As filed with the Securities and Exchange Commission on April 11, 2013

Registration No. 333-187372

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

AMENDMENT NO. 1

TO

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

 

 

ARATANA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   2834   38-3826477

(State or other jurisdiction of

incorporation or organization)

 

(Primary Standard Industrial

Classification Code Number)

 

(I.R.S. Employer

Identification No.)

1901 Olathe Boulevard

Kansas City, KS 66103

(913) 951-2132

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

 

 

Steven St. Peter, M.D.

President and Chief Executive Officer

Aratana Therapeutics, Inc.

1901 Olathe Boulevard

Kansas City, KS 66103

(913) 951-2132

(Name, address, including zip code, and telephone number, including area code, of agent for service)

 

 

Copies to:

Peter N. Handrinos, Esq.

B. Shayne Kennedy, Esq.

Latham & Watkins LLP

John Hancock Tower, 20 th Floor

200 Clarendon Street

Boston, MA 02116

(617) 948-6060

 

James A. Lebovitz, Esq.

Dechert LLP

2929 Arch Street

Philadelphia, PA 19104

(215) 994-4000

 

 

Approximate date of commencement of proposed sale to the public: As soon as practicable after this Registration Statement is declared effective.

If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.   ¨

If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.   ¨             

If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.   ¨             

If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.   ¨             

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   x   (Do not check if a smaller reporting company)    Smaller reporting company   ¨

 

 

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

 

 

 


Explanatory Note

This Amendment No. 1 is being filed to update certain fees in Item 13 of the Registration Statement on Form S-1 (333-187372) (the “ Registration Statement ”) and to file certain exhibits to the Registration Statement. In addition, due to printer error, certain exhibits to the Registration Statement are being re-filed. No change is made to the prospectus constituting Part I of the Registration Statement or Items 14, 15, 16(b) or 17 of Part II of the Registration Statement.


PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

 

Item 13. Other Expenses of Issuance and Distribution.

The following table indicates the expenses to be incurred in connection with the offering described in this registration statement, other than underwriting discounts and commissions, all of which will be paid by us. All amounts are estimated except the Securities and Exchange Commission registration fee, the Financial Industry Regulatory Authority, Inc., or FINRA, filing fee and The NASDAQ Global Market listing fee.

 

     Amount  

Securities and Exchange Commission registration fee

     $    7,843   

FINRA filing fee

     9,125   

Initial NASDAQ Global Stock Market listing fee

     25,000   

Accountants’ fees and expenses

     *   

Legal fees and expenses

     *   

Blue Sky fees and expenses

     *   

Transfer Agent’s fees and expenses

     *   

Printing and engraving expenses

     *   

Miscellaneous

     *   
  

 

 

 

Total expenses

   $ *   
  

 

 

 

 

* To be provided by amendment.

 

Item 14. Indemnification of Directors and Officers.

Section 102 of the General Corporation Law of the State of Delaware permits a corporation to eliminate the personal liability of directors of a corporation to the corporation or its stockholders for monetary damages for a breach of fiduciary duty as a director, except where the director breached his duty of loyalty, failed to act in good faith, engaged in intentional misconduct or knowingly violated a law, authorized the payment of a dividend or approved a stock repurchase in violation of Delaware corporate law or obtained an improper personal benefit. Our certificate of incorporation provides that no director of the Registrant shall be personally liable to it or its stockholders for monetary damages for any breach of fiduciary duty as a director, notwithstanding any provision of law imposing such liability, except to the extent that the General Corporation Law of the State of Delaware prohibits the elimination or limitation of liability of directors for breaches of fiduciary duty.

Section 145 of the General Corporation Law of the State of Delaware provides that a corporation has the power to indemnify a director, officer, employee or agent of the corporation, or a person serving at the request of the corporation for another corporation, partnership, joint venture, trust or other enterprise in related capacities against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by the person in connection with an action, suit or proceeding to which he was or is a party or is threatened to be made a party to any threatened, ending or completed action, suit or proceeding by reason of such position, if such person acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the corporation, and, in any criminal action or proceeding, had no reasonable cause to believe his conduct was unlawful, except that, in the case of actions brought by or in the right of the corporation, no indemnification shall be made with respect to any claim, issue or matter as to which such person shall have been adjudged to be liable to the corporation unless and only to the extent that the Court of Chancery or other adjudicating court determines that, despite the adjudication of liability but in view of all of the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses which the Court of Chancery or such other court shall deem proper.

 

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Our certificate of incorporation provides that we will indemnify each person who was or is a party or threatened to be made a party to any threatened, pending or completed action, suit or proceeding (other than an action by or in the right of us) by reason of the fact that he or she is or was, or has agreed to become, a director or officer, or is or was serving, or has agreed to serve, at our request as a director, officer, partner, employee or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise (all such persons being referred to as an “Indemnitee”), or by reason of any action alleged to have been taken or omitted in such capacity, against all expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred in connection with such action, suit or proceeding and any appeal therefrom, if such Indemnitee acted in good faith and in a manner he or she reasonably believed to be in, or not opposed to, our best interests, and, with respect to any criminal action or proceeding, he or she had no reasonable cause to believe his or her conduct was unlawful. Our certificate of incorporation provides that we will indemnify any Indemnitee who was or is a party to an action or suit by or in the right of us to procure a judgment in our favor by reason of the fact that the Indemnitee is or was, or has agreed to become, a director or officer, or is or was serving, or has agreed to serve, at our request as a director, officer, partner, employee or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise, or by reason of any action alleged to have been taken or omitted in such capacity, against all expenses (including attorneys’ fees) and, to the extent permitted by law, amounts paid in settlement actually and reasonably incurred in connection with such action, suit or proceeding, and any appeal therefrom, if the Indemnitee acted in good faith and in a manner he or she reasonably believed to be in, or not opposed to, our best interests, except that no indemnification shall be made with respect to any claim, issue or matter as to which such person shall have been adjudged to be liable to us, unless a court determines that, despite such adjudication but in view of all of the circumstances, he or she is entitled to indemnification of such expenses. Notwithstanding the foregoing, to the extent that any Indemnitee has been successful, on the merits or otherwise, he or she will be indemnified by us against all expenses (including attorneys’ fees) actually and reasonably incurred in connection therewith. Expenses must be advanced to an Indemnitee under certain circumstances.

We have entered into indemnification agreements with each of our directors and officers. These indemnification agreements may require us, among other things, to indemnify our directors and officers for some expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by a director or officer in any action or proceeding arising out of his or her service as one of our directors or officers, or any of our subsidiaries or any other company or enterprise to which the person provides services at our request.

We maintain a general liability insurance policy that covers certain liabilities of directors and officers of our corporation arising out of claims based on acts or omissions in their capacities as directors or officers.

In any underwriting agreement we enter into in connection with the sale of common stock being registered hereby, the underwriters will agree to indemnify, under certain conditions, us, our directors, our officers and persons who control us within the meaning of the Securities Act of 1933, as amended, or Securities Act, against certain liabilities.

 

Item 15. Recent Sales of Unregistered Securities.

Set forth below is information regarding shares of capital stock issued by us since our inception in December 2010. Also included is the consideration received by us for such shares and information relating to the section of the Securities Act, or rule of the Securities and Exchange Commission, under which exemption from registration was claimed.

 

(a) Issuances of Capital Stock

 

  1. On December 2, 2010, we issued an aggregate of 500,000 shares of our common stock to our two founders at a price per share of $0.001 per share for aggregate gross consideration of $500.

 

  2. On December 27, 2010, we issued an aggregate of 9,999,999 shares of our Series A convertible preferred stock to five investors at a price per share of $1.00 for aggregate gross consideration of $9,999,999.

 

II-2


  3. On December 27, 2010, we issued an aggregate of 2,750,000 shares of our Series A-1 convertible preferred stock to one investor at a price per share of $2.00 for aggregate gross consideration of $5,500,000.

 

  4. On November 1, 2011, we issued an aggregate of 2,500,000 shares of our Series B convertible preferred stock to 20 investors at a price per share of $3.00 for aggregate gross consideration of $7,500,000.

 

  5. On December 2, 2011, we issued an aggregate of 70,833 shares of our Series B convertible preferred stock to five investors at a price per share of $3.00 for aggregate gross consideration of $212,499.

 

  6. On February 15, 2012, we issued an aggregate of 2,570,834 shares of our Series B convertible preferred stock to 23 investors at a price per share of $3.00 for aggregate gross consideration of $7,712,502.

 

  7. On December 28, 2012, we issued an aggregate of 2,349,541 shares of our Series C convertible preferred stock to 28 investors at a price per share of $4.00 for aggregate gross consideration of $9,398,164.

 

  8. On January 30, 2013 we issued an aggregate of 650,459 shares of our Series C convertible preferred stock to 26 investors at a price per share of $4.00 for aggregate gross consideration of $2,601,836.

 

  9. On February 11, 2013, we issued an aggregate of 43,112 shares of our Series C convertible preferred stock to two investors at a price per share of $4.00 for aggregate gross consideration of $172,448.

No underwriters were involved in the foregoing sales of securities. The securities described in this section (a) of Item 15 were issued to investors in reliance upon the exemption from the registration requirements of the Securities Act, as set forth in Section 4(2) under the Securities Act and Regulation D promulgated thereunder relative to transactions by an issuer not involving any public offering, to the extent an exemption from such registration was required. All purchasers of shares of convertible preferred stock described above represented to us in connection with their purchase that they were accredited investors and were acquiring the shares for their own account for investment purposes only and not with a view to, or for sale in connection with, any distribution thereof and that they could bear the risks of the investment and could hold the securities for an indefinite period of time. The purchasers received written disclosures that the securities had not been registered under the Securities Act and that any resale must be made pursuant to a registration statement or an available exemption from such registration.

 

(b) Grants and Exercise of Stock Options; Awards of Restricted Stock

 

  1. From our inception in December 2010 through February 28, 2013, we granted stock options to purchase an aggregate of 3,021,833 shares of our common stock with exercise prices ranging from $0.09 to $0.27 per share, to certain of our employees and directors in connection with services provided to us by such parties. As of February 28, 2013, options to purchase 1,883,002 shares of common stock had been exercised and options to purchase 845,937 shares of common stock remained outstanding at a weighted average exercise price of $0.19 per share.

 

  2. From our inception in December 2010 through February 28, 2013, we have issued an aggregate of 223,557 shares of our common stock to employees and directors in connection with awards of restricted stock pursuant to our incentive award plan for no cash consideration.

The stock options, the common stock issuable upon the exercise of such options and the common stock issued in connection with awards of restricted stock as described in this section (b) of Item 15 were issued pursuant to written compensatory plans or arrangements with our employees and directors, in reliance on the exemption from the registration requirements of the Securities Act provided by Rule 701 promulgated under the Securities Act or the exemption set forth in Section 4(2) under the Securities Act and Regulation D promulgated thereunder relative to transactions by an issuer not involving any public offering. All recipients either received adequate information about us or had access, through employment or other relationships, to such information.

 

II-3


All of the foregoing securities are deemed restricted securities for purposes of the Securities Act. All certificates representing the issued shares of capital stock described in this Item 15 included appropriate legends setting forth that the securities had not been registered and the applicable restrictions on transfer.

 

Item 16. Exhibits and Financial Statement Schedules.

 

(a) Exhibits.

 

Exhibit
Number

 

Description of Exhibit

  1.1*   Underwriting Agreement
  3.1**   Certificate of Incorporation (currently in effect)
  3.2**   Bylaws (currently in effect)
  3.3*   Form of Fourth Amended and Restated Certificate of Incorporation (to be effective immediately prior to the closing of this offering)
  3.4*   Form of Amended and Restated Bylaws (to be effective immediately prior to the closing of this offering)
  4.1*   Specimen stock certificate evidencing the shares of common stock
  5.1*   Opinion of Latham & Watkins LLP
10.1**   Second Amended and Restated Investors’ Rights Agreement, dated as of December 28, 2012
10.2**   Second Amended and Restated Stockholders’ Agreement, dated as of December 28, 2012
10.3**   Form of Indemnification Agreement for Directors and Officers
10.4**   Employment Agreement, dated September 6, 2012, by and between Steven St. Peter and Aratana Therapeutics, Inc.
10.5**   Employment Agreement, dated September 17, 2012, by and between Louise Mawhinney and Aratana Therapeutics, Inc.
10.6**   Employment Agreement, dated September 6, 2012, by and between Linda Rhodes and Aratana Therapeutics, Inc.
10.7**   Employment Agreement, dated December 18, 2012, by and between Julia Stephanus and Aratana Therapeutics, Inc.
10.8**   Employment Agreement, dated March 12, 2013, by and between Ernst Heinen and Aratana Therapeutics, Inc.
10.9(a)**   Aratana Therapeutics, Inc. 2010 Equity Incentive Plan
10.9(b)**   Amendment No. 1 to 2010 Equity Incentive Plan
10.9(c)**   Amendment No. 2 to 2010 Equity Incentive Plan
10.9(d)**   Form of Stock Option Grant Notice and Stock Option Agreement under 2010 Equity Incentive Plan
10.10(a)*   Aratana Therapeutics, Inc. 2013 Equity Incentive Award Plan
10.10(b)*   Form of Stock Option Grant Notice and Stock Option Agreement under 2013 Equity Incentive Award Plan
10.10(c)*   Form of Nonstatutory Stock Option Agreement under 2013 Equity Incentive Award Plan
10.10(d)*   Form of Restricted Stock Award Agreement and Restricted Stock Award Grant Notice under 2013 Equity Inventive Award Plan

 

II-4


Exhibit
Number

 

Description of Exhibit

10.11*   Non-Employee Director Compensation Program
10.12**   Lease, dated September 1, 2011, by and between MPM Heartland House, LLC and Aratana Therapeutics, Inc.
10.13**   Services Agreement, dated January 1, 2011, by and between Aratana Therapeutics, Inc. and MPM Asset Management LLC
10.14**   Administrative Services Agreement, dated February 19, 2013, by and between MPM Asset Management LLC and Aratana Therapeutics, Inc.
10.15   Services Agreement, dated February 28, 2013, by and among Aratana Therapeutics, Inc., MPM Asset Management LLC and John W. Vander Vort
10.16   Loan and Security Agreement, dated March 4, 2013, by and between Square 1 Bank and Aratana Therapeutics, Inc.
10.17   Kansas Bioscience Research and Development (R&D) Voucher Program Grant Agreement, dated March 6, 2012, by and between Kansas Bioscience Authority and Aratana Therapeutics, Inc.
10.18†   Exclusive IP License Agreement for RQ-00000005, dated December 27, 2010, by and between Aratana Therapeutics, Inc. and RaQualia Pharma Inc.
10.19   First Amendment to the Exclusive IP License Agreement for RQ-00000005, dated July 12, 2012, by and between Aratana Therapeutics, Inc. and RaQualia Pharma Inc.
10.20†   Exclusive IP License Agreement for RQ-00000007, dated December 27, 2010, by and between Aratana Therapeutics, Inc. and RaQualia Pharma Inc.
10.21   First Amendment to the Exclusive IP License Agreement for RQ-00000007, dated July 12, 2012, by and between Aratana Therapeutics, Inc. and RaQualia Pharma Inc.
10.22†   API Development Agreement, dated July 12, 2012, by and between Aratana Therapeutics, Inc. and RaQualia Pharma Inc.
10.23   Letter Agreement regarding RQ-00000008 Technology, dated July 12, 2012, by and between RaQualia Pharma Inc. and Aratana Therapeutics, Inc.
10.24†   Exclusive License, Development and Commercialization Agreement, effective as of December 5, 2012, by and between Pacira Pharmaceuticals, Inc. and Aratana Therapeutics, Inc.
10.25†   Supply Agreement, dated December 5, 2012, by and between Pacira Pharmaceuticals, Inc. and Aratana Therapeutics, Inc.
23.1**   Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm
23.2*   Consent of Latham & Watkins LLP (included in Exhibit 5.1)
24.1**   Power of Attorney (included on signature page of the initial filing of the Registration Statement)

 

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

 

(b) Financial Statement Schedules. Schedules not listed above have been omitted because the information required to be set forth therein is not applicable or is shown in the financial statements or notes thereto.

Item 17. Undertakings.

The undersigned registrant hereby undertakes to provide to the underwriter, at the closing specified in the underwriting agreement, certificates in such denominations and registered in such names as required by the underwriter to permit prompt delivery to each purchaser.

 

II-5


Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

The undersigned hereby undertakes that:

 

  (1) For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.

 

  (2) For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

  (3) For the purpose of determining liability under the Securities Act to any purchaser, each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use.

 

  (4) In a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

 

  (i) Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;

 

  (ii) Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;

 

  (iii) The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and

 

  (iv) Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.

 

II-6


SIGNATURES

Pursuant to the requirements of the Securities Act, the registrant has duly caused this Amendment No. 1 to the Registration Statement on Form S-1 to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Boston, State of Massachusetts, on this 11 th day of April, 2013.

 

ARATANA THERAPEUTICS, INC.
By:   /s/    Steven St. Peter
 

Steven St. Peter, M.D.

President and Chief Executive Officer

Pursuant to the requirements of the Securities Act of 1933, this Amendment No. 1 to the Registration Statement on Form S-1 has been signed by the following persons in the capacities held on the dates indicated.

 

Signature

  

Title

 

Date

/s/    Steven St. Peter

Steven St. Peter, M.D.

   President, Chief Executive Officer and Director (principal executive officer)   April 11, 2013

/s/    Louise A. Mawhinney

Louise A. Mawhinney

  

Chief Financial Officer

(principal financial and accounting officer)

  April 11, 2013

*

Jay Lichter, Ph.D.

   Chairman of the Board of Directors   April 11, 2013

*

Robert “Rip” Gerber

   Director   April 11, 2013

*

Ronald L. Meeusen, Ph.D.

   Director   April 11, 2013

*

Linda Rhodes, V.M.D., Ph.D.

   Director   April 11, 2013

*

Craig Tooman

   Director   April 11, 2013

*

John Vander Vort, Esq.

   Director   April 11, 2013

* By:

 

 

/s/    Steven St. Peter

 

Steven St. Peter, M.D.

Attorney-in-Fact

 

II-7


EXHIBIT INDEX

 

Exhibit

Number

  

Description of Exhibit

  1.1*    Underwriting Agreement
  3.1**    Certificate of Incorporation (currently in effect)
  3.2**    Bylaws (currently in effect)
  3.3*    Form of Fourth Amended and Restated Certificate of Incorporation (to be effective immediately prior to the closing of this offering)
  3.4*    Form of Amended and Restated Bylaws (to be effective immediately prior to the closing of this offering)
  4.1*    Specimen stock certificate evidencing the shares of common stock
  5.1*    Opinion of Latham & Watkins LLP
10.1**    Second Amended and Restated Investors’ Rights Agreement, dated as of December 28, 2012
10.2**    Second Amended and Restated Stockholders’ Agreement, dated as of December 28, 2012
10.3**    Form of Indemnification Agreement for Directors and Officers
10.4**    Employment Agreement, dated September 6, 2012, by and between Steven St. Peter and Aratana Therapeutics, Inc.
10.5**    Employment Agreement, dated September 17, 2012, by and between Louise Mawhinney and Aratana Therapeutics, Inc.
10.6**    Employment Agreement, dated September 6, 2012, by and between Linda Rhodes and Aratana Therapeutics, Inc.
10.7**    Employment Agreement, dated December 18, 2012, by and between Julia Stephanus and Aratana Therapeutics, Inc.
10.8**    Employment Agreement, dated March 12, 2013, by and between Ernst Heinen and Aratana Therapeutics, Inc.
10.9(a)**    Aratana Therapeutics, Inc. 2010 Equity Incentive Plan
10.9(b)**    Amendment No. 1 to 2010 Equity Incentive Plan
10.9(c)**    Amendment No. 2 to 2010 Equity Incentive Plan
10.9(d)**    Form of Stock Option Grant Notice and Stock Option Agreement under 2010 Equity Incentive Plan
10.10(a)*    Aratana Therapeutics, Inc. 2013 Equity Incentive Award Plan
10.10(b)*    Form of Stock Option Grant Notice and Stock Option Agreement under 2013 Equity Incentive Award Plan
10.10(c)*    Form of Nonstatutory Stock Option Agreement under 2013 Equity Incentive Award Plan
10.10(d)*    Form of Restricted Stock Award Agreement and Restricted Stock Award Grant Notice under 2013 Equity Inventive Award Plan
10.11*    Non-Employee Director Compensation Program
10.12**    Lease, dated September 1, 2011, by and between MPM Heartland House, LLC and Aratana Therapeutics, Inc.


Exhibit

Number

 

Description of Exhibit

10.13**   Services Agreement, dated January 1, 2011, by and between Aratana Therapeutics, Inc. and MPM Asset Management LLC
10.14**   Administrative Services Agreement, dated February 19, 2013, by and between MPM Asset Management LLC and Aratana Therapeutics, Inc.
10.15   Services Agreement, dated February 28, 2013, by and among Aratana Therapeutics, Inc., MPM Asset Management LLC and John W. Vander Vort
10.16   Loan and Security Agreement, dated March 4, 2013, by and between Square 1 Bank and Aratana Therapeutics, Inc.
10.17   Kansas Bioscience Research and Development (R&D) Voucher Program Grant Agreement, dated March 6, 2012, by and between Kansas Bioscience Authority and Aratana Therapeutics, Inc.
10.18†   Exclusive IP License Agreement for RQ-00000005, dated December 27, 2010, by and between Aratana Therapeutics, Inc. and RaQualia Pharma Inc.
10.19   First Amendment to the Exclusive IP License Agreement for RQ-00000005, dated July 12, 2012, by and between Aratana Therapeutics, Inc. and RaQualia Pharma Inc.
10.20†   Exclusive IP License Agreement for RQ-00000007, dated December 27, 2010, by and between Aratana Therapeutics, Inc. and RaQualia Pharma Inc.
10.21   First Amendment to the Exclusive IP License Agreement for RQ-00000007, dated July 12, 2012, by and between Aratana Therapeutics, Inc. and RaQualia Pharma Inc.
10.22†   API Development Agreement, dated July 12, 2012, by and between Aratana Therapeutics, Inc. and RaQualia Pharma Inc.
10.23   Letter Agreement regarding RQ-00000008 Technology, dated July 12, 2012, by and between RaQualia Pharma Inc. and Aratana Therapeutics, Inc.
10.24†   Exclusive License, Development and Commercialization Agreement, effective as of December 5, 2012, by and between Pacira Pharmaceuticals, Inc. and Aratana Therapeutics, Inc.
10.25†   Supply Agreement, dated December 5, 2012, by and between Pacira Pharmaceuticals, Inc. and Aratana Therapeutics, Inc.
23.1**   Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm
23.2*   Consent of Latham & Watkins LLP (included in Exhibit 5.1)
24.1**   Power of Attorney (included on signature page of the initial filing of the Registration Statement)

 

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

Exhibit 10.15

SERVICES AGREEMENT

This Services Agreement (the “Agreement”) is dated as of February 28th, 2013 among Aratana Therapeutics, Inc. (the “ Company ”), MPM Asset Management LLC (“ MPM ”), and John W. Vander Vort (“ Consultant ”).

Recitals:

WHEREAS, the Company would like the Consultant to perform certain professional services for it;

WHEREAS, the Consultant is an employee of MPM; and

WHEREAS, MPM would like the Consultant to perform the services for the Company;

NOW, THEREFORE, in consideration of the premises and covenants set forth herein, the parties hereto, intending to be legally bound, do hereby agree as follows:

1. Engagement. The Company hereby engages MPM to provide the services set forth in Section 2 hereof to the Company, and MPM hereby accepts such engagement, on the terms and conditions set forth in this Agreement.

2. Services . MPM (and specifically Consultant) will provide the services set forth on Exhibit A hereto (collectively, the “ Services ”). During the term of this Agreement, MPM will use commercially reasonable efforts to cause Consultant to perform the Services. Consultant shall make himself available to the Company in order to perform the Services hereunder as specified on Exhibit A . Consultant shall render the Services in a manner that is consistent with the instructions of the Chief Executive Officer of the Company; provided that MPM shall at all times have the sole right to control the manner of the performance of the Services rendered by Consultant hereunder.

3. Term. The term of MPM’s and Consultant’s engagement hereunder shall be deemed to have commenced on the date that this Agreement is executed by the Company, MPM and Consultant (the “ Commencement Date ”), and shall continue (unless sooner terminated in accordance with Section 5) until either party gives to the other party at least 30 days’ prior written notice of the notifying party’s determination to terminate this Agreement, which notice shall specify the date of termination.

4. Compensation.

(a) Services Fee . In consideration of the Services to be performed hereunder, MPM shall be paid a services fee (the “ Services Fee ”) at the rate of $6,250.00 per month payable monthly in arrears, beginning with the payment for the month of February 2013. The Services Fee may be adjusted from time to time by the written agreement of the Company and MPM, including without limitation as additional personnel and services are utilized from MPM. As additional consideration for the successful achievement of goals associated with providing the Services, Consultant shall be paid additional consideration as described in Exhibit B (“Additional Consideration”).


(b) Reimbursement of Expenses . The Company shall reimburse MPM for an amount equal to the expenses, consistent with MPM’s expense reimbursement policies that are incurred in the performance of the Services by MPM and the Consultant.

(c) Entire Compensation . Notwithstanding anything to the contrary set forth herein, other than that certain Services Agreement between the Company and MPM dated January 1, 2011 and the Administrative Services Agreement between the Company and MPM dates February 19, 2013 (collectively, the “Prior Agreements”), the compensation provided for in this Section 4 shall constitute full payment for the Services to be rendered by MPM and Consultant to the Company. The Company shall have no obligation to pay any compensation to Consultant, who shall receive all of his compensation from MPM pursuant to his employment relationship with MPM.

5. Termination.

(a) Termination . Each of the Company, MPM and Consultant may terminate this Agreement for any reason or for no reason upon thirty (30) days prior written notice to the other party.

(b) Obligations upon Termination . In the event that the Company shall terminate this Agreement, the Company shall not have any further obligation or liability under this Agreement, except for the payment of any Services Fees accrued and any reimbursable expenses incurred by MPM prior to termination.

6. Non-Disclosure Agreements. Consultant has executed a Non-Disclosure, Inventions and Non-Solicitation Agreement with MPM (the “ Confidentiality Agreement ”) that MPM and Consultant believe protects the disclosure of confidential information of the Company. MPM shall take all reasonable best efforts necessary to ensure that each of its other employees, agents or affiliates who may perform the Services for or on behalf of the Company or may have any access to the Company’s confidential or proprietary information pursuant to this Agreement signs a Non-Disclosure, Inventions and Non-Solicitation Agreement substantially similar to the Confidentiality Agreement executed by Consultant.

7. Representations and Warranties.

(a) Representations of the Company . As an inducement to MPM and Consultant to enter into this Agreement, the Company represents and warrants to MPM and Consultant as follows:

(i) The Company is duly organized and validly existing under the laws of the State of Delaware and has all requisite corporate power to enter into this Agreement.

(ii) Neither the execution and delivery of this Agreement nor the consummation of the transactions contemplated herein nor compliance by the Company with any of the provisions hereof will: (a) violate any order, writ, injunction, decree, law, statute, rule or regulation applicable to it or (b) require the consent, approval, permission or other authorization of, or qualification or filing with or notice to, any court, arbitrator or other tribunal or any governmental, administrative, regulatory or self-regulatory agency or any other third party.

 

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(iii) This Agreement has been duly executed and delivered by the Company and constitutes a valid and binding agreement of the Company, enforceable against the Company in accordance with its terms.

(b) Representations of Consultant . As an inducement to the Company to enter into this Agreement, Consultant r e presents and warrants to the Company that Consultant is not a party to or otherwise subject to any agreements or restrictions that would prohibit Consultant from entering into this Agreement and carrying out the transactions contemplated by this Agreement in accordance with the terms hereof, and this Agreement and the transactions contemplated hereby will not infringe or conflict with, and are not inconsistent with, the rights of any other person or entity. The parties to this Agreement acknowledge that Consultant’s services are provided in connection with Consultant’s employment relationship with MPM.

8. Survival of Representations , Warranties and Covenants . The provisions of Sections 5(b) and 6 hereof shall survive the termination of this Agreement.

9. Supersedes Other Agreements . Other than the Prior Agreements, which remain in effect, this Agreement supersedes and is in lieu of any and all other consulting and compensation arrangements among MPM, Consultant and the Company.

10. No Employment Relationship . The parties hereto acknowledge and agree that Consultant is an employee of MPM and not an employee of the Company, and nothing herein shall be construed to be inconsistent with this relationship or status. MPM shall have sole responsibility for the payment of all compensation due to Consultant and the withholding of all applicable federal, state or local taxes or contributions imposed under any unemployment insurance, social security, income tax or other tax law or regulation with respect to MPM’s or Consultant’s performance of Services hereunder.

11. Amendments . Any amendment to this Agreement shall be made in writing and signed by the parties hereto.

12. Enforceability . If any provision of this Agreement shall be invalid or unenforceable, in whole or in part, then such provision shall be deemed to be modified or restricted to the extent and in the manner necessary to render the same valid and enforceable, or shall be deemed excised from this Agreement, as the case may require, and this Agreement shall be construed and enforced to the maximum extent permitted by law as if such provision had been originally incorporated herein as so modified or restricted or as if such provision had not been originally incorporated herein, as the case may be.

13. Governing Law . This Agreement shall be construed and interpreted in accordance with the internal laws of the State of Delaware, without reference to conflicts of laws principles thereunder.

 

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14. Assignment.

(a) By the Company . The rights and obligations of the Company under this Agreement shall inure to the benefit of, and shall be binding upon, the successors and assigns of the Company.

(b) By MPM or Consultant . This Agreement and the obligations created hereunder may not be assigned by MPM or Consultant and any such purported assignment shall be null and void ab initio .

15. Notices . All notices, requests, consents and other communications hereunder to any party shall be deemed to be sufficient if contained in a written instrument delivered in person or duly sent by certified mail, postage prepaid; by an overnight delivery service, charges prepaid; or by confirmed facsimile; addressed to such party at the address set forth below or such other address as may hereafter be designated in writing by the addressee to the addressor:

If to the Company:

Aratana Therapeutics, Inc.

c/o MPM Asset Management LLC

200 Clarendon Street, 54 th  Floor

Boston, Massachusetts 02116

Attention: Steven St. Peter

Facsimile: (617) 425-9201

If to MPM or Consultant:

MPM Asset Management LLC

200 Clarendon Street, 54 th  Floor

Boston, Massachusetts 02116

Attention: Lauren Cauley, CFO

Facsimile: (617) 425-9201

Any party may from time to time change its address for the purpose of notices to that party by a similar notice specifying a new address, but no such change shall be deemed to have been given until it is actually received by the party sought to be charged with its contents.

16. Waivers . No claim or right arising out of a breach or default under this Agreement shall be discharged in whole or in part by a waiver of that claim or right unless the waiver is supported by consideration and is in writing and executed by the aggrieved party hereto or its duly authorized agent. A waiver by any party hereto of a breach or default by the other party hereto of any provision of this Agreement shall not be deemed a waiver of future compliance therewith, and such provisions shall remain in full force and effect.

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

 

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IN WITNESS WHEREOF, this Agreement has been executed by the parties as of the date first above written.

 

ARATANA THERAPEUTICS, INC.
By:   /s/ Steven St. Peter
Name:   Steven St. Peter
Title:   President and CEO
MPM ASSET MANAGEMENT LLC
By:   /s/ Ansbert Gadicke
Name:   Ansbert Gadicke
Title:   Managing Director
CONSULTANT
/s/ John W. Vander Vort
John W. Vander Vort


EXHIBIT A

SERVICES

Consultant will devote approximately thirty percent (30%) of his business time to the Company in connection with helping manage the Company’s legal processes and outside law firms.


EXHIBIT B

ADDITIONAL CONSIDERATION

Restricted Stock Grant.

40,000 shares of restricted stock will be granted on February 28th, 2013 (subject to Board approval) vesting ratably over 24 months (subject to 12 month acceleration on Initial Public Offering and full acceleration on Change of Control) on terms consistent with the Company’s Plan.

Exhibit 10.16

This LOAN AND SECURITY AGREEMENT (the “Agreement”) is entered into as of March 4, 2013, by and between Square 1 Bank (“Bank”) and Aratana Therapeutics, Inc. (“Borrower”).

RECITALS

Borrower wishes to obtain credit from time to time from Bank, and Bank desires to extend credit to Borrower. This Agreement sets forth the terms on which Bank will advance credit to Borrower, and Borrower will repay the amounts owing to Bank.

AGREEMENT

The parties agree as follows:

 

1. DEFINITIONS AND CONSTRUCTION.

1.1 Definitions . As used in this Agreement, all capitalized terms shall have the definitions set forth on Exhibit A. Any term used in the Code and not defined herein shall have the meaning given to the term in the Code.

1.2 Accounting Terms . Any accounting term not specifically defined on Exhibit A shall be construed in accordance with GAAP and all calculations shall be made in accordance with GAAP (except for non­compliance with FAS 123R in monthly reporting). The term “financial statements” shall include the accompanying notes and schedules.

 

2. LOAN AND TERMS OF PAYMENT.

2.1 Credit Extensions .

(a) Promise to Pay . Borrower promises to pay to Bank, in lawful money of the United States of America, the aggregate unpaid principal amount of all Credit Extensions made by Bank to Borrower, together with interest on the unpaid principal amount of such Credit Extensions at rates in accordance with the terms hereof.

(b) Term Loans .

(i) Subject to and upon the terms and conditions of this Agreement, Bank agrees to make Term Loans to Borrower in two tranches, Tranche A and Tranche B. Bank agrees to make a term loan to Borrower in an amount equal to $5,000,000 (the “Tranche A Term Loan”) on the Closing Date or as soon thereafter as all conditions precedent to the making thereof have been met. Upon Borrower’s receipt of no less than $20,000,000 in gross cash proceeds from either (i) an IPO, (ii) the sale or issuance of Borrower’s equity securities, or (iii) a Corporate Partnership (the “Tranche B Conditions”), Borrower may request and Bank agrees to make one or more additional term loans to Borrower in an aggregate principal amount not to exceed $5,000,000 (each a “Tranche B Term Loan”, collectively the “Tranche B Term Loans”, and together with the Tranche A Term Loan, the “Term Loans”) through the Availability End Date. The proceeds of the Term Loans shall be used to supplement the growth capital needs of the Borrower and for general corporate purposes and working capital needs. The Term Loans shall not exceed $10,000,000 in total principal amount.


(ii) Interest shall accrue from the date of each Term Loan at the rate specified in Section 2.3(a), and prior to the Availability End Date shall be payable monthly in arrears beginning on the first date of the month next following the date such Term Loan was funded, and continuing on the same day of each month thereafter. Any Term Loans that are outstanding on the Availability End Date shall be payable in 24 equal monthly installments of principal, plus all accrued interest, beginning on April 1, 2014 and continuing on the same day of each month thereafter through the Term Loan Maturity Date, at which time all amounts due in connection with the Term Loans and any other amounts due under this Agreement shall be immediately due and payable. Term Loans, once repaid, may not be reborrowed. Borrower may prepay any Term Loans without penalty or premium.

(iii) Other than the Tranche A Term Loan, when Borrower desires to obtain a Term Loan, Borrower shall notify Bank (which notice shall be irrevocable) by facsimile transmission to be received no later than 3:30 p.m. Eastern time on the Business Day prior to the date on which the Term Loan is to be made. Such notice shall be substantially in the form of Exhibit C. The notice shall be signed by an Authorized Officer.

2.2 Intentionally Omitted.

2.3 Interest Rates, Payments, and Calculations.

(a) Interest Rate on Term Loans . Except as set forth in Section 2.3(b), the Term Loans shall bear interest, on the outstanding daily balance thereof, (i) prior to the Availability End Date, at a variable annual rate equal to the greater of (A) 2.25% above the Prime Rate then in effect, or (B) 5.50% and (ii) on and after the Availability End Date, at a fixed annual rate equal to the greater of (A) 2.25% above the Prime Rate in effect on the Availability End Date, or (B) 5.50%.

(b) Late Fee; Default Rate . If any payment is not made within 15 days after the date such payment is due, Borrower shall pay Bank a late fee equal to the lesser of (i) 5% of the amount of such unpaid amount or (ii) the maximum amount permitted to be charged under applicable law. All Obligations shall bear interest, from and after the occurrence and during the continuance of an Event of Default, at a rate equal to 5 percentage points above the interest rate applicable immediately prior to the occurrence of the Event of Default.

(c) Payments . Bank shall, at its option, charge such interest, all Bank Expenses, and all Periodic Payments against any of Borrower’s deposit accounts.

(d) Computation . In the event the Prime Rate is changed from time to time hereafter, the applicable rate of interest hereunder shall be increased or decreased, effective as of the day the Prime Rate is changed, by an amount equal to such change in the Prime Rate. All interest chargeable under the Loan Documents shall be computed on the basis of a 360 day year for the actual number of days elapsed.

2.4 Crediting Payments . So long as no Event of Default has occurred and is continuing, Bank shall credit a wire transfer of funds, check or other item of payment to such deposit account or Obligation as Borrower specifies, except that to the extent Borrower uses the

 

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Term Loans to purchase Collateral, Borrower’s repayment of the Term Loans shall apply on a “first-in-first-out” basis so that the portion of the Term Loans used to purchase a particular item of Collateral shall be paid in the chronological order the Borrower purchased the Collateral. After the occurrence and during the continuance of an Event of Default, Bank shall have the right, in its reasonable discretion, to immediately apply any wire transfer of funds, check, or other item of payment Bank may receive to conditionally reduce Obligations, but such applications of funds shall not be considered a payment on account unless such payment is of immediately available federal funds or unless and until such check or other item of payment is honored when presented for payment. Notwithstanding anything to the contrary contained herein, any wire transfer or payment received by Bank after 5:30 p.m. Eastern time shall be deemed to have been received by Bank as of the opening of business on the immediately following Business Day. Whenever any payment to Bank under the Loan Documents would otherwise be due (except by reason of acceleration) on a date that is not a Business Day, such payment shall instead be due on the next Business Day, and additional fees or interest, as the case may be, shall accrue and be payable for the period of such extension.

2.5 Fees . Borrower shall pay to Bank the following:

(a) Facility Fee . On or before the Closing Date, a fee equal to $50,000, which shall be nonrefundable.

(b) Bank Expenses . On the Closing Date, all Bank Expenses incurred through the Closing Date, and, after the Closing Date, all Bank Expenses, as and when they become due.

(c) Success Fee . Immediately upon consummation of an Acquisition, (i) if Bank has advanced the entire amount of the Tranche B Term Loans, Borrower, shall pay a success fee to Bank of $250,000 and (ii) if Bank has not advanced the entire amount of the Tranche B Term Loans, Borrower shall pay a success fee to Bank of $125,000.

2.6 Term . This Agreement shall become effective on the Closing Date and, subject to Section 12.7, shall continue in full force and effect for so long as any Obligations (other than inchoate indemnity obligations) remain outstanding or Bank has any obligation to make Credit Extensions under this Agreement. Notwithstanding the foregoing, (a) Bank shall have the right to terminate its obligation to make Credit Extensions under this Agreement immediately and without notice upon the occurrence and during the continuance of an Event of Default, and (b) Borrower shall have the right to terminate this Agreement upon five business days’ written notice to Bank so long as all Obligations (other than inchoate indemnity obligations) have been paid in full in cash.

 

3. CONDITIONS OF LOANS .

3.1 Conditions Precedent to Closing . The agreement of Bank to enter into this Agreement on the Closing Date is subject to the condition precedent that Bank shall have received, in form and substance satisfactory to Bank, each the following items and completed each of the following requirements:

(a) this Agreement;

 

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(b) (an officer’s certificate of Borrower, substantially in form of Exhibit F, with respect to incumbency and resolutions authorizing the execution and delivery of this Agreement;

(c) a financing statement (Form UCC-1);

(d) an account control agreement for each of Borrower’s accounts held outside of Bank;

(e) payment of the fees and Bank Expenses then due specified in Section 2.5, which may be debited from any of Borrower’s accounts with Bank;

(f) current SOS Reports indicating that except for Permitted Liens, there are no other security interests or Liens of record in the Collateral;

(g) current financial statements, including audited statements (or such other level required by the Investment Agreement) for Borrower’s most recently ended fiscal year, together with an unqualified opinion (or an opinion qualified only for going concern so long as Borrower’s investors provide additional equity as needed), company prepared consolidated and consolidating balance sheets, income statements and statements of cash flows for the most recently ended month in accordance with Section 6.2, and such other updated financial information as Bank may reasonably request;

(h) current Compliance Certificate in accordance with Section 6.2;

(i) a Borrower Information Certificate;

(j) a listing of Borrower’s Intellectual Property;

(k) such other documents or certificates, and completion of such other matters, as Bank may reasonably request; and

(l) Borrower shall have opened and funded not less than $50,000 in deposit accounts held with Bank.

3.2 Conditions Precedent to all Credit Extensions . The obligation of Bank to make each Credit Extension, including the initial Credit Extension, is contingent upon the Borrower’s compliance with Section 3.1 above, and is further subject to the following conditions:

(a) timely receipt by Bank of the Loan Advance/Paydown Request Form as provided in Section 2.1;

(b) Borrower shall have transferred substantially all of its Cash assets into operating accounts held with Bank in accordance with Section 6.6 hereof, and otherwise be in compliance with Section 6.6 hereof; and

(c) the representations and warranties contained in Section 5 shall be true and correct in all material respects on and as of the date of such Loan Advance/Paydown Request Form and on the effective date of each Credit Extension as though made at and as of each such date, and no Event of Default shall have occurred and be continuing, or would exist after giving effect to such Credit Extension (provided, however, that those representations and warranties expressly referring to another date shall be true, correct and complete in all material respects as of such date). The making of each Credit Extension shall be deemed to be a representation and warranty by Borrower on the date of such Credit Extension as to the accuracy of the facts referred to in this Section 3.2.

 

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4. CREATION OF SECURITY INTEREST.

4.1 Grant of Security Interest . Borrower grants and pledges to Bank a continuing security interest in the Collateral to secure prompt repayment of any and all Obligations and to secure prompt performance by Borrower of each of its covenants and duties under the Loan Documents. Except for Permitted Liens or as disclosed in the Schedule, such security interest constitutes a valid, first priority security interest in the presently existing Collateral, and will constitute a valid, first priority security interest in later-acquired Collateral. Borrower also hereby agrees not to sell, transfer, assign, mortgage, pledge, lease, grant a security interest in, or encumber any of its Intellectual Property; provided that Borrower shall have the right to grant licenses for the use of the Intellectual Property of Borrower or its Subsidiaries, in the ordinary course of Borrower’s or such Subsidiaries’ business, as permitted under this Agreement. Unless agreed in writing by Bank, notwithstanding any termination of this Agreement or of any filings undertaken related to Bank’s rights under the Code, Bank’s Lien on the Collateral shall remain in effect for so long as any Obligations (other than inchoate indemnity obligations) are outstanding. Upon request by Borrower and payment in full in Cash of the Obligations (other than inchoate indemnify obligations) and at such time as Bank’s obligation to make Credit Extensions has terminated, Bank shall provide, at Borrower’s sole cost and expense, Borrower with written notice that all Liens in the Collateral have been terminated and Bank shall take such action reasonably requested by Borrower in order to cause such Liens to be terminated of record (including filing UCC-3 or similar termination statements with respect to such Liens.

4.2 Perfection of Security Interest . Borrower authorizes Bank to file at any time financing statements, continuation statements, and amendments thereto that (i) either specifically describe the Collateral or describe the Collateral as all assets of Borrower of the kind pledged hereunder (other than any Intellectual Property), and (ii) contain any other information required by the Code for the sufficiency of filing office acceptance of any financing statement, continuation statement, or amendment, including whether Borrower is an organization, the type of organization and any organizational identification number issued to Borrower, if applicable. Borrower shall have possession of the Collateral, except where expressly otherwise provided in this Agreement or where Bank chooses to perfect its security interest by possession in addition to the filing of a financing statement. Where Collateral is in possession of a third party bailee, Borrower shall take such steps as Bank reasonably requests for Bank to (i) subject to Section 7.10 below, obtain an acknowledgment, in form and substance reasonably satisfactory to Bank, of the bailee that the bailee holds such Collateral for the benefit of Bank, and (ii) subject to Section 6.6, obtain “control” of any Collateral consisting of investment property, deposit accounts, letter-of-credit rights or electronic chattel paper (as such items and the term “control”

 

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are defined in Revised Article 9 of the Code) by causing the securities intermediary or depositary institution or issuing bank to execute a control agreement in form and substance reasonably satisfactory to Bank. Borrower will not create any chattel paper without placing a legend on the chattel paper acceptable to Bank indicating that Bank has a security interest in the chattel paper. Borrower from time to time may deposit with Bank specific cash collateral to secure specific Obligations; Borrower authorizes Bank to hold such specific balances in pledge and to decline to honor any drafts thereon or any request by Borrower or any other Person to pay or otherwise transfer any part of such balances for so long as the specific Obligations are outstanding. Borrower shall take such other actions as Bank reasonably requests to perfect its security interests granted under this Agreement.

 

5. REPRESENTATIONS AND WARRANTIES .

Borrower represents and warrants as follows:

5.1 Due Organization and Qualification . Borrower and each Subsidiary is an entity duly existing under the laws of the state in which it is organized and qualified and licensed to do business in any state in which the conduct of its business or its ownership of property requires that it be so qualified, except where the failure to do so would not reasonably be expected to cause a Material Adverse Effect.

5.2 Due Authorization; No Conflict . The execution, delivery, and performance of the Loan Documents are within Borrower’s powers, have been duly authorized, and are not in conflict with nor constitute a breach of any provision contained in Borrower’s Certificate of Incorporation or Bylaws, nor will they constitute an event of default under any material agreement by which Borrower is bound. Borrower is not in default under any agreement by which it is bound, except to the extent such default would not reasonably be expected to cause a Material Adverse Effect.

5.3 Collateral . Borrower has rights in or the power to transfer the Collateral, and its title to the Collateral is free and clear of Liens, adverse claims, and restrictions on transfer or pledge except for Permitted Liens. Other than movable items of personal property such as laptop computers, all Collateral having an aggregate book value not in excess of $250,000 is located solely in the Collateral States. All Inventory is in all material respects of good and merchantable quality, free from all material defects, except for Inventory for which adequate reserves have been made. Except as set forth in the Schedule, none of the Borrower’s Cash is maintained or invested with a Person other than Bank or Bank’s affiliates.

5.4 Intellectual Property . Borrower’s Intellectual Property is set forth on Exhibit E hereto. Borrower is the sole owner of the intellectual property created or purchased by Borrower, except for licenses permitted hereunder. To the best of Borrower’s knowledge, each of the copyrights, trademarks and patents created or purchased by Borrower is valid and enforceable, and no part of the intellectual property created or purchased by Borrower has been judged invalid or unenforceable, in whole or in part, and no claim has been made to Borrower that any part of the intellectual property created or purchased by Borrower violates the rights of any third party, except in each case to the extent such claim would not reasonably be expected to cause a Material Adverse Effect.

 

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5.5 Name; Location of Chief Executive Office . Except as disclosed in the Schedule, Borrower has not done business under any name other than that specified on the signature page hereof, and its exact legal name is as set forth in the first paragraph of this Agreement. The chief executive office of Borrower is located at the address indicated in Section 10 hereof.

5.6 Litigation . Except as set forth in the Schedule, there are no actions or proceedings pending by or against Borrower or any Subsidiary before any court or administrative agency in which a likely adverse decision would reasonably be expected to have a Material Adverse Effect.

5.7 No Material Adverse Change in Financial Statements . All consolidated and consolidating financial statements related to Borrower and any Subsidiary that are delivered by Borrower to Bank fairly present in all material respects Borrower’s consolidated and consolidating financial condition as of the date thereof and Borrower’s consolidated and consolidating results of operations for the period then ended, except for year-end adjustments made in the ordinary course of business. There has not been a material adverse change in the consolidated or in the consolidating financial condition of Borrower since the date of the most recent of such financial statements submitted to Bank.

5.8 Solvency, Payment of Debts . Borrower is able to pay its debts (including trade debts) as they mature; the fair saleable value of Borrower’s assets (including goodwill minus disposition costs) exceeds the fair value of its liabilities; and Borrower is not left with unreasonably small capital after the transactions contemplated by this Agreement.

5.9 Compliance with Laws and Regulations . Borrower and each Subsidiary have met the minimum funding requirements of ERISA with respect to any employee benefit plans subject to ERISA. No event has occurred resulting from Borrower’s failure to comply with ERISA that is reasonably likely to result in Borrower’s incurring any liability that could have a Material Adverse Effect. Borrower is not an “investment company” or a company “controlled” by an “investment company” within the meaning of the Investment Company Act of 1940. Borrower is not engaged principally, or as one of its important activities, in the business of extending credit for the purpose of purchasing or carrying margin stock (within the meaning of Regulations T and U of the Board of Governors of the Federal Reserve System). Borrower has not violated any statutes, laws, ordinances or rules applicable to it, the violation of which would reasonably be expected to have a Material Adverse Effect. Borrower and each Subsidiary have filed or caused to be filed all tax returns required to be filed, and have paid, or have made adequate provision for the payment of, all taxes reflected therein except those being contested in good faith with adequate reserves under GAAP or where the failure to file such returns or pay such taxes would not reasonably be expected to have a Material Adverse Effect.

5.10 Subsidiaries . Borrower does not own any stock, partnership interest or other equity securities of any Person, except for Permitted Investments.

5.11 Government Consents . Borrower and each Subsidiary have obtained all consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all governmental authorities that are necessary for the continued operation of Borrower’s business as currently conducted, except where the failure to do so would not reasonably be expected to cause a Material Adverse Effect.

 

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5.12 Inbound Licenses . Except as disclosed on the Schedule or as permitted under Section 6.8, Borrower is not a party to, nor is bound by, any material license or other material agreement important for the conduct of Borrower’s business that prohibits or otherwise restricts Borrower from granting a security interest in Borrower’s interest in such license or agreement or any other property important for the conduct of Borrower’s business, other than this Agreement or the other Loan Documents.

5.13 Full Disclosure . No representation, warranty or other statement made by Borrower in any certificate or written statement furnished to Bank taken together with all such certificates and written statements furnished to Bank contains any untrue statement of a material fact or omits to state a material fact necessary in order to make the statements contained in such certificates or statements not misleading in light of the circumstances in which they were made, it being recognized by Bank that the projections and forecasts provided by Borrower in good faith and based upon reasonable assumptions are not to be viewed as facts and that actual results during the period or periods covered by any such projections and forecasts may differ from the projected or forecasted results.

 

6. AFFIRMATIVE COVENANTS .

Borrower covenants that, until payment in full of all outstanding Obligations (other than inchoate indemnity obligations), and for so long as Bank may have any commitment to make a Credit Extension hereunder, Borrower shall do all of the following:

6.1 Good Standing and Government Compliance . Borrower shall maintain its and each of its Subsidiaries’ corporate existence and good standing in the respective states of formation, shall maintain qualification and good standing in each other jurisdiction in which the failure to so qualify would reasonably be expected to have a Material Adverse Effect, and shall furnish to Bank the organizational identification number issued to Borrower by the authorities of the state in which Borrower is organized, if applicable. Borrower shall meet, and shall cause each Subsidiary to meet, the minimum funding requirements of ERISA with respect to any employee benefit plans subject to ERISA. Borrower shall comply, and shall cause each Subsidiary to comply, with all statutes, laws, ordinances and government rules and regulations to which it is subject, and shall maintain, and shall cause each of its Subsidiaries to maintain, in force all licenses, approvals and agreements, the loss of which or failure to comply with which would reasonably be expected to have a Material Adverse Effect.

6.2 Financial Statements, Reports, Certificates . Borrower shall deliver to Bank: (i) as soon as available, but in any event within 30 days after the end of each calendar month, a company prepared consolidated and consolidating balance sheet, income statement and statement of cash flows covering Borrower’s operations available, but in any event within 180 days after the end of Borrower’s fiscal year, audited consolidated and consolidating financial statements of Borrower prepared in accordance with GAAP, consistently applied, together with an opinion which is either unqualified, qualified only for going concern so long as Borrower’s investors provide additional equity as needed or otherwise consented to in writing by Bank on such

 

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financial statements of an independent certified public accounting firm reasonably acceptable to Bank; (iii) annual budget approved by Borrower’s Board of Directors as soon as available but not later than 60 days after the beginning of each calendar year during the term hereof; (iv) if applicable, copies of all statements, reports and notices sent or made available generally by Borrower to its security holders or to any holders of Subordinated Debt (excluding any materials provided to such security holders, stockholders or holders of Subordinated Debt solely in their capacity as members of Borrower’s Board of Directors) and all reports on Forms 10-K and 10-Q filed with the Securities and Exchange Commission; (v) promptly upon receipt of notice thereof, a report of any legal actions pending or threatened against Borrower or any Subsidiary that could reasonably be expected to result in damages or costs to Borrower or any Subsidiary of $250,000 or more; (vi) promptly upon receipt, each management letter prepared by Borrower’s independent certified public accounting firm regarding Borrower’s management control systems; and (vii) such budgets, sales projections, operating plans or other financial information generally prepared by Borrower in the ordinary course of business as Bank may reasonably request from time to time. Any items that are required to be delivered under this paragraph which are made publicly available shall be deemed delivered on the date made publicly available, provided Borrower provides Bank written notice of such public availability within 5 days of such item being made publicly available.

(a) Within 30 days after the last day of each month, Borrower shall deliver to Bank with the monthly financial statements a Compliance Certificate certified as of the last day of the applicable month and signed by a Responsible Officer in substantially the form of Exhibit D hereto.

(b) As soon as possible and in any event within 3 business days after becoming aware of the occurrence or existence of an Event of Default hereunder, a written statement of a Responsible Officer setting forth details of the Event of Default, and the action which Borrower has taken or proposes to take with respect thereto.

(c) Bank (through any of its officers, employees, or agents) shall have the right, upon reasonable prior notice, from time to time during Borrower’s usual business hours but no more than once a year (unless an Event of Default has occurred and is continuing), to inspect Borrower’s Books and to make copies thereof and to check, test, inspect, audit and appraise the Collateral at Borrower’s expense in order to verify Borrower’s financial condition or the amount, condition of, or any other matter relating to, the Collateral.

Borrower may deliver to Bank on an electronic basis any certificates, reports or information required pursuant to this Section 6.2, and Bank shall be entitled to rely on the information contained in the electronic files, provided that Bank in good faith believes that the files were delivered by a Responsible Officer. Borrower shall include a submission date on any certificates and reports to be delivered electronically.

6.3 Inventory and Equipment; Returns . Borrower shall keep all Inventory and Equipment in good and merchantable condition, free from all material defects except for Inventory and Equipment (i) sold in the ordinary course of business, and (ii) for which adequate reserves have been made, in all cases in the United States and such other locations as to which Borrower gives prior written notice. Returns and allowances, if any, as between Borrower and

 

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its account debtors shall be on the same basis and in accordance with the usual customary practices of Borrower, as they exist on the Closing Date. Borrower shall promptly notify Bank of all returns and recoveries and of all disputes and claims involving inventory having a book value of more than $250,000.

6.4 Taxes . Borrower shall make, and cause each Subsidiary to make, due and timely payment or deposit of all material federal, state, and local taxes, assessments, or contributions required of it by law, including, but not limited to, those laws concerning income taxes, F.I.C.A., F.U.T.A. and state disability, and will execute and deliver to Bank, on demand, proof reasonably satisfactory to Bank indicating that Borrower or a Subsidiary has made such payments or deposits and any appropriate certificates attesting to the payment or deposit thereof; provided that Borrower or a Subsidiary need not make any payment if the amount or validity of such payment is contested in good faith by appropriate proceedings and is reserved against (to the extent required by GAAP) by Borrower or such Subsidiary.

6.5 Insurance . Borrower, at its expense, shall (i) keep the Collateral insured against loss or damage, and (ii) maintain liability and other insurance, in each case in as ordinarily insured against by other owners in businesses similar to Borrower’s. All such policies of insurance shall be in such form, with such companies, and in such amounts as reasonably satisfactory to Bank. All policies of property insurance shall contain a lender’s loss payable endorsement, in a form satisfactory to Bank, showing Bank as an additional loss payee, and all liability insurance policies shall show Bank as an additional insured and specify that the insurer must give at least 20 days notice to Bank before canceling its policy for any reason. Within 30 days of the Closing Date, Borrower shall cause to be furnished to Bank a copy of its policies or certificate of insurance including any endorsements covering Bank or showing Bank as an additional insured. Upon Bank’s request, Borrower shall deliver to Bank certified copies of the policies of insurance and evidence of all premium payments. Proceeds payable under any casualty policy will, at Borrower’s option, be payable to Borrower to replace the property subject to the claim, provided that any such replacement property shall be deemed Collateral in which Bank has been granted a first priority security interest, provided that if an Event of Default has occurred and is continuing, all proceeds payable under any such policy shall, at Bank’s option, be payable to Bank to be applied on account of the Obligations.

6.6 Primary Depository . Subject to the provisions of Section 3.1(1) and 3.2(b), Borrower shall maintain all of its operating accounts with Bank. Borrower shall maintain its primary depository accounts with Bank and (i) if the aggregate amount of Borrower’s Cash is greater than $10,000,000 at any time, Borrower shall maintain at least 50% of its Cash at Bank and (ii) if the aggregate amount of Borrower’s Cash is less than or equal to $10,000,000 at any time, Borrower shall maintain all of its Cash at Bank.

6.7 Financial Covenants . Borrower shall at all times maintain the following financial ratios and covenants:

(a) Gross Remaining Months’ Cash . From the Closing Date through December 31, 2013, Gross Remaining Months’ Cash of at least 4.00; provided that Borrower shall not be in default of this Section 6.7(a) if prior to the Gross Remaining Months’ Cash falling below 4.00, Borrower has delivered to Bank any one of the following, in any case, in form and

 

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substance satisfactory to Bank: (i) confirmation from inside investors of forthcoming Subordinated Debt an amount acceptable to Bank; (ii) a letter of intent for a strategic investment or Acquisition in an amount acceptable to Bank; or (iii) a term sheet for New Equity in an amount acceptable to Bank, to close within 60 days of execution of such term sheet.

(b) Liquidity Ratio . Beginning January 1, 2014, a Liquidity Ratio of at least 1.00:1.00; provided, however, that if Bank receives evidence in form and substance satisfactory to it that Borrower has received FDA approval for at least 2 products, the required Liquidity Ratio shall be lowered to 0.50:1.00.

6.8 Consent of Inbound Licensors . Within 30 days after entering into or becoming bound by any material inbound license or agreement, Borrower shall provide written notice to Bank of the material terms of such license or agreement with a description of its likely impact on Borrower’s business or financial condition. Borrower shall in good faith use commercially reasonable efforts to obtain the consent of, or waiver by, any person whose consent or waiver is necessary for Borrower’s interest in such licenses or contract rights to be deemed Collateral and for Bank to have a security interest in it that might otherwise be restricted by the terms of the applicable license or agreement, whether now existing or entered into in the future, provided, however, that the failure to obtain any such consent or waiver shall not constitute a default under this Agreement.

6.9 Further Assurances . At any time and from time to time Borrower shall execute and deliver such further instruments and take such further action as may reasonably be requested by Bank to effect the purposes of this Agreement.

 

7. NEGATIVE COVENANTS .

Borrower covenants and agrees that, so long as any credit hereunder shall be available and until the outstanding Obligations are paid in full or for so long as Bank may have any commitment to make any Credit Extensions, Borrower will not do any of the following without Bank’s prior written consent, which shall not be unreasonably withheld:

7.1 Dispositions . Convey, sell, lease, license, transfer or otherwise dispose of (collectively to “Transfer”), or permit any of its Subsidiaries to Transfer, all or any part of its business or property, or move cash balances on deposit with Bank to accounts opened at another financial institution, other than Permitted Transfers.

7.2 Change in Name, Location, Executive Office, or Executive Management; Change in Business; Change in Fiscal Year; Change in Control . Change its name or the state of Borrower’s formation or relocate its chief executive office without 30 days prior written notification (including, after an IPO, by public notification as required by Securities and Exchange Commission regulations) to Bank; replace or suffer the departure of its chief executive officer or chief financial officer without delivering written notification to Bank within 10 days after such replacement or departure; fail to appoint an interim replacement or fill a vacancy in the position of chief executive officer or chief financial officer for more than 90 consecutive days; suffer a change on its board of directors, which results in the failure of at least one partner of Avalon Ventures and MPM Capital or its Affiliates to serve as a voting member (and “Investor

 

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Board Departure”), or suffer the resignation of one or more directors from its board of directors in anticipation of Borrower’s insolvency, in either case without the prior written consent of Bank which may be withheld in Bank’s sole discretion, provided that after an IPO an Investor Board Departure shall not be a violation of this Section 7.2 so long as Borrower provides Bank with written notice within 30 days of such Investor Board Departure; take action to liquidate, wind up, or otherwise cease to conduct business in the ordinary course; engage in any business, or permit any of its Subsidiaries to engage in any business, other than or reasonably related or incidental to the businesses currently engaged in by Borrower; change its fiscal year end; have a Change in Control.

7.3 Mergers or Acquisitions . Merge or consolidate, or permit any of its Subsidiaries to merge or consolidate, with or into any other business organization (other than mergers or consolidations of a Subsidiary into another Subsidiary or into Borrower), or acquire, or permit any of its Subsidiaries to acquire, all or substantially all of the capital stock or property of another Person except where (a) each of the following conditions is applicable: (i) the consideration paid in connection with such transactions (including assumption of liabilities) does not in the aggregate exceed $250,000 during any fiscal year, (ii) no Event of Default has occurred, is continuing or would exist after giving effect to such transactions, (iii) such transactions do not result in a Change in Control, and (iv) Borrower is the surviving entity; or (b) the Obligations are repaid in full concurrently with the closing of any merger or consolidation of Borrower in which Borrower is not the surviving entity; provided, however, that Borrower shall not, without Bank’s prior written consent, enter into any binding contractual arrangement with any Person to attempt to facilitate a merger or acquisition of Borrower, unless (i) no Event of Default exists when such agreement is entered into by Borrower, (ii) such agreement does not give such Person the right to claim any fee, payment or damages from any parties, other than from Borrower or Borrower’s investors, in connection with a sale of Borrower’s stock or assets pursuant to or resulting from an assignment for the benefit of creditors, an asset turnover to Borrower’s creditors (including, without limitation, Bank), foreclosure, bankruptcy or similar liquidation, and (iii) Borrower notifies Bank in advance of entering into such an agreement (provided, the failure to give such notification shall not be deemed a material breach of this Agreement).

7.4 Indebtedness . Create, incur, assume, guarantee or be or remain liable with respect to any Indebtedness, or permit any Subsidiary so to do, other than Permitted Indebtedness, or prepay any Indebtedness or take any actions which impose on Borrower an obligation to prepay any Indebtedness, except Indebtedness to Bank or as permitted under any subordination agreement in connection with Subordinated Debt.

7.5 Encumbrances . Create, incur, assume or allow any Lien with respect to its property, or assign or otherwise convey any right to receive income, including the sale of any Accounts, or permit any of its Subsidiaries so to do, except for Permitted Liens, or covenant to any other Person (other than (i) the licensors of in-licensed property with respect to such property or (ii) the lessors of specific equipment or lenders financing specific equipment with respect to such leased or financed equipment) that Borrower in the future will refrain from creating, incurring, assuming or allowing any Lien with respect to any of Borrower’s property.

 

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7.6 Distributions . Pay any dividends or make any other distribution or payment on account of or in redemption, retirement or purchase of any capital stock in cash, except that Borrower may (i) repurchase the stock of former employees, consultants and directors pursuant to stock repurchase agreements entered into by Borrower in the ordinary course of business, as long as an Event of Default does not exist prior to such repurchase or would not exist after giving effect to such repurchase, and (ii) repurchase the stock of former employees, consultants and employees to Borrower regardless of whether an Event of Default exists, and (iii) upon the occurrence of an IPO, pay dividends to holders of Borrower’s Series A Preferred Stock, Series B Preferred Stock and/or Series C Preferred Stock (as defined in the Charter) pursuant to the terms of the Section 1(a), 1(b) and 1(c), respectively, in accordance with the terms of the Charter as in effect on the Closing Date.

7.7 Investments . Directly or indirectly acquire or own, or make any Investment in or to any Person, or permit any of its Subsidiaries so to do, other than Permitted Investments, or maintain or invest any of its Investment Property with a Person other than Bank or Bank’s Affiliates or permit any Subsidiary to do so unless such Person has entered into a control agreement with Bank, in form and substance reasonably satisfactory to Bank, or suffer or permit any Subsidiary to be a party to, or be bound by, an agreement that restricts such Subsidiary from paying dividends or otherwise distributing property to Borrower.

7.8 Transactions with Affiliates . Directly or indirectly enter into or permit to exist any material transaction with any Affiliate of Borrower except for: (a) transactions that are in the ordinary course of Borrower’s business, upon fair and reasonable terms that are no less favorable to Borrower than would be obtained in an arm’s length transaction with a non-affiliated Person; (b) the sale of Borrower’s equity securities to its existing venture capital investors (provided, for the sake of clarity, that no Change in Control occurs); and (c) Subordinated Debt.

7.9 Subordinated Debt . Make any payment in respect of any Subordinated Debt, or permit any of its Subsidiaries to make any such payment, except in compliance with the terms of such Subordinated Debt, or amend any provision affecting Bank’s rights contained in any documentation relating to the Subordinated Debt without Bank’s prior written consent.

7.10 Inventory and Equipment . Store the Inventory or the Equipment of a book value in excess of $100,000 with a bailee, warehouseman, collocation facility or similar third party unless the third party has been notified of Bank’s security interest and Bank (a) has received an acknowledgment from the third party that it is holding or will hold the Inventory or Equipment for Bank’s benefit or (b) is in possession of the warehouse receipt, where negotiable, covering such Inventory or Equipment. Except for Inventory sold in the ordinary course of business and for movable items of personal property having an aggregate book value not in excess of $100,000, and except for such other locations as Bank may approve in writing, Borrower shall keep the Inventory and Equipment only at the location set forth in Section 10 and such other locations of which Borrower gives Bank prior written notice and as to which Bank is able to take such actions as may be necessary to perfect its security interest or to obtain a bailee’s acknowledgment of Bank’s rights in the Collateral.

7.11 No Investment Company; Margin Regulation . Become or be controlled by an “investment company,” within the meaning of the Investment Company Act of 1940, or become

 

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principally engaged in, or undertake as one of its important activities, the business of extending credit for the purpose of purchasing or carrying margin stock, or use the proceeds of any Credit Extension for such purpose.

 

8. EVENTS OF DEFAULT .

Any one or more of the following events shall constitute an Event of Default by Borrower under this Agreement:

8.1 Payment Default . If Borrower fails to pay any of the Obligations when due;

8.2 Covenant Default .

(a) If Borrower fails to perform any obligation under Sections 6.2 (financial reporting), 6.4 (taxes), 6.5 (insurance), 6.6 (primary accounts) or 6.7 (financial covenants), or violates any of the covenants contained in Article 7 of this Agreement; or

(b) If Borrower fails or neglects to perform or observe any other material term, provision, condition, covenant contained in this Agreement, in any of the Loan Documents, or in any other present or future agreement between Borrower and Bank and as to any default under such other term, provision, condition or covenant that can be cured, has failed to cure such default within 20 days after Borrower receives notice thereof or any officer of Borrower becomes aware thereof; provided, however, that if the default cannot by its nature be cured within the 20 day period or cannot after diligent attempts by Borrower be cured within such 20 day period, and such default is likely to be cured within a reasonable time, then Borrower shall have an additional reasonable period (which shall not in any case exceed 30 days) to attempt to cure such default, and within such reasonable time period the failure to have cured such default shall not be deemed an Event of Default but no Credit Extensions will be made;

8.3 Material Adverse Change . If there occurs any circumstance or any circumstances which would reasonably be expected to have a Material Adverse Effect;

8.4 Attachment . If any material portion of Borrower’s assets is attached, seized, subjected to a writ or distress warrant, or is levied upon, or comes into the possession of any trustee, receiver or person acting in a similar capacity and such attachment, seizure, writ or distress warrant or levy has not been removed, discharged or rescinded within 10 business days, or if Borrower is enjoined, restrained, or in any way prevented by court order from continuing to conduct all or any material part of its business affairs, or if a judgment or other claim becomes a lien or encumbrance upon any material portion of Borrower’s assets, or if a notice of lien, levy, or assessment is filed of record with respect to any material portion of Borrower’s assets by the United States Government, or any department, agency, or instrumentality thereof, or by any state, county, municipal, or governmental agency, and the same is not paid within ten days after Borrower receives notice thereof, provided that none of the foregoing shall constitute an Event of Default where such action or event is stayed or an adequate bond has been posted pending a good faith contest by Borrower (provided that no Credit Extensions will be made during such cure period);

 

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8.5 Insolvency . If Borrower becomes insolvent, or if an Insolvency Proceeding is commenced by Borrower, or if an Insolvency Proceeding is commenced against Borrower and is not dismissed or stayed within 45 days (provided that no Credit Extensions will be made prior to the dismissal of such Insolvency Proceeding);

8.6 Other Agreements . If there is an uncured default or other uncured failure to perform in any agreement to which Borrower is a party with a third party or parties (a) resulting in a right by such third party or parties, whether or not exercised, to accelerate the maturity of any Indebtedness in an amount in excess of $350,000 or (b) that would reasonably be expected to have a Material Adverse Effect;

8.7 Judgments . If a final, uninsured judgment or judgments for the payment of money in an amount, individually or in the aggregate, of at least $350,000 shall be rendered against Borrower and shall remain unsatisfied and unstayed for a period of 10 days (provided that no Credit Extensions will be made prior to the satisfaction or stay of the judgment); or

8.8 Misrepresentations . If any material misrepresentation or material misstatement exists now or hereafter in any warranty or representation set forth herein or in any certificate delivered to Bank by any Responsible Officer pursuant to this Agreement or to induce Bank to enter into this Agreement or any other Loan Document.

 

9. BANK’S RIGHTS AND REMEDIES .

9.1 Rights and Remedies . Upon the occurrence and during the continuance of an Event of Default, Bank may, at its election, without notice of its election and without demand, do any one or more of the following, all of which are authorized by Borrower:

(a) Declare all Obligations, whether evidenced by this Agreement, by any of the other Loan Documents, or otherwise, immediately due and payable (provided that upon the occurrence of an Event of Default described in Section 8.5 (insolvency), all Obligations shall become immediately due and payable without any action by Bank);

(b) Demand that Borrower (i) deposit cash with Bank in an amount equal to the amount of any Letters of Credit remaining undrawn, as collateral security for the repayment of any future drawings under such Letters of Credit, and (ii) pay in advance all Letter of Credit fees scheduled to be paid or payable over the remaining term of the Letters of Credit, and Borrower shall promptly deposit and pay such amounts;

(c) Cease advancing money or extending credit to or for the benefit of Borrower under this Agreement or under any other agreement between Borrower and Bank;

(d) Settle or adjust disputes and claims directly with account debtors for amounts, upon terms and in whatever order that Bank reasonably considers advisable;

(e) Make such payments and do such acts as Bank considers necessary or reasonable to protect its security interest in the Collateral. Borrower agrees to assemble the Collateral if Bank so requires, and to make the Collateral available to Bank as Bank may designate. Borrower authorizes Bank to enter the premises where the Collateral is located, to

 

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take and maintain possession of the Collateral, or any part of it, and to pay, purchase, contest, or compromise any encumbrance, charge, or lien which in Bank’s determination appears to be prior or superior to its security interest and to pay all expenses incurred in connection therewith. With respect to any of Borrower’s owned premises, Borrower hereby grants Bank a license to enter into possession of such premises and to occupy the same, without charge, in order to exercise any of Bank’s rights or remedies provided herein, at law, in equity, or otherwise;

(f) Set off and apply to the Obligations any and all (i) balances and deposits of Borrower held by Bank, and (ii) indebtedness at any time owing to or for the credit or the account of Borrower held by Bank;

(g) Ship, reclaim, recover, store, finish, maintain, repair, prepare for sale, advertise for sale, and sell (in the manner provided for herein) the Collateral. Bank is hereby granted a license or other right, solely pursuant to the provisions of this Section 9.1, to use, without charge, Borrower’s labels, patents, copyrights, rights of use of any name, trade secrets, trade names, trademarks, service marks, and advertising matter, or any property of a similar nature, as it pertains to the Collateral, in completing production of, advertising for sale, and selling any Collateral and, in connection with Bank’s exercise of its rights under this Section 9.1, Borrower’s rights under all licenses and all franchise agreements shall inure to Bank’s benefit;

(h) Sell the Collateral at either a public or private sale, or both, by way of one or more contracts or transactions, for cash or on terms, in such manner and at such places (including Borrower’s premises) as Bank determines is commercially reasonable, and apply any proceeds to the Obligations in whatever manner or order Bank deems appropriate. Bank may sell the Collateral without giving any warranties as to the Collateral. Bank may specifically disclaim any warranties of title or the like. This procedure will not be considered adversely to affect the commercial reasonableness of any sale of the Collateral. If Bank sells any of the Collateral upon credit, Borrower will be credited only with payments actually made by the purchaser, received by Bank, and applied to the indebtedness of the purchaser. If the purchaser fails to pay for the Collateral, Bank may resell the Collateral and Borrower shall be credited with the proceeds of the sale;

(i) Bank may credit bid and purchase at any public sale;

(j) Apply for the appointment of a receiver, trustee, liquidator or conservator of the Collateral, without notice and without regard to the adequacy of the security for the Obligations and without regard to the solvency of Borrower, any guarantor or any other Person liable for any of the Obligations; and

(k) Any deficiency that exists after disposition of the Collateral as provided above will be paid immediately by Borrower.

Bank may comply with any applicable state or federal law requirements in connection with a disposition of the Collateral and compliance will not be considered adversely to affect the commercial reasonableness of any sale of the Collateral.

 

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9.2 Power of Attorney . Effective only upon the occurrence and during the continuance of an Event of Default, Borrower hereby irrevocably appoints Bank (and any of Bank’s designated officers, or employees) as Borrower’s true and lawful attorney to: (a) send requests for verification of Accounts or notify account debtors of Bank’s security interest in the Accounts; (b) endorse Borrower’s name on any checks or other forms of payment or security that may come into Bank’s possession; (c) sign Borrower’s name on any invoice or bill of lading relating to any Account, drafts against account debtors, schedules and assignments of Accounts, verifications of Accounts, and notices to account debtors; (d) dispose of any Collateral; (e) make, settle, and adjust all claims under and decisions with respect to Borrower’s policies of insurance; (f) settle and adjust disputes and claims respecting the accounts directly with account debtors, for amounts and upon terms which Bank determines to be reasonable; and (g) file, in its sole discretion, one or more financing or continuation statements and amendments thereto, relative to any of the Collateral; provided Bank may exercise such power of attorney to sign the name of Borrower on any of the documents described in clause (g) above, regardless of whether an Event of Default has occurred. The appointment of Bank as Borrower’s attorney in fact, and each and every one of Bank’s rights and powers, being coupled with an interest, is irrevocable until all of the Obligations have been fully repaid and performed and Bank’s obligation to provide advances hereunder is terminated.

9.3 Accounts Collection . At any time after the occurrence and during the continuation of an Event of Default, Bank may notify any Person owing funds to Borrower of Bank’s security interest in such funds and verify the amount of such Account. Borrower shall collect all amounts owing to Borrower for Bank, receive in trust all payments as Bank’s trustee, and immediately deliver such payments to Bank in their original form as received from the account debtor, with proper endorsements for deposit.

9.4 Bank Expenses . If Borrower fails to pay any amounts or furnish any required proof of payment due to third persons or entities, as required under the terms of this Agreement, then Bank may do any or all of the following after reasonable notice to Borrower: (a) make payment of the same or any part thereof; or (b) obtain and maintain insurance policies of the type discussed in Section 6.5 of this Agreement, and take any action with respect to such policies as Bank deems prudent. Any amounts so paid or deposited by Bank shall constitute Bank Expenses, shall be immediately due and payable, and shall bear interest at the then applicable rate hereinabove provided, and shall be secured by the Collateral. Any payments made by Bank shall not constitute an agreement by Bank to make similar payments in the future or a waiver by Bank of any Event of Default under this Agreement.

9.5 Bank’s Liability for Collateral . Bank has no obligation to clean up or otherwise prepare the Collateral for sale. All risk of loss, damage or destruction of the Collateral shall be borne by Borrower.

9.6 No Obligation to Pursue Others . Bank has no obligation to attempt to satisfy the Obligations by collecting them from any other person liable for them and Bank may release, modify or waive any collateral provided by any other Person to secure any of the Obligations, all without affecting Bank’s rights against Borrower. Borrower waives any right it may have to require Bank to pursue any other Person for any of the Obligations.

 

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9.7 Remedies Cumulative . Bank’s rights and remedies under this Agreement, the Loan Documents, and all other agreements shall be cumulative. Bank shall have all other rights and remedies not inconsistent herewith as provided under the Code, by law, or in equity. No exercise by Bank of one right or remedy shall be deemed an election, and no waiver by Bank of any Event of Default on Borrower’s part shall be deemed a continuing waiver. No delay by Bank shall constitute a waiver, election, or acquiescence by it. No waiver by Bank shall be effective unless made in a written document signed on behalf of Bank and then shall be effective only in the specific instance and for the specific purpose for which it was given. Borrower expressly agrees that this Section 9.7 may not be waived or modified by Bank by course of performance, conduct, estoppel or otherwise.

9.8 Demand; Protest . Except as otherwise provided in this Agreement, Borrower waives demand, protest, notice of protest, notice of default or dishonor, notice of payment and nonpayment and any other notices relating to the Obligations.

 

10. NOTICES .

Unless otherwise provided in this Agreement, all notices or demands by any party relating to this Agreement or any other agreement entered into in connection herewith shall be in writing and (except for financial statements and other informational documents which may be sent by first-class mail, postage prepaid) shall be personally delivered or sent by a recognized overnight delivery service, certified mail, postage prepaid, return receipt requested, or by telefacsimile to Borrower or to Bank, as the case may be, at its addresses set forth below:

 

If to Borrower:    Aratana Therapeutics, Inc.
   1901 Olathe Blvd.
   Kansas City, Kansas 66103
   Attn:  Louise Mawhinney, Chief Financial Officer
   FAX: (913) 904-9641
with copies to:    Latham & Watkins LLP
   John Hancock Tower, 20th Floor
   200 Clarendon Street
   Boston, MA 02116
   Attn:  Peter Handrinos
   FAX: (617) 948-6001
   Latham & Watkins LLP
   505 Montgomery St., Ste. 2000
   San Francisco, CA 94111
   Attn:  Haim Zaltzman
   FAX: (415) 395-8095
If to Bank:    Square 1 Bank
   406 Blackwell Street, Suite 240
   Durham, North Carolina 27701
   Attn:  Loan Operations Manager
   FAX: (919) 314-3080

 

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with a copy to:    Square 1 Bank
   12481 High Bluff Drive
   Suite 350
   San Diego, California 92130
   Attn:  Scott Foote
   FAX: (858) 436-3501

The parties hereto may change the address at which they are to receive notices hereunder, by notice in writing in the foregoing manner given to the other.

 

11. CHOICE OF LAW AND VENUE; JURY TRIAL WAIVER .

This Agreement shall be governed by, and construed in accordance with, the internal laws of the State of North Carolina, without regard to principles of conflicts of law. Jurisdiction shall lie in the State of North Carolina. All disputes, controversies, claims, actions and similar proceedings arising with respect to Borrower’s account or any related agreement or transaction shall be brought in the General Court of Justice of North Carolina sitting in Durham County, North Carolina or the United States District Court for the Middle District of North Carolina, except as provided below with respect to arbitration of such matters. BANK AND BORROWER EACH ACKNOWLEDGE THAT THE RIGHT TO TRIAL BY JURY IS A CONSTITUTIONAL ONE, BUT THAT IT MAY BE WAIVED. EACH OF THEM, AFTER CONSULTING OR HAVING HAD THE OPPORTUNITY TO CONSULT, WITH COUNSEL OF THEIR CHOICE, KNOWINGLY, VOLUNTARILY AND INTENTIONALLY WAIVES ANY RIGHT ANY OF THEM MAY HAVE TO A TRIAL BY JURY IN ANY LITIGATION BASED UPON OR ARISING OUT OF THIS AGREEMENT OR ANY RELATED INSTRUMENT OR LOAN DOCUMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT OR ANY COURSE OF CONDUCT, DEALING, STATEMENTS (WHETHER ORAL OR WRITTEN), OR ACTION OF ANY OF THEM. THESE PROVISIONS SHALL NOT BE DEEMED TO HAVE BEEN MODIFIED IN ANY RESPECT OR RELINQUISHED BY BANK OR BORROWER, EXCEPT BY A WRITTEN INSTRUMENT EXECUTED BY EACH OF THEM. If the jury waiver set forth in this Section 11 is not enforceable, then any dispute, controversy, claim, action or similar proceeding arising out of or relating to this Agreement, the Loan Documents or any of the transactions contemplated therein shall be settled by final and binding arbitration held in Durham County, North Carolina in accordance with the then current Commercial Arbitration Rules of the American Arbitration Association by one arbitrator appointed in accordance with those rules. The arbitrator shall apply North Carolina law to the resolution of any dispute, without reference to rules of conflicts of law or rules of statutory arbitration. Judgment upon any award resulting from arbitration may be entered into and enforced by any state or federal court having jurisdiction thereof. Notwithstanding the foregoing, the parties may apply to any court of competent jurisdiction for preliminary or interim equitable relief, or to compel arbitration in accordance with this Section. The costs and expenses of the arbitration, including without limitation, the arbitrator’s fees and expert witness fees, and reasonable attorneys’ fees, incurred by the parties to the arbitration may be awarded to the prevailing party, in the discretion of the arbitrator, or may be apportioned between the parties in any manner deemed appropriate by the arbitrator. Unless and until the arbitrator decides that one party is to pay for all (or a share) of such costs and expenses, both parties shall share equally in the payment of the arbitrator’s fees as and when billed by the arbitrator.

 

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12. GENERAL PROVISIONS.

12.1 Successors and Assigns . This Agreement shall bind and inure to the benefit of the respective successors and permitted assigns of each of the parties and shall bind all persons who become bound as a debtor to this Agreement; provided, however, that neither this Agreement nor any rights hereunder may be assigned by Borrower without Bank’s prior written consent, which consent may be granted or withheld in Bank’s sole discretion. Bank shall have the right without the consent of or notice to Borrower to sell, assign, transfer, negotiate, or grant participation in all or any part of, or any interest in, Bank’s obligations, rights and benefits hereunder.

12.2 Indemnification . Borrower shall defend, indemnify and hold harmless Bank and its officers, employees, and agents against: (a) all obligations, demands, claims, and liabilities claimed or asserted by any other party in connection with the transactions contemplated by this Agreement; and (b) all losses or Bank Expenses in any way suffered, incurred, or paid by Bank, its officers, employees and agents as a result of or in any way arising out of, following, or consequential to the transactions between Bank and Borrower whether under this Agreement, or otherwise (including without limitation reasonable attorneys fees and expenses), except for losses caused by Bank’s gross negligence or willful misconduct.

12.3 Time of Essence . Time is of the essence for the performance of all obligations set forth in this Agreement.

12.4 Severability of Provisions . Each provision of this Agreement shall be severable from every other provision of this Agreement for the purpose of determining the legal enforceability of any specific provision.

12.5 Amendments in Writing, Integration . All amendments to or terminations of this Agreement or the other Loan Documents must be in writing. All prior agreements, understandings, representations, warranties, and negotiations between the parties hereto with respect to the subject matter of this Agreement and the other Loan Documents, if any, are merged into this Agreement and the Loan Documents.

12.6 Counterparts . This Agreement may be executed in any number of counterparts and by different parties on separate counterparts, each of which, when executed and delivered, shall be deemed to be an original, and all of which, when taken together, shall constitute but one and the same Agreement. Executed copies of the signature pages of this Agreement sent by facsimile or transmitted electronically in Portable Document Format (“PDF”), or any similar format, shall be treated as originals, fully binding and with full legal force and effect, and the parties waive any rights they may have to object to such treatment.

12.7 Survival . All covenants, representations and warranties made in this Agreement shall continue in full force and effect so long as any Obligations remain outstanding or Bank has any obligation to make any Credit Extension to Borrower. The obligations of Borrower to

 

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indemnify Bank with respect to the expenses, damages, losses, costs and liabilities described in Section 12.2 shall survive until all applicable statute of limitations periods with respect to actions that may be brought against Bank have run.

12.8 Confidentiality . In handling any confidential information, Bank and Borrower and all employees and agents of such party shall exercise the same degree of care that such party exercises with respect to its own proprietary information of the same types to maintain the confidentiality of any non-public information thereby received or received pursuant to this Agreement except that disclosure of such information may be made (i) in the case of Bank, to the subsidiaries or Affiliates of Bank or Borrower in connection with their present or prospective business relations with Borrower, (ii) in the case of Bank, to prospective transferees or purchasers of any interest in the Credit Extensions, provided that they have entered into a comparable confidentiality agreement in favor of Borrower and have delivered a copy to Borrower, (iii) as required by law, regulations, rule or order, subpoena, judicial order or similar order, (iv) in the case of Bank, as may be required in connection with the examination, audit or similar investigation of Bank and (v) as Bank may determine in connection with the enforcement of any remedies hereunder. Confidential information hereunder shall not include information that either: (a) is in the public domain or in the knowledge or possession of the receiving party when disclosed to such party, or becomes part of the public domain after disclosure to such receiving party through no fault of such receiving party; or (b) is disclosed to the receiving party by a third party, provided such receiving party does not have actual knowledge that such third party is prohibited from disclosing such information.

[ Balance of Page Intentionally Left Blank ]

 

21


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

 

ARATANA THERAPEUTICS, INC.
By:  

/s/ Steven St. Peter

Title:  

President & CEO

SQUARE 1 BANK
By:  

/s/ Alan Faulkner

Title:  

Venture Bank Officer

[ Signature Page to Loan and Security Agreement ]


EXHIBIT A

DEFINITIONS

“Accounts” means all presently existing and hereafter arising accounts, contract rights, payment intangibles and all other forms of obligations owing to Borrower arising out of the sale or lease of goods (including, without limitation, the licensing of software and other technology) or the rendering of services by Borrower and any and all credit insurance, guaranties, and other security therefor, as well as all merchandise returned to or reclaimed by Borrower and Borrower’s Books relating to any of the foregoing.

“Acquisition” means (a) any sale, license, or other disposition of all or substantially all of the assets (including intellectual property) of Borrower, (b) any sale or disposition of all or substantially all of the capital stock of Borrower, or (c) any reorganization, consolidation, merger or sale of the voting securities of Borrower or any other transaction where the holders of 100% of Borrower’s voting securities before such transaction beneficially own less than 50% of the outstanding voting securities of the surviving entity after the transaction.

“Affiliate” means, with respect to any Person, any Person that owns or controls directly or indirectly such Person, any Person that controls or is controlled by or is under common control with such Person, and each of such Person’s senior executive officers, directors, and general partners.

“Authorized Officer” means someone designated as such in the corporate resolution provided by Borrower to Bank in which this Agreement and the transactions contemplated hereunder are authorized by Borrower’s board of directors. If Borrower provides subsequent corporate resolutions to Bank after the Closing Date, the individual(s) designated as “Authorized Officer(s)” in the most-recently provided resolution shall be the only “Authorized Officers” for purposes of this Agreement.

“Availability End Date” means March 4, 2014.

“Bank Expenses” means all reasonable costs or expenses (including reasonable attorneys’ fees and expenses, whether generated in-house or by outside counsel) incurred in connection with the preparation, negotiation, administration, and enforcement of the Loan Documents; reasonable Collateral audit fees; and Bank’s reasonable attorneys’ fees and expenses (whether generated in-house or by outside counsel) incurred in amending, enforcing or defending the Loan Documents (including fees and expenses of appeal), incurred before, during and after an Insolvency Proceeding, whether or not suit is brought.

“Borrower’s Books” means all of Borrower’s books and records including: ledgers; records concerning Borrower’s assets or liabilities, the Collateral, business operations or financial condition; and all computer programs, or tape files, and the equipment, containing such information.

“Business Day” means any day that is not a Saturday, Sunday, or other day on which banks in the State of North Carolina are authorized or required to close.

 

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“Cash” means unrestricted cash and cash equivalents.

“Cash Burn” means an amount equal to the prior period’s Cash minus the current period’s ending Cash that has been adjusted for any changes to Cash as a result of borrowings and repayments of borrowings, proceeds from the sale of equity and the exercise of stock options or warrants, paid-in-capital and minority interest, and capital expenditures financed under a capital lease.

“Change in Control” shall mean a transaction other than a bona fide equity financing or series of financings on terms and from investors reasonably acceptable to Bank or an IPO in which any “person” or “group” (within the meaning of Section 13(d) and 14(d)(2) of the Securities Exchange Act of 1934) becomes the “beneficial owner” (as defined in Rule 13d-3 under the Securities Exchange Act of 1934), directly or indirectly, of a sufficient number of shares of all classes of stock then outstanding of Borrower ordinarily entitled to vote in the election of directors, empowering such “person” or “group” to elect a majority of the Board of Directors of Borrower, who did not have such power before such transaction.

“Charter” means the Third Amended and Restated Certificate of Incorporation of Aratana Therapeutics, Inc. filed with the Delaware Secretary of State on December 28, 2012 as amended by the Certificate of Amendment of Third Amended and Restated Certificate of Incorporation or Aratana Therapeutics, Inc. filed with the Delaware Secretary of State on February 11, 2013.

“Closing Date” means the date of this Agreement.

“Code” means the North Carolina Uniform Commercial Code as amended or supplemented from time to time.

“Collateral” means the property described on Exhibit B attached hereto and all Negotiable Collateral to the extent not described on Exhibit B, except to the extent any such property (i) is nonassignable by its terms without the consent of the licensor thereof or another party (but only to the extent such prohibition on transfer is enforceable under applicable law, including, without limitation, §25-9-406 and §25-9-408 of the Code), (ii) the granting of a security interest therein is contrary to applicable law, provided that upon the cessation of any such restriction or prohibition, such property shall automatically become part of the Collateral, (iii) constitutes the capital stock of a controlled foreign corporation (as defined in the IRC), in excess of 65% of the voting power of all classes of capital stock of such controlled foreign corporations entitled to vote, or (iv) property (including any attachments, accessions or replacements) that is subject to a Lien that is permitted pursuant to clause (c) of the definition of Permitted Liens, if the grant of a security interest with respect to such property pursuant to this Agreement would be prohibited by the agreement creating such Permitted Lien or would otherwise constitute a default thereunder, provided, that such property will be deemed “Collateral” hereunder upon the termination and release of such Permitted Lien.

“Collateral State” means the state where the Collateral is located, which is Kansas.

“Contingent Obligation” means, as applied to any Person, any direct or indirect liability, contingent or otherwise, of that Person with respect to (i) any indebtedness, lease, dividend, letter

 

2


of credit or other obligation of another, including, without limitation, any such obligation directly or indirectly guaranteed, endorsed, co-made or discounted or sold with recourse by that Person, or in respect of which that Person is otherwise directly or indirectly liable; (ii) any obligations with respect to undrawn letters of credit, corporate credit cards or merchant services issued for the account of that Person; and (iii) all obligations arising under any interest rate, currency or commodity swap agreement, interest rate cap agreement, interest rate collar agreement, or other agreement or arrangement designated to protect a Person against fluctuation in interest rates, currency exchange rates or commodity prices; provided, however, that the term “Contingent Obligation” shall not include endorsements for collection or deposit in the ordinary course of business. The amount of any Contingent Obligation shall be deemed to be an amount equal to the stated or determined amount of the primary obligation in respect of which such Contingent Obligation is made or, if not stated or determinable, the maximum reasonably anticipated liability in respect thereof as determined by such Person in good faith; provided, however, that such amount shall not in any event exceed the maximum amount of the obligations under the guarantee or other support arrangement.

“Copyrights” means any and all copyright rights, copyright applications, copyright registrations and like protections in each work or authorship and derivative work thereof, whether published or unpublished and whether or not the same also constitutes a trade secret, now or hereafter existing, created, acquired or held.

“Corporate Partnership” means any corporate partnership, corporate collaboration, joint venture, licensing arrangement, or other similar arrangement, in each case, with parties and on terms reasonably acceptable to Bank.

“Credit Extension” means the Tranche A Term Loan, each Tranche B Term Loan, or any other extension of credit by Bank, to or for the benefit of Borrower hereunder.

“Equipment” means all present and future machinery, equipment, tenant improvements, furniture, fixtures, vehicles, tools, parts and attachments in which Borrower has any interest.

“ERISA” means the Employee Retirement Income Security Act of 1974, as amended, and the regulations thereunder.

“Event of Default” has the meaning assigned in Article 8.

“GAAP” means generally accepted accounting principles, consistently applied, as in effect from time to time in the United States.

“Gross Remaining Months’ Cash” means (i) Cash at Bank, plus any Tranche B Term Loans then available to be drawn divided by (ii) Cash Bum, calculated based on the actual change in Cash over the most recent 30 day period excluding any Credit Extensions made during such period.

“Indebtedness” means (a) all indebtedness for borrowed money or the deferred purchase price of property or services, including without limitation reimbursement and other obligations with respect to surety bonds and letters of credit, (b) all obligations evidenced by notes, bonds, debentures or similar instruments, (c) all capital lease obligations, and (d) all Contingent Obligations, including but not limited to any sublimit contained herein.

 

3


“Insolvency Proceeding” means any proceeding commenced by or against any Person or entity under any provision of the United States Bankruptcy Code, as amended, or under any other bankruptcy or insolvency law, including assignments for the benefit of creditors, formal or informal moratoria, compositions, extension generally with its creditors, or proceedings seeking reorganization, arrangement, or other relief.

“Intellectual Property” means all of Borrower’s right, title, and interest in and to the following:

(a) Copyrights, Trademarks and Patents;

(b) Any and all trade secrets, and any and all intellectual property rights in computer software and computer software products now or hereafter existing, created, acquired or held;

(c) Any and all design rights which may be available to Borrower now or hereafter existing, created, acquired or held;

(d) Any and all claims for damages by way of past, present and future infringement of any of the rights included above, with the right, but not the obligation, to sue for and collect such damages for said use or infringement of the intellectual property rights identified above;

(e) All licenses or other rights to use any of the Copyrights, Patents or Trademarks, and all license fees and royalties arising from such use to the extent permitted by such license or rights;

(f) All amendments, renewals and extensions of any of the Copyrights, Trademarks or Patents; and

(g) All proceeds and products of the foregoing, including without limitation all payments under insurance or any indemnity or warranty payable in respect of any of the foregoing.

“Inventory” means all present and future inventory in which Borrower has any interest.

“Investment” means any beneficial ownership of (including stock, partnership or limited liability company interest or other securities) any Person, or any loan, advance or capital contribution to any Person.

“Investment Agreement” means, collectively, Borrower’s stock purchase and other agreement(s) pursuant to which Borrower most recently issued its preferred stock.

“IPO” means the Borrower’s initial, underwritten public offering and sale of its common stock pursuant to an effective registration statement under the Securities Act of 1933, as amended.

“IRC” means the Internal Revenue Code of 1986, as amended, and the regulations thereunder.

 

4


“Letter of Credit” means a commercial or standby letter of credit or similar undertaking issued by Bank at Borrower’s request.

“Lien” means any mortgage, lien, deed of trust, charge, pledge, security interest or other encumbrance.

“Liquidity Ratio” means the ratio of unrestricted Cash at Bank plus up to 50% of net trade Accounts receivable (subject to Bank’s audit of Borrower’s Accounts) to all Indebtedness to Bank (but excluding any Indebtedness to Bank which is secured by Cash held in a segregated deposit account at Bank).

“Loan Documents” means, collectively, this Agreement, any note or notes executed by Borrower, and any other document, instrument or agreement entered into in connection with this Agreement, all as amended or extended from time to time.

“Material Adverse Effect” means a material adverse effect on (i) the operations, business or financial condition of Borrower and its Subsidiaries taken as a whole, (ii) the ability of Borrower to repay the Obligations or otherwise perform its obligations under the Loan Documents, or (iii) Borrower’s interest in, or the value, perfection or priority of Bank’s security interest in the Collateral.

“Negotiable Collateral” means all of Borrower’s present and future letters of credit of which it is a beneficiary, drafts, instruments (including promissory notes), securities, documents of title, and chattel paper, and Borrower’s Books relating to any of the foregoing.

“New Equity” means cash proceeds received after the Closing Date from the sale or issuance of Borrower’s equity securities (including any convertible indebtedness convertible into equity securities).

“Obligations” means all debt, principal, interest, Bank Expenses and other amounts owed to Bank by Borrower pursuant to this Agreement (excluding any warrants or equity securities), whether absolute or contingent, due or to become due, now existing or hereafter arising, including any interest that accrues after the commencement of an Insolvency Proceeding and including any debt, liability, or obligation owing from Borrower to others that Bank may have obtained by assignment or otherwise.

“Patents” means all patents, patent applications and like protections including without limitation improvements, divisions, continuations, renewals, reissues, extensions and continuations-in-part of the same.

“Periodic Payments” means all installments or similar recurring payments that Borrower may now or hereafter become obligated to pay to Bank pursuant to the terms and provisions of any instrument, or agreement now or hereafter in existence between Borrower and Bank.

“Permitted Indebtedness” means:

(a) Indebtedness of Borrower in favor of Bank arising under this Agreement or any other Loan Document;

 

5


(b) Indebtedness existing on the Closing Date and disclosed in the Schedule;

(c) Indebtedness not to exceed $350,000 in the aggregate in any fiscal year of Borrower secured by a lien described in clause (c) of the defined term “Permitted Liens,” provided such Indebtedness does not exceed at the time it is incurred the lesser of the cost or fair market value of the property financed with such Indebtedness;

(d) Subordinated Debt;

(e) Indebtedness to trade creditors incurred in the ordinary course of business; and

(f) Extensions, refinancings and renewals of any items of Permitted Indebtedness, provided that the principal amount is not increased or the terms modified to impose more burdensome terms upon Borrower or its Subsidiary, as the case may be.

“Permitted Investment” means:

(a) Investments existing on the Closing Date disclosed in the Schedule;

(b) (i) Marketable direct obligations issued or unconditionally guaranteed by the United States of America or any agency or any State thereof maturing within one year from the date of acquisition thereof, (ii) commercial paper maturing no more than one year from the date of creation thereof and currently having rating of at least A-2 or P-2 from either Standard & Poor’s Corporation or Moody’s Investors Service, (iii) Bank’s certificates of deposit maturing no more than one year from the date of investment therein, and (iv) Bank’s money market accounts; (v) Investments in regular deposit or checking accounts held with Bank or subject to a control agreement in favor of Bank; and (vi) Investments consistent with any investment policy adopted by the Borrower’s board of directors;

(c) Repurchases of stock from former employees or directors of Borrower under the terms of applicable repurchase agreements (i) in an aggregate amount not to exceed $350,000 in any fiscal year, provided that no Event of Default has occurred, is continuing or would exist after giving effect to the repurchases, or (ii) in any amount where the consideration for the repurchase is the cancellation of indebtedness owed by such former employees to Borrower regardless of whether an Event of Default exists;

(d) Investments accepted in connection with Permitted Transfers;

(e) Investments of Subsidiaries in or to other Subsidiaries or Borrower and Investments by Borrower in Subsidiaries not to exceed $350,000 in the aggregate in any fiscal year;

(f) Investments not to exceed $350,000 outstanding in the aggregate at any time consisting of (i) travel advances and employee relocation loans and other employee loans and advances in the ordinary course of business, and (ii) loans to employees, officers or directors relating to the purchase of equity securities of Borrower or its Subsidiaries pursuant to employee stock purchase plan agreements approved by Borrower’s Board of Directors;

 

6


(g) Investments in unfinanced capital expenditures in any fiscal year, not to exceed $350,000;

(h) Investments (including debt obligations) received in connection with the bankruptcy or reorganization of customers or suppliers and in settlement of delinquent obligations of, and other disputes with, customers or suppliers arising in the ordinary course of Borrower’s business;

(i) Investments consisting of notes receivable of, or prepaid royalties and other credit extensions, to customers and suppliers who are not Affiliates, in the ordinary course of business, provided that this subparagraph (h) shall not apply to Investments of Borrower in any Subsidiary;

(j) Joint ventures or strategic alliances in the ordinary course of Borrower’s business consisting of licensing of technology, the development of technology or the providing of technical support permitted hereunder, provided that any cash Investments by Borrower do not exceed $350,000 in the aggregate in any fiscal year;

(k) Investments permitted under Section 7.3; and

(l) Investments consisting of deposit account and securities accounts of Borrower, subject to the compliance by Borrower with the covenant set forth in Section 6.6.

“Permitted Liens” means the following:

(a) Any Liens existing on the Closing Date and disclosed in the Schedule (excluding Liens to be satisfied with the proceeds of the Credit Extensions) or arising under this Agreement, the other Loan Documents, or any other agreement in favor of Bank;

(b) Liens for taxes, fees, assessments or other governmental charges or levies, either not delinquent or being contested in good faith by appropriate proceedings and for which Borrower maintains adequate reserves;

(c) Liens not to exceed $250,000 in the aggregate in any fiscal year (i) upon or in any Equipment (other than Equipment financed by a Credit Extension) acquired or held by Borrower or any of its Subsidiaries to secure the purchase price of such Equipment or indebtedness incurred solely for the purpose of financing the acquisition or lease of such Equipment, or (ii) existing on such Equipment at the time of its acquisition, in each case provided that the Lien is confined solely to the property so acquired and improvements thereon, and the proceeds of such Equipment;

(d) Liens not to exceed $250,000 in connection with leases or subleases and licenses or sublicenses granted in the ordinary course of Borrower’s business, if the leases, subleases, licenses and sublicenses do not prohibit granting Bank a security interest;

(e) Statutory liens not to exceed $250,000 securing claims or demands of materialmen, mechanics, carriers, repairmen, or other like Liens imposed without the action of such parties arising in the ordinary course of business;

 

7


(f) Liens not to exceed $250,000 to secure payment for workers’ compensation, employment insurance, old age pensions, social security or other like obligations incurred in the ordinary course of business;

(g) Licenses permitted hereunder;

(h) Liens incurred in connection with the extension, renewal or refinancing of the indebtedness secured by Liens of the type described in clauses (a) through (c) above, provided that any extension, renewal or replacement Lien shall be limited to the property encumbered by the existing Lien and the principal amount of the indebtedness being extended, renewed or refinanced does not increase;

(i) Liens securing Subordinated Debt; and

(j) Liens arising from judgments, decrees or attachments in circumstances not constituting an Event of Default under Sections 8.4 (attachment) or 8.7 (judgments); and

(k) Liens in favor of other financial institutions arising in connection with Borrower’s deposit accounts held at such institutions to secure standard fees for deposit services charged by, but not financing made available by such institutions, provided that Bank has a perfected security interest in the amounts held in such deposit accounts.

“Permitted Transfer” means the conveyance, sale, lease, transfer or disposition by Borrower or any Subsidiary of:

(a) Inventory in the ordinary course of business;

(b) licenses and similar arrangements for the use of the property of Borrower or its Subsidiaries in the ordinary course of business;

(c) worn-out, surplus or obsolete Equipment not financed with the proceeds of Credit Extensions;

(d) grants of security interests and other Liens that constitute Permitted Liens; and

(e) other assets of Borrower or its Subsidiaries that do not in the aggregate exceed $350,000 during any fiscal year.

“Person” means any individual, sole proprietorship, partnership, limited liability company, joint venture, trust, unincorporated organization, association, corporation, institution, public benefit corporation, firm, joint stock company, estate, entity or governmental agency.

“Prime Rate” means the “prime rate” or “base rate” published by the Wall Street Journal from time to time.

“Responsible Officer” means each of the Chief Executive Officer, the Chief Operating Officer, the Chief Financial Officer, Vice President of Finance and the Controller of Borrower, as well as any other officer or employee identified as an Authorized Officer in the corporate resolution delivered by Borrower to Bank in connection with this Agreement.

 

8


“Schedule” means the schedule of exceptions attached hereto as Exhibit E and approved by Bank, if any.

“SOS Reports” means the official reports from the Secretaries of State of each Collateral State, the state where Borrower’s chief executive office is located, the state of Borrower’s formation and other applicable federal, state or local government offices identifying all current security interests filed in the Collateral and Liens of record as of the date of such report.

“Subordinated Debt” means any debt incurred by Borrower that is subordinated in writing to the debt owing by Borrower to Bank on terms reasonably acceptable to Bank (and identified as being such by Borrower and Bank).

“Subsidiary” means any corporation, partnership or limited liability company or joint venture in which (i) any general partnership interest or (ii) more than 50% of the stock, limited liability company interest or joint venture of which by the terms thereof ordinary voting power to elect the Board of Directors, managers or trustees of the entity, at the time as of which any determination is being made, is owned by Borrower, either directly or through an Affiliate.

“Term Loan Maturity Date” means March 4, 2016.

“Term Loans” has the meaning assigned in Section 2.1(b)(i).

“Trademarks” means any trademark and servicemark rights, whether registered or not, applications to register and registrations of the same and like protections, and the entire goodwill of the business of Borrower connected with and symbolized by such trademarks.

“Tranche A Term Loan” has the meaning assigned in Section 2.l(b)(i).

“Tranche B Term Loan(s)” has the meaning assigned in Section 2.1(b)(i).

 

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DEBTOR    ARATANA THERAPEUTICS, INC.
SECURED PARTY:    SQUARE 1 BANK

EXHIBIT B

COLLATERAL DESCRIPTION ATTACHMENT TO LOAN AND SECURITY AGREEMENT

All personal property of Borrower (herein referred to as “Borrower” or “Debtor”) whether presently existing or hereafter created or acquired, and wherever located, including, but not limited to:

(a) all accounts (including health-care-insurance receivables), chattel paper (including tangible and electronic chattel paper), deposit accounts, documents (including negotiable documents), equipment (including all accessions and additions thereto), financial assets, general intangibles (including patents, trademarks, copyrights, goodwill, payment intangibles, domain names and software), goods (including fixtures), instruments (including promissory notes), inventory (including all goods held for sale or lease or to be furnished under a contract of service, and including returns and repossessions), investment property (including securities and securities entitlements), letter of credit rights, money, and all of Debtor’s books and records with respect to any of the foregoing, and the computers and equipment containing said books and records;

(b) any and all cash proceeds and/or noncash proceeds of any of the foregoing, including, without limitation, insurance proceeds, and all supporting obligations and the security therefor or for any right to payment. All terms above have the meanings given to them in the North Carolina Uniform Commercial Code, as amended or supplemented from time to time, including revised Division 9 of the Uniform Commercial Code­ Secured Transactions.

Notwithstanding the foregoing, the Collateral shall not include any of the intellectual property, in any medium, of any kind or nature whatsoever, now or hereafter owned or acquired or received by Borrower, or in which Borrower now holds or hereafter acquires or receives any right or interest (collectively, the “Intellectual Property”); provided, however, that the Collateral shall include all accounts and general intangibles that consist of rights to payment and proceeds from the sale, licensing or disposition of all or any part, or rights in, the foregoing (the “Rights to Payment”).

Notwithstanding the foregoing, if a judicial authority (including a U.S. Bankruptcy Court) holds that a security interest in the underlying Intellectual Property is necessary to have a security interest in the Rights to Payment, then the Collateral shall automatically, and effective as of March 4, 2013, include the Intellectual Property to the extent and only to the extent necessary to permit perfection of Bank’s security interest in the Rights to Payment, and further provided, however, that Bank’s enforcement rights with respect to any security interest in the Intellectual Property shall be absolutely limited to the Rights to Payment only, and Bank shall have no recourse whatsoever with respect to the underlying Intellectual Property.

 

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EXHIBIT C

LOAN ADVANCE / PAYDOWN REQUEST FORM

[Please refer to New Borrower Kit]


EXHIBIT D

COMPLIANCE CERTIFICATE

[Please refer to New Borrower Kit]


EXHIBIT E

SCHEDULE OF EXCEPTIONS

Permitted Indebtedness (Exhibit A) - None.

Permitted Investments (Exhibit A) -

As of 2/23/13:

Restricted cash CD $140,000

Brokered CDs $6,382,000

Permitted Liens (Exhibit A) - None.

Intellectual Property (Section 5.4) -

See Exhibits to Exclusive License Agreements with RaQualia Pharma, Inc. and Pacira Pharmaceuticals, Inc. listed below.

Provisional Application No. 61/706,164 filed September 27, 2012: Compositions and methods of use of an inappetance controlling compound.

Prior Names (Section 5.5) - None.

Litigation (Section 5.6) - None.

Inbound Licenses (Section 5.12) -

Exclusive IP License Agreement for RQ-00000005 with RaQualia Pharma, Inc., dated December 27, 2010.

Exclusive IP License Agreement for RQ-00000007 with RaQualia Pharma, Inc., dated December 27, 2010.

Exclusive License, Development and Commercialization Agreement with Pacira Pharmaceuticals, Inc., dated December 5, 2012.

Exhibit 10.17

KANSAS BIOSCIENCE RESEARCH AND DEVELOPMENT (R&D) VOUCHER PROGRAM GRANT AGREEMENT

This Research and Development Voucher Grant Agreement (“Agreement”) dated as March 6, 2012 (the “Effective Date”) is by and between the Kansas Bioscience Authority , 10900 S. Clay Blair Blvd., Olathe, Kansas 66061 (the “KBA”) and Aratana Therapeutics, Inc. , 1901 Olathe Blvd., Kansas City, KS 66103 (the “Grantee”), collectively the “Parties.”

WHEREAS , Grantee has requested a grant from the KBA for the purposes described herein;

WHEREAS , the KBA has the power to provide the grant, as defined below, under the Kansas Bioscience Authority Act, K.S.A. 74-99b01, et seq., as amended from time to time (“KBA Act”);

WHEREAS , in accordance with the terms of the KBA Act and the policies and procedures of the KBA, the Investment Committee on February 20, 2012 has recommended and on March 6, 2012 the Board of Directors has approved funding to Grantee in the amount up to One Million Three Hundred Thirty Three Thousand Three Hundred and Thirty Three Dollars ($1,333,333) over an estimated two year period (the “Grant”) pursuant to the Kansas Bioscience R&D Voucher Program ;

WHEREAS , in accordance with the terms of the KBA Act and the policies and procedures of the KBA, Grantee acknowledges that under no circumstances does the KBA solicit or accept donations in return for KBA funds;

WHEREAS , the Parties are entering into this Agreement to set forth the terms and conditions of the Grant and acknowledge that all terms and conditions are subject to funding restrictions imposed upon the KBA by the State of Kansas and may require an award reduction or termination of this Agreement.

NOW , THEREFORE , the above recitals being made a part of this Agreement, the KBA and Grantee agree as follows:

1. Project. The KBA approved a Grant in the amount up to $1,333,333 to Grantee. Grantee agrees to use all of the Grant exclusively to support the pre-formulation, formulation, manufacture and pivotal studies of its first two companion animal development programs. Aratana will conduct work with Kansas companies to advance these programs, spending an estimated total of $4.0 million in Kansas (the “Project”).

KBA will reimburse 33% of the Grantee’s quarterly expenses that are directly related to the Project activities up to the maximum funding amount of $1,333,333. The research partner(s) authorized to be paid using KBA funds are Argenta, AlcheraBio, Xenometrics and KCAS. Additional authorized Kansas research partners may be added by Grantee only upon written approval by KBA. KBA will make payments based on Grantee’s acceptable completion of the terms of each milestone listed in Section 3, as determined by the sole judgment of the KBA and may make payments directly to the research partner(s) if requested. This includes verification that Grantee has contributed its 67% portion to the Project and that any applicable University

 

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research partner(s) have contributed at least its 20% portion of KBA funds to the Project. The applicable University research partner’s Indirect costs (Facilities and Administration) cannot be covered using KBA funds. In addition, KBA funds cannot be used for rent, capital costs, or utilities.

Grantee may not use any portion of the Grant, including any interest earned thereon, for any other purpose without the prior written approval of the KBA. At no time will the Grantee use any portion of the Grant for a purpose inconsistent with the KBA Act.

2. Reports . During the term of the Grant, and for a ten-year period after the final Grant payment made by the KBA under this Agreement, Grantee will provide a written annual report to the KBA regarding the Project and Grantee’s use of the Grant. The KBA will provide the Grantee a reporting form and require the Grantee to complete it at least annually and within 30 days from the request date. Grantee must complete the reporting form to the satisfaction of the KBA. The report may include, but not be limited to, the following as they relate to this Grant:

 

 

Full-time jobs created and jobs retained in the state of Kansas and total associated wages and average wage

 

 

Part-time jobs created and retained in the state of Kansas and total associated wages and average wage

 

 

Number of strategic partners

 

 

Number of invention disclosures and of patents applied for and granted

 

 

Annual research funding

 

 

SBIR/Federal technology development financing

 

 

Capital expenditures (purchase or rehabilitation of land, building and equipment)

 

 

New start-up companies created in the state of Kansas

 

 

Number of commercial products or services and associated income

 

 

Third party funding (cumulative equity investment)

 

   

Venture capital

 

   

Convertible debt

 

   

Other investments (e.g. strategic partners)

 

 

Indirect Outcomes

 

   

Market capitalization

 

   

Revenue from Kansas operations

 

   

Net income from Kansas operations

 

   

Income tax paid in Kansas

 

   

Property tax paid in Kansas

 

   

Total company revenue in the most recent fiscal year

 

   

Total company revenue in the previous fiscal year

 

   

Total company net income

3. Milestones . If the Grant will be paid to Grantee in increments upon achievement by Grantee of specified milestones, Grantee will provide the Award Payment Request Form attached hereto as Exhibit A; any supporting documentation; a clear statement of the objectives, tasks, and outcomes for each milestone associated with the payment request; and actual expenses against the approved budget attached hereto as Exhibit B.

 

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Grantee will report immediately in writing to the KBA each milestone achievement. KBA’s Contract Administrator will review the request for payment and if deemed appropriate will process the payment request according to KBA policies and procedures. Payment will be made within 45 days of final approval by the KBA’s executive staff.

The milestone schedule is as follows:

 

Milestone

                

Milestone Description and Documentation:

  

KBA
Payment

1. Completion of Quarterly Project Activities

 

(Expected Completion – July 2012)

  

a)

   Execution of R&D Voucher Grant Agreement between the KBA and Aratana.    33% of Project Expenditures in Kansas up to $1,333,333
  

 

b)

  

 

Copies of executed service agreements between Aratana and Argenta, AlcheraBio, Xenometrics, KCAS.

  
     

 

1)

  

 

If work is being conducted under a Master Agreement, provide a copy of the Master Agreement and copies of the specific work orders for which Aratana is seeking reimbursement.

  
  

 

c)

  

 

Quarterly Project Expenses

  
     

 

1)

  

 

Copies of research partner invoices and certification by an officer of Aratana of payment. KBA will reimburse 33% of paid project expenses for work conducted in Kansas.

  
     

 

2)

  

 

Certification by Aratana that work subject to KBA reimbursement has been conducted in Kansas.

  
  

 

d)

  

 

Summary report of Project results to date and anticipated activities for the next quarter

  

Milestones 2 thru 8

 

Completion of Quarterly Project Activities

   a)    Quarterly Project Expenses    33% of Project Expenditures in Kansas up to $1,333,333
     

 

1)

  

 

Copies of research partner invoices and certification by an officer of Aratana of payment. KBA will reimburse 33% of paid project expenses for work conducted in Kansas.

  
     

 

2)

  

 

If work is being conducted under a Master Agreement, provide a copy of the specific work orders for which Aratana is seeking reimbursement.

  
      3)    Certification by Aratana that work subject to KBA reimbursement has been conducted in Kansas.   
   b)    Summary report of Project results to date and anticipated activities for the next quarter   
   c)    The Quarterly period for project expenses and activities will be as follows:   
     

Milestone 2 – July through September 2012

Milestone 3 – October through December 2012

Milestone 4 – January through March 2013

Milestone 5 – April through June 2013

Milestone 6 – July through September 2013

Milestone 7 – October through December 2013

Milestone 8 – January through March 2014

  
   d)    Payment of all Milestone Requests will be subject to submission of applicable annual Post-Award Reports as required by KBA Grant Agreement.   

 

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   NOTE : The following will apply to specific Quarterly Milestone Payment Requests as indicated:   
   1.    With the Milestone # 4 Request, Aratana will submit a Work Plan and Budget for projects to take place over the next 12 months.   
   2.    With the Milestone # 8 Request, Aratana will submit a Final Project Report.   
   3.    If Aratana changes project partners, copies of executed Service Agreements must be provided before expenses will be reimbursed.   
        

NOT-TO-EXCEED TOTAL :

   $1,333,333

4. Term . This Agreement will begin upon the Effective Date and will terminate on the 10 th anniversary of the final Grant payment.

5. Use of Funds . Grantee agrees that the Grant will be used in accordance with the purpose submitted by Grantee as part of its Grant request, as approved by the KBA. If the Grant is for a project that has milestones, each milestone’s Grant payment is contingent upon satisfactory progress and expenditure of funds as budgeted. All Grant payments are contingent upon the KBA’s satisfaction with the reports submitted as required in Section 2 and adherence to the milestone schedule outline in Section 3. The KBA reserves the right to discontinue, modify, or withhold any payments to be made under this Agreement, if the KBA determines that (a) Grantee has not fully complied with the material terms and conditions of this Agreement; (b) action is necessary to protect the purposes and objectives of the Project; or (c) action is necessary to comply with any law or regulation applicable to Grantee, the KBA, the Project, or this Agreement. No action by the Grantee shall be in violation or frustration of the Kansas Economic Growth Act, the mission of the KBA or any other applicable laws. Grantee shall perform or comply with all terms and provisions of this Agreement. If Grantee fails to comply and such failure is not cured within a timely manner from the date of receipt of notice of the existence and nature of the failure or violation, then KBA may require a total or partial refund of any Grant payments made.

Notwithstanding the foregoing, and at the election of the KBA, this Agreement may be terminated by KBA and Grantee may be required to repay to the KBA the Grant in accordance with Kansas Statute Annotated 74-99b18 (attached hereto as Exhibit C) or upon the occurrence of any one of the following events: (a) Grantee initiates procedures to dissolve and wind up; or (b) the Grantee ceases operation within the state of Kansas during the Term of this Agreement. KBA retains all rights afforded to it, as a creditor and otherwise, under the U.S. Bankruptcy code as amended from time to time.

6. Confidentiality . Both parties agree that information marked “Proprietary” or “Confidential” related to this Project will be kept confidential by the parties to the extent permitted by law. Notwithstanding the foregoing, Grantee acknowledges that the KBA is subject to the Kansas Open Records Act (“KORA”), and Grantee therefore agrees (a) to act in accordance with any direction made by the KBA as required by KORA regarding open records, and (b) that the disclosure of any information related to the Project required under KORA does not constitute a breach of confidentiality or this Agreement. KBA agrees to provide timely

 

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notification to the Grantee of any KORA request relating to the Project. This requirement of confidentiality does not pertain to the publication of research results in peer-reviewed journals or publication of theses or dissertations. Additionally, acknowledgement of KBA funding or sponsorship in a factual statement is not prohibited by this clause.

7. Financial Statements . Grantee agrees to keep financial statements and other records in a manner satisfactory to the KBA to adequately account for the use of the Grant exclusively for the Project’s purposes, and to make such financial statements and other records available to the KBA upon request.

8. Furnishing of Information . Grantee agrees to supply the KBA with such information as the KBA requests, in its sole judgment, to establish the use of the Grant in furtherance of the Project.

9. Reserved .

10. Media .

A. Acknowledgment of Support . The Grantee is responsible for ensuring that KBA support is acknowledged as follows:

 

  i. In any publication by Grantee or publication in which Grantee has knowingly furnished information, whether in electronic or in paper form, of any material based on or developed under this Project, by specifically stating that the Project is supported in part by funding from the Kansas Bioscience Authority, except that such acknowledgement is not required when research projects are 1) fully funded by an organization other than KBA, or 2) the publication prohibits or does not provide for acknowledgement; and

 

  ii. Orally during all media interviews with Grantee’s employee when acting in their official capacities, including popular media such as radio, television and news magazines, by specifically stating that the Project is supported by funding from the Kansas Bioscience Authority.

B. News Releases . No formal news release concerning the Project shall be issued by Grantee without prior written coordination with the KBA’s Director of Marketing and Communications or his or her designee.

C. Attendance at Events . Grantee must make reasonable efforts to send representation to key events as requested by the KBA which may include Bioscience Day at the state capitol, the KBA annual meeting, and other such events.

D. Disclaimer . The Grantee is responsible for ensuring that every publication of material by Grantee, whether in electronic or paper form, based on or developed under the Project, except articles or papers appearing in scientific, technical or professional journals or comparable written presentations and communications, contains the following disclaimer: “Any opinions, findings, conclusions and recommendations expressed in this material are those of the author or authors and do not necessarily reflect the views of the Kansas Bioscience Authority.”

 

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E. Copies for KBA . The Grantee must provide the Contract Administrator with a copy of every publication by Grantee of Project material based on or developed under this Grant, promptly after publication and in either electronic or in paper form.

11. Application Fees . Any and all fees associated with the Application will be assumed by Grantee and are not eligible for payment or reimbursement by the KBA.

12. Assignability . This Agreement may not be assigned without the express written consent of the KBA. No assignment shall be approved in violation or frustration of the Kansas Economic Growth Act, the mission of the KBA or any other applicable laws.

13. Binding on Successors . This Agreement will be binding on any successors, heirs, and assigns of Grantee.

14. Authority . Each party to this Agreement represents and warrants to the other party that the execution, delivery, and performance of this Agreement by the party has been duly and validly authorized and approved by all necessary action of the party. This Agreement constitutes the legal, valid, and binding obligations of such party, enforceable against it in accordance with its terms.

15. No Violation . Grantee represents and warrants to the KBA that the execution and performance of this Agreement by Grantee will not constitute a violation of any law or any legal or contractual rights of any third party.

16. Governing Law . This Agreement will be governed by and construed in accordance with the laws of the State of Kansas, without regard to principles of conflicts of laws thereof.

17. Notice . All notices or other communications required or permitted under this Agreement will be in writing and will be deemed duly given (a) when delivered in person to the recipient party, (b) upon transmittal of a facsimile or email transmission to the recipient party at the facsimile number or email address designated below, with reasonable evidence of successful transmission, or (c) three business days after being mailed by either registered or certified U.S. mail, return receipt requested, postage prepaid to the recipient party at the mailing address designated for the recipient party as follows:

 

If to KBA :    If to Grantee :
Kansas Bioscience Authority    Aratana Therapeutics, Inc.
10900 S. Clay Blair Blvd    1901 Olathe Blvd.
Olathe, KS 66061    Kansas City, KS 66103
Telephone: (913) 397-8300    Telephone: 913-951-2132
Contracts: Nancy R. Ruf    Contracts: David K. Rosen
Email: ruf@kansasbioauthority.org    Email: drosen@aratanarx.com
Technical: Tony Simpson    Technical: David K. Rosen
Email: simpson@kansasbioauthority.orgn    Email: drosen@aratanarx.com

 

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This Agreement represents the entire understanding between the KBA and Grantee concerning the Project and supersedes all prior and contemporaneous agreements and communications of the Parties, whether written or oral.

This Agreement has been duly signed by authorized officers of each party.

 

GRANTEE:     KANSAS BIOSCIENCE AUTHORITY:
By:  

/s/ David K. Rosen

    By:  

/s/ David Vranicar

Name:   David K. Rosen     Name:   David Vranicar
Title:   President and COO     Title:   President and CEO
Date:  

10 April 2012

    Date:  

04/3/2012

 

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EXHIBIT A - Award Payment Request Form

 

Company Name:   

 

      Date:   

 

   (NOTE: name of the check payee)         
Project Name:   

Aratana R&D Voucher

      KBA Grant #: 557

 

1a. Amount Requested: $              Milestone Number(s):             

 

1b. Please circle CHECK or WIRE TRANSFER ( Provide bank info for wire transfer - required for payments over $750,000 )

 

2. Describe the milestone(s) achieved for this payment request, and attach supporting documentation.

 

3. Give a brief description of the status of the project.

 

4. Detail all subsequent milestones for which you will be requesting payment ( and give an approximate achievement date for each ).

 

5. Detail any new jobs created since the award date ( provide supporting documentation, e.g., Employee Name or ID, Title and Hire Date ).

 

6. Detail any capital expenditures since the award date ( provide supporting documentation )

 

7. Detail any research dollars received since the award date ( provide supporting documentation, e.g. Notice of Awards, Project Title, Amount, Project Period and PI ).

 

8. Detail any investment capital received since the award date ( provide supporting documentation, e.g. Cap Table ).

As a duly authorized official of                                         , I hereby attest that the information provided is a true and accurate representation of the information requested.

 

Name:  

 

Title:  

 

Address:  

 

 

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EXHIBIT B – Budget

Aratana has budgeted $14.73 million for the R&D efforts associated with developing AT-001 and AT-002 to regulatory approval over 5 years. Of that total, approximately $6.56 million is budgeted for AT-001, while the remaining $8.17 million is estimated to be spent to develop AT-002 across the three possible indications.

Over the next two years, Aratana has identified $4.0 million of this development program that can be conducted in Kansas with the collaborators identified below and in Section 1.

 

     2012 Product Development Budget  
     Kansas Collaborators  

Collaborator

   Product         Amount  

Argenta

   AT-001       $ 469,457   
   AT-002       $ 770,660   
      Total    $ 1,240,117   

AlcheraBio

   AT-001       $ 375,000   
   AT-002       $ 360,000   
      Total    $ 735,000   

XenoMetrics

   AT-001       $ 50,000   
   AT-002       $ 150,000   
      Total    $ 200,000   

KCAS

   AT-002       $ 99,000   
      Total    $ 99,000   
   Total Project Expenses    $ 2,274,117   

For work conducted beyond 2012, Aratana has indicated that approximately $2,000,000 of the Pivotal Safety and Efficacy trial work will be conducted in 2012 in Kansas with Kansas collaborators. As part of the proposed milestones, KBA staff has included the submission of an updated work plan and budget for these studies as part of Milestone # 4 of this proposed voucher.

Aratana has entered into Master Service Agreements with AlcheraBio, Xenometrics and Argenta. Specific scope of work documents for the Argenta projects can be found in Appendix C and Appendix D of this document. Projects to be conducted by KCAS will be documented on individual work orders which will be provided to KBA as part of the Award Payment process.

 

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EXHIBIT C – Repayment Statute

74-99b18

Chapter 74.—STATE BOARDS, COMMISSIONS AND AUTHORITIES

Article 99b.—BIOSCIENCE AUTHORITY

74-99b18. Companies receiving authority financing; repayment required, when.

Each bioscience company or qualified company receiving grants, awards, tax credits or any other financial assistance, including financing for any bioscience development project, under the provisions of the bioscience authority act, the emerging industry investment act, the bioscience development financing act, the tax investment incentive act, the bioscience research and development voucher program act, or the bioscience research matching funds act, shall repay such financial assistance to the authority, in the amount determined by the authority, if such bioscience company or qualified company relocates operations, in which the authority invested, outside Kansas within 10 years after receiving such financial assistance. Each such bioscience company or qualified company shall enter into a repayment agreement with the authority specifying the terms of such repayment obligation.

History : L. 2004, ch. 112, § 52; July 1.

 

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Exhibit 10.18

Execution Version

EXCLUSIVE IP LICENSE AGREEMENT FOR RQ-00000005

This E XCLUSIVE IP L ICENSE A GREEMENT FOR RQ-00000005 (this “ Agreement ”) is entered into as of December 27, 2010 (the “ Effective Date ”) by and between Aratana Therapeutics Inc. , a Delaware corporation having a place of business is 1901 Olathe Boulevard, Kansas City, KS 66103 (“ Licensee ”) and RaQualia Pharma Inc. , a Japanese corporation having a place of business at 5-2 Taketoyo, Aichi 470-2341, Japan (“ Licensor ”).

R ECITALS

W HEREAS , Licensor owns certain rights and technology pertaining to a ghrelin agonist (Capromorelin) for treating anorexia, cachexia and unintended weight loss, including all analogs, formulations thereto, and related back-up programs thereto (collectively, “ RQ-00000005 Technology ”); and

W HEREAS , Licensee desires to receive an exclusive worldwide license to RQ-00000005 Technology, and Licensor is willing to grant such license to Licensee under the terms and conditions provided herein.

N OW , T HEREFORE , in consideration of the mutual covenants set forth herein and for other consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows:

A GREEMENT

1. D EFINITIONS . As used in this Agreement:

1.1 Target Animal Safety Study ” means the pivotal regulatory study to assess animal safety in cats or dogs.

1.2 Affiliate ” of a party means any person or entity, which controls, is controlled by, or is under common control with such party, where “control” means ownership of fifty percent (50%) or more of the outstanding voting securities.

1.3 Combination Product ” means any pharmaceutical drug which consists of a Royalty-Bearing Product and other active compounds and/or active ingredients, where such combination of the Royalty-Bearing Product with the other active compound and/or active ingredient is not covered by any Licensed Patent.

 

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


1.4 First Commercial Sale ” shall mean, with respect to any Royalty-Bearing Product, the first sale for end use or consumption of such Royalty-Bearing Product in a country after the governing health regulatory authority of such country has granted regulatory approval of such Royalty-Bearing Product.

1.5 Improvements ” means any upgrade, enhancement, modification, alteration, improvement, development, or other change made to the Licensed Know How or the inventions disclosed in the Licensed Patents during the term of this Agreement.

1.6 Licensed Know-How ” shall mean unpatented information to the extent owned or controlled by Licensor as of the Effective Date associated with the Licensed Patents or related to RQ-00000005 Technology, including but not limited to research and development information, trade secrets, engineering, scientific, and practical information, data, formulas, formulations, APIs, analogs, back-up programs, 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 practice of the Licensed Patents or the RQ-00000005 Technology.

1.7 Licensed Patents ” means (i) the patents listed in Exhibit A ; (ii) any patent or patent application that claims priority to and is a divisional, continuation, continuation-in-part, reissue, renewal, reexamination, substitution or extension of any patent application identified in (i); (iii) any patents issuing on any of the patent applications identified in (i) or (ii), including any reissues, renewals, reexaminations, substitutions or extensions thereof; (iv) any foreign counterpart (including PCTs) of any of the patents or patent applications identified in (i), (ii) or (iii); and (v) any other patent or patent application owned or controlled by Licensor now or during the term of this Agreement pertaining to RQ-00000005 Technology or Licensor Improvements.

1.8 Licensed Process ” means any process that would infringe one or more Valid Claims of a Licensed Patent, but for the license granted in Section 2.1.

1.9 Licensed Products ” means any product in the Licensee Field of Use (i) that would infringe one or more Valid Claims of a Licensed Patent, but for the license granted in Section 2.1 or (ii) is manufactured using a Licensed Process or (iii) when used, practices a Licensed Process.

1.10 Licensee Field of Use ” means the field of animal health.

1.11 Licensee Improvements ” means Improvements created, conceived, or reduced to practice by or for Licensee.

1.12 Licensor Field of Use ” means the field of human health.

1.13 Licensor Improvements ” means Improvements created, conceived, or reduced to practice by or for Licensor.

1.14 NADA ” means a new animal drug application as prescribed by applicable U.S. food and drug administration (FDA) regulations, or any corresponding foreign statutes, rules or regulations.

 

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

 

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1.15 Net Sales Revenue ” means [***].

1.16 Royalty-Bearing Product ” means a pharmaceutical drug that, absent the license granted in Section 2.1, the sale of which would infringe one or more Valid Claims of an issued Licensed Patent in force in the country in which such drug is sold.

1.17 Subsidiary ” means any entity which is controlled by a party, either directly or indirectly, where “control” means ownership of fifty percent (50%) or more of the outstanding voting securities.

1.18 Valid Claim ” means a claim of an issued or granted Licensed Patent in any country that has not expired or lapsed, been abandoned or cancelled, or held or declared invalid or unenforceable.

2. L ICENSE

2.1 Patent License Grant . Licensor hereby grants to Licensee a worldwide, exclusive (without any reservation of rights by Licensor) license under the Licensed Patents during the term of this Agreement, to: (i) use, develop, make, have made, sell, offer to sell, import, export, lease, or otherwise dispose of any Licensed Product; (ii) use any method or process in manufacturing the Licensed Products; (iii) use and perform any Licensed Processes; and (iv) to otherwise practice the claimed inventions pertaining to RQ-00000005 Technology in the Licensee Field of Use.

2.2 Know-How License Grant . Licensor hereby grants to Licensee a worldwide, exclusive (without any reservation of rights by Licensor) license under the Licensed Patents during the term of this Agreement to use the Licensed Know-How in connection with any development, manufacture, sale, importation, exportation, lease or disposal of any Licensed Product or performance of any Licensed Process in the Licensee Field of Use.

2.3 Technology Transfer . Within [***] days of the Effective Date, Licensor shall provide Licensee, at no cost, copies of all documents, materials, data sheets, test results, analyses, formulations, compositions and all other tangible embodiments of the Licensed Know-How and Licensed Patents (“ Material ”). Licensor shall make available to Licensee, upon reasonable request, employees and agents of Licensor to facilitate the technology transfer of the Know-How and to respond to Licensee inquiries pertaining to the Licensed Know-How and Licensed Patents to facilitate Licensee’s full use, enjoyment, and exploitation of the licenses granted herein.

2.4 Sublicense . The licenses granted in Sections 2.1 and 2.2 include the right of Licensee to sublicense any and all of the licensed rights to one or more tiers of sublicenses including but not limited to its Affiliates. All sublicenses granted to third parties will be pursuant to written agreement that are in accordance with and no broader than the terms of this Agreement.

 

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

 

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3. F EES , R EPORTS , AND A UDIT

3.1 Initial Licensee Fees and Royalty

(a) Initial License Fees . In consideration for the licenses to the Licensed Patents, Licensed Know-How, and Licensor Improvements, [***] days after the Effective Date, Licensee will pay Licensor a license fee of [***] US Dollars ([***]).

(b) Sales Royalty . Licensee will pay to Licensor a royalty in the amount of [***] percent ([***]%) of Net Sales Revenue received by Licensee for the sale of the Royalty Bearing Products in countries where there are Valid Claims of the Licensed Patents until such Licensed Patents have expired or been abandoned. If Licensee sublicenses the Licensed Patents to a third party sublicensee, Licensee will pay to Licensor a royalty in the amount equal to [***] percent ([***]%) of the royalty paid by such sublicensee to Licensee based on the sale of the Royalty Bearing Products in countries where there are Valid Claims of the Licensed Patents until such Licensed Patents have expired or been abandoned, but in no event shall the royalty paid to Licensor be less than [***] percent ([***]%) of the Net Sales Revenue of such third party sublicensee. Royalty payments shall be due on a [***] basis within [***] days after [***].

3.2 Milestone Fees . Except with respect milestone fees triggered upon a NADA filing, within [***] days after the occurrence of the following milestones, Licensee will pay Licensor the corresponding one-time milestone fees provided below. With respect to any milestone fee based on a NADA filing, Licensee will pay Licensor the corresponding one-time milestone fee provided below for such NADA filing within [***] months after such NADA filing. For avoidance of doubt, the parties agree that Licensee’s obligation to pay each milestone fee referenced below is a one-time obligation even if the applicable milestone event occurs more than once.

 

Milestone

   Milestone Fee

[***]

   [***] US Dollars ($[***])

[***]

   [***] US Dollars ($[***])

[***]

   [***] US Dollars ($[***])

[***]

   [***] US Dollars ($[***])

[***]

   [***] US Dollars ($[***])

3.3 Third Party Patent Rights . In the event it becomes necessary for Licensee or its sublicensee to license patent rights owned by a third party to use, develop, make, have made, sell, offer to sell, import, export, lease, or otherwise dispose of any Royalty-Bearing Product, then Licensee or its sublicensee, as applicable, shall have the right to obtain a license from such third party and to credit [***] percent ([***]%) of any payment owed to such third party under such license against the royalty payable to Licensor under Section 3.1 above on a going forward basis. No such amounts deducted shall reduce royalties paid to Licensor by more than [***] percent ([***]%); provided, however, that amounts not deducted because of this limit may be carried forward and applied to future royalties paid, subject to the [***] percent ([***]%) floor.

3.4 Reports . Along with each royalty payment, Licensee will provide a statement showing the quantity of Royalty-Bearing Products sold or transferred during the preceding [***] and a calculation of the royalties accrued during such quarter, provided that Licensee shall provide an estimated royalty report within [***] days after the end of such calendar [***]. Licensor will treat these statement as Confidential Information of Licensee, will protect it from unauthorized use, access or disclosure in the same manner as Licensor protects its own confidential or proprietary information of similar nature and with no less than reasonable care, and will disclose it only to the employees or agents of Licensor who have a need to know such information for purpose of this Agreement and who are under a duty of confidentiality no less restrictive than Licensor’s duties hereunder.

 

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

 

4


3.5 Audit Rights . Licensor will have the right to request an audit of the books and records of Licensee directly relating to the royalty payments owed during the last [***] months for the sole purpose of verifying the amounts due and payable under this Agreement, not more than [***] per calendar year upon providing at least [***] weeks prior written notice to Licensee. All such audits will be conducted during reasonable business hours of Licensee, in a manner that does not unreasonably interfere with such entity’s normal business activities and will be conducted by a certified public accountant or equivalent chosen by Licensor (the “ Auditor ”) and reasonably acceptable to Licensee. Except for the statement of royalty payments due, the Auditor will not disclose any information learned during the audit to Licensor, and all such information shall be considered the Confidential Information of Licensee. The audit will be conducted at Licensor’s expense, except if the audit shows that amount of royalty payments due to Licensor is greater than [***] percent ([***]%) of the total royalty paid to Licensor for the immediately preceding calendar year, the Licensee or sublicensee will pay for the cost and expense of such audit without undue delay.

3.6 Taxes . Licensor shall be responsible for all sales, use, VAT and other taxes (including taxes based on Licensor’s net income), fees, duties and governmental charges, and any related penalties and interests, arising from the payment of any license fees and royalties to Licensor hereunder.

4. D UE D ILIGENCE IN C OMMERCIALIZATION . Licensee shall use commercially reasonable efforts to bring Licensed Products to market through a diligent program for the development, regulatory approval, and commercialization of Licensed Products to generate Net Sales Revenue during the term of this Agreement. Licensee shall be responsible for all reasonable expenses which may be incurred in connection with regulatory filings and clinical trials in support of market approval for the Licensed Products. Licensee shall provide Licensor with a progress report on [***] basis, beginning on the [***] anniversary of the Effective Date, setting forth Licensee’s development, regulatory, clinical, and commercialization efforts regarding the Licensed Products under this Agreement.

5. D EVELOPMENT  & A DVERSE E VENT

5.1 Development Plan . Within [***] days following the Effective Date, Licensee shall submit to Licensor a plan and related and estimated timetable for studies and other tests with respect to the development of Licensed Products in the United States and European Union and such plan and timetable being hereinafter referred to as “Development Plan” and attached to this Agreement as Exhibit B , upon completion. During the term of this Agreement, Licensee shall report to Licensor significant modification thereof.

5.2 Development Work . Licensee shall be responsible for all reasonable expenses which may be incurred in connection with regulatory filings and pre-clinical and clinical studies in support of market approval for the Licensed Products. Licensee shall use commercially reasonably efforts to carry out such pre-clinical and clinical studies or tests in substantial accordance with the Development Plan or any amendment thereto.

 

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

 

5


5.3 Adverse Event Reporting . In the event that any serious accidents, such as adverse drug reactions, occur during the development of the Licensed Product, both parties shall immediately notify each other of such events together with relevant information that each party may be required to disclose to meet all periodic and annual safety regulatory requirements imposed by the regulatory authorities, and shall discuss the solutions in good faith and take all the necessary measures immediately.

6. I MPROVEMENTS

6.1 Disclosure . Licensor and Licensee shall meet at least [***] during the term of this Agreement at a time and place mutually agreed upon by the parties to disclose Licensor and Licensee Improvements. At each meeting, each party will provide the other party with a brief written description of any Improvements of such party created, conceived, or reduced to practice since the last meeting, and will provide the other party with a list and description of all patent applications pertaining to the Improvements filed since the last meeting.

6.2 License from Licensor . Licensee shall automatically receive a license to all Licensor Improvements pursuant to the licenses granted in Section 2.1 and Section 2.2. All Licensor Improvements shall remain owned by Licensor. For avoidance of doubt, any patents and patent applications that claim the RQ-00000005 Technology or the Licensed Products filed by or on behalf of Licensor or any of its Subsidiaries will be considered Licensor Improvements.

6.3 License from Licensee . Licensee shall grant to Licensor a license to the Licensee Improvements in the Licensor Field of Use pursuant to a license agreement to be entered into, which will include terms substantially equivalent to those provided in this Agreement. All such Licensee Improvements shall remain owned by Licensee. For avoidance of doubt, any patents and patent applications that claim the RQ-00000005 Technology or the Licensed Products filed by or on behalf of Licensee or any of its Subsidiaries will be considered Licensee Improvements.

7. S UPPLY

7.1 Clinical Supply . Licensor and Licensee will use good faith to negotiate and enter into a non-exclusive clinical supply agreement for the API and Licensed Products for clinical use (the “ Clinical Supply Agreement ”) within [***] days of the Effective Date. The Clinical Supply Agreement shall, at a minimum, (i) provide for the supply of API as being on the effective date of the Agreement, and (ii) include customary representations and warranties and indemnifications. Initially, Licensee will order [***] of API without any compensation to Licensor. For future clinical supplies, if Licensor or any of its other licensees is using a third party manufacturer for API or Licensed Product tablets, Licensor shall allow Licensee to get supply of such API or tablets for Licensee from such third party manufacturer, including at any prices negotiated by Licensor. The Clinical Supply Agreement will contemplate a price of API and/or tablets which shall be no greater than Licensor’s cost of manufacturing such API or tablets. However, the cost for the required analytical works and the Licensor’s cost of handling solely for Licensee shall be charged to Licensee.

 

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

 

6


7.2 Commercial Supply Agreement . For avoidance of doubt, Licensee shall be entitled to purchase API’s and License Products directly from Licensor or use any third party manufacturers to manufacture API’s and Licensed Products on behalf of Licensee. Upon Licensee’s request, Licensor shall provide such third party manufacturers with all available data, quality control information, manufacturing specifications and information, and all other material and information reasonably needed by such third party manufacturers to manufacture commercially suitable Licensed Products for Licensee.

8. P ROSECUTION AND E NFORCEMENT

8.1 Prosecution . Licensor will have the right to control filing, prosecution, and maintenance of the Licensed Patents, including any patents and applications based on Licensor Improvements, at Licensor’s expense. Licensee will have the right to control filing, prosecution, and maintenance of patents and applications based on Licensee Improvements, at Licensee’s expense. The party controlling the filing, prosecution, and maintenance of an invention is referred to herein as the “ Prosecuting Party ”, while the other party is referred to herein as the “ Non-Prosecuting Party ”. The Non-Prosecuting Party shall have the right to participate, at its cost and expense, in the filing and prosecution activities of the Prosecuting Party. The Prosecuting Party will notify the Non-Prosecuting Party periodically of the status of any pending cases included in the patents or patent applications licensed to the other party, including any office actions, notice of allowance, and required filings or payments concerning such patents and patent applications. The Non-Prosecuting Party will have the opportunity to comment on any response to office actions or amendments to claims prior to their filing. The Non-Prosecuting Party will have the right to inspect the records kept by the Prosecuting Party and its patent counsel pertaining to the patents and patent applications licensed to the Non-Prosecuting Party. The Non-Prosecuting Party will, at the Prosecuting Party’s request and expense, sign all instruments and documents, including powers of attorney, necessary to effectuate the purpose of this Section 8.1 and provide any other reasonably necessary assistance requested by the Prosecuting Party. If the Prosecuting Party elects to abandon any application or patent licensed to the other party, the Non-Prosecuting Party will have the right to continue prosecution or maintenance of such application or patent at the Non-Prosecuting Party’s sole expense.

8.2 Enforcement . Each party will promptly notify the other party upon becoming aware of any known or suspected infringement of any patents licensed to the other party under this Agreement or the license agreement referenced in Section 5.3. Such notice will include the identity of the party or parties known or suspected to have infringed the licensed patent and any available information that is relevant to such infringement. The party who is the exclusive licensee of such licensed patent within the field of use subject to the infringement action (the “ Enforcing Party ”) will retain sole control over enforcement and defense of the patent against such third party infringers. If the Enforcing Party files or defends any claim, suit, or action (a “ Claim ”) against any third party based on any licensed patent, the other party (the “ Non-Enforcing Party ”) will cooperate with the Enforcing Party, at the Enforcing Party’s request, in enforcing or defending such Claim, including joining the Enforcing Party as a party to such suit or action to the extent necessary to establish standing. The Enforcing Party will be responsible

 

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

 

7


for all costs, expenses, and legal fees (collectively “ Costs ”) incurred by the Non-Enforcing party in connection with any Claim. The Enforcing Party will be entitled to all damages awarded as a result of or agreed to in a monetary settlement of any Claim, subject to any royalty payment obligation. Nothing contained in this Section will obligate the Enforcing Party to enforce or defend any patent licensed to it.

9. C ONFIDENTIALITY

9.1 Confidential Information . During the term of this Agreement, each party (the “ Receiving Party ”) may be provided with, have access to, or otherwise learn confidential and/or proprietary information of the other party (the “ Disclosing Party ”) (including certain information and materials concerning the Disclosing Party’s business, plans, customers, technology, and products) that is of substantial value to the Disclosing Party, and which is identified as confidential at the time of disclosure or which should reasonably be considered, under the circumstances of its disclosure, to be confidential to the Disclosing Party (“ Confidential Information ”).

9.2 Confidentiality Obligations . All Confidential Information remains the property of the Disclosing Party. The Receiving Party may disclose the Confidential Information of the Disclosing Party only to its employees and contractors who need to know the Confidential Information for purposes of performing under this Agreement and who are bound by the Receiving Party’s standard employee or contractor (as applicable) confidentiality agreements. The Receiving Party will not use the Confidential Information without the Disclosing Party’s prior written consent except in performance under this Agreement. The Receiving Party will take measures to maintain the confidentiality of the Confidential Information equivalent to those measures the Receiving Party uses to maintain the confidentiality of its own confidential information of like importance but in no event less than reasonable measures. The Receiving Party will give immediate notice to the Disclosing Party of any unauthorized use or disclosure of the Confidential Information that comes to the attention of the Receiving Party’s senior management and agrees to assist the Disclosing Party in remedying such unauthorized use or disclosure.

9.3 Exceptions . The confidentiality obligations do not extend to Confidential Information which: (i) becomes part of the public domain without the fault of the Receiving Party; (ii) is rightfully obtained by the Receiving Party from a third party with the right to transfer such information without obligation of confidentiality; (iii) is independently developed by the Receiving Party without reference to or use of the Disclosing Party’s Confidential Information, as evidenced by written records; or (iv) was lawfully in the possession of the Receiving Party at the time of disclosure, without restriction on disclosure, as evidenced by written records. In addition, the Receiving Party may disclose Confidential Information of the Disclosing Party as may be required by law, a court order, or a governmental agency with jurisdiction, provided that before making such a disclosure the Receiving Party first notifies the Disclosing Party promptly and in writing and cooperates with the Disclosing Party, at the Disclosing Party’s reasonable request and expense, in any lawful action to contest or limit the scope of such required disclosure. In addition, Licensee may disclose any Materials provided by Licensor to Licensee’s contract manufacturers, employees, agents and third parties without restriction, even if such Materials contain Confidential Information of Licensor.

 

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

 

8


9.4 Return of Confidential Information . Upon termination (but not expiration) of this Agreement, the Receiving Party will return to the Disclosing Party or destroy all tangible copies of Confidential Information of the Disclosing Party, which the Receiving Party no longer has the right to use, in the Receiving Party’s possession or control and will erase from its computer systems all electronic copies thereof.

9.5 Confidentiality of the Agreement . Neither party will disclose any terms or conditions of this Agreement to any third party, without the prior written consent of the other party, except: (i) as required by law; (ii) to its attorneys, accountants, and other professional advisors under a duty of confidentiality; or (iii) to a third party under a duty of confidentiality in connection with financing or a proposed merger or a proposed sale of all or part of such party’s business which relates to this Agreement.

9.6 Survival of Obligations . Licensee’s and Licensor’s respective obligation under this Section 8 shall survive any termination or expiration of this Agreement and shall extend to the earlier of such time as the Confidential Information is in the public domain or [***] years following termination or expiration of this Agreement.

10. R EPRESENTATIONS AND W ARRANTIES

10.1 Mutual Representations and Warranties . Each party represents and warrants that it has full right, power, and authority to enter into this Agreement and to perform its obligations and duties under this Agreement, and that the performance of such obligations and duties does not and will not conflict with or result in a breach of any other agreements of such party or any judgment, order, or decree by which such party is bound.

10.2 Representations and Warranties By Licensor . Licensor represents and warrants that:

(a) it exclusively owns and has full right, power, and authority to license the Licensed Patents and the Licensed Know-How to Licensee;

(b) it has not granted or will grant during the term of this Agreement any security interest, option, lien, license, or encumbrance of any nature with respect to any Licensed Patent or Licensed Know-How which would conflict with the license granted to Licensee under this Agreement;

(c) to the best knowledge of Licensor, all of the Licensed Patents that have issued are valid and enforceable, and no proceeding is pending or to the best knowledge of Licensor, threatened, nor has any claim been made, which challenges or challenged the legality, validity, or enforceability of any Licensed Patent;

(d) all maintenance fees, annuity payments, and similar payments relating to the Licensed Patents have been made and will be made in a timely manner during the term of this Agreement; and

(e) to the knowledge of Licensor, using, making, selling, or importing a Licensed Product or performing a Licensed Process shall not infringe, directly or indirectly, any patent or other intellectual property rights of any third party.

 

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

 

9


10.3 Limitation of Liability . E XCEPT FOR BREACH OR REPRESENTATIONS OF WARRANTIES PROVIDED IN THIS A GREEMENT , IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR ANY THIRD PARTY FOR ANY CONSEQUENTIAL , INDIRECT , PUNITIVE , EXEMPLARY , SPECIAL OR INCIDENTAL DAMAGES , INCLUDING ANY LOST DATA AND LOST PROFITS , ARISING FROM OR RELATING TO THIS A GREEMENT , THE L ICENSED P ATENTS , THE L ICENSED K NOW -H OW , OR I MPROVEMENTS . L ICENSEE S TOTAL CUMULATIVE LIABILITY IN CONNECTION WITH THIS A GREEMENT , THE L ICENSED P ATENTS , THE L ICENSED K NOW -H OW , OR I MPROVEMENTS , WHETHER IN CONTRACT OR TORT OR OTHERWISE , WILL NOT EXCEED THE TOTAL AMOUNT OF FEES AND ROYALTIES PAID TO L ICENSOR UNDER THIS A GREEMENT DURING THE [***] MONTHS PRECEDING THE CLAIM .

11. I NDEMNIFICATION

11.1 By Licensor . Licensor will defend, indemnify, and hold Licensee, Licensee’s Affiliates, and their directors, officers, employees, and agents harmless from and against any and all claims, losses, liabilities, damages, costs, and expenses (including attorneys’ fees, expert witness fees, and court costs) directly or indirectly arising from or relating to: (i) any product liability claims based on the manufacture, marketing, promotion, sale, distribution, or use of any Licensed Products by Licensor or its customers; and (ii) any negligence or willful misconduct by Licensor or its directors, officers, employees, or agents in the performance of this Agreement or in connection with manufacture, marketing, promotion, sale, distribution, or use of Licensed Products. In addition, Licensor will defend, indemnify, and hold Licensee, its Affiliates, sublicensees, and each of their customers, directors, officers, employees, and agents harmless from and against any and all claims, losses, liabilities, damages, costs, and expenses (including attorneys’ fees, expert witness fees, and court costs) directly or indirectly arising from or relating to any allegation that manufacture, use, offer for sale, sale, or importation of any Licensed Product or use of any Licensed Know-How as permitted under this Agreement infringes any third party’s intellectual property rights.

11.2 By Licensee . Licensee will defend, indemnify, and hold Licensor, Licensor’s Affiliates, and their directors, officers, employees, and agents harmless from and against any and all claims, losses, liabilities, damages, costs, and expenses (including attorneys’ fees, expert witness fees, and court costs) directly or indirectly arising from or relating to (i) any product liability claims based on the manufacture, marketing, promotion, sale, distribution, or use of any Licensed Products by Licensee or its customers, or (ii) any negligence or willful misconduct by Licensee or its directors, officers, employees, or agents in the performance of this Agreement or in connection with manufacture, marketing, promotion, sale, distribution, or use of Licensed Products.

11.3 Indemnity Conditions . A party’s obligation to indemnify as provided in this Agreement is conditioned upon the indemnified party promptly notifying the indemnifying party in writing within a reasonable period of time of any and all claims for which the indemnified party is entitled to indemnification, giving the indemnifying party sole control of the defense

 

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

 

10


thereof and any related settlement negotiations, and indemnified party cooperating and, at indemnifying party’s request and expense, assisting in such defense. The indemnified party may participate in the defense of the claim at its own expense with counsel of its own choosing. The indemnifying party may not settle any such claim without the indemnified party’s prior written consent.

12. P UBLICITY

12.1 Public Announcements . Except as required by applicable laws, neither Licensor nor Licensee shall make any public announcement of any information regarding this Agreement (including without limitation its execution and terms), the Licensed Products or development or commercialization activities under this Agreement without the prior written approval of the other party, which approval shall not be withheld unreasonably. Once any statement is approved for disclosure by the parties or information is otherwise made public in accordance with the preceding sentence, either party may make a subsequent public disclosure of the contents of such statement without further approval of the other party. Notwithstanding the foregoing, either party may disclose the terms of this Agreement (i) as required by law; (ii) to its attorneys, accountants, and other professional advisors under a duty of confidentiality; (iii) to a third party under a duty of confidentiality in connection with any proposed or actual financing or investment, or a proposed or actual merger or sale of all or part of such party’s business relating to this Agreement.

13. T ERM AND T ERMINATION

13.1 Term . This Agreement will take effect on the Effective Date, and remain in effect until terminated as provided in Section 13.2 or 10.3.

13.2 Termination for Good Cause . Licensor may terminate this Agreement by giving a written notice of termination to Licensee if Licensee fails to pay any undisputed fees owed under this Agreement and does not cure such breach within [***] days after a written notice is given to Licensee requesting that such breach be cured. Once all Licensed Patents have expired or have been abandoned, the licenses granted herein will be deemed fully-paid and irrevocable.

13.3 Termination for Convenience . At any time during the term of this Agreement, Licensee may terminate this entire Agreement or terminate any license granted herein on a patent-by-patent basis or country-by-country basis for any reason or no reason by giving Licensor a written notice of termination. Termination will be effective [***] days after the date of the notice of termination.

13.4 Effect of Termination . On the effective date of termination of this Agreement (the “ Termination Date ”), all licenses granted by Licensor to Licensee under this Agreement will be revoked and Licensee will cease all further use, manufacture, sale, or importation of the Licensed Products and use of the Licensed Processes, except as provided in this Section. Licensee may complete and sell any work-in-progress and inventory of the Licensed Products that exist as of the Termination Date for a period of [***] months after the Termination Date, provided that Licensee pays Licensor the applicable running royalty or other amounts due on such sales of Royalty-Bearing Products in accordance with Section 3.1. 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.

 

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

 

11


13.5 Survival . Upon termination or expiration of this Agreement, Sections 1, 9, 10.3, 11, and 13.4 will survive.

14. G ENERAL

14.1 Notice . Any notice, approval, authorization, consent, or other communication required or permitted to be delivered to either party under this Agreement must be in writing and will be deemed properly delivered, given, and received (i) when delivered by hand, or (ii) three (3) business days after delivery by international courier or express delivery service (return receipt requested). All notices shall be sent to address set forth below (or to such other address as may be designated by a party by giving written notice to the other party pursuant to this Section 11.1):

 

If to Licensor, to:    If to Licensee, to:
RaQualia Pharma, Inc.    Aratana Therapeutics LLC
5-2 Taketoyo, Aichi 470-2341    1901 Olathe Boulevard
Japan    Kansas City, KS 66103
Attention: President    USA
Phone No.:    Attention:
   Phone No.:

14.2 Governing Law; Arbitration . This Agreement will be construed in accordance with and governed in all respects by the laws of the State of New York, USA. Any dispute, controversy or claim arising out of or in connection with this Agreement, or breach, termination or invalidity thereof, shall be settled by arbitration in accordance with the commercial arbitration rules of the International Chamber of Commerce (“ICC”). The arbitral tribunal shall be composed of three arbitrators, one to be appointed by Licensor and one to be appointed by Licensee and the chairman to be appointed by the two arbitrators. If the two aforementioned parties have not appointed their arbitrators within [***] weeks from the request of the other party, or the two arbitrators have not agreed on the chairman within three weeks after their appointment, the ICC shall appoint the arbitrator or the chairman, as the case may be. In the event arbitration is requested by Licensor, the place of arbitration shall be [***]; in the event arbitration is requested by Licensee, the place of arbitration shall be [***]. The arbitration proceedings will be conducted in English. The results of the arbitration procedure will be considered Confidential Information of the parties. Any arbitration decision rendered will be final and binding, and judgment thereon may be entered in any court of competent jurisdiction. Notwithstanding this Section, neither party will be required to arbitrate any dispute or controversy relating to any actual or threatened unauthorized use or disclosure of its intellectual property or confidential information.

 

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

 

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14.3 Assignment . Upon written notice to Licensor, Licensee may assign this entire Agreement or any of its rights hereunder, without Licensor’s consent, (i) to any of Licensee’s Affiliates; and (ii) to a third party in connection with .a merger, change in control, or sale of all or substantially all of the assets of Licensee pertaining to this Agreement. This Agreement will be binding upon and shall inure to the benefit of the parties hereto and their respective successors and assigns.

14.4 Remedies . The rights and remedies of the parties will be cumulative (and not alternative). If any legal action is brought to enforce this Agreement, the prevailing party will be addition to any other relief it may receive.

14.5 Waiver . All waivers must be in writing and signed by an authorized representative of the party to be charged. Any waiver or failure to enforce any provision of this Agreement on one occasion will not be deemed a waiver of any other provision or of such provision on any other occasion.

14.6 Severability . If any provision of this Agreement is unenforceable, such provision will be changed and interpreted to accomplish the objectives of such provision to the greatest extent possible under applicable law and the remaining provisions will continue in full force and effect.

14.7 Independent Contractors . This Agreement is not intended to establish any partnership, joint venture, employment, or other relationship between the parties except that of independent contractors.

14.8 Construction . The section headings in this Agreement are for convenience of reference only, will not be deemed to be a part of this Agreement, and will not be referred to in connection with the construction or interpretation of this Agreement. Any rule of construction to the effect that ambiguities are to be resolved against the drafting party will not be applied in the construction or interpretation of this Agreement. As used in this Agreement, the words “include” and “including,” and variations thereof, will not be deemed to be terms of limitation, but rather will be deemed to be followed by the words “without limitation.” All references in this Agreement to “Sections” are intended to refer to Sections of this Agreement.

14.9 Counterparts . This Agreement may be executed in several counterparts, each of which will constitute an original and all of which, when taken together, will constitute one agreement.

14.10 English Language . This Agreement has been prepared in the English language and the English language shall control its interpretation. In addition, all notices required or permitted to be given hereunder, an all written, electronic, or other communications between the parties regarding this Agreement shall be in the English language

 

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

 

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14.11 Entire Agreement . This Agreement, along with the Exhibits hereto, set forth the entire understanding of the parties relating to the subject matter hereof and supersedes all prior agreements and understandings between the parties relating to the subject matter hereof. This Agreement may not be amended, modified, altered, or supplemented other than by means of a written instrument duly executed and delivered on behalf of both parties.

14.12 Bankruptcy . Licensor agrees that if Licensor, as a debtor in possession or a trustee in bankruptcy rejects this Agreement, Licensee may elect to retain its rights under this Agreement. Upon written request of Licensee to Licensor or the bankruptcy trustee, Licensor or such bankruptcy trustee will not interfere with the rights of Licensee as provided in this Agreement.

 

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

 

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IN WITNESS WHEREOF , the parties have executed this Agreement as of the date first above written.

 

RaQualia Pharma Inc.     Aratana Therapeutics Inc.
By:    /s/ Atsushi Nagahisa     By:    /s/ David K. Rosen
Name: Atsushi Nagahisa     Name: David K. Rosen
Title: President & CEO     Title: President
Date: December 21, 2010     Date: December 27, 2010

[SIGNATURE PAGE TO EXCLUSIVE IP LICENSE AGREEMENT FOR RQ-00000005]

 

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

 

15


E XHIBIT  A

L ICENSED P ATENTS

Title : [***]

Inventors : [***]

 

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Title : [***]

Inventors : [***]

 

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   Application Number   Patent Number

[***]

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[***]

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[***]

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[***]

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[***]

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[***]

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

 

16


Country

   Application Number   Patent Number

[***]

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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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[***]

   [***]   [***]

Title : [***]

Inventors : [***]

 

Country

   Application Number   Patent Number

[***]

   [***]  

[***]

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[***]

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[***]

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[***]

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[***]

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[***]

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[***]

   [***]   [***]

[***]

   [***]   [***]

[***]

   [***]   [***]

[***]

   [***]   [***]

[***]

   [***]   [***]

[***]

   [***]   [***]

[***]

   [***]   [***]

 

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

 

17


Title : [***]

Inventors : [***]

 

Country

   Application Number   Patent Number

[***]

   [***]   [***]

[***]

   [***]   [***]

[***]

   [***]   [***]

[***]

   [***]   [***]

[***]

   [***]   [***]

[***]

   [***]   [***]

[***]

   [***]   [***]

[***]

   [***]   [***]

[***]

   [***]  

[***]

   [***]   [***]

[***]

   [***]   [***]

 

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

 

18


E XHIBIT  B

D EVELOPMENT P LAN

(to be attached upon its completion)

 

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

 

19

Exhibit 10.19

First Amendment to the Exclusive IP License Agreement for RQ-00000005

between Aratana Therapeutics Inc. and RaQualia Pharma Inc.

This is the First Amendment ( “Amendment” ) to the Exclusive IP License Agreement for RQ-00000005 dated December 27, 2010 (the “Agreement” ) between Aratana Therapeutics Inc., a Delaware corporation ( “Licensee” ) and RaQualia Pharma Inc., a Japanese corporation ( “Licensor” ), and is made and entered into between Licensee and Licensor on July 12, 2012 (the “Amendment Effective Date” ). Licensee and Licensor are referred to herein individually as a “Party” and collectively as the “Parties” .

RECITALS

WHEREAS, the Parties have entered into the Agreement, pursuant to which Licensor granted Licensee an exclusive worldwide license to RQ-00000005 Technology (as defined in the Agreement);

WHEREAS, the Parties desire to amend the provision regarding development and supply of the API; and

NOW THEREFORE, the Parties hereby agree as set forth below:

AMENDMENT

 

A. Amendment. The Parties agree to delete Section 7 of the Agreement in its entirety. The Parties further agree that neither Party has claims and/or liabilities arising out of or in relation to the performance of or failure to perform the rights and obligations stipulated under Section 7 of the Agreement prior to Amendment Effective Date.

 

B. Other Terms: All other terms of the Agreement shall remain in full force and effect. To the extent that any provision of the Agreement conflicts with any provision of this Amendment, this Amendment will take priority.


IN WITNESS WHEREOF, the Parties have caused this Amendment to the Agreement to be executed by their authorized representatives.

 

Aratana Therapeutics Inc.     RaQualia Pharma Inc.
By:  

/s/ David K. Rosen

    By:  

/s/ Atsushi Nagahisa

Name:  

David K. Rosen

    Name:  

Atsushi Nagahisa

Title:  

President & COO

    Title:  

President & CEO

Date:  

12 July 12

    Date:  

July 23, 2012

Execution Version

Exhibit 10.20

EXCLUSIVE IP LICENSE AGREEMENT FOR RQ-00000007

This EXCLUSIVE IP L ICENSE A GREEMENT FOR RQ-00000007 (this “ Agreement ”) is entered into as of December 27 2010 (the “ Effective Date ”) by and between. Aratana Therapeutics Inc., a Delaware corporation having a place of business is 1901 Olathe Boulevard, Kansas City, KS 66103 (“ Licensee ”) and RaQualia Pharma Inc. , a Japanese corporation having a place of business at 5-2 Taketoyo, Aichi 470-2341, Japan (“ Licensor ”).

R ECITALS

W HEREAS , Licensor owns certain rights and technology pertaining to an EP4 antagonist for treating acute and chronic pain, including all analogs, formulations thereto, and related backup programs thereto (collectively, “ RQ-00000007 Technology ”); and

W HEREAS , Licensee desires to receive an exclusive worldwide license, other than with respect to the Excluded Products (defined below), to RQ-00000007 Technology, and Licensor is willing to grant such license to Licensee under the terms and conditions provided herein.

N OW , T HEREFORE , in consideration of the mutual covenants set forth herein and for other consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows:

A GREEMENT

 

1. D EFINITIONS As used in this Agreement:

1.1 Acute Indication ” means any indications, including the control of post operative pain and inflammation associated with soft tissue surgery, treated by Licensed Products for [***] days or less.

1.2 Affiliate ” of a party means any person or entity, which controls, is controlled by, or is under common control with such party, where “control” means ownership of fifty percent (50%) or more of the outstanding voting securities.

1.3 Chronic Indication ” means any indications, including the control of pain and inflammation associated with osteoarthritis in dogs, treated by Licensed Products for more than [***] days.

1.4 Combination Product ” means any pharmaceutical drug which consists of a Royalty-Bearing Product and other active compounds and/or active ingredients, where such combination of the Royalty-Bearing Product with the other active compound and/or active ingredient is not covered by any Licensed Patent.

1.5 Excluded Product ” means an injectable product for sale in Japan, Korea, China, or Taiwan, the sale of which would infringe one or more Valid Claims of an issued Licensed Patent in force in the country in which such product is sold.

 

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


1.6 First Commercial Sale ” shall mean, with respect to any Royalty-Bearing Product, the first sale for end use or consumption of such Royalty-Bearing Product in a country after the governing health regulatory authority of such country has granted regulatory approval of such Royalty-Bearing Product.

1.7 Improvements ” means any upgrade, enhancement, modification, alteration, improvement, development, or other change made to the Licensed Know How or the inventions disclosed in the Licensed Patents during the term of this Agreement.

1.8 Licensed Know-How ” shall mean unpatented information to the extent owned or controlled by Licensor as of the Effective Date associated with the Licensed Patents or related to RQ-00000007 Technology, including but not limited to research and development information, trade secrets, engineering, scientific, and practical information, data, formulas, formulations, APIs, analogs, back-up programs, 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 practice of the Licensed Patents or the RQ-00000007 Technology.

1.9 Licensed Patents ” means (i) the patents listed in Exhibit A ; (ii) any patent or patent application that claims priority to and is a divisional, continuation, continuation-in-part, reissue, renewal, reexamination, substitution or extension of any patent application identified in (i); (iii) any patents issuing on any of the patent applications identified in (i) or (ii), including any reissues, renewals, reexaminations, substitutions or extensions thereof; (iv) any foreign counterpart (including PCTs) of any of the patents or patent applications identified in (i), (ii) or (iii); and (v) any other patent or patent application owned or controlled by Licensor now or during the term of this Agreement pertaining to RQ-00000007 Technology or Licensor Improvements.

1.10 Licensed Process ” means any process that would infringe one or more Valid Claims of a Licensed Patent, but for the license granted in Section 2.1.

1.11 Licensed Products ” means any product, other than Excluded Products, in the Licensee Field of Use (i) that would infringe one or more Valid Claims of a Licensed Patent, but for the license granted in Section 2.1 or (ii) is manufactured using a Licensed Process or (iii) when used, practices a Licensed Process.

1.12 Licensee Field of Use ” means the field of animal health.

1.13 Licensee Improvements ” means Improvements created, conceived, or reduced to practice by or for Licensee.

1.14 Licensor Field of Use ” means the field of human health.

1.15 Licensor Improvements ” means Improvements created, conceived, or reduced to practice by or for Licensor.

 

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

 

2


1.16 NADA ” means a new animal drug application as prescribed by applicable U.S. food and drug administration (FDA) regulations, or any corresponding foreign statutes, rules or regulations.

1.17 Net Sales Revenue ” means [***].

1.18 Royalty-Bearing Product ” means a pharmaceutical drug, other than an Excluded Product, that, absent the license granted in Section 2.1, the sale of which would infringe one or more Valid Claims of an issued Licensed Patent in force in the country in which such drug is sold,

1.19 Subsidiary ” means any entity which is controlled by a party, either directly or indirectly, where “control” means ownership of fifty percent (50%) or more of the outstanding voting securities.

1.20 Valid Claim ” means a claim of an issued or granted Licensed Patent in any country that has not expired or lapsed, been abandoned or cancelled, or held or declared invalid or unenforceable.

 

2. L ICENSES

2.1 Patent License Grant . Licensor hereby grants to Licensee a worldwide, exclusive (without any reservation of rights by Licensor) license under the Licensed Patents during the term of this Agreement, to: (i) use, develop, make, have made, sell, offer to sell, import, export, lease, or otherwise dispose of any Licensed Product; (ii) use any method or process in manufacturing the Licensed Products; (iii) use and perform any Licensed Processes; and (iv) to otherwise practice the claimed inventions pertaining to RQ-00000007 Technology in the Licensee Field of Use.

2.2 Know-How License Grant . Licensor hereby grants to Licensee a worldwide, exclusive (without any reservation of rights by Licensor) license under the Licensed Patents during the term of this Agreement to use the Licensed Know-How in connection with any development, manufacture, sale, importation, exportation, lease or disposal of any Licensed Product or performance of any Licensed Process in the Licensee Field of Use.

2.3 Technology Transfer . Within [***] days of the Effective Date, Licensor shall provide Licensee, at no cost, copies of all documents, materials, data sheets, test results, analyses, formulations, compositions and all other tangible embodiments of the Licensed Know-How and Licensed Patents (“ Material ”), Licensor shall make available to Licensee, upon reasonable request, employees and agents of Licensor to facilitate the technology transfer of the Know-How and to respond to Licensee inquiries pertaining to the Licensed Know-How and Licensed Patents to facilitate Licensee’s full use, enjoyment, and exploitation of the licenses granted herein.

2.4 Sublicense . The licenses granted in Sections 2.1 and 2.2 include the right of Licensee to sublicense any and all of the licensed rights to one or more tiers of sublicenses including but not limited to its Affiliates. All sublicenses granted to third parties will be pursuant to written agreement that are in accordance with and no broader than the terms of this Agreement.

 

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

 

3


3. F EES , R EPORTS , AND A UDIT

 

  3.1 Initial Licensee Fees and Royalty

(a) Initial License Fees . In consideration for the licenses to the Licensed Patents, Licensed Know-How, and Licensor Improvements, within [***] days after the Effective Date, Licensee will pay Licensor a license fee of [***] US Dollars ($[***]).

(b) Sales Royalty . Licensee will pay to Licensor a royalty in the amount of [***] percent ([***]% of Net Sales Revenue received by Licensee for the sale of the Royalty Bearing Products in countries where there are Valid Claims of the Licensed Patents until such Licensed Patents have expired or been abandoned. If Licensee sublicenses the Licensed Patents to a third party sublicensee, Licensee will pay to Licensor a royalty in the amount equal to [***] percent ([***]%) ]  of the royalty paid by such sublicensee to Licensee based on the sale of the Royalty Bearing Products in countries where there are Valid Claims of the Licensed Patents until such Licensed Patents have expired or been abandoned, but in no event shall the royalty paid to Licensor be less than [***] percent ([***]%)] of the Net Sales Revenue of such third party sublicensee. Royalty payments shall be due on a quarterly basis within [***] days after [***].

3.2 Milestone Fees . Except with respect milestone fees triggered upon a NADA filing, within [***] days after the occurrence of the following milestones, Licensee will pay Licensor the corresponding one-time milestone fees provided below. With respect to any milestone fee based on a NADA filing, Licensee will pay Licensor the corresponding one-time milestone fee provided below for such NADA filing within [***] months after such NADA filing. For avoidance of doubt, the parties agree that Licensee’s obligation to pay each milestone fee referenced below is a one-time obligation even if the applicable milestone event occurs more than once.

 

Milestone

  

Milestone Fee

[***]

   [***] US Dollars ($[***])

[***]

   [***] US Dollars ($[***])

[***]

   [***] US Dollars ($[***])

[***]

   [***] US Dollars ($[***])

[***]

   [***] US Dollars ($[***])

[***]

   [***] US Dollars ($[***])

[***]

   [***] US Dollars ($[***])

[***]

   [***] US Dollars ($[***])

3.3 Third Party Patent Rights . In the event it becomes necessary for Licensee or its sublicensee to license patent rights owned by a third party to use, develop, make, have made, sell, offer to sell, import, export, lease, or otherwise dispose of any Royalty-Bearing Product, then Licensee or its sublicensee, as applicable, shall have the right to obtain a license from such third party and to credit [***] percent ([***]%) of any payment owed to such third party under such license against the royalty payable to Licensor under Section 3.1 above on a going forward

 

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

 

4


basis. No such amounts deducted shall reduce royalties paid to Licensor by more than [***] percent ([***]%) ] ; provided, however, that amounts not deducted because of this limit may be carried forward and applied to future royalties paid, subject to the [***] percent ([***]%) floor.

3.4 Reports . Along with each royalty payment, Licensee will provide a statement showing the quantity of Royalty-Bearing Products sold or transferred during the preceding [***] and a calculation of the royalties accrued during such [***], provided that Licensee shall provide an estimated royalty report within [***] days after the end of such [***]. Licensor will treat these statement as Confidential Information of Licensee, will protect it from unauthorized use, access or disclosure in the same manner as Licensor protects its own confidential or proprietary information of similar nature and with no less than reasonable care, and will disclose it only to the employees or agents of Licensor who have a need to know such information for purpose of this Agreement and who are under a duty of confidentiality no less restrictive than Licensor’s duties hereunder.

3.5 Audit Rights . Licensor will have the right to request an audit of the books and records of Licensee directly relating to the royalty payments owed during the last [***] months for the sole purpose of verifying the amounts due and payable under this Agreement, not more than [***] per calendar year upon providing at least [***] weeks prior written notice to Licensee. All such audits will be conducted during reasonable business hours of Licensee, in a manner that does not unreasonably interfere with such entity’s normal business activities and will be conducted by a certified public accountant or equivalent chosen by Licensor (the “ Auditor ”) and reasonably acceptable to Licensee. Except for the statement of royalty payments due, the Auditor will not disclose any information learned during the audit to Licensor, and all such information shall be considered the Confidential Information of Licensee. The audit will be conducted at Licensor’s expense, except if the audit shows that amount of royalty payments due to Licensor is greater than [***] percent ([***]%) of the total royalty paid to Licensor for the immediately preceding [***] the Licensee or sublicensee will pay for the cost and expense of such audit without undue delay.

3.6 Taxes . Licensor shall be responsible for all sales, use, VAT and other taxes (including taxes based on Licensor’s net income), fees, duties and governmental charges, and any related penalties and interests, arising from the payment of any license fees and royalties to Licensor hereunder.

 

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

 

5


4. D UE D ILIGENCE IN C OMMERCIALIZATION . Licensee shall use commercially reasonable efforts to bring Licensed Products to market through a diligent program for the development, regulatory approval, and commercialization of Licensed Products to generate Net Sales Revenue during the term of this Agreement. Licensee shall be responsible for all reasonable expenses which may be incurred in connection with regulatory filings and clinical trials in support of market approval for the Licensed Products. Licensee shall provide Licensor with a progress report on [***] basis, beginning on the [***] anniversary of the Effective Date, setting forth Licensee’s development, regulatory, clinical, and commercialization efforts regarding the Licensed Products under this Agreement.

 

5. D EVELOPMENT  & A DVERSE E VENT

5.1 Development Plan . Within [***] days following the Effective Date, Licensee shall submit to Licensor a plan and related and estimated timetable for studies and other tests with respect to the development of Licensed Products in the United States and European Union and such plan and timetable being hereinafter referred to as “Development Plan” and attached to this Agreement as Exhibit B , upon completion. During the term of this Agreement, Licensee shall report to Licensor significant modification thereof.

5.2 Development Work . Licensee shall be responsible for all reasonable expenses which may be incurred in connection with regulatory filings and pre-clinical and clinical studies in support of market approval for the Licensed Products. Licensee shall use commercially reasonably efforts to carry out such pre-clinical and clinical studies or tests in substantial accordance with the Development Plan or any amendment thereto.

5.3 Adverse Event Reporting . In the event that any serious accidents, such as adverse drug reactions, occur during the development of the Licensed Product, both parties shall immediately notify each other of such events together with relevant information that each party may be required to disclose to meet all periodic and annual safety regulatory requirements imposed by the regulatory authorities, and shall discuss the solutions in good faith and take all the necessary measures immediately.

 

6. I MPROVEMENTS

6.1 Disclosure . Licensor and Licensee shall meet at least [***] during the term of this Agreement at a time and place mutually agreed upon by the parties to disclose Licensor and Licensee Improvements. At each meeting, each party will provide the other party with a brief written description of any Improvements of such party created, conceived, or reduced to practice since the last meeting, and will provide the other party with a list and description of all patent applications pertaining to the Improvements filed since the last meeting.

6.2 License from Licensor . Licensee shall automatically receive a license to all Licensor Improvements pursuant to the licenses granted in Section 2.1 and Section 2.2. All Licensor Improvements shall remain owned by Licensor. For avoidance of doubt, any patents and patent applications that claim the RQ-00000007 Technology or the Licensed Products filed by or on behalf of Licensor or any of its Subsidiaries will be considered Licensor Improvements.

 

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

 

6


6.3 License from Licensee . Licensee shall grant to Licensor a license to the Licensee Improvements in the Licensor Field of Use pursuant to a license agreement to be entered into, which will include terms substantially equivalent to those provided in this Agreement. All such Licensee Improvements shall remain owned by Licensee. For avoidance of doubt, any patents and patent applications that claim the RQ-00000007 Technology or the Licensed Products filed by or on behalf of Licensee or any of its Subsidiaries will be considered Licensee Improvements.

 

7. S UPPLY

7.1 Clinical Supply . Licensor and Licensee will use good faith to negotiate and enter into a non-exclusive clinical supply agreement for the API and Licensed Products for clinical use (the “ Clinical Supply Agreement ”) within [***] days of the Effective Date, The Clinical Supply Agreement shall, at a minimum, (i) provide for the supply of API, [***] Licensed Products in tablets, and [***] Licensed Products in tablets as being on the effective date of the Agreement and any other tableted formulations as may be available at closing and as requested by Licensee, (ii) include customary representations and warranties and indemnifications, and (iii) guarantee all of the API provided are GMP compliant and fully qualified and sufficient for use in an FDA monitored study to prove safety and efficacy in Licensee’s target species. Initially, Licensee will order [***] of API, [***] Licensed Product tablets, [***] Licensed Product tablets and any other tableted formulations as may be available on the effective date of the Agreement without any compensation to Licensor. For future clinical supplies, if Licensor or any of its other licensees is using a third party manufacturer for API or Licensed Product tablets, Licensor shall allow Licensee to get supply of such API or tablets for Licensee from such third party manufacturer, including at any prices negotiated by Licensor. The Clinical Supply Agreement will contemplate a price of API and/or tablets which shall be no greater than Licensor’s cost of manufacturing such API or tablets. However, the cost for the required analytical works and the Licensor’s cost of handling solely for Licensee shall be charged to Licensee.

7.2 Commercial Supply Agreement . For avoidance of doubt, Licensee shall be entitled to purchase API’s and License Products directly from Licensor or use any third party manufacturers to manufacture API’s and Licensed Products on behalf of Licensee. Upon Licensee’s request, Licensor shall provide such third party manufacturers with all available data, quality control information, manufacturing specifications and information, and all other material and information reasonably needed by such third party manufacturers to manufacture commercially suitable Licensed Products for Licensee.

 

8. P ROSECUTION AND E NFORCEMENT

8.1 Prosecution . Licensor will have the right to control filing, prosecution, and maintenance of the Licensed Patents, including any patents and applications based on Licensor Improvements, at Licensor’s expense. Licensee will have the right to control filing, prosecution, and maintenance of patents and applications based on Licensee Improvements, at Licensee’s expense. The party controlling the filing, prosecution, and maintenance of an invention is referred to herein as the “ Prosecuting Party ”, while the other party is referred to herein as the “ Non-Prosecuting Party ”. The Non-Prosecuting Party shall have the right to participate, at its

 

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

 

7


cost and expense, in the filing and prosecution activities of the Prosecuting Party. The Prosecuting Party will notify the Non-Prosecuting Party periodically of the status of any pending cases included in the patents or patent applications licensed to the other party, including any office actions, notice of allowance, and required filings or payments concerning such patents and patent applications. The Non-Prosecuting Party will have the opportunity to comment on any response to office actions or amendments to claims prior to their filing. The Non-Prosecuting Party will have the right to inspect the records kept by the Prosecuting Party and its patent counsel pertaining to the patents and patent applications licensed to the Non-Prosecuting Party. The Non-Prosecuting Party will, at the Prosecuting Party’s request and expense, sign all instruments and documents, including powers of attorney, necessary to effectuate the purpose of this Section 8.1 and provide any other reasonably necessary assistance requested by the Prosecuting Party. If the Prosecuting Party elects to abandon any application or patent licensed to the other party, the Non-Prosecuting Party will have the right to continue prosecution or maintenance of such application or patent at the Non-Prosecuting Party’s sole expense.

8.2 Enforcement . Each party will promptly notify the other party upon becoming aware of any known or suspected infringement of any patents licensed to the other party under this Agreement or the license agreement referenced in Section 5.3. Such notice will include the identity of the party or parties known or suspected to have infringed the licensed patent and any available information that is relevant to such infringement. The party who is the exclusive licensee of such licensed patent within the field of use subject to the infringement action (the “ Enforcing Party ”) will retain sole control over enforcement and defense of the patent against such third party infringers. If the Enforcing Party files or defends any claim, suit, or action (a “ Claim ”) against any third party based on any licensed patent, the other party (the “ Non-Enforcing Party ”) will cooperate with the Enforcing Party, at the Enforcing Party’s request, in enforcing or defending such Claim, including joining the Enforcing Party as a party to such suit or action to the extent necessary to establish standing. The Enforcing Party will be responsible for all costs, expenses, and legal fees (collectively “ Costs ”) incurred by the Non-Enforcing party in connection with any Claim. The Enforcing Party will be entitled to all damages awarded as a result of or agreed to in a monetary settlement of any Claim, subject to any royalty payment obligation. Nothing contained in this Section will obligate the Enforcing Party to enforce or defend any patent licensed to it.

 

9. C ONFIDENTIALITY

9.1 Confidential Information . During the term of this Agreement, each party (the “ Receiving Party ”) may be provided with, have access to, or otherwise learn confidential and/or proprietary information of the other party (the “ Disclosing Party ”) (including certain information and materials concerning the Disclosing Party’s business, plans, customers, technology, and products) that is of substantial value to the Disclosing Party, and which is identified as confidential at the time of disclosure or which should reasonably be considered, under the circumstances of its disclosure, to be confidential to the Disclosing Party (“ Confidential Information ”).

9.2 Confidentiality Obligations . All Confidential Information remains the property of the Disclosing Party. The Receiving Party may disclose the Confidential Information of the Disclosing Party only to its employees and contractors who need to know the Confidential

 

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

 

8


Information for purposes of performing under this Agreement and who are bound by the Receiving Party’s standard employee or contractor (as applicable) confidentiality agreements. The Receiving Party will not use the Confidential Information without the Disclosing Party’s prior written consent except in performance under this Agreement. The Receiving Party will take measures to maintain the confidentiality of the Confidential Information equivalent to those measures the Receiving Party uses to maintain the confidentiality of its own confidential information of like importance but in no event less than reasonable measures. The Receiving Party will give immediate notice to the Disclosing Party of any unauthorized use or disclosure of the Confidential Information that comes to the attention of the Receiving Party’s senior management and agrees to assist the Disclosing Party in remedying such unauthorized use or disclosure.

9.3 Exceptions . The confidentiality obligations do not extend to Confidential Information which: (i) becomes part of the public domain without the fault of the Receiving Party; (ii) is rightfully obtained by the Receiving Party from a third party with the right to transfer such information without obligation of confidentiality; (iii) is independently developed by the Receiving Party without reference to or use of the Disclosing Party’s Confidential Information, as evidenced by written records; or (iv) was lawfully in the possession of the Receiving Party at the time of disclosure, without restriction on disclosure, as evidenced by written records. In addition, the Receiving Party may disclose Confidential Information of the Disclosing Party as may be required by law, a court order, or a governmental agency with jurisdiction, provided that before making such a disclosure the Receiving Party first notifies the Disclosing Party promptly and in writing and cooperates with the Disclosing Party, at the Disclosing Party’s reasonable request and expense, in any lawful action to contest or limit the scope of such required disclosure. In addition, Licensee may disclose any Materials provided by Licensor to Licensee’s contract manufacturers, employees, agents and third parties without restriction, even if such Materials contain Confidential Information of Licensor.

9.4 Return of Confidential Information . Upon termination (but not expiration) of this Agreement, the Receiving Party will return to the Disclosing Party or destroy all tangible copies of Confidential Information of the Disclosing Party, which the Receiving Party no longer has the right to use, in the Receiving Party’s possession or control and will erase from its computer systems all electronic copies thereof.

9.5 Confidentiality of the Agreement . Neither party will disclose any terms or conditions of this Agreement to any third party, without the prior written consent of the other party, except: (i) as required by law; (ii) to its attorneys, accountants, and other professional advisors under a duty of confidentiality; or (iii) to a third party under a duty of confidentiality in connection with financing or a proposed merger or a proposed sale of all or part of such party’s business which relates to this Agreement.

9.6 Survival of Obligations . Licensee’s and Licensor’s respective obligation under this Section 8 shall survive any termination or expiration of this Agreement and shall extend to the earlier of such time as the Confidential Information is in the public domain or [***] years following termination or expiration of this Agreement.

 

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

 

9


10. R EPRESENTATIONS AND W ARRANTIES

10.1 Mutual Representations and Warranties . Each party represents and warrants that it has full right, power, and authority to enter into this Agreement and to perform its obligations and duties under this Agreement, and that the performance of such obligations and duties does not and will not conflict with or result in a breach of any other agreements of such party or any judgment, order, or decree by which such party is bound.

10.2 Representations and Warranties By Licensor . Licensor represents and warrants that:

(a) it exclusively owns and has full right, power, and authority to license the Licensed Patents and the Licensed Know-How to Licensee;

(b) it has not granted or will grant during the term of this Agreement any security interest, option, lien, license, or encumbrance of any nature with respect to any Licensed Patent or Licensed Know-How which would conflict with the license granted to Licensee under this Agreement;

(c) to the best knowledge of Licensor, all of the Licensed Patents that have issued are valid and enforceable, and no proceeding is pending or to the best knowledge of Licensor, threatened, nor has any claim been made, which challenges or challenged the legality, validity, or enforceability of any Licensed Patent;

(d) all maintenance fees, annuity payments, and similar payments relating to the Licensed Patents have been made and will be made in a timely manner during the term of this Agreement; and

(e) to the knowledge of Licensor, using, making, selling, or importing a Licensed Product or performing a Licensed Process shall not infringe, directly or indirectly, any patent or other intellectual property rights of any third party.

10.3 Limitation of Liability . E XCEPT FOR BREACH OR REPRESENTATIONS OF WARRANTIES PROVIDED IN THIS A GREEMENT , IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR ANY THIRD PARTY FOR ANY CONSEQUENTIAL , INDIRECT , PUNITIVE , EXEMPLARY , SPECIAL OR INCIDENTAL DAMAGES , INCLUDING ANY LOST DATA AND LOST PROFITS , ARISING FROM OR RELATING TO THIS A GREEMENT , THE L ICENSED P ATENTS , THE L ICENSED K NOW -H OW , OR I MPROVEMENTS . L ICENSEE S TOTAL CUMULATIVE LIABILITY IN CONNECTION WITH THIS A GREEMENT , THE L ICENSED P ATENTS , THE L ICENSED K NOW -H OW , OR I MPROVEMENTS , WHETHER IN CONTRACT OR TORT OR OTHERWISE , WILL NOT EXCEED THE TOTAL AMOUNT OF FEES AND ROYALTIES PAID TO L ICENSOR UNDER THIS A GREEMENT DURING THE [***] MONTHS PRECEDING THE CLAIM .

 

11. I NDEMNIFICATION

11.1 By Licensor . Licensor will defend, indemnify, and hold Licensee, Licensee’s Affiliates, and their directors, officers, employees, and agents harmless from and against any and all claims, losses, liabilities, damages, costs, and expenses (including attorneys’ fees, expert

 

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

 

10


witness fees, and court costs) directly or indirectly arising from or relating to: (i) any product liability claims based on the manufacture, marketing, promotion, sale, distribution, or use of any Licensed Products by Licensor or its customers; and (ii) any negligence or willful misconduct by Licensor or its directors, officers, employees, or agents in the performance of this Agreement or in connection with manufacture, marketing, promotion, sale, distribution, or use of Licensed Products. In addition, Licensor will defend, indemnify, and hold Licensee, its Affiliates, sublicensees, and each of their customers, directors, officers, employees, and agents harmless from and against any and all claims, losses, liabilities, damages, costs, and expenses (including attorneys’ fees, expert witness fees, and court costs) directly or indirectly arising from or relating to any allegation that manufacture, use, offer for sale, sale, or importation of any Licensed Product or use of any Licensed Know-How as permitted under this Agreement infringes any third party’s intellectual property rights.

11.2 By Licensee . Licensee will defend, indemnify, and hold Licensor, Licenser’s Affiliates, and their directors, officers, employees, and agents harmless from and against any and all claims, losses, liabilities, damages, costs, and expenses (including attorneys’ fees, expert witness fees, and court costs) directly or indirectly arising from or relating to (i) any product liability claims based on the manufacture, marketing, promotion, sale, distribution, or use of any Licensed Products by Licensee or its customers, or (ii) any negligence or willful misconduct by Licensee or its directors, officers, employees, or agents in the performance of this Agreement or in connection with manufacture, marketing, promotion, sale, distribution, or use of Licensed Products.

11.3 Indemnity Conditions . A party’s obligation to indemnify as provided in this Agreement is conditioned upon the indemnified party promptly notifying the indemnifying party in writing within a reasonable period of time of any and all claims for which the indemnified party is entitled to indemnification, giving the indemnifying party sole control of the defense thereof and any related settlement negotiations, and indemnified party cooperating and, at indemnifying party’s request and expense, assisting in such defense. The indemnified party may participate in the defense of the claim at its own expense with counsel of its own choosing. The indemnifying party may not settle any such claim without the indemnified party’s prior written consent.

 

12. P UBLICITY

12.1 Public Announcements . Except as required by applicable laws, neither Licensor nor Licensee shall make any public announcement of any information regarding this Agreement (including without limitation its execution and terms), the Licensed Products or development or commercialization activities under this Agreement without the prior written approval of the other party, which approval shall not be withheld unreasonably. Once any statement is approved for disclosure by the parties or information is otherwise made public in accordance with the preceding sentence, either party may make a subsequent public disclosure of the contents of such statement without further approval of the other party. Notwithstanding the foregoing, either party may disclose the terms of this Agreement (i) as required by law; (ii) to its attorneys, accountants, and other professional advisors under a duty of confidentiality; (iii) to a third party under a duty of confidentiality in connection with any proposed or actual financing or investment, or a proposed or actual merger or sale of all or part of such party’s business relating to this Agreement.

 

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

 

11


13. T ERM AND T ERMINATION

13.1 Term . This Agreement will take effect on the Effective Date, and remain in effect until terminated as provided in Section 13.2 or 10.3.

13.2 Termination for Good Cause . Licensor may terminate this Agreement by giving a written notice of termination to Licensee if Licensee fails to pay any undisputed fees owed under this Agreement and does not cure such breach within [***] days after a written notice is given to Licensee requesting that such breach be cured. Once all Licensed Patents have expired or have been abandoned, the licenses granted herein will be deemed fully-paid and irrevocable.

13.3 Termination for Convenience . At any time during the term of this Agreement, Licensee may terminate this entire Agreement or terminate any license granted herein on a patent-by-patent basis or country-by-country basis for any reason or no reason by giving Licensor a written notice of termination. Termination will be effective [***] days after the date of the notice of termination.

13.4 Effect of Termination . On the effective date of termination of this Agreement (the “ Termination Date ”), all licenses granted by Licensor to Licensee under this Agreement will be revoked and Licensee will cease all further use, manufacture, sale, or importation of the Licensed Products and use of the Licensed Processes, except as provided in this Section. Licensee may complete and sell any work-in-progress and inventory of the Licensed Products that exist as of the Termination Date for a period of [***] months after the Termination Date, provided that Licensee pays Licensor the applicable running royalty or other amounts due on such sales of Royalty-Bearing Products in accordance with Section 3.1. 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.

13.5 Survival . Upon termination or expiration of this Agreement, Sections 1, 9, 10.3, 11, and 13.4 will survive.

 

14. G ENERAL

14.1 Notice . Any notice, approval, authorization, consent, or other communication required or permitted to be delivered to either party under this Agreement must be in writing and will be deemed properly delivered, given, and received (i) when delivered by hand, or (ii) three (3) business days after delivery by international courier or express delivery service (return receipt requested). All notices shall be sent to address set forth below (or to such other address as may be designated by a party by giving written notice to the other party pursuant to this Section 11.1):

 

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

 

12


If to Licensor, to:

   If to Licensee, to:   

RaQualia Pharma, Inc.

5-2 Taketoyo, Aichi 470-2341

Japan

Attention: President

Phone No.:

  

Aratana Therapeutics LLC

1901 Olathe Boulevard

Kansas City, KS 66103

USA

Attention:

Phone No.:

  

14.2 Governing Law; Arbitration. This Agreement will be construed in accordance with and governed in all respects by the laws of the State of New York, USA. Any dispute, controversy or claim arising out of or in connection with this Agreement, or breach, termination or invalidity thereof, shall be settled by arbitration in accordance with the commercial arbitration rules of the International Chamber of Commerce (“ICC”). The arbitral tribunal shall be composed of three arbitrators, one to be appointed by Licensor and one to be appointed by Licensee and the chairman to be appointed by the two arbitrators. If the two aforementioned parties have not appointed their arbitrators within [***] weeks from the request of the other party, or the two arbitrators have not agreed on the chairman within three weeks after their appointment, the ICC shall appoint the arbitrator or the chairman, as the case may be. In the event arbitration is requested by Licensor, the place of arbitration shall be [***]; in the event arbitration is requested by Licensee, the place of arbitration shall be [***]. The arbitration proceedings will be conducted in English. The results of the arbitration procedure will be considered Confidential Information of the parties. Any arbitration decision rendered will be final and binding, and judgment thereon may be entered in any court of competent jurisdiction. Notwithstanding this Section, neither party will be required to arbitrate any dispute or controversy relating to any actual or threatened unauthorized use or disclosure of its intellectual property or confidential information.

14.3 Assignment . Upon written notice to Licensor, Licensee may assign this entire Agreement or any of its rights hereunder, without Licensor’s consent, (i) to any of Licensee’s Affiliates; and (ii) to a third party in connection with a merger, change in control, or sale of all or substantially all of the assets of Licensee pertaining to this Agreement. This Agreement will be binding upon and shall inure to the benefit of the parties hereto and their respective successors and assigns.

14.4 Remedies . The rights and remedies of the parties will be cumulative (and not alternative). If any legal action is brought to enforce this Agreement, the prevailing party will be entitled to receive its attorneys’ fees, court costs, and other collection expenses, in addition to any other relief it may receive.

14.5 Waiver . All waivers must be in writing and signed by an authorized representative of the party to be charged. Any waiver or failure to enforce any provision of this Agreement on one occasion will not be deemed a waiver of any other provision or of such provision on any other occasion.

14.6 Severability . If any provision of this Agreement is unenforceable, such provision will be changed and interpreted to accomplish the objectives of such provision to the greatest extent possible under applicable law and the remaining provisions will continue in full force and effect.

 

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

 

13


14.7 Independent Contractors . This Agreement is not intended to establish any partnership, joint venture, employment, or other relationship between the parties except that of independent contractors.

14.8 Construction . The section headings in this Agreement are for convenience of reference only, will not be deemed to be a part of this Agreement, and will not be referred to in connection with the construction or interpretation of this Agreement. Any rule of construction to the effect that ambiguities are to be resolved against the drafting party will not be applied in the construction or interpretation of this Agreement. As used in this Agreement, the words “include” and “including,” and variations thereof, will not be deemed to be terms of limitation, but rather will be deemed to be followed by the words “without limitation.” All references in this Agreement to “Sections” are intended to refer to Sections of this Agreement.

 

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

 

14


IN WITNESS WHEREOF , the parties have executed this Agreement as of the date first above written.

 

RaQualia Pharma Inc.     Aratana Therapeutics Inc.
By:   /s/ Atsushi Nagahisa     By:   /s/ David K. Rosen
Name:   Atsushi Nagahisa     Name:   David K. Rosen
Title:   President & CEO     Title:   President
Date:   December 21, 2010     Date:   December 27, 2010

[SIGNATURE PAGE TO EXLUSIVE IP LICENSE AGREE FOR RQ-000000071]

 

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


E XHIBIT  A

L ICENSED P ATENTS

Title : [***]

Inventors : [***]

International Filing Date : [***]

 

Country

  

Application Number

  

Patent Number

[***]

   [***]   

[***]

   [***]    [***]

[***]

   [***]   

[***]

   [***]   

[***]

   [***]    [***]

[***]

   [***]    [***]

[***]

   [***]    [***]

[***]

   [***]    [***]

[***]

   [***]    [***]

[***]

   [***]    [***]

[***]

   [***]   

[***]

   [***]    [***]

[***]

   [***]   

[***]

   [***]    [***]

[***]

   [***]   

[***]

   [***]    [***]

[***]

   [***]    [***]

[***]

   [***]    [***]

[***]

   [***]    [***]

[***]

   [***]    [***]

[***]

   [***]    [***]

[***]

   [***]    [***]

[***]

   [***]    [***]

 

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

 

16


Title : [***]

Inventors : [***]

International Filing Date : [***]

 

Country

  

Application Number

  

Patent Number

[***]

   [***]   

[***]

   [***]   

[***]

   [***]   

[***]

   [***]    [***]

[***]

   [***]   

[***]

   [***]   

[***]

   [***]    [***]

[***]

   [***]   

[***]

   [***]   

[***]

   [***]    [***]

 

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

 

17


E XHIBIT  B

D EVELOPMENT P LAN

(to be attached upon its completion)

 

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

 

18

Exhibit 10.21

First Amendment to the Exclusive IP License Agreement for RQ-00000007

between Aratana Therapeutics Inc. and RaQualia Pharma Inc.

This is the First Amendment ( “Amendment” ) to the Exclusive IP License Agreement for RQ-00000007 dated December 27, 2010 (the “Agreement” ) between Aratana Therapeutics Inc., a Delaware corporation ( “Licensee” ) and RaQualia Pharma Inc., a Japanese corporation ( “Licensor” ), and is made and entered into between Licensee and Licensor on July 12, 2012 (the “Amendment Effective Date” ). Licensee and Licensor are referred to herein individually as a “Party” and collectively as the “Parties”.

RECITALS

WHEREAS, the Parties have entered into the Agreement, pursuant to which Licensor granted Licensee an exclusive worldwide license to RQ-00000007 Technology (as defined in the Agreement);

WHEREAS, the Parties desire to amend the provision of development and supply of the API;

WHEREAS, Licensor has developed another EP4 antagonist known as RQ-00000008 which is useful for treating acute and chronic pain and therefore could be competitive with RQ-00000007;

NOW THEREFORE, the Parties hereby agree as set forth below:

AMENDMENT

A. Amendment. The Parties agree to delete Section 7 of the Agreement in its entirety. The Parties further agree that neither Party has claims and/or liabilities arising out of or in relation to the performance of or failure to perform the rights and obligations stipulated under Section 7 of the Agreement prior to Amendment Effective Date.

B. Other Terms: All other terms of the Agreement shall remain in full force and effect. To the extent that any provision of the Agreement conflicts with any provision of this Amendment, this Amendment will take priority.


IN WITNESS WHEREOF, the Parties have caused this Amendment to the Agreement to be executed by their authorized representatives.

 

Aratana Therapeutics Inc.     RaQualia Pharma Inc.
By:  

/s/ David K. Rosen

    By:  

/s/ Atsushi Nagahisa

Name:  

David K. Rosen

    Name:  

Atsushi Nagahisa

Title:  

President & COO

    Title:  

President & CEO

Date:  

12 July 12

    Date:  

July 23, 2012

Exhibit 10.22

API DEVELOPMENT AGREEMENT

This API DEVELOPMENT AGREEMENT (this “ Agreement ”) is entered into as of July 12, 2012 (the “ Effective Date ”) by and between Aratana Therapeutics Inc., a Delaware corporation (“ Aratana ”) and RaQualia Pharma Inc., a Japanese corporation (“ RaQualia ”). Aratana and RaQualia are referred to herein individually as a “ Party ” and collectively as the “ Parties ”.

RECITALS

WHEREAS , the Parties have entered into that certain Exclusive IP License Agreement for RQ-00000007 dated December 27, 2010, as amended on July 12, 2012 (the “ License Agreement ”), pursuant to which RaQualia granted Aratana an exclusive, worldwide license to RQ-00000007 Technology for animal use only (as that term is defined in the License Agreement);

WHEREAS , Aratana desires to develop the API (as defined below) and obtain the API Information (as defined below) for animal use as licensed by RaQualia under the License Agreement.

WHEREAS , RaQualia desires to have Aratana develop the API and obtain the API Information for human use for RaQualia and a third party designated by RaQualia; and

WHEREAS , the Parties now agree that Aratana will develop the API and obtain the API Information not only for animal use to be exploited by Aratana but also for human use to be exploited by RaQualia or a third party designated by RaQualia pursuant to the terms and conditions of this Agreement.

NOW , THEREFORE , in consideration of the foregoing recitals, the terms and provisions set forth herein and other valuable and sufficient consideration, the receipt and sufficiency of which is hereby acknowledged, and intending to be legally bound hereby, the Parties agree as follows:

AGREEMENT

Article 1

Definitions

 

1.1. Act ” means the Federal Food and Drug Cosmetic Act of the United States of America, United States Code Title 21, Chapter I, as amended, and the regulations and guidelines promulgated thereunder from time to time, or any applicable European Union counterpart thereof.

 

1.2. Affiliate ” of a Party means any Person, which controls, is controlled by, or is under common control with such Party, where “control” means ownership of fifty percent (50%) or more of the outstanding voting securities.

 

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

 

1


1.3. Applicable Laws ” means the applicable, federal, state and local laws, and regulations applicable to this Agreement, including, without limitation, the Act.

 

1.4. API ” means the active pharmaceutical ingredient of the RQ-00000007 Technology, also known as AT-001.

 

1.5. API Information ” means all data, quality control information, manufacturing processes, drug manufacturing file (“ DMF ”), chemistry, manufacturing and controls (“ CMC ”) packages, and all other material and information reasonably needed by a third party manufacturer to manufacture commercially suitable API.

 

1.6. cGMPs ” means current Good Manufacturing Practices as established by the FDA Standards as promulgated under and in accordance with the Act, Title 21 of the U.S. Code of Federal Regulations, Parts 210, 211, as each may be amended from time to time, or any successors thereto, or any applicable European Union counterpart thereof.

 

1.7. CMC Technical Section ” means a phrased review component of the Investigational New Animal Drug Application (NADA) which includes CMC of an API and a drug product based on the API reviewed by the Center for Veterinary Medicine’s Division of Manufacturing. Approval of CMC Technical Section is required to gain NADA approval.

 

1.8. Confidential Information ” means, with respect to any party (the “ Disclosing Party ”), any information relating to the Disclosing Party or the Disclosing Party’s business (including, but not limited to, technical information, research, personnel, financial, marketing, strategic or other information, and, in the case of Aratana, the API Information, API, and Samples) that is disclosed in writing to the other party (“ Receiving Party ”) in the course of the Parties’ negotiation of or performance under this Agreement (it being understood that if any information is disclosed verbally, in order for that information to be considered Confidential Information, the Disclosing Party must notify the Receiving Party in writing that the information is Confidential Information within [***] days after disclosure or must be disclosed under circumstances such that the Receiving Party knows or reasonably should know such information is to be considered Confidential Information), but shall not include information that the Receiving Party can prove: (a) the Receiving Party knew, owned or controlled prior to receipt from the Disclosing Party as shown by written records; (b) is or becomes public through no fault of the Receiving Party or any Affiliate thereof; (c) is developed by the Receiving Party independent of any disclosure from the Disclosing Party; or (d) the Receiving Party obtains from a third party not under a confidentiality obligation to the Disclosing Party.

 

1.9. FDA ” means the United States Food & Drug Administration, or any successor thereto.

 

1.10. Governmental Authority ” means any federal, state, local or foreign governmental authority, agency or other body having jurisdiction over a Party.

 

1.11. Intellectual Property Rights ” means patent rights, copyrights, database rights, trademark rights, trade secret rights, and any and all other intellectual property rights available under any applicable laws

 

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

 

2


1.12. Person ” means any natural person, corporation, partnership, limited liability company, joint venture, trust, proprietorship, or other entity or organization.

 

1.13. Samples ” means samples of the API obtained during the development of the API.

 

1.14. Specifications ” is defined in Section 2.1.

Article 2

Development, Ownership, and Licensing of API

 

2.1. Specification . The specifications for the API to be developed and manufactured by Aratana pursuant to this Agreement are provided in Exhibit A hereto. (the “ Specifications ”).

 

2.2. API Development . Aratana will use commercially reasonable efforts to develop and establish a manufacturing process for the API that is cGMP compliant and fully characterized and substantially conforms to the Specifications. The target date for completion is no later than [***], provided that Aratana could be delayed due to causes beyond Aratana’s reasonable control. In case that Aratana finds the causes of delay, Aratana should promptly notify RaQualia the causes and the Parties will negotiate and set the next target date. Aratana anticipates all development of the API will take place at [***] and will be performed as generally described in [***] attached hereto as Exhibit B.

 

2.3. Ownership of API . Aratana will exclusively own all right, title, and interest in and to the API and to all Samples and API Information created, conceived, developed, made, or otherwise obtained in the course of development of the API, including all Intellectual Property Rights therein.

 

2.4. API License . Subject to the terms and conditions of this Agreement, including payment to Aratana of the amount set forth in Section 5.1 hereof, upon completion of the development of the API as set forth in Section 2.2 hereof, Aratana will grant RaQualia a limited, non-exclusive right and license to use any Samples and API Information provided by Aratana to RaQualia solely for: (a) conducting research and development; (b) filing applications for regulatory approval; and (c) manufacturing and commercializing drugs incorporating the API for human use only. RaQualia may sublicense the rights granted herein solely in conjunction with licensing RQ-0000007 Technology to a third party for human use only and may transfer the rights granted herein solely in conjunction with transferring RQ-0000007 Technology to a third party for human use only. RaQualia covenants and agrees that this license will not permit the Samples, API Information, or API to be used for the manufacture or commercialization of drugs for use in the animal field.

Article 3

Supply of API

 

3.1. Sample API . Upon completion of the development of the API (the “ Completion Date ”), Aratana will supply RaQualia up to [***] of API [***].

 

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

 

3


3.2. Supply of API after the Completion Date . With respect to the API which will be manufactured after the Completion Date, the Parties agree to negotiate in good faith an API Supply Agreement based on the form attached hereto as Exhibit C (the “ Supply Agreement ”), provided that Aratana has no obligation to supply to RaQualia the API manufactured after the Completion Date unless and until the Parties have entered into the Supply Agreement. In addition, the Parties agree that all of the provisions in Exhibit C are negotiable and modifiable under such negotiation provided hereof.

 

3.3. Other Suppliers . RaQualia and its licensees may use any third party manufacturer, other than Aratana’s contracted supplier (i.e., CML) to manufacture the API on behalf of RaQualia and/or its licensees, and upon RaQualia’s request, Aratana shall provide RaQualia and RaQualia’s other licensees in the field of human health (“ Other Licensees ”) with copies of all API Information and applicable Samples necessary for the manufacture of the API. Notwithstanding the foregoing, RaQualia and its licensees may use Aratana’s contracted supplier in the event RaQualia terminates this Agreement under Section 8.3 or 8.4 or the Supply Agreement under Section 7.3 or 7.4.

Article 4

Quality Control

 

4.1. Compliance . Aratana represents and warrants that the Sample API supplied to RaQualia pursuant to Section 3.1 hereof shall be manufactured, stored and supplied by Aratana in accordance with applicable cGMPs and shall substantially meet the Specifications. In the event Aratana is in breach of a representation or warranty set forth in this Section 4.1, then, as RaQualia’s sole and exclusive remedy, Aratana will, replace, free of charge, the API subject to the breach.

 

4.2. Changes to Specifications . Any change to Specifications shall require each Party’s mutual agreement, to be negotiated in good faith between the Parties. The Parties will report any change as required by the FDA and/or any applicable Governmental Authority. Aratana shall have at least [***] months from date of the Parties’ agreement to implement such changes to the Specifications. If any such change will result in an increase or decrease in the manufacturing costs, timing, or requirements of the API, the Parties shall negotiate in good faith and agree upon corresponding adjustments in this Agreement.

 

4.3. Disclaimer of Warranties . EXCEPT AS EXPRESSLY SET FORTH IN SECTION 4.1, ARATANA GIVES NO WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE SAMPLES, THE API INFORMATION, THE API, OR THE MANUFACTURE THEREOF. EXCEPT AS PROVIDED IN SECTION 4.1, THE SAMPLES, THE API INFORMATION, AND THE API ARE PROVIDED “AS IS.” ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT OF THIRD PARTY RIGHTS, ARE EXPRESSLY DISCLAIMED.

 

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

 

4


4.4. LIMITATION OF LIABILITY . EXCEPT FOR BREACH OF ARTICLE 6 OR ARISING OUT OF A PARTY’S INDEMNIFICATION OBLIGATIONS, IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR ANY THIRD PARTY FOR ANY CONSEQUENTIAL, INDIRECT, PUNITIVE, EXEMPLARY, SPECIAL OR INCIDENTAL DAMAGES, INCLUDING ANY LOST DATA AND LOST PROFITS, ARISING FROM OR RELATING TO THIS AGREEMENT, THE API, THE SAMPLES, OR THE API INFORMATION. ARATANA’S TOTAL CUMULATIVE LIABILITY ARISING OUT OF OR RELATING TO THIS AGREEMENT, THE API, THE SAMPLES, AND API INFORMATION, WHETHER IN CONTRACT OR TORT OR OTHERWISE, WILL NOT EXCEED THE TOTAL AMOUNT OF FEES PAID BY RAQUALIA UNDER THIS AGREEMENT.

Article 5

Purchase Price/Payment

 

5.1. API Development Cost . To offset some of the costs incurred by and to be incurred by Aratana to develop a cGMP compliant and fully characterized API that is sufficient for use in FDA monitored studies to prove safety and efficacy in Aratana’s target specifies, RaQualia will pay Aratana (USD) $[***] as follows:

 

  a) (USD) $[***] due upon the execution of this Agreement; and

 

  b) (USD) $[***] due upon the delivery of [***] of the API that (i) is cGMP compliant, (ii) substantially meets the Specifications, and (iii) conforms to International Conference on Harmonisation (ICH) guidelines for new drug substances. The API will be suitable for use in human clinical trials, but not necessarily for commercialization. Within [***] business days after receiving the API, RaQualia must send to Aratana a written notice of acceptance or rejection of the API, and if RaQualia is rejecting the API, RaQualia must describe in writing in detail the basis for the rejection. Failure to provide such notice within such period or any use of the API other than for purposes of determining acceptance or rejection will be deemed acceptance of the API by RaQualia. Upon receiving a written notice of acceptance from RaQualia, Aratana will send an invoice to RaQualia.

RaQualia will make all payments due under Section 5.1 within [***] days of the receipt of the invoice.

Article 6

Confidentiality

During the terms of this Agreement and for a period of [***] years following the termination or expiration of this Agreement, each Party shall hold in confidence and use only in furtherance of its rights and obligations under this Agreement all Confidential Information that it acquires from the other Party pursuant to this Agreement, unless (a) the Disclosing Party consents to the Receiving Party’s disclosure or use, or (b) disclosure of the Disclosing Party’s Confidential

 

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

 

5


Information by the Receiving Party is required by order of any Governmental Authority, in which event the Receiving Party will notify the Disclosing Party of that order as soon as practicable, shall use reasonable efforts (at the Disclosing Party’s expense) to obtain a protective order covering the Confidential Information and shall disclose only such Confidential Information that its legal counsel determines is legally required. Each Party shall make Confidential Information that it acquires from the other Party pursuant to this Agreement available only to those of its Affiliates, directors, officers, employees, consultants, advisors or representatives who need to have access thereto for the purposes of this Agreement and who are bound by an obligation of confidentiality consistent with the provisions herein.

Article 7

Indemnification

 

7.1. By Aratana . Aratana will defend, indemnify, and hold RaQualia, its Affiliates, and their directors, officers, employees, and agents harmless from and against any and all claims, losses, liabilities, damages, costs, and expenses (including attorneys’ fees, expert witness fees, and court costs) directly or indirectly arising from or relating to any negligence, willful misconduct, or violation of Applicable Laws by Aratana or its directors, officers, employees, or agents in the performance of this Agreement or in connection with the development of the API.

 

7.2. By RaQualia . RaQualia will defend, indemnify, and hold Aratana, Aratana’s Affiliates, and their directors, officers, employees, and agents harmless from and against any and all claims, losses, liabilities, damages, costs, and expenses (including attorneys’ fees, expert witness fees, and court costs) directly or indirectly arising from or relating to (i) any claims based on the use of any API, API Information, or products incorporating the API Information by RaQualia, its licensees, its manufacturers, its distributors, or any of their customers, or (ii) any negligence, willful misconduct, or violation of Applicable Laws by RaQualia or its directors, officers, employees, or agents in the performance of this Agreement or in connection with the use of the API, API Information, or products incorporating the API.

 

7.3. Indemnity Conditions . A Party’s obligation to indemnify as provided in this Agreement is conditioned upon the indemnified Party promptly notifying the indemnifying Party in writing within a reasonable period of time of any and all claims for which the indemnified Party is entitled to indemnification, giving the indemnifying Party sole control of the defense thereof and any related settlement negotiations, and indemnified Party cooperating and, at indemnifying Party’s request and expense, assisting in such defense. The indemnified Party may participate in the defense of the claim at its own expense with counsel of its own choosing. The indemnifying Party may not settle any such claim without the indemnified Party’s prior written consent.

 

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

 

6


Article 8

Effective Date, Term and Termination

 

8.1. Term . This Agreement shall commence on the Effective Date and, unless terminated earlier as provided below, shall continue in full force and effect until Aratana has obtained FDA approval of a CMC Technical Section.

 

8.2. Termination by Aratana for Material Breach . Aratana may terminate this Agreement for a material breach by RaQualia if RaQualia fails to cure any such breach within [***] days (or within [***] days in the event of failure to pay any amounts owed by RaQualia hereunder) after receipt of written notice from Aratana or any of its Affiliates, specifying such breach.

 

8.3. Termination by RaQualia for Material Breach . RaQualia may terminate this Agreement for a material breach of this Agreement by Aratana if Aratana fails to cure any such breach within [***] days after receipt of written notice from RaQualia specifying such breach.

 

8.4. Termination for Cause . This Agreement may further be terminated for cause at any time prior to its expiration for the following reasons: (a) by either Party, if a petition in bankruptcy with respect to the other Party is filed or if such other Party is liquidated or if a trustee is appointed, provided that in an involuntary bankruptcy proceeding, such right of termination shall only become effective if the proceeding is not dismissed within [***] days of the filing; or (b) by either Party, upon a termination or expiration of the License Agreement.

 

8.5. Termination for FDA Governmental Action . If any FDA governmental action occurs which prevents Aratana from developing and supplying the API as required under this Agreement (“ FDA Governmental Action ”), then Aratana and RaQualia will work together to establish a plan of action for handling the particular FDA Governmental Action. If the Parties are unable to agree on such a plan of action, then either Party may terminate this Agreement upon reasonable written notice to the other Party, not less than [***] days.

 

8.6.

Effect of Termination . In the event this Agreement is terminated for cause by Aratana pursuant to Sections 8.2 or 8.4(a), then all licenses granted by Aratana to RaQualia under this Agreement will be revoked and RaQualia will cease all further use of the API Information. Otherwise, in the event this Agreement expires or is terminated pursuant to Section 8.4(b) or 8.5 or terminated by RaQualia pursuant to Section 8.3 or 8.4(a), RaQualia’s license as set forth in Section 2.4 shall survive termination or expiration of this Agreement, provided that the license set forth in Section 2.4 shall immediately terminate in the event RaQualia is in breach of Section 2.4 or any other term or condition of this Agreement that survives termination or expiration and fails to cure such breach within [***] days of receiving written notice thereof. For avoidance of doubt, after termination or expiration of this Agreement, RaQualia may use any Samples and API Information provided by Aratana for (a) conducting research and development; (b) filing applications for regulatory approval; and (c) manufacturing and commercializing drugs

 

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

 

7


  incorporating the API for human use, if the license granted under Section 2.4 is to survive as stated in this Section 8.6. In addition, the Parties agree that if this Agreement is terminated prior to the Completion Date, the Supply Agreement will automatically terminate.

 

8.7. Transfer of Ownership . In the event Aratana ceases the development of the API or RQ-00000007 Technology for any reason either directly or through an assignee, successor, or licensee, and if requested by RaQualia, Aratana will negotiate with RaQualia in good faith the terms (including payment of applicable fees) under which Aratana would transfer to RaQualia all ownership in the API as provided for in Section 2.4, any remaining Samples and the API, provided that under no circumstance does Aratana have any obligation to transfer such ownership to RaQualia.

 

8.8. Survival . Upon termination or expiration of this Agreement, Sections 2.3, 2.4 (solely as stated in Section 8.6), 4.1, 4.3, 4.4, 5.1, and 8.6 and Articles 1, 3, 6, 7, and 9 will survive.

Article 9

General

 

9.1. Notice . Any notice, approval, authorization, consent, or other communication required or permitted to be delivered to either Party under this Agreement must be in writing and will be deemed properly delivered, given, and received (i) when delivered by hand, or (ii) three (3) business days after delivery by international courier or express delivery service (return receipt requested). All notices shall be sent to address set forth below (or to such other address as may be designated by a Party by giving written notice to the other party pursuant to this Section 9.1):

 

 

If to RaQualia to:

 

RaQualia Pharma, Inc.

5-2 Taketoyo, Aichi 470-2341

Japan

Attention: President

Phone No.: 89 904 790 3811

  

If to Aratana, to:

 

Aratana Therapeutics Inc.

1901 Olathe Boulevard

Kansas City, KS 66103

USA

Attention: President & COO

Phone No.: 913-951-2132

  

 

9.2.

Governing Law; Arbitration . This Agreement will be construed in accordance with and governed in all respects by the laws of the State of New York, USA. Any dispute, controversy or claim arising out of or in connection with this Agreement, or breach, termination or invalidity thereof, shall be settled by arbitration in accordance with the commercial arbitration rules of the International Chamber of Commerce (“ ICC ”). The arbitral tribunal shall be composed of three arbitrators, one to be appointed by Aratana and one to be appointed by RaQualia and the chairman to be appointed by the two arbitrators. If the two aforementioned Parties have not appointed their arbitrators within [***] weeks from the request of the other Party, or the two arbitrators have not agreed on the chairman within three weeks after their appointment, the ICC shall appoint the arbitrator or the chairman, as the case may be. In the event arbitration is requested by

 

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

 

8


  RaQualia, the place of arbitration shall be [***]; in the event arbitration is requested by Aratana, the place of arbitration shall be [***]. The arbitration proceedings will be conducted in English. The results of the arbitration procedure will be considered Confidential Information of the Parties. Any arbitration decision rendered will be final and binding, and judgment thereon may be entered in any court of competent jurisdiction. Notwithstanding this Section, neither Party will be required to arbitrate any dispute or controversy relating to any actual or threatened unauthorized use or disclosure of its intellectual property or confidential information.

 

9.3. Assignment . Neither Party may assign or transfer this Agreement or any of its rights hereunder without the prior written consent of the other Party. Notwithstanding the foregoing, either Party may assign this entire Agreement or any of its rights hereunder, upon notice to the other Party but without such other Party’s consent, (i) to any of the assigning Party’s Affiliates; and (ii) to a third party in connection with a merger, change in control, or sale of all or substantially all of the assets or business of the assigning Party pertaining to this Agreement. This Agreement will be binding upon and shall inure to the benefit of the Parties hereto and their respective successors and assigns.

 

9.4. Waiver . All waivers must be in writing and signed by an authorized representative of the Party to be charged. Any waiver or failure to enforce any provision of this Agreement on one occasion will not be deemed a waiver of any other provision or of such provision on any other occasion.

 

9.5. Severability . If any provision of this Agreement is unenforceable, such provision will be changed and interpreted to accomplish the objectives of such provision to the greatest extent possible under applicable law and the remaining provisions will continue in full force and effect.

 

9.6. Independent Contractors . This Agreement is not intended to establish any partnership, joint venture, employment, or other relationship between the Parties except that of independent contractors.

 

9.7. Construction . The section headings in this Agreement are for convenience of reference only, will not be deemed to be a part of this Agreement, and will not be referred to in connection with the construction or interpretation of this Agreement. Any rule of construction to the effect that ambiguities are to be resolved against the drafting Party will not be applied in the construction or interpretation of this Agreement. As used in this Agreement, the words “include” and “including,” and variations thereof, will not be deemed to be terms of limitation, but rather will be deemed to be followed by the words “without limitation.” All references in this Agreement to “Sections” are intended to refer to Sections of this Agreement.

 

9.8. Counterparts . This Agreement may be executed in several counterparts, each of which will constitute an original and all of which, when taken together, will constitute one agreement.

 

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

 

9


9.9. English Language . This Agreement has been prepared in the English language and the English language shall control its interpretation. In addition, all notices required or permitted to be given hereunder, an all written, electronic, or other communications between the parties regarding this Agreement shall be in the English language

 

9.10. Entire Agreement . This Agreement sets forth the entire understanding of the Parties relating to the subject matter hereof and supersedes all prior agreements and understandings between the Parties relating to the subject matter hereof. This Agreement may not be amended, modified, altered, or supplemented other than by means of a written instrument duly executed and delivered on behalf of both Parties.

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

 

RaQualia Pharma, Inc.     Aratana Therapeutics, Inc.
By:  

/s/ Atsushi Nagahisa

    By:  

/s/ David K. Rosen

Name:   Atsushi Nagahisa     Name:   David K. Rosen
Title:   President & CEO     Title:   President & COO
Date:   July 23, 2012     Date:   12 July 12

 

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

 

10


EXHIBIT A – SPECIFICATION OF RQ-00000007

 

TEST
DESCRIPTION

   METHOD   COMPONENTS   ACCEPTANCE
CRITERIA

[***]

      

[***]

   [***]   [***]   [***]

[***]

   [***]   [***]   [***]

[***]

   [***]   [***]   [***]

[***]

     [***]   [***]

[***]

   [***]   [***]   [***]

[***]

   [***]   [***]   [***]

[***]

   [***]   [***]   [***]

[***]

   [***]   [***]   [***]

[***]

   [***]   [***]   [***]

[***]

   [***]   [***]   [***]

[***]

      

[***]

   [***]   [***]   [***]

[***]

   [***]   [***]   [***]

[***]

   [***]   [***]   [***]

Note 1: [***]

Note 2: [***]

 

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

 

11


EXHIBIT B - CML PROPOSAL

[***]

 

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

 

12


EXHIBIT C - API SUPPLY AGREEMENT

This API SUPPLY AGREEMENT (this “ Agreement ”) is entered into as of             (the “ Effective Date ”) by and between Aratana Therapeutics Inc., a Delaware corporation (“ Aratana ”) and RaQualia Pharma Inc., a Japanese corporation (“ RaQualia ”). Aratana and RaQualia are referred to herein individually as a “ Party ” and collectively as the “ Parties ”.

RECITALS

WHEREAS , the Parties have entered into that certain API Development Agreement dated July 12, 2012 (the “ Development Agreement ”), pursuant to which Aratana carried out development of the API (as defined in the Development Agreement); and

WHEREAS , the Parties now desire for Aratana to supply the API to RaQualia pursuant to the terms and conditions of this Agreement.

NOW, THEREFORE , in consideration of the foregoing recitals, the terms and provisions set forth herein and other valuable and sufficient consideration, the receipt and sufficiency of which is hereby acknowledged, and intending to be legally bound hereby, the Parties agree as follows:

AGREEMENT

Article 1

Definitions

 

1.1 Act ” means the Federal Food and Drug Cosmetic Act of the United States of America, United States Code Title 21, Chapter I, as amended, and the regulations and guidelines promulgated thereunder from time to time, or any applicable European Union counterpart thereof.

 

1.2 Affiliate ” of a Party means any Person, which controls, is controlled by, or is under common control with such Party, where “control” means ownership of fifty percent (50%) or more of the outstanding voting securities.

 

1.3 Applicable Laws ” means the applicable, federal, state and local laws, and regulations applicable to this Agreement, including, without limitation, the Act.

 

1.4 API ” means the active pharmaceutical ingredient of the RQ-00000007 Technology, also known as AT-001.

 

1.5 API Information ” means all data, quality control information, manufacturing processes, drug manufacturing file (“ DMF ”), chemistry, manufacturing and controls (“ CMC ”) packages, and all other material and information reasonably needed by a third party manufacturer to manufacture commercially suitable API.

 

1.6 cGMPs ” means current Good Manufacturing Practices as established by the FDA Standards as promulgated under and in accordance with the Act, Title 21 of the U.S. Code of Federal Regulations, Parts 210, 211, as each may be amended from time to time, or any successors thereto, or any applicable European Union counterpart thereof.

 

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

 

13


1.7 Confidential Information ” means, with respect to any party (the “ Disclosing Party ”), any information relating to the. Disclosing Party or the Disclosing Party’s business (including, but not limited to, technical information, research, personnel, financial, marketing, strategic or other information, and, in the case of Aratana, the API Information, API, and Samples) that is disclosed in writing to the other party (“ Receiving Party ”) in the course of the parties’ negotiation of or performance under this Agreement (it being understood that if any information is disclosed verbally, in order for that information to be considered Confidential Information, the Disclosing Party must notify the Receiving Party in writing that the information is Confidential Information within [***] days after disclosure or must be disclosed under circumstances such that the Receiving Party knows or reasonably should know such information is to be considered Confidential Information), but shall not include information that the Receiving Party can prove: (a) the Receiving Party knew, owned or controlled prior to receipt from the Disclosing Party; (b) is or becomes public through no fault of the Receiving Party or any Affiliate thereof; (c) is developed by the Receiving Party independent of any disclosure from the Disclosing Party; or (d) the Receiving Party obtains from a third party not under a confidentiality obligation to the Disclosing Party.

 

1.8 FDA ” means the United States Food & Drug Administration, or any successor thereto.

 

1.9 Governmental Authority ” means any federal, state, local or foreign governmental authority, agency or other body having jurisdiction over a Party.

 

1.10 Intellectual Property Rights ” means patent rights, copyrights, database rights, trademark rights, trade secret rights, and any and all other intellectual property rights available under any applicable laws

 

1.11 Person ” means any natural person, corporation, partnership, limited liability company, joint venture, trust, proprietorship, or other entity or organization.

 

1.12 Specifications ” means specifications mutually agreed to by the Parties for the API and the manufacture thereof for use in human drug development and commercial application.

Article 2

Commercial Supply of API

 

2.1 Minimum Supply of API . Aratana agrees to sell RaQualia the API pursuant to the terms and conditions of this Agreement. During the term of this Agreement, RaQualia shall purchase at least [X] [***] of API per contract year at a price of $[X] per [***]. In the event RaQualia fails to submit purchase orders (POs) for such amount during any contract year, Aratana shall charge RaQualia an amount equal to the difference between (a) the amount RaQualia would have paid Aratana during the prior calendar year had the minimum amount of API been purchased, and (b) the amount of API actually purchased during the prior calendar year multiplied by the cost of such API.

 

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

 

14


Article 3

Quality Control

 

3.1 Compliance . Aratana represents and warrants that the API supplied to RaQualia pursuant to Section 2.1 hereof shall be manufactured, stored and supplied by Aratana in accordance with applicable cGMPs and shall meet Specifications. In the event Aratana is in breach of a representation or warranty set forth in this Section 3.1, then, as RaQualia’s sole and exclusive remedy, Aratana will, at its option, either: (a) replace, free of charge, the API subject to the breach, or (b) provide a refund to RaQualia for the non-conforming API.

 

3.2 Changes to Specifications . Any change to Specifications shall require each Party’s mutual agreement, to be negotiated in good faith between the Parties. The Parties will report any change as required by the FDA and/or any applicable Governmental Authority. Aratana shall have at least [***] months from date of the Parties’ agreement to implement such changes to the Specifications. If any such change will result in an increase or decrease in the manufacturing costs, timing, or requirements of the API, the Parties shall negotiate in good faith and agree upon corresponding adjustments this Agreement.

 

3.3 Disclaimer of Warranties . EXCEPT AS EXPRESSLY SET FORTH IN THIS ARTICLE 3, ARATANA GIVES NO WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE API OR THE MANUFACTURE THEREOF. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT OF THIRD PARTY RIGHTS, ARE EXPRESSLY DISCLAIMED.

 

3.4 Limitation of Liability . Except for breach of Article 5 or arising out of a Party’s indemnification obligations, in no event will either Party be liable to the other Party or any third party for any consequential, indirect, punitive, exemplary, special or incidental damages, including any lost data and lost profits, arising from or relating to this Agreement or the API. Aratana’s total cumulative liability arising out of or relating to this Agreement and the API whether in contract or tort or otherwise, will not exceed the total amount of fees paid by RaQualia under this Agreement during the [***] months preceding the event giving rise to the claim.

Article 4

Purchase Price/Payment

 

4.1 Purchase Price and Payment . The purchase price per kilogram of the API as set forth in Section 2.1 does not include sales, use, consumption, or excise tax of any taxing authority. The amount of such taxes, if any, will be added to the price in effect at the time of purchase and shall be reflected in the invoices submitted to RaQualia pursuant to this Agreement. All amounts are in U.S. dollars.

 

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

 

15


4.2 Forecast . On a             basis, RaQualia will provide to Aratana a non-binding             months forecast of expected purchase of the API. The forecast will be used by Aratana for planning purposes only.

 

4.3 Purchase Order . In the event RaQualia desires to purchase the API, RaQualia shall issue a binding PO to Aratana at least [X]  days prior to the requested delivery date of the API. The PO shall specify, at a minimum, the quantity of API, the price for the API (as set forth in Section 2.1), the requested delivery date, and the destination of delivery. Aratana shall inform RaQualia about its acceptance or rejection of any PO in writing within [***] business days of receipt of the PO. Cancellation of an accepted PO by RaQualia more than [X]  days prior to delivery will be subject to a cancellation fee of [X] %. Accepted POs may not be cancelled by RaQualia less than [X]  days prior to delivery.

 

4.4 Shipment, Title, and Delivery . Aratana will use commercially reasonable efforts to meet the requested delivery dates that are no earlier than the lead times. All sales of the API are made F.O.B. (as defined in U.C.C. § 2-319) the place of manufacture, notwithstanding any prepayment of freight by RaQualia. RaQualia will be responsible for and reimburse Aratana for all shipping costs incurred by Aratana. At the time the API is delivered to RaQualia or an agent of RaQualia, including common carrier, title and risk of loss of the API shall pass to RaQualia, and Aratana and its contracted supplier (e.g., CML) will not be responsible for any subsequent delay in transportation or non-delivery of the API. RaQualia shall provide whatever insurance against loss or damage it considers necessary once the API leaves the place of manufacture. All API shall be deemed to be irrevocably accepted unless rejected in writing by RaQualia within [***] days of delivery.

 

4.5 Payment Terms . Upon delivery of the API, Aratana shall provide RaQualia with an invoice for payment of the API. All amounts set forth in the invoice shall be paid by RaQualia net [***] days after receipt. In the event RaQualia fails to make any payments when due under this Agreement, RaQualia may be charged a late fee on any amount that is not paid when due at a rate of [***] percent [***] per month or the maximum rate allowed by applicable law, whichever is lower, from the due date until paid. In the event of any late payment by RaQualia, Aratana may decline to make further sales of the API until all amounts due and late fees are paid in full without in any way affecting its rights under this Agreement.

Article 5

Confidentiality

During the terms of this Agreement and for a period of [***] years following the termination or expiration of this Agreement, each Party shall hold in confidence and use only in furtherance of its rights and obligations under this Agreement all Confidential Information that it acquires from the other Party pursuant to this Agreement, unless (a) the Disclosing Party consents to the Receiving Party’s disclosure or use, or (b) disclosure of the Disclosing Party’s Confidential Information by the Receiving Party is required by order of any Governmental Authority, in which event the Receiving Party will notify the Disclosing Party of that order as soon as practicable, shall use reasonable efforts (at the Disclosing Party’s expense) to obtain a protective

 

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

 

16


order covering the Confidential Information and shall disclose only such Confidential Information that its legal counsel determines is legally required. Each Party shall make Confidential Information that it acquires from the other Party pursuant to this Agreement available only to those of its affiliates, directors, officers, employees, consultants, advisors or representatives who need to have access thereto for the purposes of this Agreement and who are bound by an obligation of confidentiality consistent with the provisions herein.

Article 6

Indemnification

 

6.1 By Aratana . Aratana will defend, indemnify, and hold RaQualia, its Affiliates, and their directors, officers, employees, and agents harmless from and against any and all claims, losses, liabilities, damages, costs, and expenses (including attorneys’ fees, expert witness fees, and court costs) directly or indirectly arising from or relating to: (i) any product liability claims based solely on the manufacture of the API; or (ii) any negligence, willful misconduct, or violation of Applicable Laws by Aratana or its directors, officers, employees, or agents in the performance of this Agreement or in connection with manufacture of the API.

 

6.2 By RaQualia . RaQualia will defend, indemnify, and hold Aratana, Aratana’s Affiliates, and their directors, officers, employees, and agents harmless from and against any and all claims, losses, liabilities, damages, costs, and expenses (including attorneys’ fees, expert witness fees, and court costs) directly or indirectly arising from or relating to: (i) any claims based on the marketing, promotion, sale, distribution, or use of any API, or products incorporating the API, by RaQualia or its distributors, or licensees; or (ii) any negligence, willful misconduct, or violation of Applicable Laws by RaQualia or its directors, officers, employees, or agents in the performance of this Agreement.

 

6.3 Indemnity Conditions . A Party’s obligation to indemnify as provided in this Agreement is conditioned upon the indemnified Party promptly notifying the indemnifying Party in writing within a reasonable period of time of any and all claims for which the indemnified Party is entitled to indemnification, giving the indemnifying Party sole control of the defense thereof and any related settlement negotiations, and indemnified Party cooperating and, at indemnifying Party’s request and expense, assisting in such defense. The indemnified Party may participate in the defense of the claim at its own expense with counsel of its own choosing. The indemnifying Party may not settle any such claim without the indemnified Party’s prior written consent.

Article 7

Effective Date, Term and Termination

 

7.1 Term . This Agreement shall commence on the Effective Date and shall continue in full force and effect for an initial term of [[***]] years. Thereafter, this Agreement will automatically renew for additional [***] year terms unless the Agreement is terminated in writing by either Party within [***] months of the end of the then current term.

 

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

 

17


7.2 Termination by Aratana for Material Breach . Aratana may terminate this Agreement for a material breach by RaQualia if RaQualia fails to cure any such breach within [***] days (or within [***] days in the event of failure to pay any amounts owed by RaQualia hereunder) after receipt of written notice from Aratana or any of its Affiliates, specifying such breach.

 

7.3 Termination by RaQualia for Material Breach . RaQualia may terminate this Agreement for a material breach of this Agreement by Aratana if Aratana fails to cure any such breach within [***] days after receipt of written notice from RaQualia specifying such breach.

 

7.4 Termination for Cause . This Agreement may further be terminated for cause at any time prior to its expiration for the following reasons: (a) by either Party, if a petition in bankruptcy with respect to the other Party is filed or if such other Party is liquidated or if a trustee is appointed, provided that in an involuntary bankruptcy proceeding, such right of termination shall only become effective if the proceeding is not dismissed within [***] days of the filing; or (b) by either Party, upon a termination or expiration of the License Agreement.

 

7.5 Termination for FDA Governmental Action . If any FDA governmental action occurs which prevents RaQualia from importing, purchasing or selling the API or that has the effect of making Aratana’s manufacture and RaQualia sale of products incorporating the API unlawful (“ FDA Governmental Action ”), then Aratana and RaQualia will work together to establish a plan of action for handling the particular FDA Governmental Action. If the Parties are unable to agree on such a plan of action, then either Party may terminate this Agreement upon reasonable written notice to the other Party, not less than [***] days.

 

7.6 Termination due to Change in Control . Either Party may terminate this Agreement with [***] months prior written notice to the other Party, if a controlling interest in Aratana or all or substantially all of the business or assets of Aratana is acquired by any third party, whether through merger, sale of assets, sale of stock or otherwise, or the RQ-0000007 Technology is sublicensed to a third party.

 

7.7 Survival . Upon termination or expiration of this Agreement, Sections 3.3, 3.4, Articles 1, 5, 6, 7, and 8 will survive. For avoidance of doubt, the Parties agree that the termination of this Agreement will not have any effect on the effectiveness of the Development Agreement, unless otherwise provided in the Development Agreement and/or this Agreement.

Article 8

General

 

8.1

Notice . Any notice, approval, authorization, consent, or other communication required or permitted to be delivered to either Party under this Agreement must be in writing and will be deemed properly delivered, given, and received (i) when delivered by hand, or (ii) three (3) business days after delivery by international courier or express delivery

 

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

 

18


  service (return receipt requested). All notices shall be sent to address set forth below (or to such other address as may be designated by a Party by giving written notice to the other party pursuant to this Section 8.1):

 

 

If to RaQualia to:

 

RaQualia Pharma, Inc.

5-2 Taketoyo, Aichi 470-2341

Japan

Attention: President

Phone No.: 89 904 790 3811

 

If to Aratana, to:

 

Aratana Therapeutics Inc.

1901 Olathe Boulevard

Kansas City, KS 66103

USA

Attention: President & COO

Phone No.: 913-951-2132

 

8.2 Governing Law; Arbitration . This Agreement will be construed in accordance with and governed in all respects by the laws of the State of New York, USA. Any dispute, controversy or claim arising out of or in connection with this Agreement, or breach, termination or invalidity thereof, shall be settled by arbitration in accordance with the commercial arbitration rules of the International Chamber of Commerce (“ ICC ”). The arbitral tribunal shall be composed of three arbitrators, one to be appointed by Aratana and one to be appointed by RaQualia and the chairman to be appointed by the two arbitrators. If the two aforementioned Parties have not appointed their arbitrators within [***] weeks from the request of the other Party, or the [***] have not agreed on the chairman within three weeks after their appointment, the ICC shall appoint the arbitrator or the chairman, as the case may be. In the event arbitration is requested by RaQualia, the place of arbitration shall be [***]; in the event arbitration is requested by Aratana, the place of arbitration shall be [***]. The arbitration proceedings will be conducted in English. The results of the arbitration procedure will be considered Confidential Information of the Parties. Any arbitration decision rendered will be final and binding, and judgment thereon may be entered in any court of competent jurisdiction. Notwithstanding this Section, neither Party will be required to arbitrate any dispute or controversy relating to any actual or threatened unauthorized use or disclosure of its intellectual property or confidential information.

 

8.3 Assignment . Neither Party may assign or transfer this Agreement or any of its rights hereunder without the prior written consent of the other Party. Notwithstanding the foregoing, either Party may assign this entire Agreement or any of its rights hereunder, upon notice to the other Party but without such other Party’s consent, (i) to any of the assigning Party’s Affiliates; and (ii) to a third party in connection with a merger, change in control, or sale of all or substantially all of the assets or business of the assigning Party pertaining to this Agreement. This Agreement will be binding upon and shall inure to the benefit of the Parties hereto and their respective successors and assigns.

 

8.4 Waiver . All waivers must be in writing and signed by an authorized representative of the Party to be charged. Any waiver or failure to enforce any provision of this Agreement on one occasion will not be deemed a waiver of any other provision or of such provision on any other occasion.

 

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

 

19


8.5 Severability . If any provision of this Agreement is unenforceable, such provision will be changed and interpreted to accomplish the objectives of such provision to the greatest extent possible under applicable law and the remaining provisions will continue in full force and effect.

 

8.6 Independent Contractors . This Agreement is not intended to establish any partnership, joint venture, employment, or other relationship between the Parties except that of independent contractors.

 

8.7 Construction . The section headings in this Agreement are for convenience of reference only, will not be deemed to be a part of this Agreement, and will not be referred to in connection with the construction or interpretation of this Agreement. Any rule of construction to the effect that ambiguities are to be resolved against the drafting Party will not be applied in the construction or interpretation of this Agreement. As used in this Agreement, the words “include” and “including,” and variations thereof, will not be deemed to be terms of limitation, but rather will be deemed to be followed by the words “without limitation.” All references in this Agreement to “Sections” are intended to refer to Sections of this Agreement.

 

8.8 Counterparts . This Agreement may be executed in several counterparts, each of which will constitute an original and all of which, when taken together, will constitute one agreement.

 

8.9 English Language . This Agreement has been prepared in the English language and the English language shall control its interpretation. In addition, all notices required or permitted to be given hereunder, an all written, electronic, or other communications between the parties regarding this Agreement shall be in the English language

 

8.10 Entire Agreement . This Agreement sets forth the entire understanding of the Parties relating to the subject matter hereof and supersedes all prior agreements and understandings between the Parties relating to the subject matter hereof. This Agreement may not be amended, modified, altered, or supplemented other than by means of a written instrument duly executed and delivered on behalf of both Parties.

 

RaQualia Pharma, Inc.     Aratana Therapeutics, Inc.
By:  

 

    By:  

 

Name:  

 

    Name:  

 

Title:  

 

    Title:  

 

Date:  

 

    Date:  

 

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

 

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

 

20

Exhibit 10.23

R A Q UALIA P HARMA , I NC .

5-2 Taketoyo, Aichi 470-2341

Japan

July 12, 2012

A RATANA T HERAPEUTICS , I NC .

1901 Olathe Boulevard

Kansas City, KS 66103

Attention: David K. Rosen

 

Re: Confirmation of Consent for RQ-00000008 Technology

Dear Dr. Rosen:

This letter agreement ( “Agreement” ) is intended to confirm the mutual understandings and agreements between R A Q UALIA P HARMA , I NC ., a Japanese corporation ( “RaQualia” ), and A RATANA T HERAPEUTICS , I NC . , a Delaware corporation ( “Aratana” ), with respect to certain matters pertaining to RQ-00000008. RaQualia and Aratana are referred to herein collectively as the “Parties” .

The Parties hereby agree as follows:

1. Definition. As used in this Agreement:

1.1 “Aratana’s Field of Use” means the field of animal health.

1.2 “License Agreement” means the Exclusive IP License Agreement for RQ-00000007 dated December 27, 2010 between the Parties.

2. RaQualia’s Rights and Technology. RaQualia owns certain rights and technology pertaining to an EP4 antagonist for treating acute and chronic pain, including all analogs, formulations thereto, and related back-up programs thereto (collectively, “RQ-00000007 Technology” ). RaQualia has developed another EP4 antagonist known as RQ-00000008 which is useful for treating acute and chronic pain and therefore could be competitive with RQ-00000007 and owns certain rights and technology pertaining to the EP4 antagonist for treating acute and chronic pain, including all analogs, formulations thereto, and related back-up programs with all intellectual property and know how. (collectively, “RQ-00000008 Technology” ).

3. Confirmation of Consent. RaQualia agrees that neither RaQualia nor any of its affiliates will market, manufacture, sell, or distribute any product based on the RQ-00000008 Technology for use in the Aratana’s Field of Use, assist any third party to engage in any of the foregoing activities, or license, provide, or otherwise permit any third party to use any RQ-00000008 Technology to research, develop, use, market, manufacture, sell, or distribute any product in the Aratana’s Field of Use.

4. Term. This Agreement will take effect on the signatory date, and remain in effect until the termination of the License Agreement.


5. Governing Law; Arbitration. This Agreement shall be construed in accordance with and governed in all respects by the laws of the State of New York, USA. Any dispute, controversy or claim arising out of or in connection with this Agreement, or breach, termination or invalidity thereof, shall be settled by arbitration in accordance with the commercial arbitration rules of the International Chamber of Commerce (“ICC”). The arbitral tribunal shall be composed of three arbitrators, one to be appointed by RaQualia and one to be appointed by Aratana and the chairman to be appointed by the two arbitrators. If the Parties have not appointed their arbitrators within three (3) weeks from the request of the other party, or the two arbitrators have not agreed on the chairman within three (3) weeks after their appointment, the ICC shall appoint the arbitrator or the chairman, as the case may be. In the event arbitration is requested by RaQualia, the place of arbitration shall be New York, USA; in the event arbitration is requested by Aratana, the place of arbitration shall be Tokyo, Japan. The arbitration proceedings will be conducted in English. Any arbitration decision rendered will be final and binding, and judgment thereon may be entered in any court of competent jurisdiction.

6. Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Delivery of an executed counterpart of this letter agreement by facsimile (or similar electronic means) shall be equally as effective as delivery of an original executed counterpart of this letter agreement.

7. Entire Agreement. This Agreement constitutes and contains the entire agreement and understanding of the Parties with respect to the subject matter hereof and supersedes any and all prior negotiations, correspondence, agreements, understandings, duties or obligations between the Parties respecting the subject matter hereof.

 

Sincerely,
R A Q UALIA P HARMA , I NC .

/s/ Atsushi Nagahisa

Atsushi Nagahisa
President and Chief Executive Officer

 

Acknowledged and agreed to by:
A RATANA T HERAPEUTICS , I NC .
By:  

/s/ David K. Rosen

  David K. Rosen
  President & COO

Exhibit 10.24

EXECUTION DRAFT

EXCLUSIVE LICENSE, DEVELOPMENT AND COMMERCIALIZATION

AGREEMENT

This Exclusive License, Development and Commercialization Agreement (this “ Agreement ”) is made effective as of December 5, 2012 (the “ Effective Date ”) by and between Pacira Pharmaceuticals, Inc., a California corporation with a principal place of business at 5 Sylvan Way, Parsippany, New Jersey U.S. 07054 (“ Pacira ”) and Aratana Therapeutics, Inc., a Delaware corporation with a place of business at 1901 Olathe Blvd, Kansas City, Kansas 66103 (“ Aratana ”). Pacira and Aratana are each hereafter referred to individually as a “ Party ” and together as the “ Parties .”

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

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

WHEREAS, Aratana wishes to acquire and Pacira wishes to grant to Aratana an exclusive license to Develop (as herein after defined), market, sell and distribute the Licensed Product in the Field subject to the terms and conditions of this Agreement.

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

 

1. DEFINITIONS

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

1.2 “ Additional Supply Agreement ” shall have the meaning set forth in Section 2.3.2.

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

 

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


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

1.5 “ Alternative Vial Size ” shall have the meaning set forth in Section 2.3.2.

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

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

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

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

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

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

1.12 “ Confidential Information ” shall mean with respect to a Party (the “ Receiving Party ”), all information which is disclosed by the other Party (the “ Disclosing Party ”) to the Receiving Party hereunder or to any of its employees, consultants, Affiliates, licensee or Sublicensees, except to the extent that the Receiving Party can demonstrate by written record or other suitable physical evidence that such information, (a) as of the date of disclosure is demonstrably known to the Receiving Party or its Affiliates other than by virtue of a prior confidential disclosure to such Party or its Affiliates; (b) as of the date of disclosure is in, or subsequently enters, the public domain, through no fault or omission of the Receiving Party; (c) is obtained from a Third Party having a lawful right to make such disclosure free from any

 

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

 

2


obligation of confidentiality to the Disclosing Party; or (d) is independently developed by or for the Receiving Party without reference to or reliance upon any Confidential Information of the Disclosing Party. Confidential Information shall include all information disclosed to or accessible by Aratana or Pacira, as the case may be, relating to the subject matter of this Agreement prior to the Effective Date.

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

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

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

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

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

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

1.19 “ European Union ” shall mean the member states of the European Union, as may exist from time to time, which as of the date hereof include Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and United Kingdom, and all other countries which accede to the European Union during the Term.

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

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

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

 

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

 

3


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

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

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

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

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

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

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

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

1.31 “ Initial Supply Agreement ” shall have the meaning set forth in Section 2.3.2.

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

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

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

 

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

 

4


1.35 “ Licensed Patent Rights ” shall mean any patents and patent applications, having claims directed to or providing exclusivity to the Licensed Product, or to the acquisition, manufacture, use, method of use, performance, sale, offer for sale, importation or other disposition of the Licensed Product that is owned or Controlled by Pacira, including but not limited to those patents and patent applications described in Schedule 1.35 attached hereto, and any divisional, continuation, continuation-in-part, reissue, reexamination, confirmation, revalidation, registration, patent of addition, renewal, extension, substitute or foreign counterparts thereof, or any patent issuing therefrom or any supplementary protection certificates related thereto.

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

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

1.38 “ Minimum Annual Revenue ” shall have the meaning set forth in Section 10.2.5.

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

(a) transport, freight and insurance costs;

(b) sales and excise taxes and duties;

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

(d) refunds and chargebacks;

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

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

Notwithstanding anything else contained in this Section 1.39 , the supply or other disposition of Licensed Product at no cost or charge to the recipient (x) as reasonable quantities of samples consistent with industry practice (y) for use in non-clinical or clinical studies or (z) for use in any tests or studies reasonably necessary to comply with any law, regulation or request by any Regulatory Authority shall not be included in the calculation of Net Sales.

 

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

 

5


1.40 “ OctoPlus ” means OctoPlus Sciences B.V.

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

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

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

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

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

1.46 “ RDF ” shall mean Research Development Foundation.

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

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

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

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

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

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

1.53 “ SkyePharma ” shall mean SkyePharma Holding, Inc.

 

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

 

6


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

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

1.56 “ Supply Agreement ” shall have the meaning set forth in Section 2.3.

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

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

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

1.60 “ Territory ” shall mean worldwide.

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

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

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

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

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

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

In this Agreement, unless the context requires otherwise:

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

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

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

 

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

 

7


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

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

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

 

2. GRANT OF RIGHTS

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

 

  2.2 Right to Sublicense.

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

2.2.2 Sublicenses Within United States . In the event Aratana determines to sublicense all or any portion of the rights granted in the United States in the Field hereunder

 

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

 

8


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

2.3 Manufacturing .

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

2.3.2 Supply Agreements . Concurrently herewith, the Parties are entering into a supply agreement in substantially the form attached hereto as Exhibit A (the “ Initial Supply Agreement ”), pursuant to which Pacira is agreeing to supply unlabeled vials of the Licensed Product to Aratana in the sizes and at the prices contemplated thereby. Thereafter, during the Term, in the event that Pacira manufactures the Licensed Product for its human health program in any vial size not contemplated by the Initial Supply Agreement (an “ Alternative Vial Size ”), or in the event that Aratana requires the Licensed Product in any Alternative Vial Size and agrees to pay for all reasonable costs incurred by Pacira in connection with developing the process to manufacture the Licensed Product in such Alternative Vial Size, the Parties agree that they will negotiate in good faith to enter into an additional supply agreement (the “ Additional Supply Agreement ” and, together with the Initial Supply Agreement, the “ Supply Agreements ”) on substantially similar terms as the Initial Supply Agreement with appropriate, negotiated economic adjustments based on the differences between the Alternative Vial Size and the vial sizes contemplated by the Initial Supply Agreement.

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

 

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

 

9


3. DEVELOPMENT/COMMERCIALIZATION OF LICENSED PRODUCTS

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

 

   

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

 

   

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

 

   

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

 

   

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

 

   

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

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

3.1.2 Meetings . The JCCC will meet as needed upon request from at least one of the Parties to the then-current Chairperson, but not less than [ ***] . At each meeting, the Parties shall provide updates on the status of their respective responsibilities. Meetings may be held by teleconference, videoconference or in person, as mutually agreed upon by the Parties. At each meeting, a secretary shall by appointed by the Chairperson to record meeting minutes. Within [ ***] calendar days after a meeting, the Chairperson shall circulate draft minutes to the Parties for review, comment and distribution, in order to finalize the minutes within [ ***]  calendar days of such meeting.

 

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

 

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

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

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

(b) provide to Aratana without charge (EXW Incoterms 2010 Pacira’s or its designee’s manufacturing facility) such reasonable quantities of Licensed Product in unlabeled [ ***] vials (or [ ***] vials at all such times when such vials are otherwise being manufactured for commercial sale in Pacira’s human health program for EXPAREL ® ) necessary for Aratana to conduct such studies in the Field in the Territory as necessary to seek Regulatory Approvals in accordance with the Development Plan;

(c) supply unlabeled vials (without commercial packaging) of bulk Licensed Product to Aratana (EXW Incoterms 2010 Pacira’s manufacturing facility), at the transfer prices and otherwise pursuant to the terms and conditions set forth in the Supply Agreements; and

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

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

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

 

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

 

11


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

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

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

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

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

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

(h) such other activities requested by the JCCC.

3.4 Adverse Events . The Parties agree to provide each other with Adverse Event information and product complaint information relating to Licensed Product as compiled and prepared by the Parties in the normal course of business in connection with the Development, Commercialization or sale of the Licensed Product, within time frames consistent with reporting obligations under applicable Law. All reports, updates, Adverse Events, product complaint and other information provided by one Party to the other Party under this Agreement (including under this Section 3.4) , shall be considered Confidential Information of the disclosing Party, subject to the terms of Section 6 hereof it being understood that the FDA may publish information relating to Adverse Events on its website.

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

 

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

 

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4. ADDITIONAL OBLIGATIONS OF ARATANA

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

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

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

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

4.5 No Competing Products . During the Term, neither Aratana nor any of its Affiliates shall Develop or Commercialize either directly or indirectly (including, but not limited to, by providing any assistance or license to any Third Party to do any of the foregoing), any injectible long-acting analgesic product for veterinary use other than the Licensed Product. Aratana shall not grant any Third Party (other than Pacira) a right of reference to any Drug Approval Application.

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

 

5. PAYMENTS AND ROYALTIES

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

 

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

 

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5.2 Milestone Payments

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

 

Regulatory Milestone

  

Milestone Amount

A. [***]

   U.S. $[***]

B. [***]

   U.S. $[***]

C. [***]

   U.S. $[***]

D. [***]

   U.S. $[***]

E. [***]

   U.S. $[***]

Total Potential Regulatory Milestones

   U.S. $[***]

Commercial Milestones

  

A.     Upon achievement of annual Net Sales of Licensed Product of U.S. $[ ***] in the Territory:

   U.S. $[ ***]

B.     Upon achievement of annual Net Sales of Licensed Product of U.S. $[ ***] in the Territory:

   U.S. $[ ***]

C.     Upon achievement of annual Net Sales of Licensed Product of U.S. $[ ***] in the Territory:

   U.S. $[ ***]

Total Potential Commercial Milestones

   U.S. $[ ***]

5.2.2 Milestone can only be achieved once . After the Licensed Product achieves a regulatory or commercial milestone, payment shall not come due upon the achievement of the same milestone.

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

1 [***]

2 [***]

 

[***]

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

 

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5.3 Payment of Royalties; Royalty Rates

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

 

Territory

  

Annual Net Sales

  

Royalty Rate

U.S.

   $[ ***]   

[ ***] %

[ ***] %

Ex-U.S.

   $[ ***]   

[ ***] %

[ ***] %

(collectively, the “ Royalty Rate ”). All calculations for this Section 5.3.1 shall be done in U.S. dollars. Royalties on sales by any Ex-U.S. Sublicensees and U.S. Sublicensees shall be paid in accordance with Sections 5.4.1 and 5.4.2 below.

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

5.3.3 Reduction of Royalty Rate. In the event of Generic Intrusion in any jurisdiction of the Territory, the Royalty Rate shall be reduced by [ ***] % in such jurisdiction.

5.3.4 Royalty Floor. Notwithstanding any reduction in Royalty Rate payable to Pacira as contemplated in Sections 5.3.2 and 5.3.3 above, at no time shall the Royalty Rate paid to Pacira on Net Sales by Aratana in any jurisdiction in the Territory be reduced below [ ***] percent ([ ***] %).

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

 

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

 

15


5.4 Sublicense Payments.

5.4.1 Payments for Ex-U.S. Sublicenses . Subject to any adjustments to royalty payments set forth in Section 5.4.2, Aratana shall pay to Pacira fifty percent (50%) of all (a) sublicense fees, milestones and royalty payments received by Aratana pursuant to any Ex-U.S. Sublicenses and (b) any profits, including any amounts by which resale/transfer price exceeds Product Price, derived by Aratana in connection with any transfer or resale of Bulk Product (as defined in the Supply Agreement) or Licensed Product to any Ex-U.S. Sublicensees as contemplated by the Supply Agreement; provided, however, that prior to making any such payments to Pacira, Aratana shall first be entitled to recoup from any upfront fees or milestone payments (but not from any royalty payments or supply revenue) received by Aratana from any Ex-U.S. Sublicensee its out-of-pocket Third Party direct, documented fees and expenses associated with any Drug Approval Applications for the Licensed Product in jurisdictions in the Territory outside the United States, including any fees and expenses associated with any Ex-U.S. clinical program used for submission with any such Drug Approval Application (“ Ex-U.S. Development Costs ”). For the avoidance of doubt, Aratana may not recoup identified and specified Ex-U.S. Development Costs against payments received pursuant to any Ex-U.S. Sublicense more than once. Ex-U.S. Development Costs shall not include the Upfront Payment Amount or any milestone or royalty payments due or payable to Pacira hereunder and Aratana may not recoup any Ex-U.S. Development Costs against any payments due or payable to Pacira hereunder. Aratana’s right to recoup expenses pursuant to this Section 5.4.1 shall also not supersede its payment obligations pursuant to Section 5.4.2 below.

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

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

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

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

 

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

 

16


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

5.4.3 Payments for U.S. Sublicenses. Aratana and Pacira shall equally share fifty percent (50%) of all (a) sublicense fees, milestones and royalty payments received by Aratana from any U.S. Sublicensees (b) any profits, including any amounts by which resale/transfer price exceeds Product Price, derived by Aratana in connection with any transfer or resale of Bulk Product (as defined in the Supply Agreement) or Licensed Product to any U.S. Sublicensees as contemplated by the Supply Agreement until Aratana recoups its out-of-pocket Third Party direct, documented fees and expenses associated with any Drug Approval Application in the United States for the Licensed Product, including any fees and expenses associated with the Development of the Licensed Product in the U.S. (“ U.S. Development Costs ”), and any milestones (other than the Upfront Payment Amount) paid to Pacira hereunder. Any sharing of royalty payments under this Section 5.4.3 shall be updated to reflect any sharing of SP Royalty as provided in Section 5.4.2. Following Aratana’s recoupment of its U.S. Development Costs, except as provided below, the license granted to Aratana for the United States shall terminate and Aratana shall no longer be entitled to receive any royalties or other payments due under the U.S. Sublicense with all rights thereunder reverting to Pacira, and upon such event Aratana shall comply with Section 10.3.5 below; provided, however, if Aratana enters into a U.S. Sublicense and is nevertheless able to continue to meet its financial obligations and royalty payments to Pacira as outlined in Sections 5.2 and 5.3.1, Aratana will be entitled to retain its rights to the Licensed Product and can retain all amounts in excess of the amounts due Pacira hereunder.

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

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

5.6 Taxes; Withholding; Restrictions on Payment . Each Party shall pay the applicable taxes levied on all payments made to it under this Agreement. If provision is made in Law or regulation of any jurisdiction for withholding of taxes of any type, levies or other charges with respect to any amounts payable under this Agreement to the other Party, the paying Party

 

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

 

17


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

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

5.8 Records Retention; Review .

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

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

 

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

 

18


Pacira hereunder, then: (a) Aratana shall promptly pay Pacira the amount remaining to be paid for an underpayment or take a credit towards payment of royalties for the next calendar quarter for an overpayment, and (b) if there is an underpayment exceeding [ ***] percent ([ ***] %) of any such payment, Aratana shall pay all reasonable costs and expenses incurred by Pacira in connection with the review.

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

 

6. TREATMENT OF CONFIDENTIAL INFORMATION

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

6.2 Limited Disclosure and Use . Pacira and Aratana each agree that any disclosure of the other Party’s Confidential Information to any officer, employee, consultant or agent of the other Party or any of its Affiliates or Sublicensees shall be made only if and to the extent necessary to carry out its rights and responsibilities under this Agreement, shall be limited to the maximum extent possible consistent with such rights and responsibilities and shall only be made to the extent any such persons are bound by written confidentiality obligations to maintain the confidentiality thereof and not to use such Confidential Information except as expressly permitted by this Agreement. Pacira and Aratana each further agree not to disclose or transfer the other Party’s Confidential Information to any Third Parties under any circumstance without the prior written approval from the other Party (such approval not to be unreasonably withheld), except as otherwise required by applicable Law, and except as otherwise expressly permitted by this Agreement. Each Party shall take such action, and shall cause its Affiliates or Sublicensees to take such action, to preserve the confidentiality of each other’s Confidential Information as it would customarily take to preserve the confidentiality of its own Confidential

 

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

 

19


Information, using, in all such circumstances, not less than prudent and reasonable care. Each Party, upon the request of the other Party, will return all the Confidential Information disclosed or transferred to it by the other Party pursuant to this Agreement, including all copies and extracts of documents and all manifestations in whatever form, within [ ***] calendar days of such request or, if earlier, the termination or expiration of this Agreement; provided however, that a Party may retain (a) any Confidential Information of the other Party relating to any license which expressly survives such termination and (b) one (1) copy of all other Confidential Information in inactive archives solely for the purpose of establishing the contents thereof.

6.3 Public and Private Disclosure . Neither Party may publicly disclose the existence or terms or any other matter of fact regarding this Agreement and any ancillary agreements without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed; provided, however, that either Party may make such a disclosure and provide a copy of this Agreement and any ancillary agreements (a) to the extent required by applicable Law or by the requirements of any nationally recognized securities exchange, quotation system or over-the-counter market on which such Party has its securities listed or traded or (b) in the form of the press release attached hereto as Exhibit B. In the event that such disclosure is required as aforesaid, the disclosing Party shall make reasonable efforts to provide the other Party with notice beforehand and to coordinate with the other Party with respect to the wording and timing of any such disclosure. The Parties, upon the execution of this Agreement, will mutually agree to a press release with respect to this transaction for publication. Once such press release or any other written statement is approved for disclosure by both Parties, either Party may make subsequent public disclosure of the contents of such statement without the further approval of the other Party. Notwithstanding the foregoing, either Party may disclose to a Third Party the existence or terms or any other matter of fact regarding this Agreement and any ancillary agreements and provide a copy of this Agreement and any ancillary agreements without the prior written consent of the other Party: (i) pursuant to, and in accordance with, any existing contractual obligations with such party or (b) if such Third Party is an investor or a prospective investor, purchaser, partner, lender or other potential financing source (or a representative of any of the foregoing) who is obligated in writing to keep such information confidential.

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

 

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

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

 

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

 

20


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

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

7.4 Infringement of Patent Rights .

7.4.1 By Pacira . Pacira shall have the first right (but not the obligation), at its own expense, to bring suit (or take other appropriate legal action) against any actual, alleged or, based on the reasonable belief of Pacira, threatened infringement or misappropriation of the Licensed Patent Rights in the Territory in the Field, or to defend an action seeking declaratory judgment filed against Pacira with respect to the Licensed Patent Rights in the Territory in the Field. Pacira shall have sole control over the prosecution and settlement of such claims. Aratana shall have the right, at its own expense, to be represented in any such action by Pacira by counsel of Aratana’s own choice subject to approval by Pacira.

7.4.2 Infringement Suits Requested by Aratana . Aratana shall have the right to require Pacira to sue for infringement one alleged infringer under the Licensed Patent Rights in one country of the Territory. Pacira will choose such country at its sole discretion. Pacira will be under no obligation to bring any other suit in any other country in the Territory with regard to the requested infringer nor will it be obligated to bring a lawsuit against any other alleged infringer in the Territory requested by Aratana during the pendency of the first lawsuit brought by Pacira at Aratana’s request under this Section 7.4.2. Pacira shall have sole control over the initiation, conduct and settlement of such lawsuit. Aratana shall have the right, at its own expense, to be represented in any such action by Pacira by counsel of Aratana’s own choice subject to approval by Pacira.

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

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

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

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

 

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

 

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7.5 Defense of Claims .

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

7.5.2 Pacira shall have the first right (but not the obligation) to defend any Shared Infringement Claim. If Pacira determines to defend such Shared Product Infringement Claim, Pacira shall have sole control over the defense and settlement of such Shared Infringement Claims; provided , however , that Aratana shall be entitled in each instance to participate in an advisory capacity through counsel of its selection at its own expense. Aratana agrees to give Pacira reasonable assistance and authority to defend the suit. Any damages and costs (but exclusive of any related royalty payments which are the subject of Section 5.3.2) generated in the defense of such Shared Infringement Claims (other than costs and expenses incurred by Aratana from its participation in such claim pursuant to this Section 7.5.2 , which shall be borne solely by Aratana) shall be borne by Aratana and Pacira on a pro rata basis based on the aggregate net sales of the Licensed Product and EXPAREL ® in the applicable jurisdiction of the Territory for the twelve-month period ending on the date of filing of the Shared Infringement Claim.

 

8. REPRESENTATIONS, WARRANTIES AND COVENANTS

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

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

 

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

 

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

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

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

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

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

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

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

8.2.4 Aratana and its Affiliates shall launch the Licensed Product within [ ***] months of Regulatory Approval in the Primary Territory.

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

 

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

 

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

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

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

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

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

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

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

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

 

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

 

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

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

 

9. INDEMNIFICATION

9.1 Indemnification .

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

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

 

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

 

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

9.3 Insurance .

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

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

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

 

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

 

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

 

10. TERM AND TERMINATION

10.1 Term . This Agreement shall commence on the Effective Date and unless terminated earlier in accordance with the provisions hereof shall continue for a period of fifteen (15) years (“ Initial Term ”). Upon expiration, provided that Aratana is not in any material breach of its obligations or any condition, representation, warranty or covenant under this Agreement or the Supply Agreement, Aratana shall have the option to renew this Agreement (subject to the provisions of Section 10.2.6) for a single five (5) year term (the “ Renewal Term ”) upon written notice to Pacira no later than six (6) months prior to the end of the Initial Term. The Initial Term and the Renewal Term, if applicable, are referred to herein as the “ Term .”

10.2 Termination Rights.

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

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

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

10.2.4 Termination for Failure to Receive Regulatory Approval . Pacira may terminate this Agreement (i) with respect to the United States and each country in the European Union, on a county-by-country basis on thirty (30) calendar days’ written notice in the event Aratana does not obtain Regulatory Approval for the Licensed Product in such country

 

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

 

27


within [ ***] years of the Effective Date, or (ii) with respect to jurisdictions other than the United States and European Union (the “ Other Jurisdictions ”) on a country by country basis on thirty (30) calendar days’ written notice; if Aratana has not commenced Development and dosed its first patient/subject in support of obtaining Regulatory Approval for the Licensed Product in the Other Jurisdictions within [ ***] years of the Effective Date.

10.2.5 Termination for Failure to Achieve the First Commercial Sale Within Six (6) Months of Regulatory Approval. Pacira may terminate this Agreement on sixty (60) calendar days’ written notice to Aratana with respect to any jurisdiction in the Territory on a country by country basis in the event Aratana or its Sublicensee fails to achieve the First Commercial Sale of the Licensed Product within [ ***] months of receipt of Regulatory Approval in such jurisdiction.

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

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

10.2.8 Termination by Right . Following Generic Intrusion in the Territory by a Third Party, Aratana may terminate this Agreement on a country by country basis, as the intrusion in such country occurs, with ninety (90) calendar days’ written notice to Pacira.

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

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

 

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

 

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

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

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

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

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

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

 

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

 

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

10.5 Surviving Provisions . Other than Section 10.2 herein, notwithstanding any provision herein to the contrary, the rights and obligations of the Parties set forth in Sections 6, 7 and 9 as well as any rights or obligations otherwise accrued hereunder (including any accrued payment obligations), shall survive the expiration or termination of the Term. Without limiting the generality of the foregoing, Aratana shall have no obligation to make any milestone or royalty payment to Pacira that has not accrued prior to the effective date of any termination of this Agreement, but shall remain liable for all such payment obligations accruing prior to the effective date of such termination and any milestone payment which becomes due as a result of the sell-off period provided under Section 10.3.1 above.

 

11. DISPUTES

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

For Aratana:     Chief Executive Officer, or its designee

For Pacira:        Chief Executive Officer, or its designee

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

11.2 Arbitration . Subject to Section 11.1, any dispute, controversy or claim initiated by either Party arising out of, resulting from or relating to this Agreement, or the performance by either Party of its obligations under this Agreement (other than bona fide Third Party actions or proceedings filed or instituted in an action or proceeding by a Third Party against a Party), whether before or after termination of this Agreement, shall be finally resolved by binding arbitration. Whenever a Party shall decide to institute arbitration proceedings, it shall give written notice to that effect to the other Party. Any such arbitration shall be conducted under the Commercial Arbitration Rules of the American Arbitration Association by a panel of three arbitrators appointed in accordance with such rules with the arbitration taking place in New Jersey. The method and manner of discovery in any such arbitration proceeding shall be governed by the laws of the State of New Jersey. The arbitrators shall have the authority to grant injunctions and/or specific performance and to allocate between the parties the costs of arbitration in such equitable manner as they determine. Judgment upon the award so rendered may be entered in any court having jurisdiction or application may be made to such court for judicial acceptance of any award and an order of enforcement, as the case may be. In no event

 

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

 

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shall a demand for arbitration be made after the date when institution of a legal or equitable proceeding based upon such claim, dispute or other matter in question would be barred by the applicable statute of limitations. Notwithstanding the foregoing, either Party shall have the right, without waiving any right or remedy available to such Party under this Agreement or otherwise, to seek and obtain from any court of competent jurisdiction any interim or provisional relief that is necessary or desirable to protect the rights or property of such Party, pending the selection of the arbitrators hereunder or pending the arbitrators’ determination of any dispute, controversy or claim hereunder.

 

12. MISCELLANEOUS

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

 

  If to Pacira:  

Pacira Pharmaceuticals, Inc.

5 Sylvan Way

Parsippany, NJ 07054

Attn: David Stack, CEO

Facsimile No.: (XXX) XXX-XXXX

Telephone No.: (XXX) XXX-XXXX

Email: XXXXX

 
  With a copy to:  

Pacira Pharmaceuticals, Inc.

5 Sylvan Way

Parsippany, NJ 07054

Attn: Corporate Counsel

Facsimile No.: (973) 267-0050

Email: Contracts@Pacira.com

 
  If to Aratana:  

Aratana Therapeutics, Inc.

901 Olathe Blvd

Kansas City, KS 66103

ATTN: Steven St. Peter

Facsimile No.: (913) 904-9641

Telephone No.: (913) 951-2133

Email: sstpeter@aratanarx.com

 

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

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

 

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

 

31


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

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

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

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

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

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

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

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

12.11 Severability . If any provision(s) of this Agreement are or become invalid, are ruled illegal by any court of competent jurisdiction or are deemed unenforceable under then current applicable Law from time to time in effect during the License Term, it is the intention of the Parties that the remainder of this Agreement shall not be affected thereby

 

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

 

32


provided that a Party’s rights under this Agreement are not materially affected. The Parties hereto covenant and agree to renegotiate any such term, covenant or application thereof in good faith in order to provide a reasonably acceptable alternative to the term, covenant or condition of this Agreement or the application thereof that is invalid, illegal or unenforceable, it being the intent of the Parties that the basic purposes of this Agreement are to be effectuated.

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

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

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

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

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

[Remainder of page intentionally left blank]

 

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

 

33


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

 

PACIRA PHARMACEUTICALS, INC.:     ARATANA THERAPEUTICS, INC.:
By:  

/s/ David Stack

    By:  

/s/ Steven St. Peter

Name:   David Stack     Name:   Steven St. Peter
Title:   President, CEO     Title:   President
Date:   December 5, 2012     Date:   12/5/2012

 

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


SCHEDULE 1.35

LICENSED PATENTS

See attached

 

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


EXPAREL PATENTS

 

COUNTRY

  

SERIAL#

  

PATENT#

[ ***]

     

[***]

   [***]    [***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

     

[***]

   [***]    [***]

[ ***]

     

[***]

   [***]    [***]

[ ***]

     

[***]

   [***]    [***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]   

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]   

[ ***]

   [ ***]   

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

     

[***]

   [***]    [***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]   

[ ***]

   [ ***]   

[ ***]

   [ ***]   

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]   

[ ***]

   [ ***]    [ ***]

 

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

B-1


EXPAREL PATENTS

 

COUNTRY

  

SERIAL#

  

PATENT#

[***]

   [***]    [***]

[ ***]

     

[***]

   [***]    [***]

[ ***]

   [ ***]   

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]   

[ ***]

   [ ***]   

[ ***]

   [ ***]   

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]   

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

     

[***]

   [***]   

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]   

[ ***]

   [ ***]   

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]   

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[ ***]

   [ ***]    [ ***]

[***]

 

[***]

   [***]   

[ ***]

   [ ***]   
[ ***]      
Country   

Patent or

Publication

Number

  

 

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

B-2


EXPAREL PATENTS

 

COUNTRY

  

SERIAL#

  

PATENT#

[***]

   [***]   

[ ***]

   [ ***]   

[ ***]

   [ ***]   

[ ***]

   [ ***]   

[ ***]

   [ ***]   

[ ***]

   [ ***]   

[ ***]

   [ ***]   

[ ***]

   [ ***]   

[ ***]

   [ ***]   

[ ***]

   [ ***]   

 

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

B-3


SCHEDULE 1.36

LICENSED PRODUCT

DepoBupivacaine™ Extended Release Liposome Injection

 

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


EXHIBIT A

Form of Initial Supply Agreement

Incorporated by reference to Exhibit 10.25 to Aratana’s Registration Statement on Form S-1 filed with the Securities Exchange and Commission.

 

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

A-1


EXHIBIT B

Form of Press Release

FOR IMMEDIATE RELEASE

Pacira Pharmaceuticals, Inc. and Aratana Therapeutics Inc. Enter into Global Licensing Agreement for Development and Commercialization of Bupivacaine Liposome Injectable Suspension for Animal Health Indications

PARSIPPANY, N.J. and KANSAS CITY, Kan., December 6, 2012 — Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) and Aratana Therapeutics Inc. today announced a global licensing agreement for the development and commercialization of bupivacaine liposome injectable suspension for animal health indications. Under the agreement, Aratana will develop and seek approval for the use of the product in veterinary surgery to manage postsurgical pain, focusing initially on developing the product for cats, dogs and other companion animals.

Bupivacaine liposome injectable suspension is approved for human use in the United States for the management of postsurgical pain and is currently marketed by Pacira under the name EXPAREL ® . EXPAREL is a non-opioid local anesthetic, which was approved by the U.S. Food and Drug Administration (FDA) in October 2011 for administration into the surgical site to produce postsurgical analgesia. EXPAREL utilizes DepoFoam ® , a proprietary delivery technology utilized in several Pacira products approved for human use. Veterinary development of the product may address the estimated 33 million surgical procedures performed each year on companion animals in the U.S.(1)

Steven St. Peter, M.D., chief executive officer of Aratana Therapeutics, stated, “Given the rapid and widespread implementation of EXPAREL by surgeons performing human procedures, we are confident that adoption of this innovative product by veterinary surgeons will be equally impressive. The global companion animal health market remains significantly underserved despite the more than 150 million companion animals in the U.S.(2) — many of whom will undergo surgical procedures. We believe this product fits nicely into our growing portfolio of companion animal therapeutics and will be welcomed by veterinarians committed to providing their patients with the best care available.”

“The management of postsurgical pain in animal health settings represents a large and growing market for our EXPAREL product,” said David Stack, president and chief executive officer of Pacira. “We continue to see EXPAREL adoption in a wide range of surgical settings, the generation of positive Phase 4 data and considerable sales growth during our launch year. We also have recently completed the installation of our expanded manufacturing suite — these milestones all strongly position the program for a strategic partnership. Given the Aratana team’s combined decades of veterinary drug development experience, we believe Aratana is the ideal partner for maximizing the product’s value in the companion animal health market.”

Under the agreement, Aratana made a one-time payment to Pacira of $1 million and will pay additional development and commercial milestones totaling up to $42.5 million. In addition, upon approval of the product by the FDA, Aratana will pay Pacira a double-digit royalty on net sales of the product. Should Aratana sublicense the product to a third party, Aratana and Pacira will share the proceeds by a predetermined formula (after Aratana has recovered certain direct development costs). Pacira will be responsible for all product manufacturing, and Pacira and Aratana will form a joint committee to oversee commercialization and development activities.

About Pacira

Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) is an emerging specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company’s current emphasis is the development of non-opioid products for postsurgical pain control, and its lead product, EXPAREL ® (bupivacaine liposome injectable suspension), was commercially launched in the United States in April 2012. EXPAREL and two other products have utilized the Pacira proprietary product delivery technology DepoFoam ® , a unique platform that encapsulates drugs without altering their molecular structure and then releases them over a desired period of time. Additional information about Pacira is available at http://www.pacira.com.

 

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

B-1


About Aratana Therapeutics

Aratana Therapeutics is a biopharmaceutical company positioned to deliver high quality new medicines that address significant therapeutic needs for cats and dogs (companion animals). Aratana licenses and develops proprietary, patent-protected compounds acquired from human pharmaceutical and biotechnology companies and then maximizes the value of the programs for the animal health market. For more information, please visit www.aratanatherapeutics.com.

Forward Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements about our plans to develop and commercialize a bupivacaine liposome injectable suspension product for animal health indications, the size of the market for such a product and the level and rate of adoption for such a product and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the attainment of all necessary regulatory approvals for the marketing of any product developed under the Aratana license agreement; the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and our ability to serve those markets; our commercialization and marketing capabilities; and other factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2011, our most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

For Pacira Pharmaceuticals, Inc.

James S. Scibetta, 973-254-3570

or

Media Contact:

Pure Communications, Inc.

Susan Heins, 864-286-9597

For Aratana Therapeutics Inc.

Investors & Media:

Joshua Drumm, Ph.D. / Andrew Mielach

Tiberend Strategic Advisors, Inc.

(212) 827-0020

jdrumm@tiberend.com

amielach@tiberend.com

 

(1) Small Animal and Equine Veterinary Surveys Regarding Surgical Procedures and Local Anesthetic Use (2008). Brakke Consulting, Inc., Dallas, TX. Prepared for Pacira Pharmaceuticals, Inc.
(2) American Veterinary Medical Association (2011). www.avma.org
* EXPAREL is a registered trademark of Pacira Pharmaceuticals, Inc.

 

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

B-2

Exhibit 10.25

EXECUTION DRAFT

PACIRA PHARMACEUTICALS, INC.

and

ARATANA THERAPEUTICS, INC.

 

 

SUPPLY AGREEMENT

 

 

DATED AS OF DECEMBER 5, 2012

 

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


EXECUTION DRAFT

THIS SUPPLY AGREEMENT (this “ Agreement ”) is made effective as of December 5, 2012 (the “ Effective Date ”) by and between Pacira Pharmaceuticals, Inc. , a California corporation with a principal place of business at 5 Sylvan Way, Parsippany, New Jersey 07054 (“ Pacira ”) and Aratana Therapeutics, Inc. , a Delaware corporation with a place of business at 1901 Olathe Blvd, Kansas City, Kansas 66103 (“ Aratana ”). Pacira and Aratana are each hereafter referred to individually as a “ Party ” and together as the “ Parties .” Capitalized terms used herein and not otherwise defined herein shall have the meanings set forth in Section 1.

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

WHEREAS , Pacira and Aratana have agreed that Pacira shall be the exclusive supplier of the Licensed Product to Aratana pursuant to the terms of this Agreement; and

WHEREAS , this Agreement constitutes the “Initial Supply Agreement” as contemplated by the License Agreement.

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

 

1. DEFINITIONS

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

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

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

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

 

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


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

1.6. “ Bulk Product ” shall mean Licensed Product presented in [ ***] Vials or 20ml Vials, as applicable, without commercial label and packaging.

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

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

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

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

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

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

 

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

2


1.13. “ Contract Quarter ” shall mean the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31, for so long as this Agreement is in effect.

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

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

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

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

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

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

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

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

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

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

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

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

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

 

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

3


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

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

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

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

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

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

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

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

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

1.36. “ Product Price ” shall mean either (a) [ ***] Dollars ($[ ***] ) per 20ml Vial of Bulk Product or (b) [ ***] Dollars ($[ ***] ) per [ ***] Vial of Bulk Product, in each case, as each may adjusted from time to time pursuant to Section 5.1.

1.37. “ Quality Agreement ” shall mean an agreement to be entered into pursuant to Section 6.1, which provides the responsibilities of the Parties related to the quality and regulatory requirements of the Bulk Product manufactured under this Agreement.

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

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

(b) the Bulk Product as necessary for Release.

1.39. “ Regulatory Approval ” shall mean any and all approvals or authorizations of any kind of any Regulatory Authority required prior to any commercial marketing, sale, or use of the Licensed Product in any country or jurisdiction in the Territory for a particular indication

 

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

4


within the Field. For clarity, Regulatory Approval: (i) in the United States shall consist of the approval by the FDA of the Administrative NADA; and (ii) shall not include any approvals, licenses, registrations or authorizations necessary for the manufacture or supply of the Licensed Product, or any component thereof, by Pacira to Aratana or its Affiliates or Sublicensees.

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

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

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

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

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

1.45. “ Territory ” shall mean worldwide.

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

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

In this Agreement, unless the context requires otherwise:

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

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

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

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

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

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

 

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

5


2. SUPPLY OF BULK PRODUCT

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

2.2. Pacira shall supply Bulk Product under this Agreement, in (a) 20ml Vials or (b) solely at such times as when [ ***] Vials are being manufactured for commercial sale in Pacira’s human health program for EXPAREL ® , [ ***] Vials. Each of which 20ml Vials and [ ***] Vials shall thereafter be labeled, packaged or otherwise prepared for commercial sale by Aratana. Aratana shall be solely responsible, at its sole cost and expense, for all labeling, packaging and shipping of Bulk Product in accordance with applicable Law and utilizing such branding, trade names and trade dress selected by Aratana and approved by the JCCC. Aratana shall not materially alter any Bulk Product as supplied to Aratana by Pacira (other than to label, package and otherwise prepare the Bulk Product for commercial sale as set forth above) and shall only resell such Bulk Product in accordance with this Agreement, the License Agreement and applicable Law.

2.3. Pacira shall give Aratana reasonable notice of any proposal to appoint a Third Party Manufacturer and shall satisfy all legal and regulatory requirements relating to any variation of the Administrative NADA or any other Regulatory Approval relating to such appointment at its own cost and shall procure reasonable inspection and audit rights for Aratana in respect of the Third Party Manufacturer’s site.

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

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

 

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

6


3. FORECASTING AND ORDERING

3.1. Forecasts. Not less than [ ***] days prior to the anticipated initial launch date of the Licensed Product, and on the [ ***] day prior to the first Business Day of each Contract Quarter occurring during the Term thereafter (each, a “ Forecast Delivery Date ”), Aratana shall provide to Pacira a rolling forecast in the format attached hereto as Appendix II, as such format may be reasonably modified from time to time by Pacira (a “ Rolling Forecast ”), of estimated quantities and anticipated Product Delivery Dates of units of Bulk Product in each case, for each month of the [ ***] successive Contract Quarters following such Forecast Delivery Date (without regard to potential expiration or termination of this Agreement). Absent earlier expiration or termination of this Agreement, the forecast for the first [ ***] months in each Rolling Forecast shall constitute a binding commitment by Aratana to place additional Purchase Orders pursuant to Section 3.2 that, when taken together with any Purchase Orders submitted up to such date by Aratana with respect to such period, shall be consistent with such Rolling Forecast, but in no event represent less than [ ***] percent ([ ***] %) of the amount of Bulk Product specified in such Rolling Forecast. Unless otherwise agreed by Pacira, the forecast with respect to any Contract Quarter in the Rolling Forecast shall not exceed [ ***] percent ([ ***] %) of the forecast for the immediately preceding Contract Quarter in such Rolling Forecast and Pacira agrees to supply to Aratana at least the following quantities of Bulk Product specified in the binding portion of such Rolling Forecast as provided in Sections 3.2(b) and 4.1:

 

Applicable Quarter after initial launch

of the Licensed Product by Aratana

   Committed Quantity of Bulk
Product to  be supplied by Pacira

1st Contract Quarter

   [ ***] %

2nd Contract Quarter

   [ ***] %

3rd Contract Quarter

   [ ***] %

4th Contract Quarter

   [ ***] %

5th Contract Quarter

   [ ***] %

6th Contract Quarter

   [ ***] %

7th Contract Quarter and thereafter

   [ ***] %

Notwithstanding the foregoing, Pacira shall only be entitled to supply less than [ ***] % of the amount of Bulk Product specified in the binding portion of a Rolling Forecast (or such lesser amount as may be specified in the applicable Purchase Order for such period in accordance with this Section 3.1) pursuant to the table above in the event that it determines in good faith that it is no longer commercially reasonable to supply in excess of the reduced amounts set forth in such table in light of its own supply demands for Bulk Product for its human health program for EXPAREL ® .

 

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

7


3.2. Purchase Orders .

(a) Not less than [ ***] days prior to the anticipated initial launch date of the Licensed Product, Aratana shall place with Pacira an irrevocable order (the “ Initial Purchase Order ”) for Bulk Product sufficient to meet Aratana’s projected requirements of Licensed Product in the first Contract Quarter of the Rolling Forecast. The Initial Purchase Order shall separately specify desired delivery dates for the first Contract Quarter Bulk Product. Thereafter, in accordance with the terms hereunder, Aratana shall place irrevocable orders (each, including the Initial Purchase Order, a “ Purchase Order ”) for Bulk Product with Pacira in writing. Each Purchase Order shall be in a format requested by Pacira, specifying the quantities thereof desired and applicable Product Delivery Dates, said Product Delivery Dates to be no earlier than [ ***]  calendar days after delivery of such Purchase Order. All Purchase Orders shall be sent by Aratana to the following address, which may be updated from time to time by Pacira upon notice to Aratana:

Pacira Pharmaceuticals, Inc.

10450 Science Center Drive

San Diego, CA 92121

Attention: Purchasing Manager

Telephone: [To be provided]

E-mail: [To be provided]

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

(c) Aratana shall purchase Bulk Product from Pacira in full lot quantities, consistent with Pacira’s standard minimum batch sizes, currently estimated to be not more than [ ***] 20ml Vials or [ ***] Vials (each such lot quantity, a “ Lot ”) or such other quantities as may permitted by Pacira.

 

4. DELIVERY, TITLE AND ACCEPTANCE

4.1. Delivery. Pacira shall supply all Bulk Product Ex Works (as defined in Incoterms 2010) the Approved Facilities. Pacira shall use its commercially reasonable efforts to Deliver to Aratana each of Aratana’s orders for Bulk Product on the applicable Delivery Date specified in each Purchase Order. If Pacira becomes aware that for any reason it will be unable to Deliver ordered Bulk Product on the specified Delivery Date, Pacira shall promptly advise Aratana of that fact, the reason for the delay and (if appropriate) give its reasonable, good faith estimate of the likely delayed Delivery Date. Pacira shall use its commercially reasonable efforts to minimize the delay. Pacira shall submit to Aratana with each Lot of Bulk Product Delivered by

 

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

8


Pacira a Certificate of Analysis setting out the results of the analysis of that Lot of Bulk Product and confirming that the Lot is manufactured in conformity with the Specification and cGMP. With the initial shipment of Bulk Product and annually thereafter, Pacira shall provide Aratana with a Certificate of Compliance. On Delivery, Bulk Product shall have a remaining shelf-life of at least [ ***] months; provided, that, in the event Pacira proposes to deliver to Aratana Bulk Product with a remaining expiry of less than [ ***] months, Pacira shall notify Aratana, and the Parties shall discuss in good faith such reasonable steps as may be implemented by Aratana to accommodate Aratana’s distribution of such Bulk Product (in finished form) so as not to render such Bulk Product non-saleable, it being understood that Aratana shall not be obligated to accept delivery of Bulk Product with a remaining expiry of less than [ ***] months.

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

4.3. Receipt of Product; Acceptance .

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

(b) Whether or not Pacira accepts Aratana’s assertion of nonconformity or noncompliance, promptly upon receipt of a notice of rejection, Pacira shall use commercially reasonable efforts to provide replacement Bulk Product for the quantity of Bulk Product rejected by Aratana in the original shipment as soon as reasonably possible but no later than [ ***] days after the date of receipt of the notice of rejection. Aratana shall remain responsible for the

 

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

9


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

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

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

 

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

10


5. PRICING AND PAYMENT

5.1. Pricing. During the Term, the purchase price for the supply of Bulk Product sold to Aratana shall be the applicable Product Price then in effect. As of the Effective Date, the Product Price shall be either (a) [ ***] Dollars ($[ ***] ) per 20ml Vial of Bulk Product or (b) [ ***] Dollars $[ ***] per [ ***] Vial of Bulk Product, as applicable. Pacira shall review the Product Price annually and may increase the Product Price based upon inflation and any increases in the cost of manufacture (including the cost of raw materials) of the Licensed Product; provided, however, that notwithstanding the foregoing, in no event shall any annual increase to the Product Price due solely to inflation exceed the percentage change in the Producer Price Index (Commodities) for Chemicals and Allied Products—Drugs and Pharmaceuticals (as published by the Bureau of Labor Statistics) over the preceding one (1) year period. Notice of any price increases shall be provided to Aratana [ ***] days prior to the end of each calendar year during the Term with such increases becoming effective as of the first day the next calendar year.

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

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

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

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

 

6. MANUFACTURE

6.1. Manufacture . During the Term, and subject to the provisions of this Section 6, Pacira shall manufacture and supply Bulk Product in accordance with: (a) this Agreement; (b) the applicable Specification; (c) the applicable NADA; (d) cGMP requirements; (e) the Quality Agreement; and (f) all other applicable Law. The Parties will negotiate in good faith and enter into a Quality Agreement as soon as reasonably practicable and no later than [ ***] days after the Effective Date. Notwithstanding the foregoing or any other provision of this Agreement, nothing set forth in this Agreement shall prohibit Pacira from: (i) effecting any change, modification or alteration to the manufacturing processes related to the manufacture of the Licensed Product (a “ Change to Process ”); (ii) relocating or shutting down the then

 

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

11


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

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

6.3. Changes Affecting Manufacture .

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

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

 

7. WARRANTIES

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

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

 

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

12


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

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

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

7.2. R epresentations and Warranties of Pacira . Pacira represents and warrants that:

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

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

PACIRA MAKES NO WARRANTIES, EXPRESS OR IMPLIED, OTHER THAN THOSE EXPRESSLY MADE HEREIN WITH RESPECT TO THE LICENSED PRODUCT. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, SATISFACTORY QUALITY AND FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY DISCLAIMED BY PACIRA.

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

(a) Regulatory Compliance . (i) Aratana has obtained or will obtain, and at all times during the term of this Agreement as shall be required under applicable Law shall maintain, any and all Regulatory Approvals necessary for Aratana to Commercialize the Licensed Product under the License Agreement and (ii) all Labeling (as defined below) copy and artwork approved, designated or utilized by or on behalf of Aratana will be in compliance with applicable Law.

 

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

13


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

 

8. APPROVALS, AUDITS AND INSPECTIONS

8.1. Aratana (or its representatives) shall be entitled, but in any event no more than [ ***] in any twelve (12) month period during the Term, to access records related solely to the manufacture of the Bulk Product and those portions, and only those portions, of the Approved Facilities where the Bulk Product is manufactured, in the company of a representative of Pacira as is reasonably necessary to review and audit such records and portions of the Approved Facilities or the manufacture of the Bulk Product. Such inspection shall be conducted upon reasonable prior notice by Aratana, but not less than [ ***] days prior to the proposed inspection, during normal business hours and at the specific time and date mutually agreed to by the Parties. Any information, data, technology or other materials accessed by or provided to Aratana or any of its representatives in connection with any such inspection shall be deemed Know-How (as defined in the License Agreement) of Pacira in which Pacira retains all right, title and interest, subject to the obligations contained in, and any use, as may be permitted under the License Agreement with respect thereto.

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

 

9. PROJECT MANAGEMENT

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

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

 

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

14


10. TERM AND TERMINATION

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

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

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

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

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

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

10.3. Consequences of Termination .

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

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

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

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

 

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

15


(e) After the expiration or termination of this Agreement, Aratana shall be responsible, at its own expense, for manufacturing its requirements of Bulk Product.

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

 

11. ASSIGNMENT AND SUB-CONTRACTING

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

 

12. CONFIDENTIALITY

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

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

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

 

13. FORCE MAJEURE

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

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

 

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

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14. DISPUTES

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

For Aratana: Chief Executive Officer, or its designee

For Pacira: Chief Executive Officer, or its designee

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

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

 

15. INDEMNIFICATION.

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

 

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

17


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

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

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

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

 

16. RECALLS.

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

 

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

18


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

 

17. GENERAL PROVISIONS

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

 

 

If to Pacira:

   Pacira Pharmaceuticals, Inc.,   
     5 Sylvan Way   
     Parsippany, NJ 07054   
     Attention: David Stack, CEO   
     Facsimile No.: (XXX) XXX-XXXX   
     Telephone No.: (XXX) XXX-XXXX   
     Email: XXXXX   
       
 

With a copy to:

   Pacira Pharmaceuticals, Inc.   
     5 Sylvan Way   
     Parsippany, NJ 07054   
     Attention: Corporate Counsel   
     Facsimile No.: (973) 267-0050   
     Email: Contracts@Pacira.com   
       
  If to Aratana:    Aratana Therapeutics, Inc.   
     1901 Olathe Blvd   
     Kansas City, KS 66103   
     Attention: Steven St. Peter   
     Facsimile No.: (913) 904-9641   
     Telephone No.: (913) 951-2133   
     Email: sstpeter@aratanarx.com   

 

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

19


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

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

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

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

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

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

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

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

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

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

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

 

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

20


agree to renegotiate any such term, covenant or application thereof in good faith in order to provide a reasonably acceptable alternative to the term, covenant or condition of this Agreement or the application thereof that is invalid, illegal or unenforceable, it being the intent of the Parties that the basic purposes of this Agreement are to be effectuated.

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

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

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

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

 

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

21


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

 

PACIRA PHARMACEUTICALS, INC.:     ARATANA THERAPEUTICS, INC.:
By:   /s/ David Stack     By:   /s/ Steven St. Peter
Name:   David Stack     Name:   Steven St. Peter
Title:   President, CEO     Title:   President
Date:   December 5, 2012     Date:   12/5/2012

 

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


APPENDIX I

SPECIFICATION

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

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

 

 

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

 

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


APPENDIX II

FORM OF FORECAST

[ARATANA LETTERHEAD]

 

[DATE]    Direct Telephone: [  l  ]
   E-mail: [  l  ]
  
  

Pacira Pharmaceuticals

10450 Science Center Drive

San Diego, CA 92121

Attention: [  l  ]

Re: Aratana Item #[  l  ] unlabeled DepoBupivacaine™ Extended Release Liposome Injection ®

Dear [  l  ]:

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

[*THE FOLLOWING INFORMATION IS PROVIDED

FOR ILLUSTRATIVE PURPOSES ONLY]

 

                                                                           
Quarter:   

1Q13

  

2Q13

  

3Q13

  

4Q13

Quantity:

   [ ***]    [ ***]    [ ***]    [ ***]

Delivery:

   [ ***]    [ ***]    [ ***]    [ ***]

Note: Purchased lot size is [ ***] vials.

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

If you have any questions, please do not hesitate to contact me at your earliest convenience.

Sincerely,

 

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