r<PAGE>
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
[ X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
MARCH 31, 1997
For the quarterly period ended ________________________________________________
or
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from _______________________________ to _____________
0-21330
Commission File Number:________________________________________________________
AVECOR CARDIOVASCULAR INC.
_______________________________________________________________________________
(Exact name of registrant as specified in its charter)
MINNESOTA 41-1695729
__________________________________________ ____________________________________
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
7611 NORTHLAND DRIVE, MINNEAPOLIS, MINNESOTA 55428
_______________________________________________________________________________
(Address of principal executive offices) (Zip Code)
(612) 391-9000
_______________________________________________________________________________
(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 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
As of May 5, 1997, there were 7,912,660 shares of the registrant's $.01
par value Common Stock outstanding.
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INDEX
<TABLE>
<CAPTION>
Part I. FINANCIAL INFORMATION Page
--------
<S> <C> <C>
Item 1. Financial Statements
Consolidated Balance Sheets as of March 31, 1997
(Unaudited) and December 31, 1996 3
Consolidated Statements of Operations for the
three month periods ended March 31, 1997 and
1996 (Unaudited) 4
Consolidated Statements of Cash Flows for the
three month periods ended March 31, 1997 and
1996 (Unaudited) 5
Notes to Consolidated Financial Statements
(Unaudited) 6 - 8
Item 2. Management's Discussion and Analysis of Financial
Condition and Results of Operations 9 - 14
Item 3. Quantitative and Qualitative Disclosures About
Market Risk 14
Part II. OTHER INFORMATION
Item 1. Legal Proceedings. 15
Item 2. Changes in Securities. 15
Item 3. Defaults Upon Senior Securities. 15
Item 4. Submission of Matters to a Vote of Security Holders. 15
Item 5. Other Information. 15
Item 6. Exhibits and Reports on Form 8-K. 15
SIGNATURES 16
EXHIBIT INDEX 17
</TABLE>
2
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PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
AVECOR CARDIOVASCULAR INC.
CONSOLIDATED BALANCE SHEETS
________________________
<TABLE>
<CAPTION>
ASSETS March 31, December 31,
1997 1996
---------- ------------
(Unaudited)
<S> <C> <C>
Current assets:
Cash and cash equivalents $2,287,000 $6,114,000
Short-term investments 4,837,000 2,638,000
Accounts receivable, net 8,431,000 7,298,000
Inventories 8,926,000 9,476,000
Deferred tax asset 1,274,000 1,274,000
Other current assets 617,000 744,000
----------- -----------
Total current assets 26,372,000 27,544,000
Restricted cash and investments - 4,450,000
Property, plant and equipment, net 13,734,000 4,808,000
Long-term cash investments 1,524,000 -
Other assets 399,000 359,000
----------- -----------
Total assets $42,029,000 $37,161,000
----------- -----------
----------- -----------
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $2,049,000 $2,790,000
Accrued expenses 2,753,000 3,091,000
Accrued litigation settlement 1,100,000 1,100,000
Current portion of long-term debt 258,000 -
----------- -----------
Total current liabilities 6,160,000 6,981,000
Deferred grant 183,000 205,000
Deferred tax liability 37,000 37,000
Long-term debt 4,888,000 -
Shareholders' equity:
Serial preferred stock, par value $.01 per share;
authorized 2,000,000 shares; none issued
Common stock, par value $.01 per share;
authorized 20,000,000 shares; issued and
outstanding shares 7,912,000 and 7,812,000
shares at March 31, 1997 and
December 31, 1996, respectively 79,000 78,000
Additional paid-in capital 29,623,000 29,024,000
Retained earnings 996,000 609,000
Cumulative translation adjustments 63,000 227,000
----------- -----------
Total shareholders' equity 30,761,000 29,938,000
----------- -----------
Total liabilities and shareholders' equity $42,029,000 $37,161,000
----------- -----------
----------- -----------
</TABLE>
The accompanying notes are an integral part of the
consolidated financial statements.
3
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AVECOR CARDIOVASCULAR INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
For the three months ended March 31,
------------------------------------------
1997 1996
-------------- ------------
Net sales $12,043,000 $10,293,000
Cost of sales 7,060,000 5,951,000
----------- -----------
Gross profit 4,983,000 4,342,000
Operating expenses:
Selling, general and
administrative 3,350,000 2,856,000
Litigation expense - 505,000
Research and development 1,102,000 841,000
----------- -----------
Operating income 531,000 140,000
Interest income 144,000 209,000
Interest expense 71,000 -
----------- -----------
Income before
income taxes 604,000 349,000
Income tax provision 217,000 136,000
----------- -----------
Net income $387,000 $213,000
----------- -----------
----------- -----------
Net income per share $0.05 $0.03
----------- -----------
----------- -----------
Weighted average common
and common equivalent
shares outstanding 7,946,000 7,890,000
----------- -----------
----------- -----------
The accompanying notes are an integral part of the
consolidated financial statements.
4
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AVECOR CARDIOVASCULAR INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
<TABLE>
<CAPTION>
For the three months ended March 31,
------------------------------------
1997 1996
--------------- --------------
<S> <C> <C>
Cash flows from operating activities:
Net income $387,000 $213,000
Adjustments to reconcile net income to net cash
used in operating activities:
Depreciation and amortization 342,000 345,000
Accretion of discount on investments (106,000) (165,000)
Changes in operating assets and liabilities:
Accounts receivable (1,275,000) (821,000)
Inventories 544,000 (1,544,000)
Other current assets 110,000 28,000
Accounts payable (313,000) 581,000
Accrued expenses (299,000) 387,000
--------------- --------------
Net cash used in operating activities (610,000) (976,000)
--------------- --------------
Cash flows from investing activities:
Purchase of property, plant and equipment (8,698,000) (432,000)
Purchase of investments (7,803,000) (5,951,000)
Proceeds upon sale or maturity of
short-term investments 4,186,000 2,981,000
Cash and investments restricted as to use 3,450,000 -
Increase in other assets (45,000) (11,000)
--------------- --------------
Net cash used in investing activities (8,910,000) (3,413,000)
--------------- --------------
Cash flows from financing activities:
Net proceeds from sales of common stock 71,000 58,000
Net proceeds from options exercised 529,000 (164,000)
Net proceeds from warrants excercised - 525,000
Borrowings on long-term debt 5,167,000 -
Principal payments on long-term debt (21,000) -
Grant proceeds - 101,000
--------------- --------------
Net cash provided by financing activities 5,746,000 520,000
--------------- --------------
Effect of exchange rates on cash (53,000) (19,000)
--------------- --------------
Net decrease in cash and cash equivalents (3,827,000) (3,888,000)
Cash and cash equivalents at beginning of period 6,114,000 9,178,000
--------------- --------------
Cash and cash equivalents at end of period $2,287,000 $5,290,000
--------------- --------------
--------------- --------------
Significant non-cash investing and financing
transactions:
Use of restricted funds for purchase of the
U.S. facility $1,000,000
--------------- --------------
--------------- --------------
</TABLE>
The accompanying notes are an integral part of the
consolidated financial statements.
5
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AVECOR CARDIOVASCULAR INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
--------------------------
1. BASIS OF PRESENTATION
The consolidated financial statements included in this Form 10-Q have been
prepared by AVECOR Cardiovascular Inc. (the Company), without audit, pursuant to
the rules and regulations of the Securities and Exchange Commission (SEC).
Certain information and footnote disclosures normally included in financial
statements prepared in accordance with generally accepted accounting principles
have been condensed, or omitted, pursuant to these rules and regulations. The
year-end balance sheet was derived from audited financial statements, but does
not include all disclosures required by generally accepted accounting
principles. These consolidated financial statements should be read in
conjunction with the financial statements and related notes included in the
Company's 1996 Annual Report on Form 10-K as filed with the SEC.
The consolidated financial statements presented herein as of March 31, 1997
and for the three month periods ended March 31, 1997 and 1996 reflect, in the
opinion of management, all adjustments (which include only normal, recurring
adjustments) necessary for a fair presentation of financial position and the
results of operations for the periods presented. The results of operations for
any interim period are not necessarily indicative of results for the full year.
2. ORGANIZATION
The Company was incorporated on December 13, 1990. The Company designs,
develops, manufactures and markets specialty medical devices for heart/lung
bypass surgery and long-term respiratory support.
The consolidated financial statements include the accounts of AVECOR
Cardiovascular Inc. and its wholly-owned subsidiaries, AVECOR Cardiovascular
Ltd. and AVECOR Foreign Sales Corporation after elimination of all significant
intercompany transactions and accounts.
3. LONG-TERM INVESTMENTS
Long-term investments consist of a corporate bond and a U.S. treasury
note. The Company's long-term investments are considered by management to be
"available for sale." At March 31, 1997, the estimated fair value of the
long-term investments approximated their carrying value. Unrealized gains
and losses were not significant.
6
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4. INVENTORIES
Inventories consist of the following:
March 31, December 31,
1997 1996
----------- ------------
(Unaudited)
Raw materials $3,601,000 $3,424,000
Work-in-process 2,158,000 2,343,000
Finished goods 3,167,000 3,709,000
----------- ------------
$8,926,000 $9,476,000
----------- ------------
----------- ------------
5. INDUSTRY SEGMENT INFORMATION
The Company distributes its products through its direct sales force and
independent sales representatives. Additionally, the Company distributes its
products through domestic and foreign independent distributors who then market
the products directly to medical institutions. No one independent distributor
accounted for 10% or more of the Company's net sales for the three months ended
March 31, 1997 and 1996.
6. NET INCOME PER SHARE
Net income per common and common equivalent share has been computed by
dividing net income by the weighted average number of common and common
equivalent shares outstanding. Common equivalent shares relate to stock options
and stock warrants when their effect is not antidilutive. The difference
between primary and fully diluted earnings per share was not significant in any
period presented.
7. NEW ACCOUNTING PRONOUNCEMENT
In February 1997, the Financial Accounting Standards Board issued Statement
No. 128, a new standard for computing and presenting earnings per share. The
Company is required to adopt the new standard in the fourth quarter of 1997;
earlier adoption is not permitted. The Company expects that earnings per share
computed under the new standard will approximate earnings per share currently
reported.
8. PATENT MATTERS
In March 1997, the Company filed suit in U.S. District Court for the
District of Minnesota, seeking to invalidate a newly issued U.S. patent held by
a competing manufacturer of blood oxygenators and other medical devices, and
requesting a determination that the Company's Affinity oxygenator does not
infringe the competitor's patent. The Company filed suit in response to a
December 1996 letter from the competitor, alleging that the Affinity oxygenator
infringes certain claims under the competitor's patent, and requesting
discussion regarding a possible license agreement. The Company reviewed the
subject patent and concluded, based on an opinion from its patent counsel, that
none of the claims in the patent are infringed by the
7
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Affinity oxygenator, and that the patent is, in any event, invalid. However,
the expense and effort potentially required to bring this action, as well as
the outcome of any counterclaim successfully brought against the Company by
the competitor, could have a material adverse effect on the Company's
business, financial condition and results of operations. See Part II, Item
1, "Legal Proceedings".
8
<PAGE>
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
The following is a discussion of the results of operations and financial
condition for the three month period ended March 31, 1997 compared with the
three month period ended March 31, 1996 and should be read in conjunction with
the Company's Consolidated Financial Statements and Notes thereto.
OVERVIEW
The Company was incorporated on December 13, 1990, and in June 1991, the
Company acquired the business and assets and assumed certain liabilities of the
surgical division of SCIMED Life Systems, Inc. (the Predecessor Business). On
December 1, 1992, the Company exchanged 160,000 shares of its Common Stock for
all of the outstanding shares of AVECOR Cardiovascular Ltd. (formerly Cardio Med
Ltd.) pursuant to which AVECOR Cardiovascular Ltd. became a wholly-owned
subsidiary of the Company. AVECOR Cardiovascular Ltd. had formerly been a
distributor for the Company in the United Kingdom. In October 1995, the Company
opened a sales office in France which is organized as a wholly-owned subsidiary
of AVECOR Cardiovascular Ltd.
The assets acquired by the Company from the Predecessor Business included
the Company's line of solid silicone membrane oxygenators. Since that time, the
Company has been successful in developing and obtaining marketing clearance for
a number of its proprietary products, with the goal of developing and marketing
a more complete line of proprietary products used in the heart/lung bypass
circuit. The Company began marketing its MYOtherm cardioplegia delivery system
in October 1991, and began marketing its Signature custom tubing packs in July
1993 following receipt of marketing clearance from the U.S. Food and Drug
Administration (the FDA). The Company began marketing its Affinity oxygenator
internationally in July 1993 and in the United States in February 1994,
following receipt of marketing clearance from the FDA in November 1993. The
Company received marketing clearance from the FDA to market its Affinity blood
reservoirs and Affinity arterial filter in July 1994 and October 1995,
respectively. In connection with the Company's continuing efforts to offer a
more complete line of proprietary heart/lung bypass circuit products, the
Company has developed a new blood pump and an improved Myotherm cardioplegia
system, for which 510(k) pre-market notifications were filed with the FDA in
September 1996 and March 1997, respectively.
RESULTS OF OPERATIONS
NET SALES
Net sales increased 17% to $12,043,000 for the three months ended March 31,
1997 from $10,293,000 for the three months ended March 31, 1996. This increase
was principally the result of a higher volume of product shipments of the
Company's Affinity product line and Signature custom tubing packs. Overall,
average prices of product shipments declined slightly when compared to the
corresponding period in 1996.
9
<PAGE>
Sales from the Affinity product line and Signature custom tubing packs
accounted for approximately 57% and 47% of the overall increase in net sales,
respectively. As expected, the silicone membrane oxygenator line net sales
decreased by $109,000 for the three months ended March 31, 1997 when compared to
the corresponding period in 1996.
Over the past two years, one of the Company's competitors has purchased
three companies that provide contract perfusion services to hospitals. The
Company believes that such control, as well as any future acquisitions of
contract perfusion groups by its competitors are likely to have a negative
impact on the Company's ability to market its products to perfusionists
controlled by competitors or to hospitals or other medical providers that
contract with competitor-controlled groups for perfusion services, and could
have a material adverse affect on the Company's business, financial condition
and results of operation. This forward-looking statement is subject to the
degree of control exerted by the Company's competitors with respect to
purchasing decisions made by controlled groups of perfusionists, the extent of
future acquisitions of contract perfusion groups by the Company's competitors,
the breadth of the Company's product offerings relative to those competitors
controlling contract perfusion groups, and the degree to which the Company's
research and development and marketing efforts result in the successful
commercialization of products with enhanced or superior performance
characteristics. Sales to contract perfusion groups controlled by one of the
Company's competitors decreased $192,000 to $364,000 for the three months ended
March 31, 1997 from $556,000 for the three months ended March 31, 1996.
Sales to customers located outside of the United States were approximately
41% of net sales for the three month period ended March 31, 1997 compared to 39%
of net sales for the corresponding period in 1996.
COST OF SALES / GROSS PROFIT
Cost of sales as a percentage of net sales increased to 58.6% for the three
months ended March 31, 1997 from 57.8% for the three months ended March 31,
1996. The cost of sales percentage for the three month period ended March 31,
1997 was unfavorably impacted by the significant increases in sales of the
Company's lower-margin Signature custom tubing pack line, as well as competitive
pricing pressures in the marketplace. The mix of products sold in any period
will influence the cost of sales and gross profit for the period.
Affinity oxygenator product costs continue to improve due to efficiency and
material cost improvements, although these improvements were largely offset,
primarily by an ongoing decrease in average selling prices.
The Company's future gross profit margin percentages will be influenced by
the ongoing pressures of the competitive pricing environment, changes in the
sales mix, new product introductions and the extent of further product cost
improvements through increased manufacturing efficiencies and reduced material
costs, if any. Given the uncertainty associated with new product introductions,
the ultimate realization of any such product cost improvements and the
continuing price pressures in the Company's markets, the Company cannot be
certain if its gross profit margin percentage will be maintained, improve or
decline.
10
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SELLING, GENERAL AND ADMINISTRATIVE AND LITIGATION EXPENSE
Selling, general and administrative expenses increased 17% to $3,350,000
for the three months ended March 31, 1997 from $2,856,000 for the three
months ended March 31, 1996. These increases are attributed to costs
associated with the continuing development of a direct sales force in certain
of the Company's territories formerly served by distributors and independent
sales representatives, seasonal trade show costs and marketing costs incurred
for the new blood pump in anticipation of FDA approval. As a percent of
sales, selling, general and administrative expenses increased to 27.8% for
the three month period ended March 31, 1997 from 27.7% for the three month
period ended March 31, 1996.
Management anticipates that selling, general and administrative expenses
for the year ended December 31, 1997 will be higher than the year ended
December 31, 1996 and will approximate 1996 as a percentage of sales dollars.
These forward-looking statements will be influenced by revenue increases
achieved by the Company, its ability to attract and retain qualified sales
personnel as the Company continues to develop its direct sales force, and the
timing and extent of promotional activities associated with new product
introductions, if any.
On July 17, 1996, the Company reached an agreement with COBE Laboratories
Inc. (COBE) to settle COBE's patent suit against the Company. The terms of the
settlement with COBE provide for the Company to make net payments totalling
$2,200,000, of which a net $1,100,000 was paid in August 1996. The remaining
amount is payable on or about August 6, 1997, subject to COBE's active
enforcement of its claimed patent rights with respect to other manufacturers.
The Company expensed professional fees, in connection with the COBE suit, of
approximately $505,000 for the three month period ended March 31, 1996. No
related expenses were incurred for the three month period ended March 31, 1997.
RESEARCH AND DEVELOPMENT
Research and development expenses increased 31% to $1,102,000 for the three
month period ended March 31, 1997 from $841,000 for the three month period ended
March 31, 1996. This increased research and development spending is a result
of the Company's ongoing efforts to pursue a number of potential product
opportunities. These opportunities include a new blood pump and an improved
Myotherm cardioplegia system for which the Company submitted 510(k) applications
with the FDA late in September 1996 and March 1997, respectively. There can be
no assurance that the appropriate marketing clearance from the FDA will be
received on a timely basis, if at all, or, if received, that these devices will
become commercially successful.
The Company anticipates that research and development expenses for 1997
will increase approximately 20% over 1996 levels, as the Company moves to
expand and improve its proprietary line of disposable medical devices. This
forward-looking projection is dependent upon the extent and timing of new
product development and the impact of the regulatory process in obtaining
marketing clearance for new products, including the new blood pump and
improved Myotherm cardioplegia system. The need or desire to modify the
Company's existing products could also influence the level of research and
development expenses. In addition to the aforementioned blood pump and
improved Myotherm cardioplegia system, the Company is developing proprietary
systems coatings that will improve blood handling, scheduled for mid-year
1997 FDA submission; and new oxygen saturation/hematocrit technology that is
expected to be submitted to the FDA late in the third quarter of 1997. There
can be no assurance, however,
11
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that the Company's research and development efforts will result in
regulatory submissions to the FDA as set forth above, if at all, or will
result in any commercially successful products. The forward-looking
statements regarding anticipated regulatory submissions contained in this
paragraph will be impacted by the results of the Company's development
efforts, the availability of any required clinical data, any changes in the
regulatory scheme for such products, and the Company's assessment of the cost
and anticipated benefit of such submissions.
INTEREST INCOME AND EXPENSE
Interest income decreased to $144,000 for the three months ended March 31,
1997 from $209,000 for the three months ended March 31, 1996. The decrease in
interest income for the three month period ended March 31, 1997 when compared to
the three month period ended March 31, 1996 is primarily due to the use of cash
and investments for the Company's new facility. Interest income during the
three month period ended March 31, 1997 was earned primarily from the investment
of the remaining net proceeds from the Company's June 1995 stock offering. At
March 31, 1997, the majority of these proceeds were invested with two investment
portfolio managers who invested in U.S. government securities, agency paper,
money markets, commercial paper and corporate obligations.
Interest expense for the three months ended March 31, 1997 was $71,000 and
exclusively due to the mortgage on the new facility. The closing on the
facility purchase occurred in late January 1997.
INCOME TAX PROVISION
For the three month period ended March 31, 1997, a tax provision of
$217,000 was recorded compared to a tax provision of $136,000 for the three
month period ended March 31, 1996. The tax provisions recorded correspond to
the pretax income for those respective periods.
NET INCOME
Net income was $387,000 or $.05 per share for the three month period ended
March 31, 1997 compared to net income of $213,000 or $.03 per share for the
three month period ended March 31, 1996.
LIQUIDITY AND CAPITAL RESOURCES
For the three months ended March 31, 1997, the Company used $610,000 in
operating activities compared to $976,000 of net cash used in operating
activities for the same period in 1996. The net change of approximately
$366,000 is primarily the result of decreasing levels of inventories and
$505,000 spent during the corresponding period in 1996 related to the COBE
litigation. These cash provisions were partially offset by uses of cash for
increased accounts receivable, primarily due to the Company's growth and the
timing of international remittances; a reduction to accounts payable, resulting
from the timing of check runs; reduced accrued expenses; and an increase to
other current assets. The Company believes that its existing cash and
investments as well as anticipated cash generated from operations will be
sufficient to satisfy the Company's cash requirements for the foreseeable
future.
12
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Cash expenditures for capital additions, other than the purchase of the new
facility, totaled $1,458,000 for the three months ended March 31, 1997 compared
to $432,000 for the three months ended March 31, 1996. These expenditures were
primarily related to approximately $760,000 of furniture, fixtures and equipment
additions for the Company's new U.S. manufacturing, research and development and
administrative facility. These expenditures also include equipment, molds and
tooling necessary to begin the production of the Affinity blood pump and
improved Myotherm cardioplegia system, and to further the production of the
Affinity oxygenator and related blood reservoirs.
Leases for the Company's U.S. manufacturing, research and development and
administrative facilities expired on December 31, 1996. In January, the Company
consolidated its four separate facilities into a newly constructed facility,
which the Company has purchased. The cost of this facility was approximately
$8,600,000, plus an additional $1,050,000 for the purchase of furniture,
fixtures and manufacturing equipment for the facility. To finance the
$9,650,000 total cost of the project, the Company entered into a $5,167,000 bank
note payable agreement in January 1997 and, in addition, funded $4,483,000 out
of corporate funds. Closing occurred on January 30, 1997.
The note payable agreement bears interest at 8.11% and requires monthly
principal payments of $21,531, plus interest, through January 2002 with the
remaining principal and interest due February 2002. The note payable is
collateralized by the new corporate headquarters and manufacturing facility and,
among other things, requires the Company to meet certain ratios related to
leverage, debt service and cash flow. As of March 31, 1997, the Company was in
compliance of the ratios required by the note payable. Additionally, the bank
note payable agreement prohibits the Company from distributing dividends to its
shareholders.
At March 31, 1997, the Company had no restricted cash or investments. Of
the $4,450,000 which were restricted at December 31, 1996 for payment of the
U.S. facility, $1,000,000 was used for the purchase of the facility and
$3,450,000 became unrestricted, was reinvested and will be used for general
corporate purposes, research and development and working capital.
The Company's capital expenditures for 1997 are expected to be
approximately $2,700,000, excluding any capital expenditures which were required
in connection with the new facility, as discussed above. This estimate includes
additional equipment, molds and tooling for the new blood pump, an improved
MYOtherm cardioplegia system and new oxygen saturation/hematocrit technology.
The foregoing forward-looking statements relating to the amount of capital
expenditures, ultimate cash usage and future income statement impact are
dependent on the progress of the Company's product development efforts and the
timing of the receipt of FDA marketing clearances for any future products.
13
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FOREIGN CURRENCY TRANSACTIONS
Transactions by the Company's international subsidiaries are negotiated,
invoiced and paid in various foreign currencies, primarily pounds sterling, and
U.S. dollars. Accordingly, the Company is currently subject to risks associated
with fluctuations in exchange rates between the various currencies.
Substantially all of the Company's other international transactions are
denominated in U.S. dollars. Fluctuations in currency exchange rates in other
countries may therefore reduce the demand for the Company's products by
increasing the price of the Company's products in the currency of the countries
in which the products are sold.
NEW ACCOUNTING PRONOUNCEMENT
In February 1997, the Financial Accounting Standards Board issued Statement
No. 128, a new standard for computing and presenting earnings per share. The
Company is required to adopt the new standard in the fourth quarter of 1997;
earlier adoption is not permitted. The Company expects that earnings per share
computed under the new standard will approximate earnings per share currently
reported.
CERTAIN IMPORTANT FACTORS
Except for the historical financial information contained herein, this
Form 10-Q contains certain forward-looking statements. For this purpose, any
statements contained in this Form 10-Q that are not statements of historical
fact may be deemed to be forward-looking statements. Without limiting the
foregoing, words such as "may", "will", "expect", "believe", "anticipate",
"estimate", or "continue," the negative or other variations therof, or
comparable terminology, are intended forward-looking statements. These
statements by their nature involve substantial risks and uncertainties, and
actual results may differ materially depending on a variety of factors,
including the progress of product development and clinical studies, the
timing of and ability to attain regulatory approvals, the availability of
third party reimbursement, the extent to which the Company's products gain
market acceptance, litigation regarding patent and other intellectual
property rights, the introduction of competitive products by others, and
other factors.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
Not Applicable.
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PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS.
In March 1997, the Company filed suit in U.S. District Court for
the District of Minnesota, seeking to invalidate a newly issued
U.S. patent held by a competing manufacturer of blood oxygenators
and other medical devices, and requesting a determination that the
Company's Affinity oxygenator does not infringe the competitor's
patent. The Company filed suit in response to a December 1996
letter from the competitor, alleging that the Affinity oxygenator
infringes certain claims under the competitor's patent, and
requesting discussion regarding a possible license agreement. The
Company reviewed the subject patent and concluded, based on an
opinion from its patent counsel, that none of the claims in the
patent are infringed by the Affinity oxygenator, and that the
patent is, in any event, invalid. However, the expense and effort
potentially required to bring this action, as well as the outcome
of any counterclaim successfully brought against the Company by the
competitor, could have a material adverse effect on the Company's
business, financial condition and results of operations.
ITEM 2. CHANGES IN SECURITIES.
None
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
None
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
None
ITEM 5. OTHER INFORMATION.
None
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K.
(a) Exhibits:
The exhibits to this Quarterly Report on Form 10-Q are listed in
the Exhibit Index beginning on page 17 of this Report.
(b) Reports on Form 8-K:
None
15
<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.
AVECOR CARDIOVASCULAR INC.
May 13, 1997 By /s/ Anthony Badolato
- --------------------------- ----------------------------------
Date Anthony Badolato
Chief Executive Officer
May 13, 1997 By /s/ Gregory J. Melsen
- --------------------------- -----------------------------------
Date Gregory J. Melsen
Vice President-Finance, Treasurer and Chief
Financial Officer
(Principal Financial and Accounting Officer)
16
<PAGE>
AVECOR CARDIOVASCULAR INC.
EXHIBIT INDEX TO QUARTERLY REPORT
ON FORM 10-Q
For the Quarter Ended March 31, 1997
<TABLE>
<CAPTION>
Item No. Description Method of Filing
- -------- ----------- ----------------
<S> <C> <C>
10.1 Distribution agreement dated April 2, 1997
between the Company and Cardiovascular
Diagnostics, Inc. (CVDI) Filed herewith electronically
11.1 Statement regarding computation of earnings
per share Filed herewith electronically
27.1 Financial Data Schedule Filed herewith electronically
</TABLE>
17
<PAGE>
DISTRIBUTION AGREEMENT
THIS AGREEMENT, effective as of April 2, 1996, between CARDIOVASCULAR
DIAGNOSTICS, INC., a corporation organized and existing under the laws of North
Carolina, with its principal offices located at 5301 Departure Drive, Raleigh,
North Carolina ("CVDI"), and AVECOR, a Minnesota corporation having its
principal place of business in Minneapolis, MN ("AVECOR").
W I T N E S S E T H:
WHEREAS, CVDI, among other things, is engaged in the manufacture of certain
hemostasis diagnostic products; and;
WHEREAS, AVECOR has experience and capability in the marketing and
distribution of hemostasis diagnostic products and desires to distribute such
products;
NOW, THEREFORE, the parties agree as follows:
1. DEFINITIONS.
The following capitalized terms shall have the meanings set forth below:
1.1 "ACT" means the Food, Drug and Cosmetic Act (21 U.S.C. Sections 301
et seq.) and the regulations promulgated thereunder and all foreign
equivalents thereof.
1.2 "AFFILIATE" means any person or entity which, directly or
indirectly, through one or more intermediaries, controls, is
controlled by, or is under common control with, a party. "Control"
means the direct or indirect, legal or beneficial, (a) ownership of
more than 50% of the outstanding voting rights of such person or
entity or (b) the power or ability to direct the management or
policies of such person or entity.
1.3 "FDA" means the United States Food and Drug Administration or any
successor agency, and all foreign equivalents thereof.
1.4 "FUTURE PRODUCTS" means Heparin Management Panel, AT test card and
related controls, and ACCENT hardware.
1.5 "GOOD MANUFACTURING PRACTICES" or "GMP" means the applicable current
good manufacturing practices promulgated from time to time by the
FDA in accordance with the Act, and all foreign equivalents thereof.
1.6 "INSTRUMENTS" means CVDI's manual, compact, single test, portable
analyzer, the TAS (thrombolytic assessment system), which provides
point of patient care evaluations of hemostasis.
1.7 "NEW PRODUCTS" means improvements and enhancements of Products, but
shall not include increased card dating, Alliance Cards, Specialty
Cards, nor AVECOR Alliance Cards.
1.8 "PRODUCTS" means all products described on SCHEDULE 1.11.
"PRODUCTS" includes Instruments and Specialty Cards.
1
<PAGE>
1.9 "SPECIALTY CARDS" means CVDI's HMT Card and related controls.
1.10 "TERRITORY" means the United States and Canada.
2. DISTRIBUTION OF SPECIALTY CARDS.
2.1 GRANT. Subject to the limitations contained herein, CVDI hereby
grants to AVECOR, the sole and exclusive right to sell, market,
promote, distribute, and otherwise transfer, dispose, provide and
place ("sell") the Specialty Cards in the Territory. CVDI shall not,
directly or indirectly, through technology licensing or otherwise,
grant any third party any right to sell Specialty Cards in the
Territory during the term of this Agreement. Subject to the
limitations contained herein, CVDI hereby grants AVECOR the
exclusive right to distribute Future Products in the Territory
during the term of this Agreement, provided the minimum sales
requirements for Future Products shall be as agreed by the parties
within ninety (90) days of notice by CVDI of the opportunity
regarding the distribution of Future Products. AVECOR may upon the
prior written approval of CVDI, which may be withheld in its sole
discretion, distribute the Products directly or through one or more
agents ("Subdistributors") and shall be solely responsible for
determining the number, location and qualifications of
Subdistributors; provided, however that any such permitted
Subdistributors enter into an agreement which includes the
substantive provisions of this Agreement.
2.2 EXCLUSIVITY. During the term of this Agreement, neither AVECOR, nor
any of its Affiliates, shall sell in the Territory any whole blood
or plasma, point of care Specialty Cards except under the terms of
this Agreement. Neither AVECOR nor any of its Affiliates or
distributors shall distribute Products outside the Territory.
2.3 REQUIREMENTS. AVECOR and its Affiliates shall purchase, and CVDI
shall supply all of AVECOR's and it's Affiliates' requirements of
Products, for resale within the Territory. During the term of this
Agreement, neither AVECOR nor any of its Affiliates shall
manufacture any such Products or purchase any such Products from a
supplier other than CVDI.
2.4 PERFORMANCE REQUIREMENTS. AVECOR shall use reasonable efforts to
promote the sale of the Products. AVECOR contemplates that the
promotional efforts may include preparing promotional materials to
be used in the Territory by AVECOR, participating in appropriate
trade shows, advertising in trade publications applicable to the
Territory and directly soliciting orders from customers within the
Territory by the appropriate AVECOR sales force. AVECOR shall be
responsible for training customers with respect to Products sold.
AVECOR shall comply with the Act and other applicable, legal, health
and safety requirements, laws and regulations in all of their
marketing and sales activities. AVECOR shall not promote the
Products for any uses not approved for Products by applicable
regulatory agencies.
2
<PAGE>
2.5 TERMS AND CONDITIONS. All orders for Products shall be initiated by
written purchase orders. No order shall be binding unless
consistent with this Agreement. Acceptance by CVDI of AVECOR's
purchase order is expressly limited to and conditioned upon, and
only upon, AVECOR's acceptance of the terms and conditions set forth
in this Agreement, which may not be changed or waived except in a
writing signed by the parties. AVECOR's purchase orders submitted
to CVDI shall be governed by the terms of this Agreement and CVDI's
published Standard Terms and Conditions of Sale as in effect at the
time of such purchase; provided, however, that in the event of a
conflict between the terms of this Agreement and CVDI's Standard
Terms and Conditions of Sale, this Agreement shall control and any
additional, inconsistent or different terms and conditions contained
in any purchase order, acknowledgment, confirmation, acceptance,
invoice, or other documents supplied by AVECOR or CVDI are hereby
expressly rejected. A copy of CVDI's Standard Terms and Conditions
of Sale is attached hereto as Schedule 2.5. CVDI shall not
arbitrarily change its Standard Terms and Conditions. CVDI shall
advise AVECOR in writing at least thirty (30) days in advance of any
proposed material changes to the Standard Terms and Conditions.
2.6 REJECTION. AVECOR shall notify CVDI of obvious damage relating to
the manufacturing or packaging of the Products (other than damage
solely associated with the shipping of the Products) within 90 days
of their respective receipt of the Products. Any such Product not
rejected for obvious damage within ninety (90) days after receipt
by AVECOR or its distributors (the "Rejection Period") shall be
deemed accepted. A rejection by AVECOR shall mean that CVDI has
received within the Rejection Period written notice of such
rejection stating with particularity the reason therefor. CVDI
shall as promptly as possible replace any rejected Products. After
the Rejection Period, AVECOR may not return any such obviously
damaged Products for any reason without CVDI's prior written
consent.
2.7 FUTURE PRODUCTS. CVDI and AVECOR shall negotiate the provisions of
Section 2.1 in good faith for distribution rights to Future
Products, prices and minimum sales levels relating to such Future
Products.
3
<PAGE>
3. MARKETING AND SUPPORT ACTIVITIES.
3.1 MARKETING MEETINGS; REPORTS. The parties shall meet at least semi-
annually to discuss market plans, product improvement suggestions
and other information concerning the marketing and development of
the Products. AVECOR shall provide information available to it
about the Products and its ability to compete with other diagnostic
products for related uses and to meet customer needs. AVECOR shall
provide CVDI general information regarding sales of the Products
such as pricing trends by geographic region as well as sales
information indicating sales by country and by geographic region.
3.2 PROMOTIONAL MATERIAL. CVDI will furnish AVECOR with copies of
promotional literature and advertisements it prepares for the
Product. AVECOR shall not copy or utilize any promotional material
prepared by it without obtaining the prior written approval thereof
from CVDI. CVDI's approval shall not be unreasonably withheld or
delayed. CVDI and AVECOR shall comply with all requirements of the
Act, local laws, regulations and other laws in their advertising and
other promotional activities.
3.3 PACKAGING, LABELING. CVDI shall manufacture, label and package the
Products in final form for distribution by AVECOR. In addition to
all applicable legal requirements, the labels shall comply with the
requirements set forth in Section 3.4 below, shall display "CVDI"
and shall identify CVDI as the manufacturer of the Products. AVECOR
shall not repackage or label any Products and shall not alter any
Products or any package or label used in connection with any
Products except as specifically authorized by CVDI. In the event
that CVDI shall authorize or require repackaging or re-labeling,
AVECOR shall comply in all respects with the instructions of CVDI,
at the expense of CVDI.
3.4 TRADEMARKS AND TRADE NAMES. CVDI hereby grants AVECOR the
nontransferable, nonexclusive right to use in the Territory the
trademarks and tradenames listed on Schedule 3.4, and any other
trademarks owned by CVDI which it may designate in writing for use
by AVECOR (the "Trademarks"), in connection with the marketing and
sale of the Products for the duration of the Agreement. The
Products shall be marketed and sold only under the Trademarks, and
the name "CVDI" as required under Section 3.3. AVECOR acknowledges
that it has and will obtain no proprietary interest in the
Trademarks and agrees not to use the same as part of its corporate
or business name. AVECOR's right to the use of any Trademark or
other property of CVDI shall terminate immediately upon termination
of this Agreement; provided, however, such right shall be extended
for the period of time specified in Section 11.5, at the end of
which all such rights shall terminate. AVECOR shall use the
Trademarks only in the manner prescribed by CVDI. The Products are
offered for sale and sold by CVDI subject in every case to the
condition that such sale does not convey any licenses, express or
implied, to manufacture, duplicate or otherwise copy or
4
<PAGE>
reproduce any Product. In the event of termination of this
Agreement, AVECOR shall not manufacture or have manufactured any
devices, cards, components or assemblies utilizing any information
belonging to CVDI.
3.5 MARKETING ASSISTANCE/TRAINING. CVDI agrees to provide technical
training, and technical assistance to AVECOR personnel at periodic
intervals, with the frequency and content to be determined by mutual
agreement. The training and technical assistance provided to AVECOR
shall be no less than that provided to CVDI employees and sales
force, and shall be updated from time to time with at least the
frequency such updates are provided to CVDI employees and sales
force. Each party to this Agreement shall be responsible for its
own expenses in connection with any such training and assistance.
3.6 SUPPORT. CVDI will use reasonable efforts to support the sale of
Products by AVECOR where requested by AVECOR. Such support shall be
provided in the sole discretion of CVDI.
3.7 SERVICE. Except as otherwise provided in this Section, CVDI agrees
to provide service and maintenance for Instruments sold by AVECOR
for its standard fees, as they exist from time to time, and in
accordance with its then applicable standard service agreement.
CVDI shall offer service contracts for Instruments to customers to
provide maintenance and services in accordance with its standard
contract. CVDI shall provide AVECOR with its service contract price
list and AVECOR shall be entitled to sell such contracts on behalf
of CVDI. AVECOR shall bill for the service contracts which it sells
and payment by AVECOR to CVDI shall be within thirty (30) days after
AVECOR receives payment for such service/maintenance contract.
Service and maintenance may be provided by CVDI or an independent
third party service company.
3.8 PRODUCT WARRANTY. AVECOR shall make no representation or warranty
about the Products, whether in writing or orally, except as is
contained in written materials delivered to AVECOR by CVDI expressly
for use in promoting the sale of the Product or as may otherwise be
agreed to by CVDI in writing.
3.9 DEVELOPMENT AND MARKETING COOPERATION. AVECOR will have the right
to discuss with, and propose to, CVDI additional specifications for
the Products and specifications for Future Products.
4. REGULATORY COMPLIANCE.
4.1 REGISTRATIONS.
(a) CVDI shall use commercially reasonable efforts, including
conducting clinical trials, to obtain and maintain
regulatory approvals and requirements for it to sell the
Products in the Territory. CVDI shall have sole discretion
as to the commercial reasonableness of any acts required on
its part to maintain any regulatory approval or requirement.
5
<PAGE>
(b) CVDI shall promptly provide to AVECOR copies of all required
Product notifications and registrations to regulatory
agencies (including device listing reports) including copies
of all letters received from the FDA.
4.2 REPORTING OBLIGATIONS. AVECOR shall maintain, or cause to be
maintained, all complaint files and other records required to be
maintained by the FDA and other regulatory agencies with respect to
Products purchased by AVECOR from CVDI. CVDI shall promptly provide
to AVECOR copies of all complaints received with respect to the
Products sold to AVECOR as well as responses sent, if any. AVECOR
shall promptly provide CVDI with copies of any complaints relating
to the Products received by AVECOR. Except to the extent AVECOR is
otherwise required by law, CVDI shall submit to the FDA all reports
of complaints, malfunctions, failures or deterioration in the
characteristics or performance or instructions for use or inadequacy
in labeling which may have led or lead to death or serious injury
and all other information about the Products required to be
submitted to any regulatory agency.
4.3 MANUFACTURING. CVDI shall use its best efforts to comply with all
applicable GMP requirements, including all national technical and
quality standards applicable to the Products which are incorporated
into GMP. CVDI shall have sole discretion as to the commercial
reasonableness of any acts required on its part with respect to GMP
compliance, provided, however, CVDI shall notify AVECOR of any
citations from discussions with a regulatory body where such
discussions and citations relate to a material aspect of GMP
compliance.
4.4 SAMPLES. CVDI shall retain samples of each lot of the Products for
time periods which are in accordance with GMP.
4.5 PRODUCT RECALLS AND FIELD CORRECTIVE ACTIONS. In the event (i) any
government authority issues a directive or order that a Product be
recalled, (ii) a court of competent jurisdiction orders such a
recall or (iii) CVDI determines that a Product should be recalled or
that a Field Corrective Action should occur, the parties shall take
all appropriate corrective actions. AVECOR will provide notice to
customers of the recall of the Product. Upon determination of the
party responsible for the recall or Field Corrective Action, such
party shall be responsible for the cost of notifying end users and
for determining the corrective actions to be taken and the costs
associated with such actions. CVDI and AVECOR shall fully cooperate
with one another and provide all reasonable assistance in conducting
any recall or Field Corrective Action under this Paragraph. AVECOR
shall maintain records of all sales of the Products sufficient to
carry out a recall with respect to Products purchased under the
Agreement.
6
<PAGE>
4.6 GENERAL OBLIGATIONS OF CVDI AND AVECOR.
(a) Except as otherwise expressly provided in the Agreement,
CVDI shall manufacture, test, package, and label the
Products. AVECOR shall price, invoice and have shipped in
the Territory all Products.
(b) CVDI shall manufacture, test, package, label and release and
AVECOR shall maintain, store and ship the Products in
accordance with all applicable GMP requirements.
(c) Each party shall promptly notify the other party of, and
shall provide the other party with copies of, any
correspondence and other documentation received or prepared
in connection with any of the following events: (1) receipt
of any material correspondence from the FDA in connection
with the manufacture, sale or use of the Products; (2) any
recall of the Products; (3) the withdrawal of the Products
from the market; (4) any regulatory comments relating to the
manufacture of the Products requiring a response or action
by either party.
(d) CVDI shall maintain all manufacturing and analytical
records, all records of shipments of the Products from CVDI,
and all validation data relating to the Products for the
time periods required by applicable laws and regulations.
CVDI shall make such data available to the FDA upon request
of the FDA, such request being made either directly to
AVECOR or to CVDI, or otherwise as required by applicable
law.
4.7 ORDERS.
(a) FORECASTS. Beginning with the execution hereof, AVECOR shall
provide monthly, by the fifteenth day of each month, its
estimated forecast of its and its Affiliates requirements
for the Products for each of the six (6) months following
the end of the month in which such forecast is submitted
(each a "Forecast"). All Forecasts under this Agreement and
updates thereof for any period will constitute a firm
obligation of AVECOR to purchase the quantities of Products
(Specialty Cards and Instruments) indicated only for the
first three months of such Forecast.
(b) WRITTEN ORDERS. AVECOR shall initiate orders for Products
by written purchase orders, which may be submitted by
facsimile. Orders are subject to acceptance by CVDI,
preferably by reply facsimile. In the event AVECOR's
purchase order contains terms conditions which are in
addition to, or differ from or contradict the terms of this
Agreement, the terms of this Agreement shall control.
(c) DELIVERY. CVDI shall use its best efforts to supply the
Products ordered by AVECOR and shall supply Products in
accordance with the delivery schedule and in the quantities
specified by AVECOR provided; however, CVDI shall not be
obligated to deliver Specialty Cards to the extent that
orders for such Specialty Cards exceed 125% of the
quantities stated in the portion of any forecast which
contains the firm obligation of AVECOR to purchase
7
<PAGE>
Specialty Cards. CVDI shipments of Products shall be delivered
FOB freight collect CVDI's distribution site, Raleigh, North
Carolina, to AVECOR's carrier at which time title, ownership and
risk of loss and damage shall pass to AVECOR. CVDI shall deliver
Products, properly packed for distribution (including, but not
limited to refrigerated distribution), to the carrier selected by
AVECOR at its distribution site. All freight and insurance
expenses, as well as any special handling or special packing
expenses requested by AVECOR, shall be paid by AVECOR. AVECOR
shall bear any and all applicable taxes, duties and similar
charges that may be assessed against the Products after delivery
to the carrier at CVDI's distribution site. CVDI shall include
shipping documents with Products in accordance with AVECOR's
reasonable requests.
4.8 PACKAGING. CVDI shall provide all necessary labels and package
inserts for all Specialty Cards as well as for the shipping
container, which labels and package inserts shall comply with
applicable FDA requirements. AVECOR shall not use any other labels
or package inserts for any of such Specialty Cards.
4.9 TAXES; DUTIES. The actual amount of sales, use, excise, value-added
and similar taxes levied upon or applicable to the transfer of
Product to AVECOR are payable by AVECOR. AVECOR shall pay all
duties, tariffs, surcharges and other customs and other governmental
fees levied in connection with the export of the Specialty Cards
outside of the United States but within the Territory.
5. PRODUCT WARRANTY.
5.1 STANDARD LIMITED WARRANTY. CVDI warrants that the Specialty Cards
and controls shall, at the time of shipment, (a) comply with the
requirements of the Act, if applicable, and shall until their
expiration date conform to the labeling and package inserts; (b)
will not be products that are adulterated or misbranded within the
meaning of the Act; (c) shall have been manufactured, packaged,
stored and shipped in conformity with applicable GMP requirements;
and (d) will not be products that may not be introduced into
interstate commerce pursuant to applicable federal or state law.
CVDI warrants that all Instruments shall, until the earlier of
twenty-four (24) months from shipment by CVDI; or twelve (12) months
after the date of installation with the customer: (a) comply with
the requirements of the Act, if applicable, (b) will not be products
that are adulterated or misbranded within the meaning of the Act;
(c) shall have been manufactured, packaged, stored and shipped in
conformity with applicable GMP requirements; and (d) will not be
products that may not be introduced into interstate commerce
pursuant to applicable federal or state law.
This limited warranty is contingent upon proper use of a Product in
the application for which such Product was intended and does not
cover Products that were modified without CVDI's written approval,
that have expired, or that were improperly stored or handled.
8
<PAGE>
5.2 NO OTHER WARRANTY. EXCEPT FOR THE EXPRESS LIMITED WARRANTIES SET
FORTH IN SECTION 5.1 ABOVE, CVDI GRANTS NO WARRANTIES FOR THE
PRODUCTS, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW,
BY STATUTE OR OTHERWISE, AND CVDI SPECIFICALLY DISCLAIMS ANY IMPLIED
WARRANTY OF QUALITY, WARRANTY OF MERCHANTABILITY, WARRANTY OF
FITNESS FOR A PARTICULAR PURPOSE OR WARRANTY OF NON-INFRINGEMENT.
5.3 REMEDY AND LIMITATION OF LIABILITY. EXCEPT AS OTHERWISE PROVIDED
HEREIN, CVDI'S LIABILITY AND AVECOR AND ITS CUSTOMERS SOLE REMEDY
UNDER THIS AGREEMENT AND THE LIMITED WARRANTY WITH RESPECT TO ANY
PRODUCTS SHALL BE LIMITED TO A REFUND OF AVECOR'S COST OF PRODUCTS
OR REPAIR OR REPLACEMENT, AT CVDI'S SOLE DISCRETION. IN NO EVENT
SHALL CVDI BE LIABLE FOR THE COST OF PROCUREMENT OF SUBSTITUTE
PRODUCT OR FOR ANY SPECIAL, CONSEQUENTIAL OR INCIDENTAL DAMAGES FOR
BREACH OF WARRANTY OR OTHERWISE.
6. PAYMENTS FOR PRODUCT.
6.1 PURCHASE PRICE. AVECOR shall pay CVDI a purchase price per
Specialty Card (the "Card Purchase Price") of US$2.00. Except as
otherwise provided herein, AVECOR shall pay CVDI a purchase price
per Instrument (the "Instrument Purchase Price") of US$1,850.00.
During the first twelve months of the term of this Agreement, CVDI
will sell AVECOR 36 Instruments to be used as samples for U.S.$1500
each. Specialty Card controls shall be priced at $62.50 per box of
25.
6.2 RESALE PRICES. AVECOR may offer the Products to its customers at
such prices as it, in its sole discretion, may determine. CVDI
shall have no right to determine the prices at which AVECOR may
offer the Products for resale.
6.3 SAMPLES. Upon AVECOR's request, during the first twelve months in
which this Agreement is in effect, CVDI shall supply 12,000
Specialty Cards as samples for demonstration purposes. The price
for such cards shall be US$1.90 per card FOB CVDI.
6.4 MINIMUM SALES. CVDI shall be entitled to terminate this Agreement
and to enter into alternative exclusive distribution agreements in
the Territory in the event that AVECOR fails to attain the
applicable percentage of the following annual minimum sales of
Products to end users (where the definition of sales to end users
shall include firm written orders received but not yet shipped by
AVECOR) in the United States or Canada calculated at the end of each
twelve month period for the applicable year: Said order to be
shipped within 30 days of receipt.
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<TABLE>
<CAPTION>
April 1, 1997 April 1, 1998 April 1, 1999 April 1, 2000 Each Year
to to to to Thereafter
March 31, 1998 March 31, 1999 March 31, 2000 March 31, 2001 During Term
-------------- -------------- -------------- -------------- -----------
<S> <C> <C> <C> <C> <C>
Level of Sales of Cards to End
Users 108,000 216,000 500,000 650,000 650,000
Applicable Percentage To
Maintain Rights 80% 90% 90% 90% 95%
Level of Sales of Instruments
to End Users 167 250 313 Subject to
Renegotiation but
not less than 1/3 of
prior year sales
level.
Applicable Percentage to
Maintain Rights 75% 75% 75%
</TABLE>
6.5 PAYMENT. All CVDI invoices shall be paid net 30 days from date of
invoice in US Dollars. Any invoiced amounts not paid when due shall
be subject to a service charge at the lower of the rate of one and
one-half (1.5%) percent per month or the maximum rate permitted by
law. If AVECOR fails to make any payment to CVDI when due, CVDI may
upon thirty (30) days written notice to AVECOR without affecting any
other rights under this Agreement, terminate this Agreement, cancel
or delay shipments hereunder, or terminate the grant of exclusivity
to AVECOR, provided, however, CVDI shall not be entitled to
terminate this Agreement with respect to any invoice which is being
contested by AVECOR in good faith; provided, further, that AVECOR
may not be late more than two (2) times during any twelve (12) month
period in order to be entitled to the referenced notice prior to
termination or other action by CVDI.
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<PAGE>
7. CONFIDENTIALITY.
7.1 "PROPRIETARY INFORMATION" means: all financial information,
marketing information, sales information, customer information, raw
materials, know-how, drawings, compositions, manufacturing and other
specifications, analytical procedures, flow sheets, reports, market
studies, preclinical and clinical test results, FDA and other
regulatory submissions, software and other medical, research,
technical, and marketing information disclosed, directly or
indirectly, by either party or any of its Affiliates to the other
party in writing, marked "Confidential", "Proprietary" or the like,
or, if transmitted orally or by observation of equipment or other
material, confirmed by a writing so marked within sixty (60) days of
its disclosure, or which by its nature is information normally
intended to be held in confidence, unless the same: (a) is or
becomes public knowledge through no fault of the receiving party;
(b) is legally in the possession of the receiving party prior to
receipt from the disclosing party; (c) is subsequently and lawfully
received from a third party without its breach of any nondisclosure
obligation; or (d) is independently developed by employees of the
receiving party who have had no access to the Proprietary
Information of the disclosing party.
7.2 NON-DISCLOSURE. During the duration of this Agreement and
thereafter, neither party shall disclose to third parties, or use
for its benefit, in whole or in part, any Proprietary Information
received from other party, except to the extent required to comply
with the Act or other laws. Each party shall take all reasonable
steps to minimize the risk of disclosure of Proprietary Information,
including, without limitation:
(a) ensuring that only its employees whose duties require them
to possess such information have access thereto; and
(b) exercising at least the same degree of care that it uses for
its own Proprietary Information.
7.3 DUTIES UPON TERMINATION. Except as otherwise permitted under this
Agreement, upon request by the disclosing party after expiration or
termination of this Agreement, the other party shall either return
all of such disclosing party's Proprietary Information (including
data, memoranda, drawings and other writings and tapes and all
copies thereof) received or prepared by it or destroy the same,
11
<PAGE>
and in any event shall make no further use of such Proprietary
Information provided, however, that counsel for the receiving party
may keep one copy of the Proprietary Information for purposes of
ascertaining the receiving party's obligations pursuant to this
Section 8.
7.4 USE OF PROPRIETARY INFORMATION. During the duration of this
Agreement and thereafter, neither party shall use the other party's
Proprietary Information for any purposes, except to perform its
obligations hereunder.
7.5 INJUNCTIVE RELIEF. Each party acknowledges that the other party
would not have an adequate remedy at law for breach of any of the
covenants contained in this Section 8 and hereby consents to the
enforcement of same by the other party by means of temporary or
permanent injunction issued by any court having jurisdiction thereof
and further agrees that the other party shall be entitled to assert
any claim it may have for damages resulting from the breach of such
covenants in addition to seeking injunctive or other relief.
8. INDEMNIFICATION.
8.1 INDEMNIFICATION BY CVDI. Subject to AVECOR's compliance with its
obligations set forth in Section 9.3 below, CVDI shall indemnify,
defend and hold AVECOR and its Subdistributors, Affiliates, their
shareholders, directors, officers, employees and agents harmless
from and against any and all losses, damages, liabilities, claims,
demands, judgments, settlements, costs and expenses (including,
without limitation, reasonable attorneys' fees and other costs of
defense) (collectively "Losses") attributable to, or arising out of
a breach by CVDI of any of CVDI's warranties, representations,
covenants or obligations hereunder or any claim, lawsuit or other
action by a third party for breach of contract, personal injury or
property damage to the extent caused by a breach by CVDI or any of
its Affiliates of this Agreement, or out of or connected with the
use or sale of the Product to the extent directly caused by CVDI's
fault, negligence or breach of any of its obligations hereunder
concerning the use or sale of the Product.
8.2 INDEMNIFICATION BY AVECOR. Subject to CVDI's compliance with its
obligations set forth in Section 9.3 below, AVECOR shall indemnify,
defend and hold CVDI and its Affiliates, their
12
<PAGE>
shareholders, directors, officers, employees and agents harmless
from and against any and all Losses attributable to, or arising out
of a breach by AVECOR of any of AVECOR's warranties,
representations, covenants or obligations hereunder, or any claim,
lawsuit or other action by a third party for, breach of contract,
personal injury or property damage to the extent caused by a breach
by AVECOR or any of its Affiliates of this Agreement, or out of or
connected with the use or sale of the Product to the extent directly
caused by AVECOR's fault, negligence or breach of any its
obligations hereunder concerning the use or sale of the Product.
8.3 NOTICE AND ASSISTANCE. A party (the "indemnitee") which intends to
claim indemnification under this Section 9 shall promptly notify the
other party (the "indemnitor") in writing of any action, claim or
other matter in respect of which the indemnitee or any of its
employees or agents intend to claim such indemnification. The
indemnitee shall permit, and shall cause its employees and agents to
permit, the indemnitor, at its discretion, to settle any such
action, claim or other matter and agrees to the complete control of
such defense or settlement by the indemnitor; PROVIDED, however,
that such settlement does not adversely affect the indemnitee's
rights hereunder or impose any obligations on the indemnitee in
addition to those set forth herein in order for it to exercise such
rights. No such action, claim or other matter shall be settled
without the prior written consent of the indemnitor and the
indemnitor shall not be responsible for any legal fees or other
costs incurred other than as provided herein. At the expense of the
indemnitor, the indemnitee shall render the indemnitor all
assistance reasonably necessary in defending against such claim,
suit, or action. The indemnitee party shall have the right at its
expense, to retain separate counsel to act in an advisory capacity
in connection with any matter involving a claim for indemnity and
the indemnitor will cooperate with such counsel.
9. PATENTS.
9.1 OWNERSHIP. Except as provided herein with respect to trademarks,
AVECOR acknowledges that it does not have, nor does it hereby
acquire, any right, title and interest in and to any patents, patent
applications, trademarks or other proprietary rights of CVDI.
13
<PAGE>
9.2 PATENT INFRINGEMENT.
(A) DEFENSE. AVECOR agrees that CVDI has the right to defend or
at CVDI's option to settle, and CVDI agrees at CVDI's
expense, to defend or at CVDI's option to settle, each
claim, suit or proceeding brought against AVECOR or AVECOR's
customers arising out of or related to an allegation of
infringement of any United States patent, copyright, or
trademark or misappropriation of trade secrets by the sale
of Products sold hereunder or the use thereof, subject to
the limitations hereinafter set forth. CVDI shall have sole
control of any such action or settlement negotiations, and
CVDI agrees to pay, subject to the limitations hereinafter
set forth, any final judgment (including all pre-judgment
and post-judgment interest) entered against AVECOR or
AVECOR's customers on such issue in any such suit or
proceeding defended by CVDI. AVECOR agrees that CVDI at
CVDI's sole option, shall be relieved of the foregoing
obligations unless AVECOR or AVECOR's customers shall notify
CVDI promptly in writing of such claim, suit or preceding
and gives CVDI authority to proceed as contemplated herein,
and at CVDI's expense, cooperates with CVDI to settle and/or
defend any such claim, suit or proceeding. CVDI shall not
be liable for any costs or expenses incurred without CVDI's
written authorization.
(B) LIMITATION. Notwithstanding the provisions of subsection
10.2(a) above, CVDI assumes no liability for (i)
infringements covering completed Products or any
composition, assembly, combination method or process in
which any of the Products may be used but not covering
Products when used alone; provided, however, that such
limitation shall not apply where the sale or use of the
Product (whether or not in any composition, assembly,
combination, method or process) is a sale for a use or a use
intended or approved by CVDI; (ii) infringements involving
any marking or branding not applied by CVDI or applied at
the request of AVECOR; or (iii) infringements involving the
modification or servicing of the Products, or any part
thereof unless such modification or servicing was performed
by CVDI or in accordance with CVDI's written instructions or
approved by CVDI.
14
<PAGE>
(C) THE FOREGOING PROVISIONS OF THIS SECTION 10.2 STATE THE
ENTIRE LIABILITY AND OBLIGATION OF CVDI AND THE EXCLUSIVE
REMEDY OF AVECOR AND CUSTOMER WITH RESPECT TO ANY ALLEGED
INFRINGEMENT OF PATENTS, COPYRIGHTS, TRADEMARKS, OR OTHER
INTELLECTUAL PROPERTY RIGHTS BY THE PRODUCTS OR ANY PART
THEREOF.
(D) PATENT ENFORCEMENT. If AVECOR believes that a third party
is reasonably likely infringing CVDI's patent rights in the
Territory, AVECOR shall promptly notify CVDI of that fact
and shall provide to CVDI reasonable evidence of any such
claim based upon materials available to AVECOR. Upon
receipt of evidence satisfactory to CVDI of infringement, in
CVDI's sole discretion CVDI shall then have the sole right
to take action against such infringing third party.
(E) COOPERATION. If either party takes action against a third
party pursuant to this Section 10.2, or if a third party
claims the manufacture, use or sale of Product in the
Territory infringes its patent or other proprietary rights,
the other party agrees to provide reasonable assistance by
supplying information within its control which may assist
the party taking the enforcement action or defending such
claim.
9.3 DISTRIBUTION RIGHTS. CVDI hereby grants to AVECOR the right to act
as its authorized distributor in the Territory to sell the Products
for the term of this Agreement. During the term of this Agreement
CVDI shall not bring any claim or action against AVECOR for the
infringement or misappropriation of any intellectual property owned
or licensed to CVDI based upon the use or sale by AVECOR or any of
its Affiliates of Products pursuant to the terms and conditions of
this Agreement.
10. TERM; TERMINATION.
10.1 TERM. The initial term of this Agreement shall be from the
Effective Date until March 31, 2002, unless terminated earlier under
the provisions of this Agreement. This Agreement shall renew
automatically for one year periods unless at least thirty (30) days
prior to year end, either party provides to the other written notice
of its intent to terminate.
15
<PAGE>
10.2 TERMINATION FOR CAUSE -- EITHER PARTY. Without prejudice to any
other rights it may have hereunder or at law or in equity, either
party may terminate this Agreement immediately by written notice to
the other party upon the occurrence of any of the following:
(a) the other party becomes insolvent, an order for relief is
entered against the other party under any bankruptcy or
insolvency laws or laws of similar import;
(b) the other party makes an assignment for the benefit of its
creditors or a receiver or custodian is appointed for it or
its business is placed under attachment, garnishment or
other process involving a significant portion of its
business;
(c) after sixty (60) days' written notice from the terminating
party without cure by the other party of any material breach
of this Agreement by the other party not involving minimum
sales or payments;
(d) the failure by AVECOR to make any payment due under this
Agreement; or
(e) the failure by AVECOR to maintain minimum sales to end users
under this Agreement.
10.3 RIGHTS AND DUTIES UPON TERMINATION.
(a) Termination of this Agreement, for whatever reason, shall
not affect any rights or obligations accrued by either party
prior to the effective date of termination, including under
any purchase order for Products placed prior to the
effective date of termination.
(b) Except as provided otherwise in this Section 10.3, upon
termination of the Agreement, CVDI shall use reasonable
efforts to continue to sell and supply Products to AVECOR's
Customers. CVDI will honor the terms and conditions of
AVECOR Customer contracts to the extent such agreements have
been entered into in arms-length transactions and the prices
charged for the supply of Products are consistent with the
market price for similar products sold by CVDI. Upon
termination of this Agreement, AVECOR, upon CVDI's request,
shall assign to CVDI (or such other entities designated by
CVDI) all product approvals, registrations and regulatory
approvals to sell Products in each country in the Territory;
or, if assignment of any such registration or approval is
not permissible under applicable law,
16
<PAGE>
where requested by CVDI, AVECOR shall grant CVDI (or its
designee) a right of reference to such registrations and
approvals. AVECOR shall otherwise use reasonable efforts to
enable CVDI to import and sell the Products in such countries.
(c) Upon termination of this Agreement, AVECOR will not for a
period of two (2) years sell products which are competitive
with special Cards or Instruments.
(d) Sections of this Agreement shall survive any termination of
this Agreement which relate to confidentiality and
indemnification, or otherwise which by their nature cannot
be accomplished or fulfilled prior to termination or which
relate to obligations of the parties accrued prior to
termination.
10.4 NON-COMPETITION. AVECOR shall not during the term of this
Agreement manufacture, sell, distribute or cause to be distributed
products competitive with Specialty Cards or Instruments.
11. ARBITRATION.
Except for terminations pursuant to Section 10.2(d) above, all disputes,
controversies and differences which may arise between the parties out of,
in relation to or in connection with this Agreement, or for the breach
thereof, or any claim based on or arising from any alleged wrongful conduct
or omission related to this Agreement, may upon mutual agreement of the
parties, be determined by arbitration. The arbitration shall be conducted
in accordance with the Rules of the American Arbitration Association
("AAA"), Supplementary Procedures for Large Complex Disputes, in effect as
of the commencement of the arbitration, as modified by the provisions of
this paragraph. The arbitration shall be held in Raleigh, North Carolina.
Whenever a party desires to request arbitration proceedings, such party
shall first cause its chief executive officer or other designated and
authorized officer to contact the other party; which shall cause its chief
executive officer or other designated and authorized officer to make good
faith efforts to resolve any such dispute prior to arbitration or
litigation.
No provision of this section shall limit the right of either party to this
Agreement to obtain provisional or ancillary remedies from a court of
competent jurisdiction before, after or during the pendency of any
arbitration if injunctive relief from the court is necessary to prevent
serious and irreparable injury to one party
17
<PAGE>
or the other. The parties acknowledge that for purposes of this Agreement
(1) preliminary injunctions, appointments of receivers, attachments,
temporary protective orders and writs of possession constitute "provisional
remedies," and (2) judicial actions to enforce a decision reached pursuant
to this section constitute "ancillary remedies."
18
<PAGE>
12. MISCELLANEOUS.
12.1 CHOICE OF LAW. This Agreement and all purchase orders issued
hereunder shall be governed and interpreted, and all rights and
obligations of the parties shall be determined, in accordance with
the laws of the State of North Carolina, without regard to its
conflict of laws rules.
12.2 NOTICES. All notices, approvals or other communications required
hereunder shall be in writing and shall be deemed to have been duly
given if delivered personally to such party or sent to such party by
facsimile transmission (confirmed in writing by other permitted
means), air courier or by certified mail, postage prepaid, to the
following addresses:
TO AVECOR:
AVECOR Cardiovascular Inc.
7611 Northland Drive
Minneapolis, MN 55428
Attn: Gregory J. Melsen
TO CVDI:
Cardiovascular Diagnostics, Inc.
5301 Departure Drive
Raleigh, NC 27604
Attn: President
Fax: (919) 954-9932
and WITH A COPY TO:
Larry E. Robbins, Esq.
Wyrick Robbins Yates & Ponton, L.L.P.
4101 Lake Boone Trail
Suite 300
Raleigh, NC 27607
Fax (919) 781-4865
or to such other address as the addressee may have specified in
notice duly given to the sender as provided herein. Such notice,
request, demand, waiver, consent, approval or other communications
will be deemed to have been given as of the date so delivered,
transmitted by facsimile or fifteen (15) days after so mailed.
12.3 SEVERABILITY. In the event that any provision of this Agreement
shall be found in any jurisdiction to be in violation of public
policy or illegal or unenforceable in law or equity, such finding
shall in no event invalidate any other provision of this Agreement
in that jurisdiction, and this Agreement shall be deemed amended to
the minimum extent required to comply with the law of such
jurisdiction.
19
<PAGE>
12.4 ENTIRE AGREEMENT. This Agreement states the entire agreement
between the parties hereto about the transactions contemplated
hereby and may not be amended or modified except by written
instrument duly executed by the parties hereto.
12.5 NO WAIVER. The failure of either party hereto to enforce at any
time, or for any period of time, any provision of this Agreement
shall not be construed as a waiver of such provision or of the right
of such party thereafter to enforce each and every provision.
12.6 ASSIGNMENT, BINDING EFFECT. Neither party shall assign this
Agreement nor any of their respective rights or obligations
hereunder without the prior written consent of the other party,
except that either party may assign this Agreement to any of its
Affiliates or to any person to which substantially all of the assets
comprising its hemostasis products business are transferred by
operation of law or otherwise, including, but without limitation, by
merger or transfer of stock. Any other attempted assignment without
such consent shall be void. Any assignee or transferee of this
Agreement and/or the rights or obligations hereunder shall expressly
assume in writing all obligations of the assignor/transferor
pursuant to this Agreement. For purposes of this Section 12.6, a
transfer of more than fifty (50%) percent of the stock of AVECOR
shall be deemed on assignment where such transfer is engaged in the
sale of hemostasis products.
12.7 INDEPENDENT CONTRACTOR. Each party shall act as the independent
contractor of the other party. Neither party shall be the legal
agent of the other for any purpose whatsoever and therefore has no
right or authority to make or underwrite any promise, warranty or
representation, to execute any contract or otherwise to assume any
obligation or responsibility in the name of or in behalf of the
other party, except to the extent specifically authorized in writing
by the other party. Neither of the parties hereto shall be bound by
or liable to any third persons for any act or for any obligation or
debt incurred by the other toward such third party, except to the
extent specifically agreed to in writing by the party so to be
bound.
12.8 HEADINGS. All section headings contained in this Agreement are for
convenience of reference only, do not form a part of this Agreement
and shall not affect in any way the meaning or interpretation of
this Agreement.
12.9 COUNTERPARTS. This Agreement may be executed in any number of
counterparts and any party hereto may execute any such counterpart,
each of which when executed and delivered shall be deemed to be an
original and all of which counterparts taken together shall
constitute but one and the same instrument. It shall not be
necessary in making proof of this Agreement or any counterpart
hereof to account for any of the other counterpart.
12.10 FORCE MAJEURE. Neither party shall be deemed to be in default for
failure or delay in performance to the extent of causes which are
reasonably unforeseeable or, if foreseeable, reasonably unremediable
in spite of diligent efforts to effect a reasonable remedy, and
which are caused by act or omission of
20
<PAGE>
any governmental authority or of the other party, compliance with
new governmental regulations, insurrection, riot, embargo, delays or
shortages in transportation or inability to obtain necessary
materials, and Acts of God or Nature.
12.11 INSURANCE. CVDI and AVECOR shall at all times maintain insurance,
including product liability insurance, in the amount of $5,000,000.
Each party shall, at the request of the other party, provide such
evidence of such insurance as requested, including a certificate of
insurance.
21
<PAGE>
IN WITNESS WHEREOF, this Agreement has been duly executed and delivered as
of the day and year first above written.
CARDIOVASCULAR
DIAGNOSTICS, INC. AVECOR
By: By:
------------------------- -----------------------------
As its As its
22
<PAGE>
SCHEDULE 1.11
PRODUCTS CATALOG # INITIAL SALES PRICE
TO AVECOR
- --------------------------------------------------------------------------------
HMT $2.00 per Specialty Card
TAS $1850.00 per Instrument
HMT Controls $62.50 per box of 25
Future Products
AT $7.50 per card
HMT Management Panel To be determined
Accent To be determined
23
<PAGE>
SCHEDULE 2.5
STANDARD TERMS AND CONDITIONS
1. DEFINITIONS.
CVDI: Cardiovascular Diagnostics, Inc. The person or organization that
has placed an Order with CVDI or with whom CVDI has concluded an agreement.
STANDARD TERMS: The Standard Terms and Conditions of Sale
Products: The whole of the Products the subject of this Contract, as
specified in the Offer or in the Order.
OFFER: The written proposition, made by CVDI, which includes these
Standard Terms, a specification of the Products and the current price.
ORDER: The written request, made by the Buyer, including a specification
of the Products to be ordered.
II. OFFERS, GOODS, AND SPECIFICATIONS.
1. All offers, Orders and Contracts of Sale by CVDI shall be subject to
these Standard Terms
2. These Standard Terms can only be amended with the specific written
consent of CVDI.
III. ORDERS.
1. No Order shall be binding on CVDI until expressly accepted by
CVDI in writing.
2. No Order may be canceled and/or amended by the Buyer except with
the written consent of CVDI.
3. Save as provided in a distribution agreement between CVDI and the
Buyer, these Standard Terms and any special terms agreed upon in
writing represent the Understanding between the parties and shall
supersede and exclude any previous agreements between CVDI and
the Buyer in relation to their subject matter and all terms
and/or General Conditions of whatever nature which the Buyer may
in any way seek to impose.
IV. PRICES.
1. Unless otherwise agreed upon, all prices mentioned in CVDI
current standard price list are based on deliver FOE, CVDI.
2. The price shall be exclusive of, and the Buyer shall pay, all
duties or taxes arising in connection with the sale unless
otherwise agreed to by CVDI in writing.
V. PAYMENT.
1. Subject to any agreement to the contrary, payment must be made
within 30 days from the date of the invoice.
2. If the Buyer commits any breach of this Contract, all monies
accrued and owing under this Contract shall immediately become
due and payable.
24
<PAGE>
3. In the event of any later payment, the Buyer shall pay CVDI
interest from the date payment became due, to be calculated at
the Wall Street Journal Prime Rate increased by 5% per month.
4. All payments shall be made in full without deducting any right of
equity, set-off or counterclaim.
VI. CARRIAGE AND DELIVERY.
1. Unless otherwise agreed upon, delivery of the Products shall be
FOB, CVDI.
2. Any delivery time specified by the Buyer or indicated by CVDI is
an estimate only and CVDI shall not have any liability whatsoever
for failure to deliver the Products at or within any such
delivery time. In case of any later deliver, CVDI must be
formally declare to be in default and must be granted a
reasonable term to comply with its delivery obligation.
3. If the Buyer refused to take prompt delivery or is negligent in
providing necessary information or instructions in accordance
with these Standard Terms, then the Products shall be stored at
the Buyers risk. The Buyer shall pay CVDI all additional
delivery, storage and insurance costs and any other costs
incurred along with any loss arising in connection with this
neglect or refusal.
4. The Buyer shall inspect all Products promptly upon receipt
thereof. Such inspection shall include, without limitation, a
quality control analysis. Any Product not properly rejected
within 4 weeks after receipt by the Buyer shall be deemed
accepted. The Buyer shall be deemed to have received the
correct quantity of Products upon CVDI's delivery note being
signed on behalf of the Buyer or by its carrier. In the event of
any incomplete or excessive delivery, the Buyer shall not be
entitled to reject the Products included in the Contract or to
treat the Contract as repudiated.
5. Buyer shall notify CVDI in writing within 5 days from the moment
of discovery of any other defect or within 5 days from the moment
the defect should have been discovered. Save only as provided
under these General Conditions, CVDI shall not be held liable for
any defect w2hich is not so notified. Unless expressly agreed
otherwise, the risk of loss ensuing from loading and
transporting the Products shall be borne by the Buyer even if the
transport is handled by CVDI at the Buyer's request.
VII. RETENTION OF TITLE.
1. Notwithstanding delivery, title to the Products shall remain in
CVDI and shall not pass to the Buyer until CVDI has received
payment in full with respect to all Products delivered or to be
delivered, work done in relation to sales agreements, interest
owed and/or accrued including any cost which may arise in respect
of letters of credit, bills of exchange or cheques along with any
storage and other costs, resulting from a breach of the sales
agreement by the Buyer.
VIII. INTELLECTUAL PROPERTY RIGHTS.
1. All patents, designs, trademarks, copyrights and other
intellectual property rights of CVDI or whatever nature in
respect of the Products, any of their constituent parts,
their packaging or other material supplied with the Products
shall remain the absolute property of CVDI and shall remain
vested in CVDI.
2. The Buyer shall indemnify CVDI against any and all loss, damage,
claims, costs, and expenses suffered or incurred by CVDI in
connection with any material,
25
<PAGE>
information or instruction supplied by the Buyer in relation to
the Products, including the industrial or intellectual property
rights as stated in Article VIII.1.
IX. LIABILITY.
1. CVDI's liabilities regarding the Products shall be limited in
accordance with the provisions of CVDI's Standard Limited
Warranty attached hereto as Exhibit A and incorporated by this
reference. CVDI does not give any warranty beyond these
specifications.
2. CVDI's aggregate liability to the Buyer in respect of any and all
causes of action arising at any time in connection with the
Products, including but not limited to action in relation to
negligence, shall be limited to the amount paid the Buyer for the
Products or replacement of the Product at CVDI's option. In no
event shall CVDI be liable for costs or procurement of substitute
goods by anyone. In no event shall CVDI be liable for any
special, consequential, incidental, or indirect damages,
including but not limited to damages resulting from late
delivery and loss of profit.
X. ALTERATIONS TO THE PRODUCTS AND DESCRIPTION.
1. After delivery of the Products, the Buyer shall not alter the
Products or alter any marks, designs or artwork on the Products
or on the packaging. The Buyer shall not apply its own marks on
the Products or on their packaging, and shall not cause, allow
or permit any third party to do so.
XI. DEFAULT.
1. If any of the following events occur, all monies accrued and
owing under the Contract shall become immediately due and payable
and CVDI shall be entitled at any time thereafter to terminate
the Contract and any other Contract between CVDI and the Buyer by
written notice, or to suspect further deliveries of Products,
without prejudice to its right to full indemnification:
- if the Buyer defaults or commits to breach of the Contract
or of any other obligations to CFDI and if, in CVDI's
reasonable judgment, termination of the contract or
suspension of further deliveries is justified;
- if an attachment or execution is levied upon the Buyer's
property and/or assets;
- if the Buyer makes, offers or proposes a settlement,
arrangement or composition with its creditors. If a
resolution or petition to wind up the Buyer's business is
passed or presented, if a petition for an administrative
order in respect of the Buyer is presented, if a petition
for a bankruptcy order is made against the Buyer, or if a
receiver, liquidator, trustee or manager of the Buyer's
undertaking, property, assets or any part thereof is
appointed;
- if CVDI considers that the Buyer may be unable to provide
payment in full and/or to perform any of its other
obligations under the Contract, and the Buyer is
(in CVDI's reasonable judgment) not able to provide security
covering his obligation.
2. Should the Buyer fail to fulfill one or more of his obligations,
all reasonable costs incurred in and out of count in order to
realize fulfillment will be at his expense. Such costs will in
any event include those for collecting agencies, bailiffs and
attorneys.
26
<PAGE>
XII. FORCE MAJEURE.
1. CVDI shall not be liable, if it is prevented from or hindered or
delayed in performing any of its obligations by reason of force
majeure. Force majeure shall consist of, but shall not be
limited to, the following:
- strike, lock-out or trade dispute (in each case whether
involving CVDI's or a third party's employees);
- non-availability, interruption, failure of or delay in
CVDI's usually supply sources, manufacturing facilities,
transportation routes or facilities;
- breakdown of machinery or power failure;
- default or delay by CVDI's sub-contractors, acts of national
or local government or other authorities;
- storm, tempest, fire, flood, explosion, accident, theft,
civil disturbance, insurrection or war.
XIII. GOVERNING LAW.
1. Those Standard Terms and any Contract in conjunction therewith
shall be governed by the laws of the State of North Carolina.
2. In any proceeding instigated by the Buyer in respect of any
matter which may arise in connection with the contract or these
Standard Terms, the counts of North Carolina shall have exclusive
jurisdiction. In any such proceedings brought by CVDI, CVDI shall
be at liberty to bring the proceeding before the courts of North
Carolina or any other court which would have jurisdiction in the
absence of this clause.
27
<PAGE>
SCHEDULE 3.4
TRADEMARKS AND PATENTS
28
<PAGE>
EXHIBIT 11.1 - STATEMENT RE COMPUTATION OF EARNINGS PER SHARE
(Unaudited)
Three Months Three Months
Ended Ended
March 31, March 31,
1997 1996
------------ ------------
(In thousands, except per share data)
NET INCOME $387 $213
------------ ------------
------------ ------------
PER SHARE DATA:
Net income per common equivalent share,
primary $0.05 $0.03
------------ ------------
------------ ------------
Net income per common equivalent share,
fully diluted $0.05 $0.03
------------ ------------
------------ ------------
WEIGHTED AVERAGE NUMBER OF
COMMON AND COMMON EQUIVALENT
SHARES:
Primary:
Weighted average number of common
shares outstanding 7,844 7,699
Common equivalent shares:
Warrants 2 3
Options 100 189
------------ ------------
7,946 7,890
------------ ------------
------------ ------------
Fully diluted:
Weighted average number of common
shares outstanding 7,844 7,699
Common equivalent shares:
Warrants 2 3
Options 100 193
------------ ------------
7,946 7,895
------------ ------------
------------ ------------
<TABLE> <S> <C>
<PAGE>
<ARTICLE> 5
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> DEC-31-1997
<PERIOD-START> JAN-01-1997
<PERIOD-END> MAR-31-1997
<CASH> 2,287,000
<SECURITIES> 4,837,000
<RECEIVABLES> 8,604,000
<ALLOWANCES> 173,000
<INVENTORY> 8,926,000
<CURRENT-ASSETS> 26,372,000
<PP&E> 18,531,000
<DEPRECIATION> 4,797,000
<TOTAL-ASSETS> 42,029,000
<CURRENT-LIABILITIES> 6,160,000
<BONDS> 183,000
0
0
<COMMON> 79,000
<OTHER-SE> 30,682,000
<TOTAL-LIABILITY-AND-EQUITY> 42,029,000
<SALES> 12,043,000
<TOTAL-REVENUES> 12,043,000
<CGS> 7,060,000
<TOTAL-COSTS> 11,512,000
<OTHER-EXPENSES> 0
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> (73,000)
<INCOME-PRETAX> 604,000
<INCOME-TAX> 217,000
<INCOME-CONTINUING> 0
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> 387,000
<EPS-PRIMARY> .05
<EPS-DILUTED> .05
</TABLE>
