UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549



_______________________



FORM 10-Q

_______________________







 

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



For the quarterly period ended June 30, 2018

or





 

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 001-35952

_______________________



ARATANA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)



_______________________





 

 



 

 

Delaware

 

38-3826477

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification Number)



11400 Tomahawk Creek Parkway

Suite 340

Leawood, KS 66211

(913) 353-1000

(Address of principal executive offices, zip code and 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:       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:       No:  

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



 

 

 

 

 

 

Large accelerated filer

 

  

Accelerated filer

 

Non-accelerated filer

 

  

Smaller reporting company

 



 

 

 

Emerging growth company 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes:       No:  

As of July 30, 2018 , there were 47,671,117 shares of common stock outstanding.







 


 

Table of Contents

 



ARATANA THERAPEUTICS, INC.

Table of Contents







 

 



 

Page

 PART I. FINANCIAL INFORMATION

 

Item 1.

Financial Statements (Unaudited)



Consolidated Balance Sheets as of June 30, 2018 and December 31, 2017



Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2018 and 2017



Consolidated Statements of Comprehensive Loss for the Three and Six Months Ended June 30, 2018 and 2017



Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2018 and 2017



Notes to Consolidated Financial Statements (Unaudited)

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

23 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

33 

Item 4.

Controls and Procedures

33 

 PART II. OTHER INFORMATION

 

Item 1.

Legal Proceedings

34 

Item 1A.

Risk Factors

34 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

34 

Item 3.

Defaults Upon Senior Securities

34 

Item 4.

Mine Safety Disclosures

34 

Item 5.

Other Information

34 

Item 6.

Exhibits

35 

 SIGNATURES

36 



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PART I. FINANCIAL INFORMATION

Item   1. Financial Statements

ARATANA THERAPEUTICS, INC.

Consolidated Balance Sheets (Unaudited)

(Amounts in thousands, except share and per share data)









 

 

 

 

 

 



 

 

 

 

 

 



 

June 30, 2018

 

December 31, 2017

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

59,290 

 

$

66,868 

Short-term investments

 

 

744 

 

 

747 

Accounts receivable, net

 

 

2,835 

 

 

2,406 

Inventories

 

 

15,196 

 

 

13,576 

Prepaid expenses and other current assets

 

 

928 

 

 

1,642 

Total current assets

 

 

78,993 

 

 

85,239 

Property and equipment, net

 

 

929 

 

 

1,166 

Goodwill

 

 

40,846 

 

 

41,295 

Intangible assets, net

 

 

6,357 

 

 

6,616 

Restricted cash

 

 

350 

 

 

350 

Other long-term assets

 

 

502 

 

 

526 

Total assets

 

$

127,977 

 

$

135,192 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,146 

 

$

7,451 

Accrued expenses and other current liabilities

 

 

3,449 

 

 

3,712 

Licensing and collaboration commitment

 

 

200 

 

 

7,000 

Current portion – loans payable

 

 

21,333 

 

 

17,333 

Total current liabilities

 

 

26,128 

 

 

35,496 

Loans payable, net

 

 

8,271 

 

 

19,492 

Other long-term liabilities

 

 

64 

 

 

70 

Total liabilities

 

 

34,463 

 

 

55,058 

Commitments and contingencies (Notes 5 and 16)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Common stock, $0.001 par value; 100,000,000 shares authorized at June 30, 2018 and December 31, 2017, and 46,934,304 and 42,532,725 issued and outstanding at June 30, 2018 and December 31, 2017 , respectively

 

 

47 

 

 

43 

Treasury stock, at cost; 90,366 and 80,916 shares at June 30, 2018 and December 31, 2017, respectively

 

 

(1,153)

 

 

(1,107)

Additional paid-in capital

 

 

343,615 

 

 

321,599 

Accumulated deficit

 

 

(241,437)

 

 

(233,316)

Accumulated other comprehensive loss

 

 

(7,558)

 

 

(7,085)

Total stockholders’ equity

 

 

93,514 

 

 

80,134 

Total liabilities and stockholders’ equity

 

$

127,977 

 

$

135,192 





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

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ARATANA THERAPEUTICS, INC.

Consolidated Statements of Operations (Unaudited)

(Amounts in thousands, except share and per share data)







 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



 

Three Months Ended

 

Six Months Ended



 

June 30,

 

June 30,



 

2018

 

2017

 

2018

 

2017

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

Licensing and collaboration revenue

 

$

1,891 

 

$

804 

 

$

3,597 

 

$

1,707 

Product sales

 

 

3,017 

 

 

4,354 

 

 

5,354 

 

 

7,246 

Total revenues

 

 

4,908 

 

 

5,158 

 

 

8,951 

 

 

8,953 

Costs and expenses

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales

 

 

1,305 

 

 

3,691 

 

 

1,841 

 

 

6,785 

Royalty expense

 

 

915 

 

 

353 

 

 

1,721 

 

 

676 

Research and development

 

 

1,576 

 

 

3,700 

 

 

3,781 

 

 

8,354 

Selling, general and administrative

 

 

6,709 

 

 

6,918 

 

 

14,408 

 

 

14,413 

Amortization of intangible assets

 

 

129 

 

 

86 

 

 

259 

 

 

150 

In-process research and development

 

 

 —

 

 

 —

 

 

500 

 

 

 —

Total costs and expenses

 

 

10,634 

 

 

14,748 

 

 

22,510 

 

 

30,378 

Loss from operations

 

 

(5,726)

 

 

(9,590)

 

 

(13,559)

 

 

(21,425)

Other income (expense)

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

141 

 

 

88 

 

 

282 

 

 

173 

Interest expense

 

 

(788)

 

 

(871)

 

 

(1,641)

 

 

(1,731)

Other expense, net

 

 

 —

 

 

(7)

 

 

(3)

 

 

(9)

Total other expense

 

 

(647)

 

 

(790)

 

 

(1,362)

 

 

(1,567)

Net loss

 

$

(6,373)

 

$

(10,380)

 

$

(14,921)

 

$

(22,992)

Net loss per share, basic and diluted

 

$

(0.14)

 

$

(0.26)

 

$

(0.33)

 

$

(0.60)

Weighted average shares outstanding, basic and diluted

 

 

46,258,395 

 

 

40,206,042 

 

 

45,527,293 

 

 

38,486,329 





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

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ARATANA THERAPEUTICS, INC.

Consolidated Statements of Comprehensive   Loss (Unaudited)

(Amounts in thousands)







 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



 

Three Months Ended

 

Six Months Ended



 

June 30,

 

June 30,



 

2018

 

2017

 

2018

 

2017

Net loss

 

$

(6,373)

 

$

(10,380)

 

$

(14,921)

 

$

(22,992)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustment

 

 

(878)

 

 

1,422 

 

 

(473)

 

 

1,721 

Other comprehensive income (loss)

 

 

(878)

 

 

1,422 

 

 

(473)

 

 

1,721 

Comprehensive loss

 

$

(7,251)

 

$

(8,958)

 

$

(15,394)

 

$

(21,271)





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

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ARATANA THERAPEUTICS, INC.

C onsolidated  S tatements   of Cash Flows (Unaudited)

(Amounts in thousands)









 

 

 

 

 



 

 

 

 

 



Six Months Ended



June 30,



2018

 

2017

Cash flows from operating activities

 

 

 

 

 

Net loss

$

(14,921)

 

$

(22,992)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

Stock-based compensation expense

 

2,641 

 

 

3,658 

Depreciation and amortization expense

 

496 

 

 

605 

Non-cash interest expense

 

279 

 

 

237 

Market value adjustments to inventories

 

335 

 

 

 —

Changes in operating assets and liabilities:

 

 

 

 

 

Accounts receivable, net

 

(429)

 

 

(4,806)

Inventories

 

(1,955)

 

 

4,169 

Prepaid expenses and other current assets

 

714 

 

 

(4,582)

Other assets

 

10 

 

 

33 

Accounts payable

 

(6,305)

 

 

(5,535)

Accrued expenses and other liabilities

 

(267)

 

 

(709)

Net cash used in operating activities

 

(19,402)

 

 

(29,922)

Cash flows from investing activities

 

 

 

 

 

Milestone payments for intangible assets

 

 —

 

 

(3,000)

Purchases of property and equipment, net

 

 —

 

 

(11)

Purchase of investments

 

(1,242)

 

 

(1,988)

Proceeds from maturities of investments

 

1,245 

 

 

1,490 

Net cash provided by (used in) investing activities

 

 

 

(3,509)

Cash flows from financing activities

 

 

 

 

 

Taxes paid for awards vested under equity incentive plans

 

(46)

 

 

(11)

Proceeds from stock option exercises

 

12 

 

 

152 

Proceeds from issuance of common stock, net of commission s   and underwriter fees

 

19,510 

 

 

27,462 

Payments for common stock issuance costs

 

(143)

 

 

(345)

Payments on loans payable

 

(7,500)

 

 

(2,332)

Net cash provided by financing activities

 

11,833 

 

 

24,926 

Effect of exchange rate on cash

 

(12)

 

 

21 

Net decrease in cash, cash equivalents and restricted cash

 

(7,578)

 

 

(8,484)

Cash, cash equivalents and restricted cash, beginning of period

 

67,218 

 

 

87,657 

Cash, cash equivalents and restricted cash, end of period

$

59,640 

 

$

79,173 

Supplemental disclosure of cash flow information

 

 

 

 

 

Cash paid for interest

$

1,409 

 

$

1,499 





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



 

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ARATANA THERAPEUTICS, INC.

N otes   to   C onsolidated   Financial  S tatements (Unaudited)

(A mounts in thousands, except share and per share data)

1. Summary of Significant Accounting Policies

Business Overview

Aratana Therapeutics, Inc., including its subsidiaries (the “Company” or “Aratana”) was incorporated on December 1, 2010 under the laws of the State of Delaware. T he Company is a pet therapeutics company focused on licensing, developing and commercializing innovative therapeutics for dogs and cats. The Company has one operating segment: pet therapeutics.

Basis of Presentation

The accompanying unaudited consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. These unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements of the Company for the year ended December 31, 2017 and the notes thereto in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 14, 2018 (“2017 Annual Report”). In the opinion of management, all adjustments, consisting of a normal and recurring nature, considered necessary for a fair presentation, have been included.

The Company has incurred recurring losses and negative cash flows from operations and has an accumulated deficit of $241,437 as of June 30, 2018. The Company expects to continue to generate operating losses for the foreseeable future. The Company believes that its cash, cash equivalents and short-term investments at June 30, 2018, will be sufficient to fund operations and debt obligations for at least one year from the issuance of these consolidated financial statements.

As disclosed in Note 8 to the consolidated financial statements, the Company has a term loan and a revolving credit facility with an aggregate principal balance of $29,000 as of June 30, 2018. The loan agreement requires that the Company maintain certain minimum liquidity at all times (the greater of cash equal to fifty percent (50%) of outstanding balance or remaining months’ liquidity, which is calculated on an average trailing three (3) month basis, equal to six (6) months or greater) , which as of June 30, 2018, was approximately $14,500. If the minimum liquidity covenant is not met, the Company may be required to repay the loans prior to their scheduled maturity dates. At June 30, 2018, the Company was in compliance with all financial covenants.

The Company expects continued investment related to commercial activities, including procuring of inventories needed to supply the marketplace, investing to further support adoption and awareness of the Company’s marketed products and payment of milestones related to approval and commencement of commercial sales. This will impact the minimum liquidity that needs to be maintained under the loan agreement. As a result, the Company will need additional capital to fund its operations and debt obligations beyond one year from the issuance of these consolidated financial statements, which the Company may obtain from corporate collaborations and licensing arrangements, or other sources, such as public or private equity offerings and further debt (re)financings. The future viability of the Company beyond one year from the issuance of these consolidated financial statements is dependent on its ability to raise additional capital to finance its operations, to fund on-going research and development costs, commercialization of its therapeutics and therapeutic candidates and to satisfy debt covenants. If the Company is not able to raise additional capital on terms acceptable to it, or at all, as and when needed, the Company would be forced to delay, reduce, or eliminate certain research and development programs, reduce or eliminate discretionary operating expenses or grant rights to develop and market therapeutics or therapeutic candidates that it would otherwise prefer to develop and market itself, which could otherwise adversely affect its business prospects. The Company’s failure to raise capital, as and when needed, would have a negative impact on its financial condition and its ability to pursue its business strategies as this capital is necessary for it to perform the research and development and commercial activities required to generate future revenue streams.

Consolidation

The Company’s consolidated financial statements include its financial statements and those of its wholly-owned subsidiaries . Intercompany balances and transactions are eliminated in consolidation.

Use of Estimates

The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from those estimates.

Revenue from Contracts with Customers

Effective January 1, 2018, the Company adopted ASC 606 “Revenue from Contracts with Customers” (“ASC 606”) using the modified retrospective transition method. Prior to January 1, 2018, the Company recognized revenue using the guidance of ASC 605 “Revenue Recognition” (“ASC 605”).

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The Company recognizes revenue when its customer obtains control of the promised goods or services, in an amount that reflects the consideration which the Company expects to be entitled to in exchange for those goods or services.

The Company determines revenue recognition from contracts with customers as follows:

·

identify the contract(s);

·

identify the performance obligations in the contract(s);

·

determine the transaction price;

·

allocate the transaction price to the performance obligations in the contract; and

·

recognize revenue wh en (or as) the Company satisfies a performance obligation.

The Company’s principal revenue streams and their respective accounting treatments are discussed below and further in Note 2, “Revenue” :



(i)

Product Sales, Net

The Company sells its products to its customers who could either be the end users (such as veterinarians, clinics, or animal hospitals) of the product or distributors who subsequently resell the Company’s products to end users.

Revenues from product sales are recognized when the customer obtains control of the Company’s product, which occurs at a point in time, upon delivery to the customer. The Company’s delivery of its products to customers constitutes a single performance obligation as there are no other promises to deliver goods or services beyond what is specified in each accepted customer order.

Product sales are recorded net of applicable reserves for variable consideration, including product returns, allowances, discounts, and rebates .

Reserves for Variable Consideration

Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include product returns, allowances, discounts, and rebates. These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and are classified as reductions of accounts receivable (generally, for credits that the Company issues for free goods provided by distributors to end customers in conjunction with promotional programs) or a current liability (generally, reserves for products that remained in the distribution channel inventories at each reporting period end that the Company expects the distributors will provide to end customers free of charge in conjunction with promotional programs). These estimates take into consideration a range of possible outcomes for the expected value (probability-weighted estimate) or relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts.

The amount of variable consideration included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known.

Product Returns

Consistent with the industry practice, the Company generally offers customers a limited right of return of damaged or expired product that has been purchased from the Company or the Company’s distributors in exchange for an unexpired product. Exchanges due to expiry are typically allowed for a period of six months after the product’s expiration date. The Company estimates the amount of its product sales that may be returned by its customers and records these estimates as a reduction of product revenues in the period the related product revenues are recognized, as well as within accrued expenses and other current liabilities, net in the consolidated balances sheets. The Company currently estimates product return liabilities using available industry data, its own sales data and data provided by the Company’s distributors such as the inventories remaining in the distribution channel. The Company has received an immaterial amount of returns to date and believes that returns of its products in future periods will be minimal. The Company does not record a return asset associated with the returned damaged or expired goods due to such asset is deemed to be fully impaired at the time of product return.

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Sales Discounts and Allowances

The Company compensates its distributors for sales order management, data and distribution and other services through sales discounts and allowances. However, such services are not distinct from the Company’s sale of products to distributors and, therefore, these discounts and allowances are recorded as a reduction of revenue in the consolidated statements of operations, as well as a reduction to accounts receivable, net in the consolidated balance sheets.



(ii)

Licensing and Collaboration Revenues

Revenues derived from product out-licensing arrangements typically consist of an initial non-refundable, up-front payment at inception of the license, subsequent milestone payments contingent on the achievement of certain regulatory, development and commercial milestones, and royalties on the net sales of the Company’s products.

Licenses of Intellectual Property

If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the contract, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company will evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.

Milestones

Revenues from achievement of milestones generally represent a form of variable consideration as the payments are likely to be contingent on the occurrence of future events. The Company estimates milestones probable to be achieved and includes in the transaction price based on either the expected value (probability-weighted estimate) or most likely amount approach. The most likely amount is used by the Company for milestone payments with a binary outcome (i.e., the Company receives all or none of the milestone payment). Milestone payments that are not within the control of the Company or the customer, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The estimated milestone-related variable consideration is only recognized as revenue when the related performance obligation is satisfied and the Company determines that it is probable that there will not be a significant reversal of cumulative revenue recognized in future periods (i.e. variable consideration constraint). At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect licensing and collaboration revenues and earnings in the period of adjustment.

For milestones not able to overcome the variable consideration constraint, not considered probable or that are determined to be sales-or usage royalties, as described later, the Company recognizes revenue when the milestones are achieved.

Sales-Based Royalty Revenue

The Company’s sales-based royalty revenue could consist of sales-based milestones or percentage of net sales royalties. The Company recognizes sales-based royalties related to the Company’s out-licensed intellectual property when (or as) the later of the following events occurs:



·

the sale occurs; or

·

the performance obligation to which some or all of the sales-based or usage-based royalty has been allocated has been satisfied (or partially satisfied).



Sales-based royalties revenues recorded by the Company are based on the licensee’s or sub-licensee’s sales that occurred during the relevant period. Differences between actual and estimated royalty revenues are adjusted in the period in which they become known, typically in the following quarter. If the Company is unable to reasonably estimate royalty revenue or does not have access to the information, then the Company records royalty revenue when the information needed for a reliable estimate becomes available. Royalty revenue is included in licensing and collaboration revenue in the consolidated statements of operations.

The Company recognizes revenue from sales-based milestones when the milestones are achieved.

Property and Equipment, Net

Property and equipment is recorded at historical cost, net of accumulated depreciation and amortization of $1,427 and $1,188, as of June 30, 2018 and December 31, 2017, respectively.

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New Accounting Standards  

Revenue from Contracts with Customers

In May 2014, the Financial Accounting Standards Board (“FASB”) issued guidance on recognizing revenue in contracts with customers. The guidance affects any entity that either enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets unless those contracts are within the scope of other standards (e.g., insurance contracts or lease contracts). This guidance superseded the revenue rec ognition requirements in ASC 605 and most industry-specific guidance. The core principle of the guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The Company adopted this guidance on January 1, 2018. The impact of adoption is described further in Note 2 , “Revenue.”

Leases

In February 2016, the FASB issued guidance that requires, for operating leases, a lessee to recognize a right-of-use asset and a lease liability, initially measured at the present value of the lease payments, in its balance sheet. The standard also requires a lessee to recognize a single lease cost, calculated so that the cost of the lease is allocated over the lease term, on a generally straight-line basis. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. Early adoption is permitted and is to be applied on a modified retrospective transition. The Company is currently assessing the effect that adoption of this guidance will have on its consolidated financial statements. The Company currently expects that its operating lease commitments will be subject to the new guidance which will result in recognition of operating lease liabilities and right-of-use assets in the consolidated balance sheets upon the adoption of the new guidance. However, the Company’s assessment of the impact of adoption , which may be material, is still ongoing.  

Compensation – Stock Compensation:   Scope of Modification Accounting

In May 2017, the FASB issued guidance on determining which changes to the terms or conditions of share-based payment awards require an entity to apply modification accounting. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. The Company adopted this guidance on January 1, 2018, and the adoption did not have a material impact on its consolidated financial statements.

Compensation – Stock Compensation :   Improvements to Nonemployee Share-Based Payment Accounting

In June 2018, the FASB issued guidance that largely aligns the accounting for share-based payment awards issued to employees and nonemployees. Under the new guidance, the existing employee guidance generally will apply to nonemployee share-based transactions, with the exception of specific guidance related to inputs to an option pricing model and the attribution of compensation cost. The cost of nonemployee awards will continue to be recorded as if the grantor had paid cash for the goods or services. In addition, the contractual term will be able to be used in lieu of an expected term in the option-pricing model for nonemployee awards. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. Early adoption is permitted, including in interim periods, but no earlier than an entity’s adoption of ASC 606 . The Company is currently assessing the effect that adoption of this guidance will have on its consolidated financial statements.



2.  Revenue

Adoption of ASC 606

On January 1, 2018, the Company adopted ASC 606 using the modified retrospective method applied to those contracts that were not completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and continue to be reported in accordance with the Company’s historic accounting under ASC 605.

The Company recorded a net reduction of $6,800 , net of $0 tax, to the opening balance of accumulated deficit within stockholders’ equity, and a corresponding reduction to licensing and collaboration commitment as of January 1, 2018, due to the cumulative impact of adopting ASC 606, with the impact solely related to the Company’s variable consideration within its licensing and collaboration agreement with Elanco Animal Health, Inc., a division of Eli Lilly & Co. (“Elanco”) .   Under previous guidance of ASC 605, this commitment was fully deferred and recognized as a liability until such time as payments under the obligation were made, or any unpaid portion would have been recognized as revenue when the commitment expired on December 31, 2018. Under ASC 606, this obligation is accounted for as variable consideration. At the adoption date, the Company recorded a contract liability based on the amount of the obligation expected to be paid which was $200 . This amount was determined based on management estimates, which included consideration of Elanco’s development plan. Since inception of the arrangement, no amounts had been paid out or submitted to the Company for reimbursement.

Had the Company still applied ASC 605 for the three and six months ended June 30, 2018, revenues would have been the same as compared to ASC 606.

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Disaggregated Revenues

The following table presents the Company’s revenues disaggregated by revenue source. All product sales are derived from United States sources and sales taxes are excluded from revenues.







 

 

 

 

 

 

 

 

 

 

 

 



 

Three Months Ended

 

Six Months Ended



 

June 30,

 

June 30,



 

2018

 

2017 (1)

 

2018

 

2017 (1)

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

Licensing and collaboration revenue

 

 

 

 

 

 

 

 

 

 

 

 

GALLIPRANT

 

$

1,891 

 

$

804 

 

$

3,597 

 

$

1,707 

Total licensing and collaboration revenue

 

 

1,891 

 

 

804 

 

 

3,597 

 

 

1,707 

Product sales

 

 

 

 

 

 

 

 

 

 

 

 

NOCITA

 

$

1,756 

 

$

637 

 

$

3,303 

 

$

965 

ENTYCE

 

 

1,261 

 

 

 —

 

 

2,051 

 

 

 —

GALLIPRANT

 

 

 —

 

 

3,702 

 

 

 —

 

 

6,246 

Other

 

 

 —

 

 

15 

 

 

 —

 

 

35 

Total product sales

  

 

3,017 

  

 

4,354 

 

 

5,354 

  

 

7,246 

Total revenues

 

$

4,908 

 

$

5,158 

 

$

8,951 

 

$

8,953 

(1)

Prior period amounts have not been adjusted under the modified retrospective method

Product Sales

The Company generates product sales revenues primarily by selling its marketed therapeutics directly to end users (such as veterinarians, clinics, or animal hospitals) and distributors. Direct to end user sales revenues consist primarily of NOCITA, and distributor product sales revenues consist primarily of ENTYCE.

As of June 30, 2018 and December 31, 2017, reserves for product returns related to NOCITA and ENTYCE were $199 and $90 , respectively.

Licensing and Collaboration Revenue

The Company generates licensing and collaboration revenue solely from the Elanco Collaboration, License, Development and Commercialization Agreement (as amended, the “Collaboration Agreement”) and Co-Promotion agreement (“the Co-Promotion Agreement”) (collectively, “the Elanco Agreements”) as follows:

·

sales-based royalties from the Elanco Agreements consisting of a percentage of net sales of GALLIPRANT by Elanco that are recognized as revenue as the underlying sales of GALLIPRANT are made by Elanco;

·

sales-based royalties from the Collaboration Agreement consisting of sales-based milestones of GALLIPRANT by Elanco that are recognized as revenue if and when the sales threshold is achieved by Elanco;

·

regulatory milestones from the Collaboration Agreement that are recognized as revenue if and when achieved; and

·

variable consideration related to the Collaboration Agreement licensing and collaboration commitment (contract liability) that is recognized as revenue when it is not subject to variable consideration constraint.

Reconciliation of Contract Balances  

The change in contract liability balances for the six months ended June 30, 2018, was as follows:

Licensing and Collaboration Commitment





 

 

 



 

 

2018

As of January 1,

 

$

7,000 

ASC 606 adoption

  

 

(6,800)

Revenue recognized

 

 

 —

Payments made

 

 

 —

As of the end of period,

  

$

200 

The Company recorded a net reduction of $6,800 , net of $0 tax, to the opening balance of accumulated deficit within stockholders' equity as of January 1, 2018, due to the cumulative impact of adopting ASC 606.

The Company reviewed the current facts and circumstances and concluded that no changes to the previously estimated transaction price for the Collaboration Agreement at June 30, 2018, are required, and therefore, no change in variable consideration was recognized as revenue for the three and six months ended June 30, 2018.

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Unsatisfied Performance Obligations

As of the adoption date of ASC 606 and June 30, 2018, the Company had no unsatisfied performance obligations.

Significant Judgements

The Company’s significant judgements relate to the updating of the transaction price and variable consideration of the Collaboration Agreement. The Company used current facts and circumstances to calculate the updated transaction price using the expected value (probability weighted estimate). Facts and circumstances considered included the current Elanco development plan for GALLIPRANT.

Practical Expedients and Exemptions

The Company has deemed that there is no significant financing component present in the agreements with the Company’s customers as trade payment terms with its customers do not exceed one year. The Company expenses sales commissions when incurred because the amortization period would have been one year or less. These costs are recorded within selling, general and administrative expenses.





3 . Fair Value of Financial Assets and Liabilities

Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis

The carrying values and estimated fair values of the Company’s financial assets which are measured at fair value on a recurring bas is were as follows:







 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



  

 

 

  

Fair Value Measurements as of



 

Carrying

 

June 30, 2018 Using:



  

Value

  

Level 1

  

Level 2

  

Level 3

  

Total

Assets:

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

Cash equivalents:

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Certificates of deposit

 

$

9,424 

 

$

 —

 

$

9,424 

 

$

 —

 

$

9,424 

Short-term investments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Short-term marketable securities - certificates of deposit

 

 

744 

 

 

 —

 

 

744 

 

 

 —

 

 

744 



  

$

10,168 

  

$

 —

  

$

10,168 

  

$

 —

  

$

10,168 







 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



  

 

 

  

Fair Value Measurements as of



 

Carrying

 

December 31, 2017 Using:



  

Value

  

Level 1

  

Level 2

  

Level 3

  

Total

Assets:

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

Cash equivalents:

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Certificates of deposit

 

$

8,964 

 

$

 —

 

$

8,964 

 

$

 —

 

$

8,964 

Short-term investments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Short-term marketable securities - certificates of deposit

 

 

747 

 

 

 —

 

 

747 

 

 

 —

 

 

747 



  

$

9,711 

  

$

 —

  

$

9,711 

  

$

 —

  

$

9,711 

The financial assets above are measured at fair value using quoted prices in active markets for identical assets (Level 1); significant other observable inputs (Level 2); and significant unobservable inputs (Level 3). Certain estimates and judgments are required to develop the fair value amounts shown above. The fair value amounts shown above are not necessarily indicative of the amounts that the Company would realize upon disposition, nor do they indicate the Company’s intent or ability to dispose of the financial instrument.

The following methods and assumptions were used to estimate the fair value of each material class of financial instrument:

·

Cash equivalents – the fair value of the cash equivalents has been determined to be amortized cost given the short duration of the securities.

·

Marketable securities (short-term) – the fair value of marketable securities has been determined to be amortized cost given the short duration of the securities.

The Company had no financial liabilities measured at fair value on a recurring basis as of June 30, 2018 and December 31, 2017.

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Financial Assets and Liabilities that are not Measured at Fair Value on a Recurring Basis

The carrying values and estimated fair value s of the Company’s financial liabilities which are not measured at fair value on a recurring basis were as follows:







 

 

 

 

 

 



 

 

 

 

 

 



  

June 30, 2018



  

Carrying Value

 

Fair Value

Liabilities:

  

 

 

 

 

 

Loans payable (Level 2)

  

$

29,604 

  

$

29,275 







 

 

 

 

 

 



 

 

 

 

 

 



  

December 31, 2017



  

Carrying Value

 

Fair Value

Liabilities:

  

 

 

 

 

 

Loans payable (Level 2)

  

$

36,825 

  

$

36,973 

Loans payable values above include both the current and the long-term loans balances as of June 30, 2018 and December 31, 2017.

The financial liabilities above are measured at fair value using quoted prices in active markets for identical assets (Level 1); significant other observable inputs (Level 2); and significant unobservable inputs (Level 3). Certain estimates and judgments were required to develop the fair value amounts. The fair value amount shown above is not necessarily indicative of the amounts that the Company would realize upon disposition, nor does it indicate the Company’s intent or ability to dispose of the financial instrument.

The fair value of loans payable was estimated using discounted cash flow analysis discounted at current rates.

The Company had no   material financial assets not measured at fair value on a recurring basis as of June 30, 2018 and December 31, 2017.

4 . Investments

Marketable Securities

Marketable securities consisted of the following:





 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



  

June 30, 2018



  

 

 

  

Gross

  

Gross

 

 

 



 

Amortized

 

Unrealized

 

Unrealized

 

Fair



 

Cost

 

Losses

 

Losses

 

Value

Short-term marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

Certificates of deposit

 

$

744 

 

$

 —

 

$

 —

 

$

744 

Total

  

$

744 

  

$

 —

  

$

 —

 

$

744 







 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



  

December 31, 2017



  

 

 

  

Gross

  

Gross

 

 

 



 

Amortized

 

Unrealized

 

Unrealized

 

Fair



 

Cost

 

Losses

 

Losses

 

Value

Short-term marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

Certificates of deposit

  

$

747 

  

$

 —

  

$

 —

 

$

747 

Total

  

$

747 

  

$

 —

  

$

 —

 

$

747 

At   June 30, 2018 and   December 31, 2017 , short-term marketable securities consisted of investments that mature within one year. Short-term marketable securities are recorded as short-term investments in the consolidated balance sheets.

5 . Inventories

Inventories ar e stated at the lower of cost and net realizable value and consisted of the following:







 

 

 

 

 

 



 

 

 

 

 

 



 

June 30, 2018

 

December 31, 2017

Raw materials

 

$

914 

 

$

1,132 

Work-in-process

  

 

8,857 

  

 

12,322 

Finished goods

 

 

5,425 

 

 

122 



  

$

15,196 

  

$

13,576 

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During the three and six months ended Ju ne 30, 2018 , the Company recognized inventory valuation adjustment losses in cost of product sales in the amount of  $ 335 from application of the lower of cost and net realizable value . The losses related to  ENTYCE   inventories that were written  down .

As of December 31, 2017, raw materials included $777 of GALLIPRANT inventories. As part of the manufacturing transfer of GALLIPRANT (Note 1 0 ), the Company transferred these raw materials to Elanco , and was reimburse d for the raw materials by Elanco during the first quarter of 2018 .

As of June 30, 2018 and December 31, 2017, the Company had non-cancellable open orders for the purchase of inventories of approximately $1,752 , which is ex pected to be paid in the next twelve months, and $7,132 , respectively.

6 . Goodwill

Goodwill is recorded as an indefinite-lived asset and is not amortized for financial reporting purposes but is tested for impairment on an annual basis or when indications of impairment exist. No goodwill impairment losses have been recognized to date. Goodwill is not expected to be deductible for income tax purposes. The Company performs its annual impairment test of the carrying value of the Company’s goodwill during the third quarter of each year.

Goodwill as of June 30, 2018 , was as follows:







 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 



 

Gross

 

Impairment

 

Net



  

Carrying Value

  

Losses

  

Carrying Value

Goodwill

  

$

40,846 

  

$

 —

  

$

40,846 



The change in the net book value of goodwill for the six months ended June 30, 2018 , was as follows:





 

 

 



 

 

 



  

2018

As of January 1,

  

$

41,295 

Effect of foreign currency exchange

  

 

(449)

As of the end of the period,

  

$

40,846 











7 . Intangible Assets, Net  

The change in the net book value of intangible assets for the six months ended June 30, 2018 , was as follows:





 

 

 



 

 

 



  

2018

As of January 1,

  

$

6,616 

Amortization expense

  

 

(259)

As of the end of the period,

  

$

6,357 

The Company recognized amortization expense of $129   and $259 for the   three and six months ended June 30, 2018 , respectively, and   $86 and $150 for the three and six months ended June 30, 2017, r espectively .  

Amortized Intangible Assets

Amortized intangible assets as of June 30, 2018 , were as follows (excluding intellectual property rights for formerly marketed products that were fully impaired in prior periods) :





 

 

 

 

 

 

 

 

 

 

 

 



 

Gross

 

 

 

 

Net

 

Weighted



 

Carrying

 

Accumulated

 

Carrying

 

Average



 

Value

 

Amortization

 

Value

 

Useful Life

Intellectual property rights for currently marketed products

 

$

7,000 

 

$

643 

 

$

6,357 

 

14.1 

Years

Amortized intangible assets as of December 31, 2017, were as follows:





 

 

 

 

 

 

 

 

 

 

 

 



 

Gross

 

 

 

 

Net

 

Weighted



 

Carrying

 

Accumulated

 

Carrying

 

Average



 

Value

 

Amortization

 

Value

 

Useful Life

Intellectual property rights for currently marketed products

 

$

7,000 

 

$

384 

 

$

6,616 

 

14.1 

Years

Intellectual property rights for formerly marketed products

 

 

38,652 

 

 

38,652 

 

 

 —

 

N/A

 



 

$

45,652 

 

$

39,036 

 

$

6,616 

 

 

 

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Unfavorable outcomes of the Company’s development activities or the Company’s estimates of the market opportunities for the therapeutic candidates could result in additional impairment charges in future periods.

Intellectual Property Rights for Currently Marketed Products

As of June 30, 2018 and December 31, 2017, intellectual property rights for currently marketed products relate to intangible assets capitalized for NOCITA, GALLIPRANT and ENTYCE in conjunction with approval/post-approval milestone payments made under the Company's licensing agreements.

8 . Debt

Loan and Security Agreements

Effective as of October 16, 2015, the Company and its wholly-owned subsidiary Vet Therapeutics, Inc. (the “Borrowers”), entered into a Loan and Security Agreement (“Loan Agreement”), with Pacific Western Bank, or Pacific Western, as a collatera l agent and Oxford Finance, LLC  ( collectively, the “Lenders”), pursuant to which the Lenders agreed to make available to the Company  a term loan in an aggregate principal amount up to $35,000 and a revolving credit facility in an aggregate principal amount up to $5,000 subject to certain conditions to funding. The term loan and the revolving credit facility are secured by all of the Borrowers’ personal property other than intellectual property and certain other customary exclusions. Subject to customary exceptions, the Company is not permitted to encumber its intellectual property. The outstanding principal balance under the Loan Agreement was $24,000 under the term loan facility and $5,000 under the revolving credit facility at June 30, 2018 .   D uring the three and six months ended June 30, 2018 , the Company recognized interest expense of $788 and $1,641 , respectively, and during the three and six months ended June 30, 2017, the Company recognized interest expense of $8 71 and $1,731 , respectively. Amortization of debt issuance costs and accretion of final payment and termination fees , re cognized as interest expense, were   $1 39 and $ 27 8 for the three and six months ended June 30, 2018 , respectively, and $ 120 and $ 239   for the three and six months ended June 30, 2017, respectively.

The Company was required to make interest-only payments on the revolving credit facility until October 16, 2017, when all principal and accrued interest were due. Effective as of July 31, 2017, the Borrowers and Lenders entered into a second amendment to the Loan Agreement (the “Second Amendment”). The terms of the Second Amendment, among other things, extend the maturity date of the existing revolving credit facility to October 16, 2019 (the “Revolving Line Maturity Date”), with amortized equal repayments of the principal outstanding under the revolving credit facility beginning November 1, 2018, and provide a six -month interest only period for the term loans, starting on the date of the Second Amendment. The Company is not subject to any new financial covenants as a result of the Second Amendment. At the closing of the Second Amendment, the Company paid the Lenders an amendment fee of $150 and a facility fee of $60 . The Company is also obligated to pay a new termination fee equal to $165 upon the earliest to occur of the Revolving Line Maturity Date, the acceleration of the revolving credit facility or the termination of the revolving credit facility. The existing termination fee of $165 was due upon the original revolving maturity date, October 16, 2017 , and was paid on October 17, 2017 .

The term loan and the revolving credit facility bear interest per annum at the greater of (i) 6.91% or (ii) 3.66% plus the prime rate, which is customarily defined. As of June 30, 2018 , the interest rate for the term loan and the revolving credit facility was 8. 66 % .   In addition, the Company is obligated to pay a final payment fee equal to 3.30% of the principal amount of such term loan , if the term loan is being prepaid or repaid with respect to the term loan upon the earliest to occur of October 16, 2019, the acceleration of any term loan or the prepayment of a term loan. The Company will also be obligated to pay an unused-line fee equal to 0.25% per annum of the average unused portion of the revolving credit facility.  

T he Loan Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among others, limits or restrictions on the Borrowers’ ability to incur liens, incur indebtedness, make certain restricted payments, make certain investments, merge, consolidate, make an acquisition, enter into certain licensing arrangements and dispose of certain assets. In addition, the Loan Agreement contains customary events of default that entitle the Lenders to cause the Borrowers’ indebtedness under the Loan Agreement to become immediately due and payable. The events of default, some of which are subject to cure periods, include, among others, a non-payment default, a covenant default, the occurrence of a material adverse change in the Company’s business , the occurrence of an insolvency, a material judgment default, defaults regarding other indebtedness and certain actions by governmental authorities. Upon the occurrence and for the duration of an event of default, an additional default interest rate equal to 4% per annum will apply to all obligations owed under the Loan Agreement.

The Loan Agreement requires that the Company maintain certain minimum liquidity at all times (the greater of cash equal to fifty percent ( 50% ) of outstanding credit extensions or remaining months’ liquidity, which is calculated on an average trailing three (3) month basis, equal to six (6) months or greater) , which as of June 30, 2018 , was approximately $ 14,500 . If the minimum liquidity covenant is not met, the Company may be required to repay the term loan and the revolving credit facility prior to their scheduled maturity dates. At June 30, 2018 , the Company was in compliance with all financial covenants.

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The Company’s loans payable balance as of June 30, 2018 , was as follows:



 

 

 

Principal amounts

 

 

 

Term loan, 8.66% , principal payments from February 1, 2018 through October 1, 2019

 

$

24,000 

Revolving credit facility, 8.66% , principal payments from November 1, 2018 through October 1, 2019

 

 

5,000 

Add: accretion of final payment and termination fees

 

 

840 

Less: unamortized debt issuance costs

 

 

(236)

As of the end of the period

 

$

29,604 

As of June 30, 2018 , $ 18,000 and $3,333 related to the term loan and the revolving credit facility, respectively, were classified as current portion – loans payable.



9 . Accrued Expenses and Other Current Liabilities  

Accrued expenses and other current liabilities consisted of the following:





 

 

 

 

 

 



 

 

 

 

 

 



 

June 30, 2018

 

December 31, 2017

Payroll and related expenses

 

$

1,519 

 

$

2,314 

Professional fees

 

 

375 

 

 

208 

Royalty expense

 

 

922 

 

 

718 

Interest expense

 

 

203 

 

 

249 

Research and development costs

 

 

36 

 

 

Other

 

 

394 

 

 

218 

Total

 

$

3,449 

 

$

3,712 



10. Agreements  

RaQualia Pharma Inc. (“RaQualia”)

On December 27, 2010, the Company entered into two Exclusive License Agreements with RaQualia (as amended, the “RaQualia Agreements”) that granted the Company global rights, subject to certain exceptions for injectables in Japan, Korea, China and Taiwan for development and commercialization of licensed animal health products for compounds RQ-00000005 (ENTYCE   ® , also known as AT-002) and RQ-00000007 (GALLIPRANT ® , also known as AT-001). The Company will be required to pay RaQualia remaining milestone payments associated with GALLIPRANT and ENTYCE of up to $4,000 and $3,000 , respectively, upon the Company’s achievement of certain development, regulatory and commercial milestones, as well as mid-single digit royalties on the Company’s or the Company’s sublicensee’s product sales.

As of June 30, 2018, the Company had paid $11,500 in milestone payments since execution of the RaQualia Agreements , and no milestone payments were accrued .   No milestones were achieved during the three and six months ended June 30, 2018. It is possible that a milestone related to the RaQualia Agreements will be achieved within the next twelve months totaling $2,000 .

Pacira Pharmaceuticals, Inc. (“Pacira”)

On December 5, 2012, the Company entered into an Exclusive License, Development, and Commercialization Agreement with Pacira (the “Pacira License Agreement”) that granted the Company global rights for development and commercialization of licensed animal health products for NOCITA ® (also known as AT-003). On the same date, the Company also entered into a supply agreement with Pacira (the “Pacira Supply Agreement”, and together with the Pacira License Agreement, the “Pacira Agreements”).

On July 5, 2018 (the “Effective Date”), the Company and Pacira entered into an amendment and restatement of the Pacira License Agreement (“A&R License Agreement”) and an amendment and restatement of the Pacira Supply Agreement (the “A&R Supply Agreement”, and together with the A&R Pacira Agreement, the “Amended Agreements”).

Under the A&R Supply Agreement, Pacira has agreed to manufacture and supply the licensed product in a 10 mL vial size in addition to the 20 mL vial size that is currently supplied to the Company. The supply price for the 10 mL vial size will remain fixed until December 31, 2021. Prior to December 31, 2021, the Company and Pacira have agreed to negotiate in good faith the applicable terms related to the 10 mL vial, including the price, for after December 31, 2021. If the Company and Pacira are unable to reach agreement, then as of January 1, 2022 and on each anniversary thereafter during the term of the A&R Supply Agreement, the price for the 10 mL vial will be automatically increased by a low single-digit percentage.

The A&R License Agreement amended various sections of the Pacira License Agreement, including milestone payments and royalties, to incorporate the introduction of the 10 mL vial size. Prior to December 31, 2021, the Company will not be obligated to pay any royalty payments to Pacira on the sales of the 10 mL vial and thereafter, the Company and Pacira have agreed to negotiate in good faith the applicable terms relating to the 10 mL vial in accordance with the A&R Supply Agreement. The tiered royalties on the Company’s product sales of 20 mL vials remain unchanged. In addition, the A&R License Agreement reduces the annual net sales

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thresholds for achieving each of the potential commercial milestone payments owed to Pacira. The remaining $40,000 of commercial milestones per the A&R License Agreement begin to be triggered once NOCITA annual net sales reach $50,000 with the final tier being owed to Pacira once NOCITA annual net sales reach $250,000 . Further, the A&R License Agreement lowered the minimum annual revenue payment to be provided to Pacira by the Company and delayed by one year the first period in which this minimum annual revenue payment requirement would be triggered such that the period is now expected to commence on January 1, 2023. The definition of a competing product was specified and narrowed to those injectable analgesic products preventing pain for at least forty-eight to seventy-two hours post-surgery as an active pharmaceutical ingredient labelled for the control of post-operative pain for surgical veterinary use. The term of the A&R License Agreement was extended with the initial term commencing as of the new Effective Date.

As of June 30, 2018, the Company had paid $2,500 in milestone payments since execution of the Pacira License Agreement , and no milestone payments were accrued .   No milestones were achieved during the three and six months ended June 30, 2018. The Company does not expect to achieve any milestones related to the A&R License Agreement in the next twelve months .

Elanco

GALLIPRANT

On April 22, 2016, the Company entered into the Collaboration Agreement pursuant to which the Company granted Elanco rights to develop, manufacture, market and commercialize the Company’s products based on licensed grapiprant rights and technology , including GALLIPRANT (collectively, “Grapiprant Products”) . Pursuant to the Collaboration Agreement, Elanco will have exclusive rights globally outside the United States and co-promotion rights with the Company in the United States during the term of the Collaboration Agreement.

Under the terms of the Collaboration Agreement, the Company received a non-refundable, non-creditable upfront payment of $45,000 . The Company is entitled to a $4,000 milestone payment upon European approval of a Grapiprant Product for the treatment of pain and inflammation, another $4,000 payment upon achievement of a development milestone related to the manufacturing of a Grapiprant Product from an alternate supply source, and payments up to $75,000 upon the achievement of certain sales milestones. The sales milestone payments are subject to a one -third reduction for each year the occurrence of the milestone is not achieved beyond December 31, 2021, with any non-occurrence beyond December 31, 2023, cancelling out the applicable milestone payment obligation entirely.

The Collaboration Agreement also provides that Elanco will pay the Company royalty payments on a percentage of net sales in the mid-single to low-double digits. The Company was responsible for all development activities required to obtain the first registration or regulatory approval for a Grapiprant Product for use in dogs in each of the European Union (“the EU Product Registration”) and the United States, and Elanco is responsible for all other development activities. First registration for a Grapiprant Product in the United States was achieved before the completion of the Collaboration Agreement and EU Product Registration was achieved in January 2018. In addition, the Company and Elanco have agreed to pay 25% and 75% , respectively, of all third-party development fees and expenses through December 31, 2018, in connection with preclinical and clinical trials necessary for any additional registration or regulatory approval of Grapiprant Products, provided that the Company’s contribution to such development fees and expenses is capped at $7,000 , which was recorded as licensing and collaboration commitment liability in the consolidated balance sheets at December 31, 2017. Upon adoption of ASC 606 (Note 2), the Company relieved $6,800 of its licensing and collaboration commitment liability. The licensing and collaboration commitment liability balance in future periods will be updated at each future reporting date to reflect current facts and circumstances. Any remaining balance will be recognized as licensing and collaboration revenue on December 31, 2018, when the Company’s obligation to fund 25% of Elanco’s development efforts expires.

Commencing on the effective date of the Collaboration Agreement, the Company was responsible for the manufacture and supply of all of Elanco’s reasonable requirements of active pharmaceutical ingredient (“API”) and/or finished Grapiprant Products under the supply terms agreed upon pursuant to the Collaboration Agreement. However, Elanco retained the ability to assume all or a portion of the manufacturing responsibility during the term of the Collaboration Agreement. On April 28, 2017, the Company and Elanco entered into an amendment (the “Amendment”) to the Collaboration Agreement. Under the Amendment, Elanco agreed to submit binding purchase orders to the Company, within 15 days of the effective date of the Amendment, for certain finished Grapiprant Products to be produced from certain batches of API the Company agreed to purchase from its third-party manufacturer (the “API Batches”). In addition, Elanco agreed to pay the Company for the API Batches within 30 days after the Company provides Elanco with proof of payment to the manufacturer for such API Batches. The Amendment provides that, in the event Elanco provided notice of its intent to assume responsibility for manufacturing, Elanco would assume all responsibilities of the Company with respect to any undelivered API, including paying the third-party manufacturer for such undelivered API. In July 2017, pursuant to Sections 8.2.2 and 10.1(c) of the Collaboration Agreement, as amended, Elanco provided the Company notice of its intent to assume responsibility for manufacturing of the Grapiprant Products and its intent to assume the applicable regulatory approvals. In September 2017, the Company and Elanco finalized the transfer of the applicable regulatory approvals in the United States and the responsibility for manufacturing of Grapiprant Products to Elanco. In connection with this assumption of manufacturing responsibility, Elanco compensated the Company $10,832 for certain Grapiprant Product inventories and manufacturing considerations.

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As of June 30, 2018, the Company had not earned any milestone payments since execution of the Collaboration Agreement, and no milestone payments were accrued. The Company will recognize revenue from the milestones if and when they are achieved by Elanco.

On April 22, 2016, in connection with the Collaboration Agreement, the Company entered into the Co-Promotion Agreement to co-promote Grapiprant Products in the United States.

Under the terms of the Co-Promotion Agreement, Elanco has agreed to pay the Company, as a fee for promotional services performed and expenses incurred by the Company under the Co-Promotion Agreement, (i) 25% of the gross margin on net sales of Grapiprant Product sold in the United States under the Collaboration Agreement prior to December 31, 2018 (unless extended by mutual agreement), and (ii) a mid-single digit percentage of net sales of the Grapiprant Product in the United States after December 31, 2018 through 2028 (unless extended by mutual agreement).

VetStem BioPharma, Inc. (“VetStem”)

On June 12, 2014, the Company entered into an Exclusive License Agreement with VetStem (as amended, the “VetStem Agreement”) that granted the Company the exclusive United States rights for commercialization and development of VetStem’s allogeneic stem cells being developed for the treatment of pain and inflammation of canine osteoarthritis (“AT-016”).

In January 2018, the Company exercised its right to terminate the VetStem Agreement, and on April 19, 2018, the termination became effective. During the six months ended June 30, 2018, the Company did not incur any development expenses or milestones . As a result of the termination of the VetStem Agreement, the Company does not anticipate having to reimburse any further development expenses or make milestone payments to VetStem.

AskAt Inc. (“AskAt”)

AT-019

On February 28, 2018, the Company entered into an Exclusive License Agreement with AskAt (the “AskAt Agreement”) that granted the Company an exclusive global license for development and commercialization of compound AT-019 in the field of animal health. Under the terms of the AskAt Agreement, the Company paid an initial upfront license fee of $500 in the second quarter of 2018. The AskAt Agreement was accounted for as an asset acquisition. On the date of acquisition, the licensed technology had not reached technological feasibility in animal health indications and had no alternative future use in the field of animal health. Accordingly, in-process research and development expense of $500 was recorded upon acquisition in the first quarter of 2018 and paid in the second quarter of 2018.

The Company will be required to pay remaining milestone payments of up to $15,500 upon the Company’s achievement of $3,000 of certain development/regulatory and $12,500 of commercial milestones, as well as tiered single digit royalties on the Company’s product sales, if any. The commercial milestones owed to AskAt under the AskAt Agreement begin to be triggered upon the first commercial sale with the final tier being owed to AskAt once annual net sales reach $100,000 . Milestones, at the discretion of the Company, can be paid 50% in cash and 50% in a number of the Company’s shares as determined per the terms of the AskAt Agreement. As of June 30, 2018, the Company had not accrued or paid any milestone or royalty payments since execution of the AskAt Agreement. The Company does not expect to achieve any milestones related to the AskAt Agreement in the next twelve months.

Collaboration and Option Agreement

On February 28, 2018, in connection with the AskAt Agreement, the Company entered into Collaboration and Option Agreement (the “COA”) with AskAt for animal health research, including a right of first negotiation agreement for multiple therapeutic candidates with potential in pain, allergy and cancer. During the first quarter of 2018, the Company paid an initial upfront option fee of $500 under the terms of the COA, which was recognized as research and development expense in the consolidated statements of operations.

11. Common Stock

Authorized Common Stock

As of June 30, 2018 and December 31, 2017, the authorized number of shares of common stock was 100,000,000 , par value $0.001 per share.

Common Stock Outstanding

As of June 30, 2018 and December 31, 2017 , there were 46,934,304 and 42,532,725 shares of the Company’s common stock outstanding, net of 706,097 and 491,861   shares of unvested restricted common stock, respectively.

Treasury Stock

As of June 30, 2018 and December 31, 2017, there were 90,366 and 80,916 shares of the Company’s common stock held as treasury stock at a cost of $1,153 and $1,107 , respectively. During the six months ended June 30, 2018 and 2017,   9,450   and 1,342   shares of restricted stock at a cost of $4.91   and $7.88   per share, respectively, were withheld to satisfy employee tax withholding obligations

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arising in conjunction with the vesting of restricted stock pursuant to the Company’s 2013 Incentive Award Plan (the “2013 Plan”) .  

Shelf Registration Statement

On August 4, 2017, the Company filed a shelf registration statement on Form S-3 (Reg. No. 333-219681) (the “Shelf Registration Statement”) with the SEC. The Shelf Registration Statement was declared effective by the SEC on August 16, 2017.

The Shelf Registration Statement allows the Company to offer and sell, from time to time, up to $100,000 of common stock, preferred stock, debt securities, warrants, units or any combination of the foregoing in one or more future public offerings. The terms of any future offering would be determined at the time of the offering and would be subject to market conditions and approval by the Company’s Board of Directors. Any offering of securities covered by the Shelf Registration Statement will be made only by means of a written prospectus and prospectus supplement authorized and filed by the Company.

At-the-Market Offering

Cowen and Company, LLC

On December 18, 2017, the Company entered into a Sales Agreement (“Cowen Sales Agreement”) with Cowen and Company, LLC (“Cowen”) pursuant to which the Company may sell from time to time, at its option, up to an aggregate of $50,000 of shares of its common stock through Cowen, as sales agent. Any sales of the shares of common stock would be made under the Company’s effective Registration Statement on Form S-3 (Reg. No. 333-219681), by means of ordinary brokers’ transactions on the Nasdaq Global Market or otherwise. Additionally, under the terms of the Cowen Sales Agreement, the shares of common stock may be sold at market prices, at negotiated prices or at prices related to the prevailing market price. The Company has agreed to pay Cowen a commission of 3% of the gross proceeds from the sale of such shares of common stock.

During the six months ended June 30, 2018 , the Company sold 4,182,191 shares of common stock for aggregate net proceeds of $19,367 , after deducting commission fees of   $603 and issuance costs of $143 . As of the date of this filing, approximately $29,887 of shares of common stock remained available for sale under the Cowen Sales Agreement.

Barclays Capital Inc .   (“Barclays”)

On October 16, 2015, the Company entered into a sales agreement with Barclays pursuant to which the Company could sell from time to time, at its option, up to an aggregate of $52,000 of shares of its common stock through Barclays, as sales agent. Sales of the shares of common stock were made under the Company’s then effective registration statement on Form S-3 (Reg. No. 333-197414), by means of ordinary brokers’ transactions on the Nasdaq Global Market or otherwise. Additionally, under the terms of the Barclays sales agreement, the shares of common stock could be sold at market prices, at negotiated prices or at prices related to the prevailing market price. The Company paid Barclays a commission of 2.75% of the gross proceeds from the sale of the shares of common stock.

On April 28, 2017, the Company terminated its Barclays sales agreement. As of that date, the Company had sold an aggregate of approximately $18,000 of the $52,000 available to be sold under the Barclays sales agreement.

Registered Direct Offering

On May 3, 2017, the Company entered into a Placement Agency Agreement (“PAA”) with Barclays, pursuant to which Barclays agreed to serve as placement agent for an offering of shares of common stock. In conjunction with the PAA, on May 3, 2017, the Company also entered into a Securities Purchase Agreement with certain investors for the sale by the Company of 5,000,000 shares of common stock at a purchase price of $5.25 per share (the “Offering”). The shares of common stock were offered and sold pursuant to the Company’s previously filed and then effective registration statement on Form S-3 (File No. 333-197414) and a related prospectus supplement. The Company agreed to pay Barclays an aggregate fee equal to 6.0% of the gross proceeds received by the Company from the Offering. The Offering closed on May 9, 2017 , and the Company received aggregate net proceeds from the Offering of approximately $24,400 , after deducting placement agent fees of $1,575 and offering expenses of $273 .



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12. Stock-Based Awards

2010 Equity Incentive Plan

Activity related to stock options under the 2010 Equity Incentive Plan (the “2010 Plan”) for the six months ended June 30, 2018, was as follows:





 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 



  

 

 

 

 

  

Weigh t ed

 

 

 



 

Shares

 

Weighted

 

Average

 

 

 



 

Issuable

 

Average

 

Remaining

 

Aggregate



 

Under

 

Exercise

 

Contractual

 

Intrinsic



 

Options

 

Price

 

Term

 

Value



  

 

 

 

 

  

(In Years)

  

 

 



 

 

 

 

 

 

 

 

 

 

Outstanding as of December 31, 2017

  

57,394 

 

$

4.22 

  

5.11 

  

$

73 

Granted

  

 —

 

 

 —

  

 

  

 

 

Exercised

  

 —

 

 

 —

  

 

  

 

 

Forfeited

  

 —

 

 

 —

  

 

  

 

 

Expired

  

 —

 

 

 —

  

 

  

 

 

Outstanding as of June 30, 2018

  

57,394 

 

$

4.22 

  

4.29 

  

$

58 

No stock options have been granted under the 2010 Plan since the effective date of the 2013 Plan.

2013 Plan

On January 1, 2018, the annual increase in the number of shares available for issuance under the 2013 Plan was determined to be 1,203,369 shares in accordance with the automatic annual increase provisions of the 2013 Plan. As of June 30, 2018, there were 1,717,963 shares available for future grant under the 2013 Plan.

Activity related to stock options under the 2013 Plan for the six months ended June 30, 2018, was as follows:





 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 



  

 

 

 

 

  

Weigh t ed

  

 

 



 

Shares

 

Weighted

 

Average

 

 

 



 

Issuable

 

Average

 

Remaining

 

Aggregate



 

Under

 

Exercise

 

Contractual

 

Intrinsic



 

Options

 

Price

 

Term

 

Value



 

 

 

 

 

 

(in Years)

 

 

 



 

 

 

 

 

 

 

 

 

 

Outstanding as of December 31, 2017

  

2,557,143 

 

$

11.45 

  

7.41 

  

$

794 

Granted

  

735,500 

 

 

4.87 

  

 

  

 

 

Exercised

  

(3,843)

 

 

3.14 

  

 

  

 

 

Forfeited

  

(23,873)

 

 

7.39 

  

 

  

 

 

Expired

  

(56,785)

 

 

20.74 

  

 

  

 

 

Outstanding as of June 30, 2018

  

3,208,142 

 

$

9.81 

  

7.49 

  

$

408 

For the six months ended June 30, 2018, the weighted average grant date fair value of stock options granted was $3.19 . For the six months ended June 30, 2018, the total intrinsic value of options exercised was $6 and the total received from stock option exercises was $12 .

Activity related to restricted stock under the 2013 Plan for the six months ended June 30, 2018, was as follows:





 

 

 

 

 



 

 

 

 



 

 

 

Weighted



 

 

 

Average Grant



 

Shares

 

Date Fair Value

Unvested restricted common stock as of December 31, 2017

  

491,861 

 

$

7.59 

Issued

  

444,500 

 

 

4.83 

Vested

  

(224,995)

 

 

8.41 

Forfeited

  

(5,269)

 

 

5.12 

Unvested restricted common stock as of June 30, 2018

  

706,097 

 

$

5.61 

For the six months ended June 30, 2018, the total fair value of restricted common stock vested was $ 1,100 . The Company did not receive cash proceeds for any of the restricted common stock issued during the six months ended June 30, 2018.

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Stock-Based Compensation

The Company recorded stock-based compensation expense related to stock options and restricted stock as follows:



 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 



  

Three Months Ended

 

Six Months Ended



 

June 30,

 

June 30,



  

2018

 

2017

 

2018

  

2017

Cost of product sales and inventories

 

$

32 

 

$

44 

 

$

63 

 

$

84 

Research and development

  

 

162 

  

 

238 

  

 

332 

  

 

488 

Selling, general and administrative

  

 

1,063 

  

 

1,562 

  

 

2,246 

  

 

3,086 



  

$

1,257 

  

$

1,844 

  

$

2,641 

  

$

3,658 

As of June 30, 2018, the Company had an aggregate of $ 5,216 and $ 3,379 of unrecognized stock-based compensation expense for options outstanding and restricted stock awards, respectively, which is expected to be recognized over a weighted average period of 2.64 years and 2.04 years, respectively.

1 3 . Net Loss Per Share

Basic and diluted net loss per share was calculated as follows:



 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



  

Three Months Ended

 

Six Months Ended



 

June 30,

 

June 30,



  

2018

 

2017

 

2018

 

2017

Numerator:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(6,373)

 

$

(10,380)

 

$

(14,921)

 

$

(22,992)

Denominator:

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding, basic and diluted

 

 

46,258,395 

 

 

40,206,042 

 

 

45,527,293 

 

 

38,486,329 

Net loss per share, basic and diluted

 

$

(0.14)

 

$

(0.26)

 

$

(0.33)

 

$

(0.60)

Stock options for the purchase of 3,265,536   and 2,65 2 , 79 2   shares of common stock were excluded from the computation of diluted net loss per share   for the three and six months ended June 30, 2018 and 201 7 , respectively,   because those options had an anti-dilutive impact due to the net loss incurred for the period.  

14 . Income Taxes

The Company recorded no income tax expense or benefit during the three and   six   months ended June 30, 2018 and 201 7 , due to a full valuation allowance recognized against its deferred tax assets.

The SEC issued Staff Accounting Bulletin No. 118 (“SAB 118”) on December 22, 2017. SAB 118 provides a one-year measurement period from a registrant’s reporting period that includes the Tax Cuts and Jobs Act of 2017 (“TCJA”) enactment date to allow the registrant sufficient time to obtain, prepare and analyze information to complete the accounting required under ASC 740. Although the Company made a reasonable estimate of the gross amounts of the deferred tax assets as disc ussed in the 2017 Annual Report , a final determination of the TCJA’s impact on the deferred tax assets and related valuation allowance requirements remains incomplete pending a full analysis of the provisions of the TCJA and their interpretations. The ultimate impact of the TCJA on the Company’s reported results in 2018 and beyond may differ from the estimates provided therein, possibly materially, due to, among other things, changes in interpretations and assumptions the Company has made, guidance that may be issued, and other actions the Company may take as a result of the TCJA, different from what is presently contemplated. As of June 30, 2018 , the Company has not recorded incremental accounting adjustments related to the TCJA as it continues to consider interpretations of its application, however, the Company expect s to complete the accounting by December 2018.  

1 5 . Accumulated Other Comprehensive Loss

The changes in accumulated other comprehensive loss , net of their related tax effects, were as follows:



 

 

 

 

 

 



 

 

 

 

 

 



  

Foreign

 

Accumulated



 

Currency

 

Other



 

Translation

 

Comprehensive



 

Adjustment

 

Loss

As of December 31, 2017

 

$

(7,085)

 

$

(7,085)

Foreign currency translation adjustment

 

 

(473)

 

 

(473)

As of June 30, 2018

 

$

(7,558)

 

$

(7,558)







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16. Legal Contingencies

From time to time, the Company may become subject to legal proceedings, claims and litigation arising in the ordinary course of business, including those related to patents, product liability and government investigations. The Company is not presently a party to any litigation which it believes to be material, and is not aware of any pending or threatened litigation against the Company which it believes could have a material effect on its consolidated financial statements. The Company accrues contingent liabilities when it is probable that a future liability has been incurred and such liability can be reasonably estimated.

As the Company previously disclosed, the Company and two of its current officers were named as defendants in a putative securities class action lawsuit filed in the United States District Court for the Southern District of New York (the “Court”) under the caption, In re Aratana Therapeutics, Inc. Securities Litigation, Case No. 1:17-cv-00880. The lawsuit alleged that the Company and its senior officers made false and/or misleading statements and omitted material facts regarding the Company’s business, operations, prospects and performance during the proposed class period of March 16, 2015 to March 13, 2017. The Company vigorously defended all claims asserted, including by filing a motion to dismiss. On June 11, 2018, the Court issued an Opinion and Order granting the motion to dismiss in its entirety and dismissing with prejudice all claims asserted against the Company and its senior officers (the “Opinion and Order”). The plaintiffs have not filed a notice of appeal of the Court’s Opinion and Order, and the time to file such notice has expired. The Company now considers the matter to be closed.

The Company currently is not a party to any threatened or pending litigation related to intellectual property. However, third parties might allege that the Company or its licensors are infringing their patent rights or that the Company is otherwise violating their intellectual property rights. Such third parties may resort to litigation against the Company or its licensors, which the Company has agreed to indemnify. With respect to some of these patents, the Company expects that it will be required to obtain licenses and could be required to pay license fees or royalties, or both. These licenses may not be available on acceptable terms, or at all. A costly license, or inability to obtain a necessary license, could have a material adverse effect on the Company’s financial condition, results of operations or cash flows.

















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Item 2. Manage ment’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q. Some of the statements contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q that are not statements of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. In this Quarterly Report on Form 10-Q, the words “anticipates,” “believes,” “expects,” “intends,” “future,” “could,” “estimates,” “plans,” “would,” “should,” “potential,” “continues” and similar words or expressions (as well as other words or expressions referencing future events, conditions or circumstances) identify forward-looking statements. The forward-looking statements herein include without limitation, statements with respect to our plans and strategy for our business, anticipated timing of regulatory submissions and approvals, anticipated timing of availability and announcement of study results, anticipated timing of launch and commercialization of therapeutic candidates, ongoing efforts regarding the commercialization of therapeutic candidates, beliefs regarding market opportunities for our products and potential success of our therapeutic candidates, and anticipated milestone payments. These and other forward-looking statements included in this Quarterly Report on Form 10-Q involve risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to: our history of operating losses and our expectation that we will continue to incur losses for the foreseeable future; failure to obtain sufficient capital to fund our operations; risks relating to the impairment of intangible assets; effects of   stockholder class action lawsuits; unstable market and economic conditions; restrictions on our financial flexibility due to the terms of our credit facility; our substantial dependence upon the commercial success of our therapeutics GALLIPRANT, ENTYCE and NOCITA; development of our biologic therapeutic candidates is dependent upon relatively novel technologies and uncertain regulatory pathways, and biologics may not be commercially viable; denial or delay of regulatory approval for our existing or future therapeutic candidates; failure of our therapeutics, and our current or future therapeutic candidates that may obtain regulatory approval to achieve market acceptance or commercial success; effects of product liability lawsuits; failure to realize anticipated benefits of our acquisitions and difficulties associated with integrating the acquired businesses; development of pet therapeutics is a lengthy and expensive process with an uncertain outcome; competition in the pet therapeutics market, including from generic alternatives to our therapeutic candidates, and failure to compete effectively; failure to identify, license or acquire, develop and commercialize additional therapeutic candidates; failure to attract and retain senior management and key scientific personnel; our reliance on third-party manufacturers, suppliers and collaborators; regulatory restrictions on the marketing of our approved therapeutics and therapeutic candidates; our small commercial sales organization, and any failure to create a sales force or collaborate with third-parties to commercialize our approved therapeutics and therapeutic candidates; difficulties in managing the growth of our company; significant costs of being a public company; risks related to the effectiveness of our internal controls; changes in distribution channels for pet therapeutics; consolidation of our veterinarian customers; limitations on our ability to use our net operating loss carryforwards; the impact of new legislation on tax reform on our financial position or results of operations; impacts of generic products; safety or efficacy concerns with respect to our therapeutics; effects of system failures or security breaches; failure to perform under our agreements with Elanco Animal Health, or termination thereof; failure to obtain ownership of issued patents covering our therapeutic candidates or failure to prosecute or enforce licensed patents; failure to comply with our obligations under our license agreements; effects of patent or other intellectual property lawsuits; failure to protect our intellectual property; changing patent laws and regulations; non-compliance with any legal or regulatory requirements; litigation resulting from the misuse of our confidential information; the uncertainty of the regulatory approval process and the costs associated with government regulation of our therapeutic candidates; failure to obtain regulatory approvals in foreign jurisdictions; effects of legislative or regulatory reform with respect to pet therapeutics; the volatility of the price of our common stock; our status as an emerging growth company, which could make our common stock less attractive to investors; dilution of our common stock as a result of future financings; the influence of certain significant stockholders over our business; and provisions in our charter documents and under Delaware law could delay or prevent a change in control. These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2018, and the “Risk Factors” section of this Quarterly Report on Form 10-Q, could cause actual results to differ materially from those indicated by the forward-looking statements made in this Quarterly Report on Form 10-Q.

Overview

Aratana Therapeutics, Inc. (“Aratana,” the “Company,” “we,” “us” or “our”) is a pet therapeutics company focused on licensing, developing and commercializing innovative therapeutics for dogs and cats. As a pioneer in pet therapeutics, Aratana’s mission is to deliver safe and effective therapeutics that elevate the standard of care in veterinary medicine. We work with companion animal veterinarians to bring new therapeutics to market that support the needs of pets and their owners.

We have three marketed therapeutics, including ENTYCE ® (capromorelin oral solution) for appetite stimulation in dogs; NOCITA ® (bupivacaine liposome injectable suspension) as a local post-operative analgesia for cranial cruciate ligament surgery in dogs and for use as a peripheral nerve block to provide regional post-operative analgesia following onychectomy in cats ; and GALLIPRANT ®  (grapiprant tablets) for the control of pain and inflammation associated with osteoarthritis in dogs, which we co-promote under an agreement with Elanco Animal Health, Inc., a division of Eli Lilly & Co. (“Elanco”). Our Canine Osteosarcoma Vaccine, Live Listeria Vector (AT-014) is conditionally licensed and is available at approximately two dozen study sites across the United States. Our pipeline has multiple therapeutic candidates in development for the potential treatment of pain, allergy, viral disease and cancer

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for dogs and cats.

We have incurred significant net losses since our inception. These losses have resulted principally from costs incurred in connection with in-licensing our therapeutic candidates, research and development activities, and selling, general and administrative costs associated with our operations. As of June 30, 2018 , we had a deficit accumulated since inception   of $241.4 million and cash, cash equivalents , restricted cash and short-term investments of $60.4 million .

Business Updates

During the three months ended June 30, 2018, we recorded $4.9 million in net revenues for our three Food and Drug Administration (“FDA”) approved and marketed therapeutics. In the second quarter of 2018, we recorded $1.3 million in ENTYCE net product sales. ENTYCE continues to have strong clinic penetration . We saw a sequential increase in the number of accounts that re-ordered and initial market research shows positive feedback from veterinarians on ENTYCE. As of June 30, 2018, approximately 40% of the approximately 25,000 veterinary clinics in the United States have ordered ENTYCE and more than half of those accounts re-ordered in the second quarter. For the three months ended June 30, 2018, we recorded $1.8 million in NOCITA net product sales, which was driven by strong re-order rates. We also recorded $1.9 million in licensing and collaboration revenue from Elanco for GALLIPRANT in the second quarter of 2018. According to Elanco, GALLIPRANT continues to show growth in net product sales, strong account penetration and has gained market share.

We continue to make progress on our late-stage pipeline of therapeutic candidates for cats, in particular with regard to progress on NOCITA (bupivacaine liposome injectable suspension). In June 2018, we filed a supplemental New Animal Drug Application (“NADA”) to expand the NOCITA label and on August 3 , 2018, we received FDA approval for its use as a peripheral nerve block to provide regional post-operative analgesia following onychectomy in cats.  

In accordance with the terms of the Cooperation Agreement between Aratana and Engaged Capital, LLC and certain of its affiliates, effective May 18, 2018, we have established an ad hoc Strategic Review Committee of the Board to conduct a strategic review of our business and make recommendations to the Board with respect to our strategy and opportunities to enhance stockholder value.

Sales and Marketing

We reported $4.9 million in net revenues in the second quarter of 2018 related to ENTYCE sales, NOCITA sales, and GALLIPRANT licensing and collaboration revenues, which compares to $5.2 million in net revenues in the second quarter of 2017. Revenues in the second quarter of 2017 were primarily related to $3.7 million in product sales of GALLIPRANT finished goods sold to Elanco prior to the manufacturing transfer.

ENTYCE ® (capromorelin oral solution) for appetite stimulation in dogs.  



 



 

ENTYCE is commercially available to veterinarians in the United States through our direct sales organization and our network of national and regional distributors. In the second quarter of 2018, we recorded $1.3 million in ENTYCE net product sales. According to clinic level sale s data provided by distributors, move-out of ENTYCE to veterinary clinics was higher in the second quarter of 2018 compared to the previous quarters. We believe inventory levels across the sales channels have stabilized, which is resulting in a tighter correlation between distributor purchases and move-out into veterinary clinics.

PICTURE 1

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ENTYCE continues to have strong clinic penetration and as of June 30, 2018, approximately 10,000 of the approximately 25,000 veterinary clinics in the United States have ordered ENTYCE, thus achieving one of our 2018 corporate objectives of placement in 40% of clinics by December 31, 2018. Additionally, the number of accounts re-ordering continues to increase quarter-over-quarter along with the growing account base. In the second quarter of 2018, more than half of the approximately 10,000 total ENTYCE customers re-ordered, which is compared to a 48 % re-order rate in the first quarter of 2018 and a 35% re-order rate among initial accounts in the fourth quarter of 2017. In the second quarter of 2018, c linic level sales data shows that within targeted accounts in territories served by our therapeutic spec ialists (sales representatives), net sales were 250% higher as compared to non-targeted accounts. Further, within targeted accounts, we have observed a positive correlation between the number of interactions (educational events or promotion by our therapeutic specialists) and ENTYCE net sales.

Market research completed in June 2018 showed that of the veterinarians surveyed who are prescribing ENTYCE, 90% cite doing so because of the ir belief in the therapeutic’s efficacy. We believe strong clinic penetrati on and a sequentially increasing number of accounts re-ordering, paired with positive feedback on the therapeutic profile indicate that veterinarians are satisfied with ENTYCE and that we are successfully continuing to build the canine inappetence market. In the second half of the year, we plan to focus on growing our target ed accounts by encouraging experience with the therapeutic. We continue to believe that the frequency with which a veterinarian reaches for ENTYCE and duration of therapy, as measured in days, has the potential to increase sales as veterinarians become increasingly comfortable with the use of ENTYCE.

 

We believe the addition of an FDA-approved product for the management of weight loss in cats will continue to raise awareness about the importance of nutritional intake for cats and dogs. Aratana is continuing to explore capromorelin for weight management in cats with chronic kidney disease and if approved, we believe the therapeutic candidate may better address weight loss in cats as a mimetic to the naturally occurring hunger hormone.

NOCITA ® (bupivacaine liposome injectable suspension) to provide local postoperative analgesia for cranial cruciate ligament surgery in dogs and for use as a peripheral nerve block to provide regional post-operative analgesia following onychectomy in cats.  



 



 

NOCITA is commercially available to veterinarians in the United States through our direct sales organization. In the second quarter of 2018, we recorded $1.8 million in NOCITA net product sales as compared to $0.6 million in the second quarter of 2017. We believe the continued quarter-over-quarter sequential increase in sales since launch is primarily driven by strong re-order rates in the second quarter of 2018.

PICTURE 2

We believe the sequential growth is also correlated to strong brand awareness and satisfaction among surgeons. Our market research among surgeons demonstrated more than 90% of participants are aware of NOCITA, and veterinarians prescribing NOCITA cite the therapeutic’s ability to provide 72 hours of pain relief and its safety profile as the primary benefits.

Following the FDA approval to expand the NOCITA label on August 3 , 2018, we believe a wider set of veterinarians will become increasingly interested with two administration techniques and two species on the label. However, we believe NOCITA will continue to remain most relevant to surgeons. In addition, we have amended our agreements with Pacira Pharmaceuticals, Inc. (“Pacira”), the supplier of NOCITA, and anticipate commencing the post-approval submission process for a smaller vial size (10 mL). We believe having NOCITA available in a smaller volume vial size will be attractive to veterinarians in dosing cats and smaller dogs. If approved by the FDA, we anticipate NOCITA in a 10 mL vial could be available to veterinarians in the fall of 2019.



 



GALLIPRANT ® (grapiprant tablets) for the control of pain and inflammation associated with osteoarthritis in dogs.



 

GALLIPRANT is commercially available to veterinarians in the United States through our commercial collaborator Elanco, our sales organization and distributors. In the second quarter of 2018, Aratana recorded $1.9 million in licensing and collaboration revenue from Elanco, which was generated from Elanco recording approximately $10 million in net product sales. The $1.9 million in licensing and collaboration revenue is compared to $0.8 million in the second quarter of 2017. Additionally, GALLIPRANT has been purchased by nearly two-thirds of veterinary clinics in the United States during the first half of 2018.

PICTURE 6

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According to third-party market research through June 2018, GALLIPRANT remains the second-leading therapeutic in the competitive NSAID category and has achieved approximately 13% market share. Based on trends of GALLIPRANT net product sales from the first two quarters of 2018 and assuming GALLIPRANT sales for the remainder of the year remain consistent, Aratana continues to expect to achieve a $15.0 million commercial milestone in 2018.



Canine Osteosarcoma Vaccine, Live Listeria Vector (AT-014)   for the treatment of dogs diagnosed with osteosarcoma, one year of age or older.

The Canine Osteosarcoma Vaccine is conditionally licensed by the USDA’s Center for Veterinary Biologics and is available at approximately two dozen veterinary oncology practice groups participating in an extended field study across the United States. The study is required by USDA to progress from conditional licensure to full licensure and study sites are enrolling dogs. While the study is on-going, any product purchased for use in the clinical study will offset research and development expenses .

Research and Development

The following summarizes our regulatory and development advances in the second quarter of 2018 for therapeutic candidates being developed under FDA and USDA regulations:

AT-002 (capromorelin) for cats.
The pi votal field effectiveness study evaluating capromorelin for weight management in cats with chronic kidney disease is on-going and we anticipate target enrollment will be completed in early 2019.  

NOCITA (bupivacaine liposome injectable suspension) for cats.

In October 2017 , we submitted pivotal field effectiveness study results to CVM for AT-003 (in-licensed from Pacira) and in April 2018, we received the effectiveness technical section complete letter from CVM. In June 2018, we filed the supplemental New Animal Drug Application (“sNADA”) to expand the NOCITA label. On August 3 , 2018, we received FDA approval of the NOCITA sNADA to include its use as a peripheral nerve block to provide regional post-operative analgesia following onychectomy in cats. The approval is based on a multi-center, placebo-controlled, randomized and masked field study of 241 client-owned cats undergoing an elective onychectomy surgery. Results from the study showed NOCITA met efficacy success criteria of no required rescue analgesia using a cat-specific post-operative pain assessment tool. Cats receiving NOCITA demonstrated a statistically significant improvement in pain evaluation success rates at primary and secondary endpoints. At 72 hours, NOCITA success rates were 68.4 percent compared to 35.3 percent for placebo. Separately, in a 22-day laboratory safety study with cats receiving NOCITA, bupivacaine HCl or saline as a femoral nerve block, NOCITA was well-tolerated on days 0, 9 and 18 at doses corresponding to 1, 2 and 3 times the maximum labeled total dose of 10.6 mg/kg/cat (representing 2, 4 and 6 times the maximum labeled dose of 5.3 mg/kg/forelimb ) .

Manufacturing and Supply Chain

We manage third-party manufacturers to supply active pharmaceutical ingredient (“API”), drug product and packaged product for the development and commercialization of our small molecule product candidates. We have chosen to rely on third-party contract manufacturer organizations (“CMOs”) rather than devote resources toward developing or acquiring internal manufacturing facilities.

NOCITA ® (bupivacaine liposome injectable suspension).

For NOCITA, Pacira is our exclusive supplier and under our supply agreement, Pacira is responsible for supplying us with finished drug product in vials. In July 2018, we announced that we have amended our agreement s with Pacira to include a smaller vial size (10 mL), as further discussed in Note 10 to our consolidated financial statements. We anticipate commencing the post-approval submission process with the FDA and if approved, we anticipate the 10 mL vial could be available in the fall of 2019.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of our consolidated financial statements and related disclosures requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, and revenues, costs and expenses and related disclosures during the reporting periods. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Except as discussed in Note 1,  Summary of Significant Accounting Policies – New Accounting Standards”, and Note 2, “Revenue”, to our consolidated financial statements included within this report, there have been no material changes to our critical accounting policies through June 30, 2018, from those discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed with the SEC on March 14, 2018.

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Results of Operations

Comparison of the Three and Six Months Ended June 30, 2018 and 201 7









 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

Three Months Ended

 

 

 

 

Six Months Ended

 

 

 



 

June 30,

 

 

 

 

June 30,

 

 

 



 

2018

 

2017

 

% Change

 

2018

 

2017

 

% Change



 

(Dollars in thousands)

 

 

 

 

(Dollars in thousands)

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Licensing and collaboration revenue

 

$

1,891 

 

$

804 

 

>100.0

%

 

$

3,597 

 

$

1,707 

 

>100.0

%

Product sales

 

 

3,017 

 

 

4,354 

 

(30.7)

%

 

 

5,354 

 

 

7,246 

 

(26.1)

%

Total revenues

 

 

4,908 

 

 

5,158 

 

(4.8)

%

 

 

8,951 

 

 

8,953 

 

(0.0)

%

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales

 

 

1,305 

 

 

3,691 

 

(64.6)

%

 

 

1,841 

 

 

6,785 

 

(72.9)

%

Royalty expense

 

 

915 

 

 

353 

 

>100.0

%

 

 

1,721 

 

 

676 

 

>100.0

%

Research and development

 

 

1,576 

 

 

3,700 

 

(57.4)

%

 

 

3,781 

 

 

8,354 

 

(54.7)

%

Selling, general and administrative

 

 

6,709 

 

 

6,918 

 

(3.0)

%

 

 

14,408 

 

 

14,413 

 

(0.0)

%

Amortization of intangible assets

 

 

129 

 

 

86 

 

50.0 

%

 

 

259 

 

 

150 

 

72.7 

%

In-process research and development

 

 

 —

 

 

 —

 

NA

 

 

 

500 

 

 

 —

 

NA

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

141 

 

 

88 

 

60.2 

%

 

 

282 

 

 

173 

 

63.0 

%

Interest expense

 

 

(788)

 

 

(871)

 

(9.5)

%

 

 

(1,641)

 

 

(1,731)

 

(5.2)

%

Other expense, net

 

 

 —

 

 

(7)

 

(100.0)

%

 

 

(3)

 

 

(9)

 

(66.7)

%

Revenue s

During the three and six   months ended June 30, 2018 , total revenues   decreased by $0.3 million and $2,000 , respectively, as compared to the corresponding 2017 period s .   The decrease   in total revenues during the three months ended June 30, 2018, was due to   a   decrease of $1.3 million in net product sales primarily as a result of transferring GALLIPRANT manufacturing to Elanco partially offset by an increase of $1.1 million in licensing and collaboration revenue recognized from the Collaboration Agreement and the Co-Promotion Agreement with Elanco (collectively, the “Elanco Agreements”) . The decrease in total revenues during the six months ended June 30, 2018, was due to a decrease of $1.9 million in product sales offset by an increase of $1.9 million in licensing and collaboration revenue recognized from the Elanco Agreements. During the three and six months ended June 30, 2018 , product sales consisted of net sales of NOCITA and ENTYCE .   During the three and six   months ended June 30, 2017 , product sales consisted of net sales of GALLIPRANT , which began in the first quarter of 2017 and ended in the fourth quarter of 2017, NOCITA, BLONTRESS, and TACTRESS.  

We believe that product sales for the remainder of 2018 will be a combination of sales of ENTYCE and NOCITA. Any licensing and collaboration revenue in 2018 will be substantially dependent on Elanco’s ability to successfully commercialize GALLIPRANT in accordance with the Elanco Agreements and the amount of research and development expenditures we incur towards the licensing and collaboration commitment in accordance with the Collaboration Agreement. Based on trends of GALLIPRANT net product sales f rom the first two quarters of 2018 and assuming GALLIPRANT sales for the remainder of the year remain consistent, we continue to expect to achieve a $15.0 million commercial milestone in 2018.

Cost of product sales

During the three and six   months ended June 30, 2018 , cost of product sales decreased by $2.4 million and $4.9 million, respectively, as compared to the corresponding 2017 periods. The decrease in both periods was primarily due to cost of product sales of GALLIPRANT, which we sold to Elanco during 2017, partially offset by an increase in cost of product sales of ENTYCE and NOCITA. During the three and six months ended June 30, 2018, we recognized inventory valuation adjustment losses   in cost of product sales in the amount of $0.3 million from application of the lower of cost and net realizable value. The losses related to one size of ENTYCE inventories that were written down .   Our current inventory levels represent our market expectations. As we are in the early stages of commercialization of our products, we will continue to evaluate the net realizable value of inventory levels and may experience future adjustments .

We anticipate cost of product sales as a percentage of product sales will improve in 2018 as compared to 2017. This improvement is expected to be largely due to the fact that GALLIPRANT manufacturing responsibilities have been assumed by Elanco. However, this margin improvement related to GALLIPRANT is expected to be partially offset by lower margins on ENTYCE as we are no longer sell ing inventories from process validation batches that were previously written down .

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Royalty expense

During the three and six months ended June 30, 2018 , royalty expense increased by $0.6 million and $1.0 million, respectively, as compared to the corresponding 201 7 periods. The increase   in both periods was primarily a result of our product sales of NOCITA and ENTYCE, and Elanco’s product sales of GALLIPRANT .   We believe any future royalty expense   for the remainder of 2018 will be substantially dependent on Elanco’s ability to successfully commercialize GALLIPRANT in accordance with the Elanco Agreements , and our continuing efforts to commercialize NOCITA and ENTYCE.

Research and development  







 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

Three Months Ended

 

 

 

 

Six Months Ended

 

 

 



 

June 30,

 

 

 

 

June 30,

 

 

 



 

2018

 

2017

 

% Change

 

2018

 

2017

 

% Change



 

(Dollars in thousands)

 

 

 

 

(Dollars in thousands)

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contracted development costs

 

$

635 

 

$

2,808 

 

(77.4)

%

 

$

1,396 

 

$

6,440 

 

(78.3)

%

Personnel costs

 

 

730 

 

 

781 

 

(6.5)

%

 

 

1,574 

 

 

1,692 

 

(7.0)

%

Other costs

 

 

211 

 

 

111 

 

90.1 

%

 

 

811 

 

 

222 

 

>100.0

%

Total research and development

 

$

1,576 

 

$

3,700 

 

(57.4)

%

 

$

3,781 

 

$

8,354 

 

(54.7)

%



During the three and six months ended June 30, 2018 , research and development expense decreased by $2.1 million and $4.6 million, respectively, as compared to the corresponding 2017 periods. The decrease during the three months ended June 30, 2018, was due primarily to a decrease of $2.2 million in contracted development costs due to fewer ongoing pivotal programs, partially offset by an increase of $0.1 million in other costs. The decrease during the six months ended June 30, 2018, was due primarily to a decrease of $5.0 million in contracted development costs due to fewer ongoing pivotal programs and a decrease of $0.1 million in personnel costs, partially offset by an increase of $0.6 million in other costs primarily from an initial upfront option fee of $0.5 million pursuant to the collaboration and option agreement with AskAt.

Since we have completed several of our pivotal studies and achieved several development milestones for GALLIPRANT, ENTYCE and NOCITA, we expect in the remainder of 2018 our research and development expenses to be lower than in 2017. Research and development expenses in 2018 are expected to be primarily related to expanding the label of our approved therapeutics for additional indications and/or species and advancing our development portfolio.

Selling, general and administrative   expense

During the three and six months ended June 30, 2018 , selling, general and administrative expense decreased by $0.2 million and $5,000 , respectively, as compared to the corresponding 2017 periods. The decrease during the three months ended June 30, 2018, was primarily due to lower stock-based compensation expense . W e expect selling, general and administrative expense to remain relatively consistent throughout 2018 as we have substantially completed the build out of our sales organization and corporate infrastructure in support of the commercialization of NOCITA and ENTYCE, and our co-promotion of GALLIPRANT, with a slight increase to support further adoption and awareness for our marketed brands.

In-process research and development

During the three and six   months ended June 30, 2018 , in-process research and development expense increased by $0.0 million and $0.5 million , respectively, as compared to the corresponding 2017 period s .   The increase during the six months ended June 30, 2018, was solely due to an   initial upfront license fee of $0.5 million pursuant to the e xclusive l icense a greement with AskAt .  

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Financial Condition, Liquidity and Capital Resources

Our financial condition is summarized as follows:



 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 



 

June 30, 2018

 

December 31, 2017

 

Change %



 

(Dollars in thousands)

 

 

 

Financial assets:

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

59,290 

 

$

66,868 

 

(11.3)

%

Marketable securities - short-term

 

 

744 

 

 

747 

 

(0.4)

%

Total cash, cash equivalents and marketable securities

 

$

60,034 

 

$

67,615 

 

(11.2)

%

Borrowings:

 

 

 

 

 

 

 

 

 

Loans payable, net

 

$

29,604 

 

$

36,825 

 

(19.6)

%

Working capital:

 

 

 

 

 

 

 

 

 

Current assets

 

$

78,993 

 

$

85,239 

 

(7.3)

%

Current liabilities

 

 

26,128 

 

 

35,496 

 

(26.4)

%

Total working capital

 

$

52,865 

 

$

49,743 

 

6.3 

%

We have incurred significant net losses since our inception. These losses have resulted principally from costs incurred in connection with in-licensing of our therapeutic candidates, research and development activities and selling, general and administrative costs associated with our operations. As of June 30, 2018 , we had an accumulated deficit of $ 241.4  million and cash, cash equivalents and short-term investments o f   $60.0   mill ion.

We expect to continue to incur operating losses for the foreseeable future as we work to develop and commercialize our therapeutics and therapeutic candidates. If we cannot generate sufficient cash from operations in the future, we may seek to fund our operations through corporate collaborations and licensing arrangements, or other sources such as public or private equity offerings and further debt (re)financings. If we are not able to raise additional capital on terms acceptable to us, or at all, as and when needed, we would be forced to delay, reduce, or eliminate certain research and development programs, reduce or eliminate discretionary operating expenses or grant rights to develop and market therapeutics or therapeutic candidates that we would otherwise prefer to develop and market ourselves, which could otherwise adversely affect our business prospects. Our failure to raise capital, as and when needed, would have a negative impact on our financial condition and our ability to pursue our business strategies as this capital is necessary for us to perform the research and development and commercial activities required to generate future revenue streams. As disclosed in Note 8 to our consolidated financial statements, we have a term loan and a revolving credit facility with an aggregate principal balance of $29.0  million as of June 30, 2018 . The terms of the loan agreement require us to maintain certain minimum liquidity at all times (the greater of cash equal to fifty percent (50%) of outstanding balance or remaining months’ liquidity, which is calculated on an average trailing three (3) month basis, equal to six (6) months or greater) , which as of June 30, 2018 , was approximately $14.5 million. If the minimum liquidity is not met, we may be required to repay the loans prior to their scheduled maturity dates. At June 30, 2018 , we were in compliance with all financial covenants. As of the date of the filing of this Quarterly Report on Form 10-Q, we believe that our existing cash, cash equivalents and short-term investments of $60.0   million at June 30, 2018 ,   will allow us to fund our operations and our debt obligations for at least one year from the issuance of our consolidated financial statements .   Our assessment through one year from the issuance of these consolidated financial statements does not include achievement of the $15.0 million mi lestone payment under the Collaboration Agreement with Elanco .  If such milestone is achieved and received, this may allow us to extend our cash beyond one year from the issuance of these consolidated financial statements.

Cash, Cash Equivalents and Investments  

Until required for another use in our business, we typically invest our cash reserves in bank deposits, certificates of deposit, and other interest bearing debt instruments in accordance with our investment policy. It is our policy to mitigate credit risk in our cash reserves and investments by maintaining a well-diversified portfolio that limits the amount of exposure as to institution, maturity, and investment type. The value of our investments, however, may be adversely affected by increases in interest rates, instability in the global financial markets that reduces the liquidity of securities included in our portfolio, and by other factors which may result in declines in the value of the investments. Each of these events may cause us to record charges to reduce the carrying value of our investment portfolio if the declines are other-than-temporary or sell investments for less than our acquisition cost, which could adversely impact our financial position and our overall liquidity.

Shelf Registration Statement

On August 4, 2017, we filed a new shelf registration statement on Form S-3 (Reg. No. 333-219681) (the “Shelf Registration Statement”) with the SEC. The Shelf Registration Statement was declared effective by the SEC on August 16, 2017.

The Shelf Registration Statement allows us to offer and sell, from time to time, up to $100.0 million of common stock, preferred stock, debt securities, warrants, units or any combination of the foregoing in one or more future public offerings. The terms of any future offering would be determined at the time of the offering and would be subject to market conditions and approval by our Board of Directors. Any offering of securities covered by the Shelf Registration Statement will be made only by means of a written

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prospectus and prospectus supplement authorized and filed by us.

At-the-Market Offering

Cowen and Company, LLC

On December 18, 2017, we entered into a Sales Agreement (“Cowen Sales Agreement”) with Cowen and Company, LLC (“Cowen”) pursuant to which we may sell from time to time, at our option, up to an aggregate of $50.0 million of shares of our common stock through Cowen, as sales agent. Any sales of the shares of common stock would be made under our effective Registration Statement on Form S-3 (Reg. No. 333-219681), by means of ordinary brokers’ transactions on the Nasdaq Global Market or otherwise. Additionally, under the terms of the Cowen Sales Agreement, the shares of common stock may be sold at market prices, at negotiated prices or at prices related to the prevailing market price. We have agreed to pay Cowen a commission of 3% of the gross proceeds from the sale of such shares of common stock.

During the six months ended 2018, we sold 4,182,191   shares of common stock for aggregate net proceeds of $1 9 . 4 million, after deducting commission fees of $0.6 million and issuances costs of $0.1 million. As of the date of this filing, approximately $29.9 million of shares of common stock remained available for sale under the Cowen Sales Agreement.

Indebtedness

On October 16, 2015, we and our wholly-owned subsidiary Vet Therapeutics, Inc. (together the “Borrowers”) entered into a Loan and Security Agreement, as amended on February 24, 2017 (the “Loan Agreement”), with Pacific Western Bank (“Pacific Western”) as collateral agent (“Collateral Agent”) and a lender and Oxford Finance LLC as a lender (“Oxford” and together with Pacific Western, the “Lenders”), pursuant to which the Lenders agreed to make available to the Borrowers, a term loan in an aggregate principal amount up to $35.0 million (the “Term Loan”), and a revolving credit facility in an aggregate principal amount up to $5.0 million (the “Revolving Line”), subject to certain conditions to funding. The Term Loan and the Revolving Line bear interest per annum at the greater of (i) 6.91% or (ii) 3.66% plus the prime rate, which is customarily defined. Under the Loan Agreement, all principal and accrued interest on the Term Loan is due on October 16, 2019 (the “Term Loan Maturity Date”), and all principal and accrued interest on the Revolving Line was due on October 16, 2017 (the “Prior Revolving Maturity Date”).   Effective as of July 31, 2017, we amended the Loan Agreement (the “Second Amendment”). The terms of the Second Amendment, among other things, extend the maturity of the Revolving Line to October 16, 2019 (the “Revolving Line Maturity Date”), with amortized equal repayments of the principal outstanding under the Revolving Line beginning November 1, 2018, and provide a six (6) month interest only period for the Term Loan, starting on the date of the Second Amendment.

As security for their obligations under the Loan Agreement, the Borrowers granted a security interest in substantially all of their existing and after-acquired assets except for their intellectual property and certain other customary exclusions. Subject to customary exceptions, the Borrowers are not permitted to encumber their intellectual property.

The Borrowers are obligated to pay a final payment fee equal to 3.30% of the principal amount of such Term Loan, if the Term Loan is being prepaid or repaid upon the earliest to occur of the Term Loan Maturity Date, the acceleration of any Term Loan or the prepayment of a Term Loan. The Borrowers were obligated to pay a termination fee equal to 3.30% of the highest outstanding amount of the Revolving Line with respect to the Revolving Line upon the earliest to occur of the Prior Revolving Maturity Date, the acceleration of the Revolving Line or the termination of the Revolving Line. The Borrowers will also be obligated to pay an unused-line fee equal to 0.25% per annum of the average unused portion of the Revolving Line.

We are not subject to any new financial covenants as a result of the Second Amendment. At the closing of the Second Amendment, we paid the Lenders an amendment fee of $0.2 million and a facility fee of $0.1 million. We are obligated to pay a new termination fee equal to $0.2 million upon the earliest to occur of the Revolving Line Maturity Date, the acceleration of the Revolving Line or the termination of the Revolving Line. The existing termination fee of $0.2 million was due on the Prior Revolving Maturity Date, and was paid on October 17, 2017.

The Loan Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among others, limits or restrictions on the Borrowers’ ability to incur liens, incur indebtedness, make certain restricted payments, make certain investments, merge, consolidate, make an acquisition, enter into certain licensing arrangements and dispose of certain assets. In addition, the Loan Agreement contains customary events of default that entitle the Lenders to cause the Borrowers’ indebtedness under the Loan Agreement to become immediately due and payable. The events of default, some of which are subject to cure periods, include, among others, a non-payment default, a covenant default, the occurrence of a material adverse change in our business, the occurrence of an insolvency, a material judgment default, defaults regarding other indebtedness and certain actions by governmental authorities. Upon the occurrence and for the duration of an event of default, an additional default interest rate equal to 4% per annum will apply to all obligations owed under the Loan Agreement. The Loan Agreement requires that we maintain certain minimum liquidity at all times, which as of June 30, 2018 , was approximat ely $14.5  m illio n. If the minimum liquidity requirement is not met, the Borrowers may be required to repay the loans prior to their scheduled maturity dates.   At June 30, 2018 , the Borrowers were in compliance with all financial covena nts, including the minimum liquidity covenant.

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Working Capital

We define working capital as current assets less current liabilities. The increase in working capital at June 30, 2018 , from December 31, 2017, reflects a decrease in total current assets of $6.2  million and a decrease in total current liabilities of $9.4  million. The decrease in total current assets was primarily driven by a decrease in cash and cash equivalents due to payments for our research and development activities related to our programs, payments for inventories, selling, general and administrative expenses, and payments of debt principal and interest , partially offset by proceeds from the at-the-market offering and customer payments . The decrease in total current liabilities was primarily a result of payments for ENTYCE inventories and a decrease in the current portion of loans payable due to payments of principal balance .  

Cash Flows

A s ummary of our cash flows for the six months ended June 30, 2018 and 2017 , is as follows :





 

 

 

 

 

 



 

Six Months Ended



 

June 30,



 

2018

 

2017



 

(Dollars in thousands)

Net cash used in operating activities

 

$

(19,402)

 

$

(29,922)

Net cash provided by (used in) investing activities

 

$

 

$

(3,509)

Net cash provided by financing activities

 

$

11,833 

 

$

24,926 

Net cash used in operating activities

During the six months   ended June 30, 2018 , net cash used in operating activities was $19.4  million. We had a net loss of $14.9  million which includes a non-cash expense for stock-based compensation of $2.6  million, a non-cash depreciation and amortization expense of $0.5  million , a non-cash interest expense of $0.3 million and $0.3 million market value adjustments to inventories . Our n et loss was primarily attributed to our research and development activities related to our programs and our selling, general and administrative expenses, partially offset by product sales revenues and licensing and collaboration revenues from the Collaboration Agreement. Net cash used in operating assets and liabilities was primarily due to a decrease in accounts payable of $6.3  million, a decrease in accrued expenses and other liabilities of $0.3  million , an increase in inventories of $2.0 million and an increase in accounts receivable of $0.4 million ,   partially offset by a decrease in prepaid expenses and other current assets of $0.7 million. The decrease in accounts payable was primarily related to payments for ENTYCE inventories and trade payables.

During the six months ended June 30, 2017, net cash used in operating activities was $29.9 million. We had a net loss of $23.0 million which includes a non-cash expense for stock-based compensation of $3.7 million, a non-cash depreciation and amortization expense of $0.6 million and a non-cash interest expense of $0.2 million. Our net loss was primarily attributed to our research and development activities related to our programs and our selling, general and administrative expenses, partially offset by licensing and collaboration revenues of $1.7 million from the Collaboration Agreement and product sales of $7.2 million. Net cash used in operating assets and liabilities was primarily due to a decrease in accounts payable of $5.5 million, a decrease in accrued expenses and other liabilities of $0.7 million, an increase in account receivable, net of $4.8 million, an increase in prepaid expenses and other current assets of $4.6 million and a decrease in inventories of $4.2 million. The decrease in accounts payable was primarily related to payments for GALLIPRANT inventories and trade payables. The increase in accounts receivable, net and decrease in inventories were primarily related to GALLIPRANT sales. Also, accounts receivable, net increased due to receivables from the Elanco GALLIPRANT Agreements.

Net cash provided by (used in) investing activities

During the six months ended June 30, 2018 , net cash provided by investing activities was $3,000 , which consisted of the proceeds from the maturities and sales of investments of $1.2 million offset by the purchases of investments of $1.2  million .  

During the six months ended June 30, 2017, net cash used in investing activities was $3.5 million, which primarily consisted of a $3.0 million milestone payment for intangible assets for currently marketed products and the purchases of investments of $2.0 million, partially offset by proceeds from the maturities and sales of investments of $1.5 million.

Net cash provided by financing activities

During the six months ended June 30, 2018 ,   net cash provided by financing activities was $11.8 million. Net cash provided by financing activities consisted of the proceeds , net of commission fee s, from the issuance of common stock of $19.5 million, partially offset by $7.5 million of payments on loans payable and $0.1 million of payments for common stock issuance costs .  

During the six months ended June 30, 2017, net cash provided by financing activities was $24.9 million. Net cash provided by financ ing activities consisted of the proceeds, net of commission s and underwriter fees, from the issuance of common stock of $27.5 million, partially offset by $2.3 million of payments on loans payable and $0.3 million of payments for stock issuance costs. 

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Contractual Obligations and   Off-Balance Sheet Arrangements

Contractual Obligations

Our contractual obligations primarily consist of our obligations under our loan s payable, non-cancellable operating leases, minimum royalties and other purchase obligations, excluding amounts related to other funding commitments, contingent development, regulatory and commercial milestone payments, contract manufacturer commitments and off-balance sheet arrangements as described below. As of June 30, 2018 , t here were no material changes in our contractual obligations since December 31, 2017 , e xcept for the contract manufacturer commitments described below.

Other Funding Commitments

As of June 30, 2018 , we have several ongoing development programs in various stages of the regulatory process. Our most significant expenditures are to clinical research and contract manufacturing organizations . The contracts are generally cancellable, with notice, at our option.

Contingent Development, Regulatory an d Commercial Milestone Payments

Based on our development p lans as of June 30, 2018 , we have committed to make potential future milestone payments to third parties of up to approximately $116.9 million, of which $86.4 million are for commercial milestones, as part of our various collaborations, including licensing and development programs. Approximately $79.4 million of the commercial milestones relate to the achievement of various sales thresholds. Payments under these agreements generally become due and payable only upon achievement of certain development, regulatory or commercial milestones. Because the achievement of these milestones had not occurred or was not considered probable as of June 30, 2018 , such contingencies have not been recorded in our consolidated financial statements.

We anticipate that we may pay approximately $0.0 million and $ 2 .0  million of milestone payments during the remainder of 201 8 , and the next 12 months, respectively, provided various development, regulatory or commercial milestones are achieved. Amounts related to contingent milestone payments are not considered contractual obligations as they are contingent on the successful achievement of certai n development, regulatory approval and commercial milestones that may not be achieved.

Contract Manufacturer Commitments

Our independent CMOs manufacture our products and product components based on our   forecasts. These forecasts are based on estimates of future demand for our products, which are in turn based on available historical trends and an analysis from sales and product marketing organizations, adjusted for overall market conditions. In order to reduce manufacturing lead times and plan for adequate supply, we may issue forecasts and orders for components and products that ar e non-cancelable. As of June 30, 2018 and December 31, 2017 , we had non-cancellable open o rders for the purchase of inventories of $1 .8 million   and $7.1 million , respectively.

Off-Balance Sheet Arrangements

We have not engaged in the use of any off-balance sheet arrangements, such as structured finance entities or special purpose entities .

Recently Issued and Adopted Accounting Pronouncements

For a discussion of new accounting standards please read Note 1,  Summary of Significant Accounting Policies   New Accounting Standards” to our consolidated financial statements included within this report .  

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Item 3. Quantitative and Qualitative Disclosures About Market Risk

Our market risks, and the ways we manage them are summarized in Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2017 , filed with the SEC on March  14 201 8 . As of June 30, 2018 , there were no material changes to our market risks or management of such risks since December 31, 2017 .

Item 4. Controls and Procedures

Limitations on Effectiveness of Controls and Procedures

In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated, as of the end of the period covered by this Quarterly Report on Form 10-Q, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended). Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2018 .  

Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934, as amended ) identified in connection with the evaluation of our internal control performed during the fiscal quarter ended June 30, 2018 , that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.



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Table of Contents

 

PART II. OTHE R INFORMATION

Item 1. Leg al Proceedings

From time to time, we may become involved in legal proceedings arising in the ordinary course of our business . W e are not presently a party to any litigation that we believe to be material and we are not aware of any pending or threatened litigation against us that we believe could have a material adverse effect on our business, operating results, financial condition or cash flows.

As we p reviously disclosed, we and two of our current officers were named as defendants in a putative securities class action lawsuit filed in the United States District Court for the Southern District of New York (the “Court”) under the caption, In re Aratana Therapeutics, Inc. Securities Litigation, Case No. 1:17-cv-00880. The lawsuit alleged that we and our senior officers made false and/or misleading statements and omitted material facts regarding our business, operations, prospects and performance during the proposed class period of March 16, 2015 to March 13, 2017. We vigorously defended all claims asserted, including by filing a motion to dismiss. On June 11, 2018, the Court issued an Opinion and Order granting the motion to dismiss in its entirety and dismissing with prejudice all claims asse rted against us and our senior officers (the “Opinion and Order”). The plaintiffs have not filed a notice of appeal of the Court’s Opinion and Order, and the time to file such notice has expired. We now consider the matter to be closed. 

Item 1A. Ri sk Factors

Our business faces significant risks and uncertainties, which may have a material adverse effect on our business prospects, financial condition and results of operations, and you should carefully consider them.

T here have been no material changes in the six months ended June 30, 2018 , to the ri sk factors described in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2017 .

Item 2. Unregi stered Sales of Equity Securities and Use of Proceeds

Unregistered Sales of Equity Securities

None.

Repurchases of Common Stock

The repurchase activity for the three months ended June 30, 2018, was as follows:





 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

Total Number of

 

Maximum Number of



 

Total Number

 

 

Average

 

Shares Purchased

 

Shares That May Yet Be



 

of Shares

 

 

Price Paid

 

as Part of Publicly

 

Purchased Under the



 

Purchased

 

 

Per Share

 

Announced Plan or Program

 

Plan or Program

April 1, 2018 - April 30, 2018

 

762 

(1)

 

$

5.01 

 

 —

 

N/A

May 1, 2018 - May 31, 2018

 

 —

 

 

 

 —

 

 —

 

N/A

June 1, 2018 - June 30, 2018

 

 —

 

 

 

 —

 

 —

 

N/A

  (1) 762 shares of restricted stock were withheld to satisfy employee tax withholding obligations arising in conjunction with the vesting of restricted stock pursuant to our 2013 Incentive Award Plan .

Item 3. Defa ults Upon Senior Securities

None.

Item 4. M ine Safety Disclosures

Not applicable.

Item 5. O ther Information

None.

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Item 6. Exhibits



































 

 

 

 

 

 



 

 

 

 

 

 



 

 

 

 

 

 



 

Incorporated by Reference

 

Exhibit Number

Exhibit Description

Form

File No.

Exhibit

Filing Date

Filed/ Furnished Herewith

3.1

Restated Certificate of Incorporation

8-K

001-35952

3.1

7/3/13

 

3.2

Amended and Restated Bylaws

8-K

001-35952

3.2

7/3/13

 

10.1

Cooperation Agreement, dated as of May 18, 2018, by and among Aratana Therapeutics, Inc., a Delaware corporation, Engaged Capital, LLC and the other parties listed on Annex A thereto

8-K

005-87524

10.1

5/21/18

 

10.2

Amended and Restated Exclusive License, Development and Commercialization Agreement, dated July 5, 2018, between the Company and Pacira Pharmaceuticals, Inc.

 

 

 

 

*

10.3

Amended and Restated Supply Agreement, dated July 5, 2018, between the Company and Pacira Pharmaceuticals, Inc.

 

 

 

 

*

31.1

Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

 

*

31.2

Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

 

*

32.1

Certification of Principal 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 Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

 

 

 

**

101.INS

XBRL Instance Document

 

 

 

 

 

101.SCH

XBRL Taxonomy Extension Schema Document

 

 

 

 

 

101.CAL

XBRL Taxonomy Extension Calculation Linkbase

 

 

 

 

 

101.DEF

XBRL Taxonomy Extension Definition Linkbase

 

 

 

 

 

101.LAB

XBRL Taxonomy Extension Label Linkbase

 

 

 

 

 

101.PRE

XBRL Taxonomy Extension Presentation Linkbase

 

 

 

 

 



*    Filed herewith.

**  Furnished herewith and not “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.

Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2 under the Securities Exchange Act of 1934.









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SIGNAT URES

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.





 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ARATANA THERAPEUTICS, INC.

 

 

 

 

Date :   August 3 , 201 8

 

 

 

By:

 

/s/    Steven St. Peter        

 

 

 

 

 

 

Steven St. Peter, M.D.

 

 

 

 

 

 

President and Chief Executive Officer

 

 

 

 

 

 

(Principal Executive Officer)

 

 

 

 

Date: August 3 , 201 8

 

 

 

By:

 

/s/    Craig Tooman        

 

 

 

 

 

 

Craig Tooman

 

 

 

 

 

 

Chief Financial Officer

 

 

 

 

 

 

(Principal Financial and Accounting Officer)





36


Exhibit 10.2



AMENDED AND RESTATED EXCLUSIVE LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

This Amended and Restated Exclusive License, Development and Commercialization Agreement (this “ Agreement ”) is made effective as of July 5, 2018 (the “ Effective Date ”) by and between Pacira Pharmaceuticals, Inc., a California corporation with a principal place of business at 5 Sylvan Way, Parsippany, New Jersey U.S. 07054 (“ Pacira ”) and Aratana Therapeutics, Inc., a Delaware corporation with a place of business at 11400 Tomahawk Creek Parkway Suite 340 Leawood, KS 66211 (“ Aratana ”).  Pacira and Aratana are each hereafter referred to individually as a “ Party ” and together as the “ Parties .”

WHEREAS, Pacira owns the global rights to develop and commercialize the Licensed Product (as hereinafter defined);

WHEREAS, Aratana has significant expertise in developing and commercializing pharmaceutical products in the Field (as hereinafter defined); and

WHEREAS, the Parties entered into an Exclusive License, Development and Commercialization Agreement dated December 5, 2012 (the “Original Agreement”) related to the Licensed Product; and

WHEREAS, the Parties desire to amend and restate the Original Agreement in its entirety as set forth herein.

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

1.     DEFINITIONS

1.1     “10ml Vial” shall mean a 10ml vial (without commercial labeling and packaging) containing the Licensed Product.

1.2     “20ml Vial” shall mean a 20ml vial (without commercial labeling and packaging) containing the Licensed Product.

1.3    “ Affiliate ” shall mean with respect to any entity, any other entity that, directly or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, such entity.  For purposes of this Section 1.1 , “ control ” means ownership, directly or indirectly through one or more Affiliates, of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (50%) or more of the equity interests in the case of any other type of legal entity, status as a general partner in any partnership, or any other arrangement whereby a Party controls or has the right to control the Board of Directors or equivalent governing body of a corporation or other entity.

1.4     Intentionally Omitted

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.


 

 

1.5    “ Administrative NADA ” is a new animal drug application that is submitted after all of the technical sections that fulfill the requirements for the approval of the new animal drug application under 21 CFR 514.1 have been reviewed by CVM and CVM has issued a technical section complete letter for each of those technical sections.

1.6    “ Adverse Event ” shall mean any unexpected, unusual, or untoward medical occurrence during the Development or Commercialization of the Licensed Product whether or not considered related to the Licensed Product, including, without limitation, any undesirable sign (including abnormal laboratory findings of clinical concern), symptom or disease temporally associated with the use of such Licensed Product.

1.7     “ Amended   Supply Agreement ” shall have the meaning set forth in Section 2.3.2 .

1.8    “ Aratana Indemnitees ” shall have the meaning set forth in Section 9.1.2 .

1.9    “ Chairperson ” shall have the meaning set forth in Section 3.1.1 .

1.10    “ Client-owned Animal Subject ” shall mean any animal (pet) owned by a Third Party (and not a laboratory or test animal purchased by or on behalf of Aratana for experimental purposes).

1.11    “ Clinical Data ” shall have the meaning set forth in Section 3.2(a) .

1.12    “ Commercialize ” or “ Commercialization ” shall mean any and all activities, excluding Development or manufacturing, necessary or desirable to realize and maximize commercial sales of the Licensed Product in accordance with applicable law, including distributing, importing, transporting, customs clearance, export, warehousing, packing, handling and delivering to customers, as well as offering for sale and sales, marketing, promoting and reimbursement related activities, including booking sales.  When used as a verb “ Commercialize ” means to engage in Commercialization.

1.13    “ Commercially Reasonable Efforts ” shall mean the use of commercially reasonable efforts and the dedication of commercially reasonable resources.  With respect to the Licensed Product, Commercially Reasonable Efforts means efforts and diligence in, as applicable, Development or Commercialization of Licensed Product that is in accordance with the efforts and resources a reasonably comparable animal health company (in the case of Aratana) or specialty pharmaceutical company (in the case of Pacira) would use for a product owned by it and to which it has exclusive rights which is of similar market potential and at a similar stage of its product life as the Licensed Product, taking into account the establishment of the Licensed Product in the marketplace, the proprietary position of the Licensed Product, the regulatory and reimbursement structure involved and the profitability of the Licensed Product.  Commercially Reasonable Efforts shall be determined on a jurisdiction by jurisdiction basis within the Territory for the Licensed Product.

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

- 2 -


 

 

1.14    “ Confidential Information ” shall mean with respect to a Party (the “ Receiving Party ”), all information which is disclosed by the other Party (the “ Disclosing   Party ”) to the Receiving Party hereunder or to any of its employees, consultants, Affiliates, licensee or Sublicensees, except to the extent that the Receiving Party can demonstrate by written record or other suitable physical evidence that such information, (a) as of the date of disclosure is demonstrably known to the Receiving Party or its Affiliates other than by virtue of a prior confidential disclosure to such Party or its Affiliates; (b) as of the date of disclosure is in, or subsequently enters, the public domain, through no fault or omission of the Receiving Party; (c) is obtained from a Third Party having a lawful right to make such disclosure free from any obligation of confidentiality to the Disclosing Party; or (d) is independently developed by or for the Receiving Party without reference to or reliance upon any Confidential Information of the Disclosing Party.  Confidential Information shall include all information disclosed to or accessible by Aratana or Pacira, as the case may be, relating to the subject matter of this Agreement prior to the Effective Date.

1.15    “ Control ” or “ Controlled ” shall mean with respect to Pacira the possession by ownership or contract by Pacira, as the result of its pending or issued intellectual property rights, of the right to exclude Third Parties from Developing and commercializing a given compound, product, or process.

1.16    “ CVM ” shall mean the Center for Veterinary Medicine (and any successor authority) of the FDA.

1.17    “ Delivery ” means Pacira making available at the loading docks of the manufacturing facilities the bulk vials of the Licensed Product for collection by Aratana or its nominated carrier.

1.18    “ Development ” and “ Develop ” shall mean all activities relating to research and development in connection with seeking, obtaining and/or maintaining any Regulatory Approval of the Licensed Product throughout the Territory in the Field, including all development activities, all animal clinical studies and all other activities relating to seeking, obtaining and/or maintaining any Regulatory Approvals from any Regulatory Authority, but excluding any manufacturing activities.

1.19    “ Development Plan ” shall have the meaning set forth in Section 3.1 .

1.20    “ Drug Approval Application ” shall mean any application for Regulatory Approval including, without limitation, (a) any application filed with the FDA and (b) any equivalent application filed with any Foreign Regulatory Authority for Regulatory Approval required prior to any sale or use or any Commercialization of a Licensed Product in any country or jurisdiction in the Territory.

1.21    “ European Union ” shall mean the member states of the European Union, as may exist from time to time, which as of the date hereof include Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia,

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

- 3 -


 

 

Slovenia, Spain, Sweden and United Kingdom, and all other countries which accede to the European Union during the Term.

1.22    “ EXPAREL® ” shall mean Bupivacaine Liposome Injectable Suspension – NDA #022496.

1.23    “ Ex-U.S. ” shall mean any jurisdiction in the Territory residing outside the United States of America.

1.24    “ Ex-U.S.   Development Costs ” shall have the meaning set forth in Section 5.4.1 .

1.25    “ Ex-U.S. Sublicense ” shall have the meaning set forth in Section 2.2.1 .

1.26    “ Ex-U.S. Sublicensee ” shall have the meaning set forth in Section 2.2.1 .

1.27    “ FDA ” shall mean the U.S. Food and Drug Administration and any successor agency or authority thereto.

1.28    “ First Commercial Sale ” shall mean with respect to the Licensed Product, on a jurisdiction-by-jurisdiction basis in the Territory, the date when Aratana or any Affiliate or any Sublicensee first sells or otherwise commercially disposes of such Licensed Product for use or consumption in the Field after receipt of the relevant Regulatory Approval in such jurisdiction.

1.29    “ Field ” shall mean all prophylactic or therapeutic uses of the Licensed Product for veterinary use.  For the avoidance of doubt, the Field shall not include use of the Licensed Product in humans.

1.30    “ Foreign Regulatory Authorities ” shall mean any applicable supranational, national, federal, provincial, state or local regulatory agency, department, bureau or other Governmental Authority of any country or jurisdiction in the Territory (other than the United States of America), having responsibility in such country or jurisdiction for any Regulatory Approvals of any kind in such country or jurisdiction, and any successor agency or authority thereto.

1.31    “ Generic Intrusion ” shall mean, on a jurisdiction-by-jurisdiction basis, the launch in such jurisdiction in the Territory in the Field of an extended release injectible bupivacaine referencing any Drug Approval Application which is deemed bioequivalent or directly substitutable to the Licensed Product by a Regulatory Authority in the respective jurisdiction of the Territory.

1.32    “ Governmental Authority ” shall mean any governmental or quasi-governmental department, commission, board, bureau, agency, court or other instrumentality of any country or jurisdiction in the Territory or any political subdivision thereof.

1.33    “ JCCC ” shall have the meaning set forth in Section 3.1 .

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

- 4 -


 

 

1.34    “ Know-How ” shall mean all information, data, knowledge, discoveries and trade secrets whether or not reduced to writing pertinent to the Licensed Product or to the manufacture, use or sale of the Licensed Product now or hereafter Controlled by Pacira.

1.35    “ Law ” shall mean all laws, treaties, statutes, ordinances, judgments, decrees, rules, codes, injunctions, writs, regulations, binding arbitration rulings, orders, and judicial or administrative interpretations or promulgations of any Governmental Authority having jurisdiction over the transactions contemplated hereunder.

1.36    “ Licensed Patent Rights ” shall mean any patents and patent applications, having claims directed to or providing exclusivity to the Licensed Product, or to the acquisition, manufacture, use, method of use, performance, sale, offer for sale, importation or other disposition of the Licensed Product that is owned or Controlled by Pacira, including but not limited to those patents and patent applications described in Schedule 1.36 attached hereto, and any divisional, continuation, continuation-in-part, reissue, reexamination, confirmation, revalidation, registration, patent of addition, renewal, extension, substitute or foreign counterparts thereof, or any patent issuing therefrom or any supplementary protection certificates related thereto.  

1.37    “ Licensed Product ” shall mean DepoBupivacaine™ Extended Release Liposome Injection for use in the Field.

1.38    “ Licensed Product Infringement Claim ” shall mean a claim or action alleging infringement of any claim of any patent or other proprietary right of a Third Party in the Territory by the manufacture, use or sale of the Licensed Product by Aratana, its Affiliates, or Sublicensees but which claim or action does not also allege any infringement of such claim of any patent or other proprietary right of a Third Party by the manufacture, use or sale of EXPAREL® in the human field.

1.39    “ Minimum Annual Revenue ” shall have the meaning set forth in Section 10.2.6 .

1.40    “ Net Sales ” shall mean the total gross sales of all Licensed Product invoiced and actually collected by Aratana, its Affiliates or any Sublicensees (or a further sublicensee of a Sublicensee) to Third Parties throughout the Territory, less the following amounts actually deducted or allowed during the applicable reference period (regardless of the period in which such related sales were made):

(a)     transport, freight and insurance costs;

(b)     sales and excise taxes and duties;

(c)     normal and customary trade, quantity and cash discounts and rebates;

(d)     refunds and chargebacks;

(e)     actual rebates and credits or allowances allowed to customers in respect thereof; and

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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(f)     amounts repaid or credited for actually returned or recalled Licensed Product.

Notwithstanding anything else contained in this Section 1.40 , the supply or other disposition of Licensed Product at no cost or charge to the recipient (x) as reasonable quantities of samples consistent with industry practice (y) for use in non-clinical or clinical studies or (z) for use in any tests or studies reasonably necessary to comply with any law, regulation or request by any Regulatory Authority shall not be included in the calculation of Net Sales.

1.41    “ OctoPlus ” means OctoPlus Sciences B.V.

1.42    “ OctoPlus Agreement ” means that certain Non-Exclusive License Agreement, dated September 9, 2010, between Pacira and OctoPlus, as amended, supplemented or modified from time to time.

1.43    “ Other Jurisdictions ” shall have the meaning set forth in Section 10.2.3 .

1.44    “ Pacira Indemnitees ” shall have the meaning set forth in Section 9.1.1 .

1.45    “ Pacira Intellectual Property ” shall have the meaning set forth in Section 2.4 .  

1.46    “ Primary Territory ” shall mean the United States, its territories and possessions, the SP Royalty Territory and the other countries of the European Union.

1.47    “ RDF ” shall mean Research Development Foundation.

1.48    “ RDF Agreement ” shall mean that certain Assignment Agreement between Pacira (as successor to SkyePharma, Inc.) and RDF dated February 9, 1994, as amended, supplemented or modified from time to time.

1.49    “ Regulatory Approval ” shall mean any and all approvals or authorizations of any kind of any Regulatory Authority necessary required prior to any commercial marketing, sale or use of the Licensed Product (or any component thereof) for use in the Field in any country or jurisdiction in the Territory for a particular indication in the Field.  For clarity, Regulatory Approval: (i) in the United States shall consist of approval by the FDA of the Administrative NADA; and (ii) shall not include any approvals, licenses, registrations or authorizations necessary for the manufacture or supply of the Licensed Product, or any component thereof, by Pacira to Aratana or its Affiliates or Sublicensees.

1.50    “ Regulatory Authority ” shall mean the FDA or any Foreign Regulatory.

1.51    “ Renewal Term ” shall have the meaning set forth in Section 10.1 .

1.52    “ Royalty Rate ” shall have the meaning set forth in Section 5.3.1 .

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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1.53    “ Shared Infringement Claim ” shall mean a claim or action alleging infringement of any claim of any patent or other proprietary right of a Third Party in the Territory by the manufacture, use or sale of the Licensed Product by Aratana, its Affiliates, or Sublicensees and which claim or action also alleges infringement of such claim of any patent or other proprietary right of a Third Party by the manufacture, use or sale of EXPAREL® in the human field.

1.54    “ SkyePharma ” shall mean SkyePharma Holding, Inc.

1.55    “ SkyePharma Agreement ” shall mean that certain Stock Purchase Agreement among Pacira (as successor to Blue Acquisition Corp.), SkyePharma and SkyePharma, Inc. dated January 8, 2007.

1.56    “ Sublicensee ” shall mean any Affiliate or Third Party to whom Aratana grants, in accordance with the terms of this Agreement, a sublicense of some or all of the rights granted to Aratana under this Agreement.

1.57     Intentionally Omitted .

1.58    “ SP Royalty ” shall mean [***]% of Net Sales payable to SkyePharma per the SkyePharma Agreement.

1.59    “ SP Royalty Territory ” shall mean the United Kingdom, Italy, France, Germany, Spain and Japan.

1.60    “ Term ” shall have the meaning set forth in Section 10.1 .

1.61    “ Territory ” shall mean worldwide.

1.62    “ Third Party ” shall mean any person or entity other than Aratana, Pacira and their respective Affiliates or Sublicensees.

1.63    “ Trademark(s) ” shall mean (i) EXPAREL® and (ii) any other trademark or trademarks including logo mark and/or trade dress selected by, registered or owned by Pacira, its Affiliates or sublicensees in connection with the promotion and marketing of EXPAREL in the Territory.

1.64    “ Upfront Payment Amount ” shall have the meaning set forth in Section 5.1 .

1.65    “ U.S. Development Costs ” shall have the meaning set forth in Section 5.4.3 .

1.66    “ U.S. Sublicense ” shall have the meaning set forth in Section 2.2.2 .

1.67    “ U.S. Sublicensee ” shall have the meaning set forth in Section 2.2.2 .

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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In this Agreement, unless the context requires otherwise:

(a)    the headings are included for convenience only and shall not affect the construction of this Agreement;

(b)    words denoting the singular shall include the plural and vice versa;

(c)    words denoting one gender shall include each gender and all genders;

(d)    the words “include” or “including” shall mean “include, without limitation” or “including, without limitation,” as the case may be, and the language following “include” or “including” shall not be deemed to set forth an exhaustive list; and

(e)    any reference to an enactment or statutory provision is a reference to it as it may have been, or may from time to time be amended, modified, consolidated or reenacted.

The Schedules to this Agreement comprise part of and shall be construed in accordance with the terms of this Agreement.

2.     GRANT OF RIGHTS

2.1     Grant of License .  Pacira hereby grants to Aratana an exclusive (even as to Pacira) royalty-bearing license, including the limited right to grant sublicenses (as provided herein), to the Licensed Patent Rights and Pacira’s Know-How to Develop, register, use, have used, distribute, have distributed, sell, offer for sale, have sold, import, have imported and Commercialize, the Licensed Product in the Territory, solely for any and all uses within the Field.  The license granted hereunder shall specifically not include the right of Aratana or any Affiliate or Sublicensee of Aratana to manufacture the Licensed Product or to utilize the Trademarks in connection with the Development or Commercialization of the Licensed Product.

2.2     Right to Sublicense .

2.2.1     Sublicenses Outside the United States .  Aratana shall have the limited right to grant sublicenses under the license set forth in Section 2.1 to Develop and Commercialize the Licensed Product outside the United States (an “ Ex-U.S. Sublicense ”), solely for any and all uses within the Field; provided, however, that (i) Aratana shall provide Pacira periodic updates of its ex-US sublicensing activities at each meeting of the JCCC (as hereinafter defined); (ii) Pacira shall be notified of the proposed grant of an Ex-U.S. Sublicense to any and all potential Sublicensees outside the United States (an “ Ex-U.S. Sublicensee ”), for approval by Pacira which approval shall not be unreasonably withheld together with a copy of the proposed Ex-U.S. Sublicense, such approval to be determined within [***] calendar days of receipt of the notice and copy of the proposed sublicense; (iii) any and all Ex-U.S. Sublicenses shall be consistent with all the terms and conditions of this Agreement and shall require the Ex-U.S. Sublicensee to comply fully with the obligations imposed by this Agreement; and (iv) following execution of such Ex-U.S. Sublicense, Aratana shall provide Pacira with a copy of each such Ex-U.S. Sublicense and any supplements, amendments or modifications within [***] calendar days of execution.  Aratana will be fully responsible under this Agreement for the actions and omissions of such Ex-U.S. Sublicensees as if such actions or omissions were its own.  Aratana will not grant an Ex-U.S. Sublicense other than as permitted in this Section 2.2.1 .  Notwithstanding the

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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foregoing, any Ex-U.S. Sublicense shall not provide the Ex-U.S. Sublicensee with the right to grant further sublicenses under such Ex-U.S. Sublicense unless such further sublicense is expressly conditioned upon the prior written consent of Pacira, which consent may be withheld by Pacira in its absolute discretion.

2.2.2     Sublicenses Within United States .  In the event Aratana determines to sublicense all or any portion of the rights granted in the United States in the Field hereunder to an Affiliate or Third Party (a “ U.S. Sublicense ”), the Parties will work together to find the appropriate partner.  Any such U.S. Sublicense, including any supplement, amendment or modification thereto, will require the written consent of Pacira, which consent will be considered in the good-faith business judgment of Pacira but may be withheld by Pacira in its sole discretion.  Any and all U.S. Sublicenses shall be consistent with all the terms and conditions of this Agreement and shall require each Sublicensee under a U.S. Sublicense (a “ U.S.   Sublicensee ”) to comply fully with the obligations imposed by this Agreement and, following execution of such U.S Sublicense, Aratana shall provide Pacira with a copy of each such U.S. Sublicense within [***] calendar days of execution.  Aratana will be fully responsible under this Agreement for the actions and omissions of each U.S. Sublicensee as if such actions or omissions were its own.  Aratana will not grant a U.S. Sublicense other than as permitted in this Section 2.2.2 .  Notwithstanding the foregoing, any U.S. Sublicense shall not provide the U.S. Sublicensee with the right to grant further sublicenses under such U.S. Sublicense unless such further sublicense is expressly conditioned upon the prior written consent of Pacira, which consent may be withheld by Pacira in its absolute discretion.

2.3     Manufacturing .

2.3.1     Exclusive Supplier .  During the Term, Pacira shall be the exclusive supplier of the Licensed Product to Aratana.  Neither Aratana nor any Affiliate or Sublicensee shall have the right to make or have made the Licensed Product in the Territory.

2.3.2     Supply Agreements .  Concurrently herewith, the Parties are entering into an amended supply agreement attached hereto as Exhibit A (the “ Amended Supply Agreement ”), pursuant to which Pacira is agreeing to supply 20ml Vials and 10ml Vials to Aratana at the prices contemplated thereby Aratana shall be responsible for its own costs and expenses related to the labeling, packaging, transport of all vials provided by Pacira and as detailed in the Amended Supply Agreement.

2.4     Ownership .  Aratana shall own all right, title and interest in any Drug Approval Application during the Term and all trade names, trademarks and trade dress utilized in the Commercialization of the Licensed Product.  Pacira shall own all right, title and interest in and to the Licensed Patent Rights, Know How and Trademarks (collectively “ Pacira Intellectual   Property ”).  To the extent any rights, title or interest in or to any Pacira Intellectual Property would otherwise vest in Aratana, any of its Affiliates or any of their respective personnel or contractors, Aratana hereby assigns (and shall cause Aratana’s Affiliates and the respective personnel and contractors of Aratana or Aratana’s Affiliates to assign) all such rights, title and interest to Pacira.

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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3.     DEVELOPMENT/COMMERCIALIZATION OF LICENSED PRODUCTS

3.1     Joint Clinical and Commercial Committee .  The Joint Clinical and Commercial Committee (“ JCCC ”) which was established following the effective date of the Original Agreement shall continue to direct Development and Commercialization of the Licensed Product, including but not limited to the sharing by both parties of information on Development of the Licensed Product, sublicensing and other business development activities of Aratana related to the Licensed Product, intellectual property management and Commercialization, and ensuring any plans for Development or Commercialization of the Licensed Product will not be adverse to, materially conflict with, or interfere with any regulatory approval, manufacture, marketing authorization or marketing efforts for EXPAREL® outside of the Field.  The JCCC will consist of an equal number of, and not less than [***], representatives of each Party, as determined by the CEO of each Party.  Any decisions made by the JCCC shall be unanimous with each Party’s representatives collectively having one vote.  The JCCC shall have the following powers and duties:

·

Oversee the Development of the Licensed Product in the Field, including but not limited to the clinical development program, which shall be reviewed and subject to the approval of the JCCC (the “ Development   Plan ”);

·

Review, coordination and approval of any scientific publications relating to the Licensed Product;

·

Review and approval of any Commercialization plans for the Licensed Product in the Territory;

·

Review of any sublicensing or business development activities related to the Licensed Product in the Field;

·

Review and recommend whether to continue to Commercialize the Licensed Product in a jurisdiction following Generic Intrusion in such jurisdiction; and

·

Such other powers and duties as agreed to by the Parties.

3.1.1     Chairmanship .  One JCCC representative from a Party shall chair the JCCC (the “ Chairperson ”) on a rotating annual calendar year basis, alternating between a representative from Aratana and a representative from Pacira, with the initial Chairperson to be from [***].  The Chairperson shall send notices and agendas for all JCCC meetings to all JCCC members and ensure review and approval of the minutes of each JCCC meeting within [***] calendar days of adjournment of a JCCC meeting.

3.1.2     Meetings .  The JCCC will meet as needed upon request from at least one of the Parties to the then-current Chairperson, but not less than [***].  At each meeting, the Parties shall provide updates on the status of their respective responsibilities.  Meetings may be

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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held by teleconference, videoconference or in person, as mutually agreed upon by the Parties.  At each meeting, a secretary shall by appointed by the Chairperson to record meeting minutes.  Within [***] calendar days after a meeting, the Chairperson shall circulate draft minutes to the Parties for review, comment and distribution, in order to finalize the minutes within [***] calendar days of such meeting.

3.1.3     Dispute Resolution .  If a dispute arises in connection with the Development Plan, Commercialization of the Licensed Product or any other issue addressed by the JCCC, the JCCC shall confer immediately and use commercially reasonable efforts to resolve the dispute or issue within [***] calendar days of their initial conference.  No such dispute or issue shall be considered resolved until the JCCC has unanimously agreed to the resolution; provided, however, that if the JCCC does not reach consensus, within a [***] calendar day period, the resolution of the dispute or issue shall be made by the JCCC representatives of Aratana unless such resolution in the opinion of any member of the JCCC would be reasonably expected to be adverse to, materially conflict with, or interfere with the regulatory approval, manufacture, marketing authorization or marketing efforts for EXPAREL® outside of the Field, in which case such dispute will be handled in accordance with Section 11 of this Agreement.

3.2     Responsibilities of Pacira .  Under the supervision of the JCCC, Pacira shall:

(a)     make available to Aratana copies of any and all documentation in possession of Pacira related to the Licensed Product including but not limited to research data and reports, regulatory materials and correspondence (including INDs and NDAs in U.S.), clinical and preclinical data (including all raw data), chemistry, manufacturing and controls (CMC) data, relevant to conducting animal clinical studies and obtaining Regulatory Approval in the Field in the Territory (collectively, the “ Clinical Data ”) and Aratana shall have the right to use the Clinical Data solely in connection with, and as necessary for, the Development and Commercialization of the Licensed Product;

(b)     provide to Aratana without charge (EXW Incoterms 2010 Pacira’s or its designee’s manufacturing facility) such reasonable quantities of Licensed Product in unlabeled 20ml Vials or 10ml Vials as necessary for Aratana to conduct such studies in the Field in the Territory as necessary to seek Regulatory Approvals in accordance with the Development Plan; If Pacira determines in its sole discretion to develop an additional vial size for Licensed Product, Pacira shall provide Aratana an opportunity to negotiate in good faith the terms under which Pacira would agree to supply the additional vial size to Aratana but in no instance shall Pacira be obligated to enter into an agreement to develop or supply Aratana with such additional vial size.

(c)     supply 20ml Vials and 10ml Vials to Aratana (EXW Incoterms 2010 Pacira’s manufacturing facility), at the transfer prices and otherwise pursuant to the terms and conditions set forth in the Supply Agreements; and

(d)     keep the JCCC reasonably informed of any activities concerning the manufacture of the Licensed Product, including those related to a Change in Process (as defined in the Supply Agreement).

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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3.3     Responsibilities of Aratana .  Under the supervision of the JCCC, Aratana shall:

(a)     at its sole cost and expense and using Commercially Reasonable Efforts, be responsible for Development of Licensed Product in the Territory in accordance with the Development Plan approved by the JCCC;

(b)     use Commercially Reasonable Efforts to conduct or cause to be conducted such clinical studies necessary to achieve Regulatory Milestone C described in Section 5.2.1 below;

(c)     be responsible for the preparation and filing at its sole cost and expense of any Drug Approval Applications in the Territory, including an Administrative NADA, which Drug Approval Applications shall be filed no later than [***] days following receipt of the requisite technical section complete letters for each of the technical sections that fulfill the requirements for the approval of the Administrative NADA;

(d)     be responsible for the performance of all activities and undertakings as may be required by any Regulatory Authorities to obtain approval of the Drug Approval Applications;

(e)     at its sole cost and expense, be responsible for the Commercialization of the Licensed Product, including all sales and marketing activities, in the Field in the Territory;

(f)     following Delivery by Pacira be responsible for the labeling, packaging and shipping of bulk vials of the Licensed Product for commercial sale, utilizing such branding, trade names and trade dress selected by Aratana and approved by the JCCC;

(g)     following receipt of Regulatory Approval, be responsible at its sole cost and expense for (i) the maintenance and updating of all Regulatory Approvals as may be required by any Regulatory Authorities, including any post approval studies required by any Regulatory Authorities and pharmacovigilance and (ii) any user fees relating to the manufacturing of the Licensed Product for Aratana that are required by the FDA; and

(h)     such other activities requested by the JCCC.

3.4     Adverse Events .  The Parties agree to provide each other with Adverse Event information and product complaint information relating to Licensed Product as compiled and prepared by the Parties in the normal course of business in connection with the Development, Commercialization or sale of the Licensed Product, within time frames consistent with reporting obligations under applicable Law.  All reports, updates, Adverse Events, product complaint and other information provided by one Party to the other Party under this Agreement (including under this Section 3.4 ), shall be considered Confidential Information of the disclosing Party, subject to

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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the terms of Section 6 hereof it being understood that the FDA may publish information relating to Adverse Events on its website.

3.5     Commercialization in the U.S .  In the event that Aratana proposes to exercise its rights pursuant to Section 2.2.2 to pursue a U.S. Sublicense or a co-promotion partner for the Commercialization of the Licensed Product in the U.S., Aratana shall, prior to entering into negotiations with any Third Party relating to such U.S. Sublicense, co-promotion agreement or similar arrangement, negotiate in good faith with Pacira for a period of [***] days regarding shared Commercialization rights between Aratana and Pacira in the Field in the U.S.; provided, however, that each Party’s decision to accept or reject such shared Commercialization rights on the terms offered by the other Party shall be made in its absolute discretion.

4.     ADDITIONAL OBLIGATIONS OF ARATANA

4.1     Compliance .  Aratana shall be solely responsible for compliance with all applicable Law in the Territory relating to the storage (following the delivery of the Licensed Product by Pacira), Development, Commercialization, and all other activities concerning the Licensed Product.

4.2     Permits and Licenses .  Aratana shall throughout the Term, at its expense, obtain and maintain any and all licenses, permits, orders, authorizations and consents required by any Regulatory Authorities in the Territory to perform its obligations under this Agreement.

4.3     Sale of Licensed Product .  Aratana shall use its Commercially Reasonable Efforts to market and sell the Licensed Product, either directly or through a Sublicensee, in the Territory in compliance with all applicable laws using techniques and methods which are customary in the pharmaceutical industry for veterinary products.

4.4     Exclusive Supplier .  During the Term, Aratana agrees to purchase all of its requirements for Licensed Product exclusively from Pacira, and Pacira agrees to supply the Licensed Product on the terms and conditions to be set forth in the Supply Agreements.

4.5     No Competing Products .  During the Term, neither Aratana nor any of its Affiliates shall Develop or Commercialize either directly or indirectly (including, but not limited to, by providing any assistance or license to any Third Party to do any of the foregoing), any injectable analgesic product preventing pain for at least 48-72 hours post-surgery as an active pharmaceutical ingredient labelled for the control of post-operative pain for surgical veterinary use (a “Competing Product”) other than the Licensed Product; provided however that this restriction shall not apply to (a) the grant of a license or sublicense by Aratana to a Third Party approved by Pacira either pursuant to Section 2.2.1 or 2.2.2 above. Notwithstanding anything herein to the contrary, Aratana shall not grant any Third Party (other than Pacira) a right of reference to any Drug Approval Application.

4.6     Use of Confidential Information .  Aratana shall only use Confidential Information for the purposes of this Agreement and shall not modify, copy or reverse engineer any aspect or component of the Licensed Product or Know-How nor shall Aratana authorize or permit

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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any Third Party to modify, copy or reverse engineer any aspect or component of the Licensed Product or Know How.

5.     PAYMENTS AND ROYALTIES

5.1     Upfront Payment .  In consideration of the grant of the licenses and rights hereunder, Aratana shall pay to Pacira the non-refundable sum of U.S. $1,000,000 (the “ Upfront   Payment Amount ”) which amount was paid as of the execution of the Original Agreement.

5.2     Milestone Payments

5.2.1     Milestone Payments :  In further consideration of the grant of the license and rights by Pacira hereunder, and subject to the other terms of this Agreement (including the remainder of this Section 5 ), Aratana shall pay to Pacira the following milestone payments within [***] calendar days of achievement of the designated milestones:



 

Regulatory Milestone

Milestone Amount

A.    [***]:

 

U.S. $[***]

B.    [***]:

 

U.S. $[***]

C.    [***]: 1

 

 

U.S. $[***]

D.    [***]:

 

U.S. $[***]

E.    [***]: 2

 

 

U.S. $[***]

Total Potential Regulatory Milestones

U.S. $2,500,000

Commercial Milestones

 

A.  Upon achievement of annual Net Sales of Licensed Product of U.S. $ 50 Million in the Territory:

 

U.S. $[***]



________________________

1 [***]

2 [***]

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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B.  Upon achievement of annual Net Sales of Licensed Product of U.S. $ 100 Million in the Territory:

 

U.S. $[***]

C.  Upon achievement of annual Net Sales of Licensed Product of U.S. $ 250 Million in the Territory:

 

U.S. $[***]

Total Potential Commercial Milestones

U.S. $40,000,000



5.2.2     Milestones Achieved Only Once : Each Regulatory and Commercial Milestone can only be achieved once.  After the Licensed Product achieves a regulatory or commercial milestone, payment shall not come due upon the achievement of the same milestone. As of the Effective Date, the Parties acknowledge that all Regulatory Milestones A, B, C, D and E have been paid.

5.2.3     Notice of Achievement of Milestones.  Aratana shall provide Pacira with notice of achievement of any Regulatory or Commercial Milestones within [***] calendar days of achievement of such Milestone.

5.3     Payment of Royalties; Royalty Rates

5.3.1     Royalty Payments .  Commencing on the Effective Date and continuing for the Term in the Territory, Aratana shall pay to Pacira royalty payments based on annual Net Sales by Aratana or its Affiliates in the Territory of the 20ml Vial as follows:



 

 

Territory

Annual Net Sales

Royalty Rate

U.S.

$[***]

[***]%

[***]%

Ex-U.S.

$[***]

[***]%

[***]%



5.3.2     During the Initial Price Term (as defined in the Amended Supply Agreement), Aratana shall not be obligated to pay any royalty payments based on annual Net Sales by Aratana or its Affiliates in the Territory of the 10ml Vial and thereafter, the Parties shall negotiate in good faith the applicable terms relating to the 10ml Vial in accordance with Section 5.1(b) of the Amended Supply Agreement.

All calculations for Sections 5.3.1 and 5.3.2 shall be done in U.S. dollars.  Royalties on sales by any Ex-U.S. Sublicensees and U.S. Sublicensees shall be paid in accordance with Sections 5.4.1 and 5.4.2 below.

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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5.3.3     Third-Party Royalty Payments .  Should Aratana be required to pay royalties to a Third Party (excluding any SP Royalty (which, except as provided in Section 5.4.3 , shall be the responsibility of Pacira) and any royalties due RDF under the RDF Agreement and not including any royalties that may be due Sublicensees for the sale of Licensed Product) in order to settle or avoid any Licensed Product Infringement Claim or Shared Product Infringement Claim in the Territory, the royalty paid to Pacira shall be reduced by [***] percent [***]% of the royalty paid to such Third Party, but in no event shall the royalty paid to Pacira for Net Sales in the Territory be reduced by more than [***] percent [***]%.

5.3.4     Royalty Floor .  Notwithstanding any reduction in Royalty Rate payable to Pacira as contemplated in Section 5.3.3 at no time shall the Royalty Rate paid to Pacira on Net Sales by Aratana in any jurisdiction in the Territory be reduced below [***]% for the 20ml Vial.  After the Initial Price Term, the Parties shall, in conjunction with their good faith negotiations in accordance with Section 5.1(b) of the Supply Agreement and assuming a royalty is established for the 10ml Vial, establish a royalty floor for the 10ml Vial.

5.3.5     Payment of Royalties .  Aratana shall make royalty payments owed to Pacira pursuant to Section 5.3 hereunder quarterly in arrears, within [***] calendar days from the end of each calendar quarter.  For purposes of determining when a sale of any Licensed Product occurs under this Agreement, the sale shall be deemed to occur on the earlier of (a) the date the Licensed Product (in final form) is shipped by Aratana or its Affiliates or Sublicensees for sale to a Third Party or (b) on the date of payment on the invoice to the purchaser of the Licensed Product.  Each royalty payment shall be accompanied by a report for each jurisdiction in the Territory in which sales of Licensed Products occurred in the calendar quarter covered by such statement, specifying: (i) the total gross sales and Net Sales (including an itemization of the deductions applied to gross sales to derive such Net Sales) in each jurisdiction’s currency; (ii) the number of units of Licensed Product sold (less damaged, rejected, returned or recalled Licensed Product) during the relevant Calendar Quarter; (iii) the applicable royalty rate under this Agreement; (iv) the royalties payable in each jurisdiction’s currency; (v) the applicable exchange rate to convert from each jurisdiction’s currency to U.S. dollars under Section 5.5 and (vi) the royalties payable in U.S. dollars.

5.4     Sublicense Payments .

5.4.1     Payments for Ex-U.S. Sublicenses .  Subject to any adjustments to royalty payments set forth in Section 5.4.2 , Aratana shall pay to Pacira fifty percent (50%) of all (a) sublicense fees, milestones and royalty payments received by Aratana pursuant to any Ex-U.S. Sublicenses and (b) any profits, including any amounts by which resale/transfer price exceeds Product Price, derived by Aratana in connection with any transfer or resale of Bulk Product (as defined in the Supply Agreement) or Licensed Product to any Ex-U.S. Sublicensees as contemplated by the Supply Agreement; provided, however, that prior to making any such payments to Pacira, Aratana shall first be entitled to recoup from any upfront fees or milestone payments (but not from any royalty payments or supply revenue) received by Aratana from any Ex-U.S. Sublicensee its out-of-pocket Third Party direct, documented fees and expenses associated with any Drug Approval Applications for the Licensed Product in jurisdictions in the Territory outside the United States, including any fees and expenses associated with any Ex-U.S. clinical

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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program used for submission with any such Drug Approval Application (“ Ex-U.S.   Development Costs ”).  For the avoidance of doubt, Aratana may not recoup identified and specified Ex-U.S. Development Costs against payments received pursuant to any Ex-U.S. Sublicense more than once.  Ex-U.S. Development Costs shall not include the Upfront Payment Amount or any milestone or royalty payments due or payable to Pacira hereunder and Aratana may not recoup any Ex-U.S. Development Costs against any payments due or payable to Pacira hereunder.  Aratana’s right to recoup expenses pursuant to this Section 5.4.1 shall also not supersede its payment obligations pursuant to Section 5.4.2 below.

5.4.2     SP Royalty Payments on Sales by Sublicensees in SP Royalty Territory.  In addition to Aratana’s obligation to pay to Pacira 50% of any sublicense fees, milestones and royalty payments received pursuant to Section 5.4.1 above, for as long as Pacira has an obligation to pay the SP Royalty, the Parties shall share in the responsibility for the SP Royalty in the SP Royalty Territory as follows:

(a)     If the royalty received from a Sublicensee is less than [***]% of Net Sales in the Third Party Royalty Territory, Pacira shall be responsible for [***]% and Aratana shall be responsible for [***]% of the SP Royalty such that Aratana shall pay to Pacira [***]% of any royalties on Net Sales received from a Sublicensee in the SP Royalty Territory;

(b)     If the royalty received from a Sublicensee is greater than or equal to [***]% but less than [***]% of Net Sales in the SP Royalty Territory, Pacira shall be responsible for [***]% and Aratana shall be responsible for [***]% of the SP Royalty such that Aratana shall pay to Pacira [***]% of any royalties on Net Sales received from a Sublicensee in the SP Royalty Territory;

(c)     If the royalty received from a Sublicensee is greater than or equal to [***]% of Net Sales in the SP Royalty Territory, Pacira shall be responsible for [***]% and Aratana shall be responsible for [***]% of the SP Royalty such that Aratana shall pay to Pacira [***]% of any royalties received on Net Sales from a Sublicensee in the SP Royalty Territory; and

(d)     For as long as Pacira has the obligation, Pacira shall pay the SP Royalties to SkyePharma in accordance with the terms of the SkyePharma Agreement.  Pacira shall also be responsible for payment to RDF of any amounts due under the RDF Agreement.

5.4.3     Payments for U.S. Sublicenses .  Aratana and Pacira shall equally share fifty percent (50%) of all (a) sublicense fees, milestones and royalty payments received by Aratana from any U.S. Sublicensees (b) any profits, including any amounts by which resale/transfer price exceeds Product Price, derived by Aratana in connection with any transfer or resale of Bulk Product (as defined in the Supply Agreement) or Licensed Product to any U.S. Sublicensees as contemplated by the Supply Agreement until Aratana recoups its out-of-pocket Third Party direct, documented fees and expenses associated with any Drug Approval Application in the United States for the Licensed Product, including any fees and expenses associated with the Development of the

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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Licensed Product in the U.S. (“ U.S. Development   Costs ”), and any milestones (other than the Upfront Payment Amount) paid to Pacira hereunder.  Any sharing of royalty payments under this Section 5.4.3 shall be updated to reflect any sharing of SP Royalty as provided in Section 5.4.2 .  Following Aratana’s recoupment of its U.S. Development Costs, except as provided below, the license granted to Aratana for the United States shall terminate and  Aratana shall no longer be entitled to receive any royalties or other payments due under the U.S. Sublicense with all rights thereunder reverting to Pacira, and upon such event Aratana shall comply with Section 10.3.5 below; provided, however, if Aratana enters into a U.S. Sublicense and is nevertheless able to continue to meet its financial obligations and royalty payments to Pacira as outlined in Sections 5.2 and 5.3.1 , Aratana will be entitled to retain its rights to the Licensed Product and can retain all amounts in excess of the amounts due Pacira hereunder.

5.4.4     Payment of Sublicense Payments, etc .  Aratana shall pay to Pacira within [***] calendar days of receipt of its share of any payments received by Aratana pursuant to any Ex-U.S. Sublicense or U.S. Sublicense.  Each sublicense payment shall be accompanied by a report specifying (i) the sublicense fees, milestones and royalty payments received in each jurisdiction’s currency; (ii) an account of deductions taken for any U.S. Development Costs or Ex-U.S. Development Costs (as the case may be); (iii) the applicable exchange rate to convert from each jurisdiction’s currency to U.S. dollars under Section 5.5 ; (iv) a breakdown of any SP Royalty amounts; (v) the amount payable in United States Dollars; and (vi) any other information requested by Pacira.

5.5     Accounting .  All payments hereunder shall be made in U.S. dollars.  Conversion of foreign currency to United States dollars shall be made at the conversion rate existing in the United States (as reported in The Wall Street Journal, East Coast edition) on the immediately preceding business day.  If The Wall Street Journal ceases to be published, then the rate of exchange to be used shall be that reported in such other business publication of national circulation in the United States as the Parties reasonably agree.

5.6     Taxes; Withholding; Restrictions on Payment .  Each Party shall pay the applicable taxes levied on all payments made to it under this Agreement.  If provision is made in Law or regulation of any jurisdiction for withholding of taxes of any type, levies or other charges with respect to any amounts payable under this Agreement to the other Party, the paying Party shall promptly pay such tax, levy or charge for and on behalf of the other Party to the proper governmental authority, and shall promptly furnish the other Party with receipt of such payment.  The paying Party shall have the right to deduct any such tax, levy or charge actually paid from payment due to the other Party or be promptly reimbursed by the other Party.  Each Party agrees to assist the other Party in claiming exemption from such deductions or withholdings under double taxation or similar agreement or treaty from time to time in force and in minimizing the amount required to be so withheld or deducted and shall use all reasonable and legal efforts to reduce tax withholding on payments made hereunder. If by law, regulations or fiscal policy of a particular jurisdiction in the Territory, remittance of royalties in U.S. dollars is restricted or forbidden, written notice thereof shall promptly be given to Pacira, and payment of the royalty shall be made by the deposit thereof in local currency to the credit of Pacira in a recognized banking institution reasonably designated by Pacira by written notice to Aratana.

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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5.7     Reports .  Following the date of First Commercial Sale of the first Licensed Product hereunder, Aratana shall, and shall require each of its Sublicensees to, provide monthly reports to Pacira no later than the [***] calendar day after the end of each such calendar month setting forth (i) the gross sales and Net Sales of Licensed Product in each jurisdiction of the Territory; (ii) the number of units of Licensed Product sold in each jurisdiction of the Territory; and (iii) such other information reasonably requested by Pacira.  Aratana also agrees to provide such information to, and reasonably cooperate with, Pacira as may be reasonably requested by Pacira in order to comply with its reporting obligations to SkyePharma and RDF.

5.8     Records Retention; Review .

5.8.1     Royalties .  Commencing as of the date of First Commercial Sale of the first Licensed Product hereunder, Aratana and its Affiliates and Sublicensees shall keep for at least [***] years from the end of the calendar year to which they pertain complete and accurate records of sales by Aratana or its Affiliates and Sublicensees, as the case may be, of each Licensed Product, in sufficient detail to allow the accuracy of the payments hereunder to be confirmed.

5.8.2     Review .  Subject to the other terms of this Section 5.8.2 , at the request of Pacira, which shall not be made, without cause, more frequently than [***] per calendar year during the Term, upon at least [***] calendar days’ prior written notice from Pacira, and at the expense of Pacira (except as otherwise provided herein), Aratana shall permit an independent certified public accountant reasonably selected by Pacira and reasonably acceptable to Aratana to inspect (during regular business hours) the relevant records required to be maintained by Aratana under this Section 5.8 for any period within the preceding [***] calendar years.  In every case the accountant must have previously entered into a confidentiality agreement with both Parties substantially similar to the provisions of Section 6 and limiting the disclosure and use of such information by such accountant to authorized representatives of the Parties and the purposes germane to this Section 5.8 .  Results of any such review shall be binding on both Parties absent manifest error.  Each Party agrees to treat the results of any such accountant’s review of the other Party’s records under this Section 5.8 as Confidential Information of the other Party subject to the terms of Section 6 .  If any review reveals either (i) a deficiency in the calculation and/or payment of royalties, milestones or other amounts due Pacira hereunder by Aratana or (ii) an overpayment of royalties, milestones or other payments due Pacira hereunder, then: (a) Aratana shall promptly pay Pacira the amount remaining to be paid for an underpayment or take a credit towards payment of royalties for the next calendar quarter for an overpayment, and (b) if there is an underpayment exceeding [***] percent [***] of any such payment, Aratana shall pay all reasonable costs and expenses incurred by Pacira in connection with the review.

5.8.3     Other Parties .  Aratana shall include in any agreement with its Affiliates or Sublicensees terms requiring such party to retain records as required in this Section 5.6 and to permit Pacira to inspect such records as required by this Section 5.8.3 .

6.     TREATMENT OF CONFIDENTIAL INFORMATION

6.1     Confidential Obligations .  Pacira and Aratana each recognize that the other Party’s Confidential Information constitutes highly valuable and proprietary confidential

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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information.  Pacira and Aratana each agree that during the Term and for [***] years thereafter, it will keep confidential, and will cause its employees, consultants, Affiliates and Sublicensees to keep confidential, all Confidential Information of the other Party; provided, however that Aratana’s and its employees’, consultants’, Affiliates’ and Sublicensees’ obligation to keep confidential with respect to Pacira’s Know How and trade secrets related to the Licensed Product and know how related to its proprietary manufacturing drug delivery systems shall continue in perpetuity.  Neither Pacira nor Aratana nor any of their respective employees, consultants, Affiliates or Sublicensees shall use Confidential Information of the other Party for any purpose whatsoever other than exercising any rights granted to it or reserved by it hereunder.  Without limiting the foregoing, each Party may disclose information to the extent such disclosure is reasonably necessary to (a) file and prosecute patent applications and/or maintain patents which are filed or prosecuted in accordance with the provisions of this Agreement, or (b) file, prosecute or defend litigation in accordance with the provisions of this Agreement or (c) comply with applicable laws, regulations or court orders; provided, however, that if a Party is required to make any such disclosure of the other Party’s Confidential Information in connection with any of the foregoing, it will give reasonable advance notice to the other Party of such disclosure requirement and will use reasonable efforts to assist such other Party in efforts to secure confidential treatment of such information required to be disclosed.

6.2     Limited Disclosure and Use .  Pacira and Aratana each agree that any disclosure of the other Party’s Confidential Information to any officer, employee, consultant or agent of the other Party or any of its Affiliates or Sublicensees shall be made only if and to the extent necessary to carry out its rights and responsibilities under this Agreement, shall be limited to the maximum extent possible consistent with such rights and responsibilities and shall only be made to the extent any such persons are bound by written confidentiality obligations to maintain the confidentiality thereof and not to use such Confidential Information except as expressly permitted by this Agreement.  Pacira and Aratana each further agree not to disclose or transfer the other Party’s Confidential Information to any Third Parties under any circumstance without the prior written approval from the other Party (such approval not to be unreasonably withheld), except as otherwise required by applicable Law, and except as otherwise expressly permitted by this Agreement.  Each Party shall take such action, and shall cause its Affiliates or Sublicensees to take such action, to preserve the confidentiality of each other’s Confidential Information as it would customarily take to preserve the confidentiality of its own Confidential Information, using, in all such circumstances, not less than prudent and reasonable care.  Each Party, upon the request of the other Party, will return all the Confidential Information disclosed or transferred to it by the other Party pursuant to this Agreement, including all copies and extracts of documents and all manifestations in whatever form, within [***] calendar days of such request or, if earlier, the termination or expiration of this Agreement; provided however, that a Party may retain (a) any Confidential Information of the other Party relating to any license which expressly survives such termination and (b) one (1) copy of all other Confidential Information in inactive archives solely for the purpose of establishing the contents thereof.

6.3     Public and Private Disclosure .  Neither Party may publicly disclose the existence or terms or any other matter of fact regarding this Agreement and any ancillary agreements without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed; provided, however, that either Party may make such a

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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disclosure and provide a copy of this Agreement and any ancillary agreements to the extent required by applicable Law or by the requirements of any nationally recognized securities exchange, quotation system or over-the-counter market on which such Party has its securities listed or traded.  In the event that such disclosure is required as aforesaid, the disclosing Party shall make reasonable efforts to provide the other Party with notice beforehand and to coordinate with the other Party with respect to the wording and timing of any such disclosure.  Once such press release or any other written statement is approved for disclosure by both Parties, either Party may make subsequent public disclosure of the contents of such statement without the further approval of the other Party.  Notwithstanding the foregoing, either Party may disclose to a Third Party the existence or terms or any other matter of fact regarding this Agreement and any ancillary agreements and provide a copy of this Agreement and any ancillary agreements without the prior written consent of the other Party: (i) pursuant to, and in accordance with, any existing contractual obligations with such party or (b) if such Third Party is an investor or a prospective investor, purchaser, partner, lender or other potential financing source (or a representative of any of the foregoing) who is obligated in writing to keep such information confidential.

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

7.     PROVISIONS CONCERNING THE OWNERSHIP, FILING, PROSECUTION AND MAINTENANCE OF INTELLECTUAL PROPERTY

7.1     Third Party Licensors .  The Parties agree and acknowledge that each of Pacira, RDF and OctoPlus have certain respective rights and obligations under the RDF Agreement and the OctoPlus Agreement.  The Parties agree that this Section 7 shall be subject in all respects to the applicable terms and conditions of the RDF Agreement and the OctoPlus Agreement and, in the event of any conflict between the terms of the RDF Agreement or the OctoPlus Agreement, on the one hand, and this Agreement, on the other hand, the terms of the RDF Agreement or the OctoPlus Agreement, as applicable, shall govern.

7.2     Patent Filing, Prosecution and Maintenance .  Subject to the other terms of this Section 7 , Pacira shall be responsible for preparing, filing, prosecuting, obtaining and maintaining, at its sole cost and expense, all Licensed Patent Rights in the Territory.

7.3     Notice of Infringement .  If, during the Term, either Party learns of any actual, alleged or threatened infringement by a Third Party of any Licensed Patent Rights under this Agreement, such Party shall promptly (but no later than [***] business days) notify the other Party and shall provide such other Party with available evidence of such infringement.

7.4     Infringement of Patent Rights .

7.4.1     By Pacira .  Pacira shall have the first right (but not the obligation), at its own expense, to bring suit (or take other appropriate legal action) against any actual, alleged or, based on the reasonable belief of Pacira, threatened infringement or misappropriation of the Licensed Patent Rights in the Territory in the Field, or to defend an action seeking declaratory

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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judgment filed against Pacira with respect to the Licensed Patent Rights in the Territory in the Field.  Pacira shall have sole control over the prosecution and settlement of such claims.  Aratana shall have the right, at its own expense, to be represented in any such action by Pacira by counsel of Aratana’s own choice subject to approval by Pacira.

7.4.2     Intentionally Omitted.

7.4.3     Allocation of Recovery .  Any damages, monetary awards or other amounts recovered (net of any amounts due to RDF or OctoPlus) , whether by judgment or settlement, pursuant to any suit, proceeding or other legal action taken under this Section 7.4 , shall be applied as follows:

(a)     First, to reimburse the Parties on a pro rata basis for their respective costs and expenses (including reasonable attorneys’ fees and costs) incurred in prosecuting such enforcement action; and

(b)     Second, [***] percent [***]% to Aratana and [***] percent [***]% to Pacira.

7.4.4     Cooperation .  If either Party brings any such action or proceeding contemplated by this Section 7.4 , the other Party agrees to be joined as party plaintiff if necessary to prosecute such action or proceeding, and to give the Party bringing such action or proceeding reasonable assistance including prompt access to witnesses and documents within such other Party’s control and authority to file and prosecute the suit; provided, however, that neither Party shall be required to transfer any right, title or interest in or to any property to the other Party or any Third Party to confer standing on a Party hereunder.

7.5     Defense of Claims .

7.5.1     Pacira shall have the first right (but not the obligation) to defend any Licensed Product Infringement Claim.  If Pacira determines to defend such Licensed Product Infringement Claim, Pacira shall have sole control over the defense and settlement of such Licensed Product Infringement Claims; provided ,   however , that Aratana shall be entitled in each instance to participate in an advisory capacity through counsel of its selection at its own expense.  Aratana agrees to give Pacira reasonable assistance and authority to defend the suit.  If Pacira declines to defend such Licensed Product Infringement Claim, Aratana may defend such claim; provided ,   however , Aratana may not settle any Licensed Product Infringement Claim without the consent of Pacria.  Any damages and costs (but exclusive of any related royalty payments which are the subject of Section 5.3.2 ) generated in the defense of such Licensed Product Infringement Claims by Pacira (other than costs and expenses incurred by Aratana from its participation in such claim pursuant to this Section 7.5.1 , which shall be borne solely by Aratana) shall be borne [***]% by Aratana and [***]% by Pacira.

7.5.2     Pacira shall have the first right (but not the obligation) to defend any Shared Infringement Claim.  If Pacira determines to defend such Shared Product Infringement Claim, Pacira shall have sole control over the defense and settlement of such Shared Infringement

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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Claims; provided ,   however , that Aratana shall be entitled in each instance to participate in an advisory capacity through counsel of its selection at its own expense.  Aratana agrees to give Pacira reasonable assistance and authority to defend the suit.  Any damages and costs (but exclusive of any related royalty payments which are the subject of Section 5.3.2 ) generated in the defense of such Shared Infringement Claims (other than costs and expenses incurred by Aratana from its participation in such claim pursuant to this Section 7.5.2 , which shall be borne solely by Aratana) shall be borne by Aratana and Pacira on a pro rata basis based on the aggregate net sales of the Licensed Product and EXPAREL® in the applicable jurisdiction of the Territory for the twelve-month period ending on the date of filing of the Shared Infringement Claim.

8.     REPRESENTATIONS, WARRANTIES AND COVENANTS

8.1     Representations, Warranties and Covenants .  Each Party hereby represents, warrants and covenants to the other Party as of the Effective Date, as follows:

8.1.1     Such Party (i) has the power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder, and (ii) has taken all necessary action on its part required to authorize the execution and delivery of this Agreement.  This Agreement has been duly executed and delivered on behalf of such Party and constitutes a legal, valid and binding obligation of such Party and is in accordance with its terms subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity.

8.1.2     Such Party is not aware of any pending or threatened litigation (and has not received any communication) that alleges that such Party’s activities related to this Agreement have violated, or that by conducting the activities as contemplated in this Agreement such Party would violate, any of the intellectual property rights of any Person (after giving effect to the license grants in this Agreement). 

8.1.3     All necessary consents, approvals and authorizations of all regulatory and governmental authorities and other Persons required to be obtained by such Party in connection with the execution and delivery of this Agreement and the performance of its obligations under this Agreement have been obtained (other than such consents, approvals and authorizations that the Parties will obtain in the course of performing their obligations under this Agreement).

8.1.4     The execution and delivery of this Agreement the performance of such Party’s obligations hereunder (i) do not conflict with or violate in any material way any requirement of applicable Law, (ii) do not conflict with or violate any provision of the articles of incorporation, bylaws, limited partnership agreement or any similar instrument of such Party, and (iii) do not conflict with, violate, or breach or constitute a default or require any consent under, any contractual obligation or court or administrative order by which such Party is bound.

8.2     Additional Representations, Warranties and Covenants of Aratana .  Aratana represents, warrants and covenants to Pacira, as of the Effective Date, that:

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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8.2.1     Aratana (i) is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware, and (ii) has full power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as it is contemplated to be conducted by this Agreement.

8.2.2     Neither Aratana nor any of its Affiliates has been debarred or is subject to debarment and neither Aratana nor any of its Affiliates shall use in any capacity, in connection with the services to be performed under this Agreement, any Person who has been debarred pursuant to Section 306 of the U.S. Act (21 U.S.C 335a), or who is the subject of a conviction described in such section.  Aratana agrees to inform Pacira in writing immediately if it or any Person who is performing services on behalf of Aratana under this Agreement is debarred or is the subject of a conviction described in Section 306 of the U.S. Act, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the knowledge of Aratana, is threatened, relating to the debarment or conviction of Aratana or any Person performing services on behalf of Aratana under this Agreement.

8.2.3     Aratana will use Commercially Reasonable Efforts to Develop and Commercialize the Licensed Product for the Field in the Territory.

8.2.4     Aratana and its Affiliates have launched the 20ml Vial in the United States and agree to launch the 10ml Vial in the United States within [***] months of receiving regulatory approval and having necessary quantities (as reflected in the Forecast) of the 10ml Vial size sufficient for launch.  Aratana and its Affiliates shall launch Licensed Product (in each approved vial size) within [***] months of Regulatory Approval and having necessary quantities(as reflected in the Forecast) of the appropriate vial size sufficient for launch in the other countries of the Primary Territory.

8.2.5     Aratana has, or will have, the necessary financial resources available to it to consummate the transactions contemplated hereby and satisfy its obligations hereunder, in each case when and as contemplated by this Agreement.

8.3     Additional Representations, Warranties and Covenants of Pacira .  Pacira represents, warrants and covenants to Aratana, as of the Effective Date, that:

8.3.1     Pacira (i) is a corporation duly organized, validly existing and in good standing under the laws of the State of California, and (ii) has full power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as it is contemplated to be conducted by this Agreement.

8.3.2     Neither Pacira nor any of its Affiliates has been debarred or is subject to debarment and neither Pacira nor any of its Affiliates shall use in any capacity, in connection with the services to be performed under this Agreement, any Person who has been debarred pursuant to Section 306 of the U.S. Act, or who is the subject of a conviction described in such section.  Pacira agrees to inform Aratana in writing immediately if it or any Person who is performing services on behalf of Pacira under this Agreement is debarred or is the subject of a conviction described in Section 306 of the U.S. Act, or if any action, suit, claim, investigation or

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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legal or administrative proceeding is pending or, to the knowledge of Aratana, is threatened, relating to the debarment or conviction of Pacira or any Person performing services on behalf of Pacira under this Agreement. 

8.3.3     Pacira shall pay when due any SP Royalties to SkyePharma and maintain the SkyePharma Agreement in effect as necessary to enable Aratana to exercise the rights being granted hereunder.

8.3.4     Pacira owns or Controls, and has the right, power, and authority to license, the Licensed Patent Rights and Know-How to Aratana under this Agreement.

8.3.5     Pacira has not granted or will grant during the term of this Agreement any license, or right of any similar nature with respect to any Licensed Patent Rights or Know-How which would conflict with the license granted to Aratana under this Agreement.

8.3.6     To the knowledge of Pacira, all of the Licensed Patent Rights that have issued are valid and enforceable, and no proceeding is pending or, to the knowledge of Pacira, threatened, nor to the knowledge of Pacira has any claim been made, which challenges or challenged the legality, validity, or enforceability of any Licensed Patent Right.

8.3.7     All maintenance fees, annuity payments, and similar payments relating to the Licensed Patent Rights to be made by Pacira prior to the date hereof have been made and all such payments to be made by Pacira on or after the date hereof, solely to the extent Pacira determines, in its sole discretion, that its continued payment of any such fee is warranted or desired, will be made in a timely manner during the Term; provided, however, that notwithstanding the foregoing, if Pacira exercises it right under this Section 8.3.7 to cease payment of any maintenance fees, annuity payments, or similar payments relating to the Licensed Patent Rights, Pacira will, not less than [***] calendar days prior to such non-payment, inform Aratana of such decision and upon receipt of such notice, Aratana shall have [***] calendar days to notify Pacira of its election to make such payment or to direct Pacira to make such payment and promptly reimburse Pacira for doing so (Aratana’s failure to deliver such notice to Pacira within the [***]-day period shall constitute a waiver of Aratana’s rights under this Section 8.3.7 ).

8.3.8     To the knowledge of Pacira, Aratana’s exercise of its license rights in accordance with the terms of this Agreement will not infringe any patent or other intellectual property rights of any Third Party.

8.4     Disclaimer .  EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, EACH PARTY (AND THEIR RESPECTIVE AFFILIATES) HEREBY DISCLAIMS ANY AND ALL WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING WITH RESPECT TO ANY TECHNOLOGY LICENSED UNDER THIS AGREEMENT, INCLUDING ANY WARRANTY OF QUALITY, PERFORMANCE, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE.  FOR THE AVOIDANCE OF DOUBT, NOTHING CONTAINED IN THIS SECTION 8.4 SHALL OPERATE TO LIMIT OR INVALIDATE ANY EXPRESS WARRANTY CONTAINED HEREIN.

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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9.     INDEMNIFICATION

9.1     Indemnification .

9.1.1     Aratana Indemnity .  Subject to Section 9.1.2 below, Aratana shall indemnify, defend and hold harmless Pacira, its Affiliates and their respective directors, officers, employees, stockholders and agents and their respective successors, heirs and assigns (the “ Pacira Indemnitees ”) from and against any liability, damage, loss or expense (including reasonable attorneys’ fees and expenses of litigation) incurred by or imposed upon such Pacira Indemnitees, or any of them, in connection with any Third Party claims, suits, actions, demands or judgments, including, without limitation, personal injury and product liability matters, to the extent arising out of (a) the Development or Commercialization of the Licensed Product by any person of or in connection with Licensed Product in the Territory sold by Aratana or any Affiliate or Sublicensee under this Agreement, (b) any material breach of this Agreement by Aratana, or (c) the gross negligence, willful misconduct or violation of applicable Law on the part of Aratana or any Affiliate or Sublicensee, in any such case under this Section 9.1.1 , except to the extent of Pacira’s responsibility therefor under Section  9.1.2 below.

9.1.2     Pacira Indemnity .  Subject to Section 9.1.1 above, Pacira shall indemnify, defend and hold harmless Aratana, its Affiliates and Sublicensees and their respective directors, officers, employees, and agents, and their respective successors, heirs and assigns (the “ Aratana Indemnitees ”), from and against any liability, damage, loss or expense (including reasonable attorneys’ fees and expenses of litigation) incurred by or imposed upon such Aratana Indemnitees, or any of them, in connection with any Third Party claims, suits, actions, demands or judgments, including, without limitation, personal injury and product liability matters (but excluding any patent infringement matters, which are governed by Section 7 above), to the extent arising out of (a) any material breach of this Agreement by Pacira or (b) the gross negligence, willful misconduct or violation of applicable Law on the part of Pacira, in any such case under this Section 9.1.2 , except to the extent of Aratana’s or any Affiliate’s or Sublicensee’s responsibility therefor under Section  9.1.1 above.

9.2     Indemnification Procedures .  In the event that any Indemnitee is seeking indemnification under Section 9.1 above from a Party (the “ Indemnifying Party ”), the other Party shall notify the Indemnifying Party of such claim with respect to such Indemnitee as soon as reasonably practicable after the Indemnitee receives notice of the claim, and the Party (on behalf of itself and such Indemnitee) shall permit the Indemnifying Party to assume direction and sole control of the defense of the claim (including the right to settle the claim solely for monetary consideration) and shall cooperate as requested (at the expense of the Indemnifying Party) in the defense of the claim.  The indemnification obligations under Section 9 shall not apply to any harm suffered as a direct result of any delay in notice to the Indemnifying Party hereunder or to amounts paid in settlement of any claim, demand, action or other proceeding if such settlement is effected without the consent of the Indemnifying Party, which consent shall not be withheld or delayed unreasonably.  The Indemnitee, its employees and agents, shall reasonably cooperate with the Indemnifying Party and its legal representatives in the investigation of any claim, demand, action or other proceeding covered by Section 9.1 .

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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9.3     Insurance .

9.3.1     Pacira Insurance .  In the event Aratana obtains insurance pursuant to Section 9.3.2 below, Pacira shall thereafter, during the remainder of the Term and for a period of [***] years after the expiration date of the last unit of Licensed Product sold by Aratana, maintain a policy of product liability insurance for the Product insuring against personal injury, death and damage to property.  The said policy shall have a liability limit of not less than [***]. dollars $[***] per occurrence and in the aggregate, and shall be maintained with a financially sound and reputable insurer.  If the above required insurance policy is written on a claims made basis, such policy must include a provision for an extended reporting period of not less than [***] months.  Pacira will provide [***] calendar days written notice to Aratana prior to any cancellation.  Pacira shall, within [***] calendar days from the date of obtaining insurance coverage, furnish to Aratana a certificate of insurance evidencing the foregoing coverage.

9.3.2     Aratana Insurance .  Aratana shall to the extent available, during the Term and for a period of [***] years after the expiration date of the last unit of Licensed Product sold by Aratana, maintain a policy of product liability insurance for the Licensed Product insuring against personal injury, death and damage to property.  The said policy shall have a liability limit of not less than [***] U.S. dollars $[***] per occurrence and in the aggregate, and shall be maintained with a financially sound and reputable insurer.  If the above required insurance policy is written on a claims made basis, such policy must include a provision for an extended reporting period of not less than [***] months.  Aratana shall provide [***] calendar days’ written notice to Pacira prior to any cancellation.  Aratana shall, within [***] calendar days from the date of obtaining insurance coverage furnish to Pacira a certificate of insurance evidencing the foregoing coverage.

9.4     Survival .  The indemnification obligations set forth in this Section 9 shall survive the termination of this Agreement and remain in full force and effect for an indefinite period after termination in relation to any claim based on events which occur during the Term.

9.5     Limitation of Liability .  Except in the event of a Party’s fraud, gross negligence or willful misconduct or a breach by Aratana (or any of its Affiliates or Sublicensees) of any exclusivity or confidentiality obligations under this Agreement, in no event shall either Party be liable to compensate the other Party for any indirect, incidental, punitive, special or consequential damages, including, without limitation, loss of anticipated profits, loss of time, or loss of opportunity, in connection with this Agreement or any breach thereof, and whether any such loss or damage may be based upon principles of contract, warranty, negligence or other tort, the failure of any limited or exclusive remedy to achieve its essential purpose, or for any other reason whatsoever.

10.     TERM AND TERMINATION

10.1     Term .  This Agreement shall commence on the Effective Date and unless terminated earlier in accordance with the provisions hereof shall continue for a period of fifteen (15) years (“ Initial Term ”).  Upon expiration, provided that Aratana is not in any material breach of its obligations or any condition, representation, warranty or covenant under this Agreement or

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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the Supply Agreement, Aratana shall have the option to renew this Agreement (subject to the provisions of Section 10.2.6 ) for a single five (5) year term (the “ Renewal Term ”) upon written notice to Pacira no later than six (6) months prior to the end of the Initial Term.  The Initial Term and the Renewal Term, if applicable, are referred to herein as the “ Term .”

10.2     Termination Rights .

10.2.1     Termination for Breach .  Subject to the other terms of this Agreement, this Agreement and the rights and options granted herein may be terminated by either Party upon any material breach by the other Party of any material obligation or condition, representation, warranty or covenant effective [***] calendar days after giving written notice to the breaching Party which notice shall describe such breach in reasonable detail.  The foregoing notwithstanding, if such default or breach is cured or remedied or shown to be non-existent within the aforesaid [***] day period the notice shall be automatically withdrawn and of no effect.  If the Parties agree in writing, the [***] day period may be extended.  However, prior to giving any notice of termination for breach, the Parties shall first attempt to resolve any disputes as to the existence of any breach as set forth in Section 11 .

10.2.2     Termination for Non-Payment .  Pacira may terminate this Agreement on thirty (30) calendar days’ written notice to Aratana upon the failure of Aratana to pay any amounts due hereunder.

10.2.3     Termination upon Termination of the Supply Agreement .  This Agreement shall automatically terminate upon Pacira’s termination of the Supply Agreement in accordance with the terms thereof.

10.2.4     Termination for Failure to Receive Regulatory Approval .  Pacira may terminate this Agreement (i) with respect to the United States and each country in the European Union, on a county-by-country basis on [***] calendar days’ written notice in the event Aratana does not obtain Regulatory Approval for the Licensed Product in such country within [***] years of the Effective Date, or (ii) with respect to jurisdictions other than the United States and European Union (the “ Other Jurisdictions ”) on a country by country basis on [***] calendar days’ written notice; if Aratana has not commenced Development and dosed its first patient/subject in support of obtaining Regulatory Approval for the Licensed Product in the Other Jurisdictions within [***] years of the Effective Date.

10.2.5     Termination for Failure to Achieve the First Commercial Sale Within [***] Months of Regulatory Approval .  Pacira may terminate this Agreement on sixty (60) calendar days’ written notice to Aratana with respect to any jurisdiction in the Territory on a country by country basis in the event Aratana or its Sublicensee fails to achieve the First Commercial Sale of the Licensed Product (in each approved vial size) within [***] months of receipt of Regulatory Approval in such jurisdiction.

10.2.6     Termination for Failure to Achieve Minimum Annual Revenue Commencing on January 1, 2023 or January 1 following the full calendar year after the termination of the Initial Price Term, whichever occurs first, either Party may terminate this Agreement on

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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thirty (30) calendar days’ written notice to the other Party in the event that Aratana and/or its Sublicensees fail to achieve sufficient Net Sales to provide to Pacira annual revenue of not less than U.S. $[***], which shall be calculated using the revenue from the prior calendar year (the “ Minimum Annual   Revenue ”) under this Agreement, provided, however, that should Pacira exercise its right to terminate under this Section 10.2.6 , Aratana shall have the option to pay Pacira an additional “ make-whole ” payment to satisfy the Minimum Annual Revenue within [***] calendar days of its receipt of Pacira’s notice of termination, in which case such payment shall negate Pacira’s ability to terminate the Agreement under this Section 10.2.6 solely with respect to the failure to achieve the Minimum Annual Revenue for such year.  Should Aratana exercise its right to extend the Term, the Parties shall work in good faith to renegotiate the Minimum Annual Revenue taking into consideration the global sales of the Licensed Product.  The revised Minimum Annual Revenue amount shall be agreed upon within [***] calendar days prior to the commencement of the Renewal Term.

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

10.2.8     Termination Following Generic Intrusion .  Following Generic Intrusion in the Territory by a Third Party and considering the recommendation of the JCCC pursuant to Section 3 hereof, the Parties shall discuss whether it is commercially reasonable for Pacira to continue to supply, and for Aratana to continue to sell, Licensed Product in such country with a Generic Intrusion.  In the event either Party indicates to the other Party that, as a result of its good faith assessment, it is not commercially reasonable for it to continue to meet its obligations under the existing terms of this Agreement or the Amended Supply Agreement in such country with a Generic Intrusion, the Parties agree to discuss in good faith whether a possible modification to the terms of this Agreement and the Amended Supply Agreement could be negotiated in order to continue to make Licensed Product commercially available in such country, it being understood that neither Party shall be obligated to modify the then existing terms of this Agreement or the Amended Supply Agreement.  In the event the Parties are unable to reach agreement on a possible modification to the terms of this Agreement or the Amended Supply Agreement after a [***] calendar day period of good faith negotiations, Aratana may terminate this Agreement in such country with a Generic Intrusion upon [***] calendar days’ written notice to Pacira.

10.2.9     Termination by Mutual Consent .  This Agreement may be terminated upon mutual consent of the Parties.

10.2.10     Voluntary Termination by Aratana .  Aratana may terminate this Agreement or any of the licenses granted under this Agreement, on a country-by-country basis within the Territory, at any time and without specifying a reason therefor, in each case on thirty (30) calendar days’ written notice to Pacira; provided, however, that the foregoing termination right shall not apply to the United States or any country in the European Union.

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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10.3     Effects of Termination .  Upon any termination of this Agreement pursuant to Section 10.2 , on a jurisdiction-by-jurisdiction basis, as of the effective date of such termination, all licenses granted to Aratana hereunder in such jurisdiction shall terminate and all rights to the Licensed Product and the Licensed Patent Rights and Know-How in such jurisdiction (in each case to the extent not applicable to ongoing licenses in non-terminated jurisdictions) shall be returned to Pacira, provided, however, that:

10.3.1     Aratana shall retain, for a period of [***] calendar days from the effective date of expiration or termination, a nonexclusive license to the Licensed Patent Rights and Know-How as necessary to sell off any Licensed Product in inventory or on order as of the effective date of such termination or expiration (and Aratana shall pay Pacira any Royalty Payments due with respect to such sales);

10.3.2     Neither Party shall be under any further obligation to the other in relation to the Licensed Product in the Territory provided, however that Pacira shall fulfill, and Aratana shall pay for, any Purchase Order placed by Aratana under the Supply Agreement and accepted by Pacira prior to the effective date of termination of this Agreement;

10.3.3     Aratana shall forthwith make all payments due to Pacira (including any Royalty Payments with respect to the period prior to the effective date of termination and the period during which Aratana’s exercises it sell-off rights under Section 10.3.1 above);

10.3.4     Neither Party shall have any rights in relation to the Confidential Information of the other Party.  Each Party shall return to the other Party all of the other Party’s Confidential Information and copies thereof (whatever the format) except for copies that must be retained in order to comply with applicable Laws, which information may be retained, but only for so long as required and subject to the confidentiality obligations herein; and

10.3.5     Aratana shall (and shall cause its Affiliates and Sublicensees to): (i) assign or re-assign, as applicable, to vest in Pacira all right, title and interest in all Regulatory Approvals and Drug Approval Applications for the Licensed Product in all respects (upon which Aratana shall have no further rights of any nature with respect to such Regulatory Approvals and Drug Approval Applications); (ii) assign (or, if a non-owned asset or right, exclusively license) to Pacira all rights to any intellectual property or know-how Controlled by Aratana or its Affiliates or Sublicensees with respect to the Licensed Product; (iii) deliver to Pacira all files and documents relating to any of the foregoing and/or containing any product information including any clinical data, protocols and other documents related to the Development or Commercialization of the Licensed Product; and (iv) reasonably cooperate with Pacira to ensure the smooth transition of the marketing, distribution and sale of the Licensed Product in the Territory to Pacira or its designee.

10.4     Remedies .  Except as otherwise expressly set forth in this Agreement, the termination provisions of this Section 10 are in addition to any other relief and remedies available to either Party at law.

10.5     Surviving Provisions .  Other than Section 10.2 herein, notwithstanding any provision herein to the contrary, the rights and obligations of the Parties set forth in Sections 6, 7  

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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and 9 as well as any rights or obligations otherwise accrued hereunder (including any accrued payment obligations), shall survive the expiration or termination of the Term.  Without limiting the generality of the foregoing, Aratana shall have no obligation to make any milestone or royalty payment to Pacira that has not accrued prior to the effective date of any termination of this Agreement, but shall remain liable for all such payment obligations accruing prior to the effective date of such termination and any milestone payment which becomes due as a result of the sell-off period provided under Section 10.3.1 above.

11.     DISPUTES

11.1     Negotiation .  The Parties recognize that a bona fide dispute as to certain matters may from time to time arise during the Term that relates to either Party’s rights and/or obligations hereunder.  In the event of the occurrence of such a dispute (other than a claim for non-payment under ¨ Section 10.2.2 ), either Party may, by written notice to the other Party, have such dispute referred to their respective senior officials designated below or their successors, for attempted resolution by good faith negotiations within [***] calendar days after such notice is received.  Said designated senior officials are as follows:

For Aratana:    Chief Executive Officer, or its designee

For Pacira:       Chief Executive Officer, or its designee

In the event the designated senior officials are not able to resolve such dispute within the [***] day period, either Party may invoke the provisions of Section 11.2 .  Failure to invoke Section 11.2 may cause the Agreement to be subject to an assertion of termination.

11.2     Arbitration .  Subject to Section 11.1 , any dispute, controversy or claim initiated by either Party arising out of, resulting from or relating to this Agreement, or the performance by either Party of its obligations under this Agreement (other than bona fide Third Party actions or proceedings filed or instituted in an action or proceeding by a Third Party against a Party), whether before or after termination of this Agreement, shall be finally resolved by binding arbitration.  Whenever a Party shall decide to institute arbitration proceedings, it shall give written notice to that effect to the other Party.  Any such arbitration shall be conducted under the Commercial Arbitration Rules of the American Arbitration Association by a panel of three arbitrators appointed in accordance with such rules with the arbitration taking place in New Jersey.  The method and manner of discovery in any such arbitration proceeding shall be governed by the laws of the State of New Jersey.  The arbitrators shall have the authority to grant injunctions and/or specific performance and to allocate between the parties the costs of arbitration in such equitable manner as they determine.  Judgment upon the award so rendered may be entered in any court having jurisdiction or application may be made to such court for judicial acceptance of any award and an order of enforcement, as the case may be.  In no event shall a demand for arbitration be made after the date when institution of a legal or equitable proceeding based upon such claim, dispute or other matter in question would be barred by the applicable statute of limitations.  Notwithstanding the foregoing, either Party shall have the right, without waiving any right or remedy available to such Party under this Agreement or otherwise, to seek and obtain from any court of competent jurisdiction any interim or provisional relief that is necessary or desirable to

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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protect the rights or property of such Party, pending the selection of the arbitrators hereunder or pending the arbitrators’ determination of any dispute, controversy or claim hereunder.

12.     MISCELLANEOUS

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



 

 

 

 

 

 

 

 

 



If to Pacira:

Pacira Pharmaceuticals, Inc.

5 Sylvan Way

Parsippany, NJ 07054

Attn: David Stack, CEO

Facsimile No.: [***]

Telephone No.: [***]

Email:  [***]

 



With a copy to:

Pacira Pharmaceuticals, Inc.

5 Sylvan Way

Parsippany, NJ  07054

Attn:  Corporate Counsel

Facsimile No.: (973) 267-0050

Email:  Contracts@Pacira.com

 



If to Aratana:

Aratana Therapeutics, Inc.

11400 Tomahawk Creek Parkway

Suite 340

Leawood, KS 66211

ATTN: Steven St. Peter

Facsimile No. (913) 904-9641: 

Telephone No.: (913) 353-1000

Email:  [***]

 



All notices, requests and other communications hereunder shall be deemed to have been delivered upon receipt.

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

12.3     Governing Law .  This Agreement will be construed, interpreted and applied in accordance with the laws of the State of New Jersey, excluding its conflict of law rules.

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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

12.5     Entire Agreement .  This is the entire Agreement between the Parties with respect to the subject matter hereof and supersedes all prior representations, understandings and agreements between the Parties with respect to the subject matter hereof.  No modification shall be effective unless in writing with specific reference to this Agreement and signed by the Parties.

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

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

12.8     Assignment .  Neither this Agreement nor any right or obligation hereunder may be assigned, delegated or otherwise transferred, in whole or part, by Aratana without the prior express written consent of Pacira, except with respect to a transfer to Affiliate or pursuant to a sale of substantially all of the assets of Aratana.  The terms and conditions of this Agreement shall be binding upon and inure to the benefit of the permitted successors and assigns of the parties. Any transfer by Aratana other than in accordance with the terms hereof shall be void and shall entitle Pacira to immediately terminate this Agreement.

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

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

12.11     Severability .  If any provision(s) of this Agreement are or become invalid, are ruled illegal by any court of competent jurisdiction or are deemed unenforceable under then current applicable Law from time to time in effect during the License Term, it is the intention of the Parties that the remainder of this Agreement shall not be affected thereby provided that a Party’s rights under this Agreement are not materially affected.  The Parties hereto covenant and agree to renegotiate any such term, covenant or application thereof in good faith in order to provide a

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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reasonably acceptable alternative to the term, covenant or condition of this Agreement or the application thereof that is invalid, illegal or unenforceable, it being the intent of the Parties that the basic purposes of this Agreement are to be effectuated.

12.12     Status .  Nothing in this Agreement is intended or shall be deemed to constitute a partner, agency, employer-employee, or joint venture relationship between the Parties.

12.13     Section 365(n) .  All licenses granted under this Agreement are deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to “ intellectual   property ” as defined in Section 101 of such Code.  The Parties agree that Aratana may fully exercise all of its rights and elections under the U.S. Bankruptcy Code, regardless of whether either Party files for bankruptcy in the United States or other jurisdiction.  The Parties further agree that, in the event Aratana elects to retain its rights as a licensee under such Code, Aratana shall be entitled to complete access to any technology licensed to it hereunder and all embodiments of such technology.  Such embodiments of the technology shall be delivered to Aratana not later than: (a) the commencement of bankruptcy proceedings against Pacira, upon written request, unless Pacira elects to perform its obligations under the Agreement, or (b) if not delivered under clause (a) of this Section 12.13 , upon the rejection of this Agreement by or on behalf of Aratana, upon written request.

12.14     Export Compliance .  Aratana and its Affiliates and Sublicensees shall comply with all United States laws and regulations controlling the export of certain commodities and technical data, including without limitation all Export Administration Regulations of the United States Department of Commerce.  Among other things, these laws and regulations prohibit or require a license for the export of certain types of commodities and technical data to specified countries.  Aratana hereby gives written assurance that it will comply with, and will cause its Affiliates and Sublicensees to comply with, all United States export control laws and regulations, that it bears sole responsibility for any violation of such laws and regulations by itself or its Affiliates or Sublicensees, and that it will indemnify, defend, and hold Aratana harmless (in accordance with Section 9 ) for the consequences of any such violation.

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

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

[Remainder of page intentionally left blank]

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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IN WITNESS WHEREOF, each of the Parties have caused this Amended and Restated   Exclusive License, Development and Commercialization Agreement to be executed by its duly authorized representative as of the Effective Date.





 

 

PACIRA PHARMACEUTICALS, INC.:

 

ARATANA THERAPEUTICS, INC.:

By:  /s/ Daina Borteck

 

By:  /s/ Steven St. Peter

Name:  Daina Borteck

 

Name:  Steven St. Peter

Title:   Associate General Counsel

 

Title:   President and CEO

Date:  July 3, 2018

 

Date:  June 29, 2018





 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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SCHEDULE 1.36



LICENSED PATENTS



See attached













 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.


 

EXPAREL PATENTS

 

COUNTRY

SERIAL#

PATENT#

 

 

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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.


 

EXPAREL PATENTS

 

COUNTRY

SERIAL#

PATENT#

 

 

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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

- 2 -


 

EXPAREL PATENTS

 

COUNTRY

SERIAL#

PATENT#

 

 



 

[***]

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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

- 3 -


 

 

Schedule 1.37



LICENSED PRODUCT



DepoBupivacaine™ Extended Release Liposome Injection











[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.


 

 

 

EXHIBIT A



Amended Supply Agreement





[See publicly filed agreement as exhibit to Aratana’s Form 10-Q

for quarter ended June 30, 2018]











[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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Exhibit 10.3  





























PACIRA PHARMACEUTICALS, INC.



and



ARATANA THERAPEUTICS, INC.









AMENDED AND RESTATED SUPPLY AGREEMENT









DATED AS OF JULY 5, 2018













 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.


 

 



THIS AMENDED AND RESTATED SUPPLY AGREEMENT (this “ Agreement ”) is made effective as of July 5, 2018 (the “ Effective Date ”) by and between Pacira Pharmaceuticals, Inc. , a California corporation with a principal place of business at 5 Sylvan Way, Parsippany, New Jersey 07054 (“ Pacira ”) and Aratana Therapeutics, Inc. , a Delaware corporation with a place of business at 11400 Tomahawk Creek Parkway Suite 340 Leawood, KS 66211 (“ Aratana ”).  Pacira and Aratana are each hereafter referred to individually as a “ Party ” and together as the “ Parties .”  Capitalized terms used herein and not otherwise defined herein shall have the meanings set forth in Section 1 .



Whereas , Pacira and Aratana entered into that certain Exclusive License, Development and Commercialization Agreement, dated as of December 5, 2012 (the “ Origina l   License Agreement ”), under which Aratana will develop, market, sell and distribute the Licensed Product in the Field in the Territory pursuant to the terms and conditions thereof;



WHEREAS , Pacira and Aratana on December 5, 2012 also entered into the Initial Supply Agreement (the “ Original Supply Agreement ”) as contemplated by the Original License Agreement pursuant to which Pacira and Aratana agreed that Pacira shall be the exclusive supplier of the Licensed Product to Aratana pursuant to the terms of the Initial Supply Agreement; and



WHEREAS, the parties have entered into an Amended and Restated Exclusive License Development and Commercialization Agreement made effective as of July 5, 2018 (the “ License Agreement ”) under which Aratana will continue to develop, market, sell and distribute the Licensed Product in the Field in the Territory pursuant to the terms and conditions thereof.



WHEREAS , the Parties desire to amend and restate the Original Supply Agreement in its entirety as set forth herein. This Agreement constitutes the “Amended Supply Agreement” as contemplated by the License Agreement.



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



1.     Definitions

1.1.     “10ml Vial” shall mean a 10ml vial (without commercial labeling and packaging) containing the Licensed Product.

1.2.     “20ml Vial” shall mean a 20ml vial (without commercial labeling and packaging) containing the Licensed Product.

1.3.     Administrative NADA ” is a new animal drug application that is submitted after all of the technical sections that fulfill the requirements for the approval of the NADA under 21

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

__________________

*The Specification shall be made available to Aratana as necessary for regulatory purposes.


 

CFR 514.1 have been reviewed by CVM and CVM has issued a technical section complete letter for each of those technical sections.

1.4.     “Affiliate” shall mean with respect to any entity, any other entity that, directly or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, such entity and for purposes of this definition, “control” shall mean ownership, directly or indirectly through one or more Affiliates, of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (50%) or more of the equity interests in the case of any other type of legal entity, status as a general partner in any partnership, or any other arrangement whereby a Party controls or has the right to control the board of directors or equivalent governing body of a corporation or other entity.

1.5.     “Approved Facilities” shall mean the facilities of Pacira located at 10450 Science Center Drive, San Diego, CA 92121 (or the approved facility of a Third Party Manufacturer), in each case as may be changed by Pacira from time to time, comprising buildings and equipment where Pacira shall Manufacture and store or have Manufactured and stored the Bulk Product.

1.6.     “Bulk Product” shall mean Licensed Product by Presentation, as applicable, in unlabeled filled vials without commercial label and packaging.

1.7.     Business Day ” shall mean any day other than a Saturday, a Sunday or a day on which banks in New York City, New York are authorized or obligated by Law to not open or remain closed.

1.8.     “Certificate of Analysis” shall mean a document setting out the results of analysis of a Lot of Bulk Product together with the Specification and methods by which, the tests were performed.

1.9.     “Certificate of Compliance”     shall mean a document certifying that the Approved Facility is operating in compliance with cGMP and the Bulk Product has been manufactured in compliance with cGMP and all other applicable Law.

1.10.     “cGMP” shall mean current Good Manufacturing Practice as set out in the United States 21 CFR 210 and 211, as amended from time to time, together with, as applicable, any analogous regulations, codes or guidelines having effect in any jurisdiction in the countries in which the Licensed Product is to be Manufactured and/or distributed.

1.11.     “Commercialize” or “Commercialization” shall mean any and all activities, excluding Development or manufacturing, necessary or desirable to realize commercial sales of the Licensed Product in accordance with applicable Law, including distributing, importing, transporting, customs clearance, export, warehousing, packing, handling and delivering to customers, as well as offering for sale and sales, marketing, promoting and reimbursement related activities, including booking sales.  When used as a verb “Commercialize” means to engage in Commercialization.

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

- 2 -


 

1.12.     “Confidential Information” shall mean with respect to a Party (the “ Receiving Party ”), all information which is disclosed by the other Party (the “ Disclosing Party ”) to the Receiving Party hereunder or to any of its employees, consultants, Affiliates, licensee or Sublicensees, except to the extent that the Receiving Party can demonstrate by written record or other suitable physical evidence that such information, (a) as of the date of disclosure is demonstrably known to the Receiving Party or its Affiliates other than by virtue of a prior confidential disclosure to such Party or its Affiliates; (b) as of the date of disclosure is in, or subsequently enters, the public domain, through no fault or omission of the Receiving Party; (c) is obtained from a Third Party having a lawful right to make such disclosure free from any obligation of confidentiality to the Disclosing Party; or (d) is independently developed by or for the Receiving Party without reference to or reliance upon any Confidential Information of the Disclosing Party.  Confidential Information shall include all information disclosed to or accessible by Aratana or Pacira, as the case may be, relating to the subject matter of the License Agreement or this Agreement prior to the Effective Date.

1.13.     Intentionally Omitted .

1.14.     CVM ” shall mean the Center for Veterinary Medicine (and any successor authority) of the FDA.

1.15.     Date of Manufacture ” shall mean the first manufacturing day of Bulk Product as set forth in the Certificate of Analysis.

1.16.     “Delivery” shall mean Pacira making available at the loading docks of the Approved Facilities the Bulk Product for collection by Aratana or its nominated carrier.

1.17.     “Drug Approval Application” shall mean any application for Regulatory Approval, including, without limitation, (a) any application filed with the FDA and (b) any equivalent application filed with any Foreign Regulatory Authority for Regulatory Approval required prior to any sale or use or any Commercialization of a Licensed Product in any country or jurisdiction in the Territory.

1.18.     “Drug Substance” shall mean bupivacaine liposome injectable suspension.

1.19.     “Equipment” shall mean the equipment used in the Manufacture, assembly, analysis and testing of the Product.

1.20.       “EXPAREL®” shall mean Bupivacaine Liposome Injectable Suspension – NDA #022496 dated October 28, 2011.

1.21.     “FDA” shall mean the U.S. Food and Drug Administration and any successor agency or authority thereto.

1.22.     “Field” shall mean all prophylactic or therapeutic uses of finished Licensed Product for veterinary use only.  For the avoidance of doubt, the Field shall not include use of the Licensed Product in humans.

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

- 3 -


 

1.23.     “Forecast” shall have the meaning set forth in Section 3.1 .

1.24.     “Force Majeure” shall have the meaning set forth in Section 13.1 .

1.25.     “Foreign Regulatory Authority” shall mean any applicable supranational, national, federal, state or local regulatory agency, department, bureau or other Government Authority of any country or jurisdiction in the Territory (other than the United States of America), having responsibility in such country or jurisdiction for any Regulatory Approvals of any kind in such country or jurisdiction, and any successor agency or authority thereto.

1.26.     “Frozen Period”   shall mean the initial [***] month period of each Forecast as more particularly described in Section 3.1.

1.27.     “Governmental Authority” shall mean any governmental or quasi-governmental department, commission, board, bureau, agency, court or other instrumentality of any country or jurisdiction in the Territory or any political subdivision thereof.

1.28.     “JCCC” shall have the meaning ascribed to such term in Section 3.1 of the License Agreement.

1.29.     “Labeling” shall have the meaning set forth in Section 7.3(b) .

1.30.     “Laboratory” shall have the meaning set forth in Section 4.3(c) .

1.31.     “Law” shall mean all laws, treaties, statutes, ordinances, judgments, decrees, rules, codes, injunctions, writs, regulations, binding arbitration rulings, orders, and judicial or administrative interpretations or promulgations of any Governmental Authority having jurisdiction over the transactions contemplated hereunder.

1.32.     “License Agreement” shall have the meaning set forth in the recitals to this Agreement.

1.33.     “Licensed Product” shall mean shall mean DepoBupivacaine™ Extended Release Liposome Injection for use in the Field.

1.34.     “Lot” shall have the meaning set forth in Section 3.2(c) .

1.35.     “Manufacturing Approval” shall mean all necessary or appropriate approvals, licenses, permits, registrations and authorizations in respect of the manufacture and Quality Control of the Licensed Product.

1.36.     “Manufacturing License” shall mean any license as granted by the Regulatory Authority to Pacira or the Third Party Manufacturer in the applicable territory to manufacture the Licensed Product.

1.37.     “NADA” shall mean any new animal drug application or Administrative NADA and all amendments and supplements.

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

- 4 -


 

1.38.     “Person” shall include both corporate and real persons and institutions, partnerships and associations or entities of all kinds.

1.39.     Presentation ” shall mean the 10ml Vial or 20ml Vial, as the case may be, containing the Drug Substance.

1.40.     “Product Delivery Date” shall mean that date upon which the Bulk Product is available for collection from the Approved Facilities.

1.41.     “Product Price” shall mean the prices for the Bulk Product by Presentation as set forth in Appendix II, as such prices may be amended from time to time in accordance with the terms of this Agreement.

1.42.     “Quality Agreement” shall mean the agreement dated June 30, 2016 as may be amended from time to time which provides the responsibilities of the Parties related to the quality and regulatory requirements of the Bulk Product manufactured under this Agreement.

1.43.     “Quality Control” shall mean the sampling, laboratory testing and inspection at the Approved Facilities of:

(a)     raw materials, in-process materials and Bulk Product; and

(b)     the Bulk Product as necessary for Release.

1.44.     “Regulatory Approval” shall mean any and all approvals or authorizations of any kind of any Regulatory Authority required prior to any commercial marketing, sale, or use of the Licensed Product in any country or jurisdiction in the Territory for a particular indication within the Field.  For clarity, Regulatory Approval: (i) in the United States shall consist of the approval by the FDA of the Administrative NADA; and (ii) shall not include any approvals, licenses, registrations or authorizations necessary for the manufacture or supply of the Licensed Product, or any component thereof, by Pacira to Aratana or its Affiliates or Sublicensees.

1.45.     “Regulatory Authority” shall mean the FDA or any Foreign Regulatory Authority.

1.46.     “Release” shall mean release of the Bulk Product from the Approved Facilities to Aratana or its designee for labeling and packaging by Aratana or its designee.

1.47.     “Specification” shall mean the specification of the Licensed Product as set out on Appendix I hereto.

1.48.     “Sublicensee” shall mean any Third Party to whom Aratana grants a sublicense of some or all of the rights granted to Aratana under, and in accordance with, the License Agreement.

1.49.     “Term” shall mean the term of this Agreement as set out in Section 10 .

1.50.     “Territory” shall mean worldwide.

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

- 5 -


 

1.51.     “Third Party” shall mean any person or entity other than Aratana, Pacira and their respective Affiliates.

1.52.     “Third Party Manufacturer” shall mean a Third Party appointed by Pacira to manufacture the Licensed Product on its behalf.

In this Agreement, unless the context requires otherwise:

(a)     the headings are included for convenience only and shall not affect the construction of this Agreement;

(b)     words denoting the singular shall include the plural and vice versa;

(c)     words denoting one gender shall include each gender and all genders;

(d)     the words “include” or “including” shall mean “include, without limitation” or “including, without limitation,” as the case may be, and the language following “include” or “including” shall not be deemed to set forth an exhaustive list; and

(e)     any reference to an enactment or statutory provision is a reference to it as it may have been, or may from time to time be amended, modified, consolidated or re enacted.

The Appendices comprise part of and shall be construed in accordance with the terms of this Agreement.

2.    SUPPLY OF BULK PRODUCT

2.1.     Subject to the terms and conditions of this Agreement, during the Term, Pacira shall manufacture and supply, or shall cause to be manufactured and supplied, to Aratana Bulk Product for labeling, packaging and sale by Aratana, and, in consideration of the manufacture of Bulk Product by Pacira or by its Third Party Manufacturer, during the Term, Aratana shall purchase exclusively from Pacira all of its requirements of Bulk Product.

2.2.     Pacira shall supply Bulk Product under this Agreement, by Presentation. Each Presentation shall thereafter be labeled, packaged or otherwise prepared for commercial sale by Aratana.  Aratana shall be solely responsible, at its sole cost and expense, for all labeling, packaging and shipping of Bulk Product in accordance with applicable Law and utilizing such branding, trade names and trade dress selected by Aratana and approved by the JCCC.  Aratana shall not materially alter any Bulk Product as supplied to Aratana by Pacira (other than to label, package and otherwise prepare the Bulk Product for commercial sale as set forth above) and shall only resell such Bulk Product in accordance with this Agreement, the License Agreement and applicable Law.

2.3.     Pacira shall give Aratana reasonable notice of any proposal to appoint a Third Party Manufacturer as provided in Section 6.3 .  

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

- 6 -


 

2.4.     The terms and conditions of this Agreement shall control the manufacture and supply of Bulk Product by Pacira to Aratana, and no terms or conditions contained in any purchase order, acknowledgment, invoice, bill of lading, acceptance or other preprinted form issued by any Party shall have any force or effect to the extent they are inconsistent with or purport to modify the terms and conditions of this Agreement including those set forth in this Section 2 .

2.5.     Aratana shall be permitted to transfer or resell Bulk Product purchased in accordance with the terms of this Agreement to an Affiliate or Sublicensee and any such transfer or resale shall not be considered a commercial sale of Licensed Product under the License Agreement; provided ,   however , that any mark-up or increase in transfer price or any other revenue derived by Aratana from such transfer or resale shall be subject to Pacira’s rights under the License Agreement.  In no event shall Aratana or any of its Affiliate or any Sublicensee be permitted to transfer or resell Bulk Product other than as expressly contemplated by this Agreement and the License Agreement   or as expressly agreed to by Pacira in advance of any such purported resale or transfer.  The transfer or sale of Bulk Product by Aratana to an Affiliate or Sublicensee shall in no way relieve Aratana of any of its obligations or liabilities hereunder.

3.    Forecasting and Ordering

3.1.     Forecasts.  On or before the [***] day of each calendar month during the Term, Aratana shall submit to Pacira a rolling forecast of Aratana’s anticipated demand of Bulk Product for the next [***] consecutive months, commencing with the subsequent month in which such forecast is submitted (each a Forecast” ). By way of example, the Forecast submitted on or before [***] shall be for the period of [***] through [***].  In addition, on or before [***] of each calendar year during the Term, Aratana will provide a non-binding [***] year forecast (the “ [***]”).  The Forecast and the [***] shall be submitted in the format attached hereto as Appendix III , as such format may be reasonably modified from time to time by mutual agreement of the Parties.  Each Forecast shall contain the estimated quantities and anticipated Product Delivery Dates of units of Bulk Product for each month of the subsequent [***] months (without regard to potential expiration or termination of this Agreement).  Absent earlier expiration or termination of this Agreement, the forecast for the first [***] months in each Forecast (the “ Frozen Period ”) shall constitute a binding commitment by Aratana to place Purchase Orders pursuant to Section 3.2 that, when taken together with any Purchase Orders submitted up to such date by Aratana with respect to such period, shall be consistent with such Forecast, but in no event represent less than [***] percent [***]% of the amount of Bulk Product specified in such Forecast.  The Forecast with respect to the quarter immediately following the Frozen Period shall not be less than [***] percent [***]% nor exceed [***] percent [***]% of the amount specified in the Forecast provided the month prior without the written consent of Pacira.

3.2.     Purchase Orders.

(a)     On or before the [***] day of each calendar month, Aratana shall submit an irrevocable   purchase order for that period within   the Frozen Period for which irrevocable purchase orders have not previously been submitted to and accepted by Pacira (a “ Purchase Order ”). By way of example ,   a Purchase Order for [***] shall be submitted to Pacira with the Forecast provided

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

- 7 -


 

to Pacira on or before [***]. Each Purchase Order must specify   the actual number of Lots to be manufactured, the approximate number of units in each Lot, and the requested Product Delivery Date for each Lot.  Aratana shall submit each Purchase Order to Pacira at least [***] days in advance of the earliest Product Delivery Date requested in the Purchase Order.  Pacira shall acknowledge and accept the Purchase Order from Aratana made in accordance with Section 3.2 within [***] Business Days of receipt.  All Purchase Orders shall be sent by Aratana to the following address, which may be updated from time to time by Pacira upon notice to Aratana:

Pacira Pharmaceuticals, Inc.

 10450 Science Center Drive

 San Diego ,   CA   92121

Attention: Salvatore Sansone

Telephone: [***]

E-mail: [***]



(b)     Pacira will supply quantities of Bulk Product by Presentation, in each case as set forth in the applicable Purchase Order in accordance with the delivery schedule set forth therein and, to the extent that such estimated amounts do not meet Aratana’s actual requirements, Pacira will use commercially reasonable efforts to supply Aratana with its requirements beyond the amounts specified in the applicable Forecast as stated in Section 3.2(a) , it being understood that Pacira shall have no obligation to supply Bulk Product in amounts exceeding the amounts specified in the applicable Forecast.  Aratana agrees to purchase, in accordance with any Purchase Order, the terms and conditions of this Agreement, the Specification and applicable Law, such quantities of Bulk Product supplied by Pacira.

(c)     Aratana shall purchase Bulk Product by Presentation from Pacira in minimum order quantities of a whole filled batch (each such batch quantity, a “ Lot ”) as set forth in Appendix II or such other quantities as may be mutually agreed to by the Parties.

4.    Delivery, Title AND ACCEPTANCE

4.1.     Delivery.  Pacira shall supply all Bulk Product Ex Works (as defined in Incoterms 2018) the Approved Facilities.  Pacira shall use its commercially reasonable efforts to Deliver to Aratana each of Aratana’s orders for Bulk Product on the applicable Delivery Date specified in each Purchase Order.  If Pacira becomes aware that for any reason it will be unable to Deliver ordered Bulk Product on the specified Delivery Date, Pacira shall promptly advise Aratana of that fact, the reason for the delay and (if appropriate) give its reasonable, good faith estimate of the likely delayed Delivery Date.  Pacira shall use its commercially reasonable efforts to minimize the delay.  Pacira shall submit to Aratana with each Lot of Bulk Product Delivered by Pacira a Certificate of Analysis setting out the results of the analysis of that Lot of Bulk Product and confirming that the Lot is manufactured in conformity with the Specification and cGMP.  With each shipment of Bulk Product, Pacira shall provide Aratana with a Certificate of Compliance.  On Delivery, Bulk Product shall have a Date of Manufacture that is not greater than [***] days from Delivery date; provided, that, in the event Pacira proposes to deliver to Aratana Bulk Product with a date of manufacture greater than [***] days from Delivery date, Pacira shall notify Aratana, and

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

- 8 -


 

the Parties shall discuss in good faith such reasonable steps as may be implemented by Aratana to accommodate Aratana’s distribution of such Bulk Product (in finished form) so as not to render such Bulk Product non-saleable, it being understood that Aratana shall not be obligated to accept delivery of Bulk Product with a date of manufacture greater than [***] days from Delivery date.

4.2.     Title.  Legal title shall pass to, and all risk in and responsibility for Bulk Product shall be with, Aratana from and after Delivery.  Aratana shall be responsible for all tariff, customs, clearance and other similar charges and will bear all risk of loss, delay, or damage in transit, as well as cost of freight and insurance.

4.3.     Receipt of Product; Acceptance .

(a)     Promptly after each Delivery Date, and prior to the labeling and packaging of such Bulk Product, Aratana, or its designee, shall conduct (i) a visual inspection of the Bulk Product for defects or damages and (ii) an inspection of all associated quality assurance documents, including, without limitation, the Certificate of Analysis and Certificate of Compliance delivered in accordance with Section 4.1 .  Aratana shall be entitled to reject and return any portion or all of any shipment of Bulk Product that does not conform to the Specification or otherwise fails to comply with the warranty set forth in Section 7.2(b) (unless such nonconformity or noncompliance is attributable to an act or omission of Aratana after the time such Bulk Product was Delivered by Pacira); provided, that Aratana provides notice of non-conformance discovered by Aratana based on such visual inspection and inspection of the associated quality assurance document or any other non-conformance to the warranties provided in Section 7.2(b) within [***] calendar days after Delivery of such Bulk Product.  If no notice is provided by Aratana within such time period, then Aratana shall be deemed to have accepted the shipment and all such Bulk Product Delivered to Aratana shall be deemed to materially conform with the Specification.  Any notice of rejection by Aratana shall specify the shipment and Purchase Order number and shall be accompanied by a reasonably detailed statement of Aratana’s exact reasons for rejection along with reasonable evidence of the alleged nonconformity or noncompliance (including a sample of the Bulk Product from the shipment tested) and, if applicable, a report of any pertinent analysis performed by Aratana on the allegedly nonconforming or noncomplying Bulk Product, together with the methods and procedures used to determine such non-conformity.  Pacira shall notify Aratana in writing as promptly as practicable, but in any event within [***] Business Days after receipt of such notice of rejection, whether Pacira accepts Aratana’s assertions of nonconformity or noncompliance.

(b)     Whether or not Pacira accepts Aratana’s assertion of nonconformity or noncompliance, promptly upon receipt of a notice of rejection, Pacira shall use commercially reasonable efforts to provide replacement Bulk Product for the quantity of Bulk Product rejected by Aratana in the original shipment as soon as reasonably possible but no later than [***] days after the date of receipt of the notice of rejection.  Aratana shall remain responsible for the purchase price for the allegedly nonconforming or noncomplying Bulk Product; provided, however, if the Bulk Product rejected by Aratana from such original shipment ultimately is found to be nonconforming or noncomplying (whether pursuant to Section 4.3(a) or if Pacira acknowledges such in writing), Pacira shall bear all costs and expenses of such replacement Bulk Product (including the purchase price thereof and/or disposal charges for such nonconforming or

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

- 9 -


 

noncomplying Bulk Product).  If it is determined subsequently that such Bulk Product was in fact conforming (whether pursuant to Section 4.3(a) or if Aratana acknowledges such in writing), then Aratana shall be responsible for the purchase price for the allegedly nonconforming Bulk Product, as well as, upon receipt and acceptance by Aratana in accordance with the procedures set forth herein, the replacement Bulk Product, which shall be purchased at the then-effective purchase price for such Bulk Product.  Replacement shipments shall also be subject to the procedures contained in this Section 4.3(b) .  Pacira shall be under no obligation to accept a return of Bulk Product except as provided for in this Section 4.3 .

(c)     If Pacira disagrees with any alleged nonconformity or noncompliance, then the Parties shall have [***] days from the date of Pacira’s receipt of Aratana’s notification pursuant to Section 4.2(a) to resolve any such dispute.  If such dispute is not resolved in the [***] day period then an independent cGMP-certified laboratory (or other expert or consultant) of recognized repute (the “ Laboratory ”), selected by Pacira and reasonably acceptable to Aratana, shall analyze an aliquot sample or such other portions of a shipment, furnished by Aratana from the shipment received and rejected by Aratana, as may be necessary to substantiate whether the shipment rejected by Aratana conformed in all material respects to the Specification at the time of Delivery to, which analysis shall be performed in compliance with applicable FDA regulations for re-testing of pharmaceutical products.  The Parties agree to cooperate with the Laboratory’s reasonable requests for assistance in connection with its analysis hereunder.  The Parties shall be bound by the Laboratory’s results of analysis, which, absent manifest error, shall be deemed final as to any dispute over compliance of the Bulk Product in all material respects with the Specification at the time of Delivery.  The fees and expenses of the Laboratory making such determination shall be by the Party against which the determination is made, or if the Laboratory cannot place the fault noticed and complained about, then the Parties shall share equally such costs.

(d)     If Pacira accepts rejection of any shipment due to nonconformity or noncompliance (or if not, then following the decision of the Laboratory that the shipment was nonconforming), Pacira shall promptly (and in any case within [***] Business Days thereafter) make arrangements for the return, reworking or disposal, at Pacira’s option, of any nonconforming or noncomplying Bulk Product.  If Pacira requests that Aratana dispose of such nonconforming or noncomplying Bulk Product, Pacira shall give Aratana written instructions as to how Aratana or its agent should dispose of such nonconforming or noncomplying Bulk Product, and Aratana shall provide Pacira with written certification of such destruction.  Pacira shall pay (or reimburse Aratana) for any reasonable return shipping charges or out-of-pocket costs or expenses incurred by Aratana for such return shipment or lawful disposal of such nonconforming or noncomplying Bulk Product.

5.    PRICING AND PAYMENT

5.1.     Pricing.  During the Term, the purchase price for the supply of Bulk Product sold to Aratana shall be the applicable Product Price then in effect.  As of the Effective Date the Product Price shall be as set forth in Appendix II.   Thereafter, the Product Price per vial shall be adjusted as follows:

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

- 10 -


 

(a)     20 ml Vial.  Commencing as of [***], and on each anniversary thereafter, Pacira shall review the Product Price and may increase the Product Price based upon inflation and any increases in the cost of manufacture (including the cost of raw materials) of the Licensed Product; provided, however, that notwithstanding the foregoing, in no event shall any annual increase to the Product Price for the 20 ml due solely to inflation exceed the percentage change in the Producer Price Index (Commodities) for Chemicals and Allied Products – Drugs and Pharmaceuticals (as published by the Bureas of Labor Statistics over the preceding one (1) year period;

(b)       10 ml Vial.     The Product Price for the 10ml vial shall remain in effect until December 31, 2021 (the “Initial Price Term”). Prior to the end of the Initial Price Term and no later than December 31, 2021, the parties shall negotiate in good faith the applicable terms related to 10ml Vial, including the Product Price, for the period subsequent to the Initial Price Term. If the Parties are unable to reach agreement then as of January 1, 2022 and on each anniversary thereafter during the Term, the applicable Product Price for the 10 ml Vial shall be automatically increased by [***]%  without further notice to Aratana.

5.2.     Invoices and Payments .  Payments to Pacira from Aratana pursuant to this Agreement shall be made by Aratana within [***] days of receipt of the relevant invoice from Pacira, which invoice shall be delivered at the time of Delivery of Bulk Product under a Purchase Order.  Aratana shall make all payments required under this Agreement by wire transfer to a bank account designated by Pacira in United States dollars.

5.3.     Taxes .  Any and all transfer, sales, use, registration and other taxes imposed upon or with respect to or measured by the sale or delivery by Pacira to Aratana of any Bulk Product hereunder shall be identified by Pacira and assessed to Pacira and Aratana, as applicable, as mutually agreed upon from time to time.  To the extent any such taxes are applicable to Aratana, such amounts shall be included on Pacira’s invoices to Aratana for such Bulk Product, to the extent that Aratana has not provided Pacira with an appropriate exemption certificate.

5.4.     Payments .  All payments by Aratana hereunder shall be payable in full when due, shall be absolute and non-refundable and shall not be subject to rights of set off, counterclaim, decrease, reduction or deduction whatsoever.

5.5.     Currency .  All amounts payable and calculations hereunder shall be in United States dollars.

6.    Manufacture

6.1.     Manufacture .  During the Term, and subject to the provisions of this Section 6 , Pacira shall manufacture and supply Bulk Product in accordance with: (a) this Agreement; (b) the applicable Specification; (c) the applicable NADA; (d) cGMP requirements; (e) the Quality Agreement; and (f) all other applicable Law.  Notwithstanding the foregoing or any other provision of this Agreement, nothing set forth in this Agreement shall prohibit Pacira from: (i) effecting any change, modification or alteration to the manufacturing processes related to the manufacture of the Licensed Product (a “ Change to Process ”); (ii) relocating or shutting down the then current

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

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Approved Facilities; (iii) manufacturing other pharmaceutical products or prioritizing its activities at the Approved Facilities; or (iv) prioritizing its business needs generally if and when such activities or needs conflict with its obligations to Aratana hereunder; provided ;   that (A) Pacira will notify Aratana as promptly as practicable after taking affirmative action in furtherance of any of the foregoing actions and (B) Pacira’s right to engage in any of the foregoing actions does not excuse Pacira from its obligation to supply the Bulk Product to Aratana as required under Sections 3 and 4 , subject to Section 6.3(b) .  Notwithstanding the foregoing, Pacira will notify Aratana through the JCCC of any Change to Process or any other actions described above in this Section 6.1 , in each case which would reasonably be expected to require Aratana to submit any new or supplemental filing with any Regulatory Authority or to engage in any new or supplemental clinical study.

6.2.     Compliance with Law .  While the Licensed Product is in the possession or under the control of Pacira, Pacira shall comply with all applicable Law regarding the manufacture, handling and storage of such Licensed Product.

6.3.     Changes Affecting Manufacture .

(a)     In the event that a Regulatory Authority imposes any change affecting the NADA, the Manufacturing Approval or the manufacture of the Bulk Product, each Party shall notify the other Party and the Parties shall discuss in good faith with a view to reaching agreement on the actions and timing required to effect such change, any regulatory approval required, and including any pricing implications.

(b)     In the event that Pacira effects any Change to Process or in manufacturing location, the Parties shall discuss in good faith with a view to reaching agreement on the actions and timing required to continue supply of Bulk Product to Aratana, which may include, by way of example only, incorporation of the Change to Process within the Specification via a modification to the NADA mutually agreed to by Pacira and Aratana (the submission of which, including all incidental regulatory filings and requirements, shall be the sole responsibility of Aratana); provided ,   however , in no event shall Pacira be obligated to supply Bulk Product under this Agreement or enter into any alternate supply arrangements if Pacira determines, in its sole discretion, that it is no longer commercially reasonable to supply Bulk Product in accordance with the then-current Specification in light of the Change to Process.  In furtherance, and not in limitation, of the foregoing, Pacira shall keep Aratana informed of any proposed Change to Process.

7.    Warranties

7.1.     Organization, Good Standing, Power .  Each of Pacira and Aratana represents and warrants to the other Party that:

(a)     it is duly organized, validly existing and in good standing under the Law of the jurisdiction in which it is incorporated or formed;

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

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(b)     it has the requisite corporate or other power and authority to execute and deliver this Agreement and to consummate the transactions contemplated hereby;

(c)     the execution and delivery of this Agreement and the consummation by it of the transactions contemplated hereby have been duly authorized by all necessary corporate or similar action on its part and no other or further corporate or similar proceedings will be necessary for the execution and delivery of this Agreement by such Party, the performance of such Party’s obligations hereunder, and the consummation by such Parties of the transactions contemplated hereby; and

(d)     this Agreement has been duly executed and delivered by it and constitutes a legal, valid and binding obligation of such Party enforceable against such Party in accordance with its terms, except as the same may be limited by bankruptcy, insolvency, moratorium, reorganization or other Laws of general applicability relating to or affecting the enforcement of creditors’ rights and general principles of equity.

7.2.     Representations and Warranties of Pacira.  Pacira represents and warrants that:

(a)     Approved Facilities .  The Approved Facilities (i) comply in all material respects with all relevant and applicable Law and standards and have all relevant regulatory permits and approvals including valid Manufacturing Licenses and Manufacturing Approvals; and (ii) currently have, and Pacira shall use commercially reasonable efforts to maintain, the necessary Equipment and personnel required for the manufacture of the Licensed Product in compliance with the NADA.

(b)     Conformance of Bulk Product .  Each Lot of Bulk Product supplied to Aratana under this Agreement shall: (i) meet the Specification; (ii) be manufactured in compliance with the applicable NADA or other applicable Regulatory Approval and cGMP; and (iii) be sold free from any lien or encumbrance.  THE FOREGOING WARRANTY IS EXCLUSIVE, AND IS IN LIEU OF ALL OTHER WARRANTIES (WHETHER WRITTEN, ORAL OR IMPLIED) INCLUDING A WARRANTY OF MERCHANTABILITY IN OTHER RESPECTS THAN EXPRESSLY SET FORTH ABOVE AND A WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.

Pacira makes no warranties, express or implied, other than those expressly made herein with respect to the Licensed Product.  All other warranties, express or implied, including but not limited to the implied warranties of merchantability, satisfactory quality and fitness for a particular purpose are hereby disclaimed by Pacira .

7.3.     Representations and Warranties of Aratana.  Aratana represents and warrants that:

(a)     Regulatory Compliance .  (i) Aratana has obtained or will obtain, and at all times during the term of this Agreement as shall be required under applicable Law shall maintain, any and all Regulatory Approvals necessary for Aratana to Commercialize the Licensed Product under

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

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the License Agreement and (ii) all Labeling (as defined below) copy and artwork approved, designated or utilized by or on behalf of Aratana will be in compliance with applicable Law.

(b)     Non-Infringement .  None of the (i) labels and any other written, printed or graphic matter upon any Licensed Product or any container, wrapper or other packaging utilized with the Bulk Product, (ii) any package inserts and other written material accompanying the Licensed Product or (iii) other Licensed Product-related materials or information provided by or on behalf of Aratana (collectively, “ Labeling ”), nor the use of any Labeling in connection with the Commercialization of the Licensed Product, will infringe, misappropriate or otherwise violate any patent, copyright, trade secret, trademark laws or other intellectual property right of any Third Party.

8.    Approvals, Audits and Inspections

8.1.     Aratana (or its representatives) shall be entitled, but in any event no more than once in any [***] month period during the Term, to access records related solely to the manufacture of the Bulk Product and those portions, and only those portions, of the Approved Facilities where the Bulk Product is manufactured, in the company of a representative of Pacira as is reasonably necessary to review and audit such records and portions of the Approved Facilities or the manufacture of the Bulk Product.  Such inspection shall be conducted upon reasonable prior notice by Aratana, but not less than [***] days prior to the proposed inspection, during normal business hours and at the specific time and date mutually agreed to by the Parties.  Any information, data, technology or other materials accessed by or provided to Aratana or any of its representatives in connection with any such inspection shall be deemed Know-How (as defined in the License Agreement) of Pacira in which Pacira retains all right, title and interest, subject to the obligations contained in, and any use, as may be permitted under the License Agreement with respect thereto.

8.2.     Pacira shall use all commercially reasonable efforts to obtain and maintain in force all the Manufacturing Licenses in relation to the manufacture of the Licensed Product, as may be required in the country of manufacture of the Licensed Product.

9.    Project Management

9.1.     Each Party shall assign a Supply Contact   to co-ordinate relationships between the Parties.  The Supply Contact   shall be the first point of contact between the Parties in relation to the placement of Bulk Product orders, confirmation of Delivery Dates, issues relating to manufacturing and Manufacturing Approvals.  The Supply Contacts shall form a project team comprising relevant staff from both Pacira and Aratana for the co-ordination of the supply of the Bulk Product to Aratana.

9.2.     Pacira and Aratana shall diligently carry out the tasks assigned to them hereunder, and as subsequently agreed in writing during the Term.  Each Party shall co-operate with the other in good faith particularly with respect to problems or contingencies that arise during the Term and shall perform its obligations in good faith and in a commercially reasonable, diligent and workmanlike manner.

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

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10.    Term and Termination

10.1.     Term .  This Agreement shall come into effect on signature and, subject to earlier termination pursuant to this Section 10 , shall continue for as long as the License Agreement continues in force.

10.2.     Termination by Pacira .  Pacira may terminate this Agreement, except as limited hereinafter, immediately upon written notice, in the event:

(a)     Aratana fails to make any undisputed payment (or undisputed portion of any payment) due and owing within [***] days after notice thereof from Pacira that such payment has not been timely made by Aratana;

(b)     Aratana commits a breach of any material provision of this Agreement which is not cured within [***] days of notice thereof from Pacira;

(c)     in the event that Pacira effects any Change to Process and the Parties are not able to reach agreement to continue supply of Bulk Product to Aratana after complying with Section 6.3(b) ; or

(d)     Pacira (including any successor or assignee thereof and any Third Party Manufacturer) ceases manufacture, for any reason, of EXPAREL®.

10.3.     Consequences of Termination .

(a)     Termination or expiration of this Agreement shall not relieve the Parties of any obligation accruing prior to such termination or expiration, including, but not limited, to the regulatory and quality/technical responsibility provisions herein and the obligation to pay money, and shall be without prejudice to the rights and remedies of either Party with respect to the antecedent breach of any of the provisions of this Agreement.

(b)     Upon the termination of this Agreement by Pacira pursuant to Section 10.2(c) or 10.2(d) , if requested by Aratana, Pacira shall use commercially reasonable efforts to fulfill any and all Purchase Order(s) previously submitted and accepted by Pacira.

(c)     Upon the expiration or termination of this Agreement by Pacira pursuant to Section 10.2(a) or 10.2(b) , Pacira may cancel, in whole or in part, any Purchase Order previously submitted.

(d)     Upon the expiration or termination of this Agreement by Pacira pursuant to Section 10.2(c) or 10.2(d) , if requested by Aratana, Pacira will sell to Aratana all inventory of finished Bulk Product in the possession or control of Pacira that has been designated for future sale to Aratana (and not intended for sale or use in Pacira’s human health program for EXPAREL®) and within the relevant expiry for such Bulk Product as of the effective date of termination, at the cost for such Bulk Product as of the effective date of termination.  Payment for the finished inventory and materials shall be due within [***] days of receipt of Pacira’s invoice.

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

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10.4.     Survival .  Upon expiry or termination for any reason the provisions of Sections 4.3, 6, 7.2(b), 7.3, 10.3, 11, 12, 13, 14, 15 and 16 shall continue in full force and effect in accordance with their respective terms and Pacira shall retain pharmaceutical records and samples in accordance with cGMP.

11.    Assignment and Sub-Contracting

Neither this Agreement nor any right or obligation hereunder may be assigned, delegated or otherwise transferred, in whole or part, by Aratana without the prior express written consent of Pacira , except with respect to a transfer to Affiliate or pursuant to a sale of substantially all of the assets of Aratana .  The terms and conditions of this Agreement shall be binding upon and inure to the benefit of the permitted successors and assigns of the Parties.  Any transfer by Aratana other than in accordance with the terms hereof shall be void and shall entitle Pacira to immediately terminate this Agreement.

12.    Confidentiality

12.1.     Pacira and Aratana undertake to each other to keep confidential, and to procure that their respective Affiliates, employees, directors, officers, contractors, lawyers and accountants (including those of their Affiliates) keep confidential, Confidential Information disclosed to it by or belonging to the other Party, until it ceases to be Confidential Information.

12.2.     Any Confidential Information received from the other Party shall not be disclosed to any third party or used for any purpose other than as provided or specifically envisaged by this Agreement, unless it ceases to be Confidential Information.

12.3.     The confidentiality and non-use obligations contained in this Agreement shall survive the termination of this Agreement and remain in full force and effect for an indefinite period after termination in relation to any claim based on events which occur during the Term.

13.    Force Majeure

13.1.     Neither Party shall be entitled to terminate this Agreement or shall be liable to the other under this Agreement for loss or damages attributable to acts of God. war or other hostility. civil disorder. the elements. fire. explosion. flood, or any other similar reason where failure to perform is beyond the control and not caused by the negligence of the non-performing Party (“ Force Majeure ”), provided the Party affected shall give prompt notice thereof to the other Party.  Subject to Section 13.2 , the Party giving such notice shall be excused from all affected obligations hereunder for so long as it continues to be affected by Force Majeure.

13.2.     If such Force Majeure continues unabated for a period of at least ninety (90) days, the Parties will meet to discuss in good faith what actions to take or what modifications should be made to this Agreement as a consequence of such Force Majeure in order to alleviate its consequences on the affected Party.

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

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14.    DISPUTES

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

For Aratana:    Chief Executive Officer, or its designee

For Pacira:       Chief Executive Officer, or its designee

In the event the designated senior officials are not able to resolve such dispute within the [***] day period, either Party may invoke the provisions of Section 14.2 .  Failure to invoke Section 14.2 may cause the Agreement to be subject to an assertion of termination.

14.2.     Arbitration .  Subject to Section 14.1 , any dispute, controversy or claim initiated by either Party arising out of, resulting from or relating to this Agreement, or the performance by either Party of its obligations under this Agreement (other than bona fide Third Party actions or proceedings filed or instituted in an action or proceeding by a Third Party against a Party), whether before or after termination of this Agreement, shall be finally resolved by binding arbitration.  Whenever a Party shall decide to institute arbitration proceedings, it shall give written notice to that effect to the other Party.  Any such arbitration shall be conducted under the Commercial Arbitration Rules of the American Arbitration Association by a panel of three arbitrators appointed in accordance with such rules with the arbitration taking place in New Jersey.  The method and manner of discovery in any such arbitration proceeding shall be governed by the laws of the State of New Jersey.  The arbitrators shall have the authority to grant injunctions and/or specific performance and to allocate between the parties the costs of arbitration in such equitable manner as they determine.  Judgment upon the award so rendered may be entered in any court having jurisdiction or application may be made to such court for judicial acceptance of any award and an order of enforcement, as the case may be.  In no event shall a demand for arbitration be made after the date when institution of a legal or equitable proceeding based upon such claim, dispute or other matter in question would be barred by the applicable statute of limitations.  Notwithstanding the foregoing, either Party shall have the right, without waiving any right or remedy available to such Party under this Agreement or otherwise, to seek and obtain from any court of competent jurisdiction any interim or provisional relief that is necessary or desirable to protect the rights or property of such Party, pending the selection of the arbitrators hereunder or pending the arbitrators’ determination of any dispute, controversy or claim hereunder.  

15.    Indemnification.

15.1.     Aratana Indemnity .  Aratana shall indemnify, defend and hold harmless Pacira, its Affiliates and their respective directors, officers, employees, stockholders and agents and their respective successors, heirs and assigns (the “ Pacira Indemnitees ”) from and against any liability,

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

- 17 -


 

damage, loss or expense (including reasonable attorneys’ fees and expenses of litigation) incurred by or imposed upon such Pacira Indemnitees, or any of them, in connection with any third party claims, suits, actions, demands or judgments, including, without limitation, personal injury and product liability matters, to the extent arising out of any material breach of this Agreement by Aratana, up to the amount of Aratana’s available insurance coverage provided for in the License Agreement.

15.2.     Pacira Indemnity .  Pacira shall indemnify, defend and hold harmless Aratana and its Affiliates and their respective directors, officers, employees, and agents, and their respective successors, heirs and assigns (the “ Aratana Indemnitees ”), from and against any liability, damage, loss or expense (including reasonable attorneys’ fees and expenses of litigation) incurred by or imposed upon such Aratana Indemnitees, or any of them, in connection with any Third Party claims, suits, actions, demands or judgments, including, without limitation, personal injury and product liability matters to the extent arising out of any material breach of this Agreement by Pacira, up to the amount of Pacira’s available insurance coverage provided for in the License Agreement.

15.3.     Indemnification Procedures .  In the event that any of the Pacira Indemnitees or the Aratana Indemnitees (each, an “ Indemnitee ”) is seeking indemnification under this Section 15 from a Party (the “ Indemnifying Party ”), the other Party shall notify the Indemnifying Party of such claim with respect to such Indemnitee as soon as reasonably practicable after the Indemnitee receives notice of the claim, and the Party (on behalf of itself and such Indemnitee) shall permit the Indemnifying Party to assume direction and sole control of the defense of the claim (including the right to settle the claim solely for monetary consideration) and shall cooperate as requested (at the expense of the Indemnifying Party) in the defense of the claim.  The indemnification obligations under this Section 15 shall not apply to any harm suffered as a direct result of any delay in notice to the Indemnifying Party hereunder or to amounts paid in settlement of any claim, demand, action or other proceeding if such settlement is effected without the consent of the Indemnifying Party, which consent shall not be withheld or delayed unreasonably.  The Indemnitee, its employees and agents, shall reasonably cooperate with the Indemnifying Party and its legal representatives in the investigation of any claim, demand, action or other proceeding covered by this Section 15 .

15.4.     Limitation of Liability .  Any damage, loss or expense payable by an Indemnifying Party shall be reduced by the amount of any insurance proceeds actually received by an Indemnitee against such damage, loss or expense and by the amount of any other indemnity, contribution or other similar payments actually recovered by the Indemnitee from an unrelated person with respect to such damage, loss or expense, provided that the Indemnitee has no obligation to seek recovery of any such damage, loss, or expense from its insurance provider or such unrelated person. 

16.    Recalls.

In the event (i) any Regulatory Authority issues a request, directive or order that Licensed Product be recalled, or (ii) a court of competent jurisdiction orders such a recall, or (iii) Pacira reasonably determines after consultation with Aratana that the Licensed Product should be recalled because the Licensed Product does not conform to the applicable Specification at the time of

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

- 18 -


 

shipment by Pacira, the Parties will take all appropriate corrective actions reasonably requested by the other Party hereto or by any Regulatory Authority.  In the event that such recall (a) results from the breach of Pacira’s warranties under Section 7.2 of this Agreement, Pacira will be responsible for all of the costs and expenses of the recall or (b) results from the breach of Aratana’s warranties or covenants under this Agreement, Aratana will be responsible for all of the costs and expenses of the recall.  To the extent that such recall is not covered by either clause (a) or (b) of the immediately preceding sentence, then Pacira and Aratana shall share equally the costs and expenses of the recall.  For the purposes of this Agreement, the expenses of the recall will be the expenses of notification and destruction or return of the recalled Licensed Product, as well as any reasonable out-of-pocket costs incurred by Pacira and/or Aratana in connection with any corrective action taken by Pacira and Aratana.  Notwithstanding anything to the contrary, to the extent that a recall of the Licensed Product is caused by a Party’s gross negligence or willful misconduct, all costs and expenses of the recall (regardless of the Party incurring such cost or expense) shall be borne by the responsible Party (and the responsible Party shall promptly reimburse the other Party for such Recall Expenses incurred in connection with such recall upon receipt of an invoice therefor).

17.    General Provisions

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



 

5 Sylvan Way

Parsippany ,   NJ   07054

 

No.:  [***]

No.: [***]

 

 

 



If to Pacira:

Pacira Pharmaceuticals, Inc,

5 Sylvan Way

Parsippany ,   NJ   07054

Attention: David Stack, CEO

Facsimile No.:  [***]

Telephone No.: [***]

Email:  [***]

 



With a copy to:

Pacira Pharmaceuticals, Inc.

5 Sylvan Way

Parsippany ,   NJ     07054

Attention:  Corporate Counsel

Facsimile No.:  (973) 267-0050

Email:  Contracts@Pacira.com

 



[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

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If to Aratana:

Aratana Therapeutics, Inc.

11400 Tomahawk Creek Parkway

Suite 340

Leawood, KS 66211

Attention: Steven St. Peter

Facsimile No.:  (913) 904-9641

Telephone No.: (913) 353-1000

Email:  legal@aratana.com

 



All notices, requests and other communications hereunder shall be deemed to have been delivered upon receipt.



17.2.     Further Assurances .  Each of the Parties shall do execute and perform and shall procure to be done executed and performed all such further acts, deeds, documents and things as the other Party may reasonably require from time to time to give full effect to the terms of this Agreement.

17.3.     Governing Law .  This Agreement will be construed, interpreted and applied in accordance with the laws of the state of New Jersey, excluding its conflict of law rules.

17.4.     Status .  Nothing in this Agreement is deemed to constitute a partnership between the Parties nor constitute either Party the agent of the other Party for any purpose.

17.5.     Costs and Expenses .  Each Party shall pay its own costs, charges and expenses incurred in connection with the negotiation, preparation and completion of this Agreement.

17.6.     Entire Agreement; Amendment .  This is the entire Agreement between the Parties with respect to the subject matter hereof and supersedes all prior representations, understandings and agreements between the Parties with respect to the subject matter hereof.  No modification shall be effective unless in writing with specific reference to this Agreement and signed by the Parties.  It is agreed that:

(a)     no Party has entered into this Agreement in reliance upon any representation, warranty or undertaking of the other Party which is not expressly set out in this Agreement;

(b)     no Party shall have any remedy in respect of misrepresentation or untrue statement made by the other Party or for any breach of warranty which is not contained in this Agreement; and

(c)     this Section 17.6 shall not exclude any liability for, or remedy in respect of, fraudulent misrepresentation.

17.7.     Waiver .  The terms or conditions of this Agreement may be waived only by a written instrument executed by the Party waiving compliance.  The failure of either Party at any time or times to require performance of any provision hereof shall in no manner affect its rights at

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

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a later time to enforce the same.  No waiver by either Party of any condition or term shall be deemed as a continuing waiver of such condition or term or of another condition or term.

17.8.     Severability .  If any provision(s) of this Agreement are or become invalid, are ruled illegal by any court of competent jurisdiction or are deemed unenforceable under then current applicable Law from time to time in effect during the License Term, it is the intention of the Parties that the remainder of this Agreement shall not be affected thereby provided that a Party’s rights under this Agreement are not materially affected.  The Parties hereto covenant and agree to renegotiate any such term, covenant or application thereof in good faith in order to provide a reasonably acceptable alternative to the term, covenant or condition of this Agreement or the application thereof that is invalid, illegal or unenforceable, it being the intent of the Parties that the basic purposes of this Agreement are to be effectuated.

17.9.     Remedies .  The rights and remedies of each of the Parties under or pursuant to this Agreement are cumulative, may be exercised as often as such Party considers appropriate and are in addition to its rights and remedies under general Law.

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

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



[ Remainder of Page Intentionally Left Blank; Signature Page Follows ]

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

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IN WITNESS WHEREOF, each of the Parties have caused this Amended and Restated Supply Agreement to be executed by its duly authorized representative as of the Effective Date.





 

 

PACIRA PHARMACEUTICALS, INC.:

 

ARATANA THERAPEUTICS, INC.:

By:  /s/ Daina Borteck

 

By:  /s/ Steven St. Peter

Name:  Daina Borteck

 

Name:  Steven St. Peter

Title:  Associate General Counsel

 

Title:  President and CEO

Date:  July 3, 2018

 

Date:  June 29, 2018





[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

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APPENDIX I



SPECIFICATION

Bupivacaine, Extended-Release Liposome Injection (20 ml Vials,10 ml Vials)

The Specification for Bulk Product shall be the same as the specifications for EXPAREL®.*













[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

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APPENDIX II



PRODUCT PRICE AND ESTIMATED UNITS PER LOT







 

 

 

Presentation

[***] Unit Pricing

Estimated Units per Lot

 

 

 

 

 

10 ml Vial

[***]

[***]

 

 

 

 

 

20 ml Vial

$[***]*

[***]

 

 

 

 

 

 

 

 

 

Presentation

[***] Unit Pricing

Estimated Units per Lot

 

 

 

 

 

10 ml Vial

$[***]**

[***]

 

 

 

 

 

20 ml Vial

$[***]

[***]

 











*Annual price increases [***] for the 20 ml Vial shall be in accordance with Section 5.1(a).



** The price of the 10ml Vial shall remain at $ [***] from the Effective Date through December 31, 2021 (the “Initial Price Term”) . Annual price increases after the Initial Price Term for the 10 ml Vial shall be in accordance with Section 5.1(b).



 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

- 24 -


 

 

APPENDIX III



FORM OF FORECAST



[ARATANA LETTERHEAD]





[DATE]



Pacira Pharmaceuticals

10450 Science Center Drive

San Diego, CA 92121

Attention: [ ]  



RE : Aratana NOCITA Bulk   unlabeled DepoBupivacaine™ Extended Release Liposome Injection® Vials [***] Month Rolling Forecast



Dear [ ]:



The following is an updated [***] month rolling   forecast for unlabeled DepoBupivacaine™ Extended Release Liposome Injection®   (Bulk Product) purchased by Aratana Therapeutics, Inc.







 

 

 

 

 

 

 

 

 

 

 

 

 Month / Year

[***]

[***]

[***]

[***]

[***]

[***]

[***]

{***]

[***]

[***]

[***]

[***}

 10ml Vials

 

 

 

 

 

 

 

 

 

 

 

 

 20ml Vials

 

 

 

 

 

 

 

 

 

 

 

 



The forecast shown above is based upon current best estimates of market demand and product approvals and is provided for Pacira’s planning purposes.  Actual purchase commitments will be made by formal purchase order(s).  A [***]-month rolling forecast will continue to be provided on a monthly basis.



If you have any questions, please contact me at your earliest convenience.



Sincerely,









Direct Telephone: [ ]

E-mail: [ ]

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 


 

 

[DATE]



Pacira Pharmaceuticals

10450 Science Center Drive

San Diego, CA 92121

Attention: [ ]



RE: Aratana NOCITA Bulk unlabeled DepoBupivacaine™ Extended Release Liposome Injection® Vials [***] Year Forecast



Dear [ ]:



The following is an updated [***] year forecast for unlabeled DepoBupivacaine™ Extended Release Liposome Injection® (Bulk Product) purchased by Aratana Therapeutics, Inc.





 

 

 

 

 

 

 

 

 

 

 

 

 Quarter / Year

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 10ml Vials

 

 

 

 

 

 

 

 

 

 

 

 

 20ml Vials

 

 

 

 

 

 

 

 

 

 

 

 



The forecast shown above is based upon current best estimates of market demand and product approvals and is provided for Pacira’s planning purposes only and shall be non-binding upon Aratana. 



If you have any questions, please contact me at your earliest convenience.



Sincerely,







Direct Telephone: [ ]

E-mail: [ ]





[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 


Exhibit 31.1



CERTIFICATIONS



I, Steven St. Peter, certify that:



1.

I have reviewed this Quarterly Report on Form 10-Q of Aratana Therapeutics, 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 (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and



5.

The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):



a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and



b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.



Date: August 3 , 201 8

 



 

 

/s/ Steven St. Peter

Steven St. Peter, M.D.

Chief Executive Officer

(Principal Executive Officer)




Exhibit 31.2



CERTIFICATIONS



I, Craig Tooman, certify that:



1.

I have reviewed this Quarterly Report on Form 10-Q of Aratana Therapeutics, 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 (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and



5.

The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):



a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and



b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.



Date: August 3 , 2018

 



 

 

/s/ Craig Tooman

Craig Tooman

Chief Financial Officer and Treasurer

(Principal 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



I, Steven St. Peter, Chief Executive Officer of Aratana Therapeutics, Inc. (the “Company”), hereby certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:  



(1)

The Quarterly Report on Form 10-Q of the Company for the period ended   June 30 , 2018 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and



(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.



August 3 , 2018

 

 

/s/ Steven St. Peter

Steven St. Peter, M.D.

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



I, Craig Tooman, Chief Financial Officer and Treasurer of Aratana Therapeutics, Inc. (the “Company”), hereby certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:



(1)

The Quarterly Report on Form 10-Q of the Company for the period   ended June 30 , 201 8 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and



(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.



August   3 , 2018

 



 

/s/ Craig Tooman

Craig Tooman

Chief Financial Officer and Treasurer