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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 , 2016



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 66 211

(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, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.





 

 

 

 

 

 

Large accelerated filer

 

  

Accelerated filer

 



 

 

 

Non-accelerated filer

 

  

Smaller reporting company

 



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 August 1 , 2016 , there were 3 5,415 , 772 shares of common stock outstanding.







 


 

Table of Contents

 



ARATANA THERAPEUTICS, INC.

TABLE OF CONT ENTS







 

 



 

Page

 PART I. FINANCIAL INFORMATION

 

Item 1.

Financial Statements (Unaudited)



Consolidated Balance Sheets as of June 30, 2016 and December 31, 201 5



Consolidated Statements of Operations for the Three and Six Months E nded June 30 , 2016 and 2015



Consolidated Statements of Comprehensive Income for the Three and Six Months E nded June 30, 2016 and 2015



Consolidated Statements of Cash Flows for the Six Months E nded June 30, 2016 and 201 5



Notes to Consolidated Financial Statement s (Unaudited)

Item 2.

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

24 

Item 3.

Quantitative and Qualitative Disclosures A bout Market Risk

37 

Item 4.

Controls and Procedures

37 

 PART II . OTHER INFORMATION

 

Item 1.

Legal Proceedings

38 

Item 1A.

Risk Factors

38 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

39 

Item 3.

Defaults Upon Senior Securities

39 

Item 4.

Mine Safety Disclosures

39 

Item 5.

Other Information

39 

Item 6.

Exhibits

39 

 SIGNATURES

40 



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PART I. FINANCIAL INFORMATION

Item   1. Financial Statements

ARATANA THERAPEUTICS, INC.

C onsolidated   B alance  S heets (Unaudited)

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









 

 

 

 

 

 



 

 

 

 

 

 



 

June 30, 2016

 

December 31, 2015

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

108,759 

 

$

26,755 

Short-term investments

 

 

747 

 

 

59,447 

Accounts receivable, net

 

 

17 

 

 

60 

Inventories

 

 

2,566 

 

 

1,306 

Prepaid expenses and other current assets

 

 

1,568 

 

 

1,451 

Total current assets

 

 

113,657 

 

 

89,019 

Property and equipment, net

 

 

2,273 

 

 

2,555 

Goodwill

 

 

40,006 

 

 

39,781 

Intangible assets, net

 

 

12,294 

 

 

15,067 

Restricted cash

 

 

350 

 

 

350 

Other long-term assets

 

 

280 

 

 

294 

Total assets

 

$

168,860 

 

$

147,066 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

7,272 

 

$

1,400 

Accrued expenses

 

 

4,505 

 

 

4,247 

Licensing and collaboration commitment

 

 

7,000 

 

 

 —

Current portion – loans payable

 

 

2,333 

 

 

 —

Other current liabilities

 

 

11 

 

 

37 

Total current liabilities

 

 

21,121 

 

 

5,684 

Loans payable, net

 

 

37,616 

 

 

39,710 

Other long-term liabilities

 

 

502 

 

 

122 

Total liabilities

 

 

59,239 

 

 

45,516 

Commitments and contingencies (Notes 8 and 10)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Common stock, $0.001 par value; 100,000,000 shares authorized at June 30, 2016 and December 31, 2015, 34,798,120 and 34,563,816   issued and outstanding at June 30, 2016 and December 31, 2015, respectively

 

 

35 

 

 

35 

Treasury stock

 

 

(1,088)

 

 

(1,088)

Additional paid-in capital

 

 

268,410 

 

 

263,941 

Accumulated deficit

 

 

(148,889)

 

 

(152,018)

Accumulated other comprehensive loss

 

 

(8,847)

 

 

(9,320)

Total stockholders’ equity

 

 

109,621 

 

 

101,550 

Total liabilities and stockholders’ equity

 

$

168,860 

 

$

147,066 





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,



 

2016

 

2015

 

2016

 

2015

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

Licensing and collaboration revenue

 

$

38,000 

 

$

 —

 

$

38,151 

 

$

 —

Product sales

 

 

47 

 

 

230 

 

 

68 

 

 

386 

Total revenues

 

 

38,047 

 

 

230 

 

 

38,219 

 

 

386 

Costs and expenses

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales

 

 

1,741 

 

 

109 

 

 

1,760 

 

 

219 

Royalty expense

 

 

20 

 

 

23 

 

 

38 

 

 

43 

Research and development

 

 

5,303 

 

 

6,081 

 

 

16,052 

 

 

12,302 

Selling, general and administrative

 

 

6,148 

 

 

4,879 

 

 

12,699 

 

 

9,064 

Amortization of acquired intangible assets

 

 

95 

 

 

483 

 

 

190 

 

 

966 

Impairment of acquired intangible assets

 

 

2,780 

 

 

 —

 

 

2,780 

 

 

 —

Total costs and expenses

 

 

16,087 

 

 

11,575 

 

 

33,519 

 

 

22,594 

Income (loss) from operations

 

 

21,960 

 

 

(11,345)

 

 

4,700 

 

 

(22,208)

Other income (expense)

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

83 

 

 

43 

 

 

160 

 

 

114 

Interest expense

 

 

(846)

 

 

(217)

 

 

(1,695)

 

 

(435)

Other income (expense), net

 

 

(1)

 

 

3,176 

 

 

(36)

 

 

5,141 

Total other income (expense)

 

 

(764)

 

 

3,002 

 

 

(1,571)

 

 

4,820 

Income (loss) before income taxes

 

 

21,196 

 

 

(8,343)

 

 

3,129 

 

 

(17,388)

Income tax benefit

 

 

 —

 

 

360 

 

 

 —

 

 

631 

Net income (loss)

 

 

21,196 

 

 

(7,983)

 

 

3,129 

 

 

(16,757)

Net income attributable to participating securities

 

 

(20)

 

 

 —

 

 

(3)

 

 

 —

Net income (loss) attributable to common stockholders

 

$

21,176 

 

$

(7,983)

 

$

3,126 

 

$

(16,757)

Net income (loss) per share attributable to common stockholders:

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share, basic and diluted

 

$

0.61 

 

$

(0.23)

 

$

0.09 

 

$

(0.49)

Weighted average shares outstanding, basic

 

 

34,762,533 

 

 

34,278,105 

 

 

34,708,006 

 

 

34,236,282 

Weighted average shares outstanding, diluted

 

 

34,938,455 

 

 

34,278,105 

 

 

34,779,786 

 

 

34,236,282 





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

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ARATANA THERAPEUTICS, INC.

C onsolidated Statements   of  C omprehensive Income (Unaudited)

(Amounts in thousands )







 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



 

Three Months Ended

 

Six Months Ended



 

June 30,

 

June 30,



 

2016

 

2015

 

2016

 

2015

Net income (loss)

 

$

21,196 

 

$

(7,983)

 

$

3,129 

 

$

(16,757)



 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustment

 

 

(704)

 

 

(1,390)

 

 

473 

 

 

(3,191)

Unrealized gain on available-for-sale securities

 

 

 —

 

 

958 

 

 

 —

 

 

2,622 

Net gain reclassified into income on sale of
available-for-sale securities

 

 

 —

 

 

(2,864)

 

 

 —

 

 

(3,874)

Other comprehensive income (loss)

 

 

(704)

 

 

(3,296)

 

 

473 

 

 

(4,443)

Comprehensive income (loss)

 

$

20,492 

 

$

(11,279)

 

$

3,602 

 

$

(21,200)





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,



2016

 

2015

Cash flows from operating activities

 

 

 

 

 

Net income (loss)

$

3,129 

 

$

(16,757)

Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:

 

 

 

 

 

Stock-based compensation expense

 

4,449 

 

 

4,389 

Depreciation and amortization expense

 

493 

 

 

1,056 

Impairment of acquired intangible assets

 

2,780 

 

 

 —

Gain on sale of marketable securities

 

 —

 

 

(3,874)

Non-cash interest expense

 

239 

 

 

20 

Market value adjustments to inventories

 

1,552 

 

 

 —

Change in fair value of contingent consideration

 

 —

 

 

(1,248)

Change in fair value of derivative instruments

 

 —

 

 

(1,274)

Deferred tax benefit

 

 —

 

 

(631)

Changes in operating assets and liabilities:

 

 

 

 

 

Accounts receivable, net

 

43 

 

 

194 

Inventories

 

(2,812)

 

 

(455)

Prepaid expenses

 

(101)

 

 

(57)

Other assets

 

17 

 

 

15 

Accounts payable

 

5,874 

 

 

213 

Accrued expenses and other liabilities

 

624 

 

 

603 

Licensing and collaboration commitment

 

7,000 

 

 

 —

Net cash provided by (used in) operating activities

 

23,287 

 

 

(17,806)

Cash flows from investing activities

 

 

 

 

 

Purchases of property and equipment, net

 

(19)

 

 

(1,098)

Proceeds from sales of marketable securities

 

 —

 

 

7,456 

Purchase of investments

 

(227,346)

 

 

(905,000)

Proceeds from maturities of investments

 

286,046 

 

 

922,249 

Net cash provided by investing activities

 

58,681 

 

 

23,607 

Cash flows from financing activities

 

 

 

 

 

Proceeds from stock option exercises

 

 

 

47 

Cash paid for contingent consideration

 

 —

 

 

(3,000)

Net cash provided by (used in) financing activities

 

 

 

(2,953)

Effect of exchange rate on cash

 

35 

 

 

(80)

Net increase in cash and cash equivalents

 

82,004 

 

 

2,768 

Cash and cash equivalents, beginning of period

 

26,755 

 

 

9,823 

Cash and cash equivalents, end of period

$

108,759 

 

$

12,591 

Supplemental disclosure of cash flow information

 

 

 

 

 

Cash paid for interest

$

1,447 

 

$

415 

Supplemental disclosure of noncash investing and financing activities:

 

 

 

 

 

Non-cash exercise of warrant

$

 —

 

$

750 





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”), is a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for companion animals. The Company has one operating segment: pet therapeutics.

Basis of Presentation

The accompanying unaudited consolidated financial statements have been prepared in accordance with U.S. 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, 2015 and the notes thereto in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 15, 2016. 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 $148,889 as of June 30 , 2016. 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 on hand will be sufficient to fund operations at least through June 30,  201 7 . As disclosed in Note 8 to the consolidated financial statements, the Company has a term loan and a   revolving credit facility with a n   aggregate principal balance of $40,000 as of June 30 , 201 6. The terms of this agreement require the Company to receive unrestricted net cash proceeds of at least $45,000 from partnering transactions and/or the issuance of equity securities from October 16, 2015 to October 16, 2016. The loan agreements also require that the Company have at least three products fully United States Department of Agriculture (“ USDA ”) or U.S. Food and Drug Administration (“ FDA ”) approved for commercialization by December 31, 20 16. W ith t h e FDA approval of GALLIPRANT in March   2016 and the receipt of the upfront payment of $45,000   under the Elanco Animal Health , Inc.   (“Elanco”) agreement (Note 10) entered into in April   2016, the Company has met both conditions. Additionally, the loan agreement requires that the Company maintain certain minimum liquidity at all times, which as of June 30, 2016, was approximately $20,000.

Consolidation

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

To determine if the Company holds a controlling financial interest in an entity, the Company first evaluates if it is required to apply the variable interest entity (“VIE”) model to the entity. Where the Company holds current or potential rights that give it the power to direct the activities of a VIE that most significantly impact the VIE’s economic performance combined with a variable interest that gives it the right to receive potentially significant benefits or the obligation to absorb potentially significant losses, the Company is the primary beneficiary of that VIE. When changes occur to the design of an entity, the Company reconsiders whether it is subject to the VIE model. The Company continuously evaluates whether it is the primary beneficiary of a consolidated VIE.

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 Recognition

The Company recognizes revenue when all of the following conditions are met:

  • persuasive evidence of an arrangement exists;

  • delivery has occurred or services have been rendered;

  • the seller’s price to the buyer is fixed or determinable; and

  • collectibility is reasonably assured.

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The Company’s principal revenue streams and their respective accounting treatments are discussed below:

(i) Product sales - Revenue for the sale of products is recognized when delivery has occurred and substantially all the risks and rewards of ownership have been transferred to the customer. Revenue for the sale of products are recorded net of sales returns, allowances and discounts.

(ii) Royalty revenue - Royalty revenue relating to the Company’s out-licensed technology is recognized when reasonably estimable. The revenues are recorded based on estimates of the licensee’s sales that occurred during the relevant period. Differences between actual and estimated royalty revenues are adjusted for in the period in which they become known, typically in the following quarter. If the Company is unable to reasonably estimate royalty revenue or do es not have access to the information, then the Company records royalty revenue on a cash basis.

(iii) Licensing and collaboration revenues - Revenues derived from product out-licensing arrangements typically consist of an initial up-front payment at inception of the license and subsequent milestone payments contingent on the achievement of certain regulatory, development and commercial milestones.

Product out-licensing arrangements with multiple elements are divided into separate units of accounting if certain criteria are met. The up-front payment received is allocated among the separate units of accounting based on their respective fair values, and the applicable revenue recognition criteria are applied to each of the separate units of accounting. The application of the multiple element guidance requires subjective determinations, and requires the Company to make judgments about the individual deliverables and whether such deliverables are separable from the other aspects of the contractual relationship. Deliverables are considered separate units of accounting provided that:

(1) the delivered item(s) has value to the customer on a stand-alone basis and

(2) if the arrangement includes a general right of return relative to the delivered item(s), delivery or performance of the undelivered item(s) is considered probable and substantially in the Company's control.

In determining the units of accounting, the Company evaluates certain criteria, including whether the deliverables have stand-alone value, based on the consideration of the relevant facts and circumstances for each arrangement. In addition, the Company considers whether the buyer can use the other deliverable(s) for their intended purpose without the receipt of the remaining element(s), whether the value of the deliverable is dependent on the undelivered item(s), and whether there are other vendors that can provide the undelivered element(s).

Arrangement consideration that is fixed or determinable is allocated among the separate units of accounting using the relative selling price method, and the applicable revenue recognition criteria. The Company determines the estimated selling price for deliverables within each agreement using vendor-specific objective evidence (“VSOE”) of selling price, if available, third-party evidence (“TPE”) of selling price if VSOE is not available, or management's best estimate of the selling price (“BESP”) if neither VSOE nor TPE is available. Determining the BESP for a unit of accounting requires significant judgment. In developing the BESP for a unit of accounting, the Company considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated costs.

If there are deliverables in an arrangement that are not separable from other aspects of the contractual relationship, they are treated as a combined unit of accounting, with the allocated revenue for the combined unit recognized in a manner consistent with the revenue recognition applicable to the final deliverable in the combined unit.

Amounts received prior to satisfying all relevant revenue recognition criteria are recorded as deferred revenue in the consolidated balance sheets and recognized as revenue when the related revenue recognition criteria are met. Amounts not expected to be recognized as revenue within the next twelve months of the consolidated balance sheet date are classified as long-term deferred revenue.

The Company recognizes revenue contingent upon the achievement of a milestone in its entirety in the period in which the milestone is achieved only if the milestone meets all the criteria to be considered substantive. At the inception of each arrangement that includes milestone payments, the Company evaluates each contingent payment on an individual basis to determine whether they are considered substantive milestones, specifically reviewing factors such as the degree of certainty in achieving the milestone, the research and development risk and other risks that must be overcome to achieve the milestone, as well as the level of effort and investment required and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement. This evaluation includes an assessment of whether (a) the consideration is commensurate with either (1) the entity’s performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone, (b) the consideration relates solely to past performance and (c) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement.

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Milestone payments which are non-refundable and deemed substantive, non-creditable and contingent on achieving certain development, regulatory, or commercial milestones are typically recognized as revenues either on achievement of such milestones or over the period the Company has continuing substantive performance obligations. The Company recognizes revenue associated with the non-substantive milestones upon achievement of the milestone if there are no undelivered elements and the Company has no remaining performance obligations. Revenues from commercial milestone payments are recorded as revenue upon achievement of the milestone, assuming all other revenue recognition criteria are met. 

In the event that an agreement is terminated and the Company then has no further performance obligations, the Company recognizes as revenue any amounts that had not previously been recorded as revenue but were classified as deferred revenue at the date of such termination.

Cash considerations (including a sales incentive) given by the Company to a licensee/collaborator/customer is presumed to be a reduction of the selling prices of the Company’s products or services and is recognized as a reduction of revenue unless both of the following conditions are met:

a.  The Company receives, or will receive, an identifiable benefit (goods or services) in exchange for the consideration. In order to meet this condition, the identified benefit must be sufficiently separable from the re cipient’s purchase of the Company’s products such that the Company could have entered into an exchange transaction with a party other than a purchaser of its products or services in order to receive that benefit.

b.  The Company can reasonably estimate the fair value of the benefit identified under the preceding condition. If the amount of consideration paid by the Company exceeds the estimated fair value of the benefit received, that excess amount shall be characterized as a reduction of revenue when r ecognized in the Company ’s income statement.  

If both conditions are met, the cash consideration is recognized as a cost incurred.

Pre-Launch Inventory

The Company may scale-up and make commercial quantities of certain of its product candidates prior to the date it anticipates that such products will receive final FDA/USDA approval. The scale-up and commercial production of pre-launch inventories involves the risk that such products may not be approved for marketing by the FDA/USDA on a timely basis, or ever. Inventory costs associated with product candidates that have not yet received regulatory approval are capitalized if the Company believes there is probable future commercial use and future economic benefit. If the probability of future commercial use and future economic benefit cannot be reasonably determined, then pre-launch inventory costs associated with such product candidates are expensed as research and development expense during the period the costs are incurred. Specifically, the Company has determined that for FDA-regulated product candidates there is a probable future commercial use and future economic benefit upon the receipt of the three major technical section complete letters from the FDA’s Center for Veterinary Medicine (“CVM”). For USDA product candidates, the Company has determined there is a probable future commercial use and future economic benefit upon the receipt of a conditional license from the USDA’s Center for Veterinary Biologics. The Company makes at least quarterly reassessments of the probability of regulatory approval and useful life of the pre-launch inventory, and determines whether such inventory continues to have a pro bable future economic benefit.

Property and Equipment, net

Property and equipment is recorded at historical cost, net of accumulated depreciation and amortization of $733 and $430 as of June 30 , 2016, and December 31, 2015, respectively.

Goodwill

In the first quarter of 2016, the Company completed an interim impairment assessment due to a decline in its market capitalization. In performing step one of the assessment, the Company determined that as of March 31, 2016, its fair value excee ded its carrying value by 121% . Based on this result, step two of the assessment was not required to be performed, and the Company determined there was no impairment of goodwill during the first quarter of 2016. The Company did not identify any potential indicators of goodwill impairment during the second quarter of 2016, and, accordingly, no interim assessment was performed.

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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 will supersede the revenue recognition requirements in topic, Revenue Recognition , and most industry-specific guidance. This guidance also supersedes certain cost guidance included in subtopic, Revenue Recognition – Construction-Type and Production-Type Contracts . In addition, the existing requirements for the recognition of a gain or loss on the transfer of nonfinancial assets that are not in a contract with a customer (e.g., assets within the scope of topic, Property, Plant, and Equipment , and tangible assets within the scope of topic, Intangibles – Goodwill and Other) are amended to be consistent with the guidance on recognition and measurement (including the constraint on revenue) in this 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.

In July 2015, the FASB approved a one-year delay in the effective date of the new revenue standard. These changes become effective for the Company on January 1, 2018 . E arly adoption is permitted but not before the original effective date of January 1, 2017. The standard permits the use of either the retrospective or cumulative effect transition method.   The Company is currently assessing the impact, if any, this new guidance will have on its consolidated financial statements.

Inventory – Simplifying the Measurement of Inventory

In July 2015, the FASB issued guidance that requires entities to measure most inventory “at lower of cost and net realizable value” thereby simplifying the current guidance under which an entity must measure inventory at the lower of cost or market. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years. Early adoption is permitted and is to be applied using a prospective basis. The Company does not expect that this new guidance will have a material impact on its consolidated financial statements.

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 using a modified retrospective transition method. The Company is currently assessing the effect that adoption of this guidance will have on its consolidated financial statements.

Compensation – Stock Compensation

In March 2016, the FASB issued guidance that simplifies several aspects of the accounting for employee share-based payment transactions including accounting for income taxes, forfeitures and statutory tax withholding requirements, as well as classification in the statement of cash flows. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years. Early adoption is permitted and is to be applied using a modified retrospective transition method by means of a cumulative-effect adjustment to equity as of the beginning of the period in which the guidance is adopted. The Company is currently assessing the effect that adoption of this guidance will have on its consolidated financial statements.







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2. Fair Value of Financial Assets and Liabilities

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

The following financial assets are measured at fair value on a recurring basis using quoted prices in active markets for identical assets (Level 1); significant other observable inputs (Level 2); and significant unobservable inputs (Level 3).







 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



  

 

 

  

Fair Value Measurements as of



 

Carrying

 

June 30, 2016 Using:



  

Value

  

Level 1

  

Level 2

  

Level 3

  

Total

Assets:

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

Cash equivalents:

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Certificates of deposit

 

$

7,221 

 

$

 —

 

$

7,221 

 

$

 —

 

$

7,221 

Short-term investments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Short-term marketable securities - certificates of deposit

 

 

747 

 

 

 —

 

 

747 

 

 

 —

 

 

747 



  

$

7,968 

  

$

 —

  

$

7,968 

  

$

 —

  

$

7,968 







 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



  

 

 

  

Fair Value Measurements as of



 

Carrying

 

December 31, 2015 Using:



  

Value

  

Level 1

  

Level 2

  

Level 3

  

Total

Assets:

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

Cash equivalents:

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Certificates of deposit

 

$

6,972 

 

$

 —

 

$

6,972 

 

$

 —

 

$

6,972 

Money market fund

 

 

35 

 

 

35 

 

 

 —

 

 

 —

 

 

35 

Short-term investments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Short-term marketable securities - certificates of deposit

 

 

747 

 

 

 —

 

 

747 

 

 

 —

 

 

747 

Reverse repurchase agreements

 

 

58,700 

 

 

 —

 

 

58,700 

 

 

 —

 

 

58,700 



  

$

66,454 

  

$

35 

  

$

66,419 

  

$

 —

  

$

66,454 

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:

·

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

·

Reverse repurchase agreements – the fair value of the reverse repurchase agreements has been determined to be amortized cost given the short duration of the agreements.

·

Cash equivalents – the fair value of the cash equivalents has been determined to be amortized cost or has been based on the quoted prices in active markets or exchanges for identical assets.

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

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







 

 

 

 

 

 



 

 

 

 

 

 



  

June 30, 2016



  

Carrying Value

 

Fair Value

Liabilities:

  

 

 

 

 

 

Loans payable (Level 2)

  

$

39,949 

  

$

39,938 



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December 31, 2015



  

Carrying Value

 

Fair Value

Liabilities:

  

 

 

 

 

 

Loans payable (Level 2)

  

$

39,710 

  

$

40,569 

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.

Fair value information about the intangible assets that were impaired during the six months ended June 30, 2016 (Note 7) was as follows:







 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



  

 

 

  

Fair Value



 

Carrying

 

June 30, 2016 Using:



  

Value

  

Level 1

  

Level 2

  

Level 3

  

Impairment

Intellectual property rights for currently marketed products

 

$

 —

 

$

 —

 

$

 —

 

$

 —

 

$

551 

Intellectual property rights acquired for in-process research and development

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

2,229 



  

$

 —

  

$

 —

  

$

 —

  

$

 —

  

$

2,780 



The fair value amount is presented as of the date of impairment, as these assets are not measured at fair val ue on a recurring basis (Note 7 ). The fair value reflects intangible assets written down to fair value during the six months ended June 30, 2016. Fair-value was determined using the income approach, specifically the multi-period excess earnings method, a form of a discounted cash flow method. The Company started with a forecast of all the expected net cash flows associated with the asset and then it applied an asset-specific discount rate to arrive at a net present value amount. Some of the more significant estimates and assumptions inherent in this approach include: the amount and timing of the projected net cash flows, which includes the expected impact of competitive legal and/or regulatory forces on the product and the impact of technological risk associated with IPR&D assets; the discount rate, which seeks to reflect the various risks inherent in the projected cash flows; and the tax rate, which seeks to incorporate the geographic diversity of the projected cash flows.





3. Investments

Marketable Securities

Marketable securities consisted of the following:







 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



  

June 30, 2016



  

 

 

  

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, 2016, 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.



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December 31, 2015



  

 

 

  

Gross

  

Gross

 

 

 



 

Amortized

 

Unrealized

 

Unrealized

 

Fair



 

Cost

 

Losses

 

Losses

 

Value

Short-term marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

Certificates of deposit

  

$

747 

  

$

 —

  

$

 —

 

$

747 

Total

  

$

747 

  

$

 —

  

$

 —

 

$

747 

At December 31, 2015, 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.

Reverse Repurchase Agreements

The Company, as part of its cash management strategy, may invest excess cash in reverse repurchase agreements. All reverse repurchase agreements are tri-party and have maturities of three months or less at the time of investment. The underlying collateral is U.S. government securities including U.S. treasuries, agency debt and agency mortgage securities. The underlying collateral posted by each counterparty is required to cover 102% of the principal amount and accrued interest after the application of a discount to fair value. The Company was not invested in any reverse repurchase agreements as of June 30, 2016.



4. Derivative Financial Instruments

In 2015, the Company’s derivative financial instrument, the warrant the Company received in connection with the license agreement with Advaxis, Inc. (“Advaxis”), was not designated as a hedging instrument and was adjusted to fair value through earnings in other income (expense). During the year ended December 31, 2015, the Company exercised the Advaxis warrant and subsequently sold the shares of common stock received upon exercise.

The following table shows the Company’s gain recognized in other income (expense) for the three and six months ended:





 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



 

Gain Recognized in

 

Gain Recognized in



 

Other Income (expense)

 

Other Income (expense)



 

Three Months Ended

 

Six Months Ended



 

June 30,

 

June 30,



 

2016

 

2015

 

2016

 

2015

Derivative assets:

  

 

 

 

 

 

 

 

 

 

 

 

Warrant

  

$

 —

 

$

316 

 

$

 —

 

$

1,274 



As the Company exercised the warrant and subsequently sold the shares of common stock received upon exercise resulting in a gain of $341 recognized in other income (expense) during the second quarter of 2015, no gain was recorded during the three and six months ended June 30, 2016.



5. Inventories

Inventories are stated at the lower of cost or market and comprised of the following:







 

 

 

 

 

 



 

 

 

 

 

 



 

June 30, 2016

 

December 31, 2015

Raw materials

 

$

88 

 

$

120 

Work-in-process

  

 

2,233 

  

 

441 

Finished goods

 

 

245 

 

 

745 



  

$

2,566 

  

$

1,306 



Work-in-process inventorie s at June 30, 2016, included approximately $1,738 of pre-launch GALLIPRANT ® (grapiprant tablets)   product costs capitalized due to anticipated benefit from future commercialization of this product. GALLIPRANT was approved by the CVM for the control of pain and inflammation associated with osteoarthritis in dogs in the first quarter of 2016 .   As of June 30, 2016, the Company has accrued $1,819 for pre-launch GALLIPRANT inventories received but not invoiced .

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During the three and six months ended June 30, 2016, the Company recognized inventory valuation adjustment losses in the amount $1,552 from application of lower of cost or market, in cost of product sales. The losses related to TACTRESS inventories that were written off and pre-launch GALLIPRANT inventories marked to market due to terms agreed upon in the Elanco collaboration agreement (Note 10).





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, 2016, was as follows:







 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 



 

Gross

 

Impairment

 

Net



  

Carrying Amount

  

Losses

  

Carrying Value

Goodwill

  

$

40,006 

  

$

 —

  

$

40,006 



The change in the net book value of goodwill for the six months ended June 30, 2016, was as follows:







 

 

 



 

 

 



  

2016

As of January 1,

  

$

39,781 

Effect of foreign currency exchange

  

 

225 

As of the end of the period,

  

$

40,006 

















7. Intangible Assets, Net  

The change in the net book value of intangible assets for the six months ended June 30, 2016, was as follows:







 

 

 



 

 

 



  

2016

As of January 1,

  

$

15,067 

Amortization expense

  

 

(190)

Effect of foreign currency exchange

 

 

197 

Impairment

  

 

(2,780)

As of the end of the period,

  

$

12,294 



The estimated useful lives of the individual categories of intangible assets were based on the nature of the applicable intangible asset and the expected future cash flows to be derived from the intangible asset. Amortization of intangible assets with finite lives is recognized over the shorter of the respective term of the agreement or the period of time the intangible assets are expected to contribute to future cash flows. The Company amortizes finite-lived intangible assets using the straight-line method. The Company recognized amortization expense of $95 and $190 for the three and six months ended June 30, 2016, respectively, and $483 and $966 for the three and six months ended June 30, 2015, respectively. Indefinite-lived in-process research and development (“IPR&D”) intangible assets are not amortized until a product reaches its first conditional license or approval, and then they are amortized over their estimated useful lives.

Unamortized Intangible Assets

Unamortized intangible assets as of June 30, 2016, were as follows:





 

 

 



 

 

 



 

Net



 

Carrying



 

Value

Unamortized intangible assets:

 

2016

Intellectual property rights acquired for in-process research and development

 

$

6,979 



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The net carrying value above includes asset impairment charges to date of $10,946 and $5,819 for AT-007 and AT-011, respectively.

Return of AT-006 Global Rights

On May 11, 2016, the Company and Elanco agreed to terminate the Exclusive License, Development, and Commercialization Agreement with Elanco (the “Elanco AT-006 Agreement”) (Note 10) that granted Elanco global rights for development and commercialization of licensed animal health products for an anti-viral for the treatment of feline herpes virus induced ophthalmic conditions. As a result of the termination of the Elanco AT-006 Agreement, the Company conducted an impairment assessment of the AT-006 intangible asset to assess the impact of the termination agreement . As part of the assessment, the Company considered development timing and expenses, manufacturing expenses, technology royalties and royalties due to Elanco, anticipated timing of commercial availability, as well as marketing, and selling expenses to commercialize the product. The Company concluded that the AT-006 intangible asset was not impaired due to the termination of the Elanco AT-006 Agreement .

Impairment of Unamortized Intangible Assets

AT-007 (Feline immunodeficiency v irus )

The Company has been considering out-licensing or internally advancing the AT-007 program for feline immunodeficiency virus since an impairment expense was recorded in the third quarter of 2015. Due to the return of the AT-006 global rights from Elanco in May 2016 (Note 10) and ensuing development program portfolio prioritization, including consideration of the Company’s focus on commercial launch activities to support its recently approved products, the Company decided to discontinue the development of AT-007 during the second quarter of 2016. This result ed in an impairment charge of $2,229 ,   which was recorded during the three months ended June 30, 2016, reducing the carrying value of AT-007 to $0.

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

Amortized Intangible Assets

Amortized intangible assets as of June 30, 2016, were as follows:







 

 

 

 

 

 

 

 

 

 

 

 



 

Gross

 

 

 

 

Net

 

 

 



 

Carrying

 

Accumulated

 

Carrying

 

Average

Amortized intangible assets:

 

Value

 

Amortization

 

Value

 

Useful Life

Intellectual property rights for currently marketed products:

 

 

 

 

 

 

 

 

 

 

 

 

BLONTRESS ®

 

$

28,572 

 

$

23,257 

 

$

5,315 

 

20 

Years

Accumulated amortization includes both amortization expense and asset impairment charges. Asset impairment charges for BLONTRESS to date are $20,228 .

Impairment of Amortized Intangible Assets

TACTRESS

Since the acquisition of Vet Therapeutics, Inc. (October 2013) , the Company has been performing various scientific and clinical activities to gain further knowledge around the science and efficacy of TACTRESS. In the third quarter of 2015, the Company’s interim analysis of the clinical results indicated that TACTRESS did not seem to be adding significant progression free survival in canine T-cell lymphoma ; those results were confirmed in the final study results in July 2016 . In addition, scientific studies suggested that TACTRESS was not as specific to the target as expected. Given those clinical and scientific results, the Company no longer believed that TACTRESS would capture the desired T-cell lymphoma market opportunity and recorded an impairment expense.

While TACTRESS remains commercially available, the use by oncologists has been more limited than the Company anticipated, resulting in sales during the quarter ended June 30, 2016, being significantly lower than forecasted. The Company deemed the events and market projections described above to be indicators of potential impairment of its finite-lived intangible asset TACTRESS during the second quarter of 2016. The Company performed impairment testing for the intangible asset TACTRESS as of June 30, 2016, and recorded an impairment expense of $551 , which was recorded during the three months ended June 30, 2016 , resulting in a net carrying value of $0 for TACTRESS.

Unfavorable outcomes of the Company’s development activities or the Company’s estimates of the market opportunities for the product candidates could result in additional impairment charges in future periods. For example, we anticipate the results of the mini B-CHOMP study in the fall of 2016.









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8. Debt

Loan and Security Agreements

Effective as of October 16, 2015, the Company and Vet Therapeutics, Inc., (the “borrowers”), entered into a Loan and Security Agreement (“Loan Agreement”), with Pacific Western Bank, or Pacific Western, as a collateral agent and Oxford Finance, LLC, (the “Lenders”). The loan is secured by substantially all of the borrowers’ personal property other than intellectual property. The outstanding principal balance under the Loan Agreement was $35,000 under the term loan facility and $5,000 under the revolving facility at June 30, 2016. The interest rate on the term loan and revolving credit facility as of June 30, 2016, was 7.16% . During the three and six months ended June 30, 2016, the Company recognized interest expense of $843 and $1,687 , respectively and during the three and six months ended June 30, 2015, the Company recognized interest expense of $219 and $435 , respectively.

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, 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 receive unrestricted net cash proceeds of at least $45,000 from partnering transactions and/or the issuance of equity securities from October 16, 2015 to October 16, 2016. The Loan Agreement also requires that the Company has at least three products fully USDA- or FDA-approved for commercialization by December 31, 2016. With the FDA approval of GALLIPRANT in March 2016 and the receipt of the upfront payment of $45,000   under the Elanco collaboration agreement (Note 10) entered into in April 2016, the Company has met both conditions. Additionally, the Loan Agreement requires that the Company maintain certain minimum liquidity at all times, which as of June 30, 2016 was approximately   $20,000 . At June 30, 2016, the Company was in compliance with all financial covenants. If the minimum liquidity covenant is not met , the Company may be required to repay the loan prior to scheduled maturity date.

Loans payable as of June 30, 2016, were as follows:







 

 

 

Principal amounts

 

 

 

Term loan, 7.16% , due October 16, 2019

 

$

35,000 

Revolving line, 7.16% , due October 16, 2017

 

 

5,000 

Add: accretion of final payment and termination fees

 

 

262 

Less: unamortized debt issuance costs

 

 

(313)

As of the end of the period,

 

$

39,949 

As of June 30, 2016, $2,333 related to the term loan was reclassified as Current portion –   loans payable.





9. Accrued Expenses

Accrued expenses consisted of the following:







 

 

 

 

 

 



 

 

 

 

 

 



 

June 30, 2016

 

December 31, 2015

Accrued expenses:

 

 

 

 

 

 

Payroll and related expenses

 

$

1,376 

 

$

1,922 

Professional fees

 

 

201 

 

 

388 

Royalty expense

 

 

37 

 

 

Interest expense

 

 

239 

 

 

238 

Research and development costs

 

 

444 

 

 

1,111 

  Goods received but not invoiced

 

 

1,819 

 

 

 —

Milestone

 

 

139 

 

 

500 

Other

 

 

250 

 

 

87 

Total accrued expenses

 

$

4,505 

 

$

4,247 

























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10. Agreements  

RaQualia Pharma Inc. (“RaQualia”)

On December 27, 2010, the Company entered into two Exclusive License Agreements with RaQualia (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 milestone payments associated with GALLIPRANT and ENTYCE of up to $10,000 and $8,500 , 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, if any.

The Company achieved milestones totaling $0 and $ 5 ,000 which were expensed within research and development expenses during the three and six months ended June 30, 2016, respectively, and included in accounts payable in the consolidated balance sheets . As of June 30, 2016, the Company had not paid any milestone or royalty payments since execution of the RaQualia Agreements.

It is possible that multiple additional milestones related to the RaQualia Agreements are achieved within the next 12 months totaling $6,500 .

Elanco

BLONTRESS

On January 2, 2015, the Company was granted a full product license from the USDA for BLONTRESS. The approval resulted in a $3,000 milestone payment being earned and due to the Company per the terms of the Exclusive Commercial License Agreement with Elanco (formerly Novartis Animal Health, Inc.) (the “Elanco Agreement”). During the first quarter of 2015, the Company recognized $3,000 of licensing revenue related to the milestone payment.

On February 24, 2015, the Company and Elanco agreed to terminate the Elanco Agreement. In consideration for the return of the commercial license granted to Elanco, the Company paid Elanco $2,500 in March 2015, and will be required to pay an additional $500 upon the first commercial sale by the Company. At that time the Company determined that it was probable that the $500 payment will be paid, and recorded the $500 as a current liability in the first quarter of 2015. The first commercial sale occurred in March 2016. The Company recorded the $3,000 paid to Elanco as a reduction in revenues received from Elanco as the payment was to re-acquire rights that the Company had previously licensed to Elanco.

On February 25, 2016, the Company and Elanco agreed to amend the terms related to the $500 payment due upon the first commercial sale by the Company. Under the amended terms, upon the first commercial sale, the Company will be required to pay quarterly, a royalty per vial sold until $500 in royalties are paid or the end of two years. After two years, the Company will be required to pay Elanco $500 plus 10% interest, compounded annually against any unpaid balance, less any royalties paid during the two years. If during the two years following the first commercial sale the Company withdraws BLONTRESS from the market and ceases all commercialization, the remaining royalty and related interest are no longer payable. As of June 30, 2016, $355 of the remaining $494 accrued milestone was include d in other long-term liabilities in the consolidated balance sheets.

GALLIPRANT

On April 22, 2016, the Company entered into a Collaboration, License, Development and Commercialization Agreement (the “Collaboration Agreement”) with Elanco 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 (the “Product”), including GALLIPRANT (grapiprant tablets), an FDA-approved therapeutic for the control of pain and inflammation associated with osteoarthritis in dogs. Pursuant to the Collaboration Agreement, Elanco will have exclusive rights globally outside the United States and co-exclusive 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 GALLIPRANT for the treatment of pain and inflammation ,   a nother   $4,000   payment u pon achievement of a development milestone related to the manufacturing of GALLIPRANT , 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 is responsible f or all development activities required to obtain the first registration or regulatory approval for the Product for use in dogs in each of the European Union (“the EU Product Regist ration”) and the United States, and Elanco is responsible for all other development activities. First r egistration for the Product in the U.S. was achieved before the completion of the Collaboration Agreement.   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 the Products, provided that the Company’s contribution to such development fees and expenses is capped at $7,000 (“R&D Cap”). Commencing on the effective date of the Collaboration Agreement,

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the Company is responsible for the manufacture and supply of all of Elanco’s reasonable requirements of GALLIPRANT under the supply terms agreed upon pursuant to the Collaboration Agreement . However, Elanco retains the ability to assume all or a portion of the manufacturing responsibility during the term of the Collaboration Agreement. The parties have agreed under the Collaboration Agreement to negotiate and enter into a supply agreement formalizing the terms of supply of active product ingredients and/or finished GALLIPRANT by the Company to Elanco.

On April 22, 2016, in connection with the Collaboration Agreement, the Company entered into a Co-Promotion Agreement (the “Co-Promotion Agreement”) with Elanco to co-promote the Product 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 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 Product in the United States after December 31, 2018 through 2028 (unless extended by mutual agreement).

The Company concluded that the Collaboration Agreement and Co-Promotion Agreement represent a multiple-element arrangement, and evaluated if deliverables in the arrangement represent separate units of accounting. The Company identified the following deliverables under the agreement: (i) a royalty-bearing, sub-licensable, development, manufacturing and commercialization license; (ii) manufacturing and supply services; (iii) participation in a joint manufacturing subcommittee; and (iv) services associated with obtaining the EU Product Registration. The Company performed an assessment and concluded that the license had stand-alone value from the other undelivered elements in the arrangement. The Company’s best estimate of the selling price for the manufacturing subcommittee and the EU Product Registration services were i mmaterial and, therefore , no consideration was al located to these deliverables. Under the manufacturing and supply services terms, Elanco will be obligated to pay for any future orders at a price per unit representative of market value, and , therefore, no upfront consideration was allocated to this deliverable. The Company allocated $38 ,000 of the $45 ,000 upfront payment to the lic ense, and recognized $38,000 of licensing and collaboration revenue during th e quarter ended June 30, 2016. The Company allocated $7,000 of upfront cons ideration to the R&D C ap, which was recorded as licensing and collaboration commitment liability in the consolidated b alance sheet at June 30, 2016. The Company classified the licensing and collaboration commitment liability as a current liability due to the Company having no control over when R&D Cap expenses will be incurred and the expected timing of R&D Cap expenses being unknown as of June 30, 2016. The licensing and collaboration commitment liability will be reduced in future periods as the related expenses are incurred by Elanco and paid for by the Company. Any remaining balance not paid to Elanco 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.

The Company evaluated if the sales and other milestones per the Collaboration Agreement are substantive. The Company determined that the milestones are non-substantive, and , therefore, these milestones will be allocated amongst the delivered, and any undelivered elements at the t ime the milestones are earned. If there are no undelivered elements, the milestone payments will be recognized as revenue in their entirety upon achievement of each milestone. For the three and the six months ended June 30, 2016, no milestones were achieved, and accordingly, no revenues were recognized from the milestones .    

AT-006

On May 11, 2016, the Company and Elanco agree d to terminate the Elanco AT-006 Agreement that granted Elanco global rights for development and commercialization of licensed animal health products for an anti-viral for the treatment of feline herpes virus induced ophthalmic conditions. In consideration for the return of the Elanco AT-006 Agreement global rights, the Company is required to pay Elanco a low single-digit royalty on any product sales, if any, up to an amount in the low-single digit millions.

Pacira Pharmaceuticals, Inc. (“Pacira”)

On December 5, 2012, the Company entered into an Exclusive License, Development, and Commercialization Agreement with Pacira (the “Pacira Agreement”) that granted the Company global rights for development and commercialization of licensed animal health products for NOCITA ® (also known as AT-003). The Company is required to pay Pacira milestone payments of up to $41,000 upon the Company’s achievement of certain development, regulatory ( $1,000 ) and commercial ( $40,000 ) milestones, as well as tiered royalties on the Company’s product sales, if any. The commercial milestones owed to Pacira under the Pacira Agreement begin to be triggered once NOCITA annual net sales reach $100,000 with the final tier being owed to Pacira once NOCITA annual net sales reach $500,000 .  

The Company achieved milestones totaling $1,000 and $ 1 ,000 which were expensed within research and development expenses during the three and six months ended June 30, 2016, respectively, and included in accounts payable in the consolidated balance sheets . As of June 30, 2016, the Company had paid $500 in milestone payments and no royalty payments since execution of the Pacira Agreement.

It is possible that multiple additional milestones related to the Pacira Agreement are achieved within the next 12 months totaling $1,000 .



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11. Common Stock

As of June 30, 2016, there were 34,798,120 shares of the Company’s common stock outstanding, net of 579,132 shares of unvested restricted common stock.

Sales Agreement

On October 16, 2015, the Company entered into a Sales Agreement with Barclays Capital Inc. (“Barclays”) pursuant to which the Company may sell from time to time, at its option, up to an aggregate of $52,000 of shares of its common stock (the “Shares”) through Barclays, as sales agent. Sales of the Shares, if any, will be made under the Company’s previously filed and currently 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 Sales Agreement, the Shares may be sold at market prices, at negotiated prices or at prices related to the prevailing market price. The Company will pay Barclays a commission of 2.75% of the gross proceeds from the sale of the Shares, if any. As of the date of this filing, the Company has not sold any shares pursuant to the Sales Agreement.



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, 2016, was as follows:







 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 



  

 

 

 

 

  

Weighted

 

 



 

Shares

 

Weighted

 

Average

 

 



 

Issuable

 

Average

 

Remaining

 

Aggregate



 

Under

 

Exercise

 

Contractual

 

Intrinsic



 

Options

 

Price

 

Term

 

Value



  

 

 

 

 

  

(In Years)

  

 

 



 

 

 

 

 

 

 

 

 

 

Outstanding as of December 31, 2015

  

86,490 

 

$

2.95 

  

7.09 

  

$

228 

Granted

  

 —

 

 

 —

  

 

  

 

 

Exercised

  

(1,500)

 

 

0.40 

  

 

  

 

 

Forfeited

  

 —

 

 

 —

  

 

  

 

 

Expired

  

 —

 

 

 —

  

 

  

 

 

Outstanding as of June 30, 2016

  

84,990 

 

$

2.99 

  

6.59 

  

$

283 



As of June 30, 2016, 23,112 shares of common stock granted from early exercised options are unve sted and subject to repurchase. For the six months ended June 30, 2016, the total intrinsic value of options exercised was $8 and the total received from stock option exercises was $1 .

Activity related to restricted stock under the 2010 Plan for the six months ended June 30, 2016, was as follows:







 

 

 

 

 



 

 

 

 

 



  

 

 

Weighted



 

 

 

Average Grant



 

Shares

 

Date Fair Value

Unvested restricted common stock as of December 31, 2015

  

37,078 

 

$

0.36 

Issued

  

 —

 

 

 —

Vested

  

(27,129)

 

 

0.37 

Forfeited

  

 —

 

 

 —

Unvested restricted common stock as of June 30, 2016

  

9,949 

 

$

0.32 



For the six months ended June 30, 2016, the total fair value of restricted common stock vested was $134 .  

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2013 Incentive Award Plan

Activity related to stock options under the 2013 Incentive Award Plan (the “2013 Plan”) for the six months ended June 30, 2016, was as follows:







 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 



  

 

 

 

 

  

Weighed

  

 

 



 

Shares

 

Weighted

 

Average

 

 

 



 

Issuable

 

Average

 

Remaining

 

Aggregate



 

Under

 

Exercise

 

Contractual

 

Intrinsic



 

Options

 

Price

 

Term

 

Value



 

 

 

 

 

 

(in years)

 

 

 



 

 

 

 

 

 

 

 

 

 

Outstanding as of December 31, 2015

  

1,728,199 

 

$

16.57 

  

8.31 

  

$

 —

Granted

  

626,600 

 

 

3.62 

  

 

  

 

 

Exercised

  

 —

 

 

 —

  

 

  

 

 

Forfeited

  

(49,790)

 

 

12.07 

  

 

  

 

 

Expired

  

(9,748)

 

 

10.39 

  

 

  

 

 

Outstanding as of June 30, 2016

  

2,295,261 

 

$

13.16 

  

8.19 

  

$

1,735 



For the six months ended June 30, 2016, the weighted average grant date fair value of stock options granted was $2.42 .  

Activity related to restricted stock under the 2013 Plan for the six months ended June 30, 2016, was as follows:







 

 

 

 

 



 

 

 

 

 



 

 

 

 



 

 

 

Weighted



 

 

 

Average Grant



 

Shares

 

Date Fair Value

Unvested restricted common stock as of December 31, 2015

  

333,263 

 

$

17.77 

Issued

  

385,650 

 

 

3.42 

Vested

  

(157,328)

 

 

13.43 

Forfeited

  

(15,514)

 

 

9.54 

Unvested restricted common stock as of June 30, 2016

  

546,071 

 

$

9.12 



For the six months ended June 30, 2016, the total fair value of restricted common stock vested was $700 . The Company did not receive cash proceeds for any of the restricted common stock issued during the six months ended June 30, 2016.

Stock-Based Compensation

The Company recognizes compensation expense for only the portion of awards that are expected to vest. In developing a forfeiture rate estimate, the Company has considered its historical experience to estimate pre-vesting forfeitures for service-based awards. The impact of a forfeiture rate adjustment will be recognized in full in the period of adjustment, and if the actual forfeiture rate is materially different from the Company’s estimate, the Company may be required to record adjustments to stock-based compensation expense in future periods.

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,



  

2016

 

2015

 

2016

  

2015

Cost of product sales and inventories

 

$

19 

 

$

30 

 

$

50 

 

$

67 

Research and development

  

 

264 

  

 

394 

  

 

629 

  

 

999 

Selling, general and administrative

  

 

1,913 

  

 

1,605 

  

 

3,770 

  

 

3,323 



  

$

2,196 

  

$

2,029 

  

$

4,449 

  

$

4,389 



The Company had an aggregate of $8,822 and $4,011 of unrecognized stock-based compensation expense for options outstanding and restricted stock awards, respectively, as of June 30, 2016, which is expected to be recognized over a weighted average period of 2.18 years and 1.55 years, respectively.

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13. Net Income (Loss) Per Share

Basic and diluted net income (loss) per share attributable to common stockholders was calculated as follows:







 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



  

Three Months Ended

 

Six Months Ended



 

June 30,

 

June 30,



  

2016

 

2015

 

2016

 

2015

Basic net income (loss) per share attributable to common stockholders:

 

 

 

 

 

 

 

 

 

 

 

 

Numerator:

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

21,196 

 

$

(7,983)

 

$

3,129 

 

$

(16,757)

Net income attributable to participating securities

 

 

(20)

 

 

 —

 

 

(3)

 

 

 —

   Net income (loss) attributable to common stockholders

 

$

21,176 

 

$

(7,983)

 

$

3,126 

 

$

(16,757)



 

 

 

 

 

 

 

 

 

 

 

 

Denominator:

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding – basic

 

 

34,762,533 

 

 

34,278,105 

 

 

34,708,006 

 

 

34,236,282 



 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share attributable to common stockholders  – basic

 

$

0.61 

 

$

(0.23)

 

$

0.09 

 

$

(0.49)



 

 

 

 

 

 

 

 

 

 

 

 

Diluted net income (loss) per share attributable to common stockholders:

 

 

 

 

 

 

 

 

 

 

 

 

Numerator:

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

21,196 

 

$

(7,983)

 

$

3,129 

 

$

(16,757)

Net income attributable to participating securities

 

 

(20)

 

 

 —

 

 

(3)

 

 

 —

   Net income (loss) attributable to common stockholders

 

$

21,176 

 

$

(7,983)

 

$

3,126 

 

$

(16,757)



 

 

 

 

 

 

 

 

 

 

 

 

Denominator:

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding – basic

 

 

34,762,533 

 

 

34,278,105 

 

 

34,708,006 

 

 

34,236,282 

Dilutive effect of outstanding stock awards

 

 

175,922 

 

 

 —

 

 

71,780 

 

 

 —

Weighted average shares outstanding – diluted

 

 

34,938,455 

 

 

34,278,105 

 

 

34,779,786 

 

 

34,236,282 



 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share attributable to common stockholders  – diluted

 

$

0.61 

 

$

(0.23)

 

$

0.09 

 

$

(0.49)



 

 

 

 

 

 

 

 

 

 

 

 



The Company’s participating securities consist of unvested restricted common stock issued from ear ly exercised stock options and restricted common stock awards granted under the 2010 Plan, due to the shares having non-forfeitable dividend rights.



Stock options for the purchase of 1,705,396 and 1,941,521 weighted average shares of common stock and 551,709 and 557,149  o f unvested restricted stock awards were excluded from the computation of diluted net income per share attributable to common stockholders for the three and six months ended June 30, 2016, respectively, because those awards had an anti-dilutive impact on the net income attributable to common stockholders.

Stock options for the purchase of 1,671,270 shares of common stock were excluded from the computation of diluted net loss per share attributable to common stockholders for the three and six months ended June 30, 2015, because those options had an anti-dilutive impact due to the net loss attributable to common stockholders incurred for the period.



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14. Income Taxes

The Company recorded no income tax expense or benefit during the three and six months ended June 30, 2016, compared to an income tax benefit of $360 and $631 during the three and six months ended June 30, 2015, respectively, which was recognized for losses incurred that would reduce the amount of deferred tax liability related to intangible assets. The Company projects  a   loss before income taxes for 2016 and an annual effective tax rate of zero percent for 2016.   The Company’s income for the three and six months ended June 30, 2016, was fully offset by net operating loss carryforward s , and no deferred tax expense was recognized due to a full valuation allowance recognized against its deferred tax assets.



15. 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, 2015

 

$

(9,320)

 

$

(9,320)

Foreign currency translation adjustments

 

 

473 

 

 

473 

As of June 30, 2016

 

$

(8,847)

 

$

(8,847)



Amounts reclassified from accumulated other comprehensive loss were as follows:





 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

Amounts Reclassified from

 

Amounts Reclassified from



 

 

Accumulated Other

 

Accumulated Other



 

 

Comprehensive Loss

 

Comprehensive Loss



 

 

Three Months Ended

 

Six Months Ended



Location in

 

June 30,

 

June 30,



Statements of Operations

 

2016

 

2015

 

2016

 

2015

Gain on sale of securities available-for-sale

Other income (expense)

 

$

 —

 

$

2,864 

 

$

 —

 

$

3,874 



 

 

$

 —

 

$

2,864 

 

$

 —

 

$

3,874 





16. Variable Interest Entity

ViroVet BVBA (“ViroVet”)

During the third quarter of 2015, the Company reviewed certain operations of its wholly owned subsidiary, Aratana Therapeutics NV (“Aratana NV”). As a result, the Company made a strategic decision to wind down pre-clinical discovery efforts being performed at Aratana NV and focus future efforts of Aratana NV on clinical assets, the development of core legacy programs, i.e. AT-001, AT-002 and AT-003 for EU approval and business development and monetization of production animal assets and know-how obtained in the acquisition of Okapi Sciences. To facilitate this reorganization, the Company, via Aratana NV, along with the former General Manager of Aratana NV, the current General Manager of Aratana NV and a consultant to the Company, formed ViroVet BVBA. During the third quarter of 2015 the Company began to transition some of its employees from Aratana NV to ViroVet. The Company plans to transition selected Aratana NV employees, asset s and liabilities throughout 2016 to ViroVet to further pursue the research and development of production animal products. These employees will be focused on the advancement of production animal assets/know-how and the securing of additional funding for future operations.

Except for the financing matters described below, the Company will have little to no involvement in the operations of ViroVet.

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Equity Investment

In July 2015, the Company paid $2 and committed another $4 for 28% ownership interest in ViroVet. The Company has no further obligation to provide any further capital.

Convertible Loan Agreement

On September 11, 2015, Aratana NV and ViroVet executed a convertible loan agreement in which Aratana NV agreed to loan ViroVet $335  ( €300 ) on September 15, 2015. The proceeds from the loan require ViroVet to use the monies towards the development and operations of ViroVet in accordance with the budget prepared by ViroVet. The loan bears annual interest of 7% and is unsecured.

Primary Beneficiary

The Company determined ViroVet was a VIE and it had a controlling financial interest in ViroVet due to the Company having the power to direct the activities of ViroVet that most significantly impact ViroVet’s economic performance and having the obligation to absorb losses or receive benefits . The Company will continue to consolidate ViroVet unless a reconsideration event occurs, for example, an equity financing.

Total assets and liabilities of the Company’s consolidated VIE were not material as of June 30, 2016.

For the three and six months ended June 30, 2016, ViroVet’s net loss and non-controlling interest were not material and are included in the Company’s consolidated statement of operations. Creditors in ViroVet only have recourse to the assets owned by the VIE and not to the Company’s general credit. The Company currently does not have implicit support arrangements with ViroVet.

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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 product candidates, beliefs regarding market opportunities for our products and product 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 AT-004, AT-005, AT-007 and AT-011; unstable market and economic conditions; restrictions on our financial flexibility due to the terms of our credit facility; our substantial dependence upon the success of our product candidates; development of our biologic product 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 product candidates; failure of our product candidates that receive regulatory approval to obtain market approval or achieve commercial success; 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 product candidates, and failure to compete effectively; failure to identify, license or acquire, develop and commercialize additional product 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 product candidates; our small commercial sales organization, and any failure to create a sales force or collaborate with third-parties to commercialize our product candidates; difficulties in managing the growth of our company; significant costs of being a public company; risks related to the restatement of our financial statements for the year ended December 31, 2013, and the identification of a material weakness in our internal control over financial reporting; changes in distribution channels for pet therapeutics; consolidation of our veterinarian customers; limitations on our ability to use our net operating loss carryforwards; impacts of generic products; safety or efficacy concerns with respect to our product candidates; effects of system failures or security breaches; failure to obtain ownership of issued patents covering our product 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 product 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 en ded December   31, 201 5 , filed with the Securities and Exchange Commission (the “SEC”) on March   1 5 , 201 6 , 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

 

We are a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for   companion animals. We operate in one business segment :   p et therapeutics, which sits at the intersection of the more than $ 60 billion annual U.S. pet market,   and more than $2 3 billion annual worldwide animal health market. Our current product portfolio includes multiple therapeutic products and product candidates in development consisting of small molecule pharmaceuticals and large molecule biologics that target large opportunities in   serious medical conditions in pets.

Our lead products and product candidates in development include small molecules directed at treating osteoarthritis pain and inflammation (GALLIPRANT ® ), appetite stimulation (ENTYCE ® ) and post-operative pain (NOCITA ® ).

We have incurred significant net losses since our inception. These losses have resulted principally from costs incurred in connection   with in-licensing our product candidates, research and development activities and selling, general and administrative costs associated with our   operations. As of June 30, 2016 , we had a deficit accumulated since inception o f $148.9 million, and cash, cash equivalents and short - term   investments of $ 109.5  million.

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We expect to continue to incur operating losses as we work to commercialize our products and develop and commercialize our product candidates. As a result, we expect to seek to fund our operations through corporate collaborations and licensing arrangements, as well as public or private equity offerings or further debt financings. We cannot assure you that such funds will be available on terms favorable to us, if at all. Arrangements with collaborators or others may require us to relinquish rights to certain of our technologies or product candidates. In addition, there is a risk that we may never successfully complete development of our product candidates, obtain adequate patent protection for our technology, obtain necessary regulatory approval for our product candidates or achieve commercial viability for any approved product candidates. If we are not able to raise additional capital on terms acceptable to us, or at all, as and when needed, we may be required to curtail our operations which could include delaying the commercial launch of our products, discontinuing product development programs, or granting rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.   As disclosed in Note 8 to the consolidated financial statements, we have a term loan and a revolving credit facility with an aggregate principal balance of $40.0 million as of June 30, 2016. The terms of this agreement require us to receive unrestricted net cash proceeds of at least $45.0 million from partnering transactions and/or the issuance of equity securities from October 16, 2015 to October 16, 2016. The loan agreement also require s that we have at least three products fully United States Department of Agriculture (“ USDA ”) or U.S. Food and Drug Administration (“ FDA ”)-approved for commercialization by December 31, 201 6. W ith the FDA approval of GALLIPRANT in March 2016 and the receipt of the upfront payment of $45.0 million under our   agreement with Elanco Animal Health, Inc., a division of Eli Lilly & Co. (“Elanco”) entered into in April 2016, we have met both conditions.   Additionally, the loan agreement requires that we maintain certain minimum liquidity at all times, which as of June 30, 2016 , was approximately $20 .0 million .   A s 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 investment s of $109.5 m illion, will allow us to fund our operations, at least through June 30, 2017.



Business Updates



During the six months ended June 30, 2016, w e continued to make progress towards our objective of becoming a fully integrated and commercial-stage company in 2016. During the second quarter of 2016, we received our second FDA approval, filed for our third FDA approval, entered into a collaboration, license , development and commercialization agreement and a co-promotion agreement with Elanco, continued to progress on the manufacturing of commercial supply for upcoming product launches and prepare ourselves to have a commercial presence in the pet therapeutic market.

Research and Development



The following tables identify the most advanced product candidates being developed under the FDA’s Center for Veterinary Medicine (“CVM”) regulations and their current regulatory status:

UPDATED FDA RACETRACK (002)

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GALLIPRANT

Collaboration, License, Development and Commercialization Agreement

On April 22, 2016, we entered into a Collaboration, License, Development and Commercialization Agreement (the “Collaboration Agreement”) with Elanco that granted Elanco rights to develop, manufacture and commercialize our products based upon the licensed grapiprant rights and technology (the “Product”), including GALLIPRANT (grapiprant tablets), an FDA-approved therapeutic for the control of pain and inflammation associated with osteoarthritis in dogs. Elanco will have exclusive rights globally outside the United States and co-exclusive rights with us in the United States during the term of the Collaboration Agreement.

During the second quarter of 2016, Elanco paid us an upfront payment of $45.0 million. Elanco has also agreed to pay us a $4.0 million milestone payment upon European approval of GALLIPRANT for the treatment of pain and inflammation, a $4.0 million payment upon achievement of a development milestone related to the manufacturing of GALLIPRANT and payments up to $75.0 million 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. All milestone payments are non-refundable.

Elanco also has agreed to pay us royalty payments on a percentage of net sales in the mid-single to low-double digits. We are responsible for all development activities required to obtain the first registration for the product for use in dogs in each of the European Union and the United States, and Elanco is responsible for all other development activities. In addition, we 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 the products, provided that our contribution to such development fees and expenses is capped at $7.0 million.

The term of the collaboration will continue throughout the development and commercialization of the product candidates, on a Product-by-Product and country-by-country basis, until the latest of (i) the date on which no valid claim of certain issued or granted patents specified in the Collaboration Agreement in the respective country exists, (ii) the expiration of any regulatory exclusivity in such country covering such Product, and (iii) the tenth anniversary of the first commercial sale of such product in such country.

The Collaboration Agreement may be terminated by Elanco at any time upon 90 days’ written notice to us. The Collaboration Agreement may also be terminated by either party (i) for the other party’s material breach, where such breach is not cured within the timeframe specified by the agreement, (ii) upon the bankruptcy, insolvency or dissolution of the other party, or (iii) for certain activities involving the challenge of certain patents licensed by us to Elanco. Upon Elanco’s voluntary termination or termination for Elanco’s breach, among other things, (a) all licenses and rights granted to Elanco will terminate and revert to us, and (b) Elanco has agreed to assign to us all registrations and trademarks obtained in connection with the Product. Upon termination for our breach, among other things, Elanco may elect to retain its rights to the licenses granted by us under the Collaboration Agreement subject to specified payment obligations.

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Co-Promotion Agreement

On April 22, 2016, in connection with the Collaboration Agreement, we entered into a Co-Promotion Agreement (“Co-Promotion Agreement”) with Elanco to co-promote the Product in the United States.

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

The Co-Promotion Agreement expires on December 31, 2028 , unless extended by mutual agreement. In addition, the Co-Promotion Agreement provides that it will automatically terminate if the Collaboration Agreement is terminated early.

ENTYCE

On May 16, 2016, the FDA’s CVM approved ENTYCE (capromorelin oral solution) for appetite stimulation in dogs. We intend to commercially launch ENTYCE in the United States in the first quarter of 2017 in conjunction with the North American Veterinary Conference and other major veterinary conferences .

NOCITA

In June 2016, we received the final remaining major technical section complete letter for Chemistry, Manufacturing and Controls (“CMC”) from the CVM for NOCITA (bupivacaine liposome injectable suspension) for post-operative pain management in dogs undergoing knee surgery and filed an administrative new animal drug application (“NADA”) with the CVM for NOCITA as a local post-operative analgesia for cranial cruciate ligament surgery in dogs . The Animal Drug User Fee Act (“ADUFA”) date for approval has been set for August 28, 2016. If approved, we expect to commence commercialization of NOCITA in the United States in the fall of 2016 .

AT-002 for cats

During the second quarter of 2016, we received concurrence from the FDA on the protocol for a pivotal field effectiveness study. We anticipate initiating this pivotal study in late 2016 with a cat specific formulation.

AT-003 for cats

In July 2016, we initiated the pivotal field effectiveness study for post-operative pain management in cats under a FDA concurred protocol.

AT-006 for cats

During 2014, we completed a field study of AT-006 as an anti-viral for the treatment of feline herpes virus induced ophthalmic conditions. We have subsequently been working on a refined formulation to meet the regulatory standards for both the U.S. and Europe and exploring how to move the product candidate into a pivo tal field effectiveness study. We had been collaborating and sharing the cost of developing AT-006 with Elanco but on May 11, 2016, we and Elanco agreed to terminate the Exclusive License, Development, and Commercialization Agreement that granted Elanco global rights for development and commercialization of licensed animal health products for AT-006 . In consideration for the return of the global rights for AT-006 ,   we will be required to pay Elanco a low single-digit royalty on any product sales, if any, up to an amount in the low-single digit millions. We now fully control the global rights to AT-006, and we are planning to co nduct a pilot study and eventuall y move forward with pivotal work that we anticipate will enable us to submit for regulatory approval for the product candidate.

AT-016 for dogs

As of April 2016, our exclusive license partner responsible for development, VetStem Biopharma, Inc. (“VetStem”) , received concurrence from the FDA on the protocol for a pivotal field effectiveness and safety study. We antic ipate VetStem will initiate the pivotal field effectiveness study for dogs with pain associated with osteoarthritis in 2016 .  

AT-018 for dogs  

At the end of the first quarter of 2016 , we closed enrollment of a multi-center, masked, placebo-controlled, randomized pilot field study in client-owned dogs with atopic dermatitis. We and our license partner, Atopix Therapies, Ltd, expect high-level results in the third quarter of 2016. In July 2016, we met with the FDA to discuss the regulatory path forward, and in preparation for the pivotal program, w e intend to initiate an additional pilot field stud y in 2016 .  



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Products in our pipeline regulated by the USDA are:

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BLONTRESS and TACTRESS

We anticipate the results of the BLONTRESS post-approval study, mini B-CHOMP, in the fall of 2016. In the third quarter of 2015, our interim analysis of clinical results indicated that TACTRESS did not seem to be adding significant progression free survival in canine T-cell lymphoma; those results were confirmed in the final study results in July 2016.

AT-014 for dogs

During the second quarter of 2016, we initiated a pivotal field safety study for AT-014, a potential canine osteosarcoma vaccine that we licensed from Advaxis, Inc. We anticipate conditional licensure in late-2016 or shortly thereafter.

Manufacturing and Supply Chain



During the second quarter of 2016, we continued to transfer the manufacturing technology processes for GALLIPRANT and ENTYCE to our identified active pharmaceutical ingredient (“API”) and formulated product contract manufacturers to provide commercial supplies.

GALLIPRANT

We continue to complete the required manufacturing validation work in regards to API , formulated product and packaging to produce launch inventories. We also cont inue to work with an API manufacturer towards the achievement  o f the manufacturing mileston e   under the Collaboration Agreement.

ENTYCE

We intend to make filings to the FDA in the third quarter of 2016, in support of the transfer of API and formulated contract manufacturing to the respective contract manufacturing organizations to be used for the production of launch inventories. FDA approval of these filings are required for product launch.

Sales and Marketing



To prepare for the expected commercial introduction of our products, we are building our commercial organization to target companion animal veterinarians in the U.S. who typically act as not only the prescriber of product, but as the pharmacis t as well. In June, we announced we appointed a Chief Operating Officer, a newly created role to emphasize our commitment to sales operations and distribution. In June and July 2016 , we also hired National Account Managers and Regional Sales Lead er s.



With the sales leadership team and the support of approximately two dozen thera peutic specialists covering key territories throughout the U.S, we aim to meet the needs of both general practitioners and s pecialists who we believe want to provide innovative veterinary products to their clients. In achieving our objectives , we believe our go-to-market strategy should be based on the competitive landscape, as well as the adoption and relevance to general practitioners or specialists on a product-by-product basis.

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According to independent market research commissioned by us, there are approximately 25,000 veterinary clinics in the U.S. The research indicates that to target general practitioners with products like flea and tick medicine or therapies for osteoarthritis pain , a company would need to call on approximately 10,000 clinics to cover 50 percent of the reven ue opportunity, whereas for highly specialized products like oncology, a company can expect to cover 60-70 percent of the revenue opportunity in approximately 100-200 clinics across the U.S. Therefore, we have evaluated and will continue to assess our approved, licensed products and late-stage pipeline product candidates to map the relevance to specialists, how likely general practitioners are to adopt the product or product candidate , as well as taking into account the competitive landscape to define the sales strategy. Our strategy is intended to leverage a combination of direct sales, distribution, co-promotion agreements or contract selling agreements, as well as direct sales to corporate customers, such as the approximately 1,500 locations of the two largest corporate hospitals, and an eCommerce platform for veterinarians to purchase products directly from us.



Specifically, the commercial strategy for GALLIPRANT is a global strategic collaboration with Elanco in order to access its large sales organization . We have chosen this approach because the therapeutic is more likely to be highly relevant to general practitioners and is in a competitive category. GALLIPRANT may also be used by specialists as part of a multi-modal approach in treating osteoarthritis pain, but we believe many of those cases are referred back to the general practitioner. In contrast, ENTYCE is highly relevant to specialists as a tool for treating inappetence while the veterinarian diagnoses and addresses the underlying acute or chronic condition. We believe ENTYCE is likely to be adopted by general practitioners especially for acute cases since there are no FDA-approved products in veterinary medicine and it is in what we believe to be an important market opportunity. Therefore, our strategy for ENTYCE will likely utilize direct sales with approximately two dozen therape utic specialists covering key territories throughout the U.S., as well as national and regional veterinary distributors that cover approximately 90 percent of veterinary hospitals and have as many as 300 field representatives per distributor . We believe NOCITA will primarily be adopted by specialists, such as surgeons, but eventually may be used by general practitioners. Thus, we currently plan on a direct sales approach for NOCITA to educate veterinary specialists on how the long-acting analgesia fits into the multi-modal approach, which may be complemented through contract selling. BLONTRESS ® , TACTRESS   and AT-014 are likely to be best suited for specialists and we therefore believe direct sales is most effective. For therapeutics in the pipeline, we believe the go-to-market strategy for AT-016 will be similar to NOCITA and AT-018 is anticipated to be similar to ENTYCE.

As we introduce our lead t herapeutics , we will continue to measure the success of our commercialization efforts and evaluate, on a product-by-product basis, how to continue to best to target general practitioners and/or specialists.

R ecent Developments  

Properties

Effective July 1, 2016, we renewed our lease of approximately 6,600 square feet of office, laboratory and manufacturing space in San Diego, California, that now expires on June 30, 2021.

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.

T here have been no material changes to our critical accounting policies through June 30, 2016, from those discussed in our Annual Report on Form 10-K for the fiscal year ended December   31, 201 5 , filed with the SEC on March  15 , 201 6 .  



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Results of Operations

Comparison of the Three and Six Months Ended June 30, 2016 and 201 5









 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

Three Months Ended

 

 

 

 

Six Months Ended

 

 

 



 

June 30,

 

 

 

 

June 30,

 

 

 



 

2016

 

2015

 

% Change

 

2016

 

2015

 

% Change



 

(Dollars in thousands)

 

 

 

 

(Dollars in thousands)

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Licensing and collaboration revenue

 

$

38,000 

 

$

 —

 

NA

 

 

$

38,151 

 

$

 —

 

NA

 

Product sales

 

 

47 

 

 

230 

 

(79.6)

%

 

 

68 

 

 

386 

 

(82.4)

%

Total revenues

 

 

38,047 

 

 

230 

 

>100.0

%

 

 

38,219 

 

 

386 

 

>100.0

%

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales

 

 

1,741 

 

 

109 

 

>100.0

%

 

 

1,760 

 

 

219 

 

>100.0

%

Royalty expense

 

 

20 

 

 

23 

 

(13.0)

%

 

 

38 

 

 

43 

 

(11.6)

%

Research and development

 

 

5,303 

 

 

6,081 

 

(12.8)

%

 

 

16,052 

 

 

12,302 

 

30.5 

%

Selling, general and administrative

 

 

6,148 

 

 

4,879 

 

26.0 

%

 

 

12,699 

 

 

9,064 

 

40.1 

%

Amortization of acquired intangible assets

 

 

95 

 

 

483 

 

(80.3)

%

 

 

190 

 

 

966 

 

(80.3)

%

Impairment of acquired intangible assets

 

 

2,780 

 

 

 —

 

NA

 

 

 

2,780 

 

 

 —

 

NA

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

83 

 

 

43 

 

93.0 

%

 

 

160 

 

 

114 

 

40.4 

%

Interest expense

 

 

(846)

 

 

(217)

 

>100.0

%

 

 

(1,695)

 

 

(435)

 

>100.0

%

Other income (expense), net

 

 

(1)

 

 

3,176 

 

<(100.0)

%

 

 

(36)

 

 

5,141 

 

<(100.0)

%

Income tax benefit

 

$

 —

 

$

360 

 

(100.0)

%

 

$

 —

 

$

631 

 

(100.0)

%



Revenue s

During the three and six months ended June 30, 2016, total revenues increased by $37.8 million ,   as compared to the corresponding 2015 periods. Th ese increase s  w ere primarily due to an increase of $38.0 million in licensing and collaboratio n revenue related to the Collaboration A greement, partially offset by a decrease of $0.2 million and $0.3 million, for the three and six months ended June 30, 2016, respectively,   in product sales. D uring the three and six months ended June 30, 2016 , product sales consisted of sales of BLONTRESS and TACTRESS. During the three and six months ended June 30, 2015, we recorded $0.2 million and $0.4 million, respectively, in product sales of TACTRESS, which was granted conditional approval in early 2014. We believe that BLONTRESS and TACTRESS product sales will continue to be modest for 2016, and product sales from other products will depend on the timing of their commercial launch. Any future licensing and collaboration revenue for 2016 will be substantially dependent on Elanco’s ability to successfully commercialize GALLIPRA NT in accordance with the Collaboration A greement.

Cost of product sales

During the three and the six months ended June 30, 2016, cost of product sales increased by $1,632 and $1,541, r espectively, as compared to the corresponding 2015 periods. The increase s  w ere primarily due to inventory valuation adjustment losses in the amount $1,552 from the write off of TACTRESS inventories and pre-launch GALLIPRANT inventories marked to market due to terms agreed upon in the Collaboration Agreement .  

Research and development  









 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

Three Months Ended

 

 

 

 

Six Months Ended

 

 

 



 

June 30,

 

 

 

 

June 30,

 

 

 



 

2016

 

2015

 

% Change

 

2016

 

2015

 

% Change



 

(Dollars in thousands)

 

 

 

 

(Dollars in thousands)

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contracted development costs

 

$

2,735 

 

$

3,940 

 

(30.6)

%

 

$

6,788 

 

$

8,102 

 

(16.2)

%

Milestones

 

 

1,200 

 

 

 —

 

NA

 

 

 

6,200 

 

 

 —

 

NA

 

Personnel costs

 

 

1,181 

 

 

1,704 

 

(30.7)

%

 

 

2,677 

 

 

3,416 

 

(21.6)

%

Other costs

 

 

187 

 

 

437 

 

(57.2)

%

 

 

387 

 

 

784 

 

(50.6)

%

Total research and development

 

$

5,303 

 

$

6,081 

 

(12.8)

%

 

$

16,052 

 

$

12,302 

 

30.5 

%



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During the three and six months ended June 30, 2016, research and development expense decre ased by $0.8 million and increased by $3.8 million, respectively, as compared to the corresponding 2015 periods. The decrease for the three months ended June 30, 2016, was due to a decrease of $1.2 million in contracted development costs as a result of the completion of several clinical studies for our lead programs, $0.3 million decrease in licensing fees related to option programs, and $0.5 million decrease in personnel costs relating to a lower headcount in 2016, partially offset by an in crease of $1.2 million in milestones due to achievement of ENTY CE, NOCITA and AT-016 milestones .   The increase for the six months ended June 30, 2016 , was primarily due to achievement of $6.2 million in milestones relatin g to GALLIPRANT, ENTYCE, NOCITA , and AT-016 . This increase was partially offset by a decrease of $0.7 million in personnel costs relating to a lower headcount in the 2016 six month period, a decrease of $1.3 million in contracted development costs as a result of the completion of several clinical studies for our lead programs, and a $0.4 million decrease in other costs related to supporting multiple facilities.

In addition , based on our development plans as of June 30, 2016 , we have committed to make potential future milestone payments to third parties of up to approximat ely $113.4   million as part of our various collaborations, including licensing and development programs. Pay ments under these agreements generally become due and payable only upon achievement of certain development, regulatory or commercial milestones. Of the $113.4 million, $80.4 million are commercial milestones. Of the $80.4 million, we anticipate paying $6.0 m illion in the next 12   month s, up to an additional $ 10.0 milli on in the next five years as a series of first commercial sales milestones for AT-001 and AT-002 if those products are launched in the U.S. and Europe, and the remainder if certain net revenue thresholds are achieved thereafter. Of the remaining $ 33. million, we anticipate paying an additional $ 7.8  million during the next 12   months, provided various development and regulatory milestones are achieved. The $33.0 million in milestones is spread across AT-001, AT-002, AT-003, AT-014, AT-016, AT-017, AT-018 , and o ther pre-development candidates. Amounts related to contingent milestone payments are not considered contractual obligations as they are contingent on the successful achievement of certain development, regulatory approval and commercial milestones.

I n 2016, we expect to incur research and development expenses related to technology transfer to contract manufacturing suppliers for commercial supply for our lead programs and regulatory expenses related to product filings.

We expect to fund our research and development expenses from our cash, cash equivalents and short-term investments and any future collaboration or financing arrangements. We cannot forecast with any degree of certainty which product candidates may be subject to future collaborations or contracts, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

Selling, general and administrative

During the three and six months ended June 30, 2016, s elling, general and admini strative expense increased by $1 . 3  million and $3.6 million ,   respectively, as compared to the corresponding 2015 periods .   For the three months and six months ended June 30, 2016, these increases were due to increases of $0.6 and $1.0 million, respectively, in personnel expenses primarily as a result of higher sales and marketing headcount, and $0.7 million and $1.4 million increases, respectively, in expenses incurred in preparation for the commercialization of product candidates for which we have received or anticipate regulatory approval in 2016. The increases in the commercialization expenses were primarily due to product branding, sponsorship expenses in conjunction with our participation in several key veterinary conferences to build awareness of Aratana and our product candidates, and expenses related to corporate technology and infrastructure. For the six months ended June 30, 2016, the $3.6 million increase in selling, general and administrative expenses was also due to a credit of $1.2 million recorded in the first quarter of 2015 to reduce the fair value of the contingent consideration to zero, which had originally been due under the Vet Therapeutics, Inc. merger agreement.  

We expect selling, general and administrative expense to continue to increase as we build out our sales organization and corporate infrastructure in support of the expected commercialization of GALLIPRANT, ENTYCE, NOCITA, AT-014 , and other development programs.

Royalty expense

During the three and six months ended June 30, 2016, royalty expense decreased by $3 ,000 and $5,000,   respectively, as compared to the corresponding 2015 periods. The decreases in both the three and six month periods were   primarily a result of the decreased sales of TACTRESS.  

Amortization of acquired intangible assets

During the three and six months ended June 30, 2016, a mortization of acquired intangible assets decreased by $0.4 million and $0.8 million, respectively, as compared to the corresponding 2015 periods . The decrease s in both the three and six month periods reflect the impact of the impairment of BLONTRE S S and TACTRESS in 2015. The lower carrying value due to the impairment charge resulted in the lower expense being recognized. Low er carrying values due to the 2016 TACTRESS impairment charge will also result in lower amortization of acquired intangible assets for the impaired intangibles in future periods.

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Impair ment of acquired intangible assets

Du ring   both the three and six months ended June 30, 2016, impairment of acquired intangible assets incre ased by $2.8 million, as compared to the corresponding 2015 periods. The impairment of acquired intangible assets in 2016 was related to impairment charges of TACTRESS ($0.6 million) and AT-007 ($2.2 million). The impairment charge related to TACTRESS resulted from updated sales expectations and resulted in a carrying value of $0 for TACTRESS. The impairment charge related to AT-007 was the result of our decision to discontinue the development of AT-007 due to the return of global rights of AT-006 and ensuing development   program portfolio prioritization, including consideration of our focus on commercial launch activities to support our recently approved products, and resulted in a carrying value of $0 for AT-007. For more information regarding the impairment charges, see Note 7 to the consolidated financial statements.   Unfavorable outcomes of our development activities or our estimates of the market opportunities for the product candidates could result in additional impairment charges in future periods. For example, we anticipate the results of the mini B-CHOMP study in the fall of 2016.

Interest income

During the three and six months ended June 30, 2016, i nt erest income increased by $40,000 and $46,000, respectively, as compared to the corresponding 2015 periods . The increase s primarily related to interest earned at higher interest rates and on higher   deposits held at Square 1 Bank and short-term investments in reverse repurchase agreements.  

Interest expense

During the three and six months ended June 30, 2016, i nterest expense increased by $0.6   million and $1.3 million, respectively, as compared to the corresponding 2015 periods . These increase s were due to interest expense related to our Loan A greement, as discussed below in   “Financial Condition, Liquidity and Capital Resources – Indebtedness”, which was entered into during October 2015. During the three and six months ended June 30, 2016, a ccretion of the debt discount and amortization of defer red financing costs totaled $0.1 and $0.2  million, respectively, which is non-cash interest included in our interest expense above.

Other income (expense) , net

During the three and six months ended June 30, 2016, o ther income (expense), net decreased by $ 3 . 2  million and $5.2 million ,   as compared to the corresponding 2015 period s . The decrease d uring the three month period was   primarily due to the $2.5 million gain o n the sale of Advaxis stock and $0.6 million gain related to the increase in fair value of the Advaxis warrant and subsequent sale of Ad vaxis common stock that occurred   in the corresponding period in 2015. The decrease   during the six month period   was primarily related to a $3.5 million gain on the sale of Advaxis stock, a $1.3 million increase in the fair value of the Advaxis warrant, and a $0.3 million gain on the sale of shares   received from the exercise of the Advaxis warrant that occurred in the corresponding period in 2015.

Income tax benefit

During the three and six months ended June 30, 2016, i nco me tax benefit decreased by $0.4 million and $0.6 million, respectively, as compared to the corresponding 2015 periods .   The tax benefit in 2015 was recognized for losses incurred that would reduce the amount of deferred tax liability related to intangible assets. We project a loss before income taxes in 2016 and an annual effective tax rate of zero percent for 2016.   Our income for the three and six months ended June 30, 2016, was fully offset by net operating loss carryforward s , and no deferred tax expense was recognized in 2016 due to a full valuation allowance recognized against our deferred tax assets .  

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Financial Condition, Liquidity and Capital Resources

Our financial condition is summarized as follows:







 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 



 

June 30, 2016

 

December 31, 2015

 

Change %



 

(Dollars in thousands)

 

 

 

Financial assets:

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

108,759 

 

$

26,755 

 

>100.0

%

Marketable securities - short-term

 

 

747 

 

 

747 

 

 —

%

Reverse repurchase agreements

 

 

 —

 

 

58,700 

 

(100.0)

%

Total cash, cash equivalents, marketable securities and reverse repurchase agreements

 

$

109,506 

 

$

86,202 

 

27.0 

%

Borrowings:

 

 

 

 

 

 

 

 

 

Loans payable, net

 

$

39,949 

 

$

39,710 

 

0.6 

%

Working capital:

 

 

 

 

 

 

 

 

 

Current assets

 

$

113,657 

 

$

89,019 

 

27.7 

%

Current liabilities

 

 

21,121 

 

 

5,684 

 

>100.0

%

Total working capital

 

$

92,536 

 

$

83,335 

 

11.0 

%



We have incurred significant net losses since our inception. These losses have resulted principally from costs incurred in connection with in-licensing our product candidates, research and development act ivities and selling, general and administrative costs associated with our operations. As of June 30 , 2016, we had an accumulated def icit of $148.9 million and cash, cash equivalents and short-term investments o f $109.5   mill ion.

We expect to continue to incur operating losses for the next several years as we work to develop and commercialize our product candidates. As a result, we expect to seek to fund our operations through corporate collaborations and licensing arrangements, as well as public or private equity offerings or further debt financings. If we are not able to raise additional capital on terms acceptable to us, or at all, as and when needed, we may be required to curtail our operations which could include delaying the commercial launch of our products, discontinuing product development programs, or granting rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.   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. Arrangements with collaborators or others may require us to relinquish rights to certain of our technologies or product candidates. In addition, there is a risk that we may never successfully complete development of our product candidates, obtain adequate patent protection for our technology, obtain necessary regulatory approval for our product candidates or achieve commercial viability for any approved product candidates. As disclosed in Note 8 to the consolidated financial statements, we have a term loan and a   revolving credit facility with a n aggregate principal balance of $40.0 million as of June 30, 2016. The terms of the agreement require us to receive unrestricted net cash proceeds of at least $45.0 million from partnering transactions and/or the issuance of equity securities from October 16, 2015 to October 16, 2016. The loan agreement also require s that we have at least three products fully USDA-or FDA-approved for commercialization by De cember 31, 201 6. W ith the FDA approval of GALLIPRANT in March 2016 and the receipt of the upfront payment of $45.0 million under the Collaboration A greement with Elanco entered into in April 2016, we have met both conditions.   Additionally, the loan agreement requires that we maintain certain minimum liquidity at all times, which as of June 30, 2016, was approximately $20.0 million. As of the date of the filing of th is Quarterly Report on Form 10-Q, we believe that our existing cash and cash equivalents and short-term investments of $109.5 millio n will allow us to fund our operations at least through June 30 , 201 7 .

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.

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Sales Agreement

On October 16, 2015, we entered into a Sales Agreement with Barclays Capital Inc. (“Barclays”) pursuant to which we may sell from time to time, at our option, up to an aggregate of $52.0 million of shares of our common stock (the “Shares”) through Barclays, as sales agent. Sales of the Shares, if any, will be made under our previously filed and currently 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 Sales Agreement, the Shares may be sold at market prices, at negotiated prices or at prices related to the prevailing market price. We will pay Barclays a commission of 2.75% of the gross proceeds from the sale of the Shares, if any. As of the date of this filing, we have not sold any shares pursuant to the Sales Agreement.

Indebtedness

On October 16, 2015, we and Vet Therapeutics (together the “Borrowers”) entered into a Loan and Security Agreement (“Loan Agreement”) with Pacific Western Bank (“Pacific Western Bank”) as collateral agent (“Collateral Agent”) and a lender and Oxford Finance LLC as a lender (“Oxford” and together with Pacific Western Bank, the “Lenders”), pursuant to which the Lenders agreed to make available to the Borrowers, term loans 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” and together with the Term Loan, the “Credit Extensions”), subject to certain conditions to funding. A term loan was made on October 16, 2015 in an aggregate principal amount equal to $35.0 million, and an advance under the Revolving Line was made on October 16, 2015 in an aggregate principal amount equal to $5.0 million. The Borrowers are required to make interest-only payments on the Term Loan for 18 months, and beginning on May 1, 2017, are required to make payments of principal and accrued interest on the Term Loan in equal monthly installments over a term of 30 months. The interest-only period can be extended by one year to May 1, 2018 if the Borrowers have at least four products fully USDA- or FDA-approved, plus another product conditionally- or fully-approved, in each case for commercialization by December 31, 2016, and agree to certain other financial covenants with the Lenders. The Credit Extensions bear interest per annum at the greater of (i) 6.91% or (ii) 3.66% plus the prime rate, which is customarily defined. All principal and accrued interest on the Term Loan are due on October 16, 2019 (the “Term Loan Maturity Date”), and all principal and accrued interest on the Revolving Line are due on October 16, 2017 (the “Revolving Maturity Date”).

The Borrowers used approximately $15.0 million of the proceeds from the Credit Extensions to repay all the amounts owed under their Loan and Security Agreement, dated as of March 4, 2013, as amended, with Pacific Western Bank (as successor in interest to Square 1 Bank) and the lenders party thereto.

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.

Upon execution of the Loan Agreement, the Borrowers were obligated to pay a facility fee to the Lenders of $0.2 million, and an agency fee to the Collateral Agent of $0.1 million. In addition, the Borrowers are or will be obligated to pay a final payment fee equal to 3.30% of such Term Loan being prepaid or repaid with respect to the Term Loans 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 will also be 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 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.

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, 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 Borrowers receive unrestricted net cash proceeds of at least $45.0 million from partnering transactions and/or the issuance of equity securities from October 16, 2015 to October 16, 2016. The Loan Agreement also requires that the Borrowers have at least three products fully USDA- or FDA approved for commercialization by Dece mber 31, 2016. With the FDA approval of GALLIPRANT in March 2016 and t he receipt of the upfront payment of $45.0 million under the Collaboration Agreement with Elanco entered into in April 2016, we have met both conditions. Additionally, the Loan Agreement requires that we maintain certain minimum liquidity at all times, which as of June 30, 2016, was approximat ely $20.0 m illion. At June 30, 2016, the Borrowers were in compliance with all financial covenants.

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Working Capital

We define working capital as curr ent assets less current liabilities. The increase in working capital fro m December 31, 2015, reflects an increase in total current ass ets of $24.6 mill ion and an increase in current liabili ties of $15.4 million. The increase in total current assets was primarily driven b y an increase in cash and cash equivalents due to the receipt of the $45.0 million upfront payment under the Collaboration Agreement . The increase in total current liabilities was primarily a result of the achieved resea rch and development milestones r elating to GALLIPRANT, ENTYCE and NOCITA, an increase in the current portion of loans payable and an increase in the licensing and collaboration commitment .  

Cash Flows

S ummary of our cash flows for the six months ended June 30, 2016 and 2015, was as follows :







 

 

 

 

 

 



 

Six Months Ended



 

June 30,



 

2016

 

2015



 

(Dollars in thousands)

Net cash provided by (used in) operating activities

 

$

23,287 

 

$

(17,806)

Net cash provided by investing activities

 

$

58,681 

 

$

23,607 

Net cash provided by (used in) financing activities

 

$

 

$

(2,953)



Net cash provided by ( used in ) operating activities

During the six months ended June 30, 2016, net cash provided by operating activities was $23.3 million. We had a pretax income of $3.1 million wh ich includes an adjustment of a non-cash expense for stock-based compensation of $4.5 million, a non-cash depreciation and amortization expense of $0.5 million, a non-cash impairment of acquired intangible assets expense of $2.8 million, and a lower of cost or market adjustment to inventories of $1. 6 million. Our net income was primarily attributed to licensing and collaboration revenues of $38 .0  million from the Collaboration Agreement, research and development activities related to our programs and our selling, general and administrative expenses. Net cash provided by changes in our working capital consisted primarily of an increase in accounts payable of $5.9 million , an increase of $7.0 million in licensing and collaboration commitment under the Collaboration Agreement and an increase in accrued expenses and other liabilities of $ 0 .6 million, partially offset by an increase in prepaid expenses of $0. 1 million and an increase in inventories of $2.8 million. The increase in inventories was primarily related to GALLIPRANT pre-launch inventories.   The increase in accounts payable was primarily related to the achieved milestones relating to GALLIPRANT, ENTYCE and NOCITA. The increase in accrued expenses and other current liabiliti es was primarily due to the licensing and collaboration commitment related to the Collaboration Agreement .

During the six months ended June 30, 2015, net cash used in operating activities was $17.8 million. We had a pretax loss of $17.4 million which includes a gain on sale of marketable securities of $3.9 million, an adjustment of a non-cash expense for stock-based compensation of $4.4 million, a non-cash depreciation and amortization expense of $1.1 million, off-set by a non-cash change in fair value of contingent consideration of $1.2 million, a non-cash change in fair value of derivative instruments of $1.3 million, and a non-cash deferred income tax benefit of $0.6 million.  Our net losses were primarily attributed to research and development activities related to our programs and our selling, general and administrative expense s. Net cash provided by changes in our working capital consisted primarily of an increase in accounts payable, accrued expenses and other liabilities of $0.8 million, and a   decrease in accounts receivable of $0.2 million, partially offset by an increase in inventories of $0. 4 million. T he increase in accounts payable primarily related to the timing of payments made for our outsourced research and development activities.

Net cash provided by investing activities

During the six months ended June 30, 2016, net cash provided by investing activities was $58.7 million, which related to the proceeds from the maturities and sales of marketable securities of $ 286 . 0  million, partially offset by the purchases of investments of $227 . 3  million.  

During the six months ended June 30, 2015, net cash provided by investing activities was $23.6 million, which related to the proceeds from the maturities and sales of marketable securities of $929.7 million, partially offset by the purchases of investments of $905 million. This was partially offset by $1.1 million for purchases of property and equipment.

Net cash provided by (used in) financing activities

During the six months ended June 3 0, 201 6, net cash provided by financing activities consisted solely of proceeds from stock option exercises of $1,000.  

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During the six months ended June 30, 2015, net cash used in financing activities was $3.0 million. Net cash used in financing activities primarily resulted from cash paid for contingent consideration of $3.0 million to the former shareholders of Vet Therapeutics.

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, 2016, t here were no material changes in our contractual obligations since December 31, 201 5, e xcept for the contract manufacturer commitments described below.

Other Funding Commitments

As of June 30, 2016 , we have several on-going 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 plans as of June 30 , 2016, we have committed to make potential future milestone payments to third parties of up to approximately $ 113.4   million, of which $ 80.4   million are for commercial milestones, as part of our various collaborations, including licensing and development programs. Approximatel y   $68.9 millio n of the commercial milestones relate to the achievement of various sales thre sholds. During the first six months of 2016, we achieved milestones in the amount of $ 6. million that as of the date of this filing had not been paid and are not included in the $ 113.4 million amount . 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 , 2016, such contingencies have not been recorded in our consolidated financial statements, except for $ 0 .5   million due to our former commercial licensee of BLONTRESS.

I ncluding the $ 6.0  million of unpaid milestones a chieved year to date ,   we anticipate that we may pay approximately $ 10.8  million and $ 13.8  millio n of milestone payments during the remainder of 2016, 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 certain development, regulatory approval and commercial milestones that may not be achieved.

Contract Manufacturer Commitments

Our independent contract manufacturers 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, 2016 and December 31, 2015 , we had non-cancellable open o rders of $0.3 million and $0 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, 2015, filed with the SEC on March 15, 2016. As of June 30, 2016, there were no material changes to our market risks or management of such risks since December 31, 2015.

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 (the “Exchange Act”)). 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, 2016.

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 Exchange Act) identified in connection with the evaluation of our internal control performed during the fiscal quarter ended June 30, 2016 , that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.



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PART II. OTHE R INFORMATION

Item 1. Leg al Proceedings

We are not currently a party to any material legal proceedings.

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.

Apart from the below, there have been no material changes in the six months ended June 30, 2016, to the risk factors described in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2015.

Our Collaboration Agreement and Co-Promotion Agreement with Elanco are important to our business. If we or Elanco fail to adequately perform under the Collaboration Agreement and/or the Co-Promotion Agreement, or if we or Elanco terminate the Collaboration Agreement and/or the Co-Promotion Agreement, the development and commercialization of GALLIPRANT and any other grapiprant product candidates would be delayed or terminated and our business would be adversely affected .

The Collaboration Agreement and Co-Promotion Agreement are important to our business, and our ability to develop and commercialize GALLIPRANT and any grapiprant product candidates is dependent upon these agreements.

The Collaboration Agreement may be terminated by Elanco at any time upon 90 days’ written notice to us.  The Collaboration Agreement may also be terminated by either party:

·

for the other party’s material breach, where such breach is not cured within the timeframe specified by the agreement;

·

upon the bankruptcy, insolvency or dissolution of the other party; or

·

for certain activities involving the challenge of certain patents licensed by us to Elanco.  

Upon Elanco’s voluntary termination or termination for Elanco’s breach, among other things, all licenses and rights granted to Elanco will terminate and revert to us, and Elanco has agreed to assign to us all registrations and trademarks obtained in connection with the products covered by the agre ement. Upon termination for our breach, among other things, Elanco may elect to retain its rights to the licenses granted by us under the Collaboration Agreement subject to specified payment obligations.

Elanco may terminate the Co-Promotion Agreement in the event Elanco substantially stops marketing the products covered by the Collaboration Agreement, and either party may terminate the Co-Promotion Agreement upon the other party’s material breach, where such breach is not cured within the timeframe specified by the Co-Promotion Agreement. In addition, the Co-Promotion Agreement provides that it will automatically terminate if the Collaboration Agreement is terminated early.

Termination of the Collaboration Agreement and/or the Co-Promotion Agreement could cause significant delays in our product development and commercialization efforts that could prevent us from commercializing our grapiprant product candidates, including GALLIPRANT, without first expanding our internal capabilities, securing additional financing or entering into another agreement with a third party. Any alternative collaboration or license could also be on less favorable terms to us.

Under the Collaboration Agreement, among other things, we are responsible for the manufacture and supply of all of Elanco’s reasonable requirements of the products covered by the agreement. If we are unable to meet our manufacture and supply obligations, Elanco may claim that we have materially breached the Collaboration Agreement and terminate such agreement, which could adversely affect our business and our ability to successfully develop and commercialize any products covered by the agreement, including GALLIPRANT.

Under the Collaboration Agreement, Elanco has agreed to provide funding for certain clinical development activities. If the Collaboration Agreement were terminated, we may need to seek additional financing to support the research and development of any terminated products or discontinue any terminated products, which could adversely affect our business. In addition, under the Collaboration Agreement, Elanco is solely responsible for commercializing products outside the United States. We cannot directly control Elanco’s commercialization activities or the resources it allocates to our product candidates. Our interests and Elanco’s interests may differ or conflict from time to time, or we may disagree with Elanco’s level of effort or resource allocation. Elanco may internally prioritize our product candidates differently than we do or it may not allocate sufficient resources to effectively or optimally commercialize them. If these events were to occur, our business would be adversely affected.

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

Unregistered Sales of Equity Securities

None.

Repurchases of Common Stock

There were no share repurchases during the three months ended June 30, 2016.

Item 3. Defa ults Upon Senior Securities

None.

Item 4. M ine Safety Disclosures

Not applicable.

Item 5. O ther Information

None.

Item 6. E xhibits

A list of exhibits is set forth on the Exhibit Index immediately following the signature page of this Quarterly Report on Form 10-Q, and is incorporated herein by reference.





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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 5, 2016

 

 

 

By:

 

/s/    Steven St. Peter        

 

 

 

 

 

 

Steven St. Peter, M.D.

 

 

 

 

 

 

President and Chief Executive Officer

 

 

 

 

 

 

(Principal Executive Officer)

 

 

 

 

Date: August 5, 2016

 

 

 

By:

 

/s/    Craig Tooman        

 

 

 

 

 

 

Craig Tooman

 

 

 

 

 

 

Chief Financial Officer

 

 

 

 

 

 

(Principal Financial and Accounting Officer)



40


 

Table of Contents

 

Exhibit Index



 

 

 

 

 

 



 

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

Employment Agreement, dated as of June 24, 2016, between Aratana Therapeutics, Inc. and Brent Standridge

8-K

001-35952

10.11

6/30/16

 

10.2

Non-Employee Director Compensation Program, as amended

 

 

 

 

*

10.3

Collaboration, License, Development and Commercialization Agreement, dated April 22, 2016, by and between Aratana Therapeutics, Inc. and Eli Lilly and Company, acting on behalf of its Elanco Animal Health Division

 

 

 

 

*

10.4

Co-Promotion Agreement, dated April 22, 2016, by and between Aratana Therapeutics, Inc. and Eli Lilly and Company, acting on behalf of its Elanco Animal Health Division

 

 

 

 

*

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.

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



41


 

EXHIBIT 10.2



ARATANA THERAPEUTICS, INC.

NON-EMPLOYEE DIRECTOR COMPENSATION PROGRAM

( A s   A mended)

Non-employee members of the board of directors (the “ Board ”) of Aratana Therapeutics, Inc. (the “ Company ”) shall be eligible to receive cash and equity compensation as set forth in this Non-Employee Director Compensation Program (this “ Program ”). The cash and equity compensation described in this Program shall be paid or be made, as applicable, automatically and without further action of the Board, to each member of the Board who is not an employee of the Company or any parent or subsidiary of the Company (each, a “ Non-Employee Director ”) who may be eligible to receive such cash or equity compensation, unless such Non-Employee Director declines the receipt of such cash or equity compensation by written notice to the Company. This Program shall remain in effect until it is revised or rescinded by further action of the Board. This Program may be amended, modified or terminated by the Board at any time in its sole discretion. The terms and conditions of this Program shall supersede any prior cash and/or equity compensation arrangements between the Company and any of its Non-Employee Directors. No Non-Employee Director shall have any rights hereunder, except with respect to stock options and/or restricted stock granted pursuant to the Program.

1. Cash Compensation .  

(a) Annual Retainers . Each Non-Employee Director shall be eligible to receive an annual retainer of $3 5 ,000 for service on the Board.

(b) Additional Annual Retainers . In addition, a Non-Employee Director shall receive the following annual retainers:

(i) Chairperson of the Board .  A Non-Employee Director serving as Chairperson of the Board shall receive an additional annual retainer of $25,000 for such service.

(i i )   Audit Committee . A Non-Employee Director serving as Chairperson of the Audit Committee shall receive an additional annual retainer of $15,000 for such service. A Non-Employee Director serving as a member of the Audit Committee (other than the Chairperson) shall receive an additional annual retainer of $7,500 for such service.

(ii i )   Compensation Committee . A Non-Employee Director serving as Chairperson of the Compensation Committee shall receive an additional annual retainer of $10,000 for such service. A Non-Employee Director serving as a member of the Compensation Committee (other than the Chairperson) shall receive an additional annual retainer of $5,000 for such service.

(i v )   Nominating and Corporate Governance Committee . A Non-Employee Director serving as Chairperson of the Nominating and Corporate Governance Committee shall receive an additional annual retainer of $7,500 for such service. A Non-Employee Director serving as a member of the Nominating and Corporate Governance Committee (other than the Chairperson) shall receive an additional annual retainer of $3,500 for such service.

(c) Payment of Retainers .   T he annual retainers described in Sections 1(a) and 1(b) shall be earned on a quarterly basis based on a calendar quarter and shall be paid by the Company in arrears not later than the fifteenth day following the end of each calendar quarter. In the event a Non-Employee Director does not serve as a Non-Employee Director, or in the applicable positions described in Section 1(b), for an entire calendar quarter, the retainer paid to such Non-Employee Director shall be prorated for the portion of such calendar quarter actually served as a Non-Employee Director, or in such position, as applicable.



2. Equity Compensation . Non-Employee Directors shall be granted the equity awards described below. The awards described below shall be granted under and shall be subject to the terms and provisions of the Company’s 2013 Equity Incentive Award Plan or any other applicable Company equity incentive plan then-maintained by the Company (the “ Equity Plan ”) and shall be granted subject to the execution and delivery of award agreements, including attached exhibits, in substantially the forms previously approved by the Board, setting forth the vesting schedule applicable to such awards and such other terms as may be required by the Equity Plan. All applicable terms


 

of the Equity Plan apply to this Program as if fully set forth herein, and all grants of stock options and/or restricted stock hereby are subject in all respects to the terms of the Equity Plan.

  ( a )   Initial Awards . Each Non-Employee Director who is initially elected or appointed to the Board shall be eligible to receive an option to purchase 30 ,000 shares of the Company’s common stock (subject to adjustment as provided in the Equity Plan) on the date of such initial election or appointment. The awards described in this Section 2(a) shall be referred to as “ Initial Awards .” No Non-Employee Director shall be granted more than one (1) Initial Award.

( b )   Subsequent Awards . A Non-Employee Director who (i) has been serving on the Board for at least six months as of the date of any annual meeting of the Company’s stockholders and (ii) will continue to serve as a Non-Employee Director immediately following such meeting, shall be automatically granted an option to purchase 7,500 shares of the Company’s common stock (subject to adjustment as provided in the Equity Plan) and 4,500 shares of restricted stock   (subject to adjustment as provided in the Equity Plan)   on the date of such annual meeting. The awards described in this Section 2(b) shall be referred to as “ Subsequent Awards .” For the avoidance of doubt, a Non-Employee Director elected for the first time to the Board at an annual meeting of the Company’s stockholders shall only receive an Initial Award in connection with such election, and shall not receive any Subsequent Award on the date of such meeting as well.

( c )   Termination of Employment of Employee Directors . Members of the Board who are employees of the Company or any parent or subsidiary of the Company who subsequently terminate their employment with the Company and any parent or subsidiary of the Company and remain on the Board will not receive an Initial Award pursuant to Section 2(a) above, but to the extent that they are otherwise eligible, will be eligible to receive, after termination from employment with the Company and any parent or subsidiary of the Company, Subsequent Awards as described in Section 2(b) above.

( d )   Terms of Awards Granted to Non-Employee Directors  

(i) Purchase Price . The per share exercise price of each option granted to a Non-Employee Director shall equal the Fair Market Value (as defined in the Equity Plan) of a share of common stock on the date the option is granted.

(ii) Vesting .   Each Initial Award shall vest and become exercisable in substantially equal installments on each of the first four (4) anniversaries of the date of grant, subject to the Non-Employee Director continuing in service on the Board through each such vesting date. Each Subsequent Award shall vest ( and with respect to option awards   become exercisable ) with respect to all shares subject thereto on the earlier of (i) the first anniversary of the date of grant and (ii) the day immediately preceding the date of the Company’s next annual meeting of stockholders following the date of grant, subject to the Non-Employee Director continuing in service on the Board through such vesting date. No portion of an Initial Award or Subsequent Award which is unvested and/or unexercisable (with respect to option awards) at the time of a Non-Employee Director’s termination of service on the Board shall become vested or exercisable thereafter. All of a Non-Employee Director’s Initial Awards and Subsequent Awards shall vest in full upon the occurrence of a Change in Control (as defined in the Equity Plan).

(iii) Term . The term of each stock option granted to a Non-Employee Director shall be ten (10) years from the date the option is granted. Upon a Non-Employee Director’s cessation of service on the Board for any reason, his or her options to purchase shares of the Company’s common stock granted under this Program shall remain exercisable for twelve months following the cessation of his or her service on the Board (or such longer period as the Board may determine in its discretion on or after the date of grant of such stock options).

* * * * *



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EXHIBIT 10.3











Collaboration, License, Development

and Commercialization Agreement

By and Between

Aratana Therapeutics, Inc.

and

Eli Lilly and Company

acting on behalf of

its Elanco Animal Health Division 

Effective as of

22 April 2016

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

 


 

Confidential Treatment Requested by Aratana Therapeutics, Inc.

Collaboration, License, Development
and Commercialization Agreement

This   Collaboration, L icense, Development and Commercialization   Agreement , effective as of 22 April 2016 (the “ Effective Date ”), is entered into by and between Aratana Therapeutics, Inc., a Delaware corporation and having its office at   11400 Tomahawk Creek Parkway, Suite 340, Leawood, KS 66211   (“ Licensor ”) and Eli Lilly and Company , an Indiana corporation, operating on behalf of  its Elanco Animal Health division and having its office at 2500 Innovation Way, Greenfield, Indiana 46140 and its Affiliates (“ Elanco ”).

Preliminary Statements

A. Licensor is an animal health therapeutics company developing novel therapeutic candidates that target serious medical conditions in pets, and has a worldwide, exclusive license to make, use and sell the Product (as defined below) in the Field of Use (as defined below) pursuant to the Exclusive IP License Agreement for RQ-00000007 between Licensor and RaQualia Pharma Inc. dated December 27, 2010, as amended (the “ RaQualia License Agreement ”).

B. Elanco possesses skills, knowledge and expertise in the research, development, marketing, manufacturing and distribution of food chain and companion animal products, including but not limited to animal health pharmaceutical and diagnostic products, and has the experience and resources to develop, obtain regulatory approval for, and market the Product.

C. Licensor desires to grant Elanco with co-exclusive rights (with Licensor) to develop, manufacture, market and commercialize the Product in the Co-Promotion Territory (as defined below).

D. Licensor desires to grant Elanco exclusive rights to develop, market and commercialize the Product in the Elanco Exclusive Territory (as defined below).

Now, Therefore, in consideration of the foregoing preliminary statements and the mutual agreements and covenants set forth herein, the Parties (as defined below) hereby agree as follows:

1. Definitions.

As used in this Agreement, the following terms shall have the meanings set forth in this Article 1 unless the context clearly and unambiguously dictates otherwise. Unless the context requires otherwise, references to the singular include the plural and vice versa, and references to Sections, Exhibits and Schedules are references to the sections, exhibits and schedules of this Agreement.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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1.1 Adverse Event ” shall mean any observation in animals, whether or not considered to be product-related, that is unfavorable and unintended and that occurs after any use of a veterinary medicinal product (off-label and on-label uses), including without limitation events related to a suspected lack of expected efficacy according to approved labelling or noxious reactions in humans after being exposed to veterinary medicinal products.

1.2 Affiliate ” shall mean, with respect to a Party, any entity controlling, controlled by, or under common control with, such Party, for only so long as such control exists.  For the purposes of this definition, “ control ” shall refer to: (a) the possession, directly or indirectly, of the power to direct the management or policies of an entity, whether through the ownership of voting securities, by contract or otherwise, or (b) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of an entity.

1.3 Agreement ” shall mean this Collaboration, License, Development and Commercialization Agreement together with the preliminary statements and all exhibits, schedules and attachments hereto.

1.4 Alternate Trademark ” shall have the meaning assigned to such term in Section 7.4.

1.5 Applicable Laws ”  shall mean all statutes, ordinances, regulations, rules or orders of any kind whatsoever of any Governmental Authority that may be in effect from time to time and applicable to the activities contemplated by this Agreement.

1.6 Bankruptcy Code ” shall have the meaning assigned to such term in Section  14.10 .

1.7 Breaching Party ” shall have the meaning assigned to such term in Section  14.3 .

1.8 Business Day ” shall mean any day of the year on which national banking institutions in New York City, New York are open to the public for conducting business and are not required or authorized to close.

1.9 Calendar Quarter ” shall mean each period of three (3) consecutive months ending on the last day of March, June, September, or December, respectively.

1.10 Calendar Year ” shall mean, for the first Calendar Year, the period commencing on the Effective Date and ending on December 31, 2016, and each twelve (12) month period thereafter, commencing on January 1 and ending on December 31 during the Term; provided , that the last Calendar Year shall end on the final day of the Term.

1.11 Co-Promotion Agreement ” shall have the meaning assigned to such term in Section 4.3.

1.12 Co-Promotion Territory ” shall mean the United States.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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1.13 Commercial Supply Milestone ” shall mean the [***].

1.14 Commercialization Program ” shall have the meaning assigned to such term in Section  4.1 .

1.15 Commercial Coordination Subcommittee ” or “ CCC ” shall have the meaning assigned to such term in Section 2.4.

1.16 Commercially Reasonable Efforts ” shall mean, with respect to a Party, those efforts and resources, as applicable, relating to a certain activity or activities, including, without limitation, the development, manufacturing and commercialization of Products in accordance with such Party’s business, legal, medical and scientific judgment, such efforts and resources to be in accordance with the efforts and resources the Party would use for a product owned by it, or to which it has rights, which is of similar market potential and at a similar stage in its product life.

1.17 Compliance   shall mean the adherence by the Parties in all material respects to all Applicable Laws and Party Specific Regulations, in each case with respect to the activities to be conducted under this Agreement. 

1.18 Confidential Information ” shall have the meaning assigned to such term in Section  12.2 .

1.19 Control ” or “ Controlled   means, with respect to any item of Confidential Information, Know-How, Patent Rights, or other intellectual property right, the [***] with respect thereto as provided for in this Agreement, without violating the terms of any agreement or other arrangement with, or any legal rights of any Third Party, and, for Confidential Information, Know-How, Patent Rights or other intellectual property rights that first are acquired or licensed to a Party after the Effective Date, without [***], or [***], any Third Party.

1.20 Cover ”, “ Covered ” or “ Covering ” shall mean, in connection with a Patent Right, that in [***] to a person under a [***] included in such Patent Right, the practice by such person of [***] claimed in such [***] would infringe such [***] (or, in the case of a [***] that is a patent application, would [***] an otherwise [***] in such patent application if it were to [***] ) .

1.21 Development Fees and Expenses ” shall mean third party expenses associated with the Development Program.

1.22 Development Funding Cap ” shall have the meaning assigned to such term in Section 3.5.

1.23 Development Operating Plan ” or “ DOP ” shall have the meaning assigned to such term in Section  3.2.1 .

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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1.24 Development Program ” shall have t he meaning assigned to such term in Section 3.1 .

1.25 Development Subcommittee ” or “ DSC ” shall have the meaning assigned to such term in Section 2.3.1.

1.26 Drug Delivery System ” shall mean a device or tool marketed or sold in connection with a Product that is intended for use to enhance or facilitate the delivery of such Product via a specific route of administration.  For clarity, Drug Delivery Systems shall not include any formulation technology comprised in or utilized in connection with the Product for the targeted delivery and/or controlled release of such Product. 

1.27 Effective Date ” shall have the meaning assigned to such term in the introductory paragraph of this Agreement.

1.28 Elanco ”   shall have the meaning assigned to such term in the introductory paragraph of this Agreement.

1.29 Elanco Exclusive Territory ” shall mean worldwide with the exception of the United States.

1.30 Elanco Sole Improvement ” shall mean an Improvement made solely by employees or contractors of Elanco or its Affiliates during the term of and in the course of activities performed in connection with this Agreement.

1.31 EU ” shall mean, for purposes of this Agreement, the European Union, consisting of its 28 member states as at the Effective Date, as well as additional European Economic Area (EEA) countries (Iceland, Liechtenstein and Norway), in each case as the European Union or the EEA may be enlarged or  reduced from time to time.

1.32 Excluded Product ” means an [***] produc t [***] , the [***] of which would [***] of [***]   in the country in which such product is sold.

1.33 “Executive Steering Committee ” shall have the meaning assigned to such term in Section  2.1 .

1.34   FDA ” shall mean the United States Food and Drug Administration, or any successor thereto.

1.35 Field of Use ” shall mean the field of non-human animal health.

1.36 First Commercial Sale ” shall mean the first sale of a Product for use or consumption by the general public of such Product for which payment has been received after all

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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required Registrations have been granted, or such sale is otherwise permitted in such country, excluding Product (a) for use in clinical trials or other development activities with respect to such Product by or on behalf of a Party, (b) provided as samples, (c) provided for compassionate use, or (d) provided for a bona fide charitable purpose, in each case of (a) through (d) for which no payment is received by Elanco, its Affiliates or sublicensees.

1.37 GAAP ” shall mean generally accepted accounting principles in the United States, consistently applied.

1.38 Generic Competition ” means, on a Product-by-Product and country-by-country basis, that an animal health product is manufactured, distributed or sold by a Third Party in such country (a) that contains the same active ingredient as the Product, wherein [***] shall also include without limitation any [***] or physical forms thereof, (b) for which Registration is obtained for substantially the same indication, and (c) is sold in such country by any Third Party that is not a sublicensee of Elanco or its Affiliates and did not purchase such product in a chain of distribution that included any of Elanco or any of its Affiliates or its Sublicensees.

1.39 Governmental Authority   shall mean any court, commission, authority, department, ministry, official or other instrumentality of, or being vested with public authority under any law of, any country, state or local authority or any political subdivision thereof, or any association of countries.

1.40 GxP ” shall mean compliance with all relevant Regulatory Authority requirements for Good Clinical Practices (per FDA/CVM guidance “Good Clinical Practices: VICH GL9”), Good Laboratory Practices (per FDA/DVM regulation “21 CFR Part 58”), Current Good Manufacturing Practices (per FDA/CVM regulation “21 CFR Part 211, 225 or 226”) and the applicable foreign equivalents.

1.41 Improvement ” shall mean (a) any   [***] change made after the Effective Date to the Licensor Know-How or to the inventions claimed [***] (as existing as of the Effective Date) and/or (b) any inventions [***] that are made, conceived, or reduced to practice by or on behalf of either Party, solely or jointly, during the term of and in connection with activities performed in connection with this Agreement.

1.42 Indemnitee ” shall have the meaning assigned to such term in Section  13.3 .

1.43 [***] ” shall mean the [***] as approved by the European Medicines Agency.

1.44 Infringement ” shall have the meaning assigned to such term in Section  9.4.1 .

1.45 Internal Compliance Codes ” shall mean a Party’s internal policies and procedures intended to ensure that a Party complies with Applicable Laws, Party Specific Regulations, and such Party’s internal ethical, medical and similar standards.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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1.46 Joint Improvement ” shall have the meaning assigned to such term in Section 9.2.1 (c).

1.47  “ Joint Steering Committee ” or “ JSC ” shall have the meaning assigned to such term in Section 2.2.1.

1.48 Licensed Process ” means any process that utilizes the Licensed Know-How, or that would infringe one or more Valid Claims of a Licensor Patent, but for the license granted in Article 7 of this Agreement.

1.49 Licensor ”   shall have the meaning assigned to such term in the introductory paragraph of this Agreement

1.50 Licensor Know-How ” shall mean [***] , to the extent Controlled by Licensor during the term of this Agreement (a) relating to the Product, including any such information licensed by Licensor from RaQualia, or (b) [***] relating to the Product, in each case of (a) and (b) including but not limited to regulatory submissions, research and development information, trade secrets, engineering, scientific and practical information, data, formulas, formulations, active ingredients, information about qualities, uses, test methods and results, information about materials, compositions and sources, and drawings, specifications, laboratory notebooks, work product and other relevant writings in each case, which is necessary or desirable for the development, manufacture or commercialization of the Product .  

1.51 Licensor Patents ” shall mean any and all Patent Rights Controlled by Licensor during the term of this Agreement relating to the Product, including, but not limited, to Licensor’s interest in any Patent Right Covering an Improvement relating to the Product.    

1.52 Licensor Sole Improvement ” shall mean an Improvement made solely by employees or contractors of Licensor or its Affiliates during the term of and in the course of activities performed in connection with this Agreement.

1.53 Licensor Technology ” shall mean, collectively, the Licensor Patents and Licensor Know-How. 

1.54 Manufacturing Subcommittee ” or “ MSC ” shall have the meaning assigned to such term in Section 2.5.

1.55 Net Sales ” shall mean, with respect to each country in the Territory and with respect to a Product, the gross amount invoiced by Elanco (including an Elanco Affiliate) or any sublicensee thereof to unrelated Third Parties, excluding any sublicensee, for the Product in the Territory, less :

(a) [***] discounts allowed;

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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(b) [***] which effectively reduce the net selling price;

(c) Product [***]   and [***] ;

(d) That portion of the sales value associated with [***] ;

(e) Any [***] imposed on the [***] or [***] of the Product, including, without limitation, [***] ;

(f) [***] fees;

(g) A llowance for [***] expenses; and

(h) A ny other similar and customary deductions which are in accordance with U. S. Generally Accepted Accounting Principles (U.S. GAAP) .



Such amounts shall be determined from the books and records of Elanco or sublicensee, maintained in accordance with U.S. generally accepted accounting principles (“ GAAP ”) or, in the case of sublicensees, such similar accounting principles, consistently applied.  Elanco further agrees in determining such amounts, it will use Elanco's then current standard procedures and methodology, including Elanco's then current standard exchange rate methodology for the translation of foreign currency sales into U.S. Dollars or, in the case of sublicensees, such similar methodology, consistently applied.

In the event that the Product is sold as part of a [***] means any animal health product which consists of a Product [***] , where such [***] of the Royalty-Bearing Product [***] is not covered by [***] , the Net Sales of the Product, for the purposes of determining royalty payments, shall be determined by [***] Net Sales [***] (as defined in the standard Net Sales definition) by [***] where [***] sale price of the Product when sold [***] , and [***] sale price of the [***] in finished form, in each case during the applicable royalty reporting period.

In the event that the [***] sale price cannot be determined for the Product and [***] , Net Sales for purposes of determining royalty payments shall be deemed to be equal to [***] of the Net Sales of the [***] .    

In the event that the [***] sale price of the Product can be determined but the [***] sale price [***] cannot be determined, Net Sales for purposes of determining royalty payments shall be calculated [***] the Net Sales of the [***] by [***] where [***] sale price of the Product [***] and [***] sale price of the [***] .

In the event that the [***] sale price [***] can be determined but the [***] sale price of the Product cannot be determined, Net Sales for purposes of determining royalty payments shall be calculated [***] the Net Sales of the [***] by the following formula:  [***] where [***] is the [***] sale price of the [***] when sold [***] and [***] is the [***] sale price of the [***] .  

The [***] sale price for a Product, [***] , or [***] shall be calculated once each Calendar Year and such price shall be used during all applicable royalty reporting periods for the entire following Calendar Year.  When determining the [***] sale price of a Product, [***] , or [***] , the

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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[***] sale price shall be calculated [***] the sales dollars (translated into U.S. dollars) by the [***] during the twelve (12) months (or the number of months sold in a partial calendar year) of the preceding Calendar Year for the respective Product, [***] , or [***] .  In the initial Calendar Year, a forecasted [***] sale price will be used for the Product, [***] , or [***] . Any over or under payment due to a difference between forecasted and actual [***] sale prices will be paid or credited in the first royalty payment of the following Calendar Year.

1.56  “ Non-breaching Party ” shall have the meaning assigned to such term in Section  14.3 .

1.57 Party ” shall mean, as applicable, Licensor or Elanco and, when used in the plural, shall mean Licensor and Elanco.

1.58 Party Specific Regulations ” shall mean all judgments, decrees, orders or similar decisions issued by any Governmental Authority specific to a Party, and all consent decrees, corporate integrity agreements, or other agreements or undertakings of any kind by a Party with any Governmental Authority, in each case as the same may be in effect from time to time and applicable to a Party’s activities contemplated by this Agreement.

1.59 Patent Rights ” shall mean all: (a) patents, ( [***] and [***] ) ; (b) patent applications ( [***] ) ; and (iii) all patents and patent applications anywhere in the world that at any time, directly or indirectly, claim priority from, support a claim of priority of or contain substantially identical disclosure as any of the foregoing.  

1.60  “ Pharmacovigilance Agreement ” shall mean the agreement describing Adverse Event handling and reporting to Regulatory Authorities, including without limitation, timely reporting to the other Party of adverse events delivered under Section 10.3 .

1.61 Product ” shall mean grapiprant (and any salt, hydrate, solvate or oxide anhydrides, prodrugs, isomers, polymorphs or physical forms thereof that are Covered by a Licensor Patent), which is also known as Galliprant ® (in certain countries) or AT-001 or RQ-00000007. 

1.62 Product Complaint ” shall mean a written, oral, or electronic communication that alleges deficiencies related to the safety, identity, strength, purity, quality, potency, durability, effectiveness, or performance of a product manufactured and/or distributed by Elanco that could be related to manufacturing, packaging, or labelling. Product Complaint includes also (a) suspected counterfeit products, which are products that are deliberately or fraudulently mislabelled with respect to identity and/or source; a counterfeit drug, container, or label bears the trademark, trade name, or other identifying mark (e.g., shape or color), imprint, or device of a drug manufacturer, processor, packer, or distributor without authorization and with intent to mislead purchasers into believing the product is authentic, and (b) suspected tampering, which is the manipulation of any authentic product or packaging thereby rendering it false or misleading, with malicious or illegal intent.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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1.63 [***] Third Party Manufacturer ” shall mean a Third Party [***] manufacturer [***] as of the Effective Date.

1.64  “ Quality Agreement ” shall have the meaning assigned to such term in Section 8.1.2 (b).

1.65 RaQualia License Agreement ” shall have the meaning assigned to such term in Preliminary Statement A.

1.66 RaQualia Know-How ” shall mean the confidential, unpatented know-how licensed to Licensor under the RaQualia License Agreement.

1.67 RaQualia Patents ” shall mean the Patent Rights licensed to Licensor under the RaQualia License Agreement.

1.68 Registration ” shall mean, with respect to the Product in a particular country or legal jurisdiction, all approvals, licenses, registrations or authorizations of any Regulatory Authority, necessary for the manufacturing, use, storage, import, transport and sale of such Product in such country or legal jurisdiction .

1.69 Regulatory Authority ”   or “ Regulatory Authorities ” shall mean any governmental authority that regulates Products, including but not limited to the Environmental Protection Agency (“ EPA ”), Food and Drug Administration (“ FDA ”), including the Center for Veterinary Medicine (“ CVM ”), Food Safety and Inspection Service (“ FSIS ”), U.S. Department of Agriculture (“ USDA ”) or any counterparts thereof in jurisdictions outside of the U.S. such as the European Medicines Agency (“ EMA ”) .

1.70 Regulatory Materials ” means the regulatory registrations, applications, authorizations and approvals (including approvals of new animal drug applications (“ NADA ”), supplements and amendments, pre- and post-approvals, pricing and Third Party reimbursement approvals, and labeling approvals), Registrations or other submissions made to or with any Regulatory Authority necessary for the research, development, manufacture, or commercialization of a Product in a regulatory jurisdiction, together with all related correspondence to or from any Regulatory Authority and all documents referenced in the complete regulatory chronology for each NADA, including all veterinary master file(s) (“ VMF ”) (if any), or foreign equivalents of any of the foregoing.

1.71   Royalty Term ” shall have the meaning assigned to such term in Section 5.4.

1.72 Sublicensee ” shall mean a Third Party to which Elanco grants a sublicense in accordance with the provisions of Section  7.3 .

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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1.73 Supply Agreement ” shall have the meaning assigned to such term in Section 8.1.2(a).

1.74 Tax ” or “ Taxation ” means any form of tax or taxation, levy, duty, charge, social security charge, contribution or withholding of whatever nature (including any related fine, penalty, surcharge or interest).

1.75 Taxing Authority ” shall mean any federal, national, provincial, state, local or foreign government, or any subdivision, agency, commission or authority thereof exercising tax regulatory, enforcement or collection authority.

1.76 Technology Transfer ” shall have the meaning assigned to such term in Section 8.2.1.

1.77 Technology Transfer Completion ” shall mean the completion of the Technology Transfer which shall be deemed to occur [***] following successful processing of [***] Product.

1.78 Term ” shall have the meaning assigned to such term in Section 14.1.

1.79 Termination Date ” shall have the meaning assigned to such term in Section 14.6.1.

1.80 Territory ” shall mean the world.

1.81 “Third Party ” shall mean any person or entity who or which is neither a Party nor an Affiliate of a Party.

1.82 Trademarks ” shall have the meaning assigned to such term in Section 7.4.

1.83 United States ” or “ U.S. ” shall mean The United States of America, including its possessions, territories and commonwealths.

1.84 Valid Claim ” shall mean a claim of (a) an [***] ,   (b) an [***] that [***]   that [***] and [***] or (c) an [***] patent that [***] ,   in each of (a) through (c) that is included in the Licensor Patents and   that has not expired or lapsed, been abandoned or cancelled, or held or declared invalid or unenforceable.  For clarity, a Valid Claim of an issued or granted patent shall be deemed to exist during any applicable patent term extension for the relevant patent.

2. Oversight Of The Collaboration.

2.1 Executive Steering Committee

2.1.1 The executive steering committee shall consist of [***] members, being the [***] , or [***] (or equivalent) with primary oversight of the collaboration under this Agreement, of each of the Parties (“ Executive Steering Committee ” or “ ESC ”). 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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2.1.2 The ESC shall meet [***] , unless agreed otherwise by the Parties in writing and at such places and times as the Parties shall agree. The Executive Steering Committee may elect to meet in-person, by means of telecommunications, video conferences, electronic mail or other correspondence.

2.1.3 The ESC is responsible for [***] and [***] , including without limitation, [***] regarding the [***] under this Agreement.

2.1.4 The ESC will terminate upon [***] of [***] mentioned in [***] , unless the Parties agree in writing to extend the duration of the ESC.

2.2 Joint Steering Committee .

2.2.1 The joint steering committee shall consist of [***] members, who are the [***] chair persons of each of the three subcommittees referred to in Sections 2.3 through 2.5 below (“ Joint Steering Committee ” or “ JSC ”). In the event that the Executive Steering Committee forms additional subcommittees, the chairs of such subcommittees will be added as members of the JSC and the number of members shall be expanded by [***] for each subcommittee so formed. 

2.2.2 In the event that a Party intends to replace individuals serving as members of the JSC, the Party must notify the other Party [***] calendar days following such change and include contact information of the incoming JSC member.

2.2.3 The JSC shall meet [***] times [***] (in general, meeting [***] ), unless agreed otherwise by the Parties in writing, and at such places and times as the Parties shall agree. The JSC shall additionally convene ad-hoc if so requested by a subcommittee. The JSC may elect to meet in-person, by means of telecommunications, video conferences, electronic mail or other correspondence.

2.2.4 The JSC is responsible for [***] by any [***] , including without limitation, [***] regarding the [***] under this Agreement.

2.2.5 The JSC will terminate upon [***] of [***] mentioned in this [***] , unless the Parties agree in writing to extend the duration of the JSC.

2.3 Development Subcommittee

2.3.1 Within [***] calendar days following the Effective Date, each Party shall appoint [***] representative as its chair-person for the development subcommittee and may appoint additional non-voting representatives (the “ Development Subcommittee” or “ DSC ”) and give notice of the name and contact information of its respective subcommittee representative(s) to the other Party.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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2.3.2 The DSC shall be responsible for (a) reviewing and evaluating the progress of the Parties under the Development Program; provided, that, the DSC shall not have authority to [***] is in [***] ;   (b) attempting to [***] regarding the [***] under this Agreement ; (c)   reviewing all relevant proposed scientific publications and presentations of any of the Parties or their respective Affiliates pursuant to Section 12.1 ;   (d) reviewing and discussing the [***] and [***] of the Product, including any plans to [***] of the Products; and (e) performing such other responsibilities as may be assigned by the Executive Steering Committee from time to time.  For the avoidance of doubt, [***] on the DSC has [***] decision rights in the Territory in relation to Product [***] and [***] strategy, provided that in no event may [***] exercise its [***] decision rights to require that [***] take any action that would (i) require [***] to incur expenses in excess of the [***] , or (ii) be unethical or require [***] to violate any Applicable Law.

2.3.3 The DSC will terminate on [***] , unless the Parties agree in writing to extend the duration of the DSC.

2.4 Commercial Coordination Subcommittee

2.4.1 Within [***] calendar days following the Effective Date, each Party shall appoint [***] representative as its chair-person for the commercialization subcommittee and may appoint additional non-voting representatives (the “ Commercial Coordination Subcommittee” or “ CCC ”) and give notice of the name and contact information of its respective subcommittee representative(s) to the other Party.

2.4.2 The CCC shall be responsible for: (a) discussing in good faith, and establishing and maintaining any [***] for, a [***] for each Product in the Co-Promotion Territory; (b) [***] the Parties’ activities in the Co-Promotion Territory; and (c) making any determinations required under this Agreement.   For the avoidance of doubt, [***] has [***] decision rights in the Territory in relation to [***] of the Product in accordance with the provisions of the Co-Promotion Agreement.

2.4.3 The CCC will terminate upon [***] , unless the Parties agree in writing to extend the duration of the CCC.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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2.5 Manufacturing Subcommittee .  

2.5.1 Within [***] calendar days following the Effective Date, each Party shall appoint [***] representative as its chair-person for the manufacturing and may appoint additional non-voting representatives (the “ Manufacturing Subcommittee ” or “ MSC ”) and give notice of the name and contact information of its respective subcommittee representative(s) to the other Party

2.5.2 The MSC shall be responsible for the review and discussion of the manufacturing of the Product including any [***] , as well as oversight of the execution of the Supply Agreement in line with Elanco’s manufacturing standards .  Decisions of the MSC shall be made by consensus, provided that in the event that the Parties cannot agree on any matter relating to the manufacture of Product prior to the earlier of (a) [***] , or (b) transfer of responsibility for manufacture of Product to Elanco pursuant to Article 8, [***] shall have the right to make the [***] decision on any matter relating to the manufacture of Product , unless [***] requests the [***] of the matter [***] .  

2.5.3 The MSC shall terminate once the [***] has been [***] ,   unless the Parties agree in writing to extend the duration of the MSC.

2.6 Subcommittee Operating Principles

2. 6 .1 In the event that a Party intends to replace an individual serving as subcommittee member, the Party must notify the other Party [***] calendar days following such change and include contact information of the incoming subcommittee member.

2.6 .2 Any member of a subcommittee may designate a substitute to attend and perform the functions of that member at any meeting of the subcommittee.

2. 6 .3 Each Party may, in its discretion, invite non-member representatives of such Party to attend meetings of the subcommittee upon notice to the other Party.

2.6 .4 The subcommittees shall meet [***] (while aiming at meeting   [***] ), unless agreed otherwise by the Parties in writing , on such dates, and at such places and times, as the Parties shall agree.

2.6 .5 The Parties may elect to meet in-person, by means of telecommunications, video conferences, electronic mail or other correspondence.

2.6 .6 Only the [***] chair-persons in each subcommittee have voting rights and will attempt to reach consensus on any decision; in events where consensus cannot be obtained on a decision, the chair-person appointed by [***] may take a decision, [***] by the [***] that the matter [***] . In the event that the [***] or [***] with the [***] of the [***] , the

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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matter [***] . In the event that the [***] cannot reach consensus, then the [***] member appointed by [***] will take the final decision, provided that in no event may [***] exercise such final decision making right to require that [***] take any action that would (a) require [***] to incur expenses in excess of the [***] , or (b) be unethical or require [***] to violate any Applicable Law.

2.6 .7 Each subcommittee shall [***] each meeting which shall [***] and a list of any [***] by the subcommittee and a list of any issues to be resolved by the JSC, if any.

2.6 .8 Each Party shall be responsible for all travel and related costs and expenses for its members and approved invitees to attend meetings of, and otherwise participate on, the ESC, JSC or a subcommittee.

3. The Development Program.

3.1 Overview of Development Program After the Effective Date, Elanco shall commence a program of development including [***] the Product s, including for clarity any Products incorporating Improvements in the Field of Use, which shall be designed to develop and commercialize (with input from the CCC) such Product s (the “ Development Program ”).  

3.2 Development Operating Plan .    

3.2.1 Within [***] calendar days following the Effective Date, Parties will, through the Development Subcommittee, review and approve an overall development operating plan, based on a draft developed by Elanco, (the “ Development Operating Plan ” or “ DOP ”) which shall set forth, as appropriate, from time to time and among other things: (a) the [***] under the [***] ; and (b) [***] and [***] for development of the Product , including for clarity any Products incorporating Improvements through filing of a Registration application . The Development Program will be carried out by Elanco, and to the extent that Licensor is involved, the Parties, pursuant to the D evelopment Operating Plan.

3.2.2 The Development Operating Plan shall be updated by Elanco, from time to time, and submitted to the Development Steering Committee for its review.  Each such update shall set forth in reasonable detail: (a) [***] for [***] to be undertaken by Elanco hereunder; and (b) [***]   (where applicable) .     During the duration of Licensor’s involvement in the Development Program, [***] shall consider in good faith and incorporate any comments by [***] relating to development activities to be conducted in relation to the Product prior to and for the purpose of obtaining Registrations in the United States and/or the EU.

3.3 Responsibilities of Licensor under the Development Program .  As part of the Development Program, Licensor shall (a) [***] required to obtain the first Registration for the Product for use [***] in each of the EU and the United States, and (b) [***] , perform such other

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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responsibilities with respect to the Development Program as may be agreed upon by the Parties from time to time. 

3.4 Responsibilities of Elanco under the Development Program . As part of the Development Program, Elanco shall perform such other responsibilities with respect to the Development Program as may be agreed upon by the Parties from time to time. 

3.5 Funding of Development Program Elanco shall pay seventy five percent (75%) and Licensor shall pay twenty five percent (25%) of Development Fees and Expenses incurred up to and through [***] .  Notwithstanding the foregoing, in no event shall Licensor’s portion of the Development Fees and Expenses during such period exceed $7,000,000 (seven million U.S. Dollars)   (the “ Development Funding Cap ”), which the Parties will review and adjusted by mutual written agreement in the event that an update of the Development Operating Plan results in a significant change of the Development Fees and Expenses . Notwithstanding the foregoing, each Party shall be solely responsible for all costs and expenses such Party incurs in connection with the conduct of its activities under the Development Program. 

3.6 Termination of the Development Program The Licensor’s involvement in and funding of the Development Program shall terminate with respect to the Product on [***] , unless the Parties decide in writing, through the Development Subcommittee, to extend the duration of the Development Program.

4. Commercialization Program.

4.1 Generally .   The commercialization program shall include each Party’s activities during the Term to advertise, market, promote , launch (including pre-launch activities) commercialize and sell the Product in the Territory (the “ Commercialization Program ”).  The Parties agree to cooperate with each other to coordinate their promotional and marketing activities in the Co-Promotion Territory through the Commercial Coordination Subcommittee.

4.2 Activities in the Elanco Exclusive Territory .  Elanco or its Sublicensees, shall be responsible for, and shall, subject to this Section 4.2 , have the exclusive right to direct all marketing, advertising, promotional, launch and sales activities related to the Product in the Elanco Exclusive Territory and co-exclusive rights with Licensor with respect to the Product in the Co-Promotion Territory.  As part of the Commercialization Program, Elanco shall, on a country-by-country basis:

4.2.1 use Commercially Reasonable Efforts to perform [***] activities related to the Product for the applicable countries in the Elanco Exclusive Territory;

4.2.2 use Commercially Reasonable Efforts and proceed diligently to launch the Product in each such country in the Elanco Exclusive Territory as soon as reasonably possible upon Registration in such country;  

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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4.2.3 use Commercially Reasonable Efforts to commercialize the Product following launch in each such country in the Elanco Exclusive Territory and in the Co-Promotion Territory; and  

4.2.4 maintain customary commercial records, in sufficient detail, which shall properly reflect all work done and results achieved in connection with the Commercialization Program in the form required under all applicable laws and regulations.  Licensor shall have the right, during normal business hours and upon reasonable notice, to inspect all such records no more than once each Calendar Year.  Licensor shall maintain such records and information contained therein in confidence in accordance with Section 12.2 and shall not use such records or information except to the extent otherwise permitted by this Agreement. 

4.3 Co-Promotion; Activities in the Co-Promotion Territory .  The Parties shall enter into a separate co-promotion agreement with respect to their rights and responsibilities in the Co-Promotion Territory (“ Co-Promotion Agreement ”).

5. Milestones; Royalties.

5.1 On Signing

5.1.1 As consideration to Licensor for past work undertaken with respect to the Licensor Technology, and the rights granted to Elanco under this Agreement, a non-refundable, non-creditable up-front payment of Forty Five Million U.S. Dollars (U.S. $45,000,000) will be due and payable from Elanco to Licensor within thirty (30) calendar days of the Effective Date.    

5.2 Development and Regulatory and Commercial Milestones .    

5.2.1 In partial consideration of the license and rights granted to it by Licensor under this Agreement, Elanco shall make to Licensor the following non-refundable, non-creditable milestone payments in accordance with Article 6 of this Agreement.



 

Milestone Event

Milestone Payment

(in USD)

1. First approval of a Product label in the EU with an [***]

$4,000,000

2. Achievement of the Commercial Supply Milestone

$4,000,000

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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3. [***] Sales of Product [***] in a Calendar Year prior to December 31, 2021

[***]

4. [***] Sales of Product exceed [***] in a Calendar Year prior to December 31, 2021

[***]

5. [***] Sales of Product exceed [***] in a Calendar Year prior to December 31, 2021

[***]



5.2.2 Notwithstanding the foregoing:

(a) if Milestone 3, 4 or 5 is achieved in Calendar Year 2022, Elanco shall pay 2/3 of the applicable milestone;

(b) if Milestone 3, 4 or 5 is achieved in Calendar Year 2023, Elanco shall pay 1/3 of the applicable milestone;

(c) i f Milestone 3, 4 or 5 is achieved after Calendar Year 2023 , no milestone payment will be due for the achievement of Milestone 3 or 4, respectively; 

By way of example only, if [***] Sales of Product exceed [***] USD for the first time in Calendar Year 2022, Elanco shall pay Licensor [***] USD (2/3 of [***] ), and if Milestone 5 is achieved for the first time during Calendar Year 2024, no milestone payment shall be payable to Licensor. 

5.3 Royalty Payments to Licensor .     As further consideration to Licensor for the license and other rights granted to Elanco under this Agreement, Elanco shall pay during the respective Royalty Term to Licensor  (a) [***] percent ( [***] %) royalty on Net Sales of Products sold in the Co-Promotion Territory prior to [***] , and (b) a [***] percent ( [***] %) royalty on Net Sales of Products (i) sold in the Elanco Exclusive Territory prior to [***] ; or (ii) sold anywhere in the Territory after [***] .  

5.4 Royalty Term .  Royalties shall be paid under Section 5.3 on a country-by-country and Product-by-Product basis, commencing on the First Commercial Sale of such Product in such country, in accordance with Section 5.3 until the latest of (a) the date on which there is no Valid Claim Covering the Product in the respective country; (b) the expiration of any regulatory exclusivity in such country covering such Product; and (c) the tenth (10th) anniversary of the First

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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Commercial Sale of such Product in such country, each period set out to above also referred to as  the “Royalty Term” for such Product in such country. 

5.5 Royalty Reduction; Generic Competition .

5.5.1 Notwithstanding the foregoing, if at any time during the Royalty Term for a given Product in a given country, there is no Valid Claim Covering the Product in such country, then the royalty rate payable by Elanco pursuant to Section 5.3. shall be reduced to [***] percent ( [***] %) of the rates set forth in Section 5.3. 

5.5.2 Additionally, but not cumulatively to a reduction pursuant to Section 5.5.1, if on a Product-by-Product, country-by-country and Calendar Quarter-by-Calendar Quarter basis, [***] has existed during the [***] Calendar Quarters immediately preceding the relevant Calendar Quarter (“Relevant Quarter”), and neither Party has commenced and is then continuing during the Relevant Quarter any proceeding to [***] in such country pursuant to [***] , then commencing in the Relevant Quarter, the royalties payable with respect to Net Sales of the applicable Product pursuant to Section 5.3 in such country during the Relevant Quarter shall be reduced by [***] percent ( [***] %) of the royalties otherwise payable pursuant to Section 5.3.  If a reduction under this Section 5.5.2 could apply at the same time as the reduction in Section 5.5.1, then only the reduction pursuant to Section 5.5.1 shall apply.

5.6 Anti-Stacking Provision . Should Elanco determine that access to Third Party’s patent rights is [***] due to [***] or [***] of [***] , Elanco will consult with Licensor before seeking access to such Third Party’s Patent Rights.  If Elanco pays compensation to a Third Party for Product for which compensation is also due to Licensor, Elanco shall have the right to deduct from the royalties owed to Licensor, [***] of the royalties to be paid to said Third Party .

5.7 Floor.  In no event shall the royalties payable to Licensor pursuant to this Agreement at any time be less than [***] , whether by operation of reductions provided in this Article 5 or through application of any other reductions or offsets available to Elanco pursuant to any other Section or Article of this Agreement. 

6. Payments And Reports.

6.1 Milestone Payments .  Upon achievement by or on behalf of Elanco, its Affiliates or Sublicensees of any milestone event set forth in Section 5.2, as applicable, Elanco shall promptly (but in the case of Milestones 1 and 2, in no event more than [***] Business Days after achievement thereof) notify Licensor of such achievement, and Elanco shall pay Licensor the corresponding milestone payment within [***] days after issuance by Licensor of an invoice for such milestone payment.  With respect to Milestone 3, 4 and 5, the provision by Elanco to Licensor of the report set forth in Section 6.2.1 specifying aggregate Net Sales in the applicable Calendar Year that achieve the applicable milestone event, shall constitute notice by Elanco of the achievement of the applicable Milestone.  For clarity, Elanco shall be obligated to make a

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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milestone payment corresponding to each of the events set forth in Section 5.2 only once, regardless of the number of Products that achieve such milestone event or the number of times such milestone event occurs for such Product. 

6.2 Royalty Payments  

6.2.1 Beginning with the Calendar Quarter in which the First Commercial Sale of a Product is made in the Territory that requires royalty payments to Licensor, and for each Calendar Quarter thereafter, royalty payments shall be made to Licensor in accordance with the royalty rates set forth in Section 5.3 within [***] calendar days following the end of each such Calendar Quarter.  Elanco shall deliver to Licensor within [***] days of the end of each calendar month a payment report computing an estimate of the amount due to Licensor under Section 5.3 (as adjusted pursuant to Sections 5.4 through 5.6, if and to the extent applicable) for such calendar month.  For the last month of each Calendar Quarter, Elanco shall deliver to Licensor a final report within [***] days of the end of the Calendar Quarter and for the [***] of each [***] during the term of this Agreement, the final calculation shall include [***] of the royalties due with respect to such Calendar Year.   In the event that no royalties are payable in respect of a given Calendar Quarter, Elanco shall submit a royalty report so indicating.

6.2.2 All other payments to be made under this Agreement, including payments for the Co-Promotion Territory under the Co-Promotion Agreement, shall be made in accordance with the terms set forth in the applicable Section(s) of the applicable agreement regarding such payments.

6.2.3 Elanco agrees to provide to Aratana information reasonably necessary for Aratana to comply with its financial reporting obligations to RaQualia pursuant to the RaQualia License Agreement.

6.3 Mode of Payment .  All payments required under this Agreement shall be made in U.S. Dollars, regardless of the country(ies) in which sales are made, via wire transfer of immediately available funds as directed by the other Party from time to time.  With respect to any Net Sales in currencies other than U.S. Dollars, Elanco shall convert such sales to U.S. Dollars using its standard currency conversion process .  

6.4 Records Retention Commencing with the First Commercial Sale of a Product, and for the Term or thereafter if Elanco retains rights to commercialize the Product pursuant to Section 14.7.1, Elanco shall keep complete and accurate records pertaining to the sale of each Product for a period not less than [***] Calendar Years after the year in which such sales occurred, and in sufficient detail to permit Licensor to confirm the accuracy of the amounts paid by Elanco hereunder. 

6.5 Audits .

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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6.5.1 During the Term or thereafter if Elanco retains rights to commercialize the Product pursuant to Section 14.7.1 , at the request and expense of Licensor, Elanco shall permit an independent, certified public accountant, acceptable to both Parties, at reasonable times and upon reasonable written notice, to examine such records as may be necessary for the sole purpose of verifying the calculation and reporting of Net Sales and the correctness of any royalty or other payment made under this Agreement for any period within the preceding [***] .  Each such period may only be audited one time, provided however, Elanco shall provide reasonable cooperation to Licensor’s accountant with respect to any follow-up inquiries pertaining to any particular audit. Prior to any audit, Licensor must submit an audit plan, including audit scope, to Elanco. The execution of each audit requires Elanco’s prior written consent, to be provided within [***] Business Days after Elanco’s receipt thereof, to such audit plan which Elanco must not unreasonably withhold, delay or condition. The independent certified public accountants shall keep confidential any information obtained during such inspection and shall report to the Licensor and Elanco only the amounts of net sales and amounts due and payable.

6.5.2 If determined that additional amounts are owed, or that amounts were overpaid, during such period, Elanco will pay the Licensor the additional amounts owed, or the Licensor will pay Elanco the overpaid royalties within [***] days of the date the independent certified public accountants written report is received by the paying party.  In addition, if the underpayment is [***] of the [***] and [***] ,   whichever is [***] , of the [***] , then [***] for its [***] .

6.6 Taxes. In the event that Elanco is mandated under the laws of a country to withhold any Tax to any Taxing Authorities in such country in connection with any payment to Licensor, such amount shall be deducted from the payment to be made by Elanco and timely remitted to the proper Taxing Authority, provided, that, Elanco shall promptly notify Licensor so that Licensor may take lawful actions to avoid and minimize such withholding.  Elanco shall reasonably promptly furnish Licensor with copies of any Tax certificate or other documentation evidencing such withholding as necessary to satisfy the requirements of the relevant governmental authority related to any application by Licensor for foreign tax credit for such payment. Elanco agrees to reasonably cooperate with Licensor in claiming exemptions from such deductions or withholdings under any agreement or treaty from time to time in effect. In event that pursuant to Section 17.2 Elanco assigns its rights and obligations under this Agreement (i) to an Affiliate or (ii) any acquirer of all or substantially all of its business (or that portion thereof to which this Agreement relates) or in the event of Elanco’s merger, consolidation or involvement in a similar transaction, all payments to Licensor following such assignment shall be made without deduction or withholding for any Taxes.  

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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7. Grant Of Rights.

7.1 Patent License Grant .  Subject to the terms, and on the conditions set forth in this Agreement:

7.1.1 Licensor hereby grants to Elanco a co-exclusive license under the Licensor Patents in the Co-Promotion Territory during the term of this Agreement to: (a) use, develop, make, have made, sell, offer to sell, import, export, lease, or otherwise dispose of any Product; (b) use any method or process in manufacturing the Products; (c) use and perform any Licensed Processes in connection with the Products; and (d) to otherwise exploit the Products in the Field of Use. Upon termination of the Co-Promotion Agreement, the license under this Section 7.1.1 shall become an exclusive license.

7.1.2 Licensor hereby grants to Elanco an exclusive license (without any reservation of rights by Licensor) under the Licensor Patents in the Elanco Exclusive Territory during the term of this Agreement to: (a) use, develop, make, have made, sell, offer to sell, import, export, lease, or otherwise dispose of any Product; (b) use any method or process in manufacturing the Products; (c) use and perform any Licensed Processes in connection with Products; and (d) to otherwise exploit Product in the Field of Use .  

7.2 Know-How License Grants .     Subject to the terms, and on the conditions set forth in this Agreement:

7.2.1 Licensor hereby grants to Elanco a co-exclusive license in the Co-Promotion Territory under the Licensor Know-How during the term of this Agreement to use the Licensor Know-How for the purposes of development, manufacture, sale, importation, exportation, lease or disposal of any Product or performance of any Licensed Process in connection with Products in the Field of Use . Upon termination of the Co-Promotion Agreement, the license under this Section 7.2.1 shall become an exclusive license.

7.2.2 Licensor hereby grants to Elanco an exclusive license (without any reservation of rights by Licensor) in the Elanco Exclusive Territory under the Licensor Know-How during the term of this Agreement to use the Licensor Know-How for the purposes of any development, manufacture, sale, importation, exportation, lease or disposal of any Product or performance of any Licensed Process in connection with Products in the Field of Use .  

7.3 Sublicensing

The licenses granted in Sections 7.1 and 7.2 include the right of Elanco to grant sublicenses under the Licensed Technology (a) without the consent of Licensor to (i) to any Affiliate of Elanco ,   or (ii ) any Third Party clinical research organization that is engaged by Elanco on the Effective Date, or (iii ) through one or more tiers to Third Parties performing activities for or on behalf of Elanco in the Elanco Exclusive Territory, and (b) with the prior written consent of Licensor (such

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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consent not to be unreasonably withheld, delayed or conditioned) to other Third Parties performing activities for or on behalf of Elanco in the Co-Promotion Territory.  All sublicenses granted to third parties will be pursuant to a written agreement that is in accordance with and not broader than the terms of this Agreement.

7.4 Trademarks .  In connection with, and effective as of the date of the [***] to Elanco pursuant to [***] , Licensor shall assign to Elanco all Licensor’s rights in and to the Trademarks [***] as defined below (the “ Trademark Assignment ”).  From the Effective Date, and until the date of the Trademark Assignment, Licensor hereby grants to Elanco a license in the Ter ritory to use the Trademarks   [***] in connection with any development, manufacture, sale, importation, exportation, lease or disposal of any Product. The license shall be co-exclusive (with Licensor) in the Co-Promotion Territory and exclusive (without any reservation of rights by Licensor) in the Elanco Exclusive Territory.  During the term of this Agreement, Elanco shall market the Products throughout the Territory under the Galliprant® trademarks listed on Exhibit 7.4 (collectively, the “ Trademarks ”), [***] will [***] for [***]   in [***] , until the effective date of the Trademark Assignment. During this time, Licensor will be solely responsible for obtaining and maintaining the Galliprant® trademark, [***] , for use on the Products in a given country in the Territory at Licensor’s expense . Following the Trademark Assignment, Elanco will own all right, title and interest in and to the Trademarks [***] , and all goodwill from the use of the Trademarks [***] shall vest in and inure to the benefit of Elanco.  Licensor shall take such actions at its own expense as Elanco shall reasonably request to perfect Elanco’s rights in the Trademarks [***] in the country trademark offices, including signing confirmatory assignments.  After the Trademark Assignment, Elanco shall be responsible for renewing the Trademarks [***] at its expense and its sole discretion. In the event of the institution or threatened institution of any suit by a Third Party against Elanco (in the Elanco Exclusive Territory), or against either Party (in the Co-Promotion Territory) for trademark infringement involving the use, manufacture, sale, offer for sale, importation, distribution or marketing of a Product in the Territory, where such infringement claim is a result of the use of the Trademarks [***] , Elanco shall have the sole right to defend and control such suit at its own expense and at its sole discretion and shall be responsible for all damages incurred as a result thereof.  Licensor hereby agrees to assist and cooperate with Elanco, at Elanco’s reasonable request and expense, in the defense of any suit related to the use of the Trademarks [***] (including, without limitation, consenting to being named as a nominal party thereto).  During the pendency of such action and thereafter, Elanco shall continue to make all payments due under this Agreement.  If Elanco finally prevails and receives an award from such Third Party as a result of such action (whether by way of judgment, award, decree, settlement or otherwise), such award shall be retained entirely by Elanco.

7.5 Trade-dress .  Elanco shall identify on trade-dress for Products in the Territory that the Product is being manufactured by (or on behalf of) Licensor and distributed by Elanco pursuant to a patent and know-how license from Licensor to the extent legally permissible. In the event that Elanco assumes responsibility for manufacturing the Product, Parties will decide on appropriate trade-dress through the CCC and DSC, as appropriate.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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8. Manufacturing And Supply    

8.1 Supply of Product

8.1.1 Commencing as of the Effective Date, Licensor shall be responsible for the manufacture and supply of all of Elanco’s reasonable requirements of Product in compliance with GxP, if applicable .  

8.1.2 Following the Effective Date, the Parties will expeditiously enter into negotiations and execute:

(a) an agreement governing the supply of active product ingredient and/or finished Product by Licensor (through contract manufacturing organizations) to Elanco (“ Supply Agreement ”), substantially in line with the terms attached hereto in Exhibit 8.1.2(a) ; and

(b) an agreement that addresses Product Complaints as well as procedures, testing, specifications and quality of raw materials and that sets forth the quality expectations, responsibilities, oversight and requirements relating to the manufacture and supply Products (“ Quality Agreement ”).

8.1.3 Notwithstanding any provisions of the Quality Agreement, following the Effective Date, Elanco shall have the right ,   [***] , to conduct a   quality audit   of the manufacturing process to be used in the supply of the Product to ensure GxP compliance ; provided however, that Elanco shall have the right to further audits if corrective actions are necessary based on the original audit to ensure that such corrections have been made or if quality concerns require an audit for causes related thereto , and further provided that the foregoing right to audits shall be subject to Licensor’s agreements with its Third Party manufacturers of Product or components thereof .  If any deficiency is identified by Elanco from the foregoing quality audit, the Parties shall agree to reasonable corrective actions to be implemented prior to the manufacture of the Products.

8.1.4 Licensor shall not move or otherwise modify the manufacturing processes without Elanco’s prior consent, not to be unreasonably withheld, unless such moves or modifications are done according to the change control provisions in the Quality Agreement.

8.2 Technology Transfer.

8.2.1 The Parties acknowledge and agree that [***] , Licensor is conducting technology transfer of the Licensor Know-How necessary for the manufacture of the active pharmaceutical ingredient (“ API ”) of the Product for use in commercialization of Products in the Territory to the [***] Third Party Manufacturer or, subject to Elanco’s prior written consent,

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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[***] that the Parties [***] for commercial supply of the Product to Elanco following Technology Transfer Completion (the “ Technology Transfer”) .

8.2.2 At any time during the Term, including prior to Technology Transfer Completion, Elanco has the right to notify Licensor in writing that it wishes to assume responsibility for all or a portion of the manufacturing of Products for commercialization in the Territory (the “ Manufacturing Notice ”).  In such case, each Party shall cooperate with, and shall use Commercially Reasonable Efforts to complete as promptly as possible following the delivery of the Manufacturing Notice, the transfer from Licensor (or from any existing Third Party supplier of Products under this Agreement or the Supply Agreement) to Elanco (or any contract manufacturing organization designated by Elanco) of the Licensor Know-How necessary for formulation and manufacturing of the Product, including without limitation its active ingredient and any other Product elements, to enable Elanco to manufacture the Product, including without limitation its active ingredient and any other Product elements, either itself or through any contract manufacturing organization designated by Elanco.  The Parties shall discuss, through the MSC, the process and timing to affect such technology transfer, including the wind down or cessation of manufacturing operations at any existing Third Party supplier of Products, and the timeframe in which [***] wishes to assume responsibility for manufacture.  For purposes of clarification, [***] is responsible for all costs and expense with respect to such technology transfer to Elanco, including costs incurred by Licensor and/or the applicable Third Party contract manufacturing organization , except for costs arising with respect to any Technology Transfer required because a Third Party supplier engaged by [***] has failed in any material respect to manufacture or supply API or Product for supply to Elanco as provided in this Agreement or the Supply Agreement,  which costs will instead be borne by [***]

9. Ownership; Patents and Know-How.

9.1 Ownership Licensor shall retain all right, title and interest in and to the Licensor Technology regardless of Elanco’s preparation and filing of any Registration applications, subject to the license granted to Elanco pursuant to Section s   7.1 and 7.2.

9.2 Improvements .  

9.2.1 All right, title and interest in and to any Improvements shall be owned as follows:

(a) if a Licensor Sole Improvement shall be owned solely by Licensor;

(b) if an Elanco Sole Improvement shall be owned solely by Elanco; and  

(c) if made by employees or contractors of both Parties shall be owned jointly by the Parties (“ Joint Improvements ”).  Each Party shall have the right to exploit any Joint

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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Improvements, to the extent it can do so without infringing on the other Party’s other intellectual property rights, without compensation, liability or other obligation (including, without limitation, accounting obligations) to the other Party.  Each Party grants to the other Party a [***] license under its interest in Joint Improvements, and intellectual property rights therein, to effect the intent of the foregoing.

9.2.2 Elanco shall automatically receive a license to all Licensor Sole Improvements and Licensor’s interest in Joint Improvements under Section 9.2.1 pursuant to the licenses granted in Sections 7.1 and 7.2 of this Agreement.    

9.2.3 E lanco grants to Licensor a co-exclusive license to all Elanco Sole  Improvements and Elanco’s interest in the Joint Improvements under 9.2.1 in the Co-Promotion Territory during the term of this Agreement to: (a) use, develop, make, have made, sell, offer to sell, import, export, lease, or otherwise dispose of any Product; (b) use any method or process in manufacturing the Products; (c) use and perform any Licensed Processes in connection with the Products; and (d) to otherwise exploit the Products in the Field of Use. Upon termination of the Co-Promotion Agreement, the license under this Section 9.2.3 shall terminate.  

9.3 Patent Notification, Prosecution, Maintenance and Extension .

9.3.1 Licensor shall provide a complete listing of all Licensor Patents existing as of the Effective Date in Exhibit 9.3.1 , including application number, patent number, expiration date, assignee and filing date.  Within thirty (30) calendar days of a Licensor Patent issuing, Licensor shall provide notice to Elanco including the date of issuance and a copy of the issued claims.  No more than once a year, at Elanco’s request, Licensor shall provide Elanco an updated Exhibit 9.3.1 .  

9.3.2 Subject to the terms of the RaQualia License Agreement, [***] shall have full responsibility for, and shall control , and bear all costs of, the preparation, prosecution and maintenance of the Licensor Patents existing as of the Effective Date, in [***] discretion. Notwithstanding the previous sentence, [***] shall take no action that would be reasonably likely to cause a RaQualia Patent Right to lapse, to be abandoned or cancelled, or to be held or declared invalid or unenforceable, unless Parties mutually agree in writing that such action is reasonably necessary to optimize overall patent protection on the claimed inventions, which agreement must not be unreasonably withheld, conditioned or delayed.   With the exception of such Licensor Patents, each Party shall have full responsibility for, and shall control   the preparation, prosecution and maintenance of, all Patent Rights owned solely by such Party claiming Improvements throughout the Territory. For clarity, Licensor shall in its sole discretion, determine whether or not to proceed with the preparation and prosecution of a patent application directed to any Licensor Sole Improvement (subject to Section 9.3.4), and Elanco shall determine whether or not to proceed with the preparation and prosecution of a patent application direct to any Elanco Sole Improvement. Notwithstanding the foregoing, (a) Licensor

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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agrees to provide Elanco a copy of any patent application claiming or Covering a Licensor Sole Improvement, and (b) Elanco agrees to provide Licensor a copy of any patent application claiming or Covering an Elanco Sole Improvement, in each case of (a) and (b) for review and comment by the other Party at least [***] days in advance of filing such patent application, and the filing Party shall also provide the other Party with reasonable prior notice of all material prosecution matters related thereto within a reasonable time prior to submission of the same to the relevant patent authority. Except as provided by Sections 9.3.4 and 9.3.5, the Parties shall bear their own costs of such activities for such Patent Rights.

9.3.3 Each Party agrees to promptly provide to the other Party with a complete written disclosure of any Improvement made by such Party. 

9.3.4 Notwithstanding Section 9.3.2, upon written notice by Elanco to Licensor that a patent application should be filed for a Licensor Sole Improvement in a particular country in which Elanco intends to commercialize the Product; Licensor shall promptly file patent applications for any such Licensor Sole Improvement in such country. The costs and expenses of such filings shall be borne by Elanco. 

9.3.5 Licensor and Elanco shall together determine whether or not to proceed with the preparation and prosecution of a patent application directed to any Joint Improvements.  All costs and expenses of preparing, filing, prosecuting and maintaining patent applications and patents relating to Joint Improvements shall be borne by Elanco. 

9.3.6 Each Party agrees to cooperate with the other Party to execute all lawful papers and instruments, to make all rightful oaths and declarations, and to provide consultation and assistance as may be reasonably necessary in the preparation, prosecution, maintenance and enforcement of the Patent Rights directed to Improvements.

9.3.7 Licensor, at Elanco’s reasonable request, and subject to the terms of the RaQualia License Agreement, shall cooperate on the selection of Licensor Patents, if any, for term extension and in the filing of any term extensions, supplementary protection certificates or equivalents thereof offering patent protection beyond the initial term of such Licensor Patents.

9.3.8 Licensor, at Elanco’s reasonable request, shall cooperate on the selection of Licensor Patents, if any, submitted for inclusion in the FDA Approved Animal Drug Products (Green Book) or any comparable listing under applicable laws in any country in the Territory.  

9.4 Patent and Trademark Rights Enforcement .

9.4.1 If either Party learns of an infringement, unauthorized use, misappropriation or ownership claim or threatened infringement or other such activity by a Third Party of the Licensor Technology, Improvements or Patent Rights directed to Improvements with respect to the Product within the Territory (an “ Infringement ”), such Party

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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shall promptly notify the other Party in writing and shall promptly provide such other Party with available evidence of such Infringement.    

9.4.2 Licensor shall have the first right, but not the duty, to institute , prosecute, and control any action or proceeding with respect to an Infringement based on any Licensor Technology in the Territory.  If Licensor (or its designee) does not take action to secure actual cessation of such infringement (except by granting said Third Party a license) or institute an infringement proceeding against an offending Third Party within one hundred eighty (180) calendar days after a receipt of evidence of the Infringement , Elanco shall have the right, but not the duty, to i nstitute, prosecute, and control any action or proceeding with respect to such Infringement .  The costs and expenses of any such action (including fees of attorneys and other professionals) shall be borne by the Party instituting the action, or, if the Parties elect to cooperate in instituting and maintaining such action, such costs and expenses shall be borne by the Parties in such proportions as they may agree in writing. In the event that Elanco bears costs under aforementioned sentence, Elanco may offset such costs from payments owed by Elanco under Sections 5.2 and 5.3 (subject to Section 5.7). Each Party shall execute all necessary and proper documents, take such actions as shall be appropriate to allow the enforcing Party to i nstitute, prosecute, and control such I nfringement actions and shall otherwise cooperate in the institution and prosecution of such actions (including, without limitation, consenting to being named as a nominal party thereto), at the enforcing Party’s expense.  Any award, damages or other monetary awards recovered (whether by way of settlement or otherwise) shall be applied first to reimburse both Parties for all costs and expenses incurred by the Parties with respect to such action on a pro rata basis and, if after such reimbursement any funds remain from such award, they shall be [***] , to the extent such [***] , and then as follows: (A) if [***] and [***] such [***] , [***] shall [***] such [***] ; (B) if [***] and [***] such [***] ,   [***] shall [***] such [***] , but shall [***] , as if such [***] within [***] ; or (C) if [***] have [***] and [***] such [***] ,   [***] shall [***] such [***] as they have agreed to [***] and [***] such [***] .

9.4.3 The rights of enforcement set forth in this Section 9.4 shall be subject to the RaQualia Agreement with respect to the RaQualia Patents and the RaQualia Know-how.   

9.5 Infringement Action by Third Parties .  In the event of the institution or threatened institution of any suit by a Third Party against Elanco for infringement or misappropriation involving the use, manufacture, sale, offer for sale, importation, distribution or marketing of a Product in the Territory, where such infringement claim is a direct result of the manufacture, use or sale of the composition of matter of the API or the use of a Product to treat osteoarthritis in dogs (an “Licensor-Responsible Claim”), Elanco shall promptly notify Licensor in writing of such suit.  Licensor shall defend such Licensor-Responsible Claim at its own expense and shall be responsible for all damages incurred as a result thereof.  Elanco hereby agrees to assist and cooperate with Licensor, at Licensor’s reasonable request and expense, in the defense of any such Licensor-Responsible Claim (including, without limitation, consenting to being named as a nominal party thereto).  During the pendency of such action for a Licensor-Responsible Claim and thereafter,

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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Elanco shall continue to make all payments due under this Agreement.  If Licensor finally prevails and receives an award from such Third Party as a result of such action (whether by way of judgment, award, decree, settlement or otherwise), such award shall be retained by Licensor. Elanco agrees, in connection with any such defense proceeding by Licensor, to use Commercially Reasonable Efforts to cooperate to minimize any damages incurred in connection with any such infringement claim. In the event of the institution or threatened institution of any suit by a Third Party against Elanco for infringement or misappropriation involving the use, manufacture, sale, offer for sale, importation, distribution or marketing of a Product in the Territory, where such infringement claim is not an Licensor-Responsible Claim (an “Other Claim”), Elanco shall promptly notify Licensor in writing of such Other Claim.  Elanco shall defend such Other Claim at its own expense and shall be responsible for all damages incurred as a result thereof.  Licensor hereby agrees to assist and cooperate with Elanco, at Elanco’s reasonable request and expense, in the defense of any such Other Claim (including, without limitation, consenting to being named as a nominal party thereto).  During the pendency of such action for an Other Claim and thereafter, Elanco shall continue to make all payments due under this Agreement.  If Elanco finally prevails and receives an award from such Third Party as a result of such Other Claim (whether by way of judgment, award, decree, settlement or otherwise), Elanco shall be entitled to retain such remaining funds, but shall pay Licensor a royalty, as if such remaining funds constituted Net Sales made within the month the funds are received. 

10. Regulatory Matters.

10.1 Regulatory Filings and Approvals

(a) [***] shall be responsible, at its own expense, for preparing, filing and maintaining all required Registrations [***] [***] shall be responsible, at its own expense, for preparing, filing and maintaining [***] .  

(b) Licensor will provide Elanco in a timely manner with all information and assistance required by Elanco in order to obtain and maintain such all required Registrations outside the U.S. and the EU and to otherwise interact with Regulatory Authorities.

(c) Upon written notice by Elanco that it [***] , the Parties shall cooperate to complete as promptly as possible the [***] .  Following the [***] ,   [***] shall be [***] , at its expense, for [***] Notwithstanding the foregoing, [***] shall request the [***] , and shall have [***] for [***] for Product (i) in the U.S., within [***] days following [***] or as soon as reasonably practicable thereafter, and (ii) in the EU, within [***] days following [***] for Product in the EU within [***] days following [***] , or as soon as reasonably practicable thereafter. 

10.2 Product Withdrawals and Recalls .  In the event that any Regulatory Authority threatens or initiates any action to remove any Product from the market in any country in the Territory, and in the event that a Party is notified of a material Product Complaint, the Party who

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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receives the notice shall notify the other Party of such event within [***] after becoming aware of the action, threat, or requirement (as applicable).  Licensor shall consult with Elanco  prior to initiating a recall or withdrawal of Product in any country or regulatory jurisdiction in the Territory; provided, however, that the final decision as to whether to recall or withdraw a Product shall be made (i) by Licensor for the U.S. and the EU prior to the applicable [***] for Product in such countries, and (ii) by Elanco (A) at any time after the Effective Date for all countries other than the U.S. and the EU, and (B) for the U.S. and the EU, following the [***] for such Product in the applicable country(ies).  Following the [***] in the U.S. and the EU, and at all times for all other countries in the Territory, Elanco shall be responsible, at its sole expense, for conducting any recalls or taking such other necessary remedial action with respect to Product, without prejudice to any indemnification rights or other recourse that Elanco might have against Licensor under the Supply Agreement or any other ancillary agreements . Product Complaints, Product withdrawals and recalls shall further be dealt with in accordance with the Quality Agreement.

10.3 Adverse Event Reporting Representatives of each Party will begin meeting as soon as possible but no later than [***] calendar days after the Effective Date of this Agreement and will work in good faith together to negotiate and enter into the Pharmacovigilance Agreement within [***] calendar days which shall, among other things, provide for appropriate reporting of any Adverse Events. 

11. Representations And Warranties.

11.1 Representations and Warranties of Both Parties .  Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:

11.1.1 such Party: (a) is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is incorporated; (b) has the corporate power and authority and the legal right to own and operate its property and assets, to lease the property and assets it operates under lease, and to carry on its business as it is now being conducted; and (c) is in compliance with all requirements of applicable law, except to the extent that any noncompliance would not have a material adverse effect on the properties, business, financial or other condition of such Party and would not materially adversely affect such Party’s ability to perform its obligations under this Agreement;

11.1.2 such Party: (a) has the corporate power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder; and (b) has taken all necessary corporate action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder.  The Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against such Party in accordance with its terms except to the extent that enforceability may be limited by applicable bankruptcy, insolvency or other laws affecting the enforcement of

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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creditors’ rights generally and subject to the general principles of equity (regardless of whether enforcement is sought in a court of law or equity);

11.1.3 such Party has obtained all necessary consents, approvals and authorizations of all governmental authorities and Third Parties required to be obtained by such Party in connection with this Agreement, other than any approvals required of applicable Regulatory Authorities as may be required under this Agreement from time to time; and

11.1.4 the execution and delivery of this Agreement and the performance of such Party’s obligations hereunder: (a) do not, to such Party’s knowledge, conflict with or violate any requirement of any Applicable Law ; and (b) do not conflict with, or constitute a default under, any contractual obligation of such Party .

11.2 Representations, Warranties and Covenants of Licensor .  Licensor represents, warrants and covenants to Elanco, as of the Effective Date, and except as otherwise specified, at all times during the Term, that:    

11.2.1 [***] , the manufacture, use or sale of Product as contemplated by this Agreement will not constitute an infringement, unauthorized use or misappropriation claim or threatened infringement of any issued Patent Right or other intellectual property right of any Third Party, and Licensor has no knowledge of any Third Party who conceived of an invention claimed by a Licensor Patent existing as of the Effective Date who is not listed as an inventor on such Licensor Patent;

11.2.2 L icensor shall use Commercially Reasonable Efforts to manufacture or have manufactured the Product in accordance with the terms and conditions of this Agreement, the Supply Agreement and the Quality Agreement and any ancillary agreements that Parties may execute with respect to the manufacture and supply of Product, and will manufacture and supply, or have manufactured and have supplied to Elanco, Product pursuant to such agreements that conforms to the specifications therefor   as mutually agreed upon in writing by the Parties, GxP and all Applicable Laws that are specified in such agreements.

11.2.3 as of the Effective Date there is no pending litigation that alleges, and no officer of Licensor has received any notice threatening such litigation, that Licensor’s activities relating to the Product violate or would violate any intellectual property rights of any Third Party;

11.2.4 [***] , except pursuant to the RaQualia License Agreement, no person or entity other than Licensor has any rights to or interest in the Licensor Technology or the Trademarks that would conflict with the rights granted to Elanco under this Agreement in any material respect, and such Licensor Technology and Trademarks are free and clear of all encumbrances, security interests, options and licenses, other than the RaQualia License Agreement;

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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11.2.5 as of the Effective Date, Licensor has not given any notice to any Third Party asserting infringement by such Third Party of any of the Licensor Technology or the Trademarks and, to Licensor’s knowledge, there is no unauthorized use, infringement or misappropriation of the Licensor Technology or the Trademarks;

11.2.6 Licensor has not executed or entered into any agreement with or granted to any Third Party, directly or indirectly, any rights that would conflict with the rights granted to Elanco under this Agreement in any material respect ;  

11.2.7 [***] : all information in its possession or control regarding the Product that has been provided to Elanco is accurate and complete in all material respects;

11.2.8 as of the Effective Date, Exhibit 9.3.1 is an accurate and complete listing of all Licensor Patents and Exhibit 7.4 is an accurate and complete listing of all Trademarks;

11.2.9   [***] , Licensor is not aware of any inventors of any Licensor Patent Rights other than those listed as inventors on applications filed for such Licensor Patent Rights;

11.2.10 [***] ,   Licensor has taken reasonable steps to protect the confidentiality of Licensor Know-How ; and

11.2.11 as of the Effective Date, and during the Term, Licensor will not terminate the [***] or take any action, or fail to take any action that would be reasonably likely to cause [***] , unless [***] right is predominantly based on a wrongful action or omission by [***] or an action by [***] that, if it had been performed or failed to be performed by Aratana, would constitute a [***] (an “ [***] ”). In the event Licensor receives notice from [***] alleging [***] of the [***] which Licensor believes may be predominantly based on [***] , Licensor shall provide Elanco with written notice of such alleged [***] within [***] business days of receipt. The Parties shall cooperate in good faith during the cure period under the [***] to cure such alleged [***] . Licensor shall not be deemed to be in [***]   of this Section 11.2.11 if (i) the [***] cannot be cured within the cure period and is an Elanco Activity, or (ii) the [***] could be cured and is [***] , however, Elanco has not cooperated good faith with Licensor to cure such alleged [***] .

11.3 Representations, Warranties and Covenants of Elanco .  Elanco represents, warrants and covenants to Licensor, as of the Effective Date, and except as otherwise specified, at all times during the Term, that   Elanco shall perform those activities assigned to it under the Development Program in compliance with GxP, in each case as applicable under the laws and regulations of the country where such activities are conducted, and will conduct such activities in accordance with Article 3.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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11.4 Disclaimers

11.4.1 EXCEPT AS EXPRESSLY SET FORTH IN THIS SECTION 11, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND EACH PARTY EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR PURPOSE OR USE, OR NON-INFRINGEMENT.

11.4.2 NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES, INCLUDING, BUT NOT LIMITED TO, LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTHING IN THIS SECTION IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY WITH RESPECT TO CLAIMS BY THIRD PARTIES AGAINST A PARTY FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES.

12. Publication; Confidentiality.

12.1 Notification and Review .

12.1.1 Both Parties recognize that each may wish to publish the results of their work relating to the subject matter of this Agreement.  However, both Parties also recognize the importance of acquiring patent protection.  Consequently, any proposed scientific publication, by either Party (including its Affiliates and/or sublicensees), that includes information related to the   Product , shall comply with this Section 12.1 .  At least [***] calendar days before a manuscript is to be submitted to a publisher, the publishing Party shall provide the DSC with a copy of the manuscript.  If the publishing Party wishes to make an oral presentation or publish any abstract, it shall provide the DSC with a summary of such presentation or abstract, as the case may be, at least [***] business days before such oral presentation or before such abstract is to be submitted.  Any oral presentation, including any question period, shall not include any Confidential Information of the non-publishing Party unless the non-publishing Party otherwise agrees in writing in advance of such oral presentation.  Notwithstanding the foregoing, Elanco may publish clinical trial information on Elanco’s online database. For the avoidance of doubt, this Section 12.1.1 does not apply to promotional material which Elanco may develop and make available in accordance with its internal policies.  For clarity, any publication relating to the Product submitted by Licensor prior to the Effective Date shall not be subject to the provisions of this Section 12.

12.1.2 The non-publishing Party shall notify the publishing Party in writing within [***] calendar days of receipt of the proposed publication if such Party, in good faith, determines that patentable subject matter of the non-publishing Party is or may be disclosed, or if the non-publishing Party in good faith, believes Confidential Information (as defined in

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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Section   12.2 ) is or may be disclosed.  In the event the non-publishing Party, in its reasonable discretion, determines that patent applications should be filed, the publishing Party shall delay its publication or presentation for a period not to exceed [***] calendar days from the non-publishing’s receipt of the proposed publication or presentation to allow time for the filing of patent applications directed to such subject matter.  In the event that the delay needed to complete the filing of any necessary patent application will exceed the [***] -calendar-day period, the Parties will discuss in good faith (which may be through the DSC) the need for obtaining an extension of the publication delay beyond the [***] -calendar-day period.  If the non-publishing Party determines in good faith that its Confidential Information is or may be disclosed, the Parties will promptly discuss and agree upon mutually acceptable modifications to the proposed publication or presentation to avoid such disclosure.

12.1.3 Except as expressly provided in this Article 12 , each Party agrees not to make any publication, public announcement or disclosure of the terms of this Agreement, without first obtaining the written approval of the other Party and agreement upon the nature and text of such public announcement or disclosure, which approval shall not be unreasonably withheld or delayed.  Notwithstanding the foregoing, the Parties shall agree upon a press release to announce the execution of this Agreement, together with a corresponding question and answer script for use in responding to inquiries about the Agreement and Licensor and Elanco may each disclose to Third Parties the information contained in such press release and question and answer script without the need for further approval by the other.  Unless otherwise agreed by the Parties, there shall be no public disclosure of the financial terms of this Agreement, except as may be required by law. Parties agree to publish an announcement of the Transaction on the first Business Day following the Effective Date, substantially in the form as attached hereto in Exhibit 12.1.3 .  

12.1.4 Each Party agrees that it shall reasonably cooperate with the other Party, at such other Party’s request with respect to all disclosures regarding this Agreement and any documents ancillary hereto required under applicable laws and regulations to the United States Securities and Exchange Commission and any other comparable governmental or regulatory agencies.

12.2 Confidentiality; Exceptions .  Except to the extent expressly authorized by this Agreement or otherwise agreed in writing, the Parties agree that, for the longer of: (a) during the Term and for [***] years thereafter; or (b) [***] years from Effective Date; a receiving Party shall keep, and shall ensure that its Affiliates, and their officers, directors, employees and agents, keep, completely confidential and shall not publish or otherwise disclose and shall not use for any purpose other than as set forth in this Agreement: (i) any information furnished to it by the disclosing Part y; or (ii) developed under or in connection with this Agreement by either Party; except in each of subclause (i) and (ii) to the extent that it can be established by the receiving Party by competent written proof that such information: (A) was already known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the disclosing Party;

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(B) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party; (C) became generally available to the public or was otherwise part of the public domain after its disclosure hereunder and other than through any act or omission of the receiving Party in breach of this Agreement; or (D) was disclosed to the receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the disclosing Party not to disclose such information to others (all such information to which none of the foregoing exceptions applies, “ Confidential Information ”).

12.3 Exceptions to Obligation .  The restrictions contained in Section 12.2 shall not apply to Confidential Information that: (a) is submitted by a receiving Party to governmental authorities including, for the avoidance of doubt, any Regulatory Authorities, to facilitate the issuance of Registrations for th e Product , provided that reasonable measures shall be taken to assure confidential treatment of such Confidential Information; (b) is provided by the receiving Party under confidentiality agreements having provisions at least as stringent as those in this Agreement, (i) to Third Parties for development (including clinical trials), manufacturing development, manufacturing, external testing, marketing trials and commercialization activities and/or (ii) to Third Parties who are sublicensees or other development/marketing partners hereunder with respect to any of the subject matter of this Agreement; (c) is otherwise required to be disclosed in compliance with applicable laws or regulations (including, without limitation and for the avoidance of doubt, the requirements of the U.S. Securities and Exchange Commission, Taxing Authorities and Nasdaq or any other stock exchange on which securities issued by a Party are traded) or order by a court or other regulatory body having competent jurisdiction; provided ,   that , if a Party is required to make any such disclosure of the other Party’s Confidential Information such Party will give reasonable advance written notice to the disclosing Party of such disclosure requirement, unless the disclosure is in connection with any document filed with or furnished to the SEC or unless disclosure of the terms of this Agreement is requested by a Taxing Authorities during conduct of tax examinations of either Party, and, except to the extent inappropriate in the case of patent applications, will use its reasonable efforts to secure confidential treatment of such Confidential Information required to be disclosed; or (d) was developed by the receiving Party independent of any disclosure received under this Agreement. In addition, the restrictions contained in Section 12.2 shall not apply to Licensor or Elanco to the extent the Confidential Information relates to any patent application related to: (A) any Licensor Technology solely owned by Licensor; or (B) any technology solely owned by Elanco, as the case may be.

12.4 Limitations on Use .  Each Party shall use any Confidential Information obtained by such Party from the other Party, its Affiliates, or its sublicensees, pursuant to this Agreement or otherwise, solely in connection with the activities or transactions contemplated hereby or expressly permitted hereunder.

12.5 Remedies .  Each Party shall be entitled, in addition to any other right or remedy it may have, at law or in equity, to an injunction, without the posting of any bond or other security, enjoining or restraining the other Party from any violation or threatened violation of this Article 12.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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13. Indemnification; Insurance.

13.1 By Elanco .  Elanco shall indemnify, defend and hold harmless Licensor and its Affiliates, and their respective directors, officers, employees and agents, from and against any and all liabilities, damages, losses, costs and expenses (including the reasonable fees of attorneys and other professionals) for claims of any Third Party arising out of or resulting from:  

13.1.1 negligence or wrongful intentional acts or omissions of Elanco, Sublicensees and their respective directors, officers, employees and agents, in connection with the activities contemplated under this Agreement; or

13.1.2 the [***] (after Elanco has assumed responsibility for [***] and subject to any specific indemnification provisions in the [***] between the Parties to the contrary), [***] of Product by or on behalf of Elanco or its Affiliates or Sublicensees, but only to the extent not due to the negligence or wrongful intentional acts or omissions of Licensor or its Affiliates, and their respective directors, officers, employees and agents; or

13.1.3 any breach of any obligation, covenant, representation or warranty made by Elanco pursuant to Sections 11.1 or 11.3 .

13.2 By Licensor: Licensor shall indemnify, defend and hold harmless Elanco and its respective directors, officers, employees and agents, from and against any and all liabilities, damages, losses, costs and expenses (including the reasonable fees of attorneys and other professionals) for claims of any Third Party arising out of or resulting from:

13.2.1 negligence or wrongful intentional acts or omissions of Licensor or its Affiliates, and their respective directors, officers, employees and agents, in connection with the activities contemplated under this Agreement; or

13.2.2 any breach of any representation or warranty made by Licensor pursuant to   Sections 11.1 or 11.2 or under the [***] or the [***] .  

13.3 Notice .  In the event that any person (an “ Indemnitee ”) entitled to indemnification under Section  13.1 or 13.2 is seeking such indemnification, as a condition of receiving such indemnification, such Indemnitee shall inform the indemnifying Party of the claim as soon as reasonably practicable after such Indemnitee receives notice of such claim, shall permit the indemnifying Party to assume direction and control of the defense of the claim (including the sole right to settle it at the sole discretion of the indemnifying Party, provided that such settlement does not impose any obligation on the Indemnitee or the other Party) and shall cooperate as requested (at the expense of the indemnifying Party) in the defense of the claim.

13.4 Complete Indemnification .  As the Parties intend complete indemnification, all costs and expenses, including without limitation,  reasonable legal fees and expenses, actually

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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incurred by an Indemnitee in connection with enforcement of Sections 13.1 and 13.2 shall also be reimbursed by the indemnifying Party.

13.5 Insurance .  Each Party shall maintain, and shall require its Affiliates and sublicensees hereunder to maintain, a general liability and product liability insurance program on terms customary in the animal health industry for products similar to Products covering all activities and obligations of it, and, as the case may be, its Affiliates, hereunder, or other programs with comparable coverage, up to and beyond the expiration or termination of this Agreement during (i) the period that any Product is being commercially distributed or sold by a Party, its Affiliates or Sublicensees, and (ii) a commercially reasonable period thereafter. 

14. Term; Termination.

14.1 Term .  This Agreement shall become effective as of the Effective Date and, unless earlier terminated pursuant to any other provisions of this Section 14 , shall expire upon the last to expire Royalty Term for all Products in all countries under Section 5.4 (the “ Term ”).  

14.2 Voluntary Termination .  Elanco may terminate this Agreement at any time by giving Licensor ninety (90) calendar days’ written notice of its intention to terminate.

14.3 Termination for Cause

14.3.1 E ither Party (the “ Non-breaching Party ”) may terminate this Agreement , without prejudice to any other remedies available to it at law or in equity , in the event the other Party (the “ Breaching Party ”) shall have materially breached or defaulted in the performance of any of its material obligations hereunder and such breach or default shall have continued for   [***] calendar days after wri tten notice thereof was provided to the Breaching Party by the Non - breaching Party (or, if such breach or default cannot be cured within such [***] - calendar day period, if the Breaching Party does not commence and diligently continue actions to cure such breach or default during such [***] calendar day s). 

14.3.2 Any such termination under this Section   14.3 shall become effective at the end of such [***]- calendar-day period unless the Breaching Party has cured any such noticed breach(es) or default(s) prior to the expiration of such [***] - calendar-day period, provided that if such breach(es) or default(s) cannot be cured within such [***]- calendar-day period, if the Breaching Party has commenced and diligently continued actions to cure such breach(es) or default(s), the Breaching Party shall have an additional [***] days in which to cure such breach.  The right of either Party to terminate this Agreement as provided in this Section 14.3 shall not be affected in any way by its waiver or failure to take action with respect to any previous breach or default.

14.4 T ermination for Bankruptcy .  Either Party shall have the right to terminate this Agreement upon (i) a proceeding in bankruptcy in relation to the other Party that is not dismissed

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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within ninety (90) calendar days, (ii) insolvency of the other Party, (iii) dissolution of the other Party, or (iv) winding up of the other Party. 

14.5 Termination for Patent Challenge Licensor shall have the right to terminate this Agreement upon written notice if Elanco or any Affiliate challenges the validity, scope or enforceability of or otherwise opposes any Patent Right included in the Licensor Technology that is licensed to Elanco under this Agreement (other than as may be necessary or reasonably required to assert a cross-claim or a counter-claim or to respond to a court request or order or administrative law, request or order).  If a sublicensee of Elanco challenges the validity, scope or enforceability of or otherwise opposes any Patent Right included in the Licensor Technology under which such sublicensee is sublicensed, then Elanco shall, upon written notice from Licensor, terminate such sublicense .  

14.6 Effect of Termination .    

14.6.1 E ffect of Voluntary Termination and Termination for Elanco’s Breach . In the event of termination of this Agreement by Elanco pursuant to Section 14.2 and in the event of termination of this Agreement by Licensor pursuant to Sections 14.3, 14.4 or 14.5, and on the effective date of termination of this Agreement (the “ Termination Date ”):

(a) all licenses granted by Licensor to E lanco under this Agreement will terminate, all rights of Elanco under the Licensor Technology shall revert to Licensor, and Elanco and its Affiliates and sublicensees shall cease all use of the Licensor Technology and any Licensor Confidential Information.  Following the effective date of such termination, all Products shall thereafter be deemed “ Licensor Reversion Products ”.

(b) Elanco will, as soon as reasonably practicable following the Termination Date promptly transfer and assign to Licensor all Registrations, Trademarks and Alternate Trademarks in the Territory, including promptly submitting   any necessary notices to Regulatory Authorities to effect such assignments. If applicable   laws prevent or delay the transfer of ownership of any such Registration, Trademarks and Alternate Trademarks to Licensor, Elanco will grant, and does hereby grant,   to Licensor an exclusive and irrevocable right of access and reference to such   Registration, Trademark and Alternate Trademarks, as the case may be, for purposes of developing and commercializing   the Product in the Territory, and will reasonably cooperate to   make the benefits of such Registration, Trademark and Alternate Trademarks, as the case may be, available to Licensor or its designee(s).

(c) If Elanco has any inventory of Licensor Reversion Products remaining as of the Termination Date, Elanco [***] such Licensor Reversion Products [***] of such Licensor Reversion Products (but Licensor shall be under no [***] such Licensor Reversion Products unless it agrees to do so in writing at such time).  If Licensor does not elect [***] such Licensor Reversion Products within [***] days following the Termination Date, Elanco shall have

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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the right to [***] such Licensor Reversion Products as if [***] , provided that such [***] months following the Termination Date. 

(d) Elanco shall grant, and hereby grants to Licensor, as of the effective date of such termination, a [***] license under any Patent Rights and Know-How Controlled by Elanco as of the Termination Date that Cover or claim any Improvement solely or jointly owned by Elanco, to the extent necessary to make, have made, use, sell, offer for sale and sell Licensor Reversion Products as such Licensor Reversion Products exist as of the Termination Date.

(e) All sublicenses granted prior to the Termination Date will remain in place provided that the sublicensees are in compliance with the terms and conditions of the sublicense agreements and such sublicense agreement does not impose upon Licensor obligations more extensive than those provided in this Agreement.  Any such sublicensee shall be required to enter into a direct agreement with Licensor within [***] days after termination of this Agreement.

(f) Neither Party shall be relieved of any obligation that accrued prior to the Termination Date.  For clarity, all amounts due or payable to Licensor that were accrued prior to the effective date of termination shall remain due and payable; but (except as otherwise expressly provided herein) no additional amounts shall be payable based on events occurring after the Termination Date.  

(g) Licensor shall have the right to retain all amounts previously paid to Licensor by Elanco.

14.7 Effect of Termination for Licensor Breach .   In the event of termination of this Agreement by Elanco pursuant to Section 14.3, if Elanco elects in writing to retain its licenses by written notice to Licensor within [***] days after the effective date of such termination, then:

(a) t he licenses with respect to Licensor Technology granted to Elanco under Sections 7.1 and 7.2 shall remain in effect and shall be [***] ;

(b) Licensor shall transfer to Elanco any physical or electronic embodiments of the Licensor Technology Controlled by Licensor that are necessary to enable Elanco to practice the licenses it retains as set forth in this Section 14.7;

(c) L icensor shall [***] to Elanco on or as soon as possible after the Termination Date, or if such [***] is not [***] , shall exercise its rights and perform its obligations under the [***] to enable Elanco to have the benefit thereof in connection with Products pursuant to the licenses under Sections 7.1 and 7.2, provided that in the latter case, Elanco shall, from the date on which this Agreement terminates, be responsible for all payments that become [***] pursuant to the [***] ;

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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(d) If the [***] is [***] to Elanco, Elanco shall pay to [***] incurred after the date of such [***] .  If the [***] is not [***] to by [***] , Elanco shall make payments to Licensor, and Licensor shall [***] , the amount necessary to satisfy the [***] under the [***] .  Upon expiration of the [***] , or if for other reasons no further [***] are payable to [***] under the [***] , then Elanco shall not be obligated to make any further payments under this Section 14.7.1 (d);

(e) Elanco shall pay Licensor [***] percent ( [***] %) of the amounts payable under Article 5 of this Agreement during the remaining Royalty Term; provided that the royalties payable to Licensor under this Section 14.7.1(e) shall be reduced to [***] U.S. Dollars) until such reduction in royalty payments is equal to [***] percent ( [***] %) of the [***] to have been [***] as a result of [***] resulting in [***] . For the avoidance of doubt, [***] applies to the [***] for purposes of this Section 14.7.1 (e).

(f) Nothing in this Section 14.7 shall be deemed to limit any other remedy to which either Party may be entitled by Applicable Law, except that in the event that Elanco exercises its right under Section 14.7.1(e) to reduce royalty payments to recover damages in which case Elanco would not be entitled to additionally seek damages resulting from Licensor’s breach of this Agreement under Applicable Law. 

(g) The Parties’ rights and obligations under Sections 5.4, 5.5, 5.6, 5.7, 6.2, 6.3, 6.4, 6.5, 6.6, 10.1 and 10.2 and Articles 7 and 8 shall survive such termination.

(h) L icensor shall have the right to retain all amounts previously paid to Licensor by Elanco. If Elanco does not, after a termination for material breach of Licensor, elect in writing to retain its licenses by written notice to Licensor within [***] days after the effective date of such termination, then all rights granted to Elanco pursuant to this Agreement will revert to Licensor.

14.8 Effect of Expiration .

In the event of expiration of the Term as referred to in Section 14.1,

14.8.1 all amounts due or payable to Licensor that were accrued, or that arise out of acts or events occurring, prior to the effective date of expiration shall remain due and payable; but (except as otherwise expressly provided herein) no addi tional amounts shall be payable;

14.8.2 Licensor shall have the right to retain all amounts previously paid to Licensor by Elanco ; and

14.8.3 the licenses with respect to Licensor Technology granted to Elanco under Sections 7.1 and 7.2 shall remain in effect and shall be [***] .  

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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14.9 Accrued Rights; Surviving Obligations .

14.9.1 Termination, relinquishment or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of any Party prior to such termination, relinquishment or expiration including, without limitation, any payment obligations under Article  5 and any and all damages arising from any breach hereunder. 

14.9.2 In addition to the provisions of this Agreement which expressly survive as set forth elsewhere in this Agreement, all of the Parties’ rights and obligations under , and/or the provisions contained in, Sections 6.4, 6.5, 6.6, 10.3, 11.4.2, 12.2, 12.3, 12.4, 12.5, 14.6, 14.7, 14.8, 14.9 and 14.10 and Articles 9, 13, 16 and 17 shall survive the expiration, termination ,   or relinquishment of this Agreement.

14.10 Section 365(n) of the Bankruptcy Code .  All rights and licenses granted under or pursuant to any Section of this Agreement are and shall otherwise be deemed to be for purposes of Section 365(n) of Title 11, of the United States Code (the “ Bankruptcy Code ”) licenses of rights to “intellectual property” as defined in Section 101(56) of the Bankruptcy Code.  The Parties shall retain and may fully exercise all of their respective rights and elections under the Bankruptcy Code.  Upon the bankruptcy of any Party, the non-bankrupt Party shall further be entitled to a complete duplicate of, or complete access to, any such intellectual property, and such, if not already in its possession, shall be promptly delivered to the non-bankrupt Party, unless the bankrupt Party elects to continue, and continues, to perform all of its obligations under this Agreement.  

15. Force Majeure.

Any delay in the performance of any of the duties or obligations of either Party hereto (except the payment of money due hereunder) shall not be considered a breach of this Agreement, and the time required for performance shall be extended for a period equal to the period of such delay, if such delay has been caused by or is the result of acts of God; acts of public enemy; insurrections; riots; injunctions; embargoes; labor disputes, including strikes, lockouts, job actions, or boycotts; fires; explosions; earthquakes; floods; shortages of energy; governmental prohibition or restriction; or other unforeseeable causes beyond the reasonable control and without the fault or negligence of the Party so affected.  The Party so affected shall give prompt notice to the other Party of such cause, and shall take whatever reasonable steps are necessary to relieve the effect of such cause as rapidly as reasonably possible.

16. Compliance with Laws and Regulations

16.1 Compliance with this Agreement

Each of the Parties shall, and shall cause their respective Affiliates to, comply in all material respects with the terms of this Agreement .  

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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16.2 Compliance with Applicable Law s .  The Parties have complied and will comply with all Applicable Laws, regulations and industry codes dealing with the subject matter of this Agreement including, without limitation, conflicts of interest, corruption or bribery, including, if applicable, the U.S. Foreign Corrupt Practices Act of 1977, as amended, and any laws enacted to implement the Organization of Economic Cooperation and Development (“ OECD ”) Convention on Combating Bribery of Foreign Officials in International Business Transactions.

16.3 Compliance with Party Specific Regulations .   The Parties agree to cooperate with each other as may reasonably be required to ensure that each is able to fully meet its obligations with respect to the Party Specific Regulations applicable to it. Neither Party shall be obligated to pursue any course of conduct that would result in such Party being in material breach of any Party Specific Regulation applicable to it.  All Party Specific Regulations are binding only in accordance with their terms and only upon the Party to which they relate.

16.4 Compliance with Internal Compliance Codes . All Internal Compliance Codes shall apply only to the Party to which they relate.  The Parties agree to cooperate with each other to insure that each Party is able to comply with the substance of its respective Internal Compliance Codes and, to the extent practicable, to operate in a manner consist with its usual Compliance related processes. 

16.5 Compliance Agreement . From time to time, the Parties shall discuss activities necessary to insure Compliance.  If either Party requests, the Parties will negotiate in good faith and execute a written Compliance Agreement that will set forth and define the compliance policies, standards, and procedures the Parties will adhere to when conducting activities under this Agreement.   The Compliance Agreement may also include provisions relating to interactions between the respective compliance organizations of the Parties, sharing of  Compliance related information, execution of training, implementation and monitoring activities, and resolution of Compliance issues that may arise in accordance the rule established in Section 16.6.

16.6 Responsibility for Compliance; Disputes Regarding Compliance Matters .  Each Party is solely responsible to ensure Compliance by it and its Affiliates. With respect to joint activities, in the event of any conflict between the Parties as to how to ensure Compliance that the Parties are unable to resolve, the more conservative view (i.e., the view least likely to risk non-Compliance) shall prevail.

16.7 Review Procedure for Marketing Materials and Activities . Any detailing, promoting, communication, marketing and selling activities, including promotional and educational materials and messages, used in connection with the activities contemplated by this Agreement shall comply in all material respects with Applicable Laws and Party Specific Regulations, and be consistent with the substance of the Internal Compliance Codes of both Parties. The Parties shall ensure that appropriate joint prior review procedures are established.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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17. Miscellaneous.

17.1 Relationship of Parties .  Nothing in this Agreement is intended or shall be deemed to constitute a partnership, agency, employer-employee or joint venture relationship between the Parties.  No Party shall incur any debts or make any commitments for the other, except to the extent, if at all, specifically provided herein.

17.2 Assignment .  Except pursuant to a sublicense permitted under this Agreement, neither Party shall be entitled to assign its rights or delegate its obligations hereunder without the express written consent of the other Party hereto, except that each Party may assign its rights and transfer its duties hereunder to (i) an Affiliate or (ii) any acquirer of all or substantially all of its business (or that portion thereof to which this Agreement relates) or in the event of such Party’s merger, consolidation or involvement in a similar transaction.  No assignment and transfer shall be valid or effective unless done in accordance with this Section 17.2 and unless and until the assignee/transferee shall agree in writing to be bound by the provisions of this Agreement.

17.3 Books and Records .  Any books and records to be maintained under this Agreement by a Party shall be maintained in accordance with GAAP.

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

17.5 Notice .  Any notice or request required or permitted to be given under or in connection with this Agreement shall be deemed to have been sufficiently given if in writing and personally delivered or sent by certified mail (return receipt requested), facsimile transmission (receipt verified), or overnight express courier service (signature required), prepaid, to the Party for which such notice is intended, at the address set forth for such Party below:

(a) In the case of Licensor, to:

Aratana Therapeutics, Inc.

Attn: General Counsel

11400 Tomahawk Creek Parkway,

Suite 340,

Leawood, KS 66211

Facsimile No.: (913) 273- [***]

Telephone No. . (913) 353-1000

With copy to:

Latham & Watkins, LLP

Attn: Peter Handrinos

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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200 Clarendon St,

Boston, MA 02116

Facsimile No.: (617) 948- [***]

Telephone No.: (617) 948-6000

(b) in the case of Elanco, to:

Elanco Animal Health

2500 Innovation Way

Greenfield, IN

Facsimile No.: 317-276- [***]

Telephone No.: 317-277- [***]

Attention: General Counsel

With a copy to:

Elanco Animal Health

2500 Innovation Way

Greenfield, IN 

Facsimile No.: 317-433- [***]

Telephone No.: 317-277- [***]

Attention: General Patent Counsel/EAM

or to such other address for such Party as it shall have specified by like notice to the other Party, provided that notices of a change of address shall be effective only upon receipt thereof.  With respect to notices given pursuant to this Section  17.5 : (i) if delivered personally or by facsimile transmission, the date of delivery shall be deemed to be the date on which such notice or request was given; (ii) if sent by overnight express courier service, the date of delivery shall be deemed to be the next business day after such notice or request was deposited with such service; and (iii) if sent by certified mail, the date of delivery shall be deemed to be the third business day after such notice or request was deposited with the U.S. Postal Service.

17.6 Use of Name .  Except as otherwise provided herein, neither Party shall have any right, express or implied, to use in any manner the name or other designation of the other Party or any other trade name, trademark or logo of the other Party for any purpose in connection with the performance of this Agreement.

17.7 Waiver Neither Party may waive or release any of its rights or interests in this Agreement except in writing.  The failure of either Party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition.  No waiver by either Party of any condition or term in any one or more instances shall be construed as a continuing waiver of such condition or term or of another condition or term.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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17.8 Severability If any provision hereof should be held invalid, illegal or unenforceable in any jurisdiction, the Parties shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties and all other provisions hereof shall remain in full force and effect in such jurisdiction and shall be liberally construed in order to carry out the intentions of the Parties hereto as nearly as may be possible.  Such invalidity, illegality or unenforceability shall not affect the validity, legality or enforceability of such provision in any other jurisdiction.

17.9 Amendment .  No amendment, modification or supplement of any provisions of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized officer of each Party.

17.10 Governing Law .  This Agreement shall be governed by and interpreted in accordance with the laws of the [***] , without regard to conflict of law principles.

17.11 Dispute Resolution .  

17.11.1 The Parties recognize that disputes as to certain matters may from time to time arise during the Term which relate to a Party’s rights and/or obligations hereunder. 

(a) If the Parties cannot resolve any such dispute within [***] calendar days after notice of a dispute from one Party to another, either Party may, by notice to another, have such dispute referred to the [***] .  

(b) The [***] , with the possibility of [***] , shall meet promptly to negotiate in good faith the matter referred and to determine a resolution.  During such period of negotiations, any applicable time periods under this Agreement shall be tolled.  If the [***] is unable to resolve the dispute within [***] days following referral of such dispute to the [***] , the dispute shall be [***] , or, if the Parties mutually agree in writing, [***] to the [***] (or equivalent) of each Party.

(c) If the [***] or the [***]   (or equivalent) of each Party, as applicable are unable to unanimously (in each case) resolve the dispute in a timely manner, which shall in no case be more than [***] calendar days after the matter was [***] , or the [***] (or equivalent), the matter may be referred for resolution through arbitration in accordance with the arbitration provisions set forth in Section 17.11.2 .

17.11.2  A dispute that remains unresolved after the [***] provided in Section 17.11.1, and that arises out of or relate to this Agreement, or the breach thereof, shall be settled by arbitration administered by the American Arbitration Association in accordance with the Commercial Arbitration Rules, and judgment may be entered in any court having jurisdiction thereof. The place of arbitration shall be New York, New York.  Such arbitration shall be conducted by three (3) arbitrators. Within [***] days after the commencement of arbitration,

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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each party shall select one person to act as arbitrator and the two selected shall select a third arbitrator within ten days of their appointment.  If the arbitrators selected by the parties are unable or fail to agree upon the third arbitrator, the third arbitrator shall be selected by the American Arbitration Association .   Each arbitrator shall have at least ten (10) years’ experience with disputes involving the pharmaceutical industry. The award shall be made within [***] of the appointment of the third arbitrator, and the arbitrators shall agree to comply with this schedule before accepting appointment.  However, this time limit may be extended by the arbitrators for good cause shown, or by mutual agreement of the parties. The arbitrator(s) shall award to the prevailing party, if any, as determined by the arbitrators, all of their costs and fees. “Costs and fees” mean all reasonable pre-award expenses of the arbitration, including the arbitrators’ fees, administrative fees, travel expenses, out-of-pocket expenses such as copying and telephone, court costs, witness fees, and attorneys’ fees. Except as may be required by law, neither a party nor an arbitrator may disclose the existence, content, or results of any arbitration hereunder without the prior written consent of both parties .  

17.12 Entire Agreement .  This Agreement, together with the Exhibits hereto, the Co-Promotion Agreement, the Supply Agreement, the Quality Agreement, the Pharmacovigilance Agreement and any Exhibits thereto, and the DOP, as updated, sets forth the entire agreement and understanding between the Parties as to the subject matter hereof and merges all prior discussions and negotiations between them, and neither of the Parties shall be bound by any conditions, definitions, warranties, understandings or representations with respect to such subject matter other than as expressly provided herein or as duly set forth on or subsequent to the date hereof in writing and signed by a proper and duly authorized officer or representative of the Party to be bound thereby. 

17.13 T he Mutual Nondisclosure Agreement by and between the Parties dated [***]   (as extended by letter agreement dated [***] and effective as of [***] ), and the Confidential Disclosure Agreement by and between the Parties dated [***]   (collectively the “ Prior Confidentiality Agreements ”) will be superseded by this Agreement, and all disclosures made by either Party under any of the Prior Confidentiality Agreements shall, following the Effective Date, be deemed to have been made under, and shall hereafter be subject to, the terms and conditions of this Agreement. 

17.14 Parties in Interest . All of the terms and provisions of this Agreement shall be binding upon, inure to the benefit of and be enforceable by the Parties hereto and their respective permitted successors and assigns.

17.15 Descriptive Headings .  The descriptive headings of this Agreement are for convenience only, and shall be of no force or effect in construing or interpreting any of the provisions of this Agreement.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

45

 


 

Confidential Treatment Requested by Aratana Therapeutics, Inc.

17.16 Construction of Agreement .  The terms and provisions of this Agreement represent the results of negotiations between the Parties and their representatives, each of which has been represented by counsel of its own choosing, and neither of which has acted under duress or compulsion, whether legal, economic or otherwise.  Accordingly, the terms and provisions of this Agreement shall be interpreted and construed in accordance with their usual and customary meanings, and each of the Parties hereto hereby waives the application in connection with the interpretation and construction of this Agreement of any rule of law to the effect that ambiguous or conflicting terms or provisions contained in this Agreement shall be interpreted or construed against the Party whose attorney prepared the executed draft or any earlier draft of this Agreement.

17.17 Counterparts . This Agreement may be signed in counterparts, each and every one of which shall be deemed an original, notwithstanding variations in format or file designation which may result from the electronic transmission, storage and printing of copies of this Agreement from separate computers or printers.  Facsimile signatures shall be treated as original signatures.



Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

46

 


 

Confidential Treatment Requested by Aratana Therapeutics, Inc.

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



ARATANA THERAPEUTICS, INC.





By:           /s/ Steven St. Peter

Name: Steven St. Peter, M.D.

Title: President & CEO





ELI LILLY AND COMPANY THROUGH ITS ELANCO ANIMAL HEALTH DIVISION





By:           /s/ John C. Lechleiter

Name: John C. Lechleiter, PhD

Title: Chairman, President and CEO

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

47

 


 

Confidential Treatment Requested by Aratana Therapeutics, Inc.

 

Exhibit 7.4

Trademarks



 

 

 

 

 

MARK NAME

COUNTRY

Application NO.

APPLICATION DATE

REGISTRATION NO.

REGISTRATION DATE

[***]

[***]

[***]

[***]

[***]  

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

 

[***]

[***]

[***]

[***]

 

 

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]  

[***]

[***]

[***]

[***]

[***]

[***]

 

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

48


 

Confidential Treatment Requested by Aratana Therapeutics, Inc.

 

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]  

[***]

[***]  

[***]

[***]

[***]

[***]

[***]

 

 

[***]

[***]

[***]

[***]

 

 

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

   

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

 

[***]

[***]

[***]

[***]

[***]  

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

49


 

Confidential Treatment Requested by Aratana Therapeutics, Inc.

 

[***]

[***]

[***]  

[***]

[***]

[***]

[***]

[***]

[***]  

[***]

 

 





Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

50


 

Confidential Treatment Requested by Aratana Therapeutics, Inc.

 

Exhibit 8.1.2 (a)

Supply Term Sheet



 

Term

Summary

Parties:

Elanco Animal Health, a division of Eli Lilly and Company (“Elanco”)

Aratana Therapeutics, Inc. (“Aratana”)

Definitions

Terms with capital letters used in this term sheet shall have the same meaning assigned to them in the Collaboration, License, Development and Commercialization Agreement between Elanco and Aratana (the “License Agreement”), unless defined differently in this term sheet.

Structure:

This term sheet sets forth the terms of the “Master Supply Agreement” the Parties intend to govern supply terms.

Work Order for Galliprant.

Term

Term will expire on the earlier of a) Elanco’s assumption of responsibility for manufacturing as set out in the License Agreement or b) [***] .

The Work Order will have its own length of term that reflects the supply strategy, but in no event will it extend beyond [***] .

Termination:

Each Party’s right to terminate the Master Supply Agreement will be consistent with its termination rights under the License Agreement.

Manufacture of Products

Products is defined as each of the following , and collectively as all of the following :  

Galliprant in [***] ,

[***] , and

[***] .

Agreement to supply Products:

Products will be supplied by Aratana.

Aratana intends to sub-contract the manufacturing, packaging and labelling of the finished form Products and APIs to Third Party manufacturers . Aratana may not change Third Party manufacturers without prior written consent of Elanco.

Elanco shall assume responsibility for manufacturing of the Products no later than [***] and as further set forth in the License Agreement. Elanco shall be permitted to self-manufacture all or a portion of the Products or purchase all or a portion of the Products from a Third Party source.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by Aratana Therapeutics, Inc.

 

Manufacture of Products:

Products to be supplied in accordance with Compliance requirements and generally accepted applicable industry standards and practices and in compliance with all Applicable Laws and any relevant description or specification in the Master Supply Agreement, including the Product Specifications, the Manufacturing Responsibilities Document(s) (“ MRD ”) , and the Quality Agreement.

[***] will maintain all licences, permissions, authorisations, consents and permits needed to manufacture and supply the Products during the term of, and in accordance with, the terms of the Master Supply Agreement.

Aratana will not, without Elanco's prior written consent (not to be unreasonably withheld or delayed) , (i) make any [***]; (ii) implement any [***] to the process(es) or equipment used to manufacture the Product that could affect the manufacturing process validation or deviate from the regulatory registration requirements, or ( iii ) manufa cture the Product [***].  Elanco will be deemed to have provided consent to any request therefor unless Elanco responds to any such request by Aratana within [***] after receipt of a request for consent.  Such response may include a request for additional time to make a decision on the request for consent.

Quality Agreement, Manufacturing Responsibilities Document

[***] after [***], and in any event before any supply under the Master Supply Agreement commences, and in connection with the creation of any Work Order, as applicable, the Parties (or in the case of Elanco, its designated Affiliate) shall enter into the Quality Agreement and applicable MRD.  The obligations set forth in the MRD(s) and the Quality Agreement , and any amendments thereto, shall become part of, and be incorporated into this Master Supply Agreement and the relevant Work Order.

The Quality Agreement will contain industry standard provisions, including but not limited to, rights to access and audit facilities and systems (with reasonable limitations on scope and duration), access to production records, notification of external inspections, etc., subject to standard confidentiality provisions.  

Stability Testing:

[***] will continue to perform stability testing of the Products to support product that has been supplied to the market in accordance with current commercial practice by [***] and its Affiliates, in accordance with those that it completed before the Effective Date.

Reference Standards

Aratana will supply [***] reference standards during any Technology Transfer to Elanco and provide [***] following the Technology Transfer

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

52


 

Confidential Treatment Requested by Aratana Therapeutics, Inc.

 

Oversight:

Ongoing manufacturing and supply oversight through the Manufacturing Subcommittee as set out in the License Agreement.

Technical transfer assistance:

[***] is responsible for the cost of the technical transfer and validation activities for API to the [***] Third Party Manufacturer, drug product at [***] and packaging at [***] in the U.S. 

When Elanco assumes responsibility for manufacturing, each Party shall coo perate with, and shall use Commercially Reasonable Efforts to complete as promptly as possible, the transfer from Aratana or Aratana’s contract manufacturer or analytical service provider to Elanco or Elanco’s designated contract manufacturer or contract analytical service provider of Aratana’s technology for formulation, manufacturing and packaging of the Products to enable Elanco to manufacture the Product or have the Product manufactured by a third party. 

Labelling and Packaging:

[***] is responsible for ensuring that all information on labels and leaflets that accompany Products is accurate and in line with the Compliance requirements.

Elanco to develop new packaging and labelling designs for Products.

Costs incurred by Aratana’s suppliers and CMOs in implementing new packaging designs for the Products will [***].

Forecasting:

No less than [***] Days before the beginning of each month, Elanco to give Aratana a twelve-month non-binding, rolling forecast for the Products.

On receipt of each forecast, the parties will discuss and agree a delivery schedule.

For each Product, the first [***] part of the forecast will be deemed binding and constitute firm orders.

Orders:

By the first [***], Elanco to issue a purchase order to Aratana for the Products to be purchased in the next relevant period for which a binding forecast has been given but for which a purchase order has not yet been issued.

Purchase orders to be in the form set out in Master Supply Agreement.

Delivery:

Products are to be delivered consistent with the delivery terms [***] with [***]

Products will be shipped [***], as agreed between the Parties.

Delays in delivery which are greater than [***] days entitle Elanco to reject an order.

Title and Risk:

With respect to Product , or other materials shipped pursuant to the Master Supply Agreement, [***] shall [***] title and will [***] risk of loss or other damage until [***], consistent with the delivery terms.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

53


 

Confidential Treatment Requested by Aratana Therapeutics, Inc.

 

Acceptance and Rejection of Products:

Elanco to notify Aratana within [***] days of delivery of each order whether the Products supplied conform with the certificate of analysis .  After [***] days, the Products are deemed accepted and Elanco can no longer claim non-conformance in respect of the Products, except in respect of any latent defects that are not apparent from reasonable physical inspection of those Products.

If there are manufacturing defects, Aratana will [***] to Elanco, at Elanco’s election.  On [***], Aratana has no further liability in respect to the non-conforming batch.

Supply Price:

Elanco will pay Aratana [***] U.S. Dollars per kilogram for API material purchased [***] and will pay [***] for tableting and packaging the Product in accordance with Exhibit A.

Aratana will pass through a fair and equitable allocation of any [***] that are not solely attributable to the Products but which Aratana benefits due to supply of Products.

 

Payment:

Elanco to pay the full amount invoiced within [***] days of receipt of the invoice.

Elanco may withhold payment of any amount that it may reasonably dispute in good faith until such dispute is resolved.

Elanco issues payments on a [***] basis.  All invoices which have reached their payment term maturity will be accumulated and paid in the next [***] payment.

Taxes:

The Parties would agree to customary language with respect to Taxes including income, property and VAT Taxes.

Product Recall:

Product recalls and withdrawal of Product are handled in accordance with the License Agreement , the Pharmacovigilance Agreement and the Quality Agreement.

Adverse Events, Complaints and Returns:

If during the course of supplying Product under the Master Supply Agreement, Aratana, Aratana’s representatives , or Aratana’s subcontractors become aware of an Adverse Event or Product Complaint, Aratana will follow such procedures outlined in the License Agreement ,   the Pharmacovigilance Agreement or Quality Agreement , as applicable.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

54


 

Confidential Treatment Requested by Aratana Therapeutics, Inc.

 

Regulatory Matters:

Aratana to notify Elanco of any regulatory inquiry or notified regulatory authority inspection of facilities used in the manufacturing, packaging, labelling, storage or handling of the Products and APIs as required under the Pharmacovigilance Agreement and the Quality Agreement

In the event there are written observations (or any other written communication) by a Governmental Authority which involve a Product, or any proposed written response by Aratana to any such inspection, Elanco will be informed within [***] and be provided with copies of all documentation within [***], and will have the opportunity to review and provide input to the response.

Compliance with Applicable Laws

In the performance of any applicable services , supply of Products and obligations under the Master Supply Agreement, Aratana shall comply with all Applicable Laws and professional or good practice standards or codes applicable to the nature of the Products .  

Indemnification:

Elanco will indemnify and hold harmless Aratana and its Affiliates from all losses (including Aratana’s own losses and those resulting from third party claims) to the extent arising from:

o Elanco’s gross negligence or wilful misconduct;

o any breach of the Elanco’s obligations under the Master Supply Agreement;

o any breach of Applicable Law by Elanco;

Aratana will indemnify and hold harmless Elanco from all losses (including Elanco’s own losses and those resulting from third party claims) to the extent arising from:

o Aratana’s gross negligence or wilful misconduct;

o any breach of Aratana’s obligations under the Master Supply Agreement;

o any breach of Applicable Law by Aratana or its Affiliates;

o a ny [***] claim (e.g. where a method of [***] employed by Aratana becomes the subject of a claim by a third party against the Elanco that the method infringes the [***] rights of the third party).

 

Confidentiality

Standard confidentiality requirements consistent with License Agreement.

Insurance

[***] must procure and maintain [***] insurance policies (or equivalent self-insurance) in respect of personal injury, death and property damage on its property.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

55


 

Confidential Treatment Requested by Aratana Therapeutics, Inc.

 

Force Majeure:

Neither Party is liable for any failure or delay in performing its obligations under the Master Supply Agreement and ancillary agreements if caused by force majeure , except as explicitly agreed in the Master Supply Agreement.

If the force majeure continues for [***] Business Days, Aratana and Elanco will negotiate in good faith to agree a solution.

If Force Majeure continues for [***] days and a party reasonably believes it will not come to an end, such party can terminate on [***] days’ written notice.  All exclusivity provisions affected by the force majeure shall be suspended during the occurrence of any force majeure .

Disaster Recovery and Business Continuity Plan

At all times during the course of this Agreement, Aratana will obligate its subcontractors to maintain and adequately support a disaster recovery and business continuity program ("Disaster Recovery and Business Continuity Program") that ensures the continuous operation and, in the event of an interruption, the recovery of all material business functions needed to meet Aratana's obligations under this Agreement.  The Disaster Recovery and Business Continuity Program will include at a minimum a detailed disaster recovery plan, which describes the management methodology, management team, emergency contact persons, and specific plans for potential risks that may disrupt supply of Product and Aratana’s operations.  The plan shall meet and be consistent with generally accepted industry standards.  Upon demand, Aratana will provide a copy and overview of such plans to Elanco.

Assignment:

The Master Supply Agreement shall be assignable in accordance with the assignment provision of the License Agreement .  

Governing Law and Venue:

Any disputes under or in connection with the Master Supply Agreement shall be resolved in accordance with the License Agreement.



Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

56


 

Confidential Treatment Requested by Aratana Therapeutics, Inc.

 

EXHIBIT A



 

 

 

 

 

 

 

 

[***]

 

 

 

 

 

 

 

 

 

$5,500 

 

 3 Quoted price [***]

 

# tablets

per bottle

1 API ( [***] /kg USD)

 

2 Shipping of API [***]

[***],

[***],

[***]

[***]

[***]

[***]

[***]

Total [***]

[***]

[***]

[***]

[***]

[***]           

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]  

[***]

[***]

[***]

[***]

[***]

[***]

[***]  

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

 

 

 

 

 

 

 

Assumptions:

 

 

 

 

 

 

1   [***]

 

 

 

 

 

 

 

 

 

2   [***]

 

 



 

 

 

 

 

 

 

 

3   [***]

 

   

[***]

 

 

 

 

 



Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

57


 

Confidential Treatment Requested by Aratana Therapeutics, Inc.

 

Exhibit 9.3.1

Licensor Patents



 

 

 

 

 

 

ARA-01

Patent No.

App. No.

Filing Date

Status

Owner

Priority Date

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

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[***]

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[***]

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[***]

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[***]

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[***]

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[***]

 

[***]

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[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

58


 

Confidential Treatment Requested by Aratana Therapeutics, Inc.

 

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

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[***]

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[***]

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[***]

[***]

[***]

[***]

[***]

[***]

 

[***]

[***]

[***]

[***]

[***]

[***]

 

[***]

[***]

[***]

[***]

[***]

[***]

 

[***]

[***]

[***]

[***]

[***]

[***]

 

[***]

[***]

[***]

[***]

[***]

[***]

 

[***]

[***]

[***]

[***]

[***]

[***]

 

[***]

[***]

[***]

[***]

[***]

[***]

 

[***]

[***]

[***]

[***]

[***]

[***]

 

[***]

[***]

[***]

[***]

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

59


 

Confidential Treatment Requested by Aratana Therapeutics, Inc.

 

[***]

[***]

 

[***]

[***]

[***]

[***]

[***]

[***]

 

[***]

[***]

[***]

[***]

[***]

 

[***]

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[***]

 

[***]

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[***]

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[***]

 

[***]

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[***]

[***]

 

[***]

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[***]

[***]

 

[***]

[***]

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[***]

[***]

[***]

 

[***]

[***]

[***]

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[***]

[***]

[***]

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[***]

[***]

[***]

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[***]

[***]

[***]

[***]

[***]

[***]

 

[***]

[***]

[***]

[***]

[***]

[***]

 

[***]

[***]

[***]

[***]

[***]

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

60


 

Confidential Treatment Requested by Aratana Therapeutics, Inc.

 

[***]

 

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]





 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

61


 

 

Exhibit 12.1.3

Agreed Form Press Release



Aratana, Elanco announce Global Strategic Collaboration

Agreement to expand Elanco’s companion animal portfolio, extend global reach of GALLIPRANT® (grapiprant tablets) in canine osteoarthritis therapy



Greenfield, IN and Leawood, KS – Elanco Animal Health, a division of Eli Lilly and Company (NYSE: LLY) and Aratana Therapeutics, Inc. (NASDAQ: PETX), today announced that Elanco has licensed animal health rights to Aratana’s Galliprant (grapiprant tablets), an FDA-approved therapeutic for the control of pain and inflammation associated with osteoarthritis in dogs. The agreement grants Elanco exclusive rights to develop, manufacture, market, and commercialize Galliprant globally, and co-promote the product with Aratana in the United States.

“This deal expands Elanco’s robust companion animal portfolio, which will now give our customers and their patients a spectrum of treatments for managing osteoarthritic pain,” said Jeff Simmons, president of Elanco Animal Health.  “ At Elanco, we understand the powerful role healthy animals play in making life better. As pets become important parts of our families, the need to help them live longer, healthier, higher quality lives increases as well.”

The most common type of arthritis in dogs, osteoarthritis affects up to 20 percent of the adult canine population. 1 Osteoarthritis can result when joint cartilage - the protective material that cushions and allows smooth movement in a joint – becomes thin and breaks down over time, leading to pain and inflammation in the joint. The frequent result is stiffness and a reluctance to run, jump, or even climb steps.

“Aratana understands the value of relationships with the right collaborators,” said Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics. “We believe that this collaboration with Elanco, a leading animal health company, is a watershed event for the emerging pet biotech sector and further validates our focus on the pet therapeutics opportunity.”

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  JAVMA, Vol 236, No. 1, January 1, 2010 p 59-66

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Under the terms of the agreement, Aratana will receive an upfront payment of $45 million, additional payments upon achievement of certain development, regulatory and sales milestones up to $83 million, and co-promotion fees and royalty payments.



Contacts:

For Elanco inquires:

Keri McGrath Happe

Communications Manager

Elanco Animal Health

T: +1-317-370-8394

E: mcgrath_happeks@elanco.com





For Aratana inquires:

Craig Tooman

Aratana Therapeutics, Inc.

ctooman@aratana.com

(913) 353-1026





Important Safety Information 

GALLIPRANT® (grapiprant tablets) is for use in dogs only. Do not use in dogs younger than 9 months of age and less than 8 lbs (3.6 kg), dogs used for breeding, or in pregnant or lactating dogs. Adverse reactions in dogs may include mild gastrointestinal effects including, vomiting, diarrhea and decreased appetite. Should not be used in dogs that have a hypersensitivity to grapiprant. Avoid use with COX-inhibiting NSAIDs or corticosteroids. If used long term appropriate monitoring is recommended. Please see the full Prescribing Information .  

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ABOUT ELANCO

Elanco, a division of Eli Lilly and Company, provides comprehensive products and knowledge services to improve animal health and food-animal production in more than 70 countries around the world. With a global presence of approximately 7,000 people and offices in more than 40 countries, Elanco anticipates, serves and supports the diverse and evolving needs of its customers--from veterinarians to food producers to all those concerned with animal health--to help them address the challenges of a diverse and changing world. Together with our customers, we are committed to raising awareness about global food security, and celebrating and supporting the human-animal bond. Additional information about Elanco is available at   www.elanco.com ,   or follow us @Elanco.





ABOUT ARATANA THERAPEUTICS
Aratana Therapeutics is a pet therapeutics company focused on licensing, developing and commercializing innovative pharmaceutical products for dogs and cats. Aratana believes that it can leverage the investment in the human pharmaceutical industry to bring therapeutics to pets in a capital and time efficient manner. The Company has multiple products approved by the Food and Drug Administration's Center for Veterinary Medicine or licensed by the United States Department of Agriculture. The Company's pipeline includes therapeutic candidates targeting pain, inappetence, cancer, viral diseases, allergy and other serious, unmet or underserved medical needs. Aratana believes providing innovative options to veterinarians and pet owners will help manage pets' medical needs safely and effectively, resulting in longer and improved quality of life for pets. For more information, please visit   www.aratana.com .



This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about the collaboration between Aratana and Elanco, and reflects Lilly, Elanco’s and Aratana’s current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that the research collaboration will yield successful results, that either company will achieve the anticipated benefits of that the results will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's and Aratana’s most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission, respectively Except as required by law, Elanco and Aratana undertakes no duty to update forward-looking statements to reflect events after the date of this release.



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EXHIBIT 10.4

CO-PROMOTION AGREEMENT

This   Co-Promotion   Agreement ( this “ Agreement ) , effective as of April 22, 2016 (the “ Effective Date ”), is entered into by and between Aratana Therapeutics, Inc., a Delaware corporation and having its office at   11400 Tomahawk Creek Parkway, Suite 340, Leawood, KS  66211 (“ Aratana ”) and Eli Lilly and Company , an Indiana corporation, operating on behalf of its Elanco Animal Health division and having its office at 2500 Innovation Way, Greenfield, Indiana 46140 and its Affiliates (“ Elanco ”).

WITNESSETH THAT:

WHEREAS, the Parties entered into the Collaboration, License, Development and Commercialization Agreement effective as of the Effective Date (the “ License Agreement ”);

WHEREAS, pursuant to the License Agreement, Aratana granted to Elanco a license under certain rights with respect to the Product; and

WHEREAS, the Parties have agreed to co-promote the Product in the United States in accordance with the terms and conditions contained in the License Agreement and this Agreement.

NOW, THEREFORE ,   in consideration of the foregoing preliminary statements and the mutual agreements and covenants set forth herein, the Parties (as defined below) hereby agree as follows:

1. DEFINITIONS

As used in this Agreement, capitalized terms shall have the meanings set forth in the License Agreement ,   and when not found in the License Agreement , shall have the meanings set forth below.

1.1 Aratana Report ” means Aratana’s written report setting forth the following information:  (i) the total number of [***] that [***] in the Co-Promotion Territory in a given time period ; and (ii) the [***] to [***] or [***] , by Aratana in the Co-Promotion Territory in such time period .

1.2 Brand Plan ” means the branding strategy [***] for the Co-Promotion Territory within [***] days after the Effective Date .  The Brand Plan shall be consistent with this Agreement and contain details surrounding the [***] and [***] and other matters related to the sale and distribution of the Product in the Co-Promotion Territory. 

1.3 Commercialization Expense(s) ” means all expenses incurred by Elanco in the Co-Promotion Territory in relation to the Product [***] in connection with (i) marketing, advertising, and promoting Product ( including [***] and [***] , but excluding direct [***] ), (ii) Promotional Materials used for training of sales representatives, including distributor sales representatives, and communication with veterinarians and corporate accounts, and (iii) [***] which relate to the

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

 


 

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Product . Commercialization Expenses shall not include Selling Expenses of each Party as described in Section 9.3. 

1.4 Date of Launch ” means the First Commercial Sale of the Product in the Co-Promotion Territory.

1.5 Detail(s) or Detailing ” means a person-to-person meeting between a veterinarian or corporate account representative and a professional representative of Aratana or Elanco during which a Presentation of Product is made to such veterinarian or corporate account as the first or second product mentioned. 

1.6 Presentation ” shall mean that the Elanco or Aratana representative discusses with such veterinarian or corporate account representative the uses and benefits of Product.

1.7 Promotional Materials ” has the meaning set forth in Section 7.1. 

1.8 Elanco Sales Activity Report ” means Elanco’s written report setting forth the following information:  (i) sales of the Product in the Co-Promotion Territory [***] ; (ii) [***] that promoted Product in the Co-Promotion Territory in such time period ; and (iii) [***] to [***] or [***] , by Elanco in the Co-Promotion Territory in such time period .

1.9 Gross Margin ” means [***] of [***] .

1.10 Policies and Procedures ” means a program of sales and promotion policies and procedures developed by Aratana that are substantially in line with Elanco’s policies and procedures, including without limitation, those related to off label promotion, ethical interactions with customers and privacy. 

1.11 Progress Report ” shall mean the report prepared by Elanco and submitted to the Commercial Coordination Subcommittee for review and comment [***] with respect to Products in the Territory.  The Progress Report shall provide a high level overview of activities conducted [***] , and [***] for the [***] , including: (i) the [***] supporting the Product, (ii) the [***] for [***] , (iii) [***] planned for the Product, (iv) [***] to be made with respect to the Products, (v) the [***] with respect to the Product, and (vi) such other matters as agreed upon by the CCC.

1.12 “Region” means the Elanco reporting regions of [***] .

1.13 Sample (s) or Sampling ” means quantities of Product given to veterinarians, corporate accounts or other customers for no or minimal consideration in compliance with Applicable Laws, as part of the marketing, advertising and promotion of the Product.

1.14 Selling Expenses” has the meaning set forth in Section 9.3.

 

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

 

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2. CO-PROMOTION RIGHTS  

The general licenses granted and the Parties’ related rights and obligations thereto in the Co-Promotion Territory are as set forth in the License Agreement in addition to the following:

(i) Aratana shall be the initial NADA holder for the Product, subject to the provisions, including without limitation Elanco’s eventual assumption of Registrations, pursuant to Section 10.1 of the License Agreement;

(ii) Elanco shall make and record all sales of Product;

(iii) Aratana shall supply all Product to Elanco pursuant to the Supply Agreement, subject to Elanco’s right to assume manufacturing as set forth in Article 8 of the License Agreement;

(iv) Elanco shall be responsible for distribution of all Product (other than Samples that Aratana is permitted to distribute pursuant to the Brand Plan) ; and

(v) In accordance with this Agreement, including without limitation   Section 6.1(b), and the Brand Plan,   Aratana and Elanco (or Elanco's Affiliates and/or Sublicensees) shall promote and market the Product.

3. COMMITTEES AND BRAND PLAN

3.1 Commercial Coordination Subcommittee .     T he Commercial Coordination Subcommittee, as referenced in Article 2 of the License Agreement, will coordinate the implementation of the Brand Plan. 

3.2 Final Decision Making Authority .  In the event of a disagreement between the members of the Commercial Coordination Subcommittee on matters within its jurisdiction and [***] to the [***] and the [***] , the ESC member appointed by [***] will take the final decision, as set forth under Article 2 of the License Agreement ; provided that in no event may [***] exercise its final decision right to require that [***] that would (i) [***] , (ii) [***] or [***] , or (iii) [***] of [***]

3.3 Brand Plan .  The initial Brand Plan shall be [***] to the Commercial Coordination Subcommittee within [***] days of the Effective Date of this Agreement.  The Brand Plan may be [***] from time to time , consistent with the terms and conditions of this Agreement and the License Agreement .  The Commercial Coordination Subcommittee shall have the right to review and provide comments with respect to the Brand Plan, including any amendments thereto, but [***] shall make all final decisions with respect to the content of the Brand Plan , provided that in

 

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

 

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no event may [***] exercise its final decision right to require that [***] that would (i) require [***] , (ii)  [***] or [***] , or (iii) [***] of [***] or [***] .  The Brand Plan will reflect each Party’s then-existing [***] , on a [***] .  In no event shall the Brand Plan require [***] to acquire [***] in geographic areas in which [***] does not then have them or require [***] to reallocate its [***] to geographic areas in which [***] does not then have them or limit [***]'s ability to contact any particular customers and accounts with respect to any product other than the Product.  

3.4 Compliance with Policies and Procedures .  The Commercial Coordination Subcommittee shall approve the Policies and Procedures.  All Policies and Procedures shall be consistent with all Applicable Law, and the terms and conditions of this Agreement.  Each Party agrees to comply with their respective policies and procedures and ensure that their personnel are trained on and held accountable for compliance with their respective policies and procedures.

3.5 Diligence .  Both Parties shall use Commercially Reasonable Efforts to introduce Product into the commercial market in the Co-Promotion Territory ,   consistent with the Brand Plan and prudent business judgment and all Applicable Laws.

3.6 Communications .  To facilitate efficient communication and data sharing between Elanco and Aratana personnel, Elanco will establish and maintain a secure method of sharing information between the Parties to the extent required for the execution of the Parties’ obligations under this Agreement and in compliance with all Applicable Laws .  The Parties also agree to work together to identify and support hardware, software and services appropriate for the sharing of such information. Any reasonable costs associated with such communication and data sharing shall be borne by [***]

4. OWNERSHIP AND LICENSES OF INVENTIONS AND KNOW-HOW

Ownership of Patents, Inventions , Improvements and Trademarks, to the extent not set forth herein, shall be governed by the License Agreement.

5. SUPPLY OF PRODUCT

Supply of Product in connection with this Agreement and the Parties’ obligations and responsibilities relating thereto shall be governed by the License Agreement and the Supply Agreement.

6. MARKETING AND PROMOTION

6.1 Detailing and Promotional Efforts .

(a) Objectives .  Pursuant to the terms of this Agreement, one of the principal objectives of the Parties hereunder is to maximize the value and Net Sales of the Product in the Co-Promotion

 

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

 

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Territory. The Commercial Coordination Subcommittee will coordinate the implementation of the strategies for [***] the Product in the Co-Promotion Territory, including appropriate related expenses.

(b) Diligence and Resource Allocation .  Each Party shall use Commercially Reasonable Efforts to [***] Product in the Co-Promotion Territory, and otherwise fulfill all responsibilities assigned to it by the Commercial Coordination Subcommittee .  Each Party shall conduct such activities in compliance with the Brand Plan, such Party’s respective policies and procedures and all Applicable Laws.

(c) Aratana Marketing Plans and Creative Materials .  Within [***] business days of the Effective Date, Aratana will provide to Elanco copies of existing marketing plans, art files and other materials created by Aratana and its agencies in preparation for commercial launch of the Product.

6.2 Sales Activity and Progress Reports .  For each [***] during the period commencing with the Effective Date and expiring on [***] , or such longer period as the Parties may agree to pursuant to Section 9.1(d) below, (a) Elanco shall deliver an Elanco Sales Activity Report to Aratana, (b) Elanco shall deliver a Progress Report to the CCC, and (c) Aratana shall deliver an Aratana Report to Elanco ,   no later than [***] weeks after the end of the applicable [***] ,   unless otherwise agreed to by the Commercial Coordination Subcommittee.  After [***] , or such longer period as the Parties may agree to pursuant to Section 9.1(d), such reports shall be provided [***] within [***] days of the end of the [***] .  The [***] will be due [***] weeks after [***] or such longer period as the Parties may agree to pursuant to Section 9.1(d), and the [***] will be due within [***] days after [***] , or the first anniversary of the date on which any such longer period expires.

6.3 Trademarks and Logos .  The Parties shall market the Products under the Galliprant ® Trademark, subject to Sections 7.4 and 7.5 of the License Agreement, and in accordance with the Product Registration in the Co-Promotion Territory .

7. PROMOTIONAL MATERIALS AND SAMPLES

7.1 Promotional Materials .

(a) Creation and Development .  During the Term, Elanco shall create and develop promotional materials for the Product (“ Promotional Materials ”) for use by Third Parties and for each Party’s respective sales forces. The costs and expenses incurred for creating, developing and producing such Promotional Materials are considered a Commercialization Expense.

(b) Ownership of Programs and Promotional Materials

 

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

 

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(i) Created Prior to the Effective Date .  Subject to the assignment of Trademarks from Aratana to Elanco under Section 7.4 of the License Agreement, Elanco and Aratana shall retain all rights, including, without limitation, copyrights and Trademarks, relating to all of their respective existing training program materials (including Promotional Materials and sales training materials) made prior to the Effective Date, in all formats ( whether in print, video, audio, digital, computer or other form) for use in sales training (“ Existing Works ”) as well as any modifications of such Existing Works each may develop in the future which are not specific to the Product. For copyrights for Existing Works that are specific to the Product, Aratana hereby grants to Elanco a nonexclusive license in the Territory under such copyrights to copy, modify and use such Existing Works for the purposes of this Agreement. 

(ii) Created On or After the Effective Date .  Ownership of copyrights for training program materials (including Promotional Materials and sales training materials ) made on or after the Effective Date for the commercialization of the Product shall be owned by the Party who made the program materials and if jointly made, then jointly by Elanco and Aratana.  Aratana hereby grants to Elanco [***] license in the Territory under copyrights owned solely or jointly by Aratana to copy, modify and use such program materials.  Ownership of all other intellectual property rights arising in the course of activities conducted pursuant to this Agreement shall be determined under the provisions of Article 4.

(iii) On the effective date of termination of this Agreement or expiry of its term (the “ Termination Date ”), if and for so long as Elanco retains the right to commercialize Product in the Territory pursuant to the License Agreement, Aratana will use Commercially Reasonable Efforts to [***] to [***] relating to [***] and the [***] , including [***] any [***] to [***] to [***] .  In such case, if Applicable Laws prevent or delay the [***] any such [***] ,   [***]   will [***] , to [***] under [***] and the [***] and [***] to such [***] for the [***] and [***] , and will [***] to [***] of such [***] or [***] .     However, if after the term of this Agreement, rights to commercialize the Product revert to Aratana under the License Agreement, Elanco will use Commercially Reasonable Efforts to [***] to [***] relating to [***] that are [***] , any [***] to [***] , and the [***] , including [***] any [***] to [***] to [***] .  If Applicable Laws prevent or delay the [***] any such [***] ,   [***] will [***] , to [***] and [***] under such [***] and the [***] and [***] to such [***] for the [***] and [***] , and will [***] to [***] of such [***] or [***] .    

 

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

 

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(c) Neither Party shall produce (other than as concepts for consideration by the other Party), distribute or otherwise use any Promotional Materials to promote or Detail Product that have not been approved in writing by Elanco , other than [***] as of the Effective Date that Elanco has approved in writing .

(d) Elanco shall provide Aratana with such quantities of Promotional Materials ,   consistent with the applicable Brand Plan and the provisions of this Agreement [***] for use to perform its obligations under this Agreement in accordance with the then current Brand Plan.

7.2 Samples .

(a) Diligence .  Unless Elanco exercises its option to assume responsibility for manufacturing pursuant to Article 8 of the License Agreement, Aratana shall supply [***] Samples necessary to [***] for use in accordance with the then current Brand Plan , the Supply Agreement and this Agreement . If Elanco assumes responsibility for manufacturing pursuant to Section 8.2 of the License Agreement, Elanco shall, during each subsequent year, supply [***] of Samples necessary to [***] for use in accordance with the then current Brand Plan and this Agreement .  For each year during the term of this Agreement , Samples shall be allocated [***] between the Parties as set forth in the Brand Plan .  The Parties shall use Samples strictly in accordance with the then current Brand Plan and shall distribute Samples in full compliance with all Applicable Laws . Each Party shall maintain records with regard to Samples that it uses, as required by Applicable Law and shall allow the other Party to inspect such records on request , upon reasonable advance written notice

(b) Cost of Samples .  The cost of Samples distributed in the Co-Promotion Territory shall be borne by [***] and included in [***] .  

(c) Destruction of Samples [***] shall be responsible for the destruction of any unused, expired Samples.  [***] shall ship such unused, expired Samples to [***] , for destruction.    

8. ORDERS AND DELIVERY OF PRODUCT

The following provisions under this Article 8 govern the order and delivery of Samples to be utilized in promoting the Product in the Co-Promotion Territory by the Parties:

8.1 Orders and Terms of Sale .  Elanco shall have the sole right to ( i ) fill orders for Product, ( ii ) control invoicing, order processing and collection of accounts receivable for Product sales, and ( iii ) record Product sales in its books of account.  The Brand Plan shall include commercial terms and conditions with respect to the sale and distribution of Product, including matters such as the suggested retail price for the Products.

 

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

 

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8.2 Delivery .  Elanco shall arrange and be solely responsible for shipment, distribution and delivery of the Product (excluding any Samples Aratana will distribute pursuant to the Brand Plan) .  

8.3 O rders Received by Aratana .  Aratana shall [***] and [***] for Product, and shall [***] to [***] as soon as practicable, in accordance with the procedures set forth in the Brand Plan. 

8.4 Product Returns In general the Parties intend that any Product returned by a veterinarian or corporate account or other customer should be returned to Elanco, or its distributor representative, for handling.  If, however, any Product is returned to Aratana, then Aratana shall immediately notify Elanco and ship such Product to the facility designated by Elanco. Elanco shall [***] by [***] Product. Any report of an Adverse Event in connection with such returned Product shall be handled in accordance with the Pharmacovigilance Agreement.

9. REVENUE AND COST OF PRODUCT  

9.1 Reporting and Calculation of Co-Promotion Payment .

(a) Provided Aratana meets its co-promotion obligations under Section 6.1, Elanco shall deliver to Aratana, for each Calendar Quarter,   a payment report computing the amount due to Aratana under Sections 9.1( b ) and 9.1( c ), respectively ( the “ Co-Promotion Payment ”) , as follows:  Elanco shall deliver to Aratana within [***] days of the end of each calendar month a payment report computing the amount due to Aratana under Section 9.1 for such calendar month, and for the calendar month of December of each Calendar Year during the term of this Agreement, such report shall include a statement of the [***] of the Co-Promotion Payments due with re spect to such [***] . In the event that no Co-Promotion Payments are payable in respect of a given Calendar Quarter, Elanco shall submit a Co-Promotion Payment report so indicating .

(b) For Product sold in the Co-Promotion Territory prior to December 31, 2018, or such later date as the Parties may mutually agree upon as set forth in Section 9.1(d), Elanco shall pay Aratana twenty five percent (25%) of the Gross Margin on such sales as consideration for the services rendered by Aratana under this Agreement.

(c) In anticipation of the Parties expectation that the services provided by Aratana under this Agreement will diminish after December 31, 2018 , or such later date as the Parties may mutually agree upon as set forth in Section 9.1(d) , Elanco shall pay Aratana [***] of Net Sales for the services rendered after December 31, 2018 or any such later date the Parties have agreed upon .  Notwithstanding the foregoing, the Commercial Coordination Subcommittee shall make all determinations of the Parties’ obligations to provide services under this Agreement and the Brand Plan.

 

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

 

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(d) T he Parties shall discuss, from time to time prior to December 31, 2018, whether to extend the time period before which Aratana’s services are expected to diminish to a date later than December 31, 2018.  If the Parties mutually agree to extend such time period, then such later date shall replace references to December 31, 2018 in Sections 9.1(b) and (c).  Notwithstanding the foregoing, either Party may elect to retain the December 31, 2018 date without further obligation to the other Party.

9.2 Payment of Commercialization Expenses [***] shall pay all Commercialization Expenses. [***] will not be obligated to incur any Commercialization Expenses unless the Parties otherwise agree in writing.

9.3 Exclusion of Selling Expenses .  Each Party shall be solely responsible for all costs and expenses (direct and indirect) incurred in connection with its sales forces for Product (including any contract sale representatives), including, without limitation, all compensation and benefits (including incentive pay and bonuses), travel, petty cash, transportation, training, lodging, meals, telecommunications equipment and support, computer equipment and support, office space and supplies, and all other types of equipment, support, administration and overhead necessary or useful for maintenance of a sales representative in the ordinary course of their employment (“ Selling Expenses ”). 

10. PAYMENT TERMS

Co-Promotion P ayments shall be made to Aratana in accordance with Section 9.1 within [***] calendar days following the end of each Calendar Quarter.  All other payment terms related to or arising under this Agreement, and the Parties respective rights and obligations with respect thereto, shall be governed by Sections 6.3 through 6.6 of the License Agreement.



11. REGULATORY MATTERS

Regulatory matters shall be handled in accordance with Article 10 of the License Agreement .

12. COVENANT

Each Party agrees that all activities under this Agreement by it or on its behalf, including, but not limited to, training, Detailing, promotional activities, record-keeping, collection of consumer data (if any), and Sampling, will be done in compliance with the appropriate locally-approved package insert and labeling of Product, the applicable Promotional Materials, and all Applicable Laws ,   including all privacy and data protection laws and regulations.

 

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

 

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13. INDEMNIFICATION

Indemnifications of the Parties one to the other related to or arising under this Agreement shall be governed by Article 13 of the License Agreement.

14. CONFIDENTIAL INFORMATION AND PUBLIC ANNOUNCEMENTS

The Parties’ obligations relating to confidential information, publications, publicity or other public announcements concerning the Product related to or arising under this Agreement shall be governed by Article 12 of the License Agreement.

15. TERM AND TERMINATION

15.1 Term .  The term of this Agreement shall commence on the Effective Date and shall remain in effect until December 31, 2028, unless earlier terminated as provided in Sections 15.2 through 15.5 or extended by mutual written agreement of the Parties. 

15.2 Termination by Aratana .  Aratana may terminate this Agreement at will upon ninety ( 90 )   days ’   prior written notice.

15.3 Termination by Elanco.  Elanco may terminate this Agreement with [***] days prior written notice in the event that Elanco substantially stops marketing the Product in the U.S .  For purposes of this section, “substantially stops marketing the Product in the U.S. ” means [***] is [***] or otherwise [***] ; provided, however, that [***] will [***]   if the [***] is that [***] with a [***] for [***] .

15.4 Automatic Early Termination .  In case of early termination of the License Agreement, this Agreement shall be automatically terminated without requirement for any further act or notice.    

15.5 Termination for Uncured Material Breach .  In the event that either Party shall breach any material provision set forth in this Agreement, the other Party may, at its option, terminate this Agreement by giving written notice to the defaulting Party specifying said breach and its intention to terminate and ,   unless said breach shall be rectified by the defaulting Party within [***] calendar days after said notice is given, this Agreement shall terminate [***] calendar days after said notice is given to the defaulting Party

15.6 Effect of Termination .  Upon expiration or termination of this Agreement, Elanco shall be obligated to pay any accrued and unpaid amounts otherwise payable to Aratana under this Agreement.  If this Agreement is terminated, whether at will, for material breach by a Party or otherwise, such termination shall not have any impact on the License Agreement, which shall continue in full force and effect.

 

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

 

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15.7 Survival of Certain Rights and Obligations .  The following provisions shall survive the expiry of the Term or termination of this Agreement: Articles 4, 10 ,   13, 14 and 16, and Sections 7.1(b) , 7.2(c), 15.6 and 15.7 hereo f.  

16. MISCELLANEOUS PROVISIONS

16.1 I ntegration .  Sections 17.1 through 17.11, and 17.13 through 17.16, of the License Agreement are integrated into this Agreement as if set forth herein. 

16.2 E ntire Agreement .  This Agreement, together with the License Agreement, the Supply Agreement, the Quality Agreement and the Pharmacovigilance Agreement, and any exhibits hereto and thereto, set forth the entire agreement and understanding between the Parties as to the subject matter hereof and merge all prior discussions and negotiations between them, and neither of the Parties shall be bound by any conditions, definitions, warranties, understandings or representations with respect to such subject matter other than as expressly provided herein or as duly set forth on or subsequent to the date hereof in writing and signed by a proper and duly authorized officer or representative of the Party to be bound thereby



 

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by Aratana Therapeutics, Inc.

 

IN WITNESS WHEREOF, each of the Parties has caused this   Agreement to be executed by its duly authorized representative as of the Effective Date.

ARATANA THERAPEUTICS , INC.





By : /s/ Steven St. Peter

Name : Steven St. Peter, M.D.

Title : President & CEO





ELI LILLY AND COMPANY THROUGH ITS ELANCO ANIMAL HEALTH DIVISION





By : /s/ John C. Lechleiter

Name : John C. Lechleiter, PhD

Title : Chairman, President and CEO









 

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for Confidential Treatment and have been filed separately with the Securities and Exchange Commission.

 

12

 


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 5 , 201 6

 



 

 

/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 5 , 201 6

 



 

 

/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 , 2016 (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 5 , 201 6

 

 

/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 , 2016 (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 5 , 201 6

 



 

/s/ Craig Tooman

Craig Tooman

Chief Financial Officer and Treasurer