-----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, IpTTvOMI/y9xqSVIYinv084iHyWLrFsZTwMaOoCDIkwoPXbo3L05HjvyHcFA1zFu JSUrQ2y9DO3LwnFXrroctg== 0001193125-06-220770.txt : 20061101 0001193125-06-220770.hdr.sgml : 20061101 20061101171706 ACCESSION NUMBER: 0001193125-06-220770 CONFORMED SUBMISSION TYPE: 8-K/A PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20060818 ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20061101 DATE AS OF CHANGE: 20061101 FILER: COMPANY DATA: COMPANY CONFORMED NAME: OSCIENT PHARMACEUTICALS CORP CENTRAL INDEX KEY: 0000356830 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 042297484 STATE OF INCORPORATION: MA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K/A SEC ACT: 1934 Act SEC FILE NUMBER: 000-10824 FILM NUMBER: 061179852 BUSINESS ADDRESS: STREET 1: 1000 WINTER STREET STREET 2: SUITE 2200 CITY: WALTHAM STATE: MA ZIP: 02451 BUSINESS PHONE: 7813982300 MAIL ADDRESS: STREET 1: 1000 WINTER STREET STREET 2: SUITE 2200 CITY: WALTHAM STATE: MA ZIP: 02451 FORMER COMPANY: FORMER CONFORMED NAME: GENOME THERAPEUTICS CORP DATE OF NAME CHANGE: 19941215 FORMER COMPANY: FORMER CONFORMED NAME: COLLABORATIVE RESEARCH INC DATE OF NAME CHANGE: 19920703 8-K/A 1 d8ka.htm AMENDMENT TO FORM 8-K Amendment to Form 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


FORM 8-K/A

 


CURRENT REPORT

Pursuant to

Section 13 or 15(d) of

THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of Earliest Event Reported): August 18, 2006

 


OSCIENT PHARMACEUTICALS CORPORATION

(Exact name of registrant as specified in its charter)

 


 

Massachusetts   0-10824   04-2297484

(State or other jurisdiction

of incorporation)

  (Commission File Number)  

(I.R.S. Employer

Identification Number)

1000 Winter Street, Suite 2200

Waltham, Massachusetts 02451

(Address of principal executive offices, including zip code)

(781) 398-2300

(Registrant’s telephone number, including area code)

 


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 



ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.

On August 21, 2006, Oscient Pharmaceuticals Corporation (“Oscient”) filed a current report on Form 8-K (the “Original Report”) regarding the completion on August 18, 2006 of its acquisition of the exclusive rights in the United States and its territories to the cardiovascular products ANTARA® 130mg and ANTARA® 43mg (fenofibrate) capsules from Reliant Pharmaceuticals, Inc. Oscient is filing this report to amend and supplement Item 9.01 of the Original Report to include certain financial information required by Items 9.01(a) and 9.01(b) of Form 8-K.

 

(a) Financial statements of businesses acquired.

Special Purpose Statements and Report of Independent Registered Public Accounting Firm of the ANTARA Product Line of Reliant Pharmaceuticals Inc.

 

  1) Statement of Assets Sold for the period ended June 30, 2006 (unaudited) and the periods ended December 31, 2005 and 2004 (audited)

 

  2) Statement of Direct Expenses in Excess of Net Sales for the Six Months Ended June 30, 2006 and 2005 (unaudited) and for the Years Ended December 31, 2005 and 2004 (audited)

 

(b) Pro forma financial information.

Unaudited Pro Forma Consolidated Balance Sheet as of June 30, 2006 of Oscient Pharmaceuticals Corporation

Unaudited Pro Forma Consolidated Statement of Operations for the Six Months Ended June 30, 2006 of Oscient Pharmaceuticals Corporation

Unaudited Pro Forma Consolidated Statement of Operations for the Year Ended December 31, 2005 of Oscient Pharmaceuticals Corporation

 

(d) Exhibits

2.1 Asset Purchase Agreement by and among Reliant Pharmaceuticals, Inc., Guardian II Acquisition Corporaiton and Oscient Pharmaceuticals Corporation dated as of July 21, 2006.* #

10.1 Amended and Restated Development, License and Supply Agreement dated of July 31, 2006 between Ethypharm, S.A. and Reliant Pharmaceuticals, Inc.* #

23.1 Consent of Rothstein, Kass & Company P.C.*

99.1 Press Release issued by Oscient Pharmaceuticals Corporation on August 21, 2006.**


* Filed herewith.
** Filed previously on a Current Report on Form 8-K on August 21, 2006.
# Confidential information has been omitted from this exhibit and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request.


Report of Independent Registered Public Accounting Firm

To the Board of Directors and Management of Reliant

Pharmaceuticals, Inc.

We have audited the accompanying special purpose statements of assets sold of the Antara Product Line of Reliant Pharmaceuticals, Inc. (“Reliant”) as of December 31, 2005 and 2004 and the related special purpose statements of direct expenses in excess of net sales for the years then ended. These special purpose statements are the responsibility of Reliant’s management. Our responsibility is to express an opinion on these special purpose statements based on our audits.

We conducted our audits in accordance with standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the special purpose statements are free of material misstatement. Reliant is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of Reliant’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the special purpose statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the special purpose statements. We believe that our audits provide a reasonable basis for our opinion.

The accompanying special purpose statements were prepared using the basis of presentation described in Note 1, and are not intended to be a complete presentation of the Antara Product Line’s assets, liabilities, revenues and expenses.

In our opinion, the special purpose statements present fairly, in all material respects, the assets sold of the Antara Product Line of Reliant Pharmaceuticals, Inc. as of December 31, 2005 and 2004 and the direct expenses in excess of net sales for the years then ended, pursuant to the Asset Purchase Agreement referred to in Note 1, in conformity with accounting principles generally accepted in the United States of America.

/s/ Rothstein, Kass & Company, P.C.

Roseland, New Jersey

September 26, 2006


ANTARA PRODUCT LINE OF RELIANT PHARMACEUTICALS, INC.

STATEMENTS OF ASSETS SOLD

(Dollars in thousands )

 

    

June 30,

2006

   December 31,
      2005    2004
     (Unaudited)          

Inventory, net of reserves of $115, $126 and $0 as of June 30, 2006 and December 31, 2005 and 2004, respectively

   $ 3,866    $ 5,678    $ 1,010

Samples

     836      1,003      —  

Intangible asset, net of accumulated amortization of $528, $361 and $28 as of June 30, 2006, and December 31, 2005 and 2004, respectively

     472      639      972
                    

Total Assets Sold

   $ 5,174    $ 7,320    $ 1,982
                    


ANTARA PRODUCT LINE OF RELIANT PHARMACEUTICALS, INC.

STATEMENTS OF DIRECT EXPENSES IN EXCESS OF NET SALES

(Dollars in thousands )

 

     Six-months ended
June 30,
    Year ended
December 31,
 
     2006     2005     2005     2004  
     (Unaudited)              

Net Sales

   $ 19,072     $ 7,860     $ 23,556     $ —    

Cost of Sales

     3,454       1,145       3,571       —    
                                

Gross Margin

     15,618       6,715       19,985    

Other Direct Expenses

        

Sales and marketing

     15,043       36,723       65,605       1,603  

General and administrative

     685       943       2,356       1,589  

Amortization of intangible asset

     167       167       333       28  

Research and development

     218       262       472       2,639  
                                

Direct expenses in excess of net sales

   $ (495 )   $ (31,380 )   $ (48,781 )   $ (5,859 )
                                


ANTARA PRODUCT LINE OF RELIANT PHARMACEUTICALS, INC.

NOTES TO SPECIAL PURPOSE STATEMENTS

(Dollars in thousands)

1. Basis of presentation

Reliant Pharmaceuticals, Inc. (“Reliant”), Guardian II Acquisition Corporation (“Guardian”) and Oscient Pharmaceuticals Corporation (collectively with Guardian “Oscient”) entered into an Asset Purchase Agreement (the “Agreement”) dated July 21, 2006. The Agreement transfers the ownership rights to certain assets related to the development, manufacture, marketing and sale of Reliant’s Antara (fenofibrate) product line and operations in the United States of America (“U.S.”), its territories and possessions, and the Caribbean (the “Product Line”). The assets sold include inventory, samples, the product registrations and the intellectual property assets related to the Product Line. These assets were used as collateral for Reliant’s outstanding indebtedness until they were released by Reliant’s lenders on August 18, 2006 upon sale of the assets to Oscient.

The accompanying special purpose statements present the assets sold and the direct expenses in excess of net sales of the Product Line (the “Antara Statements”) in conformity with the Agreement. Management believes the assumptions used to prepare the Antara statements from the historical financial statements of Reliant, including methods used to allocate costs, are reasonable and appropriate under the circumstances. The financial information included herein may not necessarily reflect the financial position or operating results of the Product Line in the future or what they would have been had the Product Line been operated as a separate, stand-alone entity during the periods presented.

The Antara Statements set forth only net sales and direct expenses attributable to the Product Line and do not include all the costs and expenses associated with a stand-alone, separate company. Accordingly, the Antara Statements do not include interest income and expense, depreciation expense, income tax expense and various services provided by Reliant not directly associated with the assets sold or the generation of the net sales presented.

2. Description of business and significant accounting policies

Description of Business

Antara is a once a day formulation of fenofibrate approved for the treatment of elevated cholesterol and triglycerides. In May 2001, Reliant obtained an exclusive license from Ethypharm, SA (“Ethypharm”) to market, sell and distribute Antara in the U.S., the Caribbean, Canada and Mexico. Antara is a trademark of Reliant in the U.S. Under the Ethypharm agreement, Reliant is responsible for all clinical development and regulatory activities in the identified markets. The initial term of the agreement is fifteen years from the first commercial sale of the product in the U.S. with automatic two-year renewals if notice of termination is not received from either party. Product for use in clinical development programs, as well as commercial sales, is required to be purchased at predetermined prices from Ethypharm during the license term. Reliant was required to make certain payments to Ethypharm based on the achievement of predetermined milestones and is required to pay a royalty on all net sales of this product. Reliant received approval from the Food and Drug Administration (the “FDA”) to market Antara in November 2004 and began marketing and selling the product in the U.S. in February 2005.

Use of Estimates

The preparation of the Antara Statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the amounts of assets sold at the date of the Antara Statements and the reported amounts of net sales and direct expenses during the reported periods. Actual results could differ from these estimates.


ANTARA PRODUCT LINE OF RELIANT PHARMACEUTICALS, INC.

NOTES TO SPECIAL PURPOSE STATEMENTS

(Dollars in thousands)

2. Description of business and significant accounting policies (continued)

Concentration of Supplier

Reliant currently purchases all of its fenofibrate from Ethypharm. In the event Ethypharm is unable to supply product, Reliant believes it could transfer the fenofibrate production to an alternative manufacturer. This alternative manufacturer will be required to obtain FDA approval, the receipt of which is not certain. In the event Reliant is unable to transfer the manufacturing to an alternative manufacturer, the Product Line’s business and results of operations could be adversely affected.

Inventory

Inventory is valued at the lower of first-in, first-out (“FIFO”) cost or market. Management estimates the market value or net sales value based on current realization trends. If the projected net realizable value is less than cost, a provision is made to reflect the lower value of the inventory.

Reliant considers projected demand for Antara and Antara product expiry dates in calculating the amount of its inventory reserves. Product demand is projected by estimating future prescriptions based on current and historical trends, market conditions, competitive products and other relevant information.

Intangible Asset

The intangible asset consists of milestone payments made to Ethypharm for the rights needed to market, sell, and distribute Antara in the U.S., its territories and possessions, the Caribbean, Canada and Mexico. The intangible asset is based on amounts paid to Ethypharm subsequent to regulatory approval of the product less accumulated amortization of $528 as of June 30, 2006 (unaudited), and $361 and $28 as of December 31, 2005 and 2004, respectively.

In accordance with Statement of Financial Accounting Standard (“SFAS”) No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets, Reliant first considers whether indicators of impairment of long-lived assets are present. If indicators of impairment are present, Reliant determines whether the sum of the expected undiscounted future cash flows is less than the assets’ carrying value. If the sum of the expected undiscounted future cash flows is less than the assets’ carrying value, an impairment loss would be recognized based on the excess of the carrying amount of the assets over their respective fair values. The intangible asset is reviewed for impairment on an annual basis or whenever indicators of impairment are present.

The intangible asset is amortized using the straight-line method over the estimated life of three years. The estimated annual amortization expense is $333 for 2006 and $305 for 2007.

Product Samples

Product samples held for distribution to third parties are capitalized and charged to sales and marketing expense upon distribution to a third party. Reliant records allowances for samples which are not expected to be utilized by the end user.


ANTARA PRODUCT LINE OF RELIANT PHARMACEUTICALS, INC.

NOTES TO SPECIAL PURPOSE STATEMENTS

(Dollars in thousands)

2. Description of business and significant accounting policies (continued)

Revenue Recognition

Reliant recognizes revenue in accordance with the U.S. Securities and Exchange Commission’s Staff Accounting Bulletin No. 101, Revenue Recognition in Financial Statements, as amended by Staff Accounting Bulletin No. 104, Revenue Recognition (together, “SAB 101”) and SFAS No. 48, Revenue Recognition When Right of Return Exists (“SFAS 48”). SAB 101 provides that revenue should not be recognized until it is realized or realizable and earned. Revenue is realized or realizable and earned when all of the following criteria are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the seller’s price to the buyer is fixed and determinable; and (4) collectibility is reasonably assured. SFAS 48 provides that revenue from sales transactions where the buyer has the right to return the product shall be recognized at the time of sale only if (1) the seller’s price to the buyer is substantially fixed or determinable at the date of sale, (2) the buyer has paid the seller, or the buyer is obligated to pay the seller and the obligation is not contingent on resale of the product, (3) the buyer’s obligation to the seller would not be changed in the event of theft or physical destruction or damage of the product, (4) the buyer acquiring the product for resale has economic substance apart from that provided by the seller, (5) the seller does not have significant obligations for future performance to directly bring about resale of the product by the buyer and (6) the amount of future returns can be reasonably estimated. The Company generally recognizes revenue at the time products are shipped to the customer. In the case of shipments made to wholesalers that do not meet the revenue recognition criteria of SFAS 48 and SAB 101, Reliant does not recognize revenue upon shipment of product. For these product sales, the Company invoices the wholesaler and records deferred revenue at gross invoice sales price. Reliant recognizes the deferred revenue (net of discounts, rebates, sales allowances and accruals for returns) when the inventory is utilized by the end-user, as quantified using data from third-party information sources. Reliant continues to recognize revenue on these shipments on this basis until such time as all of the revenue recognition criteria of SFAS 48 and SAB 101 are met. As of June 30, 2006 (unaudited), and December 31, 2005 and 2004, deferred revenue related to Antara was zero.

Provisions for Rebates, Returns, Chargebacks, Coupons and Discounts

Reliant provides for rebates, returns and chargebacks in the same period the related sale is recognized and, in the case of coupons, when the coupons are issued. These provisions reduce revenues. Rebates include amounts due under Medicaid, managed care and other commercial contractual programs. Reliant provides for rebates based on a percentage of selling price determined from historical experience. With respect to provisions for estimated Medicaid and managed care rebates, Reliant evaluates its historical rebate payments by product as a percentage of historical sales, product pricing and current contracts. Medicaid pricing programs involve particularly difficult interpretations of relevant statutes and regulatory guidance, which are complex and, in certain respects, ambiguous. Moreover, prevailing interpretations of these statutes and guidance can change over time. Returns are provided for based on historical experience, projected future prescriptions of the products and the amount and expiry of inventory estimated to be in the distribution channel. Chargeback provisions are based on an estimate of claims not yet submitted by customers, using historical experience. Coupons are provided for based on historical redemption rates for similar programs. In all cases, judgment is required in estimating these provisions, and actual claims for rebates, returns and chargebacks could be materially different from the estimates.


ANTARA PRODUCT LINE OF RELIANT PHARMACEUTICALS, INC.

NOTES TO SPECIAL PURPOSE STATEMENTS

(Dollars in thousands)

2. Description of business and significant accounting policies (continued)

Cost of Sales

Cost of sales includes the costs to purchase bulk micronized fenofibrate from Ethypharm, Reliant’s sole supplier of bulk product, as well as the cost to package the bulk product into finished form. Cost of sales also includes royalties payable under two royalty bearing licensing agreements on all net sales of the product.

Sales and Marketing Expenses

Sales and marketing expenses include direct promotion and marketing expenses attributable to the Product Line. In addition, an allocation of Reliant’s indirect selling expenses has been made based on the level of selling effort provided for the Product Line. Management believes these allocations to be reasonable.

Research and Development Costs

Research and development costs are expensed as incurred. Upfront and milestone payments made to third parties in connection with research and development collaborations are expensed as incurred up to the point of regulatory product approval. Payments made to third-parties subsequent to regulatory product approval are capitalized and amortized over the remaining useful life of the asset. These amounts are included in intangible assets.

3. Inventory

Inventory consisted of the following:

 

    

June 30,

2006

    December 31,
     2005     2004
     (unaudited)            

Work in process

   $ 3,261     $ 5,081     $ 851

Finished goods

     720       723       159
                      

Gross inventory

     3,981       5,804       1,010

Less: inventory reserves

     (115 )     (126 )     —  
                      

Inventory, net

   $ 3,866     $ 5,678     $ 1,010
                      

4. Related Party Transactions

Antara’s costs and expenses include an allocation from Reliant for certain sales and marketing costs. This allocation has been determined on a basis that Reliant considered to be a reasonable reflection of the utilization of services provided or the benefit received by the Product Line. The allocation method includes a computation based upon the level of selling effort provided to the Product Line by Reliant’s sales force. Allocated sales and marketing costs included in the statements of direct expenses in excess of net sales for the six-month periods ended June 30, 2006 and 2005 (unaudited) were $11,684 and $25,298, respectively, and $47,987 for the year ended December 31, 2005. There were no sales and marketing costs allocated for the year ended December 31, 2004.


ANTARA PRODUCT LINE OF RELIANT PHARMACEUTICALS, INC.

NOTES TO SPECIAL PURPOSE STATEMENTS

(Dollars in thousands)

5. Commitments and Contingencies

As part of separate royalty bearing licensing agreements with Ethypharm and a third-party, Reliant is required to pay royalties based on all net sales of the product. Royalty expenses are included in cost of sales in the accompanying statements of direct expenses in excess of net sales.

Also pursuant to its license and supply agreement with Ethypharm, in order to maintain exclusivity of the license, Reliant is required to achieve minimum annual sales of capsules in the United States and Canada during the first seven years subsequent to the first commercial sale of the product on February 1, 2005. Should Reliant fail to achieve such minimum annual capsule sales, Reliant could choose to pay Ethypharm the difference between what they would have received had such minimum capsule sales target been achieved and what Ethypharm actually received during the annual measurement period or Reliant could choose to relinquish its contractual exclusive licensing rights with respect to Antara in such territory. Reliant was in compliance with the minimum annual sales requirement for the initial measurement period from February 2, 2005 to February 1, 2006.

The Company will also be required to make an additional milestone payment of $400 to Ethypharm if and when cumulative net sales of Antara, as measured from the launch date, exceed $50,000. The cumulative net sales as of June 30, 2006 were $42,628.


OSCIENT PHARMACEUTICALS CORPORATION

PRO FORMA FINANCIAL INFORMATION (UNAUDITED)

On August 18, 2006 Oscient Pharmaceuticals Corporation (“Oscient”) and its wholly-owned subsidiary Guardian II Acquisition Corporation (“Guardian II”) acquired, for approximately $83.1 million (including inventory purchases), the exclusive rights in the United States and its territories (the “Territory”) to the cardiovascular products ANTARA® 130mg and ANTARA® 43mg (fenofibrate) capsules (“Antara”) from Reliant Pharmaceuticals, Inc. (“Reliant”). Oscient has performed a preliminary valuation study to determine the allocation of the estimated purchase price of the Antara acquisition among the tangible and intangible assets acquired as well as their estimated amortization period. The preliminary study was performed by a third party and is unaudited.

As part of the acquisition, Oscient along with Guardian II entered into several financing agreements including a Revenue Interest Assignment Agreement, a Note Purchase Agreement and a Common Stock and Warrant Purchase Agreement, for aggregate funds of $70 million.

The following unaudited pro forma condensed consolidated statements of operations for the six months ended June 30, 2006 and for the year ended December 31, 2005, give the effect to the acquisition of Antara by Oscient as if such acquisition had occurred at the beginning of the respective periods. The following unaudited pro forma condensed consolidated balance sheet as of June 30, 2006, gives effect to the Antara acquisition as if it had occurred on June 30, 2006.

The pro forma adjustments are based upon available information and certain assumptions that management believes are reasonable under the circumstances. The pro forma adjustments were applied to the respective historical financial statements to reflect and account for the acquisition using the purchase method of accounting. This transaction is being accounted for as an acquisition of a business. The pro forma financial information is not necessarily indicative of the operating result or financial position that would have been achieved had the acquisition been consummated on the dates indicated and should not be construed as representative of future operating results or financial position. Specifically, Oscient expects to incur additional selling expenses related to its promotional efforts in respect of Antara on an ongoing basis. The purchase price was allocated to intangible assets acquired based on their respective fair values as determined in a preliminary valuation study performed by a third party and management’s evaluation of the assets and liabilities. The allocation of the purchase price among the intangibles assets acquired and the estimated useful lives of these intangible assets are preliminary and are subject to change based upon further evaluation, such changes could be material.

The unaudited pro forma condensed consolidated financial statements should be read in conjunction with Oscient’s Consolidated Financial Statements and related Notes thereto, Management’s Discussion and Analysis of Financial Condition and Results of Operations included in Oscient’s Annual Report on Form 10-K for the year ended December 31, 2005 and the Quarterly Report on form 10-Q for the quarter ended June 30, 2006 and the special purpose statements of product of the Antara Product Line of Reliant Pharmaceuticals for the years ended December 31, 2005 and 2004.


Oscient Pharmaceuticals Corporation

Pro Forma Consolidated Balance Sheet

Unaudited

As of June 30, 2006

(in thousands, except per share data)

 

     Oscient
Pharmaceuticals
Corporation
   

Antara

Product
Line

   Pro Forma
Adjustment
    Pro Forma  

ASSETS

         

Current Assets:

         

Cash and cash equivalents

   $ 71,582        $ (12,376 )(a)   $ 59,206  

Restricted cash

     5,346            5,346  

Interest receivable

     403            403  

Notes receivable

     601            601  

Accounts receivable

     3,403            3,403  

Inventories

     12,375       3,866      904 (b)     17,145  

Prepaid expenses and other current assets

     3,678       836      1,720 (c)     6,234  
                               

Total current assets

     97,388       4,702      (9,752 )     92,338  

Property and Equipment, at cost:

         

Manufacturing and computer equipment

     4,426            4,426  

Equipment and furniture

     1,160            1,160  

Leasehold improvements

     134            134  
                               
     5,720            5,720  

Less—Accumulated depreciation

     4,165            4,165  
                               
     1,555            1,555  

Restricted cash

     3,763            3,763  

Long-term notes receivable

     1,602            1,602  

Other assets

     4,165          289 (d)     4,454  

Intangible assets, net

     63,225       472      60,574 (d)     123,799  
          (472 )(e)  

Goodwill

     61,529          16,613 (d)     78,142  
                               
   $ 233,227     $ 5,174    $ 67,252     $ 305,653  
                               

LIABILITIES AND SHAREHOLDERS’ EQUITY

         

Current Liabilities:

         

Accounts payable

     5,445            5,445  

Accrued expenses and other current liabilities

     11,531          2,468 (d)     13,999  

Current portion of accrued facilities impairment charge

     2,856            2,856  

Current portion of accrued restructuring charge

     499            499  

Clinical trial expense accrual

     1,291            1,291  

Deferred revenue

     234            234  
                               

Total current liabilities

     21,856          2,468       24,324  

Long-term liabilities:

         

Long-term obligations, net of current maturities

     175,060          60,000 (f)     235,060  

Noncurrent portion of accrued facilities impairment charge

     12,346            12,346  

Other long-term liabilities

     2,812            2,812  

Deferred Revenue

     19            19  

Shareholders’ Equity:

         

Common stock, $0.10 par value - Authorized - 174,375 shares, Issued and Outstanding - 96,479 and 76,688 in 2006 and 2005, respectively

     9,648          1,111 (f)     10,759  

Series B restricted common stock, $0.10 par value - Authorized - 625 shares, Issued and outstanding - none in 2006 and 2005

         

Interest in Antara product line assets sold

       5,174      (5,174 )(g)     —    

Additional paid-in-capital

     392,207          8,847 (f)     401,054  

Accumulated deficit

     (380,558 )          (380,558 )

Deferred compensation

     —              —    

Note receivable from officer

     (163 )          (163 )
                               

Total shareholders’ equity

     21,134       5,174      4,784       31,092  
                               
   $ 233,227     $ 5,174    $ 67,252     $ 305,653  
                               

The accompanying notes are an integral part of these consolidated financial statements.


Oscient Pharmaceuticals Corporation

Pro Forma Consolidated Statement of Operations

Unaudited

For the six months ended June 30, 2006

(in thousands, except per share data)

 

     Oscient Pharmaceuticals
Corporation
    Antara
Product Line
    Pro Forma
Adjustments
    Pro Forma  

Revenues:

        

Product Sales

   11,868     19,072     —       30,940  

Co-promotion

   3,416     —       —       3,416  

Biopharmaceutical

   143     —       —       143  

Other Revenues

   99     —       —       99  
                        

Total revenues

   15,526     19,072     —       34,598  

Costs and expenses:

        

Cost of product sales (1)

   5,235     3,621     2,163 (h)   10,852  
       (167 )(i)  

Research and development (1)

   6,134     218       6,352  

Selling and marketing (1)

   37,682     15,043     —       52,725  

General and administrative (1)

   7,402     685     —       8,087  
                        

Total costs and expenses

   56,453     19,567     1,996     78,016  
                        

Loss from operations

   (40,927 )   (495 )   (1,996 )   (43,418 )

Other income (expense):

        

Interest income

   1,597     —       —       1,597  

Interest expense

   (4,082 )   —       (3,694 )(j)   (7,776 )

Gain on sale of fixed assets

   2     —       —       2  

Gain on disposition of investment

   237     —       —       237  

Other Income

   43     —       —       43  
                        

Net other income (expense)

   (2,203 )   —       (3,694 )   (5,897 )
                        

Net loss

   (43,130 )   (495 )   (5,690 )   (49,315 )
                        

Net loss per common share:

        

Basic and diluted

   (0.50 )       (0.51 )
                

Weighted average common shares outstanding:

        

Basic and diluted

   85,745         96,856  
                

(1)    Includes non-cash stock-based compensation as follows:

        

Manufacturing

   33         33  

Research and development

   92         92  

Selling and marketing

   704         704  

General and Administrative

   1,261         1,261  
                
   2,090         2,090  
                

The accompanying notes are an integral part of these consolidated financial statements.

 


Oscient Pharmaceuticals Corporation

Pro Forma Consolidated Statement of Operations

Unaudited

For the year ended December 31, 2005

(in thousands, except per share data)

 

     Oscient Pharmaceuticals
Corporation
    Antara
Product Line
    Pro Forma
Adjustments
    Pro Forma  

Revenues:

        

Product sales

   $ 20,458     $ 23,556       —       $ 44,014  

Co-promotion

     2,954       —         —         2,954  

Biopharmaceutical

     198       —         —         198  
                                

Total revenues

     23,610       23,556       —         47,166  
                                

Costs and expenses:

        

Cost of product sales

     9,830       3,904       4,327 (h)     17,728  
         (333 )(i)  

Research and development (1)

     14,432       472         14,904  

Selling and marketing

     74,931       65,605       —         140,536  

General and administrative (1)

     13,088       2,356       —         15,444  
                                

Total costs and expenses

     112,281       72,337       3,994       188,612  
                                

Loss from operations

     (88,671 )     (48,781 )     (3,994 )     (141,446 )
                                

Other income (expense):

        

Interest income

     3,400       —         —         3,400  

Interest expense

     (8,126 )     —         (6,106 )(j)     (14,232 )

Gain on sale of fixed assets

     65       —         —         65  

Income from sale of intellectual property

     2,500       —         —         2,500  

Gain on disposition of investment

     2,162       —         —         2,162  

Other income

     43       —         —         43  
                                

Net other income (expense)

     44       —         (6,106 )(j)     (6,062 )
                                

Loss from continuing operations

     (88,627 )     (48,781 )     (10,100 )     (147,508 )
                                

Income from discontinued operations

     35           35  
                                

Net loss

   $ (88,592 )   $ (48,781 )   $ (10,100 )   $ (147,473 )
                                

Loss from continuing operations per common share:

        

Basic and diluted

   $ (1.16 )       $ (1.68 )
                    

Net loss per common share:

        

Basic and diluted

   $ (1.16 )       $ (1.68 )
                    

Weighted average common shares outstanding:

        

Basic and diluted

     76,549           87,660  
                    

(1)    Includes non-cash stock-based compensation as follows:

        

Research and development

     836           836  

General and Administrative

     170           170  
                    
     1,006           1,006  
                    

The accompanying notes are an integral part of these consolidated financial statements.


OSCIENT PHARMACEUTICALS CORPORATION

PRO FORMA FINANCIAL INFORMATION (UNAUDITED)

NOTES TO UNAUDITED PRO FORMA CONSOLIDATED BALANCE SHEET AND STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

1. Estimated Purchase Price and Intangible Asset Allocation

On August 18, 2006, Oscient Pharmaceuticals Corporation acquired the rights to Antara, from Reliant Pharmaceuticals in a transaction being accounted for as an acquisition of a business. The pro forma components and allocation of the estimated purchase price, based on presumed fair values at June 30, 2006, are as follows (in thousands):

 

Consideration and direct transaction costs:   

Cash

   $ 12,376  

Oscient common stock and warrants issued

     10,000  

Senior term note

     20,000  

Royalty debt

     40,000  

Estimated direct transaction costs

     760  
        

Total purchase price

   $ 83,136  
        
  
Preliminary estimate of the allocation of purchase price:   
  

Inventories

   $ 4,770  

Prepaid expenses

     2,556  

Liabilities assumed

     (2,468 )

Intangible assets

     60,574  

Goodwill

     17,704  
        

Total purchase price

   $ 83,136  
        

Oscient has performed a preliminary valuation study to determine the allocation of the estimated purchase price of the Antara acquisition among the intangible assets acquired as well as their estimated amortization period. The preliminary study was performed by a third party and is unaudited. The estimated useful life of the intangible assets is assumed to be fourteen years which was based upon the life of the existing products, the regulatory barriers to competition, and management’s knowledge of existing competitors research activities. The following table presents the preliminary estimate of the fair value of the of intangible assets acquired, their estimated useful lives and the amortization expense included in each condensed consolidated statement of operation presented:

Intangible assets

   Fair value of
intangibles
   Estimated life
(in years)
  

Amortization for the six months

ended June 30, 2006

   Amortization for the year
ended December 31, 2005

Technology

   $ 58,694    14    $ 2,096    $ 4,192

Supply Agreement

     1,880    14      67      135
                       

Total

   $ 60,574       $ 2,163    $ 4,327
                       

For each period presented in the Unaudited Pro Forma Consolidated Statements of Operations, Oscient assumed that the acquisition occurred, and the amortization began, on the first day of the period and recognized the appropriate related amortization expense. On an ongoing basis, Oscient will evaluate the useful life of these intangible assets and determine if any competitive, governmental or regulatory event has impaired the value of the assets or modified their estimated useful lives.

Pro forma Adjustments

Pro forma adjustments given effect to the acquisition in the unaudited pro forma consolidated financial statements are as follows:

a) To reflect cash paid upon acquisition of Antara.

b) To reflect estimated fair value adjustments to the carrying value of inventory.

c) To reflect the reclassification of costs of Antara marketing samples from inventory to prepaid expenses to conform to Oscient’s accounting policy.

d) To reflect the estimated fair value of intangible assets, goodwill origination and estimated direct transaction costs as part of the purchase consideration of the acquisition.

e) To eliminate the carrying value of Antara intangible assets.

f) To reflect the issuance of $20,000 term note, $40,000 royalty interest debt and $10,000 of common stock and warrants

as part of the purchase consideration of the acquisition of Antara. As described in Note 2, included in the royalty interest debt is an embedded derivative related to a call/put option contained in the royalty debt arrangement. For pro forma disclosure, the fair-value change in the derivative is not material and, therefore, not included in the pro forma consolidated statements of operations.

g) To eliminate interest in Antara product line assets sold.

h) To reflect the amortization of identified intangible assets on a straight-line basis over a 14 year estimated useful life.

i) To eliminate historical amortization of existing intangible assets of Antara.

j) To reflect the interest due related to the issuance of the $20,000 term note and the $40,000 royalty interest.

2. Financing with Paul Royalty Funds

To finance the acquisition, Oscient, along with its wholly-owned subsidiary Guardian II acquisition Corporation (“Guardian II”) entered into several financing agreements with Paul Royalty Fund Holdings II, LP, an affiliate of Paul Capital Partners (“PRF”), including the Revenue Interests Assignment Agreement, the Note Purchase Agreement and the Common Stock and Warrant Purchase Agreement, in consideration for aggregate funds of $70,000. Oscient and Guardian II entered into the Revenue Interests Assignment Agreement (the “Revenue Agreement”), pursuant to which Oscient and Guardian II sold to PRF the right to receive specified royalties on Guardian II’s and Oscient’s net sales in the United States (and the net sales of their respective affiliates and licensees) of the ANTARA products and FACTIVE® (gemifloxacin mesylate) tablets until December 31, 2016. The royalty payable to PRF on net sales of ANTARA and FACTIVE starts each fiscal year as a high single digit royalty rate and declines to a low single digit royalty rate based on achievement of annual specified sales thresholds in each fiscal year. Once the cumulative royalty payments to PRF exceed $100,000, the royalties become nominal. In accordance with Emerging Issues Task Force Issue No. 88-18 “Sales of Future Revenues,” the proceeds of the revenue agreement have been presented as debt on the pro forma balance sheet.

In the event of (i) a change of control of Oscient or Guardian II, (ii) a bankruptcy of Oscient or Guardian II, (iii) a transfer by Oscient or any of its subsidiaries of substantially all of either ANTARA or FACTIVE, (iv) subject to a cure period, breach of certain material covenants and representations in the Revenue Agreement and (v) in the event the sale of ANTARA is suspended due to a court issued injunction or Oscient elects to suspend sales of ANTARA, in each case as a result of a lawsuit by certain third parties (each a “Put Event”), PRF has the right to require Oscient and Guardian II to repurchase from PRF its royalty interest at a price in cash which equals the greater of (a) a specified multiple of cumulative payments made by PRF under the Revenue Agreement less the cumulative royalties previously to PRF; or (b) the amount which will provide PRF, when taken together with the royalties previously paid, a specified rate of return (the “Put/Call Price”). Upon a bankruptcy event, Oscient and Guardian II are automatically required to repurchase the PRF royalty interest at the Put/Call Price. In the event of a change of control of Oscient, Oscient and Guardian II have the right to repurchase the PRF royalty interest for an amount equal to the Put/Call Price.

During the first two fiscal years immediately following the fiscal year in which combined annual net sales of ANTARA and FACTIVE are equal to or greater than $125 million, Oscient and Guardian II have the right, but not the obligation, to reduce the royalty percentages due under the Revenue Agreement to PRF by fifty percent (50%) by paying PRF a price in cash which will provide PRF, when taken together with the royalties previously paid, a specified rate of return. During the first two fiscal years immediately following the fiscal year in which combined annual net sales of ANTARA and FACTIVE are equal to or greater than $250,000, Oscient and Guardian II have the right, but not the obligation, to repurchase the PRF royalty interest at a price in cash which will provide PRF, when taken together with the royalties previously paid, a specified rate of return. The Revenue Agreement also contains certain customary representations, warranties and indemnities.

Guardian II entered into a Note Purchase Agreement (the “Note Purchase Agreement”) with PRF pursuant to which Guardian II issued and sold a $20,000 aggregate principal amount of 12% senior secured note (the “Note”), due on the fourth anniversary of the closing date, subject to Guardian II’s option to extend the maturity to the sixth anniversary of the closing date, provided (i) there are no defaults under the Note at the time, and (ii) Oscient issues to PRF at the time of the exercise of such option a warrant exercisable for 2,304,147 shares of Oscient’s common stock, par value $0.10 per share (the “Common Stock”), at a price of $0.8680 per share.

Interest is payable semi-annually in arrears on the last day of each of March and September. Guardian II has the option to pay interest in cash or to have 50% of the interest paid in cash and 50% of the interest added to principal. In the event of a change of control of Oscient or on or after the second anniversary of the closing, Oscient may at its option prepay all or any part of the Note at a premium which declines over time. In the event of an event of default, with “event of default” defined as a continuing Put Event under the Revenue Agreement as described in more detail above, the outstanding principal and interest in the Note shall become immediately due and payable.

Pursuant to the terms of the Revenue Agreement and the Note Purchase Agreement, Guardian II and PRF entered into a Security Agreement (the “Security Agreement”) under which Guardian II granted to PRF a security interest in and to substantially all assets owned by Guardian II (including rights to the ANTARA products) in order to secure its performance under each of the Revenue Agreement, the Note Purchase Agreement and the Note. Oscient has agreed to use commercially reasonable efforts, which shall not require Oscient to make any payments, to obtain consents from certain pre-existing Oscient noteholders to permit Oscient to grant PRF a security interest in all of Oscient’s assets to secure the obligations under the Revenue Agreement and Guardian II’s obligations under the Note Purchase Agreement. In addition, to the extent the indebtedness under certain of Oscient’s pre-existing debt obligations is refinanced or replaced and such replacement or refinancing indebtedness is secured, Oscient has agreed to equally and ratably secure its obligations under the Revenue Agreement.

As part of the financing, Oscient and PRF also entered into a Common Stock and Warrant Purchase Agreement (the “Stock and Warrant Purchase Agreement”), pursuant to which, in exchange for $10,000, Oscient sold to PRF 11,111,111 shares (the “Shares”) of the Common Stock, at a price of $0.90 per share (the “Private Placement”) and issued PRF a warrant (the “Warrant”) to purchase 2,304,147 shares of Common Stock (the “Warrant Shares”) at an exercise price of $0.8680 per share. The Warrant is exercisable for seven years from the date of closing. The Warrant contains a cashless exercise option and penalties if Oscient does not deliver the applicable amount of Warrant Shares within three trading days of exercise of a Warrant by PRF. The Warrant also contains provisions providing that, at PRF’s election, Oscient must re-purchase the Warrant from PRF upon a sale of the Company in which the consideration for such sale is solely cash.


SIGNATURE

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 hereunto duly authorized.

 

OSCIENT PHARMACEUTICALS CORPORATION
By:  

/s/ Philippe M. Maitre

Name:   Philippe M. Maitre
Title:   Senior Vice President and Chief Financial Officer
 

Date: November 1, 2006


EXHIBIT INDEX

 

Exhibit
Number
  

Description

2.1    Asset Purchase Agreement by and among Reliant Pharmaceuticals, Inc., Guardian II Acquisition Corporaiton and Oscient Pharmaceuticals Corporation dated as of July 21, 2006.* #
10.1    Amended and Restated Development, License and Supply Agreement dates of July 31, 2006 between Ethypharm, S.A. and Reliant Pharmaceuticals, Inc.* #
23.1    Consent of Rothstein, Kass & Company P.C.*
99.1    Press Release issued by Oscient Pharmaceuticals Corporation on August 21, 2006.**

* Filed herewith.
** Filed previously on a Current Report on Form 8-K on August 21, 2006.
# Confidential information has been omitted from this exhibit and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request.
EX-2.1 2 dex21.htm ASSET PURCHASE AGREEMENT Asset Purchase Agreement

Exhibit 2.1

ASSET PURCHASE AGREEMENT

by and

among

RELIANT PHARMACEUTICALS, INC.

GUARDIAN II ACQUISITION CORPORATION

and

OSCIENT PHARMACEUTICALS CORPORATION

Dated as of July 21, 2006

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.


TABLE OF CONTENTS

 

           Page

ARTICLE I DEFINITIONS

   1

1.2

   Other Definitional Provisions    9

ARTICLE II PURCHASE AND SALE

   10

2.1

   Agreement to Purchase and Sell    10

2.2

   Excluded Assets    11

2.3

   Assumed Liabilities    12

2.4

   Excluded Liabilities    13

2.5

   Consent of Third Parties    14

2.6

   Retention of Certain Rights By Reliant; Grant-Back License by Oscient    15

ARTICLE III CONSIDERATION; ALLOCATION; PRORATIONS; DEFERRED INVENTORY PAYMENT AND OTHER AGREEMENTS

   16

3.2

   Prorations    18

3.3

   Other Agreements    18

ARTICLE IV CLOSING; CONDITIONS TO CLOSING

   18

4.1

   Closing    18

4.2

   Transactions at Closing    19

4.3

   Conditions to the Obligations of Oscient    20

4.4

   Conditions to the Obligations of Reliant    21

ARTICLE V REPRESENTATIONS AND WARRANTIES OF RELIANT

   21

5.1

   Organization    21

5.2

   Due Authorization    22

5.3

   No Conflicts; Enforceability    22

5.4

   Title    22

5.5

   Intellectual Property    22

5.6

   Litigation    23

5.7

   Consents    23

5.8

   Brokers, Etc.    24

5.9

   Compliance with Laws; Regulatory Matters    24

 


[*] Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

i


5.10

   Product Liability    24

5.11

   No Current Intention to Market Other Fenofibrate Monotherapy Product    24

5.12

   Contracts    24

5.13

   Financial Information    25

5.14

   Absence of Certain Changes    25

5.15

   Inventory    25

5.16

   Principal Purchaser/Wholesalers    25

5.17

   Disclaimer    25

ARTICLE VI REPRESENTATIONS AND WARRANTIES OF OSCIENT AND PARENT

   26

6.1

   Oscient’s Representations and Warranties    26

6.2

   Parent’s Representations and Warranties    27

ARTICLE VII COVENANTS; OTHER AGREEMENTS

   28

7.1

   Availability of Records    28

7.2

   Certain Transitional Matters    28

7.3

   Tax Matters; Bulk Sales    29

7.4

   Pre-Closing Matters    30

(f)

   Access to Premises and Information    31

7.5

   HSR Filing, Approvals and Conditions; Further Assurances    32

7.6

   Notifications    32

7.7

   Product Returns    33

7.8

   Pricing Contracts    33

7.9

   Medicaid and Other State Rebates    34

7.10

   Website Information    35

7.11

   Regulatory Matters    35

7.12

   Non-Solicitation    36

7.13

   Non-Competes    36

7.14

   Promotional Materials    37

7.15

   Non-Assertion Covenants    37

7.16

   Imports Into/Exports From Territory    37

7.17

   Post-Closing Obligations Regarding Financial Information    38

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

ii


ARTICLE VIII INDEMNIFICATION AND SURVIVAL

   38

8.1

   Indemnification by Reliant    38

8.2

   Indemnification by Oscient    38

8.3

   Notice of Claims    39

8.4

   Limitations    40

8.5

   Survival    40

8.6

   Exclusive Remedy    41

8.7

   Other Provisions    41

ARTICLE IX TERMINATION

   42

9.1

   Termination    42

9.2

   Effect of Termination    42

ARTICLE X CONFIDENTIAL INFORMATION

   43

10.1

   Confidential Information    43

10.2

   Confidentiality Obligations    43

10.3

   Permitted Disclosure and Use    44

10.4

   Notification    44

10.5

   Confidentiality of this Agreement    44

10.6

   Publicity; Filing of this Agreement    44

10.7

   Survival    45

ARTICLE XI MISCELLANEOUS

   45

11.1

   Assignment    45

11.2

   Expenses    45

11.3

   Schedules    46

11.4

   Severability    46

11.5

   Entire Agreement    46

11.6

   No Third Party Beneficiaries    46

11.7

   Waivers and Amendments; Non Contractual Remedies; Preservation of Remedies    46

11.8

   Governing Law    46

11.9

   Consent to Jurisdiction; Venue    46

11.10

   WAIVER OF JURY TRIAL    47

11.11

   Available Remedies    47

11.12

   Headings    47

11.13

   Counterparts    47

11.14

   Further Documents    47

11.15

   Notices    48

11.16

   Parent Guarantee of Payment and Performance    48

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

iii


Exhibits and Schedules

 

EXHIBITS

Exhibit A

   Form of Assignment of Patent

Exhibit B

   Form of Assignment of Trademark

Exhibit C

   Form of Bill of Sale and Assignment and Assumption Agreement

Exhibit D-1

   Form of Ethypharm Agreement Assignment

Exhibit D-2

   Form of Ethypharm Agreement Sublicense

Exhibit E

   Form of Inventory Trademark License

Exhibit F

   Form of Packaging Agreement Assignment

Exhibit G

   Form of Settlement Agreement Assignment

Exhibit 7.4(e)

   Form of Proposed Ethypharm Amendment
SCHEDULES

Schedule 1.1A

   Assigned Contracts and Orders

Schedule 1.1B

   Bundled contracts

Schedule 1.1C

   Inventory/Inventory Payment Amount

Schedule 1.1D

   Product Domain Name

Schedule 1.1E

   Product Patents

Schedule 1.1F

   Promotional Materials

Schedule 1.1G

   Registrations

Schedule 2.5(a)

   Required Consents
Reliant Disclosure Schedule

Schedule 5.4

   Title

Schedule 5.5(a)

   Intellectual Property – Adverse Claims

Schedule 5.5(b)

   Intellectual Property – Infringement

Schedule 5.5(d)

   Intellectual Property – Registrations and Applications

Schedule 5.6

   Litigation

Schedule 5.7

   Consents

Schedule 5.9

   Compliance with laws; Regulatory Matters

Schedule 5.12

   Contracts

Schedule 5.13

   Financial Information

Schedule 5.16

   Principal Purchaser/Wholesalers

Schedule 6.1(g)

   Oscient Bank Commitment Letter

Schedule 7.6

   Wholesale Distributors to be Notified Post-Closing

Schedule 7.8

   Pricing Contracts to be Terminated

Schedule 10.6

   Form of Oscient Press Release

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 


ASSET PURCHASE AGREEMENT

THIS ASSET PURCHASE AGREEMENT (this “Agreement”), dated as of July 21, 2006, is entered into by and among Reliant Pharmaceuticals, Inc., a Delaware corporation (“Reliant”), Guardian II Acquisition Corporation, a Delaware corporation (“Oscient”), and Oscient Pharmaceuticals Corporation, a Massachusetts corporation (“Parent”), solely for the purposes of Sections 6.2, 7.13(b) and 11.16 herein. Each of Reliant and Oscient is sometimes referred to herein, individually, as a “Party” and, collectively as the “Parties.” All capitalized terms used herein shall have the meanings specified in Article I below or elsewhere in this Agreement, as applicable.

WITNESSETH:

WHEREAS, Reliant owns the Product and desires to transfer ownership of the Product and certain rights related to the development, manufacturing, marketing and sale of the Product (the “Product Line Operations”) to Oscient; and

WHEREAS, subject to the terms and conditions of this Agreement, Reliant wishes to sell certain Acquired Assets and assign the Assumed Liabilities to Oscient, and Oscient wishes to purchase the Acquired Assets from Reliant and assume the Assumed Liabilities.

NOW, THEREFORE, in consideration of the foregoing and the representations, warranties, covenants, agreements and provisions herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, the Parties hereto agree as follows:

ARTICLE I

DEFINITIONS

1.1 Definitions. In addition to the terms defined above and other terms defined in other Sections of this Agreement, the following terms shall have the meanings set forth below for purposes of this Agreement:

Accounts Receivable” means all accounts receivable (including any payments received with respect thereto on or after the Closing, unpaid interest accrued on any such accounts receivable and any security or collateral related thereto) arising from sales of the Product prior to the Closing, and all rights of collection, payment and performance associated therewith.

Acquired Assets” is defined in Section 2.1.

Acquisition Proposal” is defined in Section 7.4(c).

Act” means, as applicable, the United States Federal Food, Drug and Cosmetic Act, as amended.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.


Additional Products” means any and all dosage forms, formulations, strengths, and types of pharmaceutical products, other than the Product (but including, without limitation, line extensions and improvements of the Product), whether branded or generic, regardless of indication, that contain a therapeutically active amount of fenofibrate, including, without limitation, any Combination Products; provided that Additional Products shall not include mere changes to Product presentations, such as new packages or bottle sizes or changes to existing packages or bottle sizes.

Adverse Reaction Information” is defined in Section 7.11(c).

Affiliate” means, with respect to any Person, any other Person directly or indirectly controlling or controlled by, or under direct or indirect common control with, such Person. For purposes of this definition, a Person shall be deemed to control another Person if it owns or controls more than fifty percent (50%) of the voting equity of the other Person (or other comparable ownership if the Person is not a corporation).

Agreement” means this Asset Purchase Agreement, including all schedules and exhibits hereto.

Assigned Contracts and Orders” means those contracts and purchase orders related to the Product and the Product Line Operations listed on Schedule 1.1A.

Assigned Patent” means patent application [*] including related divisionals, continuations, continuations-in-part, substitutions, provisions, converted provisions, and continued prosecution applications.

Assignment of Patent” means the Assignment of Patent, in substantially the form attached hereto as Exhibit A.

Assignment of Trademark” means the Assignment of Trademark substantially in the form attached hereto as Exhibit B, with respect to the Product Trademark.

Assumed Liabilities” is defined in Section 2.3.

Bill of Sale and Assignment and Assumption Agreement” means the Bill of Sale and Assignment and Assumption Agreement attached hereto as Exhibit C.

Bundled Contracts” means those contracts listed on Schedule 1.1B, pursuant to which Reliant is either (a) selling to third parties Product together with other products of Reliant not included in the Acquired Assets, including agreements between Reliant and group purchasing organizations and rebate agreements, or (b) receiving from third parties services related to the Product Line Operations together with services related to other businesses or products of Reliant.

Business Day” means any day other than a Saturday, Sunday or day on which banks in New York, New York are authorized or required by Law or executive order to close.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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Chargebacks” is defined in Section 2.3(g).

Closing” means the closing of the purchase and sale of the Acquired Assets and the assumption of the Assumed Liabilities contemplated by this Agreement.

Closing Date” is defined in Section 4.1.

Code” shall mean the United States Internal Revenue Code of 1986, as amended, and the Treasury Regulations promulgated thereunder.

Combination Product” shall mean any pharmaceutical composition in any dosage form containing fenofibrate in combination with a therapeutically active amount of any other pharmaceutical ingredient, including, without limitation, any * Compound.

Confidential Information” is defined in Section 10.1.

Confidentiality Agreement” means the Confidentiality Agreement, dated May 24, 2006, by and between Reliant and Parent.

Disclosing Party” is defined in Section 10.1.

Ethypharm” means Ethypharm S.A., a French corporation.

Ethypharm Agreement” means the Development, License and Supply Agreement, dated as of May 7, 2001, by and between Reliant and Ethypharm S.A., as amended by the letter between Reliant and Ethypharm S.A., dated December 18, 2002, and as further amended by Amendment No. 1, dated as of May 24, 2005, and as may be further amended prior to Closing by the Ethypharm Amendment.

Ethypharm Agreement Transfer Agreement” means either (i) if Reliant obtains a consent to the assignment of the Ethypharm Agreement to Oscient on or prior to the Closing, the Assignment and Assumption of Contract with respect to the Ethypharm Agreement substantially in the form attached hereto as Exhibit D-1, or (ii) if Reliant does not obtain a consent to the assignment of the Ethypharm Agreement on or prior to the Closing, the Sublicense Agreement substantially in the form attached hereto as Exhibit D-2.

Ethypharm Amendment” is defined in Section 7.4(e).

Excluded Assets” is defined in Section 2.2.

Excluded Combination Product” shall mean any pharmaceutical composition in any dosage form containing a therapeutically active amount of fenofibrate in combination with any [*] Compound.

Excluded Liabilities” is defined in Section 2.4.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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FDA” means the United States Food and Drug Administration, or any successor agency thereto.

Financial Information” is defined in Section 5.13.

Governmental Authority” means any nation or government, any state, regional, local or other political subdivision thereof, any supranational organization of sovereign states, and any entity, department, commission, bureau, agency, authority, board, court, official or officer, domestic or foreign, exercising executive, judicial, regulatory or administrative functions of or pertaining to government.

Guaranteed Obligations” is defined in Section 11.16.

HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder.

IND” means Investigational New Drug Application No. 66,249.

Indemnified Party” means a party entitled, or seeking to assert rights, to indemnification under Article VIII of this Agreement.

Indemnifying Party” means the party from whom indemnification is sought by the Indemnified Party under Article VIII of this Agreement.

Intellectual Property” means the entire right, title and interest in and to proprietary rights of every kind and nature, including all rights and interests pertaining to or deriving from trademarks, service marks, logos, trade dress and all the goodwill related thereto, copyrights and patents, all whether registered or unregistered, and all applications and registrations therefore; domain names, know-how, confidential information, trade secrets, inventions, discoveries, analytic models, improvements, processes, techniques, devices, methods, patterns, formulations and specifications, materials, data, results, formulae, designs, specifications, ideas, 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 all actions and rights to sue at law or equity and recover damages for any past, present or future infringement of any of the foregoing.

Inventory” means, as of the Closing Date, all inventories of finished Product (including samples and related Product Trade Dress), raw materials used to manufacture Product and Product work in process that in each case, (i) is owned by Reliant at Closing (ii) has been fully paid for by Reliant, (iii) conforms to the applicable specifications, and (iv) has at least two (2) years of remaining shelf life from July 31, 2006, as shall be set forth in Schedule 1.1C (such schedule to be updated by Reliant immediately prior to the Closing).

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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Inventory Payment Amount” shall be equal to Reliant’s actual cost for the Inventory, as shall be set forth on Schedule 1.1C, which is subject to adjustment as provided in Section 3.1(b). Schedule 1.1C shall reasonable identify the Inventory and shall include the amount of each item of Inventory itemized by form (e.g., finished product, raw material or work in process), dosage, number of items, location and cost and any other descriptive information regarding the Inventory as reasonably requested by Oscient.

Inventory Trademark License” means the Inventory Trademark License to be entered into by Reliant and Oscient in the form attached hereto as Exhibit E and providing for the limited license to Oscient to use the Reliant Brands solely in connection with the marketing and selling of the Product labeled with Reliant Brands in existence at the Closing.

Knowledge” means the actual knowledge of the relevant personnel with primary responsibility for the matter in question on a day to day basis.

Law” means each provision of any currently existing federal, state, local or foreign law, statute, ordinance, order, code, rule or regulation, promulgated or issued by any Governmental Authority, as well as any binding judgments, decrees, injunctions or agreements issued or entered into by any Governmental Authority.

Liability” or “Liabilities” means any debts, liabilities or obligations, whether accrued or fixed, known or unknown, liquidated or unliquidated, absolute or contingent, matured or unmatured or determined or undetermined.

Losses” means all losses, expenses, Liabilities or other damages, including reasonable costs of investigation, interest, penalties and attorneys’ fees.

Material Adverse Effect” means any change or effect that, individually or in the aggregate, has had, or is reasonably likely to have, a material adverse effect on the Acquired Assets or Product, taken as a whole; provided, however, that Material Adverse Effect shall exclude any effect resulting from (a) changes to general economic conditions or any occurrence or condition affecting the pharmaceutical industry generally, (b) war, hostilities, military actions or acts of terrorism, or (c) the announcement, disclosure or consummation of the transactions contemplated hereby and/or the Other Agreements.

NDA” means the United States new drug application covering the Product (NDA# 21-695), including any supplements, amendments or modifications thereto, or divisions thereof, submitted to or required by the FDA, prior to the Closing Date.

NDC Number” means the National Drug Code number applicable to the Product, which identifies the labeler (i.e., Reliant or Oscient), product, and trade package size.

Net Sales” means the gross amounts invoiced by Oscient or its Affiliates (or their licensees or sublicensees) on all sales of Additional Products (including, but not limited to, hospital sales, mail orders, retail sales, and sales to federal or state governments, wholesalers, medical institutions, etc.), in the Territory, less the following deductions, determined in

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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accordance with GAAP as consistently applied by Oscient and its Affiliates in determining net product sales, to the extent included in the gross invoiced sales price of the Additional Product or otherwise paid or incurred by Oscient or its Affiliates (or their licensees or sublicensees) with respect to the sale of such Additional Product:

(i) normal and customary trade, cash and/or quantity discounts allowed and taken, and wholesaler fees paid, with respect to sales of such Additional Product;

(ii) amounts paid, repaid or credited by reason of defects, rejection, recalls, returns and allowances with respect to such Additional Product;

(iii) charges, discounts and amounts under Rebate Programs paid or accrued on sale or dispensing of the Product and/or such Additional Product;

(iv) retroactive price reductions that are actually allowed or granted; and

(v) all transportation charges, including freight, postage and insurance related directly to any Additional Products; provided, however, that, for any applicable period, the maximum amount of deductions described in this clause (v) shall not exceed more than * percent (*%) of total gross amounts invoiced by Oscient or its Affiliates (or their licensees or sublicensees) on all sales of any Additional Products for such period.

In the case of any sale of any Additional Product between or among Oscient and its Affiliates (and their licensees and sublicensees) for resale, Net Sales shall be calculated as above only on the first arm’s length sale thereafter to a third party. In the case of any sale of any Additional Product or part thereof for value other than in an arm’s length transaction exclusively for cash, such as barter or counter-trade, Net Sales shall be calculated based on the fair market value of the consideration received.

* Compound” means a composition consisting of or containing any [*] and/or any derivatives thereof (including, without limitation, the [*] active pharmaceutical ingredient described in [*] for [*] product).

Oscient” is defined in the Preamble to this Agreement.

Oscient Indemnified Parties” is defined in Section 8.1.

Other Agreements” means, collectively, the Bill of Sale and Assignment and Assumption Agreement, the Ethypharm Agreement Transfer Agreement, the Assignment of Patent, the Assignment of Trademark, the Settlement Agreement Assignment, the Inventory Trademark License and the Packaging Agreement Assignment.

Outside Date” as defined in Section 9.1(d).

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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Packaging Agreement” means that certain Packaging Agreement between Reliant and Cardinal Health PTS, LLC, dated as of October 30, 2002, as amended.

Packaging Agreement Assignment” means the partial Assignment and Assumption of Contract with respect to the Packaging Agreement, in substantially the form attached hereto as Exhibit F.

Parent” is defined in the Preamble to this Agreement.

Party” and “Parties” are defined in the Preamble to this Agreement.

PDM Act” means the Prescription Drug Marketing Act of 1987, as amended.

Person” means any individual, corporation, partnership, joint venture, limited liability company, trust or unincorporated organization or Governmental Authority or any agency or political subdivision thereof.

Pre-Closing Financial Statements” is defined in Section 7.17.

Pricing Contract(s)” shall mean the pricing contracts listed on and attached hereto on Schedule 7.8.

Product” means the dosage forms, formulations, strengths, package sizes and types of formulations of Antara® described in the NDA.

Product Domain Name” means the domain name set forth on Schedule 1.1D and all associated portals and websites.

Product Intellectual Property” means all Intellectual Property, owned or licensed by Reliant (i) used exclusively in connection with the development, marketing, distribution and packaging of the Product in the Territory as of the Closing Date, or (ii) necessary for the manufacture, importation and sale of the Product in the Territory as of the Closing Date; in each case, including, without limitation, the Product Trade Dress, the Product Patents, the Product Trademark, the Product Domain Name and all copyrights (registered or otherwise) related to the Promotional Materials, but excluding the Reliant Brands.

Product Line Operations” is defined in the Recitals to this Agreement.

Product Patents” means the patents and patent applications owned by, licensed to or otherwise held by Reliant, including, without limitation, the Assigned Patent and related divisionals, continuations, continuations-in-part, substitutions, provisions, converted provisions, and continued prosecution applications, which are used exclusively in connection with the development, importation, manufacture, packaging, marketing, distribution and sale of the Product in the Territory as of the Closing Date or with respect to which the sale of the Product would result in infringement thereof, in each case in the Territory, each as listed on Schedule 1.1E attached hereto.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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Product Trade Dress” means the trade dress, package designs, labels, logos and associated artwork and all the goodwill related thereto owned by, licensed to or otherwise held by Reliant that are used exclusively in connection with the Product or the packaging therefore, but specifically excluding all Reliant Brands and all variations and derivatives of such Reliant Brands.

Product Trademark” means the “Antara®” trademark and all the goodwill related thereto, as registered with the United States Patent and Trademark Office (registration no. 3101801), or any other trademark or service mark owned or controlled by Reliant in the Territory, consisting of the term “Antara”, whether registered or unregistered, and all common law rights, and all goodwill associated therewith.

Promotional Materials” means the advertising, promotional, educational and media materials and sales training materials used in the Territory (including distribution and sales promotion information, market research studies, content contained on any websites owned by Reliant and toll-free telephone numbers) relating exclusively to the Product or the Acquired Assets, including those materials listed on Schedule 1.1F hereto.

Purchase Price” is defined in Section 3.1(a)(i).

Quarterly Payment Report” is defined in Section 3.1(c)(ii).

Rebate Programs” is defined in Section 7.9(a).

Receiving Party” is defined in Section 10.1.

Registrations” means the IND and the NDA and any supplements thereto and any other regulatory approvals, licenses and applications, held by Reliant relating exclusively to the Product issued by Governmental Authorities in the Territory as listed on Schedule 1.1G.

Reliant” is defined in the preamble to this Agreement.

Reliant Brands” means the trademarks, housemarks, tradenames and trade dress owned or used by Reliant, whether or not registered, including, without limitation, the name “Reliant Pharmaceuticals” and any variants of any of the foregoing used in connection with the Product and which, following the Closing, shall exclude the Product Trademark and Product Trade Dress.

Reliant Disclosure Schedule” is defined in the preamble to Article V.

Reliant Indemnified Parties” is defined in Section 8.2.

Reliant Prorated Liabilities” is defined in Section 3.2.

Representatives” is defined in Section 10.1.

Required Consents” is defined in Section 2.5(a).

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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Restricted Company” is defined in Section 7.13(a).

Royalty” is defined in Section 3.1(c)(i).

SEC” is defined in Section 7.17.

Security Interest” means any mortgage, pledge, security interest or encumbrance, charge or other lien (whether arising by contract or by operation of law).

Settlement” means the Settlement Agreement dated [*].

Settlement Agreement Assignment” means the Assignment and Assumption Agreement with respect to the [*] in substantially the form attached hereto as Exhibit G.

“[*] Patents” means U.S. Patent Nos. [*]; [*]; [*]; [*]; and [*].

Taxes” means all taxes, charges, fees, duties, levies or other assessments, including, without limitation, income, gross receipts, net proceeds, ad valorem, turnover, real and personal property (tangible and intangible), sales, use, franchise, excise, value added, license, payroll, unemployment, environmental, customs duties, capital stock, disability, stamp, leasing, lease, user, transfer, fuel, excess profits, occupational and interest equalization, windfall profits, severance and employees’ income withholding and Social Security taxes imposed by any Governmental Authority, including any interest, penalties or additions to tax attributable to such taxes.

Territory” means (a) the United States of America, its territories and possessions, including, without limitation, Puerto Rico, and (b) the Caribbean (including without limitation The Bahamas).

Third Party Payments” is defined in Section 3.1(c)(i).

Transfer Taxes” is defined in Section 7.3(b).

Unidentified Claims” is defined in Section 7.8.

1.2 Other Definitional Provisions.

(a) The language in all parts of this Agreement shall be construed, in all cases, according to its fair meaning. Reliant and Oscient acknowledge that each Party and their counsel have reviewed and revised this Agreement and that any rule of construction to the effect that any ambiguities are to be resolved against the drafting party shall not be employed in the interpretation of this Agreement.

(b) The words “hereof,” “herein,” “hereto” and “hereunder” and words of similar import, when used in this Agreement, shall refer to this Agreement as a whole and not to any particular provision of this Agreement.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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(c) The terms defined in the singular shall have a comparable meaning when used in the plural, and vice versa.

(d) Words of one gender include the other gender.

(e) The terms “dollars” and “$” shall mean United States dollars.

(f) The word “including” shall mean including without limitation and the words “include” and “includes” shall have corresponding meanings.

ARTICLE II

PURCHASE AND SALE

2.1 Agreement to Purchase and Sell. Subject to the terms and conditions contained herein, at the Closing, Reliant shall, or shall cause its Affiliates to, sell, transfer, convey and assign to Oscient, and Oscient shall purchase and accept from Reliant or its Affiliates, all right, title, and interest of Reliant and its Affiliates in and to the following assets of Reliant or its Affiliates (collectively, the “Acquired Assets”), free and clear of all Security Interests:

(a) the Registrations (provided that Reliant shall be permitted to retain one copy of the Registrations for archival purposes);

(b) the Promotional Materials;

(c) the Product Intellectual Property (it being agreed and acknowledged that (i) Reliant does not have a license to, and the Acquired Assets do not include, any rights in respect of the [*] Patents outside the United States, its territories and possessions (other than the right to manufacture or have manufactured the Reliant Products (as defined in the Settlement Agreement) outside the United States, its territories and possessions solely for distribution and sale in the United States, its territories and possessions), and (ii) any Intellectual Property developed, created or discovered by or on behalf of Oscient after the Closing relating to any of the clinical development and methods of use of the Product, in any formulation or dosage form, and any Intellectual Property that is otherwise developed by Oscient after the Closing shall be owned solely by Oscient);

(d) the Assigned Contracts and Orders;

(e) the Inventory;

(f) any and all rights to develop, market and promote any Combination Product, other than Excluded Combination Products (it being agreed and acknowledged that, Reliant has no license from any third party (other than Ethypharm) regarding any Intellectual Property related to combination products or products other than the 43mg, 87 mg and 130 mg formulations that are the subject of NDA 21-695 as in effect on the date hereof);

(g) any claims or benefits in, to or under any express or implied warranties from suppliers of goods or services relating to the Inventory;

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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(h) to the extent permitted by Law and in each case to the extent in Reliant’s possession or reasonably available to Reliant without the need to incur any undue expense, all books and records, including, without limitation, sales records, price lists and catalogues, call notes and call histories, supply records, customer lists and purchasing histories, inventory records and correspondence files, relating primarily or exclusively to the Product; provided, however, that Reliant or its Affiliates may retain a copy of any such books and records to the extent necessary for Tax, accounting, litigation or other valid business purposes; provided, further, that the Acquired Assets shall not include either the Pricing Contracts (or any information contained therein) or the Bundled Contracts;

(i) the rights under the Settlement Agreement transferred to Oscient pursuant to the Assignment of Settlement Agreement; and

(j) the rights of Reliant under the Ethypharm Agreement transferred to Oscient pursuant to the Ethypharm Agreement Transfer Agreement.

2.2 Excluded Assets. Notwithstanding anything to the contrary in this Agreement, except as set forth below, the Acquired Assets shall not include any assets, properties, rights or interests, whether or not relating to the Product, other than those specifically listed or described in Section 2.1 and, without limiting the generality of the foregoing, the Acquired Assets shall expressly exclude the following assets of Reliant and its Affiliates (collectively, the “Excluded Assets”):

(a) all rights of Reliant and its Affiliates arising under this Agreement, the Other Agreements or from the consummation of the transactions contemplated hereby or thereby;

(b) all rights, title and interest of Reliant and its Affiliates in and to the Product outside of the Territory (including the right to receive any royalties or similar payments from Ethypharm in respect thereof), except for those rights, title and interests transferred to Oscient pursuant to the Ethypharm Agreement Transfer Agreement and the Assignment of Settlement Agreement;

(c) all rights of Reliant and its Affiliates related to any Excluded Combination Product (it being agreed that any such rights transferred to Oscient pursuant to the Ethypharm Transfer Agreement shall, pursuant to the terms of such agreement, be granted back, licensed or sublicensed to Reliant such that Reliant retains exclusive (even as to Oscient) rights therein);

(d) all rights of enforcement, indemnification and similar matters under the Assigned Contracts and Orders related to any periods prior to Closing;

(e) all rights of Reliant and its Affiliates in and to any Intellectual Property, whether now existing or hereafter developed or acquired (including the Reliant Brands) other than the Product Intellectual Property;

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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(f) all rights of Reliant and its Affiliates in and to the Packaging Agreement except as otherwise assigned to Oscient pursuant to the Packaging Agreement Assignment;

(g) all Accounts Receivable;

(h) all cash (including, without limitation, cash on hand and cash in transit), cash equivalents, bank deposits, marketable securities and any advances, pre-payments, deposits or holdbacks under any contracts related to the Product;

(i) except to the extent included in the Acquired Assets, all books, documents, records and files (i) prepared in connection with or relating to the transactions contemplated by this Agreement, including, without limitation, confidentiality agreements with, and bids received from, other parties and strategic, financial or Tax analyses relating to the divestiture of the Acquired Assets, the Assumed Liabilities and the Product, (ii) maintained by Reliant or its Affiliates and/or its representatives, agents or licensees in connection with their respective Tax, legal, regulatory or reporting requirements, or (iii) that constitute attorney work product, attorney-client communications and other items protected by privilege; provided, however, that Oscient receive a copy of any such records described under clause (ii) solely to the extent related to the Product as necessary for Tax, accounting, litigation or other reasonable business purposes;

(j) all rights to refunds of Taxes paid through the Closing Date;

(k) all insurance policies and claims thereunder and any claims or benefits in, to or under any express or implied warranties from suppliers of goods or services relating to the Product manufactured by or on behalf of Reliant or its Affiliates other than relating to the Inventory; and

(l) all assets, tangible or intangible, wherever situated, not expressly included in the Acquired Assets.

2.3 Assumed Liabilities. On the Closing Date, Oscient shall assume, and shall pay and perform and discharge (or cause to be paid, performed and discharged) when due, the following Liabilities of Reliant and its Affiliates related to the Product, the Acquired Assets, the Product Intellectual Property and/or the Product Line Operations, but excluding the Excluded Liabilities (collectively, the “Assumed Liabilities”):

(a) all Liabilities to be paid, performed or discharged under the Assigned Contracts and Orders arising on or after the Closing Date, including, without limitation, under the purchase orders issued by Reliant under the Assigned Contracts and Orders not yet paid-for, delivered or provided as of the Closing Date, and all purchase orders from customers for Product not yet paid-for, delivered or provided as of the Closing Date, and excluding such Liabilities that were otherwise required to have been paid, performed or discharged prior to the Closing Date or relate to goods received by, or services provided to, Reliant, prior to the Closing Date;

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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(b) all Liabilities of Reliant and its Affiliates under the Packaging Agreement arising on or after the Closing Date and assumed by Oscient pursuant to the Packaging Agreement Assignment, excluding such Liabilities that were otherwise required to have been paid, performed or discharged prior to the Closing Date under the Packaging Agreement;

(c) all Liabilities of Reliant and its Affiliates under the Ethypharm Agreement arising on or after the Closing Date and assumed by Oscient pursuant to the Ethypharm Agreement Transfer Agreement, excluding such Liabilities that were otherwise required to have been paid, performed or discharged under the Ethypharm Agreement prior to the Closing Date or relate to goods received by, or services provided to, Reliant prior to the Closing Date; provided, however, that for the avoidance of doubt, the Parties agree and acknowledge that any milestone payment that becomes due and payable after the Closing Date under the Ethypharm Agreement shall be the responsibility and sole obligation of Oscient and shall not constitute a Reliant Prorated Liability;

(d) all Liabilities of Reliant and its Affiliates under the Settlement first arising after the Closing Date and assumed by Oscient under the Settlement Agreement Assignment;

(e) all Taxes that are the responsibility of Oscient pursuant to Section 3.4 and Section 7.3 of this Agreement and all Taxes relating to the Acquired Assets, the Product and/or the Product Line Operations attributable to any period or partial period beginning on or after the Closing Date;

(f) all Losses arising out of claims of third parties due to the use or sale of any Product (whether or not defective) sold on and after the Closing Date by or on behalf of any Oscient or any of its Affiliates and all Losses arising out of claims of third parties due to or relating to any voluntary or involuntary recall of the Product sold on or after the Closing Date;

(g) subject to Section 2.4, Section 7.8 and Section 7.9, all (i) rebates claimed or accrued by or under any Rebate Programs relating to Product dispensed pursuant to a prescription after the Closing, and (ii) all charges and discounts relating to group purchasing organizations, buying groups, pharmaceutical benefit management organizations, managed care organizations and rebate programs (other than the Rebate Programs), including wholesaler and chain pharmacy discounts, and indigent patient programs and patient discount programs relating to Product dispensed pursuant to prescriptions after the Closing (“Chargebacks”);

(h) subject to Section 2.3 and Section 7.7, all obligations for replacements of, or refunds for Product, whether or not bearing Reliant’s name, on or after the Closing Date; and

(i) all of Oscient’s Prorated Liabilities.

2.4 Excluded Liabilities. Notwithstanding anything to the contrary in this Agreement, neither Oscient nor any of Oscient’s Affiliates will assume, nor will they become responsible for, any Liability set forth hereafter (collectively, the “Excluded Liabilities”):

(a) all Liabilities of Reliant and Reliant’s Affiliates arising under this Agreement, the Other Agreements or from the consummation of the transactions contemplated hereby or thereby;

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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(b) all Liabilities required to be performed by Reliant under the Assigned Contracts and Orders prior to the Closing Date and any Liability for Reliant’s failure to so perform such Liabilities;

(c) all Liabilities of Reliant under the Packaging Agreement not assumed by Oscient pursuant to the Packaging Agreement Assignment;

(d) all Liabilities of Reliant required to be performed by Reliant under the Settlement to the extent not assigned to Oscient;

(e) all Liabilities of Reliant required to be performed by Reliant under the Ethypharm Agreement to the extent not transferred to Oscient pursuant to Section 2.3(c);

(f) all Losses arising out of claims of third parties due to the marketing, promotion, use or sale of any Product (whether or not defective) sold prior to the Closing Date by Reliant and all Losses arising out of claims of third parties due to or relating to any voluntary or involuntary recall of the Product sold prior to the Closing Date by Reliant;

(g) all of Reliant Prorated Liabilities;

(h) subject to Section 2.3 and Section 7.9, all rebates claimed or accrued by or under any Rebate Programs and Chargebacks received for Product prior to the Closing Date; and

(i) subject to Section 2.3 and Section 7.7, all obligations for replacements of, or refunds for Product distributed or sold by Reliant prior to the Closing Date.

2.5 Consent of Third Parties.

(a) Assigned Contracts and Orders. On the Closing Date, Reliant shall assign to Oscient, and Oscient will assume, the Assigned Contracts and Orders to the extent provided in this Agreement and the Other Agreements. Schedule 2.5(a) provides a list of third party consents that Reliant must obtain prior to Closing (“Required Consents”). With respect to all consents other than the Required Consents, to the extent that the assignment of all or any portion of any of the Assigned Contracts and Orders shall require the consent of the other party thereto or any other third party that has not been obtained prior to the Closing Date, this Agreement shall not constitute an agreement to assign any such Assigned Contract or Order if an attempted assignment without any such consent would constitute a breach or violation thereof. In order, however, to seek to provide Oscient the full realization and value of the Assigned Contracts and Orders of the character described in the immediately preceding sentence (i) at the Closing, Oscient and Reliant shall agree on a list of those Assigned Contracts and Orders, if any, that still require consent; and (ii) until all such consents are obtained or all such Assigned Contracts and Orders expire or are terminated, Reliant and Oscient shall cooperate, in all commercially

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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reasonable respects, to provide to Oscient the benefits under the Assigned Contracts and Orders (with Oscient entitled to all the gains and responsible for all the losses, Taxes and/or Liabilities thereunder), subject to all burdens and Liabilities thereunder, provided that neither Party shall be required to make any payments or agree to any material undertakings in connection therewith. Oscient shall perform and comply with, at Oscient’s cost, all of Reliant’s obligations under the Assigned Contracts and Orders. Oscient agrees that, except as expressly provided in this Agreement, neither Reliant nor any of its Affiliates shall have any Liability whatsoever arising out of or relating to the failure to obtain any consents (including the Required Consents) required in connection with the transactions contemplated by this Agreement or because of the default under or acceleration or termination of any contract, agreement, commitment, license or right, as a result thereof. Oscient further agrees that no covenant of Reliant contained herein shall be breached or deemed breached, no condition to Oscient’s obligations to close the transactions contemplated by this Agreement shall be deemed not satisfied as a result of the failure to obtain any consent under the Assigned Contracts and Orders other than the Required Consents.

(b) Bundled Contracts. The Parties recognize and agree that the Bundled Contracts cover both the Product and other products of Reliant and that the Bundled Contracts are not being assigned to Oscient under this Agreement. For a period not to exceed sixty (60) days following the Closing, Reliant shall diligently assist Oscient in the transition of the Product onto replacement contracts with Oscient by making introductions to the appropriate counterparties and notifying such counterparties of Oscient’s acquisition of the Product pursuant to customary termination letters. Reliant shall use commercially reasonable efforts to terminate as promptly as reasonably possible the Bundled Contracts solely to the extent that such contracts relate to the Product.

2.6 Retention of Certain Rights By Reliant; Grant-Back License by Oscient. The Parties agree and acknowledge that, as between Reliant and Oscient, Reliant retains all rights to (i) develop and commercialize the Product outside of the Territory (other than rights transferred to Oscient pursuant to the Ethypharm Agreement Transfer Agreement, if applicable), and (ii) to develop and commercialize the Excluded Combination Product within and/or outside of the Territory (other than the right to manufacture or have manufactured the Reliant Products (as defined in the Settlement Agreement) outside the United States, its territories and possessions solely for distribution and sale in the United States, its territories and possessions in accordance with the terms and conditions of the Settlement Agreement). In connection therewith, Oscient hereby grants to Reliant (or, at Reliant’s request, Reliant’s third part designee):

(a) an exclusive right and license under the Product Intellectual Property (other than the Product Trademark, the Product Trade Dress, Product Domain Names and copyrights (registered or otherwise) contained in the Promotional Materials) solely to research, develop, obtain regulatory approval for, make, have made, use, commercialize, offer for sale, sell or import/export (i) the Product (as it is currently being sold prior to Closing by Reliant within the Territory) in and to any and all locations outside of the Territory (other than the right to manufacture or have manufactured the Reliant Products (as defined in and in accordance with the Settlement Agreement) outside the United States, its territories and possessions solely for distribution and sale in the United States, its territories and possessions in accordance with the

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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terms and conditions of the Settlement Agreement); and (ii) the Excluded Combination Product in and to any and all locations within and outside of the Territory;

(b) a non-exclusive right and license under the Product Intellectual Property (other than the Product Trademark, the Product Trade Dress, Product Domain Names and copyrights (registered or otherwise) containing the Promotional Materials) to make and have made within the Territory solely for importation, commercialization and sale by Reliant, its Affiliates (and their licensees and sublicensees) outside of the Territory, the Product (as it is currently being sold prior to Closing by Reliant within the Territory);

(c) any and all rights of reference, access and such similar rights and licenses as may be required for Reliant to reference, incorporate or otherwise rely upon (A) any clinical data related to the Product as of the Closing and (B) the Registrations (including any data and information contained therein ) as the same may exist at, and at any time following, the Closing, in each case as may be necessary or desirable for Reliant (i) to secure a label amendment for its Omacor product, (ii) to research, develop, obtain regulatory approval for, make, have made, use, commercialize, offer for sale, sell or import/export any Excluded Combination Product; or (iii) to research, develop, obtain regulatory approval for, make, have made, use, commercialize, offer for sale, sell or import/export the Product (as it is currently being sold prior to Closing by Reliant within the Territory) outside of the Territory.

Nothing herein gives Reliant a right to advertise, market, or otherwise actively solicit orders for the Product from customers located within the Territory or to sell Product to such customers. Reliant agrees not to sell and agrees to include in its agreements with licensees, sublicensees and other agents that they will not sell, the Product for export back into the Territory. Reliant agrees not to sell to any party it reasonably believes is purchasing the Product for export back into the Territory. In addition, the Parties shall discuss opportunities for Reliant to specifically reference the Product Trademark as part of Reliant’s marketing of the indicated use of Omacor (or the Excluded Combination Product or any other product containing any * Compound marketed by Reliant) in conjunction with fenofibrate. Notwithstanding anything to the contrary in this Agreement, unless otherwise provided in a separate Agreement, neither Reliant nor any of its Affiliates shall have any right to use and shall not use the Product Trademark or the name “Antara” in any form or any derivate thereof in the Territory.

ARTICLE III

CONSIDERATION; ALLOCATION; PRORATIONS; DEFERRED

INVENTORY PAYMENT AND OTHER AGREEMENTS

3.1 Consideration.

(a) Payments At Closing. In consideration of the sale, assignment, conveyance, sublicense and delivery of the Acquired Assets under Article II, Oscient shall assume the Assumed Liabilities and pay to Reliant the following:

(i) Seventy-Eight Million Dollars ($78,000,000) (the “Purchase Price”); plus

(ii) the Inventory Payment Amount.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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(b) Inventory Payment Amount Adjustment. Oscient will have ten (10) days after the Closing Date to review the Inventory and to provide Reliant with a notice of any adjustments that Oscient believes need to be made to the Inventory Payment Amount to reflect the actual amount of Inventory delivered at Closing. Oscient and Reliant agree to cooperate in good faith to resolve any differences raised by Oscient’s notice within ten (10) days thereafter and agree that Reliant’s historic cost methodology (as reviewed with Oscient prior to the date hereof) shall be used to value the Inventory. Should the Parties agree that an adjustment to the Inventory Payment Amount shall be made, the paying Party shall promptly make a payment representing such adjustment to the other Party.

(c) Royalties on Net Sales of Additional Products.

(i) Following the Closing, Oscient shall pay to Reliant a royalty in an amount equal to [*] percent ([*]%) of Net Sales of any Additional Products in accordance with the provisions of this Section 3.1(c) (the “Royalty”); provided, however, that, in the event that Oscient is required to make royalty payments to one or more third parties (“Third Party Payments”) as consideration for a license to an issued patent or patents, in the absence of which the Additional Product could not legally be used or sold in the Territory, then Oscient shall have the right to reduce the Royalty by [*] percent ([*]%) of such Third Party Payments. Notwithstanding the foregoing, such reductions shall in no event reduce the Royalty to less than [*] percent ([*]%) of Net Sales. This Section 3.1(c) shall survive in full force and effect with respect to each Additional Product, on a product-by-product basis, until the later of (A) such time as such Additional Product, regardless of indication, would not infringe a valid claim of the Product Patents without regard to the license and assignment in this Agreement; and (B) [*] ([*]) years from the first commercial sale in the Territory of such Additional Product.

(ii) Oscient shall, within sixty (60) days after the end of each calendar quarter (or portion thereof) following first sale of any Additional Product in the Territory, provide to Reliant a report setting forth the total Net Sales of the Additional Products in the Territory, the “gross to net” adjustments, and the royalty payments due hereunder for the preceding calendar quarter (including, in each case, a reasonable description of the underlying calculations or support for such amounts, as applicable) (each, a “Quarterly Payment Report”), and Oscient shall pay to Reliant any Royalties due hereunder by wire transfer of immediately available funds within sixty (60) days after the end of each calendar quarter. Oscient shall keep, and shall cause each of its or any of its Affiliates, partners and licensees/sublicensees to keep, true and accurate books of account and shall keep and maintain such records and documents as are reasonably necessary for Reliant to determine the royalties due under this Agreement. For any period in which Oscient is obligated to make a Royalty payment pursuant to this Section 3.1(c), plus two (2) years thereafter, Reliant, through an independent certified public accountant of Reliant’s choice and reasonably acceptable to Oscient (it being agreed that Reliant’s then current corporate auditor is acceptable to Oscient), shall have the right to audit and validate Oscient’s Quarterly Payment Reports as well

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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as the information contained in such reports; provided, however, that, unless the prior audit resulted in an adjustment in Reliant’s favor, Reliant may not exercise such audit right more frequently than one (1) time in any twelve (12) month period. Any audit under this Section 3.1(c) shall be conducted during normal business hours, upon reasonable advance notice and in a manner that does not cause unreasonable disruption to the conduct of business of Oscient, and Reliant’s accountants will be advised on the confidentiality obligations of this Agreement and keep confidential any information obtained during such audit. If the Parties agree that the amount owed by Oscient was underpaid, Oscient shall pay any additional undisputed amount owed and all accrued interest thereon (calculated at the lower of (A) the then “prime rate” as reported in The Wall Street Journal plus [*] percent ([*]%) and (B) the highest rate allowable under applicable Law) to Reliant within five (5) Business Days after Oscient’s receipt of notice of such underpayment. If the amount underpaid was in excess of five percent (5%) of the amount owed, the reasonable fees for such audit shall also be paid by Oscient within five (5) Business Days after its receipt of notice of same; in all other circumstances, the cost of such audit will be borne by Reliant. If Oscient overpaid any amounts, Reliant shall pay such overpaid amount to Oscient within five (5) business days of the completion of such audit.

3.2 Prorations. Reliant and Oscient agree that all of the following items relating to the Acquired Assets will be prorated as of the Closing Date with Reliant liable to the extent such items relate to any time period up to and including the Closing Date (the “Reliant Prorated Liabilities”) and Oscient liable to the extent such items relate to periods on and after the Closing Date: (a) personal property Taxes (or other similar Taxes), if any, attributable to the Product or the Acquired Assets; and (b) fees, costs, rents, Taxes, royalties and other payment obligations payable by Reliant or Reliant’s Affiliates under any of the Assigned Contracts and Orders, to be assigned to or assumed by Oscient hereunder or for which Oscient is entitled to enjoy the practical benefits pursuant to Section 2.5. Reliant agrees to furnish Oscient with such documents and other records as Oscient reasonably requests in order to confirm all adjustment and proration calculations made pursuant to this Section 3.2.

3.3 Other Agreements. The Parties hereby covenant and agree to execute the Other Agreements simultaneously with the execution of this Agreement.

ARTICLE IV

CLOSING; CONDITIONS TO CLOSING

4.1 Closing. The Closing shall take place at the offices of Reliant at 10:00 a.m. (Eastern Time) on the second Business Day following the satisfaction or waiver of the conditions precedent specified in this Article IV (other than the conditions to be satisfied on the Closing Date, but subject to the waiver or satisfaction of such conditions), or at such other time and place as the parties hereto may mutually agree. The date on which the Closing shall occur is referred to herein as the “Closing Date”. The Parties to this Agreement will exchange (or cause to be exchanged) at the Closing the funds, agreements, instruments, certificates and other documents,

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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and do, or cause to be done, all of the things respectively required of each Party as specified in Sections 4.2(a) and 4.2(b).

4.2 Transactions at Closing. At the Closing, subject to the terms and conditions hereof, including, without limitation, the provisions of Section 4.3 and Section 4.4:

(a) Reliant’s Actions and Deliveries. Reliant shall:

(i) subject to Section 2.5, transfer and convey, or cause to be transferred and conveyed, to Oscient all of the Acquired Assets, including the Assigned Contracts and Orders;

(ii) execute and deliver to Oscient all of the Other Agreements to which Reliant is a party;

(iii) deliver to Oscient a letter from Reliant to the FDA, duly executed by Reliant, transferring the rights to the appropriate Registrations to Oscient, in a form reasonably satisfactory to Oscient;

(iv) transfer and convey, or cause to be transferred and conveyed, to Oscient the Inventory, which Reliant shall deliver to Oscient, EXW (INCOTERMS 2000) at Reliant’s distribution facility in Groveport, Ohio, which Inventory shall be picked up by or on behalf of Oscient during regular business hours at such location as soon as reasonably practicable after the Closing Date, but in no event more than fifteen (15) days thereafter (it being agreed that nothing in this Section 4.2(a)(iv) shall be deemed to restrict or limit either Party’s rights or obligations under Section 7.2(c));

(v) deliver to Oscient such other documents and instruments as may be reasonably necessary to effect or evidence the transactions contemplated by this Agreement and by the Other Agreements; and

(vi) execute and deliver to Oscient UCC-3 termination statements and any other documents necessary to terminate any Security Interest on any of the Acquired Assets.

(b) Oscient’s Actions and Deliveries. Oscient shall:

(i) deliver to Reliant payment, by wire transfer of immediately available funds to a bank account designated by Reliant, all payments due under Section 3.1(a);

(ii) execute and deliver to Reliant all of the Other Agreements to which Oscient is a party;

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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(iii) deliver to Reliant a letter from Oscient to the FDA duly executed by Oscient, assuming responsibility for Registrations from Reliant, in a form reasonably satisfactory to Reliant

(iv) deliver to Reliant a resale certificate for the Inventory as contemplated by Section 7.3(c); and

(v) deliver to Reliant such other documents and instruments as may be reasonably necessary to effect or evidence the transactions contemplated by this Agreement and the Other Agreements.

4.3 Conditions to the Obligations of Oscient. The obligation of Oscient to consummate the transactions contemplated by this Agreement shall be subject to the satisfaction of (or waiver in writing by Oscient) of the following conditions precedent:

(a) Performance of Agreements and Covenants. All agreements and conditions to be performed and complied with by Reliant hereunder on or prior to the Closing Date shall have been duly performed and satisfied by Reliant in all material respects.

(b) Representations and Warranties True. The representations and warranties of Reliant contained in this Agreement that are qualified as to materiality shall be true and correct, and all other representations and warranties of Reliant contained in this Agreement shall be true and correct in all material respects, in each such case on and as of the date of this Agreement, and on and as of the Closing Date, with the same effect as though made on and as of the Closing Date.

(c) Reliant’s Actions and Deliveries. Reliant shall have taken all actions and delivered to Oscient all documents as required under Section 4.2(a).

(d) Required Consents. The Required Consents shall have been obtained.

(e) HSR. All applicable waiting periods under the HSR Act shall have expired or otherwise terminated.

(f) No Material Adverse Effect. There shall not have occurred any Material Adverse Effect.

(g) Absence of Litigation/Court Order. No material litigation related to the Product or the Acquired Assets shall have commenced which would reasonably be expected to impair Oscient’s title to the Acquired Assets or preclude Oscient from consummating the transactions contemplated hereby, and no action or proceeding by any Governmental Authority having jurisdiction over the matter or other Person shall have been instituted, and no applicable Law shall have been enacted or come into effect, after the date hereof, which enjoins, restrains, or prohibits, or which seeks to enjoin, restrain or prohibit the consummation of the transactions contemplated hereby.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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(h) No Liens. All Persons having Security Interests in any of the Acquired Assets shall have released such Security Interests, and Reliant shall provide to Oscient evidence of such releases reasonably acceptable to Oscient.

4.4 Conditions to the Obligations of Reliant. The obligation of Reliant to consummate the transactions contemplated by this Agreement shall be subject to the satisfaction (or waiver in writing by Reliant) of the following conditions precedent:

(a) Performance of Agreements and Covenants. All agreements and conditions to be performed and complied with by Oscient and Parent in this Agreement or the Other Agreements on or prior to the Closing Date shall have been duly performed and satisfied by Oscient and Parent in all material respects.

(b) Representations and Warranties True. The representations and warranties of Oscient and Parent contained in this Agreement that are qualified as to materiality shall be true and correct, and all other representations and warranties of Oscient and Parent contained in this Agreement shall be true and correct in all material respects, in each such case on and as of the date of this Agreement and on and as of the Closing Date, with the same effect as though made on and as of the Closing Date.

(c) Oscient’s Actions and Deliveries. Oscient shall have taken all actions and delivered to Reliant all documents as required under Section 4.2(b).

(d) Required Consents. The Required Consents shall have been obtained.

(e) HSR. All applicable waiting periods under the HSR Act shall have expired or otherwise terminated.

(f) No Court Order. No action or proceeding by any Governmental Authority having jurisdiction over the matter or other Person shall have been instituted, and no applicable Law shall have been enacted or come into effect, after the date hereof, which enjoins, restrains, or prohibits, or which seeks to enjoin, restrain or prohibit the consummation of the transactions contemplated hereby.

ARTICLE V

REPRESENTATIONS AND WARRANTIES OF RELIANT

Except as set forth on the disclosure schedules delivered by Reliant to Oscient in connection with the execution of this Agreement (the “Reliant Disclosure Schedule”) (it being expressly agreed that disclosure of any item under any section or subsection in the Reliant Disclosure Schedule, or in attachments thereto or documents referred to therein, in a manner which is readily apparent that it refers to other sections or subsections of the Reliant Disclosure Schedule, shall be deemed disclosure for such other sections or subsections under this Article V), Reliant represents and warrants to Oscient as follows (it being agreed, solely for the purposes of this Article V, that “Reliant” shall include Reliant’s subsidiaries, as applicable):

5.1 Organization. Reliant is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware. Reliant has all requisite corporate power and authority to own, lease and operate, as applicable, the Acquired Assets.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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5.2 Due Authorization. Reliant has all requisite corporate power and authority to execute, deliver and perform its obligations under this Agreement and the Other Agreements, and to consummate the transactions contemplated hereby and thereby. The execution and delivery of this Agreement and the Other Agreements and the performance of all of its obligations hereunder and thereunder has been duly authorized by Reliant.

5.3 No Conflicts; Enforceability. The execution, delivery and performance of this Agreement and the Other Agreements by Reliant is not prohibited or limited by, and will not result in the breach of or a default (i) under, any provision of the Certificate of Incorporation or Bylaws of Reliant, (ii) of any applicable Law, order, judgment, writ, injunction or decree of any court or Governmental Authority, or (iii) under, or impair Reliant’s rights or alter the rights or obligations of any third party under, or give to others any rights of termination, amendment, acceleration or cancellation of, or result in the creation of any Security Interest on, any of the Acquired Assets. This Agreement and the Other Agreements have been duly executed and delivered by Reliant and constitute, the valid and binding obligations of Reliant, legally enforceable against Reliant in accordance with their respective terms, except as enforceability may be limited or affected by applicable bankruptcy, insolvency, moratorium, reorganization or other Laws of general application relating to or affecting creditors’ rights generally.

5.4 Title.

(a) Except as set forth on Schedule 5.4 of the Reliant Disclosure Schedule, Reliant is the owner of the Acquired Assets, free and clear of all Security Interests and no other Person has any legal title to or beneficial interest in any of the Acquired Assets to be transferred to Oscient hereunder. At the Closing, Oscient will receive legal and beneficial title to all of the Acquired Assets, free and clear of all Security Interests.

(b) To Reliant’s Knowledge, and subject to the receipt of the Required Consents, except for the Acquired Assets and the Reliant Brands (as licensed to Oscient pursuant to the terms of the Inventory Trademark License), there are no other regulatory registrations or Intellectual Property of the types included in or as part of the Acquired Assets owned by or licensed to Reliant necessary to make, have made, use or sell the Product in the Territory for the indications specified in the Registrations on the Closing Date and substantially in the manner Reliant engaged in such activities as of the Closing Date in the ordinary course of its business.

5.5 Intellectual Property.

(a) Subject to the receipt of the Required Consents, except as set forth on Schedule 5.5(a) of the Reliant Disclosure Schedule, the Product Intellectual Property is freely assignable and has not been and is not the subject of any pending or, to Reliant’s Knowledge, threatened adverse claim, judgment, injunction, order, decree or agreement restricting the use or assignment thereof by Reliant.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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(b) Subject to the receipt of the Required Consents, except as set forth on Schedule 5.5(b) of the Reliant Disclosure Schedule, to Reliant’s Knowledge, there are no circumstances in existence such that the Acquired Assets, the manufacture, importation or marketing of the Product for sale in the Territory may infringe any patent, trademark, trade name, copyright or legally protectable right of another Person nor are there in existence any claims asserted or threatened by third parties with respect to the foregoing. To Reliant’s Knowledge, no third party has infringed or misappropriated any Product Intellectual Property in the Territory.

(c) Other than the Product Domain Name, there are no other domain name registrations owned by Reliant incorporating the Product Trademark or directly related to the Product Trademark, in whole or in part. To Reliant’s Knowledge, no domain names comprised in whole or in part of the Product Trademark have been registered by third persons.

(d) Schedule 5.5(d) of the Reliant Disclosure Schedule contains a true and complete list of Product Intellectual Property registered or pending in the Territory. To Reliant’s Knowledge, all of the registrations and applications relating to the Product Intellectual Property in the Territory are in good standing, with all fees, payments and filings due prior to the date hereof duly made. Reliant has made available to Oscient copies of all registrations and applications relating to the Product Trademark and Product Patents and material written documentation evidencing ownership and prosecution of the same, in each case as are in Reliant’s possession.

(e) Reliant has taken commercially reasonable measures to protect the secrecy, confidentiality and value of all trade secrets and confidential information included in the Acquired Assets, the Product, and the Product Line Operations consistent with Reliant’s practices with respect to other products of a similar value.

(f) To Reliant’s Knowledge, none of the Product Intellectual Property has been canceled or adjudicated invalid or is subject to any outstanding order, judgment or decree restricting its use or adversely affecting Reliant’s rights therein, nor has been abandoned.

(g) Reliant has no Knowledge of any past or current unauthorized re-importation or importation into the Territory of any Products or any corresponding infringing or gray market goods.

5.6 Litigation. Except as set forth on Schedule 5.6 of the Reliant Disclosure Schedule, there is no action, suit, litigation, proceeding, claim, governmental investigation or administrative action pending or, to Reliant’s Knowledge, threatened directly or indirectly involving the Product or the transactions contemplated hereby.

5.7 Consents. Except for those notices, filings, authorizations, exemptions and consents set forth on Schedule 5.7 of the Reliant Disclosure Schedule (including the Required Consents), no notice to, filing with, authorization of, exemption by, or consent of, any Person, including any Governmental Authority, is required for Reliant to consummate the transactions contemplated hereby.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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5.8 Brokers, Etc. No broker, investment banker, agent, finder or other intermediary acting on behalf of Reliant or under the authority of Reliant is or will be entitled to any broker’s or finder’s fee or any other commission or similar fee directly or indirectly in connection with any of the transactions contemplated hereby.

5.9 Compliance with Laws; Regulatory Matters. Reliant has materially complied with all applicable Laws relating to the Product, the Product Line Operations and the Acquired Assets. The Registrations and all such other permits, government licenses, registrations, approvals, concessions, franchises and authorizations required for the manufacturing, marketing, sale and distribution of the Product in the Territory are in full force and effect. Without limiting the generality of the foregoing sentence, Reliant represents and warrants that, except as set forth in Schedule 5.9 of the Reliant Disclosure Schedule:

(a) neither Reliant nor to Reliant’s Knowledge Ethypharm has (i) received a warning letter or Form FDA 483 from any Governmental Authority with jurisdiction over the Product; (ii) any notice of any Governmental Authority detention, seizure, injunction, consent decree, notice of criminal investigation, indictment, sentencing memorandum, plea agreement, court order, target or no-target letter, or other investigation relating to the Product; or (iii) initiated or been required to effect any product recall, market withdrawal, stock replacement, or post-sale warning relating to the Product;

(b) to Reliant’s Knowledge, the Product has been manufactured, processed, packaged, labeled, stored and shipped in material compliance with applicable Law, including the current good manufacturing practice requirements of 21 U.S.C. § 351(a) and 21 C.F.R. Parts 210 and 211;

(c) to Reliant’s Knowledge, Reliant has advertised, marketed, and promoted Product in material compliance with applicable Law, including the Act, the PDM Act, the False Claims Act (31 U.S.C. §§ 3729-3733), the Social Security Act Anti-Kickback Prohibitions (42 U.S.C. § 1320a-7b), and state law equivalents of the foregoing; and

(d) Reliant has furnished Oscient with access to a complete and accurate copy of the Product NDA and all material related FDA correspondence, including all amendments and supplements thereto.

5.10 Product Liability. There are no pending, or to Reliant’s Knowledge, threatened product liability, warranty or similar claims by any third party (whether based on contract or tort and whether relating to personal injury including death, property damage or economic loss) arising from marketing or sale of the Product by Reliant.

5.11 No Current Intention to Market Other Fenofibrate Monotherapy Product. Reliant has no current intention to market or promote any prescription pharmaceutical product in which fenofibrate is the sole pharmaceutically active ingredient at any time prior to June 19, 2008.

5.12 Contracts. Reliant has delivered or made available to Parent true, correct and complete copies of all Assigned Contracts and Orders, the Settlement and the Ethypharm

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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Agreement. Except as set forth in Schedule 5.12 of the Reliant Disclosure Schedule, (a) the Assigned Contracts and Orders and the Ethypharm Agreement are in full force and effect, and are the valid and binding obligations of Reliant and, to Reliant’s Knowledge, the other parties thereto, (b) each Assigned Contract and Order is freely and fully assignable to Oscient without penalty and no consent of or notice to any third party is required in order to validly assign and transfer the Assigned Contracts and Orders to Oscient; (c) Reliant has not received notice of default by Reliant under any of the Assigned Contracts and Orders or the Ethypharm Agreement; (d) Reliant is not in breach, violation or default (and would not by the lapse of time or the giving of notice or both be in default) of any of the Assigned Contracts and Orders or the Ethypharm Agreement, except to the extent to which such breach, violation or default has not had or would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (e) to the Knowledge of Reliant, none of the other parties to any of the Assigned Contracts and Orders or the Ethypharm Agreement is in default thereunder.

5.13 Financial Information. Schedule 5.13 of the Reliant Disclosure Schedule sets forth a list and description of certain financial information previously provided to Parent by Reliant including, among other things, gross sales and net sales, with respect to Product in the Territory (the “Financial Information”). The Financial Information was based upon the information contained in the books and records of Reliant and is accurate in all material respects, except that all adjustments required by U.S. generally accepted accounting principles may not have been made.

5.14 Absence of Certain Changes. Since June 19, 2006, Reliant and its Affiliates have conducted all activities in the ordinary course of business consistent with past practices, including the promotion of the Product and the sale or offer for sale of the Product in the Territory.

5.15 Inventory. To Reliant’s Knowledge, the Inventory complies with all specifications for the Product set forth under the Ethypharm Agreement, complies with all applicable Laws, has not been adulterated or misbranded within the meaning of the Act, and has been manufactured under cGMP conditions.

5.16 Principal Purchaser/Wholesalers. Schedule 5.16 of the Reliant Disclosure Schedule contains a true and complete list of Reliant’s top ten purchasers/wholesalers (by dollar volume purchased/gross sales) with respect to the Product since February 2, 2005 and the aggregate dollar amount of their respective purchases.

5.17 Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN ARTICLE V (INCLUDING THE RELIANT DISCLOSURE SCHEDULE), RELIANT IS MAKING NO REPRESENTATION OR WARRANTY AS TO THE ACQUIRED ASSETS, THE PRODUCT OR THE PRODUCT LINE OPERATIONS, AND OSCIENT ACKNOWLEDGES AND AGREES THAT, EXCEPT AS OTHERWISE PROVIDED HEREIN, RELIANT IS SELLING AND CONVEYING THE ACQUIRED ASSETS AND THE PRODUCT ON AN “AS IS, WHERE IS” BASIS. EXCEPT TO THE EXTENT OF THE EXPRESS REPRESENTATIONS, WARRANTIES, AGREEMENTS AND COVENANTS CONTAINED IN THIS AGREEMENT, OSCIENT IS ACQUIRING THE ACQUIRED

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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ASSETS AND THE PRODUCT IN RELIANCE ON ITS OWN INVESTIGATION AND ON AN “AS IS, WHERE IS” BASIS AND WITHOUT RECOURSE AND WITHOUT ANY REPRESENTATION OR WARRANTY OF MERCHANTABILITY, FITNESS FOR ANY PARTICULAR PURPOSE, NON INFRINGEMENT OR ANY OTHER IMPLIED OR EXPRESS WARRANTIES WHATSOEVER. Oscient acknowledges and agrees that, except as otherwise expressly set forth in Article V (including the Reliant Disclosure Schedules), none of Reliant, its Affiliates nor any of their respective representatives has made any representation or warranty, express or implied, as to the accuracy or completeness of any memoranda, charts, summaries, projections or schedules heretofore made available by Reliant or its representatives to Oscient, or any information that is not included in this Agreement or referred to on the Schedules hereto, and except for the information included in this Agreement or referred to on the Schedules, neither Reliant, nor any of its representatives will have or be subject to any Liability to Oscient, Parent, any of its Affiliates or their representatives resulting from the distribution of any such information to, or the use of any such information by, Oscient, any of its Affiliates or any of their representatives.

ARTICLE VI

REPRESENTATIONS AND WARRANTIES OF OSCIENT AND PARENT

6.1 Oscient’s Representations and Warranties. Oscient represents and warrants to Reliant as follows:

(a) Organization. Oscient is a corporation duly organized and validly existing and in good standing under the laws of the State of Delaware. Oscient is a wholly owned subsidiary of Parent. Oscient has all requisite corporate power and authority to own, lease and operate its properties and to carry on its business as now being conducted.

(b) Due Authorization. Oscient has all requisite corporate power and authority to execute, deliver and perform its obligations under this Agreement and the Other Agreements and the execution and delivery of this Agreement and the Other Agreements and the performance of all of its obligations hereunder and thereunder has been duly authorized by Oscient.

(c) No Conflicts; Enforceability. The signing, delivery and performance of this Agreement and the Other Agreements by Oscient is not prohibited or limited by, and will not result in the breach of or a default under, any provision of the organization documents or other formation documents of Oscient, or of any material agreement or instrument binding on Oscient, or of any applicable order, writ, injunction or decree of any court or governmental instrumentality, except for such prohibition, limitation or default which would not prevent consummation by Oscient of the transactions contemplated hereby. This Agreement and the Other Agreements have been duly executed and delivered by Oscient and constitute the valid and binding obligations of Oscient, legally enforceable against Oscient in accordance with their respective terms, except as enforceability may be limited or affected by applicable bankruptcy, insolvency, moratorium, reorganization or other Laws of general application relating to or affecting creditors’ rights generally.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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(d) Consents. Other than with respect to the HSR filings set forth in Section 7.5(a), no notice to, filing with, authorization of, exemption by, or consent of, any Person, including any Governmental Authority, is required for Oscient to consummate the transactions contemplated hereby and by the Other Agreements.

(e) Litigation. There is no legal proceeding pending or, to Oscient’s Knowledge, threatened in writing, and relating to or affecting Oscient’s ability to perform its obligations hereunder or under the Other Agreements, or to assume the Assumed Liabilities.

(f) Brokers, Etc. No broker, investment banker, agent, finder or other intermediary acting on behalf of Oscient or under the authority of Oscient is or will be entitled to any broker’s or finder’s fee or any other commission or similar fee directly or indirectly in connection with any of the transactions contemplated hereby.

(g) Financing. Oscient has cash on hand or existing lines of credit to provide, in the aggregate, monies sufficient to fund the Purchase Price. Attached hereto as Schedule 6.1(g) is an executed bank commitment letter or similar evidence of Oscient’s ability to fund the amounts due hereunder at Closing.

(h) Independent Investigation. In making the decision to enter into this Agreement and the Other Agreements and to consummate the transactions contemplated hereby and thereby, other than reliance on the representations, warranties, covenants and obligations of Reliant set forth in this Agreement, Oscient has relied solely on its own independent investigation, analysis and evaluation of the Acquired Assets, Assumed Liabilities, the Product and the Product Line Operations (including Oscient’s own estimate and appraisal of the value of the financial condition, assets, Liabilities, operations and prospects of the Product). Oscient confirms to Reliant that Oscient is sophisticated and knowledgeable in the with respect to the pharmaceutical business, and is capable of evaluating the matters set forth above.

6.2 Parent’s Representations and Warranties. Parent represents and warrants to Reliant as follows:

(a) Organization. Parent is a corporation duly organized and validly existing and in good standing under the laws of the Commonwealth of Massachusetts.

(b) Due Authorization. Parent has all requisite corporate power and authority to execute, deliver and perform its obligations under this Agreement and the execution and delivery of this Agreement and the performance of all of its obligations hereunder has been duly authorized by Parent.

(c) No Conflicts; Enforceability. The signing, delivery and performance of this Agreement by Parent is not prohibited or limited by, and will not result in the breach of or a default under, any provision of the organization documents or other formation documents of Parent, or of any material agreement or instrument binding on Parent, or of any applicable order, writ, injunction or decree of any court or governmental instrumentality, except for such prohibition, limitation or default which would not prevent consummation by Parent of the

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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transactions contemplated hereby. This Agreement has been duly executed and delivered by Parent and constitutes the valid and binding obligation of Parent, legally enforceable against Parent in accordance with its terms, except as enforceability may be limited or affected by applicable bankruptcy, insolvency, moratorium, reorganization or other Laws of general application relating to or affecting creditors’ rights generally.

ARTICLE VII

COVENANTS; OTHER AGREEMENTS

7.1 Availability of Records. After the Closing, Reliant and Oscient shall make available to each other Party for use and to make copies as reasonably requested by such other Party, its agents and representatives, any Tax authority, or any Governmental Authority all information, records and documents in its possession relating to the Acquired Assets, Assumed Liabilities and/or the Product for all periods prior to Closing and shall preserve all such information, records and documents until the later of: (a) six (6) years after the Closing Date; (b) the expiration of all statutes of limitations for assessing or collecting Taxes for periods ending on or prior to the Closing and periods including the Closing Date, including extensions thereof applicable to Reliant or its Affiliates; or (c) the required retention period under any applicable Laws for all government contract information, records or documents (it being understood that the Parties shall not be required to provide any Tax returns to any Person, other than as required by applicable Laws). Reliant and Oscient shall also make available to each other, during normal business hours, when reasonably requested, personnel responsible for preparing or maintaining information, records and documents, in connection with Tax matters, governmental contracts, litigation or potential litigation, each as it relates to the Product prior to the Closing Date (with respect to Reliant) or from and after the Closing Date (with respect to Oscient), including, without limitation, product liability and general insurance liability.

7.2 Certain Transitional Matters.

(a) Use of Trade or Service Marks. Other than pursuant to the Inventory Trademark License and the Assignment of Trademark, neither Oscient nor any of Oscient’s Affiliates shall use or permit its distributors to use the Reliant Brands.

(b) New NDC Number; Inventory Labeling. Oscient shall use commercially reasonable efforts to obtain a new NDC Number for the Product within thirty (30) days following the Closing and shall use commercially reasonable efforts to commence labeling the Product with Oscient’s NDC Number as soon as practicable following the Closing, but in no event later than sixty (60) days thereafter; provided, however, Oscient and its Affiliates will have no obligation to re-label or over-label the Inventory. Following the Closing, Oscient shall have no right to manufacture or have manufactured any Product that is labeled or otherwise packaged with Reliant’s NDC Number without the prior written consent of Reliant on a partial-lot-by-partial-lot basis.

(c) Purchase Order/Inventory Processing Transition. Reliant shall stop shipping any open purchase orders for no longer than twenty-four (24) hours following the expiration of the waiting period under the HSR Act (or, if early, following Reliant’s receipt

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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notice of early termination of the review period thereunder). Thereafter, subject the Closing of the transactions contemplated by this Agreement, Reliant agrees to process purchase orders on behalf of Oscient, for a period of up to three (3) Business Days, as directed by Oscient on a purchase order-by-purchase order basis. The Parties agree that this provision is intended to allow Oscient sufficient time to pick up requisite quantities of Inventory and to assume purchase order processing responsibility as soon as possible following the Closing. Under no circumstances shall Reliant be obligated to process any purchase orders on behalf of Oscient prior to the Closing or following the close of business on the third (3rd) day following the Closing.

(d) Sales Force Training. Following the date of this Agreement until the date that is fourteen (14) days following the Closing Date, Reliant agrees to make appropriate personnel available to assist with the training of Oscient’s sales force for the promotion of the Product for a period not to exceed two (2) days; provided, however, that (i) all reasonable costs and expenses to be incurred by or on behalf of Reliant in connection therewith (including, without limitation, transportation, lodging and meals) shall be funded by Oscient in advance, paid for directly by Oscient or reimbursed by Oscient to Reliant immediately upon Reliant’s submission to Oscient of receipts or other appropriate documentation (it being further agreed that, in the event that such training occurs prior to Closing and the Closing does not occur for any reason, Oscient shall nevertheless be required to fund/reimburse such expenses in full such that Reliant is not required to incur any costs or liability in connection therewith); (ii) the training location shall be in the continental United States and shall be accessible by Reliant’s personnel via non-stop flights from Newark, New Jersey; and (iii) in the event that such training occurs prior to Closing, all Oscient personnel participating in such training activities shall sign confidentiality/non-disclosure agreements, in form and substance reasonably satisfactory to Reliant, to protect Reliant’s Confidential Information for all periods prior to the Closing (including in the event that the Closing does not occur for any reason).

(e) No Co-Promotion. For the avoidance of doubt, the Parties agree and acknowledge that there shall be no co-promotion of the Product between Reliant and Oscient (including, without limitation, any members of their respective sales forces), whether prior to or following the Closing.

7.3 Tax Matters; Bulk Sales.

(a) Tax Matters. After the Closing Date, Oscient and Reliant shall cooperate in filing of any Tax returns or other Tax-related forms or reports, to the extent such filing requires providing each other with necessary relevant records and documents relating to the Acquired Assets or the Product, or providing reasonable access to employees. Reliant and Oscient shall cooperate in the same manner in (i) defending or resolving any Tax audit, examination or tax-related litigation relating to the Acquired Assets or the Product; and (ii) to minimize any transfer, sales and use Taxes and notarial and registry fees and recording costs.

(b) Transfer Taxes. All excise, sales, use, transfer, stamp, documentary, filing, recordation and other similar taxes together with any notarial and registry fees and recording costs and any interest, additions or penalties with respect thereto and any interest in

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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respect of such additions or penalties (“Transfer Taxes”) resulting directly or indirectly from the transfer by Reliant of the Acquired Assets to Oscient, including but not limited to the transfer of the Registrations shall be borne entirely by Oscient, and Oscient shall indemnify Reliant and its Affiliates against any Liabilities arising in connection therewith.

(c) Inventory Resale Certificates. At the Closing, Oscient shall execute and deliver to Reliant resale certificates for all Inventory sold to Oscient.

(d) Bulk Sales Laws. Reliant and Oscient waive compliance with bulk sales Laws in connection with the purchase and sale of the Acquired Assets and the Product.

7.4 Pre-Closing Matters.

(a) Product Line Operations. Except as otherwise contemplated under this Article VII, prior to the Closing, Reliant shall conduct its business with respect to the Product and the Product Line Operations only in the ordinary course of business consistent with past practice, including without limitation, using commercially reasonable efforts to (i) maintain the Product Intellectual Property and the NDA, (ii) continue consistent promotional efforts of the Product and sales of the Product to major customers consistent with such major customer’s historical purchase pattern and volume, (iii) not enter into any new contracts related to the Product or other Acquired Assets or amending Other Agreements or amending the NDA, (iv) granting any third parties any right, title or interest in the Acquired Assets (other than sales of Product inventory in the ordinary course), (v) avoid creating any additional Securities Interests in the Acquired Assets, the Product or the Product Line Operations, and (vi) maintain in effect all Assigned Contract and Orders and preserve the present relationships of Reliant with vendors, customers, suppliers, licensees and other Persons related to the promotion, sale and distribution of the Product. Reliant agrees that after the date hereof, except as specifically permitted by this Agreement, it will not take any action with respect to any Assigned Contracts and Orders that would extend the term of such Assigned Contracts and Orders with respect to any Product, create or agree to any additional obligations with respect to any Product or change the pricing under any of the existing Assigned Contracts and Orders. Reliant will pay and discharge the Excluded Liabilities as and when the same become due and payable.

(b) Accounts Receivable Related to Pre-Closing Periods. The Parties acknowledge and agree that all Accounts Receivable shall remain the property of Reliant or Reliant’s Affiliates and shall be collected by Reliant or Reliant’s Affiliates subsequent to the Closing. In the event that, subsequent to the Closing, Oscient or any of Oscient’s Affiliates receives any payments of any kind from any obligor with respect to an Account Receivable, then, Oscient shall within fifteen (15) Business Days of receipt of such payment remit, without offset or deduction, the full amount of such payment to Reliant up to the amount owed to Reliant by the obligor until such time as the Accounts Receivables with respect to such obligor are paid in full to Reliant. In the event that, subsequent to the Closing, Reliant or any Reliant’s Affiliates receives any payments of any kind from any obligor with respect to account receivables created by Oscient or its Affiliates after the Closing, then, Reliant shall within fifteen (15) Business Days of receipt of such payment remit, without offset or deduction, the full amount of such payment to Oscient or its Affiliates up to the amount owed to Oscient or its Affiliates by the obligor.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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(c) Standstill. From the date hereof until the earlier of the Closing or the termination of this Agreement in accordance with its terms, Reliant shall not, nor shall it permit any of its Affiliates to, nor shall they authorize or permit any of its, officers, directors, employees, representatives or agents, directly or indirectly, to actively solicit, facilitate, initiate, entertain, encourage or take any action to solicit, facilitate, initiate, entertain or encourage, any proposal or offer that constitutes or may constitute an Acquisition Proposal (as defined herein). For purposes of this Agreement, the term “Acquisition Proposal” shall mean any inquiry, proposal or offer from any Person (other than Oscient or any of its Affiliates) relating to the sale, transfer, lease, exchange, license or other disposition of any of the Acquired Assets or rights to the Product. Notwithstanding the foregoing, Reliant may continue any existing discussions or negotiations with any Persons or entities conducted heretofore with respect to any Acquisition Proposal.

(d) Notification. Prior to the Closing Date, each Party and Parent shall promptly notify the other Parties if such Party or Parent has knowledge that (a) any representation or warranty of any Party or Parent in this Agreement (including the Disclosure Schedule) or any Other Agreement is not true and correct, (b) that there are any errors in, or omission from, the Reliant Disclosure Schedule to this Agreement or any Other Agreement; or (c) that any Party or Parent is in breach of any covenant under this Agreement or any Other Agreement.

(e) Amendment to Ethypharm Agreement; Consent to Assignment. The Parties acknowledge that Reliant is currently in discussions with Ethypharm regarding an amendment to the Ethypharm Agreement (the “Ethypharm Amendment”). Reliant agrees that it shall keep Oscient informed of the progress of negotiations regarding the Ethypharm Amendment and shall not execute the Ethypharm Amendment without the prior consent of Oscient, which consent shall not be unreasonably withheld, delayed or conditioned. Oscient hereby agrees that in the event that the Ethypharm Amendment is substantially identical to the form of Ethypharm Amendment attached hereto as Exhibit 7.4(e), no consent of Oscient shall be required for Reliant to execute and deliver such amendment. For the avoidance of doubt, the Parties agree that the execution and delivery of the Ethypharm Amendment in accordance with this Section 7.4(e) is expressly permitted and shall not constitute a breach of any covenant, representation or warranty of Reliant hereunder. In addition, Reliant shall use commercially reasonable efforts to obtain the consent of Ethypharm to the assignment of the Ethypharm Agreement to Oscient, provided that Reliant shall not be required to make any payments or agree to any material undertakings in connection therewith other than the execution and delivery of the Ethypharm Amendment. In the event that Ethypharm consents to the assignment of the Ethypharm Agreement, the Parties agree that they shall immediately execute and deliver the Assignment and Assumption of Contract with respect to the Ethypharm Agreement substantially in the form attached hereto as Exhibit D-1 and, as applicable, any Sublicense Agreement previously executed in respect of the Ethypharm Agreement between the Parties shall thereupon terminate.

(f) Access to Premises and Information. Subject to applicable Laws, upon reasonable notice and subject to supervision by Reliant or its agents and to the restrictions contained in confidentiality agreements to which such party is subject, between the date of this

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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Agreement and the Closing Date, Reliant will (a) permit Oscient and its authorized representatives to have reasonable access during normal operating hours for auditing purposes to the facilities where the Inventory is held and to the books and records of Reliant relating to the Acquired Assets, (b) permit Oscient to make such inspections and to make copies of such Records as it may reasonably require, and (c) furnish Oscient with such financial and operating data and other information as Oscient may from time to time reasonably request.

7.5 HSR Filing, Approvals and Conditions; Further Assurances.

(a) HSR Filing, Approvals and Conditions. Subject to the other provisions of this Agreement, each Party shall use its commercially reasonable efforts to perform its obligations hereunder and to obtain all regulatory approvals and satisfy all conditions to the obligations of the Parties under this Agreement and to cause the transactions contemplated hereby to be effected as soon as reasonably practicable and prior to the Outside Date, in accordance with the terms hereof, and shall cooperate fully with each other Party and such other Party’s respective officers, directors, employees, agents, legal counsel, accountants and other designees in connection with any steps required to be taken as a part of their respective obligations under this Agreement and the Other Agreements. In addition, each of the Parties shall promptly make their respective filings and submissions and shall take, or cause to be taken, all actions and do, or cause to be done, all things necessary, proper or advisable under applicable Laws and regulations, including the HSR Act to obtain any required approval of any U.S. federal, State or local or non-U.S. governmental agency or regulatory body with jurisdiction over the transactions contemplated hereby (it being agreed that the HSR filings shall be made within five (5) Business Days of the date of this Agreement).

(b) Further Assurances. From time to time, as and when requested by any Party, each of the Parties hereto shall, and shall cause its respective Affiliates to, at such Party’s expense except as otherwise expressly provided in this Agreement, execute such documents and other instruments and take such further actions as may be reasonably required to carry out the provisions hereof and the Other Agreements and consummate and evidence the transactions contemplated hereby and thereby, including executing and delivering or causing to be executed and delivered to the other Party such assignments, deeds, bills of sale, assumption agreements, consents and other instruments of transfer or assumption as the other Party or its counsel may reasonably request as necessary for such purpose (it being understood that any such assignment, deed, bill of sale, assumption agreement, consent or other instrument of transfer or assumption shall not provide for any representations, warranties, Liabilities that are not provided for in this Agreement).

7.6 Notifications.

(a) Notifications of Customers. Promptly after the Closing, Oscient and Reliant shall jointly notify the wholesale distributors of the Product listed on Schedule 7.6 (i) of the transfer of the Acquired Assets to Oscient, (ii) that all purchase orders for Product received by Reliant or any of its Affiliates prior to the Closing Date but not shipped prior to 11:59 p.m. (EST) on the Closing Date will be transferred to Oscient, provided that to the extent that any purchase order cannot be so transferred, Reliant and Oscient shall cooperate with each other to

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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ensure that such purchase order is filled and that Oscient receives the same economic benefit and assumes the same Liability associated with filling such purchase order as if such purchase order had been so transferred, and (iii) that all purchase orders for Product received by Reliant after the Closing Date should be sent to Oscient at address set forth in Section 11.15 herein. Oscient and Reliant shall agree upon an appropriate notice to wholesalers with respect to the transfer of chargeback submission, to Oscient effective thirty (30) days after the Closing Date.

(b) Other Notifications. Promptly after the Closing, Reliant shall send notices to all Persons that received Confidential Information about the Acquired Assets or the Product Line Operations in connection with making or potentially making Acquisition Proposals. The notices shall request that all such Confidential Information be destroyed or returned immediately. Reliant further agrees to use commercially reasonable efforts to enforce confidentiality agreements in place with such Persons at Oscient’s reasonable request and sole expense.

7.7 Product Returns. Oscient shall be responsible for processing all Product returns from and after the Closing Date, including, without limitation, any returns of Product sold by Reliant prior to the Closing Date, the reasonable cost of which, in the case of Products sold by Reliant prior to the Closing Date, shall be borne by Reliant. In the event that any Products are returned to Reliant, Reliant shall promptly notify Oscient of such returned products and shall use commercially reasonable efforts to cooperate with Oscient in order that Oscient may provide replacement Product therefore, the cost of which, in the case of Products sold by Reliant prior to the Closing Date, shall be borne by Reliant. Each of Oscient and Reliant shall be responsible to destroy, or cause to be destroyed, in a manner consistent with applicable Laws, all Product sold prior to Closing that is returned to it at its cost. Oscient shall invoice Reliant not more frequently than monthly with respect to all Product returns for which Reliant is obligated to reimburse Oscient under this Section 7.7 and Reliant shall pay such invoice within thirty (30) days without offset or reduction, other than with respect to amounts owed to Reliant pursuant to Sections 7.8 and 7.9. Notwithstanding any provision herein to the contrary, Oscient and its Affiliates shall not take any actions with the intention of encouraging or otherwise affirmatively causing Reliant’s customers or distributors to return Products (it being acknowledged and agreed that Oscient’s commencement of promotion, distribution and sale activities with respect to the Product shall not be deemed an action to encourage or otherwise affirmatively cause Reliant’s customers or distributors to return Products).

7.8 Pricing Contracts. All Chargebacks with respect to Product sales which occurred prior to the Closing or with respect to Product sales for which Reliant received the purchase price thereof shall be the liability of Reliant and all Chargebacks with respect to Product sales which occur after the Closing and with respect to which Product was sold by or on behalf of Oscient shall be the liability of Oscient. For the avoidance of doubt, the Parties agree that the Party that ultimately receives the benefit of a Product sale shall be liable for any related Chargeback on the underlying Product. Notwithstanding the preceding, in light of the difficulties of determining which party may have sold Product which is the subject of a wholesaler Chargeback as to which lot numbers are not included in the relevant Chargeback invoice, the Parties have agreed to assign liability for such Chargebacks (“Unidentified Claims”) as follows:

(a) All such Unidentified Claims with respect to wholesaler invoices to the trade dated on or before the date that is [*] ([*]) days after the Closing shall be the liability of Reliant and all such Unidentified Claims with respect to wholesaler invoices to the trade dated after the date that is [*] ([*]) days after the Closing shall be the liability of Oscient.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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(b) The Parties will cooperate and share all relevant wholesaler data so as to be able to allocate the liability for Chargebacks in accordance with the foregoing and to verify such allocations.

No later than seven (7) Business Days after Closing, Reliant shall terminate each Pricing Contract set forth on Schedule 7.8 with respect to the Product, with such termination to be effective no later than [*] ([*]) days after receipt of such termination notice for all Pricing Contracts except those specifically identified on Schedule 7.8 (which shall be terminated effective as of the date set forth on Schedule 7.8 attached hereto). Oscient shall honor the pricing set forth in such Pricing Contracts for all periods prior to such termination and shall be economically responsible for any Chargebacks related to such Pricing Contracts for Product dispensed beginning [*] ([*]) days after the Closing Date. For the avoidance of doubt, the Parties agree and acknowledge that during following the Closing Date, Reliant shall invoice Oscient in respect of any rebates paid pursuant to Pricing Contracts relating to Product sold by Oscient.

7.9 Medicaid and Other State Rebates. The Parties will administer and pay all rebates and other similar programs as follows:

(a) Sales of Product Under Reliant’s NDC Number. Reliant will process and be responsible for fulfillment of all reporting requirements and payment of all rebates owed under all federal and state government rebate programs, including Medicaid/Medicare rebates (collectively, “Rebate Programs”), in each case, related to Product sold under Reliant’s NDC Number, regardless of whether such Product was sold by Reliant or Oscient; provided, however, that Oscient will pay to Reliant (by wire transfer of immediately available funds to an account designated by Reliant) (i) within one-hundred and twenty (120) days of the Closing Date, [*] percent ([*]%) of the gross amount invoiced by Oscient during the first ninety (90) days following the Closing Date for Product bearing Reliant’s NDC Number (without regard to whether such customers have paid such invoices) and (ii) within thirty (30) days of the end of each calendar quarter thereafter, [*] percent ([*]%) of the gross amount invoiced by Oscient during such calendar quarter for Product bearing Reliant’s NDC Number (without regard to whether such customers have paid such invoices). Notwithstanding anything to the contrary in the foregoing, the Parties acknowledge and agree that nothing in this Section 7.9(a) is intended to result in a net profit or loss for either Party in respect of the matters covered in this Section 7.9(a).

(b) Sales of Product Under an NDC Number Other than Reliant’s. Oscient will process and be responsible for the administration and payment of all Rebate Programs, including Medicaid/Medicare rebates, as well as Chargebacks for the Product that is sold by Oscient in the Territory which bears an NDC Number other than Reliant’s NDC Number, and Reliant shall have no liability in respect thereof.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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7.10 Website Information. From and after twenty (20) days following the Closing Date, Reliant’s website and any site or website controlled or maintained by Reliant shall not have any references to the Product as such references relate to the Territory.

7.11 Regulatory Matters.

(a) Compliance with Laws. Oscient agrees that, for eighteen (18) months following the Closing, (i) it will materially comply with all applicable Laws relating to the Product and the Acquired Assets, (ii) it will keep all records and reports required to be kept by applicable Laws, and (iii) will make its facilities available at reasonable times during business hours for inspection by representatives of Governmental Authorities.

(b) Regulatory Approvals. Oscient shall be responsible for all regulatory matters in connection with the Product, including maintenance of the Registrations and compliance with the stability testing requirements set forth therein. Reliant shall use reasonable efforts to cooperate with Oscient to allow Oscient to fulfill any reporting or other regulatory requirements under the Act or under any other applicable Law with respect to the Product in the Territory. Except as required by applicable Law or as set forth herein, following the Closing, Reliant shall not interface, correspond or otherwise meet with the FDA or other Governmental Authorities with respect to regulatory matters related to the Product in the Territory without the prior written consent of Oscient.

(c) Pharmacovigilance. Immediately following the Closing, the Parties shall cooperate to transition pharmacovigilance matters related to the Product from Reliant’s current third party service provider (Pharmaceutical Product Development, Inc.) to Oscient’s current third party service provider (MedComm, Inc.), including, without limitation, call forwarding and other appropriate inquiry routing to Oscient’s service provider. Thereafter, Oscient shall be responsible for all processing of information related to any adverse events related to the Product in the Territory. After the Closing, each Party shall report to the other Party any actual or alleged Adverse Reaction Information with respect to the Product of which it becomes aware promptly after initial receipt of the information by or on behalf of such Party. For the purpose of this Agreement, “Adverse Reaction Information” means information relating to any experience with respect to the Product in the Territory that is an adverse drug experience as defined in 21 C.F.R. 314.80(a), as that regulation may be amended or superseded from time to time, whether or not considered serious or unexpected. Reliant agrees to share relevant information it receives (either directly or indirectly) with Oscient in a timely manner so as to allow Oscient to comply with its responsibility to process pharmacovigilance information under this Section 7.11(b).

(d) Assistance. For three (3) years from the Closing Date, each Party shall promptly give notice to the other Party of any action by, or notification or other information which it receives (directly or indirectly) from, any Governmental Authority in the Territory (together with copies of correspondence related thereto), which (a) raises any material concerns regarding the safety or efficacy of the Product, (b) which indicates or suggests a potential material liability for either Party to third parties arising in connection with the Product, or (c) which indicates a reasonable potential for a need to initiate a recall, market withdrawal or similar action with respect to the Product. In addition, each Party shall make (or cause to be

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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made) available at reasonable times during business hours for inspection by representatives of Governmental Authorities those facilities at which the Product is manufactured, stored or distributed with respect to the Product. Information to be disclosed pursuant to this Section 7.11(c) shall include, to the extent such information otherwise satisfies the requirements set forth in the preceding sentence, but not be limited to:

(i) inquiries by such Governmental Authorities concerning clinical investigation activities (including inquiries of investigators, clinical monitoring organizations and other related parties) relating to the Product, and any responses related thereto, in each case in the Territory;

(ii) any other Governmental Authority reviews or inquiries relating to any Product and any responses related thereto, in each case in the Territory;

(iii) receipt of a warning letter, untitled letter or any other related Governmental Authority action relating to the Product and any responses related thereto, in each case in the Territory; and

(iv) an initiation of any Governmental Authority investigation, detention, seizure or injunction concerning the Product in the Territory.

(e) Medical Inquiries. Following the Closing Date, Oscient shall be responsible for handling all medical questions or inquiries in the Territory with regard to the Product and Reliant shall promptly refer any medical questions or inquiries it receives relating to the Product to Oscient in accordance with all applicable Laws.

7.12 Non-Solicitation. For a period of [*] from the date of this Agreement, each Party agrees that it shall not (and shall cause its respective Affiliates not to), directly or indirectly (a) solicit, induce or encourage any employee or officer of the other Party or any of its subsidiaries to leave the employ of such Party or any such subsidiary, or to seek, obtain or accept employment with any person, or (b) hire any employee or officer of the other Party or its subsidiaries; provided, however, that the foregoing shall not (i) apply to the solicitation or hiring of any employee or officer of a Party or its subsidiaries who is terminated after the Closing by Oscient or Reliant at least thirty (30) days prior to such individual’s hire by the other Party, or (ii) prevent either Party from publishing an advertisement for employment directed at the general public.

7.13 Non-Competes.

(a) Reliant Non-Compete. For a period of [*] ([*]) years from the date of this Agreement, Reliant agrees that neither it nor any of its controlled Affiliates shall develop, promote, distribute or market any prescription pharmaceutical product in which [*] within the Territory, without the prior written consent of Oscient; provided, however, that, such provision shall not survive a change of control of Reliant or an acquisition of a third party pharmaceutical company by Reliant (other than an acquisition of or merger with [*], [*] or [*] (each a “Restricted Company”) with respect to which such non-competition covenant shall remain in effect);

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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provided, further, that this provision shall not preclude Reliant from (i) promoting, marketing, selling or otherwise discussing any [*] as part of concomitant use with [*], or (ii) developing, promoting, marketing or selling any [*]; provided, further, that in the event Reliant acquires a third-party pharmaceutical company prior to the acquisition of any Restricted Company, this Section 7.13(a) shall be deemed to apply to and restrict the operations of the Restricted Company following an acquisition by Reliant.

(b) Oscient Non-Compete. Each of Parent and Oscient agrees that neither it nor any of its controlled Affiliates shall at any time prior to the tenth (10th) anniversary of the Closing Date, develop, promote, distribute or market any Excluded Combination Product within the Territory, without the prior written consent of Reliant.

7.14 Promotional Materials. Reliant shall provide to Oscient examples of the principal uses of the Product Trademark that are in its possession or control as of the Closing including, without limitation, packaging and packaging inserts.

7.15 Non-Assertion Covenants.

(a) Reliant Non-Assert. Neither Reliant nor any of its controlled Affiliates shall assert against Oscient, or any of its Affiliates or sublicensees, any patents obtained or controlled (in whole or in part) by Reliant or any of its controlled Affiliates prior to or after the Closing which would prevent Oscient or its Affiliates or sublicensees from using the Product Intellectual Property as it exists at Closing in connection with (i) researching, developing, making, having made, distributing, using, selling, offering to sell, having sold, marketing, co-marketing, exporting, promoting and co-promoting the Product, an Additional Product or a Combination Product in the Territory; or (ii) making or having made the Product, an Additional Product or a Combination Product outside the Territory solely for selling, distributing, using, offering to sell, importing, marketing and promoting the Product, Additional Product, or Combination Product, as the case may be, in the Territory.

(b) Oscient Non-Assert. Neither Oscient nor any of its Affiliates shall assert against Reliant, or any of its Affiliates or sublicensees, any patents obtained or controlled (in whole or in part) by Oscient of any of is Affiliates prior to or after the Closing which would prevent Reliant or its Affiliates or sublicensees from using the Product Intellectual Property as it exists at Closing in connection with (i) researching, developing, making, having made, distributing, using, selling, offering to sell, having sold, marketing, co-marketing, exporting, promoting and co-promoting the Excluded Combination Product inside the Territory; or (ii) making or having made the Product inside the Territory solely for selling, distributing, using, offering to sell, importing, marketing and promoting the Product outside the Territory.

7.16 Imports Into/Exports From Territory. Except as prohibited by Law, Reliant shall not knowingly, or direct any other Person to, sell, market, promote, distribute, co-market or co-promote any Product to anyone inside the Territory or outside the Territory for subsequent distribution or resale inside the Territory and Reliant will take all reasonable precautions to prevent such distribution or resale inside the Territory. Except as prohibited by Law, Oscient shall not knowingly, or direct any other Person to, sell, market, promote, distribute, co-market or

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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co-promote any Product to anyone outside the Territory or inside the Territory for subsequent distribution or resale outside the Territory, and Oscient will take all reasonable precautions to prevent such distribution or resale outside the Territory. In connection with this Section 7.16, each Party shall, and shall cause its applicable Affiliates and sublicensees, to apply such policies and procedures intended to prevent the sale outside the Territory (in the case of Oscient) and inside the Territory (in the case of Reliant) that such Party or its applicable Affiliates typically apply to prevent the sale of its products outside any applicable permitted territories.

7.17 Post-Closing Obligations Regarding Financial Information. Reliant will deliver to Oscient, within sixty (60) days following the Closing (but in no event shall Reliant be required to make any delivery hereunder prior to October 15, 2006), audited financial statements with respect to the Product in the Territory for the required periods which are compliant with the rules and regulations of the United States Securities and Exchange Commission (“SEC”) and will specifically include net sales and gross margin of the Products in the Territory (the “Pre-Closing Financial Statements”). Reliant will cooperate with Oscient to cause such accounting firm to provide its written consent to filing, from time to time, of such financial statements and opinion in the reports or registration statements of Oscient or its Affiliates with the SEC. Oscient will reimburse Reliant for its out of pocket third party expenses incurred in connection with the audit of such financial statements and the provision of such consent.

ARTICLE VIII

INDEMNIFICATION AND SURVIVAL

8.1 Indemnification by Reliant. To the extent set forth in this Section 8.1, Reliant agrees to indemnify and hold harmless Oscient, Parent and their respective Affiliates, subsidiaries, officers, directors, managers, members, employees and agents (collectively, the “Oscient Indemnified Parties”), at all times from and against and in respect of all Losses which any Oscient Indemnified Party suffers or incurs, either directly or in connection with a third party claim, to the extent arising out of or resulting from (a) any breach of any of the representations or warranties of Reliant set forth in this Agreement or any of the Other Agreements, (b) any breach of any of the covenants or agreements of Reliant set forth in this Agreement or any of the Other Agreements, (c) any of the Excluded Assets or Excluded Liabilities, or (d) reference of the NDA by Reliant or its Affiliates, assignees, licensees or successors in interest as permitted pursuant Section 2.6; provided, however, that Reliant shall not be required to indemnify any Oscient Indemnified Party to the extent that such Losses arise out of or result from (i) the negligence, recklessness or willful misconduct of any Oscient Indemnified Party, including but not limited to, off-label promotion of Product by Oscient or promotion of Product in a manner inconsistent with the Registrations and/or any applicable Laws, (ii) any breach of this Agreement or any of the Other Agreements by Oscient, or (iii) any material breach by Reliant under this Agreement of which Oscient and/or Parent had knowledge prior to the Closing.

8.2 Indemnification by Oscient. To the extent set forth in this Section 8.2, Oscient agrees to indemnify and hold harmless Reliant and Reliant’s Affiliates and their respective Affiliates, subsidiaries, officers, directors, employees and agents (collectively, the “Reliant Indemnified Parties”) at all times from and against and in respect of Losses which any Reliant Indemnified Party suffers or incurs, either directly or in connection with a third party claim, to

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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the extent arising out of or resulting from (a) any breach of any of the representations or warranties of Oscient or Parent set forth in this Agreement or any of the Other Agreements, (b) any breach of any of the covenants or agreements of Oscient or Parent set forth in this Agreement or any of the Other Agreements, (c) any Assumed Liability, or (d) Oscient’s or any of Oscient’s Affiliates ownership or operation of the Acquired Assets, the Product, the Registrations and/or the Product Line Operations after the Closing Date; provided, however, that Oscient shall not be required to indemnify any Reliant Indemnified Party to the extent any Losses arising out of or result from the (i) negligence, recklessness or willful misconduct of any Reliant Indemnified Party, (ii) any breach of this Agreement or any of the Other Agreements by Reliant, or (iii) any material breach by Oscient or Parent under this Agreement of which Reliant had knowledge prior to the Closing.

8.3 Notice of Claims. The Indemnified Party shall promptly notify the Indemnifying Party in writing of any claim by any third party which may give rise to the right to indemnification hereunder; provided, however, that failure to timely give the notice provided in this Section 8.3 shall not be a defense to the liability of the Indemnifying Party for such claim, but the Indemnifying Party may recover any actual damages arising from the Indemnified Party’s failure to give such timely notice. The Indemnified Party shall not admit any liability with respect to, or settle, compromise or discharge any such matter covered by this Article VIII without the Indemnifying Party’s prior written consent (which shall not be unreasonably withheld). The Indemnifying Party shall have the right, with the consent of the Indemnified Party (which shall not be unreasonably withheld, delayed or conditioned), to settle all indemnifiable matters related to claims by third parties which are susceptible to being settled. In connection with any claim giving rise to indemnity hereunder resulting from or arising out of any claim or legal proceeding by a Person other than the Indemnified Party, the Indemnifying Party may, at its sole cost and expense, upon written notice to the Indemnified Party received by the Indemnified Party within ten (10) calendar days after the Indemnifying Party’s receipt of notice of such claim, assume the defense of any such claim or legal proceeding. If the Indemnifying Party assumes the defense of any such claim or legal proceeding, the Indemnifying Party shall select counsel reasonably acceptable to the Indemnified Party to conduct the defense of such claims or legal proceedings and, at the Indemnifying Party’s sole cost and expense, shall take all steps necessary in the defense or settlement thereof. The Indemnified Party shall be entitled to participate in (but not control) the defense of any such action, with its own counsel and at its own expense, and shall be entitled to any and all information and documentation relating thereto. If the Indemnifying Party does not assume the defense of any such claim or litigation resulting therefrom in accordance with the terms hereof, the Indemnified Party may, at the Indemnifying Party’s expense and upon prior written notice to the Indemnifying Party (with reasonable opportunity for the Indemnifying Party to assume such defense), defend against such claim or litigation in such manner as it may deem appropriate, including, but not limited to, settling such claim or litigation, after giving notice of the same to the Indemnifying Party, with the consent of the Indemnifying Party (such consent not to be unreasonably withheld, delayed or conditioned). The Indemnified Party will cooperate reasonably with the Indemnifying Party in its efforts to conduct or resolve such matters, including by making available to the Indemnifying Party relevant documents and witnesses. The Indemnified Party and the Indemnifying Party shall keep each other informed of all settlement negotiations with third parties and of the progress of any

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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litigation with third parties. The Indemnified Party and the Indemnifying Party shall permit each other reasonable access to books and records and shall otherwise cooperate with all reasonable requests of each other in connection with any indemnifiable matter resulting from a claim by a third Person.

8.4 Limitations.

(a) Reliant shall not be liable for any Loss described in Section 8.1(a) unless and until the aggregate of all such Losses for which Reliant is liable is in excess of [*] Dollars ($[*]), in which event, Reliant shall be liable for all Losses in excess of such amount. Notwithstanding the foregoing, subsequent to the Closing Date in no event shall the liability of Reliant under Section 8.1(a) exceed [*] Dollars ($[*]) in the aggregate; provided that such limitation shall not apply to any breach of any of the representations or warranties of Reliant set forth in Sections 5.1, 5.2, 5.4(a), and 5.8 of this Agreement.

(b) For the avoidance of doubt and without limitation to the provisions of Articles V and VI, neither Indemnifying Party shall have any obligation to indemnify, defend and hold harmless the Indemnified Party from and against any portion of Losses under Section 8.1 or Section 8.2 to the extent that such portion of such Losses results directly from any action taken by, omission of, or at the express written request of, such Indemnified Party.

(c) No Party hereto shall be entitled to recover for any Losses or other amounts due from the other Party pursuant to this Agreement or any Other Agreement by retaining or setting off amounts (whether or not such amounts are liquidated or reduced to judgment) against any amounts due or to become due from such first Party to such second Party hereunder or under any Other Agreement or under any document or instrument delivered pursuant hereto or thereto or in connection herewith or therewith. For the avoidance of doubt, the foregoing is without prejudice to any right of set-off expressly provided for in any Other Agreement, which does not involve setting off amounts due under this Agreement.

(d) All amounts paid by Reliant or Oscient under this Article VIII shall be treated for all purposes as adjustments to the Purchase Price. In the event that treatment as an adjustment to the Purchase Price is disputed by any taxing authority, the Party receiving notice of such dispute shall promptly notify and consult with the other Party concerning resolution of such dispute.

(e) Notwithstanding anything to the contrary contained in this Agreement, in no event shall the liability of Reliant under Section 8.1(b) for non-compliance or any breach of the covenant and agreement set forth in Section 7.17 exceed [*] Dollars ($[*]).

8.5 Survival. No claim may be made for indemnification pursuant to (i) Section 8.1(a) (other than claims for any Losses in respect of a breach by Reliant of the representations or warranties contained in Sections 5.1, 5.2, 5.4(a), and 5.8), or (ii) Section 8.2(a) (other than claims for any Losses in respect of a breach by Oscient of any of the representations or warranties contained in Sections 6.1(a), 6.1(b), 6.1(c), 6.1(f) or 6.2), unless written notice of

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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such claim, in reasonable detail, is given to Oscient or to Reliant, as the case may be, within the eighteen (18) month period following the Closing Date.

8.6 Exclusive Remedy. Following the Closing, absent fraud, (a) claims for indemnification pursuant to this Article VIII, and (b) claims for specific performance of the covenants and obligations of the other Party under this Agreement and the Other Agreements, shall, collectively, be the sole and exclusive remedies for claims and damages available to Reliant, Oscient and their respective Affiliates arising out of or relating to this Agreement and the purchase and sale of the Acquired Assets or any certificate or document delivered in connection herewith. Oscient and Oscient’s Affiliates shall not be entitled to bring, and hereby irrevocably waive, any other claims, rights and causes of action against Reliant or any of Reliant’s Affiliates, including, without limitation, for reduction of the Purchase Price, rescission, damages or any other legal or equitable remedies regardless of their legal or equitable basis, including breach of duty prior to contract (culpa in contrahendo) and tort. Reliant and Reliant’s Affiliates shall not be entitled to bring, and hereby irrevocably waive, any other claims, rights and causes of action against Oscient, Parent or any of their respective Affiliates, regardless of their legal or equitable basis, including, without limitation, breach of duty, contract and tort.

8.7 Other Provisions. Notwithstanding anything contained herein to the contrary, the amount of any Losses incurred or suffered by an Indemnified Party shall be calculated taking into account: (i) any insurance proceeds received by the Indemnified Party (or any of its Affiliates) with respect to such Losses; (ii) any Tax benefit reasonably expected to be realized by the Indemnified Party (or any of its Affiliates) arising from the facts or circumstances giving rise to such Losses; but take into account (iii) any recoveries obtained by the Indemnified Party (or any of its Affiliates) from any other third party. Each Indemnified Party shall exercise its commercially reasonable efforts to obtain such proceeds, benefits and recoveries. If any such proceeds or recoveries are received by an Indemnified Party (or any of its Affiliates) with respect to any Losses after the Indemnified Party (or any Affiliate) has received the benefit of any indemnification hereunder with respect thereto, the Indemnified Party (or such Affiliate) shall pay to the Indemnifying Party the amount of such recoveries (up to the amount of the Indemnifying Party’s payment).

8.8 Insurance. Each Party will obtain and keep in force, in a form reasonably acceptable to the other Party hereto, insurance in scope and amount protecting against any Liabilities arising from the operation of such Party’s business as it relates to the Products, including, without limitation, the sale and distribution of the Products, with scope and coverage as is normal and customary in the biotechnology/pharmaceutical industry generally for parties similarly situated, but in no event in an amount less than Ten Million Dollars ($10,000,000) per occurrence and in the aggregate, including umbrella coverage. It is understood that such insurance will not be construed to limit a Party’s liability with respect to its indemnification obligations under this Article VIII. Each Party will provide to the other Party upon request a certificate evidencing the insurance such Party is required to obtain and keep in force under this Article VIII. Such certificate will provide that such insurance will not expire or be cancelled or modified without at least thirty (30) days’ prior notice to the other Party.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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8.9 Limitation on Damages. NEITHER PARTY NOR ANY OF SUCH PARTY’S AFFILIATES SHALL HAVE ANY LIABILITY TO THE OTHER PARTY NOR ANY OF THE OTHER PARTY’S AFFILIATES FOR ANY CONSEQUENTIAL, INCIDENTAL, SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES UNDER THIS AGREEMENT (INCLUDING, WITHOUT LIMITATION, LOST PROFITS, LOST REVENUE, LOST INCOME, DIMINUTION OF VALUE, OR LOSS OF BUSINESS REPUTATION OR OPPORTUNITY) AND LOSSES INDEMNIFIABLE HEREUNDER SHALL NOT INCLUDE SUCH DAMAGES, EXCEPT, IN EACH CASE, TO THE EXTENT SUCH PARTY OR SUCH PARTY’S AFFILIATE IS ACTUALLY REQUIRED TO PAY SUCH AMOUNT TO A THIRD PARTY IN RESPECT TO A FINAL JUDGMENT OR ORDER OBTAINED BY THE THIRD PARTY.

ARTICLE IX

TERMINATION

9.1 Termination. Notwithstanding anything to the contrary in this Agreement, this Agreement may be terminated and the transactions contemplated by this Agreement abandoned at any time prior to Closing:

(a) by mutual written consent of Reliant and Oscient;

(b) by Reliant if any of the conditions of Section 4.4 shall have become incapable of fulfillment, and shall not have been waived by Reliant;

(c) by Oscient if any of the conditions of Section 4.3 shall have become incapable of fulfillment, and shall not have been waived by Oscient; or

(d) by either Party by giving written notice of such termination to the other Party, if the Closing shall not have occurred on or prior to October 31, 2006 (the “Outside Date”); provided that the right to terminate this Agreement under this Section 9.1(d) shall not be available to any Party whose failure to fulfill any obligation under this Agreement has been the cause of, or resulted in, the failure of the Closing to occur on or before the Outside Date; provided, further, assuming compliance with such Party’s obligations under Section 7.5(a), the non-receipt of any Required Consents shall not constitute a failure by a Party to fulfill any of its obligations hereunder and such Party shall have the right to terminate this Agreement pursuant to this Section 9.1(d) in the event that any Required Consents have not been obtained by the Outside Date.

9.2 Effect of Termination. In the event of the termination of this Agreement in accordance with Section 9.1, this Agreement shall thereafter become void and have no effect, and no Party hereto shall have any Liability to the other Party hereto or their respective Affiliates, directors, officers or employees, except for the obligations of the Parties hereto contained in this Section 9.2 and Article X and except that nothing herein will relieve any Party from Liability for any material breach of any covenant set forth in this Agreement prior to such termination.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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ARTICLE X

CONFIDENTIAL INFORMATION

10.1 Confidential Information. As used in this Agreement, the term “Confidential Information” includes all secret, confidential or proprietary information or data, whether provided in written, oral, graphic, video, computer, electronic or other form, provided pursuant to this Agreement or generated pursuant to this Agreement by one Party (the “Disclosing Party”) to the other Party (the “Receiving Party”), including but not limited to, information relating to the Disclosing Party’s existing or proposed research, development efforts, patent applications, business or products, and without limitation, all notes, analyses, compilations, studies, interpretations or other documents whether in tangible form or on electronic or other data storage media, prepared by the Receiving Party and its directors, managers, employees, independent contractors, agents or consultants (collectively, “Representatives”), which contain, reflect or are based on, in whole or in part, Confidential Information furnished to the Receiving Party or its Representatives by the Disclosing Party or any to its Representatives, and any other materials that have not been made available by the Disclosing Party to the general public. Notwithstanding the foregoing sentence, Confidential Information shall not include any information or materials that:

(a) were already known to the Receiving Party (other than under an obligation of confidentiality), at the time of disclosure by the Disclosing Party;

(b) were generally available to the public or otherwise part of the public domain at the time of disclosure thereof to the Receiving Party; or

(c) became generally available to the public or otherwise part of the public domain after disclosure or development thereof, as the case may be, and other than through any act or omission of the Receiving Party in breach of the Receiving Party’s confidentiality obligations under this Agreement.

Notwithstanding the foregoing, all information related to the Acquired Assets, the Product or the Product Line Operations that is known to Reliant other than through the means described in Sections 10.1(b) and 10.1(c) and deemed prior to Closing to be Confidential Information of Reliant shall, following the Closing, be deemed to be Confidential Information of Oscient provided to Reliant.

10.2 Confidentiality Obligations. Each Receiving Party shall keep all Confidential Information received from the other Party with the same degree of care it maintains the confidentiality of its own Confidential Information. The Receiving Party shall not use such Confidential Information for any purpose other than in performance of this Agreement or disclose the same to any other Person other than to such of its Affiliates and the Receiving Party’s and such Affiliates’ respective directors, managers, employees, independent contractors, agents or consultants who have a need to know such Confidential Information to implement the terms of this Agreement or enforce its rights under this Agreement; provided, however, that a Receiving Party shall advise its Affiliates’ and the Receiving Party’s and such Affiliates’ respective directors, managers, employees, independent contractors, agents or consultants who

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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receives such Confidential Information of the confidential nature thereof and of the obligations contained in this Agreement relating thereto, and the Receiving Party shall be responsible for the compliance by such Representatives with such obligations as if they had been a party hereto. Upon termination of this Agreement, the Receiving Party shall return or destroy all documents, tapes or other media containing Confidential Information of the Disclosing Party that remain in the possession of the Receiving Party’s Representatives. It is understood that receipt of Confidential Information under this Agreement will not limit the Receiving Party from assigning its employees to any particular job or task in any way it may choose, subject to the terms and conditions of this Agreement.

10.3 Permitted Disclosure and Use. Notwithstanding Section 10.2, either Party may disclose Confidential Information belonging to the other Party only to the extent such disclosure is reasonably necessary to: (a) comply with or enforce any of the provisions of this Agreement; (b) comply with applicable Laws; or (c) comply with applicable stock exchange, New York Stock Exchange regulation or NASDAQ regulation. If a Party deems it necessary to disclose Confidential Information of the other Party pursuant to this Section 10.3, such Party shall give prompt prior written notice of such disclosure to the other Party and shall cooperate with the other Party to minimize such disclosure.

10.4 Notification. The Receiving Party shall notify the Disclosing Party promptly (to be confirmed in writing) upon discovery of any unauthorized use or disclosure of the Disclosing Party’s Confidential Information, and will cooperate with the Disclosing Party, at the Disclosing Party’s expense, in any reasonably requested fashion to assist the Disclosing Party to regain possession of such Confidential Information and to prevent its further unauthorized use or disclosure.

10.5 Confidentiality of this Agreement. The terms of this Agreement and the Other Agreements shall be Confidential Information of each Party and, as such, shall be subject to the provisions of this Article X.

10.6 Publicity; Filing of this Agreement. Attached hereto as Schedule 10.6 is the press release Oscient shall issue concurrently herewith. The Parties shall jointly agree upon the necessity and content of any other press release in connection with the transactions contemplated hereby. Any other publication, news release or other public announcement by a Party relating to this Agreement or to the performance hereunder shall first be reviewed and consented to in writing by the other Party; provided, however, that (i) any disclosure that is required by Law as advised by the disclosing Party’s counsel may be made without the prior written consent of the other Party, and (ii) any Party may issue a press release or public announcement if the contents of such press release or public announcement have previously been made public other than through a breach of this Agreement by the issuing Party, without the prior written consent of the other Party. To the extent practicable, the disclosing Party shall give at least three (3) Business Days advance notice of any such legally required disclosure to the other Party, and such other Party shall provide any comments on the proposed disclosure during such period. To the extent that either Party determines that it or the other Party is required to file or register this Agreement or any of the Other Agreements, or a notification of any such documents to comply with the requirements of an applicable stock exchange, New York Stock Exchange regulation or

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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NASDAQ regulation or any Governmental Authority, including without limitation the SEC, such Party shall give at least three (3) Business Days advance written notice of any such required disclosure to the other Party. Prior to making any such filing, registration or notification, the Parties shall consult with respect thereto regarding confidentiality. The Parties shall cooperate, each at its own expense, in such filing, registration or notification, including without limitation such confidential treatment request, and shall execute all documents reasonably required in connection therewith.

10.7 Survival. The covenants, obligations and prohibitions contained in this Article X shall survive the Closing (or any termination of this Agreement) for a period of five (5) years.

ARTICLE XI

MISCELLANEOUS

11.1 Assignment. Neither Oscient nor Parent shall have the right to assign, license, sublicense, delegate or otherwise transfer (other than to an Affiliate or Parent) or encumber all or any portion of its rights or obligations under this Agreement prior to Closing without the prior written consent of Reliant. Following the Closing, the Parties agree that, to the extent required by Reliant’s obligations to any third party with respect to the Product or to protect any existing royalty rights, neither Oscient nor Parent shall have the right to assign, license, sublicense, delegate or otherwise transfer or encumber all or any portion of this Agreement or any of the Other Agreements (or its rights hereunder or thereunder) without the prior written consent of Reliant, which consent shall not be unreasonably withheld; provided that no such consent will be required from Reliant in connection with (but Oscient shall give Reliant at least fifteen (15) days prior written notice of) any of the following: (i) a merger of Oscient or Parent or an acquisition of Oscient or Parent by a third party, (ii) Oscient’s grant of rights to a Contract Sales Organization (as defined in the Settlement Agreement) or other third party to co-promote the Product, (iii) the grant of a security interest on any or all of its rights and interests hereunder or under the Other Agreements to one or more of its Affiliates or to any provider of the financing obtained by Oscient in connection with the transactions contemplated by this Agreement, (iv) an assignment of any or all of the rights and interests hereunder or under any of the Other Agreements to one or more of its Affiliates, or (v) the designation by Oscient of one or more of its Affiliates to perform its obligations hereunder, in each case, so long as Oscient not relieved of any of its obligations hereunder. Any transfer in violation of this section shall be deemed null and void and of no force or effect. In the event Oscient or Parent assigns, licenses, sublicenses or otherwise transfers or encumbers all or any portion of such rights to a third party (including, without limitation by way of a transaction described in the immediately preceding clauses (i) through (v)), Oscient or Parent, as the case may be, shall remain primarily liable for all of its respective obligations under this Agreement and each of the Other Agreements, and such assignment, licensing, sublicensing or other transfer shall be subject to the terms hereof and thereof.

11.2 Expenses. Except as otherwise expressly provided in this Agreement, whether or not the transactions contemplated by this Agreement are consummated, all costs and expenses incurred in connection with this Agreement and the transactions contemplated hereby shall be borne by the Party incurring such expenses.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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11.3 Schedules. Reliant may amend or supplement the Reliant Disclosure Schedule to this Agreement by delivering an amended or supplemented Reliant Disclosure Schedule to Oscient prior to the Closing, but no such amendment or supplement shall (i) relieve Reliant of any breach of this Agreement, and (ii) be deemed to constitute an admission by Reliant.

11.4 Severability. If any term, provision, covenant or restriction of this Agreement is held by a court of competent jurisdiction or other authority to be invalid, void, unenforceable or against its regulatory policy such determination shall not affect the enforceability of any others or of the remainder of this Agreement. Upon such determination that any provision of this Agreement (or any portion thereof) or the application of any such provision (or any portion thereof) to any Person or circumstance is invalid, illegal or unenforceable, the Parties shall negotiate in good faith to modify this Agreement so as to effect the original intent of the Parties as closely as possible in an acceptable manner to the end that the transactions contemplated hereby are fulfilled to the extent possible.

11.5 Entire Agreement. This Agreement, the Other Agreements and the Confidentiality Agreement contain the entire agreement of the Parties hereto with respect to the transactions covered hereby, superseding all negotiations, prior discussions and preliminary agreements made prior to the date hereof.

11.6 No Third Party Beneficiaries. Except as otherwise set forth under Article VIII, this Agreement is solely for the benefit of the Parties hereto and their respective Affiliates and no provision of this Agreement shall be deemed to confer upon any third parties any remedy, claim, liability, reimbursement, claim of action or other right in excess of those existing without reference to this Agreement.

11.7 Waivers and Amendments; Non Contractual Remedies; Preservation of Remedies. This Agreement may be amended, superseded, canceled, renewed or extended, and the terms hereof may be waived, only by a written instrument signed by each of the Parties or, in the case of a waiver, by the Party waiving compliance. No delay on the part of any Party in exercising any right, power or privilege hereunder shall operate as a waiver thereof, nor shall any waiver on the part of any Party of any right, power or privilege, or any single or partial exercise of any such right, power or privilege, preclude any further exercise thereof or the exercise of any other such right, power or privilege.

11.8 Governing Law. This Agreement (including any claim or controversy arising out of or relating to this Agreement) shall be governed by the internal laws of the State of New York without reference to New York conflict of law principles (other than Section 5-1401 of the General Obligations Law).

11.9 Consent to Jurisdiction; Venue. Each Party to this Agreement and the Parent irrevocably submits to the non-exclusive jurisdiction of and venue in the courts of the State of New York and of the United States sitting in the Borough of Manhattan, New York, New York, for the purposes of any suit, action or other proceeding arising out of this Agreement, the Other Agreements or any transaction contemplated hereby or thereby, and waives any objection based on forum non conveniens. Each Party further agrees that service of any process, summons,

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

-46-


notice or document by certified or registered mail to such Party’s respective address set forth above shall be effective service of process for any action, suit or proceeding in New York with respect to any matters to which it has submitted to jurisdiction in this Section 11.9.

11.10 WAIVER OF JURY TRIAL. EACH OF THE PARTIES AND THE PARENT HERETO HEREBY IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY PROCEEDING ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.

11.11 Available Remedies. Each Party expressly agrees that, consistent with its intention and agreement to be bound by the terms of this Agreement and to consummate the transactions contemplated hereby, subject only to the performance or satisfaction of the conditions precedent, the remedy of specific performance shall be available to a non-breaching and non-defaulting Party to enforce performance of this Agreement by a breaching or defaulting Party, including, without limitation, to require the consummation of the Closing. It is understood and agreed that injury and damages incurred by any non-breaching and non-defaulting Party due to the breach or default of the other Party would be irreparable and not adequately compensable by monetary damages. Consequently, the non-breaching and non-defaulting Party will not have an adequate remedy at law for any failure by a breaching or defaulting Party to perform its obligations hereunder to consummate the transactions contemplated hereby.

11.12 Headings. The headings of the sections and subsections of this Agreement are inserted for convenience only and shall not be deemed to constitute a part hereof.

11.13 Counterparts. The Parties and the Parent may execute this Agreement in one or more counterparts, and each fully executed counterpart, taken together, shall constitute an original.

11.14 Further Documents. Each of Oscient and Reliant shall, and shall cause its respective Affiliates to, at the request of another Party, execute and deliver to such other Party all such further instruments, assignments, assurances and other documents as such other Party may reasonably request in connection with the carrying out of this Agreement and the transactions contemplated hereby, including, without limitation, all instruments of sale, transfer, conveyance, assignment and confirmation as may be requested in order to more effectively transfer, convey and assign to Oscient and to confirm Oscient’s title to the Acquired Assets.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

-47-


11.15 Notices. All communications, notices and consents provided for herein shall be in writing and be given in person or by means of facsimile or other means of wire transmission (with request for assurance of receipt in a manner typical with respect to communications of that type), by overnight courier or by mail, and shall become effective: (a) on delivery if given in person; (b) on the date of transmission if sent by facsimile or other means of wire transmission; (c) one (1) Business Day after delivery to the overnight service; or (d) four (4) Business Days after being deposited in the United States mails, with proper postage and documentation, for first-class registered or certified mail, prepaid, and shall be addressed as follows:

 

if to Reliant, to:    Reliant Pharmaceuticals, Inc.
   110 Allen Road
   Liberty Corner, NJ 07938
   Attn: Chief Executive Officer
   Facsimile: (908) 542-9405

with copies sent

concurrently to:

   Reliant Pharmaceuticals, Inc.
   110 Allen Road
   Liberty Corner, NJ 07938
   Attn: Vice President of Legal Affairs and Secretary
   Facsimile: (908) 542-9405
   Latham & Watkins LLP
   Sears Tower, Suite 5800
   Chicago, IL 60606
   Attention: Michael A. Pucker
   Facsimile: (312) 993-9767

if to Oscient or

Parent to:

   Oscient Pharmaceuticals Corporation
   1000 Winter Street, Suite 2200
   Waltham, MA 02451
   Attn: Chief Executive Officer
   Facsimile: (781) 893-9535

with copies sent

concurrently to:

   Oscient Pharmaceuticals Corporation
   1000 Winter Street, Suite 2200
   Waltham, MA 02451
   Attn: Legal
   Facsimile: (781) 398-2530
   Ropes & Gray LLP
   One International Place
   Boston, MA 02110
   Attn: Patrick O’Brien
   Facsimile: (617) 951-7050

provided, however, that if any Party shall have designated a different address by notice to the others, then to the last address so designated.

11.16 Parent Guarantee of Payment and Performance. Parent hereby absolutely, irrevocably and unconditionally guarantees: (i) through the Closing (a) to cause Oscient to perform all of its obligations under this Agreement and the Other Agreements, and (b) the payment in full when due of all amounts required to be paid by Oscient under this Agreement

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

-48-


and the Other Agreements (collectively, the “Guaranteed Obligations”), which Guaranteed Obligations include, without limitation, any payments owed by Oscient under Sections 3.1 and 3.2, Article VII and Article VIII of this Agreement. The obligations of Parent contained herein are primary, absolute and unconditional, and shall continue in full force and effect until the payment and performance, as applicable, of all of the Guaranteed Obligations and are not conditioned upon any event or contingency or upon any attempt first to obtain payment from Oscient under this Agreement or any of the Other Agreements, or pursuit of any other right or remedy against Oscient through the commencement of legal proceedings or otherwise. With respect to its obligations hereunder, Parent expressly waives diligence, presentment, demand of payment, protest and all notices whatsoever and any requirement that Reliant exhaust any right, power or remedy or proceed first against any Person under this Agreement or any of the Other Agreements before pursuing recourse against Parent hereunder. Parent acknowledges and agrees that its obligations hereunder shall continue in full force and effect, without notice from any other party or Reliant to Parent in the event the obligations of Oscient under this Agreement or any of the Other Agreements are amended or in any way modified, and that the Guaranteed Obligations shall continue and shall apply in full to such amended obligations of Oscient as though the amended terms had been a part of under this Agreement or any of the Other Agreements, as applicable, from the original date of execution thereof.

Signature page follows.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

-49-


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

 

GUARDIAN II ACQUISITION CORPORATION

By:

  /s/ Steven Rauscher
  Name: Steven Rauscher
  Title:
RELIANT PHARMACEUTICALS, INC.
By:   /s/ Joseph Zakrewski
  Name: Joseph Zakrewski
  Title: Chief Operating Officer
OSCIENT PHARMACEUTICALS CORPORATION, for purposes of Sections 6.2, 7.13(b) and 11.16
By:   /s/ Steven Rauscher
  Name: Steven Rauscher
  Title:

[SIGNATURE PAGE TO ASSET PURCHASE AGREEMENT]

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

EX-10.1 3 dex101.htm AMENDED & RESTATED DEVELOPMENT, LICENSE & SUPPLY AGREEMENT Amended & Restated Development, License & Supply Agreement

Exhibit 10.1

 

CONFIDENTIAL

  EXECUTION COPY

AMENDED AND RESTATED

DEVELOPMENT,

LICENSE AND SUPPLY AGREEMENT

dated as of July 31, 2006

between

ETHYPHARM, S.A.

194 Bureaux de la Colline

92213 Saint Cloud

France

and

RELIANT PHARMACEUTICALS, INC.

110 Allen Road

Liberty Corner, New Jersey 07938

United States

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.


CONFIDENTIAL

 

TABLE OF CONTENTS

 

               Page
1.    DEFINITIONS    2
2.    PRODUCT DEVELOPMENT PROGRAM; CLINICAL DATA; PRODUCT REGISTRATION    11
   2.1    Product Development Program; Dosages    11
   2.2    Ownership of Clinical Data    11
   2.3    ETHYPHARM’s Right to RELIANT Clinical Data    12
   2.4    Regulatory Applications and Related Filings    12
   2.5    ETHYPHARM’s Development Responsibilities    13
   2.6    Compliance of Specifications    14
3.    GRANT OF LICENSE    14
   3.1    Grant of License; License Exclusion    14
   3.2    RELIANT Right of First Refusal Regarding License Exclusion Transactions    15
   3.3    Sublicenses    16
   3.4    Minimum Annual Sales Requirement    16
   3.5    Cooperation Regarding Fenofibrate Product Development    18
   3.6    Competing Dosage Forms    18
4.    COMPENSATION – LICENSE FEES AND MILESTONE PAYMENTS    19
   4.1    License Fees    19
   4.2    Milestone Payments    19
   4.3    Method of Payment    19
5.    DELIVERY OF PRODUCT FOR CLINICAL AND REGULATORY PURPOSES; PRODUCT LAUNCH; ADDITIONAL MANUFACTURING FACILITY    20
   5.1    Clinical Formulations and Placebos    20
   5.2    Registration Batches    20
   5.3    Promotion of the Product    21
   5.4    Additional Manufacturing Facility    21
   5.5    RELIANT Third-Party Beneficiary Rights    22
   5.6    RELIANT Step-In Rights Following Supply Failure Event    23
   5.7    Other RELIANT Rights Regarding Supply    24
6.    OWNERSHIP AND USE OF INTELLECTUAL PROPERTY; DEVELOPMENT OF COMBINATION PRODUCTS    25
   6.1    Ownership    25

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 


CONFIDENTIAL

 

 

6.2

   Patents    26
 

6.3

   Notice of Infringement    27
 

6.4

   ETHYPHARM Indemnified Claims    27
 

6.5

   RELIANT Indemnified Claims    28
 

6.6

   Infringement Indemnification by ETHYPHARM    29
 

6.7

   Infringement Indemnification by RELIANT    31
 

6.8

   Third Party Infringement    31
 

6.9

   Termination Resulting From Infringement    32
 

6.10

   Development of Combination Products    33
7.   MANUFACTURING STANDARDS; REGULATORY COMPLIANCE; SALE AND SHIPMENT OF PRODUCT; RECALL PROCEDURE AND AUDIT RIGHTS    34
 

7.1

   Standard of Manufacture    34
 

7.2

   Encapsulation by RELIANT    35
 

7.3

   Purchase and Sale; Acceptance    35
 

7.4

   Delivery Forecast; Reserve Stock of Product    36
 

7.5

   Shipment Costs; Title and Risk of Loss    37
 

7.6

   RELIANT Right of Review; Exception Notice    38
 

7.7

   Notice of Third Party Audit    38
 

7.8

   Notice of Regulatory Action    39
 

7.9

   Recall or Withdrawal    40
 

7.10

   RELIANT Audit Right Regarding Manufacturing Facilities    41
 

7.11

   Records and Accounting by ETHYPHARM    42
8.   PRICES    42
 

8.1

   Prices and Price Change    42
 

8.2

   Payment Terms    44
9.   ROYALTIES    44
 

9.1

   Royalties    44
 

9.2

   Tax Withholding    44
10.   REPRESENTATIONS AND WARRANTIES OF THE PARTIES    45
 

10.1

   Mutual Representations and Warranties of ETHYPHARM and RELIANT    45
 

10.2

   Additional Representations, Warranties and Covenants of ETHYPHARM    48
11.  

TERM

   51
 

11.1

   Basic Term    51
 

11.2

   Sale of Product Following Termination    51

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

 


CONFIDENTIAL

 

12.    EVENTS OF DEFAULT, REMEDIES AND EFFECTS OF DEFAULT    52
   12.1    Events of Default    52
   12.2    Remedies for Breach; Termination    53
   12.3    Technology Transfer    53
   12.4    Right of First Offer In Connection with Divestiture    54
13.    INDEMNIFICATION AND INSURANCE    54
   13.1    Indemnification of RELIANT    54
   13.2    Indemnification of ETHYPHARM    54
   13.3    Notice and Legal Defense    55
   13.4    Insurance    55
14.    ETHYPHARM RIGHTS IN CANADA AND MEXICO    56
   14.1    Reversion of Canadian and Mexican Rights    56
   14.2    ETHYPHARM Right to RELIANT Clinical Data for Canada and Mexico    56
   14.3    Royalties on Sales of Product in Canada and Mexico    57
   14.4    Certain Restrictions on Commercialization in Canada and Mexico    58
15.    MISCELLANEOUS    59
   15.1    Assignment    59
   15.2    Confidentiality    60
   15.3    Exchange of Information    61
   15.4    Force Majeure    61
   15.5    Amendment    62
   15.6    No Implied Waiver    62
   15.7    Choice of Law    63
   15.8    CONSENT TO JURISDICTION; AGENT FOR SERVICE OF PROCESS    63
   15.9    WAIVER OF JURY TRIAL    63
   15.10    Notice    64
   15.11    English Language    65
   15.12    Execution of Additional Documents    65
   15.13    Severability    65
   15.14    Captions    65
   15.15    Counterparts    65
   15.16    Independent Relationship    66
   15.17    Entire Agreement    66
   15.18    Continued Obligation    66
   15.19    Survival    66

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

 


CONFIDENTIAL

 

THIS AMENDED AND RESTATED DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT, dated as of July 31, 2006, by and between ETHYPHARM S.A., a corporation organized under the laws of France, with its principal offices at 194 Bureaux de la Colline, 92213 Saint Cloud, France (together with its subsidiaries and Affiliates, collectively, “ETHYPHARM”), and RELIANT PHARMACEUTICALS, INC., a Delaware corporation and the successor-by-conversion to Reliant Pharmaceuticals, LLC, with its principal offices at 110 Allen Road, Liberty Corner, New Jersey 07938, United States of America (“RELIANT”). Capitalized terms used herein without definition shall have the meanings specified in Section 1 hereof.

WITNESSETH THAT:

WHEREAS, as of May 7, 2001, Ethypharm S.A., Ethypharm Industries S.A. (which was subsequently merged into Ethypharm S.A.) and Reliant Pharmaceuticals, LLC (which was subsequently converted into Reliant Pharmaceuticals, Inc.) entered into a Development, License and Supply Agreement, which agreement was subsequently amended, modified and supplemented pursuant to a letter agreement, dated December 18, 2002, between Ethypharm S.A. and Reliant Pharmaceuticals, LLC, and Amendment No. 1 thereto, dated as of May 24, 2005 between Ethypharm S.A. and Reliant Pharmaceuticals, Inc. (as so amended, modified and supplemented, the “Original Agreement”);

WHEREAS, ETHYPHARM and RELIANT are also parties a letter agreement, dated August 15, 2005 (the “Supply Side Letter”), relating to certain supply matters under the Original Agreement; and

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.


CONFIDENTIAL

 

WHEREAS, ETHYPHARM and RELIANT desire to amend and, except for certain exhibits incorporated herein by reference to exhibits to the Original Agreement, restate the Original Agreement as set forth herein.

NOW, THEREFORE, in consideration of the agreements and covenants hereinafter set forth and intending to be legally bound hereby, the parties hereto covenant and agree as follows:

 

1. DEFINITIONS

Act” shall mean the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C. §301 et seq., and the regulations promulgated thereunder, in each case as hereafter amended from time to time, and similar legislation in other countries of the Territory.

Additional Manufacturing Facility” shall have the meaning specified in Section 5.4.

Affiliate” means, with respect to any Person, any other Person directly or indirectly controlling, controlled by, or under common control with, such other Person. For purposes hereof, the term “controlling” (including the terms “controlled by” and “under common control with”), as used with respect to any Person, will mean the direct or indirect ability or power to direct or cause the direction of management policies of such Person or otherwise direct the affairs of such Person, whether through ownership of at least fifty percent (50%) of the voting securities of such Person, by contract or otherwise. In addition and not in limitation of the foregoing, the following entities shall be deemed Affiliates of RELIANT: (i) PharmBay Investors, LLC; (ii) Bay City Capital Fund II, L.P. and Bay City Capital Fund III, L.P.; and (iii) any of the lineal descendants of Nicholas J. Pritzker, deceased, trusts primarily for the benefit of such lineal descendants, entities controlled by such lineal descendants and/or trust for their benefit.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

2


CONFIDENTIAL

 

API” or “Active Pharmaceutical Ingredient” means the raw non-micronized fenofibrate used in the Product manufactured by a party other than ETHYPHARM or any of its Affiliates.

Applicable Laws” means all laws, statutes, codes, treaties, ordinances, judgments, decrees, directives, injunctions, orders of any court, arbitrator or Governmental Authority, rules, regulations, interpretations, authorizations and Applicable Permits of any Governmental Authority applicable to any of the parties hereto, the transactions contemplated hereby and/or the Product.

Applicable Permits” means any waiver, exemption, variance, permit, license, authorization, consent, certification, registration or similar approval (including, without limitation, any NDA), including, without limitation, product registrations by or of any Governmental Authority required to be obtained or maintained under Applicable Laws in connection with the formulation, development, registration, manufacture, packaging, labeling, import, export, shipment, receipt, storage, use, pricing or sale of the Product, regardless of the formulation or dosage form thereof, and any ingredient thereof.

Audit” shall have the meaning specified in Section 7.7.

Bulk Product Form” shall mean the Product in such form which is ready for incorporation by or on behalf of RELIANT into Finished Dosage Form or such other form as may be sold commercially by RELIANT in the Territory.

Business Day” means any day except Saturday, Sunday and any day which shall be a federal legal holiday in the United States or a day on which banking institutions in the State of New Jersey or Paris, France are authorized or required by law or other government action to close.

Canadian/Mexican Product” shall have the meaning specified in Section 14.3.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

3


CONFIDENTIAL

 

cGMP” shall mean current Good Manufacturing Practices as in effect under the Act from time to time and similar regulations in other countries under Applicable Laws.

CMC” shall mean the Chemistry and Manufacturing Controls section of the IND or NDA, as applicable, as then in effect.

Combination Product” shall have the meaning specified in Section 6.10.

Competing Dosage Form” shall mean fenofibrate monotherapy product marketed by or on behalf of RELIANT other than the Product in a formulation and dosage form that is substantially similar or identical to the Product. For the purposes of this Agreement, no Combination Product shall be considered a Competing Dosage Form.

Confidential Information” means, with respect to any Person (including, without limitation, the parties hereto), all proprietary or confidential information of such Person (including such Person’s Affiliates and subsidiaries), including, without limitation, any non-public Intellectual Property, Know-How, financial information, procurement requirements, purchasing, manufacturing, customer or supplier information, business forecasts and plans, financing information, detailing, sales and merchandising, and marketing plans and information, pricing, and accounting policies and procedures of or related to such Person; provided, however, that Confidential Information shall not include and information that (a) was or becomes generally available to the public other than as a result of an unauthorized disclosure by a party hereto or any of such party’s subsidiaries, Affiliates, employees, agents or representatives; (b) was or becomes available to a party hereto on a non-confidential basis from a source other than (in the case of future information) any other party hereto (or any of such party’s subsidiaries, Affiliates, employees, agents or representatives), provided that such source was not known be bound by any agreement to keep such information confidential or otherwise prohibited from

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

4


CONFIDENTIAL

 

transmitting the information by a contractual, legal or fiduciary obligation; or (c) is independently developed by any party hereto without the use of or reference to the Confidential Information of the other party hereto or any of such other party’s subsidiaries or Affiliates.

Contract Manufacturing Agreement” shall have the meaning specified in Section 5.5.

Delivery Forecast” shall have the meaning specified in Section 7.4.

DMF” shall mean the Drug Master File (together with all subsequent submissions, supplements and amendments thereto, and any materials, documents or information referred to or relied upon thereby) in the United States and any similar files in other countries of the Territory that relate to the Product.

ETHYPHARM” shall have the meaning specified in the Preamble.

ETHYPHARM Indemnified Claims” shall have the meaning specified in Section 6.4.

ETHYPHARM Indemnified Parties” shall have the meaning specified in Section 13.2.

ETHYPHARM Infringement Indemnitees” shall have the meaning specified in Section 6.5.

ETHYPHARM Infringement Indemnity Cap” shall have the meaning specified in Section 6.6A(a).

Event of Default” shall have the meaning specified in Section 12.1.

Exception Notice” shall have the meaning specified in Section 7.6.

E-US Indemnified Claims” shall have the meaning specified in Section 6.6A(a).

FDA” shall mean the Food and Drug Administration in the United States and similar Governmental Authorities in other countries within the Territory, including any successor agencies performing comparable functions.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

5


CONFIDENTIAL

 

Finished Dosage Form” means the Product in the form of single dose capsules containing the formulation and dosage of API as developed by ETHYPHARM and such quantity and type of excipients specified in the Specifications, which shall be labeled and packaged (in high density polyethylene (HDPE) bottles and/or blister packs as specified by RELIANT) such that it is ready for immediate marketing, sale or other distribution by RELIANT.

Governmental Authority” means any international, national, domestic, foreign, regional, local or other governmental or regulatory body, agency, authority, court or other authorized Person, including, without limitation, all such Persons having jurisdiction over the formulation, development, registration, manufacture, packaging, labeling, import, export, shipment, storage, use, pricing or sale of the Product, regardless of the formulation or dosage form thereof, or health and safety matters generally.

IND” shall mean an Investigational New Drug Application under the Act (together with all subsequent submissions, supplements and amendments thereto, and any materials, documents or information referred to or relied upon thereby) seeking authorization to commence clinical trials of the Product in humans, and similar applications or filings in the other countries within the Territory.

Initial Term” shall have the meaning specified in Section 11.1.

Intellectual Property” shall mean all patents (including, without limitation, the Patents), copyrights, trademarks, service marks, service names, trade names, internet domain names, e-mail addresses, applications or registrations for any of the foregoing, or extensions, renewals, continuations or re-issues thereof, or amendments or modifications thereto, brandmarks, brand names, trade dress, labels, logos, know-how (including, without limitation, the Know-How), show-how, technical and non-technical information, trade secrets, formulae, techniques,

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

6


CONFIDENTIAL

 

sketches, drawings, models, inventions, designs, specifications, processes, apparatus, equipment, databases, research, experimental work, development, pharmacology and clinical data, software programs and applications, software source documents, third-party licenses, and any similar type of proprietary intellectual property right vesting in the owner and/or licensee thereof pursuant to the applicable laws or regulations of any relevant jurisdiction or under any applicable license or contract, whether now existing or hereafter created, together with all modifications, enhancements and improvements thereto.

Know-How” means any and all proprietary methods, devices, technology, trade secrets, inventions, compositions, designs, formulae, know-how, show-how, technical and training manuals and documentation and other information, including, without limitation, processes and analytical methodologies used in development, testing, analysis and manufacture, and medical, clinical and toxicological testing as well as other scientific data of ETHYPHARM, which is related to or used in connection with the Product or any ingredient thereof, and/or the formulation, development, registration, manufacture, packaging, labeling, import, export, receipt, shipment, storage, use, pricing or sale thereof, whether now known or hereafter developed.

Launch Date” shall mean, with respect to each country in the Territory, the first date RELIANT [*] in such country. The parties agree that for all purposes under this Agreement the Launch Date for the United States occurred on February 2, 2005.

LET Notice” shall have the meaning specified in Section 3.2.

License” shall have the meaning specified in Section 3.1.

License Exclusion Transaction” shall have the meaning specified in Section 3.1.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

7


CONFIDENTIAL

 

NDA” shall mean any New Drug Application under the Act (together with all subsequent submissions, supplements and amendments thereto, and any materials, documents or information referred to or relied upon thereby) seeking approval to market, sell or otherwise distribute the Product, in any formulation or dosage form, in the United States, and similar applications or filings in the countries within the Territory.

Net Royalties” means royalties payable to ETHYPHARM pursuant to the terms of this Agreement, net of any Taxes required to be withheld therefrom.

Net Sales” means the aggregate amounts invoiced by RELIANT (including, as applicable, RELIANT’s assignees and sublicensees hereunder) for sales of the Product produced using ETHYPHARM Intellectual Property to independent and unrelated third parties in the Territory, less any and all (a) trade, quantity and cash discounts; (b) commissions, discounts, refunds, rebates, chargebacks, retroactive price adjustments and any other allowances which effectively reduce the net selling price; (c) returns, bad debts and uncollectible accounts; (d) Taxes collected, charged or otherwise required to be paid by RELIANT (including, as applicable, RELIANT’s assignees and sublicensees hereunder) in respect thereof; and (e) insurance, freight, warehousing and other transportation and storage costs related to shipment of the Product.

Nonparticipating Party” shall have the meaning specified in Section 6.8.

Original Agreement” shall have the meaning specified in the Recitals.

Patents” shall mean any issued patents and patent applications (including, without limitation, any applications or registrations therefor, extensions, renewals, continuations or re-issues thereof, or amendments or modifications thereto) that are currently owned or hereafter acquired or applied for by ETHYPHARM, which would be infringed by the formulation, development, registration, manufacture, packaging, labeling, import, export, receipt, shipment,

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

8


CONFIDENTIAL

 

storage, use, pricing or sale of the Product or any ingredient thereof in the Territory, but for the rights granted to RELIANT by ETHYPHARM under this Agreement, including but not limited to those patents and patent applications set forth on the Schedule of Patents attached hereto (as may such schedule shall be amended from time to time).

Person” means any individual, partnership, association, joint venture, corporation, limited liability company, trust or Governmental Authority or other entity.

Product” means a product composed of or containing micronized fenofibrate, in any dosage form, including encapsulated or bulk beads, granules or similar presentations, including, without limitation, the fenofibrate product developed by ETHYPHARM for RELIANT pursuant to this Agreement and the Product Development Program.

Product Development Program” shall have the meaning specified in Section 2.1.

Recall” shall have the meaning specified in Section 7.9.

Regulatory Applications” shall have the meaning specified in Section 2.4.

RELIANT” shall have the meaning specified in the Preamble.

RELIANT Clinical Data” shall have the meaning specified in Section 2.2.

RELIANT Indemnified Claims” shall have the meaning specified in Section 6.5.

RELIANT Indemnified Parties” shall have the meaning specified in Section 13.1.

RELIANT Infringement Indemnitees” shall have the meaning specified in Section 6.4.

Specifications” means the pharmaceutical formulation, manufacture, delivery, packaging, labeling, import, export, storage, receipt and shipment specifications for the Product (including Product in Bulk Product Form and Finished Dosage Form) and any excipients set forth on Exhibit A attached to the Original Agreement (as such Exhibit A may have been or may hereafter be amended or changed from time to time upon the agreement of the parties).

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

9


CONFIDENTIAL

 

Supply Failure Event” shall mean a willful breach of this Agreement by ETHYPHARM that results in the failure of ETHYPHARM to meet its supply obligations for the Product hereunder, or an injunction or similar action or order that prohibits or prevents ETHYPHARM from meeting its supply obligations hereunder in any material respect, which failure is not cured within thirty (30) days following written notice from RELIANT thereof (including, but not limited to, any willful failure or refusal to supply as a result of or following a change of control of ETHYPHARM).

Supply Side Letter” shall have the meaning specified in the Recitals.

Tax(es)” means, with respect to any Person, all federal, state, local, county, foreign and other taxes, assessments or other government charges, including, without limitation, income, estimated income, gross receipts, profits, business, license, occupation, franchise, capital stock, real or personal property, sales use, transfer, value added, employment or unemployment, social security, disability, alternative or add-on minimum, customs, duty, excise, stamp, environmental or withholding taxes, including interest, penalties and additions in connection therewith for which such Person may be liable (including any such tax related to any other Person for which such Person is liable, by contract, as transferee or successor, by law, treaty or otherwise).

Term” shall have the meaning specified in Section 11.1.

Territory” means: (a) the United States of America, its territories and possessions including without limitation, Puerto Rico; and (b) the Caribbean (including, without limitation, The Bahamas).

Third Party Infringement” shall have the meaning specified in Section 6.8.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

2. PRODUCT DEVELOPMENT PROGRAM; CLINICAL DATA; PRODUCT REGISTRATION

2.1 Product Development Program; Dosages. Since the date of the Original Agreement, ETHYPHARM and RELIANT have developed and, as applicable, during the remaining Term of this Agreement shall develop, the Product consistent with the terms of this Agreement in accordance with product development program set forth on Exhibit B attached to the Original Agreement (the “Product Development Program”), which Exhibit B specifies the proposed development timetable and each party’s respective responsibilities related to the development of the Product for sale in the Territory, including, without limitation, the preparation and filing of an NDA and the conduct of clinical trials related to the Product. As part of the Product Development Program, RELIANT established a highest dosage of [*] mg of API per capsule, however, RELIANT, at its option, may develop in collaboration with ETHYPHARM and conduct clinical trials in respect of other formulations and/or dosage forms of the Product. ETHYPHARM shall develop the formulations and dosage forms of the Product and manufacture the Product in such formulations and dosage forms as shall be requested by RELIANT or otherwise required to comply with the Act and any applicable NDA and in compliance with the Product Development Program.

2.2 Ownership of Clinical Data. Subject to the provisions of Section 2.3, all preclinical, clinical, technical and other information relative to the clinical program, data, analyses, studies or similar information (including, without limitation, all Intellectual Property) generated or developed by or on behalf of the parties after the date hereof as a result of or in connection with the Product Development Program and the clinical trials conducted by

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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[*] hereunder and thereunder (collectively, the “RELIANT Clinical Data”), shall be owned exclusively by [*].

2.3 ETHYPHARM’s Right to RELIANT Clinical Data. The parties agree, that following the issuance of an NDA for the purpose of licensing the Product and subject to the terms and conditions of this Agreement, ETHYPHARM shall have access to the RELIANT Clinical Data for use outside the Territory on the basis of terms and conditions to be negotiated in good faith between the parties; provided, however, that the provisions of this Agreement shall not apply to the use by ETHYPHARM of the RELIANT Clinical Data in Canada and Mexico pursuant to Section 14. For the avoidance of doubt, the parties acknowledge and agree that, except as provided herein, ETHYPHARM shall have no rights in or to any RELIANT Clinical Data until the terms and conditions of access are agreed or in the event that that the NDA is revoked, cancelled, withdrawn or otherwise impaired as a result of any act or omission by or behalf of ETHYPHARM of the types described in Section 4.4 of the Original Agreement.

2.4 Regulatory Applications and Related Filings. All applications, submissions and regulatory filings (together with all documentation, correspondence and other supporting materials related thereto, collectively, the “Regulatory Applications”) shall be filed and submitted in RELIANT’s name and shall be owned exclusively by RELIANT, and all Applicable Permits issued pursuant thereto shall be in the name of and owned exclusively by RELIANT. RELIANT shall be responsible for obtaining any and all necessary regulatory approvals from any Governmental Authority under any Applicable Law or Applicable Permit as a result of any changes to the Specifications requested by RELIANT and for reporting any such modifications to the Specifications to the applicable Governmental Authority as appropriate.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

2.5 ETHYPHARM’s Development Responsibilities. ETHYPHARM has heretofore delivered (and, as applicable, shall prepare and deliver, and shall cause each applicable supplier or other third party (other than RELIANT) involved with the manufacture and packaging of the Product from time to time hereafter to prepare and deliver), to RELIANT and, as applicable, file or cause to be filed with the appropriate Governmental Authority: (a) the DMF, which shall be filed with FDA for the manufacture of the Product; and (b) the CMC section of the IND and the NDA, all of which shall be accurate and complete, and in form and substance reasonably satisfactory to RELIANT and suitable for inclusion in the applicable filing. ETHYPHARM shall, at its own cost, cooperate with and assist RELIANT in the preparation, filing and prosecution of the Regulatory Applications, and shall prepare and deliver such other documents, and take such other actions, as may be necessary or appropriate to apply for, prosecute or obtain any Applicable Permits. All materials to be prepared by or on behalf of ETHYPHARM hereunder shall be prepared and delivered and, as applicable, filed, in timely manner in accordance with timetable established by the parties hereunder. ETHYPHARM shall provide RELIANT with sufficient opportunity to review and comment upon all Regulatory Applications or portions thereof prepared by or on behalf of ETHYPHARM prior to their submission to any Governmental Authority. In the event that RELIANT requests any modifications to the Regulatory Applications or portions thereof required to be prepared by ETHYPHARM hereunder, the parties shall discuss such modifications in good faith; provided, however, that the party in whose name the Regulatory Application is being made shall retain the ultimate right to determine the contents thereof. In connection with this Agreement, ETHYPHARM shall also provide RELIANT with full access to all of its information and records, including, without limitation, its Intellectual Property and Confidential Information, related to the Product and its

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

formulation, manufacture and packaging (including, without limitation, formulation, development, pharmacology and clinical data regarding the Product, any ingredient thereof (including fenofibrate)) in order that RELIANT may obtain and maintain the Applicable Permits contemplated by this Agreement and comply with Applicable Law.

2.6 Compliance of Specifications. The Specifications shall at all times be in compliance with the requirements of the Act and, in particular, an NDA applicable to the Product, such that RELIANT shall be entitled to market, sell and distribute the Product in the Territory, and the parties agree to make any changes to the Specifications as may be required to ensure such compliance.

 

3. GRANT OF LICENSE

3.1 Grant of License; License Exclusion. Subject to the terms set forth herein and in consideration for the payments set forth in Sections 4, 8 and 9 hereof, ETHYPHARM hereby grants to RELIANT the exclusive (even as to ETHYPHARM) royalty-bearing license to all of ETHYPHARM’s Intellectual Property related to the Product to make or have made (except to make or have made the Product in Bulk Product Form), package, develop, import, export, within the Territory, use, distribute, promote, market, sell and otherwise fully exploit the Product, in whatever formulation or dosage form, within the Territory (the “License”); provided, however, that the License shall not prevent ETHYPHARM from developing, manufacturing, licensing, promoting and marketing other products containing fenofibrate as the main active pharmaceutical ingredient in the form of microgranules, directly or through third parties, provided that fenofibrate is combined with another active pharmaceutical ingredient which does not belong to the statin family and for which there is no valid patent in the Territory (a “License Exclusion Transaction”).

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

3.2 RELIANT Right of First Refusal Regarding License Exclusion Transactions. In the event that ETHYPHARM desires to enter into or consummate a License Exclusion Transaction, ETHYPHARM agrees that it shall first provide RELIANT with at least [*] days prior written notice of such proposed License Exclusion Transaction specifying the terms and conditions of the proposed product, product specifications, manufacturing specifications, product development program, license and royalty arrangement and marketing strategy related thereto (each, a “LET Notice”). Following delivery of any LET Notice, ETHYPHARM shall provide RELIANT with such information as RELIANT may reasonably request in order to allow RELIANT to evaluate the proposed License Exclusion Transaction described therein. Within [*] days following its receipt of the LET Notice, RELIANT shall have the right, but not the obligation, upon delivery of written notice to ETHYPHARM to agree to enter into the transaction described by the LET Notice upon the terms and conditions stated therein. In the event that RELIANT notifies ETHYPHARM in writing that it does not wish to exercise its rights under this Section 3.2 or fails to respond to such LET Notice within such [*] day period, ETHYPHARM shall be free to enter into the License Exclusion Transaction described therein with a third party; provided, however, that ETHYPHARM may not offer to such third party any terms or conditions more favorable to such third party than those described in the LET Notice without first re-offering such opportunity to RELIANT pursuant to this Section 3.2; provided, further, that in the event ETHYPHARM shall not have entered into a binding agreement with such third party within [*] days following the date of the LET Notice, ETHYPHARM shall not enter into or consummate such License Exclusion Transaction without re-offering such opportunity to RELIANT pursuant to this Section 3.2.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

3.3 Sublicenses. RELIANT shall have the right to sublicense any and all of the rights granted pursuant to this Agreement, in whole or in part, to one or more Persons; provided, however, that RELIANT shall promptly (a) advise ETHYPHARM of the identity of any such sublicensee; and (b) provide ETHYPHARM with a copy of the sublicense agreement to establish that such sublicensee has been informed of the obligations under this Agreement. Notwithstanding the foregoing, RELIANT shall not be required to disclose to ETHYPHARM the amount or structure of any royalty or other payments due to RELIANT from any such sublicensees. RELIANT agrees that it shall require any sublicensees of any of its rights hereunder to preserve the confidentiality of any ETHYPHARM Intellectual Property or Confidential Information to the extent RELIANT is required to do so under this Agreement.

3.4 Minimum Annual Sales Requirement. In order to maintain exclusivity of the License granted in Section 3.1, RELIANT shall be required to reach minimum annual sales of capsules containing Product (“Minimum Annual Sales”) in the United States as set forth immediately below for the year ending on the anniversary of the Launch Date in the United States (subject to adjustment for introduction of generic competing products in the Territory as described below); provided, however, that if RELIANT is unable to reach its Minimum Annual Sales as a result of failure by ETHYPHARM to supply Product, then ETHYPHARM shall not have the right to convert the license to a non-exclusive license and RELIANT shall not be obligated to make any Make-Whole Payment (as defined below) hereunder:

 

Period (Years Post Launch Date)

 

Minimum Number of Capsules to Be Sold

February 2, 2005-February 1, 2006

  [*]

February 2, 2006-February 1, 2007

 

[*]

February 2, 2007-February 1, 2008

 

[*]

February 2, 2008-February 1, 2009

 

[*]

February 2, 2009-February 1, 2010

 

[*]

February 2, 2010-February 1, 2011

 

[*]

February 2, 2011-February 1, 2012

 

[*]

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

No Minimum Annual Sales requirements shall apply after February 1, 2012 or in respect of any sales of the Product by RELIANT inside the Territory, but outside of the United States. Should RELIANT fail to reach the applicable Minimum Annual Sales target during any applicable twelve-month period, ETHYPHARM, as its sole remedy hereunder, may, upon at least sixty (60) days prior written notice to RELIANT, convert the exclusive license granted to RELIANT pursuant to Section 3.1 to a non-exclusive license in the Territory; provided, however, that RELIANT shall have the option, but not the obligation, to make an additional payment (the “Make-Whole Payment”), in addition to any other payments due to ETHYPHARM under Section 9.1 in respect of sales of the Product for said twelve-month period, such that ETHYPHARM receives an aggregate amount for sales of Product for said twelve-month period that is not less than the amount ETHYPHARM would have received under this Agreement had RELIANT achieved the applicable Minimum Annual Sales target for said twelve-month period, in which case ETHYPHARM shall have no right to convert the License to a non-exclusive license. For the purpose of calculating the amount of the Make-Whole Payment, RELIANT shall use the [*] per capsule for said applicable twelve-month period. For the avoidance of doubt, the parties agree and acknowledge that sales of the Product by RELIANT’s sublicensees shall be included for the purposes of determining whether the applicable Minimum Annual Sales target has been satisfied. The parties agree that in the event that any generic products that compete with the Product are introduced in the Territory during the period while any Minimum Annual Sales targets remain in effect, the applicable Minimum Annual Sales targets shall be reduced by [*] percent ([*]%) in the year of such introduction (pro rated for generic introductions in the middle

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

of the applicable year), by [*] percent ([*]%) in the following year, and by [*] percent ([*]%) for each remaining year thereafter. Notwithstanding any provision herein to the contrary, in the event that RELIANT shall not have transferred or sublicenced its rights under this Agreement on or prior to December 31, 2006, RELIANT and ETHYPHARM shall negotiate in good faith a mutually agreeable modification or replacement of this Section 3.4 and/or any terms of this Agreement, as applicable (it being agreed that this provision shall apply solely to RELIANT and not any assignee or sublicensee of RELIANT hereunder).

3.5 Cooperation Regarding Fenofibrate Product Development. During the term of this Agreement, ETHYPHARM shall provide RELIANT with periodic updates (not less frequently than semi-annually) regarding its products and product development plans relating to or involving fenofibrate. At RELIANT’s request, the parties shall discuss appropriate access to and/or other rights for RELIANT in respect of such other products and/or product development plans. Nothing contained in this Section 3.5 is intended to supersede or limit any other rights obligations of the parties under other provisions of this Agreement.

3.6 Competing Dosage Forms. RELIANT may not, within [*] years of the first Launch Date in the Territory, develop, have developed, promote, distribute or market any Competing Dosage Form within the Territory, without the prior written consent of ETHYPHARM; provided, however, that the foregoing restriction shall not prevent RELIANT from developing, having developed, promoting, distributing or marketing any Competing Dosage Form within the Territory provided that RELIANT pays ETHYPHARM royalties in respect of such Competing Dosage Form in accordance with Section 9 of this Agreement; provided, further, that should RELIANT decide to develop or have developed any Competing Dosage Form within the Territory, RELIANT shall send ETHYPHARM a written notification of such decision in order to

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

enable ETHYPHARM to propose within a maximum period of sixty (60) days from receipt of the written notification a similar or comparable product to the Competing Dosage Form; provided, further, RELIANT agrees to give ETHYPHARM at least ten (10) days prior written notice of RELIANT’s decision to promote, distribute or market any existing any Competing Dosage Form within the Territory. For the avoidance of doubt, the parties agree and acknowledge that the restrictions in this Section 3.6 shall not apply to any Combination Product.

 

4. COMPENSATION – LICENSE FEES AND MILESTONE PAYMENTS

4.1 License Fees. In consideration of the services by ETHYPHARM to research and develop the Product, pursuant to the License and other rights granted hereunder, RELIANT has previously paid to ETHYPHARM license fees in the aggregate amount of US$[*]. In addition, RELIANT shall pay an additional US$[*] license fee upon the earlier to occur of (i) such time as cumulative Net Sales (measured from the Launch Date in the United States) exceed US$[*] (in which case such amount shall be payable at such time as the next payment is due to ETHYPHARM in respect of Net Sales pursuant to Section 9.1 hereof), and (ii) solely in the event that RELIANT sublicenses or makes an assignment of its rights hereunder, December 31, 2006.

4.2 Milestone Payments. In addition to the license fees set forth above, RELIANT has previously paid to ETHYPHARM milestone payments in the an aggregate amount of US$[*].

4.3 Method of Payment. All payments required to be paid under this Agreement by RELIANT to ETHYPHARM, or ETHYPHARM to RELIANT, shall be paid in United States dollars by wire transfer of immediately available funds to a dollar-denominated account located in the United States pursuant to written payment instructions, which shall be delivered to by the

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

party entitled to such payment at least five (5) Business Days prior to the date such payment is due. Such payment shall be deemed to have been made upon the issuance of a federal reference number for the wire transfer of said funds.

 

5. DELIVERY OF PRODUCT FOR CLINICAL AND REGULATORY PURPOSES; PRODUCT LAUNCH; ADDITIONAL MANUFACTURING FACILITY

5.1 Clinical Formulations and Placebos. ETHYPHARM shall manufacture, deliver and sell to RELIANT such quantities of validated clinical formulations of the Product, in such formulations and dosage forms as requested by RELIANT, together with matching quantities of placebos, to enable RELIANT to conduct all clinical trials to be conducted pursuant to the Product Development Program established hereunder. All Product, regardless of formulation or dosage form, and placebos for use by RELIANT in clinical trials shall be: (a) sold to RELIANT at ETHYPHARM’S actual cost as determined in accordance with Exhibit D attached to the Original Agreement; and (b) delivered by ETHYPHARM within thirty (30) days of ETHYPHARM’s receipt of RELIANT’s order therefor.

5.2 Registration Batches. ETHYPHARM shall manufacture, deliver and sell to RELIANT such quantities of full commercial scale batches of the Product, in such formulations and dosage forms as requested by RELIANT, determined by RELIANT to be necessary to satisfy requirements under Applicable Law or Applicable Permit (including, without limitation, in connection with the filing and approval of an NDA with the FDA) to market the Product in the United States. All Product, in whatever formulation, for use by RELIANT to satisfy such requirements shall be: (a) sold to RELIANT at ETHYPHARM’S actual cost as determined in accordance with Exhibit D attached to the Original Agreement; and (b) delivered by ETHYPHARM within thirty (30) days of ETHYPHARM’s receipt of RELIANT’s order therefor.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

5.3 Promotion of the Product. For a period of three (3) years following the first Launch Date in the United States, RELIANT shall use its commercially reasonable efforts to promote the Product utilizing a sales force consisting of at least one hundred fifty (150) sales representatives.

5.4 Additional Manufacturing Facility. On or prior to December 31, 2006, ETHYPHARM shall establish, validate and certify an additional manufacturing facility at Châteauneuf-en-Thymerais, France for the Product, which facility may be owned by ETHYPHARM or a third party contract manufacturer (such facility, the “Additional Manufacturing Facility”). ETHYPHARM shall certify in writing to RELIANT that the Additional Manufacturing Facility (and, as applicable, any third party contract manufacturer): (i) has the requisite capacity to satisfy ETHYPHARM’s production, packaging and delivery obligations, and to meet RELIANT’s order requirements, hereunder with respect to the Product in accordance with the Specifications and the terms and conditions of this Agreement; (ii) complies and will comply with all Applicable Laws and holds all Applicable Permits necessary for the manufacture and packaging of the Product in compliance with cGMP; and (iii) has and will have the irrevocable right to use all Intellectual Property and Confidential Information of ETHYPHARM necessary to manufacture and package the Product in any formulation or dosage form required hereunder, in accordance with the Specifications and the terms and conditions of this Agreement.

5.4A Validation Batches. In addition to complying with any other requirements or specifications hereunder, any validation batches of the Product produced at the Additional

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

Manufacturing Facility shall be finished and delivered to RELIANT in saleable condition for sale to the trade or as samples, as shall be directed by RELIANT. RELIANT shall pay for such validation batches in accordance with Section 8.1(a).

5.4B Suspension of Certain Activities Under Supply Side Letter. Provided that ETHYPHARM is in compliance with its supply-related obligations under this Agreement, RELIANT agrees that it shall not pursue commercialization of any Product manufactured pursuant to the terms of the Supply Side Letter.

5.5 RELIANT Third-Party Beneficiary Rights. In the event that ETHYPHARM contracts with any third party (other than RELIANT or any of RELIANT’s Affiliates) to establish the Additional Manufacturing Facility and to provide the manufacturing services required under Section 5.4 hereof (such contract, a “Contract Manufacturing Agreement”): (a) ETHYPHARM shall deliver to RELIANT a true and complete copy of such Contract Manufacturing Agreement promptly following the execution thereof; (b) such Contract Manufacturing Agreement shall explicitly provide that RELIANT is a third party beneficiary thereof with the right to enforce the provisions thereof for its benefit; and (c) such Contract Manufacturing Agreement shall contain such terms and conditions that are consistent with those contained herein (including, without limitation, the obligation to manufacture, package, sell and deliver Product to RELIANT, and the right of RELIANT to conduct an audit an inspection of the Additional Manufacturing Facility pursuant to Section 7.10 hereof). The parties agree and acknowledge that the foregoing requirements are necessary in order that RELIANT may be assured that it will continue to be supplied with the Product in accordance with the terms and conditions of this Agreement, and meet its contractual obligations to various third parties. Notwithstanding the foregoing, RELIANT shall not be required to make any payment or render

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

any performance hereunder to any Person other than ETHYPHARM, except as RELIANT may agree in writing.

5.6 RELIANT Step-In Rights Following Supply Failure Event.

(a) Upon the occurrence of a Supply Failure Event, in the event that RELIANT does not exercise its rights under Section 12, RELIANT shall have the option to exercise step-in rights and ETHYPHARM shall cooperate with RELIANT in the exercise of such rights. Such step-in rights shall include, without limitation, and to the extent allowable under applicable law and regulation, ETHYPHARM’s grant to RELIANT of such additional license rights, rights of access, rights of observation and rights of management, direction and control as may be necessary or desirable to enable and permit RELIANT (or RELIANT’s designee) to attempt to cure or mitigate such Supply Failure Event, to the extent the same is subject to cure or mitigation, and/or otherwise to ensure that supply of the Product shall continue to be available to RELIANT under this Agreement. If RELIANT uses a designee, RELIANT shall be responsible for such designee’s compliance with the provisions of Section 14.2 (Confidentiality) of this Agreement. The foregoing rights shall apply with respect to any facility at which the Product (and/or API or any excipient used therein) is manufactured, tested, labeled, encapsulated, stored or otherwise handled, in each case to the extent necessary for RELIANT to preserve and protect supply of the Product as contemplated by this Agreement. In the event that ETHYPHARM cures the Supply Failure Event subsequent to RELIANT’s exercise of its step-in rights, both ETHYPHARM and RELIANT shall reasonably cooperate to effect a termination of RELIANT’s step-in rights with respect to such Supply Failure Event in such a manner and at such times so as to minimize the liabilities as a result of such termination. For the avoidance of doubt, RELIANT’s exercise of its step-in rights under this Section 5.6 shall not waive or restrict any

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

other rights or remedies of the parties under this Agreement, including, without limitation, RELIANT’s right to terminate this Agreement.

(b) In furtherance and not in limitation of the foregoing, in addition to rights provided above, the parties hereby agree that in the event of a Supply Failure Event, RELIANT shall have the right, without terminating this Agreement, to cause ETHYPHARM to effect the technology transfer as contemplated under Section 12.3.

(c) In the event that ETHYPHARM shall cure, or cause to be cured, any Supply Failure Event prior to the exercise by RELIANT of its rights under this Section 5.6, RELIANT shall cease to have any further rights hereunder in respect of such Supply Failure Event (but shall have rights hereunder with respect to any future Supply Failure Event).

5.7 Other RELIANT Rights Regarding Supply.

(a) Notwithstanding any provisions herein to the contrary, RELIANT shall, upon reasonable notice to ETHYPHARM, have the right to visit any manufacturing facility at which the Product is manufactured (or to be manufactured), and to observe the manufacture of the Product(s), not more than twice per year (except as otherwise permitted under Section 5.7(b)).

(b) In the event of any event, condition or other occurrence that could reasonably result in the inability of ETHYPHARM to meet its supply obligations hereunder, ETHYPHARM and RELIANT shall consult and cooperate to address such matter and to ensure ETHYPHARM’s ability to continue to meet such supply obligations.

(c) In the event of a shortage of supply of the Product, API and/or any other materials necessary for the manufacture and supply of the Product, ETHYPHARM shall allocate to RELIANT supply of the Product pro rata in accordance with RELIANT’s firm orders for the

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

Product so that RELIANT is treated at least as favorably as any other affected ETHYPHARM customers for such formulation, API and/or any such other materials, as applicable.

(d) Prior to July 31, 2006, ETHYPHARM shall take such actions as are necessary to appoint RELIANT as its sole and exclusive agent for United States customs purposes relating to matters under this Agreement.

 

6. OWNERSHIP AND USE OF INTELLECTUAL PROPERTY; DEVELOPMENT OF COMBINATION PRODUCT

6.1 Ownership. Subject to the terms hereof, including, without limitation, the License and other rights granted by ETHYPHARM to RELIANT hereunder, all existing and future Intellectual Property of the parties with respect to the Product shall be owned as follows:

(a) other than as provided below or elsewhere in this Agreement, all Intellectual Property owned by any party hereto on the date hereof shall continue to be owned by such party;

(b) any Intellectual Property developed, created or discovered solely by ETHYPHARM and subject to the license granted hereunder during the Term of this Agreement relating to the Product and its manufacturing shall be owned by ETHYPHARM; and

(c) any Intellectual Property developed, created or discovered by or on behalf of RELIANT during the Term of this Agreement relating to any of the clinical development and methods of use of the Product, in any formulation or dosage form, and any Intellectual Property that is otherwise developed by RELIANT shall be owned by RELIANT.

Each party agrees to execute and deliver to the party that owns or is entitled to own any Intellectual Property hereunder, such instruments of transfer and assignment as may be requested by the owner party to vest fully in such party the ownership rights in said Intellectual Property;

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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provided, however, that each party hereto shall be entitled, during the Term of this Agreement, to use and practice any and all Intellectual Property owned by the other party of the types described in foregoing clauses (a), (b) and (c), without additional payment or royalty, for purposes not inconsistent with this Agreement and in accordance with the terms and conditions hereof. In any event, RELIANT may not use ETHYPHARM’s Intellectual Property to apply for a patent outside the Territory. Each party shall be free to use and practice its own Intellectual Property in any application not inconsistent with the terms of this Agreement without the consent of the other and without an obligation to notify the other party of such intended use or to pay royalties or other compensation to the other by reason of such use during the Term of this Agreement and thereafter.

6.2 Patents. Each party shall be responsible, at its own expense, for filing and prosecuting such patent applications, as it deems appropriate, and for paying maintenance fees on any patents issuing therefrom, for the term of this Agreement, with respect to inventions owned by it that relate to or are used in connection with the manufacture, packaging, sale or use of the Product and which are necessary for, used in connection with or otherwise related to the performance of this Agreement by either party hereto. Notwithstanding anything herein to the contrary, ETHYPHARM, at its sole cost and expense, shall continue to prosecute and maintain each of the Patents and shall keep RELIANT advised of all actions relative to the same. If ETHYPHARM fails to carry out the obligations set forth in this Section 6.2 with respect to the Patents, RELIANT may carry out such obligations on ETHYPHARM’s behalf at ETHYPHARM’s cost and may set off such cost against any amounts due to ETHYPHARM hereunder thereafter. Each party shall promptly render all necessary assistance reasonably requested by the other party in applying for and prosecuting patent applications based on

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

26


CONFIDENTIAL

 

Intellectual Property owned by such other party under this Agreement. Except as otherwise provided herein, patents covering joint inventions, if any, shall be owned by the parties jointly, and the parties shall share equally in the expenses of filing for and maintaining such patents and any royalties attributable thereto. ETHYPHARM’s obligations in respect of patents pursuant to this Section 6.2 shall apply only to those patents used in the manufacture of the Product or otherwise related to the Product or necessary for the full and timely performance of ETHYPHARM’s obligations under this Agreement.

6.3 Notice of Infringement. If either party shall learn of (a) any claim or assertion that the manufacture, use or sale of the Product under, or any use of Intellectual Property contemplated by, this Agreement, or any other action taken by either party in performance of its obligations hereunder infringes, misappropriates or otherwise violates the Intellectual Property rights of any third party, or (b) the actual or threatened infringement, misappropriation or other violation by any third party of the Intellectual Property rights of any party hereto that are the subject of this Agreement, then the party becoming so informed shall as soon as reasonably practicable, but in all events within fifteen (15) Business Days thereof, notify the other party to this Agreement of such claim or assertion, or actual or threatened infringement, misappropriation or other violation.

6.4 ETHYPHARM Indemnified Claims. In the event that any third party brings or threatens to bring a claim against either party hereto and/or any of its Affiliates that alleges or demonstrates infringement of such third party’s Intellectual Property rights arising out of, resulting from or otherwise related to (i) the Product, including the formulation, the manufacture of the Product or the micronization of the API and the non-active ingredients contained therein, or (ii) any ETHYPHARM Intellectual Property used by RELIANT, its Affiliates, sublicensees or

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

27


CONFIDENTIAL

 

agents as contemplated by this Agreement (such claims, together, “ETHYPHARM Indemnified Claims”), ETHYPHARM shall defend such action at its own cost and expense, and shall, at its own cost and expense, indemnify and hold harmless RELIANT and RELIANT’s Affiliates, officers, managers, employees, trustees, representatives, consultants, sublicensees and agents (the “RELIANT Infringement Indemnitees”) as set forth in Section 6.6 below. With respect to the manufacture (but not the micronization) of the API, in the event that (a) any third party brings or threatens to bring a claim against either party hereto and/or any of its Affiliates that alleges or demonstrates infringement of such third party’s Intellectual Property rights arising out of, resulting from or otherwise related to the manufacture of the API, and (b) ETHYPHARM’s supplier of the API fails to defend, indemnify and hold harmless ETHYPHARM from such claim, both parties shall cooperate in the defense of such action and equally bear the cost and expenses thereof (it being agreed, in any event, that any indemnification or other rights or amounts received by ETHYPHARM from such supplier in respect of or as result of such claim shall be applied to the defense of such claim hereunder).

6.5 RELIANT Indemnified Claims. In the event that any third party brings or threatens to bring a claim against either party hereto and/or any of its Affiliates that alleges or demonstrates infringement of such third party’s Intellectual Property rights arising out of, resulting from or otherwise related to any RELIANT Intellectual Property used by RELIANT, its Affiliates, sublicensees or agents as contemplated by this Agreement (such claims, together, “RELIANT Indemnified Claims”), RELIANT shall defend such action at its own cost and expense, and shall, at its own cost and expense, indemnify and hold harmless ETHYPHARM, its Affiliates, officers, managers, employees, representatives, consultants and agents (the “ETHYPHARM Infringement Indemnitees”) as set forth in Section 6.7 below.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

28


CONFIDENTIAL

 

6.6 Infringement Indemnification by ETHYPHARM. Notwithstanding any other provisions of this Agreement, ETHYPHARM will defend, indemnify and hold harmless the RELIANT Infringement Indemnitees from and against any and all liabilities, losses, damages, actions, claims and expenses suffered or incurred by RELIANT Infringement Indemnitees (including reasonable attorneys’ fees, court costs and expert witnesses’ fees) resulting from any ETHYPHARM Indemnified Claims so long as any such claim does not arise from RELIANT’s breach of this Agreement, or arise from RELIANT’s negligent or intentionally wrongful conduct (it being expressly understood that RELIANT’s reasonable exercise of its rights hereunder with respect to the use of any ETHYPHARM Intellectual Property in accordance with this Agreement and RELIANT’s reasonable exercise of its rights hereunder in accordance with this Agreement shall not be deemed a RELIANT’s negligent or intentional wrongful conduct as pertaining to violation of another party’s Intellectual Property rights).

6.6A ETHYPHARM’s Infringement Indemnity Cap.

(a) In General. Contingent upon ETHYPHARM’s compliance with its supply-related obligations, including its obligations under Section 5.4, and notwithstanding any provision herein to the contrary, ETHYPHARM’s liability to the RELIANT Infringement Indemnitees for ETHYPHARM Indemnified Claims relating to third party Intellectual Property protected under federal or state law of the United States under Sections 6.4 and 6.6 of this Agreement (collectively, the “E-US Indemnified Claims”) shall be limited to the lesser of: (i) [*] percent ([*]%) of the total amount of any costs of any such defense, indemnity or holding harmless related to such E-US Indemnified Claims; and (ii) [*] payable under Section 9.1 and, as applicable, Section [*] (the lesser of such amount, hereinafter referred to as the “ETHYPHARM Infringement Indemnity Cap”). In the event that ETHYPHARM has is not in compliance with

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

29


CONFIDENTIAL

 

its supply-related obligations, including those under Section 5.4 for any reason at December 31, 2006, then this Section 6.6A(a) may, in RELIANT’s sole discretion, be deemed null and void, in which case it shall be of no further force or effect; provided, however, that in the event that ETHYPHARM’s failure to comply with such obligations is a result of force majeure and ETHYPHARM is otherwise in compliance with its supply obligations hereunder, then RELIANT shall not have the right to deem this Section 6.6A(a) null and void during the pendency of such force majeure, not to exceed ninety (90) days; provided, further, in the event of any discrepancy between the provisions of this Section 6.6A(a) and Section 14.4, the provisions of this Section 6.6A(a) shall control. For the avoidance of doubt, the parties agree and acknowledge that the ETHYPHARM Infringement Indemnity Cap does not and shall not apply to (A) any ETHYPHARM Indemnified Claims in any jurisdiction outside of the United States, or (B) any other claims for which any RELIANT Infringement Indemnitees and/or RELIANT Indemnified Parties are entitled to be indemnified by ETHYPHARM under any other provision of this Agreement.

(b) RELIANT Assumption and Control of Defense. Notwithstanding any provision herein to the contrary, RELIANT shall have the right to assume and control the defense of all ETHYPHARM Indemnified Claims, and, at RELIANT’S request, ETHYPHARM will provide complete and timely cooperation with RELIANT in such defense, which cooperation shall be at ETHYPHARM’s sole cost and expense.

(c) ETHYPHARM Waiver of Defenses; Acknowledgement. ETHYPHARM, on behalf of itself and each of its Affiliates, hereby waives each and every claimed defenses to its obligation to idemnify identified in the letter to RELIANT from the law firm of Baach, Robinson & Lewis PLLC dated January 10, 2005 (the “Claimed Defenses”) and agrees that it shall not

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

30


CONFIDENTIAL

 

hereafter assert, directly or indirectly, any of such Claimed Defenses in an effort to reduce or otherwise limit its obligation to indemnify and hold harmless RELIANT and/or any of the other RELIANT Infringement Indemnitees under this Agreement or otherwise. In addition, ETHYPHARM hereby acknowledges and agrees that all of RELIANT’s actions related to or in respect of the Product through May 20, 2005 (and all actions generally consistent therewith) constitute the “reasonable exercise” of RELIANT’s rights under this Agreement. In the event RELIANT voids the liability limitations contained in Section 6.6A(a) as provided therein, [*] provided, however, that under no circumstances shall RELIANT be required to refund, reimburse or otherwise compensate ETHYPHARM for any amounts paid by ETHYPHARM to RELIANT prior thereto.

6.7 Infringement Indemnification by RELIANT. Notwithstanding any other provisions of this Agreement, RELIANT will defend, indemnify and hold harmless the ETHYPHARM Infringement Indemnitees from and against any and all liabilities, losses, damages, actions, claims and expenses suffered or incurred by ETHYPHARM Infringement Indemnitees (including reasonable attorneys’ fees, court costs and expert witnesses’ fees) resulting from any RELIANT Indemnified Claims so long as any such claim does not arise from ETHYPHARM’s breach of this Agreement, or arise from ETHYPHARM’s negligent or intentionally wrongful conduct (it being expressly understood that ETHYPHARM’s reasonable exercise of its rights hereunder with respect to the use of any RELIANT Intellectual Property in accordance with this Agreement shall not be deemed ETHYPHARM’s negligent or intentional wrongful conduct as pertaining to violation of another party’s Intellectual Property rights).

6.8 Third Party Infringement. In the event either party believes that a third party is infringing or otherwise violating any party’s Intellectual Property rights with respect to or related

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

31


CONFIDENTIAL

 

to the Product in the Territory (a “Third Party Infringement”), ETHYPHARM and RELIANT shall consult with each other and their respective counsel in order to develop a strategy for addressing the Third Party Infringement. In the event the parties agree to take legal action to stop the Third Party Infringement, they shall agree upon legal counsel to prosecute such action. Unless the parties agree upon a different formula for sharing the expenses (including attorney and expert fees) of such action and for sharing any award or settlement, the owner of such Intellectual Property shall bear the costs of such action and shall be entitled to any award or settlement in respect thereof. In the event that one of the parties does not desire or is otherwise unwilling to participate in the action (the “Nonparticipating Party”), the other shall be free to bring the action in its own name, at its own expense and retain any award or settlement in its entirety; provided, however, that if such third party infringement adversely affects either party’s rights or obligations hereunder, then the costs of such action shall be borne by the owner of such Intellectual Property, regardless of which party brings or prosecutes such action. If necessary, the Nonparticipating Party shall join as a party to the suit but shall be under no obligation to participate except to the extent that such participation is required as the result of being a named party to the suit. The Nonparticipating Party shall offer reasonable assistance in connection therewith at no charge to the other party except for reimbursement of reasonable out-of-pocket expenses including reasonable attorney’s fees. If either party desires to retain counsel independently, the party may do so, but it shall not relieve the party of its obligations under this Section 6.8.

6.9 Termination Resulting From Infringement. In the event that Intellectual Property belonging to any party and necessary for, used in connection with or otherwise related to the performance of this Agreement by any party hereto is determined to violate or infringe upon any

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

32


CONFIDENTIAL

 

Intellectual Property rights of any third party, and the owner of said Intellectual Property is unable to obtain for itself and the benefit of the other party and its sublicensees, if any, at no additional cost to said other party and/or any of its sublicensees, a license to use the Intellectual Property upon which the claims for infringement or violation is based, then said other party shall have the right to terminate this Agreement in addition to any other rights or remedies it may have hereunder or at law or in equity.

6.10 Development of Combination Products. RELIANT shall have the right, but not the obligation, to develop and commercialize one or more products in which the API is used in combination with other pharmaceutically active substances (each, a “Combination Product”); provided, however, that RELIANT shall have no right to use any of ETHYPHARM’s Intellectual Property in connection therewith unless such development is made in cooperation with ETHYPHARM. ETHYPHARM agrees that, in the event RELIANT desires to develop one or more Combination Products with ETHYPHARM, RELIANT shall have access to ETHYPHARM’s Intellectual Property and applicable personnel for the purposes of developing such Combination Products and shall grant to RELIANT such additional licenses or other rights as may be necessary or desirable, if any, for RELIANT to develop and commercialize one or more Combination Products on reasonable terms to be negotiated in good faith by the parties. The parties agree that specific terms and conditions relating to the development, license, manufacture, marketing and sale of any Combination Product developed jointly by RELIANT and ETHYPHARM shall be set forth in a separate agreement to be negotiated and executed by the parties hereto.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

33


CONFIDENTIAL

 

7. MANUFACTURING STANDARDS; REGULATORY COMPLIANCE; SALE AND SHIPMENT OF PRODUCT; RECALL PROCEDURE AND AUDIT RIGHTS

7.1 Standard of Manufacture. Subject to Section 7.2, ETHYPHARM shall manufacture and supply, or cause to be manufactured and supplied as expressly permitted hereunder, to RELIANT the Product pursuant to orders submitted by RELIANT in accordance with Sections 7.3 and 7.4 hereof. All Product supplied to RELIANT under this Agreement shall: (a) comply with the Specifications, all Applicable Laws and Applicable Permits; (b) be consistent with the DMF and CMC, and produced in a facility and in a manner compliant with cGMP and all other Applicable Laws; (c) not be adulterated or misbranded within the meaning of the Act; (d) be manufactured under cGMP conditions at ETHYPHARM’s facility in Grand Quevilly, France or, upon at least thirty (30) days prior written notice to RELIANT, at the Additional Manufacturing Facility in Châteauneuf-en-Thymerais, France, which facility(ies) shall at all times during such manufacture be an FDA-approved manufacturing facility and shall manufacture, package, label, store and handle the Product in accordance with all Applicable Laws and Applicable Permits; and (e) be in such formulation and dosage form (e.g., Bulk Product Form or Finished Dosage Form) as requested by RELIANT. All shipments of the Product to be delivered to RELIANT under this Agreement, regardless of the formulation or dosage form thereof, shall be sampled and analyzed by or on behalf of ETHYPHARM to confirm that it meets the Specifications. ETHYPHARM shall deliver or cause to be delivered to RELIANT with each shipment of the Product a certificate of analysis stating that the Product in the formulations and dosage forms provided meets the applicable Specifications. ETHYPHARM agrees that neither it nor any third party manufacturer of the Product shall make any changes in the formulation, manufacture, production, packaging, storage and/or shipment of the Product

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

34


CONFIDENTIAL

 

without the specific written prior approval of RELIANT unless expressly required by Applicable Law (including, without limitation, cGMP or the Act), in which case ETHYPHARM shall notify RELIANT in writing immediately of such change and the reason therefor. The responsibility for the final release of the Product delivered by ETHYPHARM to RELIANT for sale or distribution in the Territory shall remain with RELIANT.

7.2 Encapsulation by RELIANT. Notwithstanding any provision herein to the contrary, RELIANT shall not have any obligation to purchase the Product in Finished Dosage Form. RELIANT shall have the option to purchase Product in Bulk Product Form so that RELIANT may encapsulate and package the Product, either directly at its own facilitates or using the services of one or more third parties. In the event that RELIANT elects not to have ETHYPHARM encapsulate and package the Product, ETHYPHARM agrees to provide to RELIANT, at cost, such assistance as may reasonably be requested by RELIANT to facilitate the transfer of the relevant Confidential Information and Intellectual Property of ETHYPHARM to RELIANT or such third party for the purposes of RELIANT’s or such third party’s encapsulation and packaging of the Product, which assistance shall be provided for a limited period of time to be reasonably agreed upon between the parties. In the event that RELIANT elects to have a third party encapsulate and package the Product using ETHYPHARM Confidential Information and Intellectual Property, RELIANT agrees that it shall obtain an agreement from such third party to keep such Confidential Information and Intellectual Property confidential in accordance with the terms of this Agreement.

7.3 Purchase and Sale; Acceptance. Subject to the terms hereof, during the Term of this Agreement, ETHYPHARM shall sell and deliver to RELIANT, and RELIANT shall purchase and accept, the Product pursuant to orders submitted by RELIANT to ETHYPHARM

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

35


CONFIDENTIAL

 

in accordance with provisions hereof. All deliveries of Product shall be deemed accepted by RELIANT unless RELIANT shall deliver an Exception Notice to ETHYPHARM in accordance with Section 7.6 hereof.

7.4 Delivery Forecast; Reserve Stock of Product.

(a) Delivery Forecast. RELIANT shall deliver to ETHYPHARM, and update at least once per calendar quarter, a twelve (12) month rolling forecast (the “Delivery Forecast”), which shall specify RELIANT’s estimated order requirements of Product, based on manufacturing batch sizes and multiples thereof, desired formulations and dosage forms (e.g., Bulk Product Form or Finished Dosage Form), and required delivery dates and destinations for the Product. Notwithstanding any provision herein to the contrary, the first ninety (90) days of the Delivery Forecast shall be binding upon the parties.

(b) Reserve/Safety Stock of Finished Product. ETHYPHARM shall maintain, or cause to be maintained, a sufficient reserve/safety stock of Product, in such forms as specified by RELIANT, equal to not less than [*]full batches (based on approximately [*] of API per batch) at no additional cost to RELIANT. RELIANT shall advance to ETHYPHARM the cost of the API that is necessary to manufacture that portion of the reserve/safety stock equal to [*] percent ([*]%) of most recent annual Delivery Forecast. As the reserve/safety stock is delivered to RELIANT, RELIANT will pay for such in accordance with this Agreement, after deduction of the API costs. As requested by RELIANT, part or all of the reserve Product stock shall be delivered within thirty (30) days after order to RELIANT’s dock in New Jersey, USA

(c) Reserve/Safety Stock of API. ETHYPHARM shall at all times maintain a reserve/safety stock of API (in micronized format) of no less than (i) [*] kgs of API manufactured by Labochim (Laboratorio Chimico Internazionale S.p.a.) (which amount shall be increased to [*]

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

36


CONFIDENTIAL

 

kgs upon the occurrence of a Supply Failure Event, such increased reserve/safety stock minimum to remain in effect for a period of one (1) year following the cure of such Supply Failure Event), or (ii) following approval of Coprima s.a. (or any other party reasonably acceptable to RELIANT) as an approved manufacturer of API for the Product for sale in the Territory, [*] kgs (which amount shall be increased to [*] kgs upon the occurrence of a Supply Failure Event, such increased reserve/safety stock minimum to remain in effect for a period of one (1) year following the cure of such Supply Failure Event), or such lesser amount as RELIANT may direct from time to time, of API manufactured by Coprima or such other approved party; provided, however, that RELIANT shall reimburse ETHYPHARM for the purchase and carrying costs of such API in an amount up to $[*] upon delivery by ETHYPHARM to RELIANT of proper verification and receipts therefor (and in the event that any such amounts are deducted from RELIANT payments to ETHYPHARM, RELIANT shall promptly reimburse ETHYPHARM for such deducted amounts).

(d) API Supply Agreement. ETHYPHARM represents and warrants to RELIANT that it has in place (and will maintain during the Term of this Agreement) one or more written binding long-term supply agreements with an API supplier approved by the FDA to ensure supply of micronized API to ETHYPHARM sufficient to meet ETHYPHARM’s obligations to RELIANT under this Agreement (including validation and full FDA approval of such API, in each case at ETHYPHARM’s sole expense).

7.5 Shipment Costs; Title and Risk of Loss. All Product to be delivered to RELIANT under this Agreement shall be shipped by ETHYPHARM to RELIANT fully insured against risk of loss, theft, seizure and destruction at ETHYPHARM’s cost. Title and risk of loss with respect to the all shipments of Product shall pass from ETHYPHARM to RELIANT upon acceptance by

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

37


CONFIDENTIAL

 

RELIANT at RELIANT’s dock (currently located in Somerset, New Jersey, USA). In the event of delivery at another location(s) within the Territory as may be specified by RELIANT or RELIANT’s sublicensee(s), the delivery prices agreed upon between the parties shall be reconsidered in order to take into account the possible increase due to such new location or insurance and transportation costs.

7.6 RELIANT Right of Review; Exception Notice. RELIANT may conduct its own analyses on each shipment of the Product, in whatever form, delivered by or on behalf of ETHYPHARM pursuant to this Agreement. RELIANT shall notify ETHYPHARM in writing within [*] days after its receipt of any shipment of Product if the same does not comply with RELIANT’s order, does not meet the Specifications, is adulterated or misbranded, or is otherwise reasonably determined by RELIANT not to comply with any Applicable Laws or Applicable Permits (each such notice, an “Exception Notice”). Any dispute arising between ETHYPHARM and RELIANT concerning the conformity of any shipment of Product which cannot be settled between the two parties within [*] days following RELIANT’s delivery of such notice, shall be submitted to an independent expert jointly agreed to by the parties in good faith. The decision of said expert shall be binding on ETHYPHARM and RELIANT. The charges, including the fees and expenses of the expert relating to any dispute described in this Section 7.6 shall be paid by ETHYPHARM if the expert declares the delivery not to be in conformity with the provisions hereof or by RELIANT if the expert declares the delivery to be in conformity.

7.7 Notice of Third Party Audit. ETHYPHARM shall give RELIANT telephonic notice (with written confirmation) of any pending or threatened audit related to the Product (including, without limitation, the manufacture, production, sale, distribution, import/export or testing of the Product, in whatever form) by any Governmental Authority or other authorized

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

38


CONFIDENTIAL

 

Person, regardless of whether such audit is of ETHYPHARM or any Person (other than RELIANT) with which ETHYPHARM has an agreement related to the Product or any ingredient thereof or process used in connection with the manufacture thereof, including, without limitation, any suppliers of raw materials used in the manufacture of the Product or any third party engaged by ETHYPHARM to manufacture the Product, in each case which audit affects or could reasonably be expected to affect the performance of ETHYPHARM’s obligations under this Agreement or otherwise affect RELIANT’s sale or distribution of the Product (each, an “Audit”); provided, however, that ETHYPHARM shall not be required to give such notice to RELIANT of an Audit by any Person that is conducted in the ordinary course pursuant to an agreement between ETHYPHARM and such Person and not in response to any suspected violation or non-compliance. ETHYPHARM shall provide any notice to RELIANT required under this Section 7.7 as soon as practicable, but in any event within five (5) Business Days, following the date ETHYPHARM first becomes aware of such Audit, and shall provide RELIANT with any documentation or other information provided or available to it relating to any such Audit, and shall provide RELIANT reasonable opportunity to review and comment, prior to submission, any response to such Audit. ETHYPHARM shall keep RELIANT fully apprised of the progress and results of any Audit and shall immediately provide RELIANT with the results of such Audit following its conclusion.

7.8 Notice of Regulatory Action. ETHYPHARM shall provide RELIANT with notification of its receipt (or the receipt by any Person with which ETHYPHARM has an agreement related to the Product, including, without limitation, suppliers of raw materials and contract manufacturers) of any warning, enforcement, penalty, default, non-compliance, notices of violation or any similar letters, notices, investigations, requests for information or orders from

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

39


CONFIDENTIAL

 

or of any Governmental Authority or other authorized Person that relate to the Product, including, without limitation, any list of observations (Form FD 483), Warning Letter, Information Letter, Establishment Inspection Report, Notice of Violation, Regulatory Letter or the like issued by the FDA. ETHYPHARM shall provide any notice to RELIANT required under this Section 7.8 as soon as practicable, but in any event within twenty-four (24) hours, following the date ETHYPHARM first receives or becomes aware of any such regulatory action, and shall provide RELIANT with any documentation or other information provided or available to it relating thereto. Notwithstanding anything herein to the contrary, ETHYPHARM maintains sole responsibility for any matter pertaining to such regulatory actions. Reliant shall have the right to review and comment on any responses of ETHYPHARM to any such regulatory action.

7.9 Recall or Withdrawal. ETHYPHARM and RELIANT will each maintain or cause to be maintained such traceability records as are necessary to permit a recall, withdrawal or field correction of the Product (each, a “Recall”). Each party will give telephonic notice (to be confirmed in writing) to the other within twenty-four (24) hours of the receipt of any information which indicates a Recall may be necessary. The decision to conduct and the right to control a Recall will be solely that of the then current NDA owner, after appropriate consultation with the other party. Each party will cooperate fully with the other in connection with any Recall efforts. If any Recall is due to any act or omission of ETHYPHARM, ETHYPHARM will bear the cost of the Recall and replace recalled Product with conforming Product at no additional charge hereunder and will reimburse RELIANT for all of RELIANT’s reasonable direct costs and expenses actually incurred by RELIANT in connection with the Recall including, but not limited to, direct costs of retrieving Product already delivered to customers and direct costs and expenses RELIANT is required to pay for notification, shipping and handling charges; provided, however,

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

that for each such Recall (a) RELIANT will in good faith consult with ETHYPHARM and, to the extent commercially reasonable, implement ETHYPHARM’s recommendations on how best to conduct the Recall including, without limitation, the notification and retrieval of Product, and (b) prior to any reimbursement hereunder, RELIANT will provide ETHYPHARM with detailed supporting documentation of all costs and expenses for which reimbursement is being sought. If a Recall of Product distributed is due to any act or omission of RELIANT, RELIANT will remain responsible for the costs of such Recall and will reimburse ETHYPHARM for all of the reasonable direct costs and expenses described above actually incurred by ETHYPHARM (if any) in connection with such Recall including, but not limited to, administration of the recall and such other reasonable direct costs as may be reasonably related to the Recall. RELIANT shall not release any Product in the Territory that has not been duly controlled by RELIANT.

7.10 RELIANT Audit Right Regarding Manufacturing Facilities. Upon prior notice to ETHYPHARM and upon a minimum of one (1) month prior notice of the anticipated audit date, ETHYPHARM will permit (and will cause any owner and operator of any Additional Manufacturing Facility to permit) RELIANT to conduct an inspection and audit, of ETHYPHARM’s or such third party’s manufacturing facilities and operations used in the manufacturing, receiving, sampling, analyzing, storing, handling, packaging and shipping of Product, including, but not limited to, the receipt, storage and issuance of raw materials, labeling and packaging components and ingredients thereof (including, without limitation, all documentation related thereto) for the purpose of quality control and to assure compliance with cGMP, Applicable Laws, Applicable Permits and the terms of this Agreement. RELIANT may not conduct an audit hereunder more frequently than once during any twelve (12) month period; provided, however, that RELIANT may conduct an additional audit(s) in the event there is a

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

41


CONFIDENTIAL

 

quality or compliance issue concerning the Product or its manufacture that RELIANT deems in good faith to be material hereunder. RELIANT may conduct such audit using its own personnel or a third party auditor/inspector and shall conduct such audit, or cause such audit to be conducted, during regular business hours and in such a manner so as to minimize interference with ETHYPHARM’s or any third party’s operations. ETHYPHARM will provide, and shall cause any applicable third party to provide, RELIANT with access to relevant personnel during the audit and ETHYPHARM will provide a written response to any written audit observations provided by RELIANT within thirty (30) days of ETHYPHARM’s receipt thereof.

7.11 Records and Accounting by ETHYPHARM. ETHYPHARM will, with respect to each lot of Product produced and manufactured by or on behalf of ETHYPHARM hereunder, for the longer of (a) any period required under Applicable Law or Applicable Permit, and (b) a period of two (2) years after expiry of the expiration dating of such lot, maintain accurate records of the manufacture and testing of such lot of the Product, including, without limitation, all such records which are required by Applicable Law or pursuant hereto. Access to such records will be made available by ETHYPHARM to RELIANT during normal business hours upon RELIANT’s reasonable written request.

 

8. PRICES

8.1 Prices and Price Change.

(a) ETHYPHARM shall sell, and RELIANT shall buy, the Product at the following price (subject to adjustment as provided herein):

 

Dosage

  

Use

   Price per
1000 capsules
   Price per kg of
Product delivered in
Bulk Product Form

130mg

   Commercial Sale    US$[*]    US$[*]

130mg

   Clinical testing, regulatory approval/compliance, and/or promotional sampling purposes    US$[*]    US$[*]

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

42


CONFIDENTIAL

 

Dosage

  

Use

   Price per
1000 capsules
   Price per kg of
Product delivered in
Bulk Product Form

43mg

   Commercial Sale    US$[*]    US$[*]

43mg

   Clinical testing, regulatory approval/compliance, and/or promotional sampling purposes    US$[*]    US$[*]

provided, however, that the total number of capsules (or, with respect to Bulk Product Form, total kilograms) that may be purchased at the price listed above for “Clinical testing, regulatory approval/compliance, and/or promotional sampling purposes” shall not exceed (i) [*] percent ([*]%) of the total number of capsules (or, with respect to Bulk Product Form, total kilograms) of the Product purchased by RELIANT from the date hereof until December 31, 2007, or (ii) [*] of the total number of capsules (or, with respect to Bulk Product Form, total kilograms) of the Product purchased by RELIANT in any twelve-month period thereafter. At any time following the third (3rd) anniversary of the Launch Date in the United States (i.e., February 2, 2008), the prices for the Product under this Section 8.1(a) shall be subject to adjustment in accordance with the annual increases to the index described on Exhibit C attached to the Original Agreement. ETHYPHARM shall provide RELIANT at least ninety (90) days prior written notice of any proposed price increase with such supporting documentation therefor as RELIANT may reasonably request. RELIANT shall indicate on any order that portion of the Product that is being purchased for clinical testing, regulatory approval and compliance, or promotional sampling purposes. On a quarterly basis, RELIANT shall file a report with ETHYPHARM reconciling its use of the Product for clinical testing, regulatory approval and compliance, and promotional sampling purposes with Net Sales and accompany that report with a payment of any balance due to ETHYPHARM. The samples of Product shall not be subject to the Net Royalty payment set forth in Section 9.1.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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8.2 Payment Terms. ETHYPHARM shall send to RELIANT an invoice showing the amount due under Section 8.1 with each shipment. RELIANT shall pay ETHYPHARM the amount due within [*] days of the date of its receipt of the applicable invoice, except to the extent of a bona fide dispute between the parties with respect thereto.

 

9. ROYALTIES

9.1 Royalties.

(a) Commencing on the first Launch Date, RELIANT shall pay ETHYPHARM a Net Royalty in an amount equal to [*] percent ([*]%) of Net Sales in accordance with the provisions of this Agreement.

(b) No later than sixty (60) days after the end of each calendar quarter, RELIANT shall report to ETHYPHARM the Net Sales of the Product sold by RELIANT in the Territory and the Net Royalties due to ETHYPHARM for such period. The payment by RELIANT to ETHYPHARM shall be made within sixty (60) days after the end of each calendar quarter. RELIANT shall keep and shall require its sublicensees to keep true and accurate books of account and shall keep and maintain such records and documents as are reasonably necessary for ETHYPHARM to determine the Net Royalties due under this Agreement.

9.2 Tax Withholding. All Taxes, if any, levied under any laws or regulations applicable to the transactions contemplated by this Agreement with respect to payments due to ETHYPHARM hereunder shall be for the account of ETHYPHARM, and if required to be withheld from payments to ETHYPHARM, shall be deducted by RELIANT from such payments to ETHYPHARM. Receipts, if available, for all such withholdings shall be provided to ETHYPHARM. ETHYPHARM shall be responsible for establishing its right to claim any exemption to such charges or to its withholding, shall keep RELIANT advised in writing or the

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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basis and status of all such exemption claims. ETHYPHARM shall be liable for, and shall indemnify RELIANT for, any penalty, interest or other assessment against RELIANT for failure to pay or withhold such charges in reliance on any such exemption claim or other advice or instructions of ETHYPHARM.

 

10. REPRESENTATIONS AND WARRANTIES OF THE PARTIES

10.1 Mutual Representations and Warranties of ETHYPHARM and RELIANT. Each of ETHYPHARM and RELIANT hereby represents and warrants to the other party as follows:

(a) Organization. Such party is duly organized, validly existing and in good standing under the laws of the jurisdiction of incorporation or organization. Such party has the requisite legal and company power and authority to conduct its business as presently being conducted and as proposed to be conducted by it and is duly qualified to do business in those jurisdictions where its ownership of property or the conduct of its business requires.

(b) Authority. Such party has all requisite legal and company power and authority to enter into this Agreement and to perform the services contemplated hereunder (including, in the case of ETHYPHARM, the manufacture and packaging of the Product, and the grant of the License hereunder). All company actions on the part of such party, the boards of director or managers, conseils d’administration or similar governing body of such party and the equity holders of such party necessary for (i) the authorization, execution, delivery and performance by such party of this Agreement, and (ii) the consummation of the transactions contemplated hereby, have been duly taken.

(c) Binding Obligation. This Agreement is a legally valid and binding obligation of such party, enforceable against such party in accordance with its terms (except in all cases as such enforceability may be limited by applicable bankruptcy, insolvency,

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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reorganization, moratorium, or similar laws affecting the enforcement of creditors’ rights generally and except that the availability of the equitable remedy of specific performance or injunctive relief is subject to the discretion of the court before which any proceeding may be brought).

(d) No Conflicts. None of the execution and delivery of this Agreement, the consummation of the transactions provided for herein or contemplated hereby, or the fulfillment by such party of the terms hereof or thereof, will (with or without notice or passage of time or both) (i) conflict with or result in a breach of any provision of the certificate or articles of incorporation or formation, by-laws, statutes, operating agreement or other governing documents of such party, (ii) result in a default, constitute a default under, give rise to any right of termination, cancellation or acceleration, or require any consent or approval (other than approvals that have heretofore been obtained) of any Governmental Authority or under any of the terms, conditions or provisions of any material note, bond, mortgage, indenture, loan, arrangement, license, agreement, lease or other instrument or obligation to which such party is a party or by which its assets may be bound, or (iii) violate any law or regulation applicable to such party or any of its assets.

(e) Insurance. Such party has in full force and effect casualty and liability insurance policies issued by issuers of internally-recognized responsibility and of such types and in such coverage amounts as customary for such party’s business and consistent with industry standards.

(f) Legal Proceedings. There is no action, suit, proceeding or investigation pending or, to such party’s knowledge, currently threatened, against such party or any other Person that questions the validity of this Agreement or the right of such party to enter into this

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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Agreement, or to consummate the transactions contemplated hereby, nor does such party have knowledge that there is any basis for the foregoing. Such party is not a party or subject to the provisions of any order, writ, injunction, judgment or decree of any Governmental Authority, which would adversely affect its rights or obligations hereunder or the transactions contemplated hereby.

(g) Consents and Approvals. All material consents, approvals, qualifications, orders or authorizations of, filings with, or notices to any Governmental Authority or any other Person required in connection with such party’s execution, delivery or performance of (i) this Agreement, and (ii) the consummation of any other transaction contemplated on the part of such party hereby have been obtained, made or given.

(h) No Violation of Law; Permits. Such party is not in violation of any law or regulation (nor is such party aware of any violation of any law or regulation by any other Person), which violation could reasonably be expected to adversely affect such party’s performance of its obligations hereunder or the ability of the other party to realize the intended benefits to such other party under this Agreement, and, except as otherwise contemplated hereby, such party holds each of the licenses, permits, approvals or authorizations necessary with respect to its current business and operations (and its rights and obligations contemplated hereby) in compliance with all laws and regulations.

(i) No Broker. Such party has not retained any finder, broker, agent, financial advisor or other intermediary in connection with the transactions contemplated by this Agreement.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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10.2 Additional Representations, Warranties and Covenants of ETHYPHARM. ETHYPHARM hereby further represents, warrants and covenants to RELIANT, as of the date hereof and during the Term of this Agreement, as follows:

(a) Product Compliance; Title. All Product to be manufactured and delivered to RELIANT pursuant to this Agreement, in whatever formulation, dosage form or packaging, will: (i) conform to the applicable Specifications; (ii) comply with all Applicable Laws and Applicable Permits (and shall not be adulterated or misbranded within the meaning of the Act); (iii) be manufactured under cGMP conditions in an FDA-approved manufacturing facility in accordance with all Applicable Laws and Applicable Permits, and (iii) upon delivery to RELIANT, good title to such Product will convey to RELIANT and such conveyance will be free and clear of any security interest, other lien or encumbrance.

(b) Permits. ETHYPHARM has and will maintain during the Term of this Agreement all Applicable Permits and such other permits, licenses and other authorizations required under Applicable Laws to permit ETHYPHARM to continue to manufacture and package the Product, including, without limitation, the Product in Bulk Product Form and Finished Dosage Form.

(c) No Investigation. There is no pending, and ETHYPHARM has no knowledge of any threatened, claim, investigation, proceeding, suit or other legal, regulatory or similar action asserting that the use, manufacture, packaging, distribution or sale of the Product constitutes an infringement of any Intellectual Property rights of any Person, including, without limitation, any extant patents, trade secrets, trademarks or other rights of any Person.

(d) Intellectual Property. ETHYPHARM (i) is the sole owner of, and has all rights necessary to use and license to RELIANT, each of the Patents identified on Schedule 1.42

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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and such Patents are the only patents required for ETHYPHARM to perform its obligations hereunder; (ii) is the sole owner of, and has all rights necessary to use and license to RELIANT, all Intellectual Property (other than the Patents) required for ETHYPHARM to perform its obligations hereunder; (iii) has not granted or transferred to, or allowed the use by, any Person in the Territory of any Intellectual Property owned or licensed by ETHYPHARM which is used in or relates to the manufacture or packaging of the Product;

(e) Product Related Intellectual Property. (i) ETHYPHARM owns or possesses adequate licenses or other Intellectual Property and Confidential Information used or held for use in connection with the Product that are necessary to permit ETHYPHARM to discharge its obligations under this Agreement with respect to the Products, including, without limitation, granting the rights and licenses granted to RELIANT under this Agreement, free and clear of any liens, licenses, obligations, transfer agreements, transfer restrictions, enforceable claims, royalties or encumbrances that would prevent ETHYPHARM from discharging its obligations under this Agreement with respect to the Product, and (ii) ETHYPHARM is unaware of any assertion or claim challenging the ownership, use or validity of any of the foregoing. Any licenses associated with the ETHYPHARM Intellectual Property related to the Product are valid and binding and are enforceable in accordance with their respective terms, and there are no material breaches or defaults thereunder. To the extent that any of the Patents are not owned by ETHYPHARM, such Patents are owned by an Affiliate of ETHYPHARM, and ETHYPHARM licenses or has the right to use such from such Affiliate of ETHYPHARM. ETHYPHARM will not take any action to terminate, and ETHYPHARM will prevent its Affiliates from taking any action to terminate, any license or grants of rights from an Affiliate of ETHYPHARM to

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

ETHYPHARM with respect to the Patents. ETHYPHARM has the right to grant to RELIANT all of the rights and licenses granted to RELIANT under this Agreement.

(f) No Infringement. The manufacture, use or sale of the Product by ETHYPHARM or the use of the ETHYPHARM Intellectual Property by RELIANT to develop, promote, market and sell the Product in the Territory do not, and to ETHYPHARM’s knowledge will not, infringe any valid rights of any third party including inter alia Intellectual Property rights. The manufacture, use or sale of any raw materials supplied to or otherwise used by ETHYPHARM with respect to the Product do not, and to ETHYPHARM’s knowledge will not, infringe any valid rights of any third party including inter alia Intellectual Property rights. To ETHYPHARM’s knowledge, ETHYPHARM is unaware of any third party infringement of the Intellectual Property rights relating to the Product.

(g) Adverse Drug Experiences. ETHYPHARM has informed RELIANT of all relevant adverse drug experiences related to the Product of which it has knowledge.

(h) Expertise. ETHYPHARM has, and will at all times during the term of this Agreement have, the requisite expertise, experience and skill to perform its obligations hereunder.

(i) Labor Matters. There is no strike or other labor dispute involving ETHYPHARM or any of its employees pending, or to the knowledge of ETHYPHARM, threatened. With respect to the foregoing, individual and unrelated personnel claims or actions do not constitute a labor dispute.

(j) No Debarment. Neither ETHYPHARM nor any Person employed or engaged by ETHYPHARM in connection with any work to be performed under this Agreement has been debarred under Section 306(a) or (b) of the Act, and no debarred Person will in the future be employed or engaged by ETHYPHARM in connection with any work to be performed hereunder.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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(k) Suppliers and Subcontractors. Any and all suppliers of any goods or services used in connection with the supply, manufacture, packaging, transport or handling of the Product, in whatever form and including any component or ingredient thereof, are and shall at all times during the Term hereof be in compliance with all laws, rules, regulations, orders and similar requirements, including, without limitation, all Applicable Laws, and possess all Applicable Permits, in each case required to manufacture, package, transport, handle or otherwise deal with of the Product or any component or ingredient thereof.

 

11. TERM

11.1 Basic Term. Unless sooner terminated pursuant to Section 11.2 hereof, this Agreement shall be effective from the date first above written and shall continue for an initial period of fifteen (15) years after the Launch Date of the Product in the United States (i.e., February 2, 2020) (the “Initial Term”). Thereafter, the term of this Agreement shall automatically renew for consecutive periods of two (2) years each. Notwithstanding the foregoing, this Agreement may be terminated by either party at the end of the Initial Term by delivery by such party to the other written notice at least one (1) year prior to the end of the Initial Term or at the end of any renewal term by delivery for such party to the other written notice at least one hundred eighty (180) days prior to expiration of any renewal term. As used herein, “Term” refers to the Initial Term of this Agreement and any renewal terms.

11.2 Sale of Product Following Termination. Upon termination of this Agreement, ETHYPHARM shall supply, manufacture, sell and deliver to RELIANT and RELIANT shall purchase from ETHYPHARM those firm orders for Product in existence as of the date of such

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

51


CONFIDENTIAL

 

termination. RELIANT and its sublicensees shall have the right to dispose of existing inventory of Product, in whatever form, manufactured and delivered by ETHYPHARM and purchased by RELIANT or its sublicensees prior to the termination (over a maximum period of twelve (12) months). Notwithstanding any termination of this Agreement, all licenses and rights granted to RELIANT hereunder shall continue in full force and effect to allow RELIANT or its sublicensee(s) to dispose of any remaining Product on the termination date, and RELIANT shall be obligated to make royalty payments to ETHYPHARM as provided hereunder.

 

12. EVENTS OF DEFAULT, REMEDIES AND EFFECTS OF DEFAULT

12.1 Events of Default. An event of default under this Agreement shall be deemed to exist upon the occurrence of any one or more of the following events (each, an “Event of Default”):

(a) failure by either party hereto to perform any covenant contained in this Agreement;

(b) a breach by either party of any material representation or warranty of such party under this Agreement;

(c) the entry by a court of competent jurisdiction of a decree or order of relief with respect to any party in any voluntary or involuntary case or proceeding under any bankruptcy, insolvency or similar law, or the appointment of a receiver, liquidator, assignee, trustee or similar official of that party, which decree or order is consented to by the party or continues unstayed and in effect for a period of sixty (60) days;

(d) the filing by any party of a voluntary petition or acquiescence in or failure to contest an involuntary petition or an involuntary petition filed against such party that is not

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

dismissed within sixty (60) days, in any case or proceeding under any bankruptcy, insolvency or similar law, or the making by any party of an assignment for the benefit of its creditors; or

(e) the involuntarily dissolution or liquidation of any party; provided, with respect to any Event of Default under clause (a) or (b) above, such default continues (i) for a period of ninety (90) days after delivery by the non-defaulting party of written notice of such default, or (ii) if the defaulting party shall commence good faith remediation of such default within such ninety (90) day period and shall thereafter proceed with all due diligence to cure such default, and such default is not cured within such longer period (not to exceed ninety (90) days) as shall be reasonably necessary for such party to cure the same with all due diligence.

12.2 Remedies for Breach; Termination. Upon the occurrence and during the continuation of any Event of Default hereunder, the party not in default may terminate this Agreement and pursue any other remedies provided under this Agreement or available at law or equity.

12.3 Technology Transfer. In the event of any termination of this Agreement as a result of any Event of Default caused by or related to any act or omission by or on behalf of ETHYPHARM or any of its Affiliates or agents, ETHYPHARM undertakes as a continuing obligation, notwithstanding such termination, that it will use all reasonable endeavors to effect a transfer of the Intellectual Property and Confidential Information used by ETHYPHARM in the performance of its obligations hereunder to RELIANT or to a third-party manufacturer designated by RELIANT, and/or grant such licenses as may be necessary to enable RELIANT or such third-party manufacturer to manufacture and package the Product in such form and quantities contemplated hereby for the Territory, subject at all times to ETHYPHARM receiving

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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reasonable undertakings as to confidentiality in respect of any ETHYPHARM Intellectual Property that is so transferred or licensed.

12.4 Right of First Offer In Connection with Divestiture. In the event RELIANT decides to divest the Product in the Territory, for whatever reason, ETHYPHARM will be granted a right of first offer to acquire all rights in relation with the Product and the relevant Intellectual Property and Confidential Information belonging to RELIANT pursuant to terms no less favorable to ETHYPHARM than those proposed to be offered third parties, such right to be exercised within a maximum period of [*] days from date of official written notification by RELIANT to ETHYPHARM. In the event ETHYPHARM does not exercise its right, RELIANT undertakes to transfer to its assignee all rights and obligations vis-à-vis ETHYPHARM provided for in this Agreement.

 

13. INDEMNIFICATION AND INSURANCE

13.1 Indemnification of RELIANT. ETHYPHARM shall indemnify and hold harmless RELIANT and its Affiliates and their respective equityholders, managers, directors, officers, trustees, agents and employees (collectively, “RELIANT Indemnified Parties”) from and against all damages, losses, expenses, claims, demands, suits, penalties, judgments or administrative and judicial orders and liabilities (including reasonable legal fees and expenses) incurred, assessed or sustained by any RELIANT Indemnified Party with respect to or involving or arising out of (i) a breach by ETHYPHARM of any representation, warranty, duty or covenant of ETHYPHARM hereunder, or (ii) any negligent act or omission, or willful misconduct of ETHYPHARM or any of its Affiliates or agents.

13.2 Indemnification of ETHYPHARM. RELIANT shall indemnify and hold harmless ETHYPHARM and its Affiliates and their respective equityholders, managers, directors,

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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officers, trustees, agents and employees (collectively, “ETHYPHARM Indemnified Parties”) from and against all damages, losses, expenses, claims, demands, suits, penalties, judgments or administrative and judicial orders and liabilities (including reasonable legal fees and expenses) incurred, assessed or sustained by any ETHYPHARM Indemnified Party with respect to or involving or arising out of (i) a breach by RELIANT of any representation, warranty, duty or covenant of RELIANT hereunder, or (ii) any negligent act or omission, or willful misconduct of RELIANT or any of its Affiliates or agents.

13.3 Notice and Legal Defense. Promptly after receipt by a party hereunder of any claim or notice of the commencement of any action, administrative or legal proceeding, or investigation as to which the indemnity provided for in Section 13.1 and 13.2 hereof may apply, the party seeking indemnification shall notify the indemnifying party of such fact. The indemnifying party shall assume the defense thereof; provided, however, that if the defendants in any such action include both the party seeking indemnification and the indemnifying party and the party seeking indemnification shall reasonably conclude that there may be legal defenses available to it which are different from or additional to, or inconsistent with, those available to the indemnifying party, the party seeking indemnification shall have the right to select separate counsel (reasonably acceptable to the indemnifying party) to participate in the defense of such action on behalf of such party seeking indemnification, at the indemnifying party’s expense.

13.4 Insurance. Each party shall, at its own cost, cause the other party and its respective agents, employees, officers, shareholders and contractors to be added as additional insureds on all policies of general commercial liability insurance and product liability insurance covering such party, which coverage shall have limits of liability which are commercially reasonable but shall not be less than US$[*] per loss occurrence. Each policy shall contain an

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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endorsement which provides that any amendments or cancellation of any such policy shall not be effective unless the other party shall have been given thirty (30) days prior written notice of any such intended amendment or cancellations. Within five (5) days of the beginning of each policy period, each party shall deliver to the other a certificate evidencing the coverage required hereby and the amount thereof. Such coverage shall be maintained for not less than five (5) years following termination of this Agreement or if such coverage is of the “claims made” type, for [*] years following termination of this Agreement.

 

14. ETHYPHARM RIGHTS IN CANADA AND MEXICO

14.1 Reversion of Canadian and Mexican Rights. In connection herewith, the parties have agreed that the Territory shall no longer include Canada and Mexico, such that ETHYPHARM hereby reacquires from RELIANT all licenses, rights, title and interest of RELIANT under the Original Agreement in respect of such countries; provided, however, that ETHYPHARM shall not have any right, either directly or indirectly, to market, promote, sell, commercialize or otherwise exploit the Product in Canada or Mexico unless and until the Additional Manufacturing Facility is fully established, validated and certified in accordance with Section 5.4, such that such RELIANT may accept delivery of, import, package, market, sell and otherwise commercialize any Product manufactured at such Additional Manufacturing Facility in the Territory; provided, further, that nothing in this Article 14 gives or shall be deemed to give ETHYPHARM the right to make, or cause to be made, any regulatory or similar filings in any jurisdiction in the Territory.

14.2 ETHYPHARM Right to RELIANT Clinical Data for Canada and Mexico. Notwithstanding the provisions of Section 2.3, RELIANT shall grant ETHYPHARM access to the RELIANT Clinical Data for use solely in Canada and Mexico in order that ETHYPHARM

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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may use such RELIANT Clinical Date for the limited purpose of obtaining registrations with the appropriate Canadian and Mexican regulatory authorities in order to allow ETHYPHARM to commercialize the Product in such country. ETHYPHARM agrees that any reference to RELIANT Clinical Data (including by means of reference to any Canadian or Mexican registrations) for use in any other country other than Canada and Mexico shall be subject to the provisions of Section 2.3.

14.3 Royalties on Sales of Product in Canada and Mexico. In consideration of the reversion of rights in Canada and Mexico and the right to use RELIANT Clinical Data in such countries, ETHYPHARM agrees to pay to RELIANT a royalty, net of any Taxes required to be withheld therefrom, in the amount equal to [*] percent ([*]%) of Net Sales of the Product and/or any Competing Dosage Form sold in Canada or Mexico (collectively, the “Canadian/Mexican Product”), which royalty payments shall be made in accordance with the provisions of this Agreement applicable to royalty payments payable by RELIANT to ETHYPHARM. For the purposes of this Section 14.3, the definition of the term “Net Sales” under Section 1 shall be read to refer to amounts invoiced by or on behalf of ETHYPHARM (including any of its Affiliates, assignees or licensees) for the Canadian/Mexican Product, rather than RELIANT, and the reference therein to Territory shall be deemed to be Canada and Mexico. Notwithstanding any provision herein to the contrary, RELIANT’s right to receive royalty payments under this Section 14.3 may be separately assigned by RELIANT to any of its Affiliates or third parties separate and apart from any assignment or sublicences of any other license or right of RELIANT hereunder. With respect to any Combination Products to be developed or commercialized by ETHYPHARM in Canada or Mexico, the parties shall negotiate in good faith the specific terms and conditions relating thereto (including any royalties in respect of sales thereof in Canada

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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and/or Mexico), which shall be set forth in a separate agreement to be negotiated and executed by ETHYPHARM and RELIANT.

14.4 Certain Restrictions on Commercialization in Canada and Mexico. In addition, in consideration of the reversion of rights in Canada and Mexico and the right to use RELIANT Clinical Data in such countries, ETHYPHARM agrees that (a) neither ETHYPHARM nor any of its Affiliates, assignees, licensees or distributors shall sell, distribute or otherwise commercialize any Canadian/Mexican Product under the trademark “Antara®” or any other a trademark or tradedress confusingly similar to those being used by RELIANT for the Product and/or any Competing Dosage Form in the United States; and (b) ETHYPHARM shall not, and shall cause each of its Affiliates, assignees, licensees and distributors not to, (i) market, distribute or sell any Canadian/Mexican Product or any pharmaceutical product containing micronized fenofibrate as an active ingredient within the Territory, (ii) knowingly cause or facilitate any Canadian/ Mexican Product to be marketed, distributed, or sold within the Territory, except by or on behalf of RELIANT pursuant to this Agreement, and (iii) market, distribute or sell any Canadian/Mexican Product outside the Territory to a third party who ETHYPHARM or any of its Affiliates, assignees, licensees and distributors knows intends to distribute such products within the Territory, (iv) knowingly supply any bulk API to any third party for ultimate sale and/or distribution in the Territory, or (v) market, sell, distribute, or manufacture generic micronized fenofibrate for any other Person in the Territory, which restrictions shall survive any termination of this Agreement. In the event that RELIANT can reasonably demonstrate that any Canadian/Mexican Product manufactured by or on behalf of ETHYPHARM under this Section 14 is being sold or otherwise entering the Territory, ETHYPHARM shall reimburse

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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RELIANT an amount sufficient to compensate RELIANT for the profits pertaining to the lost sales of the Product by RELIANT in the Territory as a result thereof.

 

15. MISCELLANEOUS

15.1 Assignment.

(a) Subject to Section 15.1(b), below, this Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors and assigns permitted under this Agreement.

(b) Neither party may assign this Agreement or any of its rights hereunder or delegate its performance of its obligations hereunder without the express prior written consent of the other party, except that either party may assign or delegate any of its rights or obligations under this Agreement to an Affiliate or subsidiary of the assigning party; provided that the assigning party shall, by express written agreement, (i) remain liable for any obligations and liabilities incurred by it under this Agreement, and (ii) be made liable for all obligations and liabilities of the assignee following such assignment; provided, further, that the assignee shall expressly acknowledge, by written agreement, its assumption of all obligations and liabilities under this Agreement. Any attempted assignment in violation of this provision shall be deemed a material breach of this Agreement.

For purposes of this Section 15.1, a transfer to an unaffiliated third party, by either RELIANT or ETHYPHARM, of all or substantially all of its assets or a controlling interest in its stock or other equity interests, shall be deemed an assignment; provided that, any of the following shall not be deemed an assignment and shall be permitted without consent from ETHYPHARM or RELIANT, as applicable, thereto: (1) any conversion in the type of legal entity of RELIANT (i.e., from a corporation to a limited liability company); (2) any issuance by RELIANT or

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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ETHYPHARM of securities in connection with any financing transaction or public offering, (3) any acquisition or merger involving RELIANT or ETHYPHARM if the acquiring or surviving company is a reputable company engaged in the pharmaceutical business with a history of substantial regulatory compliance, and/or (4) any merger or acquisition to which the other party hereto has given its prior written consent. Nothing herein shall preclude RELIANT from sublicensing any or all of its rights hereunder in accordance with the terms of this Agreement, or from entering into agreements with third parties to co-promote or assist RELIANT in the sale, marketing or promotion of the product provided that the foregoing shall not relieve RELIANT of any of its obligations hereunder.

15.2 Confidentiality. Each party will hold Confidential Information of the other party and its Affiliates in complete confidence and will not, without the prior written consent of the other, use or disclose it in whole or in part to any Person other than for the purposes set forth in this Agreement for a period ending five (5) years following expiration of this Agreement. Each party will be entitled to disclose any such Confidential Information to such of its professional advisers, directors, managers, officers and employees who are directly concerned with this Agreement and its implementation and whose knowledge of such information in the opinion of the disclosing party is necessary for these purposes. Each party will use its reasonable efforts to ensure that each individual to whom such a disclosure is made adheres to the terms of this undertaking as if he or she were a party hereto. Each party may disclose such Confidential Information to the extent such disclosure is required by law; provided, however, that the disclosing party shall (to the extent permitted) give the other party prior notice of such required disclosure and cooperate with such other party in order that such other party may seek a protective order or relief to prevent or limit the Confidential Information required to be

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

disclosed; provided, further, that the disclosing party shall only disclose that portion of the Confidential Information that such party is advised by its legal counsel is required to be disclosed by law and shall seek assurances that such Confidential Information will be maintained in confidentiality by the receiving party.

15.3 Exchange of Information. RELIANT will periodically inform ETHYPHARM with information regarding unit sales by market region in the Territory. Each party will timely report to the other any information concerning any serious adverse event (as defined by the Act) associated with clinical uses, studies, investigations or tests of the Product, whether in Bulk Product Form or in Finished Dosage Form. In reporting such incidents, the reporting party will use reasonable efforts to indicate whether, in its judgment, any of them are unexpected or unusual in type, incidence or severity.

15.4 Force Majeure. If either party is prevented from complying, either totally or in part, with any of the terms or provisions set forth herein by reason of force majeure, including, by way of example and not of limitation, fire, flood, explosion, storm, strike, lockout or other labor dispute, riot, war, rebellion, accidents, acts of God, acts of Governmental Authorities, failure of suppliers or any other similar cause, in each case to the extent beyond its reasonable control, said party will provide written notice of same to the other party. Said notice will be provided within five (5) Business Days of the occurrence of such event and will identify the requirements of this Agreement or such of its obligations as may be affected, and to the extent so affected, said obligations will be suspended during the period of such disability. If any raw materials, facility systems or capacity is used for both the manufacture and packaging of the Product in satisfaction of ETHYPHARM’s obligations hereunder and any other product or purposes, any necessary allocation will be made as between ETHYPHARM’s needs, RELIANT’s

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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needs and the needs of any other party with whom ETHYPHARM has firm contractual obligations on a basis no less favorable than pro rata on a volume basis. The party prevented from performing hereunder will use its commercially reasonable efforts to remove such disability and will continue performance whenever such causes are removed. The party so affected will give to the other party a good faith estimate of the continuing effect of the force majeure condition and the duration of the affected party’s nonperformance. If the period of any previous actual nonperformance of ETHYPHARM because of ETHYPHARM force majeure conditions plus the anticipated future period of ETHYPHARM nonperformance because of such conditions will exceed an aggregate of ninety (90) days within any six (6) month period, RELIANT may terminate this Agreement immediately by written notice to ETHYPHARM. If the period of any previous actual nonperformance of RELIANT because of RELIANT force majeure conditions plus the anticipated future period of RELIANT nonperformance because of such conditions will exceed an aggregate of ninety (90) days within any six (6) month period, ETHYPHARM may terminate this Agreement immediately by written notice to RELIANT. When such circumstances as those contemplated herein arise, the parties will discuss in good faith, what, if any, modification of the terms set forth herein may be required in order to arrive at an equitable solution.

15.5 Amendment. No amendment or modification of the terms of this Agreement shall be binding on either party unless in writing and signed by both parties.

15.6 No Implied Waiver. Failure by either party hereto on one or more occasions to avail itself of a right conferred by this Agreement shall in no event be construed as a waiver of such party’s right to enforce said right in the future.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

15.7 Choice of Law. This Agreement and all rights and obligations hereunder, including matters of construction, validity and performance, shall be governed by and construed in accordance with the laws of the state of New Jersey, without giving effect to the conflict of laws principles thereof.

15.8 CONSENT TO JURISDICTION; AGENT FOR SERVICE OF PROCESS. EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY AGREES THAT ANY SUIT, ACTION, PROCEEDING OR CLAIM AGAINST SUCH PARTY ARISING OUT OF OR IN ANY WAY RELATING TO THIS AGREEMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED HEREBY, OR ANY JUDGMENT ENTERED BY ANY COURT IN RESPECT THEREOF, MAY BE BROUGHT OR ENFORCED IN THE STATE OR FEDERAL COURTS LOCATED IN THE COUNTY OF SOMERSET IN THE STATE OF NEW JERSEY AND THE COMPANY HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY LAW, ANY OBJECTION WHICH IT MAY NOW OR HEREAFTER HAVE TO THE VENUE OF ANY PROCEEDING BROUGHT IN THE COUNTY OF SOMERSET IN THE STATE OF NEW JERSEY AND FURTHER IRREVOCABLY WAIVES ANY CLAIMS THAT ANY SUCH PROCEEDING HAS BEEN BROUGHT IN AN INCONVENIENT FORUM. ETHYPHARM HEREBY IRREVOCABLY AND UNCONDITIONALLY APPOINTS BAACH ROBINSON & LEWIS PLLC, 1201 F STREET, NW, SUITE 500, WASHINGTON, DC 20004 (ATTENTION: DWIGHT P. BOSTWICK AND BRUCE R. GRACE), AS AGENT FOR SERVICE OF PROCESS UNDER THIS AGREEMENT.

15.9 WAIVER OF JURY TRIAL. THE PARTIES HERETO HEREBY EXPRESSLY WAIVE ANY RIGHT TO A TRIAL BY JURY IN ANY ACTION OR PROCEEDING TO ENFORCE OR DEFEND ANY RIGHT, POWER, OR REMEDY UNDER OR IN

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONNECTION WITH THIS AGREEMENT OR ANY OF THE RELATED AGREEMENTS OR UNDER OR IN CONNECTION WITH ANY AMENDMENT, INSTRUMENT, DOCUMENT, OR AGREEMENT DELIVERED OR WHICH MAY IN THE FUTURE BE DELIVERED IN CONNECTION HEREWITH OR THEREWITH OR ARISING FROM ANY RELATIONSHIP EXISTING IN CONNECTION WITH THIS AGREEMENT OR ANY RELATED AGREEMENT, AND AGREE THAT ANY SUCH ACTION SHALL BE TRIED BEFORE A COURT AND NOT BEFORE A JURY. THE TERMS AND PROVISIONS OF THIS SECTION CONSTITUTE A MATERIAL INDUCEMENT FOR THE PARTIES ENTERING INTO THIS AGREEMENT.

15.10 Notice. Any notice and other communication required or permitted to be given hereunder shall be in writing and shall be deemed given when delivered personally, telecopied or received by registered mail, return receipt requested, or from an internationally-recognized courier service to the parties at the following addresses:

if to ETHYPHARM, to:

ETHYPHARM S.A.

194, Bureaux de la Colline – Bâtiment D

92213 Saint Cloud

France

Attn: Gérard M. Leduc, Managing Director

Fax:   +33 1 41 12 29 89

with copies sent simultaneously to:

Baach Robinson & Lewis PLLC

1201 F Street, NW

Suite 500

Washington, DC 20004

Attn: Dwight P. Bostwick and Bruce R. Grace

Fax:   +1 (202) 466-5738

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

if to RELIANT, to:

RELIANT PHARMACEUTICALS, INC.

110 Allen Road

Liberty Corner, New Jersey 07938

USA

Attn.: Joseph Zakrweski and Michael Lerner

Fax:   +1 (908) 542-9405

with a copy sent simultaneously to:

Latham & Watkins LLP

Sears Tower, Suite 5800

Chicago, Illinois 60606

USA

Attn: Michael A. Pucker and Thomas E. Keim, Jr.

Fax:   +1 (312) 993-9767

15.11 English Language. This Agreement and all exhibits, schedules, reports, notices and all other communications and proceedings with respect hereto shall be written and/or conducted solely in the English language.

15.12 Execution of Additional Documents. Each party hereto agrees to execute such further documents or agreements as may be reasonably necessary or desirable to effect the purpose of this Agreement and carry out its provisions.

15.13 Severability. In the event that any provision of this Agreement shall be held invalid or unenforceable by any court of competent jurisdiction, such holding shall not invalidate or render unenforceable any other provision hereof.

15.14 Captions. The article and section captions in this Agreement have been inserted as a matter of convenience and are not part of this Agreement.

15.15 Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original of this Agreement and all of which together shall constitute one and the same instrument.

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

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CONFIDENTIAL

 

15.16 Independent Relationship. Nothing herein contained shall be deemed to create an employment, agency, joint venture or partnership relationship between the parties hereto or any of their agents or employees, or any other legal arrangement that would impose liability upon one party for the act or failure to act of the other party. Neither party shall have any power to enter into any contracts or commitments or to incur any liabilities in the name of, or on behalf of, the other or to bind the other party in any respect whatsoever. All activities undertaken by ETHYPHARM hereunder shall be that of an independent contractor.

15.17 Entire Agreement. This written Agreement, together with all exhibits, schedules and attachments hereto or referenced herein, constitutes the entire understanding between the parties hereto relating to the subject matter hereof and supersedes and replaces all prior and contemporaneous agreements relating thereto, including, without limitation, the Original Agreement (excluding any exhibits or schedules thereto specifically incorporated herein by reference). No variation or modification of this Agreement or waiver of any of the terms or provisions hereof shall be deemed valid unless in writing and signed by both parties hereto.

15.18 Continued Obligation. During the pendency of any bona fide dispute, the parties shall continue to perform their respective obligations under this Agreement until such time as (a) the matter in dispute is finally resolved or (b) this Agreement is terminated in accordance with its terms.

15.19 Survival. The provisions of Sections 6, 7.7, 7.8, 7.9, 7.11, 11.2, 12.2, 13, 15.2, 15.7, 15.8, 15.9, 15.10 and 15.11, shall survive and remain in effect after termination or expiration of this Agreement.

(Signature page follows.)

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

 

66


IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly authorized representatives as of the day and year first above written.

 

ETHYPHARM S.A.
By:   /s/ Gerard Leduc
  Name: Gerard Leduc
  Title: President and CEO

 

RELIANT PHARMACEUTICALS, INC.
By:   /s/ Joseph Zakrewski
  Name: Joseph Zakrewski
  Title: CEO

 

Acceptance and acknowledgment of appointment by Baach Robinson & Lewis as its agent for service of process under Section 15.8 of this Agreement:
Baach Robinson & Lewis PLLC
By:   /s/ Dwight P. Bostwick
  Name: Dwight P. Bostwick
  Title:

SIGNATURE PAGE TO AMENDED AND RESTATED

DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.


CONFIDENTIAL

 

SCHEDULE OF PATENTS

Patents

[*] [One Page Omitted].

 


[*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
EX-23.1 4 dex231.htm CONSENT OF ROTHSTEIN, KASS & COMPANY P.C. Consent of Rothstein, Kass & Company P.C.

Exhibit 23.1

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

The undersigned, Rothstein, Kass & Company, P.C., independent registered public accountants, hereby consents to the incorporation by reference in the Registration Statements on Form S-3 (No. 333-137596, No. 333-133370, No. 333-128735, No. 333-118026, No. 333-113359, No. 333-111273, No. 333-110006 and No. 333-106602) and in the Registration Statements on Form S-8 (No. 333-138309, No. 333-116707, No. 333-112810, No. 333-106563, No. 333-97139, No. 333-58274, No. 333-39390, No. 333-30920, No. 333-92951, No. 333-49069, No. 333-30617, No. 333-15935, No. 033-61191, No. 033-75136, No. 033-45432, No. 033-27885, No. 033-12633, No. 002-95446, No. 002-81123 and No. 002-77846) of our report of Independent Registered Public Accounting Firm dated September 26, 2006, for the Antara Product Line of Reliant Pharmaceuticals, Inc, as filed with this Form 8-K/A being filed by Oscient Pharmaceuticals Corporation.

/s/ Rothstein, Kass & Company, P.C.

Roseland, New Jersey

October 30, 2006

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