-----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, RomdblYxIDYREVgTuybv7GjvLY7z/1KTUQLUCQyZTKCtTTPcvdKu/Kulf4BiFDaO MRpAGwSIeKYwrGddqzONCA== 0001157523-05-004558.txt : 20050510 0001157523-05-004558.hdr.sgml : 20050510 20050510145421 ACCESSION NUMBER: 0001157523-05-004558 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20050331 FILED AS OF DATE: 20050510 DATE AS OF CHANGE: 20050510 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ARIAD PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000884731 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 223106987 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-21696 FILM NUMBER: 05815939 BUSINESS ADDRESS: STREET 1: 26 LANDSDOWNE ST CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6174940400 MAIL ADDRESS: STREET 1: 26 LANDSDOWNE CITY: CAMBRIDGE STATE: MA ZIP: 02139 10-Q 1 d63754_10-q.htm ARIAD PHARMACEUTICALS 10-Q


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 10-Q

 

x   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2005

OR

o   TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _____   to _____

Commission File Number:  0-21696

ARIAD Pharmaceuticals, Inc.
(Exact name of Registrant as specified in its charter)

 
  Delaware 22-3106987
  (State or other jurisdiction of
incorporation or organization)
 (I.R.S. Employer Identification No.)
     

26 Landsdowne Street, Cambridge, Massachusetts 02139
(Address of principal executive offices) (Zip Code)

Registrant’s Telephone Number, Including Area Code: (617) 494-0400

Former Name, Former Address and Former Fiscal Year,
If Changed Since Last Report:  Not Applicable

 
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  o

 
Indicate by check mark whether the Registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).
 

Yes  x             No  o

 
The number of shares of the Registrant’s common stock outstanding as of April 29, 2005 was 52,876,589.
 



ARIAD PHARMACEUTICALS, INC.

TABLE OF CONTENTS

 
PART I. FINANCIAL INFORMATION   1
       
ITEM 1.      UNAUDITED FINANCIAL STATEMENTS   1
     
Condensed Consolidated Balance Sheets – March 31, 2005 and December 31, 2004   1
     
Condensed Consolidated Statements of Operations for the Three Months Ended
March 31, 2005 and 2004
  2
     
Condensed Consolidated Statements of Cash Flows for the Three Months Ended
March 31, 2005 and 2004
  3
     
Notes to Unaudited Condensed Consolidated Financial Statements   4
     
ITEM 2.      MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS   8
     
ITEM 3.      QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK   15
     
ITEM 4.      CONTROLS AND PROCEDURES   16
     
PART II.     OTHER INFORMATION   17
     
ITEM 1.      LEGAL PROCEEDINGS   17
     
ITEM 6.      EXHIBITS   17
     
SIGNATURES   18
     
EXHIBIT INDEX   19


PART I.       FINANCIAL INFORMATION
 
ITEM 1.       UNAUDITED FINANCIAL STATEMENTS
 
ARIAD PHARMACEUTICALS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
         
In thousands, except share and per share data March 31,
2005
  December 31,
2004
 
 
 
 
  (Unaudited)         
             
ASSETS        
Current assets:
             
    Cash and cash equivalents $ 7,413   $ 18,556  
    Marketable securities   55,957     56,950  
    Inventory and other current assets   2,077     1,965  


             
       Total current assets   65,447     77,471  


Property and equipment:
    Leasehold improvements   14,103     12,693  
    Equipment and furniture   7,789     6,525  
    Construction in progress   1,098     2,049  


             
       Total   22,990     21,267  
    Less accumulated depreciation and amortization   (18,399 )   (18,031 )


             
       Property and equipment, net   4,591     3,236  


             
Intangible and other assets, net   6,294     6,482  


             
Total assets $ 76,332   $ 87,189  


 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
    Current portion of long-term debt $ 1,920   $ 1,920  
    Accounts payable   1,005     2,129  
    Accrued compensation and benefits   471     310  
    Accrued product development expenses   4,460     2,934  
    Other accrued expenses   1,303     591  
    Deferred revenue – current portion   1,294     713  


             
       Total current liabilities   10,453     8,597  


             
Long-term debt   7,175     7,655  


             
Deferred revenue   343     404  


             
Deferred executive compensation   2,881     3,093  


             
Stockholders’ equity:            
    Common stock, $.001 par value; authorized, 145,000,000 shares; issued
       and outstanding, 52,870,993 shares in 2005 and 52,688,673 shares in 2004
  53     53  
    Additional paid-in capital   259,946     259,122  
    Deferred compensation   (432 )   (58 )
    Accumulated other comprehensive loss   (125 )   (61 )
    Accumulated deficit   (203,962 )   (191,616 )


             
       Total stockholders’ equity   55,480     67,440  


             
Total liabilities and stockholders’ equity $ 76,332   $ 87,189  


 

See notes to unaudited condensed consolidated financial statements.


1


ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
     
In thousands, except share and per share data Three Months Ended
March 31,
 
 
  2005   2004  


             
License revenue $ 304   $ 190  


Operating expenses:
             
   Research and development   10,654     4,333  
   General and administrative   2,316     2,218  


             
        Total operating expenses   12,970     6,551  


             
Loss from operations   (12,666 )   (6,361 )


 
Other income (expense):
      Interest income   394     192  
      Interest expense   (74 )   (66 )


             
Total other income, net   320     126  


             
Net loss $ (12,346 ) $ (6,235 )


             
Net loss per share $ (.23 ) $ (.13 )


             
Weighted average number of shares of common stock outstanding   52,807,513     47,540,854  
 
See notes to unaudited condensed consolidated financial statements.

2


ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
 
  Three Months Ended
March 31,
 
 
 
In thousands 2005   2004  


             
Cash flows from operating activities:        
             
    Net loss $ (12,346 ) $ (6,235 )
    Adjustments to reconcile net loss to net cash used in operating activities:
       Depreciation and amortization   347     237  
       Deferred executive compensation expense   82     153  
       Stock-based compensation   155     543  
       Increase (decrease) from:
           Inventory and other current assets   (112 )   (478 )
           Other assets   (69 )   12  
           Accounts payable   (1,124 )   870  
           Accrued compensation and benefits   161     (153 )
           Accrued product development expenses   1,526     540  
           Other accrued expenses   713     (92 )
           Deferred revenue   521     (190 )
           Deferred executive compensation paid       (191 )


             
       Net cash used in operating activities   (10,146 )   (4,984 )


 
Cash flows from investing activities:
    Proceeds from sales and maturities of marketable securities   9,625     12,084  
    Purchases of marketable securities   (8,501 )   (14,030 )
    Investment in property and equipment   (1,723 )   (20 )
    Investment in intangible assets   (213 )   (300 )


             
       Net cash used in investing activities   (812 )   (2,266 )


Cash flows from financing activities:
             
    Repayment of borrowings   (480 )   (450  
    Proceeds from issuance of common stock, net of issuance costs       40,001  
    Proceeds from issuance of stock pursuant to stock option and purchase plans   295     1,219  


             
       Net cash provided by (used in) by financing activities   (185 )   40,770  


             
Net increase (decrease) in cash and cash equivalents   (11,143 )   33,520  
Cash and cash equivalents, beginning of period   18,556     51,674  


             
Cash and cash equivalents, end of period $ 7,413   $ 85,194  


 

See notes to unaudited condensed consolidated financial statements.


3


ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
 
1.      Management Statement
 
In the opinion of the Company’s management, the accompanying unaudited condensed consolidated financial statements contain all adjustments (consisting of items of a normal and recurring nature) necessary to present fairly the financial position as of March 31, 2005, the results of operations for the three-month periods ended March 31, 2005 and 2004 and cash flows for the three-month periods ended March 31, 2005 and 2004. The results of operations for the three-month period ended March 31, 2005 are not necessarily indicative of the results to be expected for the full year. These financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K, as amended, for the year ended December 31, 2004, which includes consolidated financial statements and notes thereto for the years ended December 31, 2004, 2003 and 2002. Certain reclassifications have been made to prior year financial statements to conform to the 2005 presentation.
 
2.      Marketable Securities
 
The Company has classified its marketable securities as available-for-sale and, accordingly, carries such securities at aggregate fair value. At March 31, 2005, approximately 96% of the Company’s marketable securities consisted of United States government or agency securities.
 
At March 31, 2005, the aggregate fair value and amortized cost of the Company’s marketable securities were $55,957,000 and $56,082,000. Gross unrealized gains and losses were $0 and $125,000, respectively, at March 31, 2005.
 
At December 31, 2004, the aggregate fair value and amortized cost of the Company’s marketable securities were $56,950,000 and $57,011,000. Gross unrealized gains and losses were $0 and $61,000 respectively, at December 31, 2004.
 
Realized gains and losses on investment security transactions are reported on the specific-identification method. Realized gains and losses on sales of marketable securities were not material during the three months ended March 31, 2005. Changes in market values resulted in an increase in net unrealized loss of $64,000 for the three-month period ended March 31, 2005.
 
3.      Intangible and Other Assets
 
Intangible and other assets, net, was comprised of the following at March 31, 2005 and December 31, 2004:
 
In thousands 2005   2004  
 
 
 
             
Capitalized patent and license costs $ 9,009   $ 8,796  
Less accumulated amortization   (4,242 )   (4,067 )
 
 
 
    4,767     4,729  
Unvested deferred executive compensation (Note 5)   1,395     1,690  
Other   132     63  
 
 
 
  $ 6,294   $ 6,482  
 
 
 
 
The cost of purchased patents, costs incurred in filing patent applications and certain license fees are capitalized. Capitalized costs related to issued patents are amortized over a period not to exceed seventeen years or the remaining life of the patent, whichever is shorter, using the straight-line method. Capitalized license fees are amortized over the

4


period to which they relate. Amortization expense for intangible assets amounted to $175,000 and $173,000 for the three months ended March 31, 2005 and 2004, respectively. In addition, the Company wrote off capitalized patent and license costs of $0 and $2,000 for the three months ended March 31, 2005 and 2004, respectively, related to patent applications or technology no longer being pursued.
 
4.      Long-Term Debt
 
Long-term debt was comprised of the following at March 31, 2005 and December 31, 2004:
 
In thousands 2005   2004  
 
 
 
             
Bank term note at prime rate or LIBOR +2% (average of
   4.60% at March 31, 2005)
$ 9,095   $ 9,575  
             
Less current portion   (1,920 )   (1,920 )


Long-term debt $ 7,175   $ 7,655  


 
The loan is secured by a lien on all assets of the Company excluding intellectual property, which the Company has agreed not to pledge to any other party. This loan is payable in monthly installments of $160,000, plus interest, with a balloon payment of $3.3 million in March 2008. The loan requires the Company to maintain a minimum of $13.0 million in unrestricted cash, cash equivalents and investments. The agreement also contains certain covenants that restrict additional indebtedness, additional liens, sales of assets and dividends, distributions or repurchases of common stock.
 
The aggregate future principal payments of the above debt agreement are $1.4 million for the remainder of 2005, $1.9 million in each of 2006 and 2007, and $3.9 million in 2008.
 
5.      Executive Compensation Plan
 
Under the Company’s deferred executive compensation plan, participants may be granted options to purchase shares of certain designated mutual funds at a discount equal to the amount of the award. The options vest equally over four years. Total expense related to this plan amounted to $82,000 and $153,000 for the three months ended March 31, 2005 and 2004, respectively.
 
6.      Net Loss Per Share
 
Net loss per share amounts have been computed based on the weighted average number of common shares outstanding during each period. Because of the net loss reported in each period, diluted and basic per share amounts are the same. For the three months ended March 31, 2005 and 2004, options to purchase 6,033,918 and 5,565,432 shares of common stock, respectively, were not included in the computation of net loss per share, because the effect would have been anti-dilutive.
 
7.      Common Stock – Sale of Shares and Shelf Registration
 
On December 19, 2003, the Company filed a shelf registration statement with the United States Securities and Exchange Commission (“SEC”) registering 7,000,000 shares of its common stock. The filing was declared effective on January 9, 2004. On March 29, 2004, the Company sold 5,060,000 of these registered shares in an underwritten public offering at a price of $8.50 per share for net proceeds of $40.0 million. At March 31, 2005, the Company has 1,940,000 shares that remain available for issuance under this shelf registration.

5


On February 18, 2005, the Company filed a shelf registration statement with the SEC, which was amended on March 11, 2005, registering 9,500,000 shares of common stock. The filing was declared effective on March 14, 2005. At March 31, 2005, all 9,500,000 shares remain available for issuance under this shelf registration.
 
8.      Stock-Based Compensation
 
The Company uses the intrinsic value method to measure compensation expense associated with grants of stock options to employees. On a pro forma basis, had the Company used the fair value method to measure compensation for all stock options, the net loss and net loss per share would have been reported as follows:
 
Three Months
Ended March 31,
 
 
 
In thousands (except per share data) 2005   2004  
 
 
 
             
Net loss, as reported $ (12,346 ) $ (6,235 )
Effect of stock options if valued at fair value   (1,025 )   (1,005 )


             
Pro forma net loss $ (13,371 ) $ (7,240 )


             
Net loss per share, as reported $ (.23 ) $ (.13 )
Effect of stock options if valued at fair value   (.02 )   (.02 )


             
Pro forma net loss per share $ (.25 ) $ (.15 )


 
For purposes of calculating the above disclosure, the fair value of options on their grant date was measured using the Black-Scholes option pricing model. Key assumptions used to apply this pricing model included risk-free interest rates of 3.87% for 2005, and 3.1% for 2004, expected lives of the option grants ranging from one to six years and expected rates of volatility for the underlying stock of 111% for 2005, and 115% for 2004. Using this model, the weighted average fair value per option for all options granted in 2005 and 2004 was $6.20 and $8.25, respectively.
 
In December 2004, the Financial Accounting Standards Board (“FASB”) issued SFAS No. 123(R), Share-Based Payment, which revised SFAS No. 123 and superseded APB Opinion No.25, Accounting for Stock Issued to Employees. SFAS No. 123(R) requires that companies recognize compensation expense associated with grants of stock options and other equity instruments to employees in the financial statements. On April 21, 2005, the SEC amended Regulation S-X to modify the effective date of SFAS No. 123(R) and, as a result, the Company will be required to adopt SFAS No. 123(R) as of January 1, 2006. The Company has not yet determined the impact of adoption on its consolidated financial statements.
 
9.      License Revenue
 
License revenue is comprised of license fees received under agreements that provide the licensee with access to and/or the right to evaluate certain technology owned by the Company. Upfront and annual license fees and milestone payments are recorded as deferred revenue upon receipt and recognized as revenue on a systematic basis over the period of time that they are earned in accordance with the terms of the agreements. Such agreements may also include provisions for royalty payments upon successful commercialization of products. Such royalty payments are recognized as revenue when earned in accordance with the terms of the related agreements.
 
In January 2005, the Company and its majority-owned subsidiary, ARIAD Gene Therapeutics, Inc., entered into non-exclusive license and supply agreements with Medinol Ltd. (“Medinol”), a

6


cardiovascular medical device company, for the development and commercialization of stents and other medical devices to deliver the Company’s mTOR inhibitor, AP23573, to prevent reblockage of injured vessels following stent-assisted angioplasty. The license agreement provides for the payment by Medinol to the Company of an upfront license fee, payments based on achievement of development, regulatory and commercial milestones and royalties based on commercial sales of products covered by the license. The Company is recognizing revenues under these agreements in accordance with its revenue recognition policy.
 
10.   Litigation
 
NF- κB Patent Infringement Litigation
 
In 2002, the Company, together with Massachusetts Institute of Technology, The Whitehead Institute for Biomedical Research and Harvard University (collectively, the “Plaintiffs”) filed a lawsuit in the United States District Court for the District of Massachusetts (the “U.S. District Court”) against Eli Lilly and Company (“Lilly”) alleging infringement upon issuance of certain claims (“the NF-κB ‘516 Claims”) of the Plaintiffs’ U.S. Patent No. 6,410,516 (“516 Patent”) covering methods of treating human disease by regulating NF-κB cell-signaling activity through sales of Lilly’s osteoporosis drug, Evista®, and Lilly’s septic shock drug, Xigris®, and seeking monetary damages from Lilly.
 
On April 4, 2005, Lilly filed a request in the United States Patent and Trademark Office (“PTO”) to reexamine the patentability of certain claims of the ‘516 patent. Also on April 4, 2005, Lilly filed a motion in the U.S. District Court requesting a stay of the NF-κB patent infringement litigation by the Court pending reexamination of the ‘516 Patent by the PTO. The Plaintiffs filed a memorandum in opposition to Lilly’s motion to stay with the U.S. District Court on April 18, 2005.
 
On April 6, 2005, the parties appeared before the U.S. District Court for a status conference. At that conference, the Court indicated that no oral argument would be heard on Lilly’s motion to stay and that the Court would set trial date as early as 2005 if it denies Lilly’s motion.
 
The ultimate outcome of the request for reexamination and litigation cannot be determined at this time, and, as a result, an estimate of a damage award or range of awards in the litigation, if any, cannot be made.

7


ITEM 2.     MANAGEMENTS’ DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
Overview
 
We are engaged in the discovery and development of breakthrough medicines to treat disease by regulating cell signaling with small molecules. Breakthrough medicines are products, created de novo, that may be used to treat diseases in innovative ways. Our initial disease focus is cancer, and we are developing a comprehensive approach that addresses the greatest medical need – novel therapies for aggressive and advanced-stage disease for which current treatments are inadequate. In oncology, our goal is to create a series of novel small-molecule product candidates to provide targeted and highly potent anti-cancer activity to treat both solid tumors and hematologic cancers, as well as the spread of primary tumors to distant sites. We also have an exclusive license to pioneering technology and patents related to certain NF-κB cell-signaling activity, which may be useful in treating certain diseases. Additionally, we have developed a proprietary portfolio of cell-signaling regulation technologies, our ARGENT technology, to control intracellular processes with small molecules, providing versatile tools for use in cell biology, functional genomics, proteomics and drug discovery research and useful in regulated protein and cell therapy.
 
Since our inception in 1991, we have devoted substantially all of our resources to our research and development programs. We receive no revenue from the sale of pharmaceutical products, and most of our revenue to date has been received in connection with a joint venture we had with a large pharmaceutical company from 1997 to 1999. Except for the gain on the sale of our fifty percent interest in that joint venture in December 1999, which resulted in net income for fiscal 1999, we have not been profitable since inception. We expect to incur substantial operating losses for the foreseeable future, primarily due to costs associated with our pharmaceutical product development programs, including costs for clinical trials and product manufacturing, personnel and our intellectual property. We expect that losses will fluctuate from quarter to quarter and that these fluctuations may be substantial. As of March 31, 2005, we had an accumulated deficit of $204.0 million and cash, cash equivalents and marketable securities of $63.4 million and working capital of $55.0 million.
 
In January 2005, we entered into non-exclusive license and supply agreements with Medinol Ltd. (“Medinol”), a cardiovascular medical device company, for the development and commercialization of stents and other medical devices to deliver our mTOR inhibitor, AP23573, to prevent reblockage of injured vessels following stent-assisted angioplasty. The license agreement provides for the payment by Medinol to us of an upfront license fee, payments based on achievement of development, regulatory and commercial milestones and royalties based on commercial sales of products covered by the license.
 
General
 
Our operating losses are primarily due to the costs associated with our pharmaceutical product development programs, personnel and intellectual property. As our product development programs progress, we incur significant costs for toxicology and pharmacology studies, product development, manufacturing, clinical trials and regulatory support. These costs can vary significantly from quarter to quarter depending on the number of product candidates in development, the stage of development of each product candidate, the number of patients enrolled in and complexity of clinical trials and other factors. Costs associated with our intellectual property include legal fees and other costs to prosecute, maintain, protect and enforce our intellectual property, which can fluctuate from quarter to quarter depending on the status of patent issues being pursued.
 
Because we currently receive no revenue from the sale of pharmaceutical products and receive only limited license revenue, we have, most recently, relied primarily on the capital markets as our source of funding. We also utilize long-term debt to supplement our funding, particularly as a means to

8


fund investment in property and equipment and infrastructure needs. In addition, we may seek funding from collaborations with pharmaceutical, biotechnology and/or medical device companies for development and commercialization of our product candidates. These collaborations may take the form of licensing arrangements, co-development or joint venture arrangements or other structures. If funding from these various sources is unavailable on reasonable terms, we may be required to reduce our operating expenses in order to conserve cash and capital by delaying, scaling back or eliminating one or more of our product development programs.
 
Critical Accounting Policies and Estimates
 
Our financial position and results of operations are affected by subjective and complex judgments, particularly in the areas of deferred compensation benefits for executives and key employees, stock-based compensation to consultants, and the carrying value of intangible assets.
 
In determining expense related to our deferred executive compensation plan and stock-based compensation to consultants, recorded balances are adjusted at each reporting period to reflect fair value utilizing the Black-Scholes option pricing model that takes into account, among other things, the price and volatility of our common stock or other underlying securities, a risk-free discount rate, and an estimate of the life of the option contract. Fluctuations in those factors can result in uneven expense charges or credits to our statements of operations. If, for example, the market prices of the underlying securities in our executive deferred compensation plan were 10% higher at March 31, 2005, we would have recognized an additional $377,000 in compensation expense in the three month period ended March 31, 2005. Similarly, if the price and volatility of our common stock were 10% greater as of March 31, 2005, we would have recognized an increase of $5,000 in stock-based compensation to consultants in the three month period ended March 31, 2005.
 
At March 31, 2005, we reported $4.8 million of intangible assets consisting of capitalized costs related primarily to purchased and issued patents, patent applications and licenses, net of accumulated amortization. These costs are being amortized over the estimated useful lives of the underlying patents or licenses. Changes in these lives or a decision to discontinue using the technologies could result in material changes to our balance sheet and statements of operations. For example, during 2004 and 2003, we expensed $87,000 and $520,000, respectively, of unamortized costs related to certain intangible assets which we are not actively pursuing any longer. There were no such charges to our statement of operations in the three month period ended March 31, 2005. In addition, we have concluded that the carrying value of our remaining intangible assets is not currently impaired because such assets are utilized in our product development programs and/or continue to be viable technologies for collaborations or licensing efforts which we continue to pursue. If we were to abandon the underlying technologies or terminate our efforts to pursue collaborations or license agreements, we may be required to write off a portion of the carrying value of our intangible assets.
 
Results of Operations
 
For the three months ended March 31, 2005 and 2004
 
Revenue
 
We recognized license revenue of $304,000 in the three month period ended March 31, 2005 compared to $190,000 in the three month period ended March 31, 2004. The increase in license revenue was due primarily to a license agreement into which we entered in January 2005 with Medinol to develop and commercialize stents and other medical devices to deliver our mTOR inhibitor, AP23573, to prevent reblockage of injured vessels following stent-assisted angioplasty.

9


Operating Expenses
 
Research and Development Expenses
 
Research and development expenses increased by $6.3 million, or 146%, from $4.3 million in the three month period ended March 31, 2004 to $10.6 million in the corresponding period in 2005. The research and development process necessary to commercialize a pharmaceutical product is subject to extensive regulation by numerous governmental authorities in the United States and other countries. This process typically takes years to complete and requires the expenditure of substantial resources. Current requirements include:
 
preclinical toxicology, pharmacology and metabolism studies, as well as in vivo efficacy studies in relevant animal models of disease;
 
manufacturing of drug product for preclinical studies and clinical trials and ultimately for commercial supply;
 
submission of the results of preclinical studies and information regarding manufacturing and control and proposed clinical protocol to the United States Food and Drug Administration (“FDA”) in an Investigational New Drug application (“IND”) (or similar filings with regulatory agencies outside the United States);
 
conduct of clinical trials designed to provide data and information regarding the safety and efficacy of the product candidate in humans; and
 
submission of all the results of testing to the FDA in a New Drug Application (“NDA”) (or similar filings with regulatory agencies outside the United States).
 
Upon approval by the appropriate regulatory authorities, including in some countries approval of product pricing, we may commence commercial marketing and distribution of the product.
 
We group our research and development expenses into two major categories: direct external expenses and all other R&D expenses. Direct external expenses consist of costs of outside parties to conduct laboratory studies, to develop manufacturing processes and manufacture the product candidate, to conduct and manage clinical trials and similar costs related to our clinical and preclinical studies. These costs are accumulated and tracked by product candidate. All other R&D expenses consist of costs to compensate personnel, to purchase lab supplies and services, to maintain our facility, equipment and overhead and similar costs of our research and development efforts. These costs apply to work on our clinical and preclinical candidates as well as our discovery research efforts. These costs are not tracked by product candidate because the number of product candidates and projects in R&D may vary from time to time and because we utilize internal resources across multiple projects at the same time.
 
Direct external expenses are further categorized as costs for clinical programs and costs for preclinical programs. Preclinical programs include product candidates undergoing toxicology, pharmacology, metabolism and efficacy studies and manufacturing process development required before testing in humans can begin. Product candidates are designated as clinical programs once we have filed an IND with the FDA, or a similar filing with regulatory agencies outside the United States, for the purpose of commencing clinical trials in humans.

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Our research and development expenses for the three month period ended March 31, 2005 as compared to the corresponding period in 2004 were as follows:
 
Three months ended March 31,    Increase/
(decrease)
  

In thousands 2005    2004



Direct external expenses:            
       Clinical programs $ 6,150   $ 757   $ 5,393  
       Preclinical programs   437     888     (451 )
All other R&D expenses   4,067     2,688     1,379  



  $ 10,654   $ 4,333   $ 6,321  




AP23573, our lead product candidate which is in Phase 2 clinical trials, was our only clinical program in 2005 and 2004. Direct external expenses for AP23573 increased by $5.4 million in the three month period ended March 31, 2005 as compared to the corresponding period in 2004 due primarily to increases in clinical trial costs ($2.3 million) and manufacturing-related costs ($2.7 million). In 2005, we have continued to enroll patients in and manage our ongoing clinical trials of AP23573. The increase in clinical trial costs is directly related to the increased enrollment, the costs of evaluating enrolled patients, the costs of managing the trials, laboratory costs and the costs of compiling and analyzing results obtained in the trials. Manufacturing costs include product and process development work, as well as the costs to produce drug product. Manufacturing costs for AP23573 increased in the three month period ended March 31, 2005 as compared to the corresponding period in 2004 due to an increase in the quantities of drug product manufactured for the clinical trials and investments in manufacturing process development.
 
Through March 31, 2005, we have incurred a total of approximately $20.2 million in direct external expenses for AP23573 as a clinical program. We expect that our direct external costs for AP23573 will remain at approximately the current levels in 2005 as compared to 2004 as we continue our clinical trials on this product candidate and incur the related costs of manufacturing and other costs to support such trials.
 
Preclinical programs consist primarily of our oncogenic kinase inhibitor program and our bone-targeted mTOR inhibitor program. Direct external expenses on preclinical programs will increase or decrease from period to period depending on the status and number of programs in this stage of development. Direct external expenses for preclinical programs decreased by $451,000 in the three month period ended March 31, 2005 as compared to the corresponding period in 2004 due primarily to the completion of certain pharmacology and toxicology studies conducted by outside contract laboratories in 2004. We expect that our direct external expenses for preclinical programs will increase in 2005, as resources allow, as we strive to move preclinical candidates into clinical development.
 
All other R&D expenses increased by $1.4 million in the three month period ended March 31, 2005 as compared to the corresponding period in 2004 due to higher personnel and related costs ($731,000) as a result of an increase in the number of personnel and salary adjustments, increases in laboratory supplies and services, depreciation and amortization costs due to investments in property and equipment, and maintenance and utility costs related to our facility. We expect that all other R&D expenses will continue to increase moderately in 2005 in support of our clinical and preclinical development programs.
 
The successful development of our products is uncertain and subject to a number of risks. We cannot be certain that any of our product candidates will prove to be safe and effective or will meet all of the applicable regulatory requirements needed to receive and maintain marketing approval. Data from preclinical studies and clinical trials are susceptible to varying interpretations that could delay, limit or prevent regulatory clearance. We, the FDA or other regulatory authorities may suspend clinical trials at any time if we or they believe that the subjects participating in such trials are being exposed

11


to unacceptable risks or if such regulatory agencies find deficiencies in the conduct of the trials or other problems with our products under development. Delays or rejections may be encountered based on additional governmental regulation, legislation, administrative action or changes in FDA or other regulatory policy during development or the review process. Other risks associated with our product development programs are described in Risk Factors in our Form 10-K, as amended, which has been filed with the SEC. Due to these uncertainties, accurate and meaningful estimates of the ultimate cost to bring a product to market, the timing of completion of any of our programs and the period in which material net cash inflows from any of our programs will commence are unavailable.
 
General and Administrative Expenses
 
General and administrative expenses increased 4% to $2.3 million in the three month period ended March 31, 2005 from $2.2 million in the corresponding period in 2004. Professional fees increased by $244,000 to $1.2 million in the three month period ended March 31, 2005 as compared to $1.0 million in the corresponding period in 2004 due primarily to costs related to our patent infringement litigation with Eli Lilly and Company (“Lilly”) and to business and commercial development initiatives. This increase was offset in part by a decrease in expenses related to a restricted stock grant to our Chief Executive Officer in January 2004 which was fully amortized by December 31, 2004. We expect that our general and administrative expenses will increase moderately in 2005 as necessary to support our research and development programs.
 
We expect that our operating expenses in total will increase in 2005 for the reasons described above. Operating expenses may fluctuate from quarter to quarter. The actual amount of any increase in operating expenses will depend on the progress of our product development programs, including preclinical and clinical studies and product manufacturing, the status of our patent infringement litigation with Lilly and our ability to raise funding through equity offerings, partnerships, licensing, joint ventures or other sources.
 
Interest Income/Expense
 
Interest income increased by 105% to $394,000 in the three month period ended March 31, 2005 from $192,000 in the corresponding period in 2004, as a result of a higher level of funds invested and higher interest yields from our securities in 2005.
 
Interest expense increased by 12% to $74,000 in the three month period ended March 31, 2005 from $66,000 in the corresponding period in 2004, as a result of higher average loan balances and higher interest rates in 2005.
 
Operating Results
 
We reported a loss from operations of $12.7 million in the three month period ended March 31, 2005 compared to a loss from operations of $6.4 million in the corresponding period in 2004, an increase in loss of $6.3 million, or 99%. We expect that our loss from operations will remain at approximately the current level through the remainder of 2005 due to the expected research and development expenses and general and administrative expenses described above. Losses may fluctuate depending on the extent to which, if at all, we enter into collaborations or partnerships for one or more of our product candidates or licenses for our technologies. The extent of operating losses will also depend on our ability to raise funds from other sources, such as the capital markets, which will influence the amount we will spend on research and development and the development timelines for our product candidates.
 
We reported a net loss of $12.3 million in the three month period ended March 31, 2005 compared to a net loss of $6.2 million in the corresponding period in 2004, an increase in net loss of $6.1 million or 98%, and a net loss per share of $0.23 and $0.13, respectively.

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Liquidity and Capital Resources
 
We have financed our operations and investments primarily through sales of our common stock to institutional investors and, to a lesser extent, through issuances of our common stock pursuant to our stock option and employee stock purchase plans, supplemented by the issuance of long-term debt. We sell securities and incur debt when the terms of such transactions are deemed favorable to us and as necessary to fund our current and projected cash needs. We seek to balance the level of cash, cash equivalents and marketable securities on hand with our projected needs and to allow us to withstand periods of uncertainty relative to the availability of funding on favorable terms.
 
Sources of Funds
 
During the three months ended March 31, 2005, we realized net cash from sales and issuances of our common stock of $295,000 solely from issuances of common stock pursuant to our stock option and employee stock purchase plans. This compares to $41.2 million realized in the same period in 2004, due primarily to the completion of an underwritten public offering on March 29, 2004 under which we realized net proceeds of $40.0 million.
 
Uses of Funds
 
The primary uses of our cash are to fund our operations and working capital requirements and, to a lesser degree, to repay our long-term debt, to invest in intellectual property and to purchase equipment as needed for our business. Our uses of cash were as follows:
 
  Three Months Ended March 31,  
 
 
In thousands 2005   2004  


 
Net cash used in operating activities $ 10,146   $ 4,984  
Repayment of borrowings   480     450  
Investment in intangible assets   213     300  
Investment in property and equipment   1,723     20  


  $ 12,562   $ 5,754  


   
The net cash used in operating activities is comprised of our net losses, adjusted for non-cash expenses and working capital requirements. As noted above, our net loss for the three months ended March 31, 2005 increased by $6.1 million as compared to the corresponding period in 2004 due primarily to the costs of advancing our product candidates through preclinical and clinical phases of development. However, as a result of increases in our accounts payable and accrued expenses from December 31, 2004 to March 31, 2005, our net cash used in operations increased by only $5.2 million for the three months ended March 31, 2005 compared with the corresponding period in 2004. Also, as noted above, we expect that our loss from operations will increase throughout 2005 as compared to 2004 due to continued progress in development of our product candidates, and we expect that our net cash used in operations will increase accordingly. We also expect that our investment in intangible assets, consisting of our intellectual property, will also increase in support of our product development activities while our capital expenditures are expected to decrease, particularly in the second half of 2005.
 
Contractual Obligations
 
We have substantial fixed contractual obligations under various research and licensing agreements, consulting and employment agreements, lease agreements and long-term debt instruments. These contractual obligations were comprised of the following as of March 31, 2005:

13


In thousands       Payments Due By Period   
     
 
  Total In
2005
2006
through
2008
2009
through
2010
After
2010





                               
Long-term debt* $ 9,095   $ 1,440   $ 7,655   $   $  
                               
Operating leases, net of sub-leases   1,283     412     871          
                               
Other long-term obligations **   7,436     2,601     4,240     230     365  





                               
Total fixed contractual obligations $ 17,814   $ 4,453   $ 12,766   $ 230   $ 365  





   
* Long-term debt consists of scheduled principal payments on such debt. Interest on our long-term debt is based on variable interest rates. Assuming a constant interest rate of 4.6%, our average interest rate on our debt at March 31, 2005, over the remaining term of the debt, our interest expense would total approximately $322,000 for the remainder of 2005 and $569,000 in the period 2006 through 2008.
   
** Other long-term obligations are comprised primarily of employment agreements and license agreements. The license agreements generally provide for payment by us of annual license fees, milestone payments and royalties upon successful commercialization of products. All license agreements are cancelable by us. The above table reflects remaining license fees for the lives of the agreements but excludes milestone and royalty payments, as such amounts are not probable or estimable at this time.
   
Liquidity
 
At March 31, 2005, we had cash, cash equivalents and marketable securities totaling $63.4 million and working capital of $55.0 million compared to cash, cash equivalents and marketable securities totaling $75.5 million and working capital of $68.9 million at December 31, 2004.
 
We will require substantial additional funding for our research and development programs, including pre-clinical development and clinical trials, for operating expenses including intellectual property protection and enforcement, for the pursuit of regulatory approvals, and for establishing manufacturing, marketing and sales capabilities. In order to fund our needs, we may (1) sell common stock through public or private offerings as market conditions permit, (2) enter into partnerships for our product candidates, and/or (3) license our cell-signaling technologies, including our ARGENT and NF-κB intellectual property portfolios. We have available 11,440,000 shares of our common stock under currently effective shelf registration statements which may be sold to raise capital. However, there can be no assurance that adequate funding will be available when needed or on terms acceptable to us.
 
Based on our current operating plans, we believe that our currently available funds will be adequate to satisfy our capital and operating requirements through the third quarter of 2006. However, there can be no assurance that changes in our research and development plans, litigation or other future events affecting our revenues or operating expenses will not result in the earlier depletion of our funds.
 
Securities Litigation Reform Act
 
Safe harbor statement under the Private Securities Litigation Reform Act of 1995: Except for the historical information contained in this Quarterly Report on Form 10-Q, the matters discussed herein are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are identified by the use of words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Such

14


statements are based on management’s current expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such forward-looking statements. These risks include, but are not limited to, risks and uncertainties regarding our ability to accurately estimate the timing and actual research and development expenses and other costs associated with the preclinical and clinical development and manufacture of our product candidates, the adequacy of our capital resources and the availability of additional funding, risks and uncertainties regarding our ability to successfully conduct preclinical and clinical studies of its product candidates, risks and uncertainties regarding our ability to manufacture our product candidates on a commercial scale or to supply our product candidates to our collaborator for use in its product candidates, risks and uncertainties regarding our and our collaborator’s ability to successfully enroll and conduct preclinical and clinical studies of product candidates, risks and uncertainties that clinical trial results at any phase of development may be adverse or may not be predictive of future result or lead to regulatory approval of any of our or our collaborator’s product candidates, risks and uncertainties of third-party intellectual property claims relating to our and our collaborator’s product candidates, and risks and uncertainties relating to regulatory oversight, the timing, scope, cost and outcome of legal proceedings, future capital needs, key employees, dependence on our collaborators and manufacturers, markets, economic conditions, products, services, prices, reimbursement rates, competition and other risks detailed under the heading “Risk Factors” in our Annual Report on Form 10-K, as amended, for the fiscal year ended December 31, 2004, which has been filed with the SEC. As a result of these and other factors, actual events or results could differ materially from those described herein. We are not under any obligation, and we expressly disclaim any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
 
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
We invest our available funds in accordance with our investment policy to preserve principal, maintain proper liquidity to meet operating needs and maximize yields. Our investment policy specifies credit quality standards for our investments and limits the amount of credit exposure to any single issue, issuer or type of investment.
 
We invest cash balances in excess of operating requirements first in short-term, highly liquid securities, with maturities of 90 days or less, and money market accounts. Depending on our level of available funds and our expected cash requirements, we may invest a portion of our funds in marketable securities, consisting generally of corporate debt and U.S. government and agency securities. Maturities of our marketable securities are generally limited to periods necessary to fund our liquidity needs and may not in any case exceed three years. These securities are classified as available-for-sale. Available-for-sale securities are recorded on the balance sheet at fair market value with unrealized gains or losses reported as a separate component of stockholders’ equity (accumulated other comprehensive income or loss). Realized gains and losses on marketable security transactions are reported on the specific-identification method. Interest income is recognized when earned. A decline in the market value of any available-for-sale security below cost that is deemed other than temporary results in a charge to earnings and establishes a new cost basis for the security.
 
Our investments are sensitive to interest rate risk. We believe, however, that the effect, if any, of reasonable possible near-term changes in interest rates on our financial position, results of operations and cash flows generally would not be material due to the current short-term nature of these investments. In particular, at March 31, 2005, because our available funds are invested solely in short-term securities with remaining maturities of twelve months or less, our risk of loss due to changes in interest rates is not material.
 
We have an executive compensation plan which provides participants, in lieu of a cash bonus, an option to purchase certain designated mutual funds at a discount equal to the amount of the

15


bonus.  These deferred compensation arrangements are accounted for as derivatives under SFAS No. 133. The fair value of the derivatives is reflected as a liability on our balance sheet. As of March 31, 2005, in the event of a hypothetical 10% increase (decrease) in the fair market value of the underlying mutual funds and after giving effect to the related volatility change, we would incur approximately $377,000 of additional (less) compensation expense.
 
At March 31, 2005, we had $9.1 million outstanding under a bank term note which bears interest at prime or, alternatively, LIBOR + 2%. This note is sensitive to interest rate risk. In the event of a hypothetical 10% increase in the interest rate on which the loan is based (57.5 basis points), we would incur approximately $47,000 of additional interest expense per year based on expected balances over the next twelve months.
 
ITEM 4.      CONTROLS AND PROCEDURES
 
(a)      Evaluation of Disclosure Controls and Procedures. Our principal executive officer and principal financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this Quarterly Report on Form 10-Q, have concluded that, based on such evaluation, our disclosure controls and procedures were adequate and effective to ensure that material information relating to us, including our consolidated subsidiaries, was made known to them by others within those entities, particularly during the period in which this Quarterly Report on Form 10-Q was being prepared.
 
In designing and evaluating our disclosure controls and procedures, our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
 
(b)    Changes in Internal Controls. There were no changes in our internal control over financial reporting, identified in connection with the evaluation of such internal control that occurred during the last fiscal quarter, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PART II.    OTHER INFORMATION
 
ITEM 1.     LEGAL PROCEEDINGS
 
NF-κB Patent Infringement Litigation  
 
The information contained in Part II, Item 1 of our Annual Report on Form 10-K, as amended, for the year ended December 31, 2004 (File No. 0-21826) is incorporated by reference.
 
On April 4, 2005, defendant Eli Lilly and Company (“Lilly”) filed a request in the United States Patent and Trademark Office (“PTO”) to reexamine the patentability of certain claims of U.S. Patent No. 6,410,516 (“516 Patent”). Also on April 4, 2005, Lilly filed a motion in the U.S. District Court requesting a stay of the NF-κB patent infringement litigation by the Court pending reexamination of the ‘516 Patent by the PTO. We, together with co-plaintiffs Massachusetts Institute of Technology, The Whitehead Institute for Biomedical Research and Harvard University (collectively, the “Plaintiffs”) filed our memorandum in opposition to Lilly’s motion to stay with the U.S. District Court on April 18, 2005.
 
On April 6, 2005, the parties appeared before the U.S. District Court for a status conference. At that conference, the Court indicated that no oral argument would be heard on Lilly’s motion to stay and that the Court would set trial date as early as 2005 if it denies Lilly’s motion.
 
The ultimate outcome of the request for reexamination and litigation cannot be determined at this time, and, as a result, an estimate of a damage award or range of awards in the litigation, if any, cannot be made.
 
ITEM 6.    EXHIBITS
 
*10.1 License Agreement, effective January 26, 2005, by and between ARIAD Pharmaceuticals, Inc. and Medinol Ltd.
 
*10.2 Supply Agreement, entered into as of January 26, 2005, by and between ARIAD Pharmaceuticals, Inc. and Medinol Ltd.
 
31.1 Certification of the Chief Executive Officer.
 
31.2 Certification of the Chief Financial Officer.
 
32.1 Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
   
* Confidential treatment has been requested for portions of this exhibit.
 
ARIAD and the ARIAD logo are our registered trademarks and ARGENT is our trademark. The domain name and website address www.ariad.com, and all rights thereto, are registered in the name of, and owned by, ARIAD. The information in our website is not intended to be part of this Quarterly Report on Form 10-Q. We include our website address herein only as an inactive textual reference and do not intend it to be an active link to our website.

17


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.
     
                  ARIAD Pharmaceuticals, Inc.
                  (Registrant)
     
     
  By: /s/  Harvey J. Berger, M.D.
   
    Harvey J. Berger, M.D.
    Chairman and Chief Executive Officer
     
     
  By: /s/  Edward M. Fitzgerald
   
    Edward M. Fitzgerald
    Senior Vice President and Chief Financial Officer
Date:  May 9, 2005   (Duly authorized officer, principal financial officer
and chief accounting officer)

18


EXHIBIT INDEX

 
Exhibit No.       Title
   
*10.1 License Agreement, effective January 26, 2005, by and between ARIAD Pharmaceuticals, Inc. and Medinol Ltd.
 
*10.2 Supply Agreement, entered into as of January 26, 2005, by and between ARIAD Pharmaceuticals, Inc. and Medinol Ltd.
 
31.1 Certification of the Chief Executive Officer.
 
31.2 Certification of the Chief Financial Officer.
 
32.1 Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
 
* Confidential treatment has been requested for portions of this exhibit.

19


EX-10.1 2 d63754_ex10-1.htm ARIAD PHARMACEUTICALS EXHIBIT 10.1

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

LICENSE AGREEMENT

Exhibit 10.1

(AP23573 in Medical Devices)

 

This License Agreement (this “Agreement”) is made effective as of January 26, 2005 (the “Effective Date”), by and between ARIAD Pharmaceuticals, Inc. and ARIAD Gene Therapeutics, Inc., both corporations with a principal place of business at 26 Landsdowne Street, Cambridge, MA 02139 (collectively, “ARIAD”), and MEDINOL Ltd., a company with a principal place of business at Kiryat Atidim, P.O. Box 58165, Tel Aviv, 61581, Israel (“MEDINOL”). ARIAD and MEDINOL are each hereafter referred to individually as a “Party” and together as the “Parties.”

WHEREAS, ARIAD is the owner of, or otherwise controls, certain patents and technology relating to AP23573 (as defined below);

WHEREAS, MEDINOL has expertise in developing and commercializing stents, which can deliver drug products for the treatment of restenosis;

WHEREAS, MEDINOL desires to obtain the right from ARIAD to use AP23573 to evaluate, develop and commercialize certain medical devices, including stents, that will deliver AP23573;

WHEREAS, MEDINOL desires ARIAD to supply quantities of AP23573 to MEDINOL for research, clinical and commercial use with certain medical devices, including stents, that will deliver AP23573; and

WHEREAS, ARIAD desires to grant to MEDINOL rights to use AP23573 to evaluate, develop and commercialize certain medical devices, including stents, that will deliver AP23573 and to supply quantities of AP23573 to MEDINOL in connection therewith on the terms and conditions set forth in this Agreement and the Supply Agreement (as defined below).

NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Parties hereby agree as follows:

1.

DEFINITIONS

Whenever used in the Agreement with an initial capital letter, the terms defined in this Article 1 shall have the meanings specified.

1.1              Adverse Event shall mean any untoward medical occurrence required to be reported to any Regulatory Authority, including without limitation any

 

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

occurrence defined as a “serious adverse event” in applicable Regulatory Authority regulations or guidelines (including 21 CFR §§312.32 and 314.80, and European Standard EN540) in a patient who has been administered AP23573.

1.2              Affiliate shall mean any corporation, firm, limited liability company, partnership or other entity that directly controls, is controlled by or is under common control with a Party to this Agreement. For purposes of this Section 1.2, “control” means ownership, directly or indirectly through one or more entities, of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (50%) or more of the equity interests in the case of any other type of legal entity, status as a general partner in any partnership, or any other arrangement whereby a Party controls or has the right to control the Board of Directors or equivalent governing body of a corporation or other entity.

1.3

  “API shall mean the active pharmaceutical ingredient of AP23573.

1.4              AP23573 shall mean ARIAD’s proprietary compound designated “AP23573,” described in [**************] filed by ARIAD with the FDA.

1.5              AP23573 Phase 1 Clinical Data shall mean a narrative summary report prepared by ARIAD of unaudited clinical data obtained by ARIAD for patients enrolled in the AP23573 Phase 1 Clinical Trials as of the date which is three weeks preceding the date of each such summary report. Each such narrative summary report shall summarize each protocol, the number of enrolled patients receiving each dosage level in accordance with each protocol, and the safety information (which shall comprise all Adverse Events reported on draft data listings and “serious adverse events” required to be reported to any Regulatory Authority) obtained by ARIAD. For purposes of clarity, all AP23573 Phase 1 Clinical Data (i) is subject to change after audit, (ii) shall be treated as Confidential Information of ARIAD, (iii) shall be used by MEDINOL solely for internal purposes in performing its obligations and/or exercising its rights under this Agreement and the Supply Agreement, and (iv) shall not be disclosed by MEDINOL to any Third Party under any circumstances without ARIAD’s prior written consent.

1.6           AP23573 Phase 1 Clinical Trials shall mean only the following studies of AP23573: (a) [************************************************************************************
*************************************************************************************
********************************************** to be conducted in accordance with Protocol No. **********, and (b)

 

2

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

************************************************************************************** to be conducted in accordance with Protocol No. ****************.]

1.7              Authorized Distributor shall mean a seller or distributor of MEDINOL Licensed Products approved by ARIAD pursuant to Section 2.1.3.

1.8              CE Mark shall mean the “Conformite Europeene” mark issued upon approval by the European Union Regulatory Authority to market and sell MEDINOL Licensed Products in the countries of the European Union.

1.9              Change-in-Control shall have the meaning set forth in Section 11.8.

1.10           CMC Data means the chemistry, manufacturing, and controls data set forth in 21 CFR 314.50, as the same may be amended from time to time, or as otherwise required by applicable law and regulations to be included in an NDA, or the equivalent application to a Regulatory Authority for grant of marketing authorization outside the United States, as such data may be amended or supplemented from time to time. For purposes of clarity, CMC Data shall be treated as Confidential Information for purposes of this Agreement.

1.11           Confidential Information shall mean (a) with respect to a Party (the “Receiving Party”), all information (including without limitation, with respect to ARIAD, all data from AP23573 Phase 1 Clinical Trials, the chemical structure of AP23573 and, with respect to each Party, all Licensed Technology, CMC Data, development plans and schedules, marketing and sales information, clinical and pre-clinical data, information and results, specifications, and protocols), which are disclosed by the other Party (the “Disclosing Party”) to the Receiving Party hereunder or to any of its employees, consultants or Affiliates; and which is designated as confidential information, prior to, during or immediately after such disclosure. Confidential Information does not include information which (i) as of the date of disclosure, is known to the Receiving Party or its Affiliates, as demonstrated by written records, other than by virtue of a prior confidential disclosure to such Party or its Affiliates; (ii) as of the date of disclosure is in, or subsequently enters, the public domain, through no breach of this Agreement by the Receiving Party; (iii) is obtained from a Third Party having a lawful right to make such disclosure free from any obligation of confidentiality to the Disclosing Party; or (iv) is independently developed by or for the Receiving Party without reference to, or reliance upon, any Confidential Information of the Disclosing Party as demonstrated by written records.

 

3

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

1.12           Control or Controlled shall mean with respect to any Patent Rights or Technology, the possession by a Party of the ability to grant a license or sublicense of such Patent Rights or Technology, as provided for herein, without violating the terms of any agreements between such Party and any Third Party and without requiring such Party to make any contractual payment to any Third Party in connection with such grant of rights or the exercise thereof by the grantee.

1.13           Current Good Laboratory Practices or cGLP shall mean current good laboratory practice and standards as described in Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 and in Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 or in 21 CFR Part 58, as amended, from time to time.

1.14           Current Good Manufacturing Practices or cGMP shall mean European Community requirements for good manufacturing practice as set forth in Commission Directives 91/356/EEC and 2003/94/EC, as amended, and guidance documents issued pursuant to them, or as set forth in, Title 21 of the United States Code of Federal Regulations, Parts 210 and 211, as amended, from time to time.

1.15           Drug Master File or DMF shall mean a drug master file and any amendment and supplements thereto, filed and maintained with a Regulatory Authority by or on behalf of ARIAD, which shall contain, among other things, CMC Data and other relevant information concerning AP23573.

1.16           Excess API Cost,as defined in the Supply Agreement, means, the difference, if any, between (i) the purchase price per gram of API [**************] [**********************************************************] following expiration of the [********] notice period of a Refusal to Supply by ARIAD, minus (ii) [**********] amount equal to [**********] Dollars [(U.S. $******)], subject to annual adjustment for inflation, from the Effective Date to the date of purchase by MEDINOL, using the United States Bureau of Labor Statistics Producer Price Index for Pharmaceutical Preparation Manufacturing published at www.bls.gov. To calculate the Excess API Cost, all payments made by MEDINOL for API in foreign currency shall be converted into United States Dollars at the conversion rate existing in the United States (as reported in The Wall Street Journal, Eastern Edition, for purchasing United States Dollars) on the last business day of the applicable calendar quarter in which the purchase of API took place.

1.17           Exclusive Licensees shall mean MEDINOL and up to two (2) additional Third Parties who may be granted a license, under ARIAD’s interest in the Licensed Patent Rights and Licensed Technology to develop, have developed, make, have made, use, have used, sell, have sold, offer for sale, import, have imported, export,

 

4

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

have exported, distribute, market and promote Licensed Products for use in the Licensed Field.

1.18           FDA shall mean the United States Food and Drug Administration and any successor agency or authority thereto.

1.19           First Commercial Sale shall mean, on a country-by-country basis, the date of the first arm’s length transaction, transfer or disposition for value to a Third Party of a MEDINOL Licensed Product by or on behalf of MEDINOL or any Affiliate of MEDINOL in such country, but specifically excluding any transfers made in furtherance of clinical trials, research, or other such non-commercial uses.

1.20           First-In-Humans Clinical Trial shall mean, with respect to a MEDINOL Licensed Product, the first study in humans of the MEDINOL Licensed Product as an investigational device in accordance with applicable rules and regulations of the country or jurisdiction in the which the clinical trial is conducted.

1.21           IDE shall mean an investigational device exemption, as defined in Title 21 of the United States Code of Federal Regulations, Part 812 et seq., as amended from time to time, filed or to be file with the FDA.

1.22           IND shall mean an investigational new drug application, as defined in Title 21 of the United States Code of Federal Regulations, Part 312 et seq., as amended from time to time, filed or to be filed with the FDA.

1.23           Licensed Field shall mean the [*************************************] of any [*****************].

1.24           Licensed Patent Rights shall mean all Patent Rights that (i) are Controlled by ARIAD as of the Effective Date, to the extent necessary to develop, use, make, have made, import, have imported, export, have exported, sell, have sold, offer to sell, distribute, market and promote MEDINOL Licensed Products in the Licensed Field and/or (ii) become Controlled by ARIAD during the License Term, to the extent necessary for MEDINOL to develop, use, make, have made, import, have imported, export, have exported, sell, have sold, offer to sell, distribute, market and promote MEDINOL Licensed Products in the Licensed Field. The Licensed Patent Rights as of the Effective Date are listed in Schedule A attached hereto and made a part hereof. During the Term, ARIAD shall provide to MEDINOL an annual written update of Schedule A which includes any additional patents and patent applications comprising Licensed Patents not previously listed.

 

5

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

1.25           Licensed Product shall mean any Medical Device which delivers AP23573.

1.26           Licensed Technology shall mean and include all Technology, whether or not patentable, including but not limited to formulations, techniques and materials, that (i) is Controlled by ARIAD as of the Effective Date, to the extent necessary for MEDINOL to develop, use, make, have made, import, have imported, export, have exported, sell, have sold, offer to sell, distribute, market and promote MEDINOL Licensed Products in the Licensed Field, and/or (ii) becomes Controlled by ARIAD during the License Term, to the extent necessary for MEDINOL to make and have made MEDINOL Licensed Products in the Licensed Field.

1.27           License Term shall mean, with respect to each MEDINOL Licensed Product, the period commencing on the Effective Date and continuing, on a country-by-country and product-by-product basis, until the expiration or termination of the last Valid Claim covering the manufacture, sale, use or importation of AP23573 in such country.

1.28        Medical Device shall mean any [**************************************************************************************
***************************************************************************************
***************************************************************************************
***************************************************************************************
***************************************************************************************
***************************************************************************************
***************************************************************************************
***************************************************************************************
************************************************************].

1.29           MEDINOL-Gore Agreement shall mean the Collaboration Agreement between MEDINOL and W.L. Gore dated September 12, 2002.

1.30           MEDINOL Licensed Product shall mean any embodiment of a Licensed Product manufactured by or exclusively for MEDINOL and sold by MEDINOL, W.L. Gore or MEDINOL’s Authorized Distributors, for which all Patent Rights are reasonably believed by MEDINOL to be owned or Controlled by MEDINOL, or for which MEDINOL reasonably believes it otherwise has the right to practice all Patent Rights. For avoidance of doubt, MEDINOL Licensed Product shall include any embodiment of a Licensed Product manufactured by or exclusively for MEDINOL, but which is bundled for sale by MEDINOL, W.L. Gore or MEDINOL’s Authorized Distributors with any other product or products (each of which may or may not be a MEDINOL Licensed Product); for example, a MEDINOL Licensed Product sold by W.L.

 

6

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

Gore, either as a single unit or bundled with other products manufactured by or exclusively for W.L. Gore, pursuant to the MEDINOL-Gore Agreement).

1.31           NDA shall mean a New Drug Application filed with the FDA or any equivalent successor application or entity seeking authorization to market AP23573.

1.32           Net Sales shall mean the gross invoiced sales price for all MEDINOL Licensed Products sold by MEDINOL, W.L. Gore or MEDINOL’s Authorized Distributors, their respective Affiliates and the subdistributors of W.L. Gore or MEDINOL’s Authorized Distributors to Third Parties throughout the world during each calendar quarter, before the deduction of any promotional discounts, promotions, royalties, taxes, duties, fees, charges or other expenses to such seller and before any reimbursements made to its customers and after deduction of other discounts to individual customers not in excess of [*%] for any MEDINOL Licensed Product for any customer.

1.33           Patent Rights shall mean the rights and interests in and to issued patents and pending patent applications (including inventor’s certificates and utility models) in any country or jurisdiction, including all provisionals, substitutions, continuations, continuations in part, divisionals, supplementary protection certificates, renewals, all letters patent granted thereon, and all reissues, reexaminations, extensions, confirmations, revalidations, registrations, patents of addition thereof, PCTs and foreign counterparts.

1.34           Patented MEDINOL Licensed Product shall mean a MEDINOL Licensed Product manufactured or sold in a country in which there is a Valid Claim of a Licensed Patent Right at the time of manufacture or sale.

1.35           Permitted Assignee shall mean any assignee assuming the rights and obligations of a Party under this Agreement pursuant to a Change-in-Control.

1.36           Pivotal Clinical Trial shall mean, with respect to a MEDINOL Licensed Product, a well-controlled study in humans designed to determine, taking into account statistical considerations, the safety and efficacy of such MEDINOL Licensed Product, which is designed to demonstrate whether such MEDINOL Licensed Product is safe and effective for one or more indication(s) in the Licensed Field.

1.37           PMA shall mean an application to obtain pre-market approval, as defined in Title 21 of the United States Code of Federal Regulations, Part 814 et. seq., as amended from time to time, filed with the FDA.

 

7

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

1.38           Registration Process shall mean ARIAD’s manufacturing process for manufacturing API under cGMP which is validated and reproducible to achieve Regulatory Approval of the MEDINOL Licensed Product in the United States and the European Union.

1.39           Regulatory Approval shall mean any and all approvals by applicable Regulatory Authorities necessary to market and sell a MEDINOL Licensed Product in any country or jurisdiction.

1.40           Regulatory Authority shall mean any applicable supranational, national, federal, state or local regulatory agency, department, bureau or other governmental entity of any country or jurisdiction (including the FDA in the United States), having responsibility in such country or jurisdiction for any Regulatory Approvals of any kind in such country or jurisdiction, and any successor agency or authority thereto.

 

1.41           Stentshall mean a metal wire mesh tube that is placed, by means of a catheter, at the site of a blockage within an artery [********************] to keep the vessel open after balloon angioplasty.

1.42           Supply Agreement shall mean that certain Supply Agreement, entered into as of even date herewith between ARIAD and MEDINOL, in the form attached hereto as Exhibit 3.3.

1.43           Technology shall mean and include any and all unpatented proprietary ideas, inventions, discoveries, Confidential Information, biological materials, data, results, formulae, designs, specifications, methods, processes, formulations, techniques, ideas, know-how, technical information (including, without limitation, structural and functional information), process information, pre-clinical information, clinical information, and any and all proprietary biological, chemical, pharmacological, toxicological, pre-clinical, clinical, assay, control and manufacturing data and materials, and, in the case of MEDINOL, any and all mechanical, mechanical design and material science data and materials.

1.44

Term shall mean have the meaning set forth in Section 9.1.

1.45           Third Party shall mean any person or entity other than MEDINOL or ARIAD.

1.46           Unpatented MEDINOL Licensed Product shall mean a MEDINOL Licensed Product that is neither manufactured nor sold in a country in

 

8

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

which there is a Valid Claim of a Licensed Patent Right at the time of manufacture or sale.

1.47           Valid Claim shall mean a claim in an issued, unexpired patent within the Licensed Patent Rights that (a) has not been finally cancelled, withdrawn, abandoned or rejected by any administrative agency or other body of competent jurisdiction, (b) has not been revoked, held invalid, or declared unpatentable or unenforceable in a decision of a court or other body of competent jurisdiction that is unappealable or unappealed within the time allowed for appeal, (c) has not been rendered unenforceable through disclaimer or otherwise, and (d) is not lost through an interference proceeding.

1.48           [***************************************************************
*************************************************************************************
*************************************************************************************
*************************************************************************************
****************************************************************].

 

1.49

W.L. Gore shall mean W.L. Gore and Associates.

2.

GRANT OF RIGHTS

 

 

2.1

License and Retained Rights.

 

2.1.1          Grant of License. Subject to the terms and conditions of this Agreement, ARIAD hereby grants to MEDINOL a tri-exclusive, with up to two other Exclusive Licensees, worldwide royalty-bearing license during the Term, with the right to grant sublicenses solely to MEDINOL’s Affiliates, W.L. Gore, MEDINOL’s Authorized Distributors and/or other sellers and distributors of MEDINOL products who are not Affiliates of W.L. Gore or an Authorized Distributor and who purchase MEDINOL products from W.L. Gore or an Authorized Distributor (including in multi-tiered distribution channels), solely to enable such Affiliates and/or W.L. Gore and Authorized Distributors and other such sellers and distributors to market and sell MEDINOL Licensed Products, under ARIAD’s interest in the Licensed Patent Rights and Licensed Technology, to develop, have developed, make, have made, use, have used, sell, have sold, offer to sell, import, have imported, export, have exported, distribute, market and promote MEDINOL Licensed Products in the Licensed Field.

2.1.2          Retained Rights. Subject to the other terms of this Agreement, ARIAD retains all rights to the Licensed Technology and the Licensed Patent Rights, including without limitation, the right to:

 

9

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

(a)               develop, have developed, make, have made, use, have used, sell, have sold, offer for sale, import, have imported, export, have exported, distribute, market or promote any product, except that ARIAD shall not have the right to use, have used, sell, have sold, offer for sale, import, have imported, export or have exported, distribute, market or promote any Licensed Product in the Licensed Field;

(b)               grant licenses to Affiliates and Third Parties under ARIAD’s interest in the Licensed Patent Rights and Licensed Technology, except that ARIAD will not grant more than two (2) tri-exclusive licenses to Exclusive Licensees, under ARIAD’s interest in the Licensed Patent Rights and Licensed Technology, to develop, have developed, make, have made, use, have used, sell, have sold, offer for sale, import, have imported, export, have exported, distribute, market and promote Licensed Products in the Licensed Field,

(c)               make or have made and sell or supply AP23573 for any purpose, provided that ARIAD will not use AP23573 in Licensed Products in the Licensed Field nor supply AP23573 to any party for use in Licensed Products in the Licensed Field other than to MEDINOL hereunder or under the Supply Agreement or to an Exclusive Licensee licensed in accordance with clause (b) above; and

(d)               otherwise develop and exploit Licensed Patent Rights and Licensed Technology for any purpose other than Licensed Products for use in the Licensed Field.

No rights or licenses are granted hereunder (by implication, estoppel or otherwise) except as expressly set forth herein. The restrictions and limitations on ARIAD’s retained rights in clauses (a) and (b) of this Section 2.1.2 shall, on a country by country basis, terminate and become void upon the expiration or termination of the Licensed Term each such country.

2.1.3          Authorized Distributors. If MEDINOL wishes to appoint a seller or distributor of MEDINOL Licensed Products other then W.L. Gore, it shall so notify ARIAD and shall provide ARIAD with all material information regarding the relationship and a copy of all relevant agreements (collectively, the “Distributor Information”). No Third Party shall be appointed as a seller or distributor of MEDINOL Licensed Products without written approval of ARIAD, which shall not be unreasonably withheld. ARIAD shall respond to any request for approval within ten (10) days of receipt of the Distributor Information from MEDINOL. If ARIAD’s approval of any proposed seller or distributor is withheld, ARIAD shall so notify MEDINOL in writing within such 10-day period, including an explanation of the reasons therefor. Some examples (but not a complete list) of reasons ARIAD may

 

10

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

withhold its approval of a proposed seller or distributor include ARIAD’s reasonable belief that such proposed seller or distributor has a history of under performance, is competitive with ARIAD or its Affiliates, is adverse to ARIAD or its Affiliates in a pending or threatened dispute or would cause ARIAD or its Affiliates to be in breach under, or conflict with, any agreement, decree, law, rule or regulation governing ARIAD’s business. MEDINOL shall remain obligated for its performance under this Agreement notwithstanding MEDINOL’s sublicense to, or appointment of, W.L. Gore or any Authorized Distributor to sell or distribute MEDINOL License Products on MEDINOL’s behalf.

3.

DEVELOPMENT AND COMMERCIALIZATION OF PRODUCTS.

3.1              Development Obligations. ARIAD’s and MEDINOL’s obligations concerning the development and commercialization of AP23573 and MEDINOL Licensed Products are set forth in this Article 3.

3.1.1          ARIAD’s Obligations. During the Term, at ARIAD’s sole expense, ARIAD shall use commercially reasonable efforts to:

(a)               for so long as ARIAD and/or its pharmaceutical partners continue development of AP23573 for use to treat cancer, take all actions necessary to continue development and manufacture under cGMP of AP23573 in order to facilitate MEDINOL’s efforts pursuant to Section 3.1.2;

(b)               as mutually agreed, provide to MEDINOL, from time to time, such AP23573 Phase 1 Clinical Data to facilitate MEDINOL in meeting its obligations pursuant to Section 3.1.2. MEDINOL shall maintain all such AP23573 Phase 1 Clinical Data in confidence and shall not use or disclose it to any Third Party except as expressly permitted under Section 3.4 of this Agreement.

(c)               as soon as practicable following completion of its AP23573 Phase 1 Clinical Trials, provide to MEDINOL a final audited report of all clinical data, including all Adverse Events, obtained from patients enrolled in ARIAD’s AP23573 Phase 1 Clinical Trials. MEDINOL shall maintain the final audited report disclosed to it pursuant to this Section 3.1.1(c) in confidence and shall not use or disclose it to any Third Party except as expressly permitted under Section 3.4 of this Agreement;

(d)               take all actions necessary to file and maintain its U.S. DMF with respect to API made using the Registration Process on a timetable to be mutually agreed between ARIAD and MEDINOL;

 

11

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

(e)               take all actions necessary, including completion of its ongoing AP23573 Phase 1 Clinical Trials, to file and maintain a European DMF with respect to API made using the Registration Process on a timetable to be mutually agreed between ARIAD and MEDINOL; and

(f)                take all actions agreed upon by the Parties and necessary to seek marketing approval for AP23573 in Japan on a timetable to be mutually agreed between ARIAD and MEDINOL.

For purposes of clarity, it is acknowledged that (i) ARIAD’s obligation under this Section 3.1.1 shall be limited to AP23573 as a drug, independent of any Medical Device, and shall not apply to any MEDINOL Licensed Product, and (ii) ARIAD’s obligations under this Section 3.1.1 to use commercially reasonable efforts do not require ARIAD and/or its pharmaceutical partner to continue development, manufacture and regulatory approval efforts with respect to AP23573 if, in ARIAD’s and/or its pharmaceutical partner’s reasonable commercial judgment, it is not in its or their business interest to do so.

3.1.2          MEDINOL’s Obligations. During the Term, at MEDINOL’s sole expense, MEDINOL shall use commercially reasonable efforts to:

(a)               take all actions necessary to develop and manufacture MEDINOL Licensed Product(s) under cGMP and to market (itself or through its Affiliates or W.L. Gore or its Authorized Distributors) such MEDINOL Licensed Product(s) in the United States, European Union and Japan in order to achieve the milestones and cause ARIAD to receive the payments set forth in Section 4.4 as soon as practicable;

(b)               initiate First-In-Man Clinical Trials using a MEDINOL Licensed Product on a timetable to be mutually agreed between ARIAD and MEDINOL;

(c)               take all actions necessary, including the conduct of necessary clinical trials, to file a PMA for a MEDINOL Licensed Product in the U.S. on a timetable to be mutually agreed between ARIAD and MEDINOL;

(d)               take all actions necessary, including the conduct of necessary clinical trials, to file for CE Mark for a MEDINOL Licensed Product in Europe on a timetable to be mutually agreed between ARIAD and MEDINOL; and

 

12

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

(e)               take all actions necessary, including the conduct of necessary clinical trials, to seek pricing and marketing approval for MEDINOL Licensed Products in Japan on a timetable to be mutually agreed between ARIAD and MEDINOL.

MEDINOL’s obligations under this Section 3.1.2 do not require MEDINOL to continue development, manufacture clinical development and regulatory work with respect to MEDINOL Licensed Product(s) if, [***********************************************************]

*******************************************].

3.1.3          Compliance with Laws and Regulations. In undertaking its respective obligations pursuant to this Article 3, each of ARIAD and MEDINOL shall comply with all applicable laws, regulations, ordinances and guidelines. Without limiting the generality of the foregoing, with respect to the conduct of clinical trials in humans sponsored by a Party, such Party (and its agents and representatives) shall ensure compliance with, among other things, applicable standards of good clinical practice of the FDA, ICHGCP guidelines and other regulations of the FDA and other Regulatory Authorities governing the performance of such clinical investigations.

3.2              Supply Agreement. Contemporaneously with the execution hereof, ARIAD and MEDINOL shall enter into the Supply Agreement, pursuant to which ARIAD shall supply, and MEDINOL shall purchase, API on the terms and conditions set forth on Exhibit 3.3 attached hereto.

3.3

Project Committee and Reporting.

3.3.1          Project Committee. Each Party shall designate an appropriate individual to serve as its principal liaison (“Principal Liaison”). A Party’s Principal Liaison shall serve as the principal point of contact for the other Party and shall coordinate and manage the performance of that Party’s obligations under this Agreement. The Principal Liaisons shall function as a Project Committee and shall meet in person or by telephone, at a minimum, on a quarterly basis. For purposes of the Project Committee operations, the parties’ understand and acknowledge that ARIAD’s employees have and can contribute expertise in the area of pharmaceutical product development, testing and commercialization and MEDINOL’s employees have and can contribute expertise in the area of medical device product development, testing and commercialization.

3.3.2          Committee Operations. The Project Committee shall establish procedures for regular quarterly meetings at which it shall: (a) provide summary progress reports and discuss and cooperate to resolve technical and regulatory issues relating to the development and commercialization of MEDINOL Licensed Products encountered by either Party, (b) discuss and help in the development

 

13

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

of strategies to commercialize MEDINOL Licensed Products worldwide, (c) provide input for the development plans for each MEDINOL Licensed Product, including, without limitation, assistance with the development of timelines for achievement by each Party of the obligations specified in Sections 3.1.1 and 3.1.2 in order to seek marketing approval for MEDINOL Licensed Products in the United States, the European Union and Japan, and (d) discuss and implement procedures to coordinate and manage each Party’s activities in meeting its respective obligations in Sections 3.1.1 and 3.1.2. In addition to participation in such quarterly meetings, ARIAD shall use reasonable efforts to provide technical and regulatory assistance to MEDINOL, within its area of expertise and solely related to AP23573, to assist MEDINOL to develop, manufacture and obtain Regulatory Approvals to market MEDINOL Licensed Products. Such assistance shall be organized through the Principal Liaisons of ARIAD and MEDINOL who shall act as the principal contacts and project managers for development of MEDINOL Licensed Products in their respective companies. All information shared at Project Committee meetings shall be treated as Confidential Information of the disclosing party and the recipient shall use such information only for purposes expressly permitted under this Agreement. For sake of clarity, it is stressed that no information exchanged under the mutual program or pursuant to this Agreement will be shared by ARIAD with any of the other Exclusive Licensees without the written consent of MEDINOL.

3.3.3          Regulatory Information. During the Term, the Parties shall share information for clinical and regulatory purposes as follows:

3.3.4          Investigator Safety Letters. Each Party shall promptly (but in no event later than 72 hours before expiration of the earliest deadline to provide notice to clinical investigators pursuant to all relevant guidelines of Regulatory Authorities governing the conduct of clinical trials worldwide) provide a copy of all investigator safety letters generated by it or its Affiliates or licensees in connection with worldwide clinical studies of products containing AP23573 to the Principal Liaison of other Party. Upon receipt thereof, the Party receiving such investigator safety letter shall (i) timely (in accordance with all relevant guidelines of Regulatory Authorities) disseminate or cause to be disseminated such investigator safety letters to each clinical investigator conducting clinical trials in any patient population worldwide with any product containing AP23573 on behalf of it or its Affiliates or licensees, and (ii) within 24 hours thereafter, confirm in writing to the Principal Liaison of the Party disclosing such investigator safety letter that it has complied with its obligation in clause (i) of this sentence.

 

14

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

3.3.5          MEDINOL Data. Subject to applicable laws governing patient confidentiality and to the extent necessary for ARIAD to comply with applicable statutes, laws, regulations, ordinances and guidelines governing Regulatory Approval of AP23573, MEDINOL shall provide to ARIAD: (a) in electronic database format, all safety data (including Adverse Events) from its worldwide clinical trials relating to MEDINOL Licensed Products, (b) copies of all investigator safety letters provided by MEDINOL to its clinical investigators in connection with clinical studies of MEDINOL Licensed Products, and (c) only to the extent reasonably necessary for ARIAD to obtain Regulatory Approval of AP23573, summaries of relevant data generated by MEDINOL in connection with its preclinical studies of any product containing AP23573 (collectively, MEDINOL Data). MEDINOL’s Data shall be treated as Confidential Information and ARIAD shall maintain such MEDINOL Data disclosed to it pursuant to this Section 3.4.2 in confidence and shall not use or disclose it to any Third Party other than to disclose, itself or through its agent, such MEDINOL Data, after obtaining assurances that such MEDINOL Data will be afforded confidential treatment by the recipient, to its Exclusive Licensees, pharmaceutical partners or any Regulatory Authority solely as required in order for such recipient to obtain or grant, as the case may be, Regulatory Approval of a product containing AP23573.

3.3.6          ARIAD Data. Subject to applicable laws governing patient confidentiality and to the extent necessary for MEDINOL to comply with applicable statutes, laws, regulations, ordinances and guidelines governing Regulatory Approval of MEDINOL Licensed Products, ARIAD shall provide MEDINOL (i) the right to cross-reference to all safety data (including Adverse Events) reported to the FDA by ARIAD under its IND to obtain Regulatory Approval for AP23573, (ii) copies of all investigator safety letters provided by ARIAD to its clinical investigators in connection with clinical studies of AP23573, (iii) only to the extent reasonably necessary for MEDINOL to obtain Regulatory Approval of any MEDINOL Licensed Product, summaries of relevant data generated by ARIAD in connection with its preclinical studies of AP23573, and (iv) summary reports of all safety data (including Adverse Events) attributable to the use of AP23573 provided to ARIAD by any party granted a license pursuant to ARIAD’s retained rights in Section 2.1.2 (together with ARIAD’s audited report referred to in Section 3.1.1(b), ARIAD Data). ARIAD Data shall be treated as Confidential Information and MEDINOL shall maintain such ARIAD Data disclosed to it pursuant to this Section 3.4.3 in confidence and shall not use or disclose it to any Third Party other than: (i) MEDINOL, itself or through its agent, may provide a cross-reference to ARIAD Data reported to the FDA by ARIAD under its IND or corresponding foreign country filing to obtain Regulatory Approval for AP23573 in any country or may disclose ARIAD Data in a written submission to any such Regulatory Authority, in each case solely as required to obtain Regulatory Approval of MEDINOL Licensed Products

 

15

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

in the Licensed Field, but only after obtaining prior written permission from ARIAD to make such disclosure which is conditioned upon MEDINOL obtaining written assurances from the Regulatory Authorities to whom the information is being disclosed that such ARIAD Data will be afforded confidential treatment by such Regulatory Authority, and (ii) MEDINOL, upon prior notice to ARIAD, may verbally disclose ARIAD Data in any teleconference or meeting with any Regulatory Authority, in each case solely as required to obtain Regulatory Approval of MEDINOL Licensed Products in the Licensed Field, but only after obtaining prior written permission from ARIAD which is conditioned upon affording appropriate ARIAD personnel the opportunity participate in each such teleconference or meeting.

3.3.7          MEDINOL Licensed Product Reports. During the Term, in addition to the requirements set forth in Sections 3.4.1 and 3.4.2, MEDINOL shall provide the Project Committee with [********] written reports that summarize MEDINOL’s efforts to develop and commercialize MEDINOL Licensed Products hereunder. In addition, MEDINOL shall provide the Project Committee with prompt written notice of the occurrence of the First Commercial Sale of any MEDINOL Licensed Product in each country in which MEDINOL Licensed Products are introduced. ARIAD acknowledges that all reports provided by MEDINOL pursuant to this Section 3.4.4 are MEDINOL Confidential Information and shall use such information only for purposes expressly permitted under this Agreement.

3.3.8          ARIAD AP23573 Development Program Reports. During the Term, ARIAD shall provide the Project Committee with [*******] written reports that summarize ARIAD’s efforts to obtain regulatory approval for AP23573 in any territory, and its progress in arranging to supply MEDINOL with AP23573 on a timely basis according to this Agreement and the Supply Agreement (in other words, ARIAD’s progress with its manufacturing development program for AP23573). MEDINOL acknowledges that all reports provided by ARIAD pursuant to this Section 3.4.5 are ARIAD Confidential Information and shall use such information only for purposes expressly permitted under this Agreement.

4.

PAYMENTS AND ROYALTIES

4.1              License Fee. As partial consideration for this Agreement, MEDINOL hereby agrees to pay ARIAD, on the Effective Date, a non-refundable, non-creditable upfront fee in the amount of [****************] Dollars [($**********)].

4.2

[Intentionally omitted.]

 

 

16

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

4.3               Payment of Royalties; Royalty Rates. In further consideration of the grant of the license granted under Section 2.1.1, and subject to the other terms of this Agreement (including the remainder of this Section 4), commencing on the date of the First Commercial Sale of each MEDINOL Licensed Product in each country, MEDINOL shall pay to ARIAD royalties on Net Sales of MEDINOL Licensed Products as follows: The royalty rate shall be: (a) with respect to all MEDINOL Licensed Products [******* *******] (i) [****] percent [(*%)] of Net Sales for the [*************] units of any such MEDINOL Licensed Products sold in each calendar year, and (ii) [****] percent [(*%)] of Net Sales for [***************] of any such MEDINOL Licensed Product sold in each calendar year, and (b) with respect to all MEDINOL Licensed Products [**************] (i) [***] percent [(**%)] of Net Sales for the first [*****] units of any such MEDINOL Licensed Products sold in each calendar year, and (ii) [****] percent [(*%)} of Net Sales for [*******************] of any such MEDINOL Licensed Product sold in each calendar year. In the event that, in any calendar quarter, MEDINOL actually makes payments of Excess API Cost to purchase API from a Third Party Approved Manufacturer to make or have MEDINOL Licensed Products, then MEDINOL shall have the right to reduce royalties otherwise due ARIAD pursuant to this Section 4.3, but only over the next [**** (**)] consecutive quarters following the calendar quarter in which such payment of Excess API Cost is made by MEDINOL, by up to [******] percent [(*%)] of such Excess API Cost. Notwithstanding the foregoing, reductions for payments of Excess API Cost pursuant to this Section 4.3 shall in no event reduce the royalty due ARIAD in any calendar quarter to less than [*******] percent [(*%)] of Net Sales of MEDINOL Licensed Products. The Royalty Payments shall be due and payable (a) for Patented MEDINOL Licensed Products until the expiration or termination of the last Valid Claim within the Licensed Patent Rights in both the country where the MEDINOL Licensed Product is manufactured and the country where the MEDINOL Licensed Product is sold and (b) for Unpatented MEDINOL Licensed Products until [*******(***)] years from the date of first commercial sale of the Unpatented MEDINOL Licensed Product in each country, as determined on a country-by-country and MEDINOL Licensed Product-by-MEDINOL Licensed Product basis. For the avoidance of doubt, clause (b) shall be applicable to Patented MEDINOL Licensed Products which become Unpatented MEDINOL Licensed Product as a result of the expiration of patents for the remainder of the [******(**)] year period.

4.4

Milestone Payments.

4.4.1       Payment. In further consideration of the licenses granted under Section 2.1.1, and subject to the other terms and conditions of this Agreement, MEDINOL shall make the non-refundable, non-creditable payments set forth in the table below to ARIAD within thirty (30) days of the first achievement of each of the

 

17

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

following events by MEDINOL or its Affiliates or partners with respect to (i) a MEDINOL Licensed Product [**************], and (ii) each MEDINOL Licensed Product . [**************]. For purposes of clarity, it is expressly agreed that these milestone payments will be payable only once for all MEDINOL Licensed Products [**************] when the first MEDINOL Licensed Product [**************] reaches each milestone. MEDINOL Licensed Products [****************], which will trigger separate milestone payments hereunder, means another [***************************************************] *********************************************************************].

 

Milestone
Number


Milestone

Milestone Payment

1

Initiation of [***********************]

[$***********]

2

Initiation of [*************************************
*************************************************************
********************************************].

[$***********]

3

Submission of [*******************************************]

[$***********]

4

Completion of [*************************************
*************************************************************
********************************************]

[$***********]

5

Granting of [**********************************]

[$***********]

6

Filing of [***************************************************
**********]

[$***********]

7

Granting of [**********************************************]

[$ ***********]

8

Granting of ********************************************
**********************]

[$***********]

9

[************************************************************
*************************************************************
************************************]

[$***********]

10

[************************************************************
*************************************************************
********]

[$***********]

 

 

 

18

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

4.4.2          Determination that Payments are Due. MEDINOL shall provide ARIAD with prompt written notice upon its achievement of each of the milestones set forth in Section 4.4.1. In the event that ARIAD believes any milestone payment is due in spite of not having received notice from MEDINOL, it shall so notify MEDINOL and shall provide to MEDINOL the data and information reasonably supporting its belief that the conditions for payment have been achieved. If MEDINOL does not provide reasonable evidence that such milestone has not been achieved within forty five (45) days of receipt of the data and information from ARIAD, the conditions for such milestone payment under Section 4.4.1 shall be deemed to have been achieved.

4.5

Payment Terms.

4.5.1          Payment of Royalties and Milestones. Except as otherwise provided herein, MEDINOL shall make any milestone, license or royalty payments owed to ARIAD hereunder, in arrears, within sixty (60) days following the end of each calendar quarter in which such payment accrues. For purposes of determining when a sale of any MEDINOL Licensed Product occurs under this Agreement, royalties shall accrue on the date of the [payment on] invoice to the purchaser of the MEDINOL Licensed Product. Each royalty payment shall be accompanied by a report for each country in which sales of MEDINOL Licensed Products occurred, and for which a royalty payment is due, in the calendar quarter covered by such statement, specifying: (i) the gross sales (if available ) and Net Sales in each country’s currency; (ii) the applicable royalty rate under this Agreement; (iii) the royalties payable in US Dollars, including an accounting of deductions taken in the calculation of Net Sales; (iv) the applicable exchange rate used to convert from each country’s currency to United States Dollars under this Section 4.5. In no event shall more than one royalty be due ARIAD for any unit of MEDINOL Licensed Product sold by MEDINOL and/or its Affiliates or W.L. Gore, Authorized Distributors or other sellers or distributors of MEDINOL Licensed Products hereunder.

4.5.2          Overdue Royalties. Subject to the other terms of this Agreement, royalties not paid within the time period set forth in this Article 4 shall bear interest at a rate of the lesser of either the maximum legally allowable interest rate or [***] percent [(*%)] per month, from the due date until paid in full.

4.5.3          Accounting. All payments hereunder shall be made in the United States in United States Dollars. Conversion of foreign currency to U.S. dollars shall be made at the conversion rate existing in the United States (as reported in The Wall Street Journal, Eastern Edition, for purchasing United States Dollars) on the last business day of the applicable calendar quarter in which the Net Sales took place. If The Wall Street Journal ceases to be published, then the rate of exchange to be used shall be

 

19

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

that reported in such other business publication of national circulation in the United States as the Parties reasonably agree. Each Party shall deduct any taxes which the Party is obligated to pay and/or withhold in its country on the payments due under this Agreement and pay them to the proper authorities as required by applicable laws. Therefore, it is agreed and understood that any amount to be paid under the terms of this Agreement is net of any such tax, but the calculation of royalty according to Section 4.3 and milestone payments according to Section 4.4 is calculated as the gross payment. Each Party shall maintain official receipts of payment of any such taxes and forward these receipts to the other Party within sixty (60) days of such payment and shall provide reasonable assistance to the other Party in obtaining any legally due credit or refund of such taxes.

4.5.4          Tax Withholding; Restrictions on Payment. All payments hereunder shall be made free and clear of any taxes, duties, levies, fees or charges, except for withholding taxes as set forth in Section 4.5.3. If by law, regulations or fiscal policy of a particular country, remittance of royalties in United States Dollars is restricted or forbidden, written notice thereof shall promptly be given to ARIAD, and payment of the royalty shall be made by the deposit thereof in local currency to the credit of ARIAD in a recognized banking institution reasonably designated by ARIAD by written notice to MEDINOL. When, in any country, the law or regulations prohibit both the transmittal and the deposit of royalties on sales in such country, royalty payments shall be made in U.S. Dollars from the United States for as long as such prohibition is in effect.

4.6

Records Retention; Review.

4.6.1          Royalty Record Retention. Commencing as of the date of First Commercial Sale of the first MEDINOL Licensed Product, MEDINOL, W.L. Gore, the Authorized Distributors and their Affiliates shall retain, for a minimum of three (3) years from the end of the calendar year to which they pertain, complete and accurate records of sales by MEDINOL, W.L. Gore, the Authorized Distributors or their Affiliates, as the case may be, of each MEDINOL Licensed Product in sufficient detail to allow the accuracy of the payments hereunder to be confirmed.

4.6.2          Review of Royalty Records. Subject to the other terms of this Section 4.6.2, upon thirty (30) days’ prior written request from ARIAD no more frequently than once each calendar year, at ARIAD’s expense (except as provided in this Section 4.6.2 below), MEDINOL shall permit an independent certified public accountant reasonably selected by ARIAD and reasonably acceptable to MEDINOL to inspect (during regular business hours) the relevant records required to be maintained by MEDINOL under this Section 4.6. In every case, the accountant must have

 

20

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

previously entered into a confidentiality agreement with both Parties substantially similar to the provisions of Section 5 and limiting the disclosure and use of such information by such accountant to authorized representatives of the Parties and the purposes germane to this Section 4.6. Results of any such review shall be binding on both Parties, absent manifest error. Each Party agrees to treat the results of any such accountant’s review of the other Party’s records under this Section 4.6 as Confidential Information of the other Party subject to the terms of Section 5. If any review reveals a deficiency in the calculation of royalties resulting from any underpayment by MEDINOL, MEDINOL shall promptly pay ARIAD the amount remaining to be paid, and if such underpayment is by [****] percent [(*%)] or more, MEDINOL shall pay the reasonable out-of-pocket costs and expenses of the review.

4.6.3          Affiliates and Distributors. MEDINOL shall cause W.L. Gore and all Authorized Distributors of MEDINOL Licensed Products and their Affiliates to retain records relating to MEDINOL Licensed Products and permit ARIAD to inspect such records in the same manner as set forth in this Section 4.6.

5.

TREATMENT OF CONFIDENTIAL INFORMATION

 

5.1

Confidential Obligations.

 

5.1.1          Each Party shall be deemed the owner of all right, title and interest, including all intellectual property rights, in and to the Confidential Information of that Party. ARIAD and MEDINOL each agree that, during the Term and thereafter, it shall (a) keep confidential, and shall cause all of its officers, employees, consultants, Third Party contractors and licensees and the officers, employees, consultants, Third Party contractors and licensees of its Affiliates to keep confidential, all Confidential Information of the other Party, and (b) use, and shall cause all of its officers, employees, consultants, Third Party contractors and licensees and the officers, employees, consultants, Third Party contractors and licensees of its Affiliates to use, all Confidential Information of the other Party solely for purposes expressly permitted under this Agreement. Each Party shall take such action, and shall cause its Affiliates to take such action, to preserve the confidentiality of each other’s Confidential Information as it would customarily take to preserve the confidentiality of its own Confidential Information, but no less than reasonable action.

5.1.2          ARIAD and MEDINOL each agree that any disclosure of the other Party’s Confidential Information to any officer, employee, consultant, Third Party contractor or licensee of the other Party or any of its Affiliates (or W.L. Gore or an Authorized Distributor in the case of MEDINOL) shall be made only to the extent necessary to perform its obligations or exercise its rights under this Agreement, shall be

 

21

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

limited to the maximum extent possible consistent with such obligations or rights and shall only be made to persons who are bound by written confidentiality obligations to maintain the confidentiality thereof and not to use such Confidential Information except as expressly permitted by this Agreement. MEDINOL shall maintain all Confidential Information of ARIAD comprising the structure of AP23573, all CMC Data and other chemistry data in a secure file with access limited to MEDINOL’s regulatory personnel (and shall maintain a log tracking personnel access to such data). Without limiting the generality of the foregoing, MEDINOL shall cause W.L. Gore and each Authorized Distributor to execute a written Confidentiality Agreement with ARIAD in form and substance satisfactory to ARIAD. MEDINOL hereby guarantees full and complete compliance by W.L. Gore and each Authorized Distributor with the terms of such Confidentiality Agreement and shall be liable for any breach thereof by W.L. Gore, any Authorized Distributor or any person or entity receiving Confidential Information of ARIAD directly or indirectly from W.L. Gore.

5.1.3          Notwithstanding the provisions of Section 5.1.2, ARIAD and MEDINOL agree not to disclose or transfer the other Party’s Confidential Information to any Third Parties under any circumstances without the prior written approval from the other Party (such approval not to be unreasonably withheld), except (i) filing and prosecuting patent applications and maintaining patents which are filed in accordance with Article 6 of this Agreement, except that MEDINOL may not disclose the chemical structure of AP23573 or descriptive information sufficient to determine the chemical structure of AP23573 in connection therewith without ARIAD’s prior written consent, (ii) filing, prosecuting or defending litigation in accordance with the provisions of Article 6, except that MEDINOL may not voluntarily disclose the chemical structure of AP23573 or descriptive information sufficient to determine the chemical structure of AP23573 in connection therewith without ARIAD’s prior written consent, or (iii) as required to obtain Regulatory Approval to market or sell AP23573 and MEDINOL Licensed Products, (iv) as reasonably necessary to obtain the services of any Third Party contractor in connection with the preclinical or clinical development of MEDINOL Licensed Products, except that MEDINOL may not disclose the chemical structure of AP23573 without ARIAD’s prior written consent, (v) as permitted in the Supply Agreement, or (vi) complying with court orders; provided, however, that if a Party is required to make any such disclosure of the other Party’s Confidential Information pursuant to any court order or discovery request, it will give reasonable advance notice to the other Party of such disclosure requirement and will use reasonable efforts to assist such other Party in efforts to limit disclosure of such information to the maximum extent possible and to secure confidential treatment of such information required to be disclosed.

 

22

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

5.1.4          Each Party, upon the request of the other Party, will return or destroy all the Confidential Information disclosed or transferred to it by the other Party pursuant to this Agreement, including all copies and extracts of documents and all manifestations in whatever form, upon termination or expiration of this Agreement; provided however, that one (1) copy of such Confidential Information may be retained in a secure location solely for the purpose of establishing compliance with this Agreement and/or if required by law or regulation.

5.1.5          The Parties acknowledge and agree that any breach or threatened breach of the Article 5 will result in irreparable harm to the Party whose Confidential Information is subject to such breach or threatened breach, for which remedies at law will not be adequate. Each Party, as a disclosing Party, shall therefore be entitled to seek injunctive relief in any court of competent jurisdiction in addition to any other remedy at law or in equity in the event of a breach or threatened breach of this Article.

5.2              Publication. Notwithstanding the confidentiality obligations set forth in this Section 5, MEDINOL and its Affiliates and academic collaborators shall have the right to publish (solely in recognized, peer-reviewed scientific journals) or present the results of its clinical studies. In order to balance this right with ARIAD’s proprietary interests, MEDINOL will submit for ARIAD’s review manuscripts or other material intended for publication, abstracts, posters and other disclosures (“Proposed Disclosures”) at least thirty (30) days prior to the date of submission for publication or other disclosure. ARIAD will complete its review within thirty (30) days of receipt of the Proposed Disclosure. Prior to such publication or other disclosure, ARIAD shall have the right to review and to request that MEDINOL delete any reference to ARIAD Confidential Information (excluding the results of MEDINOL’s clinical studies). If not delayed pursuant to the preceding sentence, at the end of the 30-day period, MEDINOL will have the right to publish or present the disclosure as amended by ARIAD.

5.3              Publicity. Neither Party may publicly disclose the existence or terms or any other matter of fact regarding this Agreement without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed; provided, however, that either Party may make such a disclosure (a) to the extent required by law or by the requirements of any nationally recognized securities exchange, quotation system or over-the-counter market on which such Party has its securities listed or traded or intends to be listed or traded, or (b) to any professional advisors, potential acquirers, investors, prospective investors, lenders and other potential financing sources who are obligated to keep such information confidential. In the event that such disclosure is required as aforesaid in clause (a), the disclosing Party

 

23

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

shall make reasonable efforts to provide the other Party with notice beforehand and to coordinate with the other Party with respect to the wording and timing of any such disclosure. The Parties shall mutually agree to the form and timing of a press release with respect to this transaction. Once such press release or any other written statement is approved for disclosure by both Parties, either Party may make subsequent public disclosure of the contents of such statement without the further approval of the other Party.

5.4              Use of Name. Neither Party shall employ or use the name of the other Party in any promotional materials or advertising without the prior express written permission of the other Party.

5.5              Trademark. MEDINOL shall have the right to market the MEDINOL Licensed Products under trademarks selected by MEDINOL. Any commercial use of AP23573 in MEDINOL’s Licensed Products must reflect ARIAD’s then current product mark and description.

6.

PROVISIONS CONCERNING THE FILING, PROSECUTION AND MAINTENANCE OF PATENT RIGHTS; OWNERSHIP OF INVENTIONS

6.1              Patent Filing, Prosecution and Maintenance. Subject to the other terms of this Section 6.1, ARIAD shall be responsible for preparing, filing, prosecuting, obtaining and maintaining, at its sole cost, expense and discretion, and acting through patent attorneys or agents of its choice, all Licensed Patent Rights in each of the countries listed on Exhibit 6.1. MEDINOL represents that the countries listed on Exhibit 6.1 comprise all of the markets wherein MEDINOL intends to market and sell MEDINOL Licensed Products as of the Effective Date. ARIAD (i) will provide MEDINOL with a copy of pending claims of the Licensed Patent Rights that are relevant to the Licensed Field, and (ii) will keep MEDINOL reasonably informed of the issuance or abandonment of such claims.

6.2              Notice of Infringement. If, during the License Term, either Party learns of any actual, alleged or threatened infringement by a Third Party of any Licensed Patent Rights in the Licensed Field under this Agreement, such Party shall promptly notify the other Party and shall, to the extent it may lawfully do so, provide such other Party with available evidence of such infringement.

6.3              Infringement of Patent Rights. ARIAD shall have the right (but not the obligation), at its own expense and with legal counsel of its own choice, to bring suit (or take other appropriate legal action) against any actual, alleged or threatened

 

24

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

infringement of the Licensed Patent Rights in the Licensed Field. MEDINOL shall have the right, at its own expense, to be represented in any such action by counsel of MEDINOL’s own choice; provided, however, that under no circumstances shall the foregoing affect the right of ARIAD to control the suit as described in the first sentence of this Section 6.3. If ARIAD brings any such action or proceeding hereunder (i) MEDINOL agrees to be joined as party plaintiff if necessary to prosecute such action or proceeding, and (ii) at ARIAD’s expense, MEDINOL shall give ARIAD reasonable assistance and authority to file and prosecute the suit, and (iii) ARIAD shall be permitted to settle any such suit without the prior consent of MEDINOL. For the avoidance of doubt, it is hereby expressly agreed that MEDINOL shall have the sole right (but not the obligation) to take any action in respect of any actual, alleged or threatened infringement of MEDINOL Patent Rights.

6.4

Ownership of Inventions.

6.4.1          Background IP. Subject to the rights and licenses expressly granted herein, each Party shall retain all right, title and interest in and to all inventions, discoveries and other intellectual property rights owned or controlled by a Party, or which such Party otherwise has a right to use, prior to the Effective Date.

6.4.2

Sole Inventions.

(a)               Subject to the rights and licenses expressly granted herein, all right, title and interest in and to all inventions, discoveries and other intellectual property rights therein conceived or invented solely by personnel of a Party without use of the Confidential Information or proprietary materials of the other Party in connection with the performance of such Party’s rights and obligations hereunder shall be owned solely by such Party (collectively, “Sole IP”).

(b)               MEDINOL shall solely own all right, title and interest in patent claims filed by MEDINOL after the Effective Date which: (i) comprise inventions conceived or invented solely by personnel of MEDINOL after the Effective Date using the Confidential Information of ARIAD as permitted by this Agreement, and (ii) include the limitation of a Medical Device, and (iii) comprise a Medical Device, a method of using a Medical Device in the Licensed Field or a method of treatment using a Medical Device in the Licensed Field (collectively, “MEDINOL Sole IP”).

(c)               ARIAD shall solely own all right, title and interest in patent claims filed by ARIAD after the Effective Date which: (i) comprise inventions conceived or invented solely by personnel of ARIAD after the Effective Date using the Confidential Information of MEDINOL as permitted by this Agreement, and (ii) do not

 

25

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

include the limitation of a Medical Device, and (iii) comprise the composition of matter of a rapamycin analog, the use of a rapamycin analog or methods of treatment using a rapamycin analog (collectively, “ARIAD Sole IP”).

6.4.3          Joint Inventions. Except as otherwise set forth in this Section 6.4, all right, title and interest in and to all inventions, discoveries and other intellectual property rights therein conceived or invented jointly by personnel of ARIAD and MEDINOL or solely by personnel of a Party using the Confidential Information or proprietary materials of the other Party in connection with the performance of such Party’ rights and obligations hereunder shall be jointly owned by ARIAD and MEDINOL (collectively, “Joint IP”). Except as expressly provided in this Agreement, it is understood that neither Party shall have any obligation to account to the other for profits, or to obtain any approval of the other Party to license or exploit Joint IP, by reason of joint ownership thereof.

6.4.4          Assignments. The Parties hereby agree to execute and deliver any and all documents, including without limitation, any agreements relating to the assignment of ownership rights, as the other Party may reasonably request to give effect to the allocation of ownership rights set forth in this Section 6.4.

6.4.5

Licenses.

(a)               MEDINOL hereby grants to ARIAD a non-exclusive, royalty-free, fully paid up, sublicensable license under its interest in Joint IP to develop, have developed, make, have made, use, have used, sell, have sold, offer to sell, import, have imported, export, have exported, distribute, market and promote products for sale and use outside the Licensed Field (and, to the extent ARIAD retains rights in the Licensed Field pursuant to Section 2.1.1(b), also in the Licensed Field). Further, in the event that MEDINOL files any patent application which discloses the chemical structure of AP23573 or any analog of AP23573 or descriptive information sufficient to determine the chemical structure of AP23573 or any analog of AP23573 (“AP23573 Claims”), MEDINOL shall grant to ARIAD a non-exclusive, royalty-free, fully paid up, sublicensable license under its interest in AP23573 Claims (whether or not such claims constitute MEDINOL Sole IP or Joint IP) to develop, have developed, make, have made, use, have used, sell, have sold, offer to sell, import, have imported, export, have exported, distribute, market and promote products.

(b)               ARIAD hereby grants to MEDINOL a non-exclusive, royalty-free, fully paid up, sublicensable license under its interest in ARIAD Sole IP and Joint IP to develop, have developed, make, have made, use, have used, sell, have sold,

 

26

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

offer to sell, import, have imported, export, have exported, distribute, market and promote MEDINOL License Products for sale and use in the Licensed Field.

7.

REPRESENTATIONS AND WARRANTIES

7.1              ARIAD Representations. ARIAD represents and warrants to MEDINOL that:

7.1.1          The execution and delivery of this Agreement and the performance of the transactions contemplated hereby have been duly authorized by all appropriate ARIAD corporate action.

7.1.2          This Agreement is a legal and valid obligation binding upon ARIAD and enforceable in accordance with its terms, and the execution, delivery and performance of this Agreement by ARIAD does not conflict with any agreement, instrument or understanding to which ARIAD is a party or by which it is bound.

7.1.3          ARIAD is the owner of, or has sufficient rights to, all of the Licensed Patent Rights and the Licensed Technology to grant to MEDINOL the licenses granted under Section 2.1.1. All Licensed Patent Rights are in full force and effect and free of all liens, charges, encumbrances and security interests except those placed or granted in the ordinary course of business. As of the Effective Date, to the best knowledge of ARIAD, there are no actions or claims threatened (in writing) or pending against ARIAD or its Affiliates in any court with respect to the Licensed Patent Rights and the Licensed Technology.

7.1.4          As of the Effective Date, ARIAD intends to develop, make or have made and supply AP23573 in accordance with this Agreement and the Supply Agreement.

7.2              MEDINOL Representations. MEDINOL represents and warrants to ARIAD that:

7.2.1          The execution and delivery of this Agreement and the performance of the transactions contemplated hereby have been duly authorized by all appropriate MEDINOL corporate action.

7.2.2          This Agreement is a legal and valid obligation binding upon MEDINOL and enforceable in accordance with its terms, and the execution, delivery and performance of this Agreement by MEDINOL does not conflict with any agreement, instrument or understanding to which MEDINOL is a party of or by which

 

27

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

it is bound. MEDINOL further represents and warrants that it has no knowledge of any information that would affect the validity of the Licensed Patent Rights.

7.2.3          As of the Effective Date, there are no actions or claims threatened (in writing) or pending against MEDINOL or its Affiliates in any court with respect to MEDINOL Licensed Products, except as set forth in Schedule 7.2.3.

7.2.4          As of the Effective Date, MEDINOL intends to develop manufacture, market and sell MEDINOL Licensed Products in accordance with this Agreement and the Supply Agreement.

7.3

No Warranties.

7.3.1          Nothing in this Agreement is or shall be construed as: (a) a warranty or representation by either Party as to the validity or scope of any patent application or patent licensed hereunder; or (b) a warranty or representation that anything made, used, sold or otherwise disposed of under any license granted pursuant to this Agreement is or will be free from infringement of patents, copyrights, and other rights of Third Parties.

7.3.2          EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO ANY TECHNOLOGY, GOODS, SERVICES, RIGHTS OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND HEREBY DISCLAIMS ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR OF NON-INFRINGEMENT OF ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER RIGHTS OF THIRD PARTIES, OR ANY OTHER EXPRESS OR IMPLIED WARRANTIES.

7.3.3          IN NO EVENT SHALL EITHER PARTY BE LIABLE UNDER OR AS A RESULT OF THIS AGREEMENT FOR ANY SPECIAL, INDIRECT, CONSEQUENTIAL, INCIDENTAL, TREBLE, PUNITIVE, EXEMPLARY OR OTHER SIMILAR TYPES OF DAMAGES, INCLUDING, BUT NOT LIMITED TO, LOSS OF PROFITS OR BUSINESS OPPORTUNITY, INCURRED BY THE OTHER PARTY, WHETHER IN CONTRACT OR TORT OR BASED ON A WARRANTY, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

 

 

 

28

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

 

8.

INDEMNIFICATION AND INSURANCE

 

8.1

Indemnification.

 

8.1.1          MEDINOL Indemnity. MEDINOL shall at all times, during and after the Term, indemnify, defend and hold harmless ARIAD, its Affiliates and their respective directors, officers, employees, stockholders and agents and their respective successors, heirs and assigns (the “ARIAD Indemnitees”) from and against any liability, damage, loss or expense (including reasonable attorneys’ fees and expenses of litigation) incurred by or imposed upon such ARIAD Indemnitees, or any of them, in connection with any Third Party claims, suits, actions, demands or judgments, including, without limitation, personal injury and product liability matters, to the extent arising out of (i) any actions or omissions of MEDINOL and its Affiliates in the development, testing, production, manufacture, supply, promotion, import, sale or use by any person of any MEDINOL Licensed Product (or any component thereof) manufactured or sold by MEDINOL or any Affiliate under this Agreement, (ii) infringement of the intellectual property rights of any Third Party through the manufacture, use or sale of MEDINOL Licensed Products, except to the extent such infringement relates to the manufacture, sale, or use of AP23573 generally, and not to its delivery by a MEDINOL Licensed Product, (iii) any material breach of this Agreement by MEDINOL, or (iv) gross negligence or willful misconduct on the part of MEDINOL or any of its directors, officers and employees.

8.1.2          Indemnification Procedures. In the event that any Indemnitee is seeking indemnification under Section 8.1 above from a Party (the “Indemnifying Party”), the other Party shall notify the Indemnifying Party of such claim with respect to such Indemnitee as soon as reasonably practicable after the Indemnitee receives notice of the claim, and the Party (on behalf of itself and such Indemnitee) shall permit the Indemnifying Party to assume direction and control of the defense of the claim (including the right to settle the claim solely for monetary consideration) and shall cooperate as requested (at the expense of the Indemnifying Party) in the defense of the claim; provided, however, that the Indemnifying Party shall not agree to any settlement that adversely impacts the Indemnitee without first seeking and receiving the Indemnitee’s prior written consent. The indemnification obligations under Article 8 shall not apply to amounts paid in settlement of any claim, demand, action or other proceeding if such settlement is effected without the consent of the Indemnifying Party, which consent shall not be withheld or delayed unreasonably. The Indemnitee, its employees and agents, shall reasonably cooperate with the

 

29

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

Indemnifying Party and its legal representatives in the investigation of any claim, demand, action or other proceeding covered by Section 8.1.

8.2

Insurance.

8.2.1          ARIAD. During the Term and for [*****] [(*)] years thereafter, ARIAD shall have and maintain in effect, at ARIAD’s sole cost, the following insurance relating to ARIAD’s performance hereunder: (a) commercial general liability Insurance for each occurrence of bodily injury and property damage, in an amount of not less than [**********] Dollars [($*********)], and (b) product liability insurance in an amount of not less than [**********] Dollars [($********)].

8.2.2          MEDINOL. During the Term and for [****] [(*)] years thereafter, MEDINOL shall have and maintain in effect, at MEDINOL’s sole cost, the following insurance relating to MEDINOL’s performance hereunder: (a) commercial general liability insurance for each occurrence of bodily injury and property damage, in an amount of not less than [**********] Dollars [($*********)], and (b) product liability insurance in an amount of not less than [**********] Dollars [($*********).

8.2.3          Scope. The insurance required by this Section 8.3 shall cover all performance under this Agreement by the applicable Party and its agents, officers, directors, employees, and representatives.

8.2.4          Additional Insured. ARIAD shall have MEDINOL named as additional insured under the above insurance policy obtained by ARIAD. MEDINOL shall have ARIAD named as additional insured under the above insurance policy obtained by MEDINOL. Such additional insured status shall be procured and evidenced by an additional insured endorsement on the policy and certificate of insurance.

8.2.5          Certificates and Endorsements. Each Party shall furnish valid certificates of insurance and endorsements to the other Party evidencing that the first Party has obtained insurance coverage required under this Section 8.3.

9.

TERM AND TERMINATION

9.1              Term; Expiration. The “Term” of this Agreement shall commence on the Effective Date and unless earlier terminated in accordance with this Article 9 shall expire upon the later to occur of (i) the expiration of the final royalty payment obligation under Section 4.3.1 above, or (ii) fifteen (15) years after the First Commercial Sale of a MEDINOL Licensed Product. Upon the expiration of the Term, MEDINOL shall have a fully paid-up, irrevocable license under the Licensed Patent Rights and

 

30

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

Licensed Technology, to develop, use, make, have made, import, have imported, export, have exported, sell, have sold, offer to sell, distribute, market and promote MEDINOL Licensed Products, for any and all uses within the Licensed Field; and ARIAD shall provide to MEDINOL such Confidential Information of ARIAD as may be reasonably necessary, but that is not in MEDINOL’s possession as of the expiration of the Term, for MEDINOL to make or have made MEDINOL Licensed Products. MEDINOL acknowledges that all such Confidential Information provided by ARIAD pursuant to this Section 9.1 is ARIAD Confidential Information and shall continue to be subject to the provisions of Article 5 following expiration of the Term.

9.2              Termination for Breach. In addition to any other remedies available by law or in equity, this Agreement may be terminated by either Party upon any material breach by the other Party of any obligation of this Agreement or the Supply Agreement, such termination to be effective thirty (30) days, in the case of non-payment of any amount due, ninety (90) days, in the case of any other curable material breach, and immediately, in the case of any non-curable material breach, after receipt by the breaching Party of written notice of termination from the non-breaching Party describing such material breach of this Agreement and/or the Supply Agreement in reasonable detail. Notwithstanding the foregoing, if such default or breach is curable and is cured or remedied or shown to be non-existent within the aforesaid 30-day or 90-day, as the case may be, period (the Cure Period), the notice of termination shall be automatically withdrawn and of no legal force and effect; provided, that such Cure Period shall be shortened, as appropriate, if such breach or default must be cured within non-extendible time limits set forth by governmental entities (e.g., Regulatory Authorities, patent office, etc.). Any termination based upon notice of termination describing a curable material breach shall be stayed, and the Cure Period tolled, in the event that, during any Cure Period, the Party alleged to have materially breached this Agreement shall have initiated dispute resolution in accordance with Section 10.2 with respect to the alleged default, which stay and tolling shall last until a final arbitral award is made.

9.3              Termination for Bankruptcy. In the event that either Party files for protection under bankruptcy laws, makes an assignment for the benefit of creditors, appoints or suffers appointment of a receiver or trustee over its property, files a petition under any bankruptcy or insolvency act or has any such petition filed against it which is not discharged within sixty (60) days of the filing thereof, then the other Party may terminate this Agreement effective immediately upon written notice to such Party.

 

 

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

9.4

Termination Without Cause.

9.4.1       MEDINOL may terminate this Agreement upon thirty days’ prior written notice to ARIAD: (i) if MEDINOL reasonably concludes that no MEDINOL Licensed Product will be safe for use in man, [******************************************************************************
*******************************************************************************].

9.4.2          ARIAD may terminate this Agreement upon thirty days’ prior written notice to MEDINOL pursuant to Section 3.1.1.

9.5              Effects of Termination. Upon termination of this Agreement under Section 9.2, 9.3 or 9.4 and subject to Section 5.1.4, as of the effective date of any such termination:

9.5.1          Termination by Reason of Material Breach or under Section 9.4. In the event of a termination of this Agreement for material breach by either Party (other than by reason of a breach by ARIAD described in Section 9.5.2), or termination of this Agreement by MEDINOL pursuant to Section 9.4.1 above, all relevant licenses and sublicenses granted by ARIAD to MEDINOL hereunder, ARIAD’S covenants to MEDINOL in Article 2 and the Parties’ future obligations under Article 3 and Sections 4.1 through 4.4, shall terminate automatically and MEDINOL shall not be liable to make any further payments to ARIAD under this Agreement (other than payments accrued before the date of termination). Notwithstanding the foregoing, MEDINOL and its Affiliates shall have the right to sell or otherwise dispose of all MEDINOL Licensed Products then on hand, with royalties to be paid to ARIAD on all Net Sales of such MEDINOL Licensed Products as provided for in this Agreement.

9.5.2          Termination by Reason of ARIAD’s Material Breach of Supply Agreement. In the event of a termination of this Agreement for breach by ARIAD of the Supply Agreement or termination of this Agreement by ARIAD pursuant to Section 9.4.2 above at any time following the earlier of initiation by MEDINOL of a Pivotal Clinical Trial in the United States or the First Commercial Sale by MEDINOL of a MEDINOL Licensed Product in any country: (a) all relevant licenses and sublicenses granted by ARIAD to MEDINOL hereunder shall remain in full force and effect, (b) the Parties future obligations under Article 3 shall automatically terminate, (c) MEDINOL shall have the right (i) without further consent required by ARIAD, to access and refer to any and all filings made by ARIAD with Regulatory Authorities and FDA solely in furtherance of MEDINOL’s interest in developing and commercializing MEDINOL Licensed Product; and (ii) to disclose to its Third Party manufacturers (with ARIAD providing introductions to appropriate Third Party manufacturers to MEDINOL at

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

MEDINOL’s request upon any termination under this Section 9.5.2) under a confidentiality agreement containing provisions no less stringent that those set forth in Article 5 such information as is necessary to establish an alternate supply of AP23573 for use in MEDINOL Licensed Products, (d) all of MEDINOL’s obligations pursuant to Section 3.6 shall survive such termination, and (e) MEDINOL and its Affiliates shall have the right to develop, market and sell MEDINOL Licensed Products, with royalties to be paid to ARIAD on all Net Sales of such MEDINOL Licensed Products as provided for in this Agreement.

9.6              Remedies. Except as otherwise expressly set forth in this Agreement, the termination provisions of this Section 9 are in addition to any other relief and remedies available to either Party at law or equity; provided, however, that in no event will MEDINOL be required to pay any amount beyond those payments by MEDINOL pursuant to this Agreement that accrued prior to the date of termination.

9.7              Surviving Provisions. Notwithstanding any provision herein to the contrary, the rights and obligations of the Parties set forth in Article 4 (except Section 4.4), 5, 8, 10 and 11, and Sections 1.10, 2.1.2, 6.3, 6.4 and 9.4 shall survive the expiration or termination of the Term. Without limiting the generality of the foregoing, MEDINOL shall have no obligation to make any milestone payment to ARIAD that has not accrued prior to the effective date of any termination of this Agreement, but shall remain liable for all such payment obligations accruing prior to the effective date of such termination.

10.

DISPUTES

10.1           The Parties recognize that a bona fide dispute as to certain matters may from time to time arise during the term of this Agreement which relates to either Party’s rights and/or obligations hereunder. In the event of the occurrence of such a dispute, either Party may, by written notice to the other Party, have such dispute referred to their respective senior officials designated below or their successors, for attempted resolution by good faith negotiations within thirty (30) days after such notice is received. Said designated senior officials are as follows:

For MEDINOL:

Chief Executive Officer

For ARIAD:

Chief Executive Officer

In the event the designated senior officials are not able to resolve such dispute within the thirty (30) day period, either Party may invoke the provisions of Section 10.2.

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

10.2           Any dispute, controversy or claim initiated by either Party arising out of, resulting from or relating to this Agreement, or the performance by either Party of its obligations under this Agreement (other than bona fide Third Party actions or proceedings filed or instituted in an action or proceeding by a Third Party against a Party), whether before or after termination of this Agreement, shall be finally resolved by binding arbitration. Whenever a Party shall decide to institute arbitration proceedings, it shall give written notice to that effect to the other Party. Any such arbitration shall be conducted under the Commercial Arbitration Rules of the American Arbitration Association by a panel of three arbitrators appointed in accordance with such rules. Any such arbitration shall be held in Boston, Massachusetts. The method and manner of discovery in any such arbitration proceeding shall be governed by the Federal Rules of Civil Procedure and the local rules of the District Court for the District of Massachusetts. The arbitrators shall have the authority to grant injunctions and/or specific performance and to allocate between the Parties the costs of arbitration in such equitable manner as they determine. Judgment upon the award so rendered may be entered in any court having jurisdiction or application may be made to such court for judicial acceptance of any award and an order of enforcement, as the case may be. In no event shall a demand for arbitration be made after the date when institution of a legal or equitable proceeding based upon such claim, dispute or other matter in question would be barred by the applicable statute of limitations. Notwithstanding the foregoing, either Party shall have the right, without waiving any right or remedy available to such Party under this Agreement or otherwise, to seek and obtain from any court of competent jurisdiction any interim or provisional relief that is necessary or desirable to protect the rights or property of such Party, pending the selection of the arbitrators hereunder or pending the arbitrators’ determination of any dispute, controversy or claim hereunder.

11.

MISCELLANEOUS

11.1           Notification. All notices, requests and other communications hereunder shall be in writing, shall be addressed to the receiving Party’s address set forth below or to such other address as a Party may designate by notice hereunder, and shall be either: (i) delivered by hand, (ii) made by facsimile transmission (to be followed with written fax confirmation), (iii) sent by private courier service providing evidence of receipt, or (iv) sent by registered or certified mail, return receipt requested, postage prepaid. The addresses and other contact information for the Parties are as follows:

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

If to ARIAD:

ARIAD Pharmaceuticals, Inc.

 

 

ARIAD Gene Therapeutics, Inc.

 

 

26 Landsdowne Street

 

 

Cambridge, MA 02139

 

 

Telephone: (617) 494-0400

 

 

Fax: (617) 225-2860

 

 

Attn.: Chief Legal Officer

 

With a copy to:

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

 

One Financial Center

 

 

Boston, MA 02111

 

 

Phone: (617) 542-6000

 

 

Fax: (671) 542-2241

 

 

Attn.: Jeffrey M. Wiesen, Esq.

 

If to MEDINOL:

MEDINOL Inc.

 

 

Kiryat Atidim

 

 

P.O. Box 58165,

 

 

Tel Aviv, 61581, Israel

 

 

Tel: 972-3-767-9000

 

 

Fax: 972-3-648-2310

 

 

Attn.: Mr. Kobi Richter

 

 

With a copy to:

Doron Cohen-David Cohen, Law Offices

 

14 Abba Hillel Silver Road

 

 

Ramat Gan, Israel 52520

 

 

Phone: (972) 3-753-1000

 

 

Fax: (972) 3-753-1001

 

 

Attn: David Cohen, Adv.

 

All notices, requests and other communications hereunder shall be deemed to have been given either (i) if by hand, at the time of the delivery thereof to the receiving Party at the address of such Party set forth above, (ii) if made by telecopy or facsimile transmission, at the time that receipt thereof has been acknowledged by electronic confirmation or otherwise, unless not on a business day on the receiving end, in which event such communication shall be deemed to have been given on the next business day, (iii) if sent by private courier, on the third (3rd) business day following the day such notice is delivered to the courier service, or (iv) if sent by registered or certified mail, on the fifth (5th) business day following the day such mailing is made (10th business day if sent internationally).

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

11.2           Language. This Agreement has been prepared in the English language and the English language shall control its interpretation.

11.3           Governing Law. This Agreement will be construed, interpreted and applied in accordance with the laws of the Commonwealth of Massachusetts (excluding its body of law controlling conflicts of law).

11.4           Limitations. Except as set forth elsewhere in this Agreement, neither Party grants to the other Party any right or license to any of its intellectual property.

11.5           Entire Agreement. This Agreement and the Supply Agreement constitute the entire agreement between the Parties with respect to the subject matter hereof and thereof and supersede all prior representations, understandings and agreements between the Parties with respect to the subject matter hereof and thereof. No modification of this Agreement shall be effective unless in writing with specific reference to this Agreement and signed by the Parties. In the event of any conflict between this Agreement and the Supply Agreement, the terms of this Agreement shall control.

11.6           Waiver. The terms or conditions of this Agreement may be waived only by a written instrument executed by the Party waiving compliance. The failure of either Party at any time or times to require performance of any provision hereof shall in no manner affect its rights at a later time to enforce the same. No waiver by either Party of any condition or term shall be deemed as a continuing waiver of such condition or term or of another condition or term.

11.7           Headings. Section and Subsection headings are inserted for convenience of reference only and do not form part of this Agreement.

11.8           Assignment. Neither this Agreement nor any right or obligation hereunder may be assigned, delegated or otherwise transferred, in whole or part, by either Party without the prior express written consent of the other; provided, however, that (i) each of ARIAD Pharmaceuticals, Inc. or ARIAD Gene Therapeutics, Inc. may, without the written consent of MEDINOL, assign this Agreement to its Affiliates, or in connection with the transfer or sale of all or substantially all of its assets or business related to this Agreement, or in the event of its merger, consolidation, change in control or similar transaction (collectively, “Change in Control”), (ii) MEDINOL may, without ARIAD’s written consent, assign this Agreement to its Affiliates, [************], or in a transaction involving Change in Control. . In the event of a Change in Control of ARIAD, ARIAD shall use commercially reasonable efforts to cause its assignee to agree

 

36

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

that, following the effective date of such Change in Control, such assignee shall take reasonable steps to segregate any part of its business which is developing, manufacturing, using or selling Medical Devices which are directly competitive with MEDINOL Licensed Products in the Licensed Field from those activities to be performed by ARIAD after the effective date of such Change in Control pursuant to this Agreement and the Supply Agreement. In the event of a Change in Control of MEDINOL [**********************************], MEDINOL shall cause its assignee to agree that, following the effective date of such Change in Control or assignment, such assignee shall segregate any part of its business which is developing, manufacturing, using or selling rapamycin or a rapamycin analog delivered by stents which are directly competitive with Licensed Patent Rights in the Licensed Field from those activities to be performed by MEDINOL after the effective date of such Change in Control or assignment pursuant to this Agreement and the Supply Agreement. As a condition to assignment, any permitted assignee under this Section 11.8 shall assume all obligations of its assignor under this Agreement in a separate written agreement signed by the assignor and assignee. Any purported assignment in violation of this Section 11.8 shall be void. The terms and conditions of this Agreement shall be binding upon and inure to the benefit of the permitted successors and assigns of the Parties.

11.9           Force Majeure. Neither Party shall be liable for failure of or delay in performing obligations set forth in this Agreement, and neither shall be deemed in breach of its obligations, if such failure or delay is due to natural disasters or any causes beyond the reasonable control of such Party. In event of such force majeure, the Party affected thereby shall use reasonable efforts to cure or overcome the same and resume performance of its obligations hereunder.

11.10         Construction. The Parties hereto acknowledge and agree that: (i) each Party and its counsel reviewed and negotiated the terms and provisions of this Agreement and have contributed to its revision; (ii) the rule of construction to the effect that any ambiguities are resolved against the drafting Party shall not be employed in the interpretation of this Agreement; and (iii) the terms and provisions of this Agreement shall be construed fairly as to all Parties hereto and not in favor of or against any Party, regardless of which Party was generally responsible for the preparation of this Agreement.

11.11         Severability. If any provision(s) of this Agreement are or become invalid, are ruled illegal by any court of competent jurisdiction or are deemed unenforceable under then current applicable law from time to time in effect during the Term hereof, it is the intention of the Parties that the remainder of this Agreement shall not be affected thereby provided that a Party’s rights under this Agreement are not

 

37

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

materially affected. The Parties hereto covenant and agree to renegotiate any such term, covenant or application thereof in good faith in order to provide a reasonably acceptable alternative to the term, covenant or condition of this Agreement or the application thereof that is invalid, illegal or unenforceable, it being the intent of the Parties that the basic purposes of this Agreement are to be effectuated.

11.12         Further Assurances. Each Party agrees to execute, acknowledge and deliver such further instructions, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

11.13         Independent Contractors. Notwithstanding any provision to the contrary herein, the relationship of the Parties is that of independent contractor, and nothing herein shall be construed to create a partnership, joint venture, franchise, employment, or agency relationship between the Parties. Neither Party shall have authority to enter into agreements of any kind on behalf of the other Party, nor shall either Party have the power or authority to bind or obligate the other Party in any manner.

11.14         Counterparts. This Agreement may be executed simultaneously in one or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

[Remainder of page intentionally left blank]

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representative in three (3) originals.

 

 

MEDINOL, INC.

 

By:          /s/ Judith Richter                 

Name:  Judith Richter

Title:    Chief Executive Officer

ARIAD PHARMACEUTICALS, INC.

 

By:          /s/ Laurie A. Allen                         

Name:    Laurie A. Allen

Title:      Senior Vice President and Chief Legal Officer

 

 

 

ARIAD GENE THERAPEUTICS, INC.

 

By:          /s/ Harvey J. Berger, M.D.            

Name:     Harvey J. Berger, M.D.

Title:      Chairman and Chief Executive Officer

 

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

SCHEDULE A

 

LICENSED PATENT RIGHTS

 

 

[*********************************************************]

 

[*********************************************************]

 

[*********************************************************]

 

[*********************************************************]

 

[*********************************************************]

 

[*********************************************************]

[*********************************************************]

[*********************************************************]

[*********************************************************]

[*********************************************************]

[*********************************************************]

[*********************************************************]

[*********************************************************]

[*********************************************************]

[*********************************************************]

[*********************************************************]

[*********************************************************]

 

 

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

EXHIBIT 3.3

 

SUPPLY AGREEMENT

 

[ATTACHED ON FOLLOWING PAGE]

 

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

EXHIBIT 6.1

 

Countries

 

 

[*****************]

[*****************]

[*****************]

[*****************]

[*****************]

[*****************]

[*****************]

[*****************]

[*****************]

[*****************]

[*****************]

[*****************]

 

 


 

EX-10.2 3 d63754_ex10-2.htm ARIAD PHARMACEUTICALS EXHIBIT 10.2

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

Exhibit 10.2

 

SUPPLY AGREEMENT

 

THIS SUPPLY AGREEMENT (“Agreement”), made and entered into as of January 26, 2005 (the “Effective Date”) by and among ARIAD Pharmaceuticals, Inc., ARIAD Gene Therapeutics, Inc., both Delaware corporations with a principal place of business at 26 Landsdowne Street, Cambridge, Massachusetts 02139 (collectively, “ARIAD”), and Medinol Ltd., a corporation with a principal place of business at Kiryat Atidim, P.O. Box 58165, Tel Aviv, 61581, Israel (“MEDINOL”). ARIAD and MEDINOL are each hereafter referred to individually as a “Party” and together as the “Parties.” All capitalized terms used herein and not defined shall be defined as set forth in that certain License Agreement, dated as of even date herewith, between ARIAD and MEDINOL (the “License Agreement”).

WHEREAS, ARIAD intends to develop, manufacture and commercialize AP23573 as a therapeutic product for multiple clinical indications;

WHEREAS, MEDINOL intends to develop, manufacture and commercialize MEDINOL Licensed Products to deliver AP23573 for use in the Licensed Field;

WHEREAS, in furtherance of the development, manufacture and commercialization of MEDINOL Licensed Products, ARIAD and MEDINOL have entered into the License Agreement;

WHEREAS, in order to facilitate the development, manufacture and commercialization of MEDINOL Licensed Products pursuant to the License Agreement, pursuant to the terms and conditions of this Agreement, ARIAD agrees to provide, and MEDINOL agrees to purchase, the active pharmaceutical ingredient for AP23573 for use by MEDINOL in the development, manufacture and commercialization of MEDINOL Licensed Products for use in the Licensed Field; and

WHEREAS, ARIAD and MEDINOL desire to enter into this Agreement which sets forth the terms and conditions under which ARIAD will supply the active pharmaceutical ingredient for AP23573 to MEDINOL for use in MEDINOL Licensed Products;

NOW, THEREFORE, in consideration of the mutual covenants contained herein and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, ARIAD and MEDINOL hereby agree as follows:

ARTICLE I.

DEFINITIONS

1.1.  Definitions. Terms defined in the License Agreement shall have the same meaning in this Agreement unless otherwise provided. The following additional terms, shall have the respective meanings set forth below:

(a)  Batch” means a specific quantity of API that is intended to be of uniform character and quality within limits specified by ARIAD and is produced during the same cycle of manufacture using defined amounts of starting materials in a single reaction.

(b)  “Calendar Quarter” means each quarterly period consisting of three consecutive calendar months ending on March 31, June 30, September 30, or December 31, respectively.

 

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

(c)  Calendar Year” means each successive period of twelve months commencing on January 1 and ending on December 31.

(d)  Certificate of Analysis” means a document signed by an authorized representative of ARIAD or its licensee or Third Party manufacturer that describes the tests, specifications and results thereof for a particular Batch of API.

(e)   Certificate of Manufacturing Compliance” means a document, signed by an authorized representative of ARIAD or its licensee or Third Party manufacturer, attesting that a particular Batch of API was manufactured, filled, packaged, held and shipped in accordance with applicable cGMPs, and all other applicable laws, rules, regulations or requirements of the countries listed on Appendix A.

 

(f)     Excess API Cost” means, the difference, if any, between (i) the purchase price per gram of API ************************************************************* following expiration of the 24-month notice period of a Refusal to Supply by ARIAD, minus (ii) ********** amount equal to [*********] Dollars (U.S. [$*****]), subject to annual adjustment for inflation, from the Effective Date to the date of purchase by MEDINOL, using the United States Bureau of Labor Statistics Producer Price Index for Pharmaceutical Preparation Manufacturing published at www.bls.gov. To calculate the Excess API Cost, all payments made by MEDINOL for API in foreign currency shall be converted into United States Dollars at the conversion rate existing in the United States (as reported in The Wall Street Journal, Eastern Edition, for purchasing United States Dollars) on the last business day of the applicable calendar quarter in which the purchase of API took place.

(g)

Firm Order” has the meaning set forth in Section 4.2.

 

(h)

Forecasthas the meaning set forth in Section 4.1.

 

(i)     “ICH” shall mean the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.

 

(j)     Manufacturing Cost” shall mean [****************************************************************************************

*****************************************************************************************

*****************************************************************************************

*****************************************************************************************

*****************************************************************************************

*****************************************************************************************

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*****************************************************************************************

*****************************************************************************************

*****************************************************************************************

*****************************************************************************************

*************************************************

*****************************************************************************************

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*****************************************************************************************

*****************************************************************************************

*****************************************************************************************

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

*************************************************************************************

*************************************************************************************

******************************************

********************************]

 

(k)     Manufacturing Facility” means, collectively and individually, the manufacturing facility or facilities at which ARIAD shall manufacture, or arrange to have manufactured, API.

 

(l)     Manufacturing Fee” means a fee for API paid to ARIAD by MEDINOL pursuant to Section 6.1.

(m)   Specifications” means the written specifications for API in accordance with ICH guidelines and as described in Appendix C attached hereto, as amended from time to time by ARIAD based on ARIAD’s manufacturing experience with AP23573.

ARTICLE II.

ENGAGEMENT OF ARIAD

2.1    Engagement of Manufacturer. MEDINOL hereby engages ARIAD to perform the manufacturing and other services described herein, in accordance with the terms and conditions set forth herein, and ARIAD hereby accepts such engagement. ARIAD shall use commercially reasonable efforts, in accordance with this Agreement, to perform such services hereunder in accordance with the terms and conditions set forth herein.

ARTICLE III.

MANUFACTURE OF API

3.1.     Manufacture and Supply. ARIAD shall develop Specifications for and shall manufacture API in accordance with the Specifications. ARIAD shall supply API to MEDINOL in accordance with Article IV.

3.2.     Joint Manufacturing Committee. The Parties shall establish a joint manufacturing committee (“Joint Manufacturing Committee”), to meet, unless otherwise mutually agreed, once each calendar [*******] (or more often as the Parties may agree) during the Term in such time, place and manner as the Parties shall agree to review and discuss issues relating to the Specifications, manufacturing (e.g., scale up, process control, quality standards) and supply (e.g., quantity forecast of API and regulatory information regarding API) of API. Each Party shall appoint at least one (1) representative to the Joint Manufacturing Committee, and may invite such other representatives of each Party to attend such meetings, as appropriate. Each Party’s initial representative on the Joint Manufacturing Committee shall be from the research and development and/or regulatory department of that Party. Each Party may replace its representative(s) with other representatives with appropriate expertise and authority upon written notice to the other Party.

3.3.     Requirements. Except as otherwise provided herein, MEDINOL shall purchase all of its requirements for API from ARIAD during the Term.

3.4.     Manufacturing Facility. ARIAD shall manufacture or arrange for the manufacture of API at a Manufacturing Facility that complies with cGMP and all other applicable laws and Regulatory Authority requirements of the countries set forth on Appendix A. MEDINOL understands that ARIAD may use the services of a duly qualified Third Party manufacturer to

 

3

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

manufacture API ordered by MEDINOL under this Agreement. ARIAD shall notify MEDINOL in writing of the identity of any Third Party manufacturer and the location of any Manufacturing Facility at which API will be manufactured. The Parties shall confer with respect to the implications on any application for Regulatory Approval in any country listed on Appendix A for the MEDINOL Licensed Product at least three (3) months prior to change in the Manufacturing Facility including the production of API by a Third Party manufacturer designated by ARIAD.

3.5.     Changes in Manufacturing Process; Specifications. ARIAD shall be responsible for performing, or causing its Third Party manufacturer to perform, all validation testing of the Manufacturing Facility and for validating all manufacturing processes in accordance with cGMPs and all other applicable Regulatory Authority requirements for the countries listed on Appendix A as appropriate for the phase of product development. ARIAD may amend or supplement the manufacturing process for API, the CMC Data for API and/or the Specifications for API in its sole discretion and with notice to MEDINOL. The written notice shall be in reasonable detail and provided as soon as practicable after the decision by ARIAD to make such alteration is made to allow MEDINOL, together with the Joint Manufacturing Committee, to evaluate any impact such alteration may have with respect to MEDINOL’s use of API in its development or manufacture of MEDINOL Licensed Products.

3.6.     Excipients and Packaging Components. ARIAD shall purchase, at its own expense, all excipients, packaging components, and other items of any nature whatsoever that ARIAD may use in manufacturing API for supply to MEDINOL hereunder. All right, title and interest in and to such items, and in and to all work-in-process incorporating such items, shall remain the sole property of ARIAD.

3.7.     Nondisclosure of Manufacturing Information. All information relating to the manufacture and the supply of API under this Agreement, including without limitation, the CMC Data, Specifications, assay methods for validating manufacturing processes, the identity of ARIAD’s Third Party manufacturer, the location of any Manufacturing Facility at which API will be manufactured and all discussions, proceedings, notes and documents produced by or for the Joint Manufacturing Committee (collectively, “Manufacturing Information”) shall be (i) treated as Confidential Information of ARIAD, (ii) maintained in a secure file with access limited to MEDINOL’s personnel responsible for manufacturing and regulatory affairs for the MEDINOL Licensed Products (and shall maintain a log tracking personnel access to such data), (iii) used by MEDINOL solely for internal purposes in performing its obligations under this Agreement and the License Agreement, and (iv) shall not be disclosed by MEDINOL to any Third Party except as permitted under Article 5 of the License Agreement.

ARTICLE IV.

FORECASTS, ORDERS AND DELIVERY

4.1.     Forecasting. Attached as Appendix B hereto is an estimate of the quantities of API that MEDINOL expects to purchase from ARIAD during the Calendar Quarter that begins soonest after the Effective Date (the “Initial Calendar Quarter”), and the succeeding [*****(*)] Calendar Quarters, on a quarterly basis. Thereafter, on or before the first day of each Calendar Quarter following the Initial Calendar Quarter, MEDINOL shall submit to ARIAD an updated forecast of its quarterly requirements of API (the initial forecast and each updated forecast, a “Forecast”) for such Calendar Quarter and the succeeding three (3) Calendar Quarters. Except as provided in Section 4.2, these forecasts shall be non-binding and shall be used by ARIAD for planning purposes only.

 

4

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

4.2.     Firm Orders. Notwithstanding the forecasts set forth on Appendix B, as of the Effective Date, MEDINOL shall submit to ARIAD a purchase order for such quantities of API as MEDINOL commits to purchase from ARIAD during the Initial Calendar Quarter, with a statement of the dates on which delivery is requested and shipping instructions (a “Firm Order”). Thereafter, at least forty-five (45) days before the beginning of each succeeding Calendar Quarter, MEDINOL shall submit to ARIAD a Firm Order for the quantities of API to be delivered to MEDINOL during such Calendar Quarter; provided, however, that the quantity of API specified in any Firm Order for delivery in a Calendar Quarter shall not be less than [***********] percent [(*%)] nor more than [*****************************] percent [(*%)] of the quantity of API specified in the then-current Forecast for API for such Calendar Quarter delivered on or before the first day of the Calendar Quarter preceding the Calendar Quarter for which the Firm Order is placed (the “then-current Forecast”) (For example, the Firm Order for the third Calendar Quarter of any year must be delivered at least forty-five (45) days before July 1 of such year and cannot be less than [*%] nor more than [*%] of the Forecast for such third Calendar Quarter delivered on or before April 1 of such year); provided that MEDINOL may request excess quantities (i.e., in excess of [**************************] percent [(*%)] of the quantity of API specified in the then-current Forecast). ARIAD shall not be obligated to supply such excess quantities but shall use good faith efforts to do so. ARIAD shall notify MEDINOL, within five (5) days after receipt by ARIAD of each Firm Order submitted in accordance with this Section 4.2 and shall be obligated to manufacture and deliver the specified quantity of API in accordance with the delivery schedule set forth in such Firm Order. Each Firm Order shall specify the stage of development or commercialization of MEDINOL Licensed Products in which that Batch of API shall be used. ANY ADDITIONAL OR INCONSISTENT TERMS OR CONDITIONS OF ANY PURCHASE ORDER, ACKNOWLEDGMENT OR SIMILAR STANDARDIZED FORM GIVEN OR RECEIVED PURSUANT TO THIS AGREEMENT SHALL HAVE NO EFFECT AND SUCH TERMS AND CONDITIONS ARE HEREBY EXCLUDED.

4.3.     Changes in Orders. ARIAD shall use good faith efforts to comply with increases to Firm Orders that MEDINOL may request after receipt thereof by ARIAD, but shall not be obligated to do so.

4.4.     Delivery and Risk of Loss. ARIAD shall deliver the quantities of API in conformity with each Firm Order (as amended pursuant to Section 4.3), on the delivery date specified therein, to a destination designated in writing by MEDINOL. Delivery terms shall be F.O.B, freight and insurance prepaid, at ARIAD’s designated point of shipping. ARIAD shall arrange for (i) transportation of each shipment by common carrier designated by ARIAD and reasonably acceptable to MEDINOL and (ii) insurance for each such shipment which shall be reasonably acceptable to MEDINOL; the cost of such transportation and insurance being borne by and chargeable to MEDINOL. ARIAD shall deliver all API to MEDINOL in accordance with all applicable laws and regulations of the countries listed on Appendix A.

4.5.

Delay and Failure to Supply.

(a)               If ARIAD has reason to believe that it cannot deliver to MEDINOL the full quantity of API specified in a Firm Order submitted by MEDINOL in accordance with Section 4.2, by the delivery date specified therein, then ARIAD shall give prompt written notice, but no later than ten (10) business days after receipt of the Firm Order, to MEDINOL of such anticipated non-delivery, in which event the Joint Manufacturing Committee shall confer telephonically or in person within fifteen (15) business days to discuss and formulate an alternative plan.

(b)               If ARIAD shall fail to deliver to MEDINOL the full quantity of API as specified in a Firm Order submitted by MEDINOL in accordance with Section 4.2 by the delivery date specified therein,

 

5

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

then, at MEDINOL’s election: (i) without limiting the provisions of Section 4.5(c) below, ARIAD shall be relieved of any obligation to deliver the non-delivered quantity of API, such quantity to be deducted from the Firm Order, or (ii) ARIAD shall use commercially reasonable efforts to deliver the non-delivered quantity of API within thirty (30) days from the date MEDINOL notifies ARIAD of such election.

(c)    If a Release Condition (as defined below) occurs, effective as of the Release Date, ARIAD agrees to (i) release one gram of API and an executed Batch record for API (collectively, the “Release Materials”) to MEDINOL or its contract manufacturer(s) who is acceptable to ARIAD in its sole discretion and who has entered into a non-disclosure and non-use agreement with ARIAD (each, an “Approved Manufacturer”), and (ii) grant to MEDINOL a non-exclusive, non-transferable, nonsublicensable license, under ARIAD’s interest in the Licensed Patent Rights and Licensed Technology, solely to manufacture or have manufactured by an Approved Manufacturer, API. All Release Materials and Manufacturing Information in the possession of MEDINOL or its Approved Manufacturer shall be subject to the provisions of Article IX below, and shall be used only by MEDINOL or its Approved Manufacturer to manufacture API, for the sole purpose of manufacturing MEDINOL Licensed Products for use and sale by MEDINOL strictly in accordance with the terms and conditions of the License Agreement.

(d)     Release Condition” means (a) the undisputed occurrence of a Supply Failure (as defined in Section 4.6 below) or a Refusal to Supply (as defined in Section 4.7), or (b) in the event of a disputed occurrence of either of the events described in the preceding clause (a), a final arbitral award determining the occurrence of a Supply Failure or a Refusal to Supply. MEDINOL shall provide advance written notice to ARIAD of an alleged occurrence of a Release Condition, and upon receipt thereof, ARIAD shall have sixty (60) days to dispute or cure such alleged Release Condition prior to its being bound to release the Release Materials to MEDINOL or its Approved Manufacturer.

4.6.     Supply Failure. If ARIAD shall fail to supply by the specified delivery date at least [******] percent [(**%)] of the quantity of API specified in a Firm Order submitted by MEDINOL in accordance with Section 4.2 meeting the warranties set forth in Section 5.1 below, in any [*****(*)] out of [****(*)] rolling consecutive quarters, and at least [*****] percent [(*%)] for each rolling [****(*)] consecutive quarters, then, upon sixty (60) days’ prior written notice to ARIAD, MEDINOL shall have the right to manufacture itself, or engage an Approved Manufacturer to manufacture, API in accordance with the license to be granted in Section 4.5(c)(ii) (any such situation, a “Supply Failure”). All reasonable costs incurred by MEDINOL in transferring the manufacture of API to MEDINOL or an Approved Manufacturer and any incremental unit costs of API directly attributable to the change in manufacturer shall be deducted from the royalties due ARIAD under Section 4.2 of the License Agreement. For the purposes of this Section 4.6, incremental unit costs are defined as the difference between the price per gram of API charged by the Third Party manufacturer (or MEDINOL’s cost of manufacture thereof, if MEDINOL is the manufacturer) and the price that had been charged by ARIAD before the change, such difference capped at [**********] percent [(*%)] of the price that would have been charged by ARIAD.

4.7       Refusal to Supply. ARIAD may at its sole discretion cease manufacturing API for MEDINOL any time after [****(*)] years from first Commercial Sale of MEDINOL Licensed Product by providing [************(*) ********] prior written notice (i.e., notice to cease at the end of [****] years from the First Commercial Sale must be given before the end of the [*****] year from the first Commercial Sale of MEDINOL Licensed Product) to MEDINOL of such decision (any such situation, a “Refusal to Supply”). During such notice period, ARIAD shall honor its existing supply commitments to MEDINOL in accordance with this Agreement and will also use commercially reasonable efforts ******************************** during the [**********] notice period by providing introductions to, and facilitating discussions between, MEDINOL and **************************************** or with whom ARIAD

 

6

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

has an existing contractual relationship (and, if feasible under the then current circumstances, ARIAD shall ****************************************(*) ********************** to MEDINOL under terms and conditions to be negotiated directly with MEDINOL), and by providing MEDINOL or an Approved Manufacturer with all Release Materials (************************************************** **************************************************************************** **********************************************************) for the manufacture of API at no additional charge to MEDINOL. Following the expiration of such [******] notice period, MEDINOL may offset up to [*****] percent [(*%)] of its Excess API Cost *********************************************************** used in MEDINOL Licensed Products against royalties on Net Sales of MEDINOL Licensed Products to the extent, and in the manner, provided in Section 4.3 of the License Agreement.

 

ARTICLE V.

WARRANTY; QUALITY CONTROL TESTING

5.1.    Warranty. ARIAD warrants and represents to MEDINOL that, at the time of delivery to MEDINOL, API delivered hereunder: (i) will have been manufactured and shipped in accordance with applicable cGMPs and all other applicable laws, rules, regulations or requirements of the applicable countries specified on Appendix A; (ii) will have been manufactured and shipped in accordance with the Specifications and will materially conform with the information shown on the Certificate of Analysis and Certificate of Manufacturing Compliance provided for the particular shipment; and (iii) will not be adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §301 et seq., (as amended) in effect of the time of shipment.

5.2.    Testing Requirements. ARIAD shall be responsible for compliance with all API testing and other testing requirements set forth in the Specifications and applicable law and regulations of the countries specified on Appendix A. ARIAD agrees to implement and maintain validation protocols, processing control procedures, and process change procedures, including, without limitation, the assignment of identification numbers to each Batch of the API and the maintenance of production records, quality control records, Batch records, and related information. ARIAD shall perform all testing of API in accordance with the ICH guidelines which are appropriate to the stage of development or commercialization of MEDINOL Licensed Products as specified by MEDINOL in each Firm Order.

5.3.    Assay Procedure. ARIAD shall take and retain, for such period as may be required by applicable law of the countries set forth on Appendix A, samples of API from each Batch sufficient to perform at least full duplicate quality control testing (such testing to include at least that described in the Specification), and shall specify the identifiable and traceable information regarding the raw material, and dates of manufacture and packaging thereof. Additionally, ARIAD shall take and retain sufficient quantities of each Batch of API sufficient to perform at least full duplicate quality control testing (such testing to include at least that described in the Specification) (each such retained quantity, a “Sample”) and shall specify the identifiable and traceable information regarding the raw material, and dates of manufacture and packaging of such Sample, such Sample to be delivered to MEDINOL, upon MEDINOL’s written request, in order to implement analytical or other controls required by FDA or other Regulatory Authorities of the countries listed on Appendix A, or performance of quality control testing by MEDINOL or its designee; the cost of which Sample shall be invoiced to MEDINOL. In the event that MEDINOL elects to perform quality control testing of any Sample of the API, ARIAD shall provide reasonable assistance to MEDINOL by providing copies of requisite documentation describing ARIAD’s assay procedures (in addition to the quality control records described in the preceding sentence) and by making ARIAD personnel reasonably available to train, at MEDINOL’s request, MEDINOL’s personnel

 

7

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

on the methods for performing such assays. MEDINOL agrees that ARIAD shall be designated as a “Qualified Supplier” of API after confirming as a result of MEDINOL’s acceptance testing that three (3) different Batches of API each having been made from a different batch of starting materials, conform to the warranty set forth in Section 5.1.

5.4.

Rejection of Delivered API.

(a)               In the event that MEDINOL determines that any shipment of API does not conform to the Specifications, then MEDINOL shall provide notice to ARIAD thereof and send a sample from such shipment to ARIAD, together with MEDINOL’s applicable testing documentation related to such non-conforming test results (including assay performance data and any retests) within fifteen (15) days after the receipt of such shipment. Upon receipt of such sample from MEDINOL, ARIAD or its designee shall undertake appropriate review, which may include retesting thereof to determine whether such sample conforms to the Specifications. After such review, ARIAD shall notify MEDINOL whether it has confirmed such non-conformance within thirty (30) days after receipt of the sample. Failure by MEDINOL to provide notice within such 15-day period after receipt of the original sample shipped by ARIAD to MEDINOL, shall be deemed as acceptance of such shipment by MEDINOL. Failure by ARIAD to provide notice of the results of retesting and ARIAD’s conclusion regarding the retesting within such 30-day period after receipt of the sample, shall be deemed as confirmation of such non-conformance.

 

(b)               If, as a result of its review described in Section 5.4(a), ARIAD notifies MEDINOL that it has confirmed that such API conforms to the Specifications, then, unless MEDINOL agrees to accept such shipment, the Parties shall identify a mutually acceptable independent laboratory of recognized standing in the pharmaceutical industry to test a sample from the rejected shipment, such sample being taken and provided by MEDINOL. The testing by such independent laboratory shall include appropriate technical transfer and assay qualification at the independent laboratory as deemed appropriate by ARIAD. The findings of such laboratory shall be final and binding on the Parties. The expenses of such testing shall be borne by ARIAD if the testing confirms the non-conformance and by MEDINOL if the testing confirms the conformance. If the Parties agree, or the independent laboratory findings are, that the shipment is non-conforming, at MEDINOL’s option, ARIAD shall either replace the rejected API within thirty (30) days of such determination at no cost to MEDINOL, or refund to MEDINOL the price paid for such rejected API.

(c)               Without limiting the provisions of Section 4.5(c) above, the relief provided under this Section 5.4 with respect to a rejected shipment shall be the sole remedy available to MEDINOL.

ARTICLE VI.

PRICE AND PAYMENTS

 

6.1.

Manufacturing Fee.

 

 

(a)

The prices for supplies of the API (the “Manufacturing Fee”) shall be as follows:

 

ARIAD’s Manufacturing Cost

(U.S. Dollars per gram of API)

MEDINOL’s Manufacturing Fee

(U.S. Dollars per gram of API)



If ³ [$*****] per gram

[****************************]

[****************]



If < [$*****] per gram

[*******************************

[****************]



 

 

8

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

These Manufacturing Fees may be adjusted pursuant to written agreement following the fifth anniversary of the Effective Date.

6.2.     Invoices. Upon delivery of each shipment of the API, ARIAD shall promptly invoice MEDINOL therefor, and shall include in such invoice a Certificate of Analysis and a Certificate of Manufacturing Compliance pertaining to the API in such shipment. Payment shall be due thirty (30) days after receipt by MEDINOL of such invoice; provided, however, that if MEDINOL shall reject such shipment pursuant to Section 5.4 then payment shall be due, if at all, within thirty (30) days after MEDINOL’s agreement to accept the shipment pursuant to Section 5.4(b) or, if MEDINOL does not agree to accept the shipment, thirty (30) days after receipt by MEDINOL of notice from the Laboratory that the invoiced API is conforming, or the receipt by MEDINOL of replacement API, as the case may be.

6.3.     Manner of Payment. MEDINOL shall make all payments pursuant to this Article VI by check or wire transfer to a bank account designated in writing by ARIAD. All payments hereunder shall be made in United States Dollars. Payments not received on or before the due date shall bear interest at a rate of [*%] per annum or the maximum rate allowable by law, if lower.

6.4.     Maintenance of Records. ARIAD shall keep accurate records of all API shipments and invoice calculations hereunder, and, upon the request of MEDINOL, shall permit MEDINOL or its APIs to examine such records during normal business hours for the purpose of verifying the correctness of all such calculations.

6.5.     Taxes. Any duty, sales, use or excise or other taxes imposed by any governmental entity that apply to the purchase of the API shall be for the account of MEDINOL. MEDINOL shall provide to ARIAD any applicable sales, use or resale tax exemption certificates prior to shipment of API hereunder.

ARTICLE VII.

MANUFACTURING COMPLIANCE; AUDITS

7.1.     Compliance with Laws and Regulations. ARIAD agrees to comply with or cause its Third Party manufacturers to comply with all applicable laws, rules, regulations, or requirements (including cGMP and ICH requirements) of the countries set forth on Appendix A in manufacturing the API which are appropriate to the stage of development or commercialization of MEDINOL Licensed Products as specified by MEDINOL in each Firm Order.

7.2.     Recalls. In the event that MEDINOL shall be required to recall any MEDINOL Licensed Product solely due to a recall by ARIAD of API supplied by ARIAD hereunder and used in such MEDINOL Licensed Product, then the Parties shall cooperate with each other in implementing such recall. The cost of such recalled API shall be borne by ARIAD and MEDINOL shall be reimbursed therefor by ARIAD.

7.3.     Debarment. ARIAD represents and warrants that it has not been debarred and is not subject to a pending debarment and that it will not use in any capacity, in connection with the services to be performed under this Agreement, any person who has been debarred pursuant to Section 306 of the Federal Food, Drug, and Cosmetic Act (the “FDA Act”), 21 U.S.C. § 335a, or who is the subject of a conviction described in such section. ARIAD agrees to inform MEDINOL in writing immediately if it or any person who is performing services hereunder is debarred or is the subject of a conviction described in Section 306 of the FDA Act, or if any action, suit, claim, investigation, or legal or

 

9

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

administrative proceeding is pending or, to the best of ARIAD’s knowledge, is threatened, relating to the debarment or conviction of ARIAD or any person performing services hereunder.

7.4.     Manufacturing and Quality Audits. ARIAD shall permit the FDA, and other Regulatory Authorities to conduct inspections of the Manufacturing Facility as the FDA or such other Regulatory Authorities may request, and shall cooperate with such Regulatory Authorities with respect to such inspections and any related matters, in each case related to API. ARIAD agrees to give MEDINOL prior notice (when possible) of any such inspections, and to keep MEDINOL informed about the results and conclusions of each such regulatory inspection, including actions taken by ARIAD to remedy conditions cited in such inspections. ARIAD shall provide MEDINOL with copies of any written inspection reports issued by such Regulatory Authorities and all correspondence between ARIAD and the Regulatory Authorities related thereto, including, but not limited to, FDA Form 483, Notice of Observation, and all correspondence relating thereto, in each case relating to the API or general manufacturing concerns (i.e., Manufacturing Facility compliance or the like). MEDINOL shall have access, to all quality assurance and audits of ARIAD and to the buildings, records and areas of the Manufacturing Facility for the purposes of assessment of regulatory compliance. Additionally, upon notice by MEDINOL, ARIAD shall allow MEDINOL or MEDINOL’s designees, to conduct quality audits of the Manufacturing Facility and quality programs with respect to API no more frequently than once each calendar year; provided, that, MEDINOL may conduct more frequent audits in the event that specific quality issues arise as a result of manufacturing or testing.

ARTICLE VIII.

TERM AND TERMINATION

8.1.     Term. The Agreement shall take effect as of the Effective Date and, unless earlier terminated pursuant to this Article, shall be coterminous with the License Agreement.

8.2.     Termination for Breach. This Agreement may be terminated for material breach in accordance with the provisions of Section 9.2 of the License Agreement.

8.3.

Effect of Expiration or Termination.

(a)               This Agreement shall terminate immediately without requiring any action by either Party upon any termination or expiration of the License Agreement.

(b)               Notwithstanding any provision herein to the contrary, the rights and obligations of the Parties set forth in Articles IX, X, XI, XII, XIII and Sections 6.1, 6.2, 6.3 and 7.4 as well as any rights or obligations otherwise accrued hereunder (including any accrued payment obligations), shall survive the expiration or termination of the Term.

ARTICLE IX.

CONFIDENTIALITY

The terms and conditions of Section 5 of the License Agreement are hereby incorporated herein by reference mutatis mutandis.

 

ARTICLE X

INDEMNIFICATION AND INSURANCE

 

10

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

10.1    Indemnification. The terms and conditions of Section 8 of the License Agreement are hereby incorporated herein by reference mutatis mutandis.

 

10.2    Insurance. The terms and conditions of Section 8.3 of the License Agreement are hereby incorporated herein mutatis mutandis

ARTICLE XI

INTELLECTUAL PROPERTY RIGHTS

The terms and conditions of Section 6 of the License Agreement are hereby incorporated herein by reference mutatis mutandis.

ARTICLE XII

DISPUTES

The Parties recognize that a bona fide dispute as to certain matters may from time to time arise during the term of this Agreement which relates to either Party’s rights and/or obligations hereunder. The Parties agree that such disputes shall be resolved according to the procedure set forth in Section 10 of the License Agreement.

ARTICLE XIII

MISCELLANEOUS

The terms and conditions of Section 11 of the License Agreement are hereby incorporated herein by reference mutatis mutandis. Without limiting the generality of the foregoing, neither this Agreement nor any right or obligation hereunder may be assigned, delegated or otherwise transferred, in whole or part, by either Party without the prior express written consent of the other; provided, however, that (i) each of ARIAD Pharmaceuticals, Inc. or ARIAD Gene Therapeutics, Inc. may, without the written consent of MEDINOL, assign this Agreement to its Affiliates, or in connection with the transfer or sale of all or substantially all of its assets or business related to this Agreement, or in the event of its merger, consolidation, change in control or similar transaction (collectively, “Change in Control”), (ii) MEDINOL may, without ARIAD’s written consent, assign this Agreement to its Affiliates, [***********], or in a transaction involving Change in Control. In the event of a Change in Control of ARIAD, ARIAD shall use commercially reasonable efforts to cause its assignee to agree that, following the effective date of such Change in Control, such assignee shall take reasonable steps to segregate any part of its business which is developing, manufacturing, using or selling Medical Devices which are directly competitive with MEDINOL Licensed Products in the Licensed Field from those activities to be performed by ARIAD after the effective date of such Change in Control pursuant to this Agreement and the Supply Agreement. In the event of a Change in Control of MEDINOL [*****] [************************], MEDINOL shall cause its assignee to agree that, following the effective date of such Change in Control or assignment, such assignee shall segregate any part of its business which is developing, manufacturing, using or selling rapamycin or a rapamycin analog [******************] which are directly competitive with Licensed Patent Rights in the Licensed Field from those activities to be performed by MEDINOL after the effective date of such Change in Control or assignment pursuant to this Agreement and the License Agreement. As a condition to assignment, any permitted assignee under this Section 11 shall assume all obligations of its assignor under this Agreement in a separate written agreement signed by the assignor and assignee. Any purported assignment in violation of this Section 11 shall be void. The

 

11

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

terms and conditions of this Agreement shall be binding upon and inure to the benefit of the permitted successors and assigns of the Parties.

 

 

12

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their duly authorized representatives as of the date first above written.

 

MEDINOL, INC.

 

By:           /s/ Judith Richter                    

Name: Judith Richter

Title:   Chief Executive Officer

ARIAD PHARMACEUTICALS, INC.

 

By:           /s/ Laurie A. Allen                          

Name:     Laurie A. Allen

Title:       Senior Vice President and Chief Legal Officer

 

 

 

ARIAD GENE THERAPEUTICS, INC.

 

By:           /s/ Harvey J. Berger, M.D.                        

Name:     Harvey J. Berger, M.D.

Title:        Chairman and Chief Executive Officer

 

13

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

APPENDIX A

 

Countries

 

 

[*************]

[*************]

[*************]

[*************]

[*************]

[*************]

[*************]

[*************]

[*************]

[*************]

[*************]

[*************]

 

1

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

APPENDIX B

 

FORECASTS

 

 

 

Period

Quantity

Q1 2005

[*] grams

Q2 2005

[*] grams

Q3 2005

 

Q4 2005

 

Q1 2006

 

Q2 2006

 

Q3 2006

 

Q4 2006

 

Q1 2007

 

Q2 2007

 

 

 

 

 

2

 



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 

 

APPENDIX C

 

SPECIFICATIONS

 

Specifications for the API are as described in the CMC Data for AP23573.

 

 

 

 

 

 

3

 

 


EX-31.1 4 d63754_ex31-1.htm ARIAD PHARMACEUTICALS EXHIBIT 31.1
 
  Exhibit 31.1       
 

CERTIFICATIONS

 
Chief Executive Officer
 
I, Harvey J. Berger, M.D., certify that:
 
1. I have reviewed this quarterly report of ARIAD Pharmaceuticals, Inc.;
 
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
  a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
  b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
  c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report, based on such evaluation; and
 
  d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
 
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal controls over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
 
  a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
  b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
 
  /s/ Harvey J. Berger, M.D.

  Harvey J. Berger, M.D.
  Chairman and Chief Executive Officer
 
  Date:  May 9, 2005

20


EX-31.2 5 d63754_ex31-2.htm ARIAD PHARMACEUTICALS EXHIBIT 31.2
 
  Exhibit 31.2
 

CERTIFICATIONS

 
Chief Financial Officer
 
I, Edward M. Fitzgerald, certify that:
 
1. I have reviewed this quarterly report of ARIAD Pharmaceuticals, Inc.;
 
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
  a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
  b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
  c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report, based on such evaluation; and
 
  d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
 
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal controls over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
 
  a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
  b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
 
  /s/ Edward M. Fitzgerald

  Edward M. Fitzgerald
(Principal financial officer and chief accounting officer)
 
  Date:  May 9, 2005

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EX-32.1 6 d63754_ex32-1.htm ARIAD PHARMACEUTICALS EXHIBIT 32.1
 
  Exhibit 32.1
 

Certification
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
(Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code)

 
Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), each of the undersigned officers of ARIAD Pharmaceuticals, Inc., a Delaware corporation (the “Company”), does hereby certify, to such officer’s knowledge, that:
 
The Quarterly Report on Form 10-Q for the quarter ended March 31, 2005 (the “Form 10-Q”) of the Company fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934, and information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company.

     Date:  May 9, 2005 /s/ Harvey J. Berger, M.D

  Harvey J. Berger, M.D.
  Chairman and Chief Executive Officer
 
     Date:  May 9, 2005 /s/ Edward M. Fitzgerald

  Edward M. Fitzgerald
Senior Vice President and Chief Financial Officer
 
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

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