-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, SCdQsK8UJ8v6JpMEmz0QWOLd7eIASlijjUD2uxhosLoR/FAtE4QD2i3ablMc0HTz eUs2yftNKAl2YfsipVdORg== 0000950144-96-005498.txt : 19960816 0000950144-96-005498.hdr.sgml : 19960816 ACCESSION NUMBER: 0000950144-96-005498 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 19960630 FILED AS OF DATE: 19960814 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: NOVEN PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000815838 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 592767632 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-17254 FILM NUMBER: 96612711 BUSINESS ADDRESS: STREET 1: 11960 SW 144TH ST CITY: MIAMI STATE: FL ZIP: 33186 BUSINESS PHONE: 3052535099 MAIL ADDRESS: STREET 1: 11960 SW 144TH STREET CITY: MIAMI STATE: FL ZIP: 33185 10-Q 1 NOVEN PHARMACEUTICAL FORM 10-Q 06/30/96 1 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q X QUARTERLY REPORT UNDER SECTION 13 OR 15(d) --- OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 1996 ------------- OR _____ TRANSITION REPORT PURSUANT TO SECTION 13 OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to_____________ Commission file number 0-17254 ------- NOVEN PHARMACEUTICALS, INC. ------------------------------------------------------ (Exact name of Registrant as specified in its charter) STATE OF DELAWARE 59-2767632 - ------------------------------- ---------------------------- (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification Number)
11960 S.W. 144th Street, Miami, FL 33186 - --------------------------------------- ------------- (Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (305) 253-5099 -------------- Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes X No _____. --- Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the last practicable date. Class Outstanding at July 26, 1996 ----- ------------------------------- Common stock $.0001 par value 19,819,166
Page 1 of 12 2 NOVEN PHARMACEUTICALS, INC. INDEX TO FORM 10-Q ------------------
PART I - FINANCIAL INFORMATION Page No. - ------ --------------------- -------- Item 1 - Financial Statements Statements of Operations and Accumulated Deficit for the three months ended June 30, 1996 and 1995 3 Statements of Operations and Accumulated Deficit for the six months ended June 30, 1996 and 1995 4 Balance Sheets as of June 30, 1996 and December 31, 1995 5 Statements of Cash Flows for the six months ended June 30, 1996 and 1995 6 Notes to Financial Statements 7 - 8 Item 2 - Management's Discussion and Analysis of Financial Condition and Results of Operations 8 - 10 PART II - OTHER INFORMATION - -------- ----------------- Item 4 - Submission of Matters to a Vote of 10 Security Holders Item 6 - Exhibits and Reports on Form 8-K 11 SIGNATURES 12 - ----------
Page 2 3 PART I. FINANCIAL INFORMATION Item 1. Financial Statements NOVEN PHARMACEUTICALS, INC. STATEMENTS OF OPERATIONS AND ACCUMULATED DEFICIT
THREE MONTHS ENDED --------------------------------------- JUNE 30, JUNE 30, 1996 1995 ------- ------- REVENUES: Product sales $ 5,151,015 $ 918,876 License revenue 256,499 639,833 Interest income 305,459 479,668 Other income 36,250 0 ------------ ------------ Total revenues 5,749,223 2,038,377 ------------ ------------ EXPENSES: Cost of products sold 2,696,535 524,854 Research and development 1,875,996 2,800,759 Marketing, general and administrative 994,327 806,293 ------------ ------------ Total expenses 5,566,858 4,131,906 ------------ ------------ NET INCOME (LOSS) FOR THE PERIOD 182,365 (2,093,529) ACCUMULATED DEFICIT BEGINNING OF PERIOD (22,683,286) (17,250,681) ------------ ------------ ACCUMULATED DEFICIT END OF PERIOD $(22,500,921) $(19,344,210) ============ ============ NET INCOME (LOSS) PER SHARE $ 0.01 $ (0.11) ============ ============ WEIGHTED AVERAGE SHARES OF COMMON STOCK AND COMMON STOCK EQUIVALENTS 21,668,979 19,002,225 ============ ============
The accompanying notes are an integral part of this statement. Page 3 4 NOVEN PHARMACEUTICALS, INC. STATEMENTS OF OPERATIONS AND ACCUMULATED DEFICIT
SIX MONTHS ENDED ---------------------------------------- JUNE 30, JUNE 30, 1996 1995 ------- ------- REVENUES: Product sales $ 10,323,006 $ 1,070,118 License revenue 362,998 1,279,665 Interest income 581,494 908,909 Other income 36,250 15,318 ------------ ----------- Total revenues 11,303,748 3,274,010 ------------ ----------- EXPENSES: Cost of products sold 5,588,378 600,091 Research and development 4,359,287 5,006,413 Marketing, general and administrative 1,793,642 1,528,962 ------------ ----------- Total expenses 11,741,307 7,135,466 ------------ ----------- NET LOSS FOR THE PERIOD (437,559) (3,861,456) ACCUMULATED DEFICIT BEGINNING OF PERIOD (22,063,362) (15,482,754) ------------ ------------ ACCUMULATED DEFICIT END OF PERIOD $(22,500,921) $(19,344,210) ============ ============ NET LOSS PER SHARE $ (0.02) $ (0.20) ============ ============ WEIGHTED AVERAGE SHARES OF COMMON STOCK AND COMMON STOCK EQUIVALENTS 19,772,937 18,939,954 ============ ============
The accompanying notes are an integral part of this statement. Page 4 5 NOVEN PHARMACEUTICALS, INC. BALANCE SHEETS
JUNE 30, DECEMBER 31, 1996 1995 ----------- ------------ ASSETS CURRENT ASSETS: Cash and cash equivalents $ 9,763,247 $ 16,131,263 Securities held to maturity 14,378,961 7,881,397 Accounts receivable 248,641 2,512,561 Inventories 5,298,808 5,069,946 Prepaid and other current assets 147,749 258,220 ------------ ------------ Total current assets 29,837,406 31,853,387 ------------ ------------ PROPERTY AND EQUIPMENT, at cost, net of accumulated depreciation and amortization of $2,445,992 at June 30, 1996 and $1,974,138 at December 31, 1995 15,699,474 15,532,797 ------------ ------------ OTHER ASSETS: Patent development costs, net 1,333,841 1,218,630 Deposits and other assets 65,138 40,738 ------------ ------------ Total other assets 1,398,979 1,259,368 ------------ ------------ TOTAL $ 46,935,859 $ 48,645,552 ============ ============ LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable and accrued liabilities $ 3,117,164 $ 4,293,185 ------------ ------------ DEFERRED LICENSE REVENUE 6,209,013 6,322,011 ------------ ------------ COMMITMENTS AND CONTINGENCIES STOCKHOLDERS' EQUITY: Preferred stock - authorized 100,000 shares of $.01 par value; no shares issued or outstanding Common stock - authorized 30,000,000 shares, par value $.0001 per share; issued and outstanding - 19,819,166 shares at June 30, 1996 and 19,674,144 shares at December 31, 1995 1,982 1,967 Additional paid-in capital 60,108,621 60,091,751 Accumulated deficit (22,500,921) (22,063,362) ------------ ------------ Total stockholders' equity 37,609,682 38,030,356 ------------ ------------ TOTAL $ 46,935,859 $ 48,645,552 ============ ============
The accompanying notes are an integral part of this statement. Page 5 6 NOVEN PHARMACEUTICALS, INC. STATEMENT OF CASH FLOWS
SIX MONTHS ENDED ----------------------------------------- JUNE 30, JUNE 30, 1996 1995 ------------ ----------- CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $ (437,559) $(3,861,456) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 532,094 475,890 Increase in inventories (228,862) (1,439,913) Decrease in prepaid and other current assets 110,471 184,027 Decrease (increase) in accounts receivable 2,263,920 (32,045) Decrease in accounts payable and accrued liabilities (1,176,021) (137,390) Decrease in deferred license revenue (112,998) (112,998) ----------- ----------- Cash flows provided by (used in) operating activities 951,045 (4,923,885) ----------- ----------- CASH FLOWS FROM INVESTING ACTIVITIES: (Purchase) maturity of securities (6,522,564) 10,030,908 Purchase of fixed assets, net (638,531) (976,825) Payments for patent development costs (175,451) (136,650) Refund of deposits 600 1,133 ----------- ------------ Cash flows provided by (used in) investing activities (7,335,946) 8,918,566 ----------- ------------ CASH FLOWS FROM FINANCING ACTIVITIES: Sale of common stock 16,885 21,001 ----------- ------------ NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS (6,368,016) 4,015,682 CASH AND CASH EQUIVALENTS - BEGINNING OF PERIOD 16,131,263 12,070,272 ----------- ------------ CASH AND CASH EQUIVALENTS - END OF PERIOD $ 9,763,247 $ 16,085,954 =========== ============
The accompanying notes are an integral part of this statement. Page 6 7 NOTES TO FINANCIAL STATEMENTS ----------------------------- 1. BASIS OF PRESENTATION --------------------- The financial statements of Noven Pharmaceuticals, Inc. (the "Company"), included herein, do not include all footnote disclosures normally included in annual financial statements and, therefore, should be read in conjunction with the Company's financial statements and notes thereto for each of the three years in the period ended December 31, 1995 included in the Company's annual report on Form 10-K. The interim financial statements for the three months and six months ended June 30, 1996 are unaudited and, in the opinion of management, reflect all adjustments (consisting only of normal recurring accruals) necessary for fair presentation of the balance sheets, statements of operations and cash flows of the Company. The statements of operations for the three months and six months ended June 30, 1996 are not necessarily indicative of the results to be expected for the year ending December 31, 1996. 2. SUMMARY OF ACCOUNTING POLICIES ------------------------------ The following is a summary of the significant accounting policies consistently applied in the preparation of Noven's financial statements: "INVENTORIES" Inventories are stated at the lower of cost (first-in, first-out method) or net realizable value. Inventories at June 30, 1996 related primarily to the Company's transdermal estrogen delivery system. To date Noven has not experienced and does not anticipate in the future, any difficulty acquiring materials necessary to manufacture its transdermal systems. The following are the major classes of inventory:
June 30, December 31, 1996 1995 ---- ---- Finished goods $ 2,047,655 $ 2,226,603 Work in process 612,079 1,262,657 Raw materials 2,639,074 1,580,686 ----------- ----------- Total $ 5,298,808 $ 5,069,946 =========== ===========
"PROPERTY AND EQUIPMENT" Property and equipment is recorded at cost. Depreciation is provided over the estimated useful lives of the assets. Leasehold improvements are amortized over the life of the lease or the service life of the improvements, whichever is shorter. The straight-line method of depreciation is primarily followed for financial purposes. Page 7 8 NOTES TO FINANCIAL STATEMENTS ----------------------------- (CONTINUED) ----------- "PATENT DEVELOPMENT COSTS" Costs, principally legal fees related to the development of patents, are capitalized and amortized over the lesser of their estimated economic useful lives or their remaining legal lives. "EARNINGS PER SHARE" Earnings per share is based on the weighted average number of shares including common stock and common stock equivalent shares. Common stock equivalent shares include outstanding warrants and options (using the Treasury Stock Method). 3. STOCKHOLDERS' EQUITY A schedule of the transactions in the common stock and the additional paid in capital accounts is as follows:
Common Stock Additional -------------- Paid-In Shares Amount Capital --------- -------- -------- Balance, January 1, 1996 19,674,144 $ 1,967 $60,091,751 Issuance of 145,022 shares of stock pursuant to stock option plan, net 145,022 15 16,870 ---------- -------- ----------- Balance, June 30, 1996 19,819,166 $ 1,982 $60,108,621 ========== ======== ===========
ITEM 2. ------ MANAGEMENT'S DISCUSSION AND ANALYSIS ------------------------------------ OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS ------------------------------------------------ RESULTS OF OPERATIONS --------------------- Total revenues increased approximately $3,711,000 or 182% for the three month period ended June 30, 1996 from the same period in the prior year and approximately $8,030,000 or 245% for the comparable six month period. This increase in revenues was the result of the increase of approximately $4,232,000 in sales of the Company's transdermal estrogen delivery system to its licensee partners in the second quarter of 1996 and approximately $9,253,000 in the first half of 1996. License revenues Page 8 9 MANAGEMENT'S DISCUSSION AND ANALYSIS ------------------------------------ OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS ------------------------------------------------ (CONTINUED) ----------- decreased approximately $383,000 or 60% in the three month period ended June 30, 1996 from the same period in the prior year and decreased approximately $917,000 or 72% from the comparable six month period. The Company believes that license revenues will fluctuate from period to period depending on contributing factors which include, but are not limited to, future success in finalizing new collaborative agreements, timely achievement of milestones and strategic decisions on self-funding certain projects. Interest income decreased approximately 174,000 or 36% in the second quarter of 1996 and decreased approximately $327,000 or 36% in the first half of 1996 primarily due to lower average balances in cash, cash equivalents and securities. Cost of product sold increased approximately $2,172,000 or 414% for the three month period ended June 30, 1996 from the same period in the prior year and approximately $4,988,000 or 831% from the comparable six month period. The gross margin percentage was 48% in the second quarter of 1996 as compared to 43% in the same period of the prior year and was 46% for the first half of 1996 as compared to 44% in the same period of the prior year. The gross margins vary depending on the amount of product sold to each licensee partner and manufacturing efficiencies including those relating to production volumes. Research and development expenses decreased approximately $925,000 or 33% for the three month period ended June 30, 1996 from the same period in the prior year and approximately $647,000 or 13% from the comparable six month period. The decrease in research and development expenses from 1995 to 1996 was attributable to less process development activity and a reduced amount of cost associated with the validation of manufacturing equipment and facilities. In 1996 research and development expenses for new product development continued at the same rate as in 1995. New product development included work related to the transoral dental anesthetic system (DentiPatch(TM)), an estrogen/progestogen combination delivery system, a second generation estrogen delivery system, a transdermal system delivering a nonsteroidal anti-inflammatory drug, an albuterol delivery system, a transdermal system delivering selegiline and a nicotine delivery system. Marketing, general and administrative expenses increased approximately $188,000 or 23% for the three month period ended June 30, 1996 from the same period in the prior year and approximately $265,000 or 17% for the comparable six month period. The increase in marketing, general and administrative expenses was primarily due to initial marketing expenses to support the launch of the DentiPatch system, increases in staffing and associated office expenses. LIQUIDITY AND CAPITAL RESOURCES ------------------------------- Historically the Company financed its operations through equity offerings of common stock, license and contract revenues, interest income and the sale of product. During the second quarter of 1996 total revenues exceeded total expenses and the Company did not incur an operating deficit. At the end of June 30, 1996 the Company had approximately $24,000,000 in cash, cash equivalents and securities held to maturity. Page 9 10 MANAGEMENT'S DISCUSSION AND ANALYSIS ------------------------------------ OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS ------------------------------------------------ (CONTINUED) ----------- During the first half of 1996 the decrease in accounts receivable of $2,300,000 funded the net loss of approximately $438,000, the increase in inventory of approximately $229,000, the decrease in accounts payable of approximately $1,176,000 and the approximate $639,000 investment in property and equipment. As of June 30, 1996 the Company had commitments for capital expenditures of approximately $114,000. The Company's future capital requirements depend upon numerous factors, including (i) the progress of its product development programs, (ii) the time required to obtain government regulatory approvals of products in development,(iii) the resources that the Company devotes to the development of self-funded products, proprietary manufacturing methods, advanced technologies and a marketing and sales administration infrastructure, (iv) the ability of the Company to obtain additional license agreements and to manufacture products pursuant to those agreements and (v) the demand for its products. The Company expects to incur additional costs related to product development activities, increased marketing, general and administrative expenses and the completion of its manufacturing facilities. Although the Company believes that existing cash, securities held to maturity, anticipated contract and manufacturing revenues will be adequate for the foreseeable future, circumstances could arise which may result in a desire to raise additional capital. There can be no assurance that such capital will be available on acceptable terms, or at all. PART II - OTHER INFORMATION --------------------------- Item 4. Submission of Matters to a Vote of Security Holders ------- --------------------------------------------------- Annual Meeting of Stockholders held on June 11, 1996. (i) Election of Directors
For Against Abstain --- ------- -------- Steven Sablotsky 15,972,145 134,276 0 Mitchell Goldberg 15,972,145 134,276 0 Sheldon H. Becher 15,972,045 134,376 0 Sidney Braginsky 15,972,145 134,276 0 Lawrence J. Dubow 15,972,145 134,276 0
(ii) The ratification of the appointment of Deloitte & Touche LLP as the independent certified public accountants for 1996 was approved by an affirmative vote of 16,036,471 shares to a negative vote of 7,048 shares, with 62,902 shares abstaining. Page 10 11 PART II - OTHER INFORMATION --------------------------- (CONTINUED) ---------- Item 6. Exhibits and Reports on Form 8-K ------ -------------------------------- 10.28 Amendment dated May 6, 1996 to the June 9, 1994 Amendment to the License Agreement and the Supply Agreement, each dated April 27, 1989 by and between the Company and Rhone-Poulenc Rorer, Inc. (with certain portions omitted pursuant to Rule 24b-2). 27 Financial Data Schedule (for SEC use only). Page 11 12 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. NOVEN PHARMACEUTICALS, INC. (Registrant) Date: August 14, 1996 By: /s/ Steven Sablotsky --------------- --------------------------------- Steven Sablotsky, Chairman of the Board and President By: /s/ William A. Pecora --------------------------------- William A. Pecora Chief Financial Officer Page 12 EX-10.28 2 AMENDMENT 05/06/96 1 Exhibit 10.28 AMENDMENT This Amendment by and between Rhone-Poulenc Rorer Inc. (as successor to Rorer Group Inc.) ("RPR") and Noven Pharmaceuticals, Inc. ("Noven") is entered into as of this 6th day of May, 1996. WHEREAS, as of April 27, 1989, the parties entered into a license agreement (hereafter the "License Agreement") and a related supply agreement, pursuant to which they agreed to collaborate on the development and marketing of the Licensed Product (as defined in the License Agreement); WHEREAS, on several occasions since April 27, 1989, the parties have amended the License Agreement in various respects in order to reflect various adjustments in their collaborative venture, including an Amendment dated as of June 9, 1994 (hereafter the "June 1994 Amendment"); and WHEREAS, the parties now desire to enter into another amendment for the purpose of modifying certain fee provisions of the License Agreement and the June 1994 Amendment. NOW, THEREFORE, for valuable consideration and intending to be legally bound, the parties agree as follows: 1. All capitalized items used in this Amendment shall have the meaning ascribed to them in the License Agreement and the June 1994 Amendment, unless otherwise specifically provided. 2. Subparagraphs (a), (b), (c), (d) and (e) of Article 5.2 of the License Agreement, and subparagraphs (b), (c), (d) and (g)(iii) of Article 3 of the June 1994 Amendment, are deleted in their entirety and replaced by the following: "5.2 Fee (a) RPR shall pay to Noven ************* of RPR's, its Affiliates' and Sublicensees' Net Sales, subject to the provisions set forth below in this Article 5.2. To the extent that Noven engages in any ************** of the Licensed Product, RPR shall pay Noven with respect to ********** Licensed Product for which Noven performs the ************************** of RPR's, its Affiliates' and Sublicensees' Net Sales, subject to the provisions set forth below in this Article 5.2. 2 (b) Notwithstanding anything else to the contrary, the fee to be paid under subparagraph (a) above with respect to Licensed Product for which **************************** shall be no less than ********************* ****************************************** of Licensed Product; provided, however, that for purposes of calculating such minimum fee, RPR shall be deemed to obtain a fixed ********************************** ****************************** provided by Noven, regardless of the yield RPR actually obtains. Such minimum fee shall therefore equate to a minimum fee of ******************************************************* ********* material provided by Noven. Noven and RPR shall negotiate in good faith to determine an acceptable minimum fee with respect to any units of Licensed Product for which Noven performs *********************. (c) Notwithstanding the foregoing, if Noven's Cost of Licensed Product increases such that it is no longer commercially viable for Noven to manufacture the Licensed Product for the fee provided for in this Article 5.2, or if RPR's weighted average gross margin for the Licensed Product with respect to any country, computed excluding samples and sales at or below cost, is reduced to a point that it is no longer commercially viable for RPR to continue to market the Licensed Product in that country, then RPR and Noven shall negotiate in good faith for a revised fee under this Article 5.2 with respect to the Licensed Product. In the absence of the parties being able to reach a mutually satisfactory agreement, Noven shall grant RPR a non-exclusive license to manufacture Licensed Product under Noven's Technology and Noven's Patent Rights in return for a royalty of ******************************** of Net Sales, in addition to other terms and conditions as reasonably agreed by the parties. Such license shall only be for sales of Licensed Product in the country or countries that occasioned the negotiation." 3. Article 5.4 of the License Agreement and subparagraphs (f) and g(iv) of Article 3 of the June 1994 Amendment are deleted in their entirety and replaced by the following: "5.4 Payments. The fee due under Article 5.2(a) shall be payable as follows: (a) The minimum fee of Article 5.2(b) shall be due and payable within thirty (30) days of Noven's invoice for the applicable Licensed Product; and (b) within thirty (30) days after the end of each calendar quarter, RPR shall make a 2 3 payment to Noven of the remaining fee, if any, due under Article 5.2(a) with respect to such quarter, based on Net Sales in the quarter and calculated as set forth in Exhibit A, attached and incorporated by reference." 4. Subparagraph (g)(i) of Article 3 of the June 1994 Amendment is deleted in its entirety and replaced by the following: "g(i) RPR shall cause its Affiliate in Ireland to purchase ************* of Licensed Product from Noven at a price equal to the minimum fee under Article 5.2(b) of the License Agreement, which purchase price shall be credited against the fee due Noven pursuant to Article 5.2(a) of the License Agreement." 5. This Amendment shall supersede and supplant any term or provision of the License Agreement and/or the June 1994 Amendment that is in direct conflict with an express term or provision of this Amendment. Except in the case of such a conflict, the terms and provisions of the License Agreement and the June 1994 Amendment shall remain in full force and effect and unchanged. Noven Pharmaceuticals, Inc. Rhone-Poulenc Rorer Inc. By: /s/ Steven Sablotsky By: ----------------------------- ---------------------------------- Name: Steven Sablotsky Name: ------------------------- -------------------------------- Title: President Title: ------------------------- ------------------------------- 3 4 EXHIBIT A The total units of Licensed Product sold worldwide by RPR, its Affiliates or Sublicensees in the quarter = X Net Sales worldwide with respect to the quarter = Y Fee due under Article 5.2(a) of the License Agreement for the quarter = ***************** = Z Fee paid under Article 5.4(a) of the License Agreement with respect to Licensed Product sold in the quarter ** Remaining fee payable to Noven for the quarter under Article 5.4(b) of the License Agreement = Z-B In the event that Z-B is a negative number, no fee will be payable under Article 5.4(b) of the License Agreement
5 AMENDMENT This Amendment to the License Agreement ("License Agreement") and the Supply Agreement ("Supply Agreement"), each dated April 27, 1989, by and between Rhone-Poulenc Rorer Inc. (as successor to Rorer Group Inc. ("RPR") and Noven Pharmaceuticals, Inc. ("Noven") is entered into as of this 9th day of June, 1994. WHEREAS, as of April 27, 1989, the parties entered into the License Agreement, pursuant to which they agreed to collaborate on the development and marketing of the Licensed Product; WHEREAS, on that same date the parties entered into the Supply Agreement (together with the License Agreement sometimes referred to herein as the "Prior Agreements") which provided that, following regulatory approval, Noven would manufacture the License Product and package it in final form for delivery to RPR for sale and distribution by RPR; WHEREAS, on several occasions since April 27, 1989, the parties have amended the License Agreement in various respects in order to reflect various adjustments in their collaborative venture; and WHEREAS, the parties now desire to enter into another amendment for the purpose of modifying certain provisions of the Prior Agreements in order to provide that ******************************************** may be done by RPR on a non-exclusive basis under the terms and conditions of this Amendment. NOW, THEREFORE, for valuable consideration and intending to be legally bound, the parties agree as following: 1. Definitions. All capitalized terms not defined herein shall have the meaning ascribed to them in the Prior Agreements. - 1 - 6 2. Effect of this Amendment. This Amendment shall supersede and supplant any term or provision of the Prior Agreements that is in conflict with an express term of this Amendment. Except in the case of such a conflict, the terms and provisions of the Prior Agreements shall remain in full force and effect and unchanged. 3. Final Processing of Licensed Product. a. Noven shall (i) manufacture the Licensed Product through the stage of production of **************************************** (ii) test, prepare and package such ************************ and (iii) supply and deliver them to RPR's facility in Nenagh, Ireland, or such other RPR facility as RPR shall designate. Noven shall perform all such activities in accordance with the terms of the Prior Agreements, the specifications attached hereto as Exhibit A (as may be amended by the parties from time to time) and all applicable laws and regulations. RPR shall complete ************* ****************** in accordance with the terms of the Prior Agreements and this Amendment. Specifically, RPR shall be responsible for **************************************** received from Noven and ************************************************** and releasing the Licensed Product ****************************** ************. The price for Licensed Product delivered by Noven to RPR under this paragraph shall be as set forth in the Prior Agreements, as amended herein, and shall be ex Noven's factory. Title to and risk of loss to *************************** shall pass to RPR at Noven's factory, and RPR shall bear all costs and expenses for delivery of ************************ including, but not limited to, freight, insurance and duties. b. Article 5.2(a) of the License Agreement is deleted in its entirety and replaced by the following: " (a) RPR shall pay to Noven **************** of RPR's, its Affiliates' and Sublicensees' Net Sales, subject to the provisions set forth in this Article 5.2. In the event *************************************************** ******************** then costs above the Standard Packaging Cost shall be allocated ********************************************** ************************************ c. The fee calculated under Article 5.2 of the License Agreement, as amended by paragraph 3(b) of this - 2 - 7 Amendment, for each unit of Licensed Product that is ******************* ************* under this Amendment, including the minimum and maximum fees set forth in Article 5.2(b), shall be reduced by an amount equal to ******************* as such amount is adjusted from time to time under paragraph 3(d) of this Amendment (the "Fee Reduction Amount"). d. The Fee Reduction Amount shall be adjusted, up or down (but not below ($00.00), effective January 1 of each calendar year in accordance with the increase or decrease, as the case may be, during the previous calendar year of ****************************************************************** ******************************************** in accordance with the terms of this Amendment; provided, however, that no upward adjustment under this subparagraph shall exceed, on a percentage basis, the percentage increase in the Consumer Price Index (as that term is defined in the License Agreement) over the corresponding period. e. Reflecting the fact that the fee provided for in Article 5.2(b) of the License Agreement has been *************** approximately ****************** (i.e., the **********************), each of the annual minimum fees provided for in Articles 5.3(a) and 5.3(b) of the License Agreement shall be ******* by ************* provided, however, that to the extent Noven supplies RPR with Licensed Product in the final form for any market, then the foregoing ****************** shall be adjusted downward for such market(s), based upon the proportion, on a percentage basis, that such production by Noven of Licensed Product in final form has to all Licensed Product ************* *********************** and *** for such market(s). f. The first sentence of Article 5.4 of the License Agreement is deleted in its entirety and replaced by the following: " 5.4 Payments. The fee due hereunder shall be payable as follows: The minimum price of Paragraph 5.2(b), subject to the adjustment set forth in Paragraph 5.2(c) and reduced, when applicable, by the ******* ******************, shall be due and payable within thirty (30) days of Noven's invoice for such Licensed Product." 3 8 g. (i) The RPR Affiliate in Ireland shall purchase bulk rolls from Noven at the initial price of ******************************* per unit (which reflects the adjustment for CPI and the ****** **********************) for the first six months of production, which purchase price shall be credited against the fee due Noven pursuant to Article 5.2(a) of the License Agreement. (ii) Noven will invoice the RPR Affiliate in Ireland based on the number of *************************** delivered by Noven to RPR pursuant to Paragraph 3(a) of this Amendment. (iii) The amount to be invoiced by Noven for ********** shall initially be based upon a production yield of ***************** ***************************** yard for the first six months. After the first six months, the amount to be invoiced by Noven for ************ shall be adjusted up or down based upon the average actual ******************************************* for the first six months. At the end of each calendar year thereafter, the amount to be invoiced by Noven for ************* shall be adjusted up or down based upon the average actual ************************* for the previous calendar year. In the event that the average ********************************* ******************************************************** upon adjustment pursuant to this subparagraph g (iii), then the parties shall negotiate in good faith to determine an acceptable price ****************** to be invoiced by Noven; provided, however, that should the parties fail to reach agreement for a price ********************************** within sixty (60) days, then Noven shall supply RPR with Licensed Product processed in final form in accordance with the terms and pricing of the prior Agreements in lieu of **************** (iv) Any balance of the fee due to Noven pursuant to Article 5.2 of the License Agreement, as hereby amended, will be paid by RPR within thirty (30) days after the end of each calendar quarter. 4 9 (v) In the event that Noven supplies bulk laminate rolls of placebo material for educational or promotional purposes, such material shall be supplied by Noven at an agreed upon price and no other fee or royalty shall be due from RPR with respect to such material. h. ************************ anything else to the contrary contained in this Amendment, Noven shall remain liable in accordance with the terms and pricing of the Prior Agreements to manufacture and supply all Licensed Product processed in final form **************, or ******************* ********, or other conditions mutually agreed between RPR and Noven, ** *************************** pursuant to the terms of this Amendment. 4. Acquisition of Processing Technology and the Machine. a. Noven shall construct and ship to RPR at its Nenagh, Ireland facility a die cutting and pouch packaging Machine (the "Machine") along with spare parts as set forth in Exhibit B capable of performing ******************************************************************* shipped from Noven. Noven warrants that said Machine will be capable of ************************************ and said Machine will meet the minimum specifications and output requirements set forth in Exhibit B. RPR shall be responsible for providing engineering/technical support capable of installing and operating said Machine. Noven shall be responsible for packing the Machine suitable for transport and transporting same to RPR's Nenagh facility and Noven shall bear all costs and expenses for delivery of the Machine including packing, freight, insurance and duties. Risk of loss or damage to the Machine shall remain with Noven until delivery at RPR's facility in Nenagh, Ireland. RPR shall be responsible for installation of the Machine and Noven shall provide RPR with support in commissioning the Machine, as detailed in paragraphs 4.b.(i), (ii), and (iii), and training RPR's mechanics and operators in the proper maintenance and operation of the Machine. Noven shall be responsible for demonstrating the Machine's ability to operate and perform in accordance with its agreed specifications and output requirements as set forth in Exhibit B. - 5 - 10 b. Noven grants RPR a non-exclusive license to use the Machine in Ireland under Noven's Processing Technology and Noven's Patent Rights (as defined below), solely for RPR to perform ********* ************************ under this Amendment with respect to the Licensed Product. In addition, Noven shall provide RPR on an ongoing basis throughout the term of the Prior Agreements assistance and training on the following terms: (i) On completion of the Machine, Noven shall provide to RPR personnel up to two weeks training and instruction at a mutually agreed time at Noven's Miami premises. RPR shall bear the cost of travel, lodging, food and other out-of- pocket expenses for its personnel. Costs of and payment for materials used in training and acceptance shall be mutually agreed by both parties. (ii) Noven shall provide at RPR's facility at Nenagh, Ireland, and at Noven's expense, three (3) man weeks of technical support to assist RPR in the commissioning of the Machine. (iii) Subsequent to the assistance provided in subparagraph 4.b(ii) above, Noven shall provide additional assistance as may reasonably be necessary including providing an engineer/technician at RPR's facility in Nenagh, Ireland. The cost of such additional assistance shall be borne by RPR to the extent of the cost of incremental travel, food, and lodging for an additional two week period for one technician. If further Noven technical assistance is required at the RPR Nenagh facility beyond the additional two (2) weeks, RPR shall pay to Noven ******************** per Noven employee in addition to paying for any incremental travel costs, lodging and meals. c. The term "Noven's Processing Technology" shall mean any and all data, information, technologies, know-how, processes, techniques, methods, skills, proprietary information, trade secrets, developments and discoveries, that are owned or controlled by Noven and specifically related to the *************************** ******************with respect to the Licensed Product, now existing or developed in the future. The term "Noven's - 6- 11 Patent Rights" shall mean any and all patents conceived or reduced to practice prior to December 31, 1998, including but not limited to reissues, extensions and patents of additions, and patent applications, continuations, divisionals and continuations-in- part thereon that are owned or controlled by Noven and the claims of which cover the Machine with respect to the Licensed Product. No right or license to make, use or sell under Noven's Processing Technology or Noven's Patent Rights or right of resale, lease or transfer of any kind with respect to the Machine is granted herein except as provided herein or with reference to the Licensed Product. No right to make or manufacture, or have made or manufactured, the Licensed Product, is granted to RPR except to the extent stated herein. d. With respect to the matters provided for in subparagraphs 4(a) and 4(b) above, RPR shall pay Noven ********************************* in four installments, which shall be due and payable as follows: (i) *************************************************** paid in advance, the receipt of which is hereby acknowledged by Noven; (ii) ******************************************************* due upon the completion of the Machine to the stage of scoring, die cutting and transferring of cut patches to the inspection web area, as demonstrated to the satisfaction of a representative of RPR. (iii) ***************************************************** upon delivery of the Machine to RPR's facility in Nenagh, Ireland; and (iv) ****************************************** upon the date of completion of the installation of the machine and confirmation of its operation in accordance with its specifications and the terms of this Amendment. e. Noven represents and warrants its title to the Machine, that such title is free from any security interests of third parties or other liens or ecumbrances and that Noven is authorized and lawfully permitted to transfer - 7 - 12 such title to RPR. -8- 13 f. Noven shall exercise due care and diligence in constructing the Machine. Noven warrants that the Machine shall conform to all applicable federal, state and local laws and regulations, and be merchantable, fit for the purpose for which it is intended and free from defects in workmanship and materials used in its manufacture. For a period of one year after acceptance of the Machine in Ireland Noven will repair or replace at its cost any defect in the machine arising out of errors in workmanship or materials. For purchased-in components the OEM's warranties will apply. g. Noven represents and warrants that it has no actual and present knowledge of any rightful claim of any third party by way of infringement or the like of any patent or other intellectual property rights related to the machine. Noven shall defend at its own cost and hold RPR harmless from any such claims provided that RPR provides it prompt notice and an opportunity to defend. h. Noven's Processing Technology and Patent Rights shall be subject to the confidentiality obligations of Article VIII of the License Agreement. RPR shall undertake all reasonable actions to restrict access to the Machine and Noven's Processing Technology to its employees on a need to know basis and who are bound to obligations of confidentiality to the same extent as RPR is bound to Noven. i. In the event that RPR wishes to sell, lease or otherwise transfer or dispose of the Machine, Noven shall have an exclusive right of first refusal on such terms as may be mutually agreed upon by the parties acting in good faith. If Noven does not agree to such terms within forty-five (45) days of receipt of a written offer from RPR, then RPR may sell, lease or otherwise transfer or dispose of the Machine to a third party on terms no less favorable to RPR than those proposed to Noven. j. RPR shall not move the Machine from its manufacturing facility in Nenagh, Ireland, to another facility without having first given written notice to Noven. k. RPR shall not copy, duplicate or otherwise reproduce. - 9 - 14 the Machine or components thereof. IN WITNESS WHEREOF the parties have caused this Amendment to be executed by their duly authorized representatives as of the date first above written. NOVEN PHARMACEUTICALS, INC. RHONE-POULENC RORER INC. By /s/ Steven Sablotsky By /s/ Giulio Perillo ------------------------- ---------------------------- Name: Steven Sablotsky Name: Giulio Perillo ----------------------- -------------------------- Title: President Title: Vice President, ----------------------- Industrial Operations 10 15 EXHIBIT A **************************************************************** 16 EXHIBIT B **************************************************************** EX-27 3 FINANCIAL DATA SCHEDULE
5 THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE FINANCIAL STATEMENTS OF NOVEN PHARMACEUTICALS FOR THE SIX MONTHS ENDED JUNE 30, 1996, AND IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS. 6-MOS DEC-31-1996 JAN-01-1996 JUN-30-1996 9,763,247 14,378,961 248,641 0 5,298,808 29,837,406 18,145,466 2,445,992 46,935,859 3,117,164 0 0 0 1,982 37,607,700 46,935,859 10,323,006 11,303,748 5,588,378 5,588,378 4,359,287 0 0 (437,559) 0 (437,559) 0 0 0 (437,559) (.02) (.02)
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