UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
[X] Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange
Act of 1934. For the period ended March 31, 1998
OR
[ ] Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange
Act of 1934. For the transition period from____________ to ____________
Commission File Number: 0-12104
IMMUNOMEDICS, INC.
(Exact name of registrant as specified in its charter)
Delaware 61-1009366
(State or other jurisdiction of (IRS Employer Identification No.)
incorporation or organization)
300 American Road, Morris Plains, New Jersey 07950
(Address of principal executive offices) (Zip code)
(973) 605-8200
(Registrant's telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
[X] Yes [ ] No
Indicate the number of shares outstanding of each of the issuer's classes of
common stock as of the latest practicable date.
As of May 13, 1998, there were 37,586,087 shares of the registrant's common
stock outstanding.
Page 1 of 18
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IMMUNOMEDICS, INC.
INDEX
Page No.
PART I - FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements (Unaudited):
Condensed Consolidated Balance Sheets - 3
March 31, 1998 and June 30, 1997
Condensed Consolidated Statements of Operations - 4
three and nine months ended March 31, 1998 and 1997
Condensed Consolidated Statements of Cash Flows - 5
nine months ended March 31, 1998 and 1997
Notes to Condensed Consolidated Financial Statements - 6
March 31, 1998
Item 2. Management's Discussion and Analysis of 10
Financial Condition and Results of Operations
PART II - OTHER INFORMATION
Item 2. Changes in Securities and Use of Proceeds 16
Item 6. Exhibits and Reports on Form 8-K 17
SIGNATURES 18
Page 2 of 18
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<TABLE>
PART I. - FINANCIAL INFORMATION
IMMUNOMEDICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
<CAPTION>
March 31, June 30,
1998 1997
______________ ______________
<S> <C> <C>
ASSETS
Current Assets
Cash and cash equivalents $ 6,181,021 6,013,355
Marketable securities 1,578,986 9,010,275
Inventory 630,730 690,695
Other current assets 1,345,050 1,227,000
______________ ______________
Total Current Assets 9,735,787 16,941,325
Property and equipment, net of
accumulated depreciation of
$5,569,000 and $4,852,000 at
March 31, 1998 and June
30, 1997, respectively 5,184,369 5,693,193
______________ ______________
TOTAL ASSETS $ 14,920,156 22,634,518
______________ ______________
</TABLE>
<TABLE>
<CAPTION>
LIABILITIES AND STOCKHOLDERS' EQUITY
<S> <C> <C>
Current Liabilities
Accounts Payable $ 1,670,416 2,360,256
Other current liabilities 2,547,766 2,827,970
______________ ______________
Total Current Liabilities 4,218,182 5,188,226
Commitments and Contingencies
Preferred stock; $.01 par value,
authorized 10,000,000 shares;
series D convertible, authorized
200,000 shares; issued and
outstanding none and 4,999
shares at March 31, 1998 and
June 30, 1997, respectively 0 50
Common stock; $.01 par value,
authorized 70,000,000 shares;
issued and outstanding 36,818,832
and 36,297,170 shares at
March 31, 1998 and
June 30, 1997, respectively 368,188 362,971
Capital contributed in excess
of par 94,754,001 93,111,855
Accumulated deficit (84,418,921) (76,027,392)
Accumulated net unrealized
loss on securities (1,294) (1,192)
______________ ______________
Total stockholders' equity 10,701,974 17,446,292
______________ ______________
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY $ 14,920,156 22,634,518
______________ ______________
<FN>
See accompanying notes to condensed consolidated financial statements.
</FN>
</TABLE>
Page 3 of 18
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<TABLE>
IMMUNOMEDICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
<CAPTION>
Three Months Ended Nine Months Ended
March 31, March 31,
1998 1997 1998 1997
___________ ___________ ___________ ___________
<S> <C> <C> <C> <C>
REVENUES:
Product sales $ 998,756 325,464 2,858,553 564,880
Royalties and licence
fees 1,347 13,675 14,401 571,324
Research and development 160,638 196,449 1,067,223 464,096
Interest and other 99,129 316,566 2,230,913 1,028,624
___________ ___________ ___________ ___________
1,259,870 852,154 6,171,090 2,628,924
___________ ___________ ___________ ___________
COST AND EXPENSES:
Cost of goods sold 77,758 5,570 147,180 13,537
Research and development 2,806,298 3,479,020 8,939,145 10,116,987
Sales and Marketing 1,216,880 510,337 3,739,480 1,174,222
General and administrative 495,029 909,198 1,736,814 2,132,386
___________ ___________ ___________ ___________
4,595,965 4,904,125 14,562,619 13,437,132
___________ ___________ ___________ ___________
NET LOSS $(3,336,095) (4,051,971) (8,391,529) (10,808,208)
___________ ___________ ___________ ___________
Basic net loss per share $ (0.09) (0.11) (0.23) (0.31)
___________ ___________ ___________ ___________
Diluted net loss per share $ (0.09) (0.11) (0.23) (0.31)
___________ ___________ ___________ ___________
Weighted average number of
common shares outstanding 36,448,634 35,820,962 36,378,635 35,221,934
___________ ___________ ___________ ___________
<FN>
See accompanying notes to condensed consolidated financial statements.
</FN>
</TABLE>
Page 4 of 18
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<TABLE>
IMMUNOMEDICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
<CAPTION>
Nine Months Ended March 31,
1998 1997
______________ ______________
<S> <C> <C>
Cash Flows From Operating Activities:
Net loss $ (8,391,529) (10,808,208)
Adjustments to reconsile net loss to
net cash used in operating
activities:
Depreciation and amortization 716,864 852,731
Change in operating assets and
liabilities (1,028,129) (481,923)
______________ ______________
Net Cash Used In Operating
Activities $ (8,702,794) (10,437,400)
______________ ______________
Cash Flows From Investing Activities:
Purchase of marketable securities (10,345,629) (30,641,313)
Proceeds from maturities of
marketable securities 17,776,816 32,748,506
Additions to property and
equipment (208,040) (537,880)
______________ ______________
Net Cash Provided By
Investing Activities $ 7,223,147 1,569,313
______________ ______________
Cash Flows From Financing Activities:
Issuance of common stock, net 1,482,500 0
Exercise of stock options 164,813 210,947
______________ ______________
Net Cash Provided By Financing
Activities $ 1,647,313 210,947
______________ ______________
Increase / (Decrease) in cash
equivalents 167,666 (8,657,140)
Cash and cash equivalents at beginning
of period 6,013,355 13,646,000
______________ ______________
Cash and cash equivalents at end
of period $ 6,181,021 4,988,860
______________ ______________
______________ ______________
<FN>
See accompanying notes to condenced consolidated financial statements.
</FN>
</TABLE>
Page 5 of 18
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IMMUNOMEDICS, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(1) Basis of Presentation
The accompanying unaudited condensed consolidated financial statements
of Immunomedics, Inc. (the "Company"), which incorporate the Company's
wholly-owned subsidiary Immunomedics Europe, have been prepared in
accordance with generally accepted accounting principles for interim
financial information and the instructions to Form 10-Q and Rule 10-01
of Regulation S-X. Accordingly, the statements do not include all of
the information and footnotes required by generally accepted accounting
principles for complete financial statements. In the opinion of
management, all adjustments (consisting of normal recurring accruals)
considered necessary for a fair presentation have been included. The
balance sheet at June 30, 1997 has been derived from the audited
financial statements at that date. Operating results for the nine-month
period ended March 31, 1998 are not necessarily indicative of the
results that may be expected for the fiscal year ending June 30, 1998.
For further information, refer to the annual financial statements and
footnotes thereto included in the Company's Form 10-K for the fiscal
year ended June 30, 1997.
(2) Cash Equivalents and Marketable Securities
The Company considers all highly liquid investments with maturities of
three months or less, at the time of purchase, to be cash equivalents.
Included in other current assets at March 31, 1998 and June 30, 1997 is
accrued interest earned on cash equivalents and marketable securities
of $31,000 and $104,000, respectively.
(3) Income Taxes
The Company has never made payments of Federal or State income taxes
and does not anticipate generating book income in fiscal 1998;
therefore, no income taxes have been reflected for the nine-month
period ended March 31, 1998.
(4) Net Loss Per Share
Basic loss per share is based on net loss for the relevant period,
divided by the weighted average number of common shares outstanding
during the period.
Diluted loss per share is based on net loss for the relevant period,
divided by the weighted average number of common shares outstanding
during the period. Common share equivalents, such as outstanding stock
options, are not included in the computations since the effect would be
antidilutive.
Page 6 of 18
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IMMUNOMEDICS, INC.
Notes to Condensed Consolidated Financial Statements (Continued)
(Unaudited)
(5) Stockholders' Equity
On December 23, 1997, the Company entered into a structured Equity Line
Flexible Financing Agreement (the "Equity Line") with an investor (the
"Investor"), pursuant to which, subject to the satisfaction of certain
conditions, the Company may receive up to an aggregate of $30 million
over a 36-month period. During each three month period (each, an
"Investment Period"), the Company, subject to the satisfaction of
certain conditions, can require the Investor to purchase shares of the
Company's common stock for an aggregate purchase price of between $1.0
million and $2.5 million and the Investor, at its option, may purchase
additional shares of common stock for an aggregate purchase price of
$1.0 million. The Company retains the right to provide that no
purchases can be made in any given Investment Period. The Investor may
select the dates on which the purchase of shares of the Company's
common stock will occur. The purchase price per share to be paid by the
Investor for the shares of the Company's common stock acquired under
the Equity Line will equal 98% of the lowest sales price of the common
stock during the three trading days immediately preceding the notice of
purchase by the Investor. The Investor's obligation to purchase shares
of the Company's common stock under the Equity Line is subject to
various conditions, including, among other things, the price of the
Company's common stock being at least such price as the Company may
from time to time set as the minimum purchase price. In addition, the
Investor is not required to purchase, in any Investment Period, an
amount in excess of 8% of the product of the daily average value of
open market trading of the common stock and the number of trading days
in the Investment Period during either the current or immediately
preceding Investment Period. The Company has granted the Investor the
right to purchase additional $1.0 million during the Investment Period
ending May 31, 1998. As of March 31,1998, the Company had received
$1.5 million for which the Company issued 404,080 shares of common
stock. During the first Investment Period, which commenced March 1,
1998 through May 13, 1998, the Company has received total of $4.5
million for which the Company has issued 1,056,835 shares of common
stock.
In connection with entering into the Equity Line, the Investor received
a four-year warrant (the "Warrant") to purchase 50,000 shares of the
Common Stock at an exercise price equal to $7.5375 per share (180% of
closing sales price of Common Stock at the time of issuance). In
addition, the Company has agreed to issue to the Investor, at the end
of each calendar year an additional four-year warrant (each, an
"Additional Warrant" and collectively, the Additional Warrants") to
purchase Common Stock in an amount equal to 5,000 shares for each
$500,000 of Common Stock purchased by the Investor during such year.
The exercise price will be equal to 180% of the weighted average
purchase price of the Common Stock purchased by the Investor during the
year, provided that the number of shares issuable upon exercise of all
the Additional Warrants will not exceed 125,000.
Page 7 of 18
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IMMUNOMEDICS, INC.
Notes to Condensed Consolidated Financial Statements (Continued)
(Unaudited)
On June 27, 1996, the Company completed an equity financing pursuant to
Regulation S under the Securities Act of 1933, pursuant to which
several foreign investors purchased 200,000 shares of 5% Series D
Convertible Preferred Stock (the "Series D Preferred") for $10,000,000.
The terms of the transaction allow the investors, at their discretion,
to convert the Series D Preferred into shares of the Company's common
stock during a twenty-four month period beginning in June 1996, at a
price equal to 89% of the average market price per share over a 20-day
trading period surrounding the date of conversion. As of May 13, 1998,
all of the 200,000 shares of Series D Preferred had been converted into
1,795,771 shares of common stock.
(6) License and Distribution Agreements
On November 24, 1997, the Company entered into a Distribution Agreement
with Eli Lilly Deutschland GmbH ("Lilly") pursuant to which Lilly
packages and distributes LeukoScan(R) within the countries comprising
the European Union and certain other countries subject to receipt of
regulatory approvals. Also, effective April 6, 1998, Lilly began
packaging and distributing CEA-Scan within the countries comprising the
European Union. The Company will pay Lilly a service fee based
primarily on the number of units of product packaged and shipped. The
parties contemplate that other Company products may be handled under
this arrangement when appropriate.
On August 2, 1995, the Company announced that its Development and
License Agreement with Pharmacia, Inc. (which subsequently became
Pharmacia & Upjohn Inc.- "Pharmacia") was terminated and the Company
regained the North American marketing and selling rights for CEA-Scan.
The Company and Pharmacia were subsequently unable to agree on the
amount owed to the Company as a result of termination. In June, 1996,
the Company filed a claim against Pharmacia before the American
Arbitration Association. On November 28, 1997, the Company was awarded
$1.8 million, including interest, which was recognized as revenue
during the quarter ended December 31, 1997. Additionally, the Company
recognized as revenue a portion of funds previously received from
Pharmacia pertaining to CEA-Scan clinical trials for which the Company
no longer has an obligation. Such amounts had been recorded as deferred
revenue.
In March 1995, the Company entered into a License Agreement with
Mallinckrodt Medical B.V., pursuant to which Mallinckrodt Medical B.V.
undertook to market, sell and distribute CEA-Scan(R) throughout Western
Europe and in specified Eastern European countries, subject to receipt
of regulatory approval in the specified Eastern European countries. In
April 1996, the Company entered into a U.S. Marketing and Distribution
Agreement with Mallinckrodt Medical, Inc. Pursuant to which
Mallinckrodt Medical, Inc. undertook to market,
Page 8 of 18
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IMMUNOMEDICS, INC.
Notes to Condensed Consolidated Financial Statements (Continued)
(Unaudited)
sell and distribute CEA-Scan for use in colorectal cancer diagnostic
imaging in the U.S. on a consignment basis. Effective as of April 6,
1998, the Company terminated the agreements with Mallinckrodt Medical
B.V. and Mallinckrodt Medical Inc.. In addition, effective as of April
30, 1998, the Company terminated its agreement with MMD Specialty
Services, Inc. and employed directly substantially all of the people
who previously comprised the contract sales force.
Effective as of April 6, 1998, the Company entered into a non-exclusive
Distributor and Product Service Agreement (the "Agreement") with Bergen
Brunswig Specialty Company ("BBSC") pursuant to which BBSC undertook to
provide product support services including distribution, order
management and customer services for CEA-Scan and other products as
agreed from time to time. The Company has agreed to sell CEA-Scan to
BBSC at a fixed price per vial, for resale to certain customers. The
Company has retained the right to sell CEA- Scan to certain national
accounts for which it has agreed to pay a service fee based primarily
on the number of units shipped. The Company and BBSC are currently
discussing a modification to the Agreement pursuant to which sales to
all customers would be made by BBSC on a consignment basis.
(7) Commitments and Contingencies
On February 1, 1994, the Company entered into a master lease agreement,
which was subsequently amended, pursuant to which the Company may lease
equipment for research, development and manufacturing purposes having
an aggregate acquisition cost of up to $2,200,000. The basic lease
payments under the master lease agreement are determined based on
current market rates of interest at the inception of each equipment
schedule take- down, and are payable in monthly installments over a
four-year period. The lease agreement contains an early purchase option
for each equipment schedule, at an amount which is deemed to be fair
value, exercisable no later than ninety days before the thirty-ninth
installment is due. On November 1, 1996, December 9, 1996, and April 1,
1997, the Company exercised the early purchase options on equipment
leased on February 14, 1994, April 1, 1994, and June 1, 1994,
respectively. Under the lease agreement, continued compliance with
certain financial ratios is required and, in the event of default, the
Company will be required to provide an irrevocable letter of credit
which is generally equal to the outstanding balance of lease payments
due at the time of default. As of March 31, 1998, the Company was not
in compliance with certain of these ratios, but the lessor has not yet
declared an event of default or requested a letter of credit. The
Company does not believe that such a request would have a material
adverse effect on the Company. As of April 30, 1998, the Company has
leased equipment with a cost basis aggregating $1,247,000 under the
master lease agreement. The Company has recorded lease expense for the
three and nine months ended March 31, 1998 of $87,000 and $261,000,
respectively.
Page 9 of 18
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IMMUNOMEDICS, INC.
Notes to Condensed Consolidated Financial Statements (Continued)
(Unaudited)
(8) Reclassification
Certain amounts previously reported have been reclassified to conform
to current year presentation.
Page 10 of 18
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IMMUNOMEDICS, INC.
Part I - Item 2.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Overview
Statements made in this Form 10-Q, other than those concerning historical
information, should be considered forward-looking and subject to various risks
and uncertainties. Such forward-looking statements are made based on
management's belief as well as assumptions made by, and information currently
available to, management pursuant to the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995. The Company's actual results may
differ materially from the results anticipated in these forward-looking
statements as a result of a variety of factors, including those identified in
"Business" and elsewhere in the Company's Annual Report on Form 10-K for the
fiscal year ended June 30, 1997.
Since its inception, the Company has been engaged primarily in the research and
development and, more recently, the commercialization of proprietary products
relating to the detection, diagnosis and treatment of cancer and infectious
diseases. On June 28, 1996, the U.S. Food and Drug Administration ("FDA")
licensed CEA-Scan for use with other standard diagnostic modalities for the
detection of recurrent and/or metastatic colorectal cancer. On October 4, 1996,
the European Commission granted marketing authorization for use of the product
in the 15 countries comprising the European Union for the same indication. On
September 16, 1997, the Company received a notice of compliance from the Health
Protection Branch permitting it to market CEA-Scan in Canada for colorectal
cancer for recurrent and metastatic colorectal cancer.
On December 19, 1996, the Company filed a Biologics License Application for
LeukoScan with the FDA for the same indication approved in Europe, plus an
additional indication for the diagnosis of acute, atypical appendicitis. On
February 14, 1997, the Company was granted regulatory approval by the European
Commission to market LeukoScan, an in vivo infectious disease diagnostic imaging
product, in all 15 countries which are members of the European Union, for the
detection and diagnosis of osteomyelitis (bone infection) in long bones and in
diabetic foot ulcer patients. The Company has also been pursuing the broadening
of its approval for LeukoScan in Europe to include the acute, atypical
appendicitis indication. As with all filings, there can be no assurance that
regulatory approval for such indications will be received.
The Company is also engaged in developing other biopharmaceutical products,
which are in various stages of development and clinical testing. The Company has
not achieved profitable operations and does not anticipate achieving profitable
operations during fiscal year 1998. The Company will continue to experience
operating losses until such time, if at all, that it is able to generate
sufficient revenues from sales of CEA-Scan, LeukoScan and its other proposed in
vivo products. Further, the Company's working capital will continue to decrease
until such time, if at all, that the Company is able to generate positive cash
flow from operations or until such time, if at all, that the Company receives an
additional infusion of cash from the sale of the Company's securities, from
other financing or from corporate alliances to finance the Company's operating
expenses and capital expenditures.
Page 11 of 18
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Results of Operations
Revenues for the nine-month period ended March 31, 1998 were $6,171,000 as
compared to $2,629,000 for the same period in 1997, representing an increase of
$3,542,000. The product sales for the nine-month period ended March 31, 1998
increased by $2,294,000 as compared to the same period of 1997, as the product
launch for CEA-Scan and LeukoScan did not occur until October 1996 and April
1997, respectively. Royalties and license fees for the nine-month period ended
March 31, 1998 decreased by $557,000 primarily due to the receipt of a
non-recurring $500,000 license fee from a corporate partner in July 1996.
Research and development revenue for the nine-month period ended March 31, 1998
increased by $603,000 as compared to same period of 1997, due to higher grant
income and recognition of previously deferred revenue received from Pharmacia &
Upjohn. Interest and other income for the nine-month period ended March 31, 1998
increased by $1,202,000, primarily due to the receipt of an arbitration award of
$1.8 million, including interest, in its dispute with Pharmacia & Upjohn, offset
by a decrease in interest income of $615,000 due to less cash available for
investments.
Revenues for the three-month period ended March 31, 1998 were $1,260,000 as
compared to $852,000 for the same period in 1997, representing a increase of
$408,000. The product sales for the three-month period ended March 31, 1998
increased by $673,000 as compared to the same period of 1997, as the product
launch for CEA-Scan and LeukoScan did not occur until October 1996 and April
1997, respectively. Research and development revenue for the three-month period
ended March 31, 1998 decreased by $36,000 as compared to same period of 1997
primarily due to reduced deferred revenue recognition. Interest and other income
for the three-month period ended March 31, 1998 decreased by $217,000, primarily
due to less cash available for investments.
Total operating expenses for the nine-month period ended March 31, 1998 were
$14,563,000 as compared to $13,437,000 for the same period in 1997, representing
an increase of $1,126,000. Research and development costs for the nine-month
period ended March 31, 1998 decreased by $1,178,000 as compared to the same
period in 1997, primarily due to a decrease in the level of expenditures
required to obtain validation of the Company's new manufacturing facility and
lower cost associated with reduced patient enrollment for clinical trials. Sales
and marketing expenses for the nine-month period ended March 31, 1998 increased
by $2,565,000 primarily due to expenses of $1,183,000 associated with the
Company's full-time oncology sales force provided by MMD Specialty Services,
Inc. and operating expenses for Immunomedics Europe which increased by
$1,088,000 as compared to the same period of 1997. General and administrative
costs for the nine-month period ended March 31, 1998 decreased by $396,000 as
compared to the same period of 1997, primarily due to reduced legal costs as a
result of the conclusion of the Pharmacia & Upjohn arbitration which was settled
in November 1997.
Total operating expenses for the three-month period ended March 31, 1998 were
$4,596,000 as compared to $4,904,000 for the same period in 1997, representing a
decrease of $308,000. Research and development costs for the three-month period
ended March 31, 1998 decreased by $673,000 as compared to the same period in
1997, primarily due to a decrease in the level of expenditures required to
obtain validation of the Company's new manufacturing facility and lower cost
associated with reduced
Page 12 of 18
<PAGE>
Results of Operations (Continued)
patient enrollment for clinical trials. Sales and marketing expenses for the
three-month period ended March 31, 1998 increased by $707,000 primarily due to
expenses of $460,000 associated with the Company's full-time oncology sales
force provided by MMD Specialty Services, Inc. and operating expenses for
Immunomedics Europe which increased by $254,000 as compared to the same period
of 1997. General and administrative costs for the three-month period ended March
31, 1998 decreased by $414,000 as compared to the same period of 1997, primarily
due to reduced legal costs as a result of the conclusion of the Pharmacia &
Upjohn arbitration which was settled in November 1997.
Net loss for the nine-month period ended March 31, 1998 was $8,392,000, or $0.23
per share, as compared to a loss of $10,808,000, or $0.31 per share, for the
same period in 1997. The lower net loss of $2,416,000 in 1998 as compared to
1997 primarily resulted from higher revenues, partially offset by higher
operating expenses, as discussed above. In addition, the net loss per share for
the nine-month period ended March 31, 1998 was positively impacted by the higher
weighted average number of common shares outstanding for this period, as
compared to the same period in 1997. The increase in the weighted average number
of common shares outstanding was primarily due to the conversion of Preferred
Stock into the Company's Common Stock (see Note 5 to Unaudited Condensed
Consolidated Financial Statements).
Net loss for the three-month period ended March 31, 1998 was $3,336,000, or
$0.09 per share, as compared to a loss of $4,052,000, or $0.11 per share, for
the same period in 1997. The lower net loss of $716,000 in 1998 as compared to
1997 primarily resulted from higher revenues and reduced operating expenses, as
discussed above. In addition, the net loss per share for the three-month period
ended March 31, 1998 was positively impacted by the higher weighted average
number of common shares outstanding for this period, as compared to the same
period in 1997. The increase in the weighted average number of common shares
outstanding was primarily due to the conversion of Preferred Stock into the
Company's Common Stock (see Note 5 to Unaudited Condensed Consolidated Financial
Statements).
Liquidity and Capital Resources
At March 31, 1998, the Company had working capital of $5,518,000, which
represents a decrease of $6,235,000 from June 30, 1997, and had no long-term
debt other than certain lease obligations (see Note 7 to Unaudited Condensed
Consolidated Financial Statements). The net decrease in working capital resulted
principally from the funding of operating expenses and capital expenditures.
On February 1, 1994, the Company entered into a master lease agreement, which
was subsequently amended, pursuant to which the Company may lease equipment for
research, development and manufacturing purposes having an aggregate acquisition
cost of up to $2,200,000. The basic lease payments under the master lease
agreement will be determined based on current market rates of interest at the
inception of each equipment schedule take-down, and payable in monthly
installments over a four-year period. The lease agreement contains an early
purchase option for each equipment schedule, at an amount which is deemed to be
fair value, exercisable no later than ninety days before the thirty-ninth
installment is due. On November 1, 1996, December 9, 1996, and April 1, 1997,
the Company exercised the early purchase options on equipment leased on February
14, 1994, April 1, 1994, and June 1, 1994,
Page 13 of 18
<PAGE>
Liquidity and Capital Resources (Continued)
respectively. Under the lease agreement, continued compliance with certain
financial ratios is required and, in the event of default, the Company will be
required to provide an irrevocable letter of credit which is generally equal to
the outstanding balance of lease payments due at the time of default. As of
March 31, 1998, the Company was not in compliance with certain of these ratios,
but the lessor has not yet declared an event of default or requested a letter of
credit. The Company does not believe that such a request would have a material
adverse effect on the Company. As of April 30, 1998, the Company has leased
equipment with a cost basis aggregating $1,247,000 under the master lease
agreement (see Note 7 to Unaudited Condensed Consolidated Financial Statements).
The Company's liquid asset position, measured by its cash, cash equivalents and
marketable securities, was $7,760,000 at March 31, 1998, representing a decrease
of $7,264,000 from June 30, 1997. This decrease was primarily attributable to
the funding of operating expenses and capital expenditures as discussed above.
It is anticipated that working capital and cash, cash equivalents and marketable
securities will decrease during the remainder of fiscal year 1998 as a result of
planned operating and capital expenditures. At present, the Company believes
that its current cash resources and funds available under the Equity Line, as
described below, will be sufficient to fund anticipated operating expenses and
capital expenditures through fiscal year 1999.
On December 23, 1997, the Company entered into a structured Equity Line Flexible
Financing Agreement (the "Equity Line") with an investor (the "Investor"),
pursuant to which, subject to the satisfaction of certain conditions, the
Company may receive up to an aggregate of $30 million over a 36- month period.
During each three month period (each, an "Investment Period"), the Company,
subject to the satisfaction of certain conditions, can require the Investor to
purchase shares of the Company's common stock for an aggregate purchase price of
between $1.0 million and $2.5 million and the Investor, at its option, may
purchase additional shares of common stock for an aggregate purchase price of
$1.0 million. The Company retains the right to provide that no purchases can be
made in any given Investment Period. The Investor may select the dates on which
the purchase of shares of the Company's common stock will occur. The purchase
price per share to be paid by the Investor for the shares of the Company's
common stock acquired under the Equity Line will equal 98% of the lowest sales
price of the common stock during the three trading days immediately preceding
the notice of purchase by the Investor. The Investor's obligation to purchase
shares of the Company's common stock under the Equity Line is subject to various
conditions, including, among other things, the price of the Company's common
stock being at least such price as the Company may from time to time set as the
minimum purchase price. In addition, the Investor is not required to purchase,
in any Investment Period, an amount in excess of 8% of the product of the daily
average value of open market trading of the common stock and the number of
trading days in the Investment Period during either the current or immediately
preceding Investment Period (see Note 5 to Unaudited Condensed Consolidated
Financial Statements).
In addition to the funds available under the Equity Line, the Company believes
that it may require additional financial resources by the beginning of fiscal
year 2000 in order for it to continue its projected levels of research and
development and clinical trials of its proposed products and regulatory filings
for new indications of existing products.
Page 14 of 18
<PAGE>
Liquidity and Capital Resources (Continued)
In addition, the Company intends to supplement its financial resources from time
to time as market conditions permit through additional financing and through
collaborative marketing and distribution agreements. Also, the Company continues
to evaluate various programs to raise additional capital and to seek additional
revenues from the licensing of its proprietary technology. At the present time,
the Company is unable to determine whether any of these future activities will
be successful and, if so, the terms and timing of any definitive agreements.
Page 15 of 18
<PAGE>
Part II - Other Information
Item 2. Changes in Securities and Use of Proceeds.
As discussed above under "Management's Discussion and Analysis of Financial
Condition and Results of Operations - Liquidity and Capital Resources," on
December 23, 1997, the Company entered into the Equity Line. During the fiscal
quarter ended March 31, 1998, the Company issued 404,080 shares of its common
stock to the Investor and received gross proceeds of $1.5 million. The proceeds
from the Equity Line have been and will continue to be used for general
corporate purposes, including research and development, marketing, sales and
clinical and regulatory activities. The share of common stock issued to the
Investor under the Equity Line were offered for sale, and were sold, without
registration thereof under the Securities Act of 1933, pursuant to the exemption
from registration provided by Section 4 (2) under such Act.
On January 23, 1998, the Company adopted a standard Shareholder Rights Plan (the
"Plan"). Pursuant to the Plan, one Right was distributed as a dividend on each
outstanding share of the Company's common stock. Pursuant to the Plan, if a
party makes a tender offer to acquire 15% or more of the Company's common stock,
each Right will entitle shareholders, other than the acquiring party, to buy
one-hundredth of a share of a new series of junior participating preferred
stock, which is equivalent to one share of common stock. The exercise price is
$37 per Right. Should a party or group acquire 15% or more of the Company's
outstanding common stock, each Right will entitle its holder (other than such
acquiring party) to purchase, at the Right's exercise price, the Company's
common shares having a market value of twice the exercise price in lieu of
receiving preferred stock. Under those circumstances, the Board of Directors may
instead allow each Right (other than Rights owned by such acquiring party), to
be exchanged for one share of common stock. The exercising or exchanging of this
Right by Shareholders would have a substantial dilutive effect on the acquiring
party. The dividend distribution was made on February 2, 1998 to shareholders of
record on that date. The Rights will expire on January 23, 2008.
Page 16 of 18
<PAGE>
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits
10.27 Distribution and Product Services Agreement,
dated as of March 13, 1998, between
Immunomedics, Inc. and Alternate Site
Distributors, Inc. d.b.a. Bergen Brunswig
Specialty Company (Confidentiality treatment
has been requested for certain portions of
the Agreement).
27 Financial Data Schedule.
(b) Reports on Form 8-K
The Company did not file a Current Report on Form 8-K
during the three-month period ended March 31, 1998.
Page 17 of 18
<PAGE>
SIGNATURES
Pursuant to the requirements 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.
IMMUNOMEDICS, INC.
(Registrant)
DATE: May 13, 1998 /s/ David M. Goldenberg
------------------------
David M. Goldenberg,
Chairman of the Board and
Chief Executive Officer
(Principal Executive Officer)
DATE: May 13, 1998 /s/ Kevin F.X. Brophy
----------------------
Kevin F.X. Brophy,
Vice President, Finance &
Administration (Principal Financial and
Accounting Officer)
Page 18 of 18
<PAGE>
Exhibit 10.27
DISTRIBUTOR AND PRODUCT SERVICES AGREEMENT*
Dated March 13, 1998
Between
ALTERNATE SITE DISTRIBUTORS, INC.
d.b.a. BERGEN BRUNSWIG SPECIALTY COMPANY
and
IMMUNOMEDICS, INC.
___________
* Confidential portions omitted and filed separately with the Securities
and Exchange Commission.
<PAGE>
DISTRIBUTOR AND PRODUCT
SERVICES AGREEMENT
This Distributor and Product Services Agreement ("Agreement") made this
13th day of March, 1998 by and between ALTERNATE SITE DISTRIBUTORS, INC. d.b.a.
BERGEN BRUNSWIG SPECIALTY COMPANY ("BBSC") and IMMUNOMEDICS, INC. ("IMMU").
RECITALS
A. IMMU is a biopharmaceutical Company that manufactures and sells
pharmaceutical products including CEA-Scan(R) (the "Product") which has
U.S.F.D.A.
approval for human use.
B. BBSC is in the business of providing distribution and product
service support services to drug manufacturers and other sectors of the
healthcare industry.
C. IMMU desires to engage BBSC to provide product support services
including Distribution Services, Order Management and Customer Services for the
Product and such other IMMU products as the parties may agree from time to time
to add by addendum hereto.
NOW THEREFORE, for good and valuable consideration the receipt and
sufficiency of which is hereby acknowledged, the parties hereto agree as
follows:
1. Appointment
1.1 IMMU hereby appoints BBSC as its non-exclusive distributor
of Product in the U.S.A. and the U.S. territories. BBSC represents and warrants
that it has the facilities and personnel necessary to satisfactorily and timely
perform the services to be provided by it under this Agreement.
1.2 IMMU hereby engages BBSC to provide the services described
in the Agreement for the fees listed in Schedule "A" attached hereto and by this
reference made a part hereof.
2. Distribution Services
For the fees listed in Schedule "A", BBSC will provide the
following services:
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2.1 Order Process Management.
BBSC will provide customer service representatives to
perform the following order process management activities.
2.1.1 staffing during normal customer service hours
(8:00 a.m. CT to 6:00 p.m. CT) including a live operator greeting;
2.1.2 management of inbound telephone calls, faxes
and EDI transmissions relating to ordering, marketing and distribution;
2.1.3 twenty-four (24) hour availability in an
integrated voicemail pager service seven (7) days per week;
2.1.4 new account processing, including credit
verification; and
2.1.5 coordinating inquiries regarding technical,
clinical and medical issues and referring directly to IMMU to assure an
appropriate response by IMMU.
2.2 Distribution/Warehousing.
BBSC will provide distribution and warehousing
services to IMMU for IMMU's national accounts and IMMU's independent accounts as
defined below:
2.2.1 IMMU's national accounts shall mean [*] and, on
[*] days notice to BBSC, any other entities which IMMU may designate from time
to time ("National Accounts") including, without limitation, any multi-site
organization desiring to enter into a supply agreement with IMMU and meeting
IMMU's requirements therefor.
2.2.2 IMMU's independent accounts shall mean
hospital, clinic and independent pharmacy customers of IMMU and all other IMMU
customers not designated as National Accounts ("Independent Accounts").
2.2.3 For National Accounts BBSC will provide the
following distribution and warehouse services as consignee of the Product:
2.2.3.1 Acceptance of orders from IMMU or
direct from the National Account, as designated by IMMU, in "lot" quantities of
[*] doses/lot or greater.
2.2.3.2 Packaging and shipping of the
designated quantity to the National Account, to that account's central
warehouse, or on request, and for
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<PAGE>
an additional fee to be billed to the National Account, drop shipped to
individual pharmacies.
2.2.3.3 Submission of orders, associated
documentation (including manufacturing lot numbers and shipping information)
and inventory status on a daily basis by fax or electronic transmission.
2.2.3.4 Maintenance of the database
required to facilitate a recall, in accordance with FDA guidelines and
requirements should that ever become necessary.
2.2.4 For Independent Accounts, BBSC will provide the
following distribution and warehouse services as the purchaser and subsequent
owner of the Product:
2.2.4.1 Reception of incoming orders,
either direct or through an IMMU-to-BBSC "tie line".
2.2.4.2 Purchasing from IMMU the doses
required to meet those orders on a timely basis.
2.2.4.3 Packaging and shipping ordered
doses to the Independent Accounts.
2.2.4.4 Maintenance of the database
required to facilitate a recall, in accordance with FDA guidelines and
requirements should that ever become necessary.
2.2.4.5 Billing and collection of these
Independent Accounts.
2.2.4.6 Transmission of weekly and monthly
sales reports, by account, to IMMU.
2.2.5 For both National Accounts and Independent Accounts,
BBSC will warehouse and inventory the Product at BBSC's distribution facility at
[*] (the "BBSC Facility"). Product that has met all regulatory product release
requirements will be received, and placed into inventory for distribution. BBSC
and IMMU will comply with all FDA regulations including product lot record
retention. Distribution and warehousing services include the following:
2.2.5.1 Continuous inventory maintenance;
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<PAGE>
2.2.5.2 Invoicing Independent Accounts on
BBSC invoice stock;
2.2.5.3 Shipment tracking;
2.2.5.4 Security costs;
2.2.5.5 Drop shipments; and
2.2.5.6 Shipment of outdated/damaged goods
to site of disposal in accordance with the FDA regulations.
IMMU will pay all costs, expenses, insurance, and
import duties, if any, for delivery of all Product to the BBSC facility. BBSC
will visually inspect each shipment of Product for external container or package
damage or loss in transit (based upon records provided to BBSC from IMMU).
Contingent upon BBSC receiving the appropriate records to enable batch
verification, BBSC shall notify IMMU when damage or loss has occurred within
three business days of receipt of Product by BBSC. BBSC will store and ship all
Product in compliance with good manufacturing practice guidelines and other FDA
requirements. BBSC will store Product at 2(degree) to 8(degree) centigrade at
all times.
Upon receipt of the order transmission from customer
service Product will be shipped in regulatory compliant refrigerated shippers
(which will be directed to maintain the required temperature). Orders received
by [*] will be shipped the [*]. Products will be distributed on an FEFO (first
expired, first out) basis.
2.3 Emergency Deliveries. In emergencies Product will be
shipped same day if necessary and costs will be passed through to the customer.
3. Data Management and Reporting (Key Program Activity and
Management Reports)
The following types of reports will be available to IMMU for
the fees listed in Schedule "A" attached hereto:
3.1 transmission of daily sales by unit and dollars
3.2 sales reports by territory/region
3.3 inventory reports
3.4 credits
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<PAGE>
3.5 new accounts
3.6 chargeback, rebate data
3.7 program utilization data including call volume, type of
caller and reason for inquiry down to the state level and/or sales territory
level
IMMU and BBSC will jointly determine the types of
reports, data elements and formats, and the frequency of reports that will be
required to provide key management and program oversight information. MMU shall
receive up to [*] of the above standard reports without additional charge. There
will be additional charges for any further reports requested, based upon
programming charges.
4. Recalls
4.1 In the event that it becomes necessary to conduct a
recall, market withdrawal or field correction (a "Recall") of any Product, IMMU
shall conduct the Recall and shall have primary responsibility therefor, and
BBSC shall cooperate with IMMU in recalling any affected Product. If the Recall
was due to the acts or omissions of IMMU, then IMMU shall pay or reimburse, as
the case may be, all of BBSC's direct out-of-pocket expenses, including but not
limited to any reasonable attorney's fees and expenses, incurred by BBSC in
connection with performing any such Recall. If the Recall was due to the acts or
omissions of BBSC then BBSC shall pay or reimburse, as the case may be, all of
IMMU's direct out-of-pocket expenses, including but not limited to any
reasonable attorneys fees or expenses, incurred by IMMU in connection with
performing any such Recall. Each of the parties shall use its reasonable best
efforts to minimize the expenses of Recall when it occurs. IMMU shall inform
BBSC of the proposed Recall within forty-eight (48) hours of the initiation of
the Recall. IMMU and BBSC will jointly develop Recall standard operating
procedures.
4.2 FDA Correspondence and Inspections
Each of the parties shall provide the other with a
copy of any correspondence or notices received by such party from FDA
specifically relating to distribution of the Product within three (3) days
of receipt. Each party shall also provide the other copies of any responses to
any such correspondence or notices within three (3) days of making the response.
BBSC shall notify IMMU of any FDA inspections of BBSC's facilities specifically
relating to any of the Product and, if reasonably possible, shall afford IMMU
the opportunity to be present at such inspection.
5. Purchase of Product/Risk
5.1 For Independent Accounts, upon execution of this
Agreement:
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<PAGE>
5.1.1 IMMU shall sell Product to BBSC on terms
as set out in Schedule "A". The price stated in Schedule "A" may be changed by
IMMU upon [*] days prior written notice to BBSC. BBSC shall buy such quantities
of Product from IMMU as required to satisfy its obligations hereunder.
5.1.2 BBSC will obtain title to all Product on
receipt and acceptance of the Product at the BBSC Facility. BBSC shall insure
Product in its control against loss in shipment from the BBSC Facility, damage
or natural catastrophes, acts of God or other reasons of force majeure.
5.2 For National Accounts, upon execution of this
Agreement:
5.2.1 IMMU shall deliver, and BBSC shall accept,
such quantities of the Product as shall be necessary for BBSC to fill orders for
the Product and to meet the inventory requirement of National Accounts. All
Product delivered to BBSC for IMMU for National Accounts will be held by BBSC on
consignment and will remain at all times under and subject to the ownership,
direction and control of IMMU until sold through BBSC to the National Accounts.
Pricing for sales to national accounts shall be established by IMMU and, in
recognition of certain marketing, training, product preparation and other
services which will be performed by National Accounts in respect of the Product,
may well differ from those set out in Schedule "A". Title to the Product held by
BBSC on consignment will pass directly from IMMU to the National Accounts who
purchase the Product through BBSC. IMMU shall bear the risk of loss of the
Product not yet delivered by BBSC to a customer, whether by fire, theft or other
casualty; provided, however, that BBSC shall indemnify IMMU for Product which is
lost or damaged as a result of BBSC's negligence. During the term of this
Agreement, BBSC will store Product at its Facility in [*] and possibly at its
facilities in [*], BBSC shall notify IMMU promptly of any changes or additions
to the locations at which supplies of the Product will be maintained.
5.3 Return Goods Policy
5.3.1 BBSC shall accept returns from customers only
pursuant to SOPs agreed between IMMU and BBSC. BBSC shall forward unusable
Product to IMMU for final disposition in accordance with applicable regulations.
IMMU's sole obligation with respect to returned units of Product shall be to
replace such units at its expense (or, at IMMU's option, to issue a credit
therefore) in accordance with the SOPs.
5.3.2 IMMU shall replace at its expense, upon
expiration of the use period thereof, any unit of Product for which the expiry
date shall have occurred.
5.3.3 IMMU shall replace at its expense any unit of
the Product which is received by BBSC from IMMU in unsalable condition, provided
notice thereof
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<PAGE>
is given to IMMU within thirty (30) days of receipt by BBSC. Such replacement
unit will be delivered to BBSC within ten (10) days of receipt by IMMU of BBSC's
notice.
5.3.4 The parties agree to review the Return Goods
Policy in light of their experience with such policy and to make appropriate
revisions therein when necessary, such revisions to be agreed to in writing.
6. Certain Obligations of the Parties
6.1 IMMU and BBSC will jointly develop standard operating
procedures ("SOP's") in accordance with IMMU directives and consistent with FDA
regulations within thirty (30) days from execution of this Agreement.
6.2 IMMU will deliver Product in boxes containing one (1)
vial per box.
6.3 IMMU will provide package inserts for all single vial and
other quantities.
6.4 IMMU warrants and represents to BBSC that the execution
and performance of this Agreement will not breach any existing contracts or
arrangements that IMMU has entered into with any third parties including but not
limited to Mallinckrodt, Inc.
BBSC understands that IMMU has terminated its
distribution arrangements with Mallinckrodt Medical, Inc., effective April 5,
1998, or such earlier date as shall be feasible. BBSC and IMMU shall cooperate
in the transition of the distribution function from Mallinckrodt to BBSC.
6.5 IMMU will provide dedicated sales personnel to be the BBSC
account manager for all communications regarding this Agreement.
6.6 IMMU will assist BBSC in training BBSC personnel
concerning CEA-Scan.
7. Term And Termination
7.1 Initial Term
This Agreement shall be effective on April 6, 1998,
or such earlier date as IMMU's distribution arrangements with Mallinckrodt shall
terminate or Mallinckrodt shall otherwise onsent, and shall continue in full
force and effect thereafter for a period of [*] from such effective date unless
sooner terminated as provided herein. This Agreement shall automatically renew
for successive [*] periods unless terminated as provided herein.
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<PAGE>
7.2 Termination
This Agreement may be terminated by either party
without cause on ninety (90) days written notice to the other.
7.3 A party may terminate this Agreement immediately upon
written notice for the following causes:
7.3.1 the commencement of a voluntary case or other
proceeding seeking liquidation, reorganization or other relief with respect to
the other party of its debts under any bankruptcy, insolvency, corporation or
other similar law now or hereafter in effect; or (ii) the other party's making a
general assignment for the benefit of creditors, or the other party's becoming
insolvent, or the other party taking any corporate action to authorize any of
the foregoing;
7.3.2 the other party's failure to pay any amount
that is due to the non-breaching party under this Agreement and such failure
continues for seven (7) days after the other party receives notice of such
breach from the non-breaching party;
7.3.3 the other party's failure to perform any of
its material obligations under this Agreement, and such failure continues for
thirty (30) days after the other party receives notice of such breach from the
non-breaching
party; provided, however, if the other party has commenced to cure such breach
within such thirty (30) days, but such cure is not completed within said thirty
(30) days, the other party shall be afforded the amount of additional time
reasonably necessary to complete said cure, provided that the other party
diligently pursues curing the breach until completion; and
7.3.4 the other party's failure to perform the
distribution services as described in Section 2.0 for a period of more than
thirty (30) days as a result of a force majeure event specified in Section 22.
7.4 For the purposes of Section 7.3.3 above, the failure of
performance by BBSC hereunder shall be measured against mutually agreed S.O.Ps
and program performance measures.
7.5 All accrued payment obligations of the parties under this
Agreement, and Sections 11 through 15, inclusive, of this Agreement shall
survive the termination of this Agreement and, except as provided elsewhere in
this Agreement, no termination of this Agreement shall affect any obligations or
liabilities arising, or based upon acts or omissions occurring, prior to the
date of such termination. All fees shall be non-refundable. Within thirty (30)
days of termination, for whatever cause or no cause, for Independent Accounts
Product, IMMU shall repurchase all inventory
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<PAGE>
sold to BBSC at BBSC's acquisition cost and for National Accounts Product, BBSC
shall return to IMMU or destroy, in accordance with IMMU's instructions and at
IMMU's cost, all inventory of Product previously consigned to BBSC and not sold
to customers. If BBSC shall have terminated this Agreement without cause, or if
IMMU shall have terminated for cause, BBSC shall pay the freight costs to
deliver such inventory to IMMU. If this Agreement shall have terminated for any
other reason, IMMU shall pay the reasonable freight costs to deliver such
inventory to IMMU.
8. Disaster Recovery
BBSC and IMMU shall cooperate to develop a disaster recovery
service specific to IMMU's needs during the implementation process. This shall
be drafted as a standard operating procedure ("SOP").
9. Compensation - Fees for Services
9.1 Consignment Distribution Fee
IMMU shall pay fees to BBSC as detailed in Schedule
"A". BBSC shall invoice IMMU within [*] days of the previous calendar month
end. IMMU shall pay all invoices within [*] days of the invoice date.
9.2 Hourly Fees
In addition to the fees for services detailed in
Sections 1 and 2, the following services will be provided by BBSC on an as
required basis and shall be billed at the rate of [*] per hour as listed in
Schedule "A":
The provision of custom sales reports requested by
IMMU for specific territories and/or time periods. The creation of software
designed to produce such custom sales reports and all other services required
by IMMU for the provision of custom management report set-up. A reasonable
estimate of such charge shall be provided in advance.
9.3 Travel Costs
IMMU will pay to BBSC all reasonable costs incurred
while traveling for and on behalf of IMMU at IMMU's request. A reasonable
estimate of such charge shall be provided in advance.
9.4 Auditing Rights
BBSC shall keep records relating to the transactions
covered by this Agreement, which records shall be available for inspection by
IMMU to confirm
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<PAGE>
that the correct amounts have been paid under this Agreement. Such inspections
shall take place not more than once per year at BBSC's offices and on no less
than thirty (30) days notice and during normal business hours.
10. Compliance with Laws
10.1 During the term of this Agreement, each party shall
conduct its activities in connection with this Agreement in compliance with all
applicable laws. Specifically, BBSC shall comply with all applicable
Requirements of Law related to the storage, handling and distribution of
Product, and IMMU shall comply with all applicable Requirements of Law related
to the importation, manufacture, distribution, labeling, storage, sale and
handling of Product. IMMU shall have the right, not more than once per year and
on no less than thirty (30) days notice and during normal business hours, to
inspect BBSC's facilities to confirm compliance with all applicable Requirements
of Law related to the storage, handling and distribution of Product, provided
that IMMU acknowledges that such inspection shall be limited to such extent
required to comply with laws and to maintain the confidentiality of BBSC's other
customers and clients.
10.2 IMMU agrees and does hereby represent and warrant to BBSC
during the term of this Agreement that (1) all Product, and each shipment of
each, or other delivery now and hereafter made by IMMU to or on the order of
BBSC will not be, at the time of shipment or delivery, adulterated, misbranded
or otherwise prohibited within the meaning of the Act or within the meaning of
any applicable state or municipal law and (2) the Product is not, at the time of
shipment or delivery to BBSC, merchandise which may not be introduced or
delivered for introduction into interstate commerce under the provisions of
Sections 404 or 405 of the Act, and (3) all such Product will be the subject of
a duly approved BLA and may be legally transported or sold under applicable
Requirements of Law and IMMU guarantees that only those chemicals or sprays, and
the amounts of such chemicals or sprays, approved by Governmental Authority,
have been used in any of the Product, and (4) ail Product have been duly
approved by all Governmental Authority for commercial sale and shipment within
the United States.
11. Corporate Authority
During the term of this Agreement, each party continually
represents and warrants to the other that: (a) it has full power and authority
to enter into this Agreement and perform and observe all obligations and
conditions to be performed or observed by it under this Agreement without any
restriction by any other agreement or otherwise, (b) the execution, delivery and
performance of this Agreement have been duly authorized by all necessary
corporate action of that Party, (c) this Agreement constitutes the legal, valid
and binding obligation of that Party, (d) no approvals, consents, orders or
authorizations of or designation, registration, declaration or filing
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<PAGE>
with any Governmental Authority (within, as a part of, or constituting the
United States of America) is required for the sale and distribution of the
Product other than any approvals previously obtained from the FDA, (e) there is
no action, proceeding, or investigation pending or, so far as each party knows,
threatened, which questions the validity of this Agreement, the patents and
licenses related to and for the Product, any actions taken or to be taken
pursuant to this Agreement, and (f) the Product, or any part thereof, has not
been materially adversely affected in any way as a result of any legislative or
regulatory change, or any revocation of license or right to manufacture,
distribute, handle, store, sell or market any of the Product.
12. Trade Marks/Data
Neither Party shall have the right to use the name of the
other Party or the other Party's trademarks, service marks, logos, other similar
marks or data and information in any manner except to the extent necessary to
allow each party hereto to carry out their respective obligations as
contemplated herein, without the prior written approval of the other Party. Data
and information which shall be deemed to belong to IMMU will be its proprietary
information and data relating to the Product, the identity of Product customers,
prescribing physician data and the identity of payor coverage and reimbursement
policy data related to Product. Data and information which shall be deemed to
belong to BBSC shall be the data and information related to services offered and
sold by BBSC and all data and information relating to any of BBSC's customers
and their respective profiles.
13. Confidentiality
13.1 Each Party acknowledges that as a result of this
Agreement, that each Party shall learn Confidential Information of the other
Party. Each party shall treat Confidential Information furnished by the other
party as if it were its own proprietary information, and neither Party shall
disclose any Confidential Information of the other Party to any person or
entity, or use, or permit any person or entity to use, any of such Confidential
Information, excepting only: (a) disclosures on a confidential basis to and use
by the directors, officers, employees, and agents of that Party, or its
affiliates, who have a reasonable need to know such information in connection
with that Party's performance of this Agreement and who agree to keep such
information confidential, and (b) disclosures which are required by law, or
legal process, as reasonably determined by that Party or its legal counsel, or
are made on a confidential basis to that Party's attorneys, accountants, and
other professional advisors in connection with matters relating to this
Agreement. The specific material terms of this Agreement shall be deemed to be
Confidential Information of each Party.
13.2 The obligation of confidentiality hereunder shall survive
the termination of this Agreement for a period of five (5) years.
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13.3 Disclosure Required by Law. In the event that IMMU or
BBSC shall be required to make disclosure of the other's Confidential
Information as a result of the issuance of a court order or other government
process, the party subject to such requirement promptly, but in no event more
than forty-eight (48) hours after learning of such court order or other
government process, shall notify, by personal delivery, mail, express delivery
service, or facsimile, all pursuant to Section 16.0 hereof, the other party and,
at the other party's expense, the party subject to such requirements shall: (a)
take all reasonably necessary steps requested by the other party to defend
against the enforcement of such court order or other government process, and (b)
permit the other party to intervene and participate with counsel of its choice
in any proceeding relating to the enforcement thereof.
13.4 Advertising and Publicity. Except for such disclosures as
are deemed necessary in IMMU's or BBSC's, as the case may be, reasonable
judgment to comply with applicable law (such as, by way of example but not
limitation, the securities laws of the United States), each of IMMU and BBSC
agrees that neither it nor anyone acting on its behalf will make any publicly
disseminated oral or written disclosure relating to or referring to, or use any
advertising or publicity which relates or makes reference to, the other party,
this Agreement or the terms hereof, without in each case the other party's prior
approval (which approval will not be unreasonably withheld or delayed); each
party agrees to respond promptly to a disclosure request, but in any event not
later than five (5) business days from receipt of such a request.
13.5 Upon termination of this Agreement (for any reason) each
Party shall promptly: (i) return to the other Party or destroy all documentation
and other materials (including copies of original documentation or other
materials) containing any Confidential Information of the other Party; or (ii)
certify to the other Party, pursuant to a certificate in form and substance
reasonably satisfactory to the other Party, as to the destruction of all such
documentation and other materials.
14. Indemnification
14.1 Each Party shall indemnify, defend and hold harmless the
other and their respective Related Parties as defined in Appendix A attached
hereto and by this reference incorporated herein, from and against all claims,
liabilities, losses, damages, costs and expenses (including without limitation
reasonable attorneys' fees) arising directly or indirectly out of any act or
omission of that Party or any failure of that Party to perform and observe fully
all obligations and conditions to be performed or observed by that Party
pursuant to this Agreement or any breach of any warranty made by that Party in
this Agreement. Further, IMMU does hereby protect, indemnify and hold harmless
BBSC and its related parties from and against all claims, liabilities, losses,
damages, costs and expenses (including without limitation, reasonable attorneys'
fees and expenses) imposed upon or incurred by or asserted against BBSC related
to or arising from (1 ) any claim of patent or copyright infringement
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<PAGE>
relating to the subject matter of this Agreement, and (2) any loss of or damage
to property, accident, injury to or death of a person or persons occurring or
arising from the use, demonstration, consumption, ingestion, digestion,
manufacture, production and assembly, of the Product and its transportation to
BBSC, excepting only for claims arising out of the act, negligence or omission
of BBSC or its Related Parties. Further, BBSC does hereby agree to protect,
indemnify and hold harmless IMMU and its Related Parties from and against all
claims, liabilities, losses, damages, costs and expenses (including without
limitation, attorneys' fees and expenses) imposed upon or incurred by or
asserted against IMMU related to or arising from any loss of or damage to
property, accident, injury to or death of a person or persons occurring or
arising from the negligence of BBSC (or its Related Parties), excepting
herefrom, any act, negligence or omission of IMMU or its Related Parties.
NOTWITHSTANDING THE FOREGOING OR ANY OTHER PROVISION TO THE CONTRARY CONTAINED
IN THIS AGREEMENT, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY
CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, OR OTHER SIMILAR DAMAGES ARISING
OUT OF OR IN CONNECTION WITH A BREACH OF THIS AGREEMENT OR, EXCEPT AS SET FORTH
IN SECTION 7, ANY EXPENSES, CHARGES, COSTS OR LIABILITIES, WHETHER FORESEEN OR
UNFORESEEN, ARISING FROM OR RELATED TO THE ACT OF TERMINATING THIS AGREEMENT.
14.2 Each party shall give the other prompt notice of any
potential claim for indemnification hereunder, and promptly after receipt by a
party claiming indemnification under this Section 14.2 of notice of the
commencement of any action, such indemnified party will notify the indemnifying
party of the commencement of the action and generally summarize such action. The
indemnifying party shall have the right to participate in and to assume the
defense of such action with counsel of its choosing. An indemnifying party shall
not have the right to direct the defense in such an action of an indemnified
party if counsel to such indemnified party has reasonably concluded that there
may be defenses available to it that are different from or additional to those
available to the indemnifying party; provided, however, that in such event, the
indemnifying party shall bear the reasonable fees and expenses of separate
counsel reasonably satisfactory to the indemnifying party. The failure to notify
an indemnifying party promptly of the commencement of any such action, if
prejudicial to the ability to defend such action, shall relieve such
indemnifying party of any liability to the indemnified party under this Section
14.2. No settlement of any claim or action may be made without the consent of
the indemnifying party (which shall not be unreasonably withheld or delayed).
15. Insurance
During the term of this Agreement, IMMU will maintain product
liability and commercial general liability insurance having a limit of not less
than [*], pursuant to one or more insurance policies with reputable insurance
carriers. IMMU shall
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<PAGE>
designate BBSC as an "additional insured" under all insurance policies
referenced in this paragraph. As a condition precedent to the effectiveness of
this Agreement, IMMU shall execute the Guarantee in the form attached hereto as
Schedule "B".
BBSC shall provide IMMU with a certificate of insurance
showing that BBSC is a named insured covered by the commercial and general
liability policies of its parent company Bergen Brunswig Corporation.
16. Notices
Any notice or other communication required or desired to be
given to any Party under this Agreement shall be in writing and shall be deemed
duly made when: (a) delivered personally, (b) deposited in the United States
mail, first-class postage prepaid, and addressed to that Party at the address
for such Party set forth at the end of this Agreement; (c) delivered to an
express delivery service for delivery to that Party at that address; or (d) sent
by facsimile transmission, with electronic confirmation, to that Party at its
facsimile numbers set forth at the end of this Agreement. Any notice or
communication shall be deemed given and received on the date delivered
personally, three business days after mailing, one business day after delivery
to an express delivery service and upon electronic confirmation during
recipients normal business hours (or the next business day, if received
thereafter), if communicated by facsimile transmission. Any Party may change its
address or facsimile number for notices under this Agreement by giving the other
Party notice of such change.
17. Remedies
With respect to the provisions of Section 13 of this
Agreement, each Party acknowledges that in the event of any violation by that
Party of any of the provisions of Section 13 of this Agreement, the other Party
may suffer irreparable harm and its remedies at law may be inadequate.
Accordingly, in the event of any violation or attempted violation of any such
provisions of Section 13 by either Party, the other Party shall be entitled to
petition for a temporary restraining order, temporary and permanent injunctions,
specific performance, and other equitable relief. The rights and remedies of
each Party under this Agreement shall be cumulative and in addition to any other
rights or remedies available to such Party, whether under any other agreement,
at law, or in equity.
18. Governing Law and Attorneys Fees
All questions concerning the validity or meaning of this
Agreement or relating to the rights and obligations of the Parties with respect
to performance under this Agreement shall be construed and resolved under the
laws of the State of New York excluding the body of law relating to conflicts of
laws. In the event that either
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<PAGE>
party takes legal action to enforce its rights or remedies under this Agreement,
the prevailing party shall be entitled to recover its costs and expenses,
including reasonable attorneys' fees, incurred in such action.
19. Severability
The intention of the Parties is to comply fully with
all laws and public policies, and this Agreement shall be construed consistently
with all laws and public policies to the extent possible. If and to the extent
that any court of competent jurisdiction determines that it is impossible to
construe any provision of this Agreement consistently with any law or public
policy and consequently holds that provision to be invalid, such holding shall
in no way affect the validity of the other provisions of this Agreement, which
shall remain in full force and effect.
20. Tax Provision
Each party shall bear all taxes imposed on it as a
result of the performance by such party under this Agreement including, but not
limited to, any sales tax and tax on or measured by any payment required
to be made hereunder, any registration tax, or any tax imposed with respect to
the granting of other rights hereunder. The parties shall cooperate fully with
each other in obtaining and filing all requisite certificates and documents with
the appropriate authorities and shall take such further action as may be
reasonably necessary to avoid the deduction of any withholding or similar taxes
from any remittance of funds by one party to the other hereunder.
21. Non-Waiver
No failure by either Party to insist upon strict
compliance with any
term of this Agreement, to exercise any option, to enforce any right, or to seek
any remedy upon any default of the other Party shall affect, or constitute a
waiver of, the first Party's right to insist upon strict compliance, to exercise
that option, to enforce that right, or to seek that remedy with respect to that
default or any prior, contemporaneous, or subsequent default. No custom or
practice of the Parties at variance with any provision of this Agreement shall
affect, or constitute a waiver of, that Party's right to demand strict
compliance with all provisions of this Agreement.
22. Force Majeure
If the performance of any part of this Agreement by
either Party shall be affected for any length of time by fire or other casualty,
government restrictions, war, riots, strikes or labor disputes, lock out,
transportation delays, electronic disruptions, telecommunication failures, and
acts of God, or any other causes which are beyond the control of the Parties
(financial inability excepted), such
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<PAGE>
Party shall not be responsible for delay or failure of performance of this
Agreement for such length of time, provided, however, that the obligation of one
Party to pay amounts due to any other Party shall not be subject to the
provisions of this Section. Each party shall use its commercially reasonable
efforts to minimize the impact on the other of any force majeure event specified
in this Section.
23. Captions
The captions of the various sections of this
Agreement are not part of the context of this Agreement, and are only labels to
assist in locating those sections, and shall be ignored in construing this
Agreement.
24. Complete Agreement
This Agreement contains the entire agreement between
the Parties and supersedes all prior or contemporaneous discussions,
negotiations, representations, warranties, or agreements relating to the subject
matter of this Agreement. No changes to this Agreement shall be made or be
binding on either Party unless made in writing and signed by both Parties. All
schedules, Exhibits, Appendixes referred to in this Agreement are incorporated
herein and made a part hereof as fully as if set forth herein.
25. Successors
Except as set forth in this Section, neither Party
shall have the right to assign this Agreement or any of such Party's rights or
obligations under this Agreement without the prior written consent of the other
Party, which consent shall not be unreasonably withheld. After providing
written notice to IMMU, BBSC may assign this Agreement to a party that succeeds
to all or substantially all of BBSC's business or assets relating to this
Agreement whether by sale, merger, operation of law or otherwise.
26. Approvals
When this Agreement requires the approval of one or
both of the parties to this Agreement, each and every such approval sought will
not be unreasonably withheld by the party required to provide its approval.
27. Relationship of the Parties
The relationship of the Parties is and shall be that
of independent contractors. This Agreement does not establish or create a
partnership or joint venture among the Parties.
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<PAGE>
28. Interpretation
The parties have jointly negotiated this Agreement
and, thus, neither this Agreement nor any provision hereof shall be interpreted
for or against any party on the basis the party or the party's attorney drafted
the Agreement or the provision at issue.
This Agreement shall be binding upon, inure to the benefit of, and be
enforceable by and against the respective successors and assigns of the Parties.
IMMUNOMEDICS, INC. BERGEN BRUNSWIG SPECIALTY
COMPANY
By: s/ David M. Goldenberg By: s/ Randall A. Perry
Name: David M. Goldenberg Name: Randall A. Perry
Title: Chairman and Title: Vice President, Operations
Chief Executive Officer
Address and facsimile number: Address and facsimile number:
300 American Road 4006 Beltline Road
Morris Plains, New Jersey 07950 Suite 200
Attn: David M. Goldenberg, M.D. Addison, Texas 75244
Chairman and CEO Attn: Randall A. Perry
Facsimile: (973) 605-8282 Vice President, Operations
Facsimile: (888) 333-1529
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<PAGE>
APPENDIX A
As used in this Agreement,
"Act" means the Federal Food, Drug and Cosmetic Act, Title 21, United States
Code, as amended, and the regulations thereunder.
"BLA" means Biological License Application as defined in and contemplated by the
Act.
"Confidential Information" shall mean information, and data considered
confidential by the party owning such information, whether visual, oral or in
written form, but does not include (1 ) information which is or becomes public
without the fault or participation of the other party to this Agreement or which
is responsive to legal process or obligation, (2) any information lawfully in
the receiving party's possession prior to the date the receiving party receives
the disclosing party's information, or (3) any information which either party
receives from a third party who rightfully possesses and discloses such
information.
"Governmental Authority" shall mean any nation or government, any state or other
political subdivision thereof, or any entity exercising executive, legislative,
judicial, regulatory or administrative functions of or pertaining to government.
"Person" or "Persons" means any corporation, natural person, firm, joint
venture, partnership, trust, unincorporated organization, government or any
department or agency of any government.
"Related Parties" mean the successors, subsidiaries, parent corporations,
affiliates, Directors, employees, agents, representatives, related entities and
assigns of any Person.
"Requirement(s) of Law" means any law (including, without limitation, consumer
law), treaty, rule or regulation or a final and binding determination of an
arbitrator or a determination of a court or other Governmental Authority, in
each case applicable to or binding upon such Person or any of its property or to
which such Person or any of its property is subject.
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<PAGE>
SCHEDULE A
Fee Schedule
IMMU will sell CEA-Scan to BBSC at [*] Per vial. Terms
of payment shall be net [*] days. If during the first
[*] days of sales of Product by BBSC hereunder, the
average price of vials sold by BBSC is not at least
[*], IMMU will pay BBSC an amount equal to [*].
If IMMU's selling price to BBSC shall be increased
pursuant to Section 5.1.1, and the average price of
Vials sold by BBSC during the first [*] days of sales
by BBSC at the increased price is not at least [*] in
excess of BBSC's increased purchase price from IMMU,
IMMU will pay BBSC an amount equal to [*].
Consignment/Distribution Fee for National Accounts [*]
BBSC will store up to [*] pallets of refrigerated
product per month without charge. BBSC will assess a
monthly storage charge of [*] each for additional
pallets held for IMMU sale to National Accounts.
Customer reporting/software design [*]
Customer management report setup specific software
design requirements for customer beyond specific
reports) [*]
Travel on immunomedics' request [*]
Additional Costs Fee Schedule
Freight and Courier charges (Discounted Rate) [*]
Telecommunication, facsimile, Fed Ex/UPS and postage [*]
expenses
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<PAGE>
SCHEDULE B
CONTINUING GUARANTY AND INDEMNIFICATION AGREEMENT
The undersigned does hereby guarantee to Alternate Site Distributors, its parent
Bergen Brunswig Corporation ("BBC") and each of BBC's subsidiary corporations
(together the "Group") that each shipment or other delivery of any food, drugs,
devices, cosmetics, or other merchandise now or hereafter made by the
undersigned, its subsidiaries, divisions or affiliated companies to or on the
order of any member of the Group will not be, at the time of such shipment or
delivery, adulterated, misbranded, or otherwise prohibited within the meaning of
the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A. #301 et seq., as amended,
and in effect at the time of said shipment or delivery (the Act) or within the
meaning of any applicable state or municipal law in which the definition of
adulteration or misbranding are substantially the same as those contained in the
Act; and such merchandise is not, at the time of such shipment or delivery,
merchandise which may not be introduced or delivered for introduction into
interstate commerce under the provisions of section 404 or 405 of the Act (21
U.S.C.A. #344 and #355); and such merchandise is merchandise which may be
legally transported or sold under the provisions of any other applicable
federal, state or municipal law; and the undersigned guarantees further that
only those chemicals or sprays approved by federal, state or municipal
authorities have been used, and any residue in excess of the amount allowed by
any such authorities has been removed therefrom.
The undersigned hereby agrees to defend, indemnify and hold the Group harmless
against any and all claims, losses, damages, and liabilities whatsoever (and
expenses connected therewith, including reasonable counsel fees), arising as a
result of (a) any actual or asserted violation of the Act or any other federal,
state or local law or regulation by virtue of which products sold, supplied, or
delivered by the undersigned shall be alleged or determined to be adulterated,
misbranded, mislabeled or otherwise not in full compliance with any federal,
state or local law or regulation, and (b) the possession, distribution, sale
and/or use of, or by reason of the seizure of, any of the undersigned's
products, including any prosecution or action whatsoever by any government body
or agency or (subject to Section 14 of the Distributor and Product Services
Agreement between us) by any private party, including claims of bodily injury,
death or property damage. The undersigned further agrees to maintain primary and
noncontributing Products Liability Insurance of not less than [*] Combined
Single Limit (Bodily Injury and Property Damage) including each member of the
Group as Additional Insured as respects Broad Form Vendors Coverage, with
provision for at least 30 days prior written notice to the Additional Insured in
the event of cancellation or material reduction of coverage, and upon request
promptly submit satisfactory evidence of such insurance. The provisions
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<PAGE>
set forth herein are in addition to, and not in lieu of, any terms set forth in
any purchase orders accepted by the undersigned.
IMMUNOMEDICS, INC. s/ David M. Goldenberg March 13, 1998
- --------------------- -------------------------------------------------------
Guarantor(Name) Signature of Authorized Officer Date
Chairman and
David M. Goldenberg, Chief Executive Officer
Name and Title
300 American Road, Morris Plains, NJ 07950
Address of Company
(973) 605-8200
Phone
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<PAGE>
WARNING: THE EDGAR SYSTEM ENCOUNTERED ERROR(S) WHILE PROCESSING THIS SCHEDULE.
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<NAME> IMMUNOMEDICS, INC.
<MULTIPLIER> 1
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<PERIOD-TYPE> 9-MOS
<FISCAL-YEAR-END> JUN-30-1998
<PERIOD-START> JUL-01-1997
<PERIOD-END> MAR-31-1998
<CASH> 6,181,021
<SECURITIES> 1,578,986
<RECEIVABLES> 623,027
<ALLOWANCES> (18,398)
<INVENTORY> 630,730
<CURRENT-ASSETS> 9,735,787
<PP&E> 10,752,993
<DEPRECIATION> (5,568,624)
<TOTAL-ASSETS> 14,920,156
<CURRENT-LIABILITIES> 4,218,182
<BONDS> 0
0
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<COMMON> 368,188
<OTHER-SE> 10,333,786
<TOTAL-LIABILITY-AND-EQUITY> 14,920,156
<SALES> 2,858,553
<TOTAL-REVENUES> 6,171,090
<CGS> 147,180
<TOTAL-COSTS> 14,562,619
<OTHER-EXPENSES> 0
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> (8,391,529)
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