement"),
between Borrower and John N. Kapoor, as Trustee under The John N. Kapoor Trust,
dated September 20, 1989, (the trustee and the trust, together, "Kapoor"), to
which reference is hereby made.
ARTICLE 1
INTEREST
1.1 Calculation of Interest Rate. Interest shall begin to accrue on the
date hereof in accordance with the terms of this Section 1.1 and shall be
compounded as of the first business day of each calendar quarter until all
principal and accrued interest is paid. Commencing on the date hereof, interest
shall accrue at a rate of 3.6% per annum. As of the first business day of each
calendar quarter (each, a "Change Date"), commencing on January 1, 2002, Lender
shall adjust the interest rate charged on all amounts of outstanding principal
and interest accrued during the previous calendar quarter to a rate which is
equal to the average return on all of
Lender's cash and readily tradable long- and short-term securities during such
previous calendar quarter; thereafter, interest shall accrue on the unpaid
outstanding principal and accrued interest at the most recently adjusted
interest rate until the next Change Date. Lender shall furnish to Borrower a
statement showing all such cash and securities and the return thereon for the
prior calendar quarter in support of each adjustment to the interest rate.
Interest shall be computed for the actual number of days elapsed on the basis of
a year consisting of 365 days, including the date the loan is made and excluding
the date the loan or any portion thereof is paid or prepaid.
1.2 Default Rate. After an Event of Default, interest shall accrue and
be payable at a rate equal to (a) the interest rate calculated in accordance
with Section 1.1, plus (b) three percent (3%) (the "Default Rate").
ARTICLE 2
PAYMENTS
2.1 Required Repayment. Borrower shall pay all amounts of outstanding
principal and accrued but unpaid interest hereunder on the Maturity Date.
Borrower may prepay all outstanding principal and accrued but unpaid interest at
any time without penalty or premium.
2.2 Manner of Payments. All payments made by Borrower hereunder shall
be made to Lender at its principal offices located at 150 Field Drive, Suite
195, Lake Forest, Illinois 60045, Attn: Chief Financial Officer or at such other
places as Lender may designate. All payments hereunder shall be made in
immediately available funds, and shall be applied first to accrued interest and
then to principal; however, if an Event of Default occurs, Lender may, in its
sole discretion, and in such order as it may choose, apply any payment to
interest, principal and/or lawful charges and expenses then accrued. All
payments shall be made without deduction for or on account of any present or
future taxes, duties or other charges levied or imposed on this Note or the
proceeds thereof by any government or political subdivision thereof, except as
required by law.
ARTICLE 3
OPERATIONS/LYOPHILIZATION RAMP-UP
3.1 Use of Proceeds. Borrower agrees that the proceeds from the loan
evidenced by this Note shall be used solely (a) to achieve removal of all
warning letter sanctions pursuant to Form 483 or current Good Manufacturing
Practice regulations issued or imposed by the Food and Drug Administration
("FDA") with regard to Borrower's ability to handle and manufacture sterile
pharmaceuticals and provide lyophilization services; (b) to obtain FDA
validation for Borrower's operation of its facility located at 1222 West Grand
Avenue, Decatur, Illinois (the "Facility") to offer and provide lyophilization
services for the handling and manufacturing of sterile pharmaceuticals; (c) to
obtain any other required license, consent, permit or approval from the FDA or
any other governmental authority in the United States or its political
subdivisions as shall be required to establish operations at the Facility to
handle and manufacture sterile pharmaceuticals and provide lyophilization
services; (d) to establish operations at the Facility to provide lyophilization
services and to handle and manufacture sterile pharmaceuticals; and (e) to
2
make any capital expenditure necessary to provide lyophilization services (the
items set forth in subsections (a), (b), (c), (d), and (e) collectively, the
"Lyophilization Ramp-Up").
3.2 Additional Costs. Borrower shall be responsible for all costs
whatsoever related to the Lyophilization Ramp-Up in excess of the proceeds
hereunder and shall not require, request or demand additional amounts from
Lender to fund the Lyophilization Ramp-Up other than the amounts loaned by
Lender to Borrower or evidenced by this Note.
3.3 June 30, 2003. By June 30, 2003, Borrower shall (a) complete the
Lyophilization Ramp-Up; (b) maintain the continued removal of all warning letter
sanctions pursuant to Form 483 related to the Facility; and (c) be prepared to
immediately begin development of the procedures for manufacture of Lender's
products.
3.4 Change in Control. If Borrower experiences (a) a change in control
of greater than fifty percent (50%) of Borrower's voting securities or (b) a
change in control through a merger or the sale of all or substantially all of
Borrower's assets, then Lender may declare all amounts of principal and interest
under this Note immediately due and payable and/or terminate the Processing
Agreement.
ARTICLE 4
REPRESENTATIONS
4.1 Organization and Qualification. Borrower is duly organized, validly
existing and in good standing under the laws of the State of Louisiana, its
state of incorporation. Borrower is duly qualified to do business as a foreign
corporation and is in good standing in each jurisdiction in which the failure to
receive or retain such qualification would have a material adverse effect on the
business, operations or financial condition of Borrower.
4.2 Corporate Authority and Authorization. Borrower has all requisite
corporate, power, authority and legal right to execute and deliver and perform
its obligations under this Note and all of Borrower's obligations described
herein have been duly and validly authorized by all necessary corporate
proceedings on the part of Borrower.
4.3 Execution and Binding Effect. This Note has been or shall be duly
and validly executed and delivered by Borrower and this Note when executed and
delivered shall constitute the legal, valid and binding obligations of Borrower
enforceable in accordance with the terms hereof and thereof, except as such
enforceability may be limited by bankruptcy, insolvency, reorganization,
receivership, moratorium or other laws affecting creditors' rights generally.
4.4 Absence of Conflicts. The execution and delivery of this Note,
consummation of the transactions herein or Borrower's performance of or
compliance with the terms and conditions hereof or in the Processing Agreement
shall not (a) materially violate any applicable law or regulation; (b) conflict
with or result in a material breach of or a default under the certificate of
incorporation or bylaws of Borrower, or any agreement or instrument to which
Borrower is a party or by which Borrower or its properties is bound; or (c)
result in the creation or imposition of any lien upon any property (now owned or
hereafter acquired) of Borrower except as otherwise contemplated by this Note.
3
4.5 No Event of Default; Compliance with Instruments Corporate
Documents and Material Agreements. As of the date hereof Borrower is not in
violation of any term of its certificate of incorporation and/or bylaws and
Borrower is not in violation of any term of its material agreements or
instruments including, without limitation, (a) that certain Amended and Restated
Credit Agreement, dated September 15, 1999, as most recently amended by that
certain Forbearance Agreement (the "Forbearance Agreement"), dated July 12, 2001
(the Amended and Restated Credit Agreement and the Forbearance Agreement,
together, the "Northern Trust Credit Facility"), among Borrower, Borrower's
wholly owned subsidiary, Akorn (New Jersey), Inc., an Illinois corporation and
the Northern Trust Company ("Northern Trust"); (b) that certain Junior Mortgage,
dated March 21, 2001 between Borrower and Northern Trust (the "Northern
Mortgage"); (c) two Mortgage Notes (together, the "Primary Mortgage"), each
dated April 27, 1997, by and between Borrower and Standard Mortgage Investors
("Standard Investors"); (d) that certain Master Equipment Lease Agreement No.
08197, dated December 9, 1999, as amended December 26, 2000 (the "Asset Lease"),
by and between Borrower and National City Leasing Corporation ("National City");
(e) that certain Convertible Bridge Loan and Warrant Agreement, dated July 12,
2001, by and between Borrower and the John N. Kapoor Trust, dated September 20,
1989 (the "Kapoor Loans"), or (f) any other material agreement or instrument to
which Borrower is a party or by which it or its properties is bound.
4.6 Litigation. There is no pending action, suit or threatened
proceeding by or before any governmental authority against or affecting Borrower
which if adversely decided would have a material adverse effect on its financial
condition or on its ability to comply with its obligations herein, except those
disclosed on Exhibit A attached hereto.
4.7 Rights to Property. Except for the security interests (a) granted
by Borrower to Northern Trust under the terms of the Northern Credit Facility
and the Northern Mortgage; (b) granted to Standard Investors under the terms of
the Primary Mortgage; and (c) retained by National City under the terms of the
Asset Lease, Borrower has good and marketable title to all personal and real
property purported to be owned by it.
4.8 Taxes. All tax returns required to be filed by Borrower have been
properly prepared, executed and filed, and all taxes, assessments, fees and
other governmental charges levied upon Borrower or upon any of its properties,
incomes, sales or franchises which are shown to be due and payable thereon have
been paid, other than taxes or assessments the validity or amount of which
Borrower is contesting in good faith. The reserves and provisions for taxes on
the books of Borrower are adequate for all open years and for its current fiscal
period.
4.9 Financial Accounting Practices. Borrower and each of its
subsidiaries have made and kept books, records and accounts which, in reasonable
detail, accurately and fairly reflect their respective dealings or transactions
of or in relation to the plants, properties, business and affairs of the
Borrower and of each subsidiary, and Borrower shall keep, and cause each of its
subsidiaries to keep, proper books of account, in which full and correct entries
shall be made of all dealings or transactions of or in relation to the plants,
properties, business and affairs of the Borrower and of each subsidiary in
accordance with generally accepted accounting principles applied on a consistent
basis. The Borrower will at any and all times, upon the written request of the
Lender and at the Lender's expense, permit the Lender by its representatives to
inspect the plants and properties, books of account, records, reports and other
papers of the Borrower and of
4
each subsidiary, and to take copies and extracts therefrom, and will afford and
procure a reasonable opportunity to make any such inspection.
4.10 Accurate and Complete Disclosure. To the best of Borrower's
knowledge, no representation made by Borrower under this Note and no statement
made by Borrower in any financial statement, report filed with the Securities
and Exchange Commission, certificate, exhibit or document furnished by Borrower
to Lender pursuant to or in connection with this Note is false or misleading as
of the date made in any material respect (including by omission of material
information necessary to make such representation, warranty or statement not
misleading). Lender has had adequate access to Borrower's management and
opportunity to conduct it own due diligence examination of the plants and
properties, books of account, records, reports and other papers of the Borrower
and each of its subsidiaries.
4.11 Other Indebtedness. With the exception of (a) the Northern Credit
Facility together with the Northern Mortgage; (b) the Primary Mortgage; (c) the
Asset Lease; and (d) the Kapoor Loans, Borrower has no Indebtedness in excess of
$100,000.
4.12 Capital Stock. All of the outstanding capital stock of Borrower
has been duly authorized and validly issued, and is non-assessable.
4.13 Environmental Warranties. To the best of Borrower's knowledge,
Borrower and each of its subsidiaries is in substantial compliance with all
environmental laws, regulations, rules, ordinances, permits, orders, and other
requirements applicable to it, the operations of each or the real or personal
property owned, leased or operated by each, including without limitation, all
such laws governing employment, the generation, use, storage, disposal or
transportation of toxic or hazardous substances or wastes. Borrower has not
received notice of, and is not aware of, any violations or alleged violations,
or any liability or asserted liability, under any such environmental laws, with
respect to Borrower, its subsidiaries, or their respective businesses or
properties.
ARTICLE 5
COVENANTS
Except as otherwise permitted under the Northern Trust Credit Facility
or consented to in writing by Northern Trust, Borrower covenants and agrees
that, without the prior written consent of Lender, from and after the date
hereof until all amounts of principal and interest hereunder are repaid and
discharged:
5.1 Indebtedness. Borrower shall not create, incur, assume or permit to
exist any Indebtedness, after the date hereof except (a) deferred taxes; (b)
unfunded pension fund and other employee benefit plan obligations and
liabilities to the extent they are permitted to remain unfunded under applicable
law; (c) existing Indebtedness, which includes (i) amounts outstanding under the
Northern Credit Facility and any additional advances or borrowings under the
Northern Credit Facility in accordance with the terms thereof, (ii) the Primary
Mortgage, (iii) the Northern Mortgage and any additional advances or borrowings
under the Northern Mortgage, in accordance with the terms thereof, (iv) the
Asset Lease, (v) the Kapoor Loans, and (vi) the loans made by Lender evidenced
by this Note, or the refinancing of any of the documents or
5
facilities set forth in subparagraphs (i) through (vi), the refinanced terms of
which shall in any event be on terms no less favorable to Borrower or Lender
than the terms of the Indebtedness being refinanced; (d) any financing secured
by any real estate owned by Borrower; and (e) the unsecured financing by a
seller of product lines to Borrower.
"Indebtedness" shall mean (a) any obligation for the repayment of
borrowed money or, with respect to the purchase price of property, any payment
which is deferred six (6) months or more after the date of acquisition, but
excluding obligations to trade creditors incurred in the ordinary course of
business that are not overdue by more than six (6) months unless being contested
in good faith; (b) reimbursement and all other obligations with respect to
letters of credit, bankers' acceptances and surety bonds, whether or not
matured; (c) all obligations evidenced by notes, bonds, debentures or similar
instruments; (d) any obligation for the payment of money created or arising
under any conditional sale or other title retention agreement; (e) all capital
leases; and (f) any agreement to guarantee the indebtedness of a subsidiary of
Borrower or any other person or business entity.
5.2 Business. Borrower shall not make any changes in its business
objectives, purposes or operations which could in any way adversely affect the
repayment of this Note or Borrower's ability to comply with its obligations
contained in the Processing Agreement.
5.3 Liens. Borrower shall not create, incur, assume or permit to exist
any Lien on or with respect to any of its properties or assets whether now owned
or hereafter acquired, except (a) presently existing or hereafter created Liens
in favor of Lender; (b) Liens created after the date hereof by conditional sale
or other title retention agreements (including, without limitation, capital
leases) or in connection with purchase money Indebtedness with respect to
properties acquired by Borrower in the ordinary course of business, involving
the incurrence of an aggregate amount of purchase money Indebtedness and capital
lease obligations of not more than $1,000,000 outstanding at any one time for
all such Liens (provided that such Liens attach only to the assets subject to
such purchase money Indebtedness and such Indebtedness is incurred within twenty
(20) days following such purchase and does not exceed 100% of the purchase price
of the subject assets); (c) Liens in connection with any financing secured by
any real estate owned by Borrower; and (d) Liens existing on the date hereof and
described in Exhibit A hereto.
In addition, Borrower shall not become a party to any agreement, note,
indenture or instrument, or take any other action, which would prohibit the
creation of a Lien on any of its properties or other assets in favor of Lender,
as collateral for payment and satisfaction of the outstanding principal and
accrued interest under this Note, except operating leases, capital leases or
intellectual property licenses which prohibit liens upon the assets that are
subject thereto.
"Lien" shall mean any mortgage or deed of trust, pledge, hypothecation,
assignment, deposit arrangement, lien, charge, claim, security interest,
easement or encumbrance, or preference, priority or other security agreement or
preferential arrangement of any kind or nature whatsoever (including any lease
or title retention agreement, any financing lease having substantially the same
economic effect as any of the foregoing, and the filing of, or agreement to
give, any financing statement perfecting a security interest under the Uniform
Commercial Code or comparable law of any jurisdiction).
6
5.4 Cancellation of Indebtedness. Borrower shall not cancel any claim
or debt owing to it, except for reasonable consideration negotiated on an
arm's-length basis and in the ordinary course of its business consistent with
past practices.
ARTICLE 6
EVENTS OF DEFAULT: RIGHTS AND REMEDIES
6.1 Events of Default. The occurrence of any one or more of the
following events (regardless of the reason therefor) shall constitute an "Event
of Default" hereunder: (a) Borrower shall fail to make any payment of principal
of, or interest on, or any other amount owing in respect of this Note when due
and payable; (b) Borrower shall fail to pay any costs or expenses payable or
reimbursable by Borrower under this Note, and such failure shall have remained
unremedied for a period of thirty (30) days or more; (c) Borrower shall fail or
neglect to perform, keep or observe any of the provisions of this Note (and not
constituting an Event of Default under any of the other subsections of this
Section 6.1) and such failure shall have remained unremedied for a period of
thirty (30) days or more; (d) Borrower shall fail to perform, keep or observe
any provision of the Processing Agreement after the grace period (if any) set
forth therein or the Processing Agreement shall not be effective on or before
June 30, 2003; (e) a default or breach that is not waived in writing shall occur
under the Northern Credit Facility, The Northern Mortgage, the Primary Mortgage,
the Asset Lease or the Kapoor Loans; (f) a default under any agreement, document
or instrument, excluding those specified in subsection 6.1(e), to which Borrower
is a party and such default is not cured or waived within any applicable grace
period and such default or breach (i) involves the failure to make any payment
when due in respect of any Indebtedness of Borrower or any subsidiary of
Borrower in excess of $50,000 in the aggregate, or (ii) causes such Indebtedness
or a portion thereof in excess of $100,000 in the aggregate to become due prior
to its stated maturity or prior to its regularly scheduled dates of payment, or
(iii) entitles any holder of such Indebtedness to cause such Indebtedness or a
portion thereof in excess of $100,000 in the aggregate to become due prior to
its stated maturity or prior to its regularly scheduled dates of payment,
regardless of whether such right is exercised or waived by such holder or
trustee; (g) The Forbearance Agreement expires, unless the same expires without
Borrower being in breach or default thereof; (h) Kapoor breaches or repudiates
or attempts to breach or repudiate, the Subordination Agreement or the
Subordination Agreement is terminated by operation of its terms or operation of
law; (i) any representation or warranty herein or in any written statement,
report filed with the Securities and Exchange Commission, financial statement or
certificate made or delivered to Lender by Borrower shall be untrue or incorrect
in any material respect, as of the date when made or deemed made; (j) assets of
Borrower or any subsidiary thereof with a fair market value of $100,000 or more
shall be attached, seized, levied upon or subjected to a writ or distress
warrant, or come within the possession of any receiver, trustee, custodian or
assignee for the benefit of creditors of Borrower or any subsidiary thereof and
such condition shall continue for thirty (30) days or more; (k) a case or
proceeding shall have been commenced against Borrower or any subsidiary thereof
in a court having competent jurisdiction seeking a decree or order in respect of
Borrower or any subsidiary thereof (i) under Title 11 of the United States Code,
as now constituted or hereafter amended or any other applicable federal, state
or foreign bankruptcy or other similar law, (ii) appointing a custodian,
receiver, liquidator, assignee, trustee or sequestrator (or similar official)
for Borrower or any subsidiary thereof or of any substantial part of the assets
thereof, or (iii) ordering the winding-up or liquidation of the affairs of
Borrower or any subsidiary thereof and
7
such case or proceeding shall remain undismissed or unstayed for forty-five (45)
days or more or such court shall enter a decree or order granting the relief
sought in such case or proceeding; (l) Borrower or any subsidiary thereof shall
(i) file a petition seeking relief under Title 11 of the United States Code, as
now constituted or hereafter amended, or any other applicable federal, State or
foreign bankruptcy or other similar law, (ii) consent to the institution of
proceedings thereunder or to the filing of any such petition or to the
appointment of or taking possession by a custodian, receiver, liquidator,
assignee, trustee or sequestrator (or similar official) of Borrower or any
subsidiary thereof or of any substantial part of its respective assets, (iii)
make an assignment for the benefit of creditors, or (iv) take any corporate
action in furtherance of any such action; or (m) a final judgment or judgments
for the payment of money in excess of $250,000 in the aggregate shall be
rendered against Borrower or any subsidiary thereof and the same shall not (i)
be fully covered by insurance, or (ii) within thirty (30) days after the entry
thereof, have been discharged or execution thereof stayed pending appeal, or
shall not have been paid or otherwise discharged prior to the expiration of any
such stay.
6.2 Remedies. If any Event of Default shall have occurred and be
continuing (a) all of the outstanding principal and accrued and unpaid interest
under this Note shall be immediately due and payable without presentment,
demand, protest or further notice of any kind, all of which are expressly waived
by Borrower; (b) the rate of interest applicable to this Note shall be increased
to the Default Rate; and (c) Borrower may exercise any rights and remedies
provided to Lender under this Note and/or at law or equity.
6.3 Waivers by Borrower. Except as otherwise provided for in this Note
or by applicable law, Borrower waives presentment, demand and protest and notice
of presentment, dishonor, notice of intent to accelerate, notice of
acceleration, protest, default, nonpayment, maturity, release, compromise,
settlement, extension or renewal of any or all commercial paper, accounts,
contract rights, documents, instruments, chattel paper and guaranties at any
time held by Lender on which Borrower may in any way be liable, and hereby
ratifies and confirms whatever Lender may do in this regard. Borrower
acknowledges that it has been advised by counsel of its choice with respect to
this Note and the transactions evidenced by this Note.
ARTICLE 7
SUCCESSORS AND ASSIGNS
This Note shall be binding on and shall inure to the benefit of
Borrower and Lender and their respective successors and assigns, except as
otherwise provided herein. Borrower may not assign, transfer, hypothecate or
otherwise convey its rights, benefits, obligations or duties hereunder without
the prior express written consent of Lender. Any such purported assignment,
transfer, hypothecation or other conveyance by Borrower without the prior
express written consent of Lender shall be void. The terms and provisions of
this Note are for the purpose of defining the relative rights and obligations of
Borrower and Lender with respect to the transactions contemplated hereby and
there shall be no third party beneficiaries of any of the terms and provisions
of this Note.
8
ARTICLE 8
SUBORDINATION
Anything in this Note to the contrary notwithstanding, the Indebtedness
evidenced by this Note, both principal and interest, and the right to seek
enforcement of any of the rights granted to Lender herein, shall be subordinate
and junior to all obligations of Borrower incurred under the Northern Credit
Facility, between Borrower and Northern Trust.
ARTICLE 9
NOTICES
All notices, requests, demands and payments of principal and interest
given to or made under this Note shall, except as otherwise specified in this
Note, be in writing and shall be effective upon the earlier of (a) receipt or
(b) the fifth (5th) day following the date such notice was mailed properly
addressed, first class, registered or certified mail, return receipt requested,
postage prepaid, to the other party at the following addresses (which may be
changed at any time by notice under this Article 9):
If to NeoPharm, Inc.
150 Field Drive, Suite 195
Lake Forest, Illinois 60045
Facsimile No.: (847) 295-8854
Attn: James Hussey
With a copy to:
Ross & Hardies
150 North Michigan Avenue
Chicago, Illinois 60601-7567
Facsimile No.: (312) 750-8600
Attn: Scott Becker
If to Akorn, Inc.
Akorn, Inc.
2500 Millbrook Drive
Buffalo Grove, IL 60089-4694
Facsimile No. (847) 279-6123
Attn: Antonio Pera
With a copy to:
Tressler, Soderstrom, Maloney & Priess
2100 Manchester Road, Suite 950
Wheaton, Illinois
Facsimile No.: (630) 668-3003
Attn: William A. Kindorf, III
9
ARTICLE 10
GOVERNING LAW & WAIVER OF JURY TRIAL
This Note and any document or instrument executed in connection
herewith shall be governed by and construed in accordance with the internal law
of the State of Illinois, and shall be deemed to have been executed in the State
of Illinois. Unless the context requires otherwise, wherever used herein the
singular shall include the plural and vice versa, and the use of one gender
shall also denote the other. Captions herein are for convenience of reference
only and shall not define or limit any of the terms or provisions hereof;
references herein to Articles or provisions without reference to the document in
which they are contained are references to this Note. This Note shall bind
Borrower, its trustees (including without limitation successor and replacement
trustees), successors and assigns, and shall inure to the benefit of Lender, its
successors and assigns, except that Borrower may not transfer or assign any of
its rights or interest hereunder without the prior written consent of Lender.
BORROWER HEREBY IRREVOCABLY AGREES THAT, SUBJECT TO LENDER'S SOLE AND
ABSOLUTE ELECTION, ALL SUITS, ACTIONS OR OTHER PROCEEDINGS WITH RESPECT TO,
ARISING OUT OF OR IN CONNECTION WITH THIS NOTE OR ANY DOCUMENT OR INSTRUMENT
EXECUTED IN CONNECTION HEREWITH SHALL BE SUBJECT TO LITIGATION IN COURTS HAVING
SITUS WITHIN OR JURISDICTION OVER COOK COUNTY, ILLINOIS. BORROWER HEREBY
CONSENTS AND SUBMITS TO THE JURISDICTION OF ANY LOCAL, STATE OR FEDERAL COURT
LOCATED IN OR HAVING JURISDICTION OVER SUCH COUNTY, AND HEREBY IRREVOCABLY
WAIVES ANY RIGHT IT MAY HAVE TO REQUEST OR DEMAND TRIAL BY JURY, TO TRANSFER OR
CHANGE THE VENUE OF ANY SUIT, ACTION OR OTHER PROCEEDING BROUGHT BY LENDER IN
ACCORDANCE WITH THIS PARAGRAPH, OR TO CLAIM THAT ANY SUCH PROCEEDING HAS BEEN
BROUGHT IN AN INCONVENIENT FORUM.
ARTICLE 11
MISCELLANEOUS
11.1 Construction. Wherever possible, each provision of this Note shall
be interpreted in such a manner as to be effective and valid under applicable
law, but if any provision of this Note is prohibited by or invalid under
applicable law, such provision shall be ineffective only to the extent of such
prohibition or invalidity without invalidating the remainder of such provision
or the remaining provisions of this Note.
11.2 Amendments. This Note may not be and shall not be deemed or
construed to have been modified, amended, rescinded, canceled, or waived in
whole or in part, except by written instruments signed by Borrower and Lender.
11.3 No Waiver. Lender's failure at any time or times, to require
strict performance by Borrower of any provision of this Note or Promissory
Agreement shall not waive, affect or diminish any right of Lender thereafter to
demand strict compliance and performance therewith. Any suspension or waiver of
an Event of Default under this Note or Promissory Agreement shall
10
not suspend, waive or affect any other Event of Default under this Note or
Promissory Agreement whether the same is prior or subsequent thereto and whether
of the same or of a different type. None of the undertakings, agreements,
warranties, covenants and representations of Borrower contained in this Note or
Promissory Agreement and no Event of Default by Borrower under this Note or
Promissory Agreement shall be deemed to have been suspended or waived by Lender
unless such waiver or suspension is by an instrument in writing signed by an
officer of or other authorized employee of Lender and directed to Borrower
specifying such suspension or waiver.
11
IN WITNESS WHEREOF, Borrower has caused this Note to be duly executed
as of the day and year first above written.
AKORN, INC.
By:
Its:
Accepted:
NEOPHARM, INC.
By:
Its: President and Chief Executive Officer
Acknowledged:
THE NORTHERN TRUST COMPANY
By:
Its:
12
EXHIBIT A
1. LITIGATION.
1. Shareholder Class Action Lawsuit - Filed August 9, 2001
Class action lawsuit filed against the Company, Mr. Floyd
Benjamin, former CEO, and Mr. John Kapoor, current chairman
and interim CEO. Potential damages unknown at this time.
2. NovaDaq Technologies - Filed April 4, 2001
The Company was notified by the International Court of
Arbitration that NovaDaq filed a request for Arbitration in
relation to an Existing agreement between NovaDaq and the
company. Potential damages estimated at $4.4 million by
NovaDaq.
2. LIENS.
TRANSACTION SECURED PARTY DEBTOR JURISDICTION FILE NO. ACTION DATE
EQUIPMENT LEASE NO. THE CIT GROUP/ AKORN LA and 52-E7167 Filed 11/29/94
OL-8248 WITH EQUIPMENT St. Tammany 52-E7167 Correction 3/16/95
AMPLICON, INC.; FINANCING, INC. Parrish 52-E8067 Amendment 5/30/95
SECURED BY UCC 1620 W. Fountainhead 52-19775 Continuation 10/22/99
FINANCING STATEMENT Pkwy.
COVERING EQUIPMENT Tempe, AZ 85282
MORTGAGE LOAN NOS. STANDARD MORTGAGE AKORN Macon Co., IL
98021903 AND 98021904 INVESTORS
DATED 4/27/97;
SECURED BY MORTGAGES
ON DECATUR REAL
PROPERTIES; PRINCIPAL
BALANCE AT 6/30/01
$2,318,214.90, FINAL
PAYMENT DUE JUNE 2008
13
TRANSACTION SECURED PARTY DEBTOR JURISDICTION FILE NO. ACTION DATE
Amended and Restated The Northern Trust Akorn CA 9800560381 Filed 12/31/97
Credit Agreement Company Amendment 9/21/99
dated 9/15/99 as 50 South LaSalle 9800560407 Filed 12/31/97
amended by Street Amendment 9/21/99
Forbearance Agreement Chicago, IL 60675 IL 3780342 Filed 12/30/97
dated 7/12/01 for 4097177 Amendment 9/21/99
$45,000,000 line of 4203325 Partial 4/24/00
credit; secured by Release
UCC financing Taylor IL 3780343 Filed 12/30/97
statements covering Pharmaceuticals 4097192 Amendment 9/21/99
accounts, inventory (merged with
and equipment Akorn)
Akorn (New IL 4096623 Filed 9/21/99
Jersey)
NJ 01930630 Filed 9/20/99
Equipment Lease Nos. Associates Leasing, Akorn NJ 01885213 Filed 1/21/99
VJ3317 and W10811 Inc.
with Lincoln Service 8001 Ridgepoint Drive
& Equipment Co.; Irving, TX 75063
secured by UCC
financing statement
covering equipment
Equipment Lease No. Deerbart Financial Akorn IL 4022989 Filed 4/20/99
5387; secured by UCC Services Co.
financing statement 2250 E. Devon Ave.,
covering equipment Ste. 251
Des Plaines, IL 60018
Master Equipment National City Akorn IL 4314294 Filed 1/03/01
Lease Agreement No. Leasing Corp.
08197-0012, dated P.O. Box 36040
December 9, 1999, Louisville, KY 40233
as amended
December 26, 2000;
acquisition cost
$3,811,028.93 with
monthly payments
of $52,577.71
through 12/26/07;
secured by UCC
financing statement
covering equipment
Junior Mortgage dated The Northern Trust Akorn
3/21/01 Company 50 South
LaSalle Street
Chicago, IL 60675
14
Exhibit 10.18
PROCESSING AGREEMENT
THIS PROCESSING AGREEMENT (the "Agreement") is made and entered into this
20th day of December, 2001, between Akorn, Inc., a Louisiana Corporation
("Akorn") and NeoPharm, Inc., a Delaware Corporation ("NeoPharm").
WHEREAS, NeoPharm is a pharmaceutical company which has developed certain
chemotherapeutic agents (the "Products");
WHEREAS, Akorn owns and operates a lyophilization facility located at 1222
West Grand Avenue, Decatur, Illinois (the "Facility") and has the ability and
capacity to process and finish pharmaceutical products; and
WHEREAS, NeoPharm desires to contract with Akorn to process and finish the
Products at the Facility, and Akorn desires to provide such services, on the
terms and conditions set forth herein
NOW, THEREFORE, in consideration of the mutual covenants and promises set
forth herein, the parties agree as follows:
ARTICLE I
PROCESSING ESTIMATE/DELIVERY OF PRODUCTS
Section 1.1. Processing Estimate. At least thirty (30) days prior to the
Effective Date (as defined herein), and at least thirty (30) days prior to the
commencement of each twelve (12) month period thereafter, NeoPharm shall deliver
to Akorn its good faith estimate (the "Estimate") of the quantity of Products to
be Processed (as defined herein) by Akorn hereunder for the upcoming twelve (12)
month period. Such estimate shall be non-binding, and NeoPharm shall update the
Estimate quarterly based upon its expected Processing needs. Akorn agrees to
allocate to the Processing of NeoPharm's Products no less than fifteen percent
(15%) of the Facility's Processing capacity during every twelve (12) month
period during the Term of this Agreement; the actual allocation of the
Facility's capacity to NeoPharm for such period shall be agreed upon by the
parties and is referred to herein as the "Processing Maximum". Processing
Capacity shall be measured in terms of hours usage of the Facility. NeoPharm
shall have the right to audit Akorn's books and records to ascertain compliance
with this Section 1.1.
Section 1.2. Purchase Orders. From time to time, NeoPharm shall provide
Akorn with a purchase order (the "Purchase Order") which shall set forth the
Product to be Processed and the quantity of Bulk Product to be Processed by
Akorn (the "Batch"). Akorn shall provide NeoPharm with written acceptance of the
Purchase Order, which acceptance shall set forth the date the Processing Run (as
defined herein) for the Batch covered by such Purchase Order shall commence (the
"Processing Run Commencement Date"). Akorn agrees that the Processing Run
Commencement Date shall be no later than fourteen (14) days after Akorn's
receipt of the
Purchase Order. Akorn shall use its best efforts to accommodate NeoPharm's
request to amend a Purchase order to modify the size of a Batch to be Processed.
Section 1.3. Estimated Yield. Upon Akorn's acceptance of a Purchase Order,
Akorn shall calculate the estimated Final Product to be manufactured (the
"Estimated Yield") from the Batch that is the subject of the Purchase Order. The
Estimated Yield factor to be applied to each Purchase Order shall be based upon
the optimum yield determined from the first (3) Processing Runs of a particular
Product. Such determination and each such Processing Run shall be performed and
conducted in the presence of a NeoPharm representative. In the event NeoPharm
disagrees with Akorn's Estimated Yield, the Parties shall in good faith agree
upon a third party to review the data Akorn utilized to calculate the Estimated
Yield. The findings of such third party shall be binding on both parties. In the
event that the actual yield of any Batch is less than ninety-five percent (95%)
of the Estimated Yield, NeoPharm shall be entitled to an investigation of the
reason(s) for the reduced yield of the Batch, and NeoPharm shall be entitled to
an equitable reduction (the "Yield Credit") in the Processing Fee (as defined
herein).
Section 1.4. Delivery of Bulk Products. At least fifteen (15) business
days prior to each Processing Run Commencement Date, NeoPharm shall deliver to
Akorn sufficient amounts of Bulk Product for such Processing Run along with any
applicable vial labeling materials. For purposes of this Agreement, Bulk Product
shall mean formulated solutions of the Products. NeoPharm warrants that all Bulk
Product provided hereunder shall meet all applicable specifications and shall
have been produced in compliance with applicable federal, state and local laws
and regulations, including, without limitation, the Good Manufacturing Practices
Regulations ("GMPs") of the United States Food and Drug Administration ("FDA"),
21 C.F.R. part 211, in effect at the time of Processing. In connection with the
delivery of Bulk Product, NeoPharm shall provide Akorn with written
certification of the sterility of Bulk Product.
Section 1.5. Ownership/Risk of Loss. NeoPharm shall own all Bulk Product
delivered by NeoPharm and all Finished Product (as defined herein) Processed by
Akorn and, except in a case giving rise to Akorn's indemnification
responsibilities hereunder, NeoPharm shall bear the risk of loss with respect to
such materials.
ARTICLE II
PROCESSING OF BULK PRODUCTS
Section 2.1. Processing Obligations. Commencing with each Processing Run
Commencement Date, Akorn shall Process the Bulk Product corresponding to the
applicable Purchase Order in accordance with the terms of this Article II (each
a "Processing Run"). For purposes of this Agreement, "Processing" shall mean
filling into vials, lyophilizing, inspecting and packaging the Bulk Product in
order to produce finished pharmaceutical dosage forms of the Products (the
"Finished Product"). The parameters (the "Processing Parameters") under which
Akorn shall Process the Bulk Product shall be mutually agreed upon by the
Parties at least thirty (30) days prior to the Effective Date and shall be
attached hereto as Schedule 2.1. Any amendments and/or additions to the
Processing Parameters or the equipment, test methods,
2
specifications or any other requirement of this Agreement or with respect to the
operation of the Facility, must be mutually agreed to by the parties in writing
and shall be attached to Schedule 2.1. Notwithstanding the foregoing and in
addition to any supplemental parameters agreed to by the parties with respect to
a particular Processing Run, Akorn's Processing at a minimum shall consist of
the following components:
(a) Preparation and retention of the master production and control
records required by the FDA for each Product pursuant to 21
CFR 600.12 (the "Batch Records") as approved by Akorn and
NeoPharm.
(b) Compliance with the applicable standards from the USP-NF
guidelines.
(c) Furnishing vials, stoppers and seals for the Products and
conducting the appropriate inspection, testing and release
thereof.
(d) Preparation and sterilization of vials and stoppers in
accordance with Akorn's Standard Procedures;
(e) Aseptically filling vials within tolerance limits set by
NeoPharm and holding filled vials under specified conditions
which shall be provided by NeoPharm until loaded in
lyophilizer;
(f) Aseptically stopping and sealing lyophilized product vials.
(g) Performance of Quality Control Testing of finished dosage
forms in accordance with NeoPharm's specifications.
(h) Inspection of the finished dosage form.
(i) Storage of quarantined vials at mutually agreed upon
temperatures until instructed by NeoPharm to ship the Finished
Product.
(j) Shipping of the Finished Product in accordance with NeoPharm's
specifications.
Section 2.2. Addition of Other Products to the Agreement. NeoPharm may add
additional pharmaceutical products to be Processed by Akorn. The parties shall
mutually agree upon any Processing Parameters and the Processing Fee for such
additional products.
Section 2.3. Representations and Warranties of Akorn. Akorn agrees that in
performing the Processing services hereunder, it shall comply with applicable
GMPs and that it shall use its best efforts to maintain the Facility in such a
fashion as to be in compliance with all applicable federal, state and local
rules and regulations. Akorn agrees that it shall maintain all licenses and
permits required by any applicable federal, state or local agency, including but
not limited to the FDA, in order to operate the Facility and provide the
Processing services required hereunder. Without limiting the generality of the
foregoing, Akorn agrees that it will cause its
3
employees and agents to follow all procedures developed and implemented in
connection with the removal of the warning letter sanctions pursuant to Form 483
or current GMP regulations issued or imposed by the FDA with regard to the
Facility. Akorn also agrees to store all manufacturing and laboratory records on
the site where the Processing is performed and to keep such records readily
available. Further, Akorn represents and warrants that it shall use its best
efforts to insure that all filtration, filling and lyophilization of the Product
by Akorn shall be done in an aseptic processing environment and in accordance
with the Processing Parameters.
Section 2.4. Facilities Inspection. During the Term of this Agreement,
NeoPharm shall have the right, at its expense, to audit the Facility for Akorn's
compliance with GMPs and any other applicable laws. NeoPharm agrees to provide
Akorn with reasonable prior notice of the date of such audit. In addition to the
foregoing, NeoPharm shall have the right to designate an individual to be at the
Facility to monitor each Processing Run. NeoPharm agrees that its employees or
agents who inspect the Facility or who are on site at the Facility during a
Processing Run will comply with Akorn's rules, regulations and GMPs.
Section 2.5. Akorn Obligation to Meet Requirements. Akorn agrees to
fulfill, in each twelve (12) month period during the Term of this Agreement (as
defined herein), all Purchase Orders placed by NeoPharm up to one hundred
percent (100%) of NeoPharm's most recently updated Estimate. Akorn shall use
reasonable efforts to supply any quantity ordered by NeoPharm of Product in
excess of the Estimate subject to Akorn's production scheduling capabilities and
commitments to other customers.
Section 2.6. Subcontracting. Akorn shall not pass to a third party any
work entrusted to it under this Agreement without first obtaining NeoPharm's
written approval of such arrangements, which approval shall not be unreasonably
withheld.
Section 2.7. Quality Assurance Department. Akorn agrees that at all times
during the term of this Agreement, it shall maintain a quality assurance
department (the "Quality Assurance Department") for purposes of monitoring the
quality of Akorn's Processing hereunder and for purposes of approving each Batch
Processed hereunder. Akorn agrees that upon NeoPharm's request, it shall provide
NeoPharm with copies of the policies, procedures and findings of the Quality
Assurance Department.
ARTICLE III
SHIPMENT AND STORAGE
Section 3.1. Storage. Akorn shall store and handle the Bulk Product and
Finished Product as required by the Processing Parameters. Akorn shall take such
actions as are reasonably necessary to protect the Bulk Product and Finished
Product from damage and deterioration. Vials of Finished Product will be stored
at the recommended controlled temperature until shipped as instructed by
NeoPharm.
4
Section 3.2. Release of Finished Product. Upon Akorn's Quality Assurance
Department's written release of a Batch of Finished Product, Akorn shall
promptly ship the Finished Product to NeoPharm or, at NeoPharm's discretion,
warehouse Finished Product, in accordance with FDA and GMP warehousing
procedures, for a maximum of thirty (30) days at no cost, and thereafter at
charges to be mutually agreed upon, to the extent warehousing space is
available. Akorn shall provide NeoPharm with properly completed Batch Records,
prepared in conformance with the Processing Parameters, within five (5) days
following Akorn's written release of such Batch but, in no event more than four
(4) weeks from the date the Processing Run is completed (i.e., the date the
filling or lyophilization is completed).
Section 3.3. Transfer of Finished Product to NeoPharm. Finished Product
shall be shipped to NeoPharm in accordance with NeoPharm's written instructions.
Unless otherwise agreed to in writing by the Parties, there shall be only one
shipment per Batch of Finished Product. NeoPharm shall be responsible for all
costs associated with the shipment of Finished Product
Section 3.4. Rejection. NeoPharm may reject any Batch of Finished Product
failing to meet any of the Processing Parameters by providing Akorn with written
notice of such rejection (the "Rejection") within sixty (60) days following
NeoPharm's receipt of the applicable Batch Records and written notice from Akorn
stating that Akorn's Quality Assurance Department has approved the Batch. Any
rejection by NeoPharm pursuant to this Section 3.4 shall be accompanied by a
report of analysis, including a product sample from the Batch analyzed.
NeoPharm's failure to reject a Batch of Finished Product in the manner set forth
above shall constitute acceptance thereof except to the extent that any defect
in the Batch was not discovered by NeoPharm after exercising due diligence and
using customary testing procedures accepted in the industry and provided that
NeoPharm notifies Akorn of any such defect within a reasonable time after
NeoPharm discovers or should have discovered the defect and before any
substantial change in the condition of the Batch which is not caused by such
defect. In the event Akorn accepts NeoPharm's Rejection, NeoPharm shall be
entitled to a credit against the Processing Fee (the "Rejection Credit") equal
to the Processing Fee for such Batch and the cost, not to exceed $25,000, of
NeoPharm's Bulk Product. In the event the Parties can not agree upon whether the
Rejection was justified, the Parties shall mutually agree upon a third party to
test samples of such Batch and to review records and test data and other
relevant information developed by both parties relating thereto to ascertain
whether the Batch was manufactured in accordance with the Processing Parameters.
The findings of such third party shall be binding on both parties. If the third
party determines that the Batch was manufactured in accordance with the
Processing Parameters, NeoPharm shall be deemed to have accepted the affected
Batch. If the third party determines that the Batch was not manufactured in
accordance with the Processing Parameters, NeoPharm shall be entitled to the
Rejection Credit. The Parties shall share the costs of any such third party
testing. In the event a Batch was properly Rejected, Akorn agrees that NeoPharm
shall be entitled to a replacement Processing Run, regardless of whether such
replacement Processing Run will cause NeoPharm to exceed the Processing Maximum.
5
ARTICLE IV
PRICE OF MANUFACTURE
Section 4.1. Price. In consideration of the Processing provided by Akorn
hereunder, NeoPharm agrees to pay Akorn a processing fee (the "Processing Fee"),
as modified by the Yield Credit or the Rejection Credit, if applicable. The
Processing Fee shall be mutually agreed upon by the Parties at least thirty (30)
days prior to the Effective Date based upon the Processing Parameters for each
Product, after a trial run if necessary, and shall be attached hereto as
Schedule 4.1.
Section 4.2. Most Favored Pricing. Akorn agrees that the Processing Fee
charged to NeoPharm hereunder shall be no higher than the lowest fee charged by
Akorn to any customers with similar processing requirements for Processing at
the Facility, regardless of any discounts afforded to such other customers.
NeoPharm shall have the right to audit Akorn's books and records to ascertain
compliance with this Section 4.2.
ARTICLE V
TERM AND TERMINATION
Section 5.1. Term. This Agreement shall have an initial term (the "Initial
Term") commencing on the date the warning letter sanctions imposed by the FDA
pursuant to Form 483 or current GMP regulations on Akorn and/or the Facility
have been removed (the "Effective Date") and ending on the later of (i) the
fifth (5th) anniversary of the Effective Date, or (ii) two (2) years after the
date on which Akorn pays all amounts of principal and accrued interest under
that certain Promissory Note (the "Note"), dated December 20, 2001, issued by
Akorn to NeoPharm in exchange for a loan in principal amount of Three Million
Two Hundred Fifty Thousand Dollars ($3,250,000) plus interest. This Agreement
will automatically extend for two additional, five-year terms (each, an
"Additional Term") beyond the Initial Term, provided, however, that either
NeoPharm or Akorn may terminate this Agreement at the end of the Initial Term or
an Additional Term, as the case may be, by sending a termination notice ninety
(90) days prior to the end of such Initial Term or Additional Term.
Notwithstanding the foregoing, in the event the warning letter sanctions
pursuant to Form 483 or current GMP regulations have not been removed by June
30, 2003 or in the event the Akorn has not received validation from the FDA with
respect to Processing NeoPharm's Products by such date, NeoPharm may terminate
this Agreement upon written notice to Akorn.
Section 5.2. Voluntary Termination. NeoPharm or Akorn may terminate this
Agreement for any reason, provided that the terminating party first serves
written notice of such termination on the other party no later than one hundred
eighty (180) days prior to the date of such termination. Notwithstanding the
foregoing, Akorn shall not have the right to voluntarily terminate this
Agreement until the Note has been paid in full and for two (2) years thereafter.
Section 5.3. Termination for Material Breach. Either party may terminate
this Agreement in the event of a material breach by the other, provided that the
party asserting such
6
breach first serves written notice of the alleged breach on the offending party
and such alleged breach is not cured within thirty (30) days of the offending
party's receipt of such notice.
Section 5.4. Termination for Rejected Finished Products. NeoPharm may
terminate this Agreement upon written notice to Akorn in the event NeoPharm
property rejects three (3) consecutive Batches of Finished Product or six (6)
Batches of Finished Product within a two (2) month period.
Section 5.5. Termination for Insolvency. In the event that either party
shall admit in writing that it can not pay its debts, or shall suspend its
business, or shall file a voluntary petition or any answer admitting the
jurisdiction of the court and the material allegations of, or shall consent to,
an involuntary petition pursuant to or purporting to be pursuant to any
reorganization or insolvency law of any jurisdiction, or shall make an
assignment for the benefit of creditors, or shall apply for or consent to the
appointment of a receiver or trustee of all or a substantial part of its
property (such party, upon the occurrence of any such event, a "Bankrupt
Party"), then, to the extent permitted by the law, the other party hereto may
thereafter immediately terminate this Agreement by giving notice of termination
to the Bankrupt Party.
Section 5.6. Effect of Expiration or Termination. Upon termination or
expiration of this Agreement, neither party shall have any further obligations
to the other party except for those obligations which accrued prior to the date
of termination or those obligations which are intended to survive the
termination or expiration of this Agreement.
Section 5.7. Akorn Obligations Upon Expiration or Termination. Upon the
expiration of this Agreement or its earlier termination, Akorn shall, at the
request of NeoPharm and at NeoPharm's expense, return or dispose of all Bulk
Product or Finished Product to NeoPharm or to a third party pursuant to the
instructions of NeoPharm.
ARTICLE VI
INDEMNIFICATION
Section 6.1. Akorn Indemnity. Akorn agrees to indemnify, protect and
defend NeoPharm and hold NeoPharm harmless from and against any claims, damages,
liability, harm, loss, costs, penalties, lawsuits, threats of lawsuit, recalls
or other governmental action, including reasonable attorneys' fees, brought or
claimed by any third party which (i) arise as the result of Akorn's breach of
this Agreement or of any warranty or representation made to NeoPharm under this
Agreement; or (ii) which result from any claim made against NeoPharm in
connection with Akorn's manufacture of defective Finished Product for NeoPharm.
Upon the filing of any such legal claim or lawsuit against NeoPharm, NeoPharm
shall promptly notify Akorn, in writing, of any such claim and Akorn shall, at
its expense, with attorneys reasonably acceptable to NeoPharm, handle, defend
and control such claim or lawsuit. Failure to notify Akorn promptly of the
commencement of any such action, if prejudicial to the ability to defend such
action, shall
7
relieve Akorn of any liability to NeoPharm under this Section 6.1. NeoPharm
shall have the right to participate in the defense of such action at its expense
with counsel of its choosing.
Section 6.2. NeoPharm Indemnity. NeoPharm agrees to indemnify, protect and
defend Akorn and hold Akorn harmless from and against any claims, damages,
liabilities, harm, loss, costs, penalties, lawsuits, threats of lawsuit, recalls
or other governmental action, including reasonable attorneys' fees, brought or
claimed by any third party, which (i) arise out of NeoPharm's breach of this
Agreement or of any warranty or representation to Akorn under this Agreement; or
(ii) result from the negligent acts or willful malfeasance on the part of
NeoPharm or employees or agents, in connection with NeoPharm's sale, marketing
or distribution of Product manufactured by Akorn or other activities or actions
in connection with the Finished Product. Upon the filing of any such legal claim
or lawsuit against Akorn, Akorn shall promptly notify NeoPharm, in writing, of
any such claim and NeoPharm shall, at its expense, with attorneys reasonably
acceptable to Akorn, handle, defend and control such claim or lawsuit. Failure
to notify NeoPharm promptly of the commencement of any such action, if
prejudicial to the ability to defend such action, shall relieve NeoPharm of any
liability to Akorn under this Section 6.2. Akorn shall have the right to
participate in the defense of such action at its expense with counsel of its
choosing.
ARTICLE VII
RIGHT OF FIRST REFUSAL
Section 7.1. Grant of Rights. Akorn agrees that in the event it receives a
bona fide third party offer (an "Offer") to acquire the Facility from an
unrelated third party (exclusive of an offer to acquire a controlling interest
in the outstanding shares of stock or substantially all of the assets of Akorn),
it shall provide NeoPharm with written notice of the terms and conditions of
such Offer.
Section 7.2. Right of First Refusal. Upon its receipt of the notice
contemplated by Section 7.1, NeoPharm shall have the right to acquire the
Facility on the same terms and conditions as are set forth in the Offer (or
their cash equivalent in the event the Offer contains consideration other than
cash). In order to exercise the foregoing right, NeoPharm must provide Akorn
written notice of its exercise within thirty (30) days of its receipt of the
written notice from Akorn.
ARTICLE VIII
CONFIDENTIALITY
Section 8.1. Confidential Information. Each party (the "Receiving Party")
shall maintain in confidence all information heretofore or hereafter disclosed
by the other party (the "Disclosing Party") which such party knows or has reason
to know is a trade secret, and other proprietary information owned by or
licensed to the other party, including, but not limited to,
8
information relating to the Product (including without limitation, information
developed in preclinical and clinical studies) and licenses, patents, patent
applications, technology or processes and business plans of the other party,
including, without limitation, information designated as confidential in writing
from one party to the other (all of the foregoing hereinafter referred to as
"Confidential Information") and shall not use such Confidential Information
except as permitted by this Agreement or disclose the same to anyone other than
those of its officers, directors or employees as are necessary in connection
with such party's activities as contemplated by this Agreement. Each party shall
use the same efforts as such party would use to protect its own information and
to ensure that its officers, directors and employees do not disclose or make any
unauthorized use of such Confidential Information. Each party shall notify the
other promptly upon discovery of any unauthorized use or disclosure of the other
party's Confidential Information.
Section 8.2. Limitations on Confidentiality. The obligation of
confidentiality contained in this Article VIII shall not apply to the extent
that: i) the Receiving Party is required to disclose Confidential Information by
applicable law, regulation or order of a governmental agency or a court of
competent jurisdiction; ii) the Receiving Party can demonstrate that the
disclosed Confidential Information was, at the time of disclosure, already in
the public domain other than as a result of actions or failure to act of the
Receiving Party, its officers, directors or employees, in violation hereof; iii)
the disclosed Confidential Information was rightfully known by the Receiving
Party (as shown by its written records) prior to the date of disclosure to the
Receiving Party in connection with this Agreement; or iv) the disclosed
Confidential Information was received by the Receiving Party on an unrestricted
basis from a source which is not under a duty of confidentiality to the other
Party.
Section 8.3. Disclosure Required by Law. In the event that the Receiving
Party shall be required to make disclosure pursuant to the provisions of Section
8.2 (i) as a result of the issuance of a court order or other government
process, the Receiving Party shall promptly, but in no event more than
forty-eight (48) hours after learning of such court order or other government
process, notify, by personal delivery or facsimile, all pursuant to Section 9.4
hereof, the Disclosing Party and, at the Disclosing Party's expense, the
Receiving Party shall: a) take all reasonably necessary steps requested by the
Disclosing Party to defend against the enforcement of such court order or other
government process, and b) permit the Disclosing Party to intervene and
participate with counsel of its choice in any proceeding relating to the
enforcement thereof.
Section 8.4. Equitable Remedies for Breach of Confidentiality. The parties
acknowledge that their failure to comply with the provisions of Section 8.1 may
cause irreparable harm and damage to the name and reputation of the other party
for which no adequate remedy may be available at law. Accordingly, the parties
agree that upon a breach by a party of such provisions, the non-breaching party
may, at its option, enforce the obligations of the breaching party under those
provisions by seeking equitable remedies in a court of competent jurisdiction.
9
ARTICLE IX
MISCELLANEOUS
Section 9.1. Force Majeure. Neither of the parties to this Agreement shall
be liable to the other party for any loss, injury, delay, damage or other
casualty suffered or incurred by such other party due to strikes, lockouts,
accidents, fire, delays in manufacture, transportation or delivery of material,
embargoes, inability to ship, explosions, floods, war, governmental action or
any other cause similar thereto which is beyond the reasonable control of such
other party and any failure or delay by a party in the performance of any of its
obligations under this Agreement shall not be considered a breach of this
Agreement due to, but only so long as there exists, one or more of the foregoing
causes; provided, however, that if Akorn cannot complete a Processing Run within
ninety (90) days of the stated completion date due to any such cause, NeoPharm
may cancel the order without liability to Akorn.
Section 9.2. Status of the Parties. This Agreement shall not be construed
to create between the parties hereto or their respective successors or permitted
assignees the relationship of principal and agent, joint venturers, copartners
or any other similar relationship, the existence of which is hereby expressly
denied by each party. Neither party shall be liable to any third party in any
way for engagement, obligation, contract, representation or transaction or for
any negligent act or omission to act of the other except as expressly provided.
Section 9.3. Governing Law. The provisions of this Agreement shall be
governed in all respects by the laws of the State of Illinois.
Section 9.4. Notice. All notices, proposals, submissions, offers,
approvals, agreements, elections, consents, acceptances, waivers, reports,
plans, requests, instructions and other communications required or permitted to
be made or given hereunder (all of the foregoing hereinafter collectively
referred to as "Communications") shall be in writing and shall be deemed to have
been duly made or given when: a) delivered personally with receipt acknowledged;
b) sent by registered or certified mail or equivalent, return receipt requested;
c) sent by facsimile, cable or telex (which shall promptly be confirmed by a
writing sent by registered or certified mail or equivalent, return receipt
requested); or d) sent by recognized overnight courier for delivery within
twenty-four (24) hours, in each case addressed or sent to the parties at the
following addresses and facsimile numbers or to such other or additional address
or facsimile as any party shall hereafter specify by Communication to the other
parties:
To Akorn: Akorn, Inc.
2500 Millbrook Drive
Buffalo Grove, Illinois 60089-4694
Facsimile No. (847) 279-6123
Attn: Antonio Pera
With a Copy to: Tressler, Soderstrom, Maloney & Priess
2100 Manchester Road, Suite 950
10
Wheaton, Illinois 60187
Facsimile No.: (630) 668-3003
Attn: William A. Kindorf, III
To NeoPharm: Neopharm, Inc.
150 Field Drive, Illinois 60045
Facsimile No.: (847) 295-8854
Attn: James Hussey
With a Copy to: Ross & Hardies
150 North Michigan Avenue
Chicago, Illinois 60601-7567
Facsimile No.: (312) 750-8600
Attn: Scott Becker
Notice of change of address shall be deemed given when actually received, all
other Communications shall be deemed to have been given, received and dated on
the earlier of: (i) when actually received or on the date when delivered
personally; (ii) one (1) day after being sent by facsimile, cable, telex (each
promptly confirmed by a writing as aforesaid) or overnight courier; or (iii)
four (4) business days after mailing (except that in the case of any
communication given to a person with an address outside the United States, then
ten (10) business days after mailing).
Section 9.5. Legal Construction. In case any one or more of the provisions
contained in this Agreement shall be invalid or unenforceable in any respect,
the validity and enforceability of the remaining provisions contained herein
shall not in any way be affected or impaired thereby, and the parties will
attempt to agree upon a valid and enforceable provision which shall be a
reasonable substitute for such invalid and unenforceable provision in light of
the tenor of this Agreement, and, upon so agreeing, shall incorporate such
substitute provision in this Agreement.
Section 9.6. Entire Agreement, Modifications, Consents, Waivers. This
Agreement, together with the Schedules hereto, contains the entire agreement of
the parties with respect to the subject matter hereof. This Agreement may not be
modified or amended except by an instrument or instruments in writing signed by
the party against whom enforcement of any such modification or amendment is
sought. Each party hereto may, by an instrument in writing, waive compliance by
the other party hereto with any term or provision of this Agreement to be
performed or complied with by such other party. The waiver by either party
hereto of a breach of any term or provision of this Agreement shall not be
construed as a waiver of any subsequent breach. Neither anything in this
Agreement nor the execution or performance hereof shall be deemed to prejudice
in any way, and each party hereto expressly reserves, any and all rights,
remedies and claims which each party may now or hereafter have against or with
respect to the other party or any of such other party's Affiliates, relating to
any matter which is not expressly covered by this Agreement.
11
Section 9.7. Section Headings; Construction. The section headings and
titles contained herein are each for reference only and shall not be deemed to
affect the meaning or interpretation of this agreement. The words "hereby",
"herein", "herein above", "hereinafter", "hereof" and "hereunder", when used
anywhere in this Agreement, refer to this Agreement as a whole and not merely to
a subdivision in which such words appear, unless the context otherwise requires.
The singular shall include the plural, the conjunctive shall include the
disjunctive and the masculine gender shall include the feminine and neuter, and
vice versa, unless the context otherwise requires.
Section 9.8. Execution Counterparts. This Agreement may be executed in any
number of counterparts and each such duplicate counterpart shall constitute an
original, any one of which may be introduced in evidence or used for any other
purpose without the production of its duplicate counterpart. Moreover,
notwithstanding that any of the parties did not execute the same counterpart,
each counterpart shall be deemed for all purposes to be an original, and all
such counterparts shall constitute one and the same instrument, binding on all
of the parties hereto.
Section 9.9. Binding Effect, Assignment. Neither party may directly or
indirectly assign, delegate, encumber or in any other manner transfer any of its
rights, remedies, obligations, liabilities or interests in or arising under this
Agreement, without the prior consent of the other party, which consent shall not
be unreasonably withheld or delayed. Any attempted assignment, delegation,
encumbrance or other transfer in violation of this Agreement shall be void and
of no effect and shall be a material breach hereof. In the event Akorn sells the
Facility to a third party, Akorn agrees that it shall cause such third party to
agree in writing to assume Akorn's responsibilities hereunder.
* * * * * * * *
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed
as of the day and year first written above.
AKORN, INC. NEOPHARM, INC.
By:_________________________ By:______________________________
Its:________________________ Its:_____________________________
12
Schedule 2.1
Processing Parameters
Schedule 4.1
Processing Fee
Exhibit 10.19
20095718.3
12-07-01
SUBORDINATION, STANDBY AND INTERCREDITOR AGREEMENT
WHEREAS, AKORN, INC., a Louisiana corporation (hereinafter, together with
its successors and assigns, called "Akorn"), and AKORN (NEW JERSEY), INC., an
Illinois corporation ("Akorn NJ"; together with Akorn, the "Borrowers" and each
individually a "Borrower") may from time to time hereafter become indebted to
the undersigned NEOPHARM, INC., a Delaware corporation (the "Junior Lender"),
including, without limitation, indebtedness under the Promissory Note referred
to below, and the Borrowers have requested, and may from time to time hereafter
request, THE NORTHERN TRUST COMPANY, an Illinois banking corporation
(hereinafter, together with its successors and assigns, called the "Bank"), 50
South LaSalle Street, Chicago, Illinois 60675, to make or agree to make loans,
advances or other financial accommodations to the Borrowers pursuant to the
terms of the Credit Agreement (as hereinafter defined); and
WHEREAS, the Borrowers and the Bank are party to that certain Amended and
Restated Credit Agreement dated as of September 15, 1999 (as amended, restated
or supplemented from time to time, the "Credit Agreement"; capitalized terms not
otherwise defined herein shall have the same meanings herein as in the Credit
Agreement); and
WHEREAS, Akorn intends to incur an indebtedness to the Junior Lender in
the principal amount of $3,250,000 pursuant to a Promissory Note (the
"Subordinated Note"), in the form attached hereto as Schedule A; and
WHEREAS, the Junior Lender is a customer of Akorn and as such will benefit
from the continued making of loans, advances and other financial accommodations
from the Bank to the Borrowers;
NOW, THEREFORE, to induce the Bank, from time to time, at its option, to
make or agree to make loans, advances or other financial accommodations
(including, without limitation, renewals or extensions of, or forbearances with
respect to, any loans or advances heretofore or hereafter made) to Borrowers,
and for other valuable consideration, receipt whereof is hereby acknowledged,
the Junior Lender agrees as follows:
1. All obligations of each of the Borrowers, howsoever created, arising or
evidenced, whether direct or indirect, absolute or contingent or now or
hereafter existing, or due or to become due, are hereinafter called
"Liabilities". All Liabilities to the Bank (other than any arising solely by
reason of any pledge or assignment made to the Bank pursuant to paragraph 2(c)
hereof) are hereinafter called "Senior Liabilities"; and all Liabilities to the
Junior Lender, including under the Subordinated Note (including any that may be
pledged or assigned to the Bank pursuant to paragraph 2(c) hereof), other than
trade payables arising in the usual and ordinary course of business between the
Borrowers and the Junior Lender, are hereinafter called "Junior Liabilities"; it
being expressly understood and agreed that
the term "Senior Liabilities", as used herein, shall include, without
limitation, any and all interest accruing on any of the Senior Liabilities after
the commencement of any proceedings referred to in paragraph 4 hereof,
notwithstanding any provision or rule of law which might restrict the rights of
the Bank, as against the Borrowers or anyone else, to collect such interest.
2. The Junior Lender will, from time to time, (a) promptly notify the Bank
of the creation of any Junior Liabilities, and of the issuance of any promissory
note or other instrument to evidence any Junior Liabilities, (b) upon request by
the Bank, cause any Junior Liabilities which are not evidenced by a promissory
note or other instrument of either of the Borrowers to be so evidenced, and (c)
if an event of default on any of the Senior Liabilities has occurred and is
continuing beyond any applicable grace period, and if there is no written
forbearance agreement in effect between Akorn and the Bank relating to such
event of default, upon request by the Bank, and as collateral security for all
Senior Liabilities, indorse without recourse, deliver and pledge to the Bank any
or all promissory notes or other instruments evidencing Junior Liabilities, and
otherwise assign to the Bank any or all Junior Liabilities and any or all
security therefor and guaranties thereof, all in a manner satisfactory to the
Bank.
3. Except as the Bank may hereafter otherwise expressly consent in
writing, which consent may be given or withheld by the Bank in its sole and
absolute discretion, the payment of all Junior Liabilities shall be postponed
and subordinated to the payment in full of all Senior Liabilities, and no
payments or other distributions whatsoever in respect of any Junior Liabilities
shall be made by either of the Borrowers, or accepted by the Junior Lender, nor
shall any property or assets of either of the Borrowers be applied by them, or
accepted by the Junior Lender, to or for the purchase or other acquisition or
retirement of any Junior Liabilities.
4. In the event of any dissolution, winding up, liquidation, readjustment,
reorganization or other similar proceedings relating to any Borrower or its
creditors, as such, or to their property (whether voluntary or involuntary,
partial or complete, and whether in bankruptcy, insolvency or receivership, or
upon an assignment for the benefit of creditors, or any other marshalling of the
assets and liabilities of any Borrower, or any sale of all or substantially all
of the assets of any Borrower, or otherwise), the Senior Liabilities shall first
be paid in full before the Junior Lender shall be entitled to receive and to
retain any payment or distribution in respect of the Junior Liabilities, and, in
order to implement the foregoing, (a) all payments and distributions of any kind
or character in respect of the Junior Liabilities to which the Junior Lender
would be entitled if the Junior Liabilities were not subordinated, or
subordinated and pledged or assigned, pursuant to this Agreement shall be made
directly to the Bank, (b) the Junior Lender shall promptly file a claim or
claims, in the form required in such proceedings, for the full outstanding
amount of the Junior Liabilities, and shall cause said claim or claims to be
approved and all payments and other distributions in respect thereof to be made
directly to the Bank, and (c) the Junior Lender hereby irrevocably agrees that
the Bank may, at its sole discretion, in the name of the Junior Lender or
otherwise, demand, sue for, collect, receive and receipt for any and all such
payments
- 2 -
or distributions, and file, prove, and vote or consent in any such proceedings
with respect to, any and all claims of the Junior Lender relating to the Junior
Liabilities.
5. In the event that the Junior Lender receives any payment or other
distribution of any kind or character from any Borrower or from any other source
whatsoever in respect of any of the Junior Liabilities, other than as expressly
permitted by the terms of this Agreement, such payment or other distribution
shall be received in trust for the Bank and promptly turned over by the Junior
Lender to the Bank. The Junior Lender will mark its books and records, and cause
the applicable Borrower to mark its books and records, so as to clearly indicate
that the Junior Liabilities are subordinated in accordance with the terms of
this Agreement, and will cause to be clearly inserted in any promissory note or
other instrument which at any time evidences any of the Junior Liabilities a
statement to the effect that the payment thereof is subordinated in accordance
with the terms of this Agreement. The Junior Lender will execute such further
documents or instruments and take such further action as the Bank may reasonably
from time to time request to carry out the intent of this Agreement.
6. All payments and distributions received by the Bank in respect of the
Junior Liabilities, to the extent received in or converted into cash, may be
applied by the Bank first to the payment of any and all expenses (including
attorneys fees and legal expenses) paid or incurred by the Bank in enforcing
this Agreement or in endeavoring to collect or realize upon any of the Junior
Liabilities or any security therefor, and any balance thereof shall, solely as
between the Junior Lender and the Bank, be applied by the Bank, in such order of
application as the Bank may from time to time select, toward the payment of the
Senior Liabilities remaining unpaid; but, as between any Borrower and its
respective creditors, no such payments or distributions of any kind or character
shall be deemed to be payments or distributions in respect of the Senior
Liabilities; and, notwithstanding any such payments or distributions received by
the Bank in respect of the Junior Liabilities and so applied by the Bank toward
the payment of the Senior Liabilities, the Junior Lender shall be subrogated to
the then existing rights of the Bank, if any, in respect of the Senior
Liabilities only at such time as this Agreement shall have been discontinued and
the Bank shall have received payment of the full amount of the Senior
Liabilities, as provided for in paragraph 11 hereof.
7. Notwithstanding anything to the contrary contained in the Subordinated
Note, until such time as this Agreement shall have been discontinued and the
Bank shall have received payment of the full amount of the Senior Liabilities,
as provided for in paragraph 11 hereof, no action or inaction by either of the
Borrowers shall be deemed to be in violation of the provisions contained in
Article 5 of the Subordinate Note if such action or inaction either (i) is not
in violation of any of the provisions of the Credit Agreement, or (ii) has been
consented to in writing by the Bank.
8. The Junior Lender hereby waives: (a) notice of acceptance by the Bank
of this Agreement; (b) notice of the existence or creation or non-payment of all
or any of the Senior Liabilities; and (c) all
- 3 -
diligence in collection or protection of or realization upon the Senior
Liabilities or any thereof or any security therefor.
9. The Junior Lender will not without the prior written consent of the
Bank: (a) cancel, waive, forgive, transfer or assign, or attempt to enforce or
collect, or subordinate to any Liabilities other than the Senior Liabilities,
any Junior Liabilities or any rights in respect thereof; (b) take any collateral
security for any Junior Liabilities; or (c) commence, or join with any other
creditor in commencing, any bankruptcy, reorganization or insolvency proceedings
with respect to any Borrower.
10. This Agreement shall in all respects be a continuing agreement and
shall remain in full force and effect (notwithstanding, without limitation, the
dissolution of the Junior Lender or that at any time or from time to time all
Senior Liabilities may have been paid in full), subject to discontinuance only
upon receipt by the Bank of payment in full of all Senior Liabilities and
termination of any and all commitments by the Bank to extend credit to either of
the Borrowers.
11. The Bank may, from time to time, whether before or after any
discontinuance of this Agreement, at its sole discretion and without notice to
the Junior Lender, take any or all of the following actions: (a) retain or
obtain a security interest in any property to secure any of the Senior
Liabilities, (b) retain or obtain the primary or secondary obligation of any
other obligor or obligors with respect to any of the Senior Liabilities, (c)
extend or renew or forbear for one or more periods (whether or not longer than
the original period), alter or exchange any of the Senior Liabilities, or
release or compromise any obligation of any nature of any obligor with respect
to any of the Senior Liabilities, and (d) release its security interest in, or
surrender, release or permit any substitution or exchange for, all or any part
of any property securing any of the Senior Liabilities, or extend or renew or
forbear for one or more periods (whether or not longer than the original period)
or release, compromise, alter or exchange any obligations of any nature of any
obligor with respect to any such property.
12. The Bank may, from time to time, whether before or after any
discontinuance of this Agreement, without notice to the Junior Lender, assign or
transfer any or all of the Senior Liabilities or any interest therein; and,
notwithstanding any such assignment or transfer or any subsequent assignment or
transfer thereof, such Senior Liabilities shall be and remain Senior Liabilities
for the purposes of this Agreement, and every immediate and successive assignee
or transferee of any of the Senior Liabilities or of any interest therein shall,
to the extent of the interest of such assignee or transferee in the Senior
Liabilities, be entitled to the benefits of this Agreement to the same extent as
if such assignee or transferee were the Bank; provided, however, that, unless
the Bank shall otherwise consent in writing, the Bank shall have an unimpaired
right, prior and superior to that of any such assignee or transferee, to enforce
this Agreement, for the benefit of the Bank, as to those of the Senior
Liabilities which the Bank has not assigned or transferred.
- 4 -
13. The Bank shall not be prejudiced in its rights under this Agreement by
any act or failure to act of any Borrower or the Junior Lender, or any
noncompliance of any Borrower or the Junior Lender with any agreement or
obligation, regardless of any knowledge thereof which the Bank may have or with
which the Bank may be charged; and no action of the Bank permitted hereunder
shall in any way affect or impair the rights of the Bank and the obligations of
the Junior Lender under this Agreement.
14. No delay on the part of the Bank in the exercise of any right or
remedy shall operate as a waiver thereof, and no single or partial exercise by
the Bank of any right or remedy shall preclude other or further exercise thereof
or the exercise of any other right or remedy; nor shall any modification or
waiver of any of the provisions of this Agreement be binding upon the Bank
except as expressly set forth in a writing duly signed and delivered on behalf
of the Bank. For the purposes of this Agreement, Senior Liabilities shall
include all obligations of each of the Borrowers to the Bank, notwithstanding
any right or power of either Borrower or anyone else to assert any claim or
defense as to the invalidity or unenforceability of any such obligation, and no
such claim or defense shall affect or impair the agreements and obligations of
the Junior Lender hereunder.
15. This Agreement shall be binding upon the Junior Lender and upon the
heirs, legal representatives, successors and assigns of the Junior Lender; and,
to the extent that either Borrower or the Junior Lender is either a partnership
or a corporation, all references herein to such Borrower and to the Junior
Lender, respectively, shall be deemed to include any successor or successors,
whether immediate or remote, to such partnership or corporation. If more than
one party shall execute this Agreement, the term "undersigned" as used herein
shall mean all parties executing this Agreement and each of them, and all such
parties shall be jointly and severally obligated hereunder.
16. This Agreement shall be construed in accordance with and governed by
the laws of the State of Illinois. Wherever possible each provision of this
Agreement shall be interpreted in such manner as to be effective and valid under
applicable law, but if any provision of this Agreement shall be prohibited by or
invalid under such law, such provision shall be ineffective to the extent of
such prohibition or invalidity, without invalidating the remainder of such
provision or the remaining provisions of this Agreement.
17. THE JUNIOR LENDER HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT
PERMITTED BY LAW, ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING
ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED
HEREBY. THE JUNIOR LENDER HEREBY ABSOLUTELY AND IRREVOCABLY CONSENTS AND SUBMITS
TO THE JURISDICTION OF THE COURTS OF THE STATE OF ILLINOIS HAVING SITUS IN COOK
COUNTY, ILLINOIS OR THE UNITED STATES OF AMERICA FOR THE NORTHERN DISTRICT OF
ILLINOIS IN CONNECTION WITH ANY SUITS, ACTIONS OR PROCEEDINGS BROUGHT AGAINST
THE JUNIOR LENDER BY THE BANK ARISING OUT OF OR RELATING TO
- 5 -
THIS AGREEMENT, AND IRREVOCABLY AGREES THAT ALL CLAIMS IN RESPECT OF ANY SUCH
SUIT, ACTION OR PROCEEDING MAY BE HEARD AND DETERMINED IN ANY SUCH COURT. THE
JUNIOR LENDER HEREBY WAIVES AND AGREES NOT TO ASSERT IN SUCH SUIT, ACTION OR
PROCEEDING, IN EACH CASE, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY
CLAIM THAT (A) THE JUNIOR LENDER IS NOT PERSONALLY SUBJECT TO THE JURISDICTION
OF ANY SUCH COURT; (B) THE JUNIOR LENDER IS IMMUNE FROM SUIT OR ANY LEGAL
PROCESS (WHETHER THROUGH SERVICE OR NOTICE, ATTACHMENT PRIOR TO JUDGMENT,
ATTACHMENT IN AID OF EXECUTION, EXECUTION OR OTHERWISE) WITH RESPECT TO IT OR
ITS PROPERTY; (C) ANY SUCH SUIT, ACTION OR PROCEEDING IS BROUGHT IN AN
INCONVENIENT FORUM; (D) THE VENUE OF ANY SUCH SUIT, ACTION OR PROCEEDING IS
IMPROPER; OR (E) THIS AGREEMENT MAY NOT BE ENFORCED IN OR BY ANY SUCH COURT.
NOTHING CONTAINED HEREIN SHALL AFFECT ANY RIGHT THAT THE BANK MAY HAVE TO BRING
ANY SUIT, ACTION OR PROCEEDING RELATING TO THIS AGREEMENT AGAINST THE JUNIOR
LENDER OR ITS PROPERTY IN THE COURTS OF ANY OTHER JURISDICTION.
[SIGNATURE PAGE(S) AND EXHIBIT(S),
IF ANY, FOLLOW THIS PAGE]
- 6 -
IN WITNESS WHEREOF, this Agreement has been made and delivered at Chicago,
Illinois as of the_________day of December, 2001.
The Borrowers each hereby acknowledge receipt of a copy of the foregoing
Subordination, Standby and Intercreditor Agreement, waive notice of acceptance
thereof by the Bank, and agree to be bound by the terms and provisions thereof,
to make no payments or distributions contrary to the terms and provisions
thereof, and to do every other act and thing necessary or appropriate to carry
out such terms and provisions. In the event of any violation of any of the terms
and provisions of the foregoing Subordination and Standby Agreement, then, at
the election of the Bank, any and all obligations of each of the Borrowers to
the Bank shall forthwith become due and payable and any and all agreements of
the Bank to make loans, advances or other financial accommodations to the
Borrowers, or to forbear from exercising remedies, shall forthwith terminate,
notwithstanding any provisions thereof to the contrary.
Dated as of December______, 2001 AKORN, INC.
By_______________________________________
Name:
Title:
Dated as of December______, 2001 AKORN (NEW JERSEY), INC.
By_______________________________________
Name:
Title:
- 8 -
SCHEDULE A
PROMISSORY NOTE
Exhibit 10.20
SUBORDINATION AND INTERCREDITOR AGREEMENT
THIS SUBORDINATION AND INTERCREDITOR AGREEMENT (this "Agreement") is
made and entered into as of this 20th day of December, 2001, by John N. Kapoor,
as Trustee under THE JOHN N. KAPOOR TRUST, dated September 20, 1989 (the "Junior
Party") and NEOPHARM, INC., a Delaware corporation (the "Lender").
R E C I T A L S:
A. The Lender and Akorn, Inc., a Louisiana corporation (the
"Borrower"), have entered into that certain Processing Agreement, of even date
herewith (the "Processing Agreement"), and, in connection therewith, Borrower
executed and delivered that certain Promissory Note, of even date herewith (the
"Promissory Note"), evidencing a loan made by Lender to Borrower, as of the date
hereof, in aggregate principal amount of THREE MILLION TWO HUNDRED FIFTY
THOUSAND DOLLARS (US$3,250,000.00), plus accrued but unpaid interest (the
"Lender Debt").
B. On July 13, 2001, the Borrower and the Junior Party entered
into that certain Convertible Bridge Loan and Warrant Agreement (the "Junior
Agreement"), pursuant to which the Junior Party made certain loans to Borrower
in aggregate principal amount of FIVE MILLION AND 00/100 DOLLARS
($5,000,000.00), plus accrued interest thereon (the aforementioned loans,
accrued interest thereon and any other loans made by the Junior Party to the
Borrower (excluding any consulting fee, chairman's fee and expense
reimbursement, whether or not deferred, owed by Borrower to the Junior Party or
any entity controlled by the Junior Party), presently outstanding or made in the
future, to be collectively referred to as the "Junior Debt"). In connection with
the consummation of the Junior Agreement, the Junior Party entered into a
Subordination Agreement, of even date therewith, whereby the Junior Party agreed
to subordinate the Junior Debt to all outstanding debt owed by Borrower to The
Northern Trust Company ("Northern Trust"), Borrower's senior lender, under the
terms of an Amended and Restated Credit Agreement, as most recently amended by
that certain Forbearance Agreement, dated July 13, 2001, by and among Northern
Trust, the Borrower and the Borrower's wholly-owned subsidiary, Akorn (New
Jersey), Inc, an Illinois corporation.
C. Lender was unwilling to enter into the Processing Agreement or
provide Borrower with the Lender Debt unless the Junior Party entered into this
Subordination and Intercreditor Agreement.
NOW, THEREFORE, for good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, it is hereby agreed as follows:
1. Recitals. The Recitals of this Agreement are incorporated
herein and made a part hereof by this reference thereto.
2. Junior Debt Subordinate to Lender Debt. The Junior Debt is
hereby, and shall continue to be, subject and subordinate in lien and in payment
to the lien and payment of the Lender Debt and any other document evidencing,
securing or guaranteeing the Lender Debt without regard to the application of
such proceeds together with all interest, late fees, default interest, future
principal advances and all other sums due under the Promissory Note. The
foregoing shall apply notwithstanding the actual date and time of execution,
delivery, recordation, filing or perfection of the Lender Debt or the Junior
Debt, or the lien or priority of payment thereof.
Until all Lender Debt shall have been paid in full, the Junior Party
shall not, directly or indirectly, demand or accept from the Borrower nor cancel
or otherwise discharge all or any part of the Junior Debt, and the Junior Party
shall not otherwise take or permit any action prejudicial to or inconsistent
with the Lender's priority position over the Junior Party created by this
Agreement. Excluded from the provisions of this paragraph 2 are the conversion
rights under the Junior Debt of principal and interest to an equity interest in
Borrower.
3. Allocation of Collateral During Bankruptcy, Etc. In the event
of (a) any proceeding under the Bankruptcy Code or other applicable federal or
state insolvency law relative to the Borrower, or (b) any liquidation,
dissolution or other winding up of the Borrower, whether voluntary or
involuntary and whether or not involving insolvency or bankruptcy, or (c) any
assignment for the benefit of creditors or any other marshaling of assets and
liabilities of the Borrower, then and in any such event, the Lender shall be
entitled to receive payment in full in cash of all amounts due or to become due
on or in respect of the Lender Debt, and to that end the Lender shall be
entitled to receive as collateral therefor, any payment or distribution of any
kind or character, whether in cash, property or securities which may be payable
or deliverable to the Junior Party in such proceeding, dissolution, liquidation
or other winding up or event until the Lender Debt is fully repaid and
discharged.
In the event that, notwithstanding the foregoing provisions of this
Section 3, the Junior Party shall have received any cash or assets of any kind
from Borrower as payment for the Junior Debt or to secure, guarantee or
discharge all or any part of the Junior Debt before all Lender Debt is paid in
full, then and in such event such cash or assets shall be delivered forthwith to
the Lender or, if required by law, the trustee in bankruptcy, receiver,
custodian, assignee, agent or other person making payment or distribution of
assets of the Borrower as collateral for the Lender Debt remaining unpaid, to
the extent necessary to pay all the Lender Debt in full, after giving effect to
any concurrent payment or distribution to or for the Lender.
4. Certain Matters Relating to Bankruptcy. The Junior Party
hereby waives any objection it may have to the use of cash collateral or the
financing of the Borrower pursuant to either Section 363 or Section 364,
including, without limitation, Section 364(d), of the Bankruptcy Code. Notice of
a proposed financing or use of cash collateral shall be deemed given upon the
sending of such notice by telegraph, telecopy or hand delivery to the Junior
Party at address indicated on the signature page attached hereto. All
allocations of payments between the Lender and the Junior Party, subject to any
court order, continue to be made after the filing of a petition under the
Bankruptcy Code on the same basis that the payments were to be allocated prior
to the date of such filing. To the extent that the Lender receives payments on
the Lender Debt which are subsequently invalidated, declared to be fraudulent or
preferential, set aside and/or required to be repaid to a trustee, receiver or
any other party under any bankruptcy law, state or federal law, common law, or
equitable cause, then, to the extent of such payment or proceeds received, the
Lender Debt, or part thereof, intended to be satisfied shall be reinstated and
continue in full force and effect as if such payments or proceeds had not been
received by the Lender.
2
5. Continuing Nature of Subordination. This Agreement shall be
effective and may not be terminated or otherwise revoked by the Junior Party
until the Lender Debt shall have been fully repaid and discharged and all
financing arrangements between the Borrower and the Lender under the Promissory
Note as amended from time to time, have been terminated. If the Junior Party
shall have any right under applicable law to terminate or revoke this Agreement
which right cannot be waived, such termination or revocation shall not be
effective until written notice of such termination or revocation, signed by the
Junior Party, is delivered to the Lender pursuant to the provisions of Section
10, provided, however, that no such notice of termination or revocation shall
affect or impair any of the agreements and obligations of the Junior Party
hereunder with respect to any and all Lender Debt existing prior to the time of
receipt of such notice by the Lender, any and all Lender Debt created or
acquired thereafter pursuant to any previous commitments made by the Lender
under the Promissory Note, any and all extensions or renewals of any of the
foregoing, any and all interest accruing on any of the foregoing, and any and
all expenses paid or incurred by the Lender in endeavoring to collect or realize
upon any of the foregoing; and all of the agreements and obligations of the
Junior Party under this Agreement shall, notwithstanding any such notice of
termination or revocation, remain fully in effect until such Lender Debt
(including any extensions or renewals thereof and all such interest and
expenses) shall have been paid in full.
The Junior Party agrees that the Lender shall be entitled to manage
and supervise the Lender's loans to the Borrower in accordance with applicable
law, the terms of the Promissory Note and the Lender's usual practices, modified
from time to time as the Lender deems appropriate under the circumstances,
without regard to the existence of any rights that the Junior Party may now or
hereafter have and that the Lender shall have no liability to the Junior Party
for, and Junior Party hereby waives any claim which the Junior Party may now or
hereafter have against, the Lender arising out of any and all actions which the
Lender, in good faith, takes or omits to take with respect to the Promissory
Note or any other agreement related thereto or to the collection of the Lender
Debt.
6. Information Concerning Financial Condition of the Borrower.
The Junior Party hereby assumes responsibility for keeping itself informed of
the financial condition of Borrower and of all other circumstances bearing upon
the risk of nonpayment of the Lender Debt that diligent inquiry would reveal,
and the Junior Party hereby agrees that the Lender shall have no duty to advise
the Junior Party of information known to the Lender regarding such condition or
any such circumstances except as set forth below.
7. Assignment; Refinancing. The Junior Agreement and the rights
and obligations therein may be sold, assigned or transferred by the Junior Party
to an entity controlled by the Junior Party, to members of the immediate family
of the Junior Party, or to trusts, partnerships, S-corporations or other
beneficiaries of the Junior Party. In the event of such transfer, the assignee
shall become subject to the terms of this Agreement. Except for such transfers
described above, the Junior Party shall not sell, assign or otherwise transfer
any interest in the Junior Agreement without the prior written consent of the
Lender, which consent shall not be unreasonably withheld.
8. Covenants and Assurances. The Junior Party shall (a) provide
the Lender with a copy of any and all notices of default, event of default or
acceleration which the Junior Party gives Borrower under or in connection with
the Junior Agreement or Junior Debt, which notices to the Lender shall be given
at the same time as the Junior Party gives such notices to the
3
Borrower, and (b) upon the request of Lender, execute and deliver to the Lender
such other documents and assurances and do or cause to be done all such other
acts and things as may be reasonably required by the Lender in order to give
effect to this Agreement.
The Lender shall provide the Junior Party with a copy of any and all
notices of default, events of default or acceleration which the Lender gives
Borrower under or in connection with the Lender Debt, which notices to the
Junior Party shall be given at the same time Lender gives such notices to the
Borrower.
9. Waivers, Etc. No delay on the part of the Lender in its
respective exercise of any right or remedy shall operate as a waiver thereof,
and no single or partial exercise by the Lender of any right or remedy shall
preclude other or further exercise thereof or the exercise of any other right or
remedy; nor shall any modification or waiver of any of the provisions of this
Agreement be binding upon the Lender or Junior Party except as expressly set
forth in a writing duly signed and delivered on behalf of the Lender.
10. Notices. Any notice or other communication to any party in
connection with this Agreement shall be in writing and shall be sent by manual
delivery, facsimile transmission, overnight courier or United States mail
certified mail, return receipt requested (postage prepaid) addressed to such
party at the address specified on the signature page hereof, or at such other
address as such party shall have specified to the other party hereto in writing.
All periods of notice shall be measured from the date of delivery thereof if
manually delivered, from the date of sending thereof if sent by facsimile
transmission, from the first business day after the date of sending if sent by
overnight courier, or from four days after the date of mailing if mailed;
provided, however, that any notice to the Lender shall be deemed to have been
given only when received by the Lender.
11. Governing Law and Construction. The validity, construction and
enforceability of this Agreement shall be governed by the internal laws of the
State of Illinois, without giving effect to conflict of laws principles thereof.
12. Consent to Jurisdiction. AT THE OPTION OF THE LENDER, THIS
AGREEMENT MAY BE ENFORCED IN ANY FEDERAL COURT OR ILLINOIS STATE COURT SITTING
IN COOK COUNTY, ILLINOIS; AND THE BORROWER AND JUNIOR PARTY EACH CONSENT TO THE
JURISDICTION AND VENUE OF ANY SUCH COURT AND WAIVE ANY ARGUMENT THAT VENUE IN
SUCH FORUMS IS NOT CONVENIENT. IN THE EVENT THE BORROWER OR JUNIOR PARTY
COMMENCE ANY ACTION IN ANOTHER JURISDICTION OR VENUE UNDER ANY TORT OR CONTRACT
THEORY ARISING DIRECTLY OR INDIRECTLY FROM THE RELATIONSHIP CREATED BY THIS
AGREEMENT, THE LENDER AT ITS OPTION SHALL BE ENTITLED TO HAVE THE CASE
TRANSFERRED TO ONE OF THE JURISDICTIONS AND VENUES ABOVE-DESCRIBED, OR IF SUCH
TRANSFER CANNOT BE ACCOMPLISHED UNDER APPLICABLE LAW, TO HAVE SUCH CASE
DISMISSED WITHOUT PREJUDICE.
13. Waiver of Jury Trial. BORROWER AND JUNIOR PARTY IRREVOCABLY
WAIVE ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF
OR RELATING TO THIS AGREEMENT AND ANY
4
OTHER LOAN DOCUMENTS OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THEREBY.
14. Successors and Assigns. This Agreement shall be binding upon
and inure to the benefit of the successors and assigns of Borrower, the Junior
Party and the Lender.
15. Multiple Counterparts. This Agreement may be executed in one
or more counterparts, each of which shall be deemed to be an original and all of
which shall constitute one and the same instrument.
5
IN WITNESS WHEREOF, the parties hereto have executed, or caused this
agreement to be executed by the respective officers thereunto duly authorized,
as of the day and year first above written.
John N. Kapoor, as Trustee under
THE JOHN N. KAPOOR TRUST,
Dated September 20, 1989
By: _______________________________
Its: _______________________________
Address: _______________________________
_______________________________
Fax No.: _______________________________
Attn: John Kapoor
NEOPHARM, INC., a Delaware corporation
By: _____________________________________
Its: President and Chief Executive Officer
Address: 150 Field Drive, Suite 195
Lake Forest, Illinois 60045
Attn: President and Chief Executive
Officer
Fax No.: (847) 295-8854
Address: Akorn, Inc.
2500 Millbrook Drive
Buffalo Grove, IL 60089-4694
Facsimile No. (847) 279-6123
Attn: Ben Pothast
6
Exhibit 10.21
December 10, 2001
To: Akorn, Inc.
Akorn (New Jersey), Inc.
Re: Proposed Loan from NeoPharm, Inc.
Gentlemen:
Reference is made to (i) the Forbearance Agreement dated as of July 12,
2001 (the "Forbearance Agreement"), by and among Akorn, Inc., a Louisiana
corporation, Akorn (New Jersey), Inc., an Illinois corporation, and The Northern
Trust Company, an Illinois banking corporation, and (ii) the "Credit Agreement"
(as defined in the Forbearance Agreement). All capitalized terms used and not
otherwise defined herein shall have the same meanings as in the Credit
Agreement.
You have advised us that the Borrowers propose to (i) obtain a loan from
NeoPharm, Inc., a Delaware corporation ("NeoPharm"), in the principal amount of
$3,250,000 (the "NeoPharm Loan"), pursuant to a Promissory Note in the form
attached hereto as Exhibit A (the "NeoPharm Note"), and (ii) expend the proceeds
of the NeoPharm Loan for the purpose of undertaking and completing the
"Lyophilization Ramp-Up" (as defined in the NeoPharm Note). The NeoPharm Loan
would be obtained, and the NeoPharm Note would be executed and delivered, in
connection with a Processing Agreement between Akorn and NeoPharm in the form
attached hereto as Exhibit B.
The act of Akorn in obtaining and becoming obligated for the NeoPharm Loan,
Akorn's execution and delivery of the NeoPharm Note, and Akorn's expenditures
for the Lyophilization Ramp-Up will or may constitute a violation of one or more
provisions of the Credit Agreement, and will or may cause one or more of the
Forbearance Conditions (as defined in the Forbearance Agreement) to fail to be
satisfied. You have requested that the Lender waive any such violation of the
provisions of the Credit Agreement and any such failure of one or more of such
Forbearance Conditions to be satisfied (the "Waiver").
The Lender hereby grants the Waiver, but only on and subject to the
following conditions:
(i) The NeoPharm Loan will be on the terms and conditions set forth
in the NeoPharm Note.
(ii) Contemporaneously with the execution and delivery of this letter
NeoPharm and the Borrowers enter into a Subordination, Standby
and Intercreditor Agreement with the Lender in the form attached
hereto as Exhibit C (the "NeoPharm Subordination Agreement").
(iii) The Waiver shall be in effect only so long as the NeoPharm
Subordination Agreement is in effect and there is no failure on the part of
NeoPharm or either of the Borrowers to be in compliance with all of the terms
and conditions of the NeoPharm Subordination Agreement.
(iv) The Waiver shall apply only to the specific matters referred to in
this letter and shall not extend or relate to any other related or unrelated
matters, and neither the granting of the Waiver nor anything contained in this
letter shall be construed to obligate the Lender to grant any other waivers to
the Borrowers.
(iv) The Borrowers hereby (A) confirm and reaffirm all of their
obligations under the "Documents" (as defined in the Forbearance Agreement) and
under the Forbearance Agreement; (B) acknowledge and agree that the Lender, by
granting the Waiver, does not waive any existing or future default or event of
default under any of the Documents or the Forbearance Agreement, or any rights
or remedies under any of the Documents or the Forbearance Agreement, except as
expressly provided herein; (C) acknowledge and agree that the Lender has not
heretofore waived any default or event of default under any of the Documents, or
any rights or remedies under any of the Documents, except as provided in the
Forbearance Agreement; and (D) acknowledge that they do not have any defense,
set-off or counterclaim to the payment or performance of any of their
obligations under the Documents or other Forbearance Agreement.
(v) The Borrowers shall expend the proceeds of the NeoPharm Loan solely to
pay or reimburse costs incurred in connection with the Lyophilization Ramp-Up,
and the Borrowers shall not expend any funds in excess of the proceeds of the
NeoPharm Loan on the Lyophilization Ramp-Up.
(vi) The Borrowers shall provide the Bank with reports no less often than
once during each of the periods ending on the 15th day and the last day of each
calendar month, commencing with the month of December, 2001, as to the progress
of Lyophilization Ramp-Up, including, without limitation, information concerning
the budget and time schedule and changes to the budget and time schedule for the
Lyophilization Ramp-Up, contracts and commitments entered into, and payments
made and scheduled to be made. To the extent that the Lyophilization Ramp-Up
involves payment for labor, materials or property the furnishing of which could
give rise to mechanics lien claims against the premises commonly known as 1222
West Grand, Decatur, Illinois, the Borrower shall make such payment only in
exchange for waivers and releases of such mechanics lien claims, and at the time
of making each such payment, the Borrowers shall furnish to the Bank a date down
endorsement to Chicago Title Insurance Company Policy No. 120090185 insuring the
Bank's mortgage on such property, covering the date of such payment and raising
no exception for mechanics lien claims.
-2-
If the foregoing terms are acceptable to you, please so indicate by signing
below.
Very truly yours,
THE NORTHERN TRUST COMPANY
/s/ Olga Georgiov
Olga Georgiov
Vice President
-3-
-4-
Exhibit 10.22
SUPPLY AGREEMENT
THIS SUPPLY AGREEMENT (the "Agreement") is entered into as of January 4,
2002, by and between AKORN, INC. a Louisiana corporation with its principal
offices at 2500 Millbrook Drive, Buffalo Grove, Illinois 60089 ("AKORN") and
NOVADAQ TECHNOLOGIES, INC., a Canadian corporation with its principal place of
business at 924 The East Mall, Suite 100, Toronto, Canada M9B 6K1 ("NOVADAQ").
AKORN and NOVADAQ may each be referred to herein individually as a "Party" and
collectively as the "Parties."
In consideration of the mutual premises, covenants and conditions contained in
this Agreement, the Parties agree as follows:
1. DEFINITIONS
As used in this Agreement, the following terms shall have the following
respective meanings:
"ACCEPTABLE PRODUCT" shall have the meaning set forth in Section 5.1
hereof.
"AFFILIATE" shall mean, in the case of either Party, any corporation,
joint venture, or other business entity, which directly or indirectly
controls, is controlled by, or is under common control with that Party.
"Control", as used in this definition, shall mean having the power to
direct, or cause the direction of, the management and policies of an
entity, whether through ownership of voting securities, by contract or
otherwise. Notwithstanding the foregoing, for purposes of this Agreement,
the term "Affiliate" shall not include subsidiaries in which a Party or
its Affiliates owns a majority of the ordinary voting power to elect a
majority of the board of directors but is restricted from electing such
majority by contract or otherwise, until such time as such restrictions
are no longer in effect.
"AKORN KNOW-HOW" shall mean all proprietary technical and clinical
information, data and know-how relating to the manufacture of the Product,
whether or not patentable, owned or controlled, as of the Effective Date
or acquired during the term of this Agreement, by AKORN or its Affiliates.
AKORN Know-How shall include, without limitation, all processes, formulas,
discoveries and inventions whether relating to biological, chemical,
pharmacological, toxicological, pharmaceutical, physical and analytical
safety or quality control data. The term "AKORN Know-How", however, shall
not include (i) any know-how, processes, information and data which is, as
of the Effective Date or later becomes, generally available to the public
or (ii) any general manufacturing know-how not specific to the Product.
"CALENDAR QUARTER" shall mean the respective periods of three (3)
consecutive calendar months ending on March 31, June 30, September 30 or
December 31, for so long as this Agreement is in effect.
"CERTIFICATE OF ANALYSIS" shall mean the certificate for each batch of
Product delivered hereunder in the form contemplated by Section 3.1 of
this Agreement.
"cGMP" shall mean current good manufacturing practices of the FDA,
including compliance with the FD&C Act, 21 C.F.R. parts 210 and 211 and
all applicable FDA rules, regulations, policies and guidelines in effect
at a given time.
"COMMERCIALLY REASONABLE EFFORTS" shall mean efforts and resources
normally used by a Party for a compound or product owned by it or to which
it has rights, which is of similar market potential at a similar stage in
its product life, taking into account the competitiveness of the
marketplace, the proprietary position of the compound or product, the
regulatory structure involved, the profitability of the applicable
products, and other relevant factors.
"DOLLARS" AND "$" shall mean lawful money of the United States unless
otherwise indicated.
"EFFECTIVE DATE" shall mean January 4, 2002.
"FDA" shall mean the United States Food and Drug Administration, and any
successor thereto.
"FD&C ACT" shall mean the United States Federal Food, Drug and Cosmetic
Act, as amended.
"HPB" shall mean the Health Protection Branch of Health Canada or any
successor or replacement entities thereof.
"GOVERNMENTAL BODY" shall mean (i) any domestic or foreign national,
federal, provincial, state, municipal or other government or body, (ii)
any international or multilateral body, (iii) any subdivision, ministry,
department, secretariat, bureau, agency, commission, board,
instrumentality or authority of any of the foregoing governments or
bodies, (iv) any quasi-governmental or private body exercising any
regulatory, expropriation or taxing authority under or for the account of
any of the foregoing governments or bodies, or (v) any domestic, foreign,
international, multilateral, or multinational judicial, quasi-judicial,
arbitration or administrative court, grand jury, tribunal, commission,
board or panel or other regulatory or governmental authority.
"ICG" shall mean indocyanine green complying with the specifications of
U.S. Pharmacopoeia 24 and FDA approved NDA.
"INDICATIONS" means NOVADAQ's use of ICG-C for angiography of arteries,
carotid arteries, intracranial vasculature, AV fistulas and the peripheral
vasculature, for the diagnosis and treatment of age-related macular
degeneration utilizing U.S. Patents #5,279,298 and #5,394,199 and all
corresponding foreign patents that are licensed by NOVADAQ from Johns
Hopkins University, or any other patents and technologies derived from the
foregoing patents, outside of the United States ("AMD"), and for such
other applications as may be mutually agreed to by the Parties.
"MATERIAL BREACH" means, in the case of AKORN, a breach of subsections
3(i), 3(ii), 3(iii) or 3(iv) of the Settlement and Mutual Release or any
failure by AKORN to supply, either directly or through Third Parties,
ICG-C in accordance with the terms and conditions of this Agreement,
including the specifications, where such failure shall continue for three
months and shall not be the result of a Material Breach of this Agreement
by NOVADAQ, or an event of force majeure as described in Section 12.1. In
2
the case of NOVADAQ, "Material Breach" means the failure to make payment
or a series of payments of a minimum value of $50,000 or more, subject to
the terms of paragraph 12.9 hereof;
"PERMITTED MANUFACTURERS" shall have the meaning set forth in Section 2.2
hereof.
"PRODUCT" or "ICG-C" shall mean a human pharmaceutical product, of which
ICG is the sole active ingredient, and which conforms to the
Specifications and which is used in accordance with, or for the purposes
of, the Regulatory Approvals.
"REGULATORY APPROVALS" shall mean all (i) authorizations by the
appropriate Regulatory Authorities which are required for the marketing,
promotion, pricing and sale of the Product in the Territory, and (ii) new
drug applications ("NDAs") for the use of the Product in the Territory, as
applicable, for the Indications.
"REGULATORY AUTHORITY" shall mean any national, supra-national, regional,
state or local regulatory agency, department, bureau, commission, council
or other governmental entity in the Territory involved in the granting of
Regulatory Approval for the Product, including, without limitation, the
FDA and the HPB.
"SETTLEMENT AND MUTUAL RELEASE" shall mean the Settlement and Mutual
Release between AKORN and NOVADAQ dated January 4, 2002.
"SPECIFICATIONS" shall mean the specifications for or concerning the
manufacturing, testing, packaging and shipping of the Product as set forth
in the Schedule A hereto, or as may be agreed upon by the Parties in
writing from time to time.
"STORAGE PROTOCOL" shall mean that procedure and protocol prepared by
AKORN for the storage of Product, as such procedures and protocols shall
be amended from time to time.
"TERM" shall have the meaning set forth in Section 10.1 hereof.
"TERRITORY" shall mean the world, except in the case of NOVADAQ's Use for
the treatment of AMD, "Territory" shall mean the world excluding the
United States of America.
"THIRD PARTY(IES)" shall mean any person(s) or party(ies) other than
AKORN, NOVADAQ or their respective Affiliates.
2. SUPPLY OF PRODUCT
2.1 OBLIGATION TO SUPPLY. Subject to the provisions of this Agreement,
after the Effective Date and during the Term of this Agreement,
AKORN shall manufacture, or contract with Third Parties to have
manufactured, exclusively for and supply to NOVADAQ, Product for use
by NOVADAQ, its Affiliates or its permitted sub-licensees in the
Territory, and NOVADAQ shall exclusively purchase from AKORN its
entire requirements of Product for use in the Territory, in each
case for the Indications now or hereafter subject to this Agreement.
Prior to the Effective Date, AKORN shall supply NOVADAQ's
requirements for ICG-C for all clinical and pre-clinical trials on
the same terms as provided herein. All Product supplied under this
Agreement is to be supplied in finished form, as specified in
NOVADAQ's purchase orders placed with AKORN pursuant to
3
Section 2.4 below. AKORN acknowledges NOVADAQ's ownership of all
rights in and to the Product and agrees not to sell or supply
Product to any Third Party without the express written consent of
NOVADAQ.
2.2 SUBCONTRACTING. For Product intended by NOVADAQ for sale in the
U.S., AKORN may subcontract or assign any part of its manufacturing
and supply obligations hereunder to any facility approved by FDA for
the manufacture of the Product, provided, however, that AKORN shall
notify NOVADAQ prior to transferring any manufacturing and supply
obligations to a subcontractor or assignee other than SP
Pharmaceutical, Inc. 4272 Ballon Park Road, Albuquerque, NM 87107 or
Sigma-Aldrich Fine Chemicals 3050 Spruce St., St. Louis, MO 63103.
For Product intended by NOVADAQ for sale outside the U.S., AKORN may
subcontract or assign any part of its manufacturing and supply
obligations hereunder to any facility approved by the relevant
Regulatory Authority for the manufacture of the Product. AKORN shall
provide NOVADAQ documentation demonstrating that any subcontractor's
or assignee's facility has been approved by the FDA (for Product
intended for sale in the U.S.) or the relevant Regulatory Authority
(for Product intended for sale outside the U.S.) for the manufacture
of the Product.
2.3 FORECASTS.
2.3.1 ROLLING FORECASTS. Throughout the term of this Agreement,
NOVADAQ shall provide AKORN with a rolling one (1) year
forecast (the "Forecast") of its expected purchases of the
Product, the mechanism for which shall be as follows:
(a) On or before the Effective Date, NOVADAQ shall have
provided AKORN with a written forecast of its expected
purchases of the Product for the period extending three
(3) Calendar Quarters beyond the Calendar Quarter
containing the Effective Date.
(b) Beginning on the date of the first Calendar Quarter
following the Effective Date and then on or prior to the
first day of each subsequent Calendar Quarter, NOVADAQ
shall provide AKORN with an update to its previously
submitted Forecast of its expected purchases of the
Product. Such update shall consist of a repetition of
the previously forecasted three (3) Calendar Quarters
along with a newly introduced forecast for the Calendar
Quarter subsequent to the last Calendar Quarter
previously forecasted.
2.3.2 AKORN shall provide sixty (60) days written notice to NOVADAQ
in the event AKORN determines that it cannot fill an order or
meet a forecast. In the event that AKORN is unable to provide
NOVADAQ with its requirement for ICG-C, NOVADAQ may obtain the
required quantity from an alternative source, but subject to
the Termination provisions
4
hereof, only until such time as AKORN is able to again provide
the required quantity. The inability of AKORN to supply
amounts or fill orders exceeding the forecast in any quarter
by more than 100% shall not be considered a default or breach
of this Agreement.
2.4 SUBMISSION OF PURCHASE ORDERS. From time to time, NOVADAQ shall
place orders with AKORN, in a format agreed upon by the Parties, for
the purchase of Product, specifying the quantities of the Product
desired and the place(s) to which and the manner and dates by which
delivery is to be made; said delivery dates to be no earlier than
one hundred twenty (120) calendar days after the purchase order
date. All purchase orders shall be sent on forms previously reviewed
by and jointly approved by the Parties and shall be delivered by
NOVADAQ to the following address or as otherwise instructed by
AKORN.
Akorn, Inc.
2500 Millbrook Rd.
Buffalo Grove, Illinois
Attn: Director of Materials Management
Fax: (847) 279-6123
Purchase orders made in accordance with the provisions of this
Article 2 shall be deemed to be accepted by AKORN if AKORN has not
rejected said purchase orders within ten (10) business days of
receipt of the same. To the extent the terms of any purchase order
or acknowledgment thereof are inconsistent with the terms of this
Agreement, the terms of this Agreement shall prevail.
2.5 DELIVERY. AKORN shall execute all accepted purchase orders
consistent with this Agreement by delivery F.O.B. to NOVADAQ's
designated carrier at AKORN's distribution facility of all ordered
quantities of the Product no later than the delivery dates provided
in NOVADAQ's purchase orders. Title and risk of loss will pass to
NOVADAQ when each order of Product is delivered to NOVADAQ's
designated carrier at AKORN's distribution facility.
2.6 LABELING. Within thirty (30) days after the Effective Date, NOVADAQ,
at its own expense, will provide AKORN with NOVADAQ's labeling for
the Product bearing NOVADAQ's corporate name and trade dress. AKORN,
at NOVADAQ's expense, will print, either directly or through a Third
Party, labels and other printed material to be included as part of
the finished Product. Product manufactured by or for AKORN after
AKORN's receipt of any new or altered labeling for the Product,
shall bear such new labeling, provided, however, that AKORN shall
have no responsibility with respect to the content of such labeling,
provided the content of the labeling printed by AKORN is the same as
the content or specification of the labeling provided by NOVADAQ.
NOVADAQ shall reimburse AKORN for all reasonable costs incurred by
AKORN in making any modifications to the labeling, branding or
imprinting, packaging and/or manufacturing processes to accommodate
NOVADAQ's labeling or to
5
accommodate any other changes requested by NOVADAQ. Such
reimbursement shall be made pursuant to invoices submitted by AKORN
to NOVADAQ, which invoices shall be payable within thirty (30) days
after NOVADAQ's receipt thereof.
3. MANUFACTURE OF PRODUCTS
3.1 MANUFACTURE OF PRODUCT; CERTIFICATE OF ANALYSIS. AKORN shall, or
shall cause any Third Party manufacturer contracted by AKORN to
manufacture the Product to, manufacture the Product in compliance
with applicable current good manufacturing practices as described in
21 C.F.R. parts 210 and 211 for ICG-C used in the United States and
any equivalent provisions enforced by applicable Regulatory
Authorities for ICG-C used in countries outside the United States.
All Product supplied by AKORN to NOVADAQ shall materially conform to
the Specifications. AKORN shall perform, or cause to be performed,
release testing of each batch of Product, in a manner consistent
with testing methods agreed upon by the Parties, and AKORN shall
provide to NOVADAQ a Certificate of Analysis with each shipment of
the Product to NOVADAQ or its designated recipient stating that the
Product materially conforms to the Specifications. The Certificate
of Analysis shall be in a format agreed upon by the Parties.
3.2 COMPLIANCE WITH LAWS AND REGULATIONS. While the Product is in its
possession or under its, or its sub-contractor's control, AKORN
shall comply, or ensure that its subcontractors comply, with all
applicable federal, state and local statutory and regulatory
requirements regarding the manufacture, if applicable, packaging,
handling transportation and storage of the Product.
3.3 MANUFACTURING DIFFICULTIES. AKORN shall notify NOVADAQ (within 10
working days) upon any occasion in which AKORN, or any Third Party
with whom AKORN has contracted for the manufacture of the Product,
experiences any manufacturing problems in producing the Product
which AKORN reasonably believes may delay shipment of the Product to
NOVADAQ. Subject to the provisions of Section 12.1, AKORN shall use
Commercially Reasonable Efforts to resolve those problems and shall
keep NOVADAQ fully informed of the status of those efforts. If
delays are reasonably expected to (or do) cause AKORN to be unable
to supply Product in accordance with NOVADAQ'S purchase order, then
NOVADAQ may obtain ICG-C from an alternative source until the supply
problems are resolved by AKORN.
4. PURCHASE PRICE; TERMS OF PAYMENT.
4.1 PRICE. NOVADAQ shall purchase from AKORN and AKORN shall sell to
NOVADAQ Product at a purchase price which shall, at all times,
equals AKORN's best wholesale price for ICG for the calendar month
immediately preceding the date of shipment of a Purchase Order,
adjusted, however, to reflect any volume discounts resulting from
increases in the amount of Product ordered
6
by NOVADAQ for the Calendar Year in which such Purchase Order is
received and which are then being offered by AKORN to other Third
Party purchasers of ICG products.
4.2 FREIGHT, INSURANCE AND TAXES. NOVADAQ shall pay all actual freight,
insurance and government sales tax imposed on purchasers for resale,
and duties and other fees (except tax on income to AKORN) incurred
in connection with the sale and shipment of the Product to NOVADAQ.
4.3 PAYMENT. Payments to AKORN for the purchase price of delivered
Product (as well as any other payment due from NOVADAQ to AKORN
under this Agreement) shall be made by NOVADAQ within thirty (30)
days after the date of shipment, except as to Product orders which
are rejected by NOVADAQ in accordance with the procedures contained
in Section 5, or which the Parties dispute constitute Acceptable
Product. In the event Product is rejected by NOVADAQ, but is
determined to be Acceptable Product pursuant to Section 5.2 hereof,
the payment for such Product shall be due and payable within ten
(10) days after the determination with respect to such Product is
made in accordance with Section 5.2 hereof.
4.4 MAINTENANCE OF RECORDS; AUDITS. AKORN shall keep complete records of
its average wholesale cost for ICG product sales and, upon request
of NOVADAQ, shall permit an independent certified public accountant
selected by NOVADAQ, that has first executed an appropriate
confidentiality agreement with AKORN and is reasonably acceptable to
AKORN, to inspect and review AKORN's records during normal business
hours and upon reasonable prior notice, but, in any event, no more
than once per year, in order to verify or determine AKORN's average
wholesale cost of ICG products. The independent certified public
accountant selected by NOVADAQ may not disclose to NOVADAQ specific
sales prices charged to any individual Third Party, but only whether
or not the average wholesale price for ICG products as reported by
AKORN is correct. NOVADAQ shall bear the costs and fees associated
with such inspections and reviews unless it is determined by the
independent certified public accountant that the average wholesale
price was incorrect (in excess of five percent (5%)) in which case
AKORN shall bear the costs and fees of such audit. AKORN shall
promptly refund to NOVADAQ any overpayments made by NOVADAQ because
of such unsupported pricing.
5. INSPECTION OF PRODUCT.
5.1 INSPECTION; REJECTION OF PRODUCT. NOVADAQ shall analyze
representative samples of each lot of Product delivered to NOVADAQ
for purposes of determining whether the same meets the
Specifications ("Acceptable Product") and, if performed, will do so
within sixty (60) days from the date of delivery of the Product to
NOVADAQ's carrier. NOVADAQ shall notify AKORN in writing within said
sixty (60) days of any Product lot, or portion thereof, which
7
NOVADAQ is rejecting because NOVADAQ believes such Product is not
Acceptable Product. If NOVADAQ fails to so notify AKORN that it is
rejecting a lot of Product, or portion thereof, within such sixty
(60) day period, such lot of Product, or portion thereof, shall be
deemed to be Acceptable Product. Payment terms will still remain net
thirty days (30). Any Product which is properly rejected in
accordance with the procedures set forth in this Section 5 for which
NOVADAQ has already paid shall be replaced in accordance with
Section 5.3
5.2 THIRD PARTY ANALYSIS. If AKORN, after good faith consultation with
NOVADAQ, disputes any finding by NOVADAQ that Product is not
Acceptable Product, representative samples of the Product shall be
forwarded for analysis to a suitably qualified independent Third
Party jointly selected by AKORN and NOVADAQ, in their reasonable
discretion, which analysis shall be performed in compliance with
applicable FDA regulations for retesting of pharmaceutical products.
The findings of such Third Party regarding whether the Product was
Acceptable Product shall be binding upon the Parties. The cost of
such analysis by such Third Party shall be borne by the Party whose
findings differed from those generated by such Third Party
laboratory.
5.3 REPLACEMENT OF PRODUCT. AKORN shall replace any Product order, or
portion thereof, which is not Acceptable Product (unless such
non-conformance is due to any negligent or wrongful act or omission
by NOVADAQ or its agents or sub contractors), at AKORN's cost and
expense, including shipping costs.
5.4 DISPOSITION OF REJECTED PRODUCT. AKORN shall instruct NOVADAQ as to
the disposition of any Product order or portion thereof determined
not to be Acceptable Product. At the sole option of AKORN, said
Product may be returned to AKORN, at AKORN's expense including
shipping costs, or destroyed in an environmentally acceptable
manner, again at AKORN's expense.
6. INSPECTION AND ACCESS TO FACILITY AND RECORDS.
6.1 INSPECTION BY REGULATORY AUTHORITIES. Upon the request of the FDA or
other Regulatory Authority, such authority shall have access to
observe and inspect AKORN's or its Third Party manufacturers'
facilities and procedures used for the manufacture, testing or
warehousing of the Product and to audit such facilities for
compliance with cGMP and/or other applicable regulatory standards.
6.2 NOTIFICATION OF INQUIRIES. AKORN shall notify NOVADAQ as soon as
possible, and in any event, within ten (10) days, of any written or
oral inquiries, notifications or inspection activity by the FDA or
other Regulatory Authority in regard to or affecting the Product.
AKORN shall furnish to NOVADAQ (i) within ten (10) business days
after receipt, any report or correspondence issued by the FDA or
other Governmental Authority in connection with such visit or
inquiry, including, but not limited to, any FDA Form 483 (List of
Inspectional Observations), Establishment Inspection Report or
applicable portions of any
8
FDA Warning Letters which pertain to the Product in the Territory
and (ii) not later than ten (10) business days after to the time it
provides to the FDA or other Regulatory Authority, copies of
proposed responses or explanations relating to items set forth above
(each, a "Proposed Response"), in each case redacted of trade
secrets or other confidential or proprietary information that is
unrelated to the obligations under this Agreement or are unrelated
to the Product. After the filing of a response with the FDA or other
Regulatory Authority, AKORN will notify NOVADAQ of any further
contacts with such agency relating to the subject matter of the
response.
7. WARRANTIES AND INDEMNITIES.
7.1 REPRESENTATIONS AND WARRANTIES OF EACH PARTY. As of the Effective
Date, each of NOVADAQ and AKORN hereby represents, warrants and
covenants to the other Party hereto as follows:
(a) It is a corporation duly organized and validly existing
under the laws of the state, province or other
jurisdiction of its incorporation or formation;
(b) The execution, delivery and performance of this
Agreement by such Party has been duly authorized by all
requisite corporate action and does not require any
shareholder action or approval;
(c) It has the power and authority to execute and deliver
this Agreement and to perform its obligations hereunder;
(d) The execution, delivery and performance by such Party of
this Agreement and its compliance with the terms and
provisions hereof does not and will not conflict with or
result in a breach of any of the terms and provisions of
or constitute a default under (i) a loan agreement,
guaranty, financing agreement, agreement affecting a
product or other agreement or instrument binding or
affecting it or its property; (ii) the provisions of its
charter or operative documents or bylaws; or (iii) any
order, writ, injunction or decree of any court or
governmental authority entered against it or by which
any of its property is bound; and
(e) It shall at all times comply with all applicable
material laws and regulations relating to its activities
under this Agreement.
7.2 SETTLEMENT AND MUTUAL RELEASE. The Parties acknowledge the
Settlement and Mutual Release and confirm and agree that all of the
terms and conditions thereof shall be incorporated in this Agreement
to the extent applicable.
9
7.3 PRODUCT WARRANTY. In addition to the representations and warranties
made by AKORN in Section 7.1 hereof, AKORN represents and warrants
to NOVADAQ that all Product supplied hereunder will conform to the
Specifications.
7.4 DISCLAIMER OF ALL OTHER WARRANTIES. EXCEPT FOR THE WARRANTIES
EXPRESSLY MADE BY AKORN IN SECTIONS 7.1 AND 7.3 HEREOF, AKORN MAKES
NO OTHER REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED
(WHETHER WRITTEN OR ORAL), INCLUDING, WITHOUT LIMITATION ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR ANY WARRANTY OF FITNESS FOR A
PARTICULAR PURPOSE WITH RESPECT TO THE PRODUCTS OR AKORN'S
OBLIGATIONS HEREUNDER. IN ADDITION, BECAUSE AKORN WILL HAVE NO
CONTROL OVER (A) ANY OTHER PRODUCT OR PROCEDURE OF WHICH THE PRODUCT
IS A COMPONENT OR IN WHICH THE PRODUCT IS USED, (B) THE CONDITIONS
UNDER WHICH THE PRODUCT OR ANY OTHER PRODUCT OR PROCEDURE OF WHICH
THE PRODUCT IS A COMPONENT OR IS USED, (C) THE DIAGNOSIS OF THE
PATIENTS, OR (D) THE METHODS OF ADMINISTERING OR HANDLING THE
PRODUCT OR ANY OTHER PRODUCT OR PROCEDURE OF WHICH THE PRODUCT IS A
COMPONENT OR IS USED AFTER THE PRODUCT LEAVES AKORN'S POSSESSION,
AKORN DOES NOT WARRANT EITHER A GOOD EFFECT OR AGAINST AN ILL EFFECT
FOLLOWING THE USE OF THE PRODUCT OR ANY OTHER PRODUCT OR PROCEDURE
OF WHICH THE PRODUCT IS A COMPONENT OR IS USED. AKORN EXPRESSLY
DISCLAIMS ANY WARRANTY UNDER SECTION 2-312(3) OF THE UNIFORM
COMMERCIAL CODE.
7.5 INDEMNIFICATION BY AKORN. AKORN shall indemnify, defend and hold
harmless NOVADAQ, its Affiliates and each of its and their
respective officers, directors, shareholders, employees, agents and
representatives (each a "NOVADAQ Indemnified Party") from any
claims, losses, liabilities, costs, expenses (including reasonable
attorney's fees) and damages to Third Parties, including any related
to property or personal injury (each a "Liability"), which any
NOVADAQ Indemnified Party may incur, suffer or be required to pay
resulting from or arising in connection with (a) the breach by AKORN
of any representation or warranty contained in this Agreement; (b)
any violation by AKORN or any Third Party manufacturer of any
applicable federal, state or local regulation, statute or order in
the manufacture, packaging, storage or shipping of Products arising
out of AKORN's duties under this Agreement which is not attributable
to printed materials provided by NOVADAQ; or (c) any negligent act
or omission by AKORN or its Affiliates in carrying out its
obligations under this Agreement. Notwithstanding the foregoing,
AKORN shall have no obligation to defend, indemnify or hold harmless
any NOVADAQ Indemnified Party for any Liability that results from
the negligence or intentional misconduct of NOVADAQ, its Affiliates,
or any of its permitted sub-licensees or any of their respective
officers, directors, employees, agents, consultants or
representatives.
10
7.6 INDEMNIFICATION BY NOVADAQ. NOVADAQ shall indemnify, defend and hold
harmless AKORN and its Affiliates and subcontractors, and each of
its and their respective employees, officers, directors and agents
(each an "AKORN Indemnified Party") from and against any Liability
which any AKORN Indemnified Party may incur, suffer or be required
to pay resulting from or arising in connection with (a) the breach
by NOVADAQ of any representation or warranty contained in this
Agreement; (b) materials, including, but not limited to labeling, or
promotional claims supplied or made by NOVADAQ, or (c) the use,
packaging, promotion, distribution, testing, use, marketing, sale or
other disposition of Product by NOVADAQ, its Affiliates, its
permitted sub-licensees or their respective subcontractors.
Notwithstanding the foregoing, NOVADAQ shall have no obligation to
indemnify, defend, or hold harmless any AKORN Indemnified Party for
any Liability that results from the intentional misconduct or
negligence of AKORN, its Affiliates, its permitted subcontractors or
any of their respective employees, officers, directors or agents,
consultants or representatives.
7.7 CONDITIONS TO INDEMNIFICATION. The obligations of the indemnifying
Party under Sections 7.4 and 7.5 are conditioned upon the delivery
of written notice to the indemnifying Party of any potential
Liability promptly after the indemnified Party becomes aware of such
potential Liability. The indemnifying Party shall have the right to
assume the defense of any suit or claim related to the Liability if
it has assumed responsibility for the suit or claim in writing;
provided, however, if in the reasonable judgment of the indemnified
Party, such suit or claim involves an issue or matter which could
have a materially adverse effect on the business operations or
assets of the indemnified Party, the indemnified Party may waive its
rights to indemnity under this Agreement and control the defense or
settlement thereof, but in no event shall any such waiver be
construed as a waiver of any indemnification rights such Party may
have at law or in equity. If the indemnifying Party defends the suit
or claim, the indemnified Party may participate in (but not control)
the defense thereof at its sole cost and expense. Any
indemnification payable to an indemnified Party shall be net of
taxes, insurance or payment received by the indemnified Party from
any Third Party.
7.8 LIMITATION OF LIABILITY. WITH RESPECT TO ANY CLAIM BY ONE PARTY
AGAINST THE OTHER ARISING OUT OF THE PERFORMANCE OR FAILURE OF
PERFORMANCE OF THE OTHER PARTY UNDER THIS AGREEMENT WHERE THE
INABILITY OR FAILURE TO PERFORM IS FOR REASONS BEYOND THE REASONABLE
CONTROL OF SUCH PARTY, THE PARTIES EXPRESSLY AGREE THAT THE
LIABILITY OF SUCH PARTY TO THE OTHER PARTY FOR SUCH BREACH SHALL BE
LIMITED UNDER THIS AGREEMENT OR OTHERWISE AT LAW OR EQUITY TO DIRECT
DAMAGES ONLY AND IN NO EVENT SHALL A PARTY BE LIABLE FOR INCIDENTAL,
PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES OR LOST PROFITS.
11
7.9 SETTLEMENTS. Neither Party may settle a claim nor action related to
a Liability without the consent of the other Party, if such
settlement would impose any monetary obligation on the other Party,
constitute or admission by the other Party, expose the other Party
to any additional liability or prosecution, require the other Party
to submit to an injunction or otherwise limit the other Party's
rights under this Agreement. Except as otherwise expressly set forth
in this Article 7, any payment made by a Party to settle any such
claim or action shall be at its own cost and expense.
7.10 INSURANCE. AKORN and NOVADAQ shall obtain and maintain at all times
during the term of this Agreement commercial general liability
insurance, including products liability, with limits which are
commercially reasonable for similarly situated companies and each
agrees to provide the other with a Certificate of Insurance
evidencing this coverage within thirty (30) days of the Effective
Date.
8. RECALLS
8.1 PRODUCT RECALLS. In the event of an actual or threatened recall of
the Product required or recommended by a Governmental Authority of
competent jurisdiction within the Territory or if recall of any
Product is (i) reasonably deemed advisable by AKORN or by NOVADAQ,
or (ii) jointly deemed advisable by AKORN and NOVADAQ, such recall
shall be promptly implemented and administered by NOVADAQ in a
manner which is appropriate and reasonable under the circumstances
and in conformity with accepted trade practices. In the event that a
recall is caused due to the negligent acts or omissions of AKORN,
its Affiliates or subcontractors, or by the fact that the Product
supplied by AKORN to NOVADAQ does not conform to the Specifications,
the cost, including NOVADAQ's reasonable out-of-pocket expenses, of
any such recall shall be borne by AKORN. NOVADAQ shall pay all
costs, including AKORN's reasonable out-of-pocket expenses,
associated with a recall for any other reason, including, without
limitation, recalls (i) caused by actions of Third Parties occurring
after such Product is sold to NOVADAQ, or (ii) due to packaging or
label defects for which NOVADAQ has responsibility, or (iii) due to
any other breach by NOVADAQ of this Agreement.
8.2 NOTICE OF EVENTS THAT MAY LEAD TO PRODUCT RECALL. Each Party shall
keep the other fully and promptly informed of any notification,
event or other information, whether received directly or indirectly,
which might affect the marketability, safety or effectiveness of the
Product or might result in a recall of Product by the HPB, FDA or
other Governmental Body.
8.3 RECALL DUE TO BREACH BY AKORN. In the event of any recall for which
AKORN would be responsible for the costs in accordance with Section
8.1 hereof, AKORN shall, at the election of NOVADAQ either:
12
(a) Supply Product, without charge to NOVADAQ, in an amount
sufficient to replace the amounts of Product recalled,
or
(b) Refund to NOVADAQ the amount paid or give credit to
NOVADAQ against outstanding receivables due from NOVADAQ
for the price of Product to be delivered to NOVADAQ in
the future, in amounts equal to the price paid by
NOVADAQ to AKORN for Product so recalled plus the
reasonable transportation costs incurred by NOVADAQ and
not recovered by NOVADAQ in respect of such recalled
Product.
8.4 DEFINITION OF RECALL. For Purposes of the Article 8, "recall" shall
mean any action by NOVADAQ and its Affiliates, or AKORN and its
Affiliates, to recover title or possession or halt distribution,
prescription or consumption of Product sold or shipped to Third
Parties.
8.5 SURVIVAL OF OBLIGATIONS. The provisions and obligations of this
Article 8 shall survive any termination of this Agreement.
9. NON-COMPETITION AND PERMITTED USE
9.1 CONTINUING MANUFACTURE AND SALE OF OTHER ICG PRODUCTS. NOVADAQ
acknowledges that AKORN and its Affiliates have sold and will
continue to sell other products containing ICG prior to and
subsequent to the execution of this Agreement. The Parties agree
that this Agreement shall not be construed to limit the right of
AKORN and its Affiliates to manufacture, have manufactured and sell
other products containing ICG to Third Parties subject to AKORN's
obligations of confidentiality and non-use under this Agreement.
9.2 RESTRICTIVE COVENANTS. Each Party hereby covenants and agrees with
the other that for so long as this Agreement is in effect and for a
period (the "Restricted Period") of five (5) years thereafter,
neither Party shall, without the prior written consent of the other
Party, which consent shall be within the sole and exclusive
discretion of the other Party, either directly or indirectly, on its
own account or as a consultant, agent, partner, joint venturer,
owner, or shareholder of any other person (other than AKORN's status
as a shareholder of NOVADAQ), entity, or in any other capacity, in
any way:
9.2.1 Carry on, be engaged in or have any financial interest in any
business which is in competition with the business of the
other Party. For purposes of this Section 9.2, a business
shall be deemed to be in competition with AKORN if it involves
products which were at the relevant time or at the time of
termination, being marketed in the Territory or which at such
time were under study by AKORN and expected to be marketed in
the Territory within six (6) months of such date for
ophthalmic uses. For purposes of this Section 9.2, a business
shall be deemed to be in competition with
13
NOVADAQ if it involves products which were, at the relevant
time or at the time of termination, being marketed in the
Territory by NOVADAQ or which at such time were under study by
NOVADAQ and expected to be marketed in the Territory within
six (6) months of such date of termination, in either case for
any of the Indications only.
9.2.2 Solicit for the business of the other Party (as defined in
paragraph 9.2.1) any then current customer or client of the
other Party or any affiliate of the other Party or, after
termination, anyone who was a customer or client at any time
during the twelve (12) month period immediately preceding
termination.
9.2.3 Solicit, employ or engage any person who is then an employee
of the other Party or any affiliate of the other Party or was
an employee of the other Party or, after termination, any
affiliate of the other Party at any time during the twelve
(12) month period immediately preceding termination.
10. TERM AND TERMINATION.
10.1 TERM. This Agreement shall become effective upon the Effective Date
and, unless earlier terminated as provided below, shall remain in
full force and effect for a period ending on the seventh (7th)
anniversary of the Effective Date (the "Initial Term"). Thereafter,
this Agreement shall automatically renew for successive five (5)
year terms (each a "Renewal Term" and together with the Initial
Term, the "Term") unless, at least 180 days prior to any such
Renewal Term, either Party shall have notified the other of its
intention not to renew this Agreement. Upon expiration or
termination of this Agreement for any reason, all unpaid amounts due
pursuant to this Agreement, including, but not limited to, Section
4.3, shall become immediately due and payable.
10.2 TERMINATION
(a) This Agreement shall terminate upon the mutual written
agreement of the Parties.
(b) If either Party breaches or defaults in the performance
or observance of any of the material provisions of this
Agreement, and such breach or default is not cured
within 60 days after the giving of notice by the
non-defaulting Party specifying such breach or default,
the non-defaulting Party shall have the right to
terminate this Agreement, effective immediately upon
notice to the defaulting Party.
(c) Either Party shall have the right to terminate this
Agreement upon 30 days' notice to the other Party, if
that other Party becomes involved in financial
difficulties as evidenced:
14
(i) by that other Party's commencement of a voluntary
case under any applicable bankruptcy code or
statue, or by its authorizing, by appropriate
proceedings, the commencement of such voluntary
case; or
(ii) by its failing to receive dismissal of any
involuntary case under any applicable bankruptcy
code or statute within 90 days after initiation of
such action or petition; or
(iii) by its seeking relief as a debtor under any
applicable law of any jurisdiction relating to the
liquidation or reorganization of debtors or to the
modification or alteration of the rights of
creditors, or by consenting to or acquiescing in
such relief; or
(iv) by the entry of an order by a court of competent
jurisdiction finding it to be bankrupt or
insolvent, or ordering or approving its
liquidation, reorganization or any modification or
alteration of the rights of its creditors or
assuming custody of, or appointing a receiver or
other custodian for, all or a substantial part of
its property or assets; or
(v) by its making an assignment for the benefit of, or
entering into an agreement with, its creditors, or
appointing or consenting to the appointment of a
receiver or other custodian for all or a
substantial part of its property or by the
appointment of such a receiver by a Third Party,
which appointment is not revoked by a Court of
competent jurisdiction within sixty (60) days of
its occurrence.
(d) The failure by a Party to exercise its right to
terminate this Agreement pursuant to Section 9.2. in the
event of any occurrence giving rise thereto shall not
constitute waiver of the right in the event of any
subsequent occurrence.
10.3 EFFECT OF TERMINATION.
(a) Unless otherwise agreed to between the Parties, all
Product on hand as of the effective date of expiration
or termination of this Agreement will be treated as
follows as soon as practicable:
(i) Product manufactured and packaged pursuant to
purchase orders previously received from NOVADAQ,
will be delivered by AKORN to NOVADAQ, whereupon
15
NOVADAQ will pay AKORN therefore in accordance
with the terms hereof; and
(ii) Work in progress commenced by AKORN in accordance
with a Binding Quarterly Forecast will, at the
option of NOVADAQ (but at the option of AKORN in
the case of termination hereof by AKORN under
Section 10.2(b)), (A) cease, and such work in
progress will remain with AKORN (in which case
NOVADAQ will pay AKORN an amount equal to AKORN's
actual costs incurred in connection with the
performance and cessation of such work less the
cost to AKORN of materials that can be returned by
AKORN or used by AKORN in later batches of other
products manufactured by AKORN as reasonably
determined by AKORN) or (B) be completed by AKORN
and delivered to NOVADAQ whereupon NOVADAQ will
pay AKORN therefore in accordance with the terms
hereof.
(b) In the event that NOVADAQ terminates this Agreement
either pursuant to Section 10.2.(b) because of a
Material Breach, or pursuant to 10.2.(c), then, in
either event, NOVADAQ shall thereafter be permitted to
order all further supply of Product directly from any
Third Party which is at the time of termination a
Permitted Manufacturer or other qualified supplier.
AKORN will license to NOVADAQ, within 60 (sixty) days of
the date of this Agreement, for the Indications, all
required Know-How necessary to manufacture the Product
which license shall become effective only in the event
that NOVADAQ terminates this Agreement either pursuant
to Section 10.2(b) because of a Material Breach or
pursuant to 10.2(c).
10.4 ACCRUED OBLIGATIONS. Termination of this Agreement for any cause
shall not release either Party from any obligation or liability
incurred prior to or upon termination hereof or which subsequently
arises under Section 10.6.
10.5 NO WAIVER. The failure on the part of either Party to exercise or
enforce any right conferred upon it hereunder shall not be deemed to
be a waiver of any such right nor operate to bar the exercise or
enforcement thereof at any time thereafter.
10.6 SURVIVAL. Subject to Section 10.3 hereof, the following provisions
shall survive expiration or termination of this Agreement: Sections
4.4, 5.3, 5.4, 9.2, 12.3, 12.4, 12.5, 12.6, 12.7, 12.8, and 12.9 and
Articles 7, 8 and 11.
16
11. CONFIDENTIALITY.
11.1 NONDISCLOSURE OBLIGATION. Each of NOVADAQ and AKORN agree to use any
information received by it from the other Party (the "Information")
only in accordance with this Agreement and not to disclose
Information to any Third Party, without the prior written consent of
the other Party, for a period of five (5) years from the termination
or expiration of this Agreement. These obligations shall not apply
to Information that:
(a) Is known by the receiving Party at the time of its
receipt, and not through a prior disclosure by the
disclosing Party, as documented by the receiving Party's
business records;
(b) Is at the time of disclosure or thereafter becomes
published or otherwise part of the public domain without
breach of this Agreement by the receiving Party;
(c) Is subsequently disclosed to the receiving Party by a
Third Party who has the right to make such disclosure;
(d) Is developed by the receiving Party independently of the
Information received from the disclosing Party and such
independent development can be documented by the
receiving Party; or
(e) Is required by law, regulation, rule, act or order of
any governmental authority or agency to be disclosed by
a Party, provided that notice is promptly delivered to
the other Party in order to provide an opportunity to
seek a protective order or other similar order with
respect to such Information and thereafter the
disclosing Party discloses to the requesting entity only
the minimum Information required to be disclosed in
order to comply with the request, whether or not a
protective order or other similar order is obtained by
the other Party.
11.2 PERMITTED DISCLOSURES. Information may be disclosed to employees,
agents, consultants, sub-licensees or suppliers or Third Party
manufacturers of the recipient Party or its Affiliates, but only to
the extent required to accomplish the purposes of this Agreement and
only if the recipient Party obtains prior agreement from its
employees, agents, consultants, sub-licensees, suppliers or Third
Party manufacturers to whom disclosure is to be made to hold in
confidence and not make use of such Information for any purpose
other than those permitted by this Agreement. Each Party will use at
least the same standard of care as it uses to protect proprietary or
confidential information of its own to ensure that such employees,
agents, consultants, sub-licensees, suppliers or Third Party
manufacturers do not disclose or make any unauthorized use of the
Information.
17
11.3 DISCLOSURE OF AGREEMENT. Neither NOVADAQ nor AKORN shall release to
any Third Party or publish in any way any non-public information
with respect to the terms of this Agreement or concerning their
cooperation without the prior written consent of the other, which
consent will not be unreasonably withheld or delayed, provided,
however, that either Party may disclose the terms of this Agreement
to the extent required to comply with applicable laws, including,
without limitation the rules and regulations promulgated by the
United States Securities and Exchange Commission, provided, however,
that prior to making any such disclosure, the Party intending to so
disclose the terms of this Agreement shall (i) provide the
non-disclosing Party with written notice of the proposed disclosure
and a opportunity to review and comment on the intended disclosure
which is reasonable under the circumstances and (ii) shall seek
confidential treatment for as much of the disclosure as is
reasonable under the circumstances, including, without limitation,
seeking confidential treatment of any information as may be
requested by the other Party. Notwithstanding any other provision of
this Agreement, each Party may disclose the terms of this Agreement
to lenders, investment bankers and other financial institutions of
its choice solely for purposes of financing the business operations
of such Party, if the disclosing Party uses reasonable efforts to
obtain a signed confidentiality agreement with such financial
institution with respect to such information on terms substantially
similar to those contained in this Article 11.
11.4 PUBLICITY. Subject to Section 11.3, all publicity, press releases
and other announcements relating to this Agreement or the
transactions contemplated hereby shall be reviewed in advance by,
and shall be subject to the approval of, both Parties. The Party
responding to a request for such approval shall respond to the other
Party in writing within five (5) days of such request.
12. MISCELLANEOUS.
12.1 FORCE MAJEURE. Except for the obligation to make payment when due,
each Party shall be excused from liability for the failure or delay
in performance of any obligation under this Agreement by reason of
any event beyond such Party's reasonable control including but not
limited to Acts of God, fire, flood, explosion, earthquake, or other
natural forces, war, civil unrest, accident, destruction or other
casualty, any act, inaction or delay of any government or government
agency, or any other event similar to those enumerated above. Such
excuse from liability shall be effective only to the extent and
duration of the event(s) causing the failure or delay in performance
and provided that the Party has not caused such event(s) to occur.
Notice of a Party's failure or delay in performance due to force
majeure must be given to the other party within Ten (10) days after
its occurrence. All delivery dates in this Agreement that have been
affected by force majeure shall be suspended for the duration of
such force majeure.
18
12.2 ASSIGNMENT
(a) ASSIGNMENT BY NOVADAQ. NOVADAQ may assign any or all of
its rights or obligations under this Agreement in the
Territory to any of its Affiliates, for so long as they
remain Affiliates. In addition, NOVADAQ may assign any
or all of its rights or obligations under this Agreement
in the Territory in conjunction with a merger or
acquisition of NOVADAQ. NOVADAQ may not otherwise assign
any of its rights or obligations under this Agreement
without AKORN's prior written consent, which consent
shall not be unreasonably withheld. AKORN shall respond
to such requests by NOVADAQ for assignment within thirty
(30) days from such request. Any permitted assignment
shall not relieve NOVADAQ of its responsibilities for
performance of its obligations under this Agreement.
(b) ASSIGNMENT BY AKORN. AKORN may assign any or all of its
rights or obligations under this Agreement to any of its
Affiliates. AKORN may also assign any or all of its
rights or obligations under this Agreement in
conjunction with a merger or acquisition of AKORN. In
addition, AKORN may assign all or part of its
obligations to a Third Party manufacturer after
receiving NOVADAQ's prior written consent, (other than
to a Permitted Manufacturer for which consent shall not
be required) which consent shall not be unreasonably
withheld or delayed. Any permitted assignment shall not
relieve AKORN of its responsibilities for performance of
its obligations under this Agreement.
(c) BINDING NATURE OF ASSIGNMENT. This Agreement shall be
binding upon and inure to the benefit of the successors
and permitted assigns of the Parties. Any assignment not
in accordance with this Section 12.2 shall be void.
12.3 NO WAIVER. The failure of either Party to require performance by the
other Party of any of that other Party's obligations hereunder shall
in no manner affect the right of such Party to enforce the same at a
later time. No waiver by any Party hereto of any condition, or of
the breach of any provision, term, representation or warranty
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 condition or breach, or of
any other condition or of the breach of any other provision, term,
representation or warranty hereof.
12.4 SEVERABILITY. If a court or other tribunal of competent jurisdiction
should hold any term or provision of this Agreement to be excessive,
or invalid, void or unenforceable, the offending term or provision
shall be deleted or revised to the
19
extent necessary to be enforceable, and, if possible, replaced by a
term or provision which, so far as practicable achieves the
legitimate aims of the Parties.
12.5 RELATIONSHIP BETWEEN THE PARTIES. Both Parties are independent
contractors under this Agreement. Nothing herein contained shall be
deemed to create an employment, agency, joint venture or partnership
relationship between the Parties hereto or any of their agents or
employees, or any other legal arrangement that would impose
liability upon one Party for the act or failure to act of the other
Party. Neither Party shall have any express or implied power to
enter into any contracts or commitments or to incur any liabilities
in the name of, or on behalf of, the other Party, or to bind the
other Party in any respect whatsoever.
12.6 CORRESPONDENCE AND NOTICES.
(a) Ordinary Notices. Correspondence, reports,
documentation, and any other communication in writing
between the Parties in the course of ordinary
implementation of this Agreement shall be delivered by
hand, sent by facsimile, overnight courier or by airmail
to the employee or representative of the other Party who
is designated by such other Party to receive such
written communication.
(b) Extraordinary Notices. Extraordinary notices and
communications (including, without limitation, notices
of termination, force majeure, material breach, change
of address) shall be in writing and sent by prepaid
registered or certified mail, overnight courier or by
facsimile confirmed by prepaid registered or certified
mail letter, and shall be deemed to have been properly
served to the addressee three days after mailing by
registered or certified mail, the next day if sent by
overnight courier and upon receipt if sent by facsimile.
(c) Addresses. In the case of NOVADAQ, the proper address
for communications and for all payments shall be:
Novadaq Technologies, Inc.
924 The East Mall, Suite 100
Toronto, Ontario M9B 6K1
Attn: Chief Financial Officer
Fax: (416) 695-3993
and in the case of AKORN, the proper address for communications and
for all payments shall be:
Akorn, Inc.
2500 Millbrook Drive
Buffalo Grove, Illinois 60089
Attn: Chief Financial Officer
Fax: (847) 279-6123
20
12.7 CHOICE OF LAW. This Agreement is subject to and governed by the laws
of the State of Illinois, excluding its conflict of laws provisions.
12.8 ENTIRE AGREEMENT; AMENDMENT. This Agreement sets forth the complete,
final and exclusive agreement between the Parties with respect to
the subject matter hereto and supersedes and terminates all prior
and contemporaneous agreements and understandings between the
Parties, whether oral or in writing. No subsequent alteration,
amendment, change, waiver or addition to this Agreement shall be
binding upon the Parties unless reduced to writing and signed by an
authorized officer of each Party. No understanding, agreement,
representation or promise, not explicitly set forth herein, other
than the Settlement and Mutual Release executed by the Parties on
the date hereof, has been relied on by either Party in deciding to
execute this Agreement as set forth herein.
12.9 ARBITRATION. The Parties shall attempt in good faith to promptly
resolve any controversy, claim or dispute arising between them. In
the event that the Parties are unable to resolve any such
controversy, claim or dispute within 30 days, then any such
controversy, claim or dispute between the Parties, directly or
indirectly, concerning this Agreement or the breach hereof, or the
subject matter hereof, shall be finally settled by binding
arbitration in accordance with the Rules of Conciliation and
Arbitration of the International Chamber of Commerce. Prior to
initiating such arbitration proceedings the Parties shall attempt to
resolve the dispute by good faith negotiations between themselves.
The situs of the arbitration proceedings shall be the City of
Toronto, Ontario, Canada, if the arbitration was requested or
initiated by NOVADAQ, and in the City of Chicago, Illinois, U.S.A.,
if the arbitration was requested or initiated by Akorn, and judgment
upon the award rendered may be entered in any court having a
jurisdiction hereof. In deciding the dispute the arbitrator(s) shall
apply first the plain meaning of this Agreement, but in matters not
fairly provided for in this Agreement, shall apply the substantive
law of the State of Illinois. All pleadings, evidence, testimony, or
other submissions to the arbitrator(s) shall be in the English
language as shall be the judgment of the arbitrator(s). Pending
resolution of any such arbitration, any Party may deposit with its
solicitors or another mutually agreeable party an amount equal to
50% of any monetary amount in dispute or such other amount as may be
directed by the arbitrator(s) upon preliminary application.
12.10 HEADINGS. The headings and captions used in this Agreement are
solely for the convenience of reference and shall not affect its
interpretation.
12.11 COUNTERPARTS. This Agreement may be executed in one or more
counterparts each of which shall be an original and all of which
shall constitute together the same document.
12.12 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all other acts, as may
be necessary or appropriate in
21
order to carry out the purposes and intent of this Agreement
including, without limitation, any filings with any antitrust agency
which may be required.
IN WITNESS WHEREOF, this Agreement has been executed by the duly
authorized representatives of the Parties as of the date set forth below.
AKORN, INC. NOVADAQ TECHNOLOGIES, INC.
By:______________________________ By:______________________________
Name:____________________________ Name:____________________________
Title:___________________________ Title:___________________________