UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 10-Q

(Mark One)

 

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

 

For the quarterly period ended September 30, 2015

 

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

 

For the transition period from ______________________ to_______________________

 

Commission File Number 001-08568

 

Teligent, Inc.

(Formerly IGI Laboratories, Inc.)

(Exact name of registrant as specified in its charter)

 

Delaware 01-0355758
(State or other Jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)  
   
105 Lincoln Avenue  
Buena, New Jersey 08310
(Address of Principal Executive Offices) (Zip Code)

 

(856) 697-1441

(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  þ      No ¨

 

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 (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

Yes  þ      No ¨

 

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 definitions of "large accelerated filer," "accelerated filer," and "smaller reporting company" in Rule 12b-2 of the Exchange Act.

 

  Large accelerated filer ¨ Accelerated filer þ
  Non-accelerated filer ¨ Smaller reporting company ¨

 

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

Yes  ¨      No þ

 

The number of shares outstanding of the issuer's common stock is 52,872,953 shares as of November 2, 2015.

 

    1

 

 

PART I

FINANCIAL INFORMATION

 

ITEM 1. Financial Statements

 

TELIGENT, INC. AND SUBSIDIARIES

(FORMERLY IGI LABORATORIES, INC. AND SUBSIDIARIES)

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share information)

(Unaudited)

 

    Three months ended September 30,     Nine months ended September 30,  
    2015     2014     2015     2014  
Revenues:                                
Product sales, net   $ 11,375     $ 6,005     $ 30,532     $ 18,525  
Research and development income     237       635       475       1,385  
Licensing, royalty and other revenue     3       28       172       95  
Total revenues     11,615       6,668       31,179       20,005  
                                 
Costs and Expenses:                                
Cost of revenues     5,538       4,036       15,808       11,603  
Selling, general and administrative expenses     2,433       1,124       6,474       3,563  
Product development and research expenses     3,253       1,652       9,319       5,045  
Total costs and expenses     11,224       6,812       31,601       20,211  
Operating income (loss)     391       (144 )     (422 )     (206 )
                                 
Other Income (Expense):                                
Change in the fair value of derivative liability     -       -       23,144       -  
Interest and other expense, net     (3,279 )     (58 )     (9,679 )     (162 )
Income (loss) before income tax expense     (2,888 )     (202 )     13,043       (368 )
                                 
Income tax expense     -       -       -       12  
                                 
Net income (loss)   $ (2,888 )   $ (202 )   $ 13,043     $ (380 )
                                 
Basic earnings (loss) per share   $ (0.05 )   $ 0.00     $ 0.25     $ (0.01 )
Diluted earnings (loss) per share   $ (0.05 )   $ 0.00     $ (0.02 )   $ (0.01 )
                                 
Weighted average shares of common stock outstanding:                                
Basic     52,869,529       52,457,938       52,857,624       48,811,328  
Diluted     52,869,529       52,457,938       67,173,250       48,811,328  

 

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

 

    2

 

 

TELIGENT, INC. AND SUBSIDIARIES

(FORMERLY IGI LABORATORIES, INC. AND SUBSIDIARIES)

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share information)

 

    September 30, 2015     December 31,  
    (Unaudited)     2014*  
ASSETS                
Current assets:                
Cash and cash equivalents   $ 145,699     $ 158,883  
Accounts receivable, net     10,947       14,366  
Inventories     4,958       2,784  
Prepaid expenses and other receivables     1,348       1,185  
Total current assets     162,952       177,218  
Property, plant and equipment, net     7,117       3,262  
Product acquisition costs, net     12,031       10,604  
Debt issuance costs, net     4,575       5,132  
Other     479       862  
Total assets   $ 187,154     $ 197,078  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current liabilities:                
Accounts payable   $ 3,013     $ 1,643  
Accrued expenses     5,817       5,141  
Payable for product acquisition costs     -       6,000  
Other current liabilities     336       218  
Total current liabilities     9,166       13,002  
                 
Convertible 3.75% senior notes, net of debt discount (face of $143,750)     105,239       100,311  
Fair value of derivative liability - convertible 3.75% senior notes     -       41,400  
Note payable, bank     -       3,160  
Other long term liabilities     200       71  
Total liabilities     114,605       157,944  
                 
Stockholders’ equity:                
Series A Convertible Preferred stock, $0.01 par value, 100 shares authorized; 0 shares issued and outstanding as of September 30, 2015 and December 31, 2014, respectively     -       -  
Series C Convertible Preferred stock, $0.01 par value, 1,550 shares authorized; 0 shares issued and outstanding as of September 30, 2015 and December 31, 2014, respectively     -       -  
Common stock, $0.01 par value, 100,000,000 and 60,000,000 shares authorized; 52,872,953 and 52,819,787 shares issued and outstanding as of September 30, 2015 and December 31, 2014, respectively     548       548  
Additional paid-in capital     98,544       78,172  
Accumulated deficit     (26,543 )     (39,586 )
Total stockholders’ equity     72,549       39,134  
Total liabilities and stockholders' equity   $ 187,154     $ 197,078  

 

*Derived from the audited December 31, 2014 financial statements

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

 

    3

 

   

TELIGENT, INC. AND SUBSIDIARIES

(FORMERLY IGI LABORATORIES, INC. AND SUBSIDIARIES)

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

For the nine months ended September 30, 2015 and 2014

(in thousands)

(Unaudited)

 

    September 30,     September 30,  
    2015     2014  
Cash flows from operating activities:                
Net income (loss)   $ 13,043     $ (380 )
Reconciliation of net income (loss) to net cash used in operating activities                
Depreciation and amortization of fixed assets     379       292  
Amortization of license fee     75       75  
Stock based compensation     1,708       649  
Amortization of debt issuance costs     584       24  
Amortization of product acquisition costs     90       90  
Provision for write down of inventory     50       114  
Amortization of debt discount on convertible 3.75% senior notes     4,928       -  
Change in the fair value of derivative liability     (23,144 )     -  
Changes in operating assets and liabilities                
Accounts receivable     3,419       (1,422 )
Inventories     (2,224 )     (463 )
Prepaid expenses and other assets     145       (336 )
Accounts payable and accrued expenses     2,673       1,064  
Deferred income     95       (737 )
                 
Net cash provided by (used in) operating activities     1,821       (1,030 )
                 
Cash flows from investing activities:                
Product acquisition costs     (7,517 )     (2,459 )
Capital expenditures     (4,234 )     (618 )
                 
Net cash used in investing activities     (11,751 )     (3,077 )
                 
Cash flows from financing activities:                
Principal payments on note payable, bank     (3,160 )     (146 )
Proceeds from issuance of stock, net     -       24,866  
Proceeds from exercise of common stock options and warrants     31       565  
Principal payments on capital lease obligations     (98 )     (31 )
Debt issuance costs     (27 )     -  
                 
Net cash (used in) provided by financing activities     (3,254 )     25,254  
                 
Net (decrease) increase in cash and cash equivalents     (13,184 )     21,147  
Cash and cash equivalents at beginning of period     158,883       2,101  
                 
Cash and cash equivalents at end of period   $ 145,699     $ 23,248  
                 
Supplemental Cash flow information:                
Cash payments for interest   $ 2,813     $ 139  
Cash payments for income taxes     120       23  
Non cash investing and financing transactions:                
Issuance of restricted stock   $ 347     $ -  
Payable related to product acquisition costs     -       6,000  
Issuance of stock to consultant     30       -  
Reclassification of derivative liability to equity     18,256       -  

 

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

 

    4

 

 

TELIGENT, INC. AND SUBSIDIARIES

(FORMERLY IGI LABORATORIES, INC. AND SUBSIDIARIES)

CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY

For the nine months ended September 30, 2015

(in thousands, except share information)

(Unaudited)

 

          Additional           Total  
    Common Stock     Paid-In     Accumulated     Stockholders’  
    Shares     Amount     Capital     Deficit     Equity  
                               
Balance, December 31, 2014     52,819,787     $ 548     $ 78,172     $ (39,586 )   $ 39,134  
                                         
Stock based compensation expense                     1,708               1,708  
Stock options exercised     15,666               31               31  
Issuance of restricted stock     32,500               347               347  
Issuance of stock to consultant     5,000               30               30  
Reclassification of derivative liability to equity                     18,256               18,256  
Net income     -       -       -       13,043       13,043  
                                         
Balance, September 30, 2015     52,872,953     $ 548     $ 98,544     $ (26,543 )   $ 72,549  

 

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

 

    5

 

 

TELIGENT, INC. AND SUBSIDIARIES

(FORMERLY IGI LABORATORIES, INC. AND SUBSIDIARIES)

NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X . Accordingly, they do not include all of the information and footnotes required by GAAP. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, as updated by other reports we may file from time to time with the Securities and Exchange Commission (“SEC”). The condensed consolidated balance sheet as of December 31, 2014 has been derived from those audited consolidated financial statements. Operating results for the nine month period ended September 30, 2015 are not necessarily indicative of the results that may be expected for the year ending December 31, 2015.

 

 

1. Organization and Business

 

Teligent, Inc. (the “Company”) is a Delaware corporation incorporated in 1977. On October 22, 2015, the Company announced that it will change its name from IGI Laboratories, Inc. to Teligent, Inc. effective as of October 23, 2015, at 5:00 P.M. Eastern Daylight Time. The Company’s office, research and development facilities and manufacturing facilities are located at 105 Lincoln Avenue, Buena, New Jersey. The Company is a specialty generic pharmaceutical company. The Company’s mission is to become a leader in the specialty generic pharmaceutical market. Under its own label, the Company currently sells generic topical and injectable pharmaceutical products that are bioequivalent to their brand name counterparts. The Company also provides development, formulation and manufacturing services to the pharmaceutical, over-the-counter (“OTC”) and cosmetic markets.

 

 

2. Liquidity

 

The Company’s principal sources of liquidity are cash and cash equivalents of approximately $145.7 million at September 30, 2015, the $10 million available under the $10 million credit facility detailed below and cash from operations. On August 3, 2015, the Company paid the additional aggregate of $6 million, that was payable at the time of the Company’s first filling with the United States Food and Drug Administration (the “FDA”) related to any asset purchased from AstraZeneca Pharmaceuticals LP (see Note 14). On October 5, 2015, the Company, together with Teligent Jersey Limited, a wholly-owned subsidiary of the Company, entered into an Asset Purchase Agreement and certain other ancillary agreements with Concordia Pharmaceuticals Inc., S.à.r.l., Barbados Branch, to acquire all rights, title and interests of the Seller in the existing inventory and certain contracts associated with three currently marketed injectable pharmaceutical products (Fortaz®, Zinacef TM , and Zantac® Injection) (see Note 15), On October 12, 2015, the Company entered into asset purchase agreements and certain other ancillary agreements with Alveda Pharmaceuticals Inc. for the purchase of the Seller’s rights, title, and interest in the development, production, marketing, import and distribution of certain pharmaceutical products in Canada. (see Note 15).

 

The Company may require additional funding and this funding would depend, in part, on the timing and structure of potential business arrangements. If necessary, the Company may continue to seek to raise additional capital through the sale of its equity or through a strategic alliance with a third party. There may also be additional acquisition and growth opportunities that may require external financing. There can be no assurance that such financing will be available on terms acceptable to the Company, or at all. The Company also has the ability to defer certain product development and other programs, if necessary. The Company believes that our existing capital resources will be sufficient to support its current business plan and operations beyond November 2016.

 

3. Summary of Significant Accounting Policies

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates include valuation of the derivative liability, sales returns and allowances (“SRA”), allowances for excess and obsolete inventories, allowances for doubtful accounts, provisions for income taxes and related deferred tax asset valuation allowances, stock based compensation and accruals for environmental cleanup and remediation costs.

 

    6

 

 

Fair Value of Financial Instruments

 

The carrying amounts of cash and cash equivalents, trade receivables, restricted cash, notes payable, accounts payable, capital leases and other accrued liabilities at September 30, 2015 approximate their fair value for all periods presented. The Company measures fair value in accordance with ASC 820-10, “Fair Value Measurements and Disclosures”. ASC 820-10 clarifies that fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. As a basis for considering such assumptions, ASC 820-10 establishes a three-tier value hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value:

 

Level 1 Inputs: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date.

 

Level 2 Inputs: Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability.

 

Level 3 Inputs: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at measurement date. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.

 

The Company measured its derivative liability at fair value. The derivative convertible option related to Notes (as defined in Note 6) issued December 16, 2014 was valued using the “with” and “without” analysis. A “with” and “without” analysis is a standard valuation technique for valuing embedded derivatives by first considering the value of the Notes with the option and then considering the value of the Notes without the option. The difference is the fair value of the embedded derivatives. The embedded derivative was classified within Level 3 because it was valued using the “with” and “without” method, which does utilize inputs that are unobservable in the market.

 

On May 20, 2015, the Company received approval to increase its authorized shares sufficient to allow for the conversion of the embedded option into equity at the annual shareholders meeting. Therefore, the derivative liability of $18.3 million was reclassified into stockholders equity. Based on the closing price of the Company’s common stock as of September 30, 2015, the fair value of the Notes was approximately $105.2 million compared to their face value of $143.75 million as of September 30, 2015. However, this variance is due to the conversion feature in the Notes rather than to changes in market interest rates. The Notes carry a fixed interest rate and therefore do not subject the Company to interest rate risk. The Company recorded a change in the fair value of the derivative liability through May 20, 2015 of $0 for the three months ended September 30, 2015 and $23.1 million for the nine months ended September 30, 2015 on the condensed consolidated statements of operations. On May 20, 2015, the Company recorded the final change in fair value and subsequently reclassified the value of the derivative liability into stockholders equity due to the approval of sufficient shares.

 

Earnings Per Share

 

Basic earnings (loss) per share of common stock is computed based on the weighted average number of shares of common stock outstanding during the period. Diluted earnings (loss) per share of common stock is computed using the weighted average number of shares of common stock and potential dilutive common stock equivalents outstanding during the period. Potential dilutive common stock equivalents include shares issuable upon the conversion of the Notes and the exercise of options and warrants.

 

    7

 

 

(in thousands except shares and per share data)

 

    Three months ended September 30,     Nine months ended September 30,  
    2015     2014     2015     2014  
Basic earnings per share computation:                                
Net income (loss) - basic   $ (2,888 )   $ (202 )   $ 13,043     $ (380 )
Weighted average common shares - basic     52,869,529       52,457,938       52,857,624       48,811,328  
Basic earnings (loss) per share   $ (0.05 )   $ (0.00 )   $ 0.25     $ (0.01 )
                                 
Dilutive earnings per share computation:                                
Net income (loss) - basic   $ (2,888 )   $ (202 )   $ 13,043     $ (380 )
Interest expense related to convertible 3.75% senior notes     -       -       4,043       -  
Amortization of discount related to convertible 3.75% senior notes     -       -       4,928       -  
Change in the fair value of derivative     -       -       (23,144 )     -  
Net loss - diluted   $ (2,888 )   $ (202 )   $ (1,130 )   $ (380 )
                                 
Share Computation:                                
Weighted average common shares - basic     52,869,529       52,457,938       52,857,624       48,811,328  
Effect of convertible 3.75% senior notes     -       -       12,732,168       -  
Effect of dilutive stock options and warrants     -       -       1,583,458       -  
Weighted average common shares outstanding - dilluted     52,869,529       52,457,938       67,173,250       48,811,328  
Diluted loss per share   $ (0.05 )   $ (0.00 )   $ (0.02 )   $ (0.01 )

 

Revenue Recognition

 

The Company considers revenue realized or realizable and earned when it has persuasive evidence of an arrangement, delivery has occurred or contractual services rendered, the sales price is fixed or determinable, and collection is reasonably assured in conformity with ASC 605, “Revenue Recognition” .

 

The Company derives its revenues from three basic types of transactions: sales of its own generic pharmaceutical topical products, sales of manufactured product for its customers included in product sales, and research and product development services performed for third parties.  Due to differences in the substance of these transaction types, the transactions require, and the Company utilizes, different revenue recognition policies for each.

 

Product Sales: Product Sales includes Company Product Sales and Contract Manufacturing Sales.

 

Company Product Sales : The Company records revenue from Company product sales when title and risk of ownership have been transferred to the customer, which is typically upon delivery of products to the customer.

 

Revenue and Provision for Sales Returns and Allowances

 

As is customary in the pharmaceutical industry, the Company’s gross product sales from Company label products are subject to a variety of deductions in arriving at reported net product sales. When the Company recognizes revenue from the sale of products, an estimate of SRA is recorded, which reduces product sales. Accounts receivable and/or accrued expenses are also reduced and/or increased by the SRA amount. These adjustments include estimates for chargebacks, rebates, cash discounts and returns and other allowances. These provisions are estimates based on historical payment experience, historical relationship to revenues, estimated customer inventory levels and current contract sales terms with direct and indirect customers. The estimation process used to determine our SRA provision has been applied on a consistent basis and no material adjustments have been necessary to increase or decrease our reserves for SRA as a result of a significant change in underlying estimates. The Company will use a variety of methods to assess the adequacy of our SRA reserves to ensure that our financial statements are fairly stated. These will include periodic reviews of customer inventory data, customer contract programs, subsequent actual payment experience, and product pricing trends to analyze and validate the SRA reserves.

 

    8

 

 

 

The provision for chargebacks is our most significant sales allowance. A chargeback represents an amount payable in the future to a wholesaler for the difference between the invoice price paid to the Company by our wholesale customer for a particular product and the negotiated contract price that the wholesaler’s customer pays for that product. The Company’s chargeback provision and related reserve varies with changes in product mix, changes in customer pricing and changes to estimated wholesaler inventories. The provision for chargebacks also takes into account an estimate of the expected wholesaler sell-through levels to indirect customers at contract prices. The Company will validate the chargeback accrual quarterly through a review of the inventory reports obtained from our largest wholesale customers. This customer inventory information is used to verify the estimated liability for future chargeback claims based on historical chargeback and contract rates. These large wholesalers represent 90% - 95% of the Company’s chargeback payments. The Company continually monitors current pricing trends and wholesaler inventory levels to ensure the liability for future chargebacks is fairly stated.

 

Net revenues and accounts receivable balances in the Company’s consolidated financial statements are presented net of SRA estimates. Certain SRA balances are included in accounts payable and accrued expenses.

 

Gross-To-Net Sales Deductions

(in thousands)

 

    Three months ended     Nine months ended  
    September 30,     September 30,  
    2015     2014     2015     2014  
                         
Gross Company product sales   $ 23,167     $ 14,823     $ 73,347     $ 25,618  
                                 
Reduction to gross product sales:                                
Chargebacks and billbacks     9,072       10,365       37,160       13,832  
Sales discounts and other allowances     5,381       1,445       12,703       2,446  
Total reduction to gross product sales     14,453       11,810       49,863       16,278  
                                 
Company product sales, net   $ 8,714     $ 3,013     $ 23,484     $ 9,340  

 

Net Company product sales of $8.7 million and $3.0 million for the three months ended September 30, 2015 and 2014, respectively are included in product sales, net in the Condensed Consolidated Statements of Operations. Net Company product sales of $23.5 million and $9.3 million for the nine months ended September 30, 2015 and 2014, respectively, are included in product sales, net in the Condensed Consolidated Statements of Operations. Accounts receivable are presented net of SRA balances of $11.1 million and $4.2 million at September 30, 2015 and 2014, respectively. Accounts payable and accrued expenses include $1.3 million and $0.8 million at September 30, 2015 and 2014, respectively, for certain fees related to services provided by the wholesalers. Wholesale fees of $1.4 million and $0.8 million for the three month periods ended September 30, 2015 and 2014, respectively, were included in cost of goods sold. Wholesale fees of $4.7 million and $1.5 million for the nine month periods ended September 30, 2015 and 2014, respectively, were included in cost of goods sold. In addition, in connection with four of the seven products the Company currently manufactures, markets and distributes under its own label, in accordance with an agreement entered into in December 2011, the Company is required to pay a royalty calculated based on net sales to one of its pharmaceutical partners. The royalty is calculated based on contracted terms of 40% of net sales for the four products, which is to be paid quarterly to the pharmaceutical partner. In accordance with the agreement, net sales excludes fees related to services provided by the wholesalers. Accounts payable and accrued expenses include $1.0 million and $0.7 million at September 30, 2015 and 2014, respectively, related to these royalties. Royalty expense of $1.2 million and $0.7 million was included in cost of goods sold for the three months ended September 30, 2015 and 2014, respectively. Royalty expense of $2.8 million and $2.9 million was included in cost of goods sold for the nine months ended September 30, 2015 and 2014, respectively. The Company includes significant estimates to arrive at net product sales arising from wholesaler chargebacks, Medicaid and Medicare rebates, allowances and other pricing and promotional programs.

 

Contract Manufacturing Sales : The Company recognizes revenue when title transfers to its customers, which is generally upon shipment of products. These shipments are made in accordance with sales commitments and related sales orders entered into with customers either verbally or in written form. The revenues associated with these transactions, net of appropriate cash discounts, product returns and sales reserves, are recorded upon shipment of the products and are included in product sales, net on the Company’s Condensed Consolidated Statement of Operations.

 

Research and Development Income :  The Company establishes agreed upon product development agreements with its customers to perform product development services. Product development revenues are recognized in accordance with the product development agreement upon the completion of the phases of development and when the Company has no future performance obligations relating to that phase of development. Revenue recognition requires the Company to assess progress against contracted obligations to assure completion of each stage. These payments are generally non-refundable and are reported as deferred until they are recognizable as revenue. If no such arrangement exists, product development fees are recognized ratably over the entire period during which the services are performed.

 

    9

 

 

In making such assessments, judgments are required to evaluate contingencies such as potential variances in schedule and the costs, the impact of change orders, liability claims, contract disputes and achievement of contractual performance standards. Changes in total estimated contract cost and losses, if any, are recognized in the period they are determined. Billings on research and development contracts are typically based upon terms agreed upon by the Company and customer and are stated in the contracts themselves and do not always align with the revenues recognized by the Company.

 

Major Customers

 

Major customers of the Company are defined as having revenue greater than 10% of total gross revenue. For the three months ended September 30, 2015, three of the Company’s customers accounted for 47% of its revenue. For the three months ended September 30, 2014, four of the Company’s customers accounted for 59% of its revenue. Two of these customers are the same for both periods. For the nine months ended September 30, 2015 and 2014, three of the Company’s customers accounted for 58% and four of the Company’s customers accounted for 53% of the Company’s revenue, respectively. Two of these customers are the same for both periods. Accounts receivable related to the Company’s major customers comprised 80% of all accounts receivable as of September 30, 2015. The loss of one or more of these customers could have a significant impact on our revenues and harm our business and results of operations.

 

The Company had net revenue from one product, econazole nitrate cream, which accounted for 52% and 24% of total revenues for the three months ended September 30, 2015 and 2014, respectively, and 52% and 21% of total revenues for the nine months ended September 30, 2015 and 2014, respectively.

 

Derivatives

 

The Company accounts for its derivative instruments in accordance with ASC 815-10, “Derivatives and Hedging”. ASC 815-10 establishes accounting and reporting standards requiring that derivative instruments, including derivative instruments embedded in other contracts, be recorded on the balance sheet as either an asset or liability measured at its fair value. ASC 815-10 also requires that changes in the fair value of derivative instruments be recognized currently in results of operations unless specific hedge accounting criteria are met. The Company has not entered into hedging activities to date. The Company's derivative liability was the embedded convertible option of its Notes issued December 16, 2014 (see Note 6), which has been recorded as a liability at fair value and was revalued at each reporting date, with changes in the fair value of the instruments included in the consolidated statements of operations as non-operating income (expense). Due to the approval of the sufficient shares at the Company’s annual shareholder meeting, the liability for the embedded derivative was reclassified to equity on May 20, 2015. The Company has no derivatives at September 30, 2015.

 

Recent Accounting Pronouncements

 

In May 2014, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2014-09, “Revenue from Contracts with Customers”. This ASU is a comprehensive new revenue recognition model that requires a company to recognize revenue to depict the transfer of goods or services to a customer at an amount that reflects the consideration it expects to receive in exchange for those goods or services. This ASU is effective for annual reporting periods beginning after December 15, 2017 and early adoption is not permitted. Accordingly, the Company will adopt this ASU on January 1, 2018. Companies may use either a full retrospective or modified retrospective approach to adopt this ASU and management is currently evaluating which transition approach to use. The Company is currently evaluating the impact of ASU 2014-09.

 

In August 2014, the FASB issued ASU 2014-15, “Presentation of Financial Statements — Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern”.  This ASU requires management to evaluate, in connection with preparing financial statements for each annual and interim reporting period, whether there are conditions or events, considered in the aggregate, that raise substantial doubt about an entity’s ability to continue as a going concern within one year after the date that the financial statements are issued (or within one year after the date that the financial statements are available to be issued when applicable) and provide related disclosures. ASU 2014-15 is effective for the annual period ending after December 15, 2016, and for annual and interim periods thereafter.  Early adoption is permitted.  The Company is currently evaluating the impact of ASU 2014-15.

 

    10

 

 

In April 2015, the FASB issued ASU 2015-03, “Simplifying the Presentation of Debt Issuance Costs,” which requires debt issuance costs to be presented in the balance sheet as a direct deduction from the carrying value of the associated debt liability, consistent with the presentation of debt discounts or premiums. The ASU is effective for fiscal years beginning after December 15, 2015, and interim periods within those fiscal years. Early adoption is permitted for financial statements that have not been previously issued. The Company is currently evaluating the impact of ASU 2015-03.

 

In July 2015, the FASB issued ASU 2015-11, “Inventory (Topic 330): Simplifying the Measurement of Inventory”. ASU 2015-11 requires inventory measured using any method other than last-in, first out (“LIFO”) or the retail inventory method to be subsequently measured at the lower of cost or net realizable value, rather than at the lower of cost or market. Under this ASU, subsequent measurement of inventory using the LIFO and retail inventory method is unchanged. ASU 2015-11 is effective prospectively for fiscal years, and for interim periods within those years, beginning after December 15, 2016. Early application is permitted. The Company is currently evaluating the impact of this ASU on its consolidated financial statements.

 

In September 2015, the FASB issued ASU 2015-16, Simplifying the Accounting for Measurement-Period Adjustments. The standard eliminates the requirement to restate prior period financial statements for measurement period adjustments. The new guidance requires that the cumulative impact of a measurement period adjustment (including the impact of prior periods) be recognized in the reporting period in which the adjustment is identified. ASU 2015-16 will be effective for our interim and annual financial statements issued beginning January 1, 2016 and is to be adopted on a prospective basis. Early adoption is permitted for financial statements that have not been previously issued. The Company is currently evaluating the impact of ASU 2015-16.

  

4. License Fee

 

On December 12, 2005, the Company extended its license agreement with Novavax, Inc. for an additional ten years for $1 million. This extension entitles the Company to the exclusive use of the Novasome® lipid vesicle encapsulation and certain other technologies (each a “Microencapsulation Technology”, and collectively, the “Technologies”) in the fields of (i) animal pharmaceuticals, biologicals and other animal health products; (ii) foods, food applications, nutrients and flavorings; (iii) cosmetics, consumer products and dermatological over-the-counter and prescription products (excluding certain topically delivered hormones); (iv) fragrances; and (v) chemicals, including herbicides, insecticides, pesticides, paints and coatings, photographic chemicals and other specialty chemicals, and the processes for making the same (collectively, the “Teligent Field”) through 2015. This payment is being amortized ratably over the ten-year period. The Company recorded amortization expense of $25,000 related to this agreement for each of the three month periods ended September 30, 2015 and 2014 and $75,000 for each of the nine month periods ended September 30, 2015 and 2014. Remaining amortization of this license fee will amount to $25,000 in 2015.

 

5. Inventories

 

Inventories are valued at the lower of cost or market, using the first-in-first-out method.

 

Inventories at September 30, 2015 and December 31, 2014 consist of:

 

    September 30, 2015     December 31, 2014  
    (Unaudited)     (Audited)  
    (amounts in thousands)  
Raw materials   $ 4,215     $ 2,299  
Work in progress     106       140  
Finished goods     637       345  
Total   $ 4,958     $ 2,784  

 

6. Convertible 3.75% Senior Notes

 

On December 16, 2014, the Company issued $125 million aggregate principal amount of 3.75% Convertible Senior Notes due 2019 (the “Notes”). On December 22, 2014, the Company announced the closing of the initial purchasers’ exercise in full of their option to purchase an additional $18.75 million aggregate principal amount. The Notes were offered and sold only to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). The net proceeds from the sale of the Notes were approximately $139 million, after deducting underwriting fees and other related expenses of approximately $4.8 million. Accrued interest in the amount of $1.6 million related to the Notes was included in accrued expenses as of September 30, 2015.

 

    11

 

 

The Notes bear interest at a fixed rate of 3.75% per year, payable semiannually in arrears on June 15 and December 15 of each year, beginning on June 15, 2015 and mature on December 15, 2019, unless earlier repurchased, redeemed or converted. The Notes are convertible into shares of the Company’s common stock, cash or a combination thereof.

 

On May 20, 2015, the Company received shareholder approval for the increase in the number of shares of common stock authorized and available for issuance upon conversion of the Notes. As a result, the conversion option can now be share-settled in full, and now qualifies for equity classification, and the bifurcated derivative liability no longer needs to be accounted for as a separate derivative on a prospective basis as of May 20, 2015. The remaining unamortized debt discount that arose at the date of debt issuance from the original bifurcation will continue to be amortized using the effective interest method through interest expense.  After adjusting the derivative liability to market value on May 20, 2015, the Company reclassified the remaining $18.3 million value of the derivative liability to stockholders equity due to the approval of sufficient shares.

 

The Notes are convertible at an initial conversion price of approximately $11.29 per share, which is equivalent to an initial conversion rate of 88.5716 shares per $1,000 principal amount of Notes, subject to adjustment in certain events, such as distributions of dividends or stock splits. Holders may convert their Notes at their option prior to September 15, 2019, when or if certain conditions have been met or circumstances have occurred, such as if the Company’s stock price exceeds 130% of the conversion price under the Notes for a designated period of time, or the trading price of the Notes is, for a designated period of time, less than 98% of the closing sale price of the Company’s common stock multiplied by the then-current conversion rate of the Notes, or the Company calls Notes for redemption, or certain specified corporate events occur. Holders may also convert their Notes at their option at any time on or after September 15, 2019 and prior to the close of business on the business day immediately preceding the stated maturity date. In addition, following the occurrence of certain changes of control of the Company described in the Indenture governing the Notes or termination of trading of the Company’s common stock or other securities into which the Notes are convertible (a “make-whole fundamental change”) or the delivery by the Company of a notice of redemption, the conversion rate for a holder who elects to convert its Notes in connection with such make-whole fundamental change or such notice of redemption will increase. Additionally, if certain conditions have been met or circumstances have occurred, such as if the Company’s stock price exceeds 150% of the conversion price under the Notes for a designated period of time, or the trading of the Notes is, for a designated period of time, less than 98% of the closing sale price of the Company’s stock multiplied by the then-current conversion rate of the Notes, or the Company calls Notes for redemption, the Company may redeem for cash any or all outstanding Notes on or after December 19, 2017 in an amount equal to the outstanding principal amount of such Notes, plus accrued and unpaid interest.

 

The Notes and any common stock issuable upon conversion of the Notes have not been registered under the Securities Act, applicable state securities laws or the securities laws of any other jurisdiction, and may not be offered or sold in the United States without registration or an applicable exemption from registration requirements. The Company does not intend to file a registration statement for the resale of the Notes or any common stock issuable upon conversion of the Notes, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful.

 

Since the Company did not have sufficient authorized shares available to share-settle the conversion option in full prior to May 20, 2015, the embedded conversion option did not qualify for equity classification and instead was separately valued and accounted for as a derivative liability. On December 16, 2014, the initial value allocated to the derivative liability was $43.7 million of the $143.75 million principal amount of the Notes, which represents a discount to the debt to be amortized through interest expense using the effective interest method through the maturity of the Notes. Accordingly, the effective interest rate used to amortize the debt discount on the Notes is 12.94%. During each reporting period, the derivative liability was marked to fair value through May 20, 2015 with the change in fair value recorded in the consolidated statement of operations. This resulted in a change in the fair value of the derivative liability of $0 for the three months ended September 30, 2015, and a change in the fair value of the derivative liability of $23.1 million for the nine months ended September 30, 2015.

 

The Notes are being accounted for in accordance with ASC 470-20.  Under ASC 470-20, issuers of convertible debt instruments that may be settled in cash upon conversion, including partial cash settlement, are required to separately account for the liability (debt) and equity (conversion option) components.

 

    12

 

 

The application of ASC 470-20 resulted in the recognition of $0 million as the value for the liability at September 30, 2015.  The remaining unamortized discount and unamortized debt financing costs will be amortized over the remaining term of 4.21 years. At September 30, 2015 the net carrying amount of the liability component and the remaining unamortized debt discount were as follows:

 

    September 30  
    2015  
       
Face amount of the Notes   $ 143,750  
Unamortized discount of the liability component     38,511  
Carrying amount of the Notes   $ 105,239  

 

Deferred financing costs associated with the Notes include fees of $4.2 million at September 30, 2015. The assumptions used in connection with the valuation of the convertible option of the Notes issued December 16, 2014 utilizing the "with” and “without” method, discussed in Note 3 was as follows:

 

    Initial
Measurement
    Measurement     Measurement  
    December 16,     December 31,     May 20,  
    2014     2014     2015  
Issue date     12/17/2014       12/17/2014       12/17/2014  
Maturity date     12/15/2019       12/15/2019       12/15/2019  
Term     4.99       4.92       4.57  
Principal (millions)     143.75       143.75       143.75  
Coupon     3.75 %     3.75 %     3.75 %
Seniority     Senior unsecured       Senior unsecured       Senior unsecured  
Conversion shares     88.572       88.572       88.572  
Conversion price   $ 11.29     $ 11.29     $ 11.29  
                         
Stock price   $ 9.45     $ 8.80     $ 5.73  
Risk free rate     1.61 %     1.64 %     1.44 %
                         
Volatility (rounded)     40.00 %     40.00 %     46.00 %

 

The table below provides a reconciliation of beginning and ending balances for the liability measured at fair value using significant observable and unobservable inputs (Level 3). The table reflects the gains associated with the decrease in fair value and the reclassification of the balance of the derivative liability.

 

    Initial
Measurement
                Decrease in Fair
Value
    Reclassification        
    December 16,     Decrease in     December 31,     January 1, 2015 to     of derivative liability to     September 30,  
    2014     Fair Value     2014     May 20, 2015     equity on May 20, 2015     2015  
Fair value of convertible feature of 3.75% senior notes   $ 43,700     $ 2,300     $ 41,400     $ 23,144     $ 18,256     $ -  

 

For the three months and the nine months ended September 30, 2015, the Company recorded the following expenses in relation to the Notes:

 

    13

 

 

    Three months ended
September 30, 2015
    Nine months ended
September 30, 2015
 
    (in thousands)     (in thousands)  
             
Interest Expense at 3.75% coupon rate (1)   $ 1,348     $ 4,043  
Debt discount amortization (1)     1,695       4,928  
Amortization of deferred financing costs (1)     184       537  
    $ 3,227     $ 9,508  

 

  (1) Included within “Interest and other expense, net” on the Condensed Consolidated Statements of Operations

 

7. Note Payable - General Electric Capital Corporation

 

On November 18, 2014, the Company entered into an asset-based revolving senior secured credit facility (the “Credit Agreement”) with General Electric Capital Corporation, as agent (the “Agent”), and GE Capital Bank and the other financial institutions party thereto, as lenders (the “Lenders”), pursuant to which the Lenders agreed to extend credit facilities to the Company (the “Financing”).

 

To secure payment of the amounts financed under the Credit Agreement, the Company and the Agent entered into a Guaranty and Security Agreement (the “Guaranty and Security Agreement”).  Under the terms of the Guaranty and Security Agreement, the Company granted to the Agent, for the benefit of the Lenders and other secured parties, a continuing security interest in and against substantially all of its tangible and intangible assets, except intellectual property, and each of the Company’s direct and indirect future subsidiaries shall guarantee the Company’s obligations under the Credit Agreement.

 

Under the Credit Agreement, the Company can request revolving loan advances up to an aggregate total amount of $10 million, which may be increased to $15 million at the request of the Company if certain conditions are met. The Company may also request an incremental facility for revolving loan commitments of up to $10 million. Borrowings under the Credit Agreement may be made as prime rate loans with an applicable margin of 3.0% per annum or 1, 2, 3 or 6 month LIBOR loans with an applicable margin of 4.0% per annum. At September 30, 2015, the interest rate in effect was 4.2%. Availability under the Credit Agreement is calculated as 85% of the book value of eligible accounts at such time multiplied by a liquidity factor, less any reserves established by the Agent. The Company paid the balance of $3.2 million on August 24, 2015 and as of September 30, 2015, the outstanding balance of the credit facility was $0. In accordance with the Credit Agreement, the Company is required to provide the Lenders information related to working capital by which the Lenders will calculate the available line of credit, defined in the agreement as the Borrowing Base Certificate. As of September 30, 2015, the Company had a remaining availability of $10 million.

 

The term of the Credit Agreement is up to five years from November 18, 2014. The Credit Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among others, covenants that limit or restrict the Company’s ability to incur indebtedness, grant liens, merge or consolidate, dispose of assets, make investments, make acquisitions, enter into certain transactions with affiliates, pay dividends or make distributions, or repurchase stock, in each case, subject to customary exceptions for a loan facility of this size and type. In addition, the Credit Agreement contains customary events of default (subject to customary cure periods for certain events of default), including, among others, non-payment, inaccuracy of representations and warranties, covenant defaults, cross-default to material agreements, cross-default to material indebtedness, bankruptcy and insolvency and material judgment defaults. The Company must meet certain financial reporting and audit requirements, as defined by the Credit Agreement. The Company was in compliance with all covenants of the Credit Agreement as of September 30, 2015.

 

Debt issuance costs of $432,000 are being amortized over the life of the Credit Agreement.

 

The Credit Agreement was amended on September 16, 2015 to reduce the unused line fee from 0.5% to 0.375%.

 

In connection with this Financing, the Company paid in full its existing credit facility with Square 1 Bank (see Note 8) and executed a Release and Termination Note and Credit Agreement with Square 1 Bank to release the Company from any future obligations under the Credit Agreement executed on August 31, 2012, as amended July 26, 2013.

 

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8. Note Payable - Square 1 Bank

 

On August 31, 2012, as amended on July 26, 2013, the Company entered into a Loan and Security Agreement (the “Loan and Security Agreement” ) with Square 1 Bank (the “Lender” ) pursuant to which the Lender agreed to extend credit facilities to the Company.

 

On November 18, 2014, the Company paid in full its existing credit facility with the Lender under the Loan and Security Agreement. The Company recorded amortization expense in the amount of $42,000 to write-off the remaining unamortized debt issuance costs during the year ended December 31, 2014.

 

9. Stock-Based Compensation

 

Stock Options

 

The 1999 Director Stock Option Plan, as amended (the “Director Plan”), provides for the grant of stock options to non-employee directors of the Company at an exercise price equal to the fair market value per share on the date of the grant. An aggregate of 1,975,000 shares have been approved and authorized for issuance pursuant to this plan. A total of 2,514,798 options have been granted to non-employee directors through September 30, 2015 and 807,782 of those have been forfeited through September 30, 2015 and returned to the option pool. The options granted under the Director Plan vest in full one year after their respective grant dates and have a maximum term of ten years.

 

The 1999 Stock Incentive Plan, as amended (“1999 Plan”), replaced all previously authorized employee stock option plans, and no additional options may be granted under those previous plans. Under the 1999 Plan, options or stock awards may be granted to all of the Company's employees, officers, directors, consultants and advisors to purchase a maximum of 3,200,000 shares of common stock. However, pursuant to the terms of the 1999 Plan, no awards may be granted after March 16, 2009. A total of 2,892,500 options, having a maximum term of ten years, have been granted at 100% of the fair market value of the Company's common stock at the date of grant. Options outstanding under the 1999 Plan are generally exercisable in cumulative increments over four years commencing one year from date of grant.

 

On June 26, 2009, the Board of Directors adopted, and the Company’s stockholders subsequently approved by written consent, the Teligent, Inc. 2009 Equity Incentive Plan (the “2009 Plan”). The 2009 Plan became effective on July 29, 2009. The 2009 Plan allows the Company to continue to grant options and restricted stock, as under the 1999 Plan, but also authorizes the Board of Directors to grant a broad range of other equity-based awards, including stock appreciation rights, restricted stock units (“RSUs”) and performance awards. The 2009 Plan has been created, pursuant to and consistent with the Company’s current compensation philosophy, to assist the Company in attracting, retaining and rewarding designated employees, directors, consultants and other service providers of the Company and its subsidiaries and affiliates, in a manner that will be cost efficient to the Company from both an economic and financial accounting perspective. On April 12, 2010, the Board of Directors adopted, and the Company’s stockholders subsequently approved, an amendment of the 2009 Plan to increase the number of shares of Common Stock available for grant under such plan by adding 2,000,000 shares of common stock. On May 29, 2014, the Board of Directors adopted and the Company’s stockholders approved a further amendment of the 2009 Plan to increase the number of shares of common stock available for grant under such plan by adding 1,000,000 shares of common stock. The 2009 Plan, as amended on May 29, 2014, authorizes up to 5,000,000 shares of the Company’s common stock for issuance pursuant to the terms of the 2009 Plan. The maximum number of shares that may be subject to awards made to any individual in any single calendar year under the 2009 Plan is 1,000,000 shares. As of September 30, 2015, options to purchase 2,739,168 shares of common stock were outstanding under the 2009 Plan. As of September 30, 2015, 172,750 restricted stock units were outstanding under the 2009 Plan. As of September 30, 2015, 1,506,248 shares of restricted stock had been granted under the 2009 Plan and 230,420 of those have been forfeited through September 30, 2015 and returned to the pool.

 

In summary, there are 3,314,168 options outstanding under the 1999 Plan, the Director Plan and the 2009 Plan, collectively as of September 30, 2015.

 

There are 267,984 options available for issuance under the Director Plan and 720,086 options available under the 2009 Plan as of September 30, 2015.

 

    15

 

 

The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing formula that uses assumptions noted in the following table. Expected volatilities and risk-free interest rates are based upon the expected life of the grant. The interest rates used are the U.S. Treasury yield curve in effect at the time of the grant.

 

    For the nine months ended  
    September 30, 2015  
       
Expected volatility     52.7% - 65.8%  
Expected term (in years)     3.2 -3.3 years  
Risk-free rate     0.89% - 1.20%  
Expected dividends     0%  

 

A summary of option activity under the 1999 Plan, the Director Plan and the 2009 Plan as of September 30, 2015 and changes during the period are presented below:

 

          Weighted  
    Number of     Average  
    Options     Exercise Price  
Outstanding as of January 1, 2015     2,436,834     $ 1.79  
Issued     927,500     $ 9.94  
Exercised     (15,666 )   $ 1.95  
Forfeited     (34,500 )   $ 6.55  
Expired     -       -  
Outstanding as of September 30, 2015     3,314,168     $ 4.02  
                 
Exercisable as of September 30, 2015     2,152,499     $ 1.19  

 

Based upon application of the Black-Scholes option-pricing formula described above, the weighted-average grant-date fair value of options granted during the nine months ended September 30, 2015 was $3.83.

 

The following table summarizes information regarding options outstanding and exercisable at September 30, 2015:

 

Outstanding:

 

                Weighted  
    Stock     Weighted     Average  
    Options     Average     Remaining  
Range of Exercise Prices   Outstanding     Exercise Price     Contractual Life  
$0.76 - $1.00     95,000     $ 0.78       2.33  
$1.01 - $1.50     1,877,000     $ 1.07       6.39  
$1.51 - $10.67     1,342,168     $ 8.38       8.93  
Total     3,314,168     $ 4.02       7.30  

 

Exercisable:

 

    Stock     Weighted  
    Options     Average  
Range of Exercise Prices   Exercisable     Exercise Price  
$0.76 - $1.00     95,000     $ 0.78  
$1.01 - $1.50     1,857,333     $ 1.07  
$1.51 - $10.67     206,166     $ 2.45  
Total     2,158,499     $ 1.19  

 

    16

 

 

As of September 30, 2015, the intrinsic value of the options outstanding was $11.8 million and the intrinsic value of the options exercisable was $11.53 million. The intrinsic value of options exercised during the nine months ended September 30, 2015 was $71,975. As of September 30, 2015, there was approximately $2.9 million of total unrecognized compensation cost that will be recognized through September 2018 related to non-vested share-based compensation arrangements granted under the Director Plan and the 2009 Plan.

 

Restricted Stock and RSUs

 

The Company periodically grants restricted stock and RSU awards to certain officers and other employees that typically vest one to three years from their grant date. The Company recognized $250,000 and $93,000 of compensation expense during the three months ended September 30, 2015 and 2014, respectively, and $498,000 and $458,000 during the nine months ended September 30, 2015 and 2014, respectively related to restricted stock and RSU awards.  Stock compensation expense is recognized over the vesting period of the restricted stock and RSUs.  At September 30, 2015, the Company had approximately $1.5 million of total unrecognized compensation cost related to non-vested restricted stock and RSUs, all of which will be recognized through February 2018.

 

    Number of     Weighted Average  
    Restricted Stock     Exercise Price  
Non-vested balance at January 1, 2015     108,334     $ 2.86  
                 
Changes during the period:                
Shares granted     32,500       10.67  
Shares vested     (140,834 )     4.66  
Shares forfeited     -       -  
                 
Non-vested balance at September 30, 2015   $ -     $ -  

 

    Number of     Weighted Average  
    RSUs     Exercise Price  
Non-vested balance at January 1, 2015     -     $ -  
                 
Changes during the period:                
Shares granted     205,250       10.67  
Shares vested     (32,500 )     10.67  
Shares forfeited     -       -  
                 
Non-vested balance at September 30, 2015     172,750     $ 10.67  

 

10. Stock Warrants

 

Stock Warrant activity for the nine months ended September 30, 2015 and 2014 consisted of:

 

    17

 

 

    2015     2014  
          Weighted           Weighted  
    Number of     Average     Number of     Average  
    Warrants     Exercise Price     Warrants     Exercise Price  
Balance at January 1,     84,000     $ 1.21       354,546     $ 1.21  
                                 
Changes during the period:                                
Stock warrants granted     -       -       -       -  
Stock warrants expired     -       -       -       -  
Stock warrants exercised     -       -       (270,546 )     1.21  
                                 
Balance at September 30,     84,000     $ 1.21       84,000     $ 1.21  

 

In connection with the private placement of the Company’s common stock on December 8, 2010, the Company granted common stock warrants to purchase up to 338,182 and 16,364 shares, respectively, to each of its two placement agents for $1.21 per share which expire on December 8, 2015. On March 7, 2014, 270,546 of the 338,182 warrants were exercised.

 

11. Income Taxes

 

The Company’s ability to use net operating loss carry forwards is subject to substantial limitation in future periods under certain provisions of Section 382 of the Internal Revenue Code of 1986, as amended, which limit the utilization of net operating losses upon a more than 50% change in ownership of the Company’s stock that is held by 5% or greater stockholders. The Company examined the application of Section 382 with respect to an ownership change that took place during 2010, as well as the limitation on the application of net operating loss carry forwards. The Company believes that operating losses subsequent to the change date in 2010 (aggregating $7.8 million) are not subject to Section 382 limitations. The Company has estimated that the annual limitation starting in 2010 aggregates from $1.0 million to $2.3 million per year including the effect of amortization of built in gains.

 

The Company is subject to the provisions of ASC 740-10-25, “Income Taxes” (“ASC 740”). ASC 740 prescribes a more likely-than-not threshold for the financial statement recognition of uncertain tax positions. ASC 740 clarifies the accounting for income taxes by prescribing a minimum recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. On a quarterly basis, the Company undergoes a process to evaluate whether income tax accruals are in accordance with ASC 740 guidance on uncertain tax positions. The Company has not recorded a significant tax provision at September 30, 2015, as it has estimated its effective tax rate for 2015 (after considering utilization of existing net operating losses) to be insignificant.  For federal purposes, post 1998 tax years remain open to examination as a result of net operating loss carryforwards. The Company is currently open to audit by the appropriate state income taxing authorities for tax years 2012 to 2014.

 

12. Legal

 

The Company is involved from time to time in claims which arise in the ordinary course of business, including the claims described below. In the opinion of management, the Company has made adequate provision for potential liabilities, if any, arising from any such matters. However, litigation is inherently unpredictable, and the costs and other effects of pending or future litigation, governmental investigations, legal and administrative cases and proceedings (whether civil or criminal), settlements, judgments and investigations, claims and changes in any such matters, and developments or assertions by or against us relating to intellectual property rights and intellectual property licenses, could have a material adverse effect on the Company’s business, financial condition and operating results.

 

On May 21, 2015, Horizon Pharma Ireland Limited, HZNP Limited and Horizon Pharma USA, Inc. (collectively, “Horizon”) filed a complaint in the United States District Court for the District of New Jersey against the Company alleging infringement of certain United States patents based upon to the Company’s submission to the FDA of an Abbreviated New Drug Application (“ANDA”) seeking FDA approval to market diclofenac topical solution 2% w/w before the expiration of the patents asserted in the complaint. On June 30, 2015, August 11, 2015, September 17, 2015, and October 27, 2015, Horizon filed additional complaints in the United States District Court for the District of New Jersey against the Company alleging infringement of other of its United States patents in relation to the Company’s submission of the same ANDA.

 

    18

 

 

On July 21, 2015, September 11, 2015, October 6, 2015 and October 21, 2015, the Company filed answers, affirmative defenses and counterclaims with respect to the first four complaints filed by Horizon.  In those filings, the Company asserted that the patents alleged to be infringed in the complaints filed by Horizon are invalid and not infringed by the Company.

 

Again, given that the Company is a specialty generic pharmaceutical company, the Company believes that the claims made by Horizon are ordinary course. Moreover, the Company believes that its counterclaims and defenses have merit, but based on the early stage of these cases, the Company is unable to predict the outcome at this time.

 

13. 2014 Public Offering

 

On June 27, 2014, the Company entered into an underwriting agreement with Roth Capital Partners, LLC and Oppenheimer & Co., as representatives of the several underwriters named therein (the “Underwriters”), relating to the underwritten public offering and sale of up to an aggregate of 4,650,000 shares of the Company’s common stock, par value $0.01, at a price to the public of $5.00 per share (the “Offering”). The Company also granted the underwriters a 30-day option to purchase up to an aggregate of 697,500 shares to cover over-allotments, if any.

 

The Offering was made pursuant to the Company’s shelf registration statement on Form S-3 (Registration No. 333-196543), filed on June 5, 2014 with the SEC and declared effective by the SEC on June 16, 2014, as well as the prospectus supplement describing the terms of the Offering, dated June 27, 2014.

 

On July 2, 2014, the Company closed the Offering, and after giving effect to the underwriters’ exercise of the over-allotment option, the Company sold an aggregate of 5,347,500 shares of common stock in the Offering at a public offering price of $5.00 per share. The net proceeds of the Offering were approximately $24.9 million, after deducting underwriting discounts and commissions and other offering expenses paid by the Company.

 

14. Asset Purchase Agreements

 

Astra Zeneca

 

On September 24, 2014, the Company entered into an Asset Purchase Agreement (the “AZ Purchase Agreement”) with AstraZeneca Pharmaceuticals LP, a Delaware corporation (“AstraZeneca”), pursuant to which the Company acquired all rights, titles and interests of AstraZeneca and its affiliates in Abbreviated New Drug Applications and New Drug Applications associated with eighteen products (collectively the “ Purchased Regulatory Approvals”) and certain documents relating thereto (together with the Purchased Regulatory Approvals, the “Purchased Assets”).

 

In consideration for the purchase of the Purchased Assets, the Company paid AstraZeneca $0.5 million in cash in September 2014 and paid $6 million upon the compliance of a certain milestone event during the three months ended September 30, 2015. In addition, the Company has agreed to pay, for each product manufactured by the Company pursuant to a Purchased Regulatory Approval, a royalty on future gross profits from product sales. Notwithstanding the foregoing, at any time prior to December 1, 2015, the Company may satisfy in full its royalty obligations with a single payment of $3 million. The transaction is accounted for as a purchase of the product and product rights and, as such, the initial payment, milestone payment and related costs to acquire the asset are included as part of product acquisition costs totaling $6.9 million. The Company will amortize the costs over fifteen years, the useful life of the acquired products and product rights, commencing when the product can be sold.

 

Valeant

 

On September 30, 2014, the Company entered into two Asset Purchase Agreements (each, a “Valeant Purchase Agreement” and together, the “Valeant Asset Purchase Agreements”), one with Valeant Pharmaceuticals North America LLC and the other with Valeant Pharmaceuticals Luxembourg SARL (together, “Valeant”), pursuant to which the Company acquired all rights, titles and interests of Valeant and their respective affiliates in Abbreviated New Drug Applications and New Drug Applications associated with two products (collectively, the “Valeant Purchased Regulatory Approvals”) and certain documents related thereto (together with the Valeant Purchased Regulatory Approvals, the “Valeant Purchased Assets”). Pursuant to the terms of the Valeant Asset Purchase Agreements, the Company also acquired the option (each, an “Option” and, collectively, the “Options”) to purchase Abbreviated New Drug Applications and New Drug Applications associated with three additional products (the “Additional Assets”).

 

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In consideration for the purchase of the Valeant Purchased Assets, the Company paid Valeant an aggregate of $1.5 million in cash. In consideration for the purchase of the Additional Assets, the Company may exercise any Option, in its sole discretion, and pay $0.8 million for each of two additional products and $0.5 million for one additional product, for a total aggregate of $2 million if all Options are exercised. The Company exercised its Option and purchased the one additional product for $0.5 million on November 18, 2014. On March 27, 2015, the Company exercised its Option and purchased the two additional products for a total of $1.5 million in cash. The transaction is accounted for as a purchase of the product and product rights and, as such, the initial payment and related costs to acquire the Valeant Purchased Assets are included as part of product acquisition costs totaling $3.5 million. The Company will amortize the costs over fifteen years, the useful life of the acquired product and product rights, commencing when the product can be sold.

 

15. Subsequent Events

 

Chief Scientific Officer

 

On October 5, 2015, the Company appointed Stephen Richardson as the Company’s Chief Scientific Officer.

 

Under the terms of his employment agreement, Mr. Richardson will receive an annual salary of $300,000. Mr. Richardson will also be eligible to receive an annual performance bonus for each calendar year during the term of his employment, which may be payable in the form of cash, stock options and/or restricted stock. Mr. Richardson’s target bonus will be equal to 40% of his base salary for the applicable fiscal year. All performance targets pursuant to such plan shall be determined by the Company’s Compensation Committee. In addition, Mr. Richardson will be entitled to participate in certain of the Company’s benefit programs on the same terms and conditions generally provided by the Company to its executive employees.

 

As soon as practicable following the effective date of his employment agreement and subject to the approval of the Company’s Board of Directors, Mr. Richardson will also receive an equity grant pursuant to the Company’s 2009 Equity Incentive Plan consisting of 25,000 RSUs and options to purchase up to 200,000 shares of the Company’s common stock at a strike price equal to $7.42, the closing price of the Company’s common stock on October 5, 2015. The shares subject to the RSU award and the stock option award shall become fully vested over a period of three years, with one-third of such shares vesting on each of the first, second and third anniversaries of the effective date of the award.

 

Mr. Richardson is also subject to certain restrictive covenants as set forth in his employment agreement, including confidentiality, non-solicitation and non-competition. Mr. Richardson’s employment agreement further provides for payments upon certain types of employment termination events as further set forth in his employment agreement.

 

Acquisition of Three Commercialized Injectable Products

 

On October 5, 2015, the Company, together with Teligent Jersey Limited, a wholly-owned subsidiary of the Company incorporated under the laws of Jersey (the “Company Subsidiary”) established for the purpose of consummating the transaction, acquired, pursuant to an Asset Purchase Agreement and certain other ancillary agreements entered into with Concordia Pharmaceuticals Inc., S.à.r.l., Barbados Branch (the “Seller”), all rights, title and interests of the Seller in the existing inventory and certain contracts associated with three currently marketed injectable pharmaceutical products (Fortaz®, Zinacef TM , and Zantac® Injection), and the Company Subsidiary acquired all rights, title and interests of the Seller in, among other things, certain other contracts, product registrations and books and records associated with those products.

 

In consideration for the purchase of the Purchased Assets, the Purchasers paid the Seller $10,000,000 in cash and agreed to assume certain liabilities associated with the Purchased Assets. The Purchase Agreement includes customary representations, warranties and covenants by the Purchasers. Under the terms of the Purchase Agreement, the Company has agreed to indemnify the Seller and the Seller has agreed to indemnify the Purchasers against certain liabilities. The Company is currently evaluating the overall impact of this event on the financial statements.

 

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A copy of the Purchase Agreement is filed as Exhibit 10.3 to this Quarterly Report on Form 10-Q for the period ending September 30, 2015.

 

Agreement to Acquire the Assets of Canadian Pharmaceutical Company, Alveda Pharmaceuticals, Inc.

 

On October 12, 2015, the Company entered into asset purchase agreements (each, a “Purchase Agreement” and together, the “Purchase Agreements”) and certain other ancillary agreements with Alveda Pharmaceuticals Inc. (the “ Seller ”) for the purchase of the Seller’s rights, title, and interest in the development, production, marketing, import and distribution of certain pharmaceutical products. The Company agreed to purchase the intellectual property-related assets of the Seller, including certain contracts, goodwill, product registrations and books and records, pursuant to the terms of one Purchase Agreement and the non-intellectual property-related assets of Seller, including certain accounts receivable, inventory, prepaid expenses, capital assets, contracts, operational permits, books and records, and certain intellectual property, pursuant to the terms of the other Purchase Agreement. Certain employees of the Seller will be retained by the Company following the closing of the transaction.

 

The aggregate purchase price to be satisfied on the closing of the transaction in accordance with the terms of the Purchase Agreements will be approximately $47,000,000 CAD in cash and certain agreed assumed liabilities associated with the Purchased Assets. The closing of the transaction is contingent on the satisfaction of certain closing conditions by the Company and by the Seller, as set out in the Purchase Agreements. The parties anticipate that the transaction will close approximately thirty days after signing. Under the terms of the Purchase Agreements, the Company has agreed to indemnify the Seller and the Seller has agreed to indemnify the Company against certain liabilities. The Company is currently evaluating the overall impact of this event on its financial statements.

 

Approval for Listing on the NASDAQ Global Select Market

 

On October 14, 2015, the Company provided written notice to the NYSE MKT LLC (the “NYSE MKT”) that the Company intended to transfer the listing of the Company’s common stock from the NYSE MKT to the NASDAQ Global Select Market, and withdraw the listing and registration of the common stock from the NYSE MKT. The common stock has been authorized for listing on the NASDAQ Global Select Market. The Company’s common stock ceased trading on the NYSE MKT at the close of business on October 23, 2015, and began trading on the NASDAQ Global Select Market on October 26, 2015.

 

Name Change

 

On October 22, 2015, the Company announced (1) that it will change its name to Teligent, Inc. effective as of October 23, 2015, at 5:00 P.M. Eastern Daylight Time and (2) that the Company’s common stock, which was previously approved for listing on the NASDAQ Global Select Market, would be quoted under the trading symbol “TLGT” as of the first day of trading on such exchange on Monday, October 26, 2015.

 

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ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

This “Management's Discussion and Analysis of Financial Condition and Results of Operations” section and other sections of this Quarterly Report on Form 10-Q contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, that are based on current expectations, estimates, forecasts and projections about the industry and markets in which the Company operates and on management's beliefs and assumptions. In addition, other written or oral statements, which constitute forward-looking statements, may be made by or on behalf of the Company. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. These statements are based on current expectations of management and are not guarantees of future performance, and involve certain risks, uncertainties and assumptions, which are difficult to predict. These risks and uncertainties include, without limitation, competitive factors, outsourcing trends in the pharmaceutical industry, the general economic conditions in the markets in which the Company operates, levels of industry research and development spending, the Company’s ability to continue to attract and retain qualified personnel, the fixed price nature of product development agreements or the loss of customers and other factors described in the Company’s filings with the Securities and Exchange Commission, including the “Risk Factors” section as set forth in our Annual Report on Form 10-K for the year ended December 31, 2014, as updated below in this Quarterly Report on Form 10-Q. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in such forward-looking statements. The forward-looking statements set forth herein speak only as of the date of this report. The Company undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by applicable law.

 

Company Overview

 

Strategic Overview

 

Teligent, Inc. (the “Company”) is a Delaware corporation incorporated in 1977. On October 22, 2015, the Company announced (1) that it will change its name from IGI Laboratories, Inc. to Teligent, Inc. effective as of October 23, 2015, at 5:00 P.M. Eastern Daylight Time and (2) that the Company’s common stock, which was previously approved for listing on the NASDAQ Global Select Market, would be quoted under the trading symbol “TLGT” as of the first day of trading on such exchange on Monday, October 26, 2015. The Company’s office, laboratories and manufacturing facilities are located at 105 Lincoln Avenue, Buena, New Jersey. The Company is a specialty generic pharmaceutical company. The Company’s mission is to become a leader in the specialty generic pharmaceutical market. Under its own label, the Company currently sells generic topical pharmaceutical products that are bioequivalent to their brand name counterparts. The Company also provides development, formulation, and manufacturing services to the pharmaceutical, OTC and cosmetic markets.

 

Currently, we have two platforms for growth:

 

  § Developing, manufacturing and marketing a portfolio of generic pharmaceutical products in our own label in topical, injectable, complex and ophthalmic dosage forms; and

 

  § Managing our current contract manufacturing and formulation services business.

 

We currently generate revenue from the manufacture and development of topical pharmaceutical, OTC and cosmetic products. We have been in the contract manufacturing and development of topical products business since the early 1990s, but our strategy since 2010 has been focused on the growth of our own generic pharmaceutical business. Since 2010, we have focused on transitioning our business to include more customers in the topical pharmaceutical industry. In 2014, we focused on the transformation of a business that was working toward being a leader in the topical generic pharmaceutical industry into becoming a leader in the broader specialty generic pharmaceutical markets. We believe that expanding our development and commercial base beyond topical generics, historically the cornerstone of our expertise, to include injectable generics, complex generics and ophthalmic generics (what we call our “TICO strategy”), will leverage existing expertise and capabilities, and broaden our platform for strategic growth.

 

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As of the date of this report, we have 28 ANDA pending approval with the FDA for additional topical generic pharmaceutical products. As of the date of this report, we have received final approval from the FDA for two ANDAs. Due to the increased rate of review by the FDA of applications filed in Generic Drug User Fee Amendments (“GDUFA”) Year 3, which began October 1, 2014, and in an attempt to shorten our potential review times and, ultimately, obtain approvals more quickly, we have chosen to withdraw four of our applications from the FDA and resubmit them in 2016. We expect to continue to expand our presence in the generic topical pharmaceutical market through the filing of additional ANDAs with the FDA and the subsequent launch of products as these applications are approved. Our target is to file 15 to 17 ANDAs in total in 2015 through our internal research and development program. We will also seek to license or acquire further products, intellectual property, or ANDAs to expand our portfolio.

 

The manufacturing and commercialization of generic specialty pharmaceutical markets is competitive, and there are established manufacturers, suppliers and distributors actively engaged in all phases of our business. We currently only manufacture and sell topical generic pharmaceutical products under our own label. In October 2015, we acquired and began to sell our first generic injectable products. The injectable products are currently sold in another company’s label and will be transitioned to our company’s label in accordance with FDA guidance. As we continue to execute our TICO strategy, we will compete in other markets, including the injectable and ophthalmic generic pharmaceutical markets, and expect to face other competitors.

 

For the three months ended September 30, 2015, 36% of our total product sales, net were to one of the three large wholesale drug distributors, AmerisourceBergen Corporation (“ABC”), Cardinal Health, Inc. (“Cardinal”), and McKesson Drug Company (“McKesson”).   For the three months ended September 30, 2014, 28% of our total product sales, net were to one of those three large wholesale drug distributors. For the nine months ended September 30, 2015, 50% of our total product sales, net were to one of those three large wholesale drug distributors noted below. For the nine months ended September 30, 2014, 29% of our total product sales, net were to one of those three large wholesale drug distributors.

 

ABC accounted for approximately 42% and 0% of our accounts receivable as of September 30, 2015 and 2014, respectively.

 

ABC, Cardinal and McKesson are key distributors of our products, as well as a broad range of health care products for many other companies. None of these distributors is an end user of our products. Generally speaking, if sales to any one of these distributors were to diminish or cease, we believe that the end users of our products would likely find little difficulty obtaining our products either directly from us or from another distributor. However, the loss of one or more of these distributors, together with a delay or inability to secure an alternative distribution source for end users, could have a material negative impact on our revenue, business, financial condition and results of operations. Furthermore, ABC, Cardinal and McKesson have entered into strategic alliances with Walgreens, CVS Caremark and Rite-Aid, respectively.  Since Walgreens, CVS Caremark and Rite-Aid are customers for several of our products, the loss of our distributor relationship with any of the three large wholesalers could result in a reduction to our revenues.

 

We consider our business relationships with ABC, Cardinal and McKesson to be in good standing and have fee for services contracts with each of them. However, a change in purchasing patterns, a decrease in inventory levels, an increase in returns of our products, delays in purchasing products and delays in payment for products by one or more of these distributors could have a material negative impact on our revenue, business, financial condition and results of operations. We experienced a change in purchasing patterns at ABC in April 2015. We are currently evaluating the financial impact of this change on our business, and are analyzing the market for other opportunities to expand our current relationships with other customers. While we continue to seek to diversify our existing portfolio of specialty generic drug products through internal research and development, we expect to file up to 7 more ANDAs in 2015. In addition, we continue to explore business development opportunities to add additional products and /or capabilities to our existing portfolio.

 

Our customers in the contract manufacturing business generally consist of pharmaceutical companies, as well as cosmetic and OTC product marketers, who require product development/manufacturing support. For the three months ended September 30, 2015, approximately 91% of our revenue was derived from pharmaceutical customers, as compared to 85% of total contract manufacturing revenue for the three months ended September 30, 2014. For the nine months ended September 30, 2015, approximately 85% of our revenue was derived from pharmaceutical customers, as compared to 79% of total contract manufacturing revenue for the nine months ended September 30, 2014. One contract manufacturing customer represented greater than 10% of revenue for the three months ended September 30, 2015, and one of our contract manufacturing services customers represented 17% of total revenue for the three months ended September 30, 2014. One of our contract manufacturing services customers represented 11% of total revenue for the nine months ended September 30, 2015 and none of our contract manufacturing services customers represented more than 10% of total revenue for the nine months ended September 30, 2014. We do not expect any contract manufacturing or formulation services customers to exceed 10% of revenue for 2015 and beyond.

 

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Recent Events

 

On July 9, 2015, we announced that we had launched our seventh product, diclofenac sodium 1.5% topical solution after receipt of the final approval from the FDA for an ANDA. We now market seven products in twelve presentations under our own label.

 

On October 5, 2015, we, together with a wholly-owned subsidiary of ours incorporated under the laws of Jersey, entered into an Asset Purchase Agreement and certain other ancillary agreements with Concordia Pharmaceuticals Inc., S.à.r.l., Barbados Branch, pursuant to which we acquired all rights, title and interests in the existing inventory and certain contracts associated with three currently marketed injectable pharmaceutical products (Fortaz®, Zinacef TM , and Zantac® Injection), and our subsidiary acquired all rights, title and interests in, among other things, certain other contracts, product registrations and books and records associated with those products.

 

On October 5, 2015, we appointed Stephen Richardson as our Chief Scientific Officer.

 

On October 12, 2015, we entered into asset purchase agreements and certain other ancillary agreements with Alveda Pharmaceuticals, Inc. for the purchase of the rights, title, and interest in the development, production, marketing, import and distribution of certain pharmaceutical products. We agreed to purchase the intellectual property-related assets, including certain contracts, goodwill, product registrations and books and records, pursuant to the terms of one Purchase Agreement and the non-intellectual property-related assets, including certain accounts receivable, inventory, prepaid expenses, capital assets, contracts, operational permits, books and records, and certain intellectual property, pursuant to the terms of the other Purchase Agreement. Certain employees will be retained by us following the closing of the transaction.

 

As of October 22, 2015, we filed ten ANDAs in 2015. We are optimistic regarding the continued positive momentum that we are seeing in our interactions with the FDA, especially with regard to applications filed in GDUFA Year 3, which began on October 1, 2014. We believe that this increased rate of review is evidence that the implementation of GDUFA in 2012 is working. In an attempt to shorten our potential review times and, ultimately, obtain approvals more quickly, we have chosen to withdraw four of our applications from the FDA and resubmit them in 2016. Based on August 2015 IMS Health data, the addressable market for our current pipeline of twenty-eight ANDAs is estimated at $1.4 billion, excluding our four partnered submissions.

 

Results of Operations

 

Three months ended September 30, 2015 compared to September 30, 2014

 

We had a net loss of $2,888,000, or $0.05 per share, for the three months ended September 30, 2015, compared to a net loss of $202,000, or $0.00 per share, for the three months ended September 30, 2014, which resulted from the following:

 

Revenues (in thousands):

 

    Three Months Ended September 30,        
Components of Revenue:   2015     2014     $ Change     % Change  
Product sales, net   $ 11,375     $ 6,005     $ 5,370       89 %
Research and development income     237       635       (398 )     (63) %
Licensing, royalty and other revenue     3       28       (25 )     (89) %
 Total Revenues   $ 11,615     $ 6,668     $ 4,947       74 %

 

The increase in product sales for the three months ended September 30, 2015 as compared to the same period in 2014 was primarily due to increased revenue from our own generic pharmaceutical product line that was launched in the first quarter of 2013, including the launch of one additional Company label product in July 2015 and two additional Company label products in June 2014. This increase was partially offset by a decrease in product sales in our contract manufacturing services. Research and development income will not be consistent and will vary, from period to period, depending on the required timeline of each development project. Licensing, royalty and other revenue decreased slightly due to a decrease in other revenue while licensing and royalty revenue remained the same.

 

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Costs and Expenses (in thousands):

 

    Three Months Ended September 30,        
    2015     2014     $ Change     % Change  
Cost of sales   $ 5,538     $ 4,036     $ 1,502       37 %
Selling, general and administrative     2,433       1,124       1,309       116 %
Product development and research     3,253       1,652       1,601       97 %
 Totals costs and expenditures   $ 11,224     $ 6,812     $ 4,412       65 %

 

Cost of sales increased for the three months ended September 30, 2015 as a result of the increase in total revenue. Cost of sales as a percentage of total revenue was 48% for the three months ended September 30, 2015 as compared to 61% for the three months ended September 30, 2014. The decrease in cost of sales as a percentage of product sales for 2015 was attributable to the difference in product mix for the three months ended September 30, 2015 as compared to the same period in 2014. Our research and development income results primarily from services rendered under contractual agreements, and therefore cost of sales as a percentage of our research and development income is relatively low. We expect the product mix to continue to shift in the fourth quarter of 2015 and the cost of sales as a percentage of total revenue to decline over time.

 

Selling, general and administrative expenses for the three months ended September 30, 2015 increased by $1,309,000 as compared to the same period in 2014. There were increases of $220,000 in salaries, bonuses and related costs, $535,000 in the expense from the issuance of stock based compensation related to options and restricted stock, $368,000 in professional fees, $60,000 in website expenses, $54,000 in travel related expenses, $36,000 in recruiting expenses and $80,000 in other corporate expenses, partially offset by a decrease of $75,000 in commissions.

 

Product development and research expenses for the three months ended September 30, 2015 increased by $1,601,000 as compared to the same period in 2014. Consistent with our strategy to expand our portfolio of generic prescription pharmaceutical products, we increased spending on clinical studies by $505,000, consulting fees by $262,000, salaries, bonuses and related costs by $233,000, outside testing, pilot batch expense and supplies by $311,000, fees related to the Generic Drug User Fee Act and the associated filing of our applications with the FDA by $108,000 and professional fees by $106,000.

 

Other Income (Expense) (in thousands):

 

    Three Months Ended September 30,        
    2015     2014     $ Change     % Change  
Interest and other expense   $ (3,279 )   $ (58 )   $ (3,221 )     5,553 %
Change in the fair value of derivative liability     -       -       -       -  

 

Interest expense increased for the three months ended September 30, 2015 as compared to the same period in 2014 due to the inclusion of approximately $3,227,000 of interest expense, amortization of debt discount and amortization of debt issuance costs related to the Notes (see Note 6 to the Company’s Consolidated Financial Statements) in the three months ended September 30, 2015.

 

Net Loss (in thousands, except per share numbers):

 

    Three Months Ended September 30,        
    2015     2014     $ Change     % Change  
Net loss   $ (2,888 )   $ (202 )   $ (2,686 )     1,330 %
Basic loss per share   $ (0.05 )   $ (0.00 )   $ (0.05 )     -  

 

Net loss for the three months ended September 30, 2015 was $2,888,000 as compared to a net loss of $202,000 in the same period last year. The increase is due to the increases in costs and expenses, partially offset by the increases in revenues noted above.

 

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Nine months ended September 30, 2015 compared to September 30, 2014

 

We had net income of $13,043,000, or $0.25 per share, for the nine months ended September 30, 2015, compared to a net loss of $380,000, or $0.01 per share, for the nine months ended September 30, 2014, which resulted from the following:

 

Revenues (in thousands):

 

    Nine Months Ended September 30,        
Components of Revenue:   2015     2014     $ Change     % Change  
Product sales, net   $ 30,532     $ 18,525     $ 12,007       65 %
Research and development income     475       1,385       (910 )     (66) %
Licensing, royalty and other revenue     172       95       77       81 %
 Total Revenues   $ 31,179     $ 20,005     $ 11,174       56 %

 

The increase in product sales for the nine months ended September 30, 2015 as compared to the same period in 2014 was primarily due to increased revenue from our own generic pharmaceutical product line that was launched in the first quarter of 2013, including the launch of one additional Company label product in July 2015 and two additional Company label products in June 2014. This increase was partially offset by a decrease in product sales in our contract manufacturing services. Research and development income will not be consistent and will vary, from period to period, depending on the required timeline of each development project. Licensing, royalty and other revenue increased slightly due to an increase in other revenue while licensing and royalty revenue remained the same.

 

Costs and Expenses (in thousands):

 

    Nine Months Ended September 30,        
    2015     2014     $ Change     % Change  
Cost of sales   $ 15,808     $ 11,603     $ 4,205       36 %
Selling, general and administrative     6,474       3,563       2,911       82 %
Product development and research     9,319       5,045       4,274       85 %
 Totals costs and expenditures   $ 31,601     $ 20,211     $ 11,390       56 %

 

Cost of sales increased for the nine months ended September 30, 2015 as a result of the increase in total revenue. Cost of sales as a percentage of total revenue was 51% for the nine months ended September 30, 2015 as compared to 58% for the nine months ended September 30, 2014. The decrease in cost of sales as a percentage of product sales for 2015 was attributable to increased revenue from our own generic pharmaceutical product line, which has higher margins, and a shift in the mix of our contract manufacturing product sales to include greater higher margin pharmaceutical products, which was partially offset by the effect of a price decline in one product during 2015. During the nine months ended September 30, 2015, 82% of our revenue in contract manufacturing was from pharmaceutical customers as compared to 79% for the same period in 2014. Our research and development income results primarily from services rendered under contractual agreements, and therefore cost of sales as a percentage of our research and development income is relatively low. Consistent with our strategy, we expect cost of sales as a percentage of total revenue to decline over time.

 

Selling, general and administrative expenses for the nine months ended September 30, 2015 increased by $2,911,000 as compared to the same period in 2014. There were increases of $657,000 in salaries, bonuses and related costs, $737,000 in professional fees, $850,000 in the expense from the issuance of stock based compensation related to options and restricted stock, $140,000 in travel related expenses, $62,000 in website expenses, $51,000 in contributions, $73,000 in overhead costs, $35,000 in stockholder relations expenses, $63,000 in recruiting expenses and $235,000 in other corporate expenses.

 

Product development and research expenses for the nine months ended September 30, 2015 increased by $4,274,000 as compared to the same period in 2014. Consistent with our strategy to expand our portfolio of generic prescription pharmaceutical products, we increased spending on clinical studies by $1,794,000, consulting fees by $983,000, outside testing, supplies and maintenance contracts by $606,000, salaries, bonuses and related costs by $504,000, pilot batch expense by $278,000, overhead costs by $101,000, professional fees by $153,000 and $64,000 in the expense from the issuance of stock based compensation related to stock options. These increases were partially offset by a decrease of $210,000 in fees related to the Generic Drug User Fee Act and the associated filing of our applications with the FDA.

 

    26

 

 

Other Income (Expense) (in thousands):

 

    Nine Months Ended September 30,        
    2015     2014     $ Change     % Change  
Interest and other expense   $ (9,679 )   $ (162 )   $ (9,517 )     5,875 %
Change in the fair value of derivative liability     23,144       -       23,144       -  

 

Interest expense increased for the nine months ended September 30, 2015 as compared to the same period in 2014 due to the inclusion of approximately $9,509,000 of interest expense, amortization of debt discount and amortization of debt issuance costs related to the Notes (see Note 6 to the Company’s Consolidated Financial Statements) in the nine months ended September 30, 2015. We also recorded a $23,144,000 change in the fair value of the derivative liability as a result of the change in the fair value of our derivative liability, caused primarily by the decrease in the price of our common stock in the nine months ended September 30, 2015.

 

Net Income (Loss) (in thousands, except per share numbers):

 

    Nine Months Ended September 30,        
    2015     2014     $ Change     % Change  
Net income (loss)   $ 13,043     $ (380 )   $ 13,423       3,532 %
Basic earnings (loss) per share   $ 0.25     $ (0.01 )   $ 0.26       2,600 %

 

Net income for the nine months ended September 30, 2015 was $13,043,000 as compared to a net loss of $380,000 in the same period last year. The increase is due to the change in the fair value of derivative liability, increases in revenue, partially offset by the increases in costs and expenses noted above.

 

Liquidity and Capital Resources

 

The Company's operating activities provided $1,821,000 of cash during the nine months ended September 30, 2015, compared to $1,030,000 of cash used during the nine months ended September 30, 2014. The cash provided by operating activities for the nine months ended September 30, 2015 was a result of the net income, offset by the change in the fair value of derivative liability and the non-cash expenses and changes in operating assets and liabilities for the period. The cash used in operating activities for the nine months ended September 30, 2014 was a result of the net loss, adjusted for non-cash activity and a net decrease in operating assets and liabilities for the period.

 

The Company’s investing activities used $11,751,000 during the nine months ended September 30, 2015, compared to $3,077,000 of cash used in investing activities during the nine months ended September 30, 2014. The Company paid the additional aggregate of $6,000,000 that was payable at the time of the Company’s first filing with the FDA related to any asset purchased from AstraZeneca Pharmaceuticals LP that was included in operating liabilities (see Note 14 to the Company’s Condensed Consolidated Financial Statements). The funds used for the nine months ended September 30, 2015 were for the purchase of two additional products (see Note 14 to the Company’s Condensed Consolidated Financial Statements) and capital expenditures related to our purchase of the building adjacent to our facility which we had been leasing since the middle of 2014, expansion of our existing facility, additional equipment for the compounding and packaging areas and additional IT equipment. The funds used for the nine months ended September 30, 2014 were for the purchase of products (see Note 14 to the Company’s Condensed Consolidated Financial Statements) and capital expenditures related to additional computer equipment and scientific equipment and improvements incurred to expand our R & D area.

 

The Company's financing activities used $3,254,000 of cash during the nine months ended September 30, 2015, compared to $25,254,000 of cash provided during the nine months ended September 30, 2014. The cash used in the nine months ended September 30, 2015 was mainly the $3,160,000 principal payment on the note payable, bank and the $98,000 principal payments on capital lease obligations and the cash provided for the nine months ended September 30, 2014 was mainly the $24,866,000 proceeds from the issuance of stock (see Note 13 to the Company’s Condensed Consolidated Financial Statements) and the $565,000 proceeds from the exercise of common stock options and warrants.

 

    27

 

 

The Company’s principal sources of liquidity are cash and cash equivalents of approximately $145,699,000 at September 30, 2015, the $10,000,000 available on the $10,000,000 credit facility detailed in Note 8 to the Company’s Condensed Consolidated Financial Statements) and future cash from operations. The Company had working capital of $153,786,000 at September 30, 2015. See Note 15 to the Company’s Condensed Consolidated Financial Statements for events subsequent to September 30, 2015.

 

The Company may require additional funding and this funding would depend, in part, on the timing and structure of potential business arrangements. If necessary, the Company may continue to seek to raise additional capital through the sale of its equity or through a strategic alliance with a third party. There may also be additional acquisition and growth opportunities that may require external financing. There can be no assurance that such financing will be available on terms acceptable to the Company, or at all. We believe that our existing capital resources will be sufficient to support our current business plan beyond November 2016.

 

Off Balance Sheet Arrangements

 

The Company does not have any off balance sheet arrangements as of the date of this report.

 

Critical Accounting Policies and Estimates

 

The Company’s condensed consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles, which require management to make estimates and assumptions about future events that affect the amounts reported in the financial statements and the accompanying notes. Actual results could differ from these estimates.

 

Please refer to the Company’s Form 10-K for the year ended December 31, 2014 for a complete list of all Critical Accounting Policies and Estimates. See also Note 3 to the Company’s Consolidated Financial Statements.

 

ITEM 3. Quantitative and Qualitative Disclosures About Market Risk

 

As of September 30, 2015, our principal debt obligation was related to our Notes.  Interest accrues at a fixed rate of 3.75% on the outstanding principal amount of the Notes and is paid semi-annually every June 15 and December 15 until the Notes mature on December 15, 2019.  Since the interest rate is fixed, we have no market risk related to the Notes.

 

Our revolving Credit and Security Agreement with GECC calls for interest to accrue based on a premium above either the current prime rate or current LIBOR rates.  Therefore, borrowings pursuant to this revolving credit facility would be subject to market risk. As of September 30, 2015, we had $0 in outstanding loans with GECC.

 

Our financial instruments include cash and cash equivalents, accounts receivable, accounts payable and the Notes. The fair values of cash and cash equivalents, accounts receivable and accounts payable approximate book value because of the short maturity of these instruments.  Based on the closing price of our common stock as of September 30, 2015, the fair value of our Notes was approximately $105.2 million compared to their face value of $143.75 million as of September 30, 2015.  However, this variance is due to the conversion feature in the Notes rather than to changes in market interest rates.  As noted above, the Notes carry a fixed interest rate and therefore do not subject us to interest rate risk. As a result in the change in fair value, we recorded a $23.1 million change in the fair value of the derivative liability on our consolidated statements of operations.

 

ITEM 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation of our Chief Executive Officer and Principal Financial and Accounting Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of September 30, 2015. Based on that evaluation, our Chief Executive Officer and Principal Financial and Accounting Officer concluded that, as of September 30, 2015, the Company’s disclosure controls and procedures were effective.

 

    28

 

 

Changes in Internal Control over Financial Reporting

 

There was no change in our internal control over financial reporting during our third quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

    29

 

 

PART II

OTHER INFORMATION

 

ITEM 1. Legal Proceedings

 

We are involved from time to time in claims which arise in the ordinary course of business, including the claims described below. In the opinion of management, we have made adequate provision for potential liabilities, if any, arising from any such matters. However, litigation is inherently unpredictable, and the costs and other effects of pending or future litigation, governmental investigations, legal and administrative cases and proceedings (whether civil or criminal), settlements, judgments and investigations, claims and changes in any such matters, and developments or assertions by or against us relating to intellectual property rights and intellectual property licenses, could have a material adverse effect on our business, financial condition and operating results.

 

On May 21, 2015, Horizon Pharma Ireland Limited, HZNP Limited and Horizon Pharma USA, Inc. (collectively, “Horizon”) filed a complaint in the United States District Court for the District of New Jersey against us alleging infringement of certain United States patents based upon to our submission to the FDA of an ANDA seeking FDA approval to market diclofenac topical solution 2% w/w before the expiration of the patents asserted in the complaint. On June 30, 2015, August 11, 2015, September 17, 2015, and October 27, 2015, Horizon filed additional complaints in the United States District Court for the District of New Jersey against us alleging infringement of other of its United States patents in relation to our submission of the same ANDA.

 

On July 21, 2015, September 11, 2015, October 6, 2015 and October 21, 2015, we filed answers, affirmative defenses and counterclaims with respect to the first four complaints filed by Horizon.  In those filings we asserted that the patents alleged to be infringed in the complaints filed by Horizon are invalid and not infringed by us.

 

Again, given that we are a specialty generic pharmaceutical company, we believe that the claims made by Horizon are ordinary course. Moreover, we believe that our counterclaims and defenses have merit, but based on the early stage of these cases, we are unable to predict the outcome at this time.

 

ITEM 1A. Risk Factors.

 

Part I, Item 1A, “Risk Factors,” of our Annual Report on Form 10-K for the year ended December 31, 2014 includes a detailed discussion of risks and uncertainties which could adversely affect our future results. Except as set forth below, the risks described in our Annual Report on Form 10-K for the year ended December 31, 2014 have not materially changed.

 

Risks Related to Our Business

 

We rely on a limited number of customers for a large portion of our revenues.

 

We depend on a limited number of customers for a large portion of our revenue. For the three months ended September 30, 2015, three of our customers accounted for 47% of our revenue. For the three months ended September 30, 2014, four of our customers accounted for 59% of our revenue. For the nine months ended September 30, 2015 and 2014, three of our customers accounted for 58% and four of our customers accounted for 53% of our revenue, respectively. The loss of one or more of these customers could have a significant impact on our revenues and harm our business and results of operations.

 

We had net revenue from one product, econazole nitrate cream, which accounted for 52% and 24% of total revenues for the three months ended September 30, 2015 and 2014, respectively, and 52% and 21% of total revenues for the nine months ended September 30, 2015 and 2014, respectively.

 

We have a history of losses and cannot assure you that we will become profitable, and as a result, we may have to cease operations and liquidate our business.

 

Prior to 2014, our expenses have exceeded our revenue in each of the last nine years, and no net income has been available to common stockholders during each of these years. As of September 30, 2015, our stockholders’ equity was $72.5 million and we had an accumulated deficit of $26.5 million. Our future profitability depends on revenue exceeding expenses, but we cannot assure you that this will occur. If we do not become profitable or continue to raise external financing, we could be forced to curtail operations and sell or liquidate our business, and you could lose some or all of your investment.

 

    30

 

 

Risks Related to Our Securities

 

Shares of our common stock are relatively illiquid which may affect the trading price of our common stock.

 

For the nine months ended September 30, 2015, the average daily trading volume of our common stock on the NYSE MKT was approximately 805,000 shares. As a result of our relatively small public float, our common stock may be less liquid than the stock of companies with broader public ownership. Among other things, trading of a relatively small volume of our common stock may have a greater impact on the trading price for our shares than would be the case if our public float were larger.

 

Our stock price is, and we expect it to remain, volatile and subject to wide fluctuations, which may make it difficult for stockholders to sell shares of common stock at or above the price for which they were acquired.

 

Our stock price is, and we expect it to remain, volatile, which could limit investors’ ability to sell stock at a profit. During the last two fiscal years, our stock price has closed at a low of $2.93 in the first quarter of 2014 and a high of $11.52 in the first quarter of 2015. The volatile price of our stock makes it difficult for investors to predict the value of their investment, to sell shares at a profit at any given time, or to plan purchases and sales in advance. A variety of factors may affect the market price of our common stock. These include, but are not limited to:

 

  · publicity regarding actual or potential clinical results relating to products under development by our competitors or us;
  · delay or failure in initiating, completing or analyzing nonclinical or clinical trials or the unsatisfactory design or results of these trials;
  · achievement or rejection of regulatory approvals by our competitors or us;
  · announcements of technological innovations or new commercial products by our competitors or us;
  · developments concerning proprietary rights, including patents;
  · developments concerning our collaborations;
  · regulatory developments in the U.S. and foreign countries;
  · economic or other crises, especially given the recent financial deterioration in the markets in which we compete, and other external factors;
  · stock market price and volume fluctuations of other publicly traded companies and, in particular, those that are in the cosmetic, pharmaceutical and consumer products industry;
  · actual or anticipated sales of our common stock, including sales by our directors, officers or significant stockholders;
  · period-to-period fluctuations in our revenues and other results of operations; and
  · speculation about our business in the press or the investment community.

 

ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

None.

   

ITEM 3. Defaults Upon Senior Securities

 

None.

 

ITEM 4. Mine Safety Disclosures

 

Not applicable.

 

ITEM 5. Other Information

 

None.

 

    31

 

 

ITEM 6. Exhibits

 

Exhibit    
Number   Description
     
10.1*   Second Amendment to Credit Agreement, dated as of August 14, 2015, by and among Teligent, Inc., Igen, Inc. and Teligent Pharma, Inc. as Borrowers, General Electric Capital Corporation as Agent, and the Lenders signatory thereto.
     
10.2*   Third Amendment to Credit Agreement, dated as of September 16, 2015, by and among Teligent, Inc., Igen, Inc. and Teligent Pharma, Inc. as Borrowers, General Electric Capital Corporation as Agent, and the Lenders signatory thereto.
     
 10.3*†   Asset Purchase Agreement, dated as of October 5, 2015, by between Concordia Pharmaceuticals Inc., S.à.r.l., Barbados Branch, on the one hand, and Teligent, Inc. and Teligent Jersey Limited, on the other hand.
     
31.1*   Certification of the President and Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
31.2*   Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
32.1*   Certification of the President and Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
     
32.2*   Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
     
101*   The following financial information from this Quarterly Report on Form 10-Q for the period ended September 30, 2015, formatted in XBRL (Extensible Business Reporting Language): (i) the Condensed Consolidated Statements of Operations; (ii) the Condensed Consolidated Balance Sheets; (iii) the Condensed Consolidated Statements of Cash Flows; and (iv) the Notes to Consolidated Financial Statements, tagged as blocks of text.

 

* Filed herewith.

 

† Confidential treatment has been requested with respect to certain portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.

 

    32

 

 

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.

 

  Teligent, Inc.
     
Date: November 9, 2015 By: /s/   Jason Grenfell-Gardner
    Jason Grenfell-Gardner
    President and Chief Executive Officer
     
Date: November 9, 2015 By: /s/   Jenniffer Collins
    Jenniffer Collins
    Chief Financial Officer

 

    33

 

 

Exhibit Index

 

Exhibit    
Number   Description
     
10.1*   Second Amendment to Credit Agreement, dated as of August 14, 2015, by and among Teligent, Inc., Igen, Inc. and Teligent Pharma, Inc. as Borrowers, General Electric Capital Corporation as Agent, and the Lenders signatory thereto.
     
10.2*   Third Amendment to Credit Agreement, dated as of September 16, 2015, by and among Teligent, Inc., Igen, Inc. and Teligent Pharma, Inc. as Borrowers, General Electric Capital Corporation as Agent, and the Lenders signatory thereto.
     
10.3*†   Asset Purchase Agreement, dated as of October 5, 2015, by between Concordia Pharmaceuticals Inc., S.à.r.l., Barbados Branch, on the one hand, and Teligent, Inc. and Teligent Jersey Limited, on the other hand.
     
31.1*   Certification of the President and Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
31.2*   Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
32.1*   Certification of the President and Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
     
32.2*   Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
     
101*   The following financial information from this Quarterly Report on Form 10-Q for the period ended September 30, 2015, formatted in XBRL (Extensible Business Reporting Language): (i) the Condensed Consolidated Statements of Operations; (ii) the Condensed Consolidated Balance Sheets; (iii) the Condensed Consolidated Statements of Cash Flows; and (iv) the Notes to Consolidated Financial Statements, tagged as blocks of text.

 

* Filed herewith.

 

† Confidential treatment has been requested with respect to certain portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.

 

    34

 

 

Exhibit 10.1

  

SECOND AMENDMENT TO CREDIT AGREEMENT

 

THIS SECOND AMENDMENT TO CREDIT AGREEMENT (this “ Agreement ”) is entered into as of August 14, 2015 by and among IGI Laboratories, Inc., a Delaware corporation (“ IGI ”), Igen Inc., a Delaware corporation (“ Igen ”), IGI Labs, Inc., a Delaware corporation (“ IGI Labs ”) (IGI, Igen and IGI Labs are sometimes referred to herein collectively as the “ Borrowers ” and individually as a “ Borrower ”), General Electric Capital Corporation, as Agent, and the Lenders signatory hereto.

 

WITNESSETH:

 

WHEREAS, Borrowers, Agent and the other Lenders from time to time party thereto are parties to that certain Credit Agreement dated as of November 18, 2014 (as amended pursuant to that certain First Amendment to Credit Agreement, dated as of December 9, 2014, and as otherwise amended, restated, supplemented or modified from time to time, the “ Credit Agreement ”; unless otherwise defined herein, capitalized terms used herein that are not otherwise defined herein shall have the respective meanings assigned to such terms in the Credit Agreement, as amended hereby); and

 

WHEREAS, the Credit Parties have requested that the Agent and Lenders amend certain provisions of the Credit Agreement, and, subject to the satisfaction of the conditions set forth herein, the Agent and the Lenders signatory hereto are willing to do so, on the terms set forth herein.

 

NOW, THEREFORE, in consideration of the mutual agreements, provisions and covenants contained herein, the parties agree as follows:

 

1.           Amendments to Credit Agreement . Upon satisfaction of the conditions set forth in Section 2 hereof, the Credit Agreement is hereby amended as follows:

 

a.            Article VI (Financial Covenants) of the Credit Agreement is hereby modified by amending and restating such Article in its entirety as follows:

 

ARTICLE VI.

FINANCIAL COVENANTS

 

Each Credit Party covenants and agrees that, so long as any Lender shall have any Commitment hereunder, or any Loan or other Obligation (other than contingent indemnification Obligations to the extent no claim giving rise thereto has been asserted) shall remain unpaid or unsatisfied:

 

6.1            Fixed Charge Coverage Ratio . Commencing on the date on which a Financial Covenant Period begins and measured as of the end of the twelve fiscal month period ending on the last day of the Fiscal Quarter immediately preceding the date on which such Financial Covenant Period begins, and as of the last day of each Fiscal Quarter ending thereafter during such Financial Covenant Period, the Credit Parties shall not permit the Fixed Charge Coverage Ratio to be less than 1.25:1.00.

 

“Fixed Charge Coverage Ratio” shall be calculated in the manner set forth in Exhibit 4.2(b).

 

6.2            Minimum Liquidity . The Credit Parties shall maintain Liquidity of no less than the greater of $2,000,000 and 20% of the Aggregate Revolving Loan Commitment at all times during a Financial Covenant Period.

 

 

 

 

b.           Section 11.1 (Defined Terms) of the Credit Agreement is hereby amended by adding the following sentence to the end of the definition of “Reserves” appearing therein:

 

“So long as any bailee shall be in possession of Collateral located at 4850 Mendenhall Road, Memphis, Tennessee and the Credit Parties shall not have delivered a bailee waiver in respect thereof in form and substance reasonably satisfactory to Agent, Agent shall maintain a reserve against Availability in an amount equal to the greater of (i) $350,000 and (ii) the aggregate value of Collateral at such location at any time of determination.”

 

c.           Section 11.1 (Defined Terms) of the Credit Agreement is hereby amended by adding the following new definitions in the proper alphabetical order:

 

Commencement Date ” means any date on which Liquidity is less than the applicable Threshold Amount.

 

Convertible Senior Notes ” means those certain 3.75% convertible senior notes due 2019 issued pursuant to that certain Indenture, dated as of December 16, 2014, between IGI, as issuer, and Wilmington Trust, National Association, as trustee.

 

Financial Covenant Period ” means a period which shall commence on any applicable Commencement Date and shall continue until the last day of the first full fiscal month after such Commencement Date in which Liquidity shall not have been less than the applicable Threshold Amount at any time.

 

Second Amendment Effective Date ” means August 14, 2015.

 

Threshold Amount ” means (x) prior to the repurchase or redemption of all Convertible Senior Notes, $84,000,000, and (y) after the repurchase or redemption of all Convertible Senior Notes, the greater of (i) $10,000,000 and (ii) 50% of Liquidity measured immediately after such repurchase or redemption.

 

d.           Section (c) of Exhibit 4.2(b) (Form of Compliance Certificate) is hereby modified by amending and restating such subsection in its entirety as follows:

 

“(c)          [no Financial Covenant Period existed during that portion of the period covered by the financial statements delivered in connection with this certificate not already covered by a previously delivered Compliance Certificate] [a Financial Covenant Period existed during that portion of the period covered by the financial statements delivered in connection with this certificate not already covered by a previously delivered Compliance Certificate and Exhibit A hereto is a correct calculation of each of the financial covenants contained in Article VI of the Credit Agreement, as applicable]; and”

 

2.           Conditions . The effectiveness of this Agreement is subject to the satisfaction of the following conditions precedent:

 

a.            the execution and delivery of this Agreement by each Credit Party, Agent and the Required Lenders; and

 

b.            the truth and accuracy of the representations and warranties contained in Section 3 hereof.

 

  2  

 

 

3.           Representations and Warranties . Each Credit Party hereby represents and warrants to Agent and each Lender as follows:

 

a.            the execution, delivery and performance by each of the Credit Parties of this Agreement have been duly authorized by all necessary action, and do not and will not:

 

(i)           contravene the terms of any of that Person’s Organization Documents;

 

(ii)          conflict with or result in any material breach or contravention of, or result in the creation of any Lien under, any document evidencing any material Contractual Obligation to which such Person is a party or any order, injunction, writ or decree of any Governmental Authority to which such Person or its Property is subject; or

 

(iii)         violate any material Requirement of Law in any material respect;

 

b.            such Credit Party has the power and authority to execute, deliver and perform its obligations under this Agreement and the Credit Agreement, as amended hereby;

 

c.            this Agreement constitutes the legal, valid and binding obligations of each such Person which is a party hereto enforceable against such Person in accordance with its terms, except as enforceability may be limited by applicable bankruptcy, insolvency or similar laws affecting the enforcement of creditors’ rights generally or by equitable principles relating to enforceability;

 

d.            after giving effect to this Agreement and the transactions contemplated hereby, each of the representations and warranties contained in the Credit Agreement and the other Loan Documents is true and correct in all material respects on and as of the date hereof as if made on the date hereof (except for representations and warranties that speak as of a specific date, which shall be true and correct as of such specific date); and

 

e.            no Default or Event of Default exists or would result from the transactions contemplated by this Agreement.

 

4.           No Modification . Except as expressly set forth herein, nothing contained herein shall be deemed to constitute a waiver of compliance with any term or condition contained in the Credit Agreement or any of the other Loan Documents or constitute a course of conduct or dealing among the parties. Except as expressly stated herein, the Agent and Lenders reserve all rights, privileges and remedies under the Loan Documents. Except as amended or consented to hereby, the Credit Agreement and other Loan Documents remain unmodified and in full force and effect. All references in the Loan Documents to the Credit Agreement shall be deemed to be references to the Credit Agreement as modified hereby. This Agreement shall constitute a Loan Document.

 

5.           Counterparts . This Agreement may be executed in any number of counterparts and by different parties in separate counterparts, each of which when so executed shall be deemed to be an original and all of which taken together shall constitute one and the same agreement. Signature pages may be detached from multiple separate counterparts and attached to a single counterpart. Delivery of an executed signature page of this Agreement by facsimile transmission or Electronic Transmission shall be as effective as delivery of a manually executed counterpart hereof.

 

  3  

 

 

6.           Successors and Assigns . 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 none of the Credit Parties may assign or transfer any of its rights or obligations under this Agreement without the prior written consent of the Agent.

 

7.           Governing Law . The laws of the State of New York shall govern all matters arising out of, in connection with or relating to this Agreement, including, without limitation, its validity, interpretation, construction, performance and enforcement (including, without limitation, any claims sounding in contract or tort law arising out of the subject matter hereof and any determinations with respect to post-judgment interest).

 

8.           Severability . The illegality or unenforceability of any provision of this Agreement or any instrument or agreement required hereunder shall not in any way affect or impair the legality or enforceability of the remaining provisions of this Agreement or any instrument or agreement required hereunder.

 

9.           Captions . The captions and headings of this Agreement are for convenience of reference only and shall not affect the interpretation of this Agreement.

 

10.          Reaffirmation . Each of the Credit Parties as debtor, grantor, pledgor, guarantor, assignor, or in other any other similar capacity in which such Credit Party grants liens or security interests in its property or otherwise acts as accommodation party or guarantor, as the case may be, hereby (i) ratifies and reaffirms all of its payment and performance obligations, contingent or otherwise, under each of the Loan Documents to which it is a party (after giving effect hereto) and (ii) to the extent such Credit Party granted liens on or security interests in any of its property pursuant to any such Loan Document as security for or otherwise guaranteed the Borrower’s Obligations under or with respect to the Loan Documents, ratifies and reaffirms such guarantee and grant of security interests and liens and confirms and agrees that such security interests and liens hereafter secure all of the Obligations as amended hereby. Each of the Credit Parties hereby consents to this Agreement and acknowledges that each of the Loan Documents remains in full force and effect and is hereby ratified and reaffirmed. The execution of this Agreement shall not operate as a waiver of any right, power or remedy of the Agent or Lenders, constitute a waiver of any provision of any of the Loan Documents or serve to effect a novation of the Obligations.

 

11.          Release of Claims . In consideration of the Lenders’ and the Agent’s agreements contained in this Agreement, each Credit Party hereby irrevocably releases and forever discharge the Lenders and the Agent and their affiliates, subsidiaries, successors, assigns, directors, officers, employees, agents, consultants and attorneys (each, a “ Released Person ”) of and from any and all claims, suits, actions, investigations, proceedings or demands, whether based in contract, tort, implied or express warranty, strict liability, criminal or civil statute or common law of any kind or character, known or unknown, which such Credit Party ever had or now has against Agent, any Lender or any other Released Person which relates, directly or indirectly, to any acts or omissions of Agent, any Lender or any other Released Person relating to the Credit Agreement or any other Loan Document on or prior to the date hereof.

 

[Remainder of Page Intentionally Left Blank; Signature Pages Follow]

 

  4  

 

 

IN WITNESS WHEREOF, each of the undersigned has executed this Agreement as of the date set forth above.

 

  BORROWERS :  
     
  IGI LABORATORIES, INC.
       
  By: /s/ Jenniffer Collins  
  Name:

Jenniffer Collins

 
  Title: CFO & Secretary  

 

  IGEN INC.  
     
  By:

/s/ Jenniffer Collins

 
  Name:

Jenniffer Collins

 
  Title: CFO & Secretary  

 

  IGI LABS, INC.  
       
  By: /s/ Jenniffer Collins  
  Name: Jenniffer Collins  
  Title: CFO & Secretary  

 

Second Amendment to Credit Agreement

 

 

 

 

  AGENT AND LENDERS:  
     
  GENERAL ELECTRIC CAPITAL CORPORATION, as Agent
       
  By: /s/ Jason Dufour  
  Name:

Jason Dufour

 
  Title: Its Duly Authorized Signatory  

 

Second Amendment to Credit Agreement

 

 

 

 

  GE CAPITAL BANK,  
  as a Lender  
     
  By: /s/ Paul Sleet  
  Name: Paul Sleet  
  Title: Duly Authorized Signatory  

 

Second Amendment to Credit Agreement

 

 

 

 

Exhibit 10.2

  

THIRD AMENDMENT TO CREDIT AGREEMENT

 

THIS THIRD AMENDMENT TO CREDIT AGREEMENT (this “ Agreement ”) is entered into as of September 16, 2015 by and among IGI Laboratories, Inc., a Delaware corporation (“ IGI ”), Igen Inc., a Delaware corporation (“ Igen ”), IGI Labs, Inc., a Delaware corporation (“ IGI Labs ”) (IGI, Igen and IGI Labs are sometimes referred to herein collectively as the “ Borrowers ” and individually as a “ Borrower ”), General Electric Capital Corporation, as Agent, and the Lenders signatory hereto.

 

WITNESSETH:

 

WHEREAS, Borrowers, Agent and the other Lenders from time to time party thereto are parties to that certain Credit Agreement dated as of November 18, 2014 (as amended pursuant to that certain First Amendment to Credit Agreement, dated as of December 9, 2014, that certain Second Amendment to Credit Agreement, dated August 14, 2014, and as otherwise amended, restated, supplemented or modified from time to time, the “ Credit Agreement ”; unless otherwise defined herein, capitalized terms used herein that are not otherwise defined herein shall have the respective meanings assigned to such terms in the Credit Agreement, as amended hereby); and

 

WHEREAS, the Credit Parties have requested that the Agent and Lenders amend certain provisions of the Credit Agreement, and, subject to the satisfaction of the conditions set forth herein, the Agent and the Lenders signatory hereto are willing to do so, on the terms set forth herein.

 

NOW, THEREFORE, in consideration of the mutual agreements, provisions and covenants contained herein, the parties agree as follows:

 

1.           Amendment to Credit Agreement . Upon satisfaction of the conditions set forth in Section 2 hereof, Section 11.1 (Definitions) of the Credit Agreement is hereby modified by amending and restating the definition of “Applicable Unused Line Fee” appearing therein in its entirety as follows:

 

“Applicable Unused Line Fee” means 0.375% per annum.

 

2.            Conditions . The effectiveness of this Agreement is subject to the satisfaction of the following conditions precedent:

 

a.            the execution and delivery of this Agreement by each Credit Party, Agent and the Required Lenders; and

 

b.            the truth and accuracy of the representations and warranties contained in Section 3 hereof.

 

3.            Representations and Warranties . Each Credit Party hereby represents and warrants to Agent and each Lender as follows:

 

a.            the execution, delivery and performance by each of the Credit Parties of this Agreement have been duly authorized by all necessary action, and do not and will not:

 

(i)           contravene the terms of any of that Person’s Organization Documents;

 

(ii)          conflict with or result in any material breach or contravention of, or result in the creation of any Lien under, any document evidencing any material Contractual Obligation to which such Person is a party or any order, injunction, writ or decree of any Governmental Authority to which such Person or its Property is subject; or

 

 

 

 

(iii)         violate any material Requirement of Law in any material respect;

 

b.            such Credit Party has the power and authority to execute, deliver and perform its obligations under this Agreement and the Credit Agreement, as amended hereby;

 

c.            this Agreement constitutes the legal, valid and binding obligations of each such Person which is a party hereto enforceable against such Person in accordance with its terms, except as enforceability may be limited by applicable bankruptcy, insolvency or similar laws affecting the enforcement of creditors’ rights generally or by equitable principles relating to enforceability;

 

d.            after giving effect to this Agreement and the transactions contemplated hereby, each of the representations and warranties contained in the Credit Agreement and the other Loan Documents is true and correct in all material respects on and as of the date hereof as if made on the date hereof (except for representations and warranties that speak as of a specific date, which shall be true and correct as of such specific date); and

 

e.            no Default or Event of Default exists or would result from the transactions contemplated by this Agreement.

 

4.              No Modification . Except as expressly set forth herein, nothing contained herein shall be deemed to constitute a waiver of compliance with any term or condition contained in the Credit Agreement or any of the other Loan Documents or constitute a course of conduct or dealing among the parties. Except as expressly stated herein, the Agent and Lenders reserve all rights, privileges and remedies under the Loan Documents. Except as amended or consented to hereby, the Credit Agreement and other Loan Documents remain unmodified and in full force and effect. All references in the Loan Documents to the Credit Agreement shall be deemed to be references to the Credit Agreement as modified hereby. This Agreement shall constitute a Loan Document.

 

5.              Counterparts . This Agreement may be executed in any number of counterparts and by different parties in separate counterparts, each of which when so executed shall be deemed to be an original and all of which taken together shall constitute one and the same agreement. Signature pages may be detached from multiple separate counterparts and attached to a single counterpart. Delivery of an executed signature page of this Agreement by facsimile transmission or Electronic Transmission shall be as effective as delivery of a manually executed counterpart hereof.

 

6.              Successors and Assigns . 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 none of the Credit Parties may assign or transfer any of its rights or obligations under this Agreement without the prior written consent of the Agent.

 

7.              Governing Law . The laws of the State of New York shall govern all matters arising out of, in connection with or relating to this Agreement, including, without limitation, its validity, interpretation, construction, performance and enforcement (including, without limitation, any claims sounding in contract or tort law arising out of the subject matter hereof and any determinations with respect to post-judgment interest).

 

8.              Severability . The illegality or unenforceability of any provision of this Agreement or any instrument or agreement required hereunder shall not in any way affect or impair the legality or enforceability of the remaining provisions of this Agreement or any instrument or agreement required hereunder.

 

  2  

 

 

9.           Captions . The captions and headings of this Agreement are for convenience of reference only and shall not affect the interpretation of this Agreement.

 

10.          Reaffirmation . Each of the Credit Parties as debtor, grantor, pledgor, guarantor, assignor, or in other any other similar capacity in which such Credit Party grants liens or security interests in its property or otherwise acts as accommodation party or guarantor, as the case may be, hereby (i) ratifies and reaffirms all of its payment and performance obligations, contingent or otherwise, under each of the Loan Documents to which it is a party (after giving effect hereto) and (ii) to the extent such Credit Party granted liens on or security interests in any of its property pursuant to any such Loan Document as security for or otherwise guaranteed the Borrower’s Obligations under or with respect to the Loan Documents, ratifies and reaffirms such guarantee and grant of security interests and liens and confirms and agrees that such security interests and liens hereafter secure all of the Obligations as amended hereby. Each of the Credit Parties hereby consents to this Agreement and acknowledges that each of the Loan Documents remains in full force and effect and is hereby ratified and reaffirmed. The execution of this Agreement shall not operate as a waiver of any right, power or remedy of the Agent or Lenders, constitute a waiver of any provision of any of the Loan Documents or serve to effect a novation of the Obligations.

 

11.          Release of Claims . In consideration of the Lenders’ and the Agent’s agreements contained in this Agreement, each Credit Party hereby irrevocably releases and forever discharge the Lenders and the Agent and their affiliates, subsidiaries, successors, assigns, directors, officers, employees, agents, consultants and attorneys (each, a “ Released Person ”) of and from any and all claims, suits, actions, investigations, proceedings or demands, whether based in contract, tort, implied or express warranty, strict liability, criminal or civil statute or common law of any kind or character, known or unknown, which such Credit Party ever had or now has against Agent, any Lender or any other Released Person which relates, directly or indirectly, to any acts or omissions of Agent, any Lender or any other Released Person relating to the Credit Agreement or any other Loan Document on or prior to the date hereof.

 

[Remainder of Page Intentionally Left Blank; Signature Pages Follow]

 

  3  

 

 

IN WITNESS WHEREOF, each of the undersigned has executed this Agreement as of the date set forth above.

 

  BORROWERS :  
     
  IGI LABORATORIES, INC.
       
  By: /s/ Jenniffer Collins  
  Name: Jenniffer Collins  
  Title: Chief Financial Officer  
     
  IGEN INC.  
       
  By: /s/ Jenniffer Collins  
  Name: Jenniffer Collins  
  Title: Chief Financial Officer  
     
  IGI LABS, INC.  
       
  By: /s/ Jenniffer Collins  
  Name: Jenniffer Collins  
  Title: Chief Financial Officer  

 

Third Amendment to Credit Agreement

 

 

 

 

  AGENT AND LENDERS:  
     
  GENERAL ELECTRIC CAPITAL CORPORATION,
  as Agent  
       
  By: /s/ Keith Bird  
  Name: Keith Bird  
  Title: Its Duly Authorized Signatory  

 

Third Amendment to Credit Agreement

 

 

 

 

  GE CAPITAL BANK ,  
  as a Lender  
       
  By: /s/ Paul Sleet  
  Name: Paul Sleet  
  Title: Duly Authorized Signatory  

 

Third Amendment to Credit Agreement

 

 

 

 

Exhibit 10.3

 

ASSET PURCHASE AGREEMENT

 

among

 

CONCORDIA PHARMACEUTICALS INC., S.À.R.L., BARBADOS BRANCH,

 

TELIGENT JERSEY LIMITED

 

and

 

IGI LABORATORIES, INC.

 

DATED AS OF OCTOBER 5, 2015

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

TABLE OF CONTENTS

 

    Page
     
ARTICLE I
 
DEFINITIONS AND TERMS
     
Section 1.1 Definitions 1
Section 1.2 Other Definitional Provisions 9
     
ARTICLE II
 
PURCHASE AND SALE
     
Section 2.1 Purchase and Sale of Assets 10
Section 2.2 Consents 10
Section 2.3 Excluded Assets 11
Section 2.4 Assumption of Liabilities 12
Section 2.5 Excluded Liabilities 13
     
ARTICLE III
 
CLOSING
     
Section 3.1 Purchase Price 13
Section 3.2 Closing 13
Section 3.3 Closing Deliverables 14
     
ARTICLE IV
 
REPRESENTATIONS AND WARRANTIES OF SELLER
     
Section 4.1 Organization and Qualification 15
Section 4.2 Authority; Binding Effect. 15
Section 4.3 No Conflicts 15
Section 4.4 Governmental Authorization; Consents 16
Section 4.5 Absence of Material Changes 16
Section 4.6 No Litigation 16
Section 4.7 Compliance with Laws. 17
Section 4.8 Product Registrations; Regulatory Compliance. 17
Section 4.9 Intellectual Property. 18
Section 4.10 Assets 19
Section 4.11 Contracts 19
Section 4.12 Inventory 20
Section 4.13 Product Liability 20
Section 4.14 Brokers 21
Section 4.15 Taxes 21
Section 4.16 No Other Representations or Warranties 22

 

- i

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

ARTICLE V
 
REPRESENTATIONS AND WARRANTIES OF PURCHASER
     
Section 5.1 Organization and Qualification 22
Section 5.2 Authority; Binding Effect 22
Section 5.3 No Conflicts; Consents 23
Section 5.4 Governmental Authorization 23
Section 5.5 No Litigation 24
Section 5.6 Condition of the Purchased Assets 24
Section 5.7 Brokers 25
     
ARTICLE VI
 
COVENANTS
     
Section 6.1 Bulk Transfer Laws. 25
Section 6.2 Books and Records 26
Section 6.3 Insurance 26
Section 6.4 Trade Notification 26
Section 6.5 Tax Allocation 27
Section 6.6 Tax Treatment 27
Section 6.7 FDA Letters. 27
Section 6.8 Regulatory Responsibilities 28
Section 6.9 Cooperating 29
Section 6.10 Further Assurances 29
Section 6.11 Wrong Pockets 30
Section 6.12 Know-How License 30
Section 6.13 IGI Purchaser Guarantee 31
     
ARTICLE VII
 
INDEMNIFICATION
     
Section 7.1 Indemnification by Seller 31
Section 7.2 Indemnification by IGI Purchaser 32
Section 7.3 Notice of Claims 32
Section 7.4 Third Party Claims 33
Section 7.5 Expiration 34
Section 7.6 Limitations on Indemnification. 34
Section 7.7 Losses Net of Insurance, Etc. 35
Section 7.8 Reimbursement 36
Section 7.9 Sole Remedy/Waiver 36
     
ARTICLE VIII
 
MISCELLANEOUS
     
Section 8.1 Notices 36

 

- ii -

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 8.2 Amendment; Waiver 38
Section 8.3 Successors and Assigns; No Third Party Beneficiaries 38
Section 8.4 Entire Agreement 39
Section 8.5 Parties in Interest 39
Section 8.6 Confidential Information 39
Section 8.7 Expenses, Transfer Taxes and Property Taxes 40
Section 8.8 Schedules 40
Section 8.9 Governing Law; Jurisdiction 41
Section 8.10 WAIVER OF JURY TRIAL 42
Section 8.11 Counterparts 42
Section 8.12 Headings 43
Section 8.13 Severability 43
Section 8.14 Mutual Drafting 44

 

SCHEDULES OTHER THAN DISCLOSURE SCHEDULES

 

1.1(a)   IGI Purchased Assets
1.1(b)   Intellectual Property Licenses
1.1(c)   Knowledge of Purchaser
1.1(d)   Knowledge of Seller
1.1(e)   Products and Product Registrations
1.1(f)   Retained Products
1.1(g)   Shared Contracts
1.1(h)   TJL Purchased Assets
2.1(i)   Contracts Solely Relating to the Products
2.1(ii)   Purchase Orders

 

EXHIBITS

 

EXHIBIT A   IGI Assignment and Assumption Agreement
EXHIBIT B   IGI Bill of Sale
EXHIBIT C   Labeled Inventory Partial Assignment Agreement
EXHIBIT D   Receipt
EXHIBIT E   Teligent Assignment and Assumption Agreement
EXHIBIT F   Teligent Bill of Sale
EXHIBIT G   Transition Services Agreement
EXHIBIT H   List of Instruments and Documents Delivered at Closing by Seller
EXHIBIT I   List of Instruments and Documents Delivered at Closing by IGI Purchaser
EXHIBIT J   List of Instruments and Documents Delivered at Closing by TJL Purchaser

 

- iii

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

ASSET PURCHASE AGREEMENT

 

This Asset Purchase Agreement is made and entered into as of the 5 th day of October 2015, by and between Concordia Pharmaceuticals Inc., S.à.r.l., Barbados Branch, the Barbados branch of Concordia Pharmaceuticals Inc., a société à responsabilité limitée (private limited liability company) duly organized and validly existing under the laws of the Grand-Duchy of Luxembourg, with a share capital of USD 5,000,000, having its registered office at 8-10 Avenue de la Gare – L-2610 Luxembourg, Grand-Duchy of Luxembourg and in the process of registration with the Registre de Commerce et des Sociétés , Luxembourg (Luxembourg Trade and Companies Register) (formerly known as and successor-in-interest to Concordia Pharmaceuticals Inc., an international business company organized under the laws of Barbados) (“ Seller ”), on the one hand, and IGI Laboratories, Inc., a corporation organized under the laws of Delaware (“ IGI Purchaser ”), and Teligent Jersey Limited, a company incorporated in Jersey with registration number 119574 and having its registered office at 47 Esplanade, St. Helier, Jersey JE1 0BD (“ TJL Purchaser ,” and together with IGI Purchaser, “ Purchasers ”, and each, a “ Purchaser ”), on the other hand.

 

WITNESSETH:

 

WHEREAS , Seller desires to sell, transfer and assign to IGI Purchaser, and IGI Purchaser desires to acquire and assume from Seller, all of the Inventory, the IGI Assumed Contracts and all of the Assumed Liabilities associated therewith, all as more specifically provided herein; and

 

WHEREAS , Seller desires to sell, transfer and assign to TJL Purchaser, and TJL Purchaser desires to acquire and assume from Seller, all of the TJL Purchased Assets, and all of the Assumed Liabilities associated therewith, all as more specifically provided herein.

 

NOW , THEREFORE , in consideration of the foregoing and the representations, warranties, covenants and agreements contained herein, the parties hereby agree as follows:

 

ARTICLE I

 

DEFINITIONS AND TERMS

 

Section 1.1         Definitions . As used in this Agreement, the following terms shall have the meanings set forth or as referenced below:

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Affiliate ” means with respect to any Person, any other Person directly or indirectly controlling, controlled by, or under common control with, such Person at any time during the period for which the determination of affiliation is being made.

 

Agreement ” means this Agreement, as amended or supplemented from time to time in accordance with the terms hereof.

 

Ancillary Agreements ” means, collectively, the IGI Assignment and Assumption Agreement, the TJL Assignment and Assumption Agreement, the IGI Bill of Sale, the TJL Bill of Sale, the Labeled Inventory Partial Assignment Agreement, the Transition Services Agreement and each other agreement, document, instrument and/or certificate to be executed by Purchasers or Seller in connection with the transactions contemplated by this Agreement.

 

Assignment Consent ” has the meaning set forth in Section 2.2(a) .

 

Assumed Contracts ” means, with respect to IGI Purchaser, the IGI Assumed Contracts, with respect to TJL Purchaser, the TJL Assumed Contracts, and with respect to Seller, the IGI Assumed Contracts and the TJL Assumed Contracts.

 

Assumed Liabilities ” has the meaning set forth in Section 2.4 .

 

Books and Records ” means financial, accounting, operating data and records, including (a) inventory records, product specifications, customer lists, cost and pricing information, supplier lists, customer literature, quality control records and manuals; (b) product development files, and records and stability and clinical studies; (c) data relevant to the manufacturing of a Product; (d) Regulatory Documentation; and (e) Promotional Materials, in each of the foregoing clauses (a) through (e), solely to the extent (i) in Seller’s physical possession or control and (ii) of the portions thereof exclusively related to the Purchased Assets (including all data and other information stored on discs, tapes or other media); provided , however , that Seller may retain a copy of (A) all such Books and Records to the extent necessary for reporting, regulatory, Tax, accounting or litigation purposes, (B) any correspondence to, with or from any Person in connection with the Excluded Assets, the Excluded Liabilities or as otherwise required by applicable Law and (C) any books and records relating to the Excluded Assets or Excluded Liabilities.

 

Business Day ” means any day other than a Saturday, a Sunday or a day on which commercial banks in New York City or the parish of St. Michael, Barbados, are authorized or obligated by applicable law or executive order to close.

 

Cap ” has the meaning set forth in Section 7.6(b) .

 

Closing ” means the closing of the transactions described in Article III pursuant to and in accordance with the terms of this Agreement.

 

Closing Date ” has the meaning set forth in Section 3.2 .

 

Confidentiality Agreement ” means the Confidentiality Agreement between Seller and Purchaser, dated July 9, 2015, as amended or supplemented from time to time.

- 2

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Consideration ” has the meaning set forth in Section 6.5 .

 

Contract ” means any binding written contract, agreement, lease, license or commitment.

 

Copyrights ” means all copyrights and registrations and applications therefor, and all renewals, extensions, restorations and reversions thereof.

 

Distribution Activities ” has the meaning set forth in Section 6.2 .

 

Excluded Assets ” has the meaning set forth in Section 2.3(a) .

 

Excluded Liabilities ” has the meaning set forth in Section 2.5 .

 

Exploitation ” (including, with correlative meanings, the terms “ Exploit ” and “ Exploited ”) means sale.

 

FDA ” means the U.S. Food and Drug Administration or a successor thereto.

 

FDCA ” means the U.S. Federal Food, Drug and Cosmetic Act of 1938, as amended and implementing regulations.

 

FTC ” means the U.S. Federal Trade Commission or a successor thereto.

 

Fundamental Representations ” has the meaning set forth in Section 7.5 .

 

Governmental Authority ” means any supranational, national, federal, state or local judicial, legislative, executive or regulatory authority.

 

Governmental Order ” means any order, writ, judgment, injunction, decree, stipulation, determination or award entered by or with any Governmental Authority.

 

Health Care Laws ” means all applicable health care Laws and Governmental Orders, including the federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), the Anti-Inducement Law, 42 U.S.C. § 1320a-7a(a)(5), the civil False Claims Act, 31 U.S.C. §§ 3729 et seq. , the administrative False Claims Law, 42 U.S.C. § 1320a-7b(a), the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. §§ 1320d et seq. , as amended by the Health Information Technology for Economic and Clinical Health Act, 42 U.S.C. §§ 17921 et seq. , the exclusion Laws, 42 U.S.C. § 1320a-7, the FDCA and related FDA regulations, Medicare, Title XVIII of the Social Security Act, and Medicaid, Title XIX of the Social Security Act.

 

IGI Assignment and Assumption Agreement ” means the assignment and assumption agreement, dated as of the Closing Date, attached as Exhibit A to this Agreement.

 

IGI Assumed Contracts ” has the meaning set forth in Schedule 1.1(a) .

 

- 3

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

IGI Bill of Sale ” means the bill of sale, dated as of the Closing Date, attached as Exhibit B of this Agreement.

 

IGI Purchase Orders ” has the meaning set forth in Schedule 1.1(a) .

 

IGI Purchaser ” has the meaning set forth in the Preamble of this Agreement.

 

IGI Purchased Assets ” means the assets set forth on Schedule 1.1(a) , it being understood that the IGI Purchased Assets do not include the Excluded Assets.

 

Indemnified Party ” has the meaning set forth in Section 7.3(a) .

 

Indemnifying Party ” has the meaning set forth in Section 7.3(a) .

 

Indemnity Threshold ” has the meaning set forth in Section 7.6(a) .

 

Independent Accountant ” has the meaning set forth in Section 6.5 .

 

Intellectual Property ” means all worldwide Copyrights, Patents and Trademarks, and Trade Secrets.

 

Intellectual Property Licenses ” means the licenses identified in Schedule 1.1(b) .

 

Inventory ” means (a) all raw materials, active pharmaceutical ingredients, excipients, intermediaries, reagents, supplies, packaging, work in progress and finished goods owned by Seller and (b) finished goods, whether imported, procured from contract manufacturers, or otherwise, that are in Seller’s physical possession or control, in each case, as of the Closing Date and that are exclusively related to the Products and are set forth in Section 4.12 of the Seller Disclosure Schedule.

 

Inventory Value ” means the value of the Inventory as of the Closing Date, which the Parties hereby agree is $1,000,000.

 

Knowledge of Purchaser ” means the current actual (but not constructive or imputed) knowledge, without inquiry or investigation, of any of the individuals listed on Schedule 1.1(c) .

 

Knowledge of Seller ” means the current actual (but not constructive or imputed) knowledge, after reasonable inquiry, of any of the individuals listed on Schedule 1.1(d) .

 

Labeled Inventory Partial Assignment Agreement ” means the Labeled Inventory Partial Assignment Agreement, dated as of the Closing Date, by and among Seller, IGI Purchaser, Covis Pharma S.à.r.l., Zug Branch, Covis Injectables S.à.r.l., Zug Branch, and Covis Pharmaceuticals, Inc., attached as Exhibit C .

 

Labeling ” (and the correlative terms “ Label ” and “ Labeled ”) shall be as defined in Section 201(m) of the FDCA (21 U.S.C. § 321(m)) as implemented by 21 CFR Part 201, and other comparable foreign Law relating to the subject matter thereof, including the applicable Product’s label, packaging and package inserts accompanying such Product, and any other written, printed, or graphic materials accompanying such Product, including patient instructions or patient indication guides.

 

- 4

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Laws ” means any federal, state, foreign or local law, common law, statute, ordinance, rule, regulation, code or Governmental Order.

 

Liabilities ” means any and all Losses, debts, liabilities and obligations, whether accrued or unaccrued, fixed, known or unknown, absolute or contingent, matured or unmatured or determined or determinable.

 

Licensed Intellectual Property ” means all of the Intellectual Property that is licensed to Seller under the Intellectual Property Licenses.

 

Licensed Know-How ” means all Trade Secret Rights that are (a) owned by Seller or licensable by Seller under Section 6.18 of the Asset Purchase Agreement, dated March 9, 2015, by and among Covis Pharma S.à.r.l., Zug Branch, Covis Injectables S.à.r.l., Zug Branch, Concordia Pharmaceuticals Inc., Concordia Healthcare Corp. and Covis Pharma Holdings S.à.r.l., in each case immediately after the Closing and (b) used in or necessary to Exploit the Products.

 

Licenses ” means all licenses, permits, certificates and other authorizations and approvals pertaining to the Products required by applicable Laws.

 

Liens ” means any lien, security interest, mortgage, charge or similar encumbrance.

 

Loss ” or “ Losses ” has the meaning set forth in Section 7.1 .

 

Material Adverse Effect ” means an effect, event, fact, occurrence, development, condition or change that individually or considered together with all other effects, events, facts, occurrences, developments, conditions or changes (i) has or would reasonably be expected to have a materially adverse effect on the Purchased Assets or their Exploitation, taken as a whole, or (ii) prevents or materially impedes or delays the consummation by Seller of the transactions contemplated by this Agreement or the Ancillary Agreements, but does not include any change or adverse effect caused by (a) changes in conditions generally affecting (I) the healthcare industry or (II) the United States economy as a whole (whether regulatory, legislative or political conditions or securities, credit, financial or other capital markets conditions); (b) the announcement of this Agreement and the transactions contemplated by this Agreement, (c) any failure to meet any internal or publicly available projections, forecasts, estimates or predictions with respect to the Purchased Assets or their Exploitation or (d) changes in geopolitical conditions, the outbreak or escalation of hostilities, any acts of war, sabotage, terrorism or military actions, or any natural disasters or calamities; provided , however , that any effect, event, fact, occurrence, development, condition or change referred to in clause (a) or in clause (d) above shall be taken into account in determining whether a Material Adverse Effect has occurred or would reasonably be expected to occur to the extent that such effect, event, fact, occurrence, development, condition or change has a disproportionate effect on the Purchased Assets or their Exploitation relative to other Persons engaged in similarly situated businesses, in the industries in which Seller operates.

 

- 5

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

NDA ” means a new drug application.

 

NDC Number ” means the unique identifying number assigned to a drug product, including the labeler code, product code and package code, in connection with the drug listing requirements of Section 510(j) of the FDCA and applicable FDA rules and regulations.

 

Non-Assignable Asset ” has the meaning set forth in Section 2.2(a) .

 

Party ” means each of IGI Purchaser, TJL Purchaser and Seller.

 

Patents ” means all patents and patent applications, together with any extensions, supplemental protection certificates, reexaminations, reissues, divisions and continuations and foreign counterparts claiming priority to any of the foregoing.

 

Permitted Encumbrances ” means (i) Liens approved in writing by Purchasers; (ii) statutory Liens arising by operation of Law with respect to a Liability incurred in the ordinary course of business that is not delinquent or is being contested in good faith by appropriate proceedings; (iii) Liens and other imperfections of title that do not materially detract from the value or materially impair the use of the property subject thereto; (iv) Liens for Taxes not yet subject to penalties for nonpayment or that are being contested in good faith by appropriate proceedings; (v) mechanics’, materialmens’, carriers’, workmens’, warehousemens’, repairmens’, landlords’ or other like Liens and security obligations that are not delinquent and (vi) Liens arising in connection with the transactions contemplated by this Agreement.

 

Person ” means an individual, a limited liability company, joint venture, a corporation, a partnership, an association, a trust, a division or operating group of any of the foregoing or any other entity or organization.

 

Post-Closing Tax Period ” means any Tax period (or portion thereof) beginning after the Closing Date.

 

Pre-Closing Tax Period ” means any Tax period (or portion thereof) ending on or before the Closing Date.

 

Proceeding ” has the meaning set forth in Section 8.9(b) .

 

Product Registrations means the authorizations from applicable Governmental Authorities (including NDAs) and comparable regulatory filings (i) granted to Seller by, or applications therefor pending with, any applicable Governmental Authority (including applications that are in the process of being prepared by Sellers) and (ii) acquired by Seller from a third party, in each case required to manufacture, commercialize, develop, package, Label, store, use, market, import, export, distribute and/or sell any of the Products listed on Schedule 1.1(e) .

 

- 6

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Products ” means the products listed under the heading “Products” in the table set forth on Schedule 1.1(e) .

 

Promotional Materials ” means, collectively, all marketing materials, marketing research data, customer and sales information, product literature, promotional materials and data, advertising and display materials (including all underlying designs, samples, charts, diagrams, photos and electronic files related to the foregoing) and all training materials, in each case in whatever form or medium ( e.g. , audio, visual, digital or print), to the extent (i) in Seller’s physical possession or control and (ii) of the portions thereof exclusively related to the Purchased Assets.

 

Property Taxes ” has the meaning set forth in Section 8.7(b) .

 

Purchase Orders ” means, with respect to IGI Purchaser, the IGI Purchase Orders, and with respect to TJL Purchaser, the TJL Purchase Orders.

 

Purchase Price ” has the meaning set forth in Section 3.1(a) .

 

Purchased Assets ” means, with respect to IGI Purchaser, the IGI Purchased Assets, with respect to TJL Purchaser, the TJL Purchased Assets, and with respect to Seller, the IGI Purchased Assets and the TJL Purchased Assets, it being understood that the Purchased Assets do not include the Excluded Assets.

 

Purchasers ” has the meaning set forth in the Preamble of this Agreement.

 

Purchaser FDA Transfer Letter ” means each of the letters from IGI Purchaser and/or TJL Purchaser to the FDA indicating TJL Purchaser’s acquisition of each Product Registration from Seller and acceptance of the associated regulatory responsibilities.

 

Purchaser Indemnified Parties ” has the meaning set forth in Section 7.1 .

 

Receipt ” means the receipt for payment of the Purchase Price at Closing, dated as of the Closing Date, attached as Exhibit D hereto.

 

Regulatory Documentation ” means (a) all regulatory filings and supporting documents (including copies of all correspondence between Seller and the applicable Governmental Authority), chemistry, manufacturing and controls data and documentation, preclinical and clinical studies and tests, (b) the NDAs and foreign equivalents and all regulatory files related thereto, current approved Labeling and any other existing files and dossiers, including the underlying data or information used to support, maintain or obtain marketing authorization of the underlying Product, (c) all records maintained under record keeping or reporting Laws of the FDA or any other Governmental Authority, including FDA warning letters, FDA notices of adverse finding letters, FDA audit reports (including any responses to such reports), any correspondence with any office at the FDA, periodic safety update reports, complaint files, and annual product quality reviews, (d) the complete complaint, adverse event and medical inquiry filings with respect to the Products as required by applicable Laws and related to the Purchased Assets, including the Product Registrations and (e) all equivalent, comparable or analogous documentation with respect to any other country outside the United States, in each of the foregoing clauses (a) through (e), solely to the extent (i) in Seller’s physical possession or control and (ii) exclusively related to the Purchased Assets.

 

- 7

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Representatives ” means, with respect to any Person, the directors, officers, managers, employees, independent contractors, authorized agents or consultants of such Person.

 

Retained Products ” means all products owned by Seller other than the Products, including those set forth on Schedule 1.1(f) .

 

Seller ” has the meaning set forth in the Preamble of this Agreement.

 

Seller Disclosure Schedule ” has the meaning set forth in Article IV .

 

Seller FDA Transfer Letter ” means each of the letters from Seller to the FDA indicating Seller’s transfer of the ownership of each Product Registration to Purchaser.

 

Seller Indemnified Parties ” has the meaning set forth in Section 7.2 .

 

Shared Contract ” means any Contract binding upon Seller that relates to one or more Products and to one or more Retained Products and is set forth on Schedule 1.1(g) .

 

Tax ” or “ Taxes ” means any and all federal, state, local, foreign and other income, gross receipts, sales, use, value-added, production, ad valorem, transfer, franchise, registration, profits, license, lease, service, service use, withholding, payroll, employment, unemployment, estimated, excise, severance, environmental, stamp, occupation, premium, property (real or personal), real property gains, windfall profits, customs, duties or other taxes, fees, assessments or charges of any kind whatsoever, together with any interest, additions or penalties with respect thereto and any interest in respect of such interest, additions or penalties determined or assessed by a Taxing Authority.

 

Tax Return ” includes any return, report, declaration, election, notice, filing, form, statement and other document (whether in tangible, electronic or other form) and including any amendment, schedule, attachment, supplement, appendix or exhibit thereto, made, prepared, filed or required to be made, prepared or filed by applicable Laws relating to Taxes.

 

Taxing Authority ” means any Governmental Authority, body or instrumentality exercising any authority to impose, regulate or administer the imposition of Taxes.

 

TJL Assignment and Assumption Agreement ” means the assignment and assumption agreement, dated as of the Closing Date, attached as Exhibit E to this Agreement.

 

TJL Assumed Contracts ” has the meaning set forth in Schedule 1.1(h) .

 

TJL Bill of Sale ” means the bill of sale, dated as of the Closing Date, attached as Exhibit F of this Agreement.

 

- 8

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

TJL Purchase Orders ” has the meaning set forth in Schedule 1.1(h) .

 

TJL Purchased Assets ” means the assets set forth on Schedule 1.1(h) , it being understood that the TJL Purchased Assets do not include the Excluded Assets.

 

TJL Purchaser ” has the meaning set forth in the Preamble of this Agreement.

 

Third Party Claim ” has the meaning set forth in Section 7.4(a) .

 

Trade Secret ” means a “Trade Secret” as such term is defined in the Uniform Trade Secrets Act, published in 1979 and amended in 1985.

 

Trade Secret Rights ” means all rights, anywhere in the world, in or to trade secrets, inventions, discoveries, formulae, know-how, ideas, processes, designs, data, databases and other proprietary information, in each case, whether or not patentable or copyrightable.

 

Trademarks ” means all  trademarks, service marks, internet domain names, trade dress, trade names, all applications and registrations for the foregoing, and all goodwill associated therewith and symbolized thereby, including all renewals of the same.

 

Transfer Taxes ” means any federal, state, county, local, foreign and other sales, use, transfer, value added, conveyance, documentary transfer, stamp, recording, registration or other similar Tax (including any notarial fee) imposed in connection with, or otherwise relating to, the transactions contemplated by this Agreement or the recording of any sale, transfer or assignment of property (or any interest therein) effected pursuant to this Agreement, but such term shall not include Taxes imposed on or measured by net income of Seller or Purchasers, or imposed in lieu of such a Tax.

 

Transition Services Agreement ” means the Transition Services Agreement, dated as of the Closing Date, by and between Seller and Purchasers, attached as Exhibit G .

 

Section 1.2         Other Definitional Provisions . (a) The words “hereof”, “herein”, “hereto” and “hereunder” and words of similar import, when used in this Agreement, shall refer to this Agreement as a whole and not to any particular provision of this Agreement.

 

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

 

- 9

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

(c)         The terms “dollars” and “$” shall mean United States of America dollars.

 

(d)         The term “including” shall mean “including, without limitation.”

 

(e)         When a reference is made in this Agreement to an Article, a Section, an Exhibit or a Schedule, such reference shall be to an Article of, a Section of, an Exhibit to or a Schedule to, this Agreement unless otherwise indicated.

 

ARTICLE II

 

PURCHASE AND SALE

 

Section 2.1         Purchase and Sale of Assets . Upon the terms and subject to the conditions set forth herein and subject to Section 2.2 , at the Closing, Seller shall sell, convey, assign, transfer and deliver to each Purchaser, as applicable, and each Purchaser, as applicable, shall purchase, acquire and accept from Seller, free and clear of all Liens, other than Permitted Encumbrances, all of Seller’s right, title and interest in, to and under the Purchased Assets.

 

Section 2.2         Consents . (a) Notwithstanding Section 2.1 , if any of the Assumed Contracts or other Purchased Assets are not assignable or transferable (each, a “ Non-Assignable Asset ”) without the consent of, or waiver by, a third party (each, an “ Assignment Consent ”), either as a result of the provisions thereof or applicable Laws, and any of such Assignment Consents are not obtained by Seller on or prior to the Closing Date, (i) Seller shall continue its efforts pursuant to Section 2.2(b) to obtain the Assignment Consents after Closing, (ii) this Agreement and the related instruments of transfer shall not constitute an assignment or transfer of such Non-Assignable Assets and (iii) the applicable Purchaser shall not assume Seller’s rights or obligations under such Non-Assignable Asset (and such Non-Assignable Asset shall not be included in the Purchased Assets).

 

- 10

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

(b)         Seller shall use reasonable best efforts from and after the Closing to obtain the consent of the counterparty to any such Non-Assignable Asset to the assignment (in whole, or with respect to any Shared Contract, in part) of such Non-Assignable Asset to the applicable Purchaser or to otherwise cooperate with such Purchaser to enter into a reasonable and lawful arrangement, including a new Contract with such Purchaser on substantially the same terms as exist under the applicable Non-Assignable Asset, to provide such Purchaser substantially equivalent economic benefits as it would have obtained to the extent the Non-Assignable Asset had been a Purchased Asset for a period not to exceed the remaining term or useful life of such Non-Assignable Asset, including subcontracting, sublicensing or subleasing any or all of Seller’s rights and obligations with respect to such Non-Assignable Asset to the extent related to the Products, to such Purchaser, but only to the extent such cooperation would not result in a breach of the terms of such Non-Assignable Asset and is not prohibited under applicable Law ( it being understood that neither Seller nor such Purchaser shall be required to expend money, commence any litigation or offer or grant any accommodation (financial or otherwise) to any third party in connection with its obligations pursuant to this Section 2.2 ); provided that, in any such alternative arrangement, such Purchaser shall, solely to the extent related to the Products, (i) be entitled to all benefits thereof, economic or otherwise, (ii) pay, perform or discharge when due any Liabilities arising thereunder after the Closing but not transferred to such Purchaser pursuant to this Section 2.2 , and provide to Seller all support reasonably necessary or appropriate to enable Seller to perform its obligations thereunder, (iii) bear all Taxes with respect thereto or arising therefrom and (iv) shall, severally and jointly with such other Purchaser, indemnify Seller in respect of all Liabilities of Seller in respect of each such arrangement and underlying Purchased Asset, to the extent such Liabilities have been incurred before the [***] ([***])[***] anniversary of the Closing. If and when such consents or approvals are obtained or such other required actions have been taken, the assignment of such Non-Assignable Asset, to the extent related to the Products, to the applicable Purchaser will be effected in accordance with the terms of this Agreement, and such Non-Assignable Asset will be deemed to be a Purchased Asset and the obligations and liabilities related thereto will be deemed Assumed Liabilities, in each case, for all purposes of this Agreement.

 

Section 2.3         Excluded Assets . (a) Seller and Purchasers expressly agree and acknowledge that the Purchased Assets will not include any assets of any kind, nature, character or description (whether real, personal or mixed, whether tangible or intangible, whether absolute, accrued, contingent, fixed or otherwise, and wherever situated) that are not expressly included within the definition of Purchased Assets (the “ Excluded Assets ”).

 

- 11

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

(b)         After the Closing Date, Purchasers shall take all actions (or shall cause its Affiliates to take all actions) reasonably requested by Seller to effect the provisions of this Section 2.3 , including the return of any Excluded Assets.

 

Section 2.4         Assumption of Liabilities . Upon the terms and subject to the conditions of this Agreement, each Purchaser agrees, effective at the Closing, to assume and to satisfy and discharge when due the following Liabilities of Seller (all of such Liabilities other than the Excluded Liabilities being herein collectively referred to as the “ Assumed Liabilities ”):

 

(a)         all Liabilities in respect of Products Exploited by or on behalf of Purchasers on or after the Closing, including Liabilities in respect of returns, rebates and chargebacks of Products and, to the extent attributable to the period after the Closing Date, payment of user fees due for the Products under the Prescription Drug User Fee Act, as amended, as further detailed in the Transition Services Agreement;

 

(b)         all Liabilities for Taxes relating to the Purchased Assets or the Products with respect to a Post-Closing Tax Period allocated in accordance with Section 8.7(b) ;

 

(c)         all Liabilities for materials and services relating to the Purchased Assets contracted for by Seller in the ordinary course of business prior to the Closing, but not delivered or supplied until after the Closing, and all Liabilities to customers under the Purchase Orders;

 

(d)         all Liabilities under Assumed Contracts, other than any Liability to the extent arising out of, or resulting from, (i) Liabilities incurred at or prior to Closing, (ii) any event, state of facts, occurrence, circumstance, development or change that arose or existed prior to Closing or (iii) services performed or Products sold under Assumed Contracts prior to the Closing; and

 

(e)         all other Liabilities arising on or after the Closing, solely to the extent arising out of, or relating to, the Purchased Assets or the Products.

 

- 12

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 2.5         Excluded Liabilities . Except to the extent expressly included in the Assumed Liabilities, Purchasers will not assume or be responsible or liable for any (a) Liabilities arising prior to the Closing or (b) Liabilities that relate to acts, events, state of facts, occurrence, circumstances, development, change or conditions that arose or existed prior to the Closing, in each case, of Seller or its Affiliates, including any Liabilities for Taxes with respect to the Pre-Closing Tax Period allocated in accordance with Section 8.7(b) (collectively, the “ Excluded Liabilities ”).

 

ARTICLE III

 

CLOSING

 

Section 3.1         Purchase Price

 

(a)         At the Closing, in consideration of the sale and transfer of the Purchased Assets, Purchasers agree to (x) purchase from Seller the Purchased Assets for an aggregate purchase price consisting of (i) $10,000,000 in cash plus (ii) the Inventory Value (together, the “ Purchase Price ”) and (y) assume, satisfy and discharge when due the Assumed Liabilities.

 

(b)         The Purchase Price shall be paid without reduction for any Transfer Taxes or withholding Taxes imposed by the United States or any state or possession of the United States. Purchasers shall pay the Purchase Price at the Closing in immediately available funds, by wire transfer, the wire instructions for which will be specified in written instructions given by Seller to Purchasers.

 

Section 3.2         Closing . The Closing shall take place at the offices of Sullivan & Cromwell LLP, located at 125 Broad Street, New York, New York 10004, at 10:00 a.m. (New York City time) on the date of this Agreement or at such other time and place as the Parties may mutually agree in writing. The date on which the Closing occurs is called the “ Closing Date .” The Closing shall be deemed to occur and be effective as of the opening of business on the Closing Date.

 

- 13

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 3.3         Closing Deliverables .

 

(a)         At the Closing, Seller shall deliver or cause to be delivered to Purchasers the instruments and documents set forth in Exhibit H . Promptly after the Closing, but no later than [***] ([***])[***] following the Closing, Seller shall deliver, or cause to be delivered, to Purchasers physical possession of the Purchased Assets, subject to Section 2.2 and to the extent permitted by applicable Law. With respect to (i) the Inventory, delivery shall, unless the Parties otherwise mutually agree, be made at the following address: 4580 Mendenhall Road, Memphis, Tennessee 38141; and (ii) all Books and Records and related items capable of being delivered in electronic format and all other tangible Purchased Assets, delivery shall, unless the Parties otherwise mutually agree, be made in an electronic medium to the following address: Teligent Jersey Limited, c/o IGI Laboratories, Inc. 105 Lincoln Avenue, Buena, NJ 08310.

 

(b)         At the Closing, each Purchaser, as applicable, shall deliver or cause to be delivered to Seller, the following: (i) the Purchase Price, as provided in Section 3.1 , (ii) the instruments and documents set forth in Exhibit I and (iii) the instruments and documents set forth in Exhibit J .

 

ARTICLE IV

 

REPRESENTATIONS AND WARRANTIES OF SELLER

 

Except as set forth in the corresponding sections or subsections of the disclosure schedule delivered by Seller to Purchasers prior to entering into this Agreement (the “ Seller Disclosure Schedule ”) (it being agreed that disclosure of any item in any section or subsection of the Seller Disclosure Schedule shall be deemed disclosure with respect to any other section or subsection to which the relevance of such item is reasonably apparent on its face), Seller hereby represents and warrants to Purchaser as follows:

 

- 14

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 4.1         Organization and Qualification . Seller is a corporation duly organized, validly existing and in good standing under the Laws of the jurisdiction of its incorporation and is duly qualified or licensed to do business and is in good standing in each jurisdiction in which the concept of good standing is recognized and in which such qualification or licensing is necessary under applicable Laws of such jurisdiction.

 

Section 4.2         Authority; Binding Effect .

 

(a)         Seller has all requisite corporate power and authority to carry on its business as it is now being conducted and to execute and deliver this Agreement and each Ancillary Agreement to which it is a party and to perform its obligations hereunder and thereunder. The execution and delivery by Seller of this Agreement and each such Ancillary Agreement to which it is a party, and the performance by it of its obligations hereunder and thereunder, have been duly authorized by all requisite corporate action. No approval of any Affiliate of Seller, nor any of their respective shareholders is necessary for Seller to execute and deliver this Agreement and each Ancillary Agreement to which it will be a party or perform the transactions contemplated hereby or thereby, other than any such approval that has been obtained and remains in full force and effect.

 

(b)         This Agreement and each Ancillary Agreement has been duly executed and delivered by Seller and constitutes a valid and binding obligation of Seller, in each case enforceable against Seller in accordance with its terms, except as enforcement may be limited by bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium or similar laws affecting creditors’ rights generally or by general principles of equity (regardless of whether enforcement is sought in a proceeding in equity or law).

 

Section 4.3         No Conflicts . The execution, delivery and performance of this Agreement and each Ancillary Agreement by Seller and the consummation of the transactions contemplated hereby and thereby will not (i) violate any provision of the organizational documents of Seller; (ii) subject to the terms of Section 2.2 , conflict with, or result in the breach of, constitute a default under, result in the termination, cancellation or acceleration (whether after the giving of notice or the lapse of time or both) of any right or obligation of Seller under, or to a loss of any benefit to which Seller is entitled under, any Assumed Contract; or (iii) violate or result in a breach of or constitute a default under any Law or other restriction of any Governmental Authority to which Seller is subject; except, with respect to clauses (ii) and (iii), for any violations, breaches, conflicts, defaults, terminations, cancellations or accelerations that have not or would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

 

- 15

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 4.4         Governmental Authorization; Consents . Except as set forth on Section 4.4 of the Seller Disclosure Schedule, the execution, delivery or performance of the obligations under this Agreement or any Ancillary Agreement by Seller or the consummation of the transactions by Seller contemplated hereby or thereby, including the transfer of the Purchased Assets to Purchasers, does not require the consent, approval, waiver or authorizations of, filing with, notices to, or exemption by, any Governmental Authority, except for consents or approvals that the failure to obtain would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

 

Section 4.5         Absence of Material Changes . Except as otherwise contemplated by this Agreement, during the period in which Seller has owned the Purchased Assets to the date of this Agreement, except with respect to the transactions contemplated by this Agreement and the Ancillary Agreements and the sales process with respect to the Purchased Assets by Seller:

 

(a)         Seller operated the Purchased Assets, in all material respects, in the ordinary course of business; and

 

(b)         There has not been any event, fact, occurrence, development, condition or change that, individually or in the aggregate, has had or would reasonably be expected to result in a Material Adverse Effect.

 

- 16

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 4.6         No Litigation . As of the date of this Agreement, there is no Proceeding by or before any Governmental Authority that is pending against or, to the Knowledge of Seller, threatened in writing against Seller with respect to the Purchased Assets. There is no Governmental Order outstanding against Seller relating primarily to the Purchased Assets.

 

Section 4.7         Compliance with Laws .

 

(a)         Seller is conducting, and at all times during the period in which Seller has owned the Purchased Assets, has conducted, its business and operations as it relates to the Purchased Assets and the Products, in compliance in all material respects with all applicable Laws, and is not in material violation or default under any authorization of any Governmental Authority as it relates to the Purchased Assets. At all times during the period Seller has owned the Purchased Assets, all Products sold under the Product Registrations are, and have been, manufactured and marketed in all material respects in compliance with the specifications and standards contained in such Product Registrations and in compliance with all applicable Health Care Laws.

 

(b)         As of the date of this Agreement, Seller possesses and is in compliance with all Licenses necessary for the operation of the Purchased Assets and Exploitation of the Products as currently conducted by Seller.

 

Section 4.8         Product Registrations; Regulatory Compliance .

 

(a)         A true and complete list of Product Registrations is set forth on Schedule 1.1(e) . Seller is the sole and exclusive owner, free and clear of any Liens, except for Permitted Encumbrances, of the Product Registrations required for the conduct of its business as it relates to the Purchased Assets, as currently conducted by Seller, and as of the date of this Agreement, such Product Registrations are valid and in full force and effect. Excluding the Contracts set forth in Section 4.8(a) of the Seller Disclosure Schedule, no right of reference has been granted to any Person with respect to any of the Product Registrations.

 

(b)         Seller has, during the period in which Seller has owned the Purchased Assets, fulfilled and performed, and is performing, all of its material obligations with respect to the Product Registrations, and no event has occurred that allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other impairment of the rights of the holder of any Product Registration. Seller has not received any written notice, letters or other correspondence from the FDA, or any other Governmental Authority or Person (i) contesting any of the Product Registrations or (ii) otherwise alleging any violation of Health Care Laws by Seller. There are no civil, criminal or administrative Proceedings, hearings or other investigations pending or, to the Knowledge of Seller, threatened, and, to the Knowledge of Seller, no event has occurred during the period in which Seller has owned the Purchased Assets that could result in a penalty under or the revocation, cancellation, suspension, non-renewal or adverse modification of any Product Registration.

 

- 17

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

(c)         Seller has completed and filed all material reports, documents, claims, permits and notices required by any Governmental Authority to be filed by it in order to maintain the Product Registrations, including drug registration and listing submissions to the FDA. In each case, as it relates to the Products, to the Knowledge of Seller, no director, officer, employee, or agent of Seller, has made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other Governmental Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) or any similar policy. As it relates to the Products, to the Knowledge of Seller, no director, officer, employee, or agent of Seller has engaged in any conduct that has resulted, or would reasonably be expected to result, in debarments under 21 U.S.C. § 335a(a) or any similar Laws. As it relates to the Products, to the Knowledge of Seller, neither Seller nor any of its officers, employees, agents or distributors has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program.

 

(d)         Seller has not voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, nor, to the Knowledge of Seller, do any circumstances exist that are reasonably likely to give rise to, any recall, field alerts, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, safety alert, or other notice or action relating to an alleged lack of safety, efficacy or regulatory compliance of any Product.

 

(e)         Seller has not received any written notice that any Governmental Authority has (i) commenced, or threatened to initiate, any action to request the recall of any Product sold or intended to be sold by Seller or alleging any violations of any federal, state or local or any payor “fraud and abuse,” consumer protection and false claims statutes and regulations or any pricing or rebate reporting requirements, (ii) commenced, or threatened to initiate, any action to enjoin manufacture or distribution of any Product sold or intended to be sold by Seller or (iii) issued any demand letter, finding of deficiency or non-compliance or adverse inspection report in respect of any Product.

 

Section 4.9         Intellectual Property .

 

(a)         As of the date of this Agreement, to the Knowledge of Seller, (i) there is no action or proceeding pending, or any notice of any objection or claim asserted in writing or threatened by any Person, with respect to or challenging the ownership, validity or enforceability of any Licensed Intellectual Property, (ii) the rights of Seller under each Intellectual Property License are free and clear of any Liens, other than Permitted Encumbrances and the terms and conditions of each such Intellectual Property License, and (iii) none of the Licensed Intellectual Property has been since September 1, 2012, or is, the subject of (A) any pending or, to the Knowledge of Seller, threatened in writing material adverse claim, judgment, injunction, order, decree or agreement restricting its use in connection with any Product, or (B) any other pending or, to the Knowledge of Seller, threatened in writing material litigation or claim of infringement.

 

- 18

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

(b)         To the Knowledge of Seller, the manufacture, use and Exploitation of the Products, as performed by or on behalf of Seller as of the date of this Agreement, does not infringe, misappropriate or otherwise violate any Intellectual Property right of any Person.

 

(c)         To the Knowledge of Seller, except as set forth on Schedule 4.9(c) of the Seller Disclosure Schedule, the Licensed Intellectual Property and Purchasers’ other rights under this Agreement are all of the material Intellectual Property necessary for or used by Seller in connection with the manufacture, use and Exploitation of the Products as currently conducted by Seller.

 

(d)         To the Knowledge of Seller, no Person is infringing, misappropriating or otherwise violating any Licensed Intellectual Property.

 

Section 4.10         Assets . Subject to Section 2.2 and other than (i) the services provided to Seller pursuant to the Transition Services Agreement, dated April 21, 2015, by and among Covis Pharma S.à.r.l., Zug Branch, Covis Injectables S.à.r.l., Zug Branch, Covis Pharmaceuticals, Inc. and Seller, and (ii) the items set forth on Section 4.10 of the Seller Disclosure Schedule, as of the date of this Agreement, the Purchased Assets and Purchasers’ rights under this Agreement constitute all of the assets and rights of Seller necessary for Purchasers to manufacture, supply, market, distribute or Exploit the Products immediately after the Closing in substantially the same manner as Seller immediately prior to the Closing. Seller has good and marketable title to each of the Purchased Assets, free and clear of all Liens, other than Permitted Encumbrances.

 

Section 4.11         Contracts . Seller has made available to Purchasers a true, complete and accurate copy of each of the Assumed Contracts, including any and all amendments, supplements or modified thereto or detailed description of any oral Assumed Contracts. Each Assumed Contract is legal, valid, binding and enforceable against Seller (subject to applicable bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium or similar laws affecting creditors’ rights generally or by general principles of equity (regardless of whether enforcement is sought in a proceeding in equity or law)) and is in full force and effect. Neither Seller nor, to the Knowledge of Seller, any other party to an Assumed Contract is in material breach or violation of, or default under, any of the Assumed Contracts, and, to the Knowledge of Seller, no event has occurred that, after the giving of notice or with lapse of time, would constitute a material breach or default under any Assumed Contract by Seller (or, to the Knowledge of Seller, any other party), or result in a termination thereof or would cause or permit the acceleration thereof by another party under any of the Assumed Contracts. There are no material disputes pending or, to the Knowledge of Seller, threatened under any Assumed Contract and, to the Knowledge of Seller, no party has communicated any intention or threat to reduce the prices it will pay pursuant thereto, to terminate or to cancel any Assumed Contract, or has failed to renew or extend the term of any Assumed Contract upon the expiration of any such term.

 

- 19

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 4.12         Inventory . Except as set forth on Section 4.12 of the Seller Disclosure Schedule, the Inventory, as of the Closing Date, (i) shall comply with all applicable specifications in all material respects, (ii) shall have been manufactured in all material respects in accordance with current Good Manufacturing Practices, as set forth in the United States Code of Federal Regulations and the Product Registrations, (iii) shall not be misbranded or adulterated, within the meaning of the FDCA, (iv) shall be saleable in the ordinary course of business and fit for the purpose for which it was procured or manufactured and (v) to the extent the Inventory contains raw materials and work-in-process, such raw materials and work-in-process shall have been manufactured, handled, maintained, packaged and stored at all times and in all material respects in compliance with applicable Laws. The values at which such Inventory is carried in the Books and Records of Seller is consistent with the past business practices of Seller during the period in which it has owned the Purchased Assets.

  

Section 4.13         Product Liability . During the period in which Seller has owned the Purchased Assets, and, to the Knowledge of Seller, since September 1, 2012, no Proceedings or arbitrations related to product liability, including those for consumer fraud and economic loss, have been initiated with respect to the Products and, to the Knowledge of Seller, no such Proceedings or arbitrations have been threatened or filed relating to any of the Products.

 

- 20

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 4.14         Brokers . Other than Bourne Capital Partners, L.L.C., no broker, finder or investment banker is entitled to any brokerage, finder’s or other fee or commission in connection with the transactions contemplated by this Agreement and the Ancillary Agreements based upon arrangements made by or on behalf of Seller. Seller is solely responsible for the fees and expenses of Bourne Capital Partners, L.L.C.

 

Section 4.15         Taxes . (a) With respect to the period beginning on April 21, 2015 and ending on the Closing Date, all material Tax Returns required to be filed by Seller with respect to the Purchased Assets have been or will be filed when due in accordance with all applicable laws; (b) all Taxes shown on such Tax Returns, if any, have been or will be paid in timely fashion; (c) there is no action, suit, proceeding, investigation, audit or claim now pending with respect to any Tax with respect to the Purchased Assets that relates to the period beginning on April 21, 2015 and ending on the Closing Date and that would result in a Lien on the Purchased Assets that would survive the Closing Date; (d) there are no outstanding agreements extending the statutory period of limitation applicable to any claim for, or the period for the collection or assessment of, Taxes with respect to the Purchased Assets that relates to the period beginning on April 21, 2015 and ending on the Closing Date; (e) there are no Liens, other than Permitted Encumbrances, for any Tax on the Purchased Assets that relates to the period beginning on April 21, 2015 and ending on the Closing Date.

 

- 21

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 4.16         No Other Representations or Warranties . EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES EXPRESSLY CONTAINED IN THIS ARTICLE IV (AS MODIFIED BY ANY SCHEDULES HERETO), NEITHER SELLER NOR ANY OTHER PERSON MAKES ANY OTHER EXPRESS OR IMPLIED REPRESENTATION OR WARRANTY WITH RESPECT TO SELLER, THE PURCHASED ASSETS OR THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT, THE ANCILLARY AGREEMENTS, THE ASSUMED LIABILITIES AND ANY OTHER RIGHTS OR OBLIGATIONS TO BE TRANSFERRED HEREUNDER OR PURSUANT HERETO, AND SELLER DISCLAIMS ANY OTHER REPRESENTATIONS OR WARRANTIES, WHETHER MADE BY SELLER OR ANY OF ITS AFFILIATES OR REPRESENTATIVES. SELLER MAKES NO REPRESENTATIONS OR WARRANTIES TO PURCHASERS REGARDING THE PROBABLE SUCCESS OR PROFITABILITY OF THE PURCHASED ASSETS OR THE PRODUCTS.

 

ARTICLE V

 

REPRESENTATIONS AND WARRANTIES OF PURCHASER

 

Each Purchaser hereby represents and warrants to Seller, as to itself only, as follows:

 

Section 5.1         Organization and Qualification . Such Purchaser is a corporation or company duly organized, validly existing and in good standing under the Laws of its respective jurisdiction and is duly qualified or licensed to do business and is in good standing in each jurisdiction in which the concept of good standing is recognized.

 

Section 5.2         Authority; Binding Effect . (a) Such Purchaser has all requisite corporate power and authority to carry on its business as it is now being conducted and to execute and deliver this Agreement and each Ancillary Agreement to which it is a party and to perform its obligations hereunder and thereunder. The execution and delivery by such Purchaser of this Agreement and each such Ancillary Agreement to which it is a party, and the performance by it of its obligations hereunder and thereunder, have been duly authorized by all requisite corporate action.

 

- 22

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

(b)         This Agreement and each Ancillary Agreement has been duly executed and delivered by such Purchaser and constitutes a valid and binding obligation of such Purchaser, in each case enforceable against such Purchaser in accordance with its terms, except as enforcement may be limited by bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium or similar laws affecting creditors’ rights generally or by general principles of equity (regardless of whether enforcement is sought in a proceeding in equity or law).

 

Section 5.3         No Conflicts; Consents . The execution, delivery and performance of this Agreement and each Ancillary Agreement by such Purchaser and the consummation of the transactions contemplated hereby and thereby will not (i) violate any provision of the organizational documents of such Purchaser; (ii) conflict with, or result in a breach of, constitute a default under, result in the termination, cancellation or acceleration (whether after the giving of notice or the lapse of time or both) of any term or provision of any Contract to which such Purchaser and/or any of its Affiliates is a party or is subject; or (iii) violate or result in a breach of or constitute a default under any Law or other restriction of any Governmental Authority to which such Purchaser is subject; except, with respect to clauses (ii) and (iii), for any violations, breaches, conflicts, defaults, terminations, cancellations or accelerations that would not, individually or in the aggregate, reasonably be expected to prevent, materially delay or materially impair such Purchaser’s ability to effect the Closing.

 

Section 5.4         Governmental Authorization . The execution and delivery of this Agreement by such Purchaser does not require the consent or approval of any Governmental Authority, except for consents or approvals that the failure to obtain would not, individually or in the aggregate, reasonably be expected to prevent, materially delay or materially impair such Purchaser’s ability to effect the Closing.

 

- 23

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 5.5         No Litigation . There is no Proceeding by or before any Governmental Authority that is pending or, to the Knowledge of such Purchaser, threatened in writing against such Purchaser that would materially interfere with the ability of such Purchaser to perform its obligations hereunder.

 

Section 5.6         Condition of the Purchased Assets . EXCEPT AS IT MAY APPLY TO CLAIMS BY A PURCHASER FOR FRAUD OR INTENTIONAL MISREPRESENTATION, FOR THE SPECIFIC REPRESENTATIONS AND WARRANTIES EXPRESSLY MADE BY SELLER IN ARTICLE IV OF THIS AGREEMENT AS MODIFIED BY THE SELLER DISCLOSURE SCHEDULE, (I) SUCH PURCHASER ACKNOWLEDGES AND AGREES THAT SELLER IS NOT MAKING AND HAS NOT MADE ANY REPRESENTATION OR WARRANTY, EXPRESSED OR IMPLIED, AT LAW OR IN EQUITY, IN RESPECT OF THE PURCHASED ASSETS, SELLER, SELLER’S AFFILIATES OR ANY OF SELLER’S OR ITS AFFILIATES’ RESPECTIVE BUSINESSES, ASSETS, LIABILITIES, OPERATIONS, PROJECTIONS, FORECASTS, PROSPECTS OR CONDITION (FINANCIAL OR OTHERWISE), INCLUDING WITH RESPECT TO MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OF ANY ASSETS (EXCEPT AS RELATES TO THE REPRESENTATIONS AND WARRANTIES REGARDING INVENTORY IN SECTION 4.12 OF THIS AGREEMENT), THE NATURE OR EXTENT OF ANY LIABILITIES OR THE PROSPECTS OF THE PURCHASED ASSETS OR THE PRODUCTS; (II) SUCH PURCHASER SPECIFICALLY DISCLAIMS THAT IT IS RELYING UPON OR HAS RELIED UPON ANY REPRESENTATIONS, WARRANTIES OR AGREEMENTS THAT MAY HAVE BEEN MADE BY ANY PERSON AND THAT ARE NOT SPECIFICALLY SET FORTH IN THIS AGREEMENT AND SUBJECT TO THE LIMITED REMEDIES HEREIN PROVIDED, AND ACKNOWLEDGES AND AGREES THAT SELLER HAS SPECIFICALLY DISCLAIMED AND DOES HEREBY SPECIFICALLY DISCLAIM ANY SUCH OTHER REPRESENTATION OR WARRANTY MADE BY ANY PERSON; AND (III) SUCH PURCHASER IS ACQUIRING THE PURCHASED ASSETS AND THE ASSUMED LIABILITIES IN “AS IS” CONDITION AND ON A “WHERE IS” BASIS, SUBJECT ONLY TO THE SPECIFIC REPRESENTATIONS AND WARRANTIES SET FORTH IN ARTICLE IV OF THIS AGREEMENT (AS MODIFIED BY THE SELLER DISCLOSURE SCHEDULE AND SELLER’S ELECTRONIC ONLINE DATA ROOM), AS FURTHER LIMITED BY THE SPECIFICALLY BARGAINED-FOR EXCLUSIVE REMEDIES SET FORTH IN ARTICLE VII .

 

- 24

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 5.7         Brokers . No broker, finder or investment banker is entitled to any brokerage, finder’s or other fee or commission in connection with the transactions contemplated by this Agreement and the Ancillary Agreements based upon arrangements made by or on behalf of such Purchaser.

 

ARTICLE VI

 

COVENANTS

 

Section 6.1         Bulk Transfer Laws.

 

Each Party hereby waives compliance by each of the other Parties with the requirements and provisions of any “bulk transfer” Laws of any jurisdiction that may otherwise be applicable with respect to the sale of any or all of the Purchased Assets to Purchasers.

 

- 25

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 6.2         Books and Records . Purchasers will preserve, or cause to be preserved, the Books and Records and all other books and records relating to Purchasers’ and/or their Affiliates’ distribution of Products or related regulatory filing and reporting requirements and activities with respect to Products, including, without limitation, government price reporting (“ Distribution Activities ”) for applicable periods of time required by the FDA or FTC or, in any event, for a period not less than [***] ([***])[***] after the Closing Date (except with respect to government claims not subject to a statute of limitations, such as Medicaid rebate claims, which shall continue for as long as there is potential for a claim). Purchasers and their Affiliates will cooperate with Seller and its Representatives during normal business hours and, upon reasonable advance notice, to provide reasonable access to such records maintained by Purchasers and their Affiliates relating to Purchasers’ and their Affiliates’ Distribution Activities, to provide reports reasonably requested by Seller regarding such records and information and to permit copying at the expense of Seller or, where reasonably necessary, to loan original documents relating to the same.

 

Section 6.3         Insurance . As of the Closing Date, the coverage under all insurance policies related to the Purchased Assets shall continue in force only for the benefit of Seller and not for the benefit of Purchasers or any of their Affiliates. Purchasers agree to arrange for their own insurance policies with respect to the Purchased Assets covering the period commencing as of the Closing Date and agree not to seek, through any means, to benefit from any of Seller’s insurance policies that may provide coverage for claims relating in any way to the Purchased Assets prior to the Closing.

 

Section 6.4         Trade Notification . Seller and Purchasers shall agree on the method and content of the notifications to customers of the sale of the Purchased Assets to Purchasers within [***] ([***])[***] following the Closing Date. Seller and Purchasers agree that said notifications are to provide sufficient advance notice of the sale and the plans associated therewith.

 

- 26

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 6.5         Tax Allocation . The Parties to this Agreement agree that the amount of the total consideration transferred by Purchasers to Seller pursuant to this Agreement (the “ Consideration ”) is and the allocation of the Consideration will be in accordance with the fair market value of the assets and Liabilities transferred pursuant to this Agreement. The allocation of the Consideration in accordance with the fair market values of the assets and Liabilities transferred shall be provided by Seller within [***] ([***])[***] following the Closing Date, and Purchasers shall have the right to review and raise any objections in writing to the proposed allocation during the [***] ([***])[***] period after Purchasers’ receipt thereof. If Purchasers do not notify Seller of a disagreement with the proposed allocation during such [***] ([***])[***] period, the proposed allocation shall become final. If Purchasers disagree with respect to any item in the allocation, the Parties shall negotiate in good faith to resolve the dispute. If the Parties are unable to agree on the allocation within [***] ([***])[***] after the commencement of such good faith negotiations (or such longer period as Seller and Purchasers may agree in writing), then the parties shall refer such dispute to an independent internationally recognized accounting firm (“ Independent Accountant ”) at that time to review the allocation, and make a determination as to the resolution of such allocation. The determination of the Independent Accountant regarding the allocation shall be delivered as soon as practicable following engagement of the Independent Accountant, but in no event more than [***] ([***])[***] thereafter, and shall be final, conclusive and binding upon Seller and Purchasers, and Seller shall revise the allocation accordingly. Seller, on the one hand, and Purchasers on the other hand, shall each pay one-half of the cost of the Independent Accountant. The finalized allocation shall be binding on Seller and Purchasers for all Tax reporting purposes, and Seller and Purchasers agree to refrain from taking any position inconsistent therewith unless required by applicable Law or a final determination of a Taxing Authority.

 

Section 6.6         Tax Treatment . Seller, on one hand, and Purchasers, on the other hand, agree to treat all payments made either to or for the benefit of the other Party or Parties, as the case may be, under this Agreement as adjustments to the Purchase Price for Tax purposes to the extent permitted under applicable Tax Law.

 

Section 6.7         FDA Letters .

 

(a)         On or before [***] ([***])[***] after the Closing Date, Seller shall deliver the Seller FDA Transfer Letters to the FDA providing notice to the FDA of the transfer of the ownership of the Product Registrations to TJL Purchaser.  On or before [***] ([***])[***] after the Closing Date, Purchasers shall deliver the Purchaser FDA Transfer Letters to the FDA notifying the FDA of TJL Purchaser’s ownership of the Product Registrations and its acceptance of the regulatory responsibilities associated with the Product Registrations from Seller.

 

- 27

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

(b)         Promptly after the Closing and in any event within [***] ([***])[***] after the Closing, Seller and Purchasers shall make all appropriate filings and submissions with Governmental Authorities, including the Centers for Medicare & Medicaid Services and the FDA to register appropriate NDC Numbers in the name of the TJL Purchaser and transfer all regulatory responsibilities, excluding all Excluded Liabilities attaching thereto of each Product, from Seller to TJL Purchaser.

 

(c)         In accordance with the foregoing Section 6.7(a) and Section 6.7(b) , (i) Seller shall use all commercially reasonable efforts to complete the transfer of the corresponding Product Registrations as promptly as practicable after the Closing Date to the benefit of TJL Purchaser and (ii) Purchasers shall use all commercially reasonable efforts to assist Seller in the transfer of such Product Registrations, accept the transfer of the corresponding Product Registrations and formalize with Sellers and any applicable Governmental Authority, as promptly as practicable after the Closing Date, all necessary documents. Following the transfer of the Product Registrations, Sellers shall retain no rights in the Product Registrations or Regulatory Documentation, including any rights to use or reference.

 

Section 6.8         Regulatory Responsibilities . Except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any Ancillary Agreement, Purchasers, from and after the Closing, shall have the sole right and responsibility for preparing, obtaining and maintaining all approvals from Governmental Authorities of competent jurisdiction, for paying user fees due for the Products under the Prescription Drug User Fee Act (as amended) and for conducting communications with Governmental Authorities of competent jurisdiction, for the Products.

 

- 28

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 6.9         Cooperating . Subject to Section 8.6 and except to the extent any such disclosure would result, in the reasonable judgment of Seller or Purchasers, as applicable, in (a) the disclosure of trade secrets of any third parties or violate the terms of any applicable confidentiality provisions, (b) a violation of applicable Laws, (c) a waiver of the protection of any attorney-client privilege or similar doctrine or (d) the disclosure of any sensitive or personal information that would expose Seller or Purchasers, as the case may be, to liability, from and after the Closing Date, and except as set forth in any Ancillary Agreement, each of Seller, on the one hand, and Purchasers, on the other hand, shall make available to the other during normal business hours and upon reasonable prior written notice, but without unreasonably disrupting its business, all records to the extent related to the Purchased Assets, the Assumed Liabilities and the Excluded Liabilities (subject to redactions for commercially sensitive information exclusively related to the Excluded Assets or such other reasonable measures as the Parties may mutually agree) held by it and reasonably necessary to permit the defense, prosecution or investigation of any litigation, examination or audit instituted prior to the Closing or that may be instituted thereafter against or by either Party relating to or arising out of the Exploitation of the Products prior to or after the Closing (other than litigation between Purchasers or their respective Affiliates, on the one hand, and Seller or its Affiliates, on the other hand, arising out of the transactions contemplated hereby or by the Ancillary Agreements, with respect to which applicable rules of discovery shall apply), and shall preserve and retain all such records for the length of time contemplated by its standard record retention policies and schedules. The Party requesting such cooperation shall pay the reasonable out-of-pocket costs and expenses of providing such cooperation (including legal fees and disbursements) incurred by any other Party providing such cooperation and by its officers, directors, employees and agents, and any unrecoverable Transfer Taxes in connection therewith.

 

Section 6.10         Further Assurances . Subject to Section 2.2 and applicable Law, each of Seller, on the one hand, and Purchasers, on the other hand, shall, at any time or from time to time after the Closing, at the request and expense of the other, execute and deliver to the other all such instruments and documents or further assurances as the other may reasonably request in order to (a) vest in Purchasers all of Seller’s right, title and interest in and to the Purchased Assets as contemplated hereby, (b) effectuate Purchasers’ assumption of the Assumed Liabilities and (c) grant to each Party all rights contemplated herein to be granted to such Party under the Ancillary Agreements; provided , however , that after the Closing, apart from such customary further assurances, neither Seller nor Purchasers shall have any other obligations except as specifically set forth and described herein or in the Ancillary Agreements. Without limitation of the foregoing, except as expressly set forth herein (including Section 6.8 and Section 6.9 ) or in the Ancillary Agreements, neither Seller nor Purchasers shall have any obligation to assist or otherwise participate in the amendment or supplementation of the Product Registrations or otherwise to participate in any filings or other activities relating to the Product Registrations other than as necessary to effect the assignment thereof to TJL Purchaser in connection with the Closing pursuant to this Agreement.

 

- 29

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 6.11         Wrong Pockets . For a period of up to [***] ([***])[***] after the date hereof, if either of the Purchasers, on the one hand, or Seller, on the other hand, becomes aware that any of the Purchased Assets has not been transferred to Purchasers or that any of the Excluded Assets has been transferred to Purchasers, it shall promptly (but in any event within [***] ([***])[***]) notify the other and the Parties shall use reasonable best efforts to, as soon as reasonably practicable, ensure that such property is transferred, with any necessary prior consent or approval, to (a) the applicable Purchaser, at the expense of the Seller in the case of any Purchased Asset which was not, but should have been, transferred to such Purchaser at the Closing; or (b) Seller, at the expense of Purchasers in the case of any Excluded Asset which was, but should not have been, transferred to Purchasers at Closing ( it being understood that neither Seller nor Purchasers shall be required to expend money (except expenses as contemplated by the foregoing clauses (a) or (b) , as applicable), commence any litigation or offer or grant any accommodation (financial or otherwise) to any third party).

 

Section 6.12         Know-How License . Effective as of the Closing, Seller hereby grants to Purchasers a perpetual, irrevocable, transferable (solely as set forth in the last sentence of this Section 6.12 ), sublicensable (solely as set forth in the last sentence of this Section 6.12 ), non-exclusive, paid-up, royalty-free, worldwide right and license to use and otherwise exploit the Licensed Know-How solely in connection with developing, commercializing, manufacturing, using, packaging, marketing, promoting, importing, exporting, researching, transporting, selling and distributing the Products. Purchasers may (but are not obligated to) transfer the foregoing license, and/or grant sublicenses thereunder, to (a) any of their Affiliates, and (b) any acquirer of any of the assets or business of Purchasers and their Affiliates relating to any of the Products.

 

- 30

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 6.13       IGI Purchaser Guarantee . IGI Purchaser hereby irrevocably and unconditionally guarantees to Seller, as a primary obligation, the due and punctual performance of all of TJL Purchaser’s obligations under this Agreement, including the obligations to (a) perform all of TJL Purchaser’s obligations and assume all of TJL Purchaser’s liabilities as provided by this Agreement and (b) make payment of all amounts payable by TJL Purchaser under this Agreement, when and as TJL Purchaser’s payment obligations hereunder shall become due and payable. In case of a failure of TJL Purchaser to perform its obligations or pay or provide for punctually any such amounts when due and payable (in accordance with the terms of any extensions or renewals), IGI Purchaser hereby agrees, upon written demand by Seller, to promptly perform such obligations, or pay or cause to be paid punctually any such amounts when and as the same shall become due and payable. IGI Purchaser hereby agrees that its obligations under this Section 6.13 constitute a guarantee of payment when due and not of collection. IGI Purchaser hereby agrees that its obligations under the guarantee set forth in this Section 6.13 shall be irrevocable and unconditional, irrespective of the validity, regularity or enforceability of any obligations hereunder against TJL Purchaser, the absence of any action to enforce TJL Purchaser’s obligations hereunder or thereunder, any waiver or consent with respect to any provisions hereof or thereof, the bankruptcy of TJL Purchaser or any circumstance that might otherwise constitute a legal or equitable discharge or defense of a guarantor. IGI Purchaser hereby waives (i) promptness, presentment, demand of payment, protest, order and, except as set forth in this Section 6.13 , notice of any kind in connection with this Agreement and the guarantee provided for in this Section 6.13 or (ii) any requirement that Seller exhaust any right to take any action against TJL Purchaser or any other Person prior to or contemporaneously with proceeding to exercise any right against IGI Purchaser, pursuant to the guarantee set forth in this Section 6.13 . This Section 6.13 is subject to the provisions of Article VII in all respects.

 

ARTICLE VII

 

INDEMNIFICATION

 

Section 7.1         Indemnification by Seller . Subject to the provisions of this Article VII , from and after the Closing, Seller agrees to defend, indemnify and hold harmless Purchasers and their Affiliates, and, if applicable, their respective directors, officers, agents, employees, successors and assigns (collectively, the “ Purchaser Indemnified Parties ”) from and against any and all claims, actions, causes of action, judgments, awards, losses, damages, penalties or costs (including reasonable attorneys’ fees and other out-of-pocket costs incurred in investigating, preparing and defending the foregoing) (collectively, a “ Loss ” or, the “ Losses ”) to the extent arising or resulting from (i) any Excluded Liability, (ii) any breach by Seller of any of its covenants or agreements contained in this Agreement or (iii) any breach of any representation or warranty of Seller contained in this Agreement.

 

- 31

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 7.2         Indemnification by IGI Purchaser . Subject to the provisions of this Article VII , from and after the Closing, IGI Purchaser agrees to defend, indemnify and hold harmless Seller and its Affiliates, and, if applicable, their respective directors, officers, agents, employees, successors and assigns (collectively, the “ Seller Indemnified Parties ”) from and against any and all Loss to the extent arising or resulting from (i) any Assumed Liability, (ii) any breach by either Purchaser of any of its respective covenants or agreements in this Agreement, (iii) any breach of any representation or warranty of either Purchaser contained in this Agreement or (iv) the Exploitation, development, manufacture, supply, marketing or distribution of the Products following the Closing.

 

Section 7.3         Notice of Claims . (a) If any of the Persons to be indemnified under this Article VII (the “ Indemnified Party ”) has suffered or incurred any Loss subject to indemnification under this Article VII , the Indemnified Party shall so notify the Party responsible for providing indemnification therefor under this Agreement (the “ Indemnifying Party ”) promptly in writing describing such Loss, the basis for indemnification hereunder, the amount or estimated amount of such Loss, if known or reasonably capable of estimation, and the method of computation of such Loss, all with reasonable particularity and containing a reference to the provisions of this Agreement in respect of which such Loss shall have occurred. If any action at law or suit in equity is instituted by or against a third party with respect to which the Indemnified Party intends to seek indemnity under this Article VII , the Indemnified Party shall promptly notify the Indemnifying Party of such action or suit and tender to the Indemnifying Party the conduct or defense of such action or suit. A failure by the Indemnified Party to give notice and to tender the conduct or defense of the action or suit in a timely manner pursuant to this Section 7.3 shall not limit the obligation of the Indemnifying Party under this Article VII , except (i) to the extent such Indemnifying Party is prejudiced thereby, (ii) to the extent expenses are incurred during the period in which notice was not provided and (iii) as provided by Section 7.5 .

 

- 32

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

(b)         Except when a notice, report or other filing must be filed immediately pursuant to applicable Law, a Purchaser shall provide notice and an opportunity to comment to Seller before such Purchaser files any report, notification or filing with any Governmental Authority or third party in connection with an event that would be reasonably likely to result in a Loss subject to the indemnification provisions of Section 7.1 . In the event such Purchaser is required to file a report, notification or filing immediately, such Purchaser shall provide simultaneous notice to Seller when it submits such report, notification or filing to the applicable Governmental Authority.

 

Section 7.4         Third Party Claims . (a) The Indemnifying Party under this Article VII shall have the right, but not the obligation, to conduct and control, through counsel of its choosing, any third party Proceeding (a “ Third Party Claim ”), and the Indemnifying Party may compromise or settle the same, provided that the Indemnifying Party shall give the Indemnified Party advance notice of any proposed compromise or settlement. No Indemnified Party may compromise or settle any Third Party Claim for which it is seeking indemnification hereunder without the consent of the Indemnifying Party. The Indemnifying Party shall permit the Indemnified Party to participate in, but not control, the defense of any such action or suit through counsel chosen by the Indemnified Party, provided that the fees and expenses of such counsel shall be borne by the Indemnified Party. If the Indemnifying Party elects not to control or conduct the defense or prosecution of a Third Party Claim, the Indemnifying Party nevertheless shall have the right to participate in the defense or prosecution of any Third Party Claim and, at its own expense, to employ counsel of its own choosing for such purpose.

 

(b)         The Parties hereto shall cooperate in the defense or prosecution of any Third Party Claim, with such cooperation to include (i) the retention and the provision of the Indemnifying Party records and information that are reasonably relevant to such Third Party Claim and (ii) making employees available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder.

 

- 33

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 7.5         Expiration . All representations and warranties made by the Parties in this Agreement will survive until the [***] anniversary of the Closing Date, except that the representations and warranties contained in Section 4.1 ( Organization and Qualification ), Section 4.2 ( Authority; Binding Effect ), Section 4.14 ( Brokers ), Section 5.1 ( Organization and Qualification ), Section 5.2 ( Authority; Binding Effect ) and Section 5.7 ( Brokers ) (the foregoing Sections, the “ Fundamental Representations ”) shall survive indefinitely. Any matter as to which a claim has been asserted by timely notice that is pending or unresolved at the end of the applicable survival period will continue to be covered by this Article VII , notwithstanding any applicable statute of limitations, until such matter is finally terminated or otherwise resolved under this Agreement or non-appealable judgment of an arbitrator, and any amounts payable under this Agreement are finally determined and paid.

 

Section 7.6         Limitations on Indemnification .

 

(a)         Threshold . Seller shall not be liable, pursuant to Section 7.1(ii) , for any Losses suffered by any Purchaser Indemnified Party unless the aggregate of all Losses suffered by the Purchaser Indemnified Parties exceeds, on a cumulative basis, an amount equal to [***] percent ([***]%) of the Purchase Price (the “ Indemnity Threshold ”), in which event Seller shall be required to pay or be liable for all such Losses in excess of the Indemnity Threshold. IGI Purchaser shall not be liable, pursuant to Section 7.2(ii) , for any Losses suffered by the Seller Indemnified Parties unless the aggregate of all Losses suffered by the Seller Indemnified Parties exceeds, on a cumulative basis, the Indemnity Threshold, and then IGI Purchaser shall be required to pay or be liable for all such Losses in excess of the Indemnity Threshold.

 

(b)         Cap . In no event shall Seller be liable to indemnify the Purchaser Indemnified Parties pursuant to Section 7.1 for Losses in the aggregate in excess of an amount equal to [***] percent ([***]%) of the Purchase Price (the “ Cap ”), other than (i) with respect to claims for indemnification pursuant to Section 7.1(iii) for Losses arising out of any breach of any Fundamental Representations, in which case Seller shall not be liable to indemnify the Purchaser Indemnified Parties for Losses in the aggregate in excess of an amount equal to the Purchase Price, or (ii) Losses attributable to fraud or intentional misrepresentation of Seller. In no event shall IGI Purchaser be liable to indemnify the Seller Indemnified Parties pursuant to Section 7.2(iii) for Losses in the aggregate in excess of the Cap, other than (i) with respect to claims for indemnification pursuant to Section 7.2(iii) for Losses arising out of any breach of any Fundamental Representations, in which case IGI Purchaser shall not be liable to indemnify the Seller Indemnified Parties for Losses in the aggregate in excess of an amount equal to the Purchase Price, or (ii) Losses attributable to fraud or intentional misrepresentation of Purchasers.

 

(c)         Mitigation . The Parties shall cooperate with each other and use commercially reasonable efforts to satisfy their respective common law duties to mitigate or resolve any Losses that are indemnifiable hereunder, as further provided in Section 7.7 below.

 

(d)         Other Limitations . If a Party is conducting any defense against a Third Party Claim for which any other Party has sought indemnification pursuant to Section 7.1 or Section 7.2 , as applicable, the fees and expenses incurred during the defense against such Third Party Claim, including legal costs and expenses, shall constitute Losses for purposes of determining the amount subject to the Cap pursuant to Section 7.6(b) . For purposes of calculating the amount of Losses pursuant to Section 7.1(iii) or Section 7.2(iii) , the representations and warranties in this Agreement shall be read without regard to any qualification as to “material,” “materiality,” Material Adverse Effect or similar qualifiers.

 

- 34

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

(e)         Exclusion of Certain Damages . Notwithstanding anything in this Agreement to the contrary, NONE OF THE PARTIES nor THEIR RESPECTIVE Affiliates shall be liable for any indirect, INCIDENTAL, treble, remote, special, exemplary, opportunity cost, consequential or punitive damages or damages for, measured by or based on lost profits, loss of revenue or income, diminution in value, multiple of earnings, profits or cash flows, or other similar measures or for any loss of business reputation or opportunity THAT ARISES OUT OF OR RELATES TO THIS AGREEMENT OR THE PERFORMANCE OR BREACH HEREOF OF ANY LIABILITY RETAINED OR ASSUMED HEREUNDER, EXCEPT TO THE EXTENT ANY SUCH DAMAGE OR LOSS WAS A REASONABLY FORESEEABLE CONSEQUENCE OF THE BREACH; PROVIDED, FURTHER, HOWEVER, THAT THE FOREGOING LIMITATION ON DAMAGES SHALL NOT APPLY TO ANY SUCH DAMAGES (I) THAT ARE ACTUALLY AWARDED PURSUANT TO A THIRD-PARTY CLAIM OR (II) RESULTING FROM FRAUD OR intentional misrepresentation BY THE INDEMNIFYING PARTY.

 

Section 7.7         Losses Net of Insurance, Etc.

 

Any indemnifiable claim with respect to any matter shall be limited to the amount of actual out-of-pocket indemnifiable Losses sustained and incurred by the Indemnified Party by reason of such matter (and no Indemnifying Party shall have an indemnification payment obligation, nor be entitled to assert any claim for indemnification, in respect of any contingent liability unless and until such liability becomes due and payable) net of any insurance proceeds actually received as an offset against such Loss. The Indemnifying Party may require an Indemnified Party to assign to the Indemnifying Party the rights to seek recovery pursuant to the preceding sentence (to the extent such rights are capable of assignment); provided , however , that the Indemnifying Party shall then be responsible for pursuing such claim at its own expense; and provided further , that the Indemnified Party shall cooperate (at the Indemnifying Party’s expense) with the Indemnifying Party to seek such recovery. If the amount to be netted hereunder from any payment required under Section 7.1 or Section 7.2 is determined after payment by the Indemnifying Party of any amount otherwise required to be paid to an Indemnified Party pursuant to this Article VII , the Indemnified Party shall repay to the Indemnifying Party, promptly after such determination, any amount that the Indemnifying Party would not have been required to pay pursuant to this Article VII had such determination been made at the time of such payment.

 

- 35

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 7.8         Reimbursement . If an Indemnified Party recovers an amount from a third party in respect of a Loss that is the subject of indemnification hereunder after all or a portion of such Loss has been paid by an Indemnifying Party pursuant to this Article VII , the Indemnified Party shall promptly remit to the Indemnifying Party the amount received from the third party in respect thereof.

 

Section 7.9         Sole Remedy/Waiver . Should the Closing occur, the remedies provided for in this Article VII shall be the sole and exclusive remedies of any Indemnified Party in respect of this Agreement, the Ancillary Agreements, the Purchased Assets, the Products, the Excluded Assets, the Assumed Liabilities, the Excluded Liabilities or the transactions contemplated hereby or by the Ancillary Agreements, other than (a) for actions for specific performance or other equitable remedies and (b) claims for fraud or intentional misrepresentation. In furtherance of the foregoing, each Party hereby waives any provision of applicable Law to the extent that it would limit or restrict the agreement contained in this Section 7.9 .

 

ARTICLE VIII

 

MISCELLANEOUS

 

Section 8.1         Notices . All requests, notices, instructions or other communications to be given hereunder by one Party to another Party shall be deemed to have been duly given and made if in writing and if served by personal delivery upon the Party for whom it is intended, if delivered by registered or certified mail, return receipt requested, by a national courier service or by facsimile or electronic mail transmission (“e-mail”) ( provided that such facsimile or e-mail is promptly confirmed within [***] ([***])[***]by dispatch pursuant to one of the other methods described herein) to the Person at the address set forth below, or such other address as may be designated in writing hereafter, in the same manner, by such Person:

 

- 36

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

To Seller:

 

Concordia Pharmaceuticals Inc., S.à.r.l., Barbados Branch

[***]

[***]

[***]

Telephone: [***]

Facsimile: [***]

E-mail: [***]

Attn: [***]

 

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

 

Sullivan & Cromwell LLP

125 Broad Street

New York, NY 10004

Telephone: (212) 558-7931

Facsimile: (212) 291-9519

E-mail: VeeraraghavanK@sullcrom.com

Attn: Krishna Veeraraghavan

 

to Purchasers:

 

IGI Laboratories, Inc.

[***]

[***]

Telephone: [***]

Facsimile: [***]

E-mail: [***]

Attn: [***]

 

Teligent Jersey Limited

[***]

[***]

Telephone: [***]

Facsimile: [***]

E-mail: [***]

Attn: [***]

 

- 37

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

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

 

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

666 Third Avenue

New York, New York 10017

Telephone: (212) 935-3000

Facsimile: (212) 983-3155

E-mail: JIPapernik@mintz.com

Attn: Joel I. Papernik, Esq.

 

Section 8.2         Amendment; Waiver . Any provision of this Agreement may be amended or waived if, and only if, such amendment or waiver is in writing and signed, in the case of an amendment, by Purchasers and Seller, or in the case of a waiver, by the Party against whom the waiver is to be effective. 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.

 

Section 8.3         Successors and Assigns; No Third Party Beneficiaries . No Party to this Agreement may assign any of its rights or obligations under this Agreement including by sale of stock, by operation of Law in connection with a merger or by sale of all or substantially all the assets of such Party without the prior written consent of the other Parties hereto; provided , however , that nothing in the foregoing shall prohibit Purchasers or Seller from making any assignment (i) to any of its Affiliates so long as such Affiliate agrees in writing to be bound by all of the terms, conditions and provisions contained in this Agreement; provided further , that no such assignment shall release Purchasers or Seller, as the case may be, from their obligations under this Agreement; and (ii) to any successors to all or substantially all of the business and assets of Purchasers or Seller, whether in a merger, consolidation, sale of substantially all assets or other similar transaction. Any purported assignment, hypothecation or transfer in breach of this Section 8.3 shall be null and void. This Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors and permitted assigns. Except as set forth in Article VII , this Agreement is for the sole benefit of the parties hereto and their respective successors and permitted assigns and nothing herein, express or implied, is intended to or shall confer upon any other Person or entity any legal or equitable right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.

 

- 38

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 8.4         Entire Agreement . This Agreement and the Ancillary Agreements (in each case, including all Schedules and Exhibits hereto and thereto) contain the entire agreement between the Parties with respect to the subject matter hereof and supersede all prior agreements and understandings, oral or written, with respect to such matters, except for (i) the Confidentiality Agreement, which will remain in full force and effect for the term provided for therein, and (ii) any written agreement of the Parties that expressly provides that it is not superseded by this Agreement. In the event of a conflict between the provisions of this Agreement and the provisions of the Confidentiality Agreement, the provisions of this Agreement shall control.

 

Section 8.5         Parties in Interest . Nothing in this Agreement, express or implied, is intended to confer upon any Person other than Purchasers, Seller or their successors or permitted assigns, any rights or remedies under or by reason of this Agreement, except that the provisions of Article VII shall inure to the benefit of the Purchaser Indemnified Parties and Seller Indemnified Parties, as applicable.

 

Section 8.6         Confidential Information . All confidential information made available to Purchasers, their Affiliates and their respective Representatives with respect to Seller, its Affiliates, the Purchased Assets or the Assumed Liabilities shall be treated in accordance with the Confidentiality Agreement, which shall remain in full force and effect in accordance with its terms notwithstanding the termination of this Agreement.

 

- 39

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 8.7         Expenses, Transfer Taxes and Property Taxes . (a) All costs and expenses incurred in connection with this Agreement and the transactions contemplated hereby shall be borne by the Party incurring such expenses. Notwithstanding the foregoing, all Transfer Taxes imposed by the United States, or any state or possession of the United States, or Jersey shall be paid by Purchasers and all Transfer Taxes imposed by Barbados or Luxembourg shall be paid by Seller.

 

(b)         In the case of any taxable period that includes (but does not end on) the Closing Date, (i) real, personal and intangible property Taxes and similar Taxes imposed with respect to the Purchased Assets (“ Property Taxes ”) shall be allocated between the Pre-Closing Tax Period and the Post-Closing Tax Period on a per diem basis, and (ii) all other Taxes imposed with respect to the Purchased Assets (other than Transfer Taxes subject to the second sentence of Section 8.7(a) ) shall be allocated between the Pre-Closing Tax Period and the Post-Closing Tax Period as though the taxable period terminated as of the effective time of the Closing. Seller, on the one hand, and Purchasers, on the other hand, shall promptly reimburse each other in accordance with such allocation for any such Property Taxes which any Party is required to pay under applicable Law.

 

Section 8.8         Schedules . The disclosure of any matter in any Schedule to this Agreement shall be deemed to be a disclosure with respect to any other section or subsection of this Agreement with respect to which its relevance is reasonably apparent on its face for all purposes of this Agreement. Notwithstanding anything in this Agreement to the contrary, the parties hereto agree that the inclusion of an item in the Seller Disclosure Schedule as an exception to any representation, warranty or other part of this Agreement will not be deemed an admission that such item represents a material exception or a material fact, event or circumstance, that such item is required to be disclosed by this Agreement or that such item has had or would reasonably be expected to have a Material Adverse Effect.

 

- 40

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 8.9         Governing Law; Jurisdiction . (a) This Agreement and the Ancillary Agreements and their negotiation, execution, performance or non-performance, interpretation, termination, construction and all claims or causes of action (whether in contract, in tort, at law or otherwise) that may be based upon, arise out of, or relate to this Agreement, the Ancillary Agreements or the transactions contemplated hereby or thereby (including any claim or cause of action based upon, arising out of or related to any representation or warranty made in connection with this Agreement or the Ancillary Agreements or as an inducement to enter into this Agreement or the Ancillary Agreements), shall be exclusively governed by, and construed in accordance with, the Laws of the State of Delaware, regardless of Laws that might otherwise govern under any applicable conflict of Laws principles.

 

(b)         Any claim, demand, suit, action, cause of action, or proceeding (whether in contract, in tort, at law or otherwise) (each, a “ Proceeding ”) based upon, arising out of, or related to this Agreement and the Ancillary Agreements and their negotiation, execution, performance, non-performance, interpretation, termination, construction or the transactions contemplated by the Agreement or the Ancillary Agreements shall be heard and determined in the Court of Chancery in the City of Wilmington, New Castle County, Delaware or, in the event such court lacks subject matter jurisdiction, the United States District Court sitting in Wilmington, Delaware or, in the event such federal district court lacks subject matter jurisdiction, then in the Superior Court in the City of Wilmington, New Castle County, Delaware. The Parties hereby irrevocably submit to the exclusive jurisdiction and venue of such courts in any such Proceeding and irrevocably and unconditionally waive the defense of an inconvenient forum, or lack of jurisdiction to the maintenance of any such Proceeding. The consents to jurisdiction and venue set forth herein shall not constitute general consents to service of process in the State of Delaware and shall have no effect for any purpose except as provided in this Section 8.9 and shall not be deemed to confer rights on any Person other than the Parties. Each Party agrees that the service of process upon such Party in any Proceeding arising out of or relating to this Agreement or the Ancillary Agreements shall be effective if notice is given by overnight courier at the address set forth in Section 8.1 . Each of the Parties also agrees that any final, non-appealable judgment against a Party in connection with any Proceeding arising out of or relating to this Agreement shall be conclusive and binding on such Party and that such award or judgment may be enforced in any court of competent jurisdiction, either within or outside of the United States. A certified or exemplified copy of such award or judgment shall be conclusive evidence of the fact and amount of such award or judgment.

 

- 41

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 8.10      WAIVER OF JURY TRIAL . TO THE FULLEST EXTENT PERMITTED BY LAW, THE PARTIES HEREBY WAIVE THEIR RESPECTIVE R IGHTS TO A JURY TRIAL OF ANY PROCEEDING (whether in contract, in tort, at law or otherwise) BASED UPON, ARISING OUT OF OR RELATED TO THIS AGREEMENT, THE ANCILLARY AGREEMENTS OR ANY OF THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT OR THE ANCILLARY AGREEMENTS. THE SCOPE OF THIS WAIVER IS INTENDED TO BE ALL-ENCOMPASSING OF ANY AND ALL DISPUTES THAT MAY BE FILED IN ANY COURT AND THAT RELATE TO THE SUBJECT MATTER OF THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, CONTRACT CLAIMS, TORT CLAIMS, BREACH OF DUTY CLAIMS AND ALL OTHER COMMON LAW AND STATUTORY CLAIMS. THE PARTIES ACKNOWLEDGE THAT THIS WAIVER IS A MATERIAL INDUCEMENT TO ENTER INTO A BUSINESS RELATIONSHIP, THAT EACH HAS ALREADY RELIED ON THE WAIVER IN ENTERING INTO THIS AGREEMENT AND THAT EACH WILL CONTINUE TO RELY ON THE WAIVER IN THEIR RELATED FUTURE DEALINGS. THE PARTIES FURTHER WARRANT AND REPRESENT THAT EACH HAS REVIEWED THIS WAIVER WITH ITS LEGAL COUNSEL, AND THAT EACH KNOWINGLY AND VOLUNTARILY WAIVES ITS JURY TRIAL RIGHTS FOLLOWING CONSULTATION WITH LEGAL COUNSEL. THIS WAIVER IS IRREVOCABLE, MEANING THAT IT MAY NOT BE MODIFIED EITHER ORALLY OR IN WRITING, AND THIS WAIVER SHALL APPLY TO ANY SUBSEQUENT AMENDMENTS, RENEWALS, SUPPLEMENTS OR MODIFICATIONS TO THIS AGREEMENT OR THE ANCILLARY AGREEMENTS. IN THE EVENT OF LITIGATION, THIS AGREEMENT MAY BE FILED AS A WRITTEN CONSENT TO A TRIAL BY THE COURT.

 

- 42

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 8.11       Counterparts . This Agreement may be executed in one or more counterparts (including by facsimile or electronic .pdf submission), each of which shall be deemed an original, and all of which shall constitute one and the same agreement and shall become effective when one or more counterparts have been signed by each of the Parties and delivered (by telecopy or otherwise) to the other Party, it being understood that each Party need not sign the same counterpart.

 

Section 8.12     Headings . The heading references herein and the table of contents hereto are for convenience purposes only, do not constitute a part of this Agreement and shall not be deemed to limit or affect any of the provisions hereof.

 

Section 8.13      Severability . The provisions of this Agreement shall be deemed severable and the invalidity or unenforceability of any provision shall not affect the validity or enforceability of the other provisions hereof. If any term or other provision of this Agreement, or the application thereof to any Person or any circumstance, is invalid, illegal or unenforceable, (a) a suitable and equitable provision shall be substituted therefor in order to carry out, so far as may be valid and enforceable, the intent and purpose of such invalid or unenforceable provision and (b) the remainder of this Agreement and the application of such provision to other Persons or circumstances shall not be affected by such invalidity, illegality or unenforceability, nor shall such invalidity, illegality or unenforceability affect the validity or enforceability of such provision, or the application thereof, in any other jurisdiction.

 

- 43

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Section 8.14       Mutual Drafting . The Parties are sophisticated and have been represented by lawyers throughout the transactions contemplated hereby who have carefully negotiated the provisions hereof. As a consequence, the Parties do not intend that the presumptions set forth in Laws or rules relating to the interpretation of contracts against the drafter of any particular clause should be applied to this Agreement or any Schedule or Exhibit hereto, and therefore, waive their effects.

 

[Remainder of Page Intentionally Left Blank]

 

- 44

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

IN WITNESS WHEREOF , the Parties have executed or caused this Agreement to be executed as of the date first written above.

 

  CONCORDIA PHARMACEUTICALS INC., S.À.R.L., BARBADOS BRANCH
       
  By: /s/ Erin O’Neil / Neil Smith  
  Name: Erin O’Neil / Neil Smith  
  Title: COO / VP Finance  
     
  IGI LABORATORIES, INC.  
       
  By: /s/ Jason Grenfell-Gardner  
  Name: Jason Grenfell-Gardner  
  Title: President & CEO  
     
  TELIGENT JERSEY LIMITED  
       
  By: /s/ Jason Grenfell-Gardner  
  Name: Jason Grenfell-Gardner  
  Title: President  

  

[ Signature Page to Asset Purchase Agreement ]

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Exhibit 31.1

 

CERTIFICATION
OF
JASON GRENFELL-GARDNER
PRESIDENT AND CHIEF EXECUTIVE OFFICER
OF
TELIGENT, INC.
 

 

I, Jason Grenfell-Gardner, President and Chief Executive Officer of Teligent, Inc., certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Teligent, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant's other certifying officer 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:

 

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.

 

Date: November 9, 2015

 

  /s/   Jason Grenfell-Gardner  
  Jason Grenfell-Gardner  
  President and Chief Executive Officer  

 

 

 

 

Exhibit 31.2

 

CERTIFICATION

OF

JENNIFFER COLLINS

CHIEF FINANCIAL OFFICER
OF
TELIGENT, INC.
 

 

I, Jenniffer Collins, Chief Financial Officer of Teligent, Inc., certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Teligent, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant's other certifying officer 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:

 

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.

 

Date: November 9, 2015

 

  /s/   Jenniffer Collins  
  Jenniffer Collins  
  Chief Financial Officer  

 

 

 

 

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 Quarterly Report of Teligent, Inc. (the “Company”) on Form 10-Q for the period ending September 30, 2015, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Jason Grenfell-Gardner, President and Chief Executive Officer of the Company, state and certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, 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 the Company.

 

Date: November 9, 2015

 

  /s/   Jason Grenfell-Gardner  
  Jason Grenfell-Gardner  
  President and Chief Executive Officer  

 

 

 

 

 

Exhibit 32.2

 

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 Quarterly Report of Teligent, Inc. (the “Company”) on Form 10-Q for the period ending September 30, 2015, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Jenniffer Collins, Chief Financial Officer of the Company, state and certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, 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 the Company.

 

Date: November 9, 2015

 

  /s/   Jenniffer Collins  
  Jenniffer Collins  
  Chief Financial Officer