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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
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 1998
Commission file number: 0-18933
ROCHESTER MEDICAL CORPORATION
(Exact name of small business issuer as specified in its charter)
MINNESOTA 41-1613227
(State or other jurisdiction of (IRS Employer
incorporation or organization) Identification No.)
ONE ROCHESTER MEDICAL DRIVE,
STEWARTVILLE, MN 55976
(Address of principal executive offices)
(507) 533-9600
Issuer's Telephone Number
Check whether the issuer (1) filed all reports required to be filed by Section
13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter
period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes __X__ No _____
Indicate the number of shares outstanding of each of the issuer's classes of
common stock as of the latest practicable date:
5,261,500 Common Shares as of May 7, 1998.
Total Number of Pages: Index to Exhibits on Page: 10
<PAGE>
TABLE OF CONTENTS
ROCHESTER MEDICAL CORPORATION
REPORT ON FORM 10-Q
FOR QUARTER ENDED
MARCH 31, 1998
PAGE
----
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited)
Balance Sheets -- March 31, 1998 and September 30, 1997 ................ 3
Statements of Operations -- Three months ended March 31, 1998 and 1997;
Six months ended March 31, 1998 and 1997 .............................. 4
Statements of Cash Flows -- Six months ended March 31, 1998 and 1997 ... 5
Notes to the Financial Statements ...................................... 6
Item 2. Management's Discussion and Analysis of
Financial Condition and Results of Operations .......................... 7
PART II. OTHER INFORMATION ................................................. 10
<PAGE>
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (UNAUDITED)
ROCHESTER MEDICAL CORPORATION
BALANCE SHEETS
<TABLE>
<CAPTION>
MARCH 31, SEPTEMBER 30,
1998 1997
------------ ------------
<S> <C> <C>
ASSETS
CURRENT ASSETS:
Cash and Cash Equivalents .................................. $ 646,406 $ 1,191,428
Marketable Securities ...................................... 17,983,317 3,447,461
Accounts Receivable ........................................ 1,509,164 1,967,194
Inventories ................................................ 2,078,969 1,653,733
Prepaid Expenses And Other Assets .......................... 333,587 253,785
------------ ------------
TOTAL CURRENT ASSETS ..................................... 22,551,443 8,513,601
PROPERTY AND EQUIPMENT
Land and Buildings ......................................... 2,447,532 2,438,826
Equipment and Fixtures ..................................... 10,226,800 9,186,588
------------ ------------
12,674,332 11,625,414
Less: Accumulated Depreciation ............................. (2,147,372) (1,855,980)
------------ ------------
TOTAL PROPERTY AND EQUIPMENT ............................. 10,526,960 9,769,434
INTANGIBLE ASSETS
Patents, Less Accumulated Amortization ..................... 289,705 330,338
------------ ------------
TOTAL ASSETS ................................................ $ 33,368,108 $ 18,613,373
============ ============
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES
Accounts Payable ........................................... $ 296,107 $ 457,564
Accrued Expenses ........................................... 971,861 974,836
------------ ------------
TOTAL CURRENT LIABILITIES ................................ 1,267,968 1,432,400
SHAREHOLDERS' EQUITY
Common Stock, no par value:
Authorized -- 20,000,000
Issued and Outstanding Shares --
5,261,500 -- Mar, 1998 and 4,133,500 -- Sep, 1997 ......... 40,584,202 24,697,199
Accumulated Deficit ........................................ (8,484,062) (7,516,226)
------------ ------------
TOTAL SHAREHOLDERS' EQUITY 32,100,140 17,180,973
------------ ------------
TOTAL LIABILITIES & SHAREHOLDERS' EQUITY .................... $ 33,368,108 $ 18,613,373
============ ============
</TABLE>
Note -- The Balance Sheet at September 30, 1997 was derived from the audited
financial statements at that date, but does not include all of the
information and footnotes required by generally accepted accounting
principles for complete financial statements.
See Notes to Financial Statements
<PAGE>
ROCHESTER MEDICAL CORPORATION
STATEMENTS OF OPERATIONS (UNAUDITED)
<TABLE>
<CAPTION>
THREE MONTHS ENDED SIX MONTHS ENDED
MARCH 31, MARCH 31,
-------------------------- ------------------------------
1998 1997 1998 1997
---------- ---------- ------------ ------------
<S> <C> <C> <C> <C>
NET SALES ........................... $2,422,683 $1,743,537 $ 4,277,970 $ 3,471,377
Cost Of Sales ....................... 1,653,062 1,097,518 2,924,381 2,184,334
---------- ---------- ------------ ------------
GROSS PROFIT ........................ 769,621 646,019 1,353,589 1,287,043
COSTS AND EXPENSE:
Marketing and Selling .............. 655,741 449,596 1,288,355 972,612
Research and Development ........... 424,314 385,341 722,469 797,266
General and Administrative ......... 388,170 343,743 715,045 687,488
---------- ---------- ------------ ------------
TOTAL OPERATING EXPENSES ......... 1,468,225 1,178,680 2,725,869 2,457,366
---------- ---------- ------------ ------------
LOSS FROM OPERATIONS ................ (698,604) (532,661) (1,372,280) (1,170,323)
OTHER INCOME (EXPENSE):
Interest Income .................... 231,791 176,531 404,442 380,908
Interest Expense ................... (71,162) (142,412)
---------- ---------- ------------ ------------
TOTAL OTHER INCOME (EXP) ......... 231,791 105,369 404,442 238,496
---------- ---------- ------------ ------------
NET LOSS ............................ $ (466,813) $ (427,292) $ (967,838) $ (931,827)
========== ========== ============ ============
NET LOSS PER COMMON SHARE
(Basic and Diluted) ................ $ (0.09) $ (0.10) $ (0.19) $ (0.23)
========== ========== ============ ============
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING .......... 5,261,500 4,131,100 5,013,637 4,129,600
========== ========== ============ ============
</TABLE>
See Notes to Financial Statements
<PAGE>
ROCHESTER MEDICAL CORPORATION
STATEMENTS OF CASH FLOWS (UNAUDITED)
<TABLE>
<CAPTION>
SIX MONTHS ENDED
MARCH 31,
--------------------------------
1998 1997
------------- -------------
<S> <C> <C>
OPERATING ACTIVITIES
Net Loss .................................................... $ (967,838) $ (931,827)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation and amortization .............................. 355,476 266,701
Changes in assets and liabilities:
Decrease In Accounts Receivable .......................... 458,030 131,917
(Increase) In Inventories ................................ (425,236) (168,081)
(Increase) Decrease In Other Current Assets .............. (79,801) 4,519
(Decrease) In Accounts Payable ........................... (161,457) (481,038)
Increase (Decrease) In Other Current Liabilities ......... (2,974) 241,245
------------- -------------
NET CASH USED IN OPERATING ACTIVITIES ................... (823,800) (936,564)
INVESTING ACTIVITY
Capital expenditures ....................................... (1,048,918) (3,400,292)
Patents .................................................... (23,452) (44,773)
Purchase Of Marketable Securities .......................... (36,834,426) (11,003,212)
Sales and Maturities Of Marketable Securities .............. 22,298,572 9,614,846
------------- -------------
NET CASH USED IN INVESTING ACTIVITIES ................... (15,608,224) (4,833,431)
FINANCING ACTIVITIES
Interest Expense Added To Note Payable ..................... -- 142,500
Proceeds from Sale of Common Stock ......................... 15,887,003 68,500
------------- -------------
NET CASH PROVIDED BY FINANCING ACTIVITIES ............... 15,887,003 211,000
------------- -------------
DECREASE IN CASH AND CASH EQUIVALENTS ....................... (545,022) (5,558,995)
CASH AND CASH EQUIVALENTS AT
BEGINNING OF PERIOD ........................................ 1,191,428 8,394,607
------------- -------------
CASH AND CASH EQUIVALENTS AT END OF PERIOD .................. $ 646,406 $ 2,835,612
============= =============
</TABLE>
See Notes to Financial Statements
<PAGE>
ROCHESTER MEDICAL CORPORATION
NOTES TO FINANCIAL STATEMENTS (UNAUDITED)
MARCH 31, 1998
NOTE A -- BASIS OF PRESENTATION
The accompanying unaudited financial statements have been prepared in
accordance with generally accepted accounting principles for interim financial
information and with the instructions to Form 10-QSB. Accordingly, they do not
include all of the information and footnotes required by generally accepted
accounting principles for complete financial statements. These financial
statements should be read in conjunction with the financial statements and
related notes included in the Company's 1997 Form 10-KSB. In the opinion of
management, all adjustments (consisting only of normal recurring accruals)
considered necessary for a fair presentation have been included. Operating
results for the six month period ended March 31, 1998 are not necessarily
indicative of the results that may be expected for the year ending September 30,
1998.
NOTE B -- EARNINGS (LOSS) PER SHARE
The company has adopted Financial Accounting Standards Board Statement No.
128, Earnings Per Share. This Statement replaces previously reported primary and
fully diluted earnings per share (EPS) with basic and diluted EPS. Unlike
primary EPS, basic EPS excludes any dilutive effects of options, warrants and
convertible debt. Diluted EPS is very similar to the previously reported fully
diluted EPS. For the six-month periods ended March 31, 1998 and 1997, there is
no difference between basic and diluted net loss per share or between basic and
net loss per share as previously reported. Common equivalent shares from stock
options and convertible debt are excluded as their effects are antidilutive.
<PAGE>
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
INTRODUCTION
The Company develops, manufactures and markets innovative urinary
continence care products for urinary dysfunction management and urine drainage
management. The Company currently manufactures and markets a broad line of
functionally and technologically enhanced latex-free versions of standard
continence care products, including male external catheters, Foley catheters and
intermittent catheters. The Company markets its products under its own ROCHESTER
MEDICAL(R) brand and through private label arrangements.
Effective May 6, 1998, the Company and ConvaTec entered into a Revised and
Restated Distribution Agreement (the "Restated Agreement") revising and
restating their August 11, 1995, Distribution and Co-Development Agreement (the
"1995 Agreement"). Under the Restated Agreement, ConvaTec has non-exclusive
private label rights (subject to the Company's commitments to private label
customers existing prior to the 1995 Agreement) to market the Company's silicone
male external catheters and standard Foley and intermittent catherters and (ii)
exclusive private label rights to market the male external catheter in certain
markets including Africa, Central and South America, the Middle East, Australia
and New Zealand. The Restated Agreement terminates all other prior restrictions
on the Company, thereby enabling the Company to pursue additional private label
agreements for its products. The Restated Agreement grants ConvaTec a right of
first consideration until June 30, 1998 to negotiate with the Company terms
under which ConvaTec might market the Company's Nitrofuran Delivery Catheter.
RESULTS OF OPERATIONS
The following table sets forth, for the fiscal periods indicated, certain
items from the statements of operations of the Company expressed as a percentage
of net sales.
<TABLE>
<CAPTION>
THREE MONTHS ENDED SIX MONTHS ENDED
MARCH 31 MARCH 31
---------------------- ----------------------
1998 1997 1998 1997
--------- --------- --------- ---------
<S> <C> <C> <C> <C>
Net Sales
Private Label ....................... 75% 73% 74% 80%
ROCHESTER MEDICAL Brand ............. 25% 27% 26% 20%
-- -- -- --
Total Net Sales .................... 100% 100% 100% 100%
Cost of Sales ......................... 68% 63% 68% 63%
--- --- --- ---
Gross Margin .......................... 32% 37% 32% 37%
Operating Expenses
Marketing and Selling ............... 27% 26% 30% 28%
Research and Development. ........... 18% 22% 17% 23%
General and Administrative .......... 16% 20% 17% 20%
--- --- --- ---
Total Operating Expenses ........... 61% 68% 64% 71%
Loss From Operations. ................. (29%) (31%) (32%) (34%)
Interest Income (Expense) Net ......... 10% 6% 9% 7%
--- --- --- ---
Net Loss ........................... (19%) (25%) (23%) (27%)
=== === === ===
</TABLE>
THREE MONTH AND SIX MONTH PERIODS ENDED MARCH 31, 1998 AND MARCH 31, 1997
NET SALES. Net sales increased 39% to $2,423,000 for the second quarter of
fiscal 1998 from $1,744,000 for the comparable quarter of the prior year,
reflecting growth in both branded and private label sales. Branded product sales
increased up 32% overall, primarily due to 82% growth in the domestic market.
Private label sales increased 41% overall, with a 72% increase in sales to
private label
<PAGE>
customers other than ConvaTec partially offset by a 29% decrease in sales to
ConvaTec due to their inventory adjustment process. The increase in private
label sales relates to demand for the Company's silicone Foley catheter
products.
Net sales increased 23% to $4,728,000 for the six months ended March 31,
1998, from $3,471,000 for the comparable six months of the prior year. Branded
product sales growth in domestic and international markets was 82% and 37%,
respectively, for the current six-month period to date. Private label sales
growth was 14% overall for the six month period, with a 61% increase in sales to
private label customers other than ConvaTec partially offset by a 51% decrease
in sales to ConvaTec due to their inventory adjustment process.
GROSS MARGIN. The Company's gross margin as a percentage of net sales was
32% for the second quarter of fiscal 1998 compared with 37% for the second
quarter of fiscal 1997. The gross margin for the current quarter has been
impacted by expansion of production facilities and support operations, as well
as by production wage rates and product mix.
The Company's gross margin was 32% for the six months ended March 31, 1998
compared with 37% for the comparable period last year. Factors affecting margins
during the current six months are generally consistent with those described
above for the current quarter.
MARKETING AND SELLING. Marketing and selling expense increased 46% to
$656,000 for the second quarter of fiscal 1998 from $450,000 for the comparable
quarter last year. The increase in expense reflects preparation for market
introduction of the Nitrofuran Delivery Catheter, including expansion of the
domestic field sales force and product launch related marketing expenses.
Marketing and selling expense increased 33% to $1,289,000 for the six
months ended March 31, 1998 from $972,000 for the comparable period last year.
Factors affecting the increase in expense are consistent with those described
above for the current quarter, with expenses increasing progressively during the
six-month period.
RESEARCH AND DEVELOPMENT. Research and development expense increased 10% to
$424,000 in the second quarter of fiscal 1998 from $385,000 for the comparable
quarter last year. The increase in expense relates to development and testing
costs for new production processes and equipment.
Research and development expense decreased 9% to $723,000 for the six
months ended March 31, 1998 from $797,000 for the comparable period last year.
The decrease in expense relates to the completion of clinical tests for the
Nitrofuran delivery catheter in early 1997.
GENERAL AND ADMINISTRATIVE. General and administrative expense increased
13% to $388,000 in the second quarter of fiscal 1998 from $344,000 for the
comparable quarter last year. The increase in expense reflects administrative
support requirements related to business growth.
General and administrative expense increased 4% to $715,000 for the six
months ended March 31, 1998 from $687,000 for the comparable period last year.
The six-month rate of increase reflects comparatively lower costs in the first
quarter of fiscal 1998, due to deferral of hiring and other expenses pending
receipt of FDA approval for the Nitrofuran Delivery Catheter.
INTEREST INCOME AND (EXPENSE). Interest income increased by 32% to $232,000
for the second quarter of fiscal 1998 from $177,000 for the comparable quarter
last year. For the six-months ended March 31, 1998, interest income increased 6%
to $405,000 from $381,000 for the comparable period last year. The increase in
interest income in the current fiscal year is a result of investment of proceeds
from the Company's November 1997 public offering.
Interest expense has been eliminated as of the first quarter of fiscal
1998, reflecting repayment of the $3 million convertible loan from ConvaTec,
with accrued interest, on September 30, 1997.
LIQUIDITY AND CAPITAL RESOURCES
The Company's cash, cash equivalents and marketable securities were
$18,629,000 at March 31, 1998 compared with $4,639,000 at September 30, 1997.
The increase reflects the receipt of public offering proceeds of $15,887,000 in
November 1997.
<PAGE>
The Company used a net $824,000 of cash from operating activities during
the six-months ended March 31, 1998, primarily reflecting the net loss before
depreciation charges and a $164,000 decrease in current liabilities. Capital
expenditures of $1,049,000 were made during the six-month period, substantially
all of which relate to the Company's new manufacturing facilities.
Inventory balances at March 31, 1998 are in line with current sales trends.
Accounts receivable days sales outstanding (DSO) at March 31, 1998 are somewhat
improved due to increased emphasis on credit and collections. Accounts payable
at March 31, 1998 are slightly lower than recent trends due to comparatively
less capital expenditure activity in production facility expansion projects.
The Company believes that its capital resources on hand at March 31, 1998,
together with cash flows from future sales, will be sufficient to satisfy its
working capital requirements for the foreseeable future as described in the
Liquidity and Capital Resources portion of Management's Discussion and Analysis
of Financial Condition and Results of Operations in the Company's Annual Report
on Form 10-K (Part II, Item 6) for the fiscal year ended September 30, 1997.
BUSINESS OUTLOOK
The following discussion, as well as certain statements in the preceding
section, contain forward looking statements that involve risks and
uncertainties, including market acceptance of new products, the timing of
purchases by customers, the timing of clinical preference testing and product
introductions, FDA review and response times, the timing and ultimate outcome of
clinical tests, the scope and effect of patent opinions, as well as other risk
factors listed from time to time in the Company's SEC reports, including,
without limitation, the sections entitled "Business Outlook" and "Risk Factors"
in the Company's Annual Report on Form 10-K (Part II, Item 6) for the year ended
September 30, 1997.
The Company anticipates that sales of both branded product and private
label products during the current fiscal year will be affected by several
factors. Recent trends in orders for silicone Foley catheters may be partly due
to recently adopted FDA regulations requiring warning labels on latex products.
In addition, the Company intends to pursue a strategy of seeking additional
private label agreements as a result of the Restated Agreement with ConvaTec.
The Company also plans to introduce its Nitrofuran Delivery Catheter to market
in May 1998. Due to the expected sales cycle for this product, involving
customer review and evaluation, the company does not expect to begin receiving
order for this product until later this year.
The Company's FEMSOFT female continence insert is currently in clinical
tests at eight clinical sites throughout the United States. As of April 29,
1998, the device had been tested by 123 patients. Based on the interim data from
the clinical trials to date, the Company believes it will be in a position to
submit a PMA (Premarket Approval) application with the FDA for the device before
the end of the year. The results from the clinical trials are preliminary and
there can be no assurance that such trials when completed will yield data that
support the efficiency and safety of the device or that such clinical trials or
continued development efforts, will not identify significant technical,
manufacturing, design or other obstacles that could delay submitting PMA.
The Company expects to experience excess capacity costs, including
depreciation and amortization charges, associated with its new manufacturing
facilities, which will affect margins until such time as the Company's sales
volumes require a level of utilization that offsets such costs.
The Company is aware of the possibility that some computer programs may
fail or cause erroneous results due to their inability to accomodate the date
2000. The principal components of the Company's computer system have been
recently purchased. The Company has been advised by its software vendors that
the software purchased by the Company is year 2000 compliant, and the Company is
not presently aware of any such problems. The Company plans to make additional
inquiries to select vendors, and does not now know what the results of such
inquiries will be.
<PAGE>
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
The Company is not a party to any material legal proceedings.
ITEM 2. CHANGES IN SECURITIES
Not Applicable.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not Applicable
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
The Company held its annual meeting on February 4, 1998, in Minneapolis
Minnesota. The Company solicited proxies and filed its definitive proxy
statement with the Commission pursuant to Regulation 14A. The matters
voted upon at the meeting and the votes cast were as follows:
(a) Election of Directors
AUTHORITY FOR WITHHOLD
-------------------- --------- --------
Darnell L. Boehm 4,505,645 202,550
Anthony J. Conway 4,505,745 202,450
Peter R. Conway 4,505,645 202,550
Philip J. Conway 4,505,745 202,450
Richard D. Fryar 4,505,745 202,450
Roger W. Schnobrich 4,505,645 202,550
Brian J. Wierzbinski 4,505,745 202,450
(b) Approval of Ernst & Young as Accountants
For: 4,702,645 Against: 1,550 Abstain: 4,000
ITEM 5. OTHER INFORMATION
None
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits:
10. ConvaTec Agreement
27. Financial Data Schedule
(b) Reports on Form 8-K:
None
<PAGE>
SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant has
caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
Rochester Medical Corporation
Date: May 8, 1998 By: /s/ ANTHONY J. CONWAY
-----------------------------------
Anthony J. Conway
CHIEF EXECUTIVE OFFICER
Date: May 8, 1998 By: /s/ BRIAN J. WIERZBINSKI
-------------------------------------
Brian J. Wierzbinski
CHIEF FINANCIAL OFFICER
<PAGE>
EXHIBITS
PAGE
-----
10.17 Revised and Restated Distribution Agreement dated May 6, 1998,
between the Company and E.R. Squibb & Sons, Inc. (through its
ConvaTec Division).
27 Financial Data Schedule
EXHIBIT 10.17
REVISED AND RESTATED DISTRIBUTION
AGREEMENT
E. R. SQUIBB & SONS, INC.
(THROUGH ITS CONVATEC DIVISION)
AND
ROCHESTER MEDICAL CORPORATION
MAY 6, 1998
<PAGE>
SECTION TITLE PAGE
- ------- ----- ----
SECTION 1. DEFINITIONS 4
SECTION 2. REPRESENTATIONS AND WARRANTIES OF ROCHESTER 5
SECTION 3. APPOINTMENT OF DISTRIBUTOR 6
SECTION 4. RIGHT OF FIRST CONSIDERATION 7
SECTION 5. PRICING 8
SECTION 6. REGULATORY APPROVALS 9
SECTION 7. ORDERING AND FORECASTING 9
SECTION 8. STORAGE OF CONVATEC MATERIALS 10
SECTION 9. PACKAGING 10
SECTION 10. ALTERNATE SUPPLIER 10
SECTION 11. CONTINGENT MANUFACTURING 11
SECTION 12. SHIPMENT AND DELIVERY 11
SECTION 13. INVOICING AND PAYMENT 12
SECTION 14. SALES AND MARKETING 12
SECTION 15. REGULATORY COMPLIANCE 12
SECTION 16. RIGHTS OF INSPECTION 13
SECTION 17. PRODUCT WARRANTY 13
SECTION 18. INDEMNIFICATION 14
SECTION 19. PRODUCT LIABILITY INSURANCE 15
SECTION 20. CONFIDENTIAL INFORMATION 16
SECTION 21. PATENT ENFORCEMENT 17
<PAGE>
SECTION 22. PATENT INFRINGEMENT 17
SECTION 23. TRADEMARKS 18
SECTION 24. CO-DEVELOPMENT 18
SECTION 25. NON-SOLICITATION 19
SECTION 26. DURATION OF AGREEMENT 19
SECTION 27. TERMINATION 19
SECTION 28. FORCE MAJEURE 21
SECTION 29. RELATIONSHIP 21
SECTION 30. ENTIRE AGREEMENT 22
SECTION 31. AMENDMENT; ASSIGNABILITY 22
SECTION 32. GOVERNING LAW 22
SECTION 33. ARBITRATION 22
SECTION 34. SEVERABILITY 23
SECTION 35. NOTICES 23
SECTION 36. CAPTIONS 24
SECTION 37. MUTUAL RELEASE 24
SECTION 38. JOINTLY DRAFTED AGREEMENT 25
SECTION 39. REVIEW AND COMMENT 25
SIGNATURES 25
<PAGE>
REVISED AND RESTATED DISTRIBUTION AGREEMENT
This Revised and Restated Distribution Agreement ("Restated
Agreement") made and entered into this 6th day of May 1998, by and between E. R.
Squibb & Sons, Inc.,(through its CONVATEC Division), 100 Headquarters Park
Drive, Skillman, New Jersey 08558, a Delaware corporation, (hereinafter:
"CONVATEC") and ROCHESTER MEDICAL CORPORATION, One Rochester Medical Drive,
Stewartville, Minnesota 55976, a Minnesota corporation, (hereinafter
"ROCHESTER");
WITNESSETH:
WHEREAS, CONVATEC and ROCHESTER are parties to a certain
Distribution and Co-Development Agreement dated August 11, 1995 (the "1995
Agreement"); and
WHEREAS, CONVATEC and ROCHESTER are parties to a certain
Supplemental Agreement dated August 11, 1995 (the "1995 Supplement"); and
WHEREAS, certain disagreements have arisen between CONVATEC and
ROCHESTER respecting their respective compliance with and obligations under the
1995 Agreement; and
WHEREAS, CONVATEC and ROCHESTER desire to revise and restate the
1995 Agreement and the 1995 Supplement (collectively, the "1995 Agreements") in
accordance with the terms and conditions of this Restated Agreement and to
resolve and settle any disagreement under the 1995 Agreement.
WHEREAS, CONVATEC and ROCHESTER desire that CONVATEC should have,
subject to the terms of this Restated Agreement, the rights provided hereafter
to market such of ROCHESTER's products as are more particularly described
hereinafter; and
WHEREAS, CONVATEC desires ROCHESTER to manufacture and package
certain of ROCHESTER'S products for purchase by CONVATEC in accordance with
specifications agreed to by CONVATEC and ROCHESTER for each such product.
WHEREAS, ROCHESTER is agreeable, subject to the terms of this
Restated Agreement, to manufacture and package the products contemplated
<PAGE>
by this Restated Agreement for sale and distribution by CONVATEC as provided in
this Restated Agreement; and
WHEREAS, CONVATEC and ROCHESTER also desire to provide for the
possibility of cooperative development and commercialization of new products
which may result in the creation of valuable intellectual property, including
patent rights, or which may utilize or combine proprietary technologies
belonging to CONVATEC or ROCHESTER, respectively, and further desire to provide
for the respective ownership interests in such newly developed products and in
the attendant intellectual property or technology developed or created as a
result of such cooperative development activities.
NOW, THEREFORE, in consideration of the mutual promises and
covenants herein contained, CONVATEC and ROCHESTER agree as follows:
SECTION 1. DEFINITIONS
When used in this Restated Agreement, unless the context otherwise
requires, the following terms shall have the meanings ascribed to them.
Co-Exclusive Territory. "Co-Exclusive Territory" means the territory
located within the geographical boundaries of Africa, Central America (excluding
Mexico), South America, Australia, Israel, Iran, Iraq, Japan, Jordan, Kuwait,
Lebanon, New Zealand, Oman, Qatar, Saudi Arabia, Syria, United Arab Emirates or
Yemen, subject to limitations or exclusions which may be applicable, or become
applicable, to Male External Catheters; which limitations or exclusions arise
only from ROCHESTER's pre-existing sales and distribution agreements with third
parties; and which have been identified to CONVATEC.
Foley Catheter(s). "Foley Catheter(s)" means ROCHESTER's standard
Foley Catheter made from silicone in all standard and pediatric sizes that is
typically used for managed urine drainage, but excluding without limitation all
enhancements or improvements thereto and excluding specifically ROCHESTER's
Nitrofuran Delivery Catheter.
Hydrophilic Intermittent Catheter. "Hydrophilic Intermittent
Catheter" means ROCHESTER's advanced Intermittent Catheter containing a
hydrophilic coating, which is presently in development and has not yet received
marketing approval from the FDA.
Intermittent Catheter(s). "Intermittent Catheter(s)" means
ROCHESTER's standard Intermittent Catheter made from silicone in all standard
sizes that is typically self-administered for periodic urine drainage,
<PAGE>
but excluding all enhancements or improvements thereto and excluding
specifically ROCHESTER's Hydrophilic Intermittent Catheter.
Male External Catheter(s). "Male External Catheter(s)" means
ROCHESTER's standard self-adhering Male External Catheter made either from
silicone or Ultraflex(TM) Polymer in standard and abbreviated lengths, that is
worn externally and used for the management of male incontinence, but excluding
without limitation all enhancements or improvements thereto and excluding
specifically ROCHESTER's Wide Band(TM) MEC.
Marks. "Marks" means those commercial indicia as more particularly
described in Section 3(C) of this Restated Agreement.
Nitrofuran Delivery Catheter. "Nitrofuran Delivery Catheter" means
ROCHESTER's Nitrofuran Delivery Catheter which incorporates nitrofurazone into
the silicone matrix of a Foley Catheter that is used for controlling the
incidence of infections in catheterized patients, but excluding enhancements or
improvements thereto.
Packaging and Distribution Agreement. "Packaging and Distribution
Agreement" means the Packaging and Distribution Agreement between CONVATEC and
ROCHESTER dated September 7, 1994, together with any attachments or supplements
thereto.
Products. "Products" means, collectively, ROCHESTER's Foley
Catheter, Intermittent Catheter and Male External Catheter.
Restated Agreement. "Restated Agreement" means this Revised and
Restated Distribution Agreement.
Specifications. "Specifications" means the product and packaging
specifications and quality control procedures applicable, respectively, to Foley
Catheters, Intermittent Catheters, and Male External Catheters, and to the
manufacture and packaging thereof, as may be agreed in writing from time to time
by CONVATEC and ROCHESTER.
"Term of this Restated Agreement" means the Initial Term and
includes all Renewal Terms as provided in Section 26.
Wide Band MEC. "Wide Band MEC" means ROCHESTER's Wide Band(TM) Male
External Catheter which positions adhesive along the entire length of the
catheter sheath.
<PAGE>
1995 Agreement. "1995 Agreement" means the Distribution and
Co-Development Agreement dated August 11, 1995, between CONVATEC and ROCHESTER.
1995 Agreements. "1995 Agreements" mean collectively the 1995
Agreement and the 1995 Supplement.
1995 Supplement. "1995 Supplement" means the Supplemental Agreement
dated August 11, 1995 between CONVATEC and ROCHESTER.
SECTION 2. REPRESENTATIONS AND WARRANTIES OF ROCHESTER
ROCHESTER represents and warrants that it is a corporation duly
organized and in good standing under the laws of Minnesota, that it has the
requisite power and authority to enter into and carry out this Restated
Agreement and its obligations hereunder, and that the undertakings of this
Restated Agreement will not constitute a breach by ROCHESTER of any pre-existing
obligation to any third party.
ROCHESTER further represents and warrants that it has exclusive
ownership of pending U.S. patent applications and patents relating to the
Products. In the event that, during the Term of this Restated Agreement and any
renewals hereof, either CONVATEC or ROCHESTER acquire information that any of
the said patents are infringed by a product being sold or distributed by a third
party, either shall promptly notify the other party to this Restated Agreement
ROCHESTER further represents and warrants that it is generally
knowledgeable with respect to the patent rights of third parties in the United
States, Canada, Mexico and the European Union countries relating to the
Products, and has conducted such inquiry and investigation as it deemed
reasonably necessary for the purpose of determining whether the present or
presently intended manufacture, sale and/or use of the Products infringes any
patent or technology of any third party in the United States, Canada, Mexico or
the European Union countries.
ROCHESTER represents and warrants that to the best of ROCHESTER's
knowledge, based upon such inquiry and investigation, the present or presently
intended manufacture, sale and/or use of the Products by ROCHESTER does not
infringe any patent or technology of any third party in the United States,
Canada, Mexico or other European Union countries.
Except as otherwise expressly stated herein, ROCHESTER makes no
other warranty or representation (i) respecting the scope or enforceability of
<PAGE>
patent protection or the availability of patent protection in any jurisdiction,
foreign or domestic, or (ii) respecting infringement of any patent or any other
intellectual property rights of others.
SECTION 3. APPOINTMENT OF DISTRIBUTOR
A. Grant of Co-Exclusive Rights. ROCHESTER grants to CONVATEC for
the Term of this Restated Agreement the right, co-exclusive with ROCHESTER, to
distribute Male External Catheters throughout the Co-Exclusive Territory, which
grant is subject only to the limitations expressly provided in Subsection (D) of
this Section 3.
B. Grant of Non-Exclusive Rights. ROCHESTER grants to CONVATEC for
the Term of this Restated Agreement the non-exclusive right (i) to distribute
Foley Catheters and Intermittent Catheters throughout the world and (ii) to
distribute Male External Catheters throughout the remainder of the world that is
outside the Co-Exclusive Territory.
C. Marks. CONVATEC and ROCHESTER shall each have the right,
respectively, to distribute all such Products under the names, brands, marks,
styles and other commercial indicia (collectively, "Marks") as each,
respectively, shall adopt and use from time to time; but neither, without the
express written consent of the other, shall use any Mark adopted or used by the
other.
D. Pre-Existing Private Label Arrangements; Limitations. The parties
acknowledge that ROCHESTER has previously entered into contracts and
arrangements with third parties for the distribution of Male External Catheters,
such contracts and arrangements, including arrangements with current customers
who purchase on open order, being hereinafter referred to as "Third Party
Private Label Arrangements". The provisions of Subsection (A) of this Section 3
notwithstanding, ROCHESTER shall have the right to continue to honor all of its
obligations under such Third Party Private Label Arrangements as may be now
extant or subsequently revised, and to supply all of its customers pre-existing
the date of this Restated Agreement with Male External Catheters under such
Third Party Private Label Arrangements with those Customers, notwithstanding
that said pre-existing customers may distribute said products under their own
Marks; provided, however, that from and after the date of this Restated
Agreement, ROCHESTER will not revise or extend any such Third Party Private
Label Arrangement in a manner to permit ROCHESTER to sell Male External
Catheters under its own Mark within any defined geographical area of the
Co-Exclusive Territory while precluding CONVATEC from selling the same product
under its own Mark in the same geographical area.
<PAGE>
E. Covenants For Future Distribution. With the exceptions of (i)
sales pursuant to, or required by, pre-existing Third Party Private Label
Arrangements and (ii) sales to CONVATEC pursuant to this Restated Agreement,
ROCHESTER covenants that, for the Term of this Restated Agreement, ROCHESTER
will not sell any Male External Catheter to any third party for resale in the
Co-Exclusive Territory under a Mark that is not owned exclusively by ROCHESTER.
ROCHESTER shall market Male External Catheters in the Co-Exclusive Territory
under a single Mark chosen by ROCHESTER, and CONVATEC shall market Male External
Catheters in the Co-Exclusive Territory under a single Mark chosen by CONVATEC.
Neither party shall market Male External Catheters in the Co-Exclusive Territory
under multiple Marks, except in the event that a Mark chosen by ROCHESTER or
CONVATEC has any negative or derogatory connotation in a particular market or
country within the Co-Exclusive Territory, in which case a new Mark may be
adopted and used solely for that market or country.
F. Requirements. For the Term of this Restated Agreement, CONVATEC
shall purchase from ROCHESTER, and ROCHESTER shall supply CONVATEC with, all of
CONVATEC's requirements of Male External Catheters for sale in the Co-Exclusive
Territory; it being expressly understood that the requirements provision hereof
is limited to the Co-Exclusive Territory.
G. No Licenses. Neither CONVATEC nor ROCHESTER grants to the other
any right, title, interest or license in, to, or under any patent, patent
application, process, technology, Mark or intellectual property of any kind
whatsoever now or hereafter owned by CONVATEC or ROCHESTER, respectively, except
as may be implied for the manufacturing, packaging and sale of Products by
ROCHESTER to CONVATEC and for the sale of Products purchased from ROCHESTER by
CONVATEC to the extent such activities are permitted by this Restated Agreement.
H. Additional Products. Six (6) months following the date of this
Restated Agreement, ROCHESTER and CONVATEC shall undertake good faith
negotiations to determine whether, and upon what terms and conditions, ROCHESTER
may supply CONVATEC with, and CONVATEC may purchase from ROCHESTER, the Wide
Band MEC and/or the Hydrophilic Intermittent Catheter.
SECTION 4. RIGHT OF FIRST CONSIDERATION
A. ROCHESTER grants CONVATEC the right ("First Consideration Right")
expiring June 30, 1998, to negotiate in good faith with Rochester a separate
agreement relating to CONVATEC's purchase and distribution of ROCHESTER's
Nitrofuran Delivery Catheter.
<PAGE>
B. ROCHESTER agrees that, prior to June 30, 1998, ROCHESTER will not
enter into any agreement with any third party that permits such third party to
purchase the Nitrofuran Delivery Catheter for resale under any mark or brand
that is not owned exclusively by ROCHESTER. Nothing herein shall limit
ROCHESTER's ability to inquire from third parties regarding their possible
interest in distributing the Nitrofuran Delivery Catheter under either
ROCHESTER's or their own mark or brand.
C. Upon expiration of the First Consideration Right, Rochester shall
be entirely free to enter into any agreement with any third party that permits
such third party to purchase the Nitrofuran Delivery Catheter for resale under
any mark or brand that is not owned exclusively by ROCHESTER.
SECTION 5. PRICING
A. Prices. The prices for Products shall be separately agreed
between the parties pursuant to good faith negotiations. The initial prices for
Products so agreed shall remain fixed through and including December 31, 1998,
unless process or procedure changes of a material nature in any of the
referenced Specifications occur, in which case the parties shall mutually agree
upon an amended price.
B. Price Increases. During the last calendar quarter of 1998, and
during the last calendar quarter of each subsequent year during the Term of this
Restated Agreement, the price in effect for any Product may be adjusted,
consistent with Subsections B and C of this Section 5, pursuant to good faith
negotiations, with such adjusted price to be effective as of, and after, January
1 next following.
If, by December 31 of any such year, CONVATEC and ROCHESTER have
been unable to reach agreement through good faith negotiations, then the price
may be increased at the sole option of ROCHESTER as of and after January 1 next
following by an amount equal to the increase in the Consumer Price Index over
the base year (hereinafter "Base Year") of this Restated Agreement. For purposes
hereof, "Consumer Price Index" means the National Index prepared and promulgated
by the United States Bureau of Labor Statistics as "Consumer Price Index (1967 =
100), United States Average -- CPI-W, Urban Wage Earners & Clerical Workers"; or
if said Index shall no longer be published, then from an alternative Index
generally recognized as authoritative that shall be substituted upon notice from
ROCHESTER.
<PAGE>
1998 shall be considered the Base Year of this Agreement for
purposes of calculating initial price increases for Products; thereafter, the
Base Year shall be the year of the most recent price increase.
In addition to the foregoing provisions for annual Consumer Price
Index related price increases, in the event of a material increase (in excess of
the increase in the Consumer Price Index over a preceding Base Year) in the
price of raw materials, purchased by ROCHESTER for the manufacture of Products,
CONVATEC and ROCHESTER shall negotiate in good faith for a further price
adjustment relating to ROCHESTER's increased costs of such raw materials.
C. Price Arbitration. The parties agree that all price related
issues contained in this Section 5 shall be subject to good faith negotiations.
Any issue not resolved through such negotiations within sixty (60) days shall be
subject to the arbitration provisions of Section 33 of this Agreement.
D. Notice. In case of a price increase, excepting only a price
increase arrived at by agreement which includes an effective date, ROCHESTER
shall give CONVATEC ninety (90) days' written notice before any price change
becomes effective.
SECTION 6. REGULATORY APPROVALS
A. Domestic. ROCHESTER represents and warrants that all of the
Products may be lawfully manufactured, commercially distributed and sold in the
United States in accordance with laws and regulations administered by the United
States Food and Drug Administration (FDA).
B. Foreign. CONVATEC shall be responsible for all additional
registrations or approvals necessary to market the Products throughout those
areas of the rest of the world in which CONVATEC elects in its sole judgment to
market the Products.
C. Ownership of Registrations. Each party shall exclusively own the
registration(s) or approval(s) that it has, or shall have, obtained relating to
the Products in such market regions or countries in which such have issued.
D. Cooperation. Subject to the provisions of Sections 15 and 20 of
this Restated Agreement relating to Confidential Information, CONVATEC and
ROCHESTER shall freely exchange all information, data or documents required by,
or that either has provided to, any regulatory authority to enable the lawful
sale of any of the Products within the jurisdiction of such regulatory
authority; it being the express intent of the parties that each party should
thereby assist
<PAGE>
the other to obtain regulatory approvals for Products as may be necessary to
permit their lawful sale within such jurisdiction.
SECTION 7. ORDERING AND FORECASTING
A. Ordering. CONVATEC shall issue purchase orders for Products from
time to time during the Term of this Restated Agreement. Each purchase order
shall include the specific quantity of units, and the "Ship To" and "Bill To"
addresses. To the extent that the terms and conditions on any purchase order or
confirmation are in conflict with the provisions of this Restated Agreement, the
provisions of this Restated Agreement shall be controlling unless specifically
agreed in writing to the contrary.
B. Forecasting. At least once each calendar quarter, CONVATEC shall
furnish ROCHESTER with a non-binding written forecast of estimated purchases of
Products to be made during the next calendar quarter.
SECTION 8. STORAGE OF CONVATEC MATERIALS
ROCHESTER shall provide secure and clean storage for materials, if
any, provided by CONVATEC. Storage areas shall be protected from freezing
temperatures, excess heat and humidity. Materials will be stored on pallets,
covered or packaged to preclude damage or exposure to foreign matter.
SECTION 9. PACKAGING
A. Responsibility. Packaging of the Products shall be the
responsibility of ROCHESTER and shall conform in all respects, including the
imprint of CONVATEC's Mark on the specified packaging, to the Specifications
separately agreed by the parties.
B. Printing Plates. ROCHESTER shall invoice CONVATEC for the direct
cost of Printing Plates, in the event required for packaging materials, upon
production thereof. Payment for Printing Plates shall be made by CONVATEC to
ROCHESTER net cash forty-five (45) days from the date of such invoice.
C. Excess Packaging. CONVATEC shall reimburse ROCHESTER for excess
and unusable packaging acquired by ROCHESTER upon CONVATEC's approval in
accordance with this Section 9(C) (i) in case CONVATEC changes a previously
agreed packaging Specification, (ii) in case CONVATEC discontinues the purchase
from ROCHESTER of any Product then being manufactured for
<PAGE>
CONVATEC by ROCHESTER, or (iii) upon termination of this Restated Agreement.
Upon the occurrence of an event giving rise to CONVATEC's obligation to
reimburse ROCHESTER for such excess packaging, ROCHESTER shall account to
CONVATEC for such excess packaging and deliver or dispose of the same at
CONVATEC's instance. CONVATEC shall reimburse ROCHESTER for the cost of said
excess packaging within forty-five (45) days following CONVATEC's receipt of
ROCHESTER's account.
From time to time during the Term of this Restated Agreement,
ROCHESTER shall request CONVATEC's approval of ROCHESTER's proposed purchases of
packaging in quantities and prices acceptable to CONVATEC, and ROCHESTER shall
have no obligation to purchase any packaging except in quantities and prices
approved by CONVATEC.
SECTION 10. ALTERNATE SUPPLIER
If at any time during the Term of this Restated Agreement, including
but not limited to periods during the occurrence of an event of force majeure
but excepting periods of raw material shortages, ROCHESTER is unable to supply
in a timely manner to CONVATEC expected requirements of Products hereunder,
then, subject to the limitations set forth in Section 20 hereof, ROCHESTER shall
have the right to select and the obligation to utilize an alternate supplier to
fill such shortfall until such time as ROCHESTER is able to resume full
performance of its supply obligations. With regard to the portion of Product
manufactured by an alternate supplier, payment to said supplier for the costs of
manufacture shall be the responsibility of ROCHESTER. CONVATEC shall have the
right to validate the manufacturing of Product by any alternate supplier
hereunder and the right of audit of said alternate supplier upon the same terms
and conditions as shall apply to ROCHESTER pursuant to this Restated Agreement.
SECTION 11. CONTINGENT MANUFACTURING
In the event that, for any reason except raw material shortages,
ROCHESTER shall be unable to supply CONVATEC's requirements of Products and
shall have failed to arrange for an alternate supplier of same pursuant to
Section 10 above, within a commercially reasonable period of time, ROCHESTER
shall be deemed to have granted CONVATEC a non-transferable, limited,
royalty-free license to manufacture or to have manufactured Products in the
United States until such time as ROCHESTER is able to resume full performance of
its obligations. A "commercially reasonable" period of time as used herein shall
mean that period of time which a company or entity of similar capabilities,
means and expertise would utilize and/or otherwise take,
<PAGE>
under the same or similar circumstances. Upon request of CONVATEC, ROCHESTER
shall, subject to the requirements of Section 20 hereof, cooperate to furnish to
CONVATEC or a designee of CONVATEC approved by ROCHESTER the necessary
information and technology to permit the alternate manufacturing of sufficient
quantities of Products to fulfill CONVATEC's requirements, provided, however,
any such information and/or technology disclosed or furnished by ROCHESTER
hereunder shall be safeguarded by the recipient; shall not be used for any
purpose other than that contemplated by this Section; shall not be disclosed to
third parties, other than a designee of CONVATEC approved by ROCHESTER
hereunder; and shall be made available only to those employees, officers,
representatives, agents or consultants of the recipient who are directly
involved in or concerned with the manufacture contemplated hereby and who have
agreed in writing prior to such disclosure to be bound by the obligations of
confidentiality contained in this Restated Agreement. Further, it is expressly
understood and agreed by CONVATEC that under no circumstance other than that
contemplated by this Section 11 or by Section 24 below will any proprietary
technology be disclosed or furnished by ROCHESTER under this Restated Agreement.
SECTION 12. SHIPMENT AND DELIVERY
All shipments of goods shall be made F.O.B. ROCHESTER's warehouse,
Stewartville, Minnesota, to the address(es) specified in CONVATEC's delivery
instructions accompanying each purchase order.
SECTION 13. INVOICING AND PAYMENT
ROCHESTER shall invoice CONVATEC as appropriate for each shipment of
Products. Each invoice shall contain the individual purchase order number, the
mode of transportation, the date of shipment, the payment terms and any other
information required by the individual purchase order. Payment by CONVATEC shall
be made within forty-five days (45) days of shipment or receipt of invoice,
whichever is later.
SECTION 14. SALES AND MARKETING
A. Resale Prices. CONVATEC shall be solely responsible for
establishing its resale prices for any Product and for all of CONVATEC's
advertising, promotional and educational materials therewith used. ROCHESTER
shall assist CONVATEC in the preparation of such material, and
<PAGE>
shall also assist CONVATEC, at CONVATEC's expense, in training relating to a
Product if requested to do so by CONVATEC.
B. Duties. CONVATEC shall have the following obligations with
respect to the marketing and distribution of the Products:
(i) to refrain from making any warranty or representation with
respect to the performance characteristics or capabilities of
the Products except (a) as expressly stated in the ROCHESTER
product literature approved by the FDA or as otherwise
authorized in writing by ROCHESTER, (b) claims supported by
appropriate corroborating data furnished to ROCHESTER in
confidence, and which data shall not be used by ROCHESTER for
any marketing purpose, or (c) as is otherwise authorized by
ROCHESTER;
(ii) to abide by all applicable laws and regulations of the
jurisdictions, respectively, wherein the Products are sold;
and
(iii) to furnish ROCHESTER with a current list of CONVATEC product
claims for each Product.
SECTION 15. REGULATORY COMPLIANCE
A. Current. ROCHESTER shall manufacture the Products in accordance
with the Good Manufacturing Practices of the FDA or other appropriate regulatory
authority, and shall otherwise comply with all applicable laws and ordinances,
the violation of which would materially and adversely affect ROCHESTER's ability
to perform its obligations under this Restated Agreement. ROCHESTER shall obtain
and keep in force an Establishment Registration Number from FDA or other
appropriate regulatory authority, maintain traceability records on the goods
manufactured, advise CONVATEC promptly of any and all adverse reaction data of
which it has knowledge and cooperate, at ROCHESTER's own expense, with CONVATEC
in the event CONVATEC shall ever initiate any remedial action for the Products.
ROCHESTER shall notify CONVATEC promptly in writing in the event a governmental
agency issues an inspection report or other finding of non-compliance in
connection with the Products, their manufacture, storage or handling and shall
provide CONVATEC with a copy of any such report or finding, edited for data or
information not related to CONVATEC or Products. CONVATEC shall have the right
to participate with ROCHESTER, subject to ROCHESTER's ultimate control, in the
preparation of any response to said finding of non-compliance. CONVATEC shall be
responsible for creating all warnings, precautions, and labels required for the
Products, although ROCHESTER shall assist CONVATEC in the preparation of these
materials as
<PAGE>
requested. CONVATEC shall promptly advise ROCHESTER of all changes, amendments,
additions, deletions and/or modifications to any such Product literature or
labeling, and shall furnish ROCHESTER with copies of all such literature and
labeling. In the event that a particular market region or country shall require
information regarding Products in addition to that contained in the agreed
specifications, ROCHESTER shall provide said information to CONVATEC to the
extent that such information is known to ROCHESTER or readily obtainable by
ROCHESTER without undue burden or significant expense. Provided, however,
ROCHESTER need not furnish, nor consent to the furnishing of, any Confidential
Information relating to proprietary manufacturing processes or unpublished
patent applications unless confidential treatment of such Confidential
Information will be accorded by the regulatory authority to which the disclosure
is proposed to be made. ROCHESTER has obtained, and will in the future maintain,
EN ISO 9001 Standard Certification, and Quality System Certification for CE
Marking.
B. Distribution. CONVATEC shall comply with all domestic and foreign
laws and regulations applicable to the storage and sale of Products.
SECTION 16. RIGHTS OF INSPECTION
Subject to all obligations of confidentiality under this Restated
Agreement, ROCHESTER shall allow representatives of CONVATEC or of Bristol-Myers
Squibb Company, Technical Evaluation and Service Department, to inspect the
manufacturing site(s) as needed pursuant to CONVATEC or Bristol-Myers Squibb
Company auditing procedures. CONVATEC shall provide ROCHESTER with as much
advance notification as possible prior to such inspections but in no event less
than twenty-four (24) hours; however, it shall have the right of inspection at
any time during normal business hours.
SECTION 17. PRODUCT WARRANTY
ROCHESTER warrants that, when delivered, all Products shall be free
from material defects in materials, workmanship and fabrication. ROCHESTER also
warrants that all Products shall meet the agreed Specifications in all material
respects and shall not be misbranded or adulterated and that no changes in the
referenced Specifications and no material changes in applicable manufacturing
processes shall be made without the prior written approval of CONVATEC.
ROCHESTER also agrees and warrants to manufacture Products in accordance with
Good Manufacturing Practices within the meaning of applicable laws and
regulations administered by the FDA or other appropriate regulatory authority,
and in accordance with CONVATEC and Bristol-Myers Squibb Company quality
assurance standards.
<PAGE>
Any changes to CONVATEC or Bristol-Myers Squibb quality assurance standards
existing as of August 11, 1995 shall be applied only if mutually agreed by the
parties. ROCHESTER further warrants that, when delivered, the Products shall
have been packaged in accordance in all material respects with agreed
Specifications applicable. No warranty is given hereunder for misuse,
misbranding or adulteration occurring after delivery to CONVATEC. These
warranties shall survive acceptance and payment, and shall run to CONVATEC, its
permitted assigns, and to customers and users of the Products, providing used as
directed and in a normal manner, for a period of two (2) years from purchase by
consumer(s). ROCHESTER shall replace all Products which do not conform to the
applicable agreed Specifications, or otherwise meet the aforesaid warranties, at
no charge when requested to do so by CONVATEC, and shall assume all shipping and
handling costs of so doing. In the case of such request for replacement,
CONVATEC shall promptly furnish samples of defective goods to ROCHESTER for
review and adjustment before effecting the return of the entire amount of
defective goods. If the goods cannot be salvaged, ROCHESTER shall credit or
reimburse CONVATEC for the value of the goods invoiced previously and
attributable to rejected goods.
SECTION 18. INDEMNIFICATION
A. Indemnification of CONVATEC. ROCHESTER shall indemnify, hold
harmless and defend CONVATEC from and against any and all claims, costs,
demands, liabilities, losses, damages, and expenses of whatever nature
(collectively, "CONVATEC Claims"), including reasonable attorney's fees, made
against or sustained by CONVATEC with respect to the use, sale or distribution
by CONVATEC of Products if such CONVATEC Claims pertain to (i) any material
breach of a ROCHESTER representation or warranty made herein, (ii) any negligent
act or omission of ROCHESTER with respect to the design, manufacture or
production of any Products, (iii) claims of any third party pertaining to
interference with its contractual relations with ROCHESTER or (iv) patent
infringement claims of any third party. The foregoing duty of indemnification
for CONVATEC Claims shall exclude any CONVATEC Claims that (x) are based upon
CONVATEC's alleged infringement of any trademark or trade dress owned by any
third person or (y) are otherwise based upon or arise from the manner in which
CONVATEC markets the Products, including without limitation any claims,
promotion, labeling or advertising originated solely by CONVATEC.
B. Indemnification of ROCHESTER. CONVATEC shall indemnify, hold
harmless and defend ROCHESTER from and against any and all claims, costs,
demands, liabilities, losses, damages and expenses of whatever nature
(collectively, "ROCHESTER Claims"), including reasonable attorney's fees, made
against or sustained by ROCHESTER with respect to the Products, if
<PAGE>
such ROCHESTER Claims are based upon CONVATEC's alleged infringement of any
trademark or trade dress owned by any third person, or (y) are otherwise based
upon or arise from the manner in which CONVATEC markets the Products, including
without limitation any claims, promotion, labeling or advertising originated
solely by CONVATEC.
C. Procedures. For any CONVATEC Claim or ROCHESTER Claim, as the
case may be, the party seeking indemnification hereunder shall give prompt
written notice of any claim for such indemnification and shall cooperate in the
defense of any such matter at the indemnifying party's expense. The indemnifying
party shall have sole and exclusive control of any such legal action or
proceeding. The indemnified party shall not settle or compromise any such legal
action or proceeding without the indemnifying party's prior written consent,
which consent shall not be unreasonably withheld. If the indemnifying party
proposes to engage a single attorney or law firm to provide the defense of both
the indemnifying party and the indemnified party and such joint defense would
create a material conflict of interest for such attorney or law firm under
applicable rules of professional conduct, the indemnified party shall be
entitled to separate representation by another attorney or law firm at the
expense of the indemnifying party but subject to the indemnified party's
reasonable approval.
D. Consequential Damages. Neither party shall be liable to the other
for any special, indirect, incidental, consequential or punitive damages
resulting from a breach of this Restated Agreement.
E. Limitation. ANY OTHER PROVISION OF THIS RESTATED AGREEMENT TO THE
CONTRARY NOTWITHSTANDING, THE LIMIT OF THE AMOUNT OF THE INDEMNIFICATION BY
EITHER PARTY UNDER THIS SECTION 18 SHALL BE A MAXIMUM AMOUNT OF FIVE MILLION
DOLLARS ($5,000,000.00), AND NEITHER PARTY SHALL HAVE ANY DUTY TO PAY ANY SUM OR
INCUR ANY EXPENSE IN EXCESS THEREOF. THIS LIMITATION SHALL NOT, HOWEVER, RELIEVE
ROCHESTER OF THE OBLIGATION TO REPLACE ANY NON-CONFORMING PRODUCT IN ACCORDANCE
WITH THE TERMS OF THIS RESTATED AGREEMENT, REGARDLESS OF DOLLAR AMOUNT. THE
PARTIES AGREE AND ACKNOWLEDGE THAT THE FOREGOING LIMITATION ON INDEMNIFICATION
AND DAMAGES IN THIS SECTION 18(E) IS A FUNDAMENTAL AND MATERIAL CONDITION OF
THIS RESTATED AGREEMENT, AND, BUT FOR SUCH LIMITATION, THEY WOULD NOT HAVE
ENTERED INTO THIS RESTATED AGREEMENT.
F. Survival. The provisions of this Section 18 shall survive the
termination of this Restated Agreement for any reason.
<PAGE>
SECTION 19. PRODUCT LIABILITY INSURANCE
ROCHESTER will carry product liability insurance of at least five
million dollars ($5,000,000) aggregate for "Products- Completed Operations",
with CONVATEC included as a named additional insured thereunder, such policy to
provide for thirty (30) days prior notice to CONVATEC before any cancellation or
material change therein. ROCHESTER shall furnish CONVATEC a certificate of such
insurance within thirty (30) days of the Effective Date of this Restated
Agreement. ROCHESTER shall also provide written notice to CONVATEC of any change
in or termination of coverage at least thirty (30) days in advance thereof.
SECTION 20. CONFIDENTIAL INFORMATION
ROCHESTER and CONVATEC anticipate the exchange of substantial
proprietary information in connection with the transactions and activities
contemplated by this Restated Agreement. Each party undertakes to keep secret
and confidential and not to disclose to any third party, except as it is
necessary in carrying out the purposes of this Restated Agreement, during the
Term of this Restated Agreement and any renewals or continuations hereof, and
for a period of five (5) years thereafter, any information, data or know-how
disclosed to it by the other party, as well as the terms and conditions of this
Restated Agreement (hereinafter "Confidential Information"), except:
(a) information, data or know-how which at the time of disclosure
is in the public domain or publicly known or available;
(b) information, data or know-how which, after disclosure, becomes
part of the public domain or publicly known or available by
publication or otherwise, except by breach of this Restated
Agreement by the receiving party;
(c) information, data or know-how which the receiving party can
establish by competent proof was in its possession at the time
of disclosure by the other party;
(d) information, data or know-how which the receiver receives from
a third party; provided, however, that such information was
not obtained by said third party from the other party;
<PAGE>
(e) information, data or know-how which the receiver can
demonstrate by competent evidence is derived independently of
such disclosure;
(f) information which ROCHESTER must disclose, by virtue of laws
or regulations administered by the Securities and Exchange
Commission, in filings with the Commission; and
(g) such information as the parties shall agree in writing in
advance of the disclosure thereof.
Nothing to the contrary withstanding, however, all Confidential
Information that CONVATEC receives from ROCHESTER relating to proprietary
manufacturing processes or unpublished patent applications shall be maintained
as confidential by CONVATEC regardless of any lapse of time, and shall be used
for no purpose other than the purposes of this Restated Agreement; and, without
the prior written consent of ROCHESTER, shall be disclosed to no person except a
person who acknowledges the foregoing confidentiality obligations in writing
before receiving such information.
Notwithstanding the foregoing, ROCHESTER and CONVATEC may disclose
such Confidential Information as required by law; provided that the disclosing
party shall (i) immediately notify the other party of the Confidential
Information to be disclosed and the legal requirement forcing the disclosure of
such Confidential Information; and (ii) use reasonable efforts to maintain the
confidentiality of the Confidential Information. Provided, however, ROCHESTER
shall not be required to seek confidential treatment for, or to take other
affirmative steps to attempt to limit the dissemination of, information
routinely required to be filed by ROCHESTER in accordance with ROCHESTER's
reporting requirements pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934, and the Rules and Regulations of the Securities and
Exchange Commission promulgated thereunder.
SECTION 21. PATENT ENFORCEMENT
A. General Enforcement Procedures. CONVATEC and ROCHESTER shall give
prompt written notice to each other of any known or reasonably suspected
infringement of any patents held by ROCHESTER relating to the Products
("Infringement Notice").
B. ROCHESTER to Prosecute. ROCHESTER may take appropriate legal
action at its sole expense with legal counsel of its choice against the alleged
infringer, and CONVATEC shall reasonably cooperate in the prosecution thereof by
ROCHESTER. ROCHESTER shall have exclusive
<PAGE>
control of any such legal action undertaken by ROCHESTER, and ROCHESTER shall be
entitled to retain all of the proceeds thereof.
C. Sharing of Expenses and Proceeds. In any case involving an
Infringement Notice, notwithstanding Section 21(B) above, the parties may
separately agree in writing otherwise to share the expenses of any legal action
and the proceeds thereof and/or to allocate the selection of legal counsel or
control of such action.
SECTION 22. PATENT INFRINGEMENT
A. Notice. CONVATEC and ROCHESTER shall give prompt written notice
to the other ("Third Party Infringement Notice") if either party receives any
information or otherwise reasonably believes that a Product supplied by
ROCHESTER may infringe upon the claims of any valid and enforceable third party
patent ("Third Party Patent").
B. Remedies. ROCHESTER shall promptly and in good faith assess any
Third Party Infringement Notice and shall make available its patent counsel to
consult with CONVATEC's patent counsel in an analysis thereof. If ROCHESTER
determines that the continued manufacture, sale or distribution of a Product
would infringe upon such a Third Party Patent, ROCHESTER may, at its option and
its expense, do any of the following: (i) modify such product so that it is no
longer infringing upon the Third Party Patent; (ii) obtain at ROCHESTER's own
expense a fully-paid license for itself and CONVATEC from such third party for
the Third Party Patent to enable the parties to continue the manufacture, sale
and distribution of such product; or (iii), if neither of the foregoing is
commercially reasonable, then ROCHESTER may terminate the distribution rights of
CONVATEC as to that product, provided, however, ROCHESTER shall repurchase at
cost any inventory of such products which CONVATEC has previously purchased from
ROCHESTER and which CONVATEC, after reasonable efforts, is then unable to sell
and distribute in any other portion of the world where it is lawful to do so.
The foregoing shall not apply, and ROCHESTER shall have no such obligations, if
the alleged infringement of the Third Party Patent is due to any combination by
CONVATEC of a Product with any material, service, process or other product not
supplied by ROCHESTER hereunder or any refusal by CONVATEC to sell and
distribute a substituted non-infringing Product if it is both functionally and
legally the equivalent product to the allegedly infringing Product.
C. Extent of Remedies. THE FOREGOING REMEDIES IN SECTION 22(B) SHALL
BE IN ADDITION TO AND CUMULATIVE OF THE INDEMNIFICATION DUTIES OF ROCHESTER
UNDER SECTION 18 ABOVE BUT SHALL OTHERWISE BE THE SOLE AND EXCLUSIVE REMEDIES OF
<PAGE>
CONVATEC FOR ANY ALLEGED OR ACTUAL INFRINGEMENT OF A THIRD PARTY PATENT.
SECTION 23. TRADEMARKS
Neither CONVATEC nor ROCHESTER shall sell, offer to sell or promote
a Product under any Mark(s) owned by the other. CONVATEC and ROCHESTER may, in
their respective sole discretion, adopt any other Mark(s), not already owned by
the other, under which to sell, offer to sell and promote the Products, which
Mark(s) shall be the exclusive property of CONVATEC or ROCHESTER, as the case
may be.
SECTION 24. CO-DEVELOPMENT
CONVATEC and ROCHESTER may agree, but are not obligated to agree, to
work cooperatively to develop new products. At the commencement of any such
development activity ("Project"), CONVATEC and ROCHESTER shall develop a plan
for such Project ("Project Plan") in writing, which shall be agreed to by both
parties. The Project Plan shall contain a description of the Project, including
without limitation the following information:
1) a description of the products to be developed;
2) a time schedule for completing the Project, which shall
include times for completion of various phases of the Project;
3) a budget;
4) ownership of manufacturing, marketing, distribution and
intellectual property rights;
5) domestic and/or foreign regulatory filing responsibilities;
and
6) such other and further Project information as may be necessary
or appropriate.
SECTION 25. NON-SOLICITATION
CONVATEC and ROCHESTER agree that, for the term of this Restated
Agreement, unless consented to in writing by the other party, neither the
CONVATEC division of E.R. Squibb and Sons, Inc. nor ROCHESTER shall (a)
<PAGE>
directly or indirectly solicit, induce or otherwise attempt to influence any
individual who is employed by the other party or any of its subsidiaries or
affiliates during the term of this Restated Agreement to leave such entity's
employ, or (b) hire any such individual; provided, however, that this Section
shall not prohibit CONVATEC or ROCHESTER from soliciting or hiring any
individual who has been employed in a bona fide employment with an entity other
than the other party or any of its subsidiaries or affiliates for a period of at
least twelve (12) months. In no event shall this Section relieve any party, or
present or former employee thereof, of any responsibility of confidentiality
under this Restated Agreement, or any other obligation of confidentiality owed
either to CONVATEC or to ROCHESTER as the case may be.
SECTION 26. DURATION OF AGREEMENT
A. Initial Term. All terms and provisions of this Restated Agreement
shall be in effect commencing the date first written above ("the Effective
Date") and shall continue until April 30, 2006 ("Initial Term").
B. Renewal Terms. Subject to the provisions of Section 26(C), this
Restated Agreement shall automatically be renewed for successive one year
periods (each a Renewal Term") first commencing May 1, 2006, and upon each
anniversary thereof.
C. Either party may terminate this Restated Agreement at the end of
the Initial Term or any Renewal Term by furnishing to the other a written notice
of such party's intent not to renew this Restated Agreement at the expiration
thereof, as follows:
(i) by not less than one hundred eighty (180) days prior written
notice in case of termination at the end of the Initial Term;
or
(ii) by not less than ninety (90) days prior written notice in case
of termination at the end of a Renewal Term.
D. Earlier Termination. The provisions of this Section 26 are
subject to the Earlier Termination provisions of Section 27 below.
SECTION 27. TERMINATION
A. Earlier Termination. Notwithstanding the provisions of Section 26
above, a party may terminate this Restated Agreement in the following
circumstances:
<PAGE>
(i) upon thirty (30) days notice thereof, for any material breach
or default by the other party if said material breach or
default is not cured within such period or, if such breach is
not capable of cure within such period, a reasonable and good
faith commencement of such cure has not occurred within such
period. Each notice shall specify the nature and extent of the
breach or default. For purposes of this Restated Agreement,
ROCHESTER's material failure to adhere to Specifications,
ROCHESTER's material breach of any representation or warranty
given to CONVATEC herein, or CONVATEC's material breach of
Product payment obligations shall be considered, without
limitation, a material breach or default hereof;
(ii) immediately upon written notice in the event the other party
becomes bankrupt or insolvent, the other party makes an
assignment for the benefit of creditors or there is any
agreement of creditors or court proceeding initiated relating
to such other party's financial instability, which proceeding
is not dismissed within thirty (30) days of its filing; or
(iii) upon ten (10) days notice thereof if an event of force majeure
has prevented the other party from substantial performance of
its duties under this Restated Agreement for more than six (6)
months, unless substituted performance has been arranged
pursuant to Sections 10 or 11 of this Restated Agreement, and
ROCHESTER shall then be making good faith efforts to alleviate
the event of force majeure.
B. Rights and Obligations on Termination. In the event of
termination of this Restated Agreement for any reason, the parties shall have
the following rights and obligations;
(i) Termination of this Restated Agreement shall not release
either party from the obligation to make payment of all
amounts then or thereafter due and payable;
(ii) Termination of this Restated Agreement shall not affect the
rights of CONVATEC to fulfill its commitments to any customer
of CONVATEC who has entered into a valid and binding purchase
agreement for the Products prior to the effective date of such
termination;
(iii) Termination of this Restated Agreement shall not relieve
ROCHESTER of its obligation to fill then outstanding CONVATEC
<PAGE>
orders of Products, not exceeding a total of one-third (1/3)of
the previous twelve (12) months' CONVATEC orders of Product;
(iv) CONVATEC shall have the right to sell off the inventory of
Products which it has on hand and then outstanding purchase
orders of Products to the effective date of such termination;
(v) Each party shall return to the other any copies of the other
party's Confidential Information excepting one copy to be
retained by counsel for each party to be used exclusively (a)
to determine the rights and obligations of the parties arising
from this Restated Agreement and the maintenance of
Confidential Information pursuant thereto, and (b) to satisfy
any governmental record retention compliance responsibilities;
and
(vi) Section 2 (Representations and Warranties), Section 18
(Indemnification), Section 20 (Confidential Information),
Section 23 (Trademarks), Section 27(B) (Rights and Obligations
on Termination), Section 32 (Governing Law), Section 33
(Arbitration), Section 34 (Severability) and Section 37
(Mutual Release) shall survive termination of this Restated
Agreement.
C. No Compensation. In the event of any termination of this Restated
Agreement under Section 27(A), subject to Section 27(B)(i), neither party shall
owe any compensation to the other party for lost profits, lost opportunities,
good will, or any other loss or damage as a result of or arising out of such
termination.
SECTION 28. FORCE MAJEURE
The obligations of either party to perform under this Restated
Agreement shall be excused if such failure to perform or any delay is caused by
matters such as acts of God, strikes, civil commotion, riots, wars, revolution,
acts of government, or any other cause whether similar or dissimilar to those
enumerated and which is reasonably beyond the control of the party obligated to
perform. Upon the occurrence of such an event, the party sustaining such an
event shall immediately notify the other party and the duties and obligations of
the parties shall be suspended for the duration of the event preventing proper
performance under this Restated Agreement; provided, however, the parties shall
attempt to arrive at a mutually acceptable resolution within the spirit and
intent of this Restated Agreement, which shall be undertaken in good faith
negotiations. Any issue not resolved through such negotiations within sixty (60)
shall be subject to the Arbitration provisions of Section 33 of this Restated
Agreement.
<PAGE>
SECTION 29. RELATIONSHIP
The relationship between ROCHESTER and CONVATEC established by this
Restated Agreement is intended to be that of seller and buyer. Neither ROCHESTER
nor CONVATEC, their employees, agents and representatives, shall under any
circumstances be considered agents, partners, joint venturers or representatives
of the other. Neither ROCHESTER nor CONVATEC shall act or attempt to act, or
represent itself, directly or by implication, as agent, joint venturer or
representative of the other, or in any manner assume or attempt to assume or
create any obligation or liability of any kind, nature or sort expressed or
implied on behalf of or in the name of the other.
SECTION 30. ENTIRE AGREEMENT
This Restated Agreement, and the exhibits attached hereto, contain
the entire understanding of the parties with respect to the subject matter of
this Restated Agreement. This Restated Agreement shall supersede any other oral
or written agreements, including the 1995 Agreement and the 1995 Supplement, and
shall be binding upon and inure to the benefit of the respective parties, and
their permitted assigns. The Packaging and Distribution Agreement between the
parties shall continue in full force and effect according to its terms;
provided, however, that the provisions of this Restated Agreement governing
Confidential Information shall supersede any confidentiality and confidential
information provisions in the Packaging and Distribution Agreement.
SECTION 31. AMENDMENT; ASSIGNABILITY
This Restated Agreement shall not be modified in any way without
written consent of both parties, and neither party shall have the right to
assign this Restated Agreement, in whole or in part, without the prior written
consent of the other, which consent shall not be unreasonably withheld;
provided, however, that either party may assign this Restated Agreement to its
affiliates or to a purchaser or successor of its entire business related to this
subject matter.
SECTION 32. GOVERNING LAW
<PAGE>
This Restated Agreement shall be construed in accordance with laws
of the United States, State of Minnesota, with the exception of the conflicts of
laws provisions thereof.
SECTION 33. ARBITRATION
A. Negotiation. The parties agree to attempt to settle any claim,
controversy or dispute (hereinafter collectively referred to as "Dispute") that
arises in connection with this Restated Agreement through good faith
negotiations in the spirit of mutual cooperation, promptly and amicably, and
without resort to any legal process if feasible, within thirty (30) days of
receipt of a written notice by one party to the other party of the existence of
such Dispute. The foregoing requirement in Section 33(A) shall be without
prejudice to either party's rights, if applicable, to terminate this Restated
Agreement under Section 27(A), provided that the parties have first complied
with the good faith negotiation obligations under this Section 33(B).
B. Remaining Disputes. Any (i) Dispute arising out of or in
connection with this Restated Agreement which has not been settled through
negotiation under Section 33(A) within a period of thirty (30) days after the
date on which either party shall first have notified the other party in writing
of the existence of a Dispute, and (ii) other issues under this Restated
Agreement requiring good faith negotiations to resolve, and which the parties
have not resolved within sixty (60) days shall be settled by final and binding
arbitration under the then applicable Commercial Arbitration Rules of the
American Arbitration Association ("AAA"). Such arbitration shall be held in (i)
Somerset County, New Jersey, if the demand for arbitration is initiated by
ROCHESTER or (ii) Minneapolis, Minnesota, if the demand for arbitration is
initiated by CONVATEC. Any such arbitration shall be conducted by three (3)
neutral arbitrators appointed by mutual agreement of the parties or, failing
such agreement within fifteen (15) days of a demand for arbitration, in
accordance with said AAA Rules. At least one (1) arbitrator shall be an
experienced medical device professional, and at least one (1) arbitrator shall
be an experienced business attorney with background in the manufacture and
distribution of medical devices. In addition to any monetary award that may be
given, the arbitrators may order or direct either party to do any act required
of it by this Restated Agreement or to refrain from the doing of any act or
practice that is contrary to this Restated Agreement, but the arbitrators may
not award or assess punitive damages against either party. The decision of the
arbitrators shall be final and binding upon all parties and their respective
successors and assigns. Neither party shall be liable to the other for any
special, indirect, incidental or consequential damages resulting from a breach
of this Restated Agreement. Each party shall bear its own costs and expenses of
the arbitration and one-half (1/2) of the fees and costs of the arbitrators,
<PAGE>
subject to the power of the arbitrators, in their sole discretion, to award all
such reasonable costs, expenses and fees, including attorney's fees, to the
prevailing party.
SECTION 34. SEVERABILITY
The invalidity in whole or in part of any provision of this Restated
Agreement shall not affect the validity of any other provision.
SECTION 35. NOTICES
Any notices required or permitted by this Restated Agreement shall
be in writing and shall be hand delivered, sent by facsimile with confirming
original sent by regular United States mail, or sent by nationally recognized
overnight delivery service or by registered or certified mail, return receipt
requested, postage prepaid, and addressed as follows:
If to CONVATEC:
E. R. Squibb & Sons, Inc.(through its ConvaTec Division)
200 Headquarters Park Drive
Skillman, New Jersey 08558
Attention: President, ConvaTec
Telephone: (908) 904-2200
Telecopy: (908) 904-2373
With a copy to:
Legal Division, Bristol-Myers Squibb Company
100 Headquarters Park Drive
Skillman, New Jersey 08558
Attention: Counsel
Telephone: (908) 904-2368
Telecopy: (908) 904-2373
If to ROCHESTER:
Rochester Medical Corporation
<PAGE>
One Rochester Medical Drive
Stewartville, Minnesota 55976
Attention: President
Telephone: (507) 533-9600
Telecopy: (507) 533-9725
with a copy to:
George H. Frisch, Esq.
5030 Woodlawn Boulevard
Minneapolis, Minnesota 55417
Telephone: (612) 724-2929
Telecopy: (612) 724-8387
or to such other address as either party shall hereafter
designate by notice to the other party.
SECTION 36. CAPTIONS
Captions appearing in this Restated Agreement are for convenience of
reference and shall not be construed as a part of this Restated Agreement.
SECTION 37. MUTUAL RELEASE
ROCHESTER and CONVATEC forever release and discharge each other and
their respective officers, directors, agents, successors and assigns, form any
and all claims, demands, liabilities and causes of action of every kind, either
in law or in equity, whether known or unknown, fixed or contingent, arising
under or related to either the 1995 Agreement or the 1995 Supplement, with the
sole exceptions of claims, demands, liabilities or causes of action relating to
(i) payment for goods sold and delivered, (ii) breach of any product warranty
given by ROCHESTER in the 1995 Agreements, (iii) any provision respecting the
preservation of Confidential Information of the other or (iv) any provision
respecting misuse or infringement of the marks or brands owned by the other.
SECTION 38. JOINTLY DRAFTED AGREEMENT
<PAGE>
This Restated Agreement has been drafted jointly by ROCHESTER and
CONVATEC and their counsel, and any ambiguities are not presumed to be
interpreted in favor or against any of the parties.
SECTION 39. REVIEW AND COMMENT
Consistent with its disclosure obligations, ROCHESTER shall afford
CONVATEC reasonable opportunity to review and comment upon ROCHESTER's proposed
press releases or other public documents wherein CONVATEC is mentioned. Any such
proposed press release or other document shall be deemed to be Confidential
Information within the meaning of Section 20 hereof until publicly released by
ROCHESTER.
IN WITNESS WHEREOF, each of the parties hereto have caused this
Restated Agreement to be executed as of the day and year first written by their
duly authorized representatives.
E.R. SQUIBB & SONS, INC.
By:
------------------------------------
Patrice Froidure
President, ConvaTec
ROCHESTER MEDICAL CORPORATION
BY:
------------------------------------
Anthony J. Conway
Chief Executive Officer
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