-----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, RpwdtkqZpIiUB/sw2+5xg+9NMSygCfi7tl3MRkChcVx6qPKhZpBiFOu3o5tvE7ff YUF0InnugPqsYcxMrrsGbw== 0001140361-09-025244.txt : 20091109 0001140361-09-025244.hdr.sgml : 20091109 20091109161641 ACCESSION NUMBER: 0001140361-09-025244 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20090930 FILED AS OF DATE: 20091109 DATE AS OF CHANGE: 20091109 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CARACO PHARMACEUTICAL LABORATORIES LTD CENTRAL INDEX KEY: 0000887708 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 382505723 STATE OF INCORPORATION: MI FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-31773 FILM NUMBER: 091168602 BUSINESS ADDRESS: STREET 1: 1150 ELIJAH MCCOY DR CITY: DETROIT STATE: MI ZIP: 48202 BUSINESS PHONE: 3138718400 MAIL ADDRESS: STREET 1: 1150 ELIJAH MCCOY DRIVE CITY: DETROIT STATE: MI ZIP: 48202 10-Q 1 form10q.htm CARACO PHARMACEUTICALS 10-Q 9-30-2009 form10q.htm


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

FORM 10-Q

x      QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934

for the quarterly period ended September 30, 2009

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

Commission File No. 1-31773

CARACO PHARMACEUTICAL LABORATORIES, LTD.
(Exact name of registrant as specified in its charter)

MICHIGAN
38-2505723
(State or other jurisdiction of incorporation or organization)
(IRS Employer Identification No.)
   
1150 ELIJAH MCCOY DRIVE, DETROIT, MICHIGAN
48202
(Address of principal executive offices)
(Zip Code)

TELEPHONE: (313) 871-8400
Registrant’s telephone number, including area code

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes x     No o

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

Yes o     No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definition of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

Large Accelerated Filer o
Accelerated Filer x
Non- Accelerated Filer o
Smaller Reporting Company o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes o     No x

As of November 6, 2009, the registrant had 39,090,194 shares of common stock issued and outstanding.
 


 
1

 

CARACO PHARMACEUTICAL LABORATORIES LTD.
(A subsidiary of Sun Pharmaceutical Industries Limited)
BALANCE SHEETS

   
SEPTEMBER 30,
   
MARCH 31,
 
   
2009
   
2009
 
   
(UNAUDITED)
   
(AUDITED)
 
             
ASSETS
           
             
Current assets
           
Cash and cash equivalents
  $ 72,700,493     $ 65,314,397  
Short-term investments
    10,000,000       -  
Accounts receivable, net
    48,982,036       15,181,197  
Inventories
    88,292,526       79,510,832  
Prepaid expenses and deposits
    6,973,373       9,440,942  
Deferred income taxes
    5,999,648       416,985  
Total current assets
    232,948,076       169,864,353  
                 
Property, plant and equipment
               
Land
    975,311       975,311  
Buildings and improvements
    28,466,328       28,148,447  
Equipment
    27,684,543       26,216,521  
Furniture and fixtures
    1,512,852       1,509,582  
Construction in progress
    2,676,571       2,708,137  
Total
    61,315,605       59,557,998  
Less accumulated depreciation
    16,801,151       14,734,961  
Net property, plant and equipment
    44,514,454       44,823,037  
                 
Intangible assets, net
    1,334,524       1,383,048  
Deferred income taxes
    21,955,930       20,417,885  
                 
Total assets
  $ 300,752,984     $ 236,488,323  
                 
LIABILITIES AND STOCKHOLDERS' EQUITY
               
                 
Current liabilities
               
Accounts payable, trade
  $ 2,621,036     $ 7,979,341  
Accounts payable, Sun Pharma
    114,962,237       43,928,166  
Accrued expenses
    1,974,508       2,757,361  
Income taxes payable
    2,890,684       -  
Long term debt, current portion
    17,100,000       2,700,000  
Total current liabilities
    139,548,465       57,364,868  
                 
Long term debt, net of current portion
    -       15,300,000  
                 
Total liabilities
    139,548,465       72,664,868  
                 
Stockholders' equity
               
Series B convertible preferred stock, no par value; issued and outstanding 1,088,000 shares (September 30, 2009)  2,720,000 shares (March 31, 2009)
    11,320,640       23,081,920  
Common stock, no par value; authorized 50,000,000 shares, issued and outstanding 39,090,194 shares (September 30, 2009)  37,458,194 shares (March 31, 2009)
    130,330,615       118,569,335  
Additional paid in capital
    3,609,824       3,474,246  
Retained Earnings
    15,943,440       18,697,954  
Total stockholders' equity
    161,204,519       163,823,455  
                 
Total liabilities and stockholders' equity
  $ 300,752,984     $ 236,488,323  

See accompanying notes

 
2

 

CARACO PHARMACEUTICAL LABORATORIES, LTD.
(A subsidiary of Sun Pharmaceutical Industries Limited)
STATEMENTS OF OPERATIONS

   
Six Months ended
September 30,
   
Quarter ended
September 30,
 
   
2009
   
2008
   
2009
   
2008
 
   
(UNAUDITED)
   
(UNAUDITED)
   
(UNAUDITED)
   
(UNAUDITED)
 
                         
Net sales
  $ 126,445,911     $ 230,465,165     $ 78,375,895     $ 122,188,425  
Cost of goods sold
    118,243,578       184,879,891       75,010,528       100,186,562  
                                 
Gross profit before reserve for inventory seized by FDA
    8,202,333       45,585,274       3,365,367       22,001,863  
                                 
Reserve for inventory seized by FDA
    15,950,188       -       7,503,654       -  
                                 
Gross (loss) profit
    (7,747,855 )     45,585,274       (4,138,287 )     22,001,863  
                                 
Selling, general and administrative expenses
    10,452,575       8,055,246       6,793,364       4,237,244  
Research and development costs
    5,592,951       11,065,940       (1,492,184 )     5,581,711  
                                 
Operating (loss) income prior to non-recurring income
    (23,793,381 )     26,464,088       (9,439,467 )     12,182,908  
                                 
Non-recurring income
    20,000,000       -       20,000,000       -  
                                 
Operating (loss) income
    (3,793,381 )     26,464,088       10,560,533       12,182,908  
                                 
Other (expense) income
                               
Interest expense
    (258,085 )     -       (127,135 )     -  
Interest income
    264,660       420,259       160,204       142,486  
Loss on sale of equipment
    (114,272 )     -       -       -  
Other income
    46,309       -       11       -  
Other (expense) income - net
    (61,388 )     420,259       33,080       142,486  
                                 
(Loss) income before income taxes
    (3,854,769 )     26,884,347       10,593,613       12,325,394  
Income tax (benefit) expense
    (1,100,256 )     9,020,309       3,925,076       3,901,421  
                                 
Net (loss) income
  $ (2,754,513 )   $ 17,864,038     $ 6,668,537     $ 8,423,973  
                                 
Net (loss) income per common share
                               
Basic
    (0.07 )     0.54       0.17       0.25  
Diluted
    (0.07 )     0.44       0.16       0.21  

See accompanying notes

 
3

 

CARACO PHARMACEUTICAL LABORATORIES, LTD.
(A subsidiary of Sun Pharmaceutical Industries Limited)
STATEMENTS OF CASH FLOWS

   
Six months ended
September 30,
 
   
2009
   
2008
 
   
(UNAUDITED)
   
(UNAUDITED)
 
Cash flows from operating activities
           
Net (loss) income
  $ (2,754,513 )   $ 17,864,038  
Adjustments to reconcile net (loss) income  to net cash provided by (used in) operating activities
               
Depreciation and amortization
    2,240,245       1,452,749  
Loss on sale of equipment
    114,272       -  
Common stock option expense
    135,578       151,179  
Common stock grant expense
    -       169,900  
Net deferred income taxes
    (7,120,708 )     (1,773,180 )
Changes in operating assets and liabilities which (used) / provided  cash:
               
Accounts receivable
    (33,800,840 )     26,516,913  
Inventories
    (8,781,694 )     183,561,032  
Prepaid expenses and deposits
    2,467,568       46,124  
Accounts payable
    65,675,766       (237,969,471 )
Accrued expenses
    (782,853 )     (173,958 )
Income taxes payable
    2,890,684       1,960,489  
Net cash provided by (used in) operating activities
    20,283,505       (8,194,185 )
                 
Cash flows from investing activities
               
Purchases of property, plant and equipment
    (1,997,719 )     (13,665,079 )
Proceeds from sale of equipment
    310       -  
Purchase of short-term investment
    (10,000,000 )     -  
Purchases of intangibles
    -       (1,455,840 )
Net cash used in investing activities
    (11,997,409 )     (15,120,919 )
                 
Cash flows from financing activities
               
Repayments of loans payable to financial institutions
    (900,000 )     -  
Proceeds from exercise of stock options
    -       11,250  
Net cash (used in) provided by financing activities
    (900,000 )     11,250  
                 
Net increase (decrease) in cash and cash equivalents
    7,386,096       (23,303,854 )
Cash and cash equivalents, beginning of period
    65,314,397       56,906,051  
                 
Cash and cash equivalents, end of period
  $ 72,700,493     $ 33,602,197  

See accompanying notes

 
4

 

CARACO PHARMACEUTICAL LABORATORIES, LTD.
(A subsidiary of Sun Pharmaceutical Industries Limited)
STATEMENT OF STOCKHOLDERS' EQUITY  (UNAUDITED)

   
PREFERRED STOCK
   
COMMON STOCK
   
ADDITIONAL PAID IN
   
RETAINED
   
TOTAL STOCKHOLDERS'
 
   
SHARES
   
AMOUNT
   
SHARES
   
AMOUNT
   
CAPITAL
   
EARNINGS
   
EQUITY
 
                                           
Balances at April 1, 2009
    2,720,000     $ 23,081,920       37,458,194     $ 118,569,335     $ 3,474,246     $ 18,697,953     $ 163,823,454  
                                                         
Conversion of preferred stock into common stock
    (1,632,000 )     (11,761,280 )     1,632,000       11,761,280                       -  
                                                         
Common stock options expensed
                                    135,578               135,578  
                                                         
Net loss
                                            (2,754,513 )     (2,754,513 )
                                                         
Balances at September 30, 2009
    1,088,000     $ 11,320,640       39,090,194     $ 130,330,615     $ 3,609,824     $ 15,943,440     $ 161,204,519  

See accompanying notes

 
5

 

CARACO PHARMACEUTICAL LABORATORIES, LTD.

FORM 10-Q

NOTES TO UNAUDITED FINANCIAL STATEMENTS

1.
BASIS OF PRESENTATION

The balance sheet as of March 31, 2009 is audited. All other financial statements contained herein are unaudited. In the opinion of management, all adjustments necessary for a fair presentation of such financial statements have been included. Such adjustments consisted only of normal recurring items, with the exception of a reserve for inventory seized by the U.S. Food and Drug Administration (“FDA”), as discussed below.  Interim results are not necessarily indicative of results for the full year.

The financial statements contained herein should be read in conjunction with the financial statements and notes thereto included in the Annual Report on Form 10-K as of and for the year ended March 31, 2009 of Caraco Pharmaceutical Laboratories, Ltd. (“Caraco,” the “Company,” or the “Corporation” and which is also referred to as “we,” “us,” or “our”).  In preparing these financial statements, the Company has evaluated events and transactions for potential recognition or disclosure through October 26, 2009, the date the financial statements were available to be issued.

The accounting policies followed by the Corporation with respect to the unaudited interim financial statements are consistent with those stated in the Corporation’s Annual Report on Form 10-K.

2.
ORGANIZATION AND NATURE OF BUSINESS

Caraco is a corporation organized under Michigan law in 1984, engaged in the business of developing, manufacturing, marketing and distributing generic pharmaceuticals to the nation's largest wholesalers, distributors, warehousing and non-warehousing chain drugstores and managed care providers, throughout the U.S.

A generic pharmaceutical is the chemical and therapeutic equivalent of a brand-name drug as to which the patent and/or market exclusivity has expired. Generic pharmaceuticals are well accepted for substitution of brand pharmaceuticals (which substitution is regulated by individual state regulations)  as they sell at a discount to the branded product’s price and have been determined to be  their equivalent in quality and bioavailability.

Our present product portfolio includes 33 prescription products, in 80 strengths, in various package sizes. This represents products we distribute for Sun Pharmaceutical Industries Limited, a specialty pharmaceutical corporation organized under the laws of India (“Sun Pharma”) and products manufactured by other third parties relating to Caraco-owned products.  This does not include those Caraco-owned products for which the Company has temporarily ceased manufacturing and marketing, due to the enforcement actions of the FDA. The products are intended to treat a variety of disorders including but not limited to the following: hypertension, arthritis, epilepsy, diabetes, depression and pain management.

 
6

 

A significant source of our earlier funding had been from Sun Pharma.  Since August 1997, Sun Pharma has contributed equity capital and had advanced us loans. In addition, among other things, Sun Pharma had acted as a guarantor on loans to Caraco, has supplied us with a substantial portion of raw materials for our products, helped us obtain machinery and equipment to enhance our production capacities at competitive prices, transferred certain generic products to us and provided us with qualified technical professionals.  Sun Pharma has also provided services as a Clinical Research Organization, (“CRO”) by performing certain bio-equivalency studies on our future potential products.  Sun Pharma owns approximately 75% of the outstanding shares of the Company (approximately 76% including the convertible Series B Preferred Stock). (See “Current Status of the Corporation” and “Sun Pharmaceutical Industries Limited” below.)

3.
CURRENT STATUS OF THE CORPORATION

As previously disclosed, on June 25, 2009, U.S. Marshals, at the request of the FDA, arrived and seized drug products manufactured in our Michigan facilities. The seizure also included ingredients and in-process materials held at these same facilities. The estimated value of such seized inventory as of September 30, 2009 was $24.0 million. Products sold and distributed by Caraco that are manufactured by third parties and outside of these facilities are not impacted and we continue distribution and marketing of these products.

The Company voluntarily entered into a Consent Decree of Condemnation, Forfeiture and Permanent Injunction (“Consent Decree”) with the FDA on September 29, 2009. As stipulated in the Consent Decree, the Company will attempt to have the seized inventory released. The Company believes that, except for the raw materials which were opened solely for the purpose of sampling, the estimated value of which is $8.1 million, all other seized inventory would be difficult to recondition. Accordingly, a reserve in the amount of $15.9 million has been created as of September 30, 2009 for this remaining inventory. As a result of the FDA action, we have voluntarily ceased manufacturing operations and instituted, in two phases, indefinite layoffs of approximately 430 of our employees.  The Consent Decree provides a series of measures that, when satisfied, will permit the Company to resume manufacturing and distributing those products which are manufactured in its Michigan facilities. The Company has engaged a consulting firm which is comprised of current good manufacturing practice (“cGMP”) experts, in accordance with the Consent Decree.

As a result of this event, there has been a material adverse effect on our current operations and there may be a material adverse effect on our near term operations. Under the terms of the Consent Decree, Caraco's cessation of manufacturing operations will continue until it receives written notification from independent experts and the FDA that it is in compliance with the Consent Decree and regulations and can resume operations. However, there is no assurance that the steps being taken will be successful or result in resolution of the FDA complaint.  We are also not able, at this time, to estimate, the cost of these actions. We anticipate working with the FDA to resolve its concerns as effectively and expeditiously as possible in accordance with the terms of the Consent Decree.  The Consent Decree also requires the Company to abide by certain conditions and restrictions. If the Company violates any portion of the Consent Decree, it could incur penalties, such as monetary fines, forfeiture of the seized goods and other penalties.

 
7

 

During the second quarter ended September 30, 2009 and first six months of our current fiscal year (“Fiscal 2010”) ended September 30, 2009, we generated net sales of $78.4 million and $126.4 million, respectively, compared to $122.2 million and $230.5 million, respectively, during the corresponding periods of Fiscal 2009. We incurred $(1.5) million and $5.6 million, respectively, in research and development (“R&D”) expenses during the second quarter and first six months of Fiscal 2010, as compared to $5.6 million and $11.1 million, respectively, during the corresponding periods of Fiscal 2009. We generated cash from operations in the amount of $20.3 million during the first six months of Fiscal 2010, as compared to using cash from operations in the amount of $8.2 million during the corresponding period of Fiscal 2009. We earned a net pre-tax income of $10.6 million during the second quarter and incurred a net pre-tax loss of $3.9 million during the first six months of Fiscal 2010, as compared to earning net pre-tax income of $12.3 million and $26.9 million, respectively, during the corresponding periods of Fiscal 2009. Net pre-tax income in both periods of the current fiscal year were lower as we have created a reserve in the amount of $7.5 million and $15.9 million, respectively, during the second quarter and first six months of Fiscal 2010 relating to the inventory seized by the FDA as disclosed above and also due to the cessation of manufacturing at the Company’s Michigan facilities resulting in loss of revenues of such products, as also disclosed above. Net pre-tax income was also positively affected by non-recurring income earned in the amount of $20.0 million as part of an asset purchase agreement arising out of a settlement agreement entered into by the Company during the current period that is not expected to recur in future periods. The Company recorded an income tax expense of $3.9 million and provided an income tax benefit of $1.1 million for the second quarter and first six months of Fiscal 2010, respectively, as compared to an income tax expense of $3.9 million and $9.0 million, respectively, in the corresponding periods of Fiscal 2009. We earned a net income of $6.7 million during the second quarter and incurred a net loss of $2.8 million for the first six months of Fiscal 2010, as compared to net income of $8.4 million and $17.9 million, respectively, during the corresponding periods of Fiscal 2009.   At September 30, 2009, we had stockholders’ equity of $161.2 million, as compared to stockholders’ equity of $163.8 million at March 31, 2009. (See “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.”).

We have filed two Abbreviated New Drug Applications (“ANDAs”) relating to two products with the FDA during the first six months of Fiscal 2010. We have not received FDA approval for any ANDAs during the first six months of Fiscal 2010 and do not expect to receive any approvals for products out of our Michigan facilities until we resolve the FDA’s concerns as discussed above.  The total number of ANDAs pending approval by the FDA as of September 30, 2009 was 31 (including four tentative approvals) relating to 27 products.

4.
RECENT ACCOUNTING PRONOUNCEMENTS

In May 2009, the Financial Accounting Standards Board (“FASB”) issued Statement of Financial Accounting Standards (“SFAS”) No. 165, “Subsequent Events”, which was primarily codified into FASB Accounting Standards Codification (“ASC”) Topic 855.  This pronouncement provides guidance to establish general standards of accounting for and disclosures of events that occur after the balance sheet date but before financial statements are issued or are available to be issued. This standard is effective for interim or fiscal periods ending after June 15, 2009 and became effective for the Company beginning with its quarterly period ended June 30, 2009.  Its adoption did not have an impact on the Company’s results of operations, financial position or cash flows.

 
8

 

In June 2009, the FASB issued SFAS No. 168, “FASB Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting Principles- a replacement of Financial Statement No. 162”, which was primarily codified into ASC Topic 105 — “Generally Accepted Accounting Principles.”  This standard identifies the sources of accounting principles and the framework for selecting the principles used in the preparation of financial statements of non-governmental entities that are presented in conformity with GAAP. This statement is effective for financial statements issued for interim and annual periods ending after September 15, 2009. Accordingly, the Company adopted this standard effective with its quarterly report ended September 30, 2009. The adoption of this standard has changed how we reference various elements of GAAP when preparing our financial statement disclosures, but had no impact on the Company’s consolidated financial statements.

5.
COMPUTATION OF EARNINGS PER SHARE

Earnings per share is computed using the weighted average number of common shares outstanding during each period and considers a dual presentation and reconciliation of “basic” and “diluted” per share amounts. Diluted reflects the potential dilution of all common stock equivalents.

The basic and diluted weighted average numbers of common shares outstanding for the second quarter of Fiscal 2010, ended September 30, 2009, were 38,723,585 and 40,468,406, respectively, and were both 38,138,937 for the first six months of Fiscal 2010. Correspondingly, the basic and diluted weighted average numbers of common shares outstanding for the second quarter of Fiscal 2009, ended September 30, 2008, were 33,389,920 and 40,593,328, respectively, and were 33,035,602 and 40,565,004, respectively for the first six months of Fiscal 2009.

6.
SUN PHARMACEUTICAL INDUSTRIES LIMITED

Pursuant to a stock purchase agreement, Sun Pharma made an initial investment of $7.5 million for the purchase of 5.3 million common shares of Caraco in 1997.

In August 1997, Caraco entered into an agreement, whereby Sun Pharma was required to transfer the technology formulas for 25 generic pharmaceutical products over a five-year period in exchange for 544,000 shares of Caraco common stock for each technology transfer of an ANDA product (when bio-equivalency studies were successfully completed) and 181,333 common shares for each technology transfer of a Drug Efficacy Study Implementation (“DESI”) product. The products provided to the Corporation from Sun Pharma were selected by mutual agreement. Under such agreement, Caraco conducted, at its own expense, all tests including bio-equivalency studies. Pursuant to such agreement through 2002, Sun Pharma delivered the technology formula for 13 products.  This agreement expired on November 21, 2002, and the Corporation entered into a new technology transfer agreement with Sun Pharma Global, Inc. (“Sun Global”), an affiliate of Sun Pharma.

Under the agreement, which was approved by the Corporation’s independent directors, Sun Global agreed to provide the formulations for 25 new generic drugs over a five-year period.  Caraco’s rights to the products are limited to the United States and its territories or possessions, including Puerto Rico.  Sun Global retains rights to the products in all other territories. The products are selected by mutual agreement. Under this agreement, Caraco conducts at its own expense all tests, including bio-equivalency studies.  The Corporation also markets the products consistent with its customary practices.  In return for the technology transfer, Sun Global receives 544,000 shares of Series B Convertible Preferred Stock for each generic drug transferred when such drug has passed its bio-equivalency studies.

 
9

 

The products agreement was amended by the Independent Committee, comprised of the three independent directors, in the first quarter of 2004 to eliminate the provision requiring that the Independent Committee concur in the selection of each product, and provides instead that each product satisfy certain objective criteria developed by management and approved by the Independent Committee.  Pursuant to such objective criteria, all 25 of the products under this agreement had been selected, and all 25 products had passed their respective bio-equivalency studies as of March 31, 2008.

On July 10, 2009, Caraco entered into an agreement with Alkaloida Chemical Company ZRT, a Hungarian corporation ("Alkaloida") and indirect subsidiary of Sun Pharma, pursuant to which Alkaloida will provide for certain products an exclusive, non-transferable license to Caraco to manufacture and market the products in the United States, its territories and possessions, including Puerto Rico. The license for a product is for a period of five (5) years from the commencement of marketing of the product, however, Caraco may extend the license for a further five (5) year period. Alkaloida is required to deliver the product technology for a product as soon as it is developed or available or as agreed to by Caraco and Alkaloida.

The agreement expires five years from the date of approval of the first ANDA, unless renewed or extended for consecutive one (1) year periods, however, the licenses remain valid pursuant to the terms of the agreement. Under certain conditions, the agreement may be terminated in its entirety or with respect to one or more products. The agreement is governed by and construed in accordance with the laws of the State of Michigan. The agreement was approved by Caraco's Independent Committee. No technology for any product has been transferred under this agreement to date.

Sun Pharma operates research and development centers in Mumbai and Vadodara in India, where the development work for products is performed.

Sun Pharma and its subsidiaries supply the Corporation with certain raw materials and formulations, assist in acquiring machinery and equipment to enhance production capacities, and have provided qualified technical professionals who work as Caraco employees. Sun Pharma continues to provide Clinical Research Services on a product by product basis.  Also, five of the eight directors of Caraco are, or were, affiliated with Sun Pharma.

Further, Sun Pharma and its affiliates may use Caraco as a contract manufacturer and/or distributor of their products. In December 2004 and January 2005, Caraco entered into agreements for two such products, of which one is currently being marketed.

During the fiscal year ended March 31, 2007 (“Fiscal 2007”), the Corporation entered into a three-year marketing agreement with Sun Pharma, which was reviewed and approved by the Board’s Independent Committee.  Under the agreement, the Corporation purchases selected product formulations offered by Sun Pharma and markets and distributes the same as part of the current product offerings in the U.S., its territories and possessions, including Puerto Rico. Sun Pharma is not obligated to offer Caraco products under this agreement, however, Caraco has the exclusive right to market in the U.S., its territories and possessions, including Puerto Rico, any products offered by Sun Pharma and accepted by Caraco.

 
10

 

During the fiscal year ended March 31, 2008 (“Fiscal 2008”), the Corporation entered into a three-year distribution and sale agreement with Sun Pharma, which was reviewed and approved by the Board’s Independent Committee. Under this agreement the Company purchases selected formulations which have been filed under Paragraph IV certification process with the FDA by Sun Pharma and offered for distribution. Paragraph IV certified (“Paragraph IV”) products may face litigation challenges with respect to claims of patent infringement. Under the agreement the Company shares in the sales opportunity and shares the litigation risk. The Company is indemnified by Sun Pharma of any risk beyond the percentage agreed to as its profit percentage thereby limiting the Company’s exposure. Sun Pharma is not obligated to offer Caraco products under this agreement, however, Caraco has the exclusive right to market in the U.S., its territories and possessions, including Puerto Rico, any products offered by Sun Pharma and accepted by Caraco. The Company markets and distributes the same as part of its current product offerings in the U.S., its territories and possessions, including Puerto Rico. The license granted with respect to a product terminates upon the end of an exclusivity period of 180 days or a non-appealable court decision, or until a third generic manufacturer launches the product, whichever is later, or until a settlement is reached, at which time the product will become part of the standard Caraco-Sun Pharma marketing agreement disclosed above. The Company currently receives a fixed gross profit margin of 8%, or such other percentages as shall be mutually agreed upon. Under the agreement, Sun Pharma and Caraco mutually indemnify each other capped by the fixed margin percentage with respect to damages from infringement.

During the second quarter and first six months of Fiscal 2010 the Corporation made net sales of $75.9 million and $110.9 million, respectively, and during corresponding periods of Fiscal 2009, the Corporation made net sales of $89.9 million and $166.2 million, respectively, of the marketed products under the aforesaid agreements.

While management has a basis to reasonably believe that Sun Pharma's substantial investment in Caraco provides Sun Pharma with sufficient economic incentive to continue to assist Caraco in developing its business, and Sun Pharma has expressed its intent to continue to support Caraco's operations in the near term, as it has done in the past, there can be no assurance that such support will, in fact, continue.

During the first six months of Fiscal 2010, Sun Global converted 1,632,000 shares of Series B Preferred Stock into 1,632,000 shares of Common Stock. Through March 31, 2009 Sun Global had converted 10,880,000 shares of Series B Preferred Stock into 10,880,000 shares of Common Stock, respectively. Sun Pharma’s current beneficial ownership is 75% (76% including its convertible Series B Preferred Stock).

In addition to its substantial relationship with, and dependence on Sun Pharma as described above, the Corporation is subject to certain risks associated with companies in the generic pharmaceutical industry.  Profitable operations are dependent on the Corporation's ability to market its products at reasonable profit margins.  In addition to maintaining profitable operations, the ongoing success of the Corporation will depend, in part, on satisfaction of FDA concerns, its continuing ability to attract and retain key employees, obtain timely approvals of its ANDAs, and develop new products.

 
11

 

7.
ACCOUNTING FOR STOCK BASED COMPENSATION

The Company follows the provisions of ASC Topic 718, “Stock Compensation’” which requires employee share-based compensation to be accounted for under the fair value method and requires the use of an option pricing model for estimating the fair value of stock options at the date of grant. The Company estimates the fair value of stock options granted using the Black-Scholes option-pricing model, which requires the Company to estimate the expected term of the stock option grants and expected future stock price volatility over the term. The term represents the expected period of time the Company believes the options will be outstanding based on historical information. Estimates of expected future stock price volatility are based on the historical volatility of the Company’s common stock. The Company calculates the historical volatility as the standard deviation of the differences in the natural logarithms of the weekly stock closing price, adjusted for dividends and stock splits.

For the second quarter and first six months of Fiscal 2010, the Company has recognized expenses amounting to $49,795 and $135,578 respectively, related to common stock options as compared to $86,574 and $151,179 respectively, for the corresponding periods of Fiscal 2009. As of September 30, 2009, total unrecognized compensation cost related to stock options granted was $277,696. The unrecognized stock option compensation cost is expected to be recognized over a period of approximately three years. Stock options to purchase 6,000 shares of common stock were granted to Directors during the first six months of Fiscal 2010, which vest in the amount of one-third on each anniversary following the date of grant. Additionally, during the first quarter of Fiscal 2009, the Company recorded an expense of $169,900 related to a stock grant of 10,000 common shares issued to its then CEO on May 2, 2008, as part of his employment agreement, which vested immediately upon issuance.

8.
COMMON STOCK ISSUANCES

There were no common stock issuances to Directors or employees during the first six months of Fiscal 2010.  We issued 1,000 shares of common stock to our employees upon exercise of their stock options during the first six months of Fiscal 2009. Also, during the first quarter of Fiscal 2009, the Company issued a stock grant of 10,000 common shares to its former CEO on May 2, 2008, as noted above.

During the first six months of Fiscal 2010, Sun Global converted 1,632,000 shares of Series B Preferred Stock into 1,632,000 shares of Common Stock. (See “Part II – Other Information: Item 2. Unregistered Sales of Equity Securities and Use of Proceeds” below).

9.
PREFERRED STOCK ISSUANCES

No shares of preferred stock were issued during the first six months of Fiscal 2010 or Fiscal 2009.

10.
SALES AND CUSTOMERS

Sales of distributed products were significantly lower for the second quarter and first six months of Fiscal 2010, in comparison to the corresponding periods of Fiscal 2009 primarily as a result of significantly higher sales of Paragraph IV products during both periods of Fiscal 2009. See “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations – Second Quarter and First Six Months of Fiscal 2010 Compared to Second Quarter and First Six Months of Fiscal 2009.” Sales of distributed products were also lower due to price erosion for the products sold. We continue to remain competitive on products sold and marketed during the first six months of Fiscal 2010. However, during the second quarter and first six months, sales of Caraco-owned products (those products for which Caraco owns the ANDAs) were adversely affected by the actions of the FDA and the cessation of manufacturing, as disclosed above and in part due to the negative impact of our voluntary recalls,. Our organization is focused on correcting any and all manufacturing issues to allow us to emerge as a stronger company. In the interim, we will continue to focus our sales and marketing team on distributed product sales.

 
12

 

As is typical in the U.S. retail sector, many of our customers are serviced through their designated wholesalers. During the second quarter and first six months of Fiscal 2010, the Company’s three largest wholesale customers,  Amerisource-Bergen Corporation, McKesson Corporation and Cardinal Health, accounted for approximately 5%, 3% and 3%, respectively, of the Company’s total net sales during the second quarter and 7%, 6% and 5%, respectively, of total net sales for the first six months of Fiscal 2010. During the corresponding period of Fiscal 2009, shipments to Amerisource-Bergen Corporation, McKesson Corporation and Cardinal Health, accounted for approximately 7%, 10% and 38%, respectively, of the Company’s total net sales during the second quarter of Fiscal 2009, and 6%, 15 and 25%, respectively, of total net sales for the first six months of Fiscal 2009. The majority of these net sales include sales for various customers of ours that have underlying direct contracts with our Company that are facilitated through our wholesale customers. During the second quarter and first six months of Fiscal 2010, sales to CVS Caremark Corporation accounted for approximately 74% and 60% of our net sales. The sales to CVS Caremark Corporation have increased as we have entered into a new contract with it towards the end of Fiscal 2009.

11.
DEBT

As a consequence of the FDA actions disclosed above, on June 29, 2009, JP Morgan Chase Bank N.A. (“JP Morgan”) temporarily suspended the Company’s $10 million Credit Agreement until such time as the matters with the FDA are resolved to the satisfaction of JP Morgan bank or such Credit Agreement expires. The Credit Agreement is set to expire on November 30, 2009.  However, there were no borrowings under the Credit Agreement at any time during the current fiscal year.  Under the Credit Agreement, JP Morgan may make loans and issue letters of credit to the Corporation for working capital needs and general corporate purposes. Letters of credit, if issued, expire one year from their date of issuance, but no later than November 30, 2009. Borrowings are secured by the Corporation’s receivables and inventory. Interest is payable based on a LIBOR Rate or an alternate base rate (determined by reference to the prime rate or the federal funds effective rate), as selected by the Corporation. The rate of interest is LIBOR plus 75 basis points, or the bank’s prime rate minus 100 basis points (provided the prime rate is not less than the prevailing one month LIBOR Rate plus 250 basis points). The effective rates were 1.35% and 2.25%, respectively, at June 30, 2009 subsequent to which the line of credit was suspended. The Credit Agreement requires that certain financial covenants be met on a quarterly basis.

During the fourth quarter of Fiscal 2009 the Company entered into a term loan of $18 million with RBS Citizens, N.A. d/b/a Charter One Bank (“Charter One Bank”). The loan is secured by a mortgage covering the Company’s manufacturing facility and equipment located in Detroit, Michigan. The rate of interest is calculated as LIBOR plus an applicable margin thereto (based upon various leverage levels and current applicable rate is 50 basis points). The aggregate rate applicable to the Company as of September 30, 2009 was 1.5%. The principal loan payments and accrued interest are payable on a quarterly basis beginning July 2009. The principal is to be repaid in equal quarterly installments of $900,000 for ten quarters through October 2011, and thereafter, if not renewed, the remaining balance of $9 million is due in the subsequent quarter by January 2012. Subsequently, the terms of the loan were modified and we entered into an amended agreement. The amended agreement amended the loan to add to the equipment term loan for the purposes of financing new machinery and equipment and building improvements, a one year line of credit note for $15 million against which the Company can borrow funds for working capital purposes or can get letters of credit issued. The line of credit carries an interest rate of LIBOR plus 150 basis points, and if letters of credit are issued, the associated fees are 0.7% of such letters of credit on annualized basis. Also, there is an unused fee of 0.25% on an annualized basis to the extent the line remains idle. Both the line of credit and outstanding term loan are cross collaterized by all of the Company’s fixed assets and cash deposit accounts held with Charter One Bank in the same amount. These cash deposits earn interest at prevailing rates applicable to such money market  acoounts. Against this line of credit, the Bank has issued an Irrevocable Standby Letter of Credit in an amount of $15 million, in favor of the United States of America, as required to be placed with the FDA in accordance with the Consent Decree, as disclosed above. We are continuing discussions with Charter One Bank to resolve its concerns and get the cash collateral released. Charter One Bank has temporarily suspended our required compliance with the covenants in the loan agreements relating to FDA enforcement actions as previously disclosed, and has suspended testing of certain other compliance requirements until February 26, 2010. On or before such date, we anticipate either entering into revised agreements or repaying the loan in full. Currently, as the loan is in technical default due to the FDA enforcement action, the entire outstanding balance has been classified as a short-term liability.

 
13

 

As required pursuant to the terms of the Loan Agreement, the Company has entered into an Interest Rate Swap Agreement with Charter One Bank to hedge the interest rate applicable on the loan. The notional amount for the swap is $17.1 million which will continue to amortize down as principal payments are made on the related debt. The annualized fixed rate of interest as it applies to this agreement is 2.41%. Thus as of September 30, 2009 the effective rate of interest to the Company for the term loan was 2.91% (2.41% swap rate plus applicable margin of 50 basis points). The fair value of this swap agreement at September 30, 2009 was not material.

12.
LITIGATION

While it is not possible to determine with any degree of certainty the ultimate outcome of the following legal proceedings, the Company believes that it has meritorious defenses with respect to the claims asserted against it and intends to vigorously defend its position. An adverse outcome in any of these proceedings could have a material adverse effect on the Company’s financial position and results of operations.

As previously disclosed, on June 9, 2005, Novo Nordisk A/S and Novo Nordisk, Inc. (“Novo Nordisk”) filed a complaint in the United States District Court for the Eastern District of Michigan alleging that the Company’s filing of an ANDA seeking approval to market its generic version of Novo Nordisk’s Prandin® (repaglinide) drug product infringed Novo Nordisk’s U.S. Patent No. 6,677,358. Novo Nordisk seeks an order from the Court which, among other things, directs the FDA not to approve the Company’s ANDA any earlier than the claimed expiration date. The ANDA filed by the Company contains a Paragraph IV certification challenging the Novo Nordisk patent as well as a section viii statement with regard to the patent’s method claim. The Company believes that this Novo Nordisk patent is invalid and/or will not be infringed by the Company’s manufacture, use or sale of the product. The Company believes that it is the first to file an ANDA with a Paragraph IV certification for this drug product and it intends to defend this action vigorously to capitalize on the potential for obtaining 180 days exclusivity available for this product.  Earlier this year, the Company filed a supplemental answer and counterclaim challenging Novo Nordisk’s recent Orange Book use code amendment by Novo Nordisk in reference to Prandin®.  On September 25, 2009, the District Court entered an injunction requiring Novo Nordisk to correct its amended use code description for Prandin® on the ground that it does not accurately characterize the referenced method patent.  Novo Nordisk has appealed that injunction and briefing on the appeal has been expedited.  On October 14, 2009, the parties entered into a stipulation regarding the appeal. On October 27, 2009, the United States Court of Appeals for the Federal Circuit entered an Order staying the use code injunction during the appeal. We expect briefing on the appeal to be completed sometime in November of 2009..If the Company prevails on the use code injunction appeal, Novo Nordisk will stipulate to noninfringement based on Caraco’s proposed section viii split-certification.  If Novo Nordisk prevails on the use code injunction appeal, the parties will proceed to trial on patent validity and unenforceability.  Currently, the trial is anticipated to begin in February, 2010.

 
14

 

As previously disclosed, on July 10, 2006, Forest Laboratories, Inc., Forest Laboratories Holdings, Ltd., and H. Lundbeck A/S (collectively, “Forest”) filed a complaint in the United States District Court for the Eastern District of Michigan alleging that the Company’s filing of an ANDA seeking approval to market its generic version of Forest’s Lexapro® (escitalopram oxalate) drug product infringed Forest’s Patent No. Re. 34,712 (the “’712 patent”).  The ANDA contains Paragraph IV Certifications challenging the ‘712 patent, as well as two other Forest-owned patents, the 6,916,941 (“the ‘941 patent”) and 7,420,069 ("the '069 patent").  Forest did not assert the '941 patent or '069 patent, so the Company brought declaratory judgment actions seeking a declaration that it did not infringe those patents.  The Company vigorously litigated all three cases.

On July 10, 2009, the Company announced that it has reached an agreement with Forest to settle the Lexapro® litigation.  On October 2, 2009, the Company announced that it closed the Asset Purchase Agreement (the “APA”) related to that settlement.  In accordance with the previously disclosed settlement:

 
1.
Forest has agreed to provide licenses to the Company for any patents related to Lexapro® with respect to the marketing of the Company’s generic version of the product as of the date that any third party generic enters the market with final approval from the FDA other than an authorized generic or the first filer with Hatch-Waxman exclusivity.

 
2.
Forest has reimbursed the Company for a portion of its attorney’s fees related to this litigation.

 
3.
Pursuant to the APA, the Company is taking over the commercialization and sale of several products from Forest’s Inwood business and received compensation payment from Forest in connection with its Inwood business. Caraco has paid Forest an advance against royalties and will pay royalties on net sales of these products.

 
15

 

As previously disclosed, on September 22, 2004, Ortho-McNeil Pharmaceutical, Inc. (“Ortho-McNeil”) filed a complaint in the United States District Court for the Eastern District of Michigan alleging that the Company’s filing of an ANDA seeking approval to market its generic version of Ortho-McNeil’s Ultracet® brand tramadol/acetaminophen drug product infringed Ortho-McNeil’s patent, which expires on September 6, 2011. Ortho-McNeil sought an order from the district court which, among other things, directed the FDA not to approve the Company’s ANDA any earlier than the claimed expiration date. The ANDA filed by the Company contains a Paragraph IV Certification challenging the Ortho-McNeil patent. The Company asserted that the Ortho-McNeil patent is invalid and/or will not be infringed by the Company’s manufacture, use or sale of the product. Since filing this action, Ortho-McNeil authorized a generic manufacturer to provide a generic version of Ortho-McNeil’s Ultracet® product while another manufacturer launched its approved generic at risk. On October 19, 2005, the Company’s motion for summary judgment was granted. On December 19, 2005, the FDA approved the manufacture, use and sale of the Company’s generic product. Ortho-McNeil filed an appeal of the finding of noninfringement by the district court with the United States Court of Appeals for the Federal Circuit. On January 19, 2007, the United States Court of Appeals for the Federal Circuit affirmed the lower court’s decision granting the Company’s motion for summary judgment.

Additionally, the United States Patent and Trademark Office approved Ortho-McNeil’s request for a reissue patent. Although the district court had determined that the Company does not infringe Ortho-McNeil’s original patent, on July 31, 2006, Ortho-McNeil filed a lawsuit against the Company in the United States District Court for the District of New Jersey, alleging that the Company’s generic version of Ultracet® brand tramadol/acetaminophen drug product infringes its reissue patent. On September 26, 2006, the Company filed an answer denying, among other things, that its generic product infringes any valid claims of Ortho-McNeil’s reissue patent. On December 10, 2007, the Company filed a motion for summary judgment that the asserted claims of the reissue patent were obvious and therefore invalid as a matter of law. This motion was granted by Judge Cavanaugh of the District of New Jersey on April 17, 2008. Final judgment has been granted. On August 25, 2008, Ortho-McNeil filed a notice of appeal with respect to that judgment with the United States Court of Appeals for the Federal Circuit. The appeal was fully briefed and was argued on July 7, 2009.  On August 26, 2009, the Court of Appeals reversed a portion of the previously decided summary judgment.  Although the Court did find that a portion of the patent was not valid, the Court remanded the litigation back to the lower court for further proceedings.  Caraco subsequently filed a combined petition for a panel rehearing and a rehearing en banc.  That combined petition for rehearing remains pending before the Court.

As previously disclosed, on May 5, 2009, Wyeth filed a complaint against the Company and Sun Pharma in the United States District Court for the Eastern District of Michigan.  The complaint alleges that the package insert for Sun Pharma’s product that is distributed by the Company and which is a generic version of Wyeth’s Protonix® (pantoprazole) pharmaceutical product contains false and misleading statements regarding the active ingredient of that product in violation of federal and state laws. The complaint requests damages, injunctive relief and attorneys’ fees and costs. The Company and Sun Pharma believe that they have not engaged in any improper conduct and intend to vigorously contest these allegations.   On July 6, 2009, the Company and Sun Pharma filed a Motion to Dismiss the Complaint for Failure to State a Claim Upon Which Relief May Be Granted.  Plaintiff’s brief in response to the Company’s and Sun Pharma’s Motion to Dismiss was filed on July 30, 2009.  Caraco and Sun Pharma filed a reply memorandum of law in support of its Motion to Dismiss on August 13, 2009.  The Motion has been fully briefed and we are awaiting a decision from the Court.

 
16

 

As previously disclosed, on June 25th, 2009, at the direction of the FDA, the U.S. Marshal Service, arrived and seized drug products manufactured, work in process materials, and ingredients held, at the Company's Michigan facilities.  The estimated value of such seized inventory as of September 30, 2009 was $24.0 million.  The office of the United States Attorney, on behalf of the FDA and Department of Justice, filed a Warrant for Arrest In Rem to seize certain materials at the Company's Michigan facilities in the United States District Court for the Eastern District of Michigan.  A Complaint for forfeiture of those materials was filed with the court by the FDA.   The Complaint alleged that the drug products and materials are adulterated, in that the methods used in, and the facilities and controls used for, their manufacture, processing, packing and holding do not conform to cGMP requirements.  Also as previously disclosed, on September 29, 2009, the Company voluntarily entered into a Consent Decree with the FDA.  The Consent Decree provides a series of measures that, when satisfied, will permit the Company to resume manufacturing and distributing those products which are manufactured in its Michigan facilities.  Nothing in the Consent Decree prohibits the Company from distributing FDA approved drug products that are manufactured by third parties.  We intend to continue to work with the FDA under the terms of the Consent Decree to resolve its concerns as effectively and expeditiously as possible.

As previously disclosed, on July 17, 2009 and July 23, 2009, two purported class action lawsuits were filed in the United States District Court for the Eastern District of Michigan against the Company and certain of its executive officers.    The lawsuits allege securities violations related to the Company’s public statements on FDA compliance issues made between May 29, 2008 and June 25, 2009.  On September 15, 2009, plaintiffs in both of the purported lawsuits filed motions for consolidation of the cases and for approval of lead plaintiff.  The Company believes the allegations to be without merit and intends to vigorously defend itself.

On September 29, 2009, Taro Pharmaceutical Industries Ltd. and Taro Pharmaceuticals U.S.A., Inc. (“Taro”) filed suit against Caraco and Sun Pharma and certain of its affiliates.  The complaint, as it pertains to Caraco, alleges misappropriation and misuse of trade secrets, unfair competition, tortious interference with business relationships, fraud and unjust enrichment.  The claims against Caraco arise out of Caraco’s purported access to information from Taro as a part of the due diligence conducted for Sun Pharma’s tender offer for Taro Pharmaceuticals Industries Ltd.  Caraco intends to vigorously defend this action.

The Company is also involved in certain other legal proceedings from time to time incidental to normal business activities. While the outcome of any such proceedings cannot be accurately predicted, the Company does not believe the ultimate resolution of any of these certain existing matters would have a material adverse effect on its financial position or results of operations.

 
17

 

13.
INVENTORIES

Inventories consist of the following amounts:

   
September 30, 2009
   
March 31, 2009
 
Raw materials
  $ 18,325,368     $ 17,954,511  
Goods in transit (Distributed)
    22,191,773       29,236,869  
Work in process
    7,183,097       9,279,009  
Finished goods (Caraco- Owned)
    10,141,321       9,749,721  
Finished goods (Distributed)
    46,401,155       13,290,722  
Inventories before reserves
  $ 104,242,714     $ 79,510,832  
Less : Reserve for certain inventory under control of the FDA
    15,950,188       -  
Total Inventories
  $ 88,292,526     $ 79,510,832  

Total inventories at September 30, 2009 and March 31, 2009 includes materials purchased in the amount of $3,257,323 and $2,875,885, respectively, related to products for which the Company has filed ANDAs with the FDA, and the commercial launch of such products will commence once the approvals are received.

As disclosed above, on June 25, 2009, certain drug products manufactured, work in process, and ingredients held, at the Company's Michigan facilities were seized at the direction of the FDA . The estimated value of such seized inventory as of September 30, 2009 was $24.0 million. The Company voluntarily entered into a Consent Decree with the FDA on September 29, 2009. As stipulated in the Consent Decree, the Company will attempt to have the seized inventory released. The Company believes that, except for the raw materials which were opened solely for the purpose of sampling, the estimated value of which is $8.1 million, all other seized inventory would be difficult to recondition. Accordingly, a reserve in the amount of $15.9 million has been created as of September 30, 2009 for this remaining inventory which consists of work in process relating to those materials which are in various stages of production within our manufacturing facilities, all finished goods and those raw material ingredients which are partially consumed in process.  The Company believes that it will be able to use the inventory of raw materials which were opened solely for sampling purposes, however, in the event the Company is unable to recondition or recover all of such inventory, the Company will adjust the value of its inventory accordingly in future periods, which would result in a negative impact on the future operating results of the Company.

 
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14.
INCOME TAXES

The provision for income taxes is as follows:

   
Six Months Ended
 
   
September 30, 2009
   
September 30, 2008
 
             
Current
  $ 5,820,451     $ 10,743,489  
Deferred
    (7,120,707 )     (1,773,180 )
Total
  $ (1,300,256 )   $ 8,970,309  

The provision for income taxes is different from that which would be obtained by applying the statutory federal income tax rate to income before income taxes. The items causing the difference for the first six months of Fiscal 2010 and Fiscal 2009, respectively, are as follows:

   
Six Months Ended
 
   
September 30, 2009
   
September 30, 2008
 
             
Provision for income taxes at federal statutory rate
  $ (1,349,169 )   $ 9,409,521  
Permanent items and other
    48,913       (439,212 )
Income taxes
  $ (1,300,256 )   $ 8,970,309  

Deferred taxes consist of the following:

   
September 30, 2009
   
March 31, 2009
 
             
Deferred tax assets:
           
Net operating loss carryforwards
  $ 664,693     $ 797,631  
Intangibles
    25,254,680       26,458,255  
Reserve for inventory
    5,582,662       -  
Other
    416,986       417,136  
Total deferred tax assets
  $ 31,919,021     $ 27,673,022  
                 
Deferred tax liabilities:
               
                 
Intangibles
  $ 3,090,493     $ 6,180,987  
Depreciation
    872,950       657,165  
Total deferred tax liabilities
  $ 3,963,443     $ 6,838,152  
                 
Net deferred tax assets
  $ 27,955,578     $ 20,834,870  

 
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15.
SEGMENT INFORMATION

The Company operates in two reportable segments consisting of (1) Caraco-owned products (those products for which Caraco owns the ANDAs) and (2) those products distributed under various agreements with Sun Pharma and its affiliates and with others. The sales and gross profits earned on these categories of products are as follows

Fiscal 2009:
 
Quarter Ended
 September 30, 2009
   
Six Months Ended
September 30, 2009
 
                         
Category
 
Net Sales
   
Gross Profit
   
Net Sales
   
Gross Profit
 
                         
Caraco-Owned Products
  $ 2,492,443     $ (10,650,146 )   $ 15,573,630     $ (17,542,360 )
Distributed Products
    75,883,452       6,511,859       110,872,281       9,794,505  
Total
  $ 78,375,895     $ (4,138,287 )   $ 126,445,911     $ (7,747,855 )

Fiscal 2008:
 
Quarter Ended
 September 30, 2008
   
Six Months Ended
September 30, 2008
 
                         
Category
 
Net Sales
   
Gross Profit
   
Net Sales
   
Gross Profit
 
                         
Caraco-Owned Products
  $ 32,242,502     $ 15,359,842     $ 64,277,867     $ 31,747,703  
Distributed Products
    89,945,923       6,642,021       166,187,298       13,837,571  
Total
  $ 122,188,425     $ 22,001,863     $ 230,465,165     $ 45,585,274  

16.
SUBSEQUENT EVENTS

None

ITEM 2.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis provides information that management believes is relevant to an understanding of the Corporation’s results of operations and financial condition. The discussion should be read in conjunction with the financial statements and notes thereto and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the Company’s 2009 Annual Report on Form 10-K as of and for the year ended March 31, 2009 (the “Annual Report”) and the unaudited interim financial statements included in Item 1 of this Quarterly Report on Form 10-Q.

 
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Critical Accounting Policies and Estimates

Our significant accounting policies are described in Note 1 to our financial statements included in our Annual Report. Certain of our accounting policies are particularly important to the portrayal of our financial position and results of operations and require management’s subjective judgments. As a result, these judgments are subject to an inherent degree of uncertainty. In applying these policies, management makes estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.  Significant estimates include, but are not limited to, provisions for estimated customer returns, discounts, rebates and other price adjustments, including customer chargebacks, valuation allowances for deferred tax assets, valuation of overhead components in inventory and the reserve for inventory. Our discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. There have neither been material changes to our critical accounting policies for the periods presented nor any material quantitative revisions to our critical accounting estimates for the periods presented.

Revenue Recognition

Revenue from product sales, both manufactured and distributed, net of estimated provisions, is recognized when there is persuasive evidence that an arrangement exists, shipment of the goods has occurred, the selling price is fixed or determinable, and collectibility is reasonably probable. Our customers consist primarily of large pharmaceutical wholesalers who sell directly into the retail channel, chain drug stores, distributors, and managed care customers. Provisions for sales discounts, and estimates for chargebacks, rebates, and product returns are established as a reduction of product sales revenue at the time revenues are recognized, based on historical experience and current market trends adjusted to reflect known changes in the factors that impact these reserves. These revenue reductions are reflected as a direct reduction to accounts receivable through an allowance.

Chargebacks

Chargebacks represent our most significant provision against gross accounts receivable and related reduction to gross revenue. Chargebacks are retroactive credits given to our wholesale customers that represent the difference between the lower price they sell (contractual price) to retail, chain stores, and managed care organizations and what we charge the wholesaler. We estimate chargebacks at the time of sale for our wholesale customers. We are currently unable to specifically determine whether the amounts allowed in specific prior periods for chargeback reserves have been over or understated. Wholesaler customers who submit chargebacks to the Company do not reference a specific invoice that the chargeback is related to when the chargeback is submitted to the Company. Thus, we cannot determine the specific period to which the wholesaler’s chargeback relates.

We consider the following factors in the determination of the estimates of chargebacks.

1. The historical data of chargebacks as a percentage of sales, as well as actual chargeback reports received from our primary wholesaler customers.

2. Volume of all products sold to wholesaler customers and the average chargeback rates for the current quarter as compared to the previous quarter and compared to the last six month period.

 
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3. The sales trends and future estimated prices of our products, wholesale acquisition cost (WAC), the contract prices with the retailers, chain stores, managed care organizations (end-users), and our wholesaler customer’s contract prices.

4. We utilize remaining inventories on hand at our primary wholesaler customers at the end of the period in the calculation of our estimates.

Such estimated amounts, in addition to certain other deductions, are deducted from our gross sales to determine our net revenues. The amount of actual chargebacks claimed could be either higher or lower than the amounts we accrued. Changes in our estimates, if any, would be recorded in the income statement in the period the change is determined. If we materially over or under estimate the amount that will ultimately be charged back to us by our wholesale customers, there could be a material impact on our financial statements.

Shelf Stock Adjustments

Shelf stock adjustments are credits issued to our customers to reflect decreases in the selling prices of our product. These credits are customary in the industry and are intended to reduce the customers’ inventory cost to better reflect current market prices. The determination to grant a shelf stock adjustment to a customer following a price decrease is at our discretion.

Factors considered when recording a reserve for shelf stock adjustments include estimated launch dates of competing products based on market intelligence, estimated decline in market price of our product based on historical experience and input from customers and levels of inventory held by customers at the date of the adjustments as provided by them.

Product returns and other allowances

In the pharmaceutical industry, customers are normally granted the right to return product for credit if the product has not been used prior to its expiration date. Our return policy typically allows product returns for products within a twelve month window from six months prior to the expiration date and up to six months after the expiration date. We estimate the level of sale, what will ultimately be returned pursuant to our return policy, and record a related reserve at the time of sale. These amounts are deducted from our gross sales to determine our net revenues. Our estimates take into consideration historical returns of our products and our future expectations. We periodically review the reserves established for returns and adjust them based on actual experience, if necessary. The primary factors we consider in estimating our potential product returns include shelf life of expiration date of each product and historical levels of expired product returns. In case we become aware of any returns due to product related issues, such information from the customers is used to estimate an additional reserve. The amount of actual product return could be either higher or lower than the amounts we accrued. Changes in our estimates, if any, would be recorded in the income statement in the period the change is determined. If we over or under estimate the quantity of product which will ultimately be returned, there may be a material impact on our financial statements.

 
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Discounts (trade and prompt payment discounts) are accrued at the end of every reporting period based on the gross sales made to the customers during the period and based on their terms of trade. We review the contracts between the customer and us as well as the historical data and percentages to estimate the discount accrual.

Customer rebates are estimated at every period end, based on direct or indirect purchases. If the purchases are direct, the rebates are recognized when products are purchased and a periodic credit is given. For indirect purchases, the rebates are recognized based on the terms with such customer. Medicaid rebates are estimated based on the historical data we receive from the public sector benefit providers, which is based on the final dispensing of our product by a pharmacy to a benefit plan participant.

Doubtful Accounts

Doubtful accounts are estimated based on the data available from external sources, including information on financial condition of customers. Also, a regular review of past due receivables is done on a quarterly basis to identify and make provision for such receivables not expected to be collected.

Gross Sales and Related Allowances

Our gross sales for the second quarter and first six months of Fiscal 2010 were $131.5 million and $213.8 million, respectively, as compared to $250.6 million and $430.7 million, respectively, for the corresponding periods of Fiscal 2009. Sales allowances, which include chargebacks, returns, discounts, other customary customer deductions and other sales costs, constituted approximately 40% and 41% of gross sales, respectively, for the second quarter and first six months of Fiscal 2010 as compared to 51% and 46% of gross sales, respectively, for the corresponding periods of Fiscal 2009. Net sales for the second quarter and first six months of Fiscal 2010 were $78.4 million and $126.4 million, respectively, as compared to $122.2 million and $230.5 million, respectively, for the corresponding periods of Fiscal 2009. The primary cause of the decreased sales allowances for both periods of Fiscal 2010 is due to the impact of higher sales to customers other than wholesalers, which carry lower deductions from gross sales, since sales made to wholesale customers includes deductions related to chargebacks, which represent differences between wholesale acquisition costs (WAC) and the contractual prices at which the wholesalers ship to our end use customers.

 
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The following is a roll forward of the provisions for chargebacks, shelf stock adjustments, returns and allowances and estimated doubtful account allowances during Fiscal 2009 and the first six months of Fiscal 2010.

($ in Thousands)
 
   
Balances at beginning of period
   
Allowances charged to Gross Sales
   
Credits taken by customers
   
Balance at the end of period
 
         
Current Period
   
Prior Period
             
For all of Fiscal 2009
                             
Chargebacks, rebates & shelf stock adjustments
  $ 78,905     $ 291,070       -0-     $ 319,947     $ 50,028  
Returns and other allowances
    5,273       19,870       -0-       18,588       6,555  
Doubtful Accounts
    118       231       -0-       271       78  
                                         
For the first six months of Fiscal 2010
                                       
Chargebacks, rebates & shelf stock adjustments
  $ 50,028     $ 81,798       -0-     $ 65,983     $ 65,843  
Returns and other allowances
    6,555       5,573       -0-       6,540       5,588  
Doubtful Accounts
    78       9       -0-       9       78  

Research and Development Costs

Series B convertible preferred stock was issued to Sun Pharma and its affiliates under the Products Agreement between the Corporation and Sun Global in exchange for the technology of formulation products delivered by Sun Global to the Corporation.  Such Products Agreement has been completed with the last technology transfer occurring during the third quarter of Fiscal 2008.  Accordingly, no further non-cash research and development expense will be incurred thereunder.  The amount of non-cash research and development expense which was incurred for past technology transfers under the Products Agreement was charged to operations and was determined based on the fair value of the preferred shares on the date the respective product formula passed its bio-equivalency studies.  The fair value of such shares was based upon a valuation performed by Donnelly Penman & Partners, an independent, third party valuation firm. The exchange of shares was prior to the initial ANDA submission to the FDA.

 
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We were responsible for submission of the ANDAs for these transferred formulations for FDA approval.  In our experience, generally the submission of the ANDA to the FDA was approximately thirty days after the receipt of notice that the proposed drug product formula passes its bio-equivalency study and accelerated stability studies. An ANDA contains data related to a generic drug product which is submitted to the FDA for review and approval.  The FDA must first determine the completeness of the filing and may deny the filing if it is incomplete.  There are various reviews that are completed, including bio-equivalency, chemistry, manufacturing, and labeling.  The bio-equivalency of a generic drug product is established by measuring the rate and level of active ingredient(s) in the bloodstream of healthy human subjects over a period of time. These pharmacokinetic parameters and results are compared with the innovator’s drug product. The bio-equivalency results of the proposed generic drug product must meet pharmacokinetic standards set forth by the FDA. Accordingly, the generic version of a drug product must generally deliver the same amount of active ingredients into the bloodstream within the same timeframe as that of the innovator drug product.  Following an indication that the generic drug product has passed its bio-equivalency study, the generic drug product will undergo reviews for chemistry, manufacturing and labeling.  In each case, the FDA has an opportunity to raise questions or comments, or issue a deficiency letter.  In the event that one or more deficiency letters are issued by the FDA, the submission of the ANDA may be halted or delayed as necessary to accommodate the correction of any such deficiencies and the completion of any additional reviews required. Minor deficiencies traditionally could delay the approval anywhere from 10 days to 90 days or more.  Major deficiencies could stop the evaluation process.  A restart of the FDA review process after a major deficiency could take up to as many as 180 days or more.  Generally, any deficiencies we have experienced have been minor though at times approvals have faced considerable delays.  Based on these delays, the economic benefit may not be realized at its highest potential as the delay could cause our approval to be behind our competition’s approval of the same generic product.

Based on the definition and characteristics of an asset, set forth in paragraphs 25 and 26 of Statement of Financial Accounting Concepts No. 6 issued by the FASB, the Company did not capitalize the technology formulas transferred, as the probability of the future economic benefit to be derived from such formulations was uncertain at the time of technology transfer.

In addition, we have reported the technology transfers as research and development expenses pursuant to ASC Topic 730, “Research and Development,”  In connection therewith, the research and development technology transferred by Sun Global under the Products Agreement was always specific research and development technology for a specific product formula. There were no alternative future uses (in other research and development projects or otherwise) for such products. For example, Caraco has never acquired technology from Sun Global with the purpose of selling such technology and, in fact, has never sold or held for sale any of the technology transferred by Sun Global to a third party. Caraco has always developed the research and development technology into manufactured product for its own business purposes.

Research and development costs settled in cash are charged to expense as incurred.

 
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Short-Term Investments

During the first quarter of Fiscal 2010 the Company invested $10,000,000 in a bank certificate of deposit.  The term of deposit is for twelve months and earns interest at a rate of 4.5% APY. If such deposit is withdrawn prior to maturity, the Company will earn interest at the applicable LIBOR rate as on the date of such withdrawal.

Intangible Assets

The Company made a cash payment in the first quarter of Fiscal 2009 in the amount of $1,100,000 for the purchase of certain assets which included brand products, associated New Drug Applications (“NDAs”) and trademarks. These assets are recorded as intangible assets in the Company’s balance sheet at September 30, 2009. Additionally during the second quarter of Fiscal 2009, the Company paid $356,000 in cash towards product and establishment fees for these products. The total gross carrying amount for these assets is $1,456,000 as of September 30, 2009. These intangible assets are being amortized equally over a period of 15 years, the period during which the Company expects to receive economic benefits from these intangible assets. The Company recorded $49,000 in amortization expense in the first six months of Fiscal 2010, bringing the total accumulated amortization related to these intangible assets to $121,000 as of September 30, 2009.

Income Taxes

As part of the process of preparing our financial statements, we are required to estimate our income taxes in each of the jurisdictions in which we operate. We account for income taxes by the liability method. Under this method, deferred income taxes are recognized for tax consequences in future years of differences between the tax bases of assets and liabilities and their financial reporting amounts at each year-end, based on enacted laws and statutory tax rates applicable for the differences that are expected to affect taxable income. In assessing the ability to realize deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. We had net deferred tax assets of $28.0 million and $20.8 million at September 30, 2009 and March 31, 2009, respectively. Valuation allowances are provided when based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. We have recorded income tax expense of $3.9 million and an income tax benefit of $1.1 million, respectively, for the second quarter and first six months of Fiscal 2010 as compared to income tax expense of $3.9 million and $9.0 million, respectively, during the second quarter and first six months of Fiscal 2009. The income tax benefit for first six months of Fiscal 2010 was predominantly due to losses incurred as a result of FDA actions including the seizure of inventory for which a reserve has been created. We have not provided for any valuation allowance as of September 30, 2009 or March 31, 2009. Based upon the level of projected future taxable income over the periods in which these deferred assets are deductible, the Company expects that it is more likely than not that it will realize the benefit of these temporary differences. As of September 30, 2009, we had federal NOLs of approximately $1.9 million, which are restricted by limitations of Internal Revenue Code Section 382, available to reduce future taxable income.  The NOLs will expire between 2010 and 2012.

 
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The Company is subject to U.S. federal income tax as well as income tax in certain state jurisdictions. As previously disclosed, the IRS has initiated an examination of the Company’s tax return for the fiscal year ended March 31, 2007. The examination has been completed and the IRS has notified the Company that no adjustments are required to be made to the tax return filed for the period under review.  The Company’s federal statute of limitations has expired for years prior to 2003.

Inventory

We value inventories at the lower of cost or market. We determine the cost of raw materials, work in process and finished goods using the specific identification cost method. We analyze our inventory levels quarterly and write down inventory that has become obsolete and inventory that has a cost basis in excess of its expected net realizable value. Expired inventory is disposed of and the related costs are written off. Materials acquired solely for R&D are written off in the year of acquisition. Inventory includes material purchased related to products for which the Company has filed ANDAs with the FDA  and the commercial launch of such products will commence once the approvals are received. The determination of whether or not inventory costs will be realizable requires estimates by management. A critical estimate in this determination is the estimate of the future expected inventory requirements, whereby we compare our internal sales forecasts to inventory on hand. Actual results may differ from those estimates and inventory write-offs may be required. We must also make estimates about the amount of manufacturing overhead to allocate to our finished goods and work in process inventories. Although the manufacturing process is generally similar for our products, we must make judgments as to the portion of costs to allocate to purchased product, work in process and finished goods, and such allocations can vary based upon the composition of these components and the fact that each product produced does not necessarily require the same amount of time or effort for the same production step. Accordingly, the assumptions we make can impact the value of reported inventories and cost of sales.

As disclosed above, on June 25, 2009, certain drug products manufactured, work in process, and ingredients held, at the Company's Michigan facilities were seized at the direction of the FDA. The estimated value of such seized inventory as of September 30, 2009 was $24.0 million. The Company has voluntarily entered into a Consent Decree and is in the process of getting the material released. The Company believes that, except for the raw materials which were opened solely for the purpose of sampling, the estimated value of which is $8.1 million, all other seized inventory would be difficult to recondition. A reserve in the balance amount of $15.9 million has been created as of September 30, 2009 which consists of work in process relating to those materials which are in various stages of production within our manufacturing facilities, all finished goods and those raw material ingredients which are partially consumed in process.  The Company believes that it will be able to use the inventory of raw materials which were opened solely for sampling purposes, however, in the event the Company is unable to recondition or recover all of such inventory, the Company will adjust the value of its inventory accordingly in future periods, which would result in a negative impact on the future operating results of the Company.

 
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OVERVIEW

The Company voluntarily entered into a Consent Decree with the FDA on September 29, 2009. As stipulated in the Consent Decree, the Company will attempt to have the seized inventory released. The estimated value of this inventory of drug products manufactured in Caraco's Michigan facilities including ingredients and in-process materials was $24.0 million, as of September 30, 2009. The Company believes that, except for the raw materials which were opened solely for the purpose of sampling, the estimated value of which is $8.1 million, all other such inventory would be difficult to recondition. Accordingly, a reserve in the amount of $15.9 million has been created as of September 30, 2009 for this remaining inventory. As a result of the FDA action, Caraco has voluntarily ceased manufacturing operations and instituted, in two phases, indefinite layoffs of approximately 430 employees. Products sold and distributed by Caraco that are manufactured by third parties and outside of these facilities are not impacted and the Company continues distribution and marketing of these products. The Consent Decree provides a series of measures that, when satisfied, will permit the Company to resume manufacturing and distribution of those products that are manufactured in its Michigan facilities. The Company has engaged a consulting firm which is comprised of cGMP experts, in accordance with the Consent Decree.

As a result of this event, there has been a material adverse effect on our current operations and there may be a material adverse effect on our near term operations. Under terms of the Consent Decree, Caraco's cessation of manufacturing operations will continue until it receives written notification from independent experts and the FDA that it is in compliance with the Consent Decree and regulations and can resume operations. However, there is no assurance that the steps being taken will be successful or result in resolution of the FDA complaint.  We are also not able, at this time, to estimate, the cost of these actions. We anticipate working with the FDA to resolve its concerns as effectively and expeditiously as possible in accordance with the terms of the Consent Decree.  The Consent Decree also requires the Company to abide by certain conditions and restrictions. If the Company violates any portion of the Consent Decree, it could incur penalties, such as monetory fines, forfeiture of the seized goods and other penalties.

During the second quarter ended September 30, 2009 and first six months of our current fiscal year (“Fiscal 2010”) ended September 30, 2009, we generated net sales of $78.4 million and $126.4 million, respectively, compared to $122.2 million and $230.5 million, respectively, during the corresponding periods of Fiscal 2009. We incurred $(1.5) million and $5.6 million, respectively, in research and development (“R&D”) expenses during the second quarter and first six months of Fiscal 2010, as compared to $5.6 million and $11.1 million, respectively, during the corresponding periods of Fiscal 2009. We generated cash from operations in the amount of $20.3 million during the first six months of Fiscal 2010, as compared to using cash from operations in the amount of $8.2 million during the corresponding period of Fiscal 2009. We earned a net pre-tax income of $10.6 million during the second quarter and incurred a net pre-tax loss of $3.9 million during the first six months of Fiscal 2010, as compared to earning net pre-tax income of $12.3 million and $26.9 million, respectively, during the corresponding periods of Fiscal 2009. Net pre-tax income in both periods of the current fiscal year were lower as we have created a reserve in the amount of $7.5 million and $15.9 million, respectively, during the second quarter and first six months of Fiscal 2010 relating to the inventory seized by the FDA, as disclosed above and also due to the cessation of manufacturing at the Company’s Michigan facilities resulting in a loss of revenues from such products, as also disclosed above. Net pre-tax income was also positively affected by non-recurring income earned in the amount of $20.0 million as part of an asset purchase agreement arising out of a settlement agreement entered into by the Company during the current period that is not expected to recur in future periods. The Company recorded an income tax expense of $3.9 million and provided an income tax benefit of $1.1 million for the second quarter and first six months of Fiscal 2010, respectively, as compared to an income tax expense of $3.9 million and $9.0 million, respectively, in the corresponding periods of Fiscal 2009. We earned a net income of $6.7 million during the second quarter and incurred a net loss of $2.8 million for the first six months of Fiscal 2010, as compared to net income of $8.4 million and $17.9 million, respectively, during the corresponding periods of Fiscal 2009.   At September 30, 2009, we had stockholders’ equity of $161.2 million, as compared to stockholders’ equity of $163.8 million at March 31, 2009. (See “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.”).

 
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During Fiscal 2008, the Company commenced construction on the expansion of its primary facility located in Detroit, Michigan. The expansion occurred on the acreage the Company acquired for $0.3 million directly adjacent to its existing manufacturing facility. The expansion was completed during the fourth quarter of Fiscal 2009 and added approximately 140,000 square feet to our manufacturing facility. The expanded facility encompasses additional space required for manufacturing, quality control laboratories, raw material storage and administrative offices. It will also introduce additional automated equipment and process flow efficiencies in order to reduce long term costs associated with our production, while maintaining quality. As disclosed, however, the Company has voluntarily ceased manufacturing as a result of the FDA action. In addition, the Company continued updating its packaging facility located in Farmington Hills, Michigan. During Fiscal 2007, the Company acquired this packaging facility for $1.7 million. We have improved the infrastructure and process flow by replacing manual packaging lines with automated lines, thereby having less human intervention. This has already improved quality control in our packaging operations and will result in improved capacity. This 33,369 square foot facility was previously owned and operated by a third party packager of our portfolio of products. As disclosed, however, the Company has voluntarily ceased manufacturing as a result of the FDA action and accordingly operations in this facility have temporarily been suspended.

FDA COMPLIANCE

During Fiscal 2009, the FDA inspected both the Elijah McCoy manufacturing facility and the Farmington packaging facility. Forms FDA 483 were issued at the conclusion of both inspections detailing the FDA investigators’ observations. Responses to these observations were submitted to the FDA detailing the Company’s actions taken in response to the observations. On October 31, 2008, the Company received a warning letter from the Detroit District of the FDA for its manufacturing facility in Detroit Michigan. In this letter, the Agency reiterated some of the concerns detailed in the previous Form 483 issued as a result of our inspection that concluded in June 2008. These concerns included inadequate and untimely investigations by our quality control unit of certain incidents contrary to the Company’s standard operating procedures. The warning letter also stated that the FDA expressed serious concerns regarding “a) your firm’s compliance history including several past inspections that documented significant CGMP deficiencies, b) the serious nature of the observed violations, c) your plans for expansion under these violative conditions, and d) the risk to consumers associated with the CGMP deviations involving potential product contamination.”  The FDA also raised concerns about our corrective action plans. The FDA added that failure to promptly correct the deficiencies may result in legal action without further notice, including, without limitation, seizure and injunction. It also noted that other federal agencies may take this warning letter into account when considering the award of contracts. Additionally, the FDA may withhold approval of requests for export certificates, or approval of pending new drug applications. We promptly responded to the warning letter on November 24, 2008 for the deficiencies noted and provided our corrective actions. The Detroit District acknowledged our response on December 22, 2008. It noted that our corrective actions would be evaluated during the FDA’s next scheduled inspection of our Detroit facility. On March 11, 2009 the FDA began an inspection as a follow-up to the October 2008 warning letter. This inspection covered all the quality and production systems of the Company and concluded on May 12, 2009. The FDA investigators provided the Company with a list of their observations on FDA Form 483. Some of the observations were relative to the recent recalls and compliance, whereas others were focused on inventory controls. The FDA's inspection found unresolved violations of current Good Manufacturing Practice (cGMP) requirements as previously disclosed in our last SEC filing on Form 10-K filed June 15, 2009. On March 31, 2009, we recalled all tablets of Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009 to the consumer level. As a precautionary measure, in April 2009, we initiated recalls of certain product lots manufactured in our Detroit, Michigan facility, primarily to the retail and wholesale levels. The total sales revenue, related to these recalls, we believe, is approximately $4.2 million. These recalls were voluntarily initiated by the Company with the knowledge of the FDA. The recalls were made as a precautionary measure. The Company provided a written response to these observations on June 19, 2009. On June 25, 2009, U.S. Marshals, at the request of the FDA, seized drug products manufactured in our Michigan facilities. The seizure also included ingredients held at these same facilities as well as work in process. Products distributed by Caraco that are manufactured outside of these facilities are not impacted. In its complaint relating to its seizure, the FDA stated, among other things, that the May 12, 2009 inspection and the Company’s written response thereto revealed continuing significant cGMP violations.  The FDA also stated that the drug products are adulterated in that the methods used in, and the facilities and controls used for, their manufacture, processing, packing, and/or holding do not conform to and are not operated and administered in conformity with cGMP requirements.   As a result of the FDA action, we voluntarily ceased manufacturing operations and instituted an indefinite reduction in our workforce of approximately 430 employees in two phases.  This has resulted and will result in a material adverse effect on our current and near term operations.

 
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On September 29, 2009, Caraco voluntarily entered into a Consent Decree with the FDA regarding the Company's drug manufacturing operations. The Consent Decree provides a series of measures that, when satisfied, will permit Caraco to resume manufacturing and distributing those products that are manufactured in its Michigan facilities. The Company is working expeditiously to satisfy the requirements of the Consent Decree and has already retained independent cGMP experts for review of the Company's operations and to facilitate a successful result.

Under terms of the Consent Decree, Caraco's cessation of manufacturing operations will continue until it receives written notification from independent experts and the FDA that it is in compliance with the Consent Decree and regulations and can resume operations. Nothing in the Consent Decree prohibits Caraco from distributing FDA approved drug products that are manufactured by third parties. There is no assurance that the steps taken will be successful or result in resolution of the FDA complaint. We are also not able, at this time, to estimate the cost of these actions. We intend to continue to work with the FDA to resolve its concerns as effectively and expeditiously as possible.

We have not obtained FDA approvals of our ANDAs since the first quarter of Fiscal 2009. It is unlikely that we will receive any approvals for product out of our Michigan facilities until the FDA reviews our remediation response and makes a determination of our status. We have changed our leadership in both manufacturing and quality control in early 2009, in order to better align these areas with our corporate goals and taken other steps, as stated below, to improve cGMP compliance.

Customer confidence could diminish based on the recent recalls and our status with the FDA. As previously disclosed, certain government contracts have been and could be affected by the warning letter and our current status. In the fourth quarter of Fiscal 2009, due to our status with the FDA, the Veterans Administration has not renewed certain product contracts we had with it that were expiring. Once we have resolved our current issues with the FDA, we may regain this business when these contracts come up for renewal, which occurs on an annual basis.

 
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We have engaged a consulting firm which is comprised of cGMP experts in accordance with the Consent Decree. The new leadership in both our quality and production areas are effecting change as rapidly as possible in order to provide continual improvement.

Second Quarter and First Six Months Fiscal 2010 Compared to Second Quarter and First Six Months Fiscal 2009
Net Sales.  Net sales for the second quarter and first six months of Fiscal 2010, ended September 30, 2009, were $78.4 million and $126.4 million respectively, as compared to $122.2 million and $230.5 million, respectively, for the second quarter and first six months of Fiscal 2009, reflecting a decrease of 36% and 45% in the respective periods. The sales for both of the periods of Fiscal 2009 included high levels of sales of Paragraph IV products which were launched by the Company during the fourth quarter of Fiscal 2008 under the distribution and sale agreement with Sun Pharma. These product sales may or may not be sustainable, as previously disclosed. The sales of distributed products were also lower due to price erosion on the products sold, partially offset by new product launches. Sales of one product (oxcarbazepine), launched under the marketing agreement during the third quarter of Fiscal 2008 were significantly higher during the first six months of Fiscal 2009. This product was launched with 180 days shared exclusivity, which allowed its higher sales during the first quarter of Fiscal 2009. Subsequent to the end of the exclusivity period, which occurred during the first quarter of Fiscal 2009, the net realizations for this product have decreased significantly as several other competitors have entered the market for this generic product. Sales of Caraco-owned products (those products which Caraco owns the ANDAs) during the second quarter were negligible as we have stopped marketing, effective June 25, 2009, all the products which were being manufactured out of our Michigan facilities on account of the FDA actions, as previously discussed. Similarly, the sales of Caraco-owned products for first six months of Fiscal 2010 were lower due to, the FDA’s seizure of certain of our inventory and cessation of manufacturing, as previously disclosed, and in part due to  the negative impact of our voluntary recalls of certain products. We did not distribute any digoxin during the period subsequent to the recall of digoxin that occurred on March 31, 2009. We also had a recall on various products on April 17, 2009, as previously disclosed. The subsequent sales on some of those manufactured products were negatively impacted by the recall.   Net sales for distributed products were $75.9 million and $110.9 million, respectively, for the second quarter and first six months of Fiscal 2010, as compared to $89.9 million and $166.2 million, respectively, for the corresponding periods of Fiscal 2009. Net sales for Caraco-owned products were $2.5 million and $15.6 million, respectively, for the second quarter and first six months of Fiscal 2010, as compared to $32.2 million and $64.3 million, respectively, for the corresponding periods of Fiscal 2009. We were manufacturing and marketing all except two of our approved products. However, as a result of action taken by the FDA, we have ceased manufacturing operations of the products which we manufacture at our facilities located in the state of Michigan. We continue to have manufacturing products sales that are manufactured by third party manufacturers including Sun Pharma.

Overall sales of one product accounted for approximately 77% and 65% of net sales for the second quarter and first six months of Fiscal 2010 as compared to sales of two products which accounted for approximately 61% and 59% of net sales for the corresponding periods of Fiscal 2009.

 
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Gross Profit.  We incurred a gross loss of $4.1 million and $7.7 million, respectively, during the second quarter and first six months of Fiscal 2010, as compared to gross profit of $22.0 million and $45.6 million, respectively, during the corresponding periods of Fiscal 2009. The gross loss in the second quarter and first six months of Fiscal 2010 were, in large part, due to a reserve of $7.5 million and $15.9 million we provided on the inventory seized by the FDA during the respective periods. (See “Inventory” above). The gross profit has also decreased due to negligible sales in the second quarter of Caraco-owned products and lower sales of both distributed as well as Caraco-owned products in the first six months of Fiscal 2010. As disclosed above, due to the actions of the FDA, all shipments of products which were being manufactured at the Company’s Michigan facilities have ceased effective June 25, 2009, which has led to diminished sales of Caraco-owned products.

The gross profit margin for the second quarter and first six months of Fiscal 2010 as a percentage of net sales decreased to (5%) and (6%), respectively, as compared to 18% and 20%, respectively, during the corresponding periods of Fiscal 2009. As disclosed above, we have created a reserve in the amount of $7.5 million and $15.9 million, respectively, during the second quarter and first six months of Fiscal 2010 for the inventory seized by the FDA. Excluding the impact of the inventory reserve, the gross profit margins in the second quarter and first six months of Fiscal 2010 were 4% and 6% respectively, as compared to 18% and 20%, respectively, for the corresponding periods of Fiscal 2009. This decrease was due to the weight of increased sales of distributed products versus the sales of manufactured products, which had an impact on the overall margins. The gross profit margin on distributed products was 9% for both the second quarter and first six months of Fiscal 2010, as compared to 7% and 8% for the corresponding periods of Fiscal 2009. The gross profit margin for Caraco-owned products was (427%) and (113%) for the second quarter and first six months of Fiscal 2010, as compared to 48% and 49% for the corresponding periods of Fiscal 2009. Excluding the impact of the inventory reserves, the gross profit margin in the second quarter and first six months of Fiscal 2010 was (126)% and (10)%, respectively. Caraco-owned product margins have decreased mainly due to impact of overhead absorption, having similar levels of direct overhead in the first quarter and decreased levels in the second quarter, with lower sales for the second quarter and first six months of Fiscal 2010, which contributed 108% and 40%, respectively, to the decreases in gross profit margin. Price erosion on certain products and changes in the sales mix of the Caraco-owned products sold also contributed to the decrease. Also, we had initiated a recall of one product (digoxin) during the fourth quarter of Fiscal 2009. There were no sales of this product during the first six months of Fiscal 2010. The loss of sales of this product also adversely affected the gross profit margins for the referred periods. Further, as disclosed earlier, there were significantly low levels of sales of Caraco-owned products (which included none of the products which were manufactured at the Company’s Michigan facilities). Also during the second quarter of Fiscal 2010, we have written off certain non-seized inventories of approximately $0.4 million, partly relating to one DESI product which is being discontinued as stipulated in the Consent Decree, and partly related to products we purchased along with the brand, which have now become obsolete. We cannot determine the mix of distributed product sales versus Caraco-owned product sales in any given period as it depends on our ability to gain market share on each product and is relative to when the FDA approves any given product in either category of product and the revenue potential of that product once it has been approved.

Selling, General and Administrative Expenses.  Selling, general and administrative (“SG&A”) expenses during the second quarter and first six months of Fiscal 2010 were $6.8 million and $10.5 million, respectively, as compared to $4.2 million and $8.1 million, respectively, during the corresponding periods of Fiscal 2009, representing increases of 60% and 30%, respectively. SG&A expenses, as a percentage of net sales increased to 8% for the first six months of Fiscal 2010, as compared to 3% for the corresponding period of Fiscal 2009. The higher percentage of SG&A is partly due to the lower sales in the current period versus the corresponding period last year. Also during the second quarter of Fiscal 2010, the Company recorded additional expenses related to a) severance paid to its former CEO, b) legal and professional consultation fees related to FDA issues and c) payments made to its customers in lieu of contractual unfulfilled product supply obligations.

 
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Research and Development Expenses.  Total R&D expenses incurred for the second quarter and first six months of Fiscal 2010 were $(1.5) million and $5.6 million respectively, as compared to $5.6 million and $11.1 million, respectively, during the corresponding periods of Fiscal 2009. The R&D expenses during the second quarter of Fiscal 2010 were primarily lower compared to those during the corresponding period of Fiscal 2009 as we were reimbursed a certain amount relating to certain product litigation costs, as part of a settlement agreement, as previously disclosed. Also, the R&D costs were lower due to non-incurrence of any major expenses in the second quarter relating to bio-equivalency studies and material costs for development.

Non-Recurring Income. We earned a one-time non-recurring income in the amount of $20.0 million during the second quarter and first six months of Fiscal 2010 arising out of a product litigation settlement and an asset purchase agreement, as previously disclosed.

Net Other Income (Expense). We earned net other income of $33 thousand during the second quarter and incurred net other expense of $0.1 million during the first six months of Fiscal 2010, as compared to earnings of net other income of $0.1 million and $0.4 million, respectively, during the corresponding periods of Fiscal 2009. The lower net other income/expense was primarily due to interest expense incurred in relation to the Company’s term loan with Charter One Bank and a loss on removal of certain assets during the first quarter of Fiscal 2010.

Income Taxes.  We recorded income tax expense of $3.9 million during the second quarter and provided an income tax benefit of $1.1 million during the first six months  of Fiscal 2010, respectively, compared to income tax expense of $3.9 million and $9.0 million, respectively, during the corresponding periods of Fiscal 2009.  The benefit in the current six-month period is due to the losses incurred. (See discussion under “Income Taxes” above).

Results of Operations.  We earned pre-tax income of $10.6 million during the second quarter of Fiscal 2010 and incurred a net pre-tax loss of $3.9 million during the first six months of Fiscal 2010, as compared to a net pre-tax income of $12.3 million and $26.9 million, respectively, during the corresponding periods of Fiscal 2009. We earned  net income of $6.7 million for the second quarter and incurred a net loss of $2.8 million for the first six months of Fiscal 2010, as compared to net income of $8.4 million and $17.9 million, respectively, during the corresponding periods of Fiscal 2009.

 
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Liquidity and Capital Resources We generated cash from operations in the amount of $20.3 million during the first six months of Fiscal 2010, as compared to using cash in operations in the amount of $8.2 million during the corresponding period of Fiscal 2009. The cash flow from operations was lower in the first six months of Fiscal 2009 primarily due to a decrease in accounts payable balances offset, in part, by decreases in accounts receivable and inventory balances. Accounts receivable increased by $33.8 million to $49.0 million as of September 30, 2009, as compared to $15.2 million at the end of Fiscal 2009. Accounts receivable is 59 days sales outstanding (“DSO”) as of September 30, 2009 versus 27 days as of March 31, 2009. The lower level in DSO at March 31, 2009 was temporary and is mainly due to the timing of payments made by the wholesale customers. However, a deduction for chargebacks will be made by these wholesale customers as they continue to sell to retail chain stores and managed care organizations with whom we have contractual pricing. The Company believes that it has provided adequate reserves for chargeback deductions which are likely to be taken by the wholesale customers in subsequent periods. Certain wholesale customers purchased quantities of a certain product based on their own forecast, to ensure an in-stock position for such product, as there were uncertainties related to the future availability of such product and continued shipments from the Company. Inventory levels are equivalent to 167 days sales on hand, as compared to 140 days on hand as of March 31, 2009. Excluding the reserve created for inventory seized by FDA, inventory levels were equivalent to 198 days sales on hand. The inventory as of September 30, 2009 includes higher levels of inventory of Paragraph IV products to support anticipated sales in the near term period. At March 31, 2009 we had negligible stock of such product on hand. If the sale of the Paragraph IV products are not allowed by any regulatory authority and Sun Pharma does not file a timely appeal, we would have various rights to return the product to Sun Pharma. The accounts payable balance relating to Sun Pharma has also increased from $43.9 million at March 31, 2009 to $115.0 million at September 30, 2009 in line with increased levels of  inventory relating to distributed products and accounts receivable balances.

As disclosed above the FDA has initiated certain actions and, as a consequence, production at the Company’s Michigan facilities has voluntarily been ceased. This will adversely affect the overall profitability of the Company in the near term. The Company has initiated a reduction in various expenses in an effort to bring its expenses in line with its current levels of sales.  Such reduction is expected to continue until FDA concerns are resolved and the Company resumes its manufacturing activities, of which there is no assurance. The sales of distributed products and certain manufactured products made by third parties will continue and will contribute to the ongoing cash flows. Also, the Company has recently entered into an agreement with Forest, which, is expected to provide certain additional products to the Company’s product portfolio, and such products will generate incremental revenues under Caraco-owned product sales. The Company owns four products that are manufactured by other third party manufacturers including Sun Pharma and its affiliates.  As of September 30, 2009, we have $73 million in cash and another $10 million in short-term investments, including the proceeds from a loan in the amount of $17.2 million, currently classified as a short term liability. The Company believes that its cash flow from operations and cash balances will continue to support its ongoing business requirements, however, because of, among other things, decreased customer confidence, the uncertainty of future costs of FDA compliance and associated costs, there can be no assurance.

At September 30, 2009, we had working capital of $93.4 million, compared to working capital of $112.5 million at March 31, 2009.

During the fourth quarter of Fiscal 2009 the Company entered into a term loan of $18 million with Charter One Bank. The loan is secured by a mortgage covering the Company’s manufacturing facility and equipment located in Detroit, Michigan. The rate of interest is calculated as LIBOR plus an applicable margin thereto (based upon various leverage levels and current applicable rate is 50 basis points). The aggregate rate applicable to the Company as of September 30, 2009 was 1.5%. The principal loan payments and accrued interest are payable on a quarterly basis beginning July 2009. The principal is to be repaid in equal quarterly installments of $900,000 for ten quarters through October 2011, and thereafter, if not renewed, the remaining balance of $9 million is due in the subsequent quarter by January 2012. Subsequently, the terms of the loan were modified and we entered into an amended agreement. The amended agreement amended the loan to add to the equipment term loan for the purposes of financing new machinery and equipment and building improvements, a one year line of credit note for $15 million against which the Company can borrow funds for working capital purposes or can get letters of credit issued. The line of credit carries an interest rate of LIBOR plus 150 basis points, and if letters of credit are issued, the associated fees are 0.7% of such letters of credit on annualized basis. Also, there is an unused fee of 0.25% on an annualized basis to the extent the line remains idle. Both the line of credit and outstanding term loan are cross collaterized by all of the Company’s fixed assets and cash deposit accounts held with Charter One Bank in the same amount. These cash deposits earn interest at prevailing rates applicable to such money market  acoounts. Against this line of credit, the Bank has issued an Irrevocable Standby Letter of Credit in an amount of $15 million, in favor of the United States of America, as required to be placed with the FDA in accordance with the Consent Decree, as disclosed above. We are continuing discussions with Charter One Bank to resolve its concerns and get the cash collateral released. Charter One Bank has temporarily suspended our required compliance with the covenants in the loan agreements relating to FDA enforcement actions as previously disclosed, and has suspended testing of certain other compliance requirements until February 26, 2010. On or before such date, we anticipate either entering into revised agreements or repaying the loan in full. Currently, as the loan is in technical default due to the FDA enforcement action, the entire outstanding balance has been classified as a short-term liability.

 
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As required pursuant to the terms of the Loan Agreement, the Company has entered into an Interest Rate Swap Agreement with Charter One Bank to hedge the interest rate applicable on the loan. The notional amount for the swap is $17.1 million which will continue to amortize down as principal payments are made on the related debt. The annualized fixed rate of interest as it applies to this agreement is 2.41%. Thus as of September 30, 2009 the effective rate of interest to the Company for the term loan was 2.91% (2.41% swap rate plus applicable margin of 50 basis points). The fair value of this swap agreement at September 30, 2009 was not material.

Future Outlook

We intend to continue to work with the FDA to effectively and expeditiously resolve remaining concerns, although there can be no assurance that we will succeed in reaching such a resolution or the terms thereof.  We continue to focus on improving support and emphasis on quality assurance, quality control, and manufacturing areas in order to continually improve the performance of our quality system. We have hired external consultants who have experience in assisting manufacturers with FDA compliance issues.  These consultants will review all of our systems, procedures, reporting structures, and processes, as well as review training on risk management and overall cGMP.  As part of this comprehensive process we will evaluate our internal and external audit programs, and will make any improvements that we believe to be necessary to improve these programs.  All audits are based on a historical look back, and offer improvements based on Caraco’s likely future requirements. These audits will also include follow up action on compliance issues that need to be addressed. Caraco would obtain assistance and guidance wherever required from the quality group of Sun Pharma to improve its quality systems. Though near term sales of Caraco-owned products face challenges, we believe we are effecting, and intend to effect, the changes required to improve our performance on sales of these products, on a long-term basis. We voluntarily entered into a Consent Decree with the FDA regarding the Company's drug manufacturing operations. The Consent Decree provides a series of measures that, when satisfied, will permit Caraco to resume manufacturing and distributing those products that are manufactured in its Michigan facilities. We are working expeditiously to satisfy the requirements of the Consent Decree and has already retained independent cGMP experts for review of the Company's operations and to facilitate a successful result.

 
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Under terms of the Consent Decree, Caraco's cessation of manufacturing operations will continue until it receives written notification from independent experts and the FDA that it is in compliance with the Consent Decree and regulations and can resume operations. Nothing in the Consent Decree prohibits Caraco from distributing FDA approved drug products that are manufactured by third parties. There is no assurance that the steps taken will be successful or result in resolution of the FDA complaint. We intend to continue to work with the FDA to resolve its concerns as effectively and expeditiously as possible.

We believe that we will emerge a stronger company on a long-term basis. In the last two years we have added considerable amount of infrastructure in our quality control laboratories. Our current focus remains on manufacturing and quality assurance. In near term we will utilize part of our R&D team to help with technical validations and compliance initiatives. Our R&D expense will decline as a result. We anticipate gaining back our momentum on filings of new ANDAs internally once our compliance initiatives and technical needs are satisfied. Any third party development in process will continue. Our production capacity is primarily built, which should support the business for years to come once we can overcome our current obstacles.

Currently, we have 31 ANDAs pending approval at the FDA (including four tentative approvals) relating to 27 products. We continue to expand and upgrade our facilities, and expand our customer base. Our internal efforts, combined with Sun Pharma in developing new products have also picked up momentum. We now have 10 products, that we market (including Caraco-owned products being manufactured by third parties and those distributed under various agreements with of Sun Pharma), whose market share is ranked third or higher against the same products of our generic competitors. We are focused on products that are currently in our portfolio and are yet to realize their full market potential. The total portfolio consists of 33 products.

Although gross profit margins have come down due to mix of distributed products weight over Caraco-owned products, and also due to negligible sales of Caraco-owned products, we believe we can be successful in marketing distributed products and our products that are manufactured by third parties. We have had nine new distributed products launched during the first six months of Fiscal 2010 that Sun Pharma or its affiliates received approvals for from the FDA. We also may transfer certain manufactured products to an alternate manufacturing site that would allow the Company to quickly regain gain revenues from those products. Should the pricing pressures become more severe than anticipated; the result may be lower growth rates and gross margins. Management has worked, and will continue to work, diligently to counter the pricing pressures through increased sales volumes, improved market share on existing products, expansion of our customer base, improved productivity, and increased cost reductions.

The Company intends to decrease its internal development of new products. It will continue to develop products with third parties, including Alkaloida, an indirect subsidiary of Sun Pharma (see “6. Sun Pharmaceutical Industries Limited”) Our R&D expense should decline based on this provided that patent related expenses remain stable or decline.  We believe that we will continue to have the cash and other means available to meet our working capital requirements, fund potential litigation expenses relating to Paragraph IV certification and finance further capital investments. The third party product development is a critical element in meeting expectations in the future.

 
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We believe that Sun Pharma is a partner with a proven track record, and one that already has provided the Company with quality products. Moreover, Sun Pharma’s increased beneficial ownership in the Company to approximately 75% (approximately 76% including the convertible Series B Preferred Stock), should, we believe, provide it with the vested interest to continue to help the Company succeed. Sun Pharma has previously provided the Company with capital, loans, guarantees of loans, personnel, raw materials and equipment, clinical research services which have significantly helped the Company to date. In addition to the Sun Pharma products agreement, we have implemented additional development strategies with various third parties, both domestically and abroad, that will complement the Sun Pharma’s development pipeline and our own.

The FDA’s action and the Company’s voluntary actions have had, and are expected to continue to have, a material adverse effect on operations and operating results.  At September 30, 2009, the Company had $73 million in cash and $10 million in short-term investments including the proceeds from a loan in the amount of $17.2 million. The Company believes that its cash flow from operations and cash balances will continue to support its ongoing business requirements, however, because, among other things, of the uncertainty of future costs of FDA compliance and associated costs, there can be no assurance.

During Fiscal 2007, we entered into three definitive agreements with different companies to develop four additional ANDAs for Caraco and provide additional opportunities for the future development of products. These agreements contain, for three products, both milestone payments to be paid in cash and profit sharing based upon future sales for a defined period, and for one product only milestone payments in cash without any obligation to share profits in the future. During Fiscal 2008, we have signed two definitive agreements for two additional products. However we have terminated an agreement earlier entered into with one company for two of these products. During Fiscal 2009, we entered into one agreement for one additional product, and subsequent to end of Fiscal 2009, we entered into one more agreement relating to one additional product. This brings the total number of products being developed by unaffiliated third party developers to six.

We anticipate additional development agreements will be entered into in order to eliminate gaps in our calendar of approvals from the FDA. As previously mentioned, in Fiscal 2007 we entered into a definitive agreement to market Sun Pharma ANDAs that are either approved or awaiting approval at the FDA. Accordingly, we continue to market a number of these products which are categorized as distributed products. In addition, on January 29, 2008, the Company executed a distribution and sale agreement with Sun Pharma. This agreement covers certain mutually agreed upon products that have been filed or will be filed with the FDA with a Paragraph IV certification. A Paragraph IV certification states that the filer believes that it either does not infringe the patent or believes that the patent is invalid. Paragraph IV certified products face litigation challenges with respect to claims of patent infringement. Sun Pharma is not obligated to offer Caraco products under this agreement, however, Caraco has the exclusive right to market in the U.S., its territories and possessions, including Puerto Rico, any products offered by Sun Pharma and accepted by Caraco. Under the agreement, the Company participates in the sales opportunity on the products, and also shares the litigation risks to a limited extent based on percentage. If such claims are successful, however, they could have a material adverse effect on the Company. We have been marketing two products under this agreement including Pantoprazole sodium DR tablets. These agreements should provide for an alternate stream of products that will complement our internal research and development and our outsourced development. From time to time significant product launches such as we incurred under the distribution and sale agreement for Paragraph IV products in Fiscal 2008 may occur that will add near term growth that may or may not be sustainable in future periods. Additionally we will continue to work with Sun Pharma in an effort to transfer future product technology on a cash basis similar to other third party developers and in the future we may provide services to Sun Pharma, its affiliates and other third party pharmaceutical manufacturers relating to distribution of certain products, on a fee for service basis in effort to expand our product offerings and remain competitive. In this connection, see “6. Sun Pharmaceutical Industries Limited” relating to our products agreement with Alkaloida, an indirect subsidiary of Sun Pharma. It is our belief that our infrastructure and relationships we have with our customers, can be utilized to optimize sales for our own products, as well as of other companies that are entering or are planning to enter the U.S. market but do not have the infrastructure required to compete effectively.

 
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The various agreements referenced above will provide four diverse paths of development, an increased product pipeline and potential revenue. These various paths mitigate the risk of each other, potentially allowing for an ongoing stream of approvals from the FDA.

Management’s goals for Fiscal 2010 include:

 
·
Compliance with Consent Decree.

 
·
Resumption of manufacturing activities in conformance with FDA guidelines and the Consent Decree.

 
·
Continue research and development activities for ANDA filings.

 
·
Continue to invest in equipment, systems and facilities to meet requirements of projected short and long-term projects for compliance and quality.

 
·
Increase cGMP training to accommodate staff and compliance.

 
·
Increase market share for certain existing products and recently introduced products.

 
·
Enhanced customer reach and satisfaction.

 
·
Leverage distribution and marketing core competencies by marketing third party products through in-licensing agreements.

 
·
Prompt introduction of new approved products to the market.

 
·
Achieving further operational efficiencies by attaining economies of scale and cost reduction per unit.

 
·
Increase revenue and cash by marketing ANDAs owned by Sun Pharma.

 
·
Expand our relationships with financial institutions to fortify our credit position and borrowings as necessary.

 
·
Research alternate product development sources and product licenses such as in licensing authorized generics from brand innovator companies and acquisitions of ANDAs from competitor manufacturers both domestically and abroad.

 
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·
Research possible development of brands for existing stream of products where such potential exists.

 
·
Increase focus on succession planning.

 
·
Increase management training and development.

 
·
Maintain balance in trade class.

Forward Looking Statements

This report, other than the historical financial and business information, may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Without limitation, the words “believes,” “plans,” “expects,” and similar expressions are intended to identify forward-looking statements. Those statements include statements regarding our intent, belief, and current expectation. These statements are not guarantees of future performance and are subject to risks and uncertainties that cannot be predicted or quantified. Consequently, actual results could differ materially from those expressed or implied by such forward-looking statements.

Such risks and uncertainties include, but are not limited to: (i) that the information is of a preliminary nature and may be subject to further adjustment; (ii) not obtaining FDA approval for new products or delays in receiving FDA approvals; (iii) governmental restrictions on the sale of certain products; (iv) dependence on key personnel; (v) development by competitors of new or superior products or cheaper products or new technology for the production of products or the entry into the market of new competitors; (vi) market and customer acceptance and demand for new pharmaceutical products; (vii) availability of raw materials in a timely manner, at competitive prices, and in required quantities; (viii) timing and success of product development and launch; (ix) integrity and reliability of the Company’s data; (x) lack of success in attaining full compliance with regard to regulatory and cGMP compliance; (xi) experiencing difficulty in managing our recent rapid growth and anticipated future growth; (xii) dependence on limited customer base; (xiii) occasional credits to certain customers reflecting price reductions on products previously sold to them and still available as shelf-stock; (xiv) possibility of an incorrect estimate of charge-backs and the impact of such an incorrect estimate on net sales, gross profit and net income; (xv) dependence on few products generating majority of sales; (xvi) product liability claims for which the Company may be inadequately insured; (xvii) subjectivity in judgment of management in applying certain significant accounting policies derived based on historical experience, terms of contracts, our observations of trends of industry, information received from our customers and other sources, to estimate revenues, accounts receivable allowances including chargebacks, rebates, income taxes, values of assets and inventories; (xviii) litigation involving claims of patent infringement; (xix) litigation involving claims for royalties and/or options relating to a prior contract for one product and (xx) material litigation from product recalls, (xxi) the purported class action lawsuits alleging federal securities laws violations, (xxii) delays in returning the Company’s products to market, including loss of market share, (xxiii) increased reserves against the FDA-seized inventory, and (xxiv) other risks identified in this report and identified from time to time in our reports and registration statements filed with the Securities and Exchange Commission (see Item 1A hereof and our Annual Report on Form 10-K for the year ended March 31, 2009, Part I, Item 1A, for more detailed discussion of such risks). These forward-looking statements represent our judgment as of the date of this report. We disclaim, however, any intent or obligation to update our forward-looking statements.

 
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ITEM 3.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Refer to “Item 7A. Quantitative and Qualitative Disclosures About Market Risk” in our Annual Report on Form 10-K for the year ended March 31, 2009 and “11. Debt” above for a discussion of our market risk.

ITEM 4.
CONTROLS AND PROCEDURES

a. The term “disclosure controls and procedures” is defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934 (the “Exchange Act”). These rules refer to the controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files under the Exchange Act is recorded, processed, summarized and reported within required time periods. Our Chief Executive Officer and our interim Chief Financial Officer have evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report (the “Evaluation Date”), and have concluded that, as of the Evaluation Date, our disclosure controls and procedures are effective in providing them with material information relating to the Company known to others within the Company which is required to be included in our periodic reports filed under the Exchange Act.

b. There has been no change in the Company’s internal control over financial reporting that occurred during the second quarter of Fiscal 2010 that materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

PART II -- OTHER INFORMATION

ITEM 1.
LEGAL PROCEEDINGS

The information presented in Note 12 of Part I, Notes to Financial Statements, is incorporated herein by reference.

ITEM 1A.
RISK FACTORS

In addition to the risks set forth in our Form 10-K for the year ended March 31, 2009, the following are additional risks to our business:

The seizure by the FDA of drug products manufactured in our Michigan facilities and other ingredients, and our voluntary cessation of manufacturing operations, have had a material adverse effect on our current operations and are expected to have a material adverse effect on our near term operations.

 
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As a result of the FDA action, we have voluntarily ceased manufacturing operations and instituted an indefinite reduction in our workforce of approximately 430 employees in two phases. The Company voluntarily entered into a Consent Decree with the FDA on September 29, 2009. As stipulated in the Consent Decree, the Company will attempt to have the seized inventory released. The Company believes that, except for the raw materials which were opened solely for the purpose of sampling, the estimated value of which is $8.1 million, all other seized inventory would be difficult to recondition. Accordingly, a reserve in the amount of $15.9 million has been created as of September 30, 2009 for this remaining inventory. As a result of the FDA action, we have voluntarily ceased manufacturing operations and instituted, in two phases, indefinite layoffs of approximately 430 of our employees.  The Consent Decree provides a series of measures that, when satisfied, will permit the Company to resume manufacturing and distributing those products which are manufactured in its Michigan facilities. The Company has engaged a consulting firm which is comprised of cGMP experts, in accordance with the Consent Decree.

As a result of this event, there has been a material adverse effect on our current operations and there may be a material adverse effect on our near term operations. Under terms of the Consent Decree, Caraco's cessation of manufacturing operations will continue until it receives written notification from independent experts and the FDA that it is in compliance with the Consent Decree and regulations and can resume operations. However, there is no assurance that the steps being taken will be successful or result in resolution of the FDA complaint.  We are also not able, at this time, to estimate, the cost of these actions. We anticipate working with the FDA to resolve its concerns as effectively and expeditiously as possible in accordance with the terms of the Consent Decree.  The Consent Decree also requires the Company to abide by certain conditions and restrictions. If the Company violates any portion of the Consent Decree, it could incur penalties, such as monetary fines, forfeiture of the seized goods and other penalties.

Class action lawsuits have been filed against the Company and certain of its executive officers.

The purported class action litigation (See “12. Litigation” above) alleging violations of federal securities laws by the Company and certain of its executives involves claims which, if successful, could adversely affect our financial condition, operating results or cash flows and the market value of our common stock.

ITEM 2.
UNREGISTERED SALES OF EQUITY SECURITES AND USE OF PROCEEDS

During the first six months of Fiscal 2010, 1,632,000 shares of Series B Preferred Stock previously issued to Sun Global were converted into 1,632,000 shares of Caraco common stock and issued to Sun Global.

All shares of Caraco common stock issued by the Company as set forth above were issued pursuant to exemptions from registration under Section 4(2) of the Securities Act of 1933.

 
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ITEM 4.
SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

The Annual Meeting of Shareholders of the Corporation was held on September 14, 2009 in Dearborn, Michigan for the purpose of electing three directors for a three-year term expiring in 2012 and upon the election and qualification of their successors.

Director Name
 
Votes For
   
Votes Withheld
 
             
Dilip S. Shanghvi
    31,160,511       1,881,535  
                 
Gurpartap Singh Sachdeva
    31,576,242       1,465,804  

The names of the other directors and their remaining terms are as follows:

Director Name
 
Term
     
Jitendra N. Doshi
 
2011
     
Sailesh T. Desai
 
2011
     
Timothy S. Manney
 
2010
     
Madhava Reddy
 
2010
     
Sudhir V. Valia
 
2010
     
F. Folsom Bell
 
2012

The Board of Directors appointed F. Folsom Bell to fill the vacancy created by John D. Crissman’s decision to not stand for re-election, for a term commencing immediately following the 2009 annual meeting of shareholders and ending immediately following the 2012 annual meeting of shareholders.  Mr. Bell, however, resigned as a Director effective immediately prior to the Special Meeting of Shareholders held on October 26, 2009, and was elected by the shareholders at such Special Meeting as a Director to fill the vacancy created by his resignation and to serve for the remainder of the term ending immediately following the 2012 annual meeting of shareholders.  As disclosed in the proxy statement relating to the Special Meeting, on August 27, 2009, the Company received a shareholder demand letter demanding that the Company take action against certain officers and directors of the Company to recover certain damages caused by their alleged breach of fiduciary duties relating to the Company’s violation of cGMP requirements.  The demand letter further provided that if the Board did not commence such an action, the shareholder making the demand would commence a shareholder derivative proceeding on behalf of the Company seeking appropriate relief.  As disclosed in such proxy statement, the election of Mr. Bell by shareholders was necessary in order for him to be an ‘independent director’ under Michigan law who could determine in good faith after conducting a reasonable investigation upon which his conclusions are based as to whether or not the maintenance of the derivative proceeding is in the best interests of the Company.  Following his election by shareholders, the Board has authorized Mr. Bell, as a disinterested independent director, to conduct an investigation and make such a determination with respect to the allegations set forth in the demand letter.

 
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ITEM 6. 
EXHIBITS
 
Asset Purchase Agreement by and between Forest Laboratories, Inc. and Caraco Pharmaceutical Laboratories, Ltd., dated July 10, 2009, and as amended on September 8, 2009, September 11, 2009 and September 22, 2009.
   
Registrant’s Articles of Incorporation as of October 26, 2009.
   
Registrant’s By-laws as of October 26, 2009.
   
Settlement Agreement by and between Forest Laboratories, Inc., H. Lundbeck A/S, Caraco Pharmaceutical Laboratories, Ltd. and Sun Pharmaceutical Industries Ltd., dated July 10, 2009.
   
Separation Agreement and Release of All Claims between Daniel Movens and Caraco Pharmaceutical Laboratories, Ltd., dated July 28, 2009.
   
Employment Agreement of Jitendra N. Doshi, dated as of August 31, 2009.
 
 
Agreement with Alkaloida Chemical Company ZRT dated July 10, 2009.
   
Indemnification Agreement with F. Folsom Bell dated September 14, 2009.
   
Form of Grant of Independent Director’s Stock Options.
   
Form of Grant of Employee Stock Option.
   
First Amendment to Loan Agreement with RBS Citizens, N.A. dated as of August 11, 2009.
   
Second Amendment to Loan Agreement with RBS Citizens, N.A. dated as of October 9, 2009.
   
Certification of Chief Executive Officer
   
Certification of interim Chief Financial Officer.
   
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
 

* Confidential treatment has been requested for portions of this exhibit.

 
43

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 
CARACO PHARMACEUTICAL
 
LABORATORIES, LTD.
   
Date:  November 9, 2009
By:
/s/ Jitendra N. Doshi
 
 
Jitendra N. Doshi
 
Chief Executive Officer
   
Date:  November 9, 2009
By:
/s/ Mukul Rathi
 
 
Mukul Rathi
 
Interim Chief Financial Officer
 
 
44

EX-2.01 2 ex2_01.htm EXHIBIT 2.01 ex2_01.htm

EXHIBIT 2.01

EXECUTION COPY

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
 

   
   
ASSET PURCHASE AGREEMENT

by and between

FOREST LABORATORIES, INC.

and

CARACO PHARMACEUTICAL LABORATORIES, LTD.

Dated July 10, 2009
 
 
 


 
 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
TABLE OF CONTENTS

     
Page
       
LIST OF EXHIBITS AND SCHEDULES
i
       
1.
DEFINITIONS
1
       
 
1.01.
Definitions.
1
 
1.02.
Other Definitional and Interpretative Provisions
12
       
2.
PURCHASE AND SALE
12
       
 
2.01.
Purchased Assets
12
 
2.02.
Customer Agreements
13
 
2.03.
Retained Assets
14
 
2.04.
Retained Liabilities
14
 
2.05.
Assumed Liabilities
15
 
2.06.
Closing Date Inventory
15
 
2.07.
Closing
16
 
2.08.
Post-Closing Adjustments
18
 
2.09.
Post-Closing Royalty Payments
18
       
3.
REPRESENTATIONS AND WARRANTIES OF FOREST
20
       
 
3.01.
Corporate Existence and Power
20
 
3.02.
Corporate Authorization
20
 
3.03.
Governmental Authorization
21
 
3.04.
Noncontravention; Licenses and Permits
21
 
3.05.
Required Consents
21
 
3.06.
Title to Purchased Assets; Encumbrances
21
 
3.07.
Claims; Litigation
22
 
3.08.
Product Intellectual Property
22
 
3.09.
Contracts.
23
 
3.10.
Specifications.
24
 
3.11.
FDA Matters
24
 
3.12.
Taxes
25
 
3.13.
Product Records
26
 
3.14.
Closing Date Inventory
26
 
3.15.
Finders Fees
26
 
3.16.
Completeness of Certain Schedules
26
 
3.17.
Financial Data
26
 
3.18.
Customers and Suppliers
26

 
i

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
 
3.19.
Full Disclosure
27
       
4.
REPRESENTATIONS AND WARRANTIES OF CARACO
27
       
 
4.01.
Corporate Existence and Power
27
 
4.02.
Corporate Authorization
27
 
4.03.
Governmental Authorization
27
 
4.04.
Noncontravention; Licenses and Permits
28
 
4.05.
Claims; Litigation
28
 
4.06.
Financing
28
 
4.07.
Finders Fees
28
 
4.08.
HSR Act
28
       
5.
COVENANTS OF FOREST
28
       
 
5.01.
Third Party Notices and Consents; Biovail Consent.
28
 
5.02.
Stability Programs
28
 
5.03.
Manufacturing Transition Services
29
 
5.04.
Supply of Product
29
 
5.05.
Notices of Certain Events
31
 
5.06.
Conduct of the Business
31
       
6.
COVENANTS OF CARACO
32
       
 
6.01.
Access; Royalty Verification; Forest Confidentiality
32
 
6.02.
Notices of Certain Events
33
 
6.03.
Product Manufacture
33
 
6.04.
Commercialization Diligence
33
 
6.05.
Exclusivity.
34
 
6.06.
Transfers and Assignments of Purchased Assets.
35
       
7.
COVENANTS OF FOREST AND CARACO; OTHER AGREEMENTS
35
       
 
7.01.
Confidentiality.
35
 
7.02.
Further Assurances
36
 
7.03.
Chargebacks and Credits
36
 
7.04.
Closing Date Inventory Receivables
37
 
7.05.
Medicaid Rebates for Products
37
 
7.06.
Federal Government Pricing Programs
38
 
7.07.
Recalls; Complaints
38
 
7.08.
Product Returns
39
 
7.09.
Cooperation with Respect to Chargebacks, Rebates & Returns; Working Group
39
 
7.10.
Safety Data
39
 
7.11.
Regulatory Matters
39
 
7.12.
Reporting Information
41
 
7.13.
Certain Filings
41
 
7.14.
Public Announcements
41

 
ii

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
 
7.15.
WARN Act
42
       
8.
CONDITIONS TO CLOSING
42
     
 
8.01.
Conditions to Obligations of Caraco and Forest.
42
 
8.02.
Conditions to Obligation of Caraco
43
 
8.03.
Conditions to Obligation of Forest.
43
       
9.
SURVIVAL; INDEMNIFICATION
43
       
 
9.01.
Survival.
43
 
9.02.
Indemnification
44
 
9.03.
Indemnification Procedures
45
 
9.04.
Assignment of Claims
46
       
10.
TERMINATION
46
       
 
10.01.
Grounds for Termination
46
 
10.02.
Effect of Termination
47
       
11.
MISCELLANEOUS
47
       
 
11.01.
Notices
47
 
11.02.
Amendments and Waivers.
48
 
11.03.
Expenses.
49
 
11.04.
Transfer Taxes
49
 
11.05.
Successors and Assigns; Assignment
49
 
11.06.
Relationship Between the Parties
49
 
11.07.
Governing Law
49
 
11.08.
Dispute Resolution; Arbitration
50
 
11.09.
Specific Performance
51
 
11.10.
LIMITATION OF LIABILITY
51
 
11.11.
WAIVER OF JURY TRIAL
51
 
11.12.
Counterparts; Effectiveness; Third Party Beneficiaries
52
 
11.13.
Representation by Legal Counsel
52
 
11.14.
Entire Agreement
52
 
11.15.
Severability
52
 
11.16.
Disclosure Schedules
53

 
iii

 
 
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 
LIST OF EXHIBITS AND SCHEDULES
 
Exhibit A
 
Closing Date Inventory Cost of Goods
Exhibit B
 
Form of Assignment and Assumption Agreement
Exhibit C
 
Biovail Consent
Exhibit D
 
Form of Bill of Sale
Schedule 1.01(gg)
 
Customer Agreements
Schedule 1.01(aaa)
 
Manufacture and Supply Agreements
Schedule 1.01(ooo)
 
Product Rights Agreements
Schedule 1.01(lll)
 
Products
Schedule 1.01(gggg)
 
Trade Channel Inventory
Schedule 1.01(hhhh)
 
Trademarks
Schedule 2.01(h)
 
NDAs and ANDAs
Schedule 3.03
 
Governmental Authorizations – Forest
Schedule 3.05
 
Required Consents
Schedule 3.07
 
Claims; Litigation
Schedule 3.08(a)
 
Product Intellectual Property – General
Schedule 3.08(c)
 
Product Intellectual Property – Assigned / Licensed
Schedule 3.09
 
Contracts
Schedule 3.11(a)
 
Registrations
Schedule 3.17
 
Financial Data
Schedule 3.18
 
Customers and Suppliers
Schedule 4.03
 
Governmental Authorizations – Caraco
Schedule 5.04(a)
 
Initial Cost of Goods under Supply Agreement
Schedule 5.04(b)
 
Sales and Net Profit Projections

 
 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
ASSET PURCHASE AGREEMENT

ASSET PURCHASE AGREEMENT (“Agreement”) dated this 10th day of July, 2009 by and between FOREST LABORATORIES, INC., a Delaware corporation having its principal offices at 909 Third Avenue, New York, NY 10022 (on behalf of itself and its Affiliates which have an interest in the Purchased Assets, “Forest”) and CARACO PHARMACEUTICAL LABORATORIES, LTD, a Michigan corporation having its principal offices at 1150 Elijah McCoy Drive, Detroit, MI 48202 (“Caraco”).  Each of Forest and Caraco shall individually be referred to as a “Party” and collectively as the “Parties”.

W I T N E S S E T H:

A.            Pursuant to a Settlement Agreement (the “Settlement Agreement”) of even date herewith by and among Forest, Forest Laboratories Holdings Limited, H. Lundbeck A/S (“Lundbeck”), Sun Pharmaceutical Industries Ltd. (“Sun”) and Caraco, the parties thereto settled certain patent infringement litigation therein described which related to Caraco’s filing of Abbreviated New Drug Application No. 78-219 with the FDA seeking approval of a generic version of a branded product which Forest commercializes under license from Lundbeck.

B.             In accordance with the Settlement Agreement, Forest has agreed to sell certain assets relating to its “Inwood” line of generic products, including the Products (as defined herein) and related assets, and Caraco has agreed to purchase such assets from Forest, all in accordance with, and subject to, the terms and conditions hereinafter set forth.

NOW, THEREFORE, in consideration of the foregoing and of the terms and conditions hereinafter set forth, and good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows:

1.             DEFINITIONS

1.01.        Definitions.  As used herein, the following terms have the following meanings:

(a)           the “Act” shall mean the Federal Food, Drug and Cosmetic Act, as amended.

(b)           “Advance Royalty Amount” shall have the meaning set forth in Section 2.07(a)(i).

(c)           “Affiliate” shall mean any Person controlling, controlled by or under common control with the Party with respect to which such status is at issue and shall include, without limitation, any corporation 50% or more of the voting power of which (or other comparable ownership interest for an entity other than a corporation) is owned, directly or indirectly, by a Party hereto or any Person that owns 50% or more of such voting power of a Party hereto.
 
 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(d)           “Agreement” shall have the meaning set forth in the Preamble.

(e)           “Agreed Rate,” shall be adjusted every ninety days and shall mean (A) the rate of interest per annum (rounded upward, if necessary, to the nearest 1/8 of 1%) at which U.S. dollar deposits that  (i) are in an amount approximately equal to the aggregate amount of such outstanding payments, and (ii) mature in ninety days, are offered in the London Interbank currency market on the last day of each ninety day period as such rate is published in the “Money Rates” column of The Wall Street Journal (and if The Wall Street Journal publishes more than one such rate, the higher or highest of such rates and if The Wall Street Journal subsequently publishes a correction of any such previously published rate, the corrected rate as so published), plus (B) 200 basis points.

(f)            “ANDA” shall mean an Abbreviated New Drug Application, including amendments and supplements thereto, approved by the FDA in respect of the marketing of one or more of the Products in the United States.

(g)           “Applicable Law” shall mean, with respect to any Person, any federal, state or local law (statutory, common or otherwise), constitution, treaty, convention, ordinance, code, rule, regulation, order, injunction, judgment, decree, ruling or other similar requirement enacted, adopted, promulgated or applied by a Governmental Authority that is binding upon or applicable to such Person, as amended unless expressly specified otherwise, including the Act and other national, state, provincial and local laws.

(h)           “Arbitrators” shall have the meaning set forth in Section 11.08.

(i)            “Assigned Customer Agreements” shall have the meaning set forth in 1.01(gg).

(j)            “Assigned Contracts” shall mean, collectively, the Product Rights Agreements, the Manufacture and Supply Agreements and the Assigned Customer Agreements.

(k)           “Assignment and Assumption Agreement” shall have the meaning set forth in Section 2.07(a).

(l)            “Assumed Liabilities” shall have the meaning set forth in Section 2.05.

(m)           “Bill of Sale” shall have the meaning set forth in Section 2.07(b).

 
2

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(n)           “Biovail Agreements” shall mean the Manufacture and Supply Agreements and the Product Rights Agreements.

(o)           “Biovail Consent” shall mean a consent to the assignment of the Biovail Agreements substantially in the form of that attached hereto as Exhibit C or in such other form as the Parties may agree.

(p)           “Business Day” shall mean a day, other than Saturday, Sunday or other day on which commercial banks in New York, New York are authorized or required by Applicable Law to close.

(q)           “Caraco” shall have the meaning set forth in the Preamble.

(r)            “Chargebacks” shall mean discounts or rebates provided in the form of chargeback and similar payments to wholesalers or other distributors in connection with the Products.

(s)           “Claim” shall have the meaning set forth in Section 9.03.

(t)            “Closing” shall have the meaning set forth in Section 2.07.

(u)           “Closing Date” shall have the meaning set forth in Section 2.07.

(v)           “Closing Date Inventory” shall have the meaning set forth in Section 2.06.

(w)           “Closing Date Inventory Purchase Price” shall mean, for each item of Inventory included in the Closing Date Inventory, the amount equal to the per unit Cost of Goods of each such item.  Exhibit A attached hereto sets forth a schedule of the per unit Cost of Goods for each item of Inventory.

(x)            “Closing Inventory Notice” shall have the meaning set forth in Section 2.06.

(y)            “Commercially Reasonable Efforts” shall mean, with respect to either Party, the efforts, consistent with the practice of comparable pharmaceutical companies with respect to pharmaceutical products of comparable market potential to the Products, that a reasonable Person in the position of such Party would use with respect to a particular activity and, with respect to marketing a Product, the efforts a reasonable Person would use to maximize Net Sales, and shall be determined without regard to the particular circumstances of a Party, including other business opportunities available to such Party.

 
3

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(z)            “Competing Product” shall mean a product which is a generic equivalent to the same Orange Book reference product as a Product.

(aa)          “Contract Year” shall mean the twelve (12) month period beginning on the first day of the first full Quarter following the Closing Date and each consecutive twelve (12) month period, or portion thereof thereafter.  The first Contract Year shall also include the period from the Closing Date to the first day of the first Quarter of such Contract Year.

(bb)         “Contracts” shall mean those contracts, agreements, arrangements or understandings set forth on Schedule 3.09 of the Forest Disclosure Schedule.

(cc)          “Copyrights” shall mean all United States and foreign copyrights, whether or not registered, and all applications for registration of all copyrights owned by Forest or its Affiliates which have been used in connection with development, marketing, commercialization or sale of the Purchased Assets as of the Closing Date or within the two (2) year period prior to the Closing Date, including, but not limited to: (i) the right to sue or otherwise recover for any and all past, present and future infringements and misappropriations thereof; (ii) all income, royalties, damages and other payments now and hereafter due and/or payable with respect thereto; and (iii) any and all other rights corresponding thereto and all modifications, adaptations, translations, enhancements and derivative works, renewals thereof, and all other rights of any kind whatsoever of Forest accruing thereunder or pertaining thereto.

(dd)         “Cost of Goods” shall mean Forest’s direct costs of materials and labor incurred in acquiring (including any acquisition costs paid to Third Parties), manufacturing, packaging and labeling each Product, as the case may be, including quality assurance and quality control activities necessary to release Product, together with directly allocable manufacturing overheads (but excluding corporate, general or administrative overheads).  Cost of Goods shall be determined in accordance with Forest’s standard cost accounting policies, respectively, in each case as consistently applied to the manufacture of pharmaceutical products and accrued and reflected in accordance with GAAP.  From time to time Forest will provide Caraco with information as Caraco may reasonably request with respect to such standard cost accounting policies to assure compliance with the standards set forth in the preceding sentence.

(ee)          “Credits” shall mean credits, utilization based rebates (other than Medicaid rebates), reimbursements, and similar payments to buying groups, managed care organizations and benefit managers, insurers and other institutions in connection with the Products.

(ff)           “Customer” shall mean insurers, Third-Party payors, group purchasing organizations, wholesalers, managed care organizations; chain drug stores and drug stores, and any other Persons that purchase one or more of the Products from Forest or reimburse patients or health care providers for their use of one or more of the Products.

 
4

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(gg)         “Customer Agreements” shall mean those agreements set forth on Schedule 1.01(gg) pursuant to which Forest or any of its Affiliates sells one or more of the Products to a Customer or provides rebates or discounts to a Customer determined by utilization of a Product.  Customer Agreements which exclusively cover the Products (i.e. do not relate to a bundle of products including products other than the Products) are indicated on Schedule 1.01(gg) under the subheading “Assigned Customer Agreements” and are referred to herein as “Assigned Customer Agreements.”  For the sake of clarity, the Parties acknowledge that “Customer Agreements” shall not include wholesaler inventory management agreements, which shall be terminated by Forest with respect to the Products effective as of the Closing Date, and which Caraco may enter into after the Closing Date in its sole discretion and for its own account.

(hh)         “Damages” shall have the meaning set forth in Section 9.02.

(ii)           “Diltiazem Products” means the generic AB-rated to Tiazac(R) and branded pharmaceutical products containing diltiazem purchased and sold under the terms of the Biovail Agreements.

(jj)           “Dispute” shall have the meaning set forth in Section 11.08

(kk)          “Dollars” or “$” shall mean United States dollars.

(ll)           “Encumbrance” shall mean any mortgage, pledge, security interest, deed of trust, lease, lien, adverse claim (including any claim of adverse ownership or any pending legal proceeding affecting title), levy, charge, easement, right of way, covenant, restriction, or other encumbrance, third-party right or retained right of any kind whatsoever, or any conditional sale or title retention agreement or other agreement to give any of the foregoing in the future.

(mm)        “FDA” shall mean the United States Food and Drug Administration or any successor agency having a similar jurisdiction.

(nn)         “Federal Programs” shall have the meaning set forth in Section 7.06.

(oo)         “Forest” shall have the meaning set forth in Section Preamble.

(pp)         “Forest Disclosure Schedule” shall have the meaning set forth in Article 3.

(qq)         “GAAP” shall mean generally accepted accounting principles in the United States, as in effect from time to time.

 
5

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(rr)           “Governmental Authority” shall mean any transnational, domestic or foreign federal, state or local, governmental authority, department, court, agency or official, including any political subdivision thereof, including any governmental regulatory authority involved in the granting of approvals for the manufacture, sale, marketing, reimbursement or pricing of the Products (including the FDA).

(ss)           “HSR Act” shall mean the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

(tt)           “Indemnified Party” shall have the meaning set forth in Section 9.03.

(uu)         “Indemnifying Party” shall have the meaning set forth in Section 9.03.

(vv)         “Intellectual Property” shall mean (i) Copyrights; (ii) Patents; (iii) Trademarks; and (iv) Know-How.

(ww)        “Inventory” shall mean all saleable inventory of Product (other than theophylline tablets) as of the Closing in finished form (and whether in bulk tablet or final packaged form) and inventory of finished samples, if any, of each Product which comply with the applicable NDA or ANDA on hand at Forest as of the Closing.

(xx)           “Know-How” shall mean all methods, processes, techniques, compositions, technology, information, data, results of tests, studies, statistical and other analyses and expertise, to the extent related to each Product, to the extent related to the synthesis or manufacture of each Product or any component thereof, or to the extent exclusively related to the marketing, selling, offering for sale, distributing or using each Product, now in possession of Forest or an Affiliate of Forest, which are at the time of the Closing used in development, formulation, manufacture, sale or distribution of the Product.  Know-How shall include, without limitation, pharmacology, toxicology, drug stability, manufacturing and formulation methodologies and techniques, clinical and non clinical safety and efficacy studies, marketing studies and absorption, excretion, metabolism studies, quality control and quality assurance, and all tangible manifestations thereof, subject to Forest’s rights to retain a copy of documents set forth herein.

(yy)         “Knowledge,” “to the Knowledge of” or words of like import shall mean, with respect to either Party, the knowledge of such Party’s and its Affiliates’ senior executive officers after having made due investigation and reasonable inquiry of the officers and management employees of such Party and its Affiliates and other employees or individuals having responsibility for such matter(s) or having access to the relevant information.  “Know” shall have a correlative meaning.

(zz)          “Lundbeck” shall have the meaning set forth in Recital A.

 
6

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(aaa)        “Manufacture and Supply Agreements” shall mean those  agreements (including purchase orders outstanding and not fulfilled as of the Closing Date) set forth on Schedule 1.01(aaa) pursuant to which Forest or any of its Affiliates acquires one or more of the Products in finished form from a Third-Party or engages a Third-Party to process or manufacture one or more of the Products or active pharmaceutical ingredients included in such Products or perform any step in the manufacture process, which, on or as of the Closing Date, shall be assigned to Caraco or its designee.

(bbb)       “Marketing Authorization” shall mean the approval by a Governmental Authority permitting the marketing, sale and distribution (and, if applicable, pricing and reimbursement) of each Product, including, without limitation, the NDAs and the ANDAs, as applicable.

(ccc)        “Marketing Materials and Data” shall mean all physician lists, customer lists, marketing studies, market research materials, advertising and promotional materials, other similar information and data, promotional booths and displays, and all other materials used in connection with the sale or promotion of the Products whether or not located at Forest’s offices, to the extent used exclusively in the marketing or distribution of the Products within the two (2) year period prior to the date hereof.

(ddd)       “Material Adverse Effect” shall mean any change, event, development, circumstance or effect that has a material adverse effect on the Purchased Assets, the Assumed Liabilities or the ability of Caraco and its Affiliates to commercially exploit the Products or any Product; provided, however, that none of the following shall be deemed to constitute, and none of the following shall be taken into account in determining whether there has been, a Material Adverse Effect: any change, event, development, circumstance or effect to the extent arising from or relating to (i) general business or economic conditions, (ii) national or international political or social conditions, (iii) financial, banking or securities markets generally, (iv) changes in Applicable Law, (v) any “act of God,” including, but not limited to, weather, natural disasters and earthquakes, (vi) a change in the competitive market for the Products or any Product, (vii) compliance by the Parties or any Affiliate of the Parties with the terms of this Agreement or any other Transaction Document or (viii) the announcement of this Agreement or the Settlement Agreement or the transactions contemplated hereby and thereby, except, in the case of any matter referred to in any of clauses (i) through (vi), to the extent any of the same affect the Purchased Assets, the Assumed Liabilities or the ability of Caraco and its Affiliates to commercialize the Products or any Product in a disproportionate manner relative to other participants in the pharmaceutical industry in the relevant jurisdiction or jurisdictions.  The Parties agree that the breach of any representation or warranty contained herein by Forest or any failure by Forest to perform its obligations hereunder shall not be deemed to be a Material Adverse Effect to the extent that the breach or failure directly causes Forest's inability or failure to supply a Product in accordance with  its obligations of Section 5.04(a) (including by reason of issues of legal compliance, material safety or compliance with best industry practices) to Caraco, and the offset and payment mechanisms in Section 5.04(b) and 5.04(c) would cure the economic consequences of such breach or failure.

 
7

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(eee)        “NDA” shall mean a New Drug Application, including amendments and supplements thereto, approved by the FDA in respect of the marketing of a Product in the United States.

(fff)          “Net Sales” of each Product for a period following the Closing shall mean the gross proceeds from sales of such Product by Caraco, its Affiliates or permitted licensees to Third Parties, less (i) allowances for actual returns, discounts, customary discounts, Credits, adjustments and allowances given to customers, including discounts made by means of rebates, refunds, Chargebacks or contract administration fees with customers that are directly related to sales of such Product (and including rebates or other payments required to be paid to Governmental Authorities in connection with sales of Product in pursuant to the Omnibus Budget Reconciliation Act of 1990 and similar or other U.S. Federal or state legislation or programs); (ii) bad debt actually written off attributable to sales of such Product; (iii) any taxes or duties included in gross invoice amounts; and (iv) any other allowances, credits or payments which actually reduce the selling price of such Product, to the extent consistent with standard industry practices and as applied by Caraco on a consistent basis with respect to its generic products generally.  Net Sales shall be determined without regard to deductions, credits, allowances or payments made or applied on account of or in connection with Caraco’s other products or businesses (for example, discounts applicable to bundled products).  Net Sales shall be determined in accordance with GAAP.

(ggg)       “Offset Amount” shall have the meaning set forth in Section 5.04(b).

(hhh)       “Party; Parties” shall have the meaning set forth in the Preamble.

(iii)           “Patents” shall mean all United States and foreign patent applications, and letters patent, including, but not limited to: (i) any and all inventions and improvements described and claimed therein, and patentable inventions and all patents issuing therefrom or otherwise corresponding thereto; (ii) the right to sue or otherwise recover for any and all past, present and future infringements and misappropriations thereof; (iii) all income, royalties, damages and other payments now and hereafter due and/or payable with respect thereto; and (iv) any and all other rights corresponding thereto and all reissues, divisions, continuations, continuations-in-part, substitutes, renewals, and extensions thereof, all improvements thereon, and all other rights of any kind whatsoever accruing thereunder or pertaining thereto.

(jjj)           “Person” shall mean any individual, firm, corporation, partnership, trust, association, joint venture, limited liability company, limited liability partnership, Governmental Authority or other entity of any kind, and shall include any successor (by merger or otherwise) of such entity.

 
8

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(kkk)        “Potential Contributor” shall have the meaning set forth in 9.04.

(lll)           “Products” shall mean those pharmaceutical products approved for marketing in the United States pursuant to the following NDAs and ANDAs in each case including the specified active pharmaceutical ingredient as the sole active pharmaceutical ingredient and in the dosage strength(s), formulation(s) and packaging designated in the respective NDA and ANDA as approved on the date hereof and as set forth on Schedule 1.01(lll):  (i) diltiazem approved pursuant to NDA 20-401 (including Product sold under the Tiazac(R) trademark), (ii) rimantadine approved in tablet form pursuant to NDA 19-649 (including Product sold under the Flumadine(R) trademark), (iii) theophylline approved in elixir form pursuant to ANDA 85-186 (including Product sold under the Elixophyllin(R) trademark), (iv) theophylline approved in a tablet form pursuant to ANDAs 87-400, 88-320 and 88-321 (including Product sold under the Theochron(R) trademark) and (v) isosorbide dinitrate approved for marketing pursuant to ANDA 40-009 (including Product sold under the Isochron(R) trademark).

(mmm)     “Product Intellectual Property” shall mean any and all Intellectual Property now owned or controlled (including, without limitation, by means of in-license) by Forest or any of its Affiliates to the extent used in connection with (i) the Products, Marketing Materials and Data; (ii) the development, manufacture, sale, use, marketing and distribution of one or more Products; and/or (iii) the synthesis or manufacture of one or more Products or any component anywhere in the world, in each case to the extent exclusively related to the marketing, sale, offer to sell, distribution or use of any such Product in the U.S. or in obtaining Marketing Authorizations.

(nnn)       “Product Records” shall mean all books and records that relate primarily or exclusively to the Products or the Purchased Assets, but only to the extent relating to events occurring during the two (2) year period prior to the date hereof, including copies of all material supplier lists, consultant reports, invention disclosures, laboratory notebooks and records and material correspondence (excluding invoices) related to the Product or the Purchased Assets, to the extent maintained by or in the possession of Forest or its Affiliates or their agents (to the extent owned by Forest or its Affiliates) at the Closing Date, and all complaint files and adverse event files with respect to the Product.

(ooo)       “Product Rights Agreements” shall mean those agreements set forth on Schedule 1.01(ooo) pursuant to which Forest or any of its Affiliates in-license the ability to produce, market or sell one or more of the Products from a Third-Party which, on or as of the Closing Date, shall be assigned to Caraco or its designee.

(ppp)       “Projections” shall have the meaning set forth in Section 5.04(b).

 
9

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(qqq)       “Purchased Assets” shall have the meaning set forth in Section 2.01.

(rrr)          “Quarter” shall mean the calendar quarterly periods ending March 31, June 30, September 30 and December 31.  The first Quarter following the Closing Date shall include the period from the Closing Date to the first day of the first full calendar quarter after the Closing Date.

(sss)        “Registrations” shall mean the regulatory approvals, franchises, authorizations, licenses, certificates, applications, agreements, permits, exemptions, and other permissions (including the NDAs and ANDAs) issued by Governmental Authorities.

(ttt)          “Representatives” shall have the meaning set forth in Section 7.01.

(uuu)       “Required Consents” shall have the meaning set forth in Section 3.05.

(vvv)       “Retained Assets” shall mean all assets of Forest of any type, nature, status or description whatsoever, other than the Purchased Assets.  For purposes of clarity and not of limitation, “Retained Assets” shall include (i) any Forest intellectual property other than Product Intellectual Property to be delivered to Caraco pursuant to this Agreement and (ii) plant, equipment and fixed assets of Forest other than as expressly included in the Purchased Assets.

(www)     “Retained Liabilities” shall have the meaning set forth in Section 2.04.

(xxx)         “Royalties” shall have the meaning set forth in Section 2.09.

(yyy)       “Safety Data” shall have the meaning set forth in Section 7.10.

(zzz)         “Settlement Agreement” shall have the meaning set forth in Recital A.

(aaaa)      “Specifications” shall have the meaning set forth in Section 3.10.

(bbbb)     “Sun” shall have the meaning set forth in Recital A.

(cccc)      “Supply Agreement” shall have the meaning set forth in Section 5.04(a).

(dddd)     “Tax” shall mean (i) any tax, governmental fee or other like assessment or charge of any kind whatsoever (including withholding on amounts paid to or by any Person), together with any interest, penalty, addition to tax or additional amount imposed by any Governmental Authority responsible for the imposition of any such tax, or (ii) liability for the payment of any amounts of the type described in (i) as a result of being party to any agreement or any express or implied obligation to indemnify any other Person.

 
10

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(eeee)      “Third Party” shall mean a party other than Forest or Caraco or any of their respective Affiliates.

(ffff)        “Trade Channel Days” shall mean the number of days of consumer utilization maintained by wholesalers and retailers as of the Closing Date, which the Parties have mutually agreed based on a good faith estimate to be 21 days (or such other number as the Parties may agree upon prior to the Closing if information received from wholesalers prior to the Closing suggests a substantially different number is more accurate).

(gggg)    “Trade Channel Inventory” shall mean, on a Product-by-Product basis, the amount of Product sold by Forest and maintained by wholesalers and retailers as of the Closing Date based on a mutually agreed good faith estimate as set forth on Schedule 1.01(gggg).

(hhhh)     “Trademarks” shall mean the trademarks owned by Forest or its Affiliates and set forth on Schedule 1.01(hhhh) of the Forest Disclosure Schedule, including (i) all goodwill associated therewith; (ii) the right to sue or otherwise recover for any and all past, present and future infringements and misappropriations thereof; (iii) all income, royalties, damages and other payments now and hereafter due and/or payable with respect thereto; and (iv) any and all other rights corresponding thereto and all other rights of any kind whatsoever accruing thereunder or pertaining thereto, together in each case with the goodwill of the business connected with the use of, and symbolized by, each such trademark.

(iiii)           “Transaction Documents” shall mean, collectively, this Agreement, the Bill of Sale, the Assignment and Assumption Agreement and any other documents, certificates, amendments, schedules and agreements executed in connection with, or required to be delivered by, any of the foregoing, but not including the Settlement Agreement or the Patent Assignment Agreement (as such term is defined in the Settlement Agreement).

(jjjj)           “True-Up Payment” shall have the meaning set forth in Section 5.04(c).

(kkkk)      “Unidentified Claims” shall have the meaning set forth in Section 7.03.

(llll)           “United States” or “U.S.” shall mean the United States of America, and its territories and possessions, including Puerto Rico irrespective of its political status.

(mmmm)  “WARN Act” shall mean the Worker Adjustment Retraining and Notification Act of 1988, 29 U.S.C. section 2101, et seq., as amended.

 
11

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(nnnn)     “Warranty Breach” shall have the meaning set forth in Section 9.02.

(oooo)    “Written Statement” shall have the meaning set forth in Section 2.08.

1.02.        Other Definitional and Interpretative Provisions.  Captions are included for convenience of reference only and shall be ignored in the construction or interpretation of this Agreement.  All Exhibits and Schedules annexed hereto or referred to herein are incorporated in and made a part of this Agreement as if set forth in full herein.  Any capitalized terms used in any Exhibit or Schedule but not otherwise defined therein, shall have the meaning as defined in this Agreement.  Any singular term in this Agreement shall be deemed to include the plural, and any plural term the singular.  Whenever the words “include”, “includes” or “including” are used in this Agreement, they shall be deemed to be followed by the words “without limitation”, whether or not they are in fact followed by those words or words of like import.  References to any agreement or contract are to that agreement or contract as amended, modified or supplemented from time to time in accordance with the terms hereof and thereof; provided that with respect to any agreement or contract listed on any schedules hereto, all such amendments, modifications or supplements must also be listed in the appropriate schedule.  References to any Person include the successors and permitted assigns of that Person.  References from or through any date mean, unless otherwise specified, from and including or through and including, respectively.  References to “law”, “laws” or to a particular statute or law shall be deemed also to include any and all Applicable Law.

2.             PURCHASE AND SALE

2.01.        Purchased Assets.  Except as otherwise provided below and upon the terms and subject to the conditions of this Agreement, Caraco agrees to purchase from Forest (or any applicable Affiliate of Forest), and Forest agrees to sell, convey, transfer, assign and deliver, or cause to be sold, conveyed, transferred, assigned and delivered, to Caraco at the Closing, free and clear of all Encumbrances, subject to Section 5.01, all of Forest’s and its Affiliates’ right, title and interest in, to and under the assets referenced in clauses (a) through (j) below (collectively, the “Purchased Assets”), to the extent related to one or more Products:

(a)           the Product Intellectual Property;

(b)           the Closing Date Inventory;

(c)           the Product Rights Agreements;

(d)           the Manufacture and Supply Agreements;

(e)           the Assigned Customer Agreements;

12

 
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(f)            the Marketing Materials and Data;

(g)           all rights or claims of Forest or any of its Affiliates in respect to any of the foregoing against any third party including, without limitation, any prior owner of Product Intellectual Property but excluding any right of Forest to receive payment for Product shipped prior to Closing;

(h)           the Registrations, including the NDAs and the ANDAs identified on Schedule 2.01(h);

(i)            the Product Records or true and correct copies of the Product Records (but only to the extent reasonably capable of being delivered at Closing, it being understood that Caraco will continue to have access to any Product Records not delivered at Closing as provided in Section 7.02 below);

(j)            all goodwill relating to any of the above.

To the extent any Product Intellectual Property has applicability to products other than to the Products or to the synthesis or manufacture of the Products, the assignment of Product Intellectual Property hereunder shall be limited to the grant, at Closing, of an irrevocable, worldwide, perpetual license to reproduce, use, modify, adapt, create improvements to and/or create derivative works of such Product Intellectual Property solely to the extent related to the relevant Product.

Forest may retain a copy of all documents or materials included in the Purchased Assets for archival purposes, for purposes of fulfilling its obligations under this Agreement and under Applicable Law and to the extent such documents or materials include or relate to Retained Assets or Retained Liabilities.

2.02.        Customer Agreements.  With respect to each Customer Agreement that relates to a bundle of products which includes other Forest products in addition to one or more of the Products, Forest shall continue to administer such agreements (including the payment of all Chargebacks, Credits, rebates and returns and the resolution of any disputes concerning the same) to the extent related to the Products for the benefit of and the account (including costs) of Caraco from and after the Closing Date until the expiration of the current term of such Customer Agreement, but shall have no obligation to renew or extend the term of such agreement with respect to such Product or Products.  Forest shall deal exclusively with such Customers with respect to such Customer Agreements; provided, however, that any orders for Products made pursuant to such Customer Agreements shall be referred to Caraco and shall be filled by Caraco.  For the sake of clarity, with respect to Customer Agreements which contain evergreen renewal provisions, Forest shall have the right to terminate such agreements prior to the next renewal.  In order to give effect to the foregoing, Forest will collaborate with Caraco with respect to the Customer Contracts being administered by Forest on Caraco’s behalf pursuant to this Section to enable Caraco to smoothly transition the Products from such Customer Agreements to agreements to which Caraco is a party, including by providing advance notice of any contract expiration or termination.  During the period in which Forest is administering a Customer Agreement on Caraco’s behalf, Forest shall consider any requests by Caraco to participate in interactions with the Customer or requests for authorization to correspond directly with the Customer in connection with such agreement, in each case to the extent related to the Products, provided however, such decision shall be made in Forest’s sole discretion.

 
13

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.


2.03.        Retained Assets.  Notwithstanding anything contained in this Agreement to the contrary, from and after the Closing, Forest and its Affiliates, as applicable, shall retain all of their right, title and interest in and to the Retained Assets.

2.04.        Retained Liabilities.  Upon the terms and subject to the conditions of this Agreement, Forest and its applicable Affiliates shall retain the following obligations and liabilities (whether known or unknown, accrued, absolute, contingent or otherwise) relating to or arising out of the Purchased Assets, but only to the extent any such obligation or liability is not an Assumed Liability (the “Retained Liabilities”):

(a)           any and all liabilities and obligations arising under or related to the WARN Act, and any applicable state or local notification law with respect to a layoff or plant closing relating to the sale of the Purchased Assets as contemplated herein that occurred on, before or after the Closing Date;

(b)           all product liability and similar claims, whether made before or after the Closing Date, for injury to person (including death) or property (real or personal) in connection with the manufacture, storage, handling, shipment or sale by Forest or any Affiliate of  Forest of the Products prior to the Closing Date, and after the Closing Date to the extent arising from Forest’s or its Third Party Designee’s failure to comply with: (a) Applicable Law (including current Good Manufacturing Practices (as set forth in C.F.R. 21 Parts 210 and 211, or any successor law or regulation thereto); (b) the specifications for the Products or the facilities; or (c) any other quality or legal standards applicable under the Supply Agreement, in each case with respect to the manufacturing and supply of Products to be supplied by Forest to Caraco pursuant to Section 5.04(a) hereof, except to the extent such claim arises out of an act (other than the sale of a Product in the ordinary course of business) or omission of Caraco or its Affiliates on or after the Closing Date;

(c)           all liabilities and obligations in respect of returns, recalls, rebates, retrofits and warranty claims, whether arising before or after the Closing, for Products sold to Customers by Forest or any of its Affiliates prior to the Closing Date, and except for rebates for Products sold to Customers by Caraco or any of its Affiliates, after the Closing Date to the extent returns, recalls, retrofits and warranty claims arise from Forest’s failure to comply with: (a) Applicable Law (including current Good Manufacturing Practices (as set forth in C.F.R. 21 Parts 210 and 211, or any successor law or regulation thereto); (b) the specifications for the Products or the facilities; or (c) any other quality or legal standards applicable under the Supply Agreement, in each case with respect to the manufacturing and supply of Products to be supplied by Forest to Caraco pursuant to Section 5.04(a) hereof; and

 
14

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(d)           all other liabilities and obligations of Forest and its Affiliates, other than Assumed Liabilities, based upon or arising out of any act or omission of Forest or its Affiliates occurring prior to the Closing Date, including any liability relating to Product design or infringement arising out of any act or omission of Forest or its Affiliates occurring prior to the Closing Date, or any matters or events occurring prior to the Closing Date, including without limitation, any such liabilities or obligations disclosed on any Schedule attached hereto, and all other liabilities and obligations of Forest and its Affiliates (other than the Assumed Liabilities) arising on or after the Closing Date to the extent caused by Forest’s failure to comply with: (a) Applicable Law (including current Good Manufacturing Practices (as set forth in C.F.R. 21 Parts 210 and 211, or any successor law or regulation thereto); (b) the specifications for the Products or the facilities; or (c) any other quality or legal standards applicable under the Supply Agreement, in each case with respect to the manufacturing and supply of Products to be supplied by Forest to Caraco pursuant to Section 5.04(a) hereof.

2.05.        Assumed Liabilities.  Upon the terms and subject to the conditions of this Agreement, Caraco agrees, effective at the time of the Closing, to assume the following obligations and liabilities of Forest and its Affiliates (the “Assumed Liabilities”):

(a)           all liabilities and obligations of Forest or any of its Affiliates arising under the Product Rights Agreements, Manufacture and Supply Agreements and the Assigned Customer Agreements, but only to the extent any such obligation or liability arises from and after the Closing Date; and

(b)           any ongoing fees, costs or expenses related to the Products, including maintenance fees, payable with respect to the Registrations, to the extent such fees become due and payable after the Closing Date.

Caraco shall not be liable or obligated for any of the Retained Liabilities and nothing in this Agreement shall be construed in any manner to constitute an assumption by Caraco or any of its Affiliates of any Retained Liability.  Forest and its Affiliates shall retain and pay and perform when due all of the Retained Liabilities.

2.06.        Closing Date Inventory.  Prior to the Closing Date, the Parties shall cooperate in good faith to provide information to Caraco as to Inventory (including number of units, lot numbers, dosage strengths and dating) which Forest reasonably expects to have available as of the Closing Date and as to Caraco’s anticipated requirements for Products following the Closing Date.  In connection with any Inventory that has less than 18 months of remaining shelf-life, such Inventory shall not automatically be included in the Closing Date Inventory (as defined below); provided that the Parties will cooperate to try to use such Inventory, and such Inventory may be included in the Closing Date Inventory if it can be reasonably anticipated that Caraco will be able to sell such Inventory in the ordinary course following the Closing Date, recognizing that Caraco shall have the final decision making authority in that regard.  At least two (2) Business Days prior to the Closing Date, Forest shall provide Caraco with a written notice (the “Closing Inventory Notice”) setting forth the number of units of each item included in Inventory to be transferred to Caraco at the Closing pursuant to Section 2.01.  The Inventory actually delivered to Caraco pursuant to Section 2.07(b)(iii) is hereinafter referred to as the “Closing Date Inventory”.

 
15

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
2.07.           Closing.  Unless this Agreement shall have been terminated in accordance with Section 8, the closing (the “Closing”) of the purchase and sale of the Purchased Assets hereunder shall take place at the offices of Dornbush Schaeffer Strongin & Venaglia, LLP, 747 Third Avenue, New York, New York 10017, as soon as possible, but in no event later than ten (10) Business Days after satisfaction of the conditions set forth in Section 8, or at such other time or place as Forest and Caraco may agree in writing (the “Closing Date”).  Notwithstanding the immediately preceding sentence, it is understood and agreed that, to facilitate closing logistics, various Purchased Assets may be delivered at one or more mutually acceptable locations and that, if the Parties so agree, a “physical closing” may not be necessary.  The following shall be delivered in connection with the Closing at the times specified below:

(a)           At the Closing, Caraco shall deliver or cause to be delivered to Forest:

(i)           [* * *] as a non-refundable advance against the Royalties payable pursuant to Section 2.09(a) (the “Advance Royalty Amount”) in immediately available funds by wire transfer to an account designated by Forest, by notice to Caraco not later than two (2) Business Days prior to the Closing Date (or if not so designated, then by certified or official bank check payable in immediately available funds to the order of Forest in such amount);

(ii)           a certificate, dated as of the Closing Date and signed by a duly authorized officer of Caraco, to the effect that all corporate proceedings required to be taken by Caraco in connection with the transactions contemplated hereby have been taken and the representations and warranties of Caraco made herein are true and correct as of the Closing Date except to the extent that inaccuracies thereto when taken in the aggregate would not have a Material Adverse Effect;

 
16

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(iii)           duly executed counterparts of the assignment and assumption agreement with respect to the Product Rights Agreements, the Manufacture and Supply Agreements and the Assigned Customer Agreements in substantially the form attached hereto as Exhibit B or as otherwise revised pursuant to Section 5.01 (the “Assignment and Assumption Agreement”);

(iv)           duly executed counterpart of the Supply Agreement; and

(v)           duly executed counterpart of a Trademark assignment agreement in form mutually agreed by the Parties.

(b)           At the Closing, Forest shall deliver or cause to be delivered to Caraco:

(i)             physical possession (or the implementation of arrangements reasonably satisfactory to the Parties for the transfer and delivery of physical possession) of all tangible personal property (or copies thereof) included in the Purchased Assets, including all tangible personal property included in the Product Intellectual Property, the Know-How and the Marketing Materials and Data and appropriate documents of transfer related thereto in form and substance reasonably acceptable to Caraco and Forest;

(ii)            a Bill of Sale for the Purchased Assets and assignments of the Product Intellectual Property duly executed on behalf of Forest or its Affiliates, as the case may be, in substantially the form attached hereto as Exhibit C (the “Bill of Sale”);

(iii)           the Closing Date Inventory (or the implementation of arrangements reasonably satisfactory to the Parties for the transfer and delivery of the Closing Date Inventory);

(iv)           a certificate, dated as of the Closing Date and signed by a duly authorized officer of Forest, to the effect that (a) all liabilities or obligations of Forest under the Biovail Agreements have been satisfied, including, without limitation, the payment of all royalties due and owing to Biovail Laboratories, Incorporated through the Closing Date, and (b) all corporate proceedings required to be taken by Forest in connection with the transactions contemplated hereby have been taken and specifying in reasonable detail the extent, if any, that the representations and warranties of Forest made herein are not true and correct as of the Closing Date;

(v)           duly executed counterparts of the Assignment and Assumption Agreement

(vi)          duly executed counterpart of the Supply Agreement;

 
17

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(vii)         duly executed counterpart of a Trademark assignment agreement in form mutually agreed by the Parties;

(viii)         Except as otherwise provided in Section 5.01, the duly executed Required Consents;

(ix)           duly executed notices to the relevant Third Party manufacturers under the Manufacture and Supply Agreements advising such manufacturers of the Closing of the transaction and providing instructions for delivery of Product to Caraco following the Closing Date; and

(x)           copies of notifications to Governmental Authorities effecting the transfer of the NDAs and ANDAs and any other Marketing Authorization to Caraco, in customary form.

(c)           Following the Closing, within 5 Business Days following delivery of the Closing Date Inventory, Caraco shall deliver to Forest an aggregate amount equal to the product of (i) the number of units of each item of Inventory included in the Closing Date Inventory and (ii) the Closing Date Inventory Purchase Price of each such item.  Caraco shall deliver such amount in immediately available funds by wire transfer to an account designated by Forest by notice to Caraco (or if not so designated, then by certified or official bank check payable in immediately available funds to the order of Forest in such amount).

2.08.        Post-Closing Adjustments.  Caraco shall be responsible for remitting all payments arising under the Product Rights Agreements from and after the Closing Date.  Notwithstanding the foregoing, royalties payable pursuant to the Product Rights Agreements after the Closing Date with respect to sales of Products shipped by Forest or its Affiliates prior to the Closing Date shall be for Forest’s account.  Within fifteen (15) days after the last day of the royalty period under the applicable Product Rights Agreement in which the Closing Date occurs, each Party shall provide the other Party with a written statement (the “Written Statement”) setting forth its net sales for such period (as determined in accordance with the terms of the applicable Product Rights Agreement) with respect to the relevant Product(s) covered by such agreement, which statement shall be accompanied by reasonable supporting documentation. Caraco and Forest shall collaborate to calculate each Party’s share of applicable royalty obligations.  Forest shall remit any amounts due Caraco pursuant to this Section to Caraco within fifteen (15) days following the Parties completion of the allocation of applicable royalty obligations for such period.  Each Party may, from time to time upon reasonable notice and request to the other Party, audit net sales information reported to it by the other Party in the Written Statement, and shall reasonably cooperate with any such audit or inquiry by the other Party with respect to the amount or validity of its reported net sales information, subject to reasonable confidentiality obligations.

2.09.        Post-Closing Royalty Payments.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(a)           As additional consideration for the Purchased Assets, Caraco agrees to pay Forest commencing after the Closing Date and for so long as it or any of its Affiliates or any of their respective successors or assigns is selling a Product, on a Quarterly basis in arrears running royalties payable on Net Sales in accordance with the following (such Quarterly payments, the “Royalties”):
 
 
Product
Royalty
(% of Net Sales)
   
Diltiazem (including sales under the Tiazac(R) trademark)
[* * *]
   
Rimantadine (including sales under the Flumadine(R) trademark)
[* * *]
   
Isosorbide Dinitrate (including Product sold under the Isochron(R) trademark)
[* * *]
   
Theophylline (including Product sold under the Theochron(R) trademark)
[* * *]
   
Theophylline in elixir form sold under the Elixophyllin(R) trademark
[* * *]
 
(b)           The Royalties shall be payable Quarterly in Dollars within fifteen (15) Business Days of the end of the Quarter to which each payment relates and shall be reconciled on an annual basis together with the payment applicable to the fourth Quarter of each Contract Year.  Each payment of Royalties shall be accompanied by a statement setting forth the amount of gross sales and Net Sales for the Quarter in sufficient detail to confirm the accuracy of the payment made (expressed in the currency of sale and units sold), the calculation of Royalties due and the exchange rate used to convert Net Sales recorded in currencies other than Dollars to Dollars. Net Sales recorded in currencies other than Dollars shall be converted into Dollars for purposes of calculating Royalties based upon the thirty (30) day average (as of the date such Net Sales are recorded by Caraco) of the applicable currency exchange rate published by the New York edition of The Wall Street Journal or if the New York edition of The Wall Street Journal is not then published on a regular basis, then such other financial periodical of general circulation in the United States as may be widely recognized by persons active in the financial services and banking industries.  Notwithstanding the foregoing, no payments in respect of Royalties shall be made to Forest pursuant to this Section 2.09 until the aggregate amount of Royalties exceeds the Advance Royalty Amount, and then only to the extent of such excess.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(c)           All Royalty payments hereunder shall be made free and clear of any Taxes or Encumbrances, except for withholding Taxes, if applicable.  If any Taxes are required to be withheld, Caraco shall (i) send proof of the payment of such withholdings Taxes to Forest and certify its receipt by the relevant Governmental Authority within 30 days following such payment and (ii) cooperate in good faith with Forest in obtaining a refund of, or credit with respect to, any such payments.

(d)           If any payment due under this Section 2 is not made when due, the payment shall accrue interest at a rate per annum equal to the Agreed Rate.

3.             REPRESENTATIONS AND WARRANTIES OF FOREST

Except as set forth in Schedule 3 attached hereto (the “Forest Disclosure Schedule”), Forest represents and warrants to Caraco, as of the date hereof (except to the extent expressly made as of another date, in which case, solely as of such date), as follows:

3.01.        Corporate Existence and Power.  Forest and each Affiliate of Forest that is a party to any Transaction Document is duly incorporated or organized, validly existing and in good standing under the laws of its jurisdiction of organization and has all organizational powers and all material governmental licenses, authorizations, permits, consents and approvals required to carry on its business as now conducted.  Forest and each such Affiliate of Forest is duly qualified to do business and is in good standing in each jurisdiction where such qualification is necessary.

3.02.        Corporate Authorization.  The execution, delivery and performance by Forest of this Agreement and by Forest and each Affiliate of Forest of each other Transaction Document to which it is a party and the consummation of the transactions contemplated hereby and thereby are within Forest’s (and each relevant Affiliate’s) corporate, partnership, limited liability company or other entity powers and have been duly authorized by all necessary corporate, partnership, limited liability company or other entity action on the part of Forest and any relevant Affiliates of Forest.  This Agreement and each other Transaction Document to which it is a party constitutes a legal, valid and binding obligation of, and is enforceable against, Forest and each relevant Affiliate of Forest except as may be limited by bankruptcy, insolvency, reorganization, moratorium and other similar laws and equitable principles related to or limiting creditors’ rights generally and by general principles of equity and further.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
3.03.        Governmental Authorization.  Other than as set forth on Schedule 3.03 of the Forest Disclosure Schedule, the execution, delivery and performance by Forest of this Agreement, and by Forest and each Affiliate of Forest that is a party to any Transaction Document, of each of the other Transaction Documents to which it is a party and the consummation of the transactions contemplated hereby and thereby require no action by or in respect of, or filing with, any Governmental Authority.  Schedule 3.03 of the Forest Disclosure Schedule lists all material correspondence between Forest and the FDA or other applicable Governmental Authority sent or received from and after January 1, 2008 through the date hereof which relate exclusively to (i) the manufacturing and testing of the Product, (ii) regulatory warning letters with respect to the Products, (iii) the withdrawal of any Products from the marketplace or (iv) the safety and efficacy of the Products.

3.04.        Noncontravention; Licenses and Permits.  The execution, delivery and performance by Forest of this Agreement, and by Forest and each Affiliate of Forest that is a party to any Transaction Document, of each of the other Transaction Documents to which it is a party and the consummation of the transactions contemplated hereby and thereby do not and will not (i) violate the organizational documents of Forest or any relevant Affiliate of Forest, (ii) assuming compliance with the matters referred to in Section 3.03, violate any Applicable Law, (iii) assuming the obtaining of all Required Consents, violate or result in the breach of, constitute a default under, or accelerate the performance required by, (A) any term of any covenant, agreement or understanding to which Forest or any of its Affiliates is a party which is materially related to the Purchased Assets or Forest’s or any of its Affiliates’ ability to consummate the transactions contemplated by each Transaction Document to which they are a party, or (B) any judgment, order, decree, law, rule or regulation to which Forest or any of its Affiliates is subject or (iv) result in the creation or imposition of any Encumbrances on any Purchased Asset.

3.05.        Required Consents.  Schedule 3.05 of the Forest Disclosure Schedule sets forth each agreement or other instrument binding upon Forest or any of its Affiliates requiring a consent or other action by any Third Party (including any Governmental Authority) as a result of the execution, delivery and performance of this Agreement, including, without limitation, the assignment to Caraco or its Affiliates of the Product Rights Agreements, the Manufacture and Supply Agreements and the Assigned Customer Agreements (the “Required Consents”).

3.06.        Title to Purchased Assets; Encumbrances.  Forest or one or more of its Affiliates have, and on the Closing Date will have, good title to the Purchased Assets which are owned by Forest or such Affiliate, free and clear of all Encumbrances whatsoever.  Subject only to the securing of the Required Consents, Forest or one or more of its Affiliates has the valid and exclusive right to possess, use and transfer the Purchased Assets; in each case, which right shall be fully transferred to Caraco at the Closing pursuant to the terms and conditions of this Agreement.  The Purchased Assets constitute all of Forest’s and its Affiliates’ assets of the type and nature of assets constituting the Purchased Assets as enumerated in Section 2.01 relating primarily or exclusively to the Products.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.


3.07.        Claims; Litigation.  Other than as set forth on Schedule 3.07 of the Forest Disclosure Schedule, (i) there is no action, suit, investigation or proceeding pending against, or to the Knowledge of Forest, threatened against or affecting, the Purchased Assets (including, without limitation, claims in the nature of product liability or patent or other Intellectual Property infringement) before any arbitrator or any Governmental Authority or which in any manner challenges or seeks to prevent, enjoin, alter or materially delay the transactions contemplated by this Agreement or the other Transaction Documents; (ii) no officer, director, manager, employee, consultant or agent of Forest or any of its Affiliates is asserting or has asserted any claim or right in any Product or Purchased Asset and (iii) Forest and its Affiliates have not received any written notice from any Governmental Authority or any Person in the two (2) year period prior to the date hereof alleging any violation of or liability with respect to any Product or Purchased Asset which could result in a lien or claim against the Purchased Assets or could reasonably be anticipated to interfere with the commercialization of a Product by Caraco in substantially the same manner as such Product has been commercialized by Forest as of the Closing Date, and do not Know of any reasonable basis for any such actions, suits, investigations, proceeding, claims, rights or allegations.

3.08.        Product Intellectual Property.

(a)           Forest or one or more of its Affiliates own all right, title and interest in and to all of the Forest or Affiliate owned Product Intellectual Property, and the full right and interest in and to the in-licensed Product Intellectual Property, for use in the United States and, assuming compliance with the matters referred to in Section 3.03 and the receipt of the Required Consents, is legally entitled to transfer to Caraco all of the Product Intellectual Property, free and clear of all Encumbrances and free of license or royalty obligations to any third party whatsoever (other than those designated as in-licensed).  Schedule 3.08(a) of the Forest Disclosure Schedule describes all such owned Product Intellectual Property and in-licensed Product Intellectual Property.  Except with respect to the in-licensed Product Intellectual Property, no Third Party (including, for this purpose, directors, officers, employees or other consultants to or agents for Forest or any of its Affiliates) has any legal or beneficial interest in the Product Intellectual Property.

(b)           No claim of ownership, infringement or invalidity adverse to the ownership or use by Forest or any of its Affiliates of any of the Product Intellectual Property (including without limitation, any such claim by any shareholder, officer, director, manager, employee, consultant or agent of Forest or any of its Affiliate) has been asserted.  Forest does not Know of any reasonable basis for anyone to assert that the development, modification, manufacture, importation, sale, marketing, promotion or use of the Products as performed by Forest or its Affiliates prior to the Closing Date infringes or misappropriates the intellectual property rights of any Third Party.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(c)           Set forth on Schedule 3.08(c) of the Forest Disclosure Schedule is a true, correct and complete list of the Product Intellectual Property owned by Forest to be assigned to Caraco and licensed to Caraco under this Agreement.

(d)           Forest has no Knowledge of any prior use, infringement, piracy or counterfeiting of any Trademarks, any superior rights by any third party in any Trademarks, or any adverse claims pertaining to any Trademarks, and does not Know of a reasonable basis for any such claim.

(e)           With respect to all registered Patents and Trademarks, Forest and/or its Affiliates have properly executed and recorded all documents necessary to perfect their respective title in the United States to the Patents and Trademarks, and Forest has filed all documents and paid all taxes, fees, and other financial obligations required to renew and maintain in force and effect all such Product Intellectual Property until Closing.  Forest and its Affiliates have not taken any action (or failed to take any actions) that has resulted in the loss, lapse, abandonment, invalidity or unenforceability of any Product Intellectual Property. 

(f)           The execution, delivery and performance of this Agreement by Forest and each Affiliate of Forest that is party to any Transaction Document will not (i) result in Forest (including its Affiliates and predecessors in interest) granting to any Person, other than Caraco, any rights or licenses to any Product Intellectual Property, (ii) impair the right, title or interest of Caraco in or to any of the Product Intellectual Property or (iii) result in any modification of rights and obligations under any contract to which Forest or any of its Affiliates is a party, such that Caraco’s use of the Purchased Assets is subject to restrictions, impairments or payments that did not apply to Forest’s use of such Purchased Assets in such manner prior to the Closing Date.

(g)           Forest (including its Affiliates and predecessors in interest) has taken all reasonable steps to protect the Know-How, including requiring each current and former employee and independent contractor of Forest (including its Affiliates and predecessors in interest) that contributed to the Product Intellectual Property to enter into agreements with Forest (including its Affiliates and predecessors in interest) pursuant to which he, she or it agrees to protect the confidential information of Forest (including its Affiliates and predecessors in interest) and assign (and has assigned) to Forest all intellectual property related to the Product created in the course of his, her or its employment or other relationship with Forest (including its Affiliates and predecessors in interest) to the extent permitted by Applicable Law.

3.09.        Contracts.  Set forth on Schedule 3.09 of the Forest Disclosure Schedule is a true, correct and complete list of the Product Rights Agreements, the Manufacture and Supply Agreements and the Customer Agreements.  Other than the agreements set forth on Schedule 3.09 of the Forest Disclosure Schedule, there are no material contracts relating to or affecting the Product or the Purchased Assets.  The Product Rights Agreements, the Manufacture and Supply Agreements and the Customer Agreements are in full force and effect, without revocation or change, and neither Forest nor, to the best of Forest’s Knowledge, any other party to any of the Product Rights Agreements, the Manufacture and Supply Agreements or the Customer Agreements is in material default of its respective obligations thereunder, nor does any condition exist which, with notice or lapse of time or both, would constitute a material breach by any such party of its respective obligations under any of the Product Rights Agreements, the Manufacture and Supply Agreements or the Customer Agreements.  Forest is not aware of any dispute with respect to the performance of any material term or condition of any of the Product Rights Agreements, the Manufacture and Supply Agreements or the Customer Agreements.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
3.10.         Specifications.  The Products, as manufactured, sold and delivered by Forest or its Affiliates on or prior to the date hereof were (i) manufactured, packaged, labeled, stored, sold and shipped in compliance with the applicable NDA or ANDA, and with the quality control procedures, formulae and specifications (collectively, “Specifications”) in compliance with all applicable FDA, and federal, state and local laws and regulations, including, without limitation, applicable current Good Manufacturing Practice regulations promulgated by the FDA and all rules and regulations promulgated thereunder; and (ii) free from all defects in manufacture, storage, packaging and the printing and affixing of labels.  The Closing Date Inventory is labeled in compliance with all applicable FDA and state and local regulations.  The Specifications comply with all applicable FDA and corresponding state and local regulations, including, without limitation, applicable current Good Manufacturing Practice regulations promulgated by the FDA.  The NDAs and the ANDAs remain in effect and Forest or its relevant Affiliate has submitted, or, to the best of Forest’s Knowledge, the relevant Third-Party licensor of the Product has submitted, all reports to the FDA with respect to the NDAs and ANDAs required to have been submitted prior to the date hereof.  Forest has paid or has caused to be paid all fees applicable to its ownership of the NDAs and ANDAs for all periods prior to the Closing.

3.11.        FDA Matters.

(a)           All Registrations held by Forest are set forth in Schedule 3.11(a) of the Forest Disclosure Schedule.  Other than as set forth on Schedule 3.11(a) of the Forest Disclosure Schedule: (i) the approved NDAs and ANDAs provide Forest with the legal right to market the Products in the United States in accordance with such NDAs and ANDAs, including all of its approved supplements; (ii) Forest has all Registrations from the FDA required for it to develop and manufacture the Products and such Registration are in full force and effect, subject only to certain supplements which may be necessary as a result of changes in the location of the manufacture of one or more Products; (iii) to the Knowledge of Forest, there are no facts that would prevent the satisfaction of, or compliance with, any additional FDA requirements for marketing or distributing the Products in the United States.  Forest has not received any notice that the FDA is, or may consider limiting, suspending, or revoking such Registrations; (iv) to Forest’s Knowledge, there is no false or misleading information or significant omission in an application, submission, or any other communication to the FDA regarding the Products; (v) subject only to certain supplements which may be necessary as a result of changes in the location of the manufacture of one or more Products, Forest has fulfilled and performed its obligations under each Registration in all respects, and no event has occurred or condition or state of facts exists which would constitute a breach or default that would cause revocation or termination of any such Registration; and, (vi) to the Knowledge of Forest, each Third Party supplier or manufacturer that is a party to a Product Rights Agreement or Manufacture and Supply Agreement complies with all applicable requirements of the FDA (including any drug establishment registration, drug listing, and good manufacturing requirements) to supply the Product to, or manufacture the Product for, Forest.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(b)           Subject only to certain supplements which may be necessary as a result of changes in the location of the manufacture of one or more Products and the information set forth on Schedule 3.11(a) of the Forest Disclosure Schedule, Forest is in compliance with the Act and all applicable statutes, rules, regulations, standards, guidelines, registrations, policies and orders administered or issued by the FDA with respect to the Products and the Purchased Assets, including new drug approval, investigational new drugs, annual reporting, good manufacturing practices, record-keeping, adverse event reporting and labeling.

(c)           Other than as set forth on Schedule 3.11(a) of the Forest Disclosure Schedule:  (i) Forest is not subject to any obligation arising under any FDA administrative or regulatory action or from any FDA inspection, FDA warning letter, FDA notice of violation letter, recall notice, or any other notice from the FDA to Forest or its Affiliates alleging a violation of any Applicable Law or required Registration, or any response or other commitment made to or with the FDA regarding the Product or the Inventory, other than obligations arising from ownership of the Registrations that are required by the FDA and set forth in the Act or in the approval letters for the NDAs or ANDAs and set forth in the FDA regulations, and (ii) Forest has not received any written or other notice from the FDA within the period beginning two (2) years prior to the date hereof alleging that the Products or the Inventory is the subject of any pending or threatened investigation in the United States and, to the Knowledge of Forest, there are no facts or circumstances that would reasonably be expected to give rise to any such notice.

3.12.        Taxes.  There are no liens for Taxes (other than liens for current Taxes not yet due and payable) on the Purchased Assets.  There is no action in respect of Taxes pending, or, to Forest’s Knowledge, threatened, that would result in such a lien.  To the extent a breach of the following would result in a liability of Caraco for Taxes to any Person, whether as a result of applicable law, contract or otherwise, (a) Forest has timely paid all Taxes that have become due or payable and has timely filed all Tax returns it is required to have filed, and (b) all such Tax returns were correct and complete in all material respects.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
3.13.        Product Records.  Since the date which is two (2) years prior to the date hereof, all of the Product Records have been maintained in accordance, in all material respects with Applicable Law and generally accepted business practices.

3.14.        Closing Date Inventory. As of the Closing Date, all Closing Date Inventory is in good and marketable condition and is in substantial compliance with all Applicable Law applicable to its manufacture, labeling and storage.

3.15.        Finders Fees.  There is no investment banker, broker, finder or other intermediary which has been retained by or is authorized to act on behalf of Forest who might be entitled to any fee or commission in connection with the transactions contemplated by this Agreement or the other Transaction Documents which would be payable by Caraco in whole or in part.

3.16.        Completeness of Certain Schedules.  Schedule 1.01(ooo) lists all those agreements pursuant to which Forest or any of its Affiliates in-license the ability to produce, market or sell one or more of the Products from a Third-Party.  Schedule 1.01(aaa) lists all agreements (including purchase orders outstanding and not fulfilled as of the Closing Date) pursuant to which Forest or any of its Affiliates acquires one or more of the Products in finished form from a Third-Party or engages a Third-Party to process or manufacture one or more of the Products or active pharmaceutical ingredients included in such Products or perform any step in the manufacture process, which, on or as of the Closing Date, shall be assigned to Caraco or its designee.  Schedule 1.01(gg) lists all agreements pursuant to which Forest or any of its Affiliates sells one or more of the Products to a Customer or provides rebates or discounts to a Customer determined by utilization of a Product.  Schedule 1.01(gg), under the heading “Customer Agreements,” lists all agreements pursuant to which Forest or any of its Affiliates sells one or more of the Products to a Customer or provides rebates or discounts to a Customer determined by utilization of a Product which exclusively cover the Products (i.e. do not relate to a bundle of products including products other than the Products).

3.17.        Financial Data.  Forest has provided Caraco with the financial data referenced in Schedule 3.17 of the Forest Disclosure Schedule.  All such information is derived from the books and records maintained by Forest in the ordinary course of its business, and is complete and accurate for the periods indicated.  Forest makes no representation or warranty as to any Cost of Goods information with respect to theophylline tablets which may be included in Schedule 3.17 with respect to the first year only, however, Forest agrees that this in no way affects the accuracy or reliability of the amounts set forth on Schedule 5.04(b) and Forest will not claim otherwise.

3.18.        Customers and Suppliers.  Schedule 3.18 of the Forest Disclosure Schedule lists the Customers of the Products for each of the two (2) most recent fiscal years and sets forth opposite the name of each such Customer the dollar amount of net sales to such Customer on a Product-by-Product basis, taking into account chargebacks, rebates, credits and other discounts attributable to such Customer, but not reflecting adjustments for unapplied chargebacks, rebates credits or discounts generally attributable to such Products.  No supplier of Forest or its Affiliates have indicated to Forest or its Affiliates that it will stop, or materially decrease the rate of, supplying materials, products or services and no Customer of the Products has indicated to Forest or its Affiliates that it will stop, or materially decrease the rate of, purchasing materials, products or services.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
3.19.        Full Disclosure.  No representation or warranty of Forest contained in this Agreement or in any schedule hereto or in any Transaction Document delivered to Caraco pursuant hereto or in connection herewith and none of the written data or information furnished or made available to Caraco by Forest (including, without limitation, any financial statements) contains an untrue statement of a material fact or omits to state a material fact required to be stated therein or necessary to make the statements made, in the context in which made, not false or misleading.

4.             REPRESENTATIONS AND WARRANTIES OF CARACO

Caraco represents and warrants to Forest as of the date hereof that:

4.01.        Corporate Existence and Power.  Caraco is duly incorporated or organized, validly existing and in good standing under the laws of its jurisdiction of organization and has all organizational powers and all material governmental licenses, authorizations, permits, consents and approvals required to carry on its business as now conducted.  Caraco is duly qualified to do business and is in good standing in each jurisdiction where such qualification is necessary.

4.02.        Corporate Authorization.  The execution, delivery and performance by Caraco of this Agreement and each other Transaction Document to which it is a party and the consummation of the transactions contemplated hereby and thereby are within Caraco’s corporate powers and have been duly authorized by all necessary corporate action on the part of Caraco.  This Agreement and each other Transaction Document to which it is a party constitutes a legal, valid and binding obligation of, and is enforceable against, Caraco, except as may be limited by bankruptcy, insolvency, reorganization, moratorium and other similar laws and equitable principles related to or limiting creditors’ rights generally and by general principles of equity and further.

4.03.        Governmental Authorization.  Except as set forth on Schedule 4.03, the execution, delivery and performance by Caraco of this Agreement the other Transaction Documents to which it is a party and the consummation of the transactions contemplated hereby and thereby require no action by or in respect of, or filing with, any Governmental Authority.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
4.04.        Noncontravention; Licenses and Permits.  The execution, delivery and performance by Caraco of this Agreement and the other Transaction Documents to which it is a party and the consummation of the transactions contemplated hereby and thereby do not and will not (i) violate the organizational documents of Caraco, (ii) assuming compliance with the matters referred to in Section 4.03, violate any Applicable Law or (iii) constitute a default under, or accelerate the performance required by, any term of any covenant, agreement or understanding to which Caraco or any of its Affiliates is a party, or any judgment, order, decree, law, rule or regulation to which Caraco or any of its Affiliates is subject.

4.05.        Claims; Litigation.  There is no action, suit, investigation or proceeding pending against, or to the best of Caraco’s Knowledge threatened against or affecting, Caraco or any of its Affiliates before any arbitrator or any Governmental Authority which in any manner challenges or seeks to prevent, enjoin, alter or materially delay the transactions contemplated by this Agreement or the other Transaction Documents.

4.06.        Financing.  Caraco has, or will have prior to the Closing, sufficient cash, available lines of credit or other sources of immediately available funds to enable it to make payment of the payments due at Closing.

4.07.        Finders Fees.  There is no investment banker, broker, finder or other intermediary which has been retained by or is authorized to act on behalf of Caraco who might be entitled to any fee or commission in connection with the transactions contemplated by this Agreement or the other Transaction Documents which would be payable by Forest in whole or in part.

4.08.        HSR Act.  Caraco has determined that the monetary value of the transactions contemplated by this Agreement is less than the “Size-of-Transaction Test” applicable to transactions of the type contemplated by this Agreement pursuant to the HSR Act.

5.             COVENANTS OF FOREST

5.01.        Third Party Notices and Consents; Biovail Consent.  Forest shall, and shall cause its Affiliates to, use their respective reasonable efforts to obtain the Required Consents, and to give notice to all Third Parties to whom such notice is required, to ensure the transfer of the Purchased Assets to Caraco.  In the event that (i) Forest is nonetheless unable to obtain the  Biovail Consent, and (ii) all other conditions to Closing hereunder shall have been satisfied or duly waived, then and in such event: (A) this Asset Purchase Agreement (including all definitions contained herein and all schedules and exhibits attached hereto) shall automatically be deemed to be amended, without the necessity or requirement of any further action by the Parties, to eliminate (except for the purposes of the interpretation of this Section 5.01) any reference to the Diltiazem Products or the Biovail Agreements, it being understood that in such event no rights in respect of the Diltiazem Products or the Biovail Agreements shall be assigned to or acquired by Caraco hereunder, (B) the Closing shall proceed subject to the conditions to Closing set forth in Article 8, and (C) at the Closing, Forest shall pay to Caraco, by wire transfer of immediately available funds, a sum equal to [* * *], as and for liquidated damages, and not as a penalty, for Forest’s inability to deliver the assets related to the Diltiazem Products, and the Parties agree that the determination of actual damages to Caraco from Forest’s inability to obtain the Biovail Consent are difficult to measure and that the amount of such liquidated damages payment is reasonable in light of the anticipated loss to Caraco, representing, among other things, the present value of Caraco’s estimated lost profits from the sale of the Diltiazem Products net of Forest’s incremental costs in connection with its continued distribution of such Products.  Forest agrees that it will not directly or indirectly challenge the reasonableness of such amount.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
5.02.        Stability Programs.  To the extent related to the Closing Date Inventory, Forest shall continue all stability testing required by Applicable Laws to be conducted which Forest is, as of the date hereof, conducting or causing to be conducted through its completion. Forest shall report the results of such tests to Caraco as soon as practicable, but in no event later than thirty (30) days after each stability testing station.

5.03.        Manufacturing Transition Services.  In connection with Caraco’s undertaking to take over the manufacturing of the Products promptly following the Closing Date in accordance with Section 6.03, Forest shall cooperate with Caraco, at Caraco’s reasonable request, in connection with the transfer of manufacturing technology included in the Purchased Assets as reasonably necessary to effectively enable Caraco to manufacture the Products.  Caraco shall reimburse Forest for the directly allocable costs (including internal costs but excluding, corporate, general or administrative overheads) incurred by Forest in providing such services, as determined in accordance with Forest’s standard cost accounting policies consistently applied to the manufacture of pharmaceutical products.

5.04.        Supply of Product.

(a)           Promptly after the date hereof, the Parties shall form a working group of appropriately qualified personnel to negotiate definitive supply and quality agreements to be effective at Closing pursuant to which Forest will manufacture and supply the Products to Caraco (together, the “Supply Agreement”), which Supply Agreement shall include, without limitation, the obligation of Forest to do all that is necessary to be able to supply Caraco with each Product, directly or through a qualified Third Party service provider, including but not limited to securing all applicable FDA approvals, and conducting, at its sole cost and expense, all required tests and studies, including bioequivalency studies.  The Supply Agreement shall also include customary ordering and forecasting mechanisms, quality control and quality assurance procedures and shall provide for (i) maintenance of satisfactory product and other liability insurance, (ii) the supply of the Products at Forest’s Cost of Goods for first Contract Year, and (iii) if, despite Caraco’s Commercially Reasonable Efforts to assume the commercial manufacture of the Products in accordance with Section 6.03, Caraco, after the end of the first Contract Year, continues to be unable to take over manufacturing of a Product or Products, the continued supply of such Products at Forest’s Cost of Goods plus a [* * *] mark-up for a period of up to ten (10) years following the Closing Date, which ten (10) year period may be extended upon the mutual agreement of the Parties.  The Parties agree that the Cost of Goods applicable under the Supply Agreement for the first Contract Year shall be the amounts set forth on Schedule 5.04(a).  For purposes of this Section 5.04, the term “Products” shall not include diltiazem or Products sold under the Tiazac(R) trademark.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(b)           Notwithstanding the foregoing, if and to the extent Forest does not or is unable to supply a Product to Caraco for any reason (including an inability to supply because a Product does not meet applicable quality requirements) in accordance with the Supply Agreement or through a Third Party,  Caraco shall be entitled to the offset provided pursuant to this Section for its Lost Profit with respect to such Product and the True-Up Payment, if any, with respect to such Product pursuant to Section 5.04(c) as its sole and exclusive remedy for such failure to supply, as set forth below and in subsection (c) as follows:

(i)           Caraco may offset against future Royalty payments due to Forest hereunder an amount equal to Caraco’s Lost Profit caused by such failure to supply (the actual amount of such offset against Royalties referred to herein as the “Offset Amount”) during the period in which Forest is required to supply Caraco with Products hereunder (i.e., up to ten (10) years from the Closing Date).

(ii)           For purposes of this Section, “Lost Profit” shall be calculated Quarterly in arrears by subtracting from [* * *]

(iii)           For purposes of this Section 5.04(b), “Caraco Net Profit” with respect to a Product shall have the meaning set forth in the annual sales and net profit projections (the “Projections”) for the relevant period as reasonably agreed to by the Parties and consistent with the sales forecasts delivered by Caraco under the Supply Agreement, but without taking into account any projected or actual failure or inability of Forest to supply Product to Caraco.

(iv)           To illustrate the calculation contemplated by clause (ii) above: [* * * ]

(v)           The Projections for the first Contract Year are attached as Schedule 5.04(b) which has been agreed to by the Parties.  Notwithstanding Section 5.04(b)(iii), the Projections for any Product (other than rimantadine) which has not been supplied or has been supplied in a de minimis amount during a Contract Year will remain the same for any subsequent year (but reduced in the second Contract year, pro rata, by the interim period included in the first Contract Year).  The estimated offsets provided pursuant to this Section will be trued-up annually as follows:  if the cumulative Royalties withheld by Caraco pursuant to this Section 5.04(b) in respect of any Contract Year as an offset against Royalties due Forest with respect to such Contract Year exceed Caraco’s Lost Profit for such year, Caraco shall pay to Forest the amount of such excess within 45 days following the end of such Contract Year. Notwithstanding the above, the first true-up will occur at the end of the second Contract Year. For purposes of the true-up provided in the foregoing sentences, Lost Profits shall be calculated Quarterly.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(c)           At the end of the second Contract Year (and at the end of each Contract Year thereafter), the Parties shall determine the aggregate amount, if any, that the Lost Profit calculated pursuant to Section 5.04(b) in respect of the first two Contract Years (or such subsequent Contract Year, as the case may be), exceeded the Offset Amount in respect of the relevant period.  In the event Lost Profit exceeded the Offset Amount (the “Shortfall”), Forest will make a cash payment in an amount equal to such Shortfall (the “True-Up Payment”) to Caraco within 45 days following the end of the relevant period.  In the event a True-Up Payment is payable with respect to the first two Contract Years, Forest shall, together with such True-Up Payment, pay interest on the Shortfall (determined with respect to the first Contract Year) in respect of the first Contract Year, if any, from the date which is 45 days after the end of the first Contract Year to the date of payment at the Agreed Rate in effect from time to time.

5.05.        Notices of Certain Events.  Forest shall promptly notify Caraco of:

(a)           any notice or other communication from any Person alleging that the consent of such Person is or may be required in connection with the transactions contemplated by this Agreement or any other Transaction Document;

(b)           any notice or other communication from any Governmental Authority in connection with the transactions contemplated by this Agreement or any other Transaction Document; and

(c)           any actions, suits, claims, investigations or proceedings commenced relating to Forest or the Purchased Assets that, if pending on the date of this Agreement, would have been required to have been disclosed pursuant to Section 3.07.

5.06.        Conduct of the Business.  From the date hereof until the Closing Date, Forest shall, and shall cause its Affiliates to, continue to maintain and use the Purchased Assets and market and sell the Products in the ordinary course consistent with past practice. Without limiting the foregoing, between the date hereof and the Closing Date, without the consent of Caraco Forest shall not:

(a)           Fail to exercise any rights of renewal with respect to any Assigned Contract or Registration that by its terms would otherwise expire; or

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(b)           Settle or compromise any claim or take or fail to take any action if any such settlement, compromise, act or failure to act could reasonably be anticipated to have a Material Adverse Effect.

6.             COVENANTS OF CARACO

6.01.         Access; Royalty Verification; Forest Confidentiality.

(a)           On and after the Closing Date but no more than once in any twelve (12) month period, Caraco will promptly afford to Forest and its agents reasonable access on reasonable prior notice during business hours to its properties, books, records, employees and auditors to the extent necessary to permit Forest to determine any matter relating to the Purchased Assets which arose prior to the Closing Date; provided that any such access by Forest shall not unreasonably interfere with the conduct of the business of Caraco.

(b)           Without limiting the generality of the foregoing, Caraco shall maintain, and shall require its Affiliates, distributors and licensees to maintain, books and records which accurately reflect Net Sales, any Offset Amount or Shortfall and the underlying information used to calculate figures, including number of units sold, for a period of at least five (5) years after the end of the period to which they relate.  Forest shall have the right, at its own expense, by an accountant or other authorized representative to which Caraco shall have no reasonable objection (the “Initial Auditor”), to inspect, audit and copy such books and records no more than once in any twelve (12) month period upon reasonable notice solely for purposes of verifying the Royalties payable to Forest hereunder, the Offset Amount and Shortfall, if any.  Such inspection shall be at Forest’s sole expense; provided, however, that in the event the inspection determines that Royalties have been underpaid, Caraco shall promptly make the appropriate payments or refunds to correct such underpayment and if an underpayment was by [* * *] or more of the amount of the relevant Royalty as calculated by Caraco, Caraco will be responsible for the costs of the Initial Auditor.  In the event Caraco disputes a finding by the Initial Auditor of an underpayment,  Caraco’s obligation to pay the costs of the Initial Auditor shall be suspended and the Parties shall retain a reputable accounting firm selected by the mutual agreement of the Parties in good faith (the “Review Auditor”), which firm shall review the Initial Auditor’s findings to determine if such auditor’s determination was accurate.  The fees and expenses payable to the Review Auditor shall be paid by Caraco, provided that if the Review Auditor determines that Royalties have not been underpaid, Forest will be responsible for the costs of such review inspection or audit in addition to the costs of the Initial Auditor.

(c)           Forest will hold, and will use its best efforts to cause its Representatives to hold, in confidence, unless compelled to disclose by judicial or administrative process or by other requirements of Applicable Law, all confidential documents and information concerning Caraco which may be disclosed to it in the course of the exercise of its rights pursuant to this Section.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
6.02.         Notices of Certain Events.  Caraco shall promptly notify Forest of:

(a)           any notice or other communication from any Person alleging that the consent of such Person is or may be required in connection with the transactions contemplated by this Agreement or any other Transaction Document;

(b)           any notice or other communication from any Governmental Authority in connection with the transactions contemplated by this Agreement or any other Transaction Document; and

(c)           any actions, suits, claims, investigations or proceedings commenced relating to Forest or the Purchased Assets that, if pending on the date of this Agreement, would have been required to have been disclosed pursuant to Section 4.05.

6.03.         Product Manufacture.  With respect to each Product other than diltiazem AB-rated to Tiazac(R)  or Products sold under the Tiazac(R) trademark, Caraco shall use Commercially Reasonable Efforts to assume diligently the commercial manufacture of the Products following the Closing Date.  For the sake of clarity, Caraco’s inability despite its use of Commercially Reasonable Efforts to commence manufacturing due to failure to obtain FDA approval for any Product or for its facility(ies) shall not be deemed to be a breach of its obligations under this Section.  The parties agree that Caraco is not precluded from using a Third Party to commercially manufacture the Products.

6.04.        Commercialization Diligence.  From and after the Closing Date, Caraco shall, and shall cause its Affiliates which are participating in the commercialization of the Products under this Agreement to, use Commercially Reasonable Efforts to market and sell the Products.  Caraco shall have the right to cease the production, marketing or sale of any Product directly or indirectly by it if Caraco has determined in its sole discretion that, based on its level of profitability, selling the Products is no longer commercially reasonable provided that (i) Caraco has provided Forest with reasonable written evidence of such level of profitability, and (ii) Caraco has previously conferred in good faith with Forest regarding possible alternatives to the cessation of the production, marketing and sale of such Product, including, for example, negotiating a revised royalty rate or a sale of the Products to a third party in accordance with Section 6.06 or Section 11.05.  Upon the cessation of the production, marketing or sale of any Product by Caraco, Caraco shall, upon Forest’s request, assign, transfer and deliver to Forest   [* * *] the Product Intellectual Property relating to any such discontinued Product and Forest shall thereafter be free to commercially exploit such Product Intellectual Property; provided that (a) in the event Forest would like to acquire any improvements to the Product Intellectual Property developed by Caraco following the Closing, Caraco and Forest shall negotiate in good faith appropriate compensation to Caraco for such improvements, and (b) in connection with such assignment and transfer Forest shall indemnify Caraco and its Affiliates with respect to such Product in the same manner and to the same extent Caraco is required to indemnify Forest hereunder with respect to such Product pursuant to Section 9.02. For the avoidance of doubt, it is understood that each Party shall retain all responsibility and liability for any claims related to Product design or infringement of the Product Intellectual Property arising from acts or omissions occurring only during any period in which such Party held the right to commercialize the Products hereunder and not for any period prior or subsequent to such Party’s right to commercialize the Products.

 
33

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
6.05.        Exclusivity. With respect to each Product other than diltiazem AB-rated to Tiazac(R)   or Products sold under the Tiazac(R) trademark, Caraco agrees that for a period of [* * *] years following the Closing Date, without the prior written consent of Forest, neither Caraco nor any of its Affiliates shall engage either directly or indirectly, as a principal or for its own account or solely or jointly with any Third Party, or as a stockholder, member, equity owner, consultant or in any other capacity in any corporation or joint stock association or in any other entity, in the clinical development, commercialization or marketing in the United States (including its territories and possessions) of a Competing Product, provided that in lieu of complying with the foregoing requirement, Caraco may elect to clinically develop, commercialize or market a Competing Product, Royalties payable hereunder shall be payable to Forest with respect to net sales of such Competing Product (calculated in the same manner as Net Sales of a Product) for the [* * *] year period following the Closing Date based on the royalty rates applicable to the corresponding Product as set forth in Section 2.09.  In the event Caraco elects to so commercialize or market a Competing Product, Caraco shall provide Forest with prior written notice reasonably in advance of its introduction of such new product, and provided Caraco is using Commercially Reasonable Efforts to sell the Competing Product during the [* * *] year period following the Closing Date, Section 6.04 will be inapplicable with respect to the related Product and Caraco may cease to commercialize the related Product without any obligation to negotiate with Forest for the return of the same.

If any of the terms contained in this Section shall for any reason be held invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other terms in this Section, but this Section shall be construed as if such invalid, illegal or unenforceable provision had never been contained herein.  It is the intention of the Parties that if any of the restrictions or covenants contained herein is held to cover a geographic area or to be for a length of time which is not permitted by Applicable Law, or in any way construed to be too broad or to any extent invalid, such provision shall not be construed to be null, void and of no effect, but to the extent such provision would be valid or enforceable under Applicable Law, a court of competent jurisdiction shall construe and interpret or reform this Section to provide for a covenant having the maximum enforceable geographic area, time period and other provisions (not greater than those contained herein) as shall be valid and enforceable under such Applicable Law.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
6.06.        Transfers and Assignments of Purchased Assets. Neither Caraco nor its Affiliates may transfer or assign any of the Purchased Assets to a Third Party without (a) Forest’s prior written consent, which may not be unreasonably withheld (it being agreed that it would be unreasonable for Forest to withhold its consent in connection with a transfer of the Purchased Assets by Caraco to the extent such transfer is required by a Governmental Authority), and (b) the prior agreement of the transferee or assignee to perform all of the obligations of Caraco and its Affiliates set forth herein with respect to such transferred or assigned Purchased Assets (e.g., if any Product is the subject of such transfer or assignment, the agreement to pay all Royalties with respect to such Product).  No transfer or assignment pursuant to this Section 6.06 shall relieve, release or discharge Caraco’s duties, obligations and liabilities hereunder with respect to such transferred or assigned Purchased Assets.

7.             COVENANTS OF FOREST AND CARACO; OTHER AGREEMENTS

7.01.        Confidentiality.

(a)           From and after the date hereof, Caraco and its Affiliates will hold, and will use their best efforts to cause their respective officers, directors, employees, accountants, counsel, consultants, advisors and agents (collectively, “Representatives”) to hold, in confidence, unless compelled to disclose by judicial or administrative process or by other requirements of Applicable Law, all confidential documents and information which Forest has furnished to Caraco, its Affiliates or its Representatives in connection with the transactions contemplated by this Agreement, except to the extent that such documents or information (a) can be shown to have been (i) previously known on a nonconfidential basis by Caraco, (ii) in the public domain through no fault of Caraco or (iii) later lawfully acquired by Caraco from sources other than Forest or (b) are included in the Purchased Assets and have been purchased by Caraco pursuant to Section 2.01; provided that Caraco may disclose such information to its Representatives in connection with the transactions contemplated by this Agreement so long as such Persons are informed by Caraco of the confidential nature of such information and are directed by Caraco to treat such information confidentially.  Caraco shall be responsible for any failure to treat such information confidentially by such Persons.  If this Agreement is terminated, Caraco and its Affiliates will, and will use their best efforts to cause their respective Representatives to, destroy or deliver to Forest, at Caraco’s sole expense, all documents and other materials, and all copies thereof, obtained by Caraco or its Affiliates or on their behalf from Forest in connection with this Agreement that are subject to such confidence.

(b)           From and after the date hereof, Forest and its Affiliates will hold, and will use their best efforts to cause their respective Representatives to hold, in confidence, unless compelled to disclose by judicial or administrative process or by other requirements of Applicable Law, all confidential documents and information which Forest has furnished to Caraco, its Affiliates or its Representatives in connection with the transactions contemplated by this Agreement, except to the extent that such documents or information are (i) known on a nonconfidential basis by Forest following the Closing Date, (ii) in the public domain through no fault of Forest or (iii) later lawfully acquired by Forest from sources other than Caraco; provided that Forest may disclose such information to its Representatives in connection with the transactions contemplated by this Agreement so long as such Persons are informed by Forest of the confidential nature of such information and are directed by Forest to treat such information confidentially.  After the Closing, Forest and its Affiliates will, and will use their best efforts to cause their respective Representatives to, destroy or deliver to Caraco, upon Caraco’s request and at Forest’s sole expense, all such information that is subject to such confidence, provided however, Forest may retain a copy of all documents or materials included in the Purchased Assets for archival purposes, for purposes of fulfilling its obligations under this Agreement and under Applicable Law and to the extent such documents or materials include or relate to Retained Assets or Retained Liabilities.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
7.02.        Further Assurances.  Subject to the terms and conditions of this Agreement, Caraco and Forest will use their Commercially Reasonable Efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary or desirable under Applicable Law to consummate the transactions contemplated by this Agreement and the other Transaction Documents.  Forest and Caraco agree to execute and deliver such other documents, certificates, agreements and other writings and to take such other actions as may be necessary or desirable in order to consummate or implement expeditiously the transactions contemplated by this Agreement and the other Transaction Documents and to vest in Caraco good title to the Purchased Assets.  In the event that after the Closing Caraco requests additional information, data or documentation to transfer technology related to the Products, Forest shall cooperate with such transfer.  Caraco shall reimburse Forest for the directly allocable costs (including internal costs but excluding, corporate, general or administrative overheads) incurred by Forest in providing such services, as determined in accordance with Forest’s standard cost accounting policies consistently applied.

7.03.        Chargebacks and Credits.  All Chargebacks or Credits with respect to sales of the Products which were recognized prior to the Closing pursuant to a Customer Agreement or with respect to sales of the Products for which Forest or any of its Affiliates received the purchase price thereof shall be for the account of Forest or its Affiliates and all Chargebacks or Credits with respect to sales of the Products, including sales made pursuant to Section 2.02, which are recognized after the Closing pursuant to a Customer Agreement or with respect to which the Products were sold by or on behalf of Caraco shall be for the account of Caraco.  For the avoidance of doubt, the Parties agree that the Party that ultimately receives the benefit of the underlying sale of the applicable Product shall be responsible for handling and paying any related Chargeback or Credit.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
Notwithstanding the preceding, in light of the difficulties of determining which Party may have sold Product which is the subject of a wholesaler Chargeback or Credit as to which lot numbers are not included in the relevant Chargeback invoice, the Parties agree to assign responsibility for such Chargebacks and Credits (“Unidentified Claims”) as follows: all such Unidentified Claims with respect to wholesaler invoices to the trade dated on or before the date which is the Closing Date plus the Trade Channel Days shall be for the account of Forest or its Affiliates and all such Unidentified Claims with respect to wholesaler invoices to the trade dated after such date shall be for the account of Caraco.  In addition, the responsibility for the allocation of wholesaler corrections and customer re-bills, irrespective of when received by Forest or Caraco, shall be allocated in accordance with the preceding provisions based upon the date for the wholesaler invoice which originally reflected the sales to which such correction or re-bill is made.  The Parties will cooperate in good faith and share all relevant wholesaler data so as to be able to allocate the responsibility for Chargebacks and Credits in accordance with the foregoing and to verify such allocations.

7.04.        Closing Date Inventory Receivables.  From and after the Closing Date, to the extent that Caraco does not relabel, at it sole cost and expense, any Closing Date Inventory with its or its Affiliate’s National Drug Code number and such Closing Date Inventory is delivered to a Customer for sale by or on behalf of Caraco, Forest shall promptly remit to Caraco any payment amounts received by it or any of its Affiliates from any such Customer with respect to such Closing Date Inventory.  Forest may invoice Caraco for the direct cost of processing such remittances.

7.05.        Medicaid Rebates for Products.

(a)           Forest shall be responsible for Medicaid rebates associated with the first units of Product sold following the Closing Date, up to the aggregate number of units included in the Trade Channel Inventory as set forth on Schedule 1.01(gggg).  All other Medicaid rebates, including, without limitation, Medicaid rebates attributable to the Closing Date Inventory, shall be for Caraco’s account.  Subject to compliance with Applicable Law, Caraco shall have the right, but not the obligation, to relabel the Closing Date Inventory with its National Drug Code number at its sole cost and expense.  Forest shall be responsible for the processing and payment of all Medicaid rebates for Trade Channel Inventory and Closing Date Inventory bearing its or its Affiliate’s National Drug Code number; provided, however, Forest shall invoice Caraco for any such rebates representing units in excess of the number of units contained in the Trade Channel Inventory plus the direct cost of processing any such rebates.  Any and all payments due and owing to Forest under this Section shall be paid no later than thirty (30) days following Caraco’s receipt of Forest’s invoice therefor, which invoice shall include reasonable supporting documentation and shall specify: (i) each rebate program to which the rebate is paid, (ii) the period covered by the payment, (iii) the specific amount of the rebate paid to any such programs; and (iv) a reasonable description of the direct cost to Forest of processing such claim.  The parties will cooperate as contemplated in Section 7.09 to ensure a smooth and accurate processing of the Medicaid rebates in accordance with this Section.  Subject only to the foregoing, each Party shall at all times have the exclusive responsibility for the processing and payment of any and all rebates arising from or with respect to Product bearing its National Drug Code numbers.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(b)           The Parties agree that, with respect to Medicaid rebates applicable to Closing Date Inventory sold by Caraco which bears a National Drug Code number of Forest or any of its Affiliates, the “best price” (as defined under the Social Security Act, 42 U.S.C. Sec.1396r-8(c)(1)(C)) and the “average manufacturer price” (as defined under the Social Security Act, 42 U.S.C. Sec.1396r-8(k)(1)) shall be calculated on a Product by Product basis by adding (i) the per unit Cost of Goods of each such Product and (ii) the per unit Royalty due upon the sale of such Product pursuant to the terms hereof.  In furtherance of the foregoing, Caraco will deliver to Forest, within fifteen (15) days after the end of each calendar quarter, the number of units sold and the expiration date of each such Product, each identified by National Drug Code number.  Caraco agrees to provide to Forest any additional data or other information regarding sales or pricing of the Product by Caraco which Forest requests as necessary for the calculation of the “best price,” the “average manufacturer price” and the rebates contemplated in this Section 7.05.  Caraco agrees that Forest may use all information described in this Section 7.05(b) in Forest’s reporting to the Center for Medicaid Services.

7.06.        Federal Government Pricing Programs.  Promptly after the Closing Date, Forest shall notify the Center for Medicaid Services and the Veteran’s Affairs National Acquisition Center (the foregoing being hereinafter collectively referred to as the “Federal Programs”) of Caraco’s distribution rights with respect to the Product, and that as of the Closing Date that Forest will no longer support or sell the Product under any contracts in place with said Federal Programs.  Caraco shall establish its own contractual relationships with the Federal Programs as soon as commercially reasonable, and Forest shall use its reasonable efforts to cooperate with Caraco to assure the smooth transition of federal contracting to Caraco.

7.07.        Recalls; Complaints.  Except as otherwise provided in the Supply Agreement, if any Governmental Authority with applicable jurisdiction shall order, or it shall otherwise become necessary to perform, any corrective action or market action with respect to Products sold by Caraco following the Closing (including, without limitation, any recall, field correction, market withdrawal, stock recovery, customer notice or restriction), while Caraco shall have the exclusive responsibility to appropriately manage such action and shall be responsible for the costs of management of such action, this will not alter the liability of the Party responsible for the recall under this Agreement (including, but not limited to, as set forth in Section 2.04(c)).  Caraco shall also be exclusively responsible for handling all customer complaints, inquiries and similar communications, and, with respect to Product manufactured by Forest, Forest shall cooperate with Caraco, including the completion of an investigation and the preparation and submission of a complaint report to Caraco or its designees.  The preceding shall not be in lieu or limitation of any obligation of indemnity of a Party pursuant to Section 9.02.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
7.08.        Product Returns.  Returns of the Products shall be the responsibility of the Party who delivered, or caused to be delivered, to the customer the lot with respect to which a return has occurred.  From and after the Closing, each Party shall be responsible for, and shall reimburse the other Party for, the invoiced value of the returns of the Product from batches from which any sale has been made by it prior to the Closing Date. Following the Closing Date, Caraco shall be responsible for any price adjustments to Trade Channel Inventory (e.g., shelf stocking adjustments) that are related to any pricing, rebate allowance, promotional or marketing program or activities, special returns policy or special restocking program offered by Caraco.

7.09.        Cooperation with Respect to Chargebacks, Rebates & Returns; Working Group.  The Parties shall cooperate following the Closing (including, without limitation, through tracking and exchange of lot number information and pro-ration of amounts due pursuant to Customer Agreements) from time to time and for such period as may reasonably be required to implement the intended allocation of economic responsibilities set forth in Sections 7.03 through 7.08.  To facilitate such cooperation, the Parties shall establish a working group with appropriate members from each party’s finance departments to facilitate the exchange of commercial information required to allocate responsibility for Chargebacks, Credits, rebates, returns or any other payments or credits required to be made pursuant to pursuant to Sections 7.03 through 7.08.

7.10.        Safety Data.  Each of the Parties hereto shall disclose to the other Party all safety reports and other information (collectively “Safety Data”) which they may from time to time receive or obtain with respect to any adverse drug experiences with respect to the Products, in accordance with a reporting protocol to be mutually agreed by the Parties as promptly as possible following the Closing Date.  From and after the Closing, Caraco shall be responsible for the reporting of Safety Data to regulatory authorities.

7.11.        Regulatory Matters.

(a)           Responsibility for the Product.  From and after the Closing Date, Caraco shall have all post-Closing regulatory responsibilities under applicable laws and regulations, reporting and otherwise, in connection with the Products, except that Forest shall have the authority and responsibility with respect to regulatory matters and compliance with Applicable Law relating to Forest’s manufacture and supply obligations pursuant to Section 5.04(a) and the Supply Agreement referenced therein, including, securing necessary FDA approvals and site transfer approvals.

(b)           Transfer of NDAs and ANDAs; Regulatory Responsibility Transfer.

(i)           On the Closing Date, the Parties shall file with the FDA all of the documents and information required by the FDA to effect the transfer of the Product Intellectual Property, including the NDAs and ANDAs from Forest or any Affiliate of Forest to Caraco or an Affiliate of Caraco designated by Caraco.  Forest shall file and shall cause its Affiliates to file all of the documents and the information required of a former owner, including but not limited to a letter acknowledging the transfer of ownership of the Product Intellectual Property, including the NDAs and ANDAs, and Caraco shall file the information required of a new owner.  Each of Caraco and Forest shall take any and all other actions required by the FDA or other relevant Governmental Authorities, if any, to effect the transfer of the Product Intellectual Property, including the NDAs and ANDAs from Forest or its Affiliate to Caraco or its designated Affiliate as soon as reasonably practicable.  Forest may retain an archival copy of the Product Intellectual property, including the NDAs and ANDAs, including supplements and records that are required to be kept under 21 C.F.R. Sec.314.81.  In addition to the foregoing, the Parties shall file with the FDA any documentation and information required to transfer to Caraco any agency status Forest may have with respect to any in-licensed Products.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(ii)           From and after the Closing Date, Caraco shall assume from Forest or its Affiliate all responsibility for any and all post-Closing fee obligations for holders or owners of approved NDAs and ANDAs relating to the Products, including, but not limited to, those defined under the Prescription Drug User Fee Act of 1992, as the same may be amended from time to time.

(iii)           From and after the Closing Date, Caraco shall assume all regulatory responsibility with respect to the Products including those related to (A) the marketing and promotion of the Product; (B) Adverse Drug Reaction reporting relating to the Products; and (C) the filing of NDAs and ANDAs and/or supplements to NDAs and ANDAs for product line extensions, extensions of the expiry date and additional product claims or additions to the labeling of the Products.

(c)           Communications with Regulatory Agencies.  From and after the Closing Date, Caraco shall have responsibility for all communication with the FDA with respect to the matters relating to the Products.  Notwithstanding the foregoing, during any period in which Forest is responsible for manufacturing a Product or Forest has any liability under Section 5.04(a), Caraco will invite Forest to participate in all interactions between Caraco and the FDA with respect to manufacturing issues, and Forest shall have final decision making authority and responsibility with respect to all regulatory issues relating to manufacturing and supply activities being performed by Forest or its Third Party designee or for which Forest or its Third Party designee is responsible in connection with the supply of Products to Caraco pursuant to Section 5.04(a) or the Supply Agreement referenced therein.  From and after the Closing Date, Forest shall make available to Caraco, copies of all correspondence to or from the FDA or other applicable Governmental Authority relating exclusively to the manufacturing and testing of the Products.  From and after the Closing Date, Forest shall make available to Caraco copies of all regulatory correspondence regarding regulatory warning letters, withdrawal of any Products, and correspondence bearing on the safety and efficacy of the Products and reports of inspection related exclusively to the Products.  To the extent such regulatory correspondence is material and applies to the facility where the Products are manufactured generally or to Forest products in addition to the Products, to the extent practicable Forest shall provide Caraco with redacted copies of such correspondence and in any event, will promptly advise Caraco of its receipt of any such correspondence and will provide a summary of any issues affecting the Products raised by such correspondence.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(d)           Additional Information.  From and after the Closing Date, Forest shall provide to Caraco in a timely manner, but in no event less than sixty (60) days prior to the due date of Caraco’s annual report to the FDA with respect to the Products, all information (in written form) which Caraco reasonably requests regarding the manufacture of the Products which may be needed for Caraco to comply with applicable annual reporting requirements of the FDA and Applicable Laws.

7.12.        Reporting Information.  From time to time after the Closing, the Parties hereto shall deliver to each other such information and data concerning the transactions contemplated hereby as either Party may reasonably request which is required to enable such Party to complete and file all national, state and local forms, filings or other required reports required to be filed or made by it pursuant to Applicable Law and to complete all customary tax and accounting procedures and otherwise to enable such Party to satisfy its internal accounting, tax and other requirements.

7.13.        Certain Filings.  Forest and Caraco shall cooperate with one another (i) in determining whether any action by or in respect of, or filing with, any Governmental Authority is required, including filings under the HSR Act, or any actions, consents, approvals or waivers are required to be obtained from parties to any material contracts, in connection with the consummation of the transactions contemplated by this Agreement and the other Transaction Documents and (ii) in taking such actions or making any such filings, furnishing information required in connection therewith and seeking timely to obtain any such actions, consents, approvals or waivers, including, the prompt filing of the Settlement Agreement and the agreements ancillary to the Settlement Agreement, including the Transaction Documents, to the Federal Trade Commission and the Department of Justice pursuant to Section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, as amended and, if necessary, the prompt filing or submission of any notifications or additional information required or requested pursuant to the HSR Act.

7.14.           Public Announcements.  The Parties agree to consult with each other before issuing any press release or making any public statement with respect to this Agreement or the transactions contemplated hereby and, except for any press releases and public statements the making of which may be required by Applicable Law or any listing agreement with any national securities exchange, will not issue any such press release or make any such public statement prior to such consultation.  Nothing herein shall prevent a party from disclosing the terms of this Agreement as required by law, including by filing a copy of the Transaction Documents with the Securities and Exchange Commission.  In the event copies of this Agreement or any other Transaction Documents are to be filed with the Securities and Exchange Commission or as otherwise required by Applicable Laws, the disclosing Party shall consult with and shall reasonably consider comments from the non-disclosing Party with respect to proposed redactions, recognizing that the disclosing party shall have final decision making authority with respect to the form and content of the document to be so filed.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
7.15.        WARN Act.  Forest shall provide and be responsible for any notice required, pursuant to the WARN Act and any other state or local applicable plant closing notification law with respect to a mass layoff or plant closing relating to the business of manufacturing, marketing or selling the Products that occurs as a result of or after the Closing, and Forest shall indemnify and hold Caraco and its Affiliates harmless from and against any and all liability relating to any obligations or claims arising from a failure to comply with such notice requirements.

8.             CONDITIONS TO CLOSING

8.01.        Conditions to Obligations of Caraco and Forest.  The obligations of Caraco and Forest to consummate the Closing are subject to the satisfaction or waiver of the following conditions:

(a)           All conditions for the Stipulations and Orders (as such terms are defined in the Settlement Agreement) to be filed pursuant to the Settlement Agreement (other than the closing of the transactions under this Asset Purchase Agreement) have been satisfied;

(b)           No provision of any Applicable Law shall prohibit the consummation of the Closing.

(c)           At the Closing Date, there shall be no injunction, restraining order or decree of any nature of any court or governmental agency or body of competent jurisdiction that is in effect that restrains or prohibits the consummation of the transactions contemplated by this Agreement or otherwise seeks to modify any of the terms of the transactions contemplated by this Agreement or questions the validity or legality of this Agreement or any of the transactions contemplated by this Agreement.  At the Closing Date, there shall be no action, suit, or proceeding brought by any governmental agency or body pending before any court or governmental agency or body wherein an unfavorable injunction, judgment, order, decree or ruling would restrain or prohibit the consummation of the transactions contemplated by this Agreement or otherwise seeks to modify any of the terms of the transactions contemplated by this Agreement or questions the validity or legality of this Agreement or any of the transactions contemplated by this Agreement.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
8.02.        Conditions to Obligation of Caraco.  The obligation of Caraco to consummate the Closing is subject to the satisfaction of the following further conditions:

(a)           (i) Forest shall have performed in all material respects all of its obligations hereunder required to be performed by it on or prior to the Closing Date, (ii) the representations and warranties of Forest contained in this Agreement or in any other Transaction Document and in any certificate or other writing delivered by Forest pursuant hereto shall be true at and as of the Closing Date, as if made at and as of such date, with only such exceptions as would not in the aggregate reasonably be expected to have a Material Adverse Effect and (iii) Caraco shall have received a certificate signed by a duly authorized officer of Forest to the foregoing effect.

(b)           Forest shall have made the deliveries required to be made by it under Sections 2.06 and 2.07.

(c)           All material registrations, filings, applications, notices, consents, approvals, orders, qualifications and waivers required to be made, filed, given or obtained with, to or from any governmental authorities in connection with the consummation of the transactions contemplated by this Agreement shall have been made, filed, given or obtained.

(d)           There shall not have been any Material Adverse Effect.

8.03.        Conditions to Obligation of Forest.  The obligation of Forest to consummate the Closing is subject to the satisfaction of the following further conditions:

(a)           (i) Caraco shall have performed in all material respects all of its obligations hereunder required to be performed by it at or prior to the Closing Date, (ii) the representations and warranties of Caraco contained in this Agreement or any other Transaction Document and in any certificate or other writing delivered by Caraco pursuant hereto shall be true in all material respects at and as of the Closing Date, as if made at and as of such date, with only such exceptions as would not in the aggregate reasonably be expected to have a Material Adverse Effect and (iii) Forest shall have received a certificate signed by a duly authorized officer of Caraco to the foregoing effect.

(b)           Caraco shall have made the deliveries required to be made by it under Section 2.07.

9.             SURVIVAL; INDEMNIFICATION

9.01.           Survival.  The representations and warranties of the Parties hereto contained in this Agreement shall survive the Closing until [***] from the Closing Date; provided, however, that the representations and warranties of Forest contained in Sections 3.01, 3.02, 3.06, 3.08(a) and the first sentence 3.12 and the representations and warranties of Caraco contained in Sections 4.01 and 4.02 shall survive the Closing indefinitely.  The covenants and agreements of the Parties hereto contained in this Agreement or in any certificate or other writing delivered pursuant hereto or in connection herewith, including without limitation, Caraco’s obligations to use Commercially Reasonable Efforts to commercialize the Products, to pay royalties hereunder, and to perform all of the assumed liabilities and obligations, shall survive the Closing indefinitely or for the shorter period explicitly specified therein, except that for such covenants and agreements that survive for such shorter period, breaches thereof shall survive indefinitely or until the latest date permitted by Applicable Law.  Notwithstanding the preceding, any breach of a covenant, agreement, representation or warranty in respect of which indemnity may be sought under this Agreement shall survive the time at which it would otherwise terminate pursuant to the preceding sentences, if notice of the inaccuracy or breach thereof giving rise to such right of indemnity shall have been given to the Party against whom such indemnity may be sought prior to such time.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
9.02.       Indemnification.

(a)           Effective at and after the Closing, Forest hereby indemnifies Caraco and its Affiliates against and agrees to hold each of them harmless from any and all damage, loss and expense (including reasonable expenses of investigation, experts and reasonable attorneys’ fees and expenses in connection with any action, suit or proceeding) (“Damages”) actually suffered by Caraco and its Affiliates arising from Third Party Claims arising out of or otherwise relating to:

(i)            any misrepresentation or breach of warranty (each such misrepresentation and breach of warranty a “Warranty Breach”) or breach of covenant or agreement made or to be performed by Forest pursuant to this Agreement;

(ii)           the Retained Assets or Retained Liabilities (including, any Retained Liabilities that becomes a liability of Caraco and its Affiliates under any common law doctrine of de factor merger or successor liability or otherwise by operation of law).

(iii)           the manufacture, marketing, sale or distribution by Forest or its Third Party designee of the Products prior to the Closing Date, and on or after the Closing Date to the extent arising from Forest’s or its Third Party Designee’s failure to comply with: (a) Applicable Law (including current Good Manufacturing Practices (as set forth in C.F.R. 21 Parts 210 and 211, or any successor law or regulation thereto); (b) the specifications for the Products or the facilities; or (c) any other quality or legal standards applicable under the Supply Agreement, in each case with respect to the manufacturing and supply of Products to be supplied by Forest to Caraco pursuant to Section 5.04(a) hereof; provided that, in no event shall Forest be liable under Section 9.02(a) for any Damages arising from the negligence, strict liability of, or violation of any law by, Caraco, any of its Affiliates or any licensee of Caraco or any of its Affiliates.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.


(b)           Effective at and after the Closing, Caraco hereby indemnifies Forest and its Affiliates against and agrees to hold each of them harmless from any and all Damages actually suffered by Forest or any of its Affiliates arising from Third Party Claims arising out of or otherwise relating to:

(i)            any Warranty Breach or breach of covenant or agreement made or to be performed by Caraco pursuant to this Agreement;

(ii)           any Assumed Liability; or

(iii)           the manufacture, marketing, sale or distribution of the Products on or after the Closing Date by Caraco or its Third Party designee (including, without limitation, lawsuits, regulatory or other actions or proceedings, recalls, complaints or other Damages incurred with respect to the Product sold by or on behalf of Caraco or any of its Affiliates after the Closing Date, but not to the extent such claim arises from a manufacturing issue for which Forest is required to indemnify Caraco pursuant to Section 9.02(a)(iii) above);

provided that, in no event shall Caraco be liable under Section 9.02(b) for any Damages arising from the negligence, strict liability of, or violation of any law by, Forest or any of its Affiliates, including in connection with Forest’s manufacture of the Products for Caraco.

9.03.        Indemnification Procedures.

(a)           The Party seeking indemnification under Section 9.02 (the “Indemnified Party”) agrees to give prompt notice in writing to the Party against whom indemnity is to be sought (the “Indemnifying Party”) of the assertion of any claim or the commencement of any suit, action or proceeding (a “Claim”) in respect of which indemnity may be sought under such Section.  Such notice shall set forth in reasonable detail such Claim and the basis for indemnification (taking into account the information then available to the Indemnified Party).  The failure to so notify the Indemnifying Party shall not relieve the Indemnifying Party of its obligations hereunder, except to the extent such failure shall have adversely prejudiced the Indemnifying Party.

(b)           The Indemnifying Party shall be entitled to participate in the defense of any Claim brought by any Third Party and, subject to the limitations set forth in Section 9.03(c), shall be entitled to control and appoint lead counsel for such defense, in each case at its own expense.  Each Party shall cooperate, and cause their respective Affiliates to cooperate, in the defense or prosecution of any Claim brought by any Third Party and shall furnish or cause to be furnished such records, information and testimony, and attend such conferences, discovery proceedings, hearings, trials or appeals, as may be reasonably requested in connection therewith.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(c)           If the Indemnifying Party shall assume the control of the defense of any Claim brought by any Third Party in accordance with the provisions of Section 9.03(b), (i) the Indemnifying Party shall obtain the prior written consent of the Indemnified Party (which shall not be unreasonably withheld) before entering into any settlement of such Claim if the settlement does not release the Indemnified Party and its affiliates from all liabilities and obligations with respect to such Claim or the settlement imposes injunctive or other equitable relief against the Indemnified Party or any of its affiliates and (ii) the Indemnified Party shall be entitled to participate in the defense of such Claim and to employ separate counsel of its choice for such purpose.  The fees and expenses of such separate counsel shall be paid by the Indemnified Party.

9.04.           Assignment of Claims.  If the Indemnified Party receives any payment from an Indemnifying Party in respect of any Damages pursuant to Section 9.02 and the Indemnified Party could have recovered all or a part of such Damages from a third party other than an insurance company (a “Potential Contributor”) based on the underlying Claim asserted against the Indemnifying Party, the Indemnified Party shall assign such of its rights to proceed against the Potential Contributor as are necessary to permit the Indemnifying Party to recover from the Potential Contributor the amount of such payment.

10.           TERMINATION

10.01.      Grounds for Termination.  This Agreement may be terminated at any time prior to the Closing:

(a)           By either Party hereto if the Parties (as defined in the Settlement Agreement) have returned to the Court (as defined in the Settlement Agreement) pursuant to Section 6(a) of the Settlement Agreement.

(b)           by mutual written agreement of Forest and Caraco;

(c)           by either Party hereto if the other Party or any of its Affiliates is in breach of the Settlement Agreement or any agreement ancillary to the Settlement Agreement.

(d)           by either Forest or Caraco if consummation of the transactions contemplated hereby would violate any nonappealable final order, decree or judgment of any Governmental Authority having competent jurisdiction.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
The Party desiring to terminate this Agreement pursuant to clause 10.01(b) or 10.01(c) shall give notice of such termination to the other Party.

10.02.      Effect of Termination.  If this Agreement is terminated as permitted by Section 10.01, such termination shall be without liability of either Party (or any stockholder, director, officer, employee, agent, consultant or representative of such party) to the other Party to this Agreement; provided that if such termination shall result from the willful (i) failure of either Party to fulfill a condition to the performance of the obligations of the other Party, (ii) failure to perform a covenant of this Agreement or (iii) breach by either Party hereto of any representation or warranty or agreement contained herein, such party shall be fully liable for any and all Damages incurred or suffered by the other Party as a result of such failure or breach.  The provisions of Sections 7.01 (Confidentiality), 11.02 (Amendments and Waivers), 11.05 (Successors and Assigns), 11.06 (Governing Law), 11.08 (Dispute Resolution; Arbitration), 11.08 (Limitation of Liability) and 11.09 (Waiver of Jury Trial) shall survive any termination hereof pursuant to Section 10.01.

11.           MISCELLANEOUS

11.01.      Notices.  All notices, requests and other communications to any Party hereunder shall be in writing (including facsimile transmission) and shall be given,

 
(a)
if to Forest, to:

Forest Laboratories, Inc.
909 Third Avenue
New York, New York 10022
Facsimile: 212-224-6740
Attention: Chief Executive Officer

 
With a copy to (which copy shall not constitute notice):

Forest Laboratories, Inc.
909 Third Avenue
New York, New York 10022
Facsimile: 212-224-6740
Attention: General Counsel

 
With a copy to (which copy shall not constitute notice):

Dornbush Schaeffer Strongin & Venaglia, LLP
747 Third Avenue
New York, New York 10017
Facsimile: 212-753-7673
Attention: Melissa E. Cooper, Esq.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
 
(b)
if to Caraco, to:

Caraco Pharmaceutical Laboratories, Ltd.
1150 Elijah McCoy Dr.
Detroit, Michigan 48202
Facsimile: (313) 556-4102
Attention: Daniel H. Movens

With a copy to (which copy shall not constitute notice):

Caraco Pharmaceutical Laboratories, Ltd.
1150 Elijah McCoy Dr.
Detroit, Michigan 48202
Facsimile: (313) 556-4198
Attention: Andrew D. Bos

With a copy to (which copy shall not constitute notice):

Bodman, LLP
1901 St. Antoine Street
Detroit, Michigan 48226
Facsimile: (313) 393-7579
Attention: Fred B. Green

or such other address or facsimile number as such party may hereafter specify for the purpose by notice to the other Parties hereto.  All such notices, requests and other communications shall be deemed received on the date of receipt by the recipient thereof if received prior to 5:00 p.m. in the place of receipt and such day is a Business Day in the place of receipt.  Otherwise, any such notice, request or communication shall be deemed not to have been received until the next succeeding Business Day in the place of receipt.

11.02.      Amendments and Waivers.

(a)           Any provision of this Agreement may be amended or waived if, but only if, such amendment or waiver is in writing and is signed, in the case of an amendment, by each Party to this Agreement, or in the case of a waiver, by the Party against whom the waiver is to be effective.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(b)           No failure or delay by any party in exercising any right, power or privilege hereunder shall operate as a waiver thereof nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any other right, power or privilege.  The rights and remedies herein provided shall be cumulative and not exclusive of any rights or remedies provided by law.

11.03.      Expenses.  Except as otherwise provided herein, all costs and expenses incurred in connection with this Agreement shall be paid by the Party incurring such cost or expense.

11.04.     Transfer Taxes.  All excise, sales, use, value added, registration stamp, recording, documentary, conveyancing, franchise, property, transfer, gains and similar Taxes, levies, charges and fees incurred in connection with the transactions contemplated by this Agreement, if any, shall be borne by Caraco.

11.05.      Successors and Assigns; Assignment.  The provisions of this Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and assigns; provided that (i) Caraco may not assign its rights or delegate its obligations under this Agreement, in whole or in part, without the prior written consent of Forest, which consent shall not be unreasonably withheld, and (ii) Forest may not assign its obligations to manufacture and supply Products to Caraco without Caraco’s prior written consent, which consent may not be unreasonably withheld, and (iii) Forest shall not assign any of its rights to Royalty payments without Caraco’s prior written consent, which consent shall not be unreasonably withheld.  No transfer or assignment pursuant to this Section shall relieve, release or discharge a Party’s duties, obligations and liabilities hereunder.  Any attempted assignment or delegation in violation of this Section shall be void.

11.06.      Relationship Between the Parties.  The Parties’ relationship hereunder, including pursuant to Sections 7.03 through 7.09, is solely that of independent contractors.  This Agreement does not create any partnership, joint venture, agency or similar business relationship between the Parties.  Neither Party is a legal representative of the other Party, and neither Party can assume or create any obligation, representation, warranty or guarantee, express or implied, on behalf of the other Party for any purpose whatsoever.

11.07.      Governing Law.  This Agreement shall be governed by and construed in accordance with the law of the State of Illinois, without regard to the conflicts of law rules of such state.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
11.08.      Dispute Resolution; Arbitration.

(a)           The Parties recognize that a bona fide dispute as to certain matters may, from time to time, arise during that relates to a Party’s rights and/or obligations under the Transaction Documents (a “Dispute”).  In the event of the occurrence of a Dispute, either Party may, by written notice to the other Party, have such Dispute referred to the respective officers designated below, or their successors, for attempted resolution by good faith negotiation within thirty (30) days after such notice is received.  Such designated officers are as follows:

 
For Caraco:
Chief Executive Officer
 
For Forest:
Chief Executive Officer

(b)           In the event of a Dispute arising in connection with any Transaction Document which is not resolved under Section 11.08(a), such Dispute shall be submitted to arbitration under the then existing Commercial Arbitration Rules of the American Arbitration Association.  Unless the Parties otherwise agree in writing, the arbitration proceedings shall be conducted and the arbitrators shall be appointed in accordance with the Rules then in effect, subject to the procedures described in this Section 11.08.

(c)           The arbitration proceedings shall take place in Chicago, Illinois, or such other location as may be mutually agreed by the Parties.  The arbitration will be conducted in the English language.

(d)           The arbitration shall be held before a panel of three arbitrators (the “Arbitrators”).  One Arbitrator shall be chosen by Forest and one Arbitrator shall be chosen by Caraco, and the third Arbitrator shall be chosen by mutual agreement of the Arbitrators chosen by Forest and Caraco.

(e)           Unless the Parties otherwise agree in writing, during the period of time that any arbitration proceeding is pending under this Agreement, the Parties shall continue to comply with all those terms and provisions of this Agreement that are not the subject of the pending arbitration proceeding.

(f)           The award or decision of a majority of the arbitrators pursuant to this Section shall be binding and conclusive on the Parties, provided that the enforcement of such award or decision may be obtained in any court having jurisdiction over the Party against whom such enforcement is sought.  The losing party shall pay all reasonable attorneys fees and costs associated with such arbitration.  If there is any dispute that is not subject to arbitration and for which the United States District Court for the Northern District of Illinois does not have subject matter jurisdiction, the state courts in Illinois shall have jurisdiction.  In connection with any dispute arising out of or in connection with this Agreement that is not subject to arbitration, each Party hereby expressly consents and submits to the personal jurisdiction of the federal and state courts in the State of Illinois.

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
Nothing contained in this Agreement shall deny any Party the right to seek injunctive or other equitable relief from a court of competent jurisdiction in the context of a bona fide emergency or prospective irreparable harm, and such an action may be filed and maintained notwithstanding any ongoing arbitration proceeding.

11.09.       Specific Performance.  The Parties hereto agree that irreparable damage would occur if any provision of this Agreement were not performed in accordance with the terms hereof and that, with respect to Disputes arising prior to the Closing Date, following the issuance of a decision in an arbitration conducted pursuant to Section 11.08, the Parties shall be entitled to an injunction or injunctions to prevent breaches of this Agreement or to enforce specifically the performance of the terms and provisions hereof in the United States District Court for the Northern District of Illinois or any Illinois State court sitting in Chicago, Illinois, in addition to any other remedy to which they are entitled at law or in equity.

11.10.      LIMITATION OF LIABILITY.

(a)           Each Party’s maximum liability for all Warranty Breaches shall not exceed [* * *] and neither Party shall be liable to the other for Warranty Breaches unless the aggregate amount of Damages with respect to such Warrant Breaches exceeds [* * *] and then only to the extent of such excess, provided, however, that the foregoing limitations of liability shall not apply to the liabilities arising from either Party’s indemnification obligations with respect to Third Party claims pursuant to Section 9.02 or to Forest’s obligations pursuant to Section 5.04(b).

(b)           IN NO EVENT SHALL EITHER PARTY, ITS DIRECTORS, OFFICERS, EMPLOYEES, AGENTS OR AFFILIATES BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, INCIDENTAL, PUNITIVE, SPECIAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES (INCLUDING ,WITHOUT LIMITATION, LOST PROFITS), WHETHER BASED UPON A CLAIM OR ACTION OF CONTRACT, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER TORT, ARISING OUT OF OR RELATED TO THIS AGREEMENT; PROVIDED, HOWEVER, THAT THE FOREGOING LIMITIATION OF LIABILITYSHALL NOT APPLY TO THE LIABILITIES ARISING FROM EITHER PARTY’S GROSS NEGLIGENCE OR WILLFULL MISCONDUCT OR LIMIT EITHER PARTY’S INDEMNIFICATION OBLIGATIONS WITH RESPECT TO THIRD PARTY CLAIMS.

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

 
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
11.12.      Counterparts; Effectiveness; Third Party Beneficiaries.  This Agreement may be signed in any number of counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument.  Any counterpart may be signed and transmitted by facsimile with the same force and effect as if such counterpart was an ink-signed original.  This Agreement shall become effective when each Party hereto shall have received a counterpart hereof signed by the other Party hereto. Until and unless each Party has received a counterpart hereof signed by the other Party hereto, this Agreement shall have no effect and no Party shall have any right or obligation hereunder (whether by virtue of any other oral or written agreement or other communication).  No provision of this Agreement is intended to confer any rights, benefits, remedies, obligations, or liabilities hereunder upon any Person other than the Parties hereto and their respective successors and assigns.

11.13.      Representation by Legal Counsel.  Each Party hereto represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting.  In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption shall exist or be implied against the Party which drafted such terms and provisions.

11.14.      Entire Agreement.  This Agreement and the other Transaction Documents constitute the entire agreement between the Parties with respect to the subject matter of hereby and thereby and supersedes all prior agreements and understandings, both oral and written, between the Parties with respect to the subject matter of this Agreement and the other Transaction Documents.  Notwithstanding the foregoing, the Settlement Agreement shall be deemed of equal dignity to this Agreement and this Agreement shall be construed together with the Settlement Agreement in a consistent manner as reflecting a single intent and purpose.

11.15.      Severability.  If any term, provision, covenant or restriction of this Agreement is held by a court of competent jurisdiction or other Governmental Authority to be invalid, void or unenforceable, the remainder of the terms, provisions, covenants and restrictions of this Agreement shall remain in full force and effect and shall in no way be affected, impaired or invalidated so long as the economic or legal substance of the transactions contemplated hereby is not affected in any manner materially adverse to any Party.  Upon such a determination, 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 in order that the transactions contemplated hereby be consummated as originally contemplated to the fullest extent possible.

 
52

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
11.16.      Disclosure Schedules.  Forest has set forth information on the Forest Disclosure Schedule in a section thereof that corresponds to the section of this Agreement to which it relates.  A matter set forth in one section of the Forest Disclose Schedule need not be set forth in any other section so long as its relevance to such other section of the Forest Disclosure Schedule or section of the Agreement is reasonably apparent on the face of the information disclosed therein to the Person to which such disclosure is being made.  The parties acknowledge and agree that (i) the schedules to this Agreement may include certain items and information solely for informational purposes for the convenience of the Person to which such disclosure is being made and (ii) the disclosure by Forest of any matter in the Forest Disclosure Schedules shall not be deemed to constitute an acknowledgment by Forest that the matter is required to be disclosed by the terms of this Agreement or that the matter is material.

[SIGNATURE PAGE FOLLOWS]

 
53

 
 
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be duly executed by their respective authorized officers as of the day and year first above written.

 
FOREST LABORATORIES, INC.
 
By: /s/ Howard Solomon
 
Name: Howard Solomon
Title: Chairman and CEO
   
 
CARACO PHARMACEUTICAL LABORATORIES, LTD.
 
By: /s/ Daniel H. Movens
 
Name: Daniel H. Movens
Title: CEO

 
 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
Forest Laboratories, Inc.
909 Third Avenue
New York, NY 10022

September 8, 2009

Caraco Pharmaceutical Laboratories, Ltd.
1150 Elijah McCoy Drive
Detroit, Michigan 48202

 
Re:
That certain Asset Purchase Agreement (the “Agreement”) dated July 10, 2009 by and between Forest Laboratories, Inc. (“Forest”) and Caraco Pharmaceutical Laboratories, Ltd. (“Caraco”)

Gentlemen,

Forest and Caraco have agreed to amend the Agreement in accordance with the following terms and conditions:

 
1.
The first sentence of the first paragraph of Section 2.07 of the Agreement is amended hereby to read in its entirety as follows:

Unless this Agreement shall have been terminated in accordance with Section 8, the closing (the “Closing”) of the purchase and sale of the Purchased Assets hereunder shall take place at the offices of Dornbush Schaeffer Strongin & Venaglia, LLP, 747 Third Avenue, New York, New York 10017, as soon as possible, but in no event later than fifteen (15) Business Days after satisfaction of the conditions set forth in Section 8, or at such other time or place as Forest and Caraco may agree in writing (the “Closing Date”).

 
2.
Except to the extent amended hereby, the Agreement remains unmodified and in full force and effect in accordance with its terms.

[SIGNATURE PAGE FOLLOWS]

 
 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
Very truly yours,


  FOREST LABORATORIES, INC.
     
 
By:
/s/ Fancis I. Perier, Jr.
 
Name:      Fancis I. Perier, Jr.
Title:    Senior Vice President - Finance & CFO
 
AGREED AND ACCEPTED:

CARACO PHARMACEUTICAL LABORATORIES, LTD.
 
By:           
/s/ GP Singh  
Name:
Title:
GP Singh
Senior Vice President - Business Strategies

 
 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
Forest Laboratories, Inc.
909 Third Avenue
New York, NY 10022

September 11, 2009

Caraco Pharmaceutical Laboratories, Ltd.
1150 Elijah McCoy Drive
Detroit, Michigan 48202

 
Re:
That certain Asset Purchase Agreement dated July 10, 2009, as amended by that certain letter agreement dated September 8, 2009 (as so amended, the “Agreement”), by and between Forest Laboratories, Inc. (“Forest”) and Caraco Pharmaceutical Laboratories, Ltd. (“Caraco”).

Gentlemen,

Forest and Caraco have agreed to amend the Agreement in accordance with the following terms and conditions:

 
3.
The first sentence of the first paragraph of Section 2.07 of the Agreement is amended hereby to read in its entirety as follows:

Unless this Agreement shall have been terminated in accordance with Section 8, the closing (the “Closing”) of the purchase and sale of the Purchased Assets hereunder shall take place at the offices of Dornbush Schaeffer Strongin & Venaglia, LLP, 747 Third Avenue, New York, New York 10017, as soon as possible, but in no event later than twenty (20) Business Days after satisfaction of the conditions set forth in Section 8, or at such other time or place as Forest and Caraco may agree in writing (the “Closing Date”).

 
4.
Except to the extent amended hereby, the Agreement remains unmodified and in full force and effect in accordance with its terms.

[SIGNATURE PAGE FOLLOWS]

 
 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
 
Very truly yours,
   
 
FOREST LABORATORIES, INC.
 
By:
/s/ Francis I. Perier, Jr.
 
Name:    Francis I. Perier, Jr.
Title:      Senior Vice President - Finance & CFO

AGREED AND ACCEPTED:

CARACO PHARMACEUTICAL LABORATORIES, LTD.
 
By:
/s/ GP Singh  
Name:    GP Singh
Title:      Senior Vice President - Business Strategies

 
 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
Forest Laboratories, Inc.
909 Third Avenue
New York, NY 10022

September 22, 2009

Caraco Pharmaceutical Laboratories, Ltd.
1150 Elijah McCoy Drive
Detroit, Michigan 48202

 
Re:
That certain Asset Purchase Agreement dated July 10, 2009, as amended by the letter agreements dated September 8, 2009 and September 11, 2009 (as so amended, the “Agreement”), by and between Forest Laboratories, Inc. (“Forest”) and Caraco Pharmaceutical Laboratories, Ltd. (“Caraco”).

Gentlemen,

Forest and Caraco have agreed to amend the Agreement in accordance with the following terms and conditions:

 
5.
Section 5.01 of the Agreement is amended hereby to read in its entirety as follows:

Section 5.01. Third Party Notices and Consents; Biovail Consent.  Forest shall, and shall cause its Affiliates to, use their respective reasonable efforts to obtain the Required Consents, and to give notice to all Third Parties to whom such notice is required, to ensure the transfer of the Purchased Assets to Caraco.  In the event that (i) Forest is nonetheless unable to obtain the Biovail Consent, and (ii) all other conditions to Closing hereunder shall have been satisfied or duly waived, then and in such event:

 
(A)
(1) this Agreement (including all definitions contained herein and all schedules and exhibits attached hereto) shall automatically be deemed to be amended, without the necessity or requirement of any further action by the Parties, to eliminate (except for the purposes of the interpretation of this Section 5.01) any reference to the Diltiazem Products or the Biovail Agreements, it being understood that in such event no rights in respect of the Diltiazem Products or the Biovail Agreements shall be assigned to or acquired by Caraco hereunder and (2) the Closing shall proceed subject to the conditions to Closing set forth in Article 8; provided that the Parties shall not be required to execute and deliver the Assignment and Assumption Agreement as contemplated by Section 2.07; and

 
 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
 
(B)
during the period beginning on the Closing Date and ending six (6) Business Days thereafter, Forest shall continue to use its respective reasonable efforts to obtain the Biovail Consent and (1) if the Biovail Consent is received within such six (6) Business Day period, each Party shall execute and deliver to the other Party the Assignment and Assumption Agreement and the deemed amendments to this Agreement made in accordance with the preceding clause (A) shall, upon the execution and delivery of the Assignment and Assumption Agreement, automatically be deemed to be null and void without the necessity or requirement of any further action by the Parties and Forest’s rights in respect of the Diltiazem Products and the Biovail Agreements shall be assigned to or acquired by Caraco in accordance with and subject to the terms of this Agreement as if they were assigned or acquired at the Closing, or (2) if the Biovail Consent is not received within such six (6) Business Day period, then, upon the expiration of such six (6) Business Day period Forest shall pay to Caraco, by wire transfer of immediately available funds, a sum equal to [* * *], as and for liquidated damages, and not as a penalty, for Forest’s inability to deliver the assets related to the Diltiazem Products, and the Parties agree that the determination of actual damages to Caraco from Forest’s inability to obtain the Biovail Consent are difficult to measure and that the amount of such liquidated damages payment is reasonable in light of the anticipated loss to Caraco, representing, among other things, the present value of Caraco’s estimated lost profits from the sale of the Diltiazem Products net of Forest’s incremental costs in connection with its continued distribution of such Products.  Forest agrees that it will not directly or indirectly challenge the reasonableness of such amount.  Caraco agrees that if the Biovail Consent is not so obtained, Forest shall retain all of its rights to and interests in the Diltiazem Products and the Biovail Agreements and shall be relieved of any obligation to transfer the same to Caraco.  Caraco and Forest agree that, upon the receipt of the Biovail Consent as contemplated by clause (1) above or the payment of the [* * *] in liquidated damages by Forest to Caraco as contemplated by clause (2) above, the transactions contemplated hereby shall be deemed closed for the purposes of Section 6(b) of the Settlement Agreement.

 
6.
Except to the extent amended hereby, the Agreement remains unmodified and in full force and effect in accordance with its terms.

[SIGNATURE PAGE FOLLOWS]

 
 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
 
Very truly yours,
   
 
FOREST LABORATORIES, INC.
   
 
By:
/s/ David F. Solomon
 
Name:     David F. Solomon
Title:       Corporate Vice President - Business Development and Strategic Planning

AGREED AND ACCEPTED:

CARACO PHARMACEUTICAL LABORATORIES, LTD.
 
By:
/s/ GP Singh  
Name:      GP Singh
Title:        Senior Vice President - Business Strategies
 
signature page to asset purchase agreement
 
 

EX-3.01 3 ex3_01.htm EXHIBIT 3.01 ex3_01.htm

EXHIBIT 3.01
 
ARTICLES OF INCORPORATION
OF CARACO PHARMACEUTICAL LABORATORIES, LTD.
(a compilation of the current articles in effect as of October 26, 2009)
 
The corporation identification number (CID) assigned by the Bureau is 345-364.
 
ARTICLE I
 
The name of the corporation (the “Corporation”) is Caraco Pharmaceutical Laboratories, Ltd.
 
ARTICLE II
 
The purpose or purposes for which the Corporation is formed is to engage in any activity within the purposes for which corporations may be organized under the Business Corporation Act of Michigan, as amended (the “Act”).
 
ARTICLE III
 
 
1.
The total authorized capital stock is:
 
 
Common shares
50,000,000
 
 
Preferred shares
15,000,000
 
2.           A statement of all or any of the relative rights, preferences and limitations of the shares of each class is as follows:
 
(a)           Common Shares.  Each common share (“Common Share”) shall entitle the holder of record thereof to one vote at all meetings of the Corporation’s shareholders, except meetings at which only holders of another specified class or series of capital stock are entitled to vote. Subject to any preference rights with respect to the payment of dividends attaching to the Preferred Shares or any series thereof, the holders of Common Shares shall be entitled to receive, as and when declared by the Board, dividends that may be paid in money, property or by the issuance of fully paid capital stock of the Corporation. In the event of a liquidation, dissolution or winding up of the Corporation or other distribution of the Corporation’s assets among shareholders for the purpose of winding up the Corporation’s affairs, whether voluntary or involuntary, and subject to the rights, privileges, conditions and restrictions attaching to the Preferred Shares (as defined herein) or any series thereof, the Common Shares shall entitle the holders thereof to receive the Corporation’s remaining assets following payment and satisfaction of all of the Corporation’s liabilities as contemplated by the Act.
 
 
 

 

(b)           Preferred Shares.  The Board of Directors (the “Board”) is hereby authorized, subject to any limitations prescribed by law or these Amended and Restated Articles of Incorporation, to provide for the issuance of preferred shares (“Preferred Shares”) from time to time in one or more series, each such series to have such distinctive designation or title, powers, prefences, dividend rates and rights as may be fixed by the Board of Directors prior to the issuance of any shares thereof.
 
ARTICLE IV
 
1.           The address of the current registered office is:  30600 Telegraph Road, Bingham Farms, Michigan 48025.
 
2.           The name of the current resident agent is:  CT Corp.
 
ARTICLE V
 
When a compromise or arrangement or a plan of reorganization of the Corporation is proposed between the Corporation and its creditors or any class of them or between the Corporation and its shareholders or any class of them, a court of equity jurisdiction within the state, on application of the Corporation or of a creditor or shareholder thereof, or on application of a receiver appointed for the Corporation, may order a meeting of the creditors or class of creditors or of the shareholders or class of shareholders to be affected by the proposed compromise or arrangement or reorganization, to be summoned in such manner as the court directs. If a majority in number representing 3/4 in value of the creditors or class of creditors or of the shareholders or class of shareholders to be affected by the proposed compromise or arrangement or a reorganization, agree to a compromise or arrangement or a reorganization of the Corporation as a consequence of the compromise or arrangement, the compromise or arrangement and the reorganization, if sanctioned by the court to which the application has been made, shall be binding on all the creditors or class of creditors, or on all the shareholders or class of shareholders and also on the Corporation.
 
ARTICLE VI
 
1.             (a)           The number of directors of the Corporation shall be determined by and provided for in the manner set forth in the Bylaws of the Corporation.
 
(b)           Subject to the rights of the holders of any series of Preferred shares then outstanding, the directors shall be classified, with respect to the time for which they severally hold office, into three (3) classes, as nearly equal in number as reasonably possible, with the term of office of the first class to expire initially at the 1995 annual meeting of shareholders, the term of office of the second class to expire initially at the 1996 annual meeting of shareholders and the term of office of the third class to expire initially at the 1997 annual meeting of shareholders, and with the directors of each class to hold office until their successors are duly elected and qualified. At each annual meeting of shareholders following such classification and election, directors elected to succeed those directors whose terms expire shall be elected for a term of office to expire at the third succeeding annual meeting of shareholders after their election.
 
2.           Advance notice of nominations for the election of directors, other than by the Board or a committee thereof, shall be given in the manner provided in the Bylaws.
 
3.           All elections of directors by shareholders shall be determined by a vote of a majority of the shares present in person or represented by proxy and voting on such elections.
 
 
2

 

4.           Subject to the rights of the holders of any series of Preferred Shares then outstanding, newly created directorships resulting from any increase in the authorized number of directors and any vacancies on the Board resulting from death, resignation, retirement, disqualification, removal from office or other cause shall be filled only by a majority vote of the remaining directors then in office though less than a quorum, and/or by a vote to ratify or elect by a majority of the shares present in person or represented by proxy and voting on such ratification or election, and directors so chosen shall hold office for a term expiring at the annual meeting of shareholders at which the term of office of the class to which they have been elected expires or until their successors have been duly elected and qualified. No decrease in the number of directors constituting the Board shall shorten the term of any incumbent director.
 
5.           Subject to the rights of the holders of any series of Preferred Shares then outstanding, any director, or the entire Board, may be removed from office at any time, but only for cause and only by the affirmative vote of the holders of at least a majority of the voting power of all of the then outstanding shares of capital stock of the Corporation entitled to vote generally in the election of directors, voting together as a single class at a duly convened meeting of the shareholders.
 
6.           Elections of the Corporation’s directors need not be by written ballot unless the Corporation’s Bylaws shall so provide.
 
ARTICLE VII
 
The Corporation is to have perpetual existence; provided, however, that the Corporation may be dissolved in accordance with the applicable provisions of the Act.
 
ARTICLE VIII
 
The private property or assets of the shareholders of the Corporation shall not, to any extent whatsoever, be subject to the payment of liabilities of the Corporation.
 
ARTICLE IX
 
The provisions for the regulation of the Corporation’s internal affairs are to be stated in the Corporation’s Bylaws, as the same may be amended from time to time.
 
ARTICLE X
 
1.           In addition to the rights, powers, privileges and discretionary authority expressly conferred by statute upon the Board, the Board is hereby authorized and empowered to adopt, amend and repeal the Bylaws of the Corporation and to exercise any and all powers and privileges and to do any and all acts and things as may at any time or from time to time be exercised or done by the Corporation; subject, nevertheless, to the provisions of the statutes of the State of Michigan, of these Amended and Restated Articles of Incorporation, and of any Bylaws of the Corporation from time to time adopted; provided, however, that no Bylaw so adopted shall serve to invalidate any prior action of the Board which would have been valid if such Bylaw had not been adopted.
 
 
3

 

2.           Any adoption, amendment or repeal of the Corporation’s Bylaws shall be effected in the manner provided in the Bylaws.
 
ARTICLE XI
 
The Corporation’s books may be kept within or outside the State of Michigan as may be designated from time to time by the Board.
 
ARTICLE XII
 
The Board, when evaluating any offer of another party, (i) to make a tender or exchange offer for any voting capital stock of the Corporation, or (ii) to effect a Business Combination, as that term is defined in Chapter 7A of the Act, is, in connection with the exercise of its judgment in determining what is in the best interests of the Corporation as a whole, authorized to give due consideration to such factors as the Board determines to be relevant, including, without limitation:
 
(a)           the interests of the Corporation’s shareholders;
 
(b)           whether the proposed transaction might violate federal or state laws, rules or regulations;
 
(c)           not only the consideration being offered in the proposed transaction (in relation to the then current market price for the Corporation’s capital stock) but also the market price for the Corporation’s capital stock over a period of years, the estimated price that might be achieved in a negotiated sale of the Corporation’s assets as a whole or in part or through orderly liquidation, the premiums over market price which would be paid for the securities of other corporations in similar transactions, current political, economic and other factors bearing on securities prices, and the Corporation’s financial condition, employment practices and policies and future prospects; and
 
(d)           the social, legal and economic effects upon employees, suppliers, customers and others having similar relationships with the Corporation, and the communities in which the Corporation conducts its business.
 
In connection with any such evaluation, the Board is authorized to conduct such investigations and to engage in such legal proceedings as the Board may determine.
 
ARTICLE XIII
 
1.           Notwithstanding any provision in these Amended and Restated Articles of Incorporation or the Corporation’s Bylaws, or any provision of law which might otherwise require a lesser vote or no vote, but in addition to any vote of the holders of any class or series of the Corporation’s capital stock required by these Amended and Restated Articles of Incorporation or by law, the affirmative vote of the holders of at least 66-2/3% of the voting power of all the then-outstanding shares of the Corporation’s capital stock entitled to vote generally in the election of directors, voting together as a single class, shall be required (i) to change any powers, preferences or rights with respect to any class or series of shares of the Corporation, including but not limited to reducing the amounts payable thereon upon liquidation of the Corporation or diminishing or eliminating any voting rights pertaining thereto, or (ii) to amend or repeal, or to adopt any provision inconsistent with, this Article XIII, Article VI or Chapter 7B of the Act.
 
 
4

 

2.           Notwithstanding any other provisions of these Amended and Restated Articles of Incorporation or the Corporation’s Bylaws (and. notwithstanding the fact that a lesser percentage or separate class vote may be specified by law, these Amended and Restated Articles of Incorporation or the Corporation’s Bylaws), the following vote shall be required to amend or repeal, or adopt any provision inconsistent with Chapter 7A of the Act:  (i) the affirmative votes of holders of at least 90% of the voting power of all outstanding capital stock voting together as a single class; and (ii) the affirmative vote (excluding votes cast by the Interested Shareholder or its Affiliate or Associate, as defined in Chapter 7A of the Act, who is, or whose Affiliate is, a party to the business combination being voted upon) of the holders of at least 66-2/3% of the voting power of all capital stock.
 
3.           In addition to the vote requirements specified in paragraphs 1 and 2 of this Article XIII, the affirmative vote of at least 66-2/3% of the voting power of all of the then-outstanding shares of the Corporation’s capital stock entitled to vote generally in the election of directors, other than such capital stock of which an Interested Shareholder, as that term is defined in Chapter 7A of the Act, is the beneficial owner, voting together as a single class, shall be required to amend, repeal or adopt any provision inconsistent with Article XII hereof.
 
ARTICLE XIV
 
1.           The Corporation shall not purchase, directly or indirectly, at a price above the Market Price (as hereinafter defined), any shares of any class, now or hereafter authorized, of the Corporation’s capital stock from any Selling Shareholder (as hereinafter defined) or any Affiliate or Associate (as hereinafter defined) of a Selling Shareholder, unless such purchase has been approved in advance by an affirmative vote of the holders of at least a majority of the voting power of all of the outstanding shares of capital stock of the Corporation held by shareholders other than the Selling Shareholder or any Affiliate or Associate of the Selling Shareholder who is, or whose Affiliate is, a party to the transaction described in this Section 1 being voted upon, voting together as a single class. Such affirmative vote shall be required notwithstanding the fact that no vote may be required, or that a lesser percentage may be specified, by law or any agreement with any national securities exchange, or otherwise, but no such affirmative vote shall be required with respect to any purchase or other acquisition of securities made as part of a tender or exchange offer by the Corporation to purchase securities of the same class made on the same terms to all holders of such securities and complying with the applicable requirements of the Securities Exchange Act of 1934, as amended (the “1934 Act”) and the rules and regulations thereunder as then in effect.
 
2.           For purposes of this Article XIV:
 
(a)           “Selling Shareholder” shall mean any Person (other than the Corporation or any Subsidiary (as hereinafter defined)) who or which proposes to sell to, or cause to be acquired by, the Corporation all or any portion of the capital stock of the Corporation then beneficially owned, directly or indirectly, by such Person and who or which:
 
 
5

 

 
(i)
is the beneficial owner, directly or indirectly, of 3% or more of the class of capital stock to be acquired; or
 
 
(ii)
is an Affiliate of the Corporation and at any time within the two year period immediately prior to the date in question was the beneficial owner, directly or indirectly, of 3% or more of the class of capital stock to be acquired; or
 
 
(iii)
is an assignee or has otherwise succeeded to any shares of the class of securities to be acquired which were at any time within the two-year period immediately prior to the date in question beneficially owned by a Selling Shareholder, if such assignment or succession shall have occurred in the course of a transaction or transactions not involving a public offering within the meaning of the Securities Act of 1933, as amended.
 
(b)           “Person” shall mean any individual, firm, corporation or other entity and shall include any group comprising any Person with whom such Person or any Affiliate or Associate of such Person has any agreement, arrangement or understanding, directly or indirectly, for the purpose of acquiring, holding, voting or disposing of the Corporation’s capital stock.
 
(c)           A Person shall be a “beneficial owner” or shall “beneficially own” any security:
 
 
(i)
which such Person or any of its Affiliates or Associates beneficially owns, directly or indirectly, within the meaning of Rule 13d-3 of the General Rules and Regulations under the 1934 Act, as in effect on the effective date of these Amended and Restated Articles of Incorporation; or
 
 
(ii)
which such Person or any of its Affiliates or Associates has (a) the right to acquire (whether such right is exercisable immediately or only after the passage of time), pursuant to any agreement, arrangement or understanding or upon the exercise of conversion rights, exchange rights, warrants or options, or otherwise, or (b) the right to vote pursuant to any agreement, arrangement or understanding; or
 
 
(iii)
which are beneficially owned, directly or indirectly, by any other Person with which such Person or any of its Affiliates or Associates has any agreement, arrangement or understanding for the purpose of acquiring, holding, voting or disposing of any Shares.
 
 
6

 

(d)           “Market Price” shall mean the average closing sale price during the 30-day period immediately preceding the date in question of a share of the Corporation’s capital stock on the principal United States securities exchange registered under the 1934 Act on which such stock is listed, or, if such stock is not listed on any such exchange, the average closing bid quotation with respect to a share of such stock during the 30-day period immediately preceding the date in question on the National Association of Securities Dealers, Inc. Automated Quotations System or any comparable system then in use, or if no such quotations are available, the fair market value on the date in question of a share of such stock as determined in good faith by a majority of the directors.
 
(e)           An “Affiliate” of a specified person, is a person that directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, the person specified.  The term “control” (including the terms “controlling”, “controlled by” and “under common control with”) means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a person, whether through the ownership of voting capital stock, by contract, or otherwise.
 
(f)           The term “Associate” means (i) any corporation or organization (other than the Corporation or a Subsidiary) of which such person is an officer or partner or is directly or indirectly, the beneficial owner of ten percent (10%) or more of any class of capital stock, (ii) any trust or other estate in which such person has a substantial beneficial interest or as to which such person serves as trustee or in a similar fiduciary capacity, and (iii) any relative or spouse of such person, or any relative of such spouse, who has the same residence as such person or who is a director or officer of the Corporation or a Subsidiary.
 
(g)           Nothing contained in this Article XIV shall be construed to relieve any Selling Shareholder or any other Person from any fiduciary obligation imposed by law.
 
(h)           The Board shall have the power and duty to construe and interpret this Article XIV, including, without limitation (i) whether a Person is a Selling Shareholder, (ii) whether a Person is an Affiliate or Associate of another, (iii) whether Section 1 of this Article XV is or has become applicable in respect of a proposed transaction, (iv) what the Market Price is and whether a price is above Market Price, and (v) when or whether a purchase or agreement to purchase any share or shares of any of the capital stock of the Corporation has occurred and when or whether a Person has become a beneficial owner of any of the Corporation’s securities.
 
(i)           “Subsidiary” means any corporation of which a majority of each class of voting capital stock is owned, directly or indirectly, by the Corporation.
 
(j)           Notwithstanding any other provision of these Amended and Restated Articles of Incorporation or the Corporation’s Bylaws (and notwithstanding the fact that a lesser percentage or separate class vote may be specified by law, these Amended and Restated Articles of Incorporation or the Corporation’s Bylaws), the affirmative vote (excluding votes cast by the Selling Shareholder or its Affiliate or Associate who is, or whose Associate or Affiliate is, a party to the transaction described in Section 1 of this Article XV being voted upon) of the holders of at least 66-2/3% of the voting power of all outstanding capital stock, voting together as a single class, shall be required to amend, repeal or adopt any provision inconsistent with this Article XIV.
 
 
7

 

3.           In the event that a purchase of shares of any capital stock by the Corporation is subject to and governed by paragraph 1 of this Article XIV and such capital stock is listed on a national securities exchange, the purchase of such capital stock, in addition to satisfying all other requirements of this Article XIV, shall be made on the open market and not as the result of a privately negotiated transaction.
 
ARTICLE XV
 
A director of the Corporation shall not be personally liable to the Corporation or its shareholders for monetary damages for breach of fiduciary duty as a director, except for liability (i) for any breach of the director’s duty of loyalty to the. Corporation or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (iii) for a violation of section 551(1) of the Act, (iv) for any transaction from which the director derived an improper personal benefit, or (v) for any act or omission occurring prior to the effective date of this Article XV.  If the Act hereafter is amended to further eliminate or limit the liability of a director, then a director of the Corporation, in addition to the circumstances in which a director is not personally liable as set forth in the immediately preceding sentence, shall not be liable to the fullest extent permitted by the Act, so amended. For purposes of this Article XV, “fiduciary duty as a director” shall include, but not be limited to, any fiduciary duty arising out of serving at the request of the Corporation as a director of another corporation, partnership, joint venture, trust or other enterprise, and “personal liability to the Corporation or its shareholders” shall include, but not be limited to, any liability to such other corporation, partnership, joint venture, trust or other enterprise, and any liability to the Corporation in its capacity as a security holder, joint venturer, partner, beneficiary, creditor or investor of or in any such other corporation, partnership, joint venture, trust or other enterprise. Any repeal or modification of the foregoing provisions of this Article XV by the shareholders of the Corporation shall not adversely affect any right or protection of a director of this Corporation existing at the time of such repeal or modification.
 
ARTICLE XVI
 
In the event that the Business Combination Chapter (Chapter 7A of the Act) and or the Control Share Acquisitions Chapter (Chapter 7B of the Act) is or are repealed in their entirety and no Michigan statute governing the subject matter of the Business Combination Chapter and/or the Control Share Acquisitions Chapter, as the case may be, is enacted effective the date of the repeal thereof, every Business Combination or Control Share Acquisition with respect to the Corporation shall continue to be governed by and subject to that version of the Business Combination Chapter, or the Control Share Acquisitions Chapter, as the case may be, or similar statutory provision, then in effect on the date of its repeal.
 
ARTICLE XVII
 
The Corporation shall indemnify each of the directors and officers of the Corporation, and may indemnify any other individual, to the fullest extent permitted by Sections 561 and 562 of the Act and as otherwise permitted by law, and shall promptly make or cause to be made any determination required by Section 564a of the Act. The Corporation shall pay and reimburse each of the directors and officers of the corporation, and may pay and reimburse any other individual, to the fullest extent permitted by Section 564b of the Act and as otherwise permitted by law, and the Corporation shall promptly make or cause to be made any determination required by Section 564b.
 
 8

EX-3.02 4 ex3_02.htm EXHIBIT 3.02 ex3_02.htm

EXHIBIT 3.02

BYLAWS OF
 
CARACO PHARMACEUTICAL LABORATORIES, LTD.
 
(a compilation of the current bylaws in effect as of October 26, 2009)
 
ARTICLE I.
Offices

The Corporation shall continuously maintain a registered office in Michigan and may have such other office(s) at such place(s), both within and outside the State of Michigan, as the Board of Directors (the "Board") from time to time determines or as the business of the Corporation from time to time requires.
 
ARTICLE II.
Meetings of Shareholders

Section 1.  Annual Meetings.  Subject to the provisions of Section 6(c) of Article IX of these bylaws (the "Bylaws"), annual meetings of the Corporation's shareholders ("Shareholders") shall be held at such time and place (within or outside the State of Michigan) as shall be designated from time to time by the Board and stated in the notice of the meeting.  Subject to the Amended and Restated Articles of Incorporation of the Corporation (the "Articles"), at each annual meeting Shareholders shall elect directors to succeed those whose terms expire and shall transact such other business as may properly be brought before the meeting.
 
Section 2.  Special Meetings.  Unless otherwise prescribed by law, the Articles or these Bylaws, special meetings of Shareholders for any purpose or purposes may be called only by the Chairman of the Board, the chief executive officer, the president, or by the secretary or assistant secretary upon the written request of two or more Directors of the total number of Directors of the Corporation. Requests for special meetings shall state the purpose or purposes of the proposed meeting and shall state that no other business shall be conducted.  Special meetings of Shareholders shall be held at such time and place (within or outside the State of Michigan) as shall be designated from time to time by the Board and stated in the notice of the meeting.  Business transacted at special meetings shall be confined to the purpose or purposes stated in the notice.
 
Section 3.  Notices of Annual and Special Meetings.
 
 
(a)
Except as otherwise provided by law, the Articles or these Bylaws, written notice of any annual or special meeting of shareholders shall state the place, date and time thereof and, in the case of a special meeting, the purpose or purposes for which the meeting is called, and shall be given, either personally, by electronic transmission (in accordance with Article IX, Section 7 of these Bylaws), or by mail to each shareholder of record entitled to vote at such meeting not less than 10 or more than 60 days prior to the meeting.  If by electronic transmission, the notice shall be given when electronically transmitted to the shareholder entitled to the notice in a manner authorized by the shareholder.  If mailed, the notice shall be directed to the shareholder at his address as it appears on the records of the Corporation unless, prior to the time of mailing, he has filed with the Secretary a written request that notices intended for him be mailed to some other address, in which case it should be mailed to the address designated in such request.
 
 
 

 

 
(b)
Notice of any meeting of Shareholders (whether annual or special) to act upon an amendment to the Articles, a reduction of stated capital or a plan of merger, consolidation or sale of all or substantially all of the Corporation's assets shall be accompanied by a copy of the proposed amendment or plan of reduction, merger, consolidation or sale.
 
Section 4.  List of Shareholders.  At least 10 days (but not more than 60 days) before any meeting of Shareholders, the officer or transfer agent in charge of the stock transfer books of the Corporation shall prepare and make a complete list of the Shareholders entitled to vote at such meeting, which list shall be arranged alphabetically within each class and series of shares and shall show the address of each Shareholder and the number of shares registered in the name of each Shareholder.  The list so prepared shall be maintained at a place within the locality where the meeting is to be held, which place shall be specified in the notice of the meeting, or, if not so specified, at the place where the meeting is to be held, and shall be open to inspection by any Shareholder, for any purpose germane to the meeting, during ordinary business hours during a period of no less than 10 days prior to the meeting.  The list also shall be produced and kept open at the meeting (during the entire duration thereof) and, except as otherwise provided by law, may be inspected by any Shareholder or proxy of a Shareholder who is present in person at such meeting.
 
Section 5.  Presiding Officers; Order of Business.
 
 
(a)
Meetings of Shareholders shall be presided over by the Chairman of the Board, if the chairman is not present, by the chief executive officer, if the chief executive officer is not present, by the president, or, if the president is not present, by a vice president, or, if a vice president is not present, by such person who is chosen by the Board, or, if none, by a chairperson to be chosen at the meeting by Shareholders present in person or by proxy who own a majority of the shares of common stock of the Corporation entitled to vote and represented at such meeting. The secretary of meetings shall be the secretary or assistant secretary of the Corporation, or, if an assistant secretary is not present, such person as may be chosen by the Board, or, if none, by such person who is chosen by the chairperson at the meeting.
 
 
(b)
The following order of business, unless otherwise ordered at the meeting by the chairperson thereof, shall be observed as far as practicable and consistent with the purposes of the meeting:
 
 
(i)
Call of the meeting to order.
 
 
(ii)
Presentation of proof of mailing of notice of the meeting and, if the meeting is a special meeting, the call thereof.
 
 
(iii)
Presentation of proxies.
 
 
(iv)
Determination and announcement that a quorum is present.
 
 
(v)
Reading and approval (or waiver thereof) of the minutes of the previous meeting.
 
 
(vi)
Reports, if any, of officers.
 
 
 

 

 
(vii)
Election of directors to succeed those whose terms expired, if the meeting is an annual meeting or a special meeting called for such purpose.
 
 
(viii)
Consideration of the specific purpose or purposes for which the meeting has been called  (other than the election of directors).
 
 
(ix)
Transaction of such other business as may properly come before the meeting.
 
 
(x)
Adjournment.
 
Section 6.  Quorum; Adjournments.
 
 
(a)
The holders of a majority of the shares of common stock of the Corporation issued and outstanding and entitled to vote at any given meeting present in person or by proxy shall be necessary to and shall constitute a quorum for the transaction of business at all meetings of Shareholders, except as otherwise provided by law or by the Articles; provided, however, that no quorum shall be deemed to exist unless 33-1/3% of the outstanding shares of the Corporation's common voting stock is present in person or by proxy.
 
 
(b)
If a quorum is not present in person or by proxy at any meeting of Shareholders, the chairman of the meeting or the holders of a majority of all of the shares of stock entitled to vote at the meeting, present in person or by proxy, shall have the power to adjourn the meeting from time to time, without notice of the adjourned meeting if the time and place thereof are announced at the meeting at which the adjournment is taken and at the adjourned meeting only business is transacted as might have been transacted at the original meeting, until a quorum is present in person or by proxy.
 
 
(c)
Even if a quorum is present in person or by proxy at any meeting of the Shareholders, the Shareholders entitled to vote thereat present in person or by proxy shall have the power to adjourn the meeting from time to time for good cause, without notice of the adjourned meeting if the time and place thereof are announced at the meeting at which the adjournment is taken and at the adjourned meeting only business is transacted as might have been transacted at the original meeting, until a date which is not more than 30 days after the date of the original meeting.
 
 
(d)
Anything in paragraph (b) of this Section 6 to the contrary notwithstanding, if an adjournment is for more than 30 days, or if after an adjournment a new record date is fixed for the adjourned meeting, notice of the adjourned meeting shall be given to each Shareholder of record entitled to vote thereat.
 
Section 7.  Voting.
 
 
(a)
At any meeting of Shareholders every Shareholder having the right to vote shall be entitled to vote in person or by proxy authorized by an instrument in writing filed in accordance with the procedure established for the meeting.  Except as otherwise provided by law or by the Articles, each Shareholder of record shall be entitled to one vote (on each matter submitted to a vote) for each share of common stock registered in his name on the books of the Corporation.
 
 
 

 

 
(b)
All elections of directors and, except as otherwise provided by law or by the Articles, all other matters, shall be determined by a vote of a majority of the shares present in person or represented by proxy and voting on such other matters.
 
 
(c)
All voting, including on the election of directors but excepting where otherwise required by law, may be by a voice vote; provided, however, that upon demand therefor by a Shareholder entitled to vote or his proxy, a written share vote shall be taken.  Every written share vote shall be taken by ballots, each of which shall state the name of the Shareholder or proxy voting and such other information as may be required under the procedure established for the meeting.  Every vote taken by ballots shall be counted by an inspector or inspectors appointed by the chairman of the meeting.
 
 
(d)
If the Board consents, a shareholder may participate in a meeting of shareholders by conference telephone or by other means of remote communication through which all persons participating in a meeting may communicate with other participants.  Assuming the Board consents, all participants shall be advised of the means of remote communication, and the names of the participants shall be divulged to all participants.  Participation in a meeting pursuant to this sub-section constitutes presence in person at the meeting.  Assuming the Board consents, shareholders not physically present at a meeting of shareholders may participate in the meeting by means of remote communication and are considered present in person and may vote at the meeting if: (i) reasonable measures are implemented to verify that each person considered present and permitted to vote at the meeting by means of remote communication is a shareholder or proxy holder; (ii) reasonable measures are implemented to provide each shareholder or proxy holder a reasonable opportunity to participate in the meeting and to vote on matters submitted to the shareholders, including an opportunity to read or hear the proceedings of the meeting substantially concurrently with the proceedings; and (iii) if any shareholder or proxy holder votes or takes other action at the meeting by means of remote communication, a record of the vote or other actions maintained by the Corporation.
 
Section 8.  Notice of Shareholder Business.  At any annual or special meeting of Shareholders, only such business shall be conducted as shall have been properly brought before the meeting.  To be properly brought before a meeting, business must be (a) specified in the notice of meeting (or any supplement thereto) given by or at the direction of the Board, (b) properly brought before the meeting by or at the direction of the Board, or (c) properly brought before an annual meeting by a Shareholder, and if and only if the notice of a special meeting provides for business to be brought before the special meeting by Shareholders, properly brought before the special meeting by a Shareholder.  For business to be properly brought before a meeting by a Shareholder, the Shareholder must have given timely notice thereof in writing to the secretary or assistant secretary of the Corporation.  To be timely, a shareholder’s notice must be delivered to or mailed and received at the principal executive offices of the Corporation not less than 120 calendar days before the date of the Corporation’s proxy statement released to shareholders in connection with the previous year’s annual meeting; provided, however, if the Corporation did not hold an annual meeting the previous year, or if the date of the current year’s annual meeting has been changed by more than 30 days from the date of the previous year’s meeting, then in order for a shareholder’s notice to be timely, it must be received a reasonable time before the Corporation begins to print and mail its proxy materials.  Furthermore, Shareholders are not permitted to nominate individuals to serve as directors, unless notice of such nomination is given to the Corporation in accordance with Section 13 of Article III of these Bylaws.  A Shareholder's notice to the secretary or assistant secretary shall set forth as to each matter the Shareholder proposes to bring before the meeting:  (a) a brief description of the business desired to be brought before the meeting and the reasons for conducting such business at the meeting; (b) the name and address, as they appear on the Corporation's books, of the Shareholder proposing such business; (c) the class and number of shares of the Corporation which are beneficially owned by the Shareholder; and (d) any material interest of the Shareholder in such business.  Notwithstanding anything in these Bylaws to the contrary, no business shall be conducted at any meeting of Shareholders except in accordance with the procedures set forth in this Section 8 of Article II.  The chairman of a meeting shall, if the facts warrant, determine and declare to the meeting that business was not properly brought before the meeting and in accordance with the provisions of this Section 8, and if he should so determine, he shall so declare that the meeting and any such business not properly brought before the meeting shall not be transacted.  Notwithstanding anything in these Bylaws to the contrary, the Corporation shall be under no obligation to submit for action any shareholder proposal at any meeting of shareholders, if either the shareholder is not eligible, or the Corporation would otherwise be permitted to omit the proposal, in accordance with applicable rules under the Securities Exchange Act 1934 as amended.
 
 
 

 

Section 9.  Meetings Required; No Action by Less Than Unanimous Consent.  Any action required or permitted to be taken by the Shareholders must be taken at a duly called annual or special meeting of Shareholders and may not be effected by any consent in writing signed by fewer than all of such Shareholders.
 
Section 10.  Proxies.  The Corporation shall solicit proxies and provide proxy statements for all meetings of Shareholders and shall provide copies of such proxy solicitation to any national securities exchange ("Exchange") on which the Corporation's shares are listed.
 
ARTICLE III.
Directors

Section 1.  General Powers; Number; Tenure.  The business and affairs of the Corporation shall be managed under the direction of the Board, which may exercise all powers of the Corporation and perform or authorize the performance of all lawful acts and things which are not by law, the Articles or these Bylaws directed or required to be exercised or performed by the Shareholders. The number of directors of the Corporation shall be fixed from time to time exclusively by the Board pursuant to a resolution adopted by a majority of the total number of authorized directors (whether or not there exist any vacancies in previously authorized directorships at the time any such resolution is presented to the Board for adoption), but shall not at any time be less than five (5) and no more than eleven (11), with such number (between 5 and 11) to be fixed from time to time by the Board pursuant to a resolution adopted by a majority vote of the entire Board of Directors.  Subject to the rights of the holders of any class or series of preferred shares of the Corporation then outstanding, the directors shall be classified, with respect to the time for which they severally hold office, into three (3) classes, as nearly equal in number as reasonably possible and with the directors of each class to hold office until their successors are duly elected and qualified.  At each annual meeting of shareholders following such classification and election, directors elected to succeed those directors whose terms expire shall be elected for a term of office to expire at the third succeeding annual meeting of shareholders after their election. Directors need not be shareholders of the Corporation nor residents of the State of Michigan.
 
Section 2.  Vacancies.  Subject to the rights of the holders of any series of Preferred Shares then outstanding, newly created directorships resulting from any increase in the authorized number of directors and any vacancies on the Board resulting from death, resignation, retirement, disqualification, removal from office or other cause shall be filled by a majority vote of the remaining directors then in office, though less than a quorum, and/or by a vote to ratify or elect by a majority of the shares present in person or represented by proxy and voting on such ratification or election, and directors so chosen shall hold office for a term expiring at the annual meeting of shareholders at which the term of office of the class to which they have been elected expires or until their successors have been duly elected and qualified.  No decrease in the number of directors constituting the Board shall shorten the term of any incumbent director.
 
 
 

 

Section 3.  Removal; Resignation.
 
 
(a)
Subject to the rights of the holders of any class or series of preferred shares of the Corporation then outstanding, and except as otherwise provided by law, the Articles or these Bylaws, at any meeting of the Shareholders called expressly for such purpose, any director, or the entire Board, may be removed, but only for cause, by a vote of Shareholders holding a majority of the shares issued and outstanding and entitled to vote at an election of directors, voting together as a single class.
 
 
(b)
Any director may resign at any time by giving written notice to the Board, the Chairman of the Board, the president, the secretary or the assistant secretary of the Corporation.  Unless a subsequent time is specified in such written notice, a resignation shall take effect upon its receipt by the Corporation.
 
Section 4.  Place of Meetings.  The Board may hold both regular and special meetings either within or outside the State of Michigan, at such place as the Board from time to time deems advisable.
 
Section 5.  Annual Meeting.  The annual meeting of each newly elected Board shall be held as soon as is practicable following the annual meeting of Shareholders, and no notice to the newly elected directors of such meeting shall be necessary for such meeting to be lawful.
 
Section 6.  Regular Meetings.  Additional regular meetings of the Board may be held without notice, at such time and place as from time to time may be determined by the Board.
 
Section 7.  Special Meetings.  Special meetings of the Board may be called by the Chairman of the Board, by the chief executive officer, by the Executive Committee or by a majority of the Board, upon 24 hours' notice to each director if such notice is delivered personally or sent by telegram, or facsimile or upon 5 days' notice if sent by mail, unless such notice is waived. The notice should set forth the purpose of such meeting.  Except as set forth in the notice, no other business may be transacted at the special meeting.  In addition, notices of special meetings may also be delivered to each director by electronic transmissions (in accordance with Article IX, Section 7 of these bylaws) and shall be deemed given when electronically transmitted to the director in a manner authorized by the director.
 
Section 8.  Quorum; Adjournments.  A majority of the total number of directors then in office shall constitute a quorum for the transaction of business at each and every meeting of the Board, and the act of a majority of the directors present at any meeting at which a quorum is present shall be the act of the Board, except as otherwise specifically provided by law, the Articles or these Bylaws.  If a quorum is not present at any meeting of the Board, the directors present may adjourn the meeting, from time to time, without notice other than announcement at the meeting, until a quorum is present.
 
Section 9.  Duties of Directors.  The directors of the Corporation shall have a fiduciary duty to the Shareholders to arrange, oversee and supervise the affairs and business of the Corporation.
 
Section 10.  Compensation.  Directors shall be entitled to such compensation for their services as directors as from time to time may be fixed by the board, including, without limitation, for their services as members of committees of the board and in any event shall be entitled to reimbursement of all reasonable expenses incurred by them in attending directors’ meetings.
 
Section 11.  Action by Consent.  Any action required or permitted to be taken at any meeting of the Board or a committee of the Board may be taken without a meeting and without prior notice if a written consent in lieu of such meeting which sets forth the action so taken is signed either before or after such action by all directors or all members of the committee, as the case may be.  All written consents shall be filed with the minutes of the Board's proceedings.  A written consent has the same effect as a vote of the Board or committee for all purposes.
 
 
 

 

Section 12.  Meetings by Telephone or Remote Communication. Members of the Board or any committee appointed by the Board may participate in a meeting of the Board or any committee by means of conference telephone or other means of remote communication through which all persons participating in the meeting can communicate with the other participants.  Participation in a meeting in such manner shall constitute presence in person at such meeting.  A written record shall be made of all actions taken at any meeting conducted by means of a conference telephone or other means of remote communication.
 
Section 13.  Nomination of Director Candidates.  Subject to the rights of holders of any class or series of preferred shares then outstanding, nominations for the election of directors may be made by: (a) the Board or a proxy committee appointed by the Board or (b) any Shareholder entitled to vote in the election of directors generally; provided, however, any Shareholder entitled to vote in the election of directors generally may nominate one or more persons for election as directors at a meeting only if timely notice of such Shareholder's intent to make such nomination or nominations has been given in writing to the secretary or assistant secretary of the Corporation.  To be timely, a shareholder’s notice must be delivered to or mailed and received at the principal executive offices of the Corporation not less than 120 calendar days before the date of the Corporation’s proxy statement released to shareholders in connection with the previous year’s annual meeting; provided, however, if the Corporation did not hold an annual meeting the previous year, or if the date of the current year’s annual meeting has been changed by more than 30 days from the date of the previous year’s meeting, then in order for a shareholder’s notice to be timely, it must be received a reasonable time before the Corporation begins to print and mail its proxy materials.  Each such notice shall set forth: (a) the name and address of the Shareholder who intends to make the nomination and of the person or persons to be nominated; (b) a representation that the Shareholder is a holder of record of stock of the Corporation entitled to vote for the election of directors on the date of such notice and intends to appear in person or by proxy at the meeting to nominate the person or persons specified in the notice; (c) a description of all arrangements or understandings between the Shareholder and each nominee and any other person or persons (naming such person or persons) pursuant to which the nomination or nominations are to be made by the Shareholder; (d) such other information regarding each nominee proposed by such Shareholder as would be required to be included in a proxy statement filed pursuant to the proxy rules of the Securities and Exchange Commission, had the nominee been nominated, or intended to be nominated, by the Board; and (e) the consent of each nominee to serve as a director of the Corporation if so elected.
 
In the event that a person is validly designated as a nominee in accordance with this Section 13 and shall thereafter become unable or unwilling to stand for election to the Board, the Board or the Shareholder who proposed such nominee, as the case may be, may designate a substitute nominee upon delivery, not fewer than 10 days prior to the date of the meeting for the election of such nominee, of a written notice to the secretary or assistant secretary setting forth such information regarding such substitute nominee as would have been required to be delivered to the secretary or assistant secretary pursuant to this Section 13 had such substitute nominee been initially proposed as a nominee.  Such notice shall include a signed consent to serve as a director of the Corporation, if elected, of each such substitute nominee.
 
If the chairman of the meeting for the election of directors determines that a nomination of any candidate for election as a director at such meeting was not made in accordance with the applicable provisions of this Section 13, such nomination shall be void.
 
Section 14.  Advisory Panel to the Board.  The Board of Directors may, by resolution adopted by affirmative vote of a majority of the whole of the Board of Directors, appoint an advisory panel of persons, none of whom shall be current members of the Board of Directors, for the purpose of advising the members of the Board in carrying out their duties to the corporation.  Such advisors shall have no power to act on behalf of the Corporation or the Board or to in any way bind the Corporation or the Board by their actions, nor shall they possess any other powers reserved to directors or officers in these Bylaws or owe any fiduciary obligation to the Corporation or the shareholders.  The Board of Directors shall have the power to determine the size and membership of any such panel of advisors and may, at its discretion remove individual advisors from the panel, or disband the panel as a whole.
 
 
 

 

ARTICLE IV.
Committees

Section 1.  Formation of Committees.  The Board may, by resolution passed by a majority of the directors present at any meeting at which a quorum is present, designate one or more committees, with each committee consisting of one (1) or more directors of the Corporation. The Board shall designate an Audit Committee, which satisfies applicable regulations of the exchange or Nasdaq on which the Corporation’s securities are listed.  Except as prohibited by law, any such committee, to the extent provided in the resolution, shall have and may exercise the powers of the Board conferred upon such committee by the Board in the management of the business and affairs of the Corporation and may authorize the seal of the Corporation to be affixed to all papers which may require it.  Such committee or committees shall have the name or names as may be determined from time to time by resolution adopted by the Board.

Section 2.  Other Provisions Regarding Committees.
 
 
(a)
Subject to the limitations set forth in Section 1 of this Article IV, the Board shall have the power at any time to fill vacancies in, change the membership of, or discharge any committee.
 
 
(b)
Members of any committee shall be entitled to such compensation for their services as from time to time may be fixed by the Board and in any event shall be entitled to reimbursement of all reasonable expenses incurred in attending committee meetings.  Any member of a committee may waive compensation for any meeting.  No committee member who receives compensation as a member of any one or more committees shall be barred from serving the Corporation in any other capacity or from receiving compensation and reimbursement of reasonable expenses for any or all such other services.
 
 
(c)
Unless prohibited by law, the provisions of Section 11 ("Action by Consent") and Section 12 ("Meetings by Telephone or Similar Communications") of Article III shall apply to all committees from time to time created by the Board.
 
 
(d)
Each committee may determine the procedural rules for meeting and conducting its business and shall act in accordance therewith, except as otherwise provided herein or required by law.  Adequate provision shall be made for notice to members of all meetings.  A majority of the members must be present to constitute a quorum; and all matters shall be determined by a majority vote of the members present.
 
 
(e)
No committee shall have the power or authority to do any of the following:
 
 
(i)
Amend the Articles of Incorporation;
 
 
(ii)
Adopt an agreement of merger or share exchange;
 
 
 

 

 
(iii)
Recommend to shareholders the sale, lease, or exchange of all or of substantially all of the Corporation's property and assets;
 
 
(iv)
Recommend to shareholders a dissolution of the Corporation or a revocation of a dissolution;
 
 
(v)
Amend the Bylaws of the Corporation;
 
 
(vi)
Fill vacancies in the board; and
 
 
(vii)
Declare a distribution, dividend, or authorize the issuance of shares of the Corporation.
 
ARTICLE V.
Officers

Section 1.  Positions.  The Corporation's officers shall be chosen and appointed by the Board and shall consist of a chief executive officer, president, one or more vice presidents (if and to the extent required by law or if not required, if the Board from time to time appoints a vice president or vice presidents), a secretary and a treasurer, one or more assistant secretaries and/or assistant treasurers and such other officers and/or agents as the Board from time to time deems necessary or appropriate.   The Board may delegate to the chief executive officer or the president of the Corporation the authority to appoint any officer or agent of the Corporation and to fill a vacancy other than the Chairman of the Board, president, secretary or treasurer.  The election or appointment of any officer of the Corporation in itself shall not create contract rights for any such officer.  All officers of the Corporation shall exercise such powers and perform such duties as from time to time shall be determined by the Board.  Any two or more offices may be held by the same person.
 
Section 2.  Term of Office; Removal.  Each officer of the Corporation shall hold office at the pleasure of the Board and any officer may be removed, with or without cause, at any time by the affirmative vote of a majority of the directors then in office, provided that any officer appointed by the president pursuant to authority delegated to the president by the Board may be removed, with or without cause, at any time whenever the president in his or her absolute discretion shall consider that the best interests of the Corporation shall be served by such removal.  Removal of an officer by the Board or by the president, as the case may be, shall not prejudice the contract rights, if any, of the person so removed.  Vacancies (however caused) in any office may be filled for the unexpired portion of the term by the Board (or by the president in the case of a vacancy occurring in an office to which the president has been delegated the authority to make appointments).
 
Section 3.  Compensation.  The salaries of all officers of the Corporation shall be fixed from time to time by the Board, and no officer shall be prevented from receiving a salary by reason of the fact that he also receives from the Corporation compensation in any other capacity.
 
Section 4.  Action With Respect to Securities of Other Corporations. Unless otherwise directed by the Board, the president or any officer of the Corporation authorized by the president shall have power to vote and otherwise act on behalf of the Corporation, in person or by proxy, at any meeting of Shareholders of or with respect to any action of Shareholders of any other corporation in which this Corporation may hold securities and otherwise to exercise any and all rights and powers which this Corporation may possess by reason of its ownership of securities in such other corporation.
 
Section 5.  Chairman of the Board.  The Chairman of the Board shall be elected by the Board of Directors and, subject to the direction of the Board, shall perform such functions and duties as from time to time may be assigned to him or her by the Board.  The Chairman of the Board, if present, shall preside at all meetings of the Shareholders and all meetings of the Board or may appoint another member of the board to preside.  The Board of Directors shall determine, in its discretion, whether any individual appointed to the position of Chairman of the Board is deemed to be an officer of the Corporation.
 
 
 

 

Section 6. Chief Executive Officer.  The chief executive officer shall have the powers and perform the duties incident to that position.  Subject to the powers of the Board of Directors, he or she shall be in the general and active charge of the entire business and affairs of the Corporation, and shall be its chief policy-making officer.  The chief executive officer shall, in the absence or disability of its Chairman of the Board, act with all of the powers, perform all of the duties and be subject to all of the restrictions of the Chairman of the Board.  The chief executive officer shall have such other powers and perform such other duties as may be prescribed by the Chairman of the Board or the Board of Directors or as may be provided in these Bylaws.
 
Section 7.  President.  The President, subject to the direction of the Chief Executive Officer, shall have general charge of the business, affairs and property of the Corporation and general supervision of its other officers and agents.   In general, the president shall perform all duties incident to the office of president of a stock corporation and shall see that all orders and resolutions of the Board are carried into effect.  Unless otherwise prescribed by the Board, the president shall have full power and authority on behalf of the Corporation to attend, act and vote at any meeting of security holders of other corporations in which the Corporation may hold securities.  At any such meeting the president shall possess and may exercise any and all rights and powers incident to the ownership of such securities which the Corporation possesses and has the power to exercise.  The Board from time to time may confer like powers upon any other person or persons.
 
Section 8.  Vice Presidents.  In the absence or disability of the president, the vice president, if any (or in the event there is more than one, the vice presidents in the order designated, or in the absence of any designation, in the order of their election), shall perform the duties and exercise the powers of the president.  The vice president(s) also generally shall assist the president and shall perform such other duties and have such other powers as from time to time may be prescribed by the Board.
 
Section 9.  Secretary.  The secretary shall attend all meetings of the Board and of the Shareholders and shall record all votes and the proceedings of all meetings in a book to be kept for such purposes. The secretary also shall perform like duties for the committees, if required by any such committee.  The secretary shall give (or cause to be given) notice of all meetings of the Shareholders and all special meetings of the Board and shall perform such other duties as from time to time may be prescribed by the Board, the Chairman of the Board or the president.  The secretary shall have custody of the seal of the Corporation, shall have authority (as shall any assistant secretary) to affix the same to any instrument requiring it, and to attest the seal by his or her signature.  The Board may give general authority to officers other than the secretary or any assistant secretary to affix the seal of the Corporation and to attest the affixing thereof by his or her signature.
 
Section 10.  Assistant Secretary.  The assistant secretary, if any, in the absence or disability of the secretary, shall perform the duties and exercise the powers of the secretary.  The assistant secretary(ies) shall perform such other duties and have such other powers as from time to time may be prescribed by the Board.
 
Section 11.  Treasurer.  The treasurer shall have the custody of the corporate funds, securities, other similar valuable effects, and evidence of indebtedness, shall keep full and accurate accounts of receipts and disbursements in books belonging to the Corporation and shall deposit all moneys and other valuable effects in the name and to the credit of the Corporation in such depositories as from time to time may be designated by the Board.  The treasurer shall disburse the funds of the Corporation in such manner as may be ordered by the Board from time to time and shall render to the Chairman of the Board, the president and the Board, at regular meetings of the Board or whenever any of them may so require, an account of all transactions and of the financial condition of the Corporation.
 
 
 

 

Section 12.  Assistant Treasurer.  The assistant treasurer, if any (or in the event there is more than one, the assistant treasurers in the order designated, or in the absence of any designation, in the order of their election), in the absence or disability of the treasurer, shall perform the duties and exercise the powers of the treasurer.  The assistant treasurer(s) shall perform such other duties and have such other powers as from time to time may be prescribed by the Board.
 
ARTICLE VI.
Notices

Section 1.  Form; Delivery.  Any notice required or permitted to be given to any director, officer, Shareholder or committee member shall be given in writing, either personally, by first-class mail with postage prepaid, or facsimile addressed to the recipient at his or her address as it appears in the records of the Corporation. Personally delivered and facsimile notices shall be deemed to be given at the time they are delivered at the address of the named recipient as it appears in the records of the Corporation, and mailed notices shall be deemed to be given at the time they are deposited in the United States mail.  Notice to a director also may be given by telegram sent to his address as it appears on the records of the Corporation and shall be deemed given at the time delivered at such address.
 
Section 2.  Waiver; Effect of Attendance.  Whenever any notice is required to be given by law, the Articles or these Bylaws, a written waiver thereof, signed by the person or persons entitled to such notice, whether before or after the time stated therein, shall be the equivalent of the giving of such notice.  Any director or committee member who attends a meeting of the Board or a committee thereof shall be deemed to have had timely and proper notice of the meeting, unless such director or committee member attends for the express purpose of objecting to the transaction of any business on the grounds that the meeting is not lawfully called or convened.  A Shareholder's attendance at a meeting (whether in person or by proxy) shall result in: (i) waiver of objection to lack of notice or defective notice of the meeting, unless the Shareholder at the beginning of the meeting objects to holding the meeting or transacting business at the meeting and (ii) waiver of objection to consideration of a particular matter at the meeting that is not within the purpose or purposes described in the meeting notice, unless the Shareholder objects to considering the matter when it is presented.
 
ARTICLE VII.
Indemnification

Section 1.  Indemnification.  The Corporation shall indemnify each of the directors and officers of the Corporation, and may indemnify any other individual, to the fullest extent permitted by Sections 561 and 562 of the Business Corporation Act of Michigan, as it may be amended from time to time (the "Act") and as otherwise permitted by law, and shall promptly make or cause to be made any determination required by Section 564a of the Act.  The Corporation shall pay and reimburse each of the directors and officers of the Corporation, and may pay and reimburse any other individual, to the fullest extent permitted by Section 564b of the Act and as otherwise permitted by law, and the Corporation shall promptly make or cause to be made any determination required by Section 564b.
 
Section 2.  Insurance.  The Corporation shall maintain insurance to the extent reasonably available, at its expense, to protect itself and any director, officer, employee or agent of the Corporation or of another corporation, partnership, joint venture, trust or other enterprise against any expense, liability or loss, whether or not the Corporation would have the power to indemnify such person against such expense, liability or loss under the Act.
 
 
 

 

Section 3.  Effect of Amendment.  Any amendment, repeal or modification of any provision of this Article VII by the Shareholders or the directors of the Corporation shall not adversely affect any right or protection of a director, officer, employee or agent of the Corporation existing at the time of such amendment, repeal or modification.
 
ARTICLE VIII.
Stock Certificates

Section 1.  Form; Signatures.  Each Shareholder who has fully paid for any stock of the Corporation shall be entitled to receive a certificate representing such shares, which shall be non-assessable, and such certificate shall be signed by the Chairman of the Board or the president or a vice president and by the treasurer or an assistant treasurer or the secretary or an assistant secretary of the Corporation.  Signatures on the certificate may be facsimile, in the manner prescribed by law.  Each certificate shall exhibit on its face the number and class (and series, if any) of the shares it represents. Each certificate also shall state upon its face the name of the person to whom it is issued and that the Corporation is organized under the laws of the State of Michigan.  Each certificate may (but need not) be sealed with the seal of the Corporation or facsimile thereof.  In the event any officer, transfer agent or registrar who has signed or whose facsimile signature has been placed upon a certificate ceases to be such officer, transfer agent or registrar before the certificate is issued, the certificate nevertheless may be issued by the Corporation with the same effect as if such person were such officer at the date of issue of the certificate.  All stock certificates representing shares of common stock which are subject to restrictions on transfer or to other restrictions may have imprinted thereon a notation or legend of such restriction.
 
A certificate representing shares issued by the Corporation shall substantially set forth on its face or back that the Corporation will furnish to a Shareholder upon request and without charge a full statement of the designation, relative rights, preferences, and limitations of the shares, and if any class of shares has been issued in series, the designation, relative rights, preferences, and limitations of each series so far as the same have been prescribed and the authority of the Board to designate and prescribe the relative rights, preferences, and limitations of other series.
 
Section 2.  Registration of Transfer.  Upon surrender to the Corporation or to any transfer agent of the Corporation of a certificate for shares duly endorsed or accompanied by proper evidence of succession, assignment or authority to transfer, the Corporation, or its transfer agent, shall issue a new certificate to the person entitled thereto, cancel the old certificate and record the transaction upon the Corporation's books.
 
Section 3.  Registered Shareholders.  Except as otherwise provided by law, the Corporation shall be entitled to recognize the exclusive right of a person who is registered on its  books as the owner of shares of its common stock to receive dividends or other distributions (to the extent otherwise distributable or distributed) and to vote (in the case of voting stock) as such owner, and to hold liable for calls and assessments a person who is registered on its books as the owner of shares of its common stock.  The Corporation shall not be bound to recognize any equitable or legal claim to or interest in such shares on the part of any other person.  The Corporation (or its transfer agent) shall not be required to send notices or dividends to a name or address other than the name and address of the Shareholders appearing on the stock ledger maintained by the Corporation (or by the transfer agent or registrar, if any), unless any such Shareholder shall have notified the Corporation (or the transfer agent or registrar, if any), in writing, of another name or address at least 10 days prior to the mailing of such notice or dividend.
 
Section 4.  Record Date.  In order that the Corporation may determine the Shareholders of record who are entitled (i) to notice of or to vote at any meeting of Shareholders or any adjournment thereof, (ii) to receive payment of any dividend or other distribution or allotment of any rights, or (iii) to exercise any rights in respect of any change, conversion or exchange of stock, or for the purpose of any other lawful action, the Board, in advance, may fix a date as the record date for any such determination.  Such date shall not be more than 60 days nor less than 10 days before the date of such meeting, nor more than 60 days prior to the date of any other action.  A determination of Shareholders of record entitled to notice of or to vote at a meeting of the Shareholders shall apply to any adjournment of the meeting taken pursuant to Section 6 of Article II; provided, however, that the Board, in its discretion, may fix a new record date for the adjourned meeting.
 
 
 

 

Section 5.  Lost, Stolen or Destroyed Certificate.  The Board may direct a new certificate to be issued in place of any certificate theretofore issued by the Corporation which is claimed to have been lost, stolen or destroyed, upon the making of an affidavit of that fact by the person claiming the certificate to be lost, stolen or destroyed. When authorizing such issue of a new certificate, the Board, in its discretion, may require as a condition precedent to issuance that the owner of such lost, stolen or destroyed certificate, or his or her legal representative, advertise the same in such manner as the Board shall require and/or to give the Corporation a bond in such sum, or other security in such form, as the Board may direct, as indemnity against any claim that may be made against the Corporation with respect to the certificate claimed to have been lost, stolen or destroyed.
 
Section 6.  Regulations.  The issue, transfer, conversion and registration of certificates of stock shall be governed by such other regulations as the Board may establish.
 
ARTICLE IX.
General Provisions

Section 1.  Dividends.  Subject to the Act and to any provisions of the Articles relating to dividends, dividends upon the outstanding common stock of the Corporation may be declared by the Board at any annual, regular or special meeting and may be paid in cash, in property or in shares of the Corporation's common stock.  Any distribution to Shareholders of income or capital assets of the Corporation will be accompanied by a written statement disclosing the source of the funds distributed.  If, at the time of distribution, this information is not available, a written explanation of the relevant circumstances will accompany the distribution and the written statement disclosing the source of the funds distributed will be sent to the Shareholders not later than 60 days after the close of the fiscal year in which the distribution was made.
 
Section 2.  Reserves.  The Board, in its sole discretion, may fix a sum which may be set aside or reserved over and above the paid-in capital of the Corporation for working capital or as a reserve for any proper purpose, and from time to time may increase, diminish or vary such fund or funds.
 
Section 3.  Fiscal Year.  The fiscal year of the Corporation shall be as determined from time to time by the Board.
 
Section 4.  Seal.  The corporate seal shall have inscribed thereon the name of the Corporation, the year of its incorporation and the words "Corporate Seal" and "State of Michigan".
 
Section 5.  Amendment of the Bylaws.  The Board is expressly empowered to adopt, amend or repeal Bylaws of the Corporation.  Any adoption, amendment or repeal of Bylaws by the Board shall require the approval of the affirmative vote of 2/3 of the entire Board of Directors (whether or not there exist any vacancies in previously authorized directorships at the time any resolution providing for adoption, amendment or repeal is presented to the Board).  The Shareholders shall also have power to adopt, amend or repeal the Bylaws.  In addition to any vote of the holders of any class or series of stock of the Corporation required by law or by these Bylaws, the affirmative vote of the holders of at least 66-2/3% of the voting power of all of the then-outstanding shares of the common stock of the Corporation entitled to vote generally in the election of directors, voting together as a single class, shall be required to adopt, amend or repeal any provisions of the Bylaws.
 
 
 

 

Section 6.  Reports.
 
 
(a)
The Chairman of the Board or the president shall prepare or cause to be prepared annually a full and correct annual report ("Annual Report") concerning the operations of the Corporation and containing audited financial statements of the Corporation and its subsidiaries for the preceding fiscal year prepared in accordance with generally accepted accounting principles.
 
 
(b)
The Annual Report shall be mailed or delivered to each Shareholder as of a record date after the end of such fiscal year and each holder of other publicly held securities of the Corporation within 150 days after the end of the fiscal year, and shall be filed at the time the Annual Report is distributed to the Shareholders with any Exchange on which the Corporation's shares are listed and traded.
 
 
(c)
There shall be an annual meeting of the Corporation's Shareholders upon reasonable notice following delivery of the Annual Report.  The Annual Report shall also be submitted at the annual meeting and shall be placed on file thereafter at the principal office of the Corporation.
 
 
(d)
To the extent that the Corporation is required to file with the Securities Exchange Commission ("SEC") quarterly reports, including statements of operating results, the Corporation shall make copies of such quarterly reports available to the Shareholders on a timely basis.  The statement of operations contained in such quarterly reports shall disclose, as a minimum, any substantial items of an unusual or non-recurrent nature and net income before and after estimated federal income tax or net income in the amount of estimated federal taxes.
 
 
(e)
To the extent that the Corporation is required to file with the SEC or another federal or state  regulatory authority interim reports relating primarily to operations and financial positions, the Corporation shall make reports which reflect the information contained in such interim reports available to the Shareholders before or as soon as practicable after such interim reports are filed with the SEC or other regulatory authority.  If the form of the report provided to the Shareholders differs from the interim report filed with the SEC or the regulatory authority, the Corporation shall file a copy of the report provided to the Shareholders with any Exchange  (including NASDAQ) on which the Corporation's shares are listed and traded.
 
Section 7.  Inspection of Books and Records.  Inspection of the Corporation's books and records (including Shareholder records) shall be provided to the Shareholders and to the official or agency administering the securities laws of the various states upon reasonable notice for any proper purpose and as is consistent with applicable laws and regulations.
 
Section 8.  Review of Transactions.  As long as the Corporation's shares are listed and traded on any Exchange (including NASDAQ), the Corporation shall conduct an appropriate review of all related party transactions on an ongoing basis and shall utilize the Corporation's Audit Committee or a comparable body for the review of potential conflict of interest situations where appropriate.
 
Section 9.  Special Voting Provisions.  The affirmative vote of two-thirds (2/3)  of the entire Board of Directors shall be required for the approval of any of the following corporate actions:
 
 
(a)
The sale or disposition of all or substantially all of the assets of the Corporation;
 
 
(b)
The liquidation, winding up or dissolution of the Corporation;
 
 
 

 

 
(c)
The issuance of or receipt of subscription for any capital stock of the Corporation to Sun Pharmaceutical Industries Ltd and/or it's affiliates.
 
 
(d)
The amendment of the Corporation's Articles of Incorporation or Bylaws.
 
Section 10.  Electronic Transmission.  In accordance with the Michigan Business Corporation Act and the Articles of Incorporation, any shareholder or Board of Director action which requires the notice to a shareholder or director or written signature of a shareholder or director may be delivered to or by such shareholder or director via electronic transmission, including, but not limited to, notices of shareholder and director meetings and shareholder and director consents.  “Electronic transmission” or “electronically transmitted” means any form of communication that meets all of the following:  (i) it does not directly involve the physical transmission of paper; (ii) it creates a record that may be retained and retrieved by the recipient; (iii) it may be directly reproduced in paper form by the recipient through an automated process.
 
Section 11.  Opt Into Control Share Acquisition Statute.  The provisions of Chapter 7B, Control Share Acquisitions, of the Michigan Business Corporation Act, as amended from time to time, relating to control share acquisitions, shall be applicable to this Corporation.
 
 

EX-10.24 5 ex10_24.htm EXHIBIT 10.24 ex10_24.htm

EXHIBIT 10.24

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

SETTLEMENT AGREEMENT
 
 
This Settlement Agreement is made and entered into this 10th day of July, 2009, by and between, on the one hand, Forest and Lundbeck, and on the other hand, Caraco and Sun.
 
RECITALS
 
WHEREAS Forest sells LEXAPRO® brand escitalopram oxalate products in the Territory under New Drug Application 21-323 and those products are covered by multiple claims of the '712 Patent, the '941 Patent, and the '069 Patent;
 
WHEREAS the '712 Patent, the '941 Patent, and the '069 Patent are owned by Lundbeck and licensed exclusively to Forest in the Territory;
 
WHEREAS Caraco has sought approval from the FDA to market proposed generic escitalopram oxalate products in the Territory under ANDA 78-219;
 
WHEREAS Forest and Lundbeck have maintained an action against Caraco and Sun for infringement of the '712 Patent in connection with the proposed generic escitalopram oxalate products defined by the Caraco ANDA in the United States District Court for the Eastern District of Michigan, which action is captioned Forest Laboratories, Inc. et al. v. Caraco Pharmaceutical Laboratories, Ltd. et al., Civil Action No. 06-13143 (E.D. Mich.);
 
WHEREAS the '712 Patent was previously litigated in Forest Laboratories, Inc. et al. v. Ivax Pharmaceuticals, Inc. et al., 438 F. Supp. 2d 479 (D. Del. 2006), and Forest Laboratories, Inc. et al. v. Ivax Pharmaceuticals, Inc. et al., 501 F.3d 1263 (Fed. Cir. 2007);
 
WHEREAS Caraco and Sun stipulated that the Generic Products defined by the Caraco ANDA infringe claims 1, 3, 5, 7, and 9 of the '712 Patent in the '712 Patent Action, but contested the validity of those claims;
 
WHEREAS Caraco has maintained two actions against Forest and Lundbeck seeking declaratory judgments of non-infringement of the '941 Patent and the '069 Patent in the Court, which actions are captioned Caraco Pharmaceutical Laboratories, Ltd. v. Forest Laboratories, Inc. et al., Civil Action No. 07-10737 (E.D. Mich.), and Caraco Pharmaceutical Laboratories, Ltd. v. Forest Laboratories, Inc. et al., Civil Action No. 09-10274 (E.D. Mich.), each regarding the Caraco ANDA and the proposed generic escitalopram oxalate products that are the subject of that ANDA;

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
WHEREAS, subject to the terms and conditions herein, Forest and Lundbeck have agreed to grant Caraco and Sun a non-exclusive license to make, have made, use, offer to sell, sell or import the generic escitalopram oxalate products that are the subject of the Caraco ANDA in the Territory as of the date, and upon the terms, set forth in this Agreement; and
 
WHEREAS the Parties are willing to settle the Actions on the terms set forth herein.
 
NOW THEREFORE, in consideration of the promises and mutual covenants set forth herein, the sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
 
 
1.
Definitions.
 
1.1.           "'069 Patent" means U.S. Patent No. 7,420,069.
 
1.2.           "'069 Patent Action" means the case captioned Caraco Pharmaceutical Laboratories, Ltd. v. Forest Laboratories, Inc. et al., Civil Action No. 09-10274 (E.D. Mich.).
 
1.3.           "'712 Patent" means U.S. Patent No. Re.34,712.
 
1.4.           "''712 Patent Action" means the case captioned Forest Laboratories, Inc. et al. v. Caraco Pharmaceutical Laboratories, Ltd. et al., Civil Action No. 06-13143 (E.D. Mich.).
 
1.5.           "'941 Patent" means U.S. Patent No. 6,916,941.
 
1.6.           "'941 Patent Action" means the case captioned Caraco Pharmaceutical Laboratories, Ltd. v. Forest Laboratories, Inc. et al., Civil Action No. 07-10737 (E.D. Mich.).
 
1.7.           "Actions" means the '712 Patent Action, the '941 Patent Action and the '069 Patent Action, collectively.
 
1.8.           "Affiliate" means any person or legal entity controlling, controlled by or under common control with the Party with respect to which such status is at issue and shall include, without limitation, any corporation 50% or more of the voting power of which (or other comparable ownership interest for an entity other than a corporation) is owned, directly or indirectly, by a Party hereto or any corporation, person or entity that owns 50% or more of such voting power of a Party hereto.
 
1.9.           "Agencies" means the DOJ and the FTC, collectively.

 
2

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
1.10.         "Agreement" means this Settlement Agreement (including Exhibits A through F).
 
1.11.         "Alphapharm" means Alphapharm Pty Ltd. and its successors in interest and Affiliates.
 
1.12.         "ANDA" means Abbreviated New Drug Application.
 
1.13.         "Authorized Generic" means Alphapharm, as defined above.
 
1.14.         "Caraco" means Caraco Pharmaceutical Laboratories, Ltd.
 
1.15.         "Caraco ANDA" means ANDA 78-219, as supplemented and amended as of the Effective Date, as defined below, and further including any Permitted Modification, as defined below, after the Effective Date.
 
1.16.         "Control" or "Controlled" means, with respect to any Licensed Patent, the ownership of such Licensed Patent by a Party or the possession by a Party of rights sufficient to grant licenses or sublicenses to such Licensed Patent.
 
1.17.         "Court" means the United States District Court for the Eastern District of Michigan.
 
1.18.         "DOJ" means the Antitrust Division of the Department of Justice.
 
1.19.         "Effective Date" means the date on which this document is fully executed, which is July 10, 2009.
 
1.20.         "FDA" means United States Food and Drug Administration.
 
1.21.         "Forest" means Forest Laboratories, Inc. and Forest Laboratories Holdings, Ltd., collectively.
 
1.22.         "Forest Product" means the escitalopram oxalate products manufactured or sold for use in the Territory under NDA 21-323 as of the Effective Date under the trademark LEXAPRO® (or any replacement trademark).
 
1.23.         "FTC" means the Federal Trade Commission of the United States.
 
1.24.         "Generic Product" means the products described by the Caraco ANDA, as defined above.
 
1.25.         "Ivax" means Ivax Pharmaceuticals and its successors in interest and Affiliates.

 
3

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
1.26.         "Launch Date" means the date that any third party generic enters the market in the Territory with a generic equivalent of the Forest Product that has received final approval from the FDA, other than an authorized generic or first-filer with Hatch Waxman related exclusivity. If and only if:  [***] the License, as defined below, shall be of no effect from the date [***] until [***]
 
1.27.         "License" means the license granted by Section 5.1.
 
1.28.         "Licensed Patents" means patents Controlled by Forest or Lundbeck, either now or in the future, that, but for the License, would be infringed if Caraco and Sun make, have made, use, sell, offer for sale, or import the Generic Product in or for the Territory after the Launch Date.  Any assignment or transfer of any Licensed Patents by Forest or Lundbeck shall be subject to the License.  Licensed Patents includes, but is not limited to the '712 Patent, the '941 Patent and the '069 Patent.
 
1.29.         "Lundbeck" means H. Lundbeck A/S.
 
1.30.         "Parties" means Forest, Lundbeck, Caraco and Sun.
 
1.31.         "Party" means any one of the Parties, as indicated.
 
1.32.         "Permitted Modification" means any modification to ANDA 78-219 as supplemented and amended as of the Effective Date, as defined above, that does not change the active ingredient (i.e., use an additional or different active ingredient), dosage form, indication(s), reference listed drug or bioequivalence rating of the generic products defined by said ANDA as of the Effective Date.
 
1.33.         "Stipulations and Orders" means the documents attached hereto as Exhibits A, B and C, collectively.
 
1.34.         "Sun" means Sun Pharmaceutical Industries Ltd.
 
1.35.         "Territory" means the United States and all of its territories and possessions, including Puerto Rico.  For purposes of this Agreement, Territory also includes the manufacture of some or all of the components or ingredients of the Licensed Product outside the U.S. solely for purposes of importation into the U.S. for use in the U.S. and its territories and possessions.
 
2.             Stipulations And Orders.  In consideration of the mutual benefits of entering into this Agreement, the Parties shall enter into and cause to be filed with the Court, subject to Section 6 below:

 
4

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(a)           In the '712 Patent Action, a stipulation and order dismissing, without prejudice, all claims, defenses and counterclaims, substantially in the form annexed hereto as Exhibit A.  If the Court does not grant the Order substantially in the form annexed hereto as Exhibit A, the Parties agree to confer in good faith and revise that document consistent with its purpose and the requirements of the Court.
 
(b)           In the '941 Patent Action, a stipulation and order dismissing, without prejudice, all claims and defenses, substantially in the form annexed hereto as Exhibit B.  If the Court does not grant the Order substantially in the form annexed hereto as Exhibit B, the Parties agree to confer in good faith and revise that document consistent with its purpose and the requirements of the Court.
 
(c)           In the '069 Patent Action, a stipulation and order dismissing, without prejudice, all claims, defenses and counterclaims, substantially in the form annexed hereto as Exhibit C.  If the Court does not grant the Order substantially in the form annexed hereto as Exhibit C, the Parties agree to confer in good faith and revise that document consistent with its purpose and the requirements of the court.
 
3.             Other Agreements. Contemporaneously with the execution of this Agreement, Forest and Caraco shall enter into the agreement attached hereto as Exhibit D (the "Inwood Agreement"), and Lundbeck and Sun shall enter into the agreement attached hereto as Exhibit E (the "Patent Assignment Agreement").  The Inwood Agreement shall govern the terms and conditions related to the transfer of Forest's Inwood products to Caraco.  The Patent Assignment Agreement shall govern the terms and conditions related to the assignment to Lundbeck of certain patent applications owned by Sun related to escitalopram.
 
4.             Legal Fees.  Within ten (10) days after the Effective Date, in partial consideration of Forest and Lundbeck's saved legal fees associated with the Actions and Caraco's expended legal fees associated with the Actions, Forest and Lundbeck shall reimburse [* * *] of Caraco's attorneys' fees and costs up to a maximum total reimbursement of [* * *].  Caraco hereby represents and warrants that its attorneys' fees to date have been in excess of [* * *].  Thus, [* * *] of legal fees shall be paid from Forest and Lundbeck to Caraco.  This payment shall be non-refundable.  Except for the foregoing, each Party will pay its own legal fees and other costs incurred in the preparation, conduct and settlement of the Actions.
 
5.             License to Distribute Generic Product.
 
5.1           Commercial License.  Subject to the terms, conditions, and limitations hereof, Forest and Lundbeck hereby license and sublicense, as the case may be, on a fully paid-up basis, the Licensed Patents to Caraco and Sun solely for them to make, have made, use, sell, offer for sale, or import the Generic Product in or for the Territory as of the Launch Date.  The foregoing license shall be non-exclusive.  Except to the extent of the assignment permitted under Section 11, neither Caraco nor Sun shall have the right to sublicense or assign any of its rights under the License, except for a sublicense to their respective Affiliates.

 
5

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
5.2           Foreign Patents and Proceedings.  The Parties acknowledge and agree that this Agreement, and the fact that the Parties have entered into this Agreement and consummated the transactions contemplated hereby, shall not have any effect outside the Territory on the assertion of any foreign patents or patent applications against any foreign counterparts to any Generic Product.  The Parties hereby agree that neither this Agreement nor those facts may be proffered, or be referred to in any testimonial or other evidence, by any Party or any of their respective Affiliates at any trial, action or other proceedings outside the Territory regarding the assertion of any foreign patents or patent applications against any foreign counterparts to any Generic Product.  Nothing herein shall be construed as an admission or waiver as to any factual or legal matter by any Party or their respective Affiliates with respect to any jurisdiction outside of the Territory.
 
5.3           Regulatory Matters.
 
(a)           Forest and Lundbeck (for themselves and their Affiliates) hereby grant to Caraco and Sun and their Affiliates a fully paid-up license or waiver (as applicable) under any regulatory exclusivities that would apply to the Generic Product from and after the Launch Date (including any applicable pediatric exclusivities).  Such license or waiver shall be of the same scope and duration as the License contained in Section 5.1.
 
(b)           Forest and Lundbeck shall execute such further documents or notices as Caraco may reasonably request to further confirm the grant of the License contained in Section 5.1 and/or the license or waiver contained in Section 5.3(a).
 
(c)           Subject to Caraco and Sun's compliance with the terms of this Agreement, Forest and Lundbeck shall not initiate any activity directly or indirectly (such as by way of Citizen's Petition) against Caraco or Sun related to the Generic Product to interfere with Caraco's efforts to:  (i) obtain FDA approval of the Caraco ANDA; or (ii) launch the Generic Product from and after the Launch Date.  Nothing set forth in this Agreement shall be construed as a representation by Forest or Lundbeck that the FDA or any other applicable regulatory authority will or should approve of Caraco marketing a product incorporating escitalopram oxalate in the Territory.
 
(d)           The Generic Product shall be manufactured by or on behalf of Sun or Caraco in substantial accordance with current Good Manufacturing Practices ("GMPs") regulations promulgated by the FDA, as further defined by FDA guidance documents.

 
6

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(e)           Forest and Lundbeck shall take reasonable steps, including cooperating with any necessary FDA submissions, to help ensure Caraco's market entry in the Territory with the Generic Product on the Launch Date.
 
(f)           Forest and Lundbeck agree that, regardless of whether they continue to sell the Forest Product, they will not request that the FDA rescind its approval of all of the existing indications (as of the Effective Date) for the Forest Product unless required by law to do so.

5.4           Covenants.
 
(a)           Except to the extent of the License, neither Caraco, Sun nor any of their respective Affiliates shall under any circumstances:  (a) offer to sell or sell in the Territory any Generic Product prior to the Launch Date; or (b) knowingly and voluntarily aid, abet, enable or contract with any third party regarding the marketing in the Territory of any Generic Product prior to the Launch Date.
 
(b)           Neither Forest, Lundbeck nor any of their respective Affiliates shall under any circumstances enter into an agreement with Ivax to delay the lawful market entry of a generic equivalent of the Forest Product.  Nothing in this Agreement, however, shall prevent Lundbeck, Forest or any of their respective Affiliates from enforcing any of their patent rights against Ivax or entering into any settlement agreements (which may have provisions related to Ivax's generic entry), as necessary, to resolve disputes associated with such enforcement.
 
(c)           Forest and Lundbeck covenant not to sue Caraco and/or Sun for their use of the Licensed Patents after the Launch Date in connection with the Generic Product.  Caraco and Sun covenant not to challenge any of the Licensed Patents in connection with the Generic Product.
 
6.             Legal Compliance.  The Parties shall submit this Agreement to the appropriate personnel at the Agencies for review under Section 1112 of the Medicare Prescription Drug Improvement and Modernization Act of 2003, as soon as practicable after the Effective Date and in no event later than three (3) days after the Effective Date.

 
7

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(a)           If, within forty (40) days of receipt of this Agreement by the Agencies, any Agency objects to, responds to, or otherwise comments on such submission, the Parties shall use commercially reasonable efforts to address or resolve such objection, response or comment provided that there shall be no material change to the rights and obligations of the Parties under this Agreement, except as the Parties may mutually agree.  These efforts to address or resolve any such objection, response or comment shall continue for a period of not more than thirty (30) days from when the objection, response or comment is first raised, unless the Parties mutually agree to extend that period.  During that thirty (30) day period or agreed extension, all obligations under this Agreement (except for the payment of legal fees under Section 4 above), the Inwood Agreement, and the Patent Assignment Agreement shall be temporarily suspended while the Parties engage in commercially reasonable and good-faith efforts to address or resolve any such objection, response or comment.  If, despite such commercially reasonable efforts, the Parties are unable to address or resolve any such objection, response or comment during that thirty (30) day period or agreed extension, the Parties shall promptly return to the Court and jointly seek the earliest possible trial date for which lead counsel is available (but starting no later than thirty (30) days from the date of the request, regardless of the trial schedules of lead counsel, if the Court's schedule allows; if the Court's schedule does not allow for a trial within thirty (30) days, then as quickly thereafter as the Court is available, regardless of the trial schedules of lead counsel).  In that event, except for the legal fees paid pursuant to Section 4 above, the Parties shall take all commercially reasonable steps to return the Parties to the position they were in before signing this Agreement, including without limitation the return by Sun of any payment by Lundbeck under the Patent Assignment Agreement.  Upon accomplishing this return, this Agreement shall terminate.
 
(b)           If there is no objection from any Agency within forty (40) days of receipt of this Agreement, or if an objection is received and the Parties address or resolve the objection, all obligations in this Agreement shall be in force.  Within three (3) days of that date, or within three (3) days of the closing of the transaction referenced in the Inwood Agreement, whichever is later, the Parties shall file the Stipulations and Orders described in Section 2 above.
 
(c)           If, after forty (40) days of receipt of this Agreement by the Agencies, any Agency objects to, responds to, or otherwise comments on such submission, the Parties shall use commercially reasonable efforts to address or resolve such objection, response or comment, provided that there shall be no material change to the rights and obligations of the Parties under this Agreement, except as the Parties may mutually agree.  If, despite such commercially reasonable efforts, the Parties are unable to address or resolve any such objection, response or comment, the Parties may mutually agree to return the Parties to the position they were in before the signing of this Agreement (except for the payment of legal fees under Section 4 above).  If such a return is accomplished, this Agreement shall terminate.  If such mutual agreement to return is reached, any Party shall have the right to reinitiate the '712 Action, the '941 Action, and/or the '069 Action, and the Parties shall promptly return to Court in any such reinitiated action and jointly seek the earliest possible scheduling conference for each such action.
 
For purposes of this Agreement, "commercially reasonable efforts" shall mean the reasonable, diligent and good-faith efforts as such Party would normally use to accomplish a similar objective under similar circumstances.

 
8

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
7.             Released Claims.  In addition to the dismissal of the Actions, as set forth in the Stipulations And Orders, Forest and Lundbeck, and Caraco and Sun, make the following releases, which shall be effective upon the grant of the last of the Stipulations And Orders by the Court in the Actions:
 
(a)            Caraco and Sun for themselves and their respective Affiliates hereby irrevocably release and discharge Forest and Lundbeck and their respective Affiliates, successors, assigns, directors, officers, employees, agents and customers from all causes of action, demands, claims, damages and liabilities of any nature, whether known or unknown, arising between Caraco, Sun and/or any of their respective Affiliates, on the one hand, and Forest, Lundbeck and/or any of their respective Affiliates, on the other hand, from or in connection with the Actions or the Caraco ANDA, occurring prior to the Effective Date of this Agreement, including, without limitation, all claims that Caraco and Sun have asserted or could have asserted in the Actions or in any judicial proceeding that the '712 Patent, the '941 Patent and/or the '069 Patent are somehow invalid, unenforceable or not infringed by the sale of the generic escitalopram oxalate products that are the subject of the Caraco ANDA in the Territory (all of the above collectively, the "Caraco Released Claims");
 
(b)            Forest and Lundbeck for themselves and their respective Affiliates hereby irrevocably release and discharge Caraco and Sun and their respective Affiliates, successors, assigns, directors, officers, employees, agents, distributors, suppliers and customers from all causes of action, demands, claims, damages and liabilities of any nature, whether known or unknown, arising between Forest, Lundbeck and/or any of their respective Affiliates, on the one hand, and Caraco, Sun and/or any of their respective Affiliates, on the other hand, from or in connection with the Actions or the Caraco ANDA, occurring prior to the Effective Date of this Agreement, including, without limitation, all claims that Forest and Lundbeck have asserted or could have asserted in the Actions or in any judicial proceeding that the '712 Patent, the '941 Patent and/or the '069 Patent are infringed by the sale of the generic escitalopram oxalate products that are the subject of the Caraco ANDA in the Territory (all of the above collectively, the "Forest Released Claims");
 
(c)            this Agreement shall constitute a final settlement of the Actions by the Parties, subject to the possibility the Actions are reinstituted under Section 6;
 
(d)            Caraco and Sun shall not release, to the extent there is a release provision or control, any agent or consultant retained by Caraco and Sun (whether retained for Caraco and Sun's benefit by Caraco and Sun or by any Caraco and Sun attorney) to assist or cooperate with any litigant in any litigation against Forest and Lundbeck with respect to the '712 Patent, the '941 Patent and/or the '069 Patent regarding any Forest Product.  Similarly, in any such action Caraco and Sun shall not release any attorney who represented Caraco and Sun in the Actions from maintaining the confidentiality of non-public information to which such attorney had access in connection with the Actions or grant any waivers with respect to such maintenance unless so ordered by the Court or compelled by law.  Nothing in this Agreement shall prohibit Sun and Caraco from using agents, consultants or attorneys in any way should the Actions be reinstituted under Section 6 or for attorneys to represent other clients regarding the same patents;

 
9

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
(e)            to the extent necessary, Caraco and Sun shall permit and cooperate with Forest and Lundbeck to enforce the obligations of such agents, consultants or attorneys referred to under Section 7(d) herein; and
 
(f)            nothing in this Agreement shall prohibit any Party from challenging or enforcing any patent (including any of the Licensed Patents) in connection with a product other than the Generic Product.
 
8.             ACKNOWLEDGMENTS.  Caraco and Sun, and Forest and Lundbeck, acknowledge as follows:
 
(a)           CARACO AND SUN ACKNOWLEDGE THAT THEY MAY HEREAFTER DISCOVER CLAIMS OR FACTS IN ADDITION TO OR DIFFERENT FROM THOSE WHICH THEY NOW KNOW OR BELIEVE TO EXIST WITH RESPECT TO THE CARACO RELEASED CLAIMS, THE FACTS AND CIRCUMSTANCES ALLEGED IN THE ACTIONS, AND/OR THE SUBJECT MATTER OF THIS AGREEMENT, WHICH, IF KNOWN OR SUSPECTED AT THE TIME OF EXECUTING THIS AGREEMENT, MAY HAVE MATERIALLY AFFECTED THIS AGREEMENT.  NEVERTHELESS, UPON THE EFFECTIVENESS OF THE RELEASE OF THE CARACO RELEASED CLAIMS AS SET FORTH IN SECTION 7 ABOVE, CARACO AND SUN HEREBY ACKNOWLEDGE THAT THE CARACO RELEASED CLAIMS INCLUDE WAIVERS OF ANY RIGHTS, CLAIMS OR CAUSES OF ACTION THAT MIGHT ARISE AS A RESULT OF SUCH DIFFERENT OR ADDITIONAL CLAIMS OR FACTS.  CARACO AND SUN ACKNOWLEDGE THAT THEY UNDERSTAND THE SIGNIFICANCE AND POTENTIAL CONSEQUENCES OF SUCH A RELEASE OF UNKNOWN UNITED STATES JURISDICTION CLAIMS AND OF SUCH A SPECIFIC WAIVER OF RIGHTS.  CARACO AND SUN INTEND THAT THE CLAIMS RELEASED BY THEM UNDER THIS RELEASE BE CONSTRUED AS BROADLY AS POSSIBLE TO THE EXTENT THEY RELATE TO UNITED STATES JURISDICTION CLAIMS.  CARACO AND SUN ARE AWARE OF CALIFORNIA CIVIL CODE SECTION 1542, WHICH PROVIDES AS FOLLOWS:
 
"A general release does not extend to claims which the creditor does not know or suspect to exist in his or her favor at the time of executing the release, which if known by him or her, must have materially affected his or her settlement with the debtor."

 
10

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
CARACO AND SUN AGREE TO EXPRESSLY WAIVE ANY RIGHTS THEY MAY HAVE UNDER THIS CODE SECTION OR UNDER FEDERAL, STATE OR COMMON LAW STATUTES OR JUDICIAL DECISIONS OF A SIMILAR NATURE, AND KNOWINGLY AND VOLUNTARILY WAIVE SUCH UNKNOWN CARACO RELEASED CLAIMS.
 
(b)           FOREST AND LUNDBECK ACKNOWLEDGE THAT THEY MAY HEREAFTER DISCOVER CLAIMS OR FACTS IN ADDITION TO OR DIFFERENT FROM THOSE WHICH THEY NOW KNOW OR BELIEVE TO EXIST WITH RESPECT TO THE FOREST RELEASED CLAIMS, THE FACTS AND CIRCUMSTANCES ALLEGED IN THE ACTIONS, AND/OR THE SUBJECT MATTER OF THIS AGREEMENT, WHICH, IF KNOWN OR SUSPECTED AT THE TIME OF EXECUTING THIS AGREEMENT, MAY HAVE MATERIALLY AFFECTED THIS AGREEMENT.  NEVERTHELESS, UPON THE EFFECTIVENESS OF THE RELEASE OF THE FOREST RELEASED CLAIMS AS SET FORTH IN SECTION 7 ABOVE, FOREST AND LUNDBECK HEREBY ACKNOWLEDGE THAT THE FOREST RELEASED CLAIMS INCLUDE WAIVERS OF ANY RIGHTS, CLAIMS OR CAUSES OF ACTION THAT MIGHT ARISE AS A RESULT OF SUCH DIFFERENT OR ADDITIONAL CLAIMS OR FACTS.  FOREST AND LUNDBECK ACKNOWLEDGE THAT THEY UNDERSTAND THE SIGNIFICANCE AND POTENTIAL CONSEQUENCES OF SUCH A RELEASE OF UNKNOWN UNITED STATES JURISDICTION CLAIMS AND OF SUCH A SPECIFIC WAIVER OF RIGHTS.  FOREST AND LUNDBECK INTEND THAT THE CLAIMS RELEASED BY THEM UNDER THIS RELEASE BE CONSTRUED AS BROADLY AS POSSIBLE TO THE EXTENT THEY RELATE TO UNITED STATES JURISDICTION CLAIMS.  FOREST AND LUNDBECK ARE AWARE OF CALIFORNIA CIVIL CODE SECTION 1542, WHICH PROVIDES AS FOLLOWS:
 
"A general release does not extend to claims which the creditor does not know or suspect to exist in his or her favor at the time of executing the release, which if known by him or her, must have materially affected his or her settlement with the debtor."
 
FOREST AND LUNDBECK AGREE TO EXPRESSLY WAIVE ANY RIGHTS THEY MAY HAVE UNDER THIS CODE SECTION OR UNDER FEDERAL, STATE OR COMMON LAW STATUTES OR JUDICIAL DECISIONS OF A SIMILAR NATURE, AND KNOWINGLY AND VOLUNTARILY WAIVE SUCH UNKNOWN FOREST RELEASED CLAIMS.

 
11

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
9.             Confidentiality.  The terms of this Agreement shall be maintained in confidence by all of the Parties except that:  (i) the press release to be issued by Forest in connection with the Agreement is set forth on Part A of Exhibit F, the press release to be issued by Lundbeck in connection with this Agreement is set forth on Part B of Exhibit F, the press release to be issued by Caraco in connection with this Agreement is set forth on Part C of Exhibit F, and the press release to be issued by Sun in connection with this Agreement is set forth on Part D of Exhibit F; (ii) Forest and Lundbeck may disclose such terms as may be necessary or useful in connection with any anticipated, pending or actual patent litigation or other legal proceeding with a third party in the Territory relating to any of the Licensed Patents; and (iii) as otherwise required by law, including without limitation United States Securities and Exchange Commission reporting requirements, or by the rules or regulations of any stock exchange to which any of the Parties are subject.
 
10.           Term and Termination.  Unless terminated earlier under Section 6, this Agreement shall continue from the Effective Date until the expiration of the last to expire of the Licensed Patents.  The releases and discharges set forth in Section 7 of this Agreement shall survive the expiration of this Agreement, but shall terminate in connection with any earlier termination of this Agreement under Section 6.  The confidentiality obligations set forth in Section 9 shall survive and continue from the Effective Date until the expiration of the last to expire of the Licensed Patents, notwithstanding any earlier expiration or termination of this Agreement.
 
If any Party believes that another Party has breached this Agreement, it shall specify such breach in a written notice and the breaching Party shall have fourteen (14) days to remedy any such breach prior to the initiation of arbitration or litigation, except with respect to any sale or offer to sell the Generic Product in the Territory prior to the Launch Date, which shall have no such notice or cure period.
 
11.           No Assignment.  This Agreement may not be assigned or transferred to a third party without the express prior written consent of the other Parties hereto, except to a successor to all or substantially all of the business of the assigning or transferring Party to which this Agreement pertains (whether by sale of stock, merger, consolidation or otherwise), in which case the Party shall assign this Agreement to such successor, provided that a Party may in the ordinary course of its business assign its rights under this Agreement to an Affiliate or may transfer the rights under this Agreement from one Affiliate to another without the prior consent of the other Party.  The covenants, rights and obligations of a Party under this Agreement shall remain binding upon the assigning or transferring Party and shall inure to the benefit of and be binding upon any successor or permitted assignee of the Party.

 
12

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
12.           Notice.  Any notice required or permitted to be given or sent under this Agreement shall be hand delivered or sent by express delivery service or certified or registered mail, postage prepaid, to the Parties at the addresses indicated below.
 
 
If to Forest, to:
Charles S. Ryan
Vice President, Chief Intellectual Property Counsel
Forest Research Institute, Inc.
909 Third Avenue
New York, NY  10022

 
with copies to:
Peter J. Armenio
Kirkland & Ellis LLP
601 Lexington Avenue
New York, New York  10022

 
If to Lundbeck, to:
John Meidahl Petersen
Director, Corporate Patents
H. Lundbeck A/S
Ottiliavej 9
DK-2500 Valby
Copenhagen, Denmark

 
with copies to:
Peter J. Armenio
Kirkland & Ellis LLP
601 Lexington Avenue
New York, New York  10022

 
If to Caraco, to:
Daniel Movens
Chief Executive Officer
Caraco Pharmaceutical Laboratories Ltd.
1150 Elijah McCoy Drive
Detroit, Michigan  48202

 
with copies to:
Derek J. Sarafa
Winston & Strawn LLP
35 West Wacker Drive
Chicago, Illinois  60601

 
13

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
 
If to Sun, to:
Arshad Jamil
General Counsel
Sun Pharmaceutical Industries Ltd.
Acme Plaza
Andheri - Kurla Rd, Andheri (E)
Mumbai - 400 059

 
with copies to:
Derek J. Sarafa
Winston & Strawn LLP
35 West Wacker Drive
Chicago, Illinois  60601

Any such notice shall be deemed to have been received on the date actually received.  Any Party may change its address by giving the other Party written notice, delivered in accordance with this Section.
 
13.           Entire Agreement.  This Agreement, as defined herein to include Exhibits A through F, constitutes the complete, final and exclusive agreement between the Parties with respect to the subject matter hereof and supersedes and terminates any prior or contemporaneous agreements and/or understandings between the Parties, whether oral or in writing, relating to such subject matter.  There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as are set forth in this Agreement.  No subsequent alteration, amendment, change, waiver or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party.  Each Party in deciding to execute this Agreement has retained counsel and has not relied on any understanding, agreement, representation or promise by the other Party that is not explicitly set forth herein.
 
14.           Governing Law.  This Agreement shall be governed, interpreted and construed in accordance with the laws of the State of Illinois, without giving effect to choice of law principles.   The Parties hereto agree that any disputes arising with respect to the interpretation or enforcement of any provision hereof shall be submitted to arbitration in Chicago, Illinois, or such other location as may be mutually agreed by the Parties, in accordance with the then existing Commercial Arbitration Rules of the American Arbitration Association.  Such arbitration shall be conducted before a panel of three arbitrators, one chosen by Forest and Lundbeck, one chosen by Caraco and Sun, and the third chosen by such other two arbitrators.  The award or decision of a majority of the arbitrators pursuant to this Section 14 shall be binding and conclusive on the Parties, provided that the enforcement of such award or decision may be obtained in any court having jurisdiction over the Party against whom such enforcement is sought.  The losing party shall pay all reasonable attorneys fees and costs associated with such arbitration.

 
14

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
Notwithstanding the preceding, nothing set forth herein shall be deemed to preclude either Party from seeking appropriate judicial injunctive relief in any Court of competent jurisdiction with respect to the provisions of Section 9 hereof or the enforcement of any other provision hereunder the breach of which would cause irreparable harm to the other Party and which would not have an adequate remedy at law.  If there is any dispute that is not subject to arbitration and for which the United States District Court for the Northern District of Illinois does not have subject matter jurisdiction, the state courts in Illinois shall have jurisdiction.  In connection with any dispute arising out of or in connection with this Agreement that is not subject to arbitration, each Party hereby expressly consents and submits to the personal jurisdiction of the federal and state courts in the State of Illinois.
 
15.           Severability.  Subject to the provisions and the mechanisms of Section 6 above, if any provision of this Agreement is declared illegal, invalid or unenforceable by a court having competent jurisdiction, it is mutually agreed that this Agreement shall endure except for the part declared invalid or unenforceable by order of such court; provided, however, that in the event that the terms and conditions of this Agreement are materially altered, the Parties will, in good faith, renegotiate the terms and conditions of this Agreement in an effort to reasonably replace such invalid or unenforceable provisions in light of the intent of this Agreement.
 
16.           Waiver.  Any delay or failure in enforcing a Party's rights under this Agreement, or any acquiescence as to a particular default or other matter, shall not constitute a waiver of such Party's rights to the enforcement of such rights, nor operate to bar the exercise or enforcement thereof at any time or times thereafter, except as to an express written and signed waiver as to a particular matter for a particular period of time.
 
17.           Counterparts.  This Agreement shall become binding when any one or more counterparts hereof, individually or taken together, bears the signatures of each of the Parties hereto.  This Agreement may be executed in any number of counterparts (including facsimile or electronic counterparts), each of which shall be an original as against a Party whose signature appears thereon, but all of which taken together shall constitute one and the same instrument.
 
18.           Representations and Warranties. The Parties hereby represent and warrant that:  (a) they have approved the execution of this Agreement and have authorized and directed the signatory officers below to execute and deliver this Agreement; (b) they each have the full right and power to enter into this Agreement, and there are no other persons or entities whose consent or joinder in this Agreement is necessary to make fully effective those provisions of this Agreement that obligate, burden or bind either of them; (c) when so executed by each Party, this Agreement shall constitute a valid and binding obligation of such Party, enforceable in accordance with its terms; and (d) they have not transferred or assigned or pledged to any third party, whether or not Affiliated, the right to bring, pursue or settle any of the claims, counterclaims or demands made in the Actions.  Forest and Lundbeck further represent that they are not aware of any pending claim by a third party of incorrect ownership, invalidity or unenforceability asserted against the Licensed Patents.  Sun and Caraco further represent that they are not aware of any pending claim by a third party of patent infringement asserted against the Generic Product.

 
15

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
 
19.           Costs.  Except as otherwise stated in this Agreement, each Party shall bear its own costs, expenses and taxes in the performance of this Agreement.
 
20.           Construction. This Agreement has been jointly negotiated and drafted by the Parties through their respective counsel and no provision shall be construed or interpreted for or against any of the Parties on the basis that such provision, or any other provision, or this Agreement as a whole, was purportedly drafted by the particular Party.  All references to periods of days for taking certain actions in this Agreement shall be construed in the same manner they are construed in the Federal Rules of Civil Procedure.
 
*           *           *           *           *

 
16

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 
IN WITNESS WHEREOF, this Agreement has been executed by the duly authorized representatives of the Parties.
 
FOREST LABORATORIES, INC.
FOREST LABORATORIES HOLDINGS, LTD.
           
By:
/s/ Howard Solomon
 
By:
/s/ Howard Solomon
 
Name:
Howard Solomon
Name:
Howard Solomon
Title:
Chief Executive Officer
Title:
Chief Executive Officer
           
H. LUNDBECK A/S
     
       
By:
/s/ Ulf Wiinberg
       
Name:
Ulf Wiinberg
     
Title:
Chief Executive Officer
     
           
CARACO PHARMACEUTICAL
SUN PHARMACEUTICAL
LABORATORIES, LTD.
INDUSTRIES LTD.
           
By:
/s/ Daniel H. Movens
 
By:
/s/ Dilip Shanghvi
 
Name:
Daniel H. Movens
Name:
Dilip Shanghvi
Title:
Chief Executive Officer
Title:
Chairman and Managing Director
 
 

EX-10.25 6 ex10_25.htm EXHIBIT 10.25 ex10_25.htm

EXHIBIT 10.25

SEPARATION AGREEMENT AND RELEASE OF ALL CLAIMS

This Separation Agreement and Release of All Claims (“Agreement”) is made between Caraco Pharmaceutical Laboratories Limited (“Company”) and Daniel Movens (“Executive”), as follows:

1.           Resignation from Employment.  Effective July 28, 2009 (the “Separation Date”), Executive resigns voluntarily from employment as the Chief Executive Officer of Company and from all positions with Company and its affiliates including without limitation as a director of Company.  This Agreement without more shall evidence such resignations.  Executive will be paid Executive’s salary and receive all benefits through the Separation Date.  Executive will be paid for Executive’s accrued but unused vacation days in accordance with Company policy.  Except as set forth in this Agreement, all compensation and benefits from the Company shall terminate on the Separation Date.

2.           Separation Payment.  Executive will be paid, as a separation payment, the sum of Eight Hundred Seventy Thousand, Six Hundred and Twenty-One Dollars ($870,621), an amount equal to one and a half (1.5) times the highest annual base and one and a half (1.5) times the last earned bonus of Executive, less applicable withholding (“Separation Payment”).  The Separation Payment shall be paid in a lump sum after Executive signs and returns this Agreement and the seven (7) day revocation period in Section 14(c) expires without revocation.  The Separation Payment shall be increased if necessary by an amount representing a gross-up of any federal, state and local income tax liability arising from any amounts payable to Executive under this Agreement which are considered to be a “parachute payment” under Internal Revenue Code Section 280G and the regulations promulgated thereunder.

3.           Continuation of Health, Vision and Dental Insurance.  For twelve (12) months after the Separation Date, (a) Company shall pay and provide Executive with health insurance coverage and (b) Company shall provide vision and dental insurance to Executive with the premiums for vision and dental insurance to be paid by Executive.

4.           Stock Options and Stock Grants.  All stock options and stock grants from Company to Executive shall immediately vest, to the extent not previously vested, and the rights of Executive regarding such stock options and stock grants shall be as set forth in the respective plans and agreements governing them.

5.           Release of All Claims.  In consideration for the Separation Payment and except for the performance of this Agreement, Executive, for Executive and any person or representative claiming through Executive, releases and forever discharges the Company, its predecessors, parent company, subsidiaries and affiliated organizations, joint ventures, successors and assigns, and their past and present shareholders, members, directors, officers, employees, agents, attorneys, benefit plans and plan administrators, sureties and insurers (collectively “Releasees”) from and against any and all claims, liabilities, demands, costs, attorney fees, causes of action and damages, including all consequential and incidental damages, whether known or unknown, arising from the beginning of time to the date of this Agreement, including without limitation those relating directly or indirectly to Executive’s employment with the Company and all claims for personal injury, defamation, breach of contract, wrongful discharge, violation of due process or civil rights and violation of any federal, state or local statute, law or ordinance and the common law, including without limitation violation of the Employee Retirement Income Security Act, Title VII of the Civil Rights Act, the Age Discrimination in Employment Act, the Fair Labor Standards Act, the Americans with Disabilities Act, the Equal Pay Act, the Family and Medical Leave Act, the Michigan Elliott-Larsen Civil Rights Act, the Michigan Persons with Disabilities Act, the Michigan Wage and Fringe Benefits Act, the Michigan Whistleblower’s Protection Act, and/or any federal, state or local law regarding discrimination. Notwithstanding this Agreement, Company acknowledges that Executive is not releasing Executive’s 401(k) plan balance and rights to continue health, vision or dental insurance under COBRA.

 
 

 

It is understood and agreed that except for the exceptions set forth in this Agreement, this is a full and final release in complete settlement of all claims and rights of every nature and kind whatsoever which Executive has or may have against the Company and other Releasees.  Executive acknowledges that Executive does not have any personal injuries and/or disabilities related to Executive’s employment with the Company.

Executive agrees that Executive will never make any claim or demand against the Company and/or other Releasees as to any matter released under this Agreement, including without limitation the filing of a lawsuit in any state or federal court or, to the full extent authorized by law, the filing of a claim with any governmental agency provided, however, that the foregoing does not (a) impose any limitation adversely affecting Executive’s right to challenge the validity of this Agreement or (b) affect any right to file an administrative charge with the Equal Employment Opportunity Commission, subject to the restriction that if any such charge is filed, Executive agrees not to seek or in any way obtain or accept any monetary award, recovery, settlement or relief therefrom.  Executive agrees that in the event that he makes such claim or demand in violation of this paragraph, (a) this Agreement shall serve as a full and complete defense, and (b) Executive shall be responsible to pay Company’s/Releasees’ attorney fees and costs to the full extent authorized by law.

6.           Confidential Information and Non-Competition.  Executive and Company executed an Employment Agreement effective May 2, 2005 (the “Employment Agreement”).  Section 8 of the Employment Agreement and the Confidentiality and Non-Competition Agreement previously executed by Executive shall remain in full force and effect and be fully complied with by Executive.

7.           No Negative Comments or Interference.  Except as otherwise required by law provided in which case,  Executive provides Company as promptly as possible with prior written notice of any such disclosure,: (a) Executive and Company shall not disparage, criticize or make negative comments about the other party, its predecessors, parent company, subsidiaries and affiliated organizations, joint ventures, successors ,their directors, officers, employees, products or services, (b) Executive and Company shall not take any action having the effect of damaging the business reputation of the other party, its predecessors, parent company, subsidiaries and affiliated organizations, joint ventures, successors (c) Executive shall not take any action interfering with or adversely affecting Company’s and those of, its predecessors, parent company, subsidiaries and affiliated organizations, joint ventures, successors' relationships with its employees, customers or vendors, or (d) Executive shall not contact any of Company’s, its predecessors', parent company's, subsidiaries' and affiliated organizations', joint ventures', successors' customers for any purpose related to Executive’s employment with Company.  Executive agrees that Executive will not directly or indirectly induce any employee of the Company, its predecessors, parent company, subsidiaries and affiliated organizations, joint ventures, successors to engage in any activities prohibited to Executive under this Agreement or to terminate the employee’s employment with the Company, its predecessors, parent company, subsidiaries and affiliated organizations, joint ventures, successors.  The foregoing is not intended to extend the prohibition on Executive’s direct or indirect solicitation of customers of the Company for business in competition with the Company or of employees of the Company for employment for a period beyond two (2) years after the termination of Executive’s employment with the Company as set forth in the Confidentiality and Non-Competition Agreement.

 
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8.            Confidentiality of Agreement.  Except as required by law provided in which case, Executive provides Company as promptly as possible with prior written notice of any such disclosure, Executive agrees to keep the terms of this Agreement confidential and to not disclose any such terms to anyone other than Executive’s spouse, attorney and financial consultant, and then only upon their agreement to keep such terms confidential for which Executive indemnifies Company. Executive may also disclose the terms of this Agreement to the Internal Revenue Service or a governmental agency as required for reporting purposes.  This Section 8 shall not prevent Executive from disclosing to prospective employers that he resigned from employment with Company.

9.             Injunctive Relief.  In addition to any other recovery allowed by law, Company shall be entitled to a temporary restraining order, preliminary and permanent injunctive relief and such other equitable relief as appropriate for any breach by Executive of Sections 6, 7, or 8.

10.           Return of Property.  By the close of business on the Separation Date Executive shall return any property of the Company in Executive’s possession including, but not limited to: identification cards, door access cards, keys, credit cards, telephones, computers, equipment, tools, software and all Company records and documents whether in hard copy or electronic form and Company’s customer documents.  Return of all Company property is a condition to payment of the Separation Payment.  Executive shall also reconcile all expense reports prior to the Separation Date.

11.           No Support for Claims Against Company.  Unless compelled by law provided in which case, Executive provides Company as promptly as possible with prior written notice of any such disclosure, Executive will not provide, directly or indirectly, any information, encouragement or assistance to any person or entity considering or pursuing a claim or lawsuit against the Company.

12.           No Admission of Wrongdoing.  Neither this Agreement nor the payment of any amounts hereunder shall be construed as an admission of liability or wrongdoing by the Company or by the Executive.

 
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13.           Cooperation in Litigation, Investigations and Company Business.  Executive agrees to cooperate fully with the Company in its defense of or other participation in any administrative, judicial, arbitral, investigative or other proceeding arising from any charge, complaint or other action that has been or may be filed, or with respect to which the Company, its predecessors, parent company, subsidiaries and affiliated organizations, joint ventures, successors may be or become involved, relating to any matter that occurred during Executive’s employment with the Company.  Executive further agrees to reasonably assist the Company with respect to transition or questions regarding any business matters with which Executive was involved for the Company.  Company hereby agrees to indemnify Executive as provided in paragraph 15 of this Agreement.

14.           Representations and Revocation Right.

a.            Executive has been given a period of at least twenty-one (21) days in which to consider this Agreement.  Executive acknowledges that if Executive signed this Agreement before expiration of the twenty-one (21) days, Executive did so voluntarily and with the intention of waiving the remainder of such period.

b.            Executive is advised by Company to consult with an attorney.

c.            This Agreement shall not be effective or enforceable for a period of seven (7) days following the date of Executive’s signature below, during which time only, Executive may revoke this Agreement.  Any such revocation must be in writing, signed by Executive and delivered or mailed so as to arrive within such seven (7) days to Fred Green, Bodman LLP, 6th Floor at Ford Field, 1901 St. Antoine Street, Detroit, Michigan 48226.  If Executive revokes Executive’s acceptance of this Agreement, Executive shall not receive the Separation Payment.

15.           Indemnification of Executive.  Company agrees to continue to indemnify Executive for actions taken in the course of his employment with, or as a director for, Company to the fullest extent allowed by law and as generally provided to officers and directors of Company.  Executive shall continue to receive the benefit of D&O and EPL insurance to the extent in force during his employment.

16.           Miscellaneous.

a.            Executive relies wholly on Executive’s own judgment in consultation with Executive’s attorney or other advisor in executing this Agreement.  Executive has carefully read this Agreement in its entirety and signs as Executive’s free act.  Executive acknowledges that Executive has had a reasonable period of time in which to consider this Agreement.

b.            This five (5) page Agreement constitutes the entire agreement between Executive and the Company with respect to the subject matter hereof and supersedes any prior or contemporaneous promises, agreements or representations between them as to such subject matter, including the Employment Agreement which shall be of no further force or effect, except as otherwise set forth in this Agreement.  This Agreement cannot be modified orally but only in a written document signed by Executive and an authorized representative of the Company.  Except as to applicable federal law which may preempt state law, this Agreement shall be governed by the laws of the State of Michigan.

 
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c.           If any provision of this Agreement, in whole or in part, is determined to be unlawful or unenforceable, the parties agree that such provision shall be deemed modified, if possible, to the extent necessary to render such provision valid and enforceable to the maximum extent permitted by law and, if not possible, it shall be severed from the Agreement.  In either event all remaining provisions of this Agreement shall remain in full force and effect.

d.           The prevailing party shall be entitled to recover its/his costs and attorney fees in any action for violation of this Agreement.

e.           The Agreement accurately sets forth the intent and understanding of each party.  This Agreement may be signed in counterparts which together shall be one Agreement.  Facsimile signatures are effective as originals.

Agreed to and signed below to be effective on the eighth (8th) day following the date of Executive’s signature below:

READ BEFORE SIGNING

7-28-09
 
/s/ Daniel Movens
Date
 
Daniel Movens
     
     
   
CARACO PHARMACEUTICAL LABORATORIES LIMITED
     
     
7-28-09
 
By: /s/ Jitendra N. Doshi
Date
 
Jitendra N. Doshi
   
Its:  Chief Executive Officer
 
 
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EX-10.26 7 ex10_26.htm EXHIBIT 10.26 ex10_26.htm

EXHIBIT 10.26
 
EMPLOYMENT AGREEMENT
 
THIS EMPLOYMENT AGREEMENT (the “Agreement”) is made this 31st day of August, 2009, by and between CARACO PHARMACEUTICAL LABORATORIES, LTD. (the “Company”) and JITENDRA N. DOSHI (“Executive”).
 
WITNESSETH
 
WHEREAS, the Company desires to employ Executive as interim Chief Executive Officer; and
 
WHEREAS, Executive desires to be employed by the Company as its interim Chief Executive Officer; and
 
WHEREAS, the parties hereto are desirous of entering into a formal agreement of employment.
 
NOW, THEREFORE, in consideration of the premises and covenants herein contained, the parties covenant and agree as follows:
 
1.
Employment.  Executive shall serve as the Chief Executive Officer of the Company on an interim basis.
 
2.
Duties.  Executive shall diligently and conscientiously devote, on a full-time basis, his best efforts to the discharge of his duties as established from time to time by the Bylaws of the Company, the Board of Directors of the Company and the Compensation Committee of the Company.
 
3.
Compensation.  Executive shall receive the following compensation from the Company:
 
(a)           Base Salary.  The Company shall pay Executive a base salary at a rate of $275,000 annually, subject to all applicable withholdings, for services rendered as the interim Chief Executive Officer.  To the extent applicable, Executive’s base salary shall be reviewed annually, and may be adjusted based upon performance and other relevant factors deemed reasonable by the Company.
 
(b)           Other Benefits.  Executive shall be entitled to participate in any plan or program of employee benefits maintained by the Company for all employees as of the date hereof, and which may be hereafter adopted or modified by the Company, and which is or shall be available to Executive as a result of his employment by the Company pursuant to this Agreement, subject to the requirements of such plans or programs. In addition, a list of specific benefits to which Executive shall be entitled is set forth in Exhibit “A,” a copy of which is attached hereto and is herein incorporated by reference.
 
(c)           Vacations. Executive shall be entitled to four (4) weeks paid vacation on an annual basis.
 
4.
Term.  Unless terminated earlier in accordance with Section 5 hereof, the term of this Agreement shall be deemed to have commenced as of July 28, 2009, and shall continue for a period of one (1) year thereafter, and shall automatically renew for successive one-year periods at the end of the each one (1) year term.
 
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5.
At-Will Employment.  The parties agree that the Executive’s employment with the Company will be “at-will” employment and may be terminated at any time with or without cause or notice.  However, as described in Section 6 hereof, Executive may be entitled to severance benefits depending upon the circumstances of Executive’s termination of employment.
 
6.
Severance Benefits.  Executive shall receive the severance described below in full settlement of the termination of his employment with the Company:
 
(a)           If the Company terminates Executive for “just cause” or if Executive terminates his employment without cause or in the event of the death of Executive, Executive shall only be entitled to the base salary and benefits earned by him prior to such termination or date of death.  For purposes of this Agreement, “just cause” shall mean dishonesty, or refusal or failure by Executive to faithfully or diligently perform the duties contemplated by this Agreement, including but not limited to the failure of Executive to adhere to the policies of the Board.
 
(b)           In the event that the Company terminates Executive without “just cause”, or if Executive terminates for “cause not attributable to him,” Executive shall receive a severance package as follows:
 
 
i.
Executive shall receive monthly base salary payments, less all applicable withholdings, for six (6) months from the date of termination;
 
 
ii.
The Company shall continue premium coverage payments for health insurance for six (6) months from the date of such termination; and
 
 
iii.
Any stock options that would become available for exercise at the end of the year during which such termination occurred shall vest.
 
For purposes of this Agreement, for “cause” not attributable to Executive shall mean the Company failing to make any payment of base salary to him within thirty (30) days after such payment is due.
 
7.
Resignation From Board.  Upon termination from employment for any reason, Executive shall be deemed to thereby resign from the Board of Directors of the Company and shall also be deemed to thereby resign from all director and officer positions with any subsidiary of the Company.  Executive shall provide the Company, upon request, with a signed letter(s) further evidencing such resignation(s).
 
8.
Confidentiality.  At all times, Executive shall keep secret and inviolate and shall not divulge, communicate, use to the detriment of the Company or for the benefit of any other person or persons or misuse in any way any knowledge or secrets, personnel histories, sales information, computer programs, assets, accounts, books, records, customers, operations, personnel and contracts of the Company which Executive knows or hereafter comes to know as a result of his association with or which is unique to the Company (“Confidential Information”).  Executive may disclose Confidential Information if required by any judicial or governmental request, requirement or order; provided that he take reasonable steps to give the Company sufficient prior notice to contest such request, requirement or order.  The provisions of this Paragraph 8 shall survive the termination of this Agreement and Executive’s employment with the Company.
 
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9.
Waiver.  Failure by either party to insist upon strict compliance with any of the terms, covenants, or conditions hereof shall not be deemed a waiver by that party of any such term, covenant or condition, nor shall any waiver or relinquishment of any right or power hereunder at any one or more times be deemed a waiver or relinquishment of any such right or power at any other time or times.
 
10.
Severability.  The invalidity or unenforceability of any provision hereof shall in no way affect the validity or enforceability of any other provision.
 
11.
Nontransferability.  Neither Executive, nor his heirs, assigns or estate shall have the right to assign, encumber or dispose of any payment or right hereunder, which payment and right is expressly declared nonassignable and nontransferable except as otherwise specifically provided herein.
 
12.
Successors and Assigns.  The Company and Executive bind themselves, and their respective partners, successors, permitted assigns, heirs and legal representatives to all of the terms and conditions of this Agreement.
 
13.
Assignment.  This Agreement, and any or all rights hereunder, may not be assigned, in whole or in part, by Executive.  The Company may assign this Agreement, in whole or in part, and any or all of its rights hereunder.
 
14.
Notices.  Every notice or other communication required or permitted to be given under this Agreement (“Notice”) shall be in writing and shall be given by registered or certified mail, postage prepaid, return receipt requested, or by delivery of such Notice personally or by causing such Notice to be delivered next day delivery by reputable air courier.  All such Notices shall be mailed or delivered to the parties at the following addresses:
 
If to Company:  CARACO PHARMACEUTICAL LABORATORIES, LTD.
Board of Directors
1150 Elijah McCoy Drive
Detroit, Michigan  48202

If to Employee:  Jitendra N. Doshi
4020 Kodiak Ct.
Powell, Ohio 43065
 
or other such addresses as the parties may from time to time designate by written notice.  Delivery under this Paragraph 14, when by mail, shall be effective as of the date upon which the return receipt is accepted or refused.  A Notice personally delivered under this Section 14 shall be effective upon such delivery or, if delivery is refused, upon such refusal.  A Notice delivered next day delivery by reputable air courier shall be effective upon the next business day after having been sent.
 
15.
Applicable Law.  This Agreement shall be governed by, and construed in accordance with, the laws of the State of Michigan.
 
16.
Counterparts.  This Agreement may be executed in any number of counterparts, each of which when so executed and delivered shall be an original, but such counterparts together shall constitute one instrument.
 
17.
Entire Agreement.  The foregoing provisions contain the entire agreement of the parties hereto, and no modification hereof shall be binding upon the parties unless the same is in writing and signed by the respective parties hereto.
 
 
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IN WITNESS WHEREOF, the parties have executed this Agreement on the date first above written.
 
 
CARACO PHARMACEUTICAL
 
LABORATORIES, LTD.
 
a Michigan corporation
   
 
By: /s/ Dilip S. Shanghvi
 
Dilip S. Shanghvi
 
Chair, Compensation Committee
   
   
 
EMPLOYEE
   
 
By: /s/ Jitendra N. Doshi
 
Jitendra N. Doshi
 
 
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EX-10.27 8 ex10_27.htm EXHIBIT 10.27 ex10_27.htm

 
EXHIBIT 10.27
 
 
AGREEMENT
 
THIS AGREEMENT, made this 10th day of July, 2009 (the "Effective Date"), by and between CARACO PHARMACEUTICAL LABORATORIES, LTD., a Michigan corporation (“CARACO”), with an address of 1150 Elijah McCoy Drive, Detroit, MI 48202, USA,

AND

ALKALOIDA CHEMICAL COMPANY ZRT, a Hungarian corporation (“ALKALOIDA”) having its Registered office at H-4440, Tiszavasvari, Kabay János u. 29, Hungary.

R E C I T A L S

A.            ALKALOIDA has, or may develop or may obtain, proprietary rights to know-how, data and other Intellectual Property rights (defined below) to various generic pharmaceutical products and wishes to exploit the same.

B.            CARACO is interested in the filing of ANDA’s, (defined below), manufacturing, distribution and sale of the generic pharmaceutical products and is therefore interested in obtaining the technologies for the filing of ANDA’s, manufacturing of such products in the US Territory including Puerto Rico.

C.            ALKALOIDA and CARACO each wish to enter into an agreement pursuant to which ALKALOIDA shall license the product technology to CARACO for use in the Territory and provide or cause to be provided certain support to CARACO in pursuance of the said license.

1.
Definitions.
 
For the purposes of this Agreement:

1.1
“Affiliate” means any person or entity that directly or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with a party.  As used in this definition “control” (including, with correlative meanings, “controlled by” and “under common control with”) shall mean possession, directly or indirectly, of power to direct or cause the direction of management or policies (whether through ownership of securities or other ownership interest, by contract or otherwise).
 
1.2
“ANDA” means an Abbreviated New Drug Application which contains data when submitted to U.S. FDA’s center for Drug evaluation and Research, office of Generic Drugs, and provides for the review and ultimate approval of a generic drug product.
 
1.3
“Bioequivalence” shall have the meaning provided in the regulations of the U.S. Food and Drug Administration, as set forth in 21 C.F.R. §320.1.

 
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1.4
“First Commercial Sale” shall mean, in the Territory, the first sale by CARACO, its Affiliates or permitted subcontractor or sub licensee of a Product to a third party after the required regulatory approval to sell such Product in that country has been granted. A First Commercial Sale shall be deemed to occur on the earlier of (a) the date the Product is shipped, or (b) the date of the invoice to the purchaser of the Product.
 
1.5
“Improvement” means any alteration, modification or enhancement to, and embodying, the Product and / or the Product Technology  which changes or improves the effectiveness, efficiency, performance or other attribute of, or related to, the Products, or any element thereof.  Unless otherwise expressly set forth in this Agreement, the defined term “Product Technology” includes any and all Improvements, whether made by CARACO, its sub contractor, its sub licensee,  ALKALOIDA and/or the parties jointly.
 
1.6
“Intellectual Property” means all know-how, technical information, methods and processes belonging to either party, including without limitation Intellectual Property rights and other proprietary rights in any jurisdiction throughout the world including, without limitation, (a) patents and patent applications and any divisions, continuations, continuations-in-part, reissues, renewals, extensions, or reexaminations thereof, (b) inventions, trade secrets, know-how and other confidential or proprietary information, (c) copyrights and copyright applications, copyrightable works and mask works, (d) trademarks and trademark applications, and (e) any additions, advances, changes, derivatives, improvements, enhancements, refinements or modifications made to any of the foregoing.  The term defined, as used in this Agreement, shall include any rights analogous to those set forth in this definition such as moral rights, rights of paternity or integrity and any other proprietary rights relating to intangible property.
 
1.7
“Net Sales” means gross sales to a third party (other than an Affiliate) less returns, allowances, service level fees, chargebacks, cash discounts, free goods, shelf stock adjustments, credits for damaged Products or expired Products, and customary discounts given In addition, all costs incurred as a result of any recall, field correction, market withdrawal, stock recovery, or similar action with respect to a Product will be deducted in the calculation of Net Sales for that Product. However, to the extent such costs are recovered by CARACO, they will be added back to Net Sales for such Product upon receipt by CARACO. In case of sales to Affiliates by CARACO for the purpose of resale to a non affiliate, the net sales as above shall be computed by such Affiliate and such net sales by such Affiliate to a non affiliate shall be considered & treated as Net Sales for all the intents and purposes under this Agreement.
 
1.8
“Product” means one or more generic pharmaceutical products, as specified in Schedule A and to which further products may be added or deleted from time to time, that may be identified and mutually agreed by the parties hereto in pursuance of this Agreement and which require the filing and approval as an ANDA from the United States Food and Drug Administration (US-FDA) of the United States of America for the purpose of marketing the same in the Territory.

 
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1.9
“Product Technology” means, for each Product, all properties, specifications, research, technology and formulations relating to Product, including know-how, stability data analytical methods, manufacturing processes and other relevant information.  “Product Technology” also includes such advice and counseling regarding information provided by ALKALOIDA and/or its nominee as may be reasonably required by CARACO.
 
1.10
“Territory” means, the United States, its territories and possessions, including Puerto Rico.
 
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereto, intending to be legally bound, hereby agree as follows:

2.
PROVIDING OF TECHNOLOGY BY ALKALOIDA TO CARACO
 
2.1
License.
 

 
(a)
Subject to the terms of this Agreement, ALKALOIDA hereby grants to CARACO:
 
 
(i)
a non-exclusive, non-transferable (except as provided herein) license (with the right to sublicense as provided herein) to the Product Technology for a period of 5 (five) years from the date of commencement of the marketing of the Product Technology by ALKALOIDA to CARACO to create Improvements to the Product; and
 
 
(ii)
an exclusive, non-transferable (except as provided herein) license (with the right to sublicense as provided herein) for the product for a period of 5 (five) years from the date of commencement of the marketing of the Product Technology by ALKALOIDA to CARACO to:
 
 
(A)
manufacture the Products, and have the Products manufactured, in the Territory using the Product Technology;
 
 
(B)
market, advertise, promote, distribute, sell, offer to sell, license and otherwise exploit the Products in the Territory using the Product Technology; and
 
 
(C)
further develop, make, use, license and otherwise exploit in the Territory, the formulations, technology, manufacturing process, know-how, stability data and other relevant information  with respect to the Products.
 
 
(b)
The license rights set forth in Section 2.1(a) include, without limitation, the exclusive rights to use all Intellectual Property embodied in or relating to the Products, or any Product Technology for a Product, within the Territory for a period of 5 (five) years from the date of transfer of  the Product Technology by ALKALOIDA to CARACO.

 
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(c)
CARACO is permitted to grant a sublicense to any third party manufacturers, resellers, distributors and/or subcontractors (collectively, “Subcontractors”) to perform its obligations and/or exercise its rights under this Agreement; provided that: (i) no use of any Subcontractor shall relieve CARACO of any of its obligations under this Agreement; and (ii) CARACO shall remain fully responsible for each such Subcontractor’s compliance with, and/or breach of, this Agreement.
 
 
(d)
The license period as set forth in Sections 2.1(a) and (b) herein above, if required by CARACO, shall be extended for further period /block of 5 years from the end of block of each such 5 years on the terms and conditions of this Agreement or on such terms as may be mutually agreed upon by CARACO  and ALKALOIDA.
 
2.2
Timing of Providing Product Technology.
 
 
(a)
ALKALOIDA will deliver the Product Technology as soon as it is developed or available with ALKALOIDA or as agreed to by both the parties or otherwise deemed fit by the parties, to CARACO for the Products set forth in Schedule A, which CARACO covenants to use, either alone or with others, directly or indirectly, solely to exercise its rights and/or perform its obligations under this Agreement.
 
 
(b)
Thereafter, so long as CARACO is promptly performing its obligations pursuant hereto, ALKALOIDA shall promptly give to CARACO, any updates to the Product Technology in respect of any Products in Schedule A, and any Products added to Schedule A during the term of this Agreement.
 
2.3
Selection of the Products.
 
The Products shall be selected from time to time by the mutual agreement of ALKALOIDA and CARACO’s management.  The Products so identified shall be registered by CARACO with US-FDA.  The Products so identified and developed shall be added to the Schedule A from time to time. The ownership of ANDAs for use in the Territory shall lie with CARACO.  It is expressly agreed and acknowledged that the parties have not, as of the date hereof, agreed on what Products shall be added, and ALKALOIDA shall not, as of the date hereof, have any obligation to deliver Product Technology in respect of any specific Product in the future during the term of this Agreement, but solely to deliver the Product Technology in respect of the Products, which are to be hereafter identified as set forth in this Section 2.3.
 
2.4
Right of First Refusal
 
If at any time before the termination of this agreement, CARACO wishes to sell the ANDAs for any Product registered in its name under this agreement to any person, it shall be subject to a Right of First Refusal by ALKALOIDA. The Right of First Refusal shall be exercised in the following manner:
 
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(a)
CARACO shall provide written notice (the “Offer Notice”) to ALKALOIDA expressing its desire sell any of the ANDAs for the Products. The Offer Notice shall indicate the details of the ANDAs being sold and the price at which CARACO desires to sell the Offered ANDAs (the “Offer Price”) and all other material terms and conditions of the offer.
 
 
(b)
ALKALOIDA may agree to acquire, by itself or through its nominee, the Offered ANDAs at the Offer Price by providing CARACO a written notice within 30 days from the date of receipt by ALKALOIDA of the Offer Notice (the “Reply Notice”).
 
 
(c)
If ALKALOIDA refuses to acquire the Offered ANDAs and states the same in the Reply Notice or fails to provide the Reply Notice within the period specified hereinabove, CARACO shall be entitled to sell the Offered ANDAs to any bona fide third party, at a price not less than the Offer Price and at the terms and conditions not more favourable than those offered to ALKALOIDA under this Article, within 30 days from the date of such refusal or failure to provide Reply Notice by ALKALOIDA.
 
 
(d)
If CARACO is not able to sell the Offered ANDAs to any third party as prescribed in this Article, then the Offered ANDAs shall again be subject to the Right of First Refusal by ALKALOIDA.
 
 
(e)
Any third party purchasing such Offered ANDAs in compliance with this Clause shall not be entitled to take title or beneficial ownership of any Offered ANDAs until such time as the third party has agreed in writing to be bound by the terms of this Agreement or as may be mutually agreed by and between the said Purchaser and ALKALOIDA.
 
2.5
Continuing Rights of ALKALOIDA.
 
Notwithstanding the providing of Product Technology for any Product hereunder by ALKALOIDA to CARACO, nothing herein shall in any way limit the right of ALKALOIDA to develop, produce, market or take any other action for exploiting the Product Technology with respect to any Product outside of the Territory.  CARACO shall have the exclusive right to develop, produce, market or take any other action with respect to any Product inside the Territory.

3.
OBLIGATIONS OF CARACO WITH RESPECT TO PRODUCTS.
 
3.1
Delivery of Protocol.
 
To the extent that the United States Food and Drug Administration (“US-FDA”) has a required protocol for the studies designed to demonstrate the Bioequivalency of a Product, (an “FDA Protocol”), then within sixty (60) days of signing of this Agreement and subsequently within sixty (60) days of selection of the Product by the parties, CARACO shall deliver, in writing, to ALKALOIDA, a proposed protocol, which is believed in good faith by CARACO to be acceptable to the US-FDA (or, if applicable, a waiver of evidence of in vivo bioavailability).  To the extent that no US-FDA Protocol exists with respect to any Product, CARACO will, in consultation with the US-FDA and ALKALOIDA, develop such a protocol within one hundred fifty (150) days of the selection of the Product by the parties; and will promptly deliver such protocol to ALKALOIDA after it has been developed.

 
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3.2
Conduct of Tests and Studies.
 
CARACO shall, at its own expense, conduct all tests, including a Bioequivalency study (or studies) and/or pilot studies designed to provide clinical information to assist in the development of clinical bioequivalence protocols and bioanalytic methods, and any clinical trials which ALKALOIDA and/or CARACO deem to be reasonably necessary to enable CARACO to prepare and to file with the FDA an application for an ANDA for each Product.  CARACO shall select suitable clinical research organizations to conduct any such studies and trials.

 
(a)
CARACO shall, at its own expense, produce quantities of any Product as necessary for use in such studies and trials.  Such Products shall be produced in accordance with those current good manufacturing regulations established in 21 CFR Parts 210 and 211, as such sections, from time to time, may be amended or supplemented, or any successor provisions (“Current Good Manufacturing Practices” or “CGMP”).
 
 
(b)
CARACO shall, in connection with its clinical studies, develop manufacturing procedures, batch records, packaging and labeling instructions, release specifications, and quality assurance procedures and put the procedures into an US-FDA accepted format.
 
 
(c)
ALKALOIDA shall have the right, but not the obligation, to monitor all Bioequivalency studies and clinical trials, and discuss the methodologies and results of such studies and clinical trials with the persons responsible for the design and conduct of such studies and/or trial by or on behalf of CARACO.  At the request of ALKALOIDA, CARACO shall submit relevant production records, including the product formulation, master batch record, specifications, analytical results, copies and details of Bioequivalency study and related supporting documentation.  ALKALOIDA reserves the right to use, outside the Territory, as and when it may elect to do so, any information, data, studies and formulations which it may be furnished hereunder, without any royalty, premium or other payment to CARACO notwithstanding that this Agreement is terminated or this Agreement is terminated for any Product.  CARACO shall have no liability or responsibility whatsoever in connection with ALKALOIDA’s use outside the Territory of any information, data, studies and formulations which it may be furnished hereunder.
 
 
(d)
The expense on conducting all tests including Bioequivalency study and on producing quantities of any product necessary for use in such studies and trials shall be paid by CARACO itself.

 
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3.3
Preparation and Submission of ANDAs.
 
CARACO shall complete and submit the ANDA for each Product to the US-FDA as promptly as commercially practicable after the mutual selection of such Product by the parties, shall promptly respond to inquiries by the US-FDA in connection with the Product, and shall monitor and support the ANDA.  CARACO shall pay all expenses in connection with such submission and monitoring for each submitted Product ANDA, including the filing fee and all legal and consulting fees and expenses.  In any ANDA, CARACO shall:

 
(a)
identify itself as the manufacturer, and identify the packagers, labelers, and contract laboratories whose components or services are used in production of the Product;
 
 
(b)
submit methods, process and cleaning validations;
 
 
(c)
submit a signed certificate evidencing its compliance with CGMP;
 
 
(d)
submit executed master formula and batch production and control records;
 
 
(e)
adequately describe the precautions taken to ensure proper labeling;
 
 
(f)
submit specifications and test methods for testing the Product during the manufacturing process;
 
 
(g)
submit the appropriate packaging information;
 
 
(h)
submit the appropriate stability information; and
 
 
(i)
submit such other information, documentation or other matters as (i) required by applicable FDA rules or regulations, (ii) reasonably determined by ALKALOIDA or CARACO to be necessary or advisable to permit the expeditious approval of such ANDA or (iii) requested by the FDA.
 
3.4
Intellectual Property Analysis.
 
CARACO shall perform, at its own cost, an Intellectual Property analysis before the development / license hereunder of the Product Technology for a Product by ALKALOIDA to determine whether the Product will infringe on the Intellectual Property of any third party in the Territory based upon the Intellectual Property strategy made available by ALKALOIDA.  In the event that CARACO, initially and/or at any time after selection of the Product Technology but before the commencement of any development by ALKALOIDA, determines that a Product, as formulated in the Product Technology, will infringe the Intellectual Property of any third party in the Territory, CARACO shall provide written notice of its conclusions to ALKALOIDA, and shall make its counsel available to discuss such analysis with ALKALOIDA’s counsel; provided that CARACO and/or ALKALOIDA shall have no obligation to disclose any written materials that would result in the waiver of any attorney-client or other legal privilege.  CARACO may require that ALKALOIDA reformulate the Product and ALKALOIDA shall use its commercially reasonable efforts to do so within a reasonable time.  In the event that ALKALOIDA is unable or is not willing to reformulate the Product Technology to avoid possible infringement within a mutually agreed upon reasonable time (not to exceed nine (9) months, unless otherwise mutually agreed upon), then CARACO or ALKALOIDA may terminate this Agreement as to the applicable Product upon written notice to the other party.  However, if CARACO and ALKALOIDA mutually decide that the innovator's patent is challengeable as invalid or unenforceable under the relevant law, both ALKALOIDA and CARACO may mutually decide, prior to development of the Product Technology, to launch the Product at risk whether or not the Product Technology for the Product may be infringing.

 
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3.5
Manufacture of Products.
 
CARACO shall manufacture each Product in accordance with CGMP as defined under 21 C.F.R. 210 and 211, whether such Products are being manufactured in connection with the submission and seeking of approval of an ANDA or for sale to the public following approval of an ANDA with respect thereto.

3.6
Marketing of Products.
 
Subject to any limitations imposed as a result of its financial condition, CARACO shall use its best efforts, consistent with CARACO’s usual customary practices to market each Product in the Territory, and provide marketing personnel and such other capabilities as are reasonably appropriate. If CARACO does not start marketing within one (1) year from the date of approval of ANDA, CARACO shall be liable to pay to ALKALOIDA  for the 1st year of delay at the rate of US $300,000 and at the rate of US $100,000 for each succeeding year of delay till the time this Agreement is terminated for the relevant Product, provided that the reason for the delay is not due to the product not being marketable and/or profitable, not due to any ongoing analysis or discussion as to whether the Product would infringe on the Intellectual Property of any third party, or CARACO has determined that there is no return on investment based on the current market conditions at time of launch, however, further subject to the condition that CARACO shall have reimbursed to ALKALOIDA its proportionate share of the cost of the development of the Product Technology for the Product by ALKALOIDA, which amount will not exceed an amount to be mutually determined prior to the selection of any such Product for inclusion in this Agreement. To this extent, CARACO shall not, at any time after delivery of any Product, enter into any agreement or otherwise obligate itself to restrict or limit its manufacture of such Product, except with the consent of ALKALOIDA.  Notwithstanding anything else herein to the contrary (a) CARACO shall not be required to manufacture the Products in quantities or to sell the Products at prices other than those which are commercially reasonable; and (b) CARACO shall have full authority to determine the methods of marketing and selling the Products and the discounts and terms of sale to its customers provided however that CARACO shall provide ALKALOIDA prior written notice of any special bundling of Products which CARACO may offer its customers which may affect the sales of the Products.  In the event that any special bundling would result in a materially adverse price impact on the Products, then CARACO shall obtain ALKALOIDA's prior written consent.

3.7
No Activities Outside of the Territory.
 
CARACO shall not make, use or sell, or grant rights to others to make, use or sell a Product outside the Territory, but only to ALKALOIDA without the written consent of ALKALOIDA which may be granted with or without consideration or be withheld in its sole discretion.

 
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3.8
Exclusivity, IP Ownership and Enforcement.
 
 
(a)
Subject to the licenses granted above, ALKALOIDA shall own and retain all right, title and interest, including all Intellectual Property rights, in and to the Products, all Product Technology, and all Improvements to the Products created by a party in connection with, or pursuant to, this Agreement (“Proprietary Materials”).  CARACO shall, at no additional cost to ALKALOIDA, provide reasonable assistance to ALKALOIDA, including executing all documents provided by ALKALOIDA, as reasonably necessary for ALKALOIDA to register, record, protect or otherwise enforce its rights in the Territory in the Proprietary Materials.
 
 
(b)
In the event ALKALOIDA and/or CARACO becomes aware of any actual or threatened misappropriation, violation and/or infringement by a third party of any Intellectual Property related to or embodied in any of the Products and / or the Product Technology in the Territory, that party shall promptly notify the other party.  In the absence of an agreement to the contrary at that time, CARACO shall have the sole right to determine what, if any, action is to be taken against any such third party and the sole right to take, or not take, any action against such third party.  If CARACO elects to take action against the third party, CARACO shall bear all costs, expenses and fees, including attorneys’ fees, associated with the action, provided, however, that, in the event that such action is unsuccessful, ALKALOIDA shall reimburse CARACO in the amount of 25% of the costs, expenses and fees, including attorneys' fees, of any such action.  After the payment of all legal costs and expenses (including, without limitation, attorneys' fees) CARACO shall be entitled to retain all amounts of any award or settlement resulting from the action less a payment of consideration as further described in Section 5.1 hereof (i.e., 25% of the net amount of such award or settlement) considering such award or settlement as the part of consideration under this Agreement.  CARACO shall obtain the prior written approval from ALKALOIDA for such award or settlement before agreeing for any such award or settlement.  In connection with any such action, ALKALOIDA will reasonably cooperate in any such action, at CARACO’s expense, and will grant CARACO all rights and authorizations reasonably necessary in association with each action.
 
 
(c)
It is agreed and understood between ALKALOIDA and CARACO that all ANDAs for the Products shall be owned by and shall belong exclusively to CARACO however subject to ALKALOIDA's right to use, outside the Territory, as and when ALKALOIDA may elect to do so, any information, data, studies and formulations which it may be furnished hereunder, without any royalty, premium or other payment to CARACO as per the Section 3.2(c) hereinabove.  It is agreed and understood between ALKALOIDA and CARACO that CARACO may market or sell the Products outside the Territory using the Product Technology covered by this Agreement only with the prior written consent of ALKALOIDA, which consent may be withheld in its sole discretion, and pursuant to the same terms and conditions of this Agreement, including the payment of consideration as provided by this Agreement.

 
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4.
SUPPORT TO AND FOR CARACO.
 
4.1
Provision of Technical Personnel.
 
ALKALOIDA agrees to use its best efforts to provide to CARACO with qualified technical professional personnel, if required by CARACO for its operations during the term of this Agreement at the cost of CARACO unless the cost is associated with the transfer of the technology itself prior to or at the time of completion of the transfer of the technology.

4.2
Assistance with Raw Materials.
 
ALKALOIDA agrees to use its best efforts to assist CARACO in obtaining quantities of raw materials, if required by CARACO in its operations at competitive prices.

4.3
Regulatory Approvals; ANDA Submittals.
 
 
(a)
ALKALOIDA will use commercially reasonable efforts to support CARACO in gaining regulatory approval (ANDAs, etc.) for the Products in the Territory.  ALKALOIDA will timely supply copies of all existing information and/or Product Technology necessary for each Product to CARACO.
 
 
(b)
ALKALOIDA will use commercially reasonable efforts to correct any problems or issues regarding the information needed for submittal of the ANDA for Product by CARACO. Should CARACO be unable to submit the ANDA for approval for the Product for any reason, including without limitation due to the failure of either the pilot or pivotal biostudy, directly attributable to the Product Technology and/or information and technology transferred by ALKALOIDA, then CARACO or ALKALOIDA may terminate this Product upon advance written notice to the other party; provided, however, that, to the extent that any problems or issues precluding regulatory approval are the result of CARACO's willful misconduct or negligence, CARACO shall reimburse the cost borne by ALKALOIDA for the development of the Product Technology for Product.
 
4.4
Sales Support.
 
In connection with the sale of a Product, ALKALOIDA will provide to CARACO the requisite analytical procedures (which, without limitation, include stability indicia and cleaning methods), stability data, pilot biostudy data, a development report and development data customarily prepared by ALKALOIDA.

 
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4.5
Subcontractors.
 
ALKALOIDA is permitted to use subcontractors to develop the Product Technology under this Agreement; provided that: (a) no use of any subcontractor shall relieve ALKALOIDA of any of its obligations under this Agreement, and (b) ALKALOIDA shall remain fully responsible for each such Subcontractor’s compliance with, and/or breach of, this Agreement.

5.
CONSIDERATION.
 
5.1
CONSIDERATION.
 
In consideration of the licenses granted herein and the performance by ALKALOIDA of its obligations under this Agreement, for each Product, ALKALOIDA shall receive a royalty of ten percent (10%) of the Net Sales effected by CARACO of the applicable Products or shall receive such percentage of the net selling price of the applicable Products as may be mutually agreed upon in writing for any Product by and between the parties to this Agreement, as the case may be.  The consideration will become due with respect to each Product at such time as such Product is sold by CARACO to any third party within the Territory.  CARACO shall notify ALKALOIDA when the First Commercial Sale of the Products has been effectuated. CARACO will pay consideration on a quarterly basis no later than forty-five (45) days after the end of the quarter and will provide necessary workings etc. to support the computation of the royalty payment, as described below.  ALKALOIDA shall then notify CARACO as to where and in whose name (ALKALOIDA's or an Affiliate's) ALKALOIDA wishes the consideration to be received.  Within fifteen (15) business days of CARACO's receipt of such notice from ALKALOIDA, it shall, as applicable, either directly remit such consideration to ALKALOIDA and/or its Affiliates promptly.

It is hereby agreed and understood by the parties that all the marketing, selling and distribution expenses for the sale of the Product shall be paid and borne by Caraco.

Provided that the royalty of 10% of the Net Sales  may be increased or reduced as mutually agreed from time to time to comply with the provisions of Transfer Pricing or similar other regulations applicable to either of the parties.

5.2
TERMS OF PAYMENT
 
 
(a)
Sales Reports.  CARACO shall provide a quarterly sales report for the Products.  The report shall generally include sales details by customer and Product (e.g. sales value during the period, sales quantity, average sales price of the Products, average credit period allowed, charge backs or any other pricing calculations, special bundling of Products' offers which CARACO may have with customers which may affect the sales of the Products, realization of Products). CARACO further agrees to provide such other reports and/or details as may be reasonably requested by ALKALOIDA and agreed to by CARACO.
 
 
(b)
Manner of Payment.  All payments hereunder shall be payable in United States dollars, by wire transfer to a bank account designated by ALKALOIDA unless otherwise specified in writing by ALKALOIDA.

 
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(c)
Late Payments.  In the event that any payment due hereunder is not made when due, the payment shall accrue interest from that date due at an annual interest rate that is equal to 1% over the prevailing 90 Libor rate as published on the date the payment was due; provided, however, that in no event shall such range exceed the maximum legal annual interest rate.  The payment of such interest shall not limit ALKALOIDA from exercising any other rights it may have as a consequence of the delay of any payment.
 
 
(d)
Records.  During the term of this Agreement, and for a period of a minimum of five (5) years after its expiration or termination (or whatever is required by applicable law or any regulatory authority), CARACO and ALKALOIDA shall keep complete and accurate records in sufficient detail to permit ALKALOIDA or CARACO, as the case may be, to confirm the accuracy of all payments due and paid hereunder.
 
 
(e)
Taxes.  The parties agree that each is responsible for its own taxes attributable to this Agreement.
 
6.
ADVANCED DRUG DELIVERY SYSTEMS.
 
If ALKALOIDA desires to transfer the Technology in respect an advanced drug delivery system (such as a time-release formulation or any other complex formulation), the terms and conditions of such transfer may be discussed and negotiated independently, and mutually agreed to, between ALKALOIDA and the management of CARACO.

7.
REPRESENTATIONS AND WARRANTIES OF ALKALOIDA.
 
ALKALOIDA, as an inducement to CARACO to enter into this Agreement, represents, warrants and covenants to CARACO as follows:

7.1
Rights to Product Technology Information.
 
ALKALOIDA has or will have at the time the Product Technology of a Product is delivered to CARACO, the full right, power and authority to grant the licenses set forth herein relating to each Product in the Territory pursuant to the terms of this Agreement to permit CARACO to perform pursuant to this Agreement and develop, market and sell each Product free and clear of any mortgage, lien, encumbrance or any other third-party interest of any kind.  ALKALOIDA is not aware of any facts or circumstances that a Product is subject to any restriction, covenant, license (other than this Agreement) or judicial or administrative order of any kind which detract in any material respect from the value of the Product's Technology, or which could interfere with the use thereof by CARACO in the Territory as contemplated by this Agreement unless anything contrary is specified/indicated in writing to CARACO.

 
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7.2
Knowledge of no FDA Approval.
 
ALKALOIDA is not aware of any facts that would reasonably lead it to conclude that any Product will be unable to receive the contemplated approval from the US-FDA or approval from any other regulatory authority upon satisfactory completion of clinical trials, and ALKALOIDA has no knowledge of any facts which would reasonably lead it to conclude that satisfactory completion of clinical trials is not likely.

7.3
Rights to Products.
 
ALKALOIDA has not received any notice and has no knowledge that (a) the rights to develop, market and sell any of the Products have been challenged in any judicial or administrative proceeding, or (b) any person, entity or product has infringed or will infringe any patent or other rights with respect to any Product, or (c) any Intellectual Property rights have been infringed by ALKALOIDA or will be infringed by CARACO by virtue of performing the activities contemplated by this Agreement.

7.4
Right to Execute and Perform.
 
ALKALOIDA has full right, power and authority to execute and deliver this Agreement, and to perform its obligations under it, and has taken all necessary action to authorize such execution, delivery and performance.  This Agreement constitutes a legal, valid and binding obligation of ALKALOIDA, enforceable against it in accordance with its terms.

7.5
Compliance with Laws.
 
ALKALOIDA will comply with all applicable laws in connection with performance of its obligations under this Agreement.  The execution, delivery and performance of this Agreement by ALKALOIDA does not violate any provision of applicable law or of any regulation, order decree of any court, arbitration or governmental authority, or any other agreement to which ALKALOIDA is a party.  No consents, approvals or authorizations, registrations or filings are required in connection with the execution, delivery, performance, validity or enforceability of this Agreement, except as have been obtained or set forth in this Agreement.

7.6
Survivability.
 
The foregoing representations, warranties and covenants shall survive the termination of this Agreement and shall be deemed to be made anew each time that the Product Technology of a Product is delivered by ALKALOIDA to CARACO in pursuance hereof and shall not be affected by any examination made by or on behalf of CARACO, the knowledge of its officers, directors, stockholders, employees or agents or the acceptance of any certificate or opinion.

8.
REPRESENTATIONS AND WARRANTIES OF CARACO.
 
As an inducement to ALKALOIDA to enter into this Agreement, CARACO represents and warrants to ALKALOIDA as follows:

 
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8.1
Right to Execute and Perform.
 
CARACO has full right, power and authority to execute and deliver this Agreement, and to perform its obligations under it, and has taken all necessary action to authorize such execution, delivery and performance.  This Agreement constitutes the legal, valid and binding obligation of CARACO, enforceable against it in accordance with its terms.

8.2
COMPETING PRODUCTS.
 
During the term of this Agreement, CARACO shall not, directly or indirectly, manufacture, sell, distribute or market products with the same formulae and dosage strengths as the Products which are subject to this Agreement, from other suppliers in Territory. ALKALOIDA shall not offer  the same technology to partners outside the Territory to be used for manufacture and sales within the Territory during the term of validity of the license to CARACO under this Agreement.

8.3
Compliance with Law.
 
CARACO will comply with all applicable laws in connection with performance of its obligations under this Agreement.  The execution, delivery and performance of this Agreement by CARACO does not and will not violate any provision of applicable law or of any regulation, order decree of any court, arbitration or governmental authority or any other agreement to which CARACO is a party.  No consents, approvals or authorizations, registrations or filings are required in connection with the execution, delivery, performance, validity or enforceability of this Agreement, except as had been obtained or set forth in this Agreement.

8.4
Survivability.
 
The foregoing representations, warranties and covenants, shall survive the termination of this Agreement, shall be deemed to be made anew each time that a Product is selected by the parties, and shall not be affected by any examination made by or on behalf of ALKALOIDA, the knowledge of its officers, directors, stockholders, employees or agents or the acceptance of any certificate or opinion.

9.
INDEMNIFICATION.
 
9.1
Indemnification by ALKALOIDA.
 
ALKALOIDA shall defend, at its sole expense, any third party claim, demand or suit (“Claim”) against CARACO and/or its Affiliates (“CARACO Indemnitees”) alleging and/or arising out of the following in connection with this Agreement, and shall indemnify and hold CARACO Indemnitees harmless from and against any and all losses, liabilities, damages, fines, penalties, costs, expenses and/or fees (including reasonable attorneys’ fees) incurred by, or awarded or assessed against, CARACO Indemnitees in connection with a Claim, or reached through a negotiated settlement of a Claim:

 
(a)
that ALKALOIDA, its employees, or subcontractors were negligent or committed an intentional act that caused injury to a person or damage to property, or failed to comply with any applicable law, statute, regulation or ordinance;
 

 
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(b)
product liability arising from the development of the Product; and/or
 
 
(c)
ALKALOIDA’s breach of this Agreement, including, without limitation, any representation or warranty set forth in this Agreement.
 
9.2
Indemnification by CARACO.
 
Except for those Claims that are ALKALOIDA’s responsibility under Section 9.1 above, CARACO shall defend, at its sole expense, any third party Claim against ALKALOIDA and/or its Affiliates (“ALKALOIDA Indemnitees”) alleging and/or arising out of the following in connection with this Agreement, and shall indemnify and hold ALKALOIDA Indemnitees harmless from and against any and all losses, liabilities, damages, fines, penalties, costs, expenses and/or fees (including reasonable attorneys’ fees) awarded or assessed against ALKALOIDA Indemnitees in connection with a Claim, or reached through a negotiated settlement of a Claim:

 
(a)
that the Products infringe a third party’s Intellectual Property rights under U.S. law;
 
 
(b)
that CARACO, its employees, or Subcontractors were negligent or committed an intentional act that caused injury to a person or damage to property, or failed to comply with any applicable law, statute, regulation or ordinance; and/or
 
 
(c)
CARACO’s breach of this Agreement including, without limitation, any representation or warranty set forth in this Agreement.
 
9.3
Procedures.
 
In order to receive indemnification under this Section, the party seeking indemnification must provide the other party with prompt written notice of the assertion of the Claim; permit the other party to retain sole control over the defense and/or settlement of the Claim; and cooperate with the other party, at the other party’s expense, in the defense and/or settlement of the Claim.  No Claim described in this Section may be settled without the written consent of both parties, which shall not be unreasonably withheld.  This Section sets forth the parties’ exclusive indemnification obligations and remedies in connection with the Claims described in this Section.

10.
TERM AND TERMINATION.
 
10.1
Term.
 
This Agreement shall be effective on the date first written above and shall expire sixty (60) months from the date of the first approval of an 1st ANDA under this Agreement.  However, the licenses granted with respect to any Product as to which CARACO and ALKALOIDA have fulfilled their obligations thereunder, shall continue for a period of 5 years pursuant to the Clause 2.1 of this Agreement and CARACO shall pay the consideration as agreed to in terms of this Agreement for so long as CARACO continues to sell the Product/s during the period of the agreement.  This Agreement may be renewed or extended for consecutive periods of one (1) year each, if agreed to by parties in writing; however, the licence granted under this Agreement shall remain valid pursuant to its terms under this Agreement.

 
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10.2
Termination.
 
At any time, this Agreement may be terminated in its entirety or with respect to one or more  Products, as provided below, by giving  180 days written notice unless denoted otherwise  as follows:

 
(a)
by either party, if the other party is in material default or in material breach of any term or provision hereof or material breach of any representation or warranty in this Agreement, and such material default or material breach continues and is not remedied with thirty (30) days of the breaching party’s receipt of written notice of such default or breach.  As noted above, termination of the Agreement will not affect the licenses with respect to any Product pursuant to which ALKALOIDA and CARACO have fulfilled their obligations with respect to such Product under this Agreement.
 
 
(b)
by CARACO for any given Product in case of material technical, scientific or regulatory problems or, if the results in data achieved and generated during the development of any given Product, in CARACO’s reasonable determination, shows that approval for such Product will be unlikely to be granted, again with respect to the specific Product only.  In the event of termination by CARACO pursuant to this sub-paragraph, no obligation shall stand for consideration of any kind other than its proportionate share of the cost of development of the Product Technology for the Product by ALKALOIDA or its subcontractor (as further described in Section 3.6 Marketing of Products) until the time when CARACO terminated under this Section however that CARACO shall make available, at no cost to ALKALOIDA, all relevant production records, including the product formulation, master batch record, specifications, analytical results, copies and details of Bioequivalency study and related supporting documentation for use by ALKALOIDA within or outside Terittory.  CARACO shall have no liability or responsibility whatsoever in connection with ALKALOIDA’s use outside the Territory of any such production records, including the product formulation, master batch record, specifications, analytical results, copies and details of Bioequivalency study and related supporting documentation.
 
 
(c)
by CARACO, for any given Product, if prior to a Product passing the applicable Bioequivalency study or studies, CARACO in its reasonable discretion determines that it would not be viable to develop and market the Product in the Territory a 30 day written notice will be provided.  In the event of termination by CARACO pursuant to this sub-paragraph, no consideration other than its proportionate share of the cost of development of the Product Technology for the Product to ALKALOIDA (as further described in Section 3.6 Marketing of Products) shall be paid with respect to such Product to ALKALOIDA and/or its affiliates and, if such consideration has already been paid, ALKALOIDA agrees to refund such consideration in excess of its proportionate share of the cost of development of the Product Technology for the Product by ALKALOIDA (as further described in Section 3.6 Marketing of Products) to CARACO however that CARACO shall make available, at no cost to ALKALOIDA, all relevant production records, including the product formulation, master batch record, specifications, analytical results, copies and details of Bioequivalency study and related supporting documentation for use by ALKALOIDA within or outside Terittory.  CARACO shall have no liability or responsibility whatsoever in connection with ALKALOIDA’s use outside the Territory of any such production records, including the product formulation, master batch record, specifications, analytical results, copies and details of Bioequivalency study and related supporting documentation.

 
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(d)
by ALKALOIDA, for any given Product, if prior to a Product passing the applicable Bioequivalency study or studies, ALKALOIDA in its reasonable discretion and concurrence of Caraco determines that it would not be viable to develop and market the Product in the Territory a 30 day written notice will be provided.  In the event of termination by ALKALOIDA pursuant to this sub-paragraph, ALKALOIDA shall reimburse to CARACO all reasonable expenses incurred by CARACO for this Agreement for the relevant Product and CARACO shall make available all relevant production records, including the product formulation, master batch record, specifications, analytical results, copies and details of Bioequivalency study and related supporting documentation to ALKALOIDA.    CARACO shall have no liability or responsibility whatsoever in connection with ALKALOIDA’s use outside the Territory of any such production records, including the product formulation, master batch record, specifications, analytical results, copies and details of Bioequivalency study and related supporting documentation.
 
 
(e)
by ALKALOIDA, for any given Product, if CARACO does not start marketing within reasonable time without any reasonable cause from the date of approval of ANDA,  ALKALOIDA in its reasonable discretion determines without prejudice to the right of other recovery by ALKALOIDA under this Agreement.  In the event of termination by ALKALOIDA pursuant to this sub-paragraph, CARACO shall make available all relevant production records, including the product formulation, master batch record, specifications, analytical results, copies and details of Bioequivalency study and related supporting documentation to ALKALOIDA.  CARACO shall have no liability or responsibility whatsoever in connection with ALKALOIDA’s use outside the Territory of any such production records, including the product formulation, master batch record, specifications, analytical results, copies and details of Bioequivalency study and related supporting documentation.
 
 
(f)
by ALKALOIDA, for any given Product, in the event CARACO materially fails to perform its material obligations with respect to the Product, and fails to cure such failure within thirty (30) days of notice of such failure from ALKALOIDA (or if a cure is not reasonably possible within thirty (30) days, such longer period as is necessary to cure such failure so long as at all relevant times after such thirty (30) days, CARACO is using its best efforts to effect such cure).  In such event, ALKALOIDA may elect to have the rights sold in such Product to revert back to ALKALOIDA.  Also, in addition to any other rights it may have hereunder or under law, ALKALOIDA shall have the right to qualify an alternative company for the manufacture and sale of the Product in the Territory and the right to submit an ANDA for the manufacture and sale of the Product at an alternative company in the Territory.  In such situation, no obligation shall stand for consideration of any kind. Upon reversion of the Product to ALKALOIDA, CARACO shall retain no rights to develop, produce, market or otherwise exploit or deal in any manner with the Product in the Territory and CARACO shall immediately return to ALKALOIDA the original versions and all copies of all Product Technology Information (but not including any Bioequivalency studies, any other information CARACO is obligated to retain under applicable law, and one copy of all Proprietary Technical Information for CARACO’s record keeping purposes).

 
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10.3
No Prejudice to Rights.
 
The termination of this Agreement or of any given Product shall be without prejudice to any rights and obligations of either party accrued prior to the effective date of such termination, unless explicitly otherwise agreed or otherwise provided in this Agreement.

11.
ARBITRATION.
 
Any dispute between the parties regarding any provision of this Agreement shall be resolved by binding arbitration in the State of Michigan pursuant to the commercial arbitration rules then prevailing of the American Arbitration Association.  The parties shall use good faith to cause the arbitration proceeding to be completed as soon as practicable, preferably within ninety (90) days after the date the arbitrator accepts his or her appointment.  Any decision or award of the arbitrator shall be based solely on the terms of this Agreement and the substantive governing law applicable to this Agreement and such other information as the arbitrator determines is appropriate in ascertaining an appropriate remedy.  The decision of the arbitrator shall be in writing stating the reasons therefor, shall be final and conclusive, and shall be binding on the parties.  Judgment upon the award rendered in the arbitration may be entered and enforced by any court of competent jurisdiction.  The parties agree to exclude, to the fullest extent permitted by law, any right of application or appeal to any court in connection with any questions of law arising in the course of the arbitration proceedings or out of any decision or award by the arbitrator.  The parties hereby expressly agree that the arbitrator shall have the authority to award specific performance or any injunction to the prevailing party or to make an award of damages but that the arbitrator shall not have the power to award punitive or exemplary damages.

12.
NO THIRD-PARTY BENEFICIARIES.
 
This Agreement shall not confer any rights or remedies upon any person other than the parties and their respective officers, directors, heirs, executors, administrators, successors, affiliates and associates and permitted assigns.

 
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13.
FURTHER ASSURANCES.
 
The parties hereto hereby agree to execute and deliver to one another such further instruments and other documentation as may be requested by any other party hereto at any time and from time to time to carry out the terms of this Agreement.

14.
ENTIRE AGREEMENT.
 
This Agreement, all Schedules, and any amendments thereto, contain the entire understanding of the parties with respect to the subject matter addressed herein and supersede, replace and merge all prior understandings, promises, representations and agreements, whether written or oral, relating thereto.  The provisions of the various Agreement documents shall, to the extent possible, be interpreted so as supplement each other and avoid any conflict between them.  However, in the event of a conflict or inconsistency between the Agreement documents, such conflict or inconsistency shall be resolved in accordance with the following order of precedence: (a) any amendments to this Agreement and/or any Schedule; (b) the applicable Schedule; and (c) this Agreement.

15.
BINDING EFFECT, ASSIGNMENT.
 
Neither party may assign this Agreement, in whole or in part, without the other party’s prior express written consent, which shall not be unreasonably withheld or delayed.  Any attempted assignment without such written consent shall be void.  Notwithstanding the foregoing, each party may assign this Agreement without the other party’s consent, in whole, but not in part: (a) to one or more Affiliates, provided that each such Affiliate agrees to be bound by this Agreement and the assigning party remains liable and responsible for such Affiliates’ compliance with and/or breach of this Agreement; and (b) as reasonably necessary in connection with any merger, acquisition, sale of assets or other corporate restructuring.  In addition, ALKALOIDA may assign, transfer and/or convey all or a portion of its rights in and to the Products, without CARACO’s consent, provided that any such assignment, transfer and/or conveyance is made expressly subject to the terms of this Agreement, and the rights and remedies granted to CARACO.  Subject to the provisions of this Section, this Agreement will be binding upon and will inure to the benefit of the parties and their respective successors and assigns.

16.
AFFILIATES.
 
ALKALOIDA and CARACO agree and understand that ALKALOIDA may perform some of its obligations through its affiliates. However, ALKALOIDA is ultimately legally responsible for the actions of its affiliates.  Any action of an affiliate of ALKALOIDA under this Agreement which would constitute breach of this Agreement if performed directly by ALKALOIDA constitutes a breach of this Agreement by ALKALOIDA.  In addition, CARACO in taking any actions under this Agreement with affiliates of ALKALOIDA shall thereby satisfy its obligations to ALKALOIDA.  This provision does not limit or restrict the rights of CARACO to pursue any right or remedy against any affiliate of ALKALOIDA in connection with such affiliate’s performance of the obligations of ALKALOIDA under this Agreement.

 
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17.
COUNTERPARTS.
 
This Agreement may be executed in one or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instruments.

18.
HEADINGS.
 
The headings of this Agreement are for ease of reference only and shall not affect its construction or interpretation.  The captions contained in this Agreement are not a part of this Agreement, but are merely guides or labels to assist in locating and reading the several articles hereof.

19.
NOTICES.
 
Any notices or consents required or permitted by this Agreement shall be in writing and shall be deemed delivered if sent by certified mail, postage prepaid, return receipt requested, or overnight delivery service (receipt confirmed), or facsimile (receipt confirmed), as follows, unless such address is changed by written notice hereunder.

If to CARACO:
CARACO Pharmaceutical Laboratories, Ltd.,
 
1150 Elijah McCoy Drive,
 
Detroit, MI 48202, USA.
 
Attn: Mr. Daniel Movens
   
If to ALKALOIDA:
ALKALOIDA Chemical Company ZRT
 
H-4440, Tiszavasvari,
 
Kabay János u. 29,
 
Hungary
 
Attn: Mr. Harin Mehta

Any notice sent by mail shall be deemed to have been delivered within 12 working days after dispatch and any notice sent by telex or telecopy shall be deemed to have been delivered within 96 hours of the time of the dispatch.  Notice of change of address shall be effective upon receipt.

20.
GOVERNING LAW.
 
This Agreement shall be governed by and construed in accordance with the laws of the State of Michigan (exclusive of its choice of law rules), and the federal laws of the U.S. The parties agree to bring any suit, claim or proceeding against each other arising from this Agreement in Michigan and, solely for any such suit, claim or proceeding, they consent to the personal jurisdiction of such court and waive any objections to venue in such court.

 
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21.
AMENDMENTS AND WAIVERS.
 
This Agreement may be amended and any provision hereof waived only in a writing signed by the party against whom an amendment or waiver is sought to be enforced.  The parties hereto shall have the right at all times to enforce the provisions of this Agreement in strict accordance with the terms hereof, notwithstanding any conduct or custom on the part of such party in refraining from so doing at any time or times.  The failure of any party at any time to enforce its rights under such provisions strictly in accordance with the same shall not be construed as having created a custom in any way or manner contrary to specific provisions of this Agreement or as having in any way or manner modified or waived the same.

22.
SEVERABILITY.
 
If any provision of this Agreement shall be held invalid under any applicable law, such invalidity shall not affect any other provisions of this Agreement that can be given effect without the invalid provision, and, to this end, the provisions hereof are severable.

23.
EXPENSES.
 
Except as otherwise expressly provided in this Agreement, the parties will bear their respective costs and expenses (including legal fees and expenses) incurred in connection with this Agreement and the transactions contemplated hereby.

24.
CONSTRUCTION.
 
The parties have participated jointly in the negotiation and drafting of this Agreement.  In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the parties and no presumption or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any of the provisions of this Agreement.  Any reference to any federal, state or local statute or law shall be deemed also to refer to all rules and regulations promulgated thereunder, unless the context requires otherwise.  The word “including” shall mean including without limitation.  Words used herein, regardless of the number and gender specifically used, shall be deemed and construed to include any other number, singular or plural, and any other gender, masculine, feminine or neuter, as the context requires.

25.
MISCELLANEOUS PROVISIONS.
 
25.1
Secrecy.
 
 
(a)
Prior to and during the term of this Agreement, each party may disclose, and may have disclosed, to the other party (orally, in writing, or electronically), or a party may obtain, observe, or otherwise be granted access to, information and materials considered confidential by the other party.  Confidential information includes, but is not limited to, information relating to Product Technology, the Products, compensation, research, services, developments, inventions, processes, protocols, methods of operation, techniques, strategies, programs (both software and firmware), designs, systems, proposed business arrangements, results of testing, distribution, engineering, marketing, financial, merchandising and/or sales information, individual customer profiles, customer lists and/or aggregated customer data (“Confidential Information”).  Confidential Information must be marked or identified as “confidential” by the disclosing party, unless the information should reasonably be understood by the receiving party to be confidential or proprietary under the circumstances. However, information shall not be subject to the restrictions and prohibitions set forth herein to the extent that such information:

 
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(i)
is available to the public in public literature or otherwise, or after disclosure by one party to the other becomes public knowledge through no fault of the party receiving such information; or
 
 
(ii)
was known to the party receiving such information prior to the receipt of such information by such party as established by relevant documentary evidence, whether received before or after the date of this Agreement; or
 
 
(iii)
is obtained by the party receiving such information from a third party not subject to a requirement of confidentiality with respect to such information as established by relevant documentary evidence; or
 
 
(iv)
is independently developed by employees of the party receiving such information who did not have access to or use of the other party’s Confidential Information as established by relevant documentary evidence; or
 
 
(v)
is required to be disclosed pursuant to (i) any order of a court having jurisdiction and power to order such information  to be released or made public; or (ii) any lawful action of a governmental or regulatory agency provided that each party shall notify the other in writing of any disclosure of information required hereunder prior to such disclosure; provided that the party provides reasonable prior notice of such required disclosure to the other party and, if requested by such other party, uses all reasonable efforts to secure confidential protection of such Confidential Information.
 
 
(b)
Each party shall use the other party’s Confidential Information only for the purposes of this Agreement, and not for its own or any third party’s benefit except as otherwise expressly provided in this Agreement.  Each party shall maintain the confidentiality of the other party’s Confidential Information in the same manner in which it protects its own Confidential Information of like kind, but in no event shall either party take less than reasonable precautions to prevent the unauthorized disclosure or use of the other party's Confidential Information.
 
 
(c)
Each party is permitted to disclose the other party’s Confidential Information to its employees, contractors and other third parties on a need to know basis only, provided that such employees, contractors and/or third parties have written or legal confidentiality obligations to that party no less stringent than those contained in this Agreement.  Each party shall be and remain fully liable and responsible for its recipients’ unauthorized disclosure or use of the other party’s Confidential Information.

 
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(d)
Each party acknowledges and agrees that its unauthorized disclosure or use of the other party’s Confidential Information will cause damage to the other party that may not be adequately compensated through money damages.  As such, each party expressly consents to the entry of an order for equitable remedies, including, but not limited to, temporary, preliminary and permanent injunctions to remedy any actual or threatened breach of its obligations under this Agreement.  These remedies are cumulative and in addition to all other remedies available at law or in equity.
 
 
(e)
At the disclosing party’s request, each party shall return the other party’s Confidential Information.  Neither party shall use the other party’s Confidential Information for its own, or any third party’s, benefit.  However, each party shall be permitted to retain and use a copy of the other party’s Confidential Information as reasonably necessary to exercise its rights that survive termination of this Agreement, for regulatory purposes and/or as otherwise necessary to protect such party’s interests; provided that party continues to comply with its confidentiality obligations set forth herein.  The provisions of this Section shall survive termination of this Agreement for so long as the Confidential Information remains confidential.
 
 
(f)
ALKALOIDA and CARACO shall also co-operate in good faith with respect to any stock exchange filings, public announcements, or filings with the United States Securities and Exchange Commission which maybe necessary following execution of this Agreement.
 
25.2
Binding Obligation.
 
As of the EFFECTIVE DATE of this Agreement, each party hereby represents and warrants that this Agreement is a legal and valid obligation binding upon it and is enforceable in accordance with its terms, except that the enforcement of the rights and remedies created hereby is subject bankruptcy, insolvency, reorganizing and similar laws of general application affecting the rights and remedies of creditors and that the availability of the remedy of specific performance or of injunctive relief is subject to the discretion of the court before which any proceeding therefore may be brought.  The execution, delivery and performance of this Agreement by such party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it maybe bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having authority over it.

25.3
Force Majeure.
 
Neither party shall be liable to the other for delay or failure in the performance of the obligations on its part contained in this Agreement if and to the extent that such failure or delay is due to circumstances beyond its control which it could not have avoided by the exercise of reasonable diligence including but not limited to: act of God, war or insurrection, civil commotion, destruction of essential facilities or materials by earthquake, fire, flood or storm, labor disturbance (whether or not any such labor disturbance is within the power of the affected party to settle); epidemic; or other similar event;  provided, however, that the  party so affected shall notify the other party promptly should such circumstances arise, giving an indication of the likely extent and duration thereof, and shall use all commercially reasonable efforts to avoid, remove or alleviate such causes of non-performance and shall resume performance of its obligations hereunder with the utmost dispatch whenever such causes are removed.  In the event of force majeure lasting more than two (2) months, the parties agree to meet and discuss how this Agreement can be justly and fairly implemented under the circumstances prevailing in such country or countries and if the parties are unable to agree upon how the Agreement can be implemented then either party may terminate the Agreement in relation to such country or countries, or to such Product or Products, upon thirty (30) days written notice.

 
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25.4
Relationship of the parties.
 
It is expressly agreed that, with respect to each other and for purposes of this Agreement, ALKALOIDA and CARACO shall be independent parties, and nothing contained in this Agreement is intended to, or is to be construed to, constitute ALKALOIDA and CARACO as partners or members of a joint venture or either party as an employee of the other.  Neither party hereto shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other party or to bind the other party to any contract, agreement or undertaking with any third party.

25.5
Further Actions.
 
Upon the terms and subject to the conditions hereof, each of the parties hereto shall use its commercially reasonable efforts to (a) take, or cause to be taken, all appropriate action and do, or cause to be done, all things necessary, proper or advisable under applicable law or otherwise to consummate and  make effective the transactions contemplated by this Agreement, (b) obtain from competent authorities any consents, licenses, permits, waivers, approvals, authorizations or orders required to be obtained or made by the parties in connection with the authorization, execution and delivery of this Agreement and the consumption of the transactions contemplated by this Agreement and (c) make all necessary filings, and thereafter make any other required submissions, with respect to this transaction under (A) the Securities Exchange Act of 1934, as amended and the Securities Act of 1933, as amended, and the rules and regulations thereunder and any other applicable federal or state securities laws, (B) the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and any other antitrust regulations and (C) any other applicable law.  The parties hereto shall cooperate with each other in connection with the making of all such filings, including by providing copies of all such documents to the other party’s counsel (subject to appropriate confidentiality restrictions) prior to filing and, if requested, by accepting all reasonable additions, deletions or changes suggested in connection therewith.

 
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25.6
Commercially Reasonable Efforts.
 
Each party shall use commercially reasonable efforts to perform its responsibilities under this Agreement.  As used herein, the term “commercially reasonable efforts” means unless the parties agree otherwise, those efforts consistent with the exercise of prudent scientific and business judgment, as applied to other products of similar scientific and commercial potential within the relevant product lines of the parties.

25.7
Limitation of Representation.
 
 
(a)
This Agreement shall not be construed to appoint CARACO as the agent of ALKALOIDA for the purpose of binding ALKALOIDA or any affiliated company or firm as principal to any representation commitment or agreement made by CARACO in connection with the sale or distribution of the product. CARACO shall incur no expenses on the account of ALKALOIDA without the prior written approval of ALKALOIDA.
 
 
(b)
In all relevant correspondence and other dealings relating to the Products, CARACO shall clearly indicate that it is acting as principal and shall in no circumstances expressly or impliedly do, or suffer to be done, any act or thing which may cause it to be taken by any third party as acting as an agent of ALKALOIDA and shall assume full responsibility for the proper performance of orders for Products it receives and accepts.
 
25.8
Insurance.
 
CARACO undertakes that it shall carry out within reasonable time of entering into this Agreement and will continue to carry, with insurance companies rated A- or better, the insurance coverages set forth in this Section, continuously during the term of this Agreement, and thereafter as provided herein:

 
(a)
Commercial general liability insurance on an occurrence basis containing such limits as may be mutually agreed upon by ALKALOIDA and CARACO protecting against bodily injury, property damage and personal injury claims arising from the exposures of: (i) product liability; and (ii) contractual liability; and:
 
 
(i)
this coverage must specifically state that the insurance provided by  CARACO shall be considered primary and non-contributory, any of  ALKALOIDA ’s insurance ,if any shall be considered excess for the purpose of responding to claims;
 
 
(ii)
The Parties shall add the other as an Additional Insured on the policy by having the insurance carrier issue an Additional Insured Endorsement(s);
 
 
(iii)
Commercial general liability insurance coverage must be maintained for six (6) years after the termination or expiration of this Agreement.

 
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25.9
Limitation of Liability.
 
Except as expressly provided herein, in no event shall either party be liable to the other party in connection with this Agreement and/or the Products, regardless of the form of action or theory of recovery, for any: (a) indirect, special, exemplary, consequential, incidental or punitive damages, even if that party has been advised of the possibility of such damages; and/or (b) lost profits, lost revenues, lost business expectancy and/or business interruption losses. The limitations set forth in this Section do not apply to any liability or amounts related to or arising from a party’s indemnification obligations under this Agreement and/or a party’s breach of its confidentiality obligations under this Agreement.  Any claim arising out of this Agreement must be initiated within two (2) years of the date the party knew, or reasonably should have known, of the existence of such claim against the other party.

25.10
General.
 
If new issues arise or a new situation emerges or changes in legislation in Hungary or in the U.S.A is effected, which are not covered by this Agreement, CARACO or ALKALOIDA have the right to request further negotiations with the other party to implement amendments to this Agreement which remedy the deficiency.

IN WITNESS WHEREOF, the parties hereto have executed this Agreement, themselves or by their duly authorized representatives, under seal, the day and year first above written.

CARACO PHARMACEUTICAL LABORATORIES, LTD,

/s/ Daniel H. Movens
 
   
By:
Daniel H. Movens
 
   
Title:
Chief Executive Officer
 
   
ALKALOIDA CHEMICAL COMPANY ZRT
 
   
/s/ Harin Mehta
 
   
By:
Harin Mehta
 
   
Title:
Director
 

 
 26

EX-10.28 9 ex10_28.htm EXHIBIT 10.28 ex10_28.htm

EXHIBIT 10.28
 
INDEMNIFICATION AGREEMENT
 
This Agreement (“Agreement”) is made and entered into as of the 14th day of September, 2009, by and between Caraco Pharmaceutical Laboratories, Ltd., a Michigan corporation (the “Company”), and F. Folsom Bell (“Indemnitee”).
 
RECITALS
 
A.           Highly competent and experienced persons are reluctant to serve corporations as directors, executive officers or in other capacities unless they are provided with adequate protection through insurance and indemnification against claims and actions against them arising out of their service to and activities on behalf of the Company.
 
B.           The Board of Directors of the Company (the “Board”) has determined that the inability to attract and retain such persons would be detrimental to the best interests of the Company and its stockholders and that the Company should act to assure such persons that there will be increased certainty of such protection in the future.
 
C.           The Board has also determined that it is reasonable, prudent and necessary for the Company, to contractually obligate itself to indemnify such persons to the fullest extent permitted by applicable law so that they will serve or continue to serve the Company free from undue concern that they will not be adequately protected.
 
D.           Indemnitee is willing to serve, continue to serve and to take on additional service for or on behalf of the Company on the condition that Indemnitee be so indemnified to the fullest extent permitted by law.
 
E.           Article XVII of the Amended and Restated Articles of Incorporation and Article VII of the Amended and Restated Bylaws of the Company each provide for indemnification of directors and officers to the fullest extent permitted by law.
 
In consideration of the foregoing and the mutual covenants herein contained, and other good and valuable consideration, the sufficiency and receipt of which are hereby acknowledged, the parties hereby agree as follows:
 
ARTICLE I
 
Certain Definitions
 
As used herein, the following words and terms shall have the following respective meanings (whether singular or plural):
 
“Acquiring Person” means any Person other than (i) the Company, (ii) any of the Company’s Subsidiaries, (iii) any employee benefit plan of the Company or of a Subsidiary of the Company or of a Company owned directly or indirectly by the stockholders of the Company in substantially the same proportions as their ownership of stock of the Company, or (iv) any trustee or other fiduciary holding securities under an employee benefit plan of the Company or of a Subsidiary of the Company or of a Company owned directly or indirectly by the stockholders of the Company in substantially the same proportions as their ownership of stock of the Company.
 
 
 

 

“Claim” means an actual or threatened claim or request for relief in connection with a Proceeding which was, is or may be made by reason of anything done or not done by Indemnitee in, or by reason of any event or occurrence related to, Indemnitee’s Corporate Status.
 
“Corporate Status” means the status of a person who is, becomes or was a director, officer, employee, agent or fiduciary of the Company or is, becomes or was serving at the request of the Company as a director, officer, partner, member, venturer, proprietor, trustee, employee, agent, fiduciary or similar functionary of another foreign or domestic corporation, partnership, limited liability company, joint venture, sole proprietorship, trust, employee benefit plan or other enterprise. For purposes of this Agreement, the Company agrees that Indemnitee’s service on behalf of or with respect to any Subsidiary of the Company shall be deemed to be at the request of the Company.
 
“Disinterested Director” with respect to any request by Indemnitee for indemnification hereunder, means a director of the Company who at the time of the vote is not a named defendant or respondent in the Proceeding or threatened to be so named in respect of which indemnification is sought by Indemnitee.
 
“Exchange Act” means the Securities Exchange Act of 1934.
 
“Expenses” means all attorneys’ fees and disbursements, accountant’s fees and disbursements, retainers, court costs, transcript costs, fees and expenses of experts, witness fees and expenses, travel expenses, duplicating costs, printing and binding costs, telephone charges, postage, delivery service fees and all other disbursements, costs or expenses of the types customarily incurred in connection with prosecuting, defending (including affirmative defenses and counterclaims), preparing to prosecute or defend, investigating, being or preparing to be a witness in, or participating in or preparing to participate in (including on appeal) a Proceeding and all interest or finance charges attributable to any thereof. Should any payments by the Company under this Agreement be determined to be subject to any federal, state or local income or excise tax, “Expenses” shall also include such amounts as are necessary to place Indemnitee in the same after-tax position (after giving effect to all applicable taxes) as Indemnitee would have been in had no such tax been determined to apply to such payments.
 
“Incumbent Board” means the individuals who, as of the date of this Agreement, constitute the Board and any other individual who becomes a director of the Company after that date and whose election or appointment by the Board or nomination for election by the Company’s stockholders was approved by a vote of at least a majority of the directors then comprising the Incumbent Board, but excluding, for this purpose, any such individual whose initial assumption of office occurs as a result of an actual or threatened election contest with respect to the election or removal of directors or other actual or threatened solicitation of proxies or consents by or on behalf of a Person other than the Incumbent Board.
 
 
2

 

“Independent Counsel” means a law firm, or a member of a law firm, that is experienced in matters of corporation law and neither contemporaneously is, nor in the five years theretofore has been, retained to represent: (a) the Company or Indemnitee in any matter material to either such party (other than as Independent Counsel under this Agreement or similar agreements), (b) any other party to the Proceeding giving rise to a claim for indemnification hereunder or (c) the beneficial owner, directly or indirectly, of securities of the Company representing 5% or more of the combined voting power of the Company’s then outstanding voting securities (other than, in each such case, with respect to matters concerning the rights of Indemnitee under this Agreement, or of other indemnitees under similar indemnification agreements). Notwithstanding the foregoing, the term “Independent Counsel” shall not include any person who, under the applicable standards of professional conduct then prevailing, would have a conflict of interest in representing either the Company or Indemnitee in an action to determine Indemnitee’s rights under this Agreement.
 
“Independent Directors” means the directors on the Board that are independent directors as defined in Section 803A of the NYSE Amex Company Guide or successor provision, or, if the Company’s common stock is not then quoted on the NYSE Amex, that qualify as independent, disinterested, or a similar term as defined in the rules of the principal securities exchange or interdealer quotation system on which the Company’s common stock is then listed or quoted.
 
“MBCA” means the Michigan Business Corporation Act and any successor statute thereto, as either of them may from time to time be amended.
 
“Person” means any individual, entity or group (within the meaning of Sections 13(d)(3) and 14(d)(2) of the Exchange Act).
 
 “Proceeding” means any threatened, pending or completed action, suit, arbitration, investigation, inquiry, alternate dispute resolution mechanism, administrative or legislative hearing, or any other proceeding (including, without limitation, any securities laws action, suit, arbitration, alternative dispute resolution mechanism, hearing or procedure) whether civil, criminal, administrative, arbitrative or investigative and whether or not based upon events occurring, or actions taken, before the date hereof; and any appeal in or related to any such action, suit, arbitration,  hearing or proceeding.
 
“Subsidiary” means, with respect to any Person, any corporation or other entity of which a majority of the voting power of the voting equity securities or equity interest is owned, directly or indirectly, by that Person.
 
“Voting Securities” means any securities that vote generally in the election of directors, in the admission of general partners, or in the selection of any other similar governing body.
 
ARTICLE II
 
Services by Indemnitee
 
Indemnitee is serving as a director of the Company. Indemnitee may from time to time also agree to serve, as the Company may request from time to time, in another capacity for the Company (including another officer or director position) or as a director, officer, partner, member, venturer, proprietor, trustee, employee, agent, fiduciary or similar functionary of another foreign or domestic corporation, partnership, joint venture, limited liability company, sole proprietorship, trust, employee benefit plan or other enterprise. Indemnitee and the Company each acknowledge that they have entered into this Agreement as a means of inducing Indemnitee to serve, or continue to serve, the Company in such capacities. Indemnitee may at any time and for any reason resign from such position or positions (subject to any other contractual obligation or any obligation imposed by operation of law). The Company shall have no obligation under this Agreement to continue Indemnitee in any such position or positions.
 
 
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ARTICLE III
 
Indemnification
 
Section 3.1      General. The Company shall indemnify and advance Expenses to, Indemnitee to the fullest extent permitted by applicable law in effect on the date hereof and to such greater extent as applicable law may hereafter from time to time permit. The other provisions set forth in this Agreement are provided as a means of furtherance and implementation of, and not in limitation of, the obligations expressed in this Article III. No requirement, condition to or limitation of any right to indemnification or to advancement of Expenses under this Article III shall in any way limit the rights of Indemnitee under Article VI.
 
Section 3.2      Indemnity of the Company. Indemnitee shall be entitled to indemnification pursuant to this Section 3.2 if, by reason of anything done or not done by Indemnitee in, or by reason of any event or occurrence related to, Indemnitee’s Corporate Status, Indemnitee is, was or becomes, or is threatened to be made, a party to, any Proceeding. Pursuant to this Section 3.2, Indemnitee shall be indemnified against any and all Expenses, judgments, penalties (including excise or similar taxes), fines and amounts paid in settlement (including all interest, assessments and other charges paid or payable in connection with or in respect of any such Expenses, judgments, penalties, fines and amounts paid in settlement) actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection with such Proceeding or any Claim, issue or matter therein. Notwithstanding the foregoing, the obligations of the Company under this Section 3.2 shall be subject to the condition that no determination (which, in any case in which Independent Counsel is involved, shall be in a form of a written opinion) shall have been made pursuant to Article IV that Indemnitee would not be permitted to be indemnified under applicable law. In addition, in an action by or in the right of the Company, indemnification shall be limited as set forth in Section 561 of the MBCA except to the extent authorized under Section 564c of the MBCA.  Nothing in this Section 3.2 shall limit the benefits of Section 3.1, Section 3.3 or any other Section hereunder.
 
Section 3.3    Advancement of Expenses. The Company shall pay all Expenses reasonably incurred by, or in the case of retainers to be incurred by, or on behalf of Indemnitee (or, if applicable, reimburse Indemnitee for any and all Expenses reasonably incurred by Indemnitee and previously paid by Indemnitee) in connection with any Claim or Proceeding, whether brought by the Company or otherwise, in advance of any determination respecting entitlement to indemnification pursuant to Article IV hereof (and shall continue to pay such Expenses after such determination and until it shall ultimately be determined (in a final adjudication by a court from which no appeal is taken or in a final adjudication of an arbitration pursuant to Sections 5.1 or 5.3 if Indemnitee or Company respectively elects to seek such arbitration) that Indemnitee is not entitled to be indemnified by the Company against such Expenses) within 10 days after the receipt by the Company of a written request from Indemnitee requesting such payment or payments from time to time, whether prior to or after final disposition of such Proceeding. Any such payment by the Company is referred to in this Agreement as an “Expense Advance.” In connection with any request for an Expense Advance, if requested by the Company, Indemnitee or Indemnitee’s counsel shall also submit an affidavit stating that the Expenses incurred were, or in the case of retainers to be incurred are, reasonably incurred. Any question as to the reasonableness of the incurrence of any Expense shall not delay an Expense Advance by the Company, and the Company agrees that any such question shall be resolved in a final adjudication by a court from which no appeal is taken or in a final adjudication of an arbitration pursuant to Sections 5.1 or 5.3 if Indemnitee or Company respectively elects to seek such arbitration. Indemnitee hereby undertakes and agrees that Indemnitee will reimburse and repay the Company with interest for any Expense Advances to the extent that it shall ultimately be determined (in a final adjudication by a court from which no appeal is taken or in a final adjudication of an arbitration pursuant to Sections 5.1 and 5.3 if Indemnitee or the Company respectively elects to seek such arbitration) that Indemnitee is not entitled to be indemnified by the Company against such Expenses. Indemnitee shall not be required to provide collateral or otherwise secure the undertaking and agreement described in the prior sentence. The Company shall make all advances pursuant to this Section 3.3 without regard to the financial ability of the Indemnitee to make repayment and without regard to the prospect of whether the Indemnitee may ultimately be found to be entitled to indemnification under the provisions of this Agreement.
 
 
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Section 3.4     Indemnification for Additional Expenses. The Company shall, to the maximum extent permitted by law, indemnify Indemnitee against any and all costs and expenses (of the types described in the definition of Expenses in Article I) and, if requested by Indemnitee, shall advance those costs and expenses to Indemnitee, that are incurred by Indemnitee in connection with any claim asserted against, or action brought by, Indemnitee for enforcement of, or claims for breaches of, any provision of this Agreement, regardless of whether Indemnitee ultimately is determined to be entitled to that enforcement, and regardless of whether the nature of the proceeding with respect to such matter is judicial, by arbitration, or otherwise.
 
Section 3.5    Partial Indemnity. If Indemnitee is entitled under any provision of this Agreement to indemnification by the Company for some or a portion of the Expenses, judgments, fines, penalties, and amounts paid in settlement of a Claim or Proceeding but not, however, for all of the total amount thereof, the Company shall nevertheless indemnify Indemnitee for the portion thereof to which Indemnitee is entitled. Moreover, notwithstanding any other provision of this Agreement, to the extent that Indemnitee has been successful on the merits or otherwise in defense of any or all Claims or Proceedings, Indemnitee shall be indemnified against all Expenses incurred in connection therewith.
 
 
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ARTICLE IV
 
Procedure for Determination of Entitlement
to Indemnification
 
Section 4.1      Request by Indemnitee. To obtain indemnification under this Agreement, Indemnitee shall submit to the Company a written request, including therein or therewith such documentation and information as is reasonably available to Indemnitee and is reasonably necessary to determine whether and to what extent Indemnitee is entitled to indemnification (including for all purposes of the Agreement whether the indemnification is reasonable). The Secretary or an Assistant Secretary of the Company shall, promptly upon receipt of such a request for indemnification, advise the Board in writing that Indemnitee has requested indemnification.
 
Section 4.2      Determination of Request. Upon written request by Indemnitee for indemnification pursuant to the first sentence of Section 4.1 hereof; a determination, if required by applicable law, with respect to whether Indemnitee is permitted under applicable law to be indemnified shall be made in accordance with the terms of MBCA, in the specific case in any of the following ways:
 
(a)            (i) by a majority vote of a quorum of the Board consisting of Disinterested Directors, or (ii) if a quorum cannot be obtained under subdivision (i), by a majority vote of a committee consisting solely of two or more Disinterested Directors designated to act by the Board even though less than a quorum of the Board, or  (iii) by all independent directors as defined under the MBCA who are Disinterested Directors, or (iv) in a written opinion to the Board and Indemnitee by Independent Counsel selected by a committee of the Board by a vote as set forth in clauses (i) and (ii) of this paragraph (a), or if a quorum of the Board cannot be obtained under subdivision (i) and a committee cannot be established under subdivision (ii), by a majority vote of all directors, or (v) by the stockholders of the Company in a vote that excludes the shares held by directors who are not Disinterested Directors and officers, employees and agents who are named defendants or respondents in the Proceeding or threatened to be so named.  In the designation of a committee under subdivision (ii) or in the selection of independent counsel, all Directors may participate.
 
(b)           If a determination has been made pursuant to subsection (a) above, that indemnity is permitted under applicable law to be indemnified, the authorization of payment of indemnification shall be made in any of the following ways:
 
 
(1)
By the Board in one of the following ways:
 
 
(i)
By majority vote of two or more Directors who are Disinterested Directors.
 
(ii)
By a majority of the members of a committee of two or more Disinterested Directors.

 
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(iii)
By one or more independent directors as defined under the MBCA who are Disinterested Directors.
 
(iv)
If there are no independent directors as defined under the MBCA and less than two Directors who are Disinterested Directors, then by the Board by majority vote.
 
 
(2)
By the stockholders of the Company in a vote that excludes the shares held by Directors who are not Disinterested Directors and officers, employees and agents who are named defendants or respondents in the Proceedings or threatened to be so named.
 
If it is so determined that Indemnitee is permitted to be indemnified and payment is authorized under applicable law, payment to Indemnitee shall be made within 10 days after such determination. Nothing contained in this Agreement shall require that any determination be made under this Section 4.2 prior to the disposition or conclusion of a Claim or Proceeding against Indemnitee; provided, however, that Expense Advances shall continue to be made by the Company pursuant to, and to the extent required by, the provisions of Article III. Indemnitee shall cooperate with the person or persons making such determination with respect to Indemnitee’s entitlement to indemnification, including providing to such person upon reasonable advance request any documentation or information that is not privileged or otherwise protected from disclosure and that is reasonably available to Indemnitee and reasonably necessary to such determination. Any costs or expenses (including attorneys’ fees and disbursements) incurred by Indemnitee in so cooperating with the person or persons making such determination shall be borne by the Company (irrespective of the determination as to Indemnitee’s entitlement to indemnification).
 
Section 4.3                      Presumptions and Effect of Certain Proceedings.
 
(a)           If the person or persons empowered or selected under Article IV of this Agreement to determine whether Indemnitee is entitled to indemnification shall not have made a determination within 60 days after receipt by the Company of the request by Indemnitee therefor, the determination of entitlement to indemnification shall be deemed to have been made and Indemnitee shall be entitled to such indemnification; provided, however, that such 60-day period may be extended for a reasonable time, not to exceed an additional 30 days, if the person making the determination with respect to entitlement to indemnification in good faith requires such additional time for the obtaining or evaluating of documentation and/or information relating to such determination; and provided, further, that the 60-day limitation set forth in this Section 4.3(a) shall not apply and such period shall be extended as necessary (1) if within 30 days after receipt by the Company of the request for indemnification under Section 4.1 Indemnitee and the Company have agreed, and the Board has resolved to submit such determination to the stockholders of the Company pursuant to Section 4.2(b) for their consideration at an annual meeting of stockholders to be held within 90 days after such agreement and such determination is made thereat, or a special meeting of stockholders is called within 30 days after such receipt for the purpose of making such determination, such meeting is held for such purpose within 60 days after having been so called and such determination is made thereat, or (ii) if the determination of entitlement to indemnification is to be made by Independent Counsel pursuant to Section 4.2(a) of this Agreement, in which case the applicable period shall be as set forth in Section 5.1(c).  Nothing contained in this Agreement shall require that any determination be made under this Section 4.3 prior to the disposition or conclusion of a Claim or Proceeding against Indemnitee; provided, however, that Expense Advances shall continue to be made by the Company pursuant to, and to the extent required by, the provisions of Article III.
 
 
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(b)           Other than an action by or in the right of the Company, the termination of any Proceeding or of any Claim issue or matter by judgment, order, settlement (whether with or without court approval) or conviction, or upon a plea of nolo contendere or its equivalent, shall not (except as otherwise expressly provided in this Agreement) by itself create a presumption that the person did not act in good faith and in a manner which he or she reasonably believed to be in or not opposed to the best interests of the Company or its shareholders, and, with respect to a criminal action or proceeding, had reasonable cause to believe that his or her conduct was unlawful.
 
ARTICLE V
 
Certain Remedies of Indemnitee
 
Section 5.1    Indemnitee Entitled to Adjudication in an Appropriate Court. If (a) a determination is made pursuant to Article IV that Indemnitee is not entitled to indemnification under this Agreement; (b) there has been any failure by the Company to make timely payment or advancement of any amounts due hereunder (including, without limitation, any Expense Advances); or (c) the determination of entitlement to indemnification is to be made by Independent Counsel pursuant to Section 4.2 and such determination shall not have been made and delivered in a written opinion within 90 days after such Independent Counsel’s being appointed, Indemnitee shall be entitled to commence an action seeking an adjudication in the Court of Indemnitee’s entitlement to such indemnification or advancements due hereunder, including, without limitation, Expense Advances. Alternatively, Indemnitee, at Indemnitee’s option, may seek an award in arbitration to be conducted by a single arbitrator pursuant to the commercial arbitration rules of the American Arbitration Association. Indemnitee shall commence such action seeking an adjudication or an award in arbitration within 180 days following the date on which Indemnitee first has the right to commence such action pursuant to this Section 5.1, or such right shall expire. The Company agrees not to oppose Indemnitee’s right to seek any such adjudication or award in arbitration and it shall continue to pay Expense Advances pursuant to Section 3.3 until it shall ultimately be determined (in a final adjudication by a court from which no appeal is taken or in a final adjudication of an arbitration pursuant to this Section 5.1 if Indemnitee elects to seek such arbitration) that Indemnitee is not entitled to be indemnified by the Company against such Expenses.
 
Section 5.2     Adverse Determination Not to Affect any Judicial Proceeding. If a determination shall have been made pursuant to Article IV that Indemnitee is not entitled to indemnification under this Agreement, any judicial proceeding or arbitration commenced pursuant to this Agreement shall be conducted in all respects as a de novo trial or arbitration on the merits, and Indemnitee shall not be prejudiced by reason of such initial adverse determination.
 
 
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Section 5.3    Company May Seek Judicial Proceeding or Arbitration. If a determination shall have been made or deemed to have been made pursuant to Article IV that Indemnitee is or is not entitled to indemnification, the Company shall be entitled to commence an action seeking an adjudication in court or arbitration of Indemnitee’s entitlement to such indemnification or advancements due hereunder, including, without limitation, Expense Advances. Arbitration may be conducted by a single arbitrator pursuant to the commercial arbitration rules of the American Arbitration Association. Company shall commence such action seeking an adjudication or arbitration within 180 days following the date on which the determination shall have been made or deemed to have been made pursuant to Article IV that Indemnitee is entitled to indemnification, or such right shall expire. Indemnitee agrees not to oppose Company’s right to seek any such adjudication or award in arbitration.  Any judicial proceeding or arbitration commenced pursuant to this Agreement shall be conducted in all respects as a de novo trial or arbitration on the merits, and Company shall not be prejudiced by reason of such initial determination.
 
Section 5.4     Company and Indemnitee Bound by the Agreement. The Company and Indemnitee shall be precluded from asserting in any judicial proceeding or arbitration commenced pursuant to this Article V that the procedures of this Agreement are not valid, binding and enforceable and shall stipulate in any such court or before any such arbitrator that the Company and Indemnitee are bound by all the provisions of this Agreement.
 
ARTICLE VI
 
Miscellaneous
 
Section 6.1   Non-Exclusivity. No amendment or alteration of the charter or bylaws of the Company or any provision thereof shall adversely affect Indemnitee’s rights hereunder and such rights shall be in addition to any rights Indemnitee may have under the charter, bylaws and the MBCA or other applicable law. To the extent that there is a change in the MBCA or other applicable law (whether by statute or judicial decision) that allows greater indemnification by agreement than would be afforded currently under the Company’s charter or bylaws and this Agreement, it is the intent of the parties hereto that Indemnitee shall enjoy by virtue of this Agreement the greater benefit so afforded by such change. Any amendment, alteration or repeal of the MBCA that adversely affects any right of Indemnitee shall be prospective only and shall not limit or eliminate any such right with respect to any Proceeding involving any occurrence or alleged occurrence of any action or omission to act that took place before such amendment or repeal.
 
Section 6.2    Insurance and Subrogation.
 
(a)           To the extent that the Company maintains an insurance policy or policies providing liability insurance for directors, officers, employees, agents or fiduciaries of the Company or for individuals serving at the request of the Company as directors, officers, partners, members, venturers, proprietors, trustees, employees, agents, fiduciaries or similar functionaries of another foreign or domestic corporation, partnership, limited liability company, joint venture, sole proprietorship, trust, employee benefit plan or other enterprise, Indemnitee shall be covered by such policy or policies in accordance with its or their terms to the maximum extent of the coverage available for any such director, officer, employee, agent or fiduciary under such policy or policies.
 

 
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(b)           In the event of any payment by the Company under this Agreement for which reimbursement is available under any insurance policy or policies obtained by the Company, the Company shall be subrogated to the extent of such payment to all of the rights of recovery of Indemnitee under such insurance policy or policies, who shall execute all papers required and take all action necessary to secure such rights, including execution of such documents as are necessary to enable the Company to bring suit to enforce such rights, provided that all Expenses relating to such action shall be borne by the Company.
 
(c)           The Company shall not be liable under this Agreement to make any payment of amounts otherwise indemnifiable hereunder if and to the extent that Indemnitee has otherwise actually received such payment under the Company’s charter or bylaws or any insurance policy, contract, agreement or otherwise.
 
(d)           Following the execution of this Agreement, the Company will attempt to procure as soon as practicable and on commercially reasonable terms, an additional $5 million in D&O insurance from a reputable, highly rated carrier covering only the Company’s Independent Directors. Indemnitee understands and agrees that because of the Company’s current situation, it may not be practical or commercially feasible to obtain such insurance on commercially reasonable terms in the near future and until its situation significantly improves.
 
(e)           If Indemnitee is a director of the Company, the Company will advise the Board of any proposed material reduction in the coverage for directors to be provided by the Company’s directors’ and officers’ liability insurance policy, and will not effect such a reduction with respect to directors without the prior approval of at least 80% of the Independent Directors of the Company.
 
(f)           If Indemnitee is a director of the Company during the term of this Agreement and if Indemnitee ceases to be a director of the Company for any reason, the Company shall attempt to procure as soon as practicable and on commercially reasonable terms, a run-off directors’ and officers’ liability insurance policy with respect to claims arising from facts or events that occurred before the time Indemnitee ceased to be a director of the Company and covering Indemnitee, which policy, without any lapse in coverage, will provide coverage for a period of six years after the time Indemnitee ceased to be a director of the Company and will provide coverage (including amount and type of coverage and size of deductibles) that are substantially comparable to the Company’s directors’ and officers’ liability insurance policy that was most protective of Indemnitee in the 12 months preceding the time Indemnitee ceased to be a director of the Company; provided, however, that:
 
(i)           this obligation shall be suspended during the period immediately following the time Indemnitee ceases to be a director of the Company if and only so long as the Company has a directors’ and officers’ liability insurance policy in effect covering Indemnitee for such claims that, if it were a run-off policy, would substantially meet or exceed the foregoing standards; and
 
 
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(ii)           no later than the end of the suspension period provided in the preceding clause (i), the Company shall procure a run-off directors’ and officers’ liability insurance policy meeting the foregoing standards and lasting for the remainder of the six-year period.
 
Indemnitee understands and agrees that because of the Company’s current situation, it may not be practical or commercially feasible to obtain such run-off directors’ and officers’ liability insurance policy on commercially reasonable terms in the near future and until its situation significantly improves.
 
Section 6.3     Certain Settlement Provisions. The Company shall have no obligation to indemnify Indemnitee under this Agreement for amounts paid in settlement of a Proceeding or Claim without the Company’s prior written consent or if such indemnification is prohibited under the MBCA. The Company shall not settle any Proceeding or Claim in any manner that would impose any fine or other obligation on Indemnitee without Indemnitee’s prior written consent. Neither the Company nor Indemnitee shall unreasonably withhold their consent to any proposed settlement.
 
Section 6.4    Duration of Agreement. This Agreement shall continue for so long as Indemnitee serves as a director, officer, employee, agent or fiduciary of the Company or, at the request of the Company, as a director, officer, partner, member, venturer, proprietor, trustee, employee, agent, fiduciary or similar functionary of another foreign or domestic corporation, partnership, limited liability company, joint venture, sole proprietorship, trust, employee benefit plan or other enterprise, and thereafter shall survive until and terminate upon the later to occur of: (a) the final termination of all pending Proceedings in respect of which Indemnitee is granted rights of indemnification or advancement of Expenses hereunder and of any proceeding commenced by Indemnitee pursuant to Article IV relating thereto; or (b) the expiration of all statutes of limitation applicable to possible Claims arising out of Indemnitee’ s Corporate Status.
 
Section 6.5     Notice by Each Party. Indemnitee shall promptly notify the Company in writing upon being served with any summons, citation, subpoena, complaint, indictment information or other document or communication relating to any Proceeding or Claim for which Indemnitee may be entitled to indemnification or advancement of Expenses hereunder; provided, however, that any failure of Indemnitee to so notify the Company shall not adversely affect Indemnitee’s rights under this Agreement except to the extent the Company shall have been materially prejudiced as a direct result of such failure. The Company shall promptly notify Indemnitee in writing as to the pendency of any Proceeding or Claim that may involve a claim against Indemnitee for which Indemnitee may be entitled to indemnification or advancement of Expenses hereunder.
 
Section 6.6    Amendment. This Agreement may not be modified or amended except by a written instrument executed by or on behalf of each of the parties hereto.
 
 
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Section 6.7   Waivers. The observance of any term of this Agreement may be waived (either generally or in a particular instance and either retroactively or prospectively) by the party entitled to enforce such term only by a writing signed by the party against which such waiver is to be asserted. Unless otherwise expressly provided herein, no delay on the part of any party hereto in exercising any right, power or privilege hereunder shall operate as a waiver thereof, nor shall any waiver on the part of any party hereto of any right, power or privilege hereunder operate as a waiver of any other right, power or privilege hereunder nor shall any single or partial exercise of any right, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, power or privilege hereunder.
 
Section 6.8    Entire Agreement. This Agreement and the documents expressly referred to herein constitute the entire agreement between the parties hereto with respect to the matters covered hereby, and any other prior or contemporaneous oral or written understandings or agreements with respect to the matters covered hereby, including without limitation any prior indemnification agreements, are expressly superseded by this Agreement.
 
Section 6.9   Severability. If any provision of this Agreement (including any provision within a single section, paragraph or sentence) or the application of such provision to any Person or circumstance, shall be judicially declared to be invalid, unenforceable or void, such decision will not have the effect of invalidating or voiding the remainder of this Agreement or affect the application of such provision to other Persons or circumstances, it being the intent and agreement of the parties that this Agreement shall be deemed amended by modifying such provision to the extent necessary to render it valid, legal and enforceable while preserving its intent, or if such modification is not possible, by substituting therefor another provision that is valid, legal and unenforceable and that achieves the same objective. Any such finding of invalidity or unenforceability shall not prevent the enforcement of such provision in any other jurisdiction to the maximum extent permitted by applicable law.
 
Section 6.10   Notices. All notices and other communications hereunder shall be in writing and shall be deemed given upon (a) transmitter’s confirmation of a receipt of a facsimile transmission if during normal business hours of the recipient, otherwise on the next business day, (b) confirmed delivery of a standard overnight courier or when delivered by hand or (c) the expiration of five business days after the date mailed by certified or registered mail (return receipt requested), postage prepaid, to the parties at the following addresses (or at such other addresses for a party as shall be specified by like notice):
 
If to the Company, to it at:     1150 Elijah McCoy Drive
Detroit, MI 48226
Attn:   Jitendra N. Doshi, Chief Executive Officer
 
If to Indemnitee, to Indemnitee at:    5528 Nakoma
Dallas, TX 75209
Attn:   F. Folsom Bell
 
 
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or to such other address or to such other individuals as any party shall have last designated by notice to the other parties. All notices and other communications given to any party in accordance with the provisions of this Agreement shall be deemed to have been given when delivered or sent to the intended recipient thereof in accordance with and as provided in the provisions of this Section 6.10.
 
Section 6.11                      Governing Law. This Agreement shall be construed in accordance with and enforced and governed by the laws of the State of Michigan without regard to the principles of conflict of laws.
 
Section 6.12                      Certain Construction Rules.
 
(a)           The article and section headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement. As used in this Agreement, unless otherwise provided to the contrary, (1) all references to days shall be deemed references to calendar days and (2) any reference to a “Section” or “Article” shall be deemed to refer to a section or article of this Agreement. The words “hereof,” “herein” and “hereunder” and words of similar import referring to this Agreement refer to this Agreement as a whole and not to any particular provision of this Agreement, Whenever the words “include,” “includes” or “including” are used in this Agreement, they shall be deemed to be followed-by the words “without limitation.” Unless otherwise specifically provided for herein, the term “or” shall not be deemed to be exclusive. Whenever the context may require, any pronoun used in this Agreement shall include the corresponding masculine, feminine or neuter forms, and the singular form of nouns, pronouns and verbs shall include the plural and vice versa.
 
(b)           For purposes of this Agreement, references to “other enterprises” shall include employee benefit plans; references to “fines” shall include any excise taxes assessed on a person with respect to any employee benefit plan; references to “serving at the request of the Company” shall include any service as a director, officer, employee or agent of the Company which imposes duties on, or involves services by, such director, nominee, officer, employee or agent with respect to an employee benefit plan, its participants or beneficiaries; and a person who acted in good faith and in a manner the person reasonably believed to be in the interests of the participants and beneficiaries of an employee benefit plan shall be deemed to have acted in a manner “not opposed to the best interest of the Company” for purposes of this Agreement and the MBCA.
 
Section 6.13  Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed to be an original and all of which together shall be deemed to be one and the same instrument, notwithstanding that both parties are not signatories to the original or same counterpart.
 
Section 6.14  Certain Persons Not Entitled to Indemnification. The Company shall not be obligated pursuant to the terms of this Agreement to indemnify Indemnitee for the payment to the Company of profits pursuant to Section 16(b) of the Exchange Act, or Expenses incurred by Indemnitee for Proceedings in connection with such payment under Section 16(b) of the Exchange Act.
 
 
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Section 6.15   Indemnification for Negligence, Gross Negligence, etc. Without limiting the generality of any other provision hereunder, it is the express intent of this Agreement that Indemnitee be indemnified and Expenses be advanced regardless of Indemnitee’s acts of negligence or gross negligence, intentional or willful misconduct, to the extent that indemnification and advancement of Expenses is allowed pursuant to the terms of this Agreement and under applicable law.
 
Section 6.16   Mutual Acknowledgments. Both the Company and Indemnitee acknowledge that in certain instances, applicable law (including applicable federal law that may preempt or override applicable state law) or public policy may prohibit the Company from indemnifying the directors, officers, employees, agents or fiduciaries of the Company under this Agreement or otherwise. For example, the Company and Indemnitee acknowledge that the U.S. Securities and Exchange Commission has taken the position that indemnification of directors, officers and controlling Persons of the Company for liabilities arising under federal securities laws is against public policy and, therefore, unenforceable. Indemnitee understands and acknowledges that the Company has undertaken or may be required in the future to undertake with the Securities and Exchange Commission to submit the question of indemnification to a court in certain circumstances for a determination of the Company’s right under public policy to indemnify Indemnitee. In addition, the Company and Indemnitee acknowledge that federal law prohibits indemnifications for certain violations of the Employee Retirement Income Security Act of 1974, as amended.
 
Section 6.17  Enforcement. The Company and Indemnitee agree that their respective execution of this Agreement shall constitute a stipulation by which each shall be irrevocably bound in any Michigan court or arbitration pursuant to Section 6.19 in which a proceeding by Indemnitee for enforcement of Indemnitee’s rights or a proceeding by Company against Indemnitee hereunder shall have been commenced, continued or appealed, that their respective obligations set forth in this Agreement are unique and special, and that failure of the Company or Indemnitee, as applicable, to comply with the provisions of this Agreement will cause irreparable and irremediable injury to Indemnitee and Company, respectively, for which a remedy at law will be inadequate. As a result, in addition to any other right or remedy Company or Indemnitee may have at law or in equity with respect to breach of this Agreement, Company and Indemnitee shall be entitled to injunctive or mandatory relief directing specific performance by the Company or Indemnitee, as applicable, of their respective obligations under this Agreement. The Company and Indemnitee each agree not to seek, and agrees to waive any requirement for the securing or posting of, a bond in connection with the other’s seeking or obtaining such relief:
 
Section 6.18   Successors and Assigns. All of the terms and provisions of this Agreement shall be binding upon, shall inure to the benefit of and shall be enforceable by the parties hereto and their respective successors, assigns, heirs, executors, administrators, legal representatives.
 
Section 6.19   Consent to Jurisdiction. Company and Indemnitee hereby submit to the exclusive jurisdiction of the courts of the State of Michigan or arbitration in the State of Michigan in respect of the interpretation and enforcement of the provisions of this Agreement, and hereby waive, and agree not to assert, as a defense in any action, suit or proceeding for the interpretation or enforcement of this Agreement, that they are not subject thereto or that such action, suit or proceeding may not be brought or is not maintainable in such court or arbitration, that the suit, action or proceeding is brought in an inconvenient forum, or that the venue of the suit, action or proceeding is improper.  Service of process with respect thereto may be made upon Company and Indemnitee by mailing a copy thereof by registered or certified mail, postage prepaid, to such party at its address provided in Section 6.10 hereof.
 
 
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IN WITNESS WHEREOF, this Agreement has been duly executed and delivered to be effective as of the date first above written.
 
 
INDEMNITEE:
   
   
 
/s/ F. Folsom Bell
 
F. Folsom Bell
   
   
 
COMPANY:
   
 
By:   /s/ Jitendra N. Doshi
 
        Jitendra N. Doshi
 
Its:   Chief Executive Officer
 
 
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EX-10.29 10 ex10_29.htm EXHIBIT 10.29 ex10_29.htm

EXHIBIT 10.29

FORM OF
GRANT OF INDEPENDENT DIRECTOR’S STOCK OPTION

Date:

Re:
Non-qualified Stock Option

The Board, which administers The 2008 Equity Participation Plan of Caraco Pharmaceutical Laboratories, Ltd. (the “Plan”), with respect to Directors, hereby grants you (the “Grantee”) a non-qualified stock option (the “Option”), pursuant to the Plan, in consideration for your rendering faithful and efficient service in your capacity as Director of the Company.  Certain capitalized terms used in this agreement (the “Agreement”) are defined herein.  Certain capitalized terms used in this Agreement, which are not defined herein, have the meanings indicated for such terms in Article I of the Plan. As used herein reference to the “Company” refers to Caraco Pharmaceutical Laboratories, Ltd.

 
1.
Stock Option. The Option entitles the Grantee (and such Grantee’s permitted transferee as described in paragraph 3(a) below)(each such person, a “Purchaser”) to purchase up to the number of shares of the Company’s Common Stock, no par value (the “Option Shares”), specified below opposite such Grantee’s name, at an option price of $____ per share, the Fair Market Value of the Company’s Common Stock at the close of business on the date prior to the grant (the “Option Price”), subject to the terms and conditions of this Agreement:

Grantee
Number of Option Shares
 
 
2.
Additional Terms. The Option is also subject to the following provisions:

 
(a)
Exercisability. The Option may be exercised and Option Shares may be purchased at any time and from time to time after the execution of this Agreement, subject to the vesting limitations imposed by paragraph 2(b) of this Agreement. The Option Price for Option Shares shall be paid in full (i) in cash or by check by the Purchaser of such Option Shares to the Secretary of the Company for the shares with respect to which the Option, or portion thereof, is exercised; (ii) in whole or in part, through the delivery of shares of Common Stock owned by the Purchaser, duly endorsed for transfer to the Company with a Fair Market Value on the date of delivery equal to the aggregate exercise price of the Option or exercised portion thereof; (iii) in whole or in part, through the surrender of shares of Common Stock then issuable upon exercise of the Option having a Fair Market Value on the date of Option exercise equal to the aggregate exercise price of the Option or exercised portion thereof; (iv) in whole or in part, through the delivery of a notice that the Purchaser has placed a market sell order with a broker with respect to shares of Common Stock then issuable upon exercise of the Option, and that the broker has been directed to pay a sufficient portion of the net proceeds of the sale to the Company in satisfaction of the Option exercise price (a “cashless exercise”); or (v) through any combination of the consideration provided in the foregoing subparagraphs (i), (ii), (iii) and (iv).  Option Shares acquired by Purchaser under this Agreement are hereinafter referred to as the “Exercise Shares.”

 
 

 

 
(b)
Vesting/Exercisability. (i) Grantee may only exercise the Option to purchase Option Shares to the extent that such Option has vested and become exercisable with respect to such Option Shares.  Except as otherwise provided in Paragraph 2(b)(ii) below, the Option Shares will vest and become exercisable in accordance with the following schedule, if, as of each such date, the Grantee is a member of the Board of Directors:

Date
 
Cumulative Percentage of Option Shares Vested and Exercisable
     
1st Anniversary
 
33 1/3%
2nd Anniversary
 
33 1/3%
3rd Anniversary
 
33 1/3%

Option Shares, which have become vested and exercisable, are referred to herein as “Vested Shares” and all other Option Shares are referred to herein as “Unvested Shares.”

(ii) Upon the occurrence of a Change in Control of the Company, the Option shall vest and all Unvested Shares shall become Vested Shares if, on the date of such occurrence, the Grantee is a member of the Board of Directors.

 
(c)
Procedure For Exercise. Subject to the vesting limitation of Paragraph 2(b) above, a Purchaser may exercise all or any portion of the Option, so long as it is valid and outstanding, at any time and from time to time prior to its termination by delivering written notice to the Company as provided in Section 5.2 of the Plan, and written acknowledgement substantially in the form of Exhibit “A” hereto that such Purchaser has read, and has been afforded an opportunity to ask questions of the Company’s management regarding all financial and other information provided to Purchaser concerning the Company, together with payment of the Option Price times the number of Option Shares purchased.

 
 

 

 
3.
Transferability Of The Option.

 
(a)
The Grantee shall not sell, transfer, assign, pledge or otherwise dispose of (a “Transfer”) any interest in any Option with respect to any Unvested Shares. Any Option with respect to any Vested Shares of the Grantee shall not be Transferred other than as a result of the death of such Grantee, testate or intestate, and the restrictions herein shall apply to any Transfer by any such permitted transferee.

 
(b)
The Company may assign its rights and delegate its duties under this Agreement.

 
4.
Transferability Of Exercise Shares. No holder of any Exercise Shares may Transfer any such shares (except pursuant to an effective registration statement and/or re-offer prospectus or Rule 144, as applicable, under the Securities Act) without first delivering to the Company an opinion of counsel (reasonably acceptable in form and substance to the Company) that neither registration nor qualification under the Securities Act and applicable state securities law is required in connection with such Transfer.

 
5.
Conformity With Plan. The Option is intended to conform in all respects with, and is subject to all applicable provisions of, the Plan, which is incorporated herein by reference.  Inconsistencies between this Agreement and the Plan shall be resolved in accordance with the terms of the Plan, except as modified by Paragraph 2(b)(ii) of this Agreement. By executing this Agreement, the Grantee acknowledges receipt of the Plan and agrees to be bound by all of the other terms of the Plan.

 
6.
Adjustment. There shall be made appropriate and proportionate adjustments to the terms of the Option to reflect any stock dividend, stock split, combination or exchange of shares, merger, consolidation, other change in the capitalization of the Company which is similar, in its substantive effect upon the Plan or the Option, spin-off, spin-out or other distribution of assets to shareholders or any acquisition of the Company’s stock or assets similar in its substantive effect upon the Plan or Option. In the event of any adjustments described in the preceding sentence, any and all new, substituted, or additional securities or other property to which any Purchaser is entitled by reason of the Option shall be immediately subject to such Option and be included in the word “Option Shares” for all purposes of such Option with the same force and effect as the Option Shares presently subject to such Option. After each such event, the number of Option Shares and/or the Option Price shall be appropriately adjusted.

 
7.
Share Legend. Unless the Exercise Shares are the subject of an effective registration statement and/or re-offer prospectus, as applicable, all certificates representing any Exercise Shares subject to the provisions of this Agreement shall have endorsed thereon the following legend:

 
 

 

“THE SECURITIES REPRESENTED BY THIS CERTIFICATE WERE ORIGINALLY ISSUED AS OF _______________, HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), AND MAY NOT BE SOLD OR TRANSFERRED IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT UNDER THE ACT OR AN EXEMPTION FROM REGISTRATION THEREUNDER. THE SECURITIES REPRESENTED BY THIS CERTIFICATE ARE ALSO SUBJECT TO ADDITIONAL RESTRICTIONS ON TRANSFER AND CERTAIN OTHER AGREEMENTS SET FORTH IN A GRANT OF INDEPENDENT DIRECTOR’S STOCK OPTION BETWEEN THE COMPANY AND THE DIRECTOR DATED _______________.  A COPY OF SUCH AGREEMENT MAY BE OBTAINED BY THE HOLDER HEREOF AT THE COMPANY’S PRINCIPAL PLACE OF BUSINESS WITHOUT CHARGE.”

In addition, all certificates representing any Exercise Shares of affiliates of the Company (generally, directors, executive officers and holders of more than 10% of the outstanding shares of the Company) shall have endorsed  thereon the following legend:

THE REGISTERED HOLDER OF THE SHARES REPRESENTED BY THE CERTIFICATE MAY BE AN AFFILIATE (AS SUCH TERM IS DEFINED BY RULE 144 (“RULE 144”) PROMULGATED UNDER THE SECURITIES ACT OF 1933 AS AMENDED (THE “SECURITIES ACT”)) OF THE COMPANY.  IF SUCH HOLDER IS AN AFFILIATE OF THE COMPANY, THESE SHARES MAY ONLY BE SOLD, TRANSFERRED OR ASSIGNED PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR IN ACCORDANCE WITH THE TERMS OF RULE 144 OR ANOTHER EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT.
 
 
8.
Investment Representations. Upon the purchase of Option Shares hereunder, the Purchaser thereof shall execute and deliver to the Company a letter, substantially in the form attached hereto as Exhibit “A”, confirming such Purchaser’s investment representation.

 
9.
Expiration.  Grantee’s Option shall expire (a) with respect to Vested/Unvested Shares, at the earlier of (i) a determination by the Board that the Grantee has been grossly negligent in the performance of his duties to the Company; (ii) Grantee no longer is serving as a member of the Board, or (iii) at 5:00 p.m., Detroit time, on the sixth Anniversary of the date hereof.

 
 

 

Further, notwithstanding the above, with respect to Vested Shares, if Grantee is no longer a member of the Board due to Grantee’s death, resignation or end of term of service (other than by Removal for Cause), then the Option shall expire on the earlier of (i) the 90th day following Grantee no longer serving as a member of the Board of the Company; or (ii) until 5:00 p.m., Detroit time, on the sixth anniversary of the date hereof.

Further, notwithstanding the above, with respect to Vested Shares, if, following cessation of Grantee’s service to the Company for whatever reason, the Company discovers that Grantee engaged in conduct that would have justified Removal for Cause, Grantee’s Option shall expire immediately on the date of such discovery and any proceeds, gains or other economic benefit actually or constructively received by Grantee upon any exercise of the Option or upon the receipt or resale of any Common Stock underlying the Option, must and shall be paid to the Company.

 
10.
Definitions.

“Removal for Cause” means removal by the Company of Grantee from membership on the Board for cause as provided under Michigan law.

 
11.
Further Actions. The Parties agree to execute such further instruments and to take such further actions as may reasonably be required to carry out the intent of this Agreement.

 
12.
Severability. Whenever possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement is held to be prohibited by or invalid under applicable law, such provision will be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of this Agreement.

 
13.
Counterparts. This Agreement may be executed simultaneously in two or more counterparts, any one of which need not contain the signatures of more than one party, and all such counterparts taken together will constitute one and the same Agreement.

 
14.
Notices. Any notices, consent, approval or other communications given pursuant to the provision of this Agreement shall be in writing and shall be (a) mailed by certified mail or registered mail, return receipt requested, postage prepaid, or (b) delivered by a nationally recognized overnight courier, U.S. Post Office Express Mail, or similar overnight courier, and addressed as follow:

Grantor’s Address

Caraco Pharmaceutical Laboratories, Ltd.
1150 Elijah McCoy Drive
Detroit, Michigan 48202
Attention: Secretary or CEO of the Company

Grantee’s Address
_____________________
_____________________

 
 

 

The time of giving of any notice shall be the time of delivery by the applicable overnight courier or with respect to registered or certified mail, the time of receipt thereof by the addressee or any agent of the addressee, except that in the event the addressee or such agent of the addressee shall refuse to receive any notice given by registered mail or certified mail as above provided or there shall be no person available at the time of the delivery thereof to receive such notice, the time of the giving of such notice shall be the time of such refusal or the time of such delivery, as the case may be. Any party hereto may, giving five (5) days written notice to the other party hereto, designate any other address in substitution of the foregoing address to which notice shall be given.

 
15.
Successors And Assigns. This Agreement shall be binding upon and inure to the benefit of the successors and assigns of the Company and, subject to the restrictions on transfer herein set forth, be binding upon Grantee’s heirs, executors, administrators, successors and permitted assigns.

 
16.
Governing Law. This Agreement and all documents contemplated hereby, and all remedies in connection therewith and all questions or transactions relating thereto, shall be construed in accordance with and governed by the laws of the state of Michigan, and jurisdiction and venue shall properly lie in the courts of the state of Michigan.

 
17.
Entire Agreement. This Agreement and the Plan constitute the entire understanding between the Grantee and the Company with respect to the Option granted hereunder.

Please sign as Grantee in the space provided below and return the Agreement to the Secretary or CEO of the Company to confirm your understanding and acceptance of the agreements contained in this letter.

 
Very truly yours,
     
 
CARACO PHARMACEUTICAL
 
LABORATORIES, LTD.
     
     
 
By:
 
   
Secretary or CEO of the Company
 
Dated:

THE UNDERSIGNED hereby acknowledges having read this Agreement, and the other enclosures to this Agreement, and hereby agrees to be bound by all provisions set forth herein and in the Plan.

 
Grantee
   
   
 
 
Dated:
 
 

EX-10.30 11 ex10_30.htm EXHIBIT 10.30 ex10_30.htm

EXHIBIT 10.30
 
FORM OF
GRANT OF EMPLOYEE STOCK OPTION

Date:

Re:
Employee Incentive Stock Option

The Committee or, as applicable, Subcommittee, which administers The 2008 Equity Participation Plan of Caraco Pharmaceutical Laboratories, Ltd. (the “Plan”), hereby grants you (the “Grantee”) an employee incentive stock option (the “Option”), pursuant to the Plan, in consideration for your rendering faithful and efficient service to the Company.  Certain capitalized terms used in this agreement (the “Agreement”) are defined herein. Certain capitalized terms used in this Agreement, which are not defined herein, have the meanings indicated for such terms in Article I of the Plan. As used herein reference to the “Company” refers to Caraco Pharmaceutical Laboratories, Ltd.

 
1.
Stock Option. The Option entitles the Grantee (and such Grantee’s permitted transferee as described in paragraph 3(a) below)(each such person, a “Purchaser”) to purchase up to the number of shares of the Company’s Common Stock, no par value (the “Option Shares”), specified below opposite such Grantee’s name, at an option price of  $_____ per share, the Fair Market Value of the Company’s Common Stock at the close of business on the date prior to the grant (the “Option Price”), subject to the terms and conditions of this Agreement:

Grantee
 
Number of Option Shares
     
     
     
     

 
2.
Additional Terms. The Option is also subject to the following provisions:

 
(a)
Exercisability.  The Option may be exercised and Option Shares may be purchased at any time and from time to time after the execution of this Agreement, subject to the vesting limitations imposed by paragraph 2(b) of this Agreement. The Option Price for Option Shares shall be paid in full (i) in cash or by check by the Purchaser of such Option Shares to the Secretary of the Company for the shares with respect to which the Option, or portion thereof, is exercised; (ii) in whole or in part, through the delivery of shares of Common Stock owned by the Purchaser, duly endorsed for transfer to the Company with a Fair Market Value on the date of delivery equal to the aggregate exercise price of the Option or exercised portion thereof; (iii) in whole or in part, through the surrender of shares of Common Stock then issuable upon exercise of the Option having a Fair Market Value on the date of Option exercise equal to the aggregate exercise price of the Option or exercised portion thereof; (iv) in whole or in part, through the delivery of a notice that the Purchaser has placed a market sell order with a broker with respect to shares of Common Stock then issuable upon exercise of the Option, and that the broker has been directed to pay a sufficient portion of the net proceeds of the sale to the Company in satisfaction of the Option exercise price (a “cashless exercise”); or (v) through any combination of the consideration provided in the foregoing subparagraphs (i), (ii), (iii) and (iv).  Option Shares acquired by Purchaser under this Agreement are hereinafter referred to as the “Exercise Shares.”

 
 

 

 
(b)
Vesting/Exercisability. (i) Grantee may only exercise the Option to purchase Option Shares to the extent that such Option has vested and become exercisable with respect to such Option Shares.  Except as otherwise provided in Paragraph 2(b)(ii) below, the Option Shares will vest and become exercisable in accordance with the following schedule, if as of each such date the Grantee is still employed with the Company:

Date
 
Cumulative Percentage of Option Shares Vested and Exercisable
     
1st Anniversar
 
33 1/3%
2nd Anniversary
 
33 1/3%
3rd Anniversary
 
33 1/3%

Option Shares, which have become vested and exercisable, are referred to herein as “Vested Shares” and all other Option Shares are referred to herein as “Unvested Shares.”

(ii) Upon the occurrence of a Change in Control of the Company, each Option shall vest and all Unvested Shares shall become Vested Shares if, but only if, the Grantee is employed by the Company or any of its subsidiaries on the date of such occurrence.

 
(c)
Procedure For Exercise. Subject to the vesting limitation of Paragraph 2(b) above, a Purchaser may exercise all or any portion of the Option, so long as it is valid and outstanding, at any time and from time to time prior to its termination by delivering written notice to the Company as provided in Section 5.2 of the Plan and written acknowledgement substantially in the form of Exhibit “A” hereto that such Purchaser has read, and has been afforded an opportunity to ask questions of the Company’s management regarding all financial and other information provided to Purchaser concerning the Company, together with payment of the Option Price times the number of Option Shares purchased.
 
 
 

 

 
3.
Transferability Of The Option.

 
(a)
The Grantee shall not sell, transfer, assign, pledge or otherwise dispose of (a “Transfer”) any interest in any Option with respect to any Unvested Shares. Any Option with respect to any Vested Shares of the Grantee shall not be Transferred other than as a result of the death of such Grantee, testate or intestate, and the restrictions herein shall apply to any Transfer by any such permitted transferee.

 
(b)
The Company may assign its rights and delegate its duties under this Agreement.

 
4.
Transferability Of Exercise Shares.

(a)  No Purchaser shall Transfer any Exercise Shares or any interest therein except in accordance with the provisions of this Agreement.  Purchaser shall promptly notify the Company of any disposition of shares of common stock acquired upon the exercise of the Option within (i) two years from the date of grant (including the date the Option is modified, extended or renewed for purposes of Section 424(h) of the Code), or (ii) one year after the exercise of the Option.

(b)  No holder of any Exercise Shares may Transfer any such shares (except pursuant to an effective registration statement and/or re-offer prospectus or Rule 144, as applicable, under the Securities Act) without first delivering to the Company an opinion of counsel (reasonably acceptable in form and substance to the Company) that neither registration nor qualification under the Securities Act and applicable state securities law is required in connection with such Transfer.

 
5.
Conformity With Plan. The Option is intended to conform in all respects with, and is subject to all applicable provisions of, the Plan, which is incorporated herein by reference.  Inconsistencies between this Agreement and the Plan shall be resolved in accordance with the terms of the Plan, except as modified by Paragraph 2(b)(ii) of this Agreement. By executing this Agreement, the Grantee acknowledges receipt of the Plan and agrees to be bound by all of the other terms of the Plan.

6.
Employment. Notwithstanding any contrary oral representation or promises made to the Grantee prior to or after the date hereof, the Grantee and the Company acknowledge that such Grantee’s employment with the Company is and will continue to be subject to the willingness of each to continue such employment and nothing set forth herein or otherwise confers any right or obligation on such Grantee to continue in the employ of the Company or shall affect in any way such Grantee’s right or the right of the Company to terminate such Grantee’s employment at any time, for any reason, with or without cause, subject to any applicable employment agreement between Grantee and the Company.

 
 

 

 
7.
Adjustment. There shall be made appropriate and proportionate adjustments to the terms of the Option to reflect any stock dividend, stock split, combination or exchange of shares, merger, consolidation, other change in the capitalization of the Company which is similar, in its substantive effect upon the Plan or the Option, spin-off, spin-out or other distribution of assets to shareholders or any acquisition of the Company’s stock or assets similar in its substantive effect upon the Plan or Option. In the event of any adjustments described in the preceding sentence, any and all new, substituted, or additional securities or other property to which any Purchaser is entitled by reason of the Option shall be immediately subject to such Option and be included in the word “Option Shares” for all purposes of such Option with the same force and effect as the Option Shares presently subject to such Option. After each such event, the number of Option Shares and/or the Option Price shall be appropriately adjusted.

 
8.
Share Legend. Unless the Exercise Shares are the subject of an effective registration statement and/or re-offer prospectus, as applicable, all certificates representing any Exercise Shares subject to the provisions of this Agreement shall have endorsed thereon the following legend:

“THE SECURITIES REPRESENTED BY THIS CERTIFICATE WERE ORIGINALLY ISSUED AS OF _______________, HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), AND MAY NOT BE SOLD OR TRANSFERRED IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT UNDER THE ACT OR AN EXEMPTION FROM REGISTRATION THEREUNDER. THE SECURITIES REPRESENTED BY THIS CERTIFICATE ARE ALSO SUBJECT TO ADDITIONAL RESTRICTIONS ON TRANSFER AND CERTAIN OTHER AGREEMENTS SET FORTH IN A GRANT OF EMPLOYEE STOCK OPTION BETWEEN THE COMPANY AND EMPLOYEE OF THE COMPANY DATED ____________. A COPY OF SUCH AGREEMENT MAY BE OBTAINED BY THE HOLDER HEREOF AT THE COMPANY’S PRINCIPAL PLACE OF BUSINESS WITHOUT CHARGE.”

In addition, all certificates representing any Exercise Shares of affiliates of the Company (generally, directors, executive officers and holders of more than 10% of the outstanding shares of the Company) shall have endorsed thereon the following legend:

 
 

 

THE REGISTERED HOLDER OF THE SHARES REPRESENTED BY THE CERTIFICATE MAY BE AN AFFILIATE (AS SUCH TERM IS DEFINED BY RULE 144 (“RULE 144”) PROMULGATED UNDER THE SECURITIES ACT OF 1933 AS AMENDED (THE “SECURITIES ACT”)) OF THE COMPANY.  IF SUCH HOLDER IS AN AFFILIATE OF THE COMPANY, THESE SHARES MAY ONLY BE SOLD, TRANSFERRED OR ASSIGNED PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR IN ACCORDANCE WITH THE TERMS OF RULE 144 OR ANOTHER EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT.
 
 
9.
Investment Representations. Upon the purchase of Option Shares hereunder, the Purchaser thereof shall execute and deliver to the Company a letter, substantially in the form attached hereto as Exhibit “A”, confirming such Purchaser’s investment representation.

 
10.
Expiration. Grantee’s Option shall expire (a) with respect to Vested/Unvested Shares, at the earlier of (i) a determination by the Committee or, as applicable, Subcommittee, that the Grantee has been grossly negligent in the performance of his duties to the Company; (ii) termination of Grantee’s employment with the Company;  or (iii) at 5:00 p.m., Detroit time, on the sixth Anniversary of the date hereof.

Further, notwithstanding the above, with respect to Vested Shares, if the termination of Grantee’s employment is due to death, disability or Termination Without Cause, then the Option shall expire on the earlier of (i) the 90th day following the termination of Grantee’s employment; or (ii) until 5:00 p.m., Detroit time, on the sixth anniversary of the date hereof.

Further, notwithstanding the above, with respect to Vested Shares, if, following cessation of Grantee’s service to the Company for whatever reason, the Company discovers that Grantee engaged in conduct that would have justified Removal for Cause, Grantee’s Option shall expire immediately on the date of such discovery and any proceeds, gains or other economic benefit actually or constructively received by Grantee upon any exercise of the Option or upon the receipt or resale of any Common Stock underlying the Option, must and shall be paid to the Company.

 
11.
Definitions.

“Disability” means permanent and total disability as such term is defined in Section 22(e)(3) of the Internal Revenue Code of 1986, as amended.

“Fully  Diluted Basis” means, without duplication, (i) all shares of Common Stock outstanding at the time of determination plus (ii) all shares of Common Stock issuable upon conversion of any convertible securities or the exercise of any option, warrant or similar right, whether or not such conversion, right or option, warrant or similar right is then exercisable.

 
 

 

“Termination for Cause” means termination by the Company of Grantee’s employment because of Grantee’s personal dishonesty, willful misconduct, breach of fiduciary duty involving personal profit, intentional or continued failure to perform stated duties, the unlawful violation of any law, rule or regulation (other than minor traffic violations or similar offenses).

“Termination Without Cause” means any termination by the Company of Grantee’s employment which is not a termination for Cause, including but not limited to a voluntary quit by Grantee.

 
12.
Further Actions. The Parties agree to execute such further instruments and to take such further actions as may reasonably be required to carry out the intent of this Agreement.

 
13.
Severability. Whenever possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement is held to be prohibited by or invalid under applicable law, such provision will be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of this Agreement.

 
14.
Counterparts. This Agreement may be executed simultaneously in two or more counterparts, any one of which need not contain the signatures of more than one party, and all such counterparts taken together will constitute one and the same Agreement.

 
15.
Notices. Any notices, consent, approval or other communications given pursuant to the provision of this Agreement shall be in writing and shall be (a) mailed by certified mail or registered mail, return receipt requested, postage prepaid, or (b) delivered by a nationally recognized overnight courier, U.S. Post Office Express Mail, or similar overnight courier, and addressed as follow:

Grantor’s Address

Caraco Pharmaceutical Laboratories, Ltd.
1150 Elijah McCoy Drive
Detroit, Michigan 48202
Attention: CEO or Secretary of the Company

Grantee’s Address

 
 

 

The time of giving of any notice shall be the time of delivery by the applicable overnight courier or with respect to registered or certified mail, the time of receipt thereof by the addressee or any agent of the addressee, except that in the event the addressee or such agent of the addressee shall refuse to receive any notice given by registered mail or certified mail as above provided or there shall be no person available at the time of the delivery thereof to receive such notice, the time of the giving of such notice shall be the time of such refusal or the time of such delivery, as the case may be. Any party hereto may, giving five (5) days written notice to the other party hereto, designate any other address in substitution of the foregoing address to which notice shall be given.

 
16.
Successors And Assigns. This Agreement shall be binding upon and inure to the benefit of the successors and assigns of the Company and, subject to the restrictions on transfer herein set forth, be binding upon Grantee’s heirs, executors, administrators, successors and permitted assigns.

 
17.
Governing Law. This Agreement and all documents contemplated hereby, and all remedies in connection therewith and all questions or transactions relating thereto, shall be construed in accordance with and governed by the laws of the state of Michigan, and jurisdiction and venue shall properly lie in the courts of the state of Michigan.

 
18.
Entire Agreement. This Agreement and the Plan constitute the entire understanding between the Grantee and the Company with respect to the Option granted hereunder.

Please sign as Grantee in the space provided below and return the Agreement to the CEO or Secretary of the Company to confirm your understanding and acceptance of the agreements contained in this letter.

 
Very truly yours,
   
CARACO PHARMACEUTICAL LABORATORIES, LTD.
   
 
By:
 
 
CEO or Secretary
 
Dated:

THE UNDERSIGNED hereby acknowledges having read this Agreement and the other enclosures to this Agreement, and hereby agrees to be bound by all provisions set forth herein and in the Plan.

 
GRANTEE:
   
   
 
 

EX-10.31 12 ex10_31.htm EXHIBIT 10.31 ex10_31.htm

EXHIBIT 10.31
 
FIRST AMENDMENT TO LOAN AGREEMENT
 
THIS FIRST AMENDMENT TO LOAN AGREEMENT, dated as of August 11, 2009 (“First Amendment”), is made by and among CARACO PHARMACEUTICAL LABORATORIES, LTD., a Michigan corporation, with an address at 1150 Elijah McCoy Drive, Detroit, Michigan 48202 (“Borrower”), and RBS CITIZENS, N.A., a national association, d/b/a Charter One, with an address of 27777 Franklin Road, Suite 1900, Southfield, Michigan 48034 (together with its affiliates, successors and assigns, “Bank”).
 
W I T N E S S E T H :
 
WHEREAS, Borrower and Bank are parties to that certain Loan Agreement dated February 27, 2009 (the “Loan Agreement”), together with other Loan Documents related thereto as described in the Loan Agreement; and
 
WHEREAS, Borrower and Bank desire to increase the minimum deposit account covenant to be not less than the estimated amount of Indebtedness of Borrower to Bank, and modify other provisions of the Loan Agreement as provided herein.
 
NOW, THEREFORE,  in consideration of the amended provisions herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereto agree as follows:
 
1.           Section 6.10 of the Loan Agreement is hereby amended to increase the minimum balance of the deposit account to be not less than the outstanding balance of the Indebtedness of Borrower to Bank from time to time, which is approximately $17,400,000 as of the date hereof, which shall be reduced by the amount of principal repaid toward the Equipment Term Loan.  The required balance shall increase by the amount of accrued and unpaid interest as of the date of any required interest payment if such payment is not made on or before the date the failure to make such payment would become an Event of Default.
 
2.             The continuance of regulatory enforcement efforts by the Food and Drug Administration or other restrictions on Borrower’s operations, voluntarily imposed by Borrower or otherwise, on or after October 26, 2009, shall constitute a violation of the covenants described in Section 6.7 (b) of the Loan Agreement and shall be deemed an “Event of Default” without further notice or an opportunity to cure, notwithstanding any other provision of the Loan Agreement or other document to the contrary.

3.           Except as hereby amended, the Loan Agreement shall remain in full force and effect.  If any conflict exists between the terms and provisions of the Loan Agreement, and the terms and provisions of this First Amendment, the terms and provisions of this First Amendment shall govern and control.

4.           Each party covenants, warrants and represents that it has the authority to execute and bind each respective party to this First Amendment.  Borrower further reconfirms all of its obligations under the Loan Documents, along with all of its representations and warranties to Bank as set forth in the Loan Documents as being true in all respect, and that there are no existing Events of Default under any provision of the Loan Agreement or any of the related Loan Documents or other Indebtedness to Bank other than as noted herein that have not otherwise been suspended by Bank.  The Loan Agreement and Loan Documents executed in connection therewith, whether prior to, or simultaneously herewith, are hereby ratified and certified as being in full force and effect.

 
1

 

5.           Borrower acknowledges and agrees that Bank has fully performed all of its obligations under all documents executed in connection with the Loan Documents and all actions taken by Bank have been reasonable and appropriate under the circumstances and within their rights under the Loan Agreement and the Loan Documents.  Borrower represents and warrants that it is aware of no claims or causes of action against Bank or its officers, directors, employees or agents.  Notwithstanding such representation and warranty, and as further consideration for the agreements set forth in this First Amendment, Borrower, for itself and its successors and assigns, releases Bank and it officers, directors, employees, agents, attorneys, affiliates, subsidiaries, and successors and assigns, from any liability, claim, right or cause of action which now exists or hereafter arises, whether known or unknown, arising from or in any way related to facts in existence as of the date hereof.  Borrower also acknowledges and agrees to pay or otherwise reimburse Bank, upon the execution of this First Amendment, for all reasonable out-of-pocket costs incurred by Bank in the enforcement of the Loan Agreement, and the negotiations and drafting of this First Amendment and related Loan Documents.

6.           The Loan Agreement shall not be further amended, altered, modified, or changed in any way except in writing signed by all the parties to this First Amendment, or their successors or assigns.

7.           This First Amendment constitutes the entire agreement between the parties and supersedes all prior and contemporaneous agreements or understandings, whether written or oral, between the parties with respect to the subject matter hereof.  This First Amendment shall be binding on the parties hereto, and their respective successor and assigns.

8.           The submission of this First Amendment for examination or its negotiation of the terms described herein does not constitute an offer to amend the Loan Agreement, and this First Amendment does not constitute a binding agreement until such time as the First Amendment has been fully and finally executed by all parties to this First Amendment.


Signatures on following page

 
2

 

THE UNDERSIGNED individuals have executed this First Amendment on behalf of the respective parties hereto, effective as of the day and year first above written.
 
 
BANK:
 
RBS CITIZENS, N.A.
 
(d/b/a CHARTER ONE)
     
     
 
By:
/s/ John Sherman
 
Name:
John Sherman
 
Its:
Senior Vice President
     
     
 
BORROWER:
 
CARACO PHARMACEUTICAL
 
LABORATORIES, LTD.
     
     
 
By:
/s/ Jitendra Doshi
 
Name:
Jitendra Doshi
 
Its:
Chief Executive Officer
     
     
 
By:
/s/ Mukul Rathi
 
Name:
Mukul Rathi
 
Its:
Interim Chief Financial Officer
 
 
3

EX-10.32 13 ex10_32.htm EXHIBIT 10.32 ex10_32.htm

EXHIBIT 10.32

 
SECOND AMENDMENT TO LOAN AGREEMENT
 
THIS SECOND AMENDMENT TO LOAN AGREEMENT, dated as of October 9, 2009 (“Second Amendment”), is made by and among CARACO PHARMACEUTICAL LABORATORIES, LTD., a Michigan corporation, with an address at 1150 Elijah McCoy Drive, Detroit, Michigan 48202 (“Borrower”), and RBS CITIZENS, N.A., a national association, d/b/a Charter One, with an address of 27777 Franklin Road, Suite 1900, Southfield, Michigan 48034 (together with its affiliates, successors and assigns, “Bank”).
 
W I T N E S S E T H :
 
WHEREAS, Borrower and Bank are parties to that certain Loan Agreement dated February 27, 2009, as amended by First Amendment to Loan Agreement dated August 11, 2009 (collectively, the “Loan Agreement”), together with other Loan Documents related thereto as described in the Loan Agreement; and
 
WHEREAS, Borrower and Bank desire to extend a revolving line of credit loan, increase the minimum deposit account requirement to cash-collateralize the amount of available credit to Borrower, and modify other provisions of the Loan Agreement as provided herein.
 
NOW, THEREFORE,  in consideration of the amended provisions herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereto agree as follows:
 
1.           Section 1.1 shall be amended to delete the definition of Loan and Note, and replace with the following:
 
“Loan” means the Equipment Term Loan, and the Revolving Line of Credit Loan, individually or collectively, as appropriate.
 
“Note” means the Equipment Term Note, and the Revolving Line of Credit Note, individually or collectively, as appropriate.
 
2.           Section 2 shall be amended to delete said Sections in its entirety and replaced with the following:
 
SECTION 2.
LOAN FACILITIES
 
 
2.1
Equipment Term Loan.
 
(a)           Equipment Term Loan.  Bank hereby grants an “Equipment Term Loan” pursuant to which Bank agrees to make on the Funding Date, a non-revolving advance to Borrower, for the purposes of financing new machinery and equipment and building improvements (the “Assets”), in the amount of Eighteen Million Dollars ($18,000,000).  Funding of the loan shall be in accordance with the conditions set forth in Section 4 below.
 
 
1

 

(b)           Equipment Term Note.  The advance of the Equipment Term Loan shall be evidenced by and be repayable to Bank in accordance with the terms of the Equipment Term Note, which Borrower shall execute and deliver to Bank simultaneously herewith.  All provisions of the Equipment Term Note are incorporated herein by this reference as terms and conditions of this Loan Agreement.
 
 
2.2
Revolving Line of Credit Loan.
 
           (a) Revolving Line of Credit Loan.  Bank hereby establishes a “Revolving Line of Credit Loan” pursuant to which, until October ___, 2010 or such earlier termination as provided herein, and subject to the terms and conditions hereof, Bank agrees to make, from time to time, revolving credit loan advances in the form of letters of credit issued to the United States Food and Drug Administration, or cash demands thereon, as may be requested by Borrower or beneficiaries of the letters of credit (“Revolving Line of Credit Loan Advances”), in accordance with the borrowing procedures below.  The sum of the aggregate amount of outstanding Revolving Line of Credit Loan Advances shall not at any one time exceed Fifteen Million Dollars ($15,000,000) (the “Revolving Line of Credit Loan Amount”).  Amounts borrowed hereunder and repaid may be reborrowed as provided herein, it being agreed and understood this is a revolving credit facility.
 
           (b) Borrowing Procedure.  Borrower may request Revolving Line of Credit Loan Advances in the form of a letter of credit by submitting to Bank a fully completed Revolving Line of Credit Loan Advance request in the form acceptable to Bank and other reasonable requirements for the issuance of the letter of credit.  Bank shall make the requested Revolving Line of Credit Loan Advances available to Borrower as directed in the Revolving Line of Credit Loan Advance request, in the amount requested, unless:
 
(i) The requested Revolving Line of Credit Loan Advance, when aggregated with all of Borrower's previously unpaid Revolving Line of Credit Loan Advances under the Revolving Line of Credit Loan, would cause the unpaid principal balance of the Revolving Line of Credit Loan Note to exceed the Revolving Line of Credit Loan Amount; or

(ii) Bank has not been furnished with sufficient reports or other information to determine eligibility for such Revolving Line of Credit Loan Advance; or

(iii) An Event of Default has occurred and is continuing.

Such Revolving Line of Credit Loan Advances will then be made available to Borrower by Bank issuing its letter of credit within ten (10) days of said request, or by crediting the account of Borrower on the books of Bank if demand for payment is made on such letters of credit, by the close of Bank's business on such date.

(c)           Revolving Line of Credit Note.  The Revolving Line of Credit Loan Advances shall be evidenced by and be repayable to Bank upon demand in accordance with the terms of a Revolving Line of Credit Note, which Borrower shall execute and deliver to Bank simultaneously herewith.  All of the provisions of the Revolving Line of Credit Note are incorporated herein by this reference as terms and conditions of this Loan Agreement.
 
(d)           Letters of Credit; Fees.  Borrower may request an Advance only in the form of a letter of credit from time to time until thirty (30) days prior to the expiry of the Revolving Line of Credit Loan, in an amount, when aggregated with all other outstanding letters of credit, not to exceed the available Revolving Line of Credit Loan Amount, and provided such letters of credit expire on the earlier of one hundred eighty (180) day after issuance, or the expiry of the Revolving Line of Credit Loan and Maturity Date of the Revolving Line of Credit Note.  Borrower shall provide Bank any reasonable information requested in order to confirm the use of the letter of credit meets the requirements of this Loan Agreement.  Borrower agrees to pay Bank a letter of credit fee equal to seventy basis points (70 bps) of the face value of each letter of credit when issued by Bank.  Borrower shall also reimburse Bank for its standard documentation, administration and cancellation charges based on its standard rates.  Notwithstanding anything herein to the contrary, if demand for payment pursuant to a letter of credit is presented to Bank by the benefiting party, notice shall be provided to Borrower and such funds shall be paid to the benefiting party from the Revolving Line of Credit Loan as if a cash Advance request had been made to Borrower, and such amount shall be reflected on the Revolving Line of Credit Loan Note as of such day.
 
 
2

 

 
2.3
Security.
 
(a)           Borrower hereby grants to Bank as security for any Note, a security interest in: (i) all fixed assets of Borrower; (ii) cash deposits in possession and control of Bank in accounts numbered 4512225217 and 4514958602 or successor accounts; (iii) other cash deposits not in possession or control of Bank, provided such cash are proceeds of subsection (i) hereof,, all as described in the Security Agreement, as amended; and (iv) a mortgage on the real estate and improvements constituting real property located at 1150 Elijah McCoy Drive, Detroit, Michigan, as more particularly described in the Mortgage executed simultaneously hereto.
 
All of the specified property in this subsection (a) above shall be collectively referred to as the “Collateral”.  Notwithstanding the foregoing, if Borrower pays off the Equipment Term Loan and all charges related thereto, including any Hedging Obligations, and is not otherwise in default hereof, upon request from Borrower, Bank shall release its security and mortgage interests and liens in that certain portion of the Collateral described in (a) (i), (iii) and (iv).  All remaining Collateral described in (a) (ii) shall continue to be secured by Bank until all remaining obligations relating to the Revolving Line of Credit Loan and Revolving Line of Credit Note have been paid in full and cancelled, and not further obligations or liabilities remain outstanding on behalf of Borrower or Bank thereunder.
 
(b)           Borrower shall execute and deliver to Bank such documents in addition to those documents specified in this Loan Agreement, on the Closing Date, Funding Date, and thereafter from time to time, as Bank shall request, for the purpose of perfecting and continuing the perfection of Bank’s security interest and mortgage in the Collateral.
 
(c)           It is further agreed that any security agreement, mortgage, or other document hereafter executed by Borrower in favor of Bank shall secure repayment of all of the Obligations, whether or not presently contemplated by the parties, including that created under the Loan Agreement of the same date relating to any Note; and, that an Event of Default under any note, security agreement, mortgage or other agreement from Borrower to Bank after any applicable grace period shall constitute an Event of Default under all notes, security agreements and other agreements, and that Bank may, at its option, proceed in exercising its rights thereunder in any order or manner it may choose, the purpose of this Loan Agreement being to cross-collateralize and cross-default all of the Obligations.
 
 
3

 

3.           Section 5.11 shall be amended to delete said section in its entirety and replace with the following:
 
5.11           Use of Proceeds. The advance of either Loan hereunder shall be used only for purposes stated in Section 2.1 and 2.2 respectively.
 
4.           Borrower acknowledges that the continuance of regulatory enforcement efforts by the Food and Drug Administration or other restrictions on Borrower’s operations, voluntarily imposed by Borrower or otherwise, on or after February 26, 2010, shall constitute a violation of the covenants described in Section 6.7 (b) of the Loan Agreement and shall be deemed an “Event of Default” without further notice or an opportunity to cure, notwithstanding any other provision of the Loan Agreement or other document to the contrary.
 
5.           Bank agrees to suspend testing of Minimum Fixed Charge Coverage Ratio and Minimum EBITDA described in Sections 6.8 and 6.9 respectively, until February 26, 2010.

6.           Section 6.10 of the Loan Agreement is hereby amended to increase the minimum balance of the deposit account to be not less than the outstanding balance of the Indebtedness of Borrower to Bank from time to time, which is approximately $32,400,000 as of the date hereof, which shall be reduced by the amount of principal repaid toward the Equipment Term Loan.  The required balance shall increase by the amount of accrued and unpaid interest as of the date of any required interest payment if such payment is not made on or before the date the failure to make such payment would become an Event of Default.

7.           Nothing herein shall be deemed or implied as a waiver of any rights, interests or remedies available to Bank pursuant to the Loan Agreement or any other Loan Document, whether previously occurring, now existing, or arising in the future.  Bank reserves all such rights, interests and remedies, including those existing but temporarily suspended pursuant to any other documents executed in connection with this Second Amendment.  No failure by Bank to take any action in respect of a default  of any covenant or obligation under the Loan Agreement or other Loan Documents by Borrower shall be deemed a waiver of any subsequent or future default of Borrower, and any partial action or exercise of rights remedies will not prohibit further action or exercise of rights and remedies by Bank.  No course of dealing will be deemed to amend any terms of the Loan Agreement or other Loan Documents or preclude Bank from exercising its rights or remedies notwithstanding such course of dealing.

8.           Except as hereby amended, the Loan Agreement shall remain in full force and effect.  If any conflict exists between the terms and provisions of the Loan Agreement, and the terms and provisions of this Second Amendment, the terms and provisions of this Second Amendment shall govern and control.

9.           Each party covenants, warrants and represents that it has the authority to execute and bind each respective party to this Second Amendment.  Borrower further reconfirms all of its obligations under the Loan Documents, along with all of its representations and warranties to Bank as set forth in the Loan Documents as being true in all respect, and that there are no existing Events of Default under any provision of the Loan Agreement or any of the related Loan Documents or other Indebtedness to Bank other than as noted herein that have not otherwise been suspended by Bank.  The Loan Agreement and Loan Documents executed in connection therewith, whether prior to, or simultaneously herewith, are hereby ratified and certified as being in full force and effect.

10.           Borrower acknowledges and agrees that Bank has fully performed all of its obligations under all documents executed in connection with the Loan Documents and all actions taken by Bank have been reasonable and appropriate under the circumstances and within their rights under the Loan Agreement and the Loan Documents.  Borrower represents and warrants that it is aware of no claims or causes of action against Bank or its officers, directors, employees or agents.  Notwithstanding such representation and warranty, and as further consideration for the agreements set forth in this Second Amendment, Borrower, for itself and its successors and assigns, releases Bank and it officers, directors, employees, agents, attorneys, affiliates, subsidiaries, and successors and assigns, from any liability, claim, right or cause of action which now exists or hereafter arises, whether known or unknown, arising from or in any way related to facts in existence as of the date hereof.  Borrower also acknowledges and agrees to pay or otherwise reimburse Bank, upon the execution of this Second Amendment, for all reasonable out-of-pocket costs incurred by Bank in the enforcement of the Loan Agreement, and the negotiations and drafting of this Second Amendment and related Loan Documents.

 
4

 

11.           This Second Amendment constitutes the entire agreement between the parties and supersedes all prior and contemporaneous agreements or understandings, whether written or oral, between the parties with respect to the subject matter hereof.  This Second Amendment shall be binding on the parties hereto, and their respective successor and assigns, and shall not be further amended, altered, modified, or changed in any way except in writing signed by all the parties to this Second Amendment, or their successors or assigns.

12.           The submission of this Second Amendment for examination or its negotiation of the terms described herein does not constitute an offer to amend the Loan Agreement, and this Second Amendment does not constitute a binding agreement until such time as the Second Amendment has been fully and finally executed by all parties to this Second Amendment.

THE UNDERSIGNED individuals have executed this Second Amendment on behalf of the respective parties hereto, effective as of the day and year first above written.
 
 
BANK:
 
RBS CITIZENS, N.A.
 
(d/b/a CHARTER ONE)
     
     
 
By:
/s/ John Sherman
 
Name:
John Sherman
 
Its:
Senior Vice President
     
     
 
BORROWER:
 
CARACO PHARMACEUTICAL
 
LABORATORIES, LTD.
     
     
 
By:
/s/ Jitendra Doshi
 
Name:
Jitendra Doshi
 
Its:
Chief Executive Officer
     
 
and
 
 
By:
/s/ Mukul Rathi
 
Name:
Mukul Rathi
 
Its:
Interim Chief Financial Officer
 
 
5

EX-31.1 14 ex31_1.htm EXHIBIT 31.1 ex31_1.htm

EXHIBIT 31.1

CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER

I, Jitendra N. Doshi, the Chief Executive Officer of Caraco Pharmaceutical Laboratories, Ltd. (the “registrant”) certify that:

1.             I have reviewed this quarterly report on Form 10-Q of the registrant;

2.             Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.             Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.             The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have:

(a)           Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)           Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)           Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)           Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during registrant’s most recent Fiscal quarter (registrant’s fourth Fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, registrant’s internal control over financial reporting; and

5.             The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons fulfilling the equivalent functions):

(a)           All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b)           Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

November 9, 2009

 
/s/ Jitendra N. Doshi
 
 
Jitendra N. Doshi
 
 
Chief Executive Officer
 
 
 

EX-31.2 15 ex31_2.htm EXHIBIT 31.2 ex31_2.htm
EXHIBIT 31.2

CERTIFICATION OF THE INTERIM CHIEF FINANCIAL OFFICER

I, Mukul Rathi, the interim Chief Financial Officer of Caraco Pharmaceutical Laboratories, Ltd. (the “registrant”) certify that:

1.             I have reviewed this quarterly report on Form 10-Q of the registrant;

2.             Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.             Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.             The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have:

(a)           Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)           Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)           Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)           Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during registrant’s most recent Fiscal quarter (registrant’s fourth Fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, registrant’s internal control over financial reporting; and

5.             The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons fulfilling the equivalent functions):

(a)           All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b)           Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

November 9, 2009

 
/s/ Mukul Rathi
 
 
Mukul Rathi
 
 
interim Chief Financial Officer
 
 
 

EX-32.1 16 ex32_1.htm EXHIBIT 32.1 ex32_1.htm
EXHIBIT 32.1

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO SECTION 906 OF THE

SARBANES-OXLEY ACT OF 2002

In connection with the accompanying Quarterly Report on Form 10-Q of Caraco Pharmaceutical Laboratories, Ltd. (“Caraco”) for the period ended September 30, 2009 (the “Report”), the undersigned hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to the best of their respective knowledge and belief, that:

(1)  The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2)  The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Caraco.

 
/s/ Jitendra N. Doshi
 
 
Jitendra N. Doshi
 
Chief Executive Officer
   
 
/s/ Mukul Rathi
 
 
Mukul Rathi
 
interim Chief Financial Officer

November 9, 2009
 

  
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