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, 2014

 

¨ 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

 

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   08310
Buena , New Jersey   (Zip Code)
(Address of Principal Executive Offices)    

 

(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 ¨
Non-accelerated filer ¨ Smaller reporting company   þ

 

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 52,787,787 shares, net of treasury stock, as of November 6, 2014.

 

 
 

 

PART I

FINANCIAL INFORMATION

 

ITEM 1. Financial Statements

 

IGI LABORATORIES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except shares and per share information)

(Unaudited)

 

    Three months ended September 30,     Nine months ended September 30,  
    2014     2013     2014     2013  
Revenues:                                
Product sales, net   $ 6,005     $ 3,950     $ 18,525     $ 11,124  
Research and development income     635       10       1,385       278  
Licensing, royalty and other revenue     28       35       95       97  
Total revenues     6,668       3,995       20,005       11,499  
                                 
Costs and Expenses:                                
Cost of sales     4,036       2,684       11,603       7,932  
Selling, general and administrative expenses     1,124       692       3,563       2,078  
Product development and research expenses     1,652       661       5,045       2,123  
Total costs and expenses     6,812       4,037       20,211       12,133  
Operating loss     (144 )     (42 )     (206 )     (634 )
Interest expense and other, net     (58 )     (53 )     (174 )     (121 )
                                 
Net loss   $ (202 )   $ (95 )   $ (380 )   $ (755 )
                                 
Basic and diluted loss per share   $ 0.00     $ 0.00     ($ 0.01 )   ($ 0.02 )
                                 
                                 
Weighted average shares of common stock outstanding:                                
Basic and diluted     52,457,938       43,395,980       48,811,328       43,179,898  

 

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

 

 
 

 

IGI LABORATORIES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share information)

 

    (Unaudited)        
    September 30,
2014
    December 31,
2013*
 
ASSETS                
Current assets:                
Cash and cash equivalents   $ 23,248     $ 2,101  
Accounts receivable, net     6,369       4,947  
Inventories     3,218       2,869  
Prepaid expenses and other receivables     1,011       641  
Total current assets     33,846       10,558  
Property, plant and equipment, net     3,169       2,623  
Product acquisition costs, net     10,135       1,766  
Restricted cash, long term     54       54  
License fee, net     125       200  
Debt issuance costs, net     45       69  
Other     143       157  
Total assets   $ 47,517     $ 15,427  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current liabilities:                
Accounts payable   $ 2,143     $ 1,523  
Accrued expenses     3,359       2,915  
Payable for product acquisition costs     6,000       -  
Deferred income, current     34       768  
Capital lease obligation, current     131       15  
Total current liabilities     11,667       5,221  
                 
Note payable, bank     2,854       3,000  
Other long term liabilities     105       15  
Total liabilities     14,626       8,236  
                 
Commitments and contingencies                
                 
Stockholders’ equity:                
Common stock, $0.01 par value, 60,000,000 shares authorized; 52,577,787 and 46,748,575 shares issued and outstanding as of September 30, 2014 and December 31, 2013, respectively     545       487  
Additional paid-in capital     77,563       51,541  
Accumulated deficit     (45,217 )     (44,837 )
Total stockholders’ equity     32,891       7,191  
Total liabilities and stockholders' equity   $ 47,517     $ 15,427  

 

*Derived from the audited December 31, 2013 financial statements

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

 

 
 

 

IGI LABORATORIES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

For the nine months ended September 30, 2014 and 2013

(in thousands)

(Unaudited)

 

    2014     2013  
Cash flows from operating activities:                
Net loss   $ (380 )   $ (755 )
Reconciliation of net loss to net cash used in operating activities:                
Depreciation     292       280  
Amortization of license fee     75       75  
Stock-based compensation expense     649       169  
Provision for write down of inventory     114       94  
Amortization of debt issuance costs     24       23  
Amortization of product acquisition costs     90       30  
Changes in operating assets and liabilities:                
Accounts receivable     (1,422 )     (1,318 )
Inventories     (463 )     (844 )
Prepaid expenses and other receivables     (547 )     21  
Other assets     211       (12 )
Accounts payable and accrued expenses     1,064       729  
Deferred income     (737 )     117  
                 
Net cash used in operating activities     (1,030 )     (1,391 )
                 
Cash flows from investing activities:                
Capital expenditures     (618 )     (223 )
Product acquisition costs     (2,459 )     (1,826 )
Net cash used in investing activities     (3,077 )     (2,049 )
                 
Cash flows from financing activities:                
Proceeds from issuance of stock, net     24,866       (53 )
Proceeds from exercise of common stock warrants and options     565       372  
Principal payments on capital lease obligation     (31 )     (13 )
Payments on note payable, bank     (146 )     -  
Proceeds from note payable, bank     -       2,000  
Net cash provided by financing activities     25,254       2,306  
                 
Net increase (decrease) in cash and cash equivalents     21,147       (1,134 )
Cash and cash equivalents at beginning of period     2,101       2,536  
Cash and cash equivalents at end of period   $ 23,248     $ 1,402  
                 
Supplemental Cash flow information:                
Cash payments for interest   $ 139     $ 102  
Cash payments for taxes   $ 23     $ 10  
                 
Non cash investing and financing transactions:                
Payable related to product acquisition costs   $ 6,000     $ -  
Common stock issued for Series A Convertible Preferred stock   $ -     $ 500  

 

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

 

 
 

 

IGI LABORATORIES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY

For the nine months ended September 30, 2014 (unaudited)

(in thousands, except share information)

 

                Additional           Total  
    Common Stock     Paid-In     Accumulated     Stockholders’  
    Shares     Amount     Capital     Deficit     Equity  
                               
Balance, December 31, 2013     46,748,575     $ 487     $ 51,541     $ (44,837 )   $ 7,191  
                                         
Issuance of stock pursuant to a public offering, net of associated fees of $1,868     5,347,500       53       24,813               24,866  
Stock based compensation expense – stock options                     191               191  
Stock based compensation expense - restricted stock                     458               458  
Stock warrants exercised     270,546       3       325               328  
Stock options exercised     211,166       2       235               237  
Net loss     -       -       -       (380 )     (380 )
                                         
Balance, September 30, 2014 (unaudited)     52,577,787     $ 545     $ 77,563     $ (45,217 )   $ 32,891  

 

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

 

 
 

 

IGI LABORATORIES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or 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 U.S. generally accepted accounting principles for complete financial statements. 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, 2013. The condensed consolidated balance sheet as of December 31, 2013 has been derived from those audited consolidated financial statements. Operating results for the nine month period ended September 30, 2014 are not necessarily indicative of the results that may be expected for the year ending December 31, 2014.

 

1. Organization and Business

 

IGI Laboratories, Inc. is a Delaware corporation incorporated in 1977. On May 7, 2008, the stockholders of IGI, Inc. approved the name change of the Company from IGI, Inc. to IGI Laboratories, Inc. 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. In its own label, the Company currently sells generic topical pharmaceutical products that are bioequivalent to their brand name counterparts. The Company also provides contract manufacturing and formulation services to the pharmaceutical, over-the-counter, or (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.

 

In addition, we may continue to explore ways to accelerate our growth through the creation of unique opportunities from the acquisition of additional intellectual property, and the expansion of the use of our existing intellectual property, including our licensed Novasome ® technology.

 

To date, we have filed nineteen Abbreviated New Drug Applications, or ANDAs, with the United States Food and Drug Administration, or FDA, for additional pharmaceutical products. 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 at least ten ANDAs in 2014 through our internal research and development program. On March 12, 2014, the Company received our first approval from the FDA for an ANDA. The FDA has approved IGI's application for lidocaine hydrochloride USP 4% topical solution. On May 7, 2014, the Company received tentative approval from the FDA for its ANDA for diclofenac sodium 1.5% topical solution. On June 26, 2014, the Company executed an agreement to enable it to launch the product in March 2015 after final FDA approval. We will also seek to license or acquire further products, intellectual property, or ANDAs to expand our portfolio.

 

On February 1, 2013, we acquired assets and intellectual property, including an ANDA, for econazole nitrate cream 1%, which we launched in September 2013.

 

On September 24, 2014, we acquired from AstraZeneca ANDAs and NDAs associated with eighteen products, seventeen of which were injectable products. On September 30, 2014, we acquired ANDAs and NDAs associated with two ophthalmic products from Valeant, in addition to the exclusive right to acquire three additional injectable products from Valeant.

 

We also develop, manufacture, fill, and package topical semi-solid and liquid products for branded and generic pharmaceutical customers as well as the OTC and cosmetic markets. These products are used in a wide range of applications from cosmetics and cosmeceuticals to the prescription treatment of conditions like dermatitis, psoriasis, and eczema. We are currently exploring various options to enable us to expand our development and manufacturing capabilities to include sterile injectable and ophthalmic products.

 

 
 

 

2. Liquidity

 

The Company’s principal sources of liquidity are cash and cash equivalents of approximately $23,248,000 at September 30, 2014, the $2,000,000 available under the $5,000,000 credit facility detailed below and cash from operations. The Company had a net loss of $380,000 for the nine months ended September 30, 2014 and a net loss of $755,000 for the nine months ended September 30, 2013, and had working capital of $22,179,000 at September 30, 2014. The Company will be required to pay up to an additional aggregate of $6,000,000 related to the assets purchased from AstraZeneca (see Note 10).

 

On June 27, 2014, the Company announced the pricing of its underwritten public offering of 4,650,000 shares of its common stock at a price to the public of $5.00 per share (See Note 12). The offer closed on July 2, 2014, and, after giving effect to the underwriters’ exercise of the over-allotment option in full, 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 was approximately $24.9 million.

 

Prior to the most recent public offering, the Company’s business operations have been primarily funded over the past five years through private placements of its capital stock. The Company raised an aggregate of $2,000,000 through private placements of equity with accredited investors in 2012, $7,213,000 in 2010 and $5,304,000 in 2009 principally from private equity investors. The proceeds from these private placements were used for general working capital as well as the acquisition of econazole nitrate cream 1%, which was purchased on February 1, 2013 and launched in September 2013.

 

In August 2012, the Company entered into a $3,000,000 line of credit, which was amended on July 26, 2013. The amendment increased the line of credit to $5,000,000 effective as of December 31, 2013 upon the Company’s compliance with certain covenants (See Note 8). As of September 30, 2014 the outstanding principal balance on the line of credit was $2,854,000. The Company may require additional funding and this funding will 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 2015.

 

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 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 allowances for excess and obsolete inventories, allowances for sales returns, chargebacks, rebates, cash discounts, allowances for doubtful accounts, provisions for income taxes and related deferred tax asset valuation allowance, stock based compensation, and accruals for environmental cleanup and remediation costs. Actual results could differ from those estimates.

 

Loss Per Share

 

Basic net loss per share of common stock is computed based on the weighted average number of shares of common stock outstanding during the period. Diluted net 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. Due to the net loss for the three months ended September 30, 2014 and 2013 and the nine months ended September 30, 2014 and 2013, the effect of the Company’s potential dilutive common stock equivalents was anti-dilutive for those periods; as a result, the basic and diluted weighted average number of shares of common stock outstanding and net loss per common share are the same. Potentially dilutive common stock equivalents include options and warrants to purchase the Company’s common stock and the conversion of preferred stock, which were excluded from the net loss per share calculation for those periods due to their anti-dilutive effect. Potentially dilutive common stock equivalents amounted to 2,588,334 and 5,602,089 at September 30, 2014 and 2013, respectively.

 

 
 

 

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, 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 IGI Product Sales and Contract Manufacturing Sales.

 

IGI Product Sales : The Company records revenue from IGI 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 IGI 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 sales returns and allowances (“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. Currently these provisions are based on industry standards and current contract sales terms with direct and indirect customers. Over time, these provisions are adjusted as estimates are 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 and product pricing trends to analyze and validate the SRA reserves.

 

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

 

    Three months ended September 30,     Nine months ended September 30,  
    2014     2013     2014     2013  
                         
Gross IGI product sales   $ 14,823     $ 3,038     $ 25,618     $ 7,417  
                                 
Reduction to gross product sales:                                
Chargebacks and billbacks     10,365       1,395       13,832       2,618  
Sales discounts and other allowances     1,445       254       2,446       619  
Total reduction to gross product sales   $ 11,810     $ 1,649     $ 16,278     $ 3,237  
                                 
Net IGI product sales   $ 3,013     $ 1,389     $ 9,340     $ 4,180  

 

Accounts receivable are presented net of SRA balances of $4.2 million and $0.5 million at September 30, 2014 and 2013, respectively. Accounts payable and accrued expenses include $0.8 million and $0.3 million at September 30, 2014 and 2013, respectively, for certain fees related to services provided by the wholesalers. Wholesale fees of $0.8 million and $0.1 million for the three month periods ended September 30, 2014 and 2013, respectively, were included in cost of goods sold. Wholesale fees of $1.5 million and $0.4 million for the nine month periods ended September 30, 2014 and 2013, respectively, were included in cost of goods sold. In addition, in connection with four of the six products the Company currently manufactures, markets and distributes in its own label, in accordance with an agreement entered into in December of 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 $0.7 million and $0.5 million at September 30, 2014 and 2013, respectively, related to these royalties. Royalty expense of $0.7 million and $0.5 million was included in cost of goods sold for the three months ended September 30, 2014 and 2013, respectively. Royalty expense of $2.9 million and $1.5 million was included in cost of goods sold for the nine months ended September 30, 2014 and 2013, 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.

 

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.

 

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, 2014, four of the Company’s customers accounted for 59% of the Company’s revenue. For the three months ended September 30, 2013, three of the Company’s customers accounted for 49% of the Company’s revenue. Two of these customers are the same for both periods. For the nine months ended September 30, 2014 and 2013, four of the Company’s customers accounted for 53% and four of the Company’s customers accounted for 55% 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 65% of all accounts receivable as of September 30, 2014. 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 .

 

 
 

 

Recent Accounting Pronouncements

 

In May 2014, 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, 2016 and early adoption is not permitted. Accordingly, the Company will adopt this ASU on January 1, 2017. 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, FASB issued Accounting Standards Update (“ASU”) 2014-15, “Presentation of Financial Statements — Gong 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.

  

4. Inventories

 

Inventories are valued at the lower of cost, using the first-in, first-out (“FIFO”) method, or market.

 

Inventories at September 30, 2014 and December 31, 2013 consist of:

 

    September 30, 2014     December 31, 2013  
    (Unaudited)     (Audited)  
    (amounts in thousands)  
Raw materials   $ 2,647     $ 2,172  
Work in progress     50       271  
Finished goods     521       426  
Total   $ 3,218     $ 2,869  

 

5. 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 2,339,798 options have been granted to non-employee directors through September 30, 2014 and 807,782 of those have been forfeited through September 30, 2014 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 partial written consent, the IGI Laboratories, 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 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 and May 19, 2010, 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, 2014, options to purchase 1,872,334 shares of common stock were outstanding under the 2009 Plan. As of September 30, 2014, 1,473,748 shares of restricted stock had been granted under the 2009 Plan and 230,420 of those have been forfeited through September 30, 2014 and returned to the pool.

 

 
 

 

In summary, there are 2,504,334 options outstanding under the 1999 Plan, the Director Plan and the 2009 Plan, collectively as of September 30, 2014.

 

There are 2,250,820 options available for issuance under the Director Plan and the 2009 Plan collectively as of September 30, 2014.

 

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, 2014  
       
Expected volatility     44.0% - 51.0%  
Expected term (in years)     3.2 -3.3 years  
Risk-free rate     0.74% - 1.11%  
Expected dividends     0%  

 

A summary of option activity under the 1999 Plan, the Director Plan and the 2009 Plan as of September 30, 2014 and changes during the period are presented below:

 

          Weighted  
    Number of
Options
    Average
Exercise Price
 
Outstanding as of January 1, 2014     2,643,500     $ 1.13  
Issued     228,000     $ 3.74  
Exercised     (211,166 )   $ 1.13  
Forfeited     (156,000 )   $ 2.71  
Expired     -       -  
Outstanding as of September 30, 2014     2,504,334     $ 1.27  
                 
Exercisable as of September 30, 2014     1,790,997     $ 1.11  

 

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, 2014 was $1.24.

 

 
 

 

The following table summarizes information regarding options outstanding and exercisable at September 30, 2014:

 

Outstanding:

 

          Weighted
Average
    Weighted
Average
 
Range of Exercise Prices   Stock Options
Outstanding
    Exercise
Price
    Remaining
Contractual Life
 
$0.55 -   $1.00     167,000     $ 0.74       3.70  
$1.01 -  $1.50     2,023,500     $ 1.09       7.14  
$1.51 -   $7.47     313,834     $ 2.68       8.12  
Total     2,504,334     $ 1.27       7.04  

 

Exercisable:

 

    Stock     Weighted
Average
 
Range of Exercise Prices   Options
Exercisable
    Exercise
Price
 
             
$0.55 -   $1.00     167,000     $ 0.74  
$1.01 -  $1.50     1,499,997     $ 1.10  
$1.51 -  $7.47     124,000     $ 1.67  
Total     1,790,997     $ 1.11  

 

As of September 30, 2014, the intrinsic value of the options outstanding is $20,170,218 and the intrinsic value of the options exercisable is $14,709,580. The intrinsic value of options exercised during the nine months ended September 30, 2014 was $1,730,487. As of September 30, 2014, there was approximately $242,000 of total unrecognized compensation cost that will be recognized through September 2017 related to non-vested share-based compensation arrangements granted under the Plans.

 

Restricted Stock

 

The Company periodically grants restricted stock awards to certain officers and other employees that typically vest one to three years from their grant date. The Company recognized $458,000 and $14,700 of compensation expense during the nine months ended September 30, 2014 and 2013, respectively, related to restricted stock awards.  Stock compensation expense is recognized over the vesting period of the restricted stock.  At September 30, 2014, the Company had approximately $163,000 of total unrecognized compensation cost related to non-vested restricted stock, all of which will be recognized from October 2014 through July 2015.

 

    Number of
Restricted Stock
    Weighted Average
Exercise Price
 
Non-vested balance at January 1, 2014     246,001     $ 2.64  
                 
Changes during the period:                
Shares granted     -       -  
Shares vested     (137,667 )     2.46  
Shares forfeited     -       -  
                 
Non-vested balance at September 30, 2014     108,334     $ 2.86  

  

6. Income Taxes

 

The Company has a history of tax losses and has recorded a full valuation allowance against its net deferred tax assets.  The Company has not recorded a significant tax provision at September 30, 2014, as it has estimated its effective tax rate for 2014 (after considering utilization of existing net operating losses) to be insignificant.  The tax years 2010-2013 remain open to examination by the major taxing jurisdictions to which th e Company is subject.

 

 
 

 

The Company’s ability to use net operating loss carry forwards may be subject to substantial limitation in future periods under certain provisions of Section 382 of the Internal Revenue Code, 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 2009 and 2010, as well as the possibility of such limitation having any material effect on the application of net operating loss carry forwards in the immediate future. The Company believes that it is likely that a change in ownership took place in 2009 and that the net operating loss carry forwards generated prior to such date will be limited.

 

7. License Fee

 

On December 12, 2005, the Company extended its license agreement for an additional ten years with Novavax, Inc. for $1,000,000. 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 “IGI Field”) through 2015. This payment is being amortized ratably over the ten-year period. The Company recorded amortization expense of $75,000 related to this agreement for each of the nine month periods ended September 30, 2014 and 2013.

 

8. Note Payable - Bank

 

On August 31, 2012, IGI Laboratories, Inc. and its subsidiaries 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 (the “Financing”). The Company drew down $1,000,000 in principal amount on August 31, 2012, $1,000,000 in principal amount on February 5, 2013 and $1,000,000 in principal amount on August 2, 2013. At September 30, 2014, $2,854,000 in principal was outstanding.

 

To secure payment of the amounts financed under the Loan and Security Agreement, the Company has granted to the Lender a continuing security interest in and against, generally, all of its tangible and intangible assets, except intellectual property.

 

Under the Loan and Security Agreement, the Company can request revolving loan advances under (a) the Formula Revolving Line and (b) the Non-Formula Revolving Line, and term loan advances under the term loans. The aggregate total borrowings under the facilities cannot exceed the total borrowing limit of $3,000,000 at any one time outstanding. Formula Revolving Line advances shall bear interest, on the outstanding balance thereof, at a variable rate equal to the greater of (A) 1.9% above the prime rate then in effect, and (B) 5.65%. Non-Formula Revolving Line advances shall bear interest, on the outstanding balance thereof, at a variable rate equal to the greater of (A) 2.15% above the prime rate then in effect, and (B) 5.9%. Term loan advances shall bear interest, on the outstanding balance thereof, at a variable rate equal to the greater of (A) 2.4% above the prime rate then in effect, and (B) the rate in effect at September 30, 2014, which was 6.15%.

 

The term of the Formula Revolving Line and the Non-Formula Revolving Line is one year from the date of the Loan and Security Agreement and can be extended by mutual agreement of the parties. The term of the term loans is 42 months from the date of the Loan and Security Agreement, and the Company is finalizing negotiations to extend the drawdown period.

 

In accordance with the Loan and Security Agreement, the Company had to maintain a liquidity ratio of at least 1.25 to 1.00 (the “LQR Threshold”), provided that the LQR Threshold was reduced to 1.00 so long as the Company had achieved minimum revenue, measured monthly on a trailing three month basis, of at least the amounts listed in the document for the corresponding reporting periods. To further clarify, if at any time the Company is not in compliance with the minimum revenue amounts set forth below, the LQR Threshold would be increased to 1.25 to 1.00. “Liquidity” means the sum of: (i) unrestricted cash in bank plus (ii) the Borrowing Base (as defined under the Loan and Security Agreements, or the amount drawn to date). In accordance with the Loan and Security Agreement, liquidity ratio means the ratio of Liquidity to all Indebtedness (as defined under the Loan and Security Agreement) to the Lender (but excluding any Indebtedness to the Lender which is secured by cash held in a segregated deposit account at the Lender). As of September 30, 2014, the Company was in compliance with the LQR Threshold required under the Loan and Security Agreement.

 

 
 

 

On July 26, 2013, the Company entered into an Amendment to the Loan and Security Agreement (the “Amendment”). In accordance with the Amendment, notwithstanding the existing LQR Thresholds, for so long as the Company is in compliance with the minimum revenue requirements established in this Amendment, the Company shall be permitted to maintain a liquidity ratio of not less than .90 to 1.00 for a continuous 60 day period every 12 months. In connection with the lower liquidity ratio, in accordance with the Amendment, under the Formula Revolving Line advances shall bear interest, on the outstanding balance thereof, at a variable rate equal to the greater of (A) 4.9% above the prime rate then in effect, and (B) 8.65%. Non-Formula Revolving Line advances shall bear interest, on the outstanding balance thereof, at a variable rate equal to the greater of (A) 5.15% above the prime rate then in effect, and (B) 8.9%, until such time that the lower liquidity ratio is no longer in place. On December 31, 2013, the aggregate borrowing amount was increased from $3,000,000 to $5,000,000.

 

9. Stock Warrants

 

Stock Warrant activity for the quarters ended September 30, 2014 and 2013 consisted of:

 

    2014     2013  
          Weighted           Weighted  
          Average           Average  
    Warrants     Exercise Price     Warrants     Exercise Price  
                         
Beginning balance     354,546     $ 1.21       782,259     $ 0.85  
                                 
Stock warrants granted     -       -       -       -  
Stock warrants expired     -       -       -       -  
Stock warrants exercised     (270,546 )     1.21       (427,713 )     0.55  
                                 
Ending balance     84,000     $ 1.21       354,546     $ 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.

 

In addition, as of December 31, 2012 the Company executed a settlement agreement with Amzak Capital Management, LLC in connection with a common stock purchase warrant that we issued to Amzak on December 21, 2012 under which the Company issued a ten-year warrant to purchase up to 427,713 shares of the Company’s common stock, with an exercise price of $0.55 per share. The warrants were exercised in full on February 8, 2013. The amount of the fair value of the warrant issued was $209,000, and included as interest expense in 2012, as it related to the credit agreement which was terminated in August of 2012.

 

10. Asset Purchase Agreements

 

On February 1, 2013, the Company entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Prasco, LLC, an Ohio limited liability company (“Prasco”), pursuant to which the Company purchased from Prasco assets associated with econazole nitrate cream 1% (the “Product”), which is available in 15g, 30g, and 85g tubes and has the FDA approved indications for the treatment of tinea pedis, tinea cruris, and tinea corporis as well as the treatment of cutaneous candidiasis and tinea versicolor.

 

In consideration for the purchase of the assets pursuant to the Purchase Agreement, the Company paid Prasco $1,400,000 in cash and an additional aggregate of $400,000 upon the occurrence of certain milestone events (the “Milestone Payment”). The Milestone Payment is secured by a first-priority security interest in the acquired assets under the Purchase Agreement. 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 $1,800,000.  The Company capitalized and amortized the costs over fifteen years, the useful life of the acquired product and product rights.

 

 
 

 

Under and subject to the terms and conditions of the Purchase Agreement, Prasco continued to distribute the Product during a six-month period following the closing of the Purchase Agreement, and the Company completed the technical transfer of the Product and begun manufacturing the Product under its own label during the third quarter of 2013. Beginning in the third quarter of 2013, the Company’s product sales included sales of the product.

 

In addition, the Purchase Agreement contains certain non-compete restrictions preventing Prasco from selling the Product in the United States for a period of seven years.

 

On October 23, 2013, the Company announced that it had received formal approval from the FDA for the CBE-30 supplemental filing to approve the site transfer of the Econazole nitrate cream 1%, to the Company’s manufacturing facility in Buena, New Jersey.

 

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 $500,000 in cash and will be required to pay up to an additional aggregate of $6,000,000 upon the occurrence of a certain milestone event. 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 $3,000,000. 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 $6,914,000.  The Company capitalized and amortized the costs over fifteen years, the useful life of the acquired products and product rights.

 

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 one 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 relating 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”).

 

In consideration for the purchase of the Valeant Purchased Assets, the Company paid Valeant an aggregate of $1,500,000 in cash. In consideration for the purchase of the Additional Assets, the Company may exercise any Option, in its sole discretion, and pay $750,000 for each of two additional products and $500,000 for one additional product, for a total aggregate of $2,000,000 if all Options are exercised. 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 $1,545,000.  The Company capitalized and amortized the costs over fifteen years, the useful life of the acquired product and product rights.

 

11. Legal

 

The Company is involved from time to time in claims which arise in the ordinary course of business. 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 the Company relating to intellectual property rights and intellectual property licenses, could have a material adverse effect on its business, financial condition and operating results.

 

On December 19, 2013, the Company filed a complaint in the United States District Court for the District of Delaware against Mallinckrodt LLC, Mallinckrodt, Inc. and Nuvo Research Inc. (collectively, “Mallinckrodt”) seeking a declaration of non-infringement of United States Patent Nos. 8,217,078 and 8,546,450 so that the Company can bring its generic diclofenac sodium topical solution 1.5% to market at the earliest possible date under applicable statutory and FDA regulatory provisions.

 

 
 

 

On January 10, 2014, Mallinckrodt filed an answer and counterclaim alleging that IGI Laboratories, Inc. infringes the patents at issue. On January 28, 2014, the Company filed a motion to dismiss Mallinckrodt’s counterclaim and, on March 5, 2014, Mallinckrodt filed an opposition to such motion. On April 22, 2014, the court issued a Memorandum Order, granting in part and denying in part IGI’s motion to dismiss Mallinckrodt’s counterclaims.

 

On June 26, 2014, the Company entered into an agreement with Mallinckrodt to settle a declaratory judgment action brought by IGI, concerning the Company’s filing of an ANDA with the FDA seeking approval to market a generic version of Pennsaid® (diclofenac sodium topical solution) 1.5% w/w. Under the terms of this agreement, Mallinckrodt granted the Company a non-exclusive license to launch its diclofenac sodium topical solution 1.5% product on March 28, 2015.  There was no material impact on the financial statements as a result of the settlement. The Company received tentative approval of its diclofenac sodium topical solution 1.5% from the FDA on May 7, 2014.

 

12. 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 (the “shares ”), 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 Securities and Exchange Commission (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.

 

The Company intends to use the net proceeds of the offering for general corporate purposes, including, without limitation, research and development, general and administrative, manufacturing and marketing expenses, and potential not yet identified acquisitions of companies, products, ANDAs, technologies and assets that complement the Company’s business.

 

 
 

 

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, 2013, 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

 

IGI Laboratories, Inc. is a specialty generic pharmaceutical company. Our mission is to become a leader in the specialty generic pharmaceutical market. Under our IGI label, we currently sell generic topical pharmaceutical products that are bioequivalent to their brand name counterparts. We also provide development, formulation, and manufacturing services to the pharmaceutical, over-the-counter (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.

 

In addition, we may continue to explore ways to accelerate our growth through the creation of unique opportunities from the acquisition of additional intellectual property, and the expansion of the use of our existing intellectual property, including our licensed Novasome® technology.

 

To date, we have filed nineteen Abbreviated New Drug Applications, or ANDAs, with the United States Food and Drug Administration, or FDA for additional pharmaceutical products. 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 at least ten ANDAs in 2014 through our internal research and development program. On March 12, 2014, the Company received our first approval from the FDA for an ANDA. The FDA has approved IGI's application for lidocaine hydrochloride USP 4% topical solution. On May 7, 2014, the Company received tentative approval from the FDA for its ANDA for diclofenac sodium 1.5% topical solution. On June 26, 2014, the Company executed an agreement to enable it to launch the product in March 2015 after final FDA approval. We will also seek to license or acquire further products, intellectual property, or ANDAs to expand our portfolio.

 

On February 1, 2013, we acquired assets and intellectual property, including an ANDA, for econazole nitrate cream 1%, which we launched in September 2013.

 

 
 

 

On September 24, 2014, we acquired from AstraZeneca ANDAs and NDAs associated with eighteen products, seventeen of which were injectable products. On September 30, 2014, we acquired ANDAs and NDAs associated with two ophthalmic products from Valeant, in addition to the exclusive right to acquire three additional injectable products from Valeant.

 

We also develop, manufacture, fill, and package topical semi-solid and liquid products for branded and generic pharmaceutical customers as well as the OTC and cosmetic markets. These products are used in a wide range of applications from cosmetics and cosmeceuticals to the prescription treatment of conditions like dermatitis, psoriasis, and eczema. We are currently exploring various options to enable us to expand our development and manufacturing capabilities to include sterile injectable and ophthalmic products.

 

IGI also develops, manufactures, fills, and packages topical semi-solid and liquid products for branded and generic pharmaceutical customers as well as the OTC and cosmetic markets. These products are used in a wide range of applications from cosmetics and cosmeceuticals to the prescription treatment of conditions like dermatitis, psoriasis, and eczema.

 

Recent Events

 

On March 12, 2014, we received our first approval from the FDA for an ANDA. Lidocaine hydrochloride USP 4% topical solution is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract. Based on November 2013 IMS Health data, the total addressable market for the generic version of this product is approximately $1.8 million, in which IGI will currently compete with two other manufacturers. IGI originally submitted this ANDA to the FDA in May 2012.

 

On May 7, 2014, we received a tentative approval from the FDA for an ANDA. Diclofenac sodium topical solution, 1.5% is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain of osteoarthritis of the knee. Based on recent IMS Health data, the total addressable market for this product is approximately $29 million. IGI originally submitted this ANDA to the FDA in December 2010.

 

On June 26, 2014, we entered into an agreement with Mallinckrodt to settle a declaratory judgment action brought by the Company, concerning our filing of an ANDA with the FDA seeking approval to market a generic version of Pennsaid® (diclofenac sodium topical solution) 1.5% w/w. Under the terms of this agreement, Mallinckrodt granted us a non-exclusive license to launch our diclofenac sodium topical solution 1.5% product on March 28, 2015.  We received tentative approval of our diclofenac sodium topical solution 1.5% from the FDA on May 7, 2014.

 

On July 2, 2014, after giving effect to the underwriters’ exercise of the over-allotment option in full, we closed the sale of an aggregate of 5,347,500 shares of common stock in a public underwritten offering at a public offering price of $5.00 per share. The net proceeds of the offering was approximately $24.9 million.

 

On September 24, 2014, we acquired from AstraZeneca ANDAs and NDAs associated with eighteen AstraZeneca products, seventeen of which were injectable products.

 

On September 30, 2014, we acquired ANDAs and NDAs associated with two ophthalmic products from Valeant, in addition to the exclusive right to acquire three additional injectable products from Valeant.

 

Results of Operations

 

Three months ended September 30, 2014 compared to September 30, 2013

 

We had a net loss of $202,000, or $0.00 per share, for the three months ended September 30, 2014, compared to $95,000, or $0.01 per share, for the three months ended September 30, 2013, which resulted from the following:

 

 
 

 

Revenues (in thousands):

 

    Three Months Ended September 30,        
Components of Revenue:   2014     2013     $ Change     % Change  
Product sales, net   $ 6,005     $ 3,950     $ 2,055       52 %
Research and development income     635       10       625       6250 %
Licensing, royalty and other revenue     28       35       (7 )     (20 )%
Total Revenues   $ 6,668     $ 3,995     $ 2,673       67 %

 

The increase in product sales for the three months ended September 30, 2014 as compared to the same period in 2013 was primarily due to increased revenue from our own generic pharmaceutical product line that was launched in the first quarter of 2013, the launch of econazole nitrate cream 1% in September 2013 and the launch of two additional IGI label products in June 2014. In addition we increased product sales in our contract manufacturing services to three of our major pharmaceutical customers, which was only partially offset by decreased sales to three of our cosmetic customers and one of our pharmaceutical customers. 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.

 

Costs and expenses (in thousands):

 

    Three Months Ended September 30,        
    2014     2013     $ Change     % Change  
Cost of sales   $ 4,036     $ 2,684     $ 1,352       50 %
Selling, general and administrative     1,124       692       432       62 %
Product development and research     1,652       661       991       150 %
Totals costs and expenditures   $ 6,812     $ 4,037     $ 2,775       69 %

 

Cost of sales increased for the three months ended September 30, 2014 as a result of the increase in total revenue. Cost of sales as a percentage of total revenue was 61% for the three months ended September 30, 2014 as compared to 67% for the three months ended September 30, 2013. The decrease in cost of sales as a percentage of product sales for 2014 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. 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 three months ended September 30, 2014 increased by $432,000 as compared to the same period in 2013. There were increases of $246,000 in salaries, bonuses and related costs, $74,000 in the expense from the issuance of stock based compensation related to options and restricted stock, $72,000 in professional fees, $21,000 in dues and subscriptions and $15,000 in travel related.

 

Product development and research expenses for the three months ended September 30, 2014 increased by $991,000 as compared to the same period in 2013. Consistent with our strategy to expand our portfolio of generic prescription pharmaceutical products, we increased spending on clinical studies by $246,000, pilot batch expense by $224,000, outside testing and supplies by $267,000, consulting fees by $248,000 and salaries, bonuses and related costs by $27,000. These increases were partially offset by a decrease of $23,000 in fees related to the Generic Drug User Fee Act and the associated filing of our applications with the FDA.

 

Interest expense and other, net (in thousands):

 

    Three Months Ended September 30,        
    2014     2013     $ Change     % Change  
Interest expense   $ 58     $ 53     $ 5       9 %

 

 
 

 

Interest expense increased for the three months ended September 30, 2014 as compared to the same period in 2013 due to the increase in the amount of the Note Payable – Bank (see Note 8 to the Company’s Consolidated Financial Statements) outstanding during the three months ended September 30, 2014 as compared to the same period in 2013.

 

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

 

    Three Months Ended September 30,        
    2014     2013     $ Change     % Change  
Net loss   $ (202 )   $ (95 )   $ 107       113 %
Net loss per share   $ 0.00     $ 0.00     $ 0.00       0 %

 

Net loss for the three months ended September 30, 2014 was $202,000 as compared to $95,000 in the same period last year. The increase is due to the increases in costs and expenses described above, partially offset by the increases in revenues.

 

Nine months ended September 30, 2014 compared to September 30, 2013

 

The Company had a net loss of $380,000, or $0.01 per share, for the nine months ended September 30, 2014, compared to $755,000, or $0.02 per share, in the comparable period in 2013, which resulted from the following:

 

Revenues (in thousands):

 

    Nine Months Ended September 30,        
Components of Revenue:   2014     2013     $ Change     % Change  
Product sales   $ 18,525     $ 11,124     $ 7,401       67 %
Research and development income     1,385       278       1,107       398 %
Licensing, royalty and other income     95       97       (2 )     (2 )%
Total Revenues   $ 20,005     $ 11,499     $ 8,506       74 %

 

The increase in product sales for the nine months ended September 30, 2014 as compared to the same period in 2013 was primarily due to the increased revenue from our own generic pharmaceutical product line that was launched in the first quarter of 2013, the launch of econazole nitrate cream 1% in September 2013 and the launch of two additional IGI label products in June 2014. In addition we increased product sales in our contract services business to two of our pharmaceutical customers, which was only partially offset by decreased sales to two of our cosmetic customers. 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.

 

Costs and expenses (in thousands):

 

    Nine Months Ended September 30,        
    2014     2013     $ Change     % Change  
Cost of sales   $ 11,603     $ 7,932     $ 3,671       46 %
Selling, general and administrative     3,563       2,078       1,485       71 %
Product development and research     5,045       2,123       2,922       138 %
Totals costs and expenditures   $ 20,211     $ 12,133     $ 8,078       67 %

 

Cost of sales increased for the nine months ended September 30, 2014 as a result of the increase in total revenue. Cost of sales as a percentage of total revenue was 58% for the nine months ended September 30, 2014 as compared to 69% for the nine months ended September 30, 2013. Cost of sales as a percentage of total revenue declined as a result of an increase in revenue from our own generic pharmaceutical product line and a shift in the mix of our contract manufacturing product sales to include greater higher margin pharmaceutical products. We expect cost of sales as a percentage of product sales to decline over time.

 

 
 

 

Selling, general and administrative expenses for the nine months ended September 30, 2014 increased by $1,485,000 as compared to the same period in 2013. There were increases in salaries and related costs of $550,000 due to an increase in headcount, professional fees of $277,000, $478,000 in the expense from the issuance of stock based compensation related to options and restricted stock, travel related costs of $47,000, $60,000 in amortization of product acquisition costs and dues, subscriptions and corporate fees of $98,000 during the nine months ended September 30, 2014 as compared to the same period in 2013. These increases were partially offset by a decrease of $31,000 in trade show expenses.

 

Product development and research expenses for the nine months ended September 30, 2014 increased by $2,922,000 as compared to the same period in 2013. Consistent with our strategy to expand our portfolio of generic prescription pharmaceutical products, we increased headcount, which resulted in an increase of $65,000 in salaries and related costs, we increased spending on clinical studies by $874,000, pilot batch expense by $677,000, outside testing and supplies by $529,000 and consulting fees by $248,000. In addition, fees related to the Generic Drug User Fee Act, and the associated filing of our applications with the FDA increased by $531,000.

 

Interest expense and other, net (in thousands):

 

    Nine Months Ended September 30,        
    2014     2013     $ Change     % Change  
Interest expense   $ 163     $ 126     $ 37       29 %
Other (income) expense   $ 11     $ (5 )   $ 16       320 %

 

Interest expense increased for the nine months ended September 30, 2014 as compared to the same period in 2013 due to the increase in the amount of the Note Payable – Bank (see Note 8 to the Company’s Consolidated Financial Statements) outstanding during the nine months ended September 30, 2014 as compared to the same period in 2013.

 

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

 

    Nine Months Ended September 30,        
    2014     2013     $ Change     % Change  
Net loss   $ (380 )   $ (755 )   $ (375 )     (50 )%
Net loss per share   $ (0.01 )   $ (0.02 )   $ (0.01 )     (50 )%

 

The decrease in net loss for the nine months ended September 30, 2014 as compared to the same period in 2013 is due to the increase in revenues partially offset by the increases in costs and expenses noted above.

 

Liquidity and Capital Resources

 

The Company's operating activities used $1,030,000 of cash during the nine months ended September 30, 2014 compared to $1,391,000 of cash used in operating activities during the nine months ended September 30, 2013. The cash used by operating activities for the nine months ended September 30, 2014 was partially a result of the net loss, in addition to non-cash expenses for the period offset by a net increase in operating assets and liabilities. The use of cash for the nine months ended September 30, 2013 was a result of the net loss and the changes in operating assets and liabilities, particularly a significant increase in accounts receivable related to the launch of our IGI label products.

 

The Company’s investing activities used $3,077,000 during the nine months ended September 30, 2014 compared to $2,049,000 of cash used in investing activities during the nine months ended September 30, 2013. The funds used for the nine months ended September 30, 2014 were for the purchase of products (see Note 10 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 funds used for the period ended September 30, 2013 were for the purchase of econazole nitrate cream (see Note 10 to the Company’s Condensed Consolidated Financial Statements) and additional equipment and improvements in the compounding area and packaging and filling lines.

 

 
 

 

The Company's financing activities provided $25,254,000 of cash during the nine months ended September 30, 2014 compared to $2,306,000 of cash provided during the nine months ended September 30, 2013. The cash provided for the nine months ended September 30, 2014 was mainly the $24,870,000 proceeds from the issuance of stock (see Note 12 to the Company’s Consolidated Financial Statements) and the $565,000 proceeds from the exercise of common stock warrants and options and the cash provided for the nine month period ended September 30, 2013 was mainly the proceeds of $2,000,000 from the drawdown of the Note Payable (see Note 8 to the Company’s Consolidated Financial Statements) and $372,000 of proceeds from the exercise of common stock warrants and options.

 

The Company’s principal sources of liquidity are cash and cash equivalents of approximately $23,248,000 at September 30, 2014, the $2,000,000 available on the $5,000,000 credit facility detailed in Note 8 and future cash from operations. The Company had working capital of $22,179,000 at September 30, 2014. The Company will be required to pay up to an additional aggregate of $6,000,000 related to the assets purchased from AstraZeneca Pharmaceuticals LP (see Note 10).

 

The Company may require additional funding and this funding will 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 2015.

 

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

 

IGI’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, 2013 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

 

This item is not required as we are a smaller reporting company.

 

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, 2014. Based on that evaluation, our Chief Executive Officer and Principal Financial and Accounting Officer concluded that, as of September 30, 2014, the Company’s disclosure controls and procedures were effective.

 

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.

 

 
 

 

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. 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 December 19, 2013, we filed a complaint in the United States District Court for the District of Delaware against Mallinckrodt LLC, Mallinckrodt, Inc. and Nuvo Research Inc. (collectively, “Mallinckrodt”) seeking a declaration of non-infringement of United States Patent Nos. 8,217,078 and 8,546,450 so that we can bring our generic diclofenac sodium topical solution 1.5% to market at the earliest possible date under applicable statutory and FDA regulatory provisions.

 

On January 10, 2014, Mallinckrodt filed an answer and counterclaim alleging that IGI Laboratories, Inc. infringes the patents at issue. On January 28, 2014, we filed a motion to dismiss Mallinckrodt’s counterclaim and, on March 5, 2014, Mallinckrodt filed an opposition to such motion. On April 22, 2014, the court issued a Memorandum Order, granting in part and denying in part IGI’s motion to dismiss Mallinckrodt’s counterclaims.

 

On June 26, 2014, we entered into an agreement with Mallinckrodt to settle a declaratory judgment action brought by IGI, concerning our filing of an ANDA with the FDA seeking approval to market a generic version of Pennsaid® (diclofenac sodium topical solution) 1.5% w/w. Under the terms of this agreement, Mallinckrodt granted us a non-exclusive license to launch our diclofenac sodium topical solution 1.5% product on March 28, 2015.  We received tentative approval of our diclofenac sodium topical solution 1.5% from the FDA on May 7, 2014.

 

ITEM 1A. Risk Factors .

 

Part I, Item 1A, “Risk Factors,” of our Annual Report on Form 10-K for the year ended December 31, 2013 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, 2013 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. Four of our customers accounted for 59% of our revenue for the three months ended September 30, 2014 and three of our customers accounted for 49% of our revenue for the three months ended September 30, 2013. Four of our customers accounted for 53% of our revenue for the nine months ended September 30, 2014 and four of our customers accounted for 55% of our revenue for the nine months ended September 30, 2013. 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 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.

 

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, 2014, our stockholders’ equity was $33 million and we had an accumulated deficit of $45 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.

 

 
 

 

We may not be able to fully realize the expected benefits from the acquisition of certain products.

 

Our recent acquisition of certain products subjects us to additional operational and financial risks, including the following:

 

· additional costs that we may need to incur in order to return the products to the market and to comply with regulatory requirements;
· difficulties in coordinating research and development activities;   
· uncertainties in the business relationships with our customers and suppliers; and   
· lack of previous experiences in manufacturing, commercializing, and distributing products in therapeutic areas outside of the topical generic pharmaceutical market.  

 

Our approved products may not achieve commercialization at levels of market acceptance that allow us to achieve profitability, which could have a material adverse effect on its business, financial position and results of operations.

 

We seek to develop, license or acquire products that we can commercialize at levels of market acceptance that would allow us to recoup the costs of development and commercialization, grow market share, and achieve profitability. Even if we are able to obtain regulatory approvals for certain pharmaceutical products, if we fail to accurately predict demand for such products, our business, financial position, and results of operations could be adversely impacted. Levels of market acceptance for products could be impacted by several factors, including but not limited to:

 

  · the availability of alternative products from our competitors;
  · the price of our products relative to that of our competitors;
  · the effectiveness of our marketing relative to that of our competitors;
  · the timing of our market entry;
  · the ability to market our products effectively to the retail level; and
  · the acceptance of our products by government and private formularies.

 

Some of these factors are not within our control and, if any arises, our profitability, business, financial position and results of operations could be materially adversely affected.

 

Future acquisitions and investments could disrupt our business and harm our financial condition and operating results.

 

Our growth will depend, in part, on its continued ability to develop, commercialize and expand its drug products, including in response to changing regulatory and competitive pressures. In some circumstances, we accelerate our growth through the acquisition of complementary products and technologies rather than through internal development. The identification of suitable products to be acquired can be difficult, time-consuming and costly, and we may not be able to successfully complete or successfully execute strategies for identified acquisitions. The risks faced in connection with acquisitions include:

 

  · diversion of management time and focus from operating the Company's business to addressing acquisition and/or product integration challenges;
  · coordination of research and development and sales and marketing functions;
  · retention of key employees from the acquired company;
  · integration of the acquired company’s accounting, management information, human resources and other administrative systems; 
  · the need to implement or improve controls, procedures, and policies at a business that prior to the acquisition may have lacked effective controls, procedures and policies; 
  · liability for activities of the acquired company and/or products before the acquisition, including patent infringement claims, violations of laws, commercial disputes, tax liabilities and other known and unknown liabilities;
  · unanticipated write-offs or charges; and 
  · litigation or other claims in connection with the acquired company or product, including claims from product users, former stockholders or other third parties.

 

In any acquisition that we may undertake, our failure to address these risks or other problems encountered in connection with any acquisitions and investments could cause us to fail to realize the anticipated benefits of these acquisitions or investments, cause us to incur unanticipated liabilities, and harm our business generally.

 

 
 

 

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, 2014, the average daily trading volume of our Common Stock on the NYSE MKT was approximately 506,000 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.

 

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.

 

ITEM 6.    Exhibits

 

Exhibit    
Number   Description
     
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 June 30, 2014, 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.

 

 
 

 

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.

 

  IGI Laboratories, Inc.
   
Date: November 13, 2014 By: /s/    Jason Grenfell-Gardner
    Jason Grenfell-Gardner
    President and Chief Executive Officer
Date: November 13, 2014 By: /s/    Jenniffer Collins
    Jenniffer Collins
    Chief Financial Officer

 

 
 

 

Exhibit Index

 

Exhibit    
Number   Description
     
10.1†   Asset Purchase Agreement dated as of September 24, 2014, by and between IGI Laboratories, Inc. and
    AstraZeneca Pharmaceuticals LP
     
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 June 30, 2014, 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, which portions have been omitted and filed separately with the Securities and Exchange Commission as part of an application for confidential treatment pursuant to the Securities and Exchange Act of 1934, as amended.

 

 

 

Exhibit 10.1

 

Confidential

 

ASSET PURCHASE AGREEMENT

 

By and between

 

AstraZeneca Pharmaceuticals LP

 

and

 

IGI Laboratories, Inc.

 

Dated as of September 24, 2014

 

 
 

   

TABLE OF CONTENTS

 

ARTICLE 1 DEFINITIONS 1
     
  1.1 Certain Defined Terms 1
  1.2 Construction 9
       
ARTICLE 2 SALE AND PURCHASE OF ASSETS; LIABILITIES; TRANSITIONAL TRADEMARK LICENSE 9
   
  2.1 Sale of Purchased Assets 9
  2.2 Liabilities 10
  2.3 Consideration 10
  2.4 Closing. 14
  2.5 Withholding Rights 15
       
ARTICLE 3 REPRESENTATIONS AND WARRANTIES 15
     
  3.1 Representations and Warranties of Seller 15
  3.2 Representations and Warranties of Buyer 17
  3.3 Exclusivity of Representations 18
       
ARTICLE 4 ADDITIONAL COVENANTS 19
     
  4.1 Cooperation in Litigation and Investigations 19
  4.2 Further Assurances 19
  4.3 Publicity 20
  4.4 Confidentiality 20
  4.5 FDA Letters 22
  4.6 Regulatory Responsibilities 22
  4.7 Certain Tax Matters 22
  4.8 Wrong Pockets 23
       
ARTICLE 5 INDEMNIFICATION 24
     
  5.1 Indemnification 24
  5.2 Claim Procedure 25
  5.3 Limitations on Indemnification 26
  5.4 Tax Treatment of Indemnification Payments 27
  5.5 Exclusive Remedy 27
  5.6 Disclaimer 28
       
ARTICLE 6 MISCELLANEOUS 28
     
  6.1 Governing Law, Jurisdiction, Venue and Service 28

 

i
 

  

  6.2 Notices 28
  6.3 No Benefit to Third Parties 30
  6.4 Waiver and Non-Exclusion of Remedies 30
  6.5 Expenses 30
  6.6 Assignment 30
  6.7 Amendment 30
  6.8 Severability 31
  6.9 Equitable Relief 31
  6.10 English Language 31
  6.11 Bulk Sales Statutes 31
  6.12 Counterparts 31
  6.13 Entire Agreement 31

 

EXHIBITS

 

Exhibit A Form of Bill of Sale and Assignment and Assumption Agreement
Exhibit B Form of Buyer FDA Intent Letter
Exhibit C Form of Buyer FDA Transfer Letter
Exhibit D Form of Seller FDA Intent Letter
Exhibit E Form of Seller FDA Transfer Letter
Exhibit F-1 Form of Joint Press Release
Exhibit F-2 Form of Current Report on Form 8-K

 

SCHEDULES

 

Schedule 1.1.36 Discontinued Products
Schedule1.1.68 Products
Schedule 1.1.85 Seller’s Knowledge

 

ii
 

  

Schedule 2.1.1(a) Purchased Regulatory Approvals
Schedule 2.1.1(b) Box Inventory Listing
Schedule 2.3.2(b) Senior Officers

 

iii
 

  

Schedule 2.4.2(a)(ii)         Delivery of Tangible Purchased Assets

 

iv
 

  

ASSET PURCHASE AGREEMENT

 

This Asset Purchase Agreement (this “ Agreement ”) is made and executed as of September 24, 2014 (the “ Effective Date ”), by and between AstraZeneca Pharmaceuticals LP, a Delaware corporation (“ Seller ”), and IGI Laboratories, Inc., a Delaware corporation (“ Buyer ”). Seller and Buyer are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties .”

 

RECITALS

 

WHEREAS , Seller wishes to sell to Buyer, and Buyer desires to purchase from Seller, certain assets and rights associated with the Products (as defined below), upon the terms and conditions hereinafter set forth.

 

NOW, THEREFORE , in consideration of the mutual benefits to be derived from this Agreement and of the representations, warranties, conditions, agreements and promises contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, hereby agree as follows:

 

ARTICLE 1
DEFINITIONS

 

1.1         Certain Defined Terms. As used herein, the following terms shall have the following meanings:

 

1.1.1          Accountants ” means an accounting firm of national reputation in the United States (excluding each of Seller’s and Buyer’s respective regular outside accounting firms) as may be mutually acceptable to Seller and Buyer; provided , however , if Seller and Buyer are unable to agree on such accounting firm within 10 days or any such mutually selected accounting firm is unwilling or unable to serve, then Seller shall deliver to Buyer a list of three other accounting firms of national reputation in the United States that have not performed services for Seller or Buyer in the preceding three years, and Buyer shall select one of such three accounting firms.

 

1.1.2          Act ” means the Federal Food, Drug, and Cosmetic Act.

 

1.1.3          Affiliate ” means, with respect to a Person, any other Person that, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with such first Person. For purposes of this definition, “control” and, with correlative meanings, the terms “controlled by” and “under common control with” mean (a) the possession, directly or indirectly, of the power to direct the management or policies of a business entity, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise or (b) the ownership, directly or indirectly, of more than 50% of the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity).

 

1.1.4          Agreement ” has the meaning set forth in the preamble hereto.

 

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

 

 
 

  

1.1.5          Allocation ” has the meaning set forth in Section 2.3.8.

 

1.1.6          Ancillary Agreements ” means the Bill of Sale.

 

1.1.7          ANDA ” means an Abbreviated New Drug Application as defined in the Act.

 

1.1.8          Apportioned Obligations ” has the meaning set forth in Section 4.7.1(b).

 

1.1.9          Assumed Liabilities ” has the meaning set forth in Section 2.2.1.

 

1.1.10        Bill of Sale ” means that certain Bill of Sale and Assignment and Assumption Agreement, in substantially the form of Exhibit A .

 

1.1.11        Business Day ” means any day other than Saturday, Sunday or a day on which banking institutions in New York, New York are permitted or obligated by Law to remain closed.

 

1.1.12        Buy-Out Payment ” has the meaning set forth in Section 2.3.3(c).

 

1.1.13        Buyer ” has the meaning set forth in the preamble hereto.

 

1.1.14        Buyer Confidential Information ” has the meaning set forth in Section 4.4.2.

 

1.1.15        Buyer FDA Intent Letters ” means the letters to the FDA in the form of Exhibit B , indicating Buyer’s intent to accept the transfer of rights to the Purchased Regulatory Approvals from Seller.

 

1.1.16        Buyer FDA Transfer Letters ” means the letters to the FDA in the form of Exhibit C , indicating Buyer’s acceptance of the rights to the Purchased Regulatory Approvals from Seller.

 

1.1.17        Buyer Indemnitees ” has the meaning set forth in Section 5.1.1.

 

1.1.18        Buyer Material Adverse Effect ” means any event, fact, condition, occurrence, change or effect that prevents or materially impedes or delays the consummation by Buyer of the transactions contemplated by this Agreement or the Ancillary Agreements.

 

1.1.19        Buyer Permitted Purpose ” has the meaning set forth in Section 4.4.3.

 

1.1.20        Calendar Quarter ” means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30 and December 31.

 

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

 

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1.1.21        Calendar Year ” means each successive period of 12 calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the this Agreement shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs.

 

1.1.22        Cap ” has the meaning set forth in Section 5.3.1.

 

1.1.23        Claim Notice ” has the meaning set forth in Section 5.2.2.

 

1.1.24        Closing ” has the meaning set forth in Section 2.4.1.

 

1.1.25        Code ” means the Internal Revenue Code of 1986.

 

1.1.26        Confidential Information ” has the meaning set forth in Section 4.4.1.

 

1.1.27        Confidentiality Agreement ” means that certain Confidential Disclosure Agreement, dated June 9, 2014, among Seller, Buyer and RF Consulting LLC.

 

1.1.28        Contract ” means any contract, agreement, lease, sublease, license, sublicense or other legally binding commitment or arrangement.

 

1.1.29        Controlling Party ” has the meaning set forth in Section 5.2.2.

 

1.1.30        Cost of Goods ” means, with respect to a Royalty Product, [***].

 

1.1.31        Deductible ” has the meaning set forth in Section 5.3.1.

 

1.1.32        Delivery Date ” has the meaning set forth in Schedule 2.4.2(a)(ii).

 

1.1.33       Diligent Efforts ” means [***].

 

1.1.34        Disclosing Party ” has the meaning set forth in Section 4.4.1.

 

1.1.35        Disclosure Schedules ” means the disclosure schedules of Seller related to the representations and warranties of Seller set forth in Section 3.1.

 

1.1.36        Discontinued Products ” means the Products set forth on Schedule 1.1.36 .

 

1.1.37        Excluded Assets ” means all assets, property, rights and interests of Seller and its Affiliates other than the Purchased Assets.

 

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

 

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1.1.38        Excluded Liabilities ” means [***].

 

1.1.39        Effect ” has the meaning set forth in the definition of Material Adverse Effect.

 

1.1.40        Effective Date ” has the meaning set forth in the preamble hereto.

 

1.1.41        Exploit ” or “ Exploitation means to make, have made, manufacture, import, export, use, sell, offer for sale, research, develop, commercialize, hold or keep (whether for disposal or otherwise), transport, distribute, promote, market, or otherwise dispose of.

 

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

 

1.1.43        First Commercial Sale ” means, with respect to a Royalty Product, the first sale for monetary value for use or consumption by the end user of such Royalty Product [***].

 

1.1.44        GAAP ” means generally accepted accounting principles in the United States, consistently applied.

 

1.1.45        Governmental Authority ” means any supranational, international, federal, state or local court, administrative agency or commission or other governmental authority or instrumentality, domestic or foreign, including the FDA and any corresponding foreign agency.

 

1.1.46        Gross Profits ” means, with respect to a Royalty Product during any period of time [***].

 

1.1.47        IND ” means an Investigational New Drug Application as defined in the Act.

 

1.1.48        Indemnification Certificate ” has the meaning set forth in Section 5.2.1.

 

1.1.49        Indemnified Party ” has the meaning set forth in Section 5.2.1.

 

1.1.50        Indemnifying Party ” has the meaning set forth in Section 5.2.1.

 

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

 

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1.1.51        Law ” means any domestic or foreign, federal, state or local statute, law, treaty, judgment, ordinance, rule, administrative interpretation, regulation, order or other requirement having the force of law of any Governmental Authority.

 

1.1.52        Liabilities ” means any debts, liabilities, obligations, commitments, claims or complaints, whether accrued or fixed, known or unknown, fixed or contingent, determined or determinable (including all adverse reactions, recalls, product and packaging complaints and other liabilities) due or to become due, wherever or however arising and whether or not the same would be required to be reflected in financial statements or disclosed in the notes thereto.

 

1.1.53        Lien ” means, with respect to any Purchased Asset, any lien, security interest, mortgage, pledge, assessment, hypothecation, easement, title retention clause, or other encumbrance, whether or not of record, or any contract to give any of the foregoing.

 

1.1.54        Litigation ” means any claim, action, arbitration, mediation, hearing, proceeding, suit, warning letter, or notice of violation.

 

1.1.55        Loss ” or “ Losses ” means any Liabilities, losses, damages, judgments, fines, penalties, amounts paid in settlement and reasonable costs and expenses incurred in connection therewith, including reasonable costs and expenses of suits and proceedings, and reasonable fees and disbursements of counsel.

 

1.1.56        Material Adverse Effect ” means an event, fact, condition, occurrence, change or effect (“ Effect ”) that, individually or considered together with all other Effects, (a) is, or would reasonably be expected to be, materially adverse to the [***].

 

1.1.57        Milestone Event ” has the meaning set forth in Section 2.3.2(a).

 

1.1.58        Milestone Payment ” has the meaning set forth in Section 2.3.2(a)

 

1.1.59        NDA ” means a New Drug Application as defined in the Act.

 

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

 

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1.1.60        Net Sales ” means, with respect to a Royalty Product during any period of time, [***].

 

1.1.61        Non-Controlling Party ” has the meaning set forth in Section 5.2.2.

 

1.1.62        Notice ” has the meaning set forth in Section 6.2.1.

 

1.1.63        Party(ies) ” has the meaning set forth in the preamble hereto.

 

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

 

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1.1.64        Permitted Lien ” means [***].

 

1.1.65        Person ” means any individual, partnership, limited partnership, limited liability company, joint venture, syndicate, sole proprietorship, corporation, unincorporated association, trust, trustee, executor, administrator or other legal personal representative, or any other legal entity, including a Governmental Authority.

 

1.1.66        Post-Closing Tax Period ” has the meaning set forth in Section 4.7.1(b).

 

1.1.67        Pre-Closing Tax Period ” has the meaning set forth in Section 4.7.1(b).

 

1.1.68        Products ” means, collectively, the pharmaceutical products set forth on Schedule 1.1.68 , and “ Product ” means any of the foregoing.

 

1.1.69        Purchase Price ” means the sum of the Closing Payment, and to the extent actually paid by Buyer in accordance with Sections 2.3.2 and 2.3.3, (a) the Milestone Payment and (b) the Royalty Payments or the Buy-Out Payment, as applicable.

 

1.1.70        Purchased Assets ” has the meaning set forth in Section 2.1.1.

 

1.1.71        Purchased Regulatory Approvals ” has the meaning set forth in Section 2.1.1(a).

 

1.1.72        Receiving Party ” has the meaning set forth in Section 4.4.1.

 

1.1.73        Regulatory Approval means, with respect to the Royalty Products, any and all approvals (including ANDAs, NDAs and supplements and amendments thereto), licenses, registrations (except manufacturing establishment registrations) or authorizations of any Governmental Authority necessary to commercially distribute, sell or market the Royalty Products, as applicable, including, where applicable, (a) pricing or reimbursement approvals, (b) marketing authorizations, and (c) labeling approvals.

 

1.1.74        Representatives ” has the meaning set forth in Section 4.3.

 

1.1.75        Royalty Payments ” means the royalty payments described in Section 2.3.3.

 

1.1.76        Royalty Products ” means (a) the Products and (b) any products resulting directly from the Regulatory Approvals with respect thereto.

 

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

 

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1.1.77        Royalty Term ” means, with respect to a Royalty Product, the period that begins on [***].

 

1.1.78        Sales, General and Administrative Expenses ” or “ SG&A ” means, with respect to any Royalty Product during any period of time, [***].

 

1.1.79        Seller ” has the meaning set forth in the preamble hereto.

 

1.1.80        Seller Confidential Information ” has the meaning set forth in Section 4.4.3.

 

1.1.81        Seller FDA Intent Letters ” means the letters to the FDA in the form of Exhibit D , indicating Seller’s intent to transfer the rights to the Purchased Regulatory Approvals to Buyer.

 

1.1.82        Seller FDA Letters ” means the letters to the FDA in the form of Exhibit E , transferring the rights to the Purchased Regulatory Approvals to Buyer.

 

1.1.83        Seller Indemnitees ” has the meaning set forth in Section 5.1.2.

 

1.1.84        Seller Permitted Purpose ” has the meaning set forth in Section 4.4.2.

 

1.1.85        Seller’s Knowledge ” means [***].

 

1.1.86        Senior Officers ” has the meaning set forth on Schedule 2.3.2(b).

 

1.1.87        Tax Return ” means any return, declaration, report, claim for refund, information return or statement relating to Taxes, including any schedule or attachment thereto, filed or maintained, or required to be filed or maintained, in connection with the calculation, determination, assessment or collection of any Tax and includes any amended returns required as a result of examination adjustments made by the Internal Revenue Service or other Tax authority.

 

1.1.88        Taxes ” means all taxes of any kind, and all charges, fees, customs, levies, duties, imposts, required deposits or other assessments, including all federal, state, local or foreign net income, capital gains, gross income, gross receipt, property, franchise, sales, use, excise, withholding, payroll, employment, social security, worker’s compensation, unemployment, occupation, capital stock, transfer, gains, windfall profits, net worth, asset, transaction and other taxes, and any interest, penalties or additions to tax with respect thereto, imposed upon any Person by any taxing authority or other Governmental Authority under applicable Law.

 

1.1.89        Territory ” means the United States, its territories, possessions and military bases.

 

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

 

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1.1.90        Third Party ” means any Person other than Seller, Buyer and their respective Affiliates and permitted successors and assigns.

 

1.1.91        Transfer Taxes ” has the meaning set forth in Section 4.7.1(a).

 

1.2         Construction . Except where the context otherwise requires, wherever used, the singular includes the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word “or” is used in the inclusive sense (and/or). The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The term “including” as used herein does not limit the generality of any description preceding such term. The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction shall be applied against either Party. Unless otherwise specified or where the context otherwise requires, (a) references in this Agreement to any Article, Section, Schedule or Exhibit are references to such Article, Section, Schedule or Exhibit of this Agreement; (b) references in any Section to any clause are references to such clause of such Section; (c) “hereof,” “hereto,” “hereby,” “herein” and “hereunder” and words of similar import when used in this Agreement refer to this Agreement as a whole and not to any particular provision of this Agreement; (d) references to a Person are also to its permitted successors and assigns; (e) references to a Law include any amendment or modification to such Law and any rules or regulations issued thereunder, in each case, as in effect at the relevant time of reference thereto; (f) references to any agreement, instrument or other document in this Agreement refer to such agreement, instrument or other document as originally executed or, if subsequently amended, replaced or supplemented from time to time, as so amended, replaced or supplemented and in effect at the relevant time of reference thereto; and (g) references to monetary amounts are denominated in United States Dollars.

 

ARTICLE 2
SALE AND PURCHASE OF ASSETS; LIABILITIES; TRANSITIONAL TRADEMARK LICENSE

 

2.1         Sale of Purchased Assets .

 

2.1.1        Purchase and Sale of Purchased Assets . Upon the terms and subject to the conditions of this Agreement and the Ancillary Agreements, at and effective as of the Closing, Seller shall (or shall cause its applicable Affiliates to) sell, transfer, convey, assign and deliver to Buyer, and Buyer shall purchase and accept from Seller (or such Affiliates), the following (collectively, the “ Purchased Assets ”) free and clear of any Liens other than Permitted Liens:

 

(a)           all rights, titles and interests of Seller and its Affiliates to or in all Regulatory Approvals listed on Schedule 2.1.1(a) from and after the Closing (the “ Purchased Regulatory Approvals ”); and

 

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

 

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(b)           all rights, titles and interests of Seller or its Affiliates to or in all tangible embodiments of the Purchased Regulatory Approvals, batch records, laboratory notebooks, chemistry information, periodic safety update reports and the other information, including any data rights or other intangible property represented by or reflected in any of the foregoing, in each case exclusively related to the Products, that are [***] , excluding any rights, claims or causes of action (including warranty claims) of Seller or any of its Affiliates thereunder related to Excluded Assets or Excluded Liabilities (the “ Purchased Documents ”).

 

2.1.2       Excluded Assets . Buyer shall not acquire pursuant to this Agreement or any Ancillary Agreement, and Seller shall retain following the Effective Date, the Excluded Assets.

 

2.2         Liabilities .

 

2.2.1       Assumed Liabilities . Upon the terms and subject to the conditions of this Agreement, at the Closing, Seller shall assign and Buyer shall unconditionally assume and agree to pay and discharge when due [***], ((a) and (b) collectively, the “ Assumed Liabilities ”).

 

2.2.2       Excluded Liabilities . Buyer shall not assume any Liabilities of Seller or any of its Affiliates other than the Assumed Liabilities, and the Excluded Liabilities shall remain the sole obligation and responsibility of Seller and its Affiliates.

 

2.3         Consideration.

 

2.3.1       Consideration . In consideration for the Purchased Assets, Buyer shall pay to Seller (a) $500,000 (the “ Closing Payment ”) to be paid on the Effective Date by wire transfer of immediately available funds to the account or accounts designated by Seller by written notice to Buyer no later than one Business Day prior to the Effective Date, (b) the Milestone Payment, as provided in Section 2.3.2, and (c) the Royalty Payments or the Buy-Out Payment, as applicable, as and to the extent provided in Section 2.3.3.

 

2.3.2       Milestone Payment .

 

(a)           Buyer shall pay to Seller an amount equal to $6,000,000 (the “ Milestone Payment ”) [***] (such date, the “ Milestone Event ”); [***].

 

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

 

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(b)           Buyer shall notify Seller promptly of the achievement of the Milestone Event. If, notwithstanding the fact that Buyer has not provided Seller such a notice, Seller believes that the Milestone Event has been achieved, it shall so notify Buyer in writing and the Parties shall reasonably promptly meet and discuss in good faith whether the Milestone Event has been achieved. If the Parties are unable to resolve any dispute under this Section 2.3.2(b) regarding whether or not the Milestone Event has been achieved, then either Party shall have the right to refer such a dispute to the Senior Officers for attempted resolution by good faith negotiations during a period of [***]. Any final decision mutually agreed to by the Senior Officers in writing shall be conclusive and binding on the Parties. If the Senior Officers are unable to reach a final decision, then Seller shall be entitled to seek any dispute resolution and remedy available to it under this Agreement.

 

(c)           The Milestone Payment shall be treated as an adjustment to the Purchase Price for all Tax purposes, unless otherwise required by applicable Law and unless any portion of such Milestone Payment is required to be treated as interest in respect of deferred consideration for Tax purposes.

 

(d)           Commencing on the Effective Date, Buyer shall use Diligent Efforts with respect to the [***].

 

2.3.3       Royalty Payments .

 

(a)           Buyer shall pay to Seller a royalty on Gross Profits of all Royalty Products in the Territory (excluding Gross Profits of each Royalty Product for which the Royalty Term has expired) in each Calendar Year as follows:

 

(i)           [***]; [***]

 

(ii)          [***];[***]

 

(iii)         [***].

 

(b)           Buyer shall pay Seller the applicable Royalty Payments within [***] after the end of each [***] during the applicable Royalty Term. Buyer also shall provide to Seller, at the same time each such payment is made, a report showing: (i) the Net Sales of the applicable Royalty Products, including the basis for any deductions to determine Net Sales; (ii) the Cost of Goods with respect to the applicable Royalty Products; and (iii) a calculation of the amount of any Royalty Payment due to Seller.

 

(c)           Notwithstanding anything contained herein to the contrary, Buyer may at any time prior to December 1, 2015 elect to satisfy in full its royalty obligations hereunder by providing Seller written notice of such election and paying to Seller a single payment in an amount equal to $3,000,000 (the “ Buy-Out Payment ”). Buyer’s payment to Seller of the Buy-Out Payment shall be in lieu of and in full and final satisfaction of any and all Royalty Payments hereunder.

 

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

 

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(d)           The Royalty Payments or the Buy-Out Payment, as applicable, shall be treated as an adjustment to the Purchase Price for all Tax purposes, unless otherwise required by applicable Law and unless any portion of such Royalty Payment or Buy-Out Payment is required to be treated as interest in respect of deferred consideration for Tax purposes.

 

2.3.4       Mode of Payment; Interest . Buyer shall pay to Seller the Milestone Payment and Royalty Payments or Buy-Out Payment, as applicable, by wire transfer of immediately available funds to such bank account or accounts as Seller may from time to time designate by advance written notice to Buyer. If Buyer fails to make any payment pursuant to this Agreement when due, any such late payment shall bear simple interest, to the extent not prohibited by Law, at a per annum rate equal to the [***].

 

2.3.5       Financial Records; Audits .

 

(a)           Buyer shall, and shall cause its Affiliates and its and their respective licensees to, keep complete and accurate books and records pertaining to the sale, delivery and use of the Royalty Products during the Royalty Term, including books and records of Net Sales (including any deductions therefrom) and Cost of Goods with respect to the Royalty Products. Buyer shall, and shall cause its Affiliates and its and their respective licensees to, retain such books and records until the later of three years after the end of the period to which such books and records pertain and the expiration of the applicable Tax statute of limitations (or any extensions thereof), or for such longer period as may be required by Law.

 

(b)           At the request of Seller, Buyer shall, and shall cause its Affiliates and its and their respective licensees to, permit an independent certified public accountant retained by Seller, during normal business hours and upon reasonable notice, to audit the books and records maintained pursuant to Section 2.3.5(a). Such audits may not (i) be conducted for any Calendar Quarter more than [***] after the end of such Calendar Quarter, (ii) be conducted [***]), (iii) be repeated for any Calendar Quarter (unless a previous audit for such Calendar Quarter revealed an underpayment with respect to such Calendar Quarter or Buyer restates or revises such books and records for such Calendar Quarter) or (vi) be conducted for any period after the Buy-Out Payment is made to Seller. The cost of any audit shall be borne by Seller, unless the audit reveals a variance of more than [***] from the reported amounts, in which case Buyer shall bear the cost of the audit. Unless disputed pursuant to Section 2.3.5(c), if such audit concludes that additional payments were owed or that excess payments were made during such period, Buyer shall pay the additional amounts, with interest from the date originally due as provided in Section 2.3.4, or Seller shall reimburse such excess payments, in either case, within [***] after the date on which such audit is completed and the conclusions thereof are notified to the Parties.

 

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

 

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(c)           In the event of a dispute over the results of any audit conducted pursuant to Section 2.3.5(b), Seller and Buyer shall work in good faith to resolve such dispute. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within [***] of the date of notice of such dispute, the dispute shall be submitted for arbitration to the Accountants. The decision of the Accountants shall be final and the costs of such arbitration as well as the initial audit [***]. Not later than [***] after such decision and in accordance with such decision, Buyer shall pay the additional royalties, with interest from the date originally due as provided in Section 2.3.4 or Seller shall reimburse such excess payments, as applicable.

 

(d)           Seller shall treat all information subject to review under Section 2.3.5(b) in accordance with the confidentiality provisions of Section 4.4 and Seller shall cause the independent public accountant retained by Seller pursuant to Section 2.3.5(b) or the Accountants, as applicable, to enter into a reasonably acceptable confidentiality agreement with Buyer or its Affiliates or (sub)licensees, as the case may be, that includes an obligation to retain all such Confidential Information (as defined in Section 4.4) in confidence.

 

(e)           Buyer’s obligations under this Section 2.3.5 shall terminate upon the date on which the Buy-Out Payment is made to Seller.

 

2.3.6       Buyer’s Diligence Obligations . Commencing after Buyer’s payment of the Milestone Payment and continuing through the expiration of the Royalty Term, Buyer shall use commercially reasonable efforts to commercialize the Royalty Products in the Territory.

 

2.3.7      Transfer of Products . Prior to [***], Buyer shall not transfer, sell, convey or dispose of any Royalty Product or rights in and to any Royalty Product unless the transferee or assignee of such Royalty Product or rights in and to such Royalty Product expressly agrees to be bound by the obligations with respect to the Milestone Payment and Royalty Payments or Buy-Out Payment, as applicable, in this Section 2.3 and Buyer remains primarily responsible for the payment of the Milestone Payment and Royalty Payments or Buy-Out Payment, as applicable. For the avoidance of doubt, Buyer’s obligations under this Section 2.3.7 shall terminate upon the date on which the Buy-Out Payment is made to Seller.

 

2.3.8       Allocation of Consideration . Buyer shall allocate the Purchase Price (including the Assumed Liabilities, to the extent properly taken into account under Section 1060 of the Code) among the Purchased Assets in accordance with Section 1060 of the Code (the “ Allocation ”) prior to or within 120 days following the Closing and shall deliver to Seller a copy of such Allocation (IRS Form 8594) promptly after such determination. Seller shall have the right to review and raise any objections in writing to the Allocation during the 10-day period after its receipt thereof. If Seller disagrees 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 30 days after the commencement of such good faith negotiations (or such longer period as Seller and Buyer may mutually agree in writing), then the Accountants shall be engaged at that time to review the Allocation, and shall make a determination as to the resolution of such Allocation. The determination of the Accountants regarding the Allocation shall be delivered as soon as practicable following engagement of the Accountants, but in no event more than 60 days thereafter, and shall be final, conclusive and binding upon Seller and Buyer, and Buyer shall revise the Allocation accordingly. Seller, on the one hand, and Buyer on the other hand, shall each pay one-half of the cost of the Accountants.

 

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

 

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2.4         Closing.

 

2.4.1       Closing . Pursuant to the terms and subject to the conditions of this Agreement, the closing of the transactions contemplated hereby (the “ Closing ”) shall take place simultaneously with the execution of this Agreement on the Effective Date at the Washington, D.C. offices of Covington & Burling LLP, at 10:00 a.m., local time. The Closing shall be deemed to have occurred at 12:00 a.m., eastern time, on the Effective Date, such that Buyer shall be deemed the owner of the Purchased Assets on and after the Effective Date.

 

2.4.2       Closing Deliveries .

 

(a)           Except as otherwise indicated below, at the Closing, Seller shall deliver the following to Buyer:

 

(i)           each of the Ancillary Agreements, validly executed by a duly authorized officer of Seller;

 

(ii)          the Purchased Assets; provided , that (A) with respect to tangible Purchased Assets, delivery shall, unless the Parties otherwise mutually agree, be in accordance with Schedule 2.4.2(a)(ii) , and (B) prior to delivering or making available any files, documents, instruments, papers, books and records to Buyer, Seller shall be entitled to redact from such files, documents, instruments, papers, books and records any information to the extent that it does not relate to the Products; provided , that Seller shall retain an unredacted copy of any such redacted files, documents, instruments, papers, books or records for a period of [***] following the Closing;

 

(iii)         the Seller FDA Intent Letters;

 

(iv)         the Seller FDA Transfer Letters; and

 

(v)          a duly executed and acknowledged certificate, in form and substance reasonably acceptable to Buyer, certifying such facts necessary to establish that the sale of the Purchased Assets and any other transactions contemplated hereby are exempt from withholding pursuant to Section 1445 of the Code.

 

(b)           At the Closing, Buyer shall deliver the following to Seller:

 

(i)           each of the Ancillary Agreements, validly executed by a duly authorized officer of Buyer.

 

(ii)          the Closing Payment in accordance with Section 2.3.1;

 

(iii)         the Buyer FDA Intent Letters; and

 

(iv)         the Buyer FDA Transfer Letters.

 

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

 

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2.5          Withholding Rights .

 

2.5.1       Notwithstanding anything in this Agreement to the contrary, and subject to Section 2.5.2, Buyer shall be entitled to withhold and deduct from the consideration otherwise payable pursuant to this Agreement such amounts as Buyer is required to withhold and deduct with respect to the making of such payment under applicable Tax Laws. Buyer shall pay any such withheld amounts to the appropriate taxing authority within the time periods required under the applicable Tax Laws. To the extent that amounts are so withheld and paid over to the appropriate taxing authority, such amounts shall be treated for all purposes of this Agreement as having been paid to the Person in respect of which such deduction and withholding were made. Buyer shall inform Seller reasonably in advance of any payment to be made hereunder of any withholdings that are required to me made with respect to any such payments, and shall assist Seller in obtaining any exemption from, or reduction of, the applicable withholding in a manner that is commercially reasonable. Notwithstanding the foregoing, Buyer shall not deduct or withhold and shall be solely responsible for any Tax or other obligation that is incurred as a result of Buyer assigning its rights or obligations under this Agreement.

 

2.5.2       Notwithstanding anything in this Agreement to the contrary, if Seller is entitled under any applicable Tax treaty to a reduction of rate of, or the elimination of, or recovery of, applicable withholding Tax, it shall deliver to Buyer or the appropriate Governmental Authority (with the assistance of Buyer to the extent that this is reasonably required and is expressly requested in writing) the prescribed forms necessary to reduce the applicable rate of withholding or to relieve Buyer of its obligation to withhold Tax, and Buyer shall apply the reduced rate of withholding, or dispense with the withholding, as the case may be. If, in accordance with the foregoing, Buyer withholds any amount, it shall make timely payment to the proper taxing authority of the withheld amount, and send to Seller proof of such payment within 60 days following that payment.

 

ARTICLE 3
REPRESENTATIONS AND WARRANTIES

 

3.1         Representations and Warranties of Seller. Seller represents and warrants to Buyer as follows, with each such representation and warranty subject to such exceptions, if any, as are set forth in the Disclosure Schedules. Disclosures in any section or paragraph of the Disclosure Schedules are made generally and shall not only address the corresponding section or paragraph of this Agreement, but also other sections or paragraphs of this Agreement to the extent that it is reasonably apparent from the face of such disclosure that such disclosure is applicable to such other sections or paragraphs.

 

3.1.1       Entity Status . Seller is a corporation duly formed, validly existing and in good standing under the Laws of Delaware. Seller is duly qualified to do business and in good standing (to the extent such concept is recognized by the applicable jurisdiction) in each jurisdiction in which the ownership of the Purchased Assets so requires, except to the extent the failure to be so qualified and in good standing would not constitute a Material Adverse Effect.

 

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

 

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3.1.2       Authority .

 

(a)           Seller has the requisite corporate power and authority to (i) own, use and operate the Purchased Assets as now being conducted and (ii) enter into this Agreement and the Ancillary Agreements to which it is a party, to perform its obligations hereunder and thereunder and to consummate the transactions contemplated hereby and thereby. The execution and delivery of this Agreement and the Ancillary Agreements to which Seller is a party and the consummation of the transactions contemplated hereby and thereby have been duly authorized by all necessary corporate actions of Seller. This Agreement constitutes, and each Ancillary Agreement to which it is a party, when executed and delivered by Seller, will constitute, the valid and legally binding obligation of Seller, enforceable against Seller in accordance with its terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium or similar Laws of general application affecting or relating to the enforcement of creditors rights generally, and subject to equitable principles of general applicability, whether considered in a proceeding at law or in equity.

 

3.1.3       Non-Contravention . The execution, delivery and performance by Seller of this Agreement and each Ancillary Agreement to which it is a party do not and will not (a) violate the certificate of incorporation or bylaws or comparable organizational documents of Seller, (b) violate any Law applicable to Seller or the Purchased Assets or (c) subject to obtaining the consents referred to in Section 3.1.5(b), (i) violate, breach or constitute a default under or result in the termination of any Contract to which Seller or to which the Purchased Assets is subject, or (ii) violate any order or judgment of a Governmental Authority to which Seller is subject relating primarily to the Purchased Assets, except, in the case of (b) or (c), for such violations, breaches, defaults or terminations that would not constitute a Material Adverse Effect.

 

3.1.4       No Broker . There is no broker, finder or financial advisor acting or who has acted on behalf of Seller or any of its Affiliates, who is entitled to receive any brokerage or finder’s or financial advisory fee from Buyer or any of its Affiliates in connection with the transactions contemplated by this Agreement.

 

3.1.5       No Litigation; Consents .

 

(a)           As of the Effective Date, (i) to Seller’s Knowledge, there is no Litigation pending or threatened in writing against Seller or any of its Affiliates before any Governmental Authority relating primarily to the Purchased Assets, and (ii) there is no order or judgment of a Governmental Authority to which Seller or any of its Affiliates is subject relating primarily to the Purchased Assets, except, in each case ((i) and (ii) immediately above), for such Litigation, orders and judgments that would not constitute a Material Adverse Effect.

 

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

 

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(b)           Except for (i) consents, permits or authorizations that if not received, or declarations, filings or registrations that if not made, would not have a Material Adverse Effect, (ii) consents, permits, authorizations, declarations, filings or registrations that have become applicable solely as a result of the specific regulatory status of Buyer or its Affiliates and (iii) items disclosed in Section 3.1.5(b) of the Disclosure Schedules, no notice to, filing with, permit of, authorization of, exemption by, or consent of, any Governmental Authority or other Person is required for Seller to consummate the transactions contemplated hereby or by the Ancillary Agreements.

 

3.1.6       Purchased Assets . Seller has, or its Affiliates have, good title to, or valid contract rights in, as applicable, the Purchased Assets, free and clear of all Liens other than Permitted Liens. To Seller’s Knowledge, the regulatory status of the Products as of the Effective Date is as set forth in Section 3.1.6 of the Disclosure Schedules. To the extent the Products were commercially distributed by Seller at any time prior to the Closing, the Regulatory Approvals set forth on Schedule 1.1.68 with respect thereto were duly obtained and were in full force and effect at such time.

 

3.1.7       Taxes . (a) all material Tax Returns required to be filed by the Seller with respect to the Purchased Assets have been or will be filed when due in accordance with all applicable laws; and (b) all Taxes shown on such Tax Returns have been or will be paid in timely fashion or have been accrued for on Seller’s financial statements.

 

3.2         Representations and Warranties of Buyer. Buyer represents and warrants to Seller as follows:

 

3.2.1       Corporate Status . Buyer is a corporation duly organized, validly existing and in good standing under the Laws of Delaware.

 

3.2.2       Authority . Buyer has the requisite corporate power and authority to enter into this Agreement and the Ancillary Agreements to which it is a party, to perform its obligations hereunder and thereunder and to consummate the transactions contemplated hereby and thereby. The execution and delivery of this Agreement and Ancillary Agreements to which Buyer is a party and the consummation of the transactions contemplated hereby and thereby have been duly authorized by the necessary corporate actions of Buyer. This Agreement constitutes and each Ancillary Agreement to which Buyer is a party, when executed and delivered by Buyer will constitute, the valid and legally binding obligation of Buyer, enforceable against Buyer in accordance with its terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium or similar Laws of general application affecting or relating to the enforcement of creditors rights generally, and subject to equitable principles of general applicability, whether considered in a proceeding at law or in equity.

 

3.2.3       Non-Contravention . The execution, delivery and performance by Buyer of this Agreement and of each Ancillary Agreement to which it is a party do not and will not (a) violate the certificate of incorporation or bylaws of Buyer, (b)  violate any Law or other restriction of any Governmental Authority applicable to Buyer or (c) violate, breach or constitute a default under or result in the termination of any material Contract to which Buyer is a party.

 

3.2.4       No Broker . There is no broker, finder, financial advisor or other Person acting or who has acted on behalf of Buyer or its Affiliates, who is entitled to receive any brokerage or finder’s or financial advisory fee from Seller or any of its Affiliates in connection with the transactions contemplated by this Agreement, [***].

 

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

 

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3.2.5       Litigation; Consents .

 

(a)           (i) To the actual knowledge of Buyer, there is no Litigation pending or threatened against Buyer or any of its Affiliates before any Governmental Authority, and (ii) there is no order or judgment of a Governmental Authority to which Buyer or any of its Affiliates is subject, except for such Litigation, orders and judgments that would not reasonably be expected to have a Buyer Material Adverse Effect.

 

(b)           Except for consents, permits or authorizations that if not received, or declarations, filings or registrations that if not made, would not reasonably be expected to have a Buyer Material Adverse Effect, no notice to, filing with, permit of, authorization of, exemption by, or consent of, Governmental Authority or other Person is required for Buyer to consummate the transactions contemplated hereby or by the Ancillary Agreements.

 

3.2.6       Financial Capacity . Buyer has immediately available cash that is sufficient to enable it to complete the transactions contemplated hereby and to perform all of its obligations under this Agreement and the Ancillary Agreements.

 

3.3         Exclusivity of Representations.

 

3.3.1       BUYER ACKNOWLEDGES AND AGREES THAT, EXCEPT FOR THE EXPRESS REPRESENTATIONS AND WARRANTIES CONTAINED IN SECTION 3.1, (A) SELLER HAS MADE NO REPRESENTATION OR WARRANTY WHATSOEVER HEREIN OR OTHERWISE RELATED TO THE TRANSACTIONS CONTEMPLATED HEREBY AND (B) BUYER HAS NOT RELIED ON ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, IN CONNECTION WITH THE TRANSACTIONS CONTEMPLATED HEREBY. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, BUYER ACKNOWLEDGES AND AGREES THAT, EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, BUYER IS ACQUIRING THE PURCHASED ASSETS ON AN “AS IS, WHERE IS” BASIS WITHOUT ANY EXPRESS OR IMPLIED WARRANTIES, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, INCLUDING ANY WARRANTY AS TO QUALITY, THE FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY, CONDITION OF THE ASSETS OR AS TO ANY OTHER MATTER.

 

3.3.2       SELLER ACKNOWLEDGES AND AGREES THAT, EXCEPT FOR THE EXPRESS REPRESENTATIONS AND WARRANTIES CONTAINED IN SECTION 3.2, BUYER HAS MADE NO REPRESENTATION OR WARRANTY WHATSOEVER HEREIN OR OTHERWISE RELATED TO THE TRANSACTIONS CONTEMPLATED HEREBY AND SELLER HAS NOT RELIED ON ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, IN CONNECTION WITH THE TRANSACTIONS CONTEMPLATED HEREBY.

 

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

 

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ARTICLE 4
ADDITIONAL COVENANTS

 

4.1         Cooperation in Litigation and Investigations. Subject to Section 4.4 and except as set forth in any Ancillary Agreement, from and after the Effective Date, Buyer and Seller shall fully cooperate with each other in the defense or prosecution 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 Buyer and Seller or their respective Affiliates arising out of the transactions contemplated hereby or by the Ancillary Agreements). In connection therewith, and except as set forth in any Ancillary Agreement, from and after the Effective Date, each of Seller and Buyer shall make available to the other during normal business hours and upon reasonable prior written notice, but without unreasonably disrupting its business, all records relating exclusively to the Purchased Assets, the Assumed Liabilities and the Excluded Liabilities held by it and reasonably necessary to permit the defense or investigation of any such Litigation, examination or audit (other than Litigation between Buyer and Seller or their respective Affiliates 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. [***].

 

4.2         Further Assurances.

 

4.2.1          Each of Seller and Buyer 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 Buyer all of Seller’s right, title and interest in and to the Purchased Assets as contemplated hereby, (b) effectuate Buyer’s 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 Buyer 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 or in the Ancillary Agreements, neither Seller nor Buyer shall have any obligation to assist or otherwise participate in the amendment or supplementation of the Purchased Regulatory Approvals or otherwise to participate in any filings or other activities relating to the Purchased Regulatory Approvals other than as necessary to effect the assignment thereof to Buyer in connection with the Closing pursuant to this Agreement.

 

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

 

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4.2.2          To the extent that Seller’s rights under any Purchased Asset may not be assigned without the approval, consent or waiver of another Person and such approval, consent or waiver has not been obtained prior to the Closing, this Agreement shall not constitute an agreement to assign the same if an attempted assignment would constitute a breach thereof or be unlawful. If any such approval, consent or waiver shall not have been obtained prior to the Closing, Seller shall for a period of [***] after the Closing, (a) use its commercially reasonable efforts to obtain all necessary approvals, consents and waivers to the assignment and transfer thereof, and Buyer shall use its commercially reasonable efforts to assist and cooperate with Seller in connection therewith; provided , that neither Seller nor any of its Affiliates shall be required to pay money to any Third Party, commence any Litigation or offer or grant any accommodation (financial or otherwise) to any Third Party in connection with such efforts; and (b) until any such approval, consent or waiver is obtained and the related Purchased Asset is transferred and assigned to Buyer or Buyer’s designee, use its commercially reasonable efforts to provide to Buyer substantially comparable benefits thereof and enforce, at the request of and for the account of Buyer, any rights of Seller arising under any such Purchased Asset against any Person. To the extent that Buyer is provided with benefits of any such Purchased Asset, Seller shall perform the obligations of Seller thereunder.

 

4.3         Publicity. No public announcement related to this Agreement or the transactions contemplated herein will be issued without the joint written approval of Seller and Buyer, which approval shall not be unreasonably withheld, conditioned or delayed, except in any public disclosure which either Seller or Buyer, in its good faith judgment, believes is required by applicable Law or by any stock exchange on which its securities or those of its Affiliates are listed. If either Party, in its good faith judgment, believes such disclosure is required, such Party shall use its commercially reasonable efforts to consult with the other Party and its officers, employees, agents, attorneys, consultants, advisors and other representatives (collectively, “ Representatives ”), and to consider in good faith any revisions proposed by the other Party or its Representatives, as applicable, prior to making (or prior to any of its Affiliates making) such disclosure, and shall limit such disclosure to only that information which is legally required to be disclosed. Attached as Exhibits F-1 and F-2 hereto are forms of a press release to be issued, and Current Report on Form 8-K to be filed respectively, by Buyer, each in a form mutually agreed by Seller and Buyer.

 

4.4         Confidentiality.

 

4.4.1          All Confidential Information provided by one Party (or its Representatives or Affiliates) (collectively, the “ Disclosing Party ”) to the other Party (or its Representatives or Affiliates) (collectively, the “ Receiving Party ”) shall be subject to and treated in accordance with the terms of this Section 4.4. As used in this Section 4.4, “ Confidential Information ” means (a) all information disclosed to the Receiving Party by the Disclosing Party in connection with this Agreement or any Ancillary Agreement, including all information with respect to the Disclosing Party’s licensors, licensees or Affiliates, (b) all information disclosed to the Receiving Party by the Disclosing Party under the Confidentiality Agreement and (c) all memoranda, notes, analyses, compilations, studies and other materials prepared by or for the Receiving Party to the extent containing or reflecting the information in the preceding clause (a) or (b). Notwithstanding the foregoing, Confidential Information shall not include information that, in each case as demonstrated by competent written documentation:

 

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

 

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

 

(ii)          was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party;

 

(iii)         became generally available to the public or otherwise part of the public domain after its disclosure to the Receiving Party other than through any act or omission of the Receiving Party in breach of this Agreement or the Confidentiality Agreement;

 

(iv)         is subsequently disclosed to the Receiving Party by a Third Party without obligations of confidentiality with respect thereto; or

 

(v)          is subsequently independently discovered or developed by the Receiving Party without the aid, application or use of Confidential Information.

 

4.4.2          All Confidential Information obtained by Seller (or its Affiliates or Representatives) from Buyer (or its Affiliates or Representatives) and all Confidential Information relating solely to the Products, the Purchased Assets and the Assumed Liabilities (the “ Buyer Confidential Information ”) shall be deemed to be Confidential Information disclosed by Buyer to Seller for purposes of this Section 4.4 and shall be used by Seller solely as required to (a) perform its obligations or exercise or enforce its rights under this Agreement or any Ancillary Agreement, or (b) comply with applicable Law (each of (a) and (b), a “ Seller Permitted Purpose ”), and for no other purpose. For a period of [***], Seller shall not disclose, or permit the disclosure of, any of the Buyer Confidential Information to any Person except those Persons to whom such disclosure is necessary in connection with any Seller Permitted Purpose. Seller shall treat, and shall cause its Affiliates and the Representatives of Seller or any of its Affiliates to treat, the Buyer Confidential Information as confidential, using the same degree of care as Seller normally employs to safeguard its own confidential information from unauthorized use or disclosure, but in no event less than a reasonable degree of care.

 

4.4.3          All Confidential Information obtained by Buyer (or its Affiliates or Representatives) from Seller (or its Affiliates or Representatives) other than the Buyer Confidential Information (the “ Seller Confidential Information ”) shall be used by Buyer solely as required to (a) perform its obligations or exercise or enforce its rights under this Agreement or any Ancillary Agreement or (b) comply with applicable Law (each of (a) and (b), a “ Buyer Permitted Purpose ”), and for no other purpose. For a period of [***], Buyer shall not disclose, or permit the disclosure of, any of Seller Confidential Information to any Person except those Persons to whom such disclosure is necessary in connection with a Buyer Permitted Purpose. Buyer shall treat, and will cause its Affiliates and the Representatives of Buyer or any of its Affiliates to treat, Seller Confidential Information as confidential, using the same degree of care as Buyer normally employs to safeguard its own confidential information from unauthorized use or disclosure, but in no event less than a reasonable degree of care.

 

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

 

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4.4.4       In the event either Party is requested pursuant to, or required by, applicable Law to disclose any of the other Party’s Confidential Information ( i.e ., Seller Confidential Information or Buyer Confidential Information, as applicable), it will notify the other Party in a timely manner so that such Party may seek a protective order or other appropriate remedy or, in such Party’s sole discretion, waive compliance with the confidentiality provisions of this Agreement. Each Party will cooperate in all reasonable respects in connection with any reasonable actions to be taken for the foregoing purpose. In any event, the Party requested or required to disclose such Confidential Information may furnish it as requested or required pursuant to applicable Law (subject to any such protective order or other appropriate remedy) without liability hereunder, provided that such Party furnishes only that portion of the Confidential Information which such Party is advised by its counsel is legally required, and such Party exercises reasonable efforts to obtain reliable assurances that confidential treatment will be accorded such Confidential Information.

 

4.4.5       Nothing in this Section 4.4 shall be construed as preventing or in any way inhibiting either Party from complying with applicable Law governing activities and obligations undertaken pursuant to this Agreement or any Ancillary Agreement in any manner which it reasonably deems appropriate.

 

4.4.6        This Section 4.4 shall supersede the existing Confidentiality Agreement in its entirety.

 

4.5         FDA Letters. Buyer and Seller shall file the Buyer FDA Intent Letters and the Seller FDA Intent Letters, respectively, with FDA within two Business Days after the Effective Date. Seller shall file the Seller FDA Transfer Letters with the FDA within [***] after the Closing. Buyer shall file the Buyer FDA Transfer Letters within one Business Day after receiving the complete copies of the Regulatory Approvals as required under 21 CFR §314.72(a)(2)(iii). Transfer of title to the Purchased Regulatory Approvals for the Products shall be effective as of the Delivery Date (as defined below) as to each such Product.

 

4.6         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, Buyer, from and after the Closing, shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals, and for conducting communications with Governmental Authorities of competent jurisdiction, for the Products.

 

4.7         Certain Tax Matters.

 

4.7.1       Transfer Taxes and Apportioned Obligations .

 

(a)           All amounts payable hereunder or under any Ancillary Agreement are exclusive of all recordation, transfer, documentary, excise, sales, value added, use, stamp, conveyance or other similar Taxes, duties or governmental charges, and all recording or filing fees or similar costs, imposed or levied by reason of, in connection with or attributable to this Agreement and the Ancillary Agreements or the transactions contemplated hereby and thereby (collectively, “ Transfer Taxes ”). Buyer shall be solely responsible for the payment of all Transfer Taxes, and shall pay all amounts due and owing in respect of any Transfer Taxes, these amounts in addition to the sums otherwise payable, at the rate in force at the due time for payment or such other time as is stipulated under applicable Law.

 

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

 

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(b)           All personal property and similar ad valorem obligations levied with respect to the Purchased Assets for a taxable period which includes (but does not end on) the Effective Date (collectively, the “ Apportioned Obligations ”) shall be apportioned between Seller and Buyer based on the number of days of such taxable period ending on the day prior to the Effective Date (such portion of such taxable period, the “ Pre-Closing Tax Period ”) and the number of days of such taxable period on and after the Effective Date (such portion of such taxable period, the “ Post-Closing Tax Period ”). Seller shall be liable for the proportionate amount of such Apportioned Obligations that is attributable to the Pre-Closing Tax Period, and Buyer shall be liable for the proportionate amount of such Apportioned Obligations that is attributable to the Post-Closing Tax Period.

 

(c)           Apportioned Obligations and Transfer Taxes shall be timely paid, and all applicable filings, reports and returns shall be filed, as provided by applicable Law. The paying Party shall be entitled to reimbursement from the non-paying Party in accordance with Section 4.7.1(a) or Section 4.7.1(b), as the case may be. Upon payment of any such Apportioned Obligation or Transfer Tax, the paying Party shall present a statement to the non-paying Party setting forth the amount of reimbursement to which the paying Party is entitled under Section 4.7.1(a) or Section 4.7.1(b), as the case may be, together with such supporting evidence as is reasonably necessary to calculate the amount to be reimbursed. The non-paying Party shall make such reimbursement promptly but in no event later than 10 days after the presentation of such statement.

 

4.7.2          Cooperation and Exchange of Information . Each of Seller and Buyer shall (a) provide the other with such assistance as may reasonably be requested by the other in connection with the preparation of any Tax Return, audit or other examination by any taxing authority or judicial or administrative proceeding relating to Liability for Taxes in connection with the Purchased Assets, (b) retain and provide the other with any records or other information that may be relevant to such Tax Return, audit or examination, proceeding or determination and (c) inform the other of any final determination of any such audit or examination, proceeding or determination that affects any amount required to be shown on any Tax Return of the other for any period.

 

4.7.3          Survival of Covenants . The covenants contained in this Section 4.7 shall survive until 30 days after the expiration of the applicable statute of limitations (including extensions thereof).

 

4.8         Wrong Pockets. For a period of [***], if either Buyer or Seller becomes aware that any of the Purchased Assets has not been transferred to Buyer or that any of the Excluded Assets has been transferred to Buyer, it shall promptly (but in any event within [***]) notify the other and the Parties shall, as soon as reasonably practicable, ensure that such property is transferred, [***] and with any necessary prior Third-Party consent or approval, to (a) Buyer, in the case of any Purchased Asset which was not transferred to Buyer at the Closing; or (b) Seller, in the case of any Excluded Asset which was transferred to Buyer at the Closing.

 

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

 

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ARTICLE 5
INDEMNIFICATION

 

5.1         Indemnification.

 

5.1.1       Indemnification by Seller . Following the Closing, but subject to the provisions of this Article 5, Seller shall indemnify, defend and hold harmless Buyer and its Affiliates, and its and their respective officers, directors, employees and agents (collectively, “ Buyer Indemnitees ”) from and against any and all Losses incurred by any Buyer Indemnitee arising out of or related to:

 

(a)           any breach by Seller of any of the representations or warranties made by Seller in this Agreement;

 

(b)           any failure of Seller to perform or any breach by Seller of any of its covenants, agreements or obligations contained in this Agreement;

 

(c)           any Excluded Liability;

 

(d)           any failure of Seller to pay its share of Transfer Taxes or Apportioned Obligations allocated to Seller under Section 4.7.1; or

 

(e)           the ownership or operation of the Purchased Assets or the Exploitation of the Products before the Effective Date.

 

5.1.2       Indemnification by Buyer . Following the Closing, but subject to the provisions of this Article 5, Buyer shall indemnify and hold harmless Seller and its Affiliates, and their respective officers, directors, employees and agents (collectively, “ Seller Indemnitees ”) from and against any and all Losses incurred by any Seller Indemnitee arising out of or related to:

 

(a)           any breach by Buyer of any of the representations or warranties made by Buyer in this Agreement;

 

(b)           any failure of Buyer to perform or any breach by Buyer of any of its covenants, agreements or obligations contained in this Agreement;

 

(c)           any Assumed Liability;

 

(d)           any failure of Buyer to pay its share of Transfer Taxes or Apportioned Obligations allocated to Buyer under Section 4.7.1; or

 

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

 

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(e)           the ownership or operation of the Purchased Assets or the Exploitation of the Products on or after the Effective Date.

 

5.2         Claim Procedure.

 

5.2.1       Indemnification Claim Procedure . Except as provided in Section 5.2.2 with respect to Third Party claims, in the event of a claim made by a Buyer Indemnitee or Seller Indemnitee (the “ Indemnified Party ”), the Indemnified Party shall give reasonably prompt written notice to the other Party (the “ Indemnifying Party ”), which notice (an “ Indemnification Certificate ”) shall: (a) state that the Indemnified Party has paid or properly accrued or reasonably anticipates that it will have to pay or accrue Losses that are subject to indemnification by the Indemnifying Party pursuant to Section 5.1.1 or Section 5.1.2, as applicable, and (b) specify in reasonable detail the individual items and amounts of such Losses, the date each such item was paid or properly accrued, or the basis for such anticipated Liability, and a description of the basis of such Indemnified Party’s claim for indemnification; provided , however , that the failure to give reasonably prompt notice shall not relieve the applicable Indemnifying Party of its indemnification obligations under this Agreement except to the extent that the Indemnifying Party is materially prejudiced by any delay in receiving such notice. In the event that the Indemnifying Party agrees to or is determined to have an obligation to reimburse the Indemnified Party for Losses as provided in this Article 5, the Indemnifying Party shall, subject to the provisions of Section 5.3, promptly (but, in any event, within 30 days) pay such amount to the Indemnified Party by wire transfer of immediately available funds to the account specified in writing by the Indemnified Party. The Indemnifying Party may defer making such payment if it objects in a written statement to the claim made in the Indemnification Certificate and delivers such statement to the Indemnifying Party prior to the expiration of such 30-day period. An Indemnifying Party’s failure to object within such 30-day period to any claim set forth in an Indemnification Certificate shall be deemed to be the Indemnifying Party’s acceptance of, and waiver of any objections to, such claim. If an Indemnifying Party shall so object in writing to any claim or claims made in any Indemnification Certificate, the Indemnifying Party and the Indemnified Party shall attempt in good faith for a period of 20 days following the Indemnified Party’s receipt of such objection notice to agree upon the respective rights of the parties with respect to each of such claims. If no such agreement can be reached after such 20-day period of good faith negotiation, either the Indemnifying Party or the Indemnified Party may initiate Litigation for purposes of having the matter settled in accordance with the terms of this Agreement.

 

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

 

25
 

  

5.2.2        Third Party Claim Procedure . In the event an Indemnified Party becomes aware of a claim made by a Third Party (including any action or proceeding commenced or threatened to be commenced by any Third Party) that such Indemnified Party reasonably believes may result in an indemnification claim pursuant to Section 5.1, such Indemnified Party shall promptly (and in any event within three Business Days after becoming aware of such claim) notify the Indemnifying Party in writing of such claim (such notice, the “ Claim Notice ”). The Claim Notice shall be accompanied by reasonable supporting documentation submitted by the Third Party making such claim and shall describe in reasonable detail (to the extent known by the Indemnified Party) the facts constituting the basis for such claim and the amount of the claimed damages; provided , however , that no delay or failure on the part of the Indemnified Party in delivering a Claim Notice shall relieve the Indemnifying Party from any Liability hereunder except to the extent of any damage or Liability caused by or arising out of such delay or failure. Within 30 days after receipt of any Claim Notice, the Indemnifying Party may, upon written notice thereof to the Indemnified Party, assume control of the defense of the claim referred to therein at the Indemnifying Party’s sole cost and expense (which shall be subject to Section 5.3) with counsel reasonably satisfactory to the Indemnified Party. If the Indemnifying Party does not so assume control of the defense of such claim, the Indemnified Party shall control the defense of such claim. The Party not controlling the defense of such claim (the “ Non-Controlling Party ”) may participate therein at its own expense; provided , however , that if the Indemnifying Party assumes control of the defense of such claim and the Indemnifying Party and the Indemnified Party have materially conflicting interests or different defenses available with respect to such claim that cause the Indemnified Party to hire its own separate counsel with respect to such proceeding, the reasonable fees and expenses of a single counsel to the Indemnified Party shall be considered “Losses” for purposes of this Agreement. The Party controlling the defense of such claim (the “ Controlling Party ”) shall keep the Non-Controlling Party reasonably advised of the status of such claim and the defense thereof and shall consider in good faith recommendations made by the Non-Controlling Party with respect thereto. The Non-Controlling Party shall furnish the Controlling Party with such information as it may have with respect to such claim (including copies of any summons, complaint or other pleading that may have been served on such party and any written claim, demand, invoice, billing or other document evidencing or asserting the same) and shall otherwise cooperate with and assist the Controlling Party in the defense of such claim. Neither the Indemnified Party nor the Indemnifying Party shall agree to any settlement of, or the entry of any judgment arising from, any such claim without the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned or delayed; provided , however , that the consent of the Indemnified Party shall not be required with respect to any such settlement or judgment if the Indemnifying Party agrees in writing to pay or cause to be paid any amounts payable pursuant to such settlement or judgment (net of the applicable deductible amount specified in Section 5.3.1) and such settlement or judgment includes no admission of liability by or other obligation on the part of the Indemnified Party and includes a complete release of the Indemnified Party from further Liability.

 

5.3         Limitations on Indemnification.

 

5.3.1       The provisions for indemnity under Section 5.1.1(a) or Section 5.1.2(a) shall be effective only (a) for any individual claim or series of related claims arising from the same facts and circumstances where the Loss exceeds [***] or (b) when the aggregate amount of all Losses for claims or series of related claims arising from the same facts and circumstances in excess of [***] for which indemnification is sought from any Indemnifying Party exceeds [***] (the “ Deductible ”), in which case the Indemnified Party shall be entitled to indemnification of the Indemnified Party’s Losses in excess thereof. In no event shall any Indemnifying Party have liability for indemnification under Section 5.1.1(a) or Section 5.1.2(a), as applicable, for any amount exceeding, in the aggregate, [***] (the “ Cap ”). Notwithstanding anything herein to the contrary, the Deductible and Cap shall not apply to any breach attributable to fraud or intentional misrepresentation. [***].

 

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

 

26
 

  

5.3.2          If the Indemnified Party receives any payment from an Indemnifying Party in respect of any Losses pursuant to Section 5.1.1 or Section 5.1.2 and the Indemnified Party could have recovered all or a part of such Losses from a Third Party based on the underlying claim asserted against the Indemnifying Party, the Indemnified Party shall assign such of its rights to proceed against such Third Party as are necessary to permit the Indemnifying Party to recover from the Third Party the amount of such payment.

 

5.3.3          The representations and warranties of Seller and Buyer contained in this Agreement shall survive the Closing and continue in full force and effect thereafter through and including the date that is [***] after the Effective Date. None of the covenants or agreements contained in this Agreement shall survive the Closing other than those that by their terms expressly contemplate performance after the Effective Date and such surviving covenants and agreements shall survive the Closing until fully performed.

 

5.3.4          TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW AND EXCEPT AS A RESULT OF FRAUD OR WILLFUL MISCONDUCT, NEITHER BUYER NOR SELLER SHALL BE LIABLE TO THE OTHER, OR THEIR AFFILIATES, FOR ANY CLAIMS, DEMANDS OR SUITS FOR CONSEQUENTIAL, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, INDIRECT OR MULTIPLE DAMAGES, INCLUDING LOSS OF PROFITS, REVENUE OR INCOME, DIMINUTION IN VALUE OR LOSS OF BUSINESS OPPORTUNITY (WHETHER OR NOT FORESEEABLE AT THE EXECUTION DATE), CONNECTED WITH OR RESULTING FROM ANY BREACH OF THIS AGREEMENT, OR ANY ACTIONS UNDERTAKEN IN CONNECTION WITH, OR RELATED HERETO, INCLUDING ANY SUCH DAMAGES WHICH ARE BASED UPON BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE AND MISREPRESENTATION), BREACH OF WARRANTY, STRICT LIABILITY, STATUTE, OPERATION OF LAW OR ANY OTHER THEORY OF RECOVERY.

 

5.4         Tax Treatment of Indemnification Payments. All payments made pursuant to this Article 5 shall be treated as adjustments to the Purchase Price for all Tax purposes, unless otherwise required by applicable Law.

 

5.5         Exclusive Remedy. Except as expressly provided otherwise in this Agreement and subject to Section 6.9, each Party acknowledges and agrees that, following the Closing, the remedies provided for in this Article 5 shall be the sole and exclusive remedies for claims and damages available to the Parties and their respective Affiliates arising out of or relating to this Agreement and the transactions contemplated hereby, except that nothing herein shall limit the Liability of either Party for common law fraud or willful misconduct.

 

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

 

27
 

  

5.6         Disclaimer . Except as expressly set forth in any representation or warranty in Section 3.1, Buyer acknowledges and agrees that it and other Buyer Indemnitees shall have no claim or right to indemnification pursuant to this Article 5 (or otherwise) with respect to any information, documents, or materials furnished to or for Buyer by Seller or any of its Affiliates or any of their officers, directors, employees, agents or advisors, including any information, documents, or material made available to Buyer in any form in connection with the transactions contemplated by this Agreement or any Ancillary Agreement, except that nothing herein shall limit the Liability of either Party for common law fraud or willful misconduct.

 

ARTICLE 6
MISCELLANEOUS

 

6.1         Governing Law, Jurisdiction, Venue and Service.

 

6.1.1       Governing Law . This Agreement shall be governed by and construed in accordance with the Laws of the State of New York, excluding any conflicts or choice of Law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive Law of another jurisdiction.

 

6.1.2       Jurisdiction . Subject to Section 6.9, the Parties hereby irrevocably and unconditionally consent to the exclusive jurisdiction of the courts of the State of New York and the United States District Court for the Southern District of New York for any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement, and agree not to commence any action, suit or proceeding (other than appeals therefrom) related thereto except in such courts. The Parties irrevocably and unconditionally waive their right to a jury trial.

 

6.1.3       Venue . The Parties further hereby irrevocably and unconditionally waive any objection to the laying of venue of any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement in the courts of the State of New York or in the United States District Court for the Southern District of New York, and hereby further irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum.

 

6.1.4       Service . Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section 6.2.2 shall be effective service of process for any action, suit or proceeding brought against it under this Agreement in any such court.

 

6.2         Notices.

 

6.2.1       Notice Requirements . Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement (each, a “ Notice ”) shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if delivered by hand or sent by facsimile transmission (with transmission confirmed) or by internationally recognized overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in Section 6.2.2 or to such other address as the Party to whom notice is to be given may have provided to the other Party at least 10 days’ prior to such address taking effect in accordance with this Section 6.2. Such Notice shall be deemed to have been given as of the date delivered by hand or internationally recognized overnight delivery service or confirmed that it was received by facsimile (with receipt confirmed by telephone or email). Any Notice delivered by facsimile shall be confirmed by a hard copy delivered as soon as practicable thereafter.

 

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

 

28
 

  

6.2.2       Address for Notice .

 

If to Seller, to:

 

AstraZeneca Pharmaceuticals LP
1800 Concord Pike
P.O. Box 15437
Wilmington, DE 19850-5437
Attention: [***]
Facsimile:  [***]

 

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

 

AstraZeneca Pharmaceuticals LP
1800 Concord Pike
P.O. Box 15437
Wilmington, DE 19850-5437
Attention: General Counsel
Facsimile: [***]

 

and to:

 

Covington & Burling LLP
1201 Pennsylvania Avenue, N.W.
Washington, DC 20004
Facsimile:  [***]

Attention: [***]

                   [***]

 

If to Buyer, to:

 

IGI Laboratories, Inc.

105 Lincoln Avenue

Buena, New Jersey

Facsimile: (856) 697-2259

Attention: Jason Grenfell Gardner

 

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

 

29
 

  

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

Facsimile: (212) 983-3115

Attention: Joel Papernik, Esq.

 

6.3         No Benefit to Third Parties. The covenants and agreements set forth in this Agreement are for the sole benefit of the Parties and their successors and permitted assigns, and, except for the rights of Buyer Indemnitees and Seller Indemnitees under Article 5, they shall not be construed as conferring any rights on any other Persons.

 

6.4         Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other Party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by applicable Law or otherwise available except as expressly set forth herein.

 

6.5         Expenses. Except as otherwise specified herein, and whether or not the Closing takes place, each Party shall bear any costs and expenses incurred by it with respect to the transactions contemplated herein.

 

6.6         Assignment. Neither this Agreement nor either Party’s rights or obligations hereunder may be assigned or delegated by such Party without the prior written consent of the other Party, and any attempted assignment or delegation of this Agreement or any of such rights or obligations by either Party without the prior written consent of the other Party shall be void and of no effect; provided , however , that either Party may assign or delegate any or all of its rights or obligations hereunder without the prior written consent of the other Party to an Affiliate or to a successor, whether in a merger, sale of stock, sale of assets or other similar transaction with respect to the business to which this Agreement relates, which assignment or delegation shall not relieve the assigning Party of its obligations under this Agreement. Subject to the preceding sentence, this Agreement will be binding upon, inure to the benefit of, and be enforceable by, the Parties and their respective successors and permitted assigns.

 

6.7         Amendment. This Agreement may not be modified, amended, altered or supplemented except upon the execution and delivery of a written agreement executed by both Parties.

 

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

 

30
 

  

6.8         Severability. If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future Law, and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agreement shall be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance herefrom and (d) in lieu of such illegal, invalid or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid and enforceable provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to the Parties.

 

6.9         Equitable Relief. The Parties agree that irreparable damage would occur in the event that any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached. It is accordingly agreed that the Parties shall be entitled to an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions of this Agreement in any court of the United States or any state having jurisdiction, this being in addition to any other remedy to which they are entitled at law or in equity. Each Party hereby waives (a) any requirement that the other Party post a bond or other security as a condition for obtaining any such relief, and (b) any defenses in any action for specific performance, including the defense that a remedy at law would be adequate.

 

6.10       English Language. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control.

 

6.11       Bulk Sales Statutes. Buyer hereby waives compliance by Seller with any applicable bulk sales statutes in any jurisdiction in connection with the transactions under this Agreement.

 

6.12      Counterparts. This Agreement may be executed in any number of counterparts, and each such counterpart hereof shall be deemed to be an original instrument, but all such counterparts together shall constitute but one agreement. Delivery of an executed counterpart of a signature page of this Agreement by facsimile or other electronic transmission shall be effective as delivery of a manually executed original counterpart of this Agreement.

 

6.13       Entire Agreement. This Agreement, together with the Schedules and Exhibits expressly contemplated hereby and attached hereto, the Disclosure Schedules, the Ancillary Agreements and the other agreements, certificates and documents delivered in connection herewith or therewith or otherwise in connection with the transactions contemplated hereby and thereby, contain the entire agreement between the Parties with respect to the transactions contemplated hereby or thereby and supersede all prior agreements, understandings, promises and representations, whether written or oral, between the Parties with respect to the subject matter hereof and thereof. In the event of any inconsistency between any such Schedules and Exhibits and this Agreement, the terms of this Agreement shall govern.

 

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

 

31
 

  

[ Signature page follows ]

 

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

 

32
 

  

IN WITNESS WHEREOF , the Parties have executed this Agreement as of the Effective Date.

 

  AstraZeneca Pharmaceuticals LP
     
  By: /s/ WM F. Mongan
    Name: WM F. Mongan
    Title: Vice President
     
  IGI Laboratories, Inc.
     
  By: /s/ J. Grenfell-Gardner
    Name: J. Grenfell-Gardner
    Title: President & CEO

 

[Signature Page to Asset Purchase Agreement]

 

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

 

 
 

  

Schedule 1.1.36

Discontinued Products

 

[***]

 

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

 

 
 

  

Schedule 1.1.68

Products

 

[***]

 

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

 

 
 

  

Schedule 1.1.85

Seller’s Knowledge

 

[***]

 

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

 

 
 

  

Schedule 2.1.1(a)

Purchased Regulatory Approvals

 

See Schedule 1.1.68.

 

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

 

 
 

  

Schedule 2.1.1(b)

Box Inventory Listing

 

[***].

 

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

 

 
 

  

Schedule 2.3.2(b)

Senior Officers

 

[***]

For Buyer: Jason Grenfell Gardner

 

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

 

 
 

  

Schedule 2.4.2(a)(ii)

Delivery of Tangible Purchased Assets

 

[***]

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange 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
IGI LABORATORIES, INC.

 

 

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

 

1. I have reviewed this quarterly report on Form 10- Q of IGI Laboratories, 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 13, 2014

 

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

 

 

 

Exhibit 31.2

 

CERTIFICATION
OF

 

JENNIFFER COLLINS
CHIEF FINANCIAL OFFICER
OF
IGI LABORATORIES, INC.

 

 

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

 

1. I have reviewed this quarterly report on Form 10-Q of IGI Laboratories, 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 13, 2014

 

  /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 IGI Laboratories, Inc. (the “Company”) on Form 10- Q for the period ending September 30, 2014, 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 re sults of operations of the Company.

 

Date: November 13, 2014

 

  /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 IGI Laboratories, Inc. (the “Company”) on Form 10- Q for the period ending September 30, 2014, 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 13, 2014

 

  /s/ Jenniffer Collins
  Jenniffer Collins
  Chief Financial Officer