As filed with the Securities and Exchange Commission on June 17, 2014

Registration No. 333-196081

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

Amendment No. 2

to

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

 

 

Kite Pharma, Inc.

(Exact Name of Registrant as Specified in Its Charter)

 

 

 

Delaware   2836   27-1524986

(State or Other Jurisdiction of

Incorporation or Organization)

 

(Primary Standard Industrial

Classification Code Number)

 

(I.R.S. Employer

Identification Number)

2225 Colorado Avenue

Santa Monica, California 90404

(310) 824-9999

(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)

 

 

Arie S. Belldegrun, M.D.

President, Chief Executive Officer, Chairman, Founder

Kite Pharma, Inc.

2225 Colorado Avenue

Santa Monica, California 90404

(310) 824-9999

(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent for Service)

Copies to:

 

Frederick T. Muto, Esq.

Charles S. Kim, Esq.

Charles J. Bair, Esq.

Cooley LLP

1333 2nd Street, Suite 400

Santa Monica, California 90401

(310) 883-6400

 

Donald J. Murray, Esq.

Covington & Burling LLP

The New York Times Building

620 Eighth Avenue

New York, New York 10018

(212) 841-1000

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement.

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 that 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 Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.


EXPLANATORY NOTE

This Amendment No. 2 (“Amendment No. 2”) to the Registration Statement on Form S-1 (File No. 333-196081) of Kite Pharma, Inc. (“Registration Statement”) is being filed soley for the purpose of filing certain exhibits as indicated in Part II of this Amendment No. 2. This Amendment No. 2 does not modify any provisions of the prospectus that forms a part of the Registration Statement. Accordingly, a preliminary prospectus has been omitted.


PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 13. Other Expenses of Issuance and Distribution.

The following table sets forth all costs and expenses, other than underwriting discounts and commissions, payable by Kite Pharma, Inc. (the “Registrant”) in connection with the sale of the common stock being registered. All amounts shown are estimates except for the Securities and Exchange Commission (“SEC”) registration fee, the Financial Industry Regulatory Authority, Inc. (“FINRA”) filing fee and The NASDAQ Global Market listing fee.

 

 

 

     AMOUNT TO BE PAID  

SEC registration fee

   $ 14,812   

FINRA filing fee

     17,750   

NASDAQ Global Market filing fee

     150,000   

Printing and engraving expenses

     225,000   

Legal fees and expenses

     1,300,000   

Accounting fees and expenses

     250,000   

Transfer agent and registrar fees and expenses

     7,900   

Miscellaneous expenses

     134,358   
  

 

 

 

Total

   $ 2,100,000   
  

 

 

 

 

 

Item 14. Indemnification of Directors and Officers.

The Registrant is incorporated under the laws of the State of Delaware. Section 145 of the Delaware General Corporation Law provides that a Delaware corporation may indemnify any persons who were, are, or are threatened to be made, parties to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of such corporation), by reason of the fact that such person is or was an officer, director, employee or agent of such corporation, or is or was serving at the request of such corporation as an officer, director, employee or agent of another corporation or enterprise. The indemnity may include expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such action, suit or proceeding, provided that such person acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the corporation’s best interests and, with respect to any criminal action or proceeding, had no reasonable cause to believe that his or her conduct was illegal. A Delaware corporation may indemnify any persons who were, are, or are threatened to be made, a party to any threatened, pending or completed action or suit by or in the right of the corporation by reason of the fact that such person is or was a director, officer, employee or agent of such corporation, or is or was serving at the request of such corporation as a director, officer, employee or agent of another corporation or enterprise. The indemnity may include expenses (including attorneys’ fees) actually and reasonably incurred by such person in connection with the defense or settlement of such action or suit provided such person acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the corporation’s best interests except that no indemnification is permitted without judicial approval if the officer or director is adjudged to be liable to the corporation. Where an officer or director is successful on the merits or otherwise in the defense of any action referred to above, the corporation must indemnify him or her against the expenses (including attorneys’ fees) actually and reasonably incurred.

The Registrant’s amended and restated certificate of incorporation provides for the indemnification of its directors to the fullest extent permitted under the Delaware General Corporation Law. The Registrant’s amended and restated bylaws provide for the indemnification of its directors and officers to the fullest extent permitted under the Delaware General Corporation Law. Each of the Registrant’s amended and restated certificate of incorporation and amended and restated bylaws will become effective upon the closing of this offering.

 

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Section 102(b)(7) of the Delaware General Corporation Law permits a corporation to provide in its certificate of incorporation that a director of the corporation shall not be personally liable to the corporation or its stockholders for monetary damages for breach of fiduciary duties as a director, except for liability for any:

 

   

transaction from which the director derives an improper personal benefit;

 

   

act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;

 

   

unlawful payment of dividends or redemption of shares; or

 

   

breach of a director’s duty of loyalty to the corporation or its stockholders.

The Registrant’s amended and restated certificate of incorporation includes such a provision. Under the Registrant’s amended and restated bylaws, expenses incurred by any director or officers in defending any such action, suit or proceeding in advance of its final disposition shall be paid by the Registrant upon delivery to it of an undertaking, by or on behalf of such director or officer, to repay all amounts so advanced if it shall ultimately be determined that such director or officer is not entitled to be indemnified by the Registrant, as long as such undertaking remains required by the Delaware General Corporation Law.

Section 174 of the Delaware General Corporation Law provides, among other things, that a director who willfully or negligently approves of an unlawful payment of dividends or an unlawful stock purchase or redemption, may be held liable for such actions. A director who was either absent when the unlawful actions were approved or dissented at the time may avoid liability by causing his or her dissent to such actions to be entered in the books containing minutes of the meetings of the board of directors at the time such action occurred or immediately after such absent director receives notice of the unlawful acts.

As permitted by the Delaware General Corporation Law, the Registrant has entered into indemnity agreements with each of its directors and officers, that require the Registrant to indemnify such persons against any and all costs and expenses (including attorneys’, witness or other professional fees) actually and reasonably incurred by such persons in connection with any action, suit or proceeding (including derivative actions), whether actual or threatened, to which any such person may be made a party by reason of the fact that such person is or was a director or officer or is or was acting or serving as an officer, director, employee or agent of the Registrant or any of its affiliated enterprises. Under these agreements, the Registrant is not required to provide indemnification for certain matters, including:

 

   

indemnification beyond that permitted by the Delaware General Corporation Law;

 

   

indemnification for any proceeding with respect to the unlawful payment of remuneration to the director or officer;

 

   

indemnification for certain proceedings involving a final judgment that the director or officer is required to disgorge profits from the purchase or sale of the Registrant’s stock;

 

   

indemnification for proceedings involving a final judgment that the director’s or officer’s conduct was in bad faith, knowingly fraudulent or deliberately dishonest or constituted willful misconduct (but only to the extent of such specific determination) or a breach of his or her duty of loyalty or resulting in any personal profit or advantage to which the director or officer is not legally entitled;

 

   

indemnification for proceedings or claims brought by an officer or director against the Registrant or any of the Registrant’s directors, officers, employees or agents, except for (i) claims to establish or enforce a right of indemnification, (ii) claims approved by the Registrant’s board of directors, or (iii) claims required by law;

 

   

indemnification for settlements the director or officer enters into without the Registrant’s consent; or

 

   

indemnification in violation of any undertaking required by the Securities Act of 1933, as amended (the “Securities Act”) or in any registration statement filed by the Registrant.

The indemnification agreements also set forth certain procedures that will apply in the event of a claim for indemnification thereunder.

There is at present no pending litigation or proceeding involving any of the Registrant’s directors or executive officers as to which indemnification is required or permitted, and the Registrant is not aware of any threatened litigation or proceeding that may result in a claim for indemnification.

 

II-2


The Registrant has an insurance policy in place that covers its officers and directors with respect to certain liabilities, including liabilities arising under the Securities Act or otherwise.

The Registrant plans to enter into an underwriting agreement which provides that the underwriters are obligated, under some circumstances, to indemnify the Registrant’s directors, officers and controlling persons against specified liabilities, including liabilities under the Securities Act.

Item 15. Recent Sales of Unregistered Securities.

The following sets forth information regarding all unregistered securities sold by the Registrant since January 1, 2011:

 

  (1) In February 2011 and March 2011, the Registrant issued and sold to investors convertible promissory notes in the aggregate principal amount of $15.0 million, which notes bore no interest per annum. These notes converted into 9,522,672 shares of the Registrant’s Series A convertible preferred stock in May 2013 at a 15% discount to the Series A convertible preferred stock purchase price as described in paragraph (4) below.

 

  (2) In February 2011, the Registrant issued 27,400 shares to the Regents of the University of California (the “Regents”) in connection with entering into a license agreement with the Regents.

 

  (3) In November 2012, the Registrant issued and sold to an investor a convertible promissory note in the principal amount of $250,000, which note bore interest at the rate of 4.0% per annum. This note, including accrued interest of $4,411, converted into 137,289 shares of the Registrant’s Series A convertible preferred stock in May 2013 at a price equal to the Series A preferred stock purchase price as described in paragraph (4) below.

 

  (4) In May 2013, pursuant to a Series A convertible preferred stock purchase agreement, the Registrant issued an aggregate of 20,315,397 shares of its Series A convertible preferred stock. The Registrant received net proceeds of $19.6 million including the note and accrued interest referred to in paragraph (3) above, for which it issued 10,655,436 shares of Series A convertible preferred stock, at a purchase price of $1.8531 per share. In addition, the aggregate principal amount of $15.0 million of convertible notes referred to in paragraph (1) above converted into 9,522,672 shares of Series A convertible preferred stock at a conversion price equal to $1.5751, representing a 15% discount to the purchase price, and the note referred to in paragraph (3) above converted into 137,289 shares of Series A convertible preferred stock at a conversion price of $1.8531.

 

  (5) In May 2013, the Registrant issued warrants to purchase 159,049 shares of its common stock, with an exercise price of $1.73 per share.

 

  (6) In April 2014, the Registrant issued and sold to investors convertible promissory notes in the aggregate principal amount of $50.0 million. In connection with the completion of the Registrant’s initial public offering, the principal amount of the convertible promissory notes and accrued interest thereon will automatically convert into 4,316,349 shares of the Registrant’s common stock, assuming an initial public offering price of $13.00 per share and a conversion date of June 25, 2014.

 

  (7) From January 1, 2011 to June 11, 2014, the Registrant granted stock options under its 2014 equity incentive plan, as amended (the “EIP”), to purchase up to an aggregate of 6,637,280 shares of its common stock to its employees, directors and consultants, at a weighted-average exercise price of $1.80 per share. 91,666 shares of common stock were issued in July 2012 upon the exercise of options issued prior to January 1, 2011 and the payment of $4,583 to the Registrant was made. 7,500 shares of common stock were issued in November 2013 upon the exercise of options granted prior to January 1, 2011 and the payment of $375 to the Registrant was made. 2,702,695 shares of common stock were issued in April 2014 upon the exercise of options granted to certain officers of the Registrant and the payment of $2,966,138 to the Registrant was made. 49,792 shares of common stock were issued in May 2014 upon the exercise of options, 7,500 of which were granted prior to January 1, 2011, and the payment of $16,446 to the Registrant was made. 5,000 shares of common stock were issued on June 6, 2014 upon the exercise of options and the payment of $1,900 to the Registrant was made. No other options have been exercised through June 10, 2014.

The offers, sales and issuances of the securities described in paragraphs (1) through (6) above were deemed to be exempt from registration under the Securities Act in reliance on Section 4(2) of the Securities Act and Rule 506

 

II-3


promulgated under Regulation D promulgated thereunder as transactions by an issuer not involving a public offering. The recipients of securities in each of these transactions acquired the securities for investment only and not with a view to or for sale in connection with any distribution thereof and appropriate legends were affixed to the securities issued in these transactions. Each of the recipients of securities in these transactions was an accredited investor within the meaning of Rule 501 of Regulation D under the Securities Act and had adequate access, through employment, business or other relationships, to information about the Registrant. No underwriters were involved in these transactions.

The offers, sales and issuances of the securities described in paragraph (7) above were deemed to be exempt from registration under the Securities Act in reliance on Rule 701 in that the transactions were under compensatory benefit plans and contracts relating to compensation as provided under Rule 701. The recipients of such securities were employees, directors or bona fide consultants of the Registrant and received the securities under the Registrant’s EIP. Appropriate legends were affixed to the securities issued in these transactions. Each of the recipients of securities in these transactions had adequate access, through employment, business or other relationships, to information about the Registrant.

 

II-4


Item 16. Exhibits and Financial Statement Schedules.

(a) Exhibits.

 

 

 

EXHIBIT
NUMBER

 

DESCRIPTION OF DOCUMENT

  1.1   Form of Underwriting Agreement.
  3.1#   Amended and Restated Certificate of Incorporation, as amended and as currently in effect.
  3.2#   Certificate of Designation of Convertible Preferred Stock to be Designated as Series A Convertible Preferred Stock, as filed with the Secretary of State of Delaware on May 10, 2013.
  3.3#   Form of Amended and Restated Certificate of Incorporation to become effective upon closing of this offering.
  3.4#   Bylaws, as currently in effect.
  3.5#   Form of Amended and Restated Bylaws to become effective upon closing of this offering.
  4.1#   Form of Common Stock Certificate of the Registrant.
  4.2#   Amended and Restated Investors’ Rights Agreement by and among the Registrant and certain of its stockholders, dated April 25, 2014.
  5.1#   Opinion of Cooley LLP.
10.1+#   Form of Indemnity Agreement by and between the Registrant and its directors and officers.
10.2+#   Kite Pharma, Inc. 2014 Equity Incentive Plan and Form of Stock Option Agreement, Notice of Exercise and Stock Option Grant Notice thereunder, and amendments thereto.
10.3+#   Kite Pharma, Inc. Non-Employee Director Compensation Policy.
10.4+#   Employment Letter Agreement by and between the Registrant and Rizwana F. Sproule, Ph.D., dated November 12, 2012.
10.5+#   Employment Letter Agreement by and between the Registrant and Marc Better, Ph.D., dated December 17, 2012.
10.6+#   Employment Letter Agreement by and between the Registrant and Keith Nolop, M.D., dated May 8, 2013.
10.7#   Severance Agreement by and between the Registrant and Keith Nolop, M.D., dated June 9, 2014.
10.8#   Consulting Agreement by and between the Registrant and Keith Nolop, M.D., dated June 9, 2014.
10.9+   Employment Letter Agreement by and between the Registrant and Margo Roberts, Ph.D., dated July 17, 2013.
10.10+#   Employment Letter Agreement by and between the Registrant and Cynthia Butitta, dated January 28, 2014.
10.11+#   Employment Letter Agreement by and between the Registrant and Arie S. Belldegrun, M.D., FACS, dated March 25, 2014.
10.12+#   Employment Letter Agreement by and between the Registrant and Aya Jakobovits, Ph.D., dated August 9, 2010.
10.13+#   Employment Letter Agreement by and between the Registrant and Jeffrey Wiezorek, dated April 15, 2014.
10.14+#   Employment Agreement by and between the Registrant and David Chang, M.D., Ph.D., dated May 22, 2014.
10.15#   Consulting Agreement by and between the Registrant and Two River Consulting, LLC, dated June 1, 2009.
10.16#   Standard Industrial Commercial Single-Tenant Lease by and between the Registrant and Clover Associates, LLC, dated May 9, 2013.
10.17*   License Agreement by and among the Registrant, Cabaret Biotech Ltd. and Dr. Zelig Eshhar, dated December 12, 2013.
10.18*#   License Agreement by and between the Registrant and the National Institutes of Health, dated April 11, 2013.

 

 

 

 

II-5


 

 

EXHIBIT
NUMBER

 

DESCRIPTION OF DOCUMENT

10.19*   License Agreement by and between the Registrant and the National Institutes of Health, dated May 29, 2014.
10.20*#   Cooperative Research and Development Agreement for Intramural-PHS Clinical Research by and between the Registrant and the U.S. Department of Health and Human Services, as represented by the National Cancer Institute an Institute, Center, or Division of the National Institutes of Health, effective August 31, 2012.
10.21#   Warrant to Purchase Stock issued to Joshua A. Kazam, dated May 10, 2013.
10.22#   Warrant to Purchase Stock issued to Peter M. Kash, dated May 10, 2013.
10.23#   Warrant to Purchase Stock issued to David M. Tanen, dated May 10, 2013.
10.24#   Warrant to Purchase Stock issued to M. Tarique Farooqui, dated May 10, 2013.
10.25#   Warrant to Purchase Stock issued to Timothy McInerney, dated May 10, 2013.
10.26#   Warrant to Purchase Stock issued to Scott L. Navins, dated May 10, 2013.
23.1#   Consent of Crowe Horwath LLP, an Independent Registered Public Accounting Firm.
23.2#   Consent of Cooley LLP. Reference is made to Exhibit 5.1.
24.1#   Power of Attorney (included on the signature page of the registration statement on Form S-1 filed with the SEC on May 19, 2014).

 

 

+   Indicates management contract or compensatory plan.
*   Confidential treatment has been requested with respect to certain portions of this exhibit. Omitted portions have been filed separately with the SEC.
#   Previously filed.

(b) Financial Statement Schedules.

No financial statement schedules are provided because the information called for is not required or is shown either in the financial statements or the notes thereto.

Item 17. Undertakings.

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

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 SEC 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 of 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 Registrant hereby undertakes that:

 

  (a) 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.

 

  (b) 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.

 

II-6


SIGNATURES

Pursuant to the requirements of the Securities Act, the Registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Los Angeles, State of California, on the 17 th day of June, 2014.

 

KITE PHARMA, INC.

/s/ Arie Belldegrun, M.D.

Arie Belldegrun, M.D.

President and Chief Executive Officer

Pursuant to the requirements of the Securities Act, this registration statement has been signed by the following persons in the capacities and on the dates indicated.

 

SIGNATURE

  

TITLE

 

DATE

/s/ Arie Belldegrun, M.D.

Arie Belldegrun, M.D.

  

President, Chief Executive Officer and Chairman

of the Board of Directors

(Principal Executive Officer)

  June 17, 2014

/s/ Cynthia M. Butitta

Cynthia M. Butitta

  

Chief Operating Officer and Chief Financial Officer

(Principal Financial and Accounting Officer)

  June 17, 2014

/s/ David Bonderman*

David Bonderman

   Member of the Board of Directors   June 17, 2014

/s/ Farah Champsi*

Farah Champsi

   Member of the Board of Directors   June 17, 2014

/s/ Roy Doumani*

Roy Doumani

   Member of the Board of Directors   June 17, 2014

/s/ Joshua A. Kazam*

Joshua A. Kazam

   Member of the Board of Directors   June 17, 2014

/s/ Ran Nussbaum*

Ran Nussbaum

   Member of the Board of Directors   June 17, 2014

/s/ Steven B. Ruchefsky*

Steven B. Ruchefsky

   Member of the Board of Directors   June 17, 2014

/s/ Jonathan M. Peacock*

Jonathan M. Peacock

   Member of the Board of Directors   June 17, 2014

 

* Pursuant to Power of Attorney

 

By:  

/s/ Arie Belldegrun, M.D.

  Arie Belldegrun, M.D.


 

EXHIBIT INDEX

 

EXHIBIT
NUMBER

  

DESCRIPTION OF DOCUMENT

  1.1    Form of Underwriting Agreement.
  3.1#    Amended and Restated Certificate of Incorporation, as amended and as currently in effect.
  3.2#    Certificate of Designation of Convertible Preferred Stock to be Designated as Series A Convertible Preferred Stock, as filed with the Secretary of State of Delaware on May 10, 2013.
  3.3#    Form of Amended and Restated Certificate of Incorporation to become effective upon closing of this offering.
  3.4#    Bylaws, as currently in effect.
  3.5#    Form of Amended and Restated Bylaws to become effective upon closing of this offering.
  4.1#    Form of Common Stock Certificate of the Registrant.
  4.2#    Amended and Restated Investors’ Rights Agreement by and among the Registrant and certain of its stockholders, dated April 25, 2014.
  5.1#    Opinion of Cooley LLP.
10.1+#    Form of Indemnity Agreement by and between the Registrant and its directors and officers.
10.2+#    Kite Pharma, Inc. 2014 Equity Incentive Plan and Form of Stock Option Agreement, Notice of Exercise and Stock Option Grant Notice thereunder, and amendments thereto.
10.3+#    Kite Pharma, Inc. Non-Employee Director Compensation Policy.
10.4+#    Employment Letter Agreement by and between the Registrant and Rizwana F. Sproule, Ph.D., dated November 12, 2012.
10.5+#    Employment Letter Agreement by and between the Registrant and Marc Better, Ph.D., dated December 17, 2012.
10.6+#    Employment Letter Agreement by and between the Registrant and Keith Nolop, M.D., dated May 8, 2013.
10.7#    Severance Agreement by and between the Registrant and Keith Nolop, M.D., dated June 9, 2014.
10.8#    Consulting Agreement by and between the Registrant and Keith Nolop, M.D., dated June 9, 2014.
10.9+    Employment Letter Agreement by and between the Registrant and Margo Roberts, Ph.D., dated July 17, 2013.
10.10+#    Employment Letter Agreement by and between the Registrant and Cynthia Butitta, dated January 28, 2014.
10.11+#    Employment Letter Agreement by and between the Registrant and Arie S. Belldegrun, M.D., FACS, dated March 25, 2014.
10.12+#    Employment Letter Agreement by and between the Registrant and Aya Jakobovits, Ph.D., dated August 9, 2010.
10.13+#    Employment Letter Agreement by and between the Registrant and Jeffrey Wiezorek, dated April 15, 2014.
10.14+#    Employment Agreement by and between the Registrant and David Chang, M.D., Ph.D., dated May 22, 2014.
10.15#    Consulting Agreement by and between the Registrant and Two River Consulting, LLC, dated June 1, 2009.
10.16#    Standard Industrial Commercial Single-Tenant Lease by and between the Registrant and Clover Associates, LLC, dated May 9, 2013.

 

 

 


 

 

EXHIBIT
NUMBER

 

DESCRIPTION OF DOCUMENT

10.17*   License Agreement by and among the Registrant, Cabaret Biotech Ltd. and Dr. Zelig Eshhar, dated December 12, 2013.
10.18*#   License Agreement by and between the Registrant and the National Institutes of Health, dated April 11, 2013.
10.19*   License Agreement by and between the Registrant and the National Institutes of Health, dated May 29, 2014.
10.20*#   Cooperative Research and Development Agreement for Intramural-PHS Clinical Research by and between the Registrant and the U.S. Department of Health and Human Services, as represented by the National Cancer Institute an Institute, Center, or Division of the National Institutes of Health, effective August 31, 2012.
10.21#   Warrant to Purchase Stock issued to Joshua A. Kazam, dated May 10, 2013.
10.22#   Warrant to Purchase Stock issued to Peter M. Kash, dated May 10, 2013.
10.23#   Warrant to Purchase Stock issued to David M. Tanen, dated May 10, 2013.
10.24#   Warrant to Purchase Stock issued to M. Tarique Farooqui, dated May 10, 2013.
10.25#   Warrant to Purchase Stock issued to Timothy McInerney, dated May 10, 2013.
10.26#   Warrant to Purchase Stock issued to Scott L. Navins, dated May 10, 2013.
23.1#   Consent of Crowe Horwath LLP, an Independent Registered Public Accounting Firm.
23.2#   Consent of Cooley LLP. Reference is made to Exhibit 5.1.
24.1#   Power of Attorney (included on the signature page of the registration statement on Form S-1 filed with the SEC on May 19, 2014).

 

 

+   Indicates management contract or compensatory plan.
*   Confidential treatment has been requested with respect to certain portions of this exhibit. Omitted portions have been filed separately with the SEC.
#   Previously filed.

Exhibit 1.1

[ ]

Kite Pharma, Inc.

UNDERWRITING AGREEMENT

[ ], 2014

JEFFERIES LLC

CREDIT SUISSE SECURITIES (USA) LLC

As Representatives of the several Underwriters

c/o JEFFERIES LLC

520 Madison Avenue

New York, New York 10022

c/o CREDIT SUISSE SECURITIES (USA) LLC

Eleven Madison Avenue

New York, New York 10010

Ladies and Gentlemen:

Introductory. Kite Pharma, Inc., a Delaware corporation (the “ Company ”), proposes to issue and sell to the several underwriters named in Schedule A (the “ Underwriters ”) an aggregate of [ ] shares of its common stock, par value $0.001 per share (the “ Shares ”). The Shares to be sold by the Company are called the “ Firm Shares .” In addition, the Company has granted to the Underwriters an option to purchase up to an additional [ ] Shares as provided in Section 2. The additional [ ] Shares to be sold by the Company pursuant to such option are collectively called the “ Optional Shares .” The Firm Shares and, if and to the extent such option is exercised, the Optional Shares are collectively called the “ Offered Shares .” Jefferies LLC (“ Jefferies ”) and Credit Suisse Securities (USA) LLC (“ Credit Suisse ”) have agreed to act as representatives of the several Underwriters (in such capacity, the “ Representatives ”) in connection with the offering and sale of the Offered Shares. To the extent there are no additional underwriters listed on Schedule A , the term “Representatives” as used herein shall mean you, as Underwriters, and the term “Underwriters” shall mean either the singular or the plural, as the context requires.

Jefferies agrees that up to [ ] of the Firm Shares to be purchased by the Underwriters (the “ Directed Shares ”) shall be reserved for sale to certain eligible directors, officers and employees of the Company and persons associated with the directors, officers or employees of the Company (collectively, the “ Participants ”), as part of the distribution of the Offered Shares by the Underwriters (the “ Directed Share Program ”) subject to the terms of this Agreement, the applicable rules, regulations and interpretations of the Financial Industry Regulatory Authority, Inc. (“ FINRA ”) and all other applicable laws, rule and regulations. The Directed Share Program shall be administered by Jefferies. To the extent that the Directed Shares are not orally confirmed for purchase by the Participants by the end of the first business day after the date of this Agreement, such Directed Shares may be offered to the public by the Underwriters as part of the public offering contemplated hereby.


The Company has prepared and filed with the Securities and Exchange Commission (the “ Commission ”) a registration statement on Form S-1, File No. 333-196081 which contains a form of prospectus to be used in connection with the public offering and sale of the Offered Shares. Such registration statement, as amended, including the financial statements, exhibits and schedules thereto, in the form in which it became effective under the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder (collectively, the “ Securities Act ”), including any information deemed to be a part thereof at the time of effectiveness pursuant to Rule 430A under the Securities Act, is called the “ Registration Statement .” Any registration statement filed by the Company pursuant to Rule 462(b) under the Securities Act in connection with the offer and sale of the Offered Shares is called the “ Rule 462(b) Registration Statement ,” and from and after the date and time of filing of any such Rule 462(b) Registration Statement the term “Registration Statement” shall include the Rule 462(b) Registration Statement. The prospectus, in the form first used by the Underwriters to confirm sales of the Offered Shares or in the form first made available to the Underwriters by the Company to meet requests of purchasers pursuant to Rule 173 under the Securities Act, is called the “ Prospectus .” The preliminary prospectus dated June 11, 2014 describing the Offered Shares and the offering thereof is called the “ Preliminary Prospectus ,” and the Preliminary Prospectus and any other prospectus in preliminary form that describes the Offered Shares and the offering thereof and is used prior to the filing of the Prospectus is called a “ preliminary prospectus .” As used herein, “ Applicable Time ” is [ ][a.m.][p.m.] (New York City time) on June [ ], 2014. As used herein, “ free writing prospectus ” has the meaning set forth in Rule 405 under the Securities Act, and “ Time of Sale Prospectus ” means the Preliminary Prospectus together with the free writing prospectuses, if any, identified in Schedule B hereto and the pricing information set forth on Schedule B hereto. As used herein, “ Road Show ” means a “road show” (as defined in Rule 433 under the Securities Act) relating to the offering of the Offered Shares contemplated hereby that is a “written communication” (as defined in Rule 405 under the Securities Act). As used herein, “ Section 5(d) Written Communication ” means each written communication (within the meaning of Rule 405 under the Securities Act) that is made in reliance on Section 5(d) of the Securities Act by the Company or any person authorized to act on behalf of the Company to one or more potential investors that are qualified institutional buyers (“ QIBs ”) and/or institutions that are accredited investors (“ IAIs ”), as such terms are respectively defined in Rule 144A and Rule 501(a) under the Securities Act, to determine whether such investors might have an interest in the offering of the Offered Shares; “ Section 5(d) Oral Communication ” means each oral communication, if any, made in reliance on Section 5(d) of the Securities Act by the Company or any person authorized to act on behalf of the Company made to one or more QIBs and/or one or more IAIs to determine whether such investors might have an interest in the offering of the Offered Shares; “ Marketing Materials ” means any materials or information provided to investors by, or with the approval of, the Company in connection with the marketing of the offering of the Offered Shares, including any roadshow or investor presentations made to investors by the Company (whether in person or electronically); and “ Permitted Section 5(d) Communications ” means the Section 5(d) Written Communication(s) and Marketing Materials listed on Schedule C attached hereto.

All references in this Agreement to (i) the Registration Statement, any preliminary prospectus (including the Preliminary Prospectus), or the Prospectus, or any amendments or supplements to any of the foregoing, or any free writing prospectus, shall include any copy thereof filed with the Commission pursuant to its Electronic Data Gathering, Analysis and Retrieval System (“ EDGAR ”) and (ii) the Prospectus shall be deemed to include any “electronic Prospectus” provided for use in connection with the offering of the Offered Shares as contemplated by Section 3(o) of this Agreement.

The Company hereby confirms its agreements with the Underwriters as follows:

Section 1. Representations and Warranties. The Company hereby represents, warrants and covenants to each Underwriter, as of the date of this Agreement, as of the First Closing Date (as hereinafter defined) and as of each Option Closing Date (as hereinafter defined), if any, as follows:

 

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(a) Compliance with Registration Requirements . The Registration Statement has become effective under the Securities Act. The Company has complied, to the Commission’s satisfaction with all requests of the Commission for additional or supplemental information, if any. No stop order suspending the effectiveness of the Registration Statement is in effect and no proceedings for such purpose have been instituted or are pending or, to the knowledge of the Company, are contemplated or threatened by the Commission.

(b) Disclosure . Each preliminary prospectus and the Prospectus when filed complied in all material respects with the Securities Act and, if filed by electronic transmission pursuant to EDGAR, was identical (except as may be permitted by Regulation S-T under the Securities Act) to the copy thereof delivered to the Underwriters for use in connection with the offer and sale of the Offered Shares. Each of the Registration Statement and any post-effective amendment thereto, at the time it became or becomes effective, complied and will comply in all material respects with the Securities Act and did not and will not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading. As of the Applicable Time, the Time of Sale Prospectus (including any preliminary prospectus wrapper) did not, and at the First Closing Date (as defined in Section 2) and at each applicable Option Closing Date (as defined in Section 2), will not, contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading. The Prospectus (including any Prospectus wrapper), as of its date, did not, and at the First Closing Date and at each applicable Option Closing Date, will not, contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The representations and warranties set forth in the three immediately preceding sentences do not apply to statements in or omissions from the Registration Statement or any post-effective amendment thereto, or the Prospectus or the Time of Sale Prospectus, or any amendments or supplements thereto, made in reliance upon and in conformity with written information relating to any Underwriter furnished to the Company in writing by the Representatives expressly for use therein, it being understood and agreed that the only such information consists of the information described in Section 9(b) below. There are no contracts or other documents required to be described in the Time of Sale Prospectus or the Prospectus or to be filed as an exhibit to the Registration Statement which have not been described or filed as required.

(c) Free Writing Prospectuses; Road Show . As of the determination date referenced in Rule 164(h) under the Securities Act, the Company was not, is not or will not be (as applicable) an “ineligible issuer” in connection with the offering of the Offered Shares pursuant to Rules 164, 405 and 433 under the Securities Act. Each free writing prospectus that the Company is required to file pursuant to Rule 433(d) under the Securities Act has been, or will be, filed with the Commission in accordance with the requirements of the Securities Act. Each free writing prospectus that the Company has filed, or is required to file, pursuant to Rule 433(d) under the Securities Act or that was prepared by or on behalf of or used or referred to by the Company complies or will comply in all material respects with the requirements of Rule 433 under the Securities Act, including timely filing with the Commission or retention where required and legending, and each such free writing prospectus, as of its issue date and at all subsequent times through the completion of the public offer and sale of the Offered Shares did not, does not and will not include any information that conflicted, conflicts or will conflict with the information contained in the Registration Statement, the Prospectus or any preliminary prospectus and not superseded or modified. Except for the free writing prospectuses, if any, identified in Schedule B , and electronic road shows, if any, furnished to you before first use, the Company has not prepared, used or referred to, and will not, without your prior written consent, prepare, use or refer to, any free writing prospectus. Each Road Show, when considered together with the Time of Sale Prospectus, did not, as of the Applicable Time, contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading.

 

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(d) Directed Share Program . (i) The Registration Statement, the Prospectus, the Time of Sale Prospectus and any preliminary prospectus comply, and any further amendments or supplements thereto will comply, with any applicable laws or regulations of foreign jurisdictions in which the Prospectus, Time of Sale Prospectus or any preliminary prospectus, as amended or supplemented, if applicable, are distributed in connection with the Directed Share Program, and (ii) no authorization, approval, consent, license, order registration or qualification of or with any government, governmental instrumentality or court, other than such as have been obtained, is necessary under the securities laws and regulations of foreign jurisdictions in which the Directed Shares are offered outside the United States. The Company has not offered, or caused the Underwriters to offer, any Offered Shares to any person pursuant to the Directed Share Program with the intent to unlawfully influence (i) a customer or supplier of the Company to alter the customer’s or supplier’s level or type of business with the Company or (ii) a trade journalist or publication to write or publish favorable information about the Company or its products.

(e) Distribution of Offering Material By the Company . Prior to the later of (i) the expiration or termination of the option granted to the several Underwriters in Section 2, (ii) the completion of the Underwriters’ distribution of the Offered Shares and (iii) the expiration of 25 days after the date of the Prospectus , the Company has not distributed and will not distribute any offering material in connection with the offering and sale of the Offered Shares other than the Registration Statement, the Time of Sale Prospectus, the Prospectus or any free writing prospectus reviewed and consented to by the Representatives, the free writing prospectuses, if any, identified on Schedule B hereto and any Permitted Section 5(d) Communications.

(f) The Underwriting Agreement . This Agreement has been duly authorized, executed and delivered by the Company.

(g) Authorization of the Offered Shares . The Offered Shares have been duly authorized for issuance and sale pursuant to this Agreement and, when issued and delivered by the Company against payment therefor pursuant to this Agreement, will be validly issued, fully paid and nonassessable, and the issuance and sale of the Offered Shares is not subject to any preemptive rights, rights of first refusal or other similar rights to subscribe for or purchase the Offered Shares.

(h) No Applicable Registration or Other Similar Rights . There are no persons with registration or other similar rights to have any equity or debt securities registered for sale under the Registration Statement or included in the offering contemplated by this Agreement.

(i) No Material Adverse Change . Except as otherwise disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, subsequent to the respective dates as of which information is given in the Registration Statement, the Time of Sale Prospectus and the Prospectus: (i) there has been no material adverse change, or any development that would reasonably be expected to result in a material adverse change, in the condition, financial or otherwise, or in the earnings, business, properties, operations, assets, liabilities or prospects, whether or not arising from transactions in the ordinary course of business, of the Company (any such change being referred to herein as a “ Material Adverse Change ”); (ii) the Company has not incurred any material liability or obligation, indirect, direct or contingent, including without limitation any losses or interference with its business from fire, explosion, flood, earthquakes, accident or other calamity, whether or not covered by insurance, or from any strike, labor dispute or court or governmental action, order or decree, that are material, individually or in the aggregate, to the Company, or has entered into any transactions not in the ordinary course of business; and (iii) there has not been any material decrease in the capital stock or any material increase in any short-term or long-term indebtedness of the Company and there has been no dividend or distribution of any kind declared, paid or made by the Company or any repurchase or redemption by the Company of any class of capital stock.

 

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(j) Independent Accountants . Crowe Horwath LLP, which has expressed its opinion with respect to the financial statements (which term as used in this Agreement includes the related notes thereto) filed with the Commission as a part of the Registration Statement, the Time of Sale Prospectus and the Prospectus, is (i) an independent registered public accounting firm as required by the Securities Act, the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder (collectively, the “ Exchange Act ”), and the rules of the Public Company Accounting Oversight Board (“ PCAOB ”), (ii) in compliance with the applicable requirements relating to the qualification of accountants under Rule 2-01 of Regulation S-X under the Securities Act and (iii) a registered public accounting firm as defined by the PCAOB whose registration has not been suspended or revoked and who has not requested such registration to be withdrawn.

(k) Financial Statements . The financial statements filed with the Commission as a part of the Registration Statement, the Time of Sale Prospectus and the Prospectus present fairly, in all material respects, the financial position of the Company as of the dates indicated and the results of its operations, changes in stockholders’ equity and cash flows for the periods specified. Such financial statements have been prepared in conformity with generally accepted accounting principles as applied in the United States applied on a consistent basis throughout the periods involved, except as may be expressly stated in the related notes thereto and except in the case of unaudited financial statements, which are subject to normal and recurring year-end adjustments and do not contain certain footnotes as permitted by the applicable rules of the Commission. No other financial statements or supporting schedules are required to be included in the Registration Statement, the Time of Sale Prospectus or the Prospectus. The financial data set forth in each of the Registration Statement, the Time of Sale Prospectus and the Prospectus under the captions “Prospectus Summary—Summary Financial Data,” “Selected Financial Data” and “Capitalization” fairly present, in all material respects, the information set forth therein on a basis consistent with that of the audited financial statements contained in the Registration Statement, the Time of Sale Prospectus and the Prospectus. To the Company’s knowledge, no person who has been suspended or barred from being associated with a registered public accounting firm, or who has failed to comply with any sanction pursuant to Rule 5300 promulgated by the PCAOB, has participated in or otherwise aided the preparation of, or audited, the financial statements, supporting schedules or other financial data filed with the Commission as a part of the Registration Statement, the Time of Sale Prospectus and the Prospectus.

(l) Company’s Accounting System . The Company makes and keeps accurate books and records and maintains a system of internal accounting controls designed, and which the Company believes is sufficient, to provide reasonable assurance that: (i) transactions are executed in accordance with management’s general or specific authorization; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with generally accepted accounting principles as applied in the United States and to maintain accountability for assets; (iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with existing assets at reasonable intervals and appropriate action is taken with respect to any differences.

(m) Disclosure Controls and Procedures; Deficiencies in or Changes to Internal Control Over Financial Reporting . The Company has established and maintains disclosure controls and procedures (as defined in Rules 13a-15 and 15d-15 under the Exchange Act), which (i) are designed to ensure that material information relating to the Company is made known to the Company’s principal executive officer and its principal financial officer by others within the Company, particularly during the periods in which the periodic reports required under the Exchange Act are being prepared; (ii) have been evaluated by management of the Company for effectiveness, and (iii) are effective in all material respects to perform the functions for which they were established. Since the end of the Company’s most recent audited fiscal year, there have been no significant deficiencies or material weakness in the Company’s internal control over

 

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financial reporting (whether or not remediated) and no change in the Company’s internal control over financial reporting that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting. The Company is not aware of any change in its internal control over financial reporting that has occurred during its most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

(n) Incorporation and Good Standing of the Company . The Company has been duly incorporated and is validly existing as a corporation in good standing under the laws of the jurisdiction of its incorporation and has the corporate power and authority to own, lease and operate its properties and to conduct its business as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus and to enter into and perform its obligations under this Agreement. The Company is duly qualified as a foreign corporation to transact business and is in good standing in the State of California and each other jurisdiction in which such qualification is required, whether by reason of the ownership or leasing of property or the conduct of business, except where the failure to so qualify or to be in good standing would not reasonably be expected, individually or in the aggregate, to have a material adverse effect on the condition (financial or otherwise), earnings, business, properties, operations, assets, liabilities or prospects of the Company (a “Material Adverse Effect”).

(o) Subsidiaries . The Company has no subsidiaries (as defined in Rule 405 under the Securities Act).

(p) Capitalization and Other Capital Stock Matters . The authorized, issued and outstanding capital stock of the Company is as set forth in the Registration Statement, the Time of Sale Prospectus and the Prospectus under the caption “Capitalization” (other than for subsequent issuances, if any, pursuant to employee benefit plans, or upon the exercise of outstanding options or warrants, in each case described in the Registration Statement, the Time of Sale Prospectus and the Prospectus). The Shares (including the Offered Shares) conform in all material respects to the description thereof contained in the Time of Sale Prospectus. All of the issued and outstanding Shares have been duly authorized and validly issued, are fully paid and nonassessable and have been issued in compliance with all federal and state securities laws. None of the outstanding Shares was issued in violation of any preemptive rights, rights of first refusal or other similar rights to subscribe for or purchase securities of the Company. There are no authorized or outstanding options, warrants, preemptive rights, rights of first refusal or other rights to purchase, or equity or debt securities convertible into or exchangeable or exercisable for, any capital stock of the Company other than those described in the Registration Statement, the Time of Sale Prospectus and the Prospectus. The descriptions of the Company’s stock option, stock bonus and other stock plans or arrangements, and the options or other rights granted thereunder, set forth in the Registration Statement, the Time of Sale Prospectus and the Prospectus accurately and fairly presents, in all material respects, the information required to be shown with respect to such plans, arrangements, options and rights.

(q) Stock Exchange Listing . The Offered Shares have been approved for listing on The NASDAQ Global Market (the “ NASDAQ ”), subject only to official notice of issuance.

(r) Non-Contravention of Existing Instruments; No Further Authorizations or Approvals Required . The Company is not in violation of its charter or by-laws or in default (or, with the giving of notice or lapse of time, would be in default) (“ Default ”) under any indenture, loan, credit agreement, note, lease, license agreement, contract, franchise or other instrument (including, without limitation, any pledge agreement, security agreement, mortgage or other instrument or agreement evidencing, guaranteeing, securing or relating to indebtedness) to which the Company is a party or by which it may be bound, or to which its properties or assets are subject (each, an “ Existing Instrument ”), except for such Defaults as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect. The Company’s execution, delivery and performance of this Agreement, consummation of the transactions contemplated hereby and by the Registration Statement, the Time of Sale Prospectus and the Prospectus and

 

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the issuance and sale of the Offered Shares (including the use of proceeds from the sale of the Offered Shares as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus under the caption “Use of Proceeds”) (i) have been duly authorized by all necessary corporate action and will not result in any violation of the provisions of the charter or by-laws of the Company (ii) will not conflict with or constitute a breach of, or Default or a Debt Repayment Triggering Event (as defined below) under, or result in the creation or imposition of any lien, charge or encumbrance upon any property or assets of the Company pursuant to, or require the consent of any other party to, any Existing Instrument and (iii) will not result in any violation of any law, administrative regulation or administrative or court decree applicable to the Company, except for such conflicts, breaches, Defaults or Debt Repayment Triggering Event, lien, charge or encumbrance specified in clause (ii) and (iii) above that would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. No consent, approval, authorization or other order of, or registration or filing with, any court or other governmental or regulatory authority or agency, is required for the Company’s execution, delivery and performance of this Agreement and consummation of the transactions contemplated hereby and by the Registration Statement, the Time of Sale Prospectus and the Prospectus, except (A) such as have been obtained or made by the Company and are in full force and effect under the Securities Act and such as may be required under applicable state securities or blue sky laws or FINRA and (B) such as have been obtained under the laws and regulations of jurisdictions outside the United States in which Directed Shares are offered. As used herein, a “ Debt Repayment Triggering Event ” means any event or condition which gives, or with the giving of notice or lapse of time would give, the holder of any note, debenture or other evidence of indebtedness (or any person acting on such holder’s behalf) the right to require the repurchase, redemption or repayment of all or a portion of such indebtedness by the Company.

(s) Compliance with Laws. The Company has been and is in compliance with all applicable laws, rules and regulations, except where failure to be so in compliance would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect.

(t) No Material Actions or Proceedings . There is no action, suit, proceeding, inquiry or investigation brought by or before any governmental entity now pending or, to the knowledge of the Company, threatened, against or affecting the Company, which would reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect or materially and adversely affect the consummation of the transactions contemplated by this Agreement or the performance by the Company of its obligations hereunder; and the aggregate of all pending legal or governmental proceedings to which the Company is a party or of which any of its properties or assets is the subject, including ordinary routine litigation incidental to the business, if determined adversely to the Company, would not reasonably be expected to have a Material Adverse Effect. No material labor dispute with the employees of the Company, or with the employees of any principal supplier, manufacturer, customer or contractor of the Company, exists or, to the knowledge of the Company, is threatened or imminent.

(u) Intellectual Property Rights . The Company owns, or has obtained valid and enforceable licenses for, the inventions, patent applications, patents, trademarks, trade names, service names, copyrights, trade secrets and other intellectual property described in the Registration Statement, the Time of Sale Prospectus and the Prospectus as being owned or licensed by it or , except as disclosed in the Registration Statement, the Time of Sale Prospectus or the Prospectus, which are necessary for the conduct of its business as currently conducted or as currently proposed to be conducted (collectively, “ Intellectual Property ”). To the Company’s knowledge, and except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect: (i) there are no third parties who have rights to any Intellectual Property, except for customary reversionary rights of third-party licensors with respect to Intellectual Property that is disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus as licensed to the Company; and (ii) there is no infringement by third parties of any Intellectual Property. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse

 

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Effect, there is no pending or, to the Company’s knowledge, threatened action, suit, proceeding or claim by others: (A) challenging the Company’s rights in or to any Intellectual Property, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim; (B) challenging the validity, enforceability or scope of any Intellectual Property, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim; or (C) asserting that the Company infringes or otherwise violates, or would, upon the commercialization of any product or service described in the Registration Statement, the Time of Sale Prospectus or the Prospectus as under development, infringe or violate, any patent, trademark, trade name, service name, copyright, trade secret or other proprietary rights of others, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim. The Company has complied in all material respects with the terms of each agreement pursuant to which Intellectual Property has been licensed to the Company, and all such agreements are in full force and effect. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the product candidates described in the Registration Statement, the Time of Sale Prospectus and the Prospectus as under development by the Company fall within the scope of the claims of one or more patents or patent applications owned by, or exclusively licensed to, the Company.

(v) All Necessary Permits, etc . The Company possesses such valid and current certificates, authorizations or permits required by state, federal or foreign regulatory agencies or bodies to conduct its business as currently conducted and as described in the Registration Statement, the Time of Sale Prospectus or the Prospectus (“ Permits ”), except where failure to so possess would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company is not in violation of, or in default under, any of the Permits or has received any notice of proceedings relating to the revocation or modification of, or non-compliance with, any such certificate, authorization or permit.

(w) Title to Properties . The Company has good and marketable title to all of the real and personal property and other assets reflected as owned in the financial statements referred to in Section 1(k) above (or elsewhere in the Registration Statement, the Time of Sale Prospectus or the Prospectus), in each case free and clear of any security interests, mortgages, liens, encumbrances, equities, adverse claims and other defects, except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect. The real property, improvements, equipment and personal property held under lease by the Company are held under valid and enforceable leases, with such exceptions as are not material and do not materially interfere with the use made or proposed to be made of such real property, improvements, equipment or personal property by the Company.

(x) Tax Law Compliance . The Company has filed all necessary federal, state and foreign income and franchise tax returns or has properly requested extensions thereof. The Company has paid all taxes required to be paid by it and, if due and payable, any related or similar assessment, fine or penalty levied against it except as may be being contested in good faith and by appropriate proceedings. The Company has made adequate charges, accruals and reserves in the applicable financial statements referred to in Section 1(k) above in respect of all federal, state and foreign income and franchise taxes for all periods as to which the tax liability of the Company or has not been finally determined.

(y) Insurance . The Company is insured by recognized, financially sound and reputable institutions with policies in such amounts and with such deductibles and covering such risks as are generally deemed adequate and customary for its business including, but not limited to, policies covering real and personal property owned or leased by the Company against theft, damage, destruction, acts of vandalism. The Company has no reason to believe that it will not be able (i) to renew its existing insurance coverage as and when such policies expire or (ii) to obtain comparable coverage from similar institutions as may be necessary or appropriate to conduct its business as now conducted and at a cost that would not reasonably be

 

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expected to have a Material Adverse Effect. The Company has not been denied any insurance coverage which it has sought or for which it has applied.

(z) Compliance with Environmental Laws . Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect: (i) the Company is not in violation of any federal, state, local or foreign statute, law, rule, regulation, ordinance, code, policy or rule of common law or any judicial or administrative interpretation thereof, including any judicial or administrative order, consent, decree or judgment, relating to pollution or protection of human health, the environment (including, without limitation, ambient air, surface water, groundwater, land surface or subsurface strata) or wildlife, including, without limitation, laws and regulations relating to the release or threatened release of chemicals, pollutants, contaminants, wastes, toxic substances, hazardous substances, petroleum or petroleum products (collectively, “ Hazardous Materials ”) or to the manufacture, processing, distribution, use, treatment, storage, disposal, transport or handling of Hazardous Materials (collectively, “ Environmental Laws ”); (ii) the Company has all permits, authorizations and approvals required under any applicable Environmental Laws and is in compliance with their requirements; (iii) there are no pending or, to the Company’s knowledge, threatened administrative, regulatory or judicial actions, suits, demands, demand letters, claims, liens, notices of noncompliance or violation, investigation or proceedings relating to any Environmental Law against the Company; and (iv) to the Company’s knowledge, there are no events or circumstances that might reasonably be expected to form the basis of an order for clean-up or remediation, or an action, suit or proceeding by any private party or governmental body or agency, against or affecting the Company relating to Hazardous Materials or any Environmental Laws.

(aa) ERISA Compliance . The Company and any “employee benefit plan” (as defined under the Employee Retirement Income Security Act of 1974, as amended, and the regulations and published interpretations thereunder (collectively, “ ERISA ”)) established or maintained by the Company or its “ERISA Affiliates” (as defined below) are in compliance in all material respects with ERISA. “ ERISA Affiliate ” means, with respect to the Company, any member of any group of organizations described in Sections 414(b), (c), (m) or (o) of the Internal Revenue Code of 1986, as amended, and the regulations and published interpretations thereunder (the “ Code ”) of which the Company is a member. No “reportable event” (as defined under ERISA) has occurred or is reasonably expected to occur with respect to any “employee benefit plan” established or maintained by the Company or its ERISA Affiliates. No “employee benefit plan” established or maintained by the Company, or its ERISA Affiliates, if such “employee benefit plan” were terminated, would have any “amount of unfunded benefit liabilities” (as defined under ERISA). Neither the Company nor its ERISA Affiliates has incurred or reasonably expects to incur any liability under (i) Title IV of ERISA with respect to termination of, or withdrawal from, any “employee benefit plan” or (ii) Sections 412, 4971, 4975 or 4980B of the Code. Each employee benefit plan established or maintained by the Company or its ERISA Affiliates that is intended to be qualified under Section 401(a) of the Code is so qualified and nothing has occurred, whether by action or failure to act, which would cause the loss of such qualification.

(bb) Company Not an “Investment Company.” The Company is not, and will not be, either after receipt of payment for the Offered Shares or after the application of the proceeds therefrom as described under “Use of Proceeds” in the Registration Statement, the Time of Sale Prospectus or the Prospectus, required to register as an “investment company” under the Investment Company Act of 1940, as amended (the “ Investment Company Act ) .

(cc) No Price Stabilization or Manipulation; Compliance with Regulation M . The Company has not taken, directly or indirectly, without giving effect to activities by the Underwriters, any action designed to or that might reasonably cause or result in stabilization or manipulation of the price of the Shares or of any “reference security” (as defined in Rule 100 of Regulation M under the Exchange Act

 

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(“ Regulation M ”)) with respect to the Shares, whether to facilitate the sale or resale of the Offered Shares or otherwise, and has taken no action which would directly or indirectly violate Regulation M.

(dd) Related-Party Transactions . There are no business relationships or related-party transactions involving the Company or any other person required to be described in the Registration Statement, the Time of Sale Prospectus or the Prospectus that have not been described as required.

(ee) FINRA Matters . All of the information provided to the Underwriters or to counsel for the Underwriters by the Company, its counsel, its officers and directors and, to the knowledge of the Company, the holders of any securities (debt or equity) or options to acquire any securities of the Company in connection with the offering of the Offered Shares is true, complete, correct in all material respects and compliant with FINRA’s rules and any letters, filings or other supplemental information provided to FINRA by the Company and, to the Company’s knowledge, by the Company’s officers, directors and the holders of any securities (debt or equity) or options to acquire any securities of the Company in connection with the offering of the Offered Shares pursuant to FINRA Rules or NASD Conduct Rules is true, complete and correct.

(ff) Parties to Lock-Up Agreements . The Company has furnished to the Underwriters a letter agreement in the form attached hereto as Exhibit C (the “ Lock-up Agreement ”) from the directors and officers (as defined in Rule 16a-1(f) under the Exchange Act) of the Company and certain additional securityholders of the Company. If any additional persons shall become directors or officers (as defined in Rule 16a-1(f) under the Exchange Act) of the Company prior to the end of the Company Lock-up Period (as defined below), the Company shall cause each such person, prior to or contemporaneously with their appointment or election as a director or officer of the Company, to execute and deliver to Jefferies a Lock-up Agreement.

(gg) Statistical and Market-Related Data . All statistical, demographic and market-related data included in the Registration Statement, the Time of Sale Prospectus or the Prospectus are based on or derived from sources that the Company believes to be reliable and accurate in all material respects. To the extent required, the Company has obtained the written consent to the use of such data from such sources.

(hh) No Unlawful Contributions or Other Payments . Neither the Company nor, to the Company’s knowledge, any employee or agent of the Company, has made any contribution or other payment to any official of, or candidate for, any federal, state or foreign office in violation of any applicable law or of the character required to be disclosed in the Registration Statement, the Time of Sale Prospectus or the Prospectus.

(ii) Foreign Corrupt Practices Act . Neither the Company nor, to the knowledge of the Company, any director, officer, agent, employee, affiliate or other person acting on behalf of the Company has, in the course of its actions for, or on behalf of, the Company (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expenses relating to political activity; (ii) made any direct or indirect unlawful payment to any domestic government official, “foreign official” (as defined in the U.S. Foreign Corrupt Practices Act of 1977, as amended, and the rules and regulations thereunder (collectively, the “ FCPA ”) or employee from corporate funds; (iii) violated or is in violation of any provision of the FCPA or any applicable non-U.S. anti-bribery statute or regulation; or (iv) made any unlawful bribe, rebate, payoff, influence payment, kickback or other unlawful payment to any domestic government official, such foreign official or employee; and the Company and, to the knowledge of the Company, the Company’s affiliates have conducted their respective businesses in compliance with the FCPA and have instituted and maintain policies and procedures designed to ensure, and which are reasonably expected to continue to ensure, continued compliance therewith.

 

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(jj) Money Laundering Laws . The operations of the Company are, and have been conducted at all times, in compliance with applicable financial recordkeeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, the money laundering statutes of all applicable jurisdictions, the rules and regulations thereunder and any related or similar applicable rules, regulations or guidelines, issued, administered or enforced by any governmental agency (collectively, the “ Money Laundering Laws ”) and no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company with respect to the Money Laundering Laws is pending or, to the knowledge of the Company, threatened.

(kk) OFAC . Neither the Company nor, to the knowledge of the Company, after due inquiry, any director, officer, agent, employee, affiliate or person acting on behalf of the Company is currently subject to any U.S. sanctions administered by the Office of Foreign Assets Control of the U.S. Treasury Department (“ OFAC ”); and the Company will not directly or indirectly use the proceeds of this offering, or lend, contribute or otherwise make available such proceeds to any joint venture partner or other person or entity, for the purpose of financing the activities of or business with any person, or in any country or territory, that currently is the subject to any U.S. sanctions administered by OFAC or in any other manner that will result in a violation by any person (including any person participating in the transaction whether as underwriter, advisor, investor or otherwise) of U.S. sanctions administered by OFAC.

(ll) Brokers . Except pursuant to this Agreement, there is no broker, finder or other party that is entitled to receive from the Company any brokerage or finder’s fee or other fee or commission as a result of any transactions contemplated by this Agreement.

(mm) Forward-Looking Statements. Each financial or operational projection or other “forward-looking statement” (as defined by Section 27A of the Securities Act or Section 21E of the Exchange Act) contained in the Registration Statement, the Time of Sale Prospectus or the Prospectus (i) was so included by the Company in good faith and with reasonable basis after due consideration by the Company of the underlying assumptions, estimates and other applicable facts and circumstances and (ii) is accompanied by meaningful cautionary statements identifying those factors that could cause actual results to differ materially from those in such forward-looking statement. No such statement was made with the knowledge of an executive officer or director of the Company that it was false or misleading.

(nn) Emerging Growth Company Status . From the time of initial confidential submission of the Registration Statement to the Commission (or, if earlier, the first date on which the Company engaged in any Section 5(d) Written Communication or any Section 5(d) Oral Communication) through the date hereof, the Company has been and is an “emerging growth company,” as defined in Section 2(a) of the Securities Act (an “ Emerging Growth Company ”).

(oo) Communications . The Company (i) has not alone engaged in communications with potential investors in reliance on Section 5(d) of the Securities Act other than Permitted Section 5(d) Communications or Section 5(d) Oral Communications, in each case, with the consent of the Representatives with entities that are QIBs or IAIs and (ii) has not authorized anyone other than the Representatives to engage in such communications; the Company reconfirms that the Representatives have been authorized to act on its behalf in undertaking Marketing Materials, Section 5(d) Oral Communications and Section 5(d) Written Communications; as of the Applicable Time, each Permitted Section 5(d) Communication, when considered together with the Time of Sale Prospectus, did not, as of the Applicable Time, include an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading; and each Permitted Section 5(d) Communication, if any, does not, as of the date hereof, conflict with the information contained in the Registration Statement, the Preliminary Prospectus and the Prospectus; and the Company has filed publicly on EDGAR at least 21 calendar days prior to any “road show” (as defined in

 

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Rule 433 under the Act), any confidentially submitted registration statement and registration statement amendments relating to the offer and sale of the Offered Shares.

(pp) Clinical Data and Regulatory Compliance. The descriptions of the results of any preclinical tests and clinical trials, and other studies (collectively, “studies”) included in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus are accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectuses or the Prospectus; the Company is not currently conducting any clinical trials; the Company have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); the Company has not received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company has operated and currently is in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

(qq) No Rights to Purchase Preferred Stock. The issuance and sale of the Shares as contemplated hereby will not cause any holder of any shares of capital stock, securities convertible into or exchangeable or exercisable for capital stock or options, warrants or other rights to purchase capital stock or any other securities of the Company to have any right to acquire any shares of preferred stock of the Company.

(rr) No Contract Terminations. The Company has not sent or received any communication regarding termination of, or intent not to renew, any of the contracts or agreements referred to or described in any preliminary prospectus, the Prospectus or any free writing prospectus, or referred to or described in, or filed as an exhibit to, the Registration Statement, and no such termination or non-renewal has been threatened by the Company or, to the Company’s knowledge, any other party to any such contract or agreement, which threat of termination or non-renewal has not been rescinded as of the date hereof.

(ss) No Indebtedness. Except as otherwise disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the Company has no outstanding long-term indebtedness and no short-term indebtedness in excess of $250,000.

Any certificate signed by any officer of the Company and delivered to any Underwriter or to counsel for the Underwriters in connection with the offering, or the purchase and sale, of the Offered Shares shall be deemed a representation and warranty by the Company to each Underwriter as to the matters covered thereby.

The Company has a reasonable basis for making each of the representations set forth in this Section 1. The Company acknowledges that the Underwriters and, for purposes of the opinions to be delivered pursuant to Section 6 hereof, counsel to the Company and counsel to the Underwriters, will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.

Section 2. Purchase, Sale and Delivery of the Offered Shares .

(a) The Firm Shares . Upon the terms herein set forth, the Company agrees to issue and sell to the several Underwriters an aggregate of 6,000,000 Firm Shares. On the basis of the representations, warranties and agreements herein contained, and upon the terms but subject to the conditions herein set

 

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forth, the Underwriters agree, severally and not jointly, to purchase from the Company the respective number of Firm Shares set forth opposite their names on Schedule A . The purchase price per Firm Share to be paid by the several Underwriters to the Company shall be $[ ] per share.

(b) The First Closing Date . Delivery of certificates for the Firm Shares to be purchased by the Underwriters and payment therefor shall be made at the offices of Covington & Burling LLP (or such other place as may be agreed to by the Company and the Representatives) at 9:00 a.m. New York City time, on June [ ], 2014, or such other time and date not later than 1:30 p.m. New York City time, on June [ ], 2014 as the Representatives shall designate by notice to the Company (the time and date of such closing are called the “ First Closing Date ”). The Company hereby acknowledges that circumstances under which the Representatives may provide notice to postpone the First Closing Date as originally scheduled include, but are not limited to, any determination by the Company or the Representatives to recirculate to the public copies of an amended or supplemented Prospectus or a delay as contemplated by the provisions of Section 11.

(c) The Optional Shares; Option Closing Date . In addition, on the basis of the representations, warranties and agreements herein contained, and upon the terms but subject to the conditions herein set forth, the Company hereby grants an option to the several Underwriters to purchase, severally and not jointly, up to an aggregate of 900,000 Optional Shares from the Company at the purchase price per share to be paid by the Underwriters for the Firm Shares. The option granted hereunder may be exercised at any time and from time to time in whole or in part upon notice by the Representatives to the Company, which notice may be given at any time within 30 days from the date of this Agreement. Such notice shall set forth (i) the aggregate number of Optional Shares as to which the Underwriters are exercising the option and (ii) the time, date and place at which certificates for the Optional Shares will be delivered (which time and date may be simultaneous with, but not earlier than, the First Closing Date; and in the event that such time and date are simultaneous with the First Closing Date, the term “ First Closing Date ” shall refer to the time and date of delivery of certificates for the Firm Shares and such Optional Shares). Any such time and date of delivery, if subsequent to the First Closing Date, is called an “ Option Closing Date ,” shall be determined by the Representatives and shall not be earlier than three or later than five full business days after delivery of such notice of exercise. If any Optional Shares are to be purchased, each Underwriter agrees, severally and not jointly, to purchase the number of Optional Shares (subject to such adjustments to eliminate fractional shares as the Representatives may determine) that bears the same proportion to the total number of Optional Shares to be purchased as the number of Firm Shares set forth on Schedule A opposite the name of such Underwriter bears to the total number of Firm Shares. The Representatives may cancel the option at any time prior to its expiration by giving written notice of such cancellation to the Company.

(d) Public Offering of the Offered Shares . The Representatives hereby advise the Company that the Underwriters intend to offer for sale to the public, initially on the terms set forth in the Registration Statement, the Time of Sale Prospectus and the Prospectus, their respective portions of the Offered Shares as soon after this Agreement has been executed and the Registration Statement has been declared effective as the Representatives, in their sole judgment, have determined is advisable and practicable.

(e) Payment for the Offered Shares .

(i) Payment for the Offered Shares shall be made at the First Closing Date (and, if applicable, at each Option Closing Date) by wire transfer of immediately available funds to the order of the Company.

(ii) It is understood that Jefferies has been authorized, for its own account and the accounts of the several Underwriters, to accept delivery of and receipt for, and make payment of the purchase price for, the Firm Shares and any Optional Shares the Underwriters have agreed to purchase. Jefferies,

 

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individually and not as a Representative of the Underwriters, may (but shall not be obligated to) make payment for any Offered Shares to be purchased by any Underwriter whose funds shall not have been received by Jefferies by the First Closing Date or the applicable Option Closing Date, as the case may be, for the account of such Underwriter, but any such payment shall not relieve such Underwriter from any of its obligations under this Agreement.

(f) Delivery of the Offered Shares . The Company shall deliver, or cause to be delivered, through the facilities of The Depository Trust Company (“DTC”) unless Jefferies shall otherwise instruct, to Jefferies for the accounts of the several Underwriters certificates for the Firm Shares at the First Closing Date, against the irrevocable release of a wire transfer of immediately available funds for the amount of the purchase price therefor. The Company shall also deliver, or cause to be delivered, through the facilities of DTC unless Jefferies shall otherwise instruct, to Jefferies for the accounts of the several Underwriters, certificates for the Optional Shares the Underwriters have agreed to purchase at the First Closing Date or the applicable Option Closing Date, as the case may be, against the irrevocable release of a wire transfer of immediately available funds for the amount of the purchase price therefor. The certificates for the Offered Shares shall be registered in such names and denominations as Jefferies shall have requested at least two full business days prior to the First Closing Date (or the applicable Option Closing Date, as the case may be) and shall be made available for inspection on the business day preceding the First Closing Date (or the applicable Option Closing Date, as the case may be) at a location in New York City as Jefferies may designate. Time shall be of the essence, and delivery at the time and place specified in this Agreement is a further condition to the obligations of the Underwriters.

Section 3. Additional Covenants. The Company further covenants and agrees with each Underwriter as follows:

(a) Delivery of Registration Statement, Time of Sale Prospectus and Prospectus. The Company shall furnish to you in New York City, without charge, prior to 10:00 a.m. New York City time on the second business day succeeding the date of this Agreement and during the period when a prospectus relating to the Offered Shares is required by the Securities Act to be delivered (whether physically or through compliance with Rule 172 under the Securities Act or any similar rule) in connection with sales of the Offered Shares, as many copies of the Time of Sale Prospectus, the Prospectus and any supplements and amendments thereto or to the Registration Statement as you may reasonably request.

(b) Representatives’ Review of Proposed Amendments and Supplements. During the period when a prospectus relating to the Offered Shares is required by the Securities Act to be delivered (whether physically or through compliance with Rule 172 under the Securities Act or any similar rule), the Company (i) will furnish to the Representatives for review, a reasonable period of time prior to the proposed time of filing of any proposed amendment or supplement to the Registration Statement, a copy of each such amendment or supplement and (ii) will not amend or supplement the Registration Statement without the Representatives’ prior written consent (not to be unreasonably withheld). Prior to amending or supplementing any preliminary prospectus, the Time of Sale Prospectus or the Prospectus, the Company shall furnish to the Representatives for review, a reasonable amount of time prior to the time of filing or use of the proposed amendment or supplement, a copy of each such proposed amendment or supplement. The Company shall not file or use any such proposed amendment or supplement without the Representatives’ prior written consent (not to be unreasonably withheld). The Company shall file with the Commission within the applicable period specified in Rule 424(b) under the Securities Act any prospectus required to be filed pursuant to such Rule.

(c) Free Writing Prospectuses. The Company shall furnish to the Representatives for review, a reasonable amount of time prior to the proposed time of filing or use thereof, a copy of each proposed free writing prospectus or any amendment or supplement thereto prepared by or on behalf of, used by, or referred

 

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to by the Company, and the Company shall not file, use or refer to any proposed free writing prospectus or any amendment or supplement thereto without the Representatives’ prior written consent (not to be unreasonably withheld). The Company shall furnish to each Underwriter, without charge, as many copies of any free writing prospectus prepared by or on behalf of, used by or referred to by the Company as such Underwriter may reasonably request. If at any time when a prospectus is required by the Securities Act to be delivered (whether physically or through compliance with Rule 172 under the Securities Act or any similar rule) in connection with sales of the Offered Shares (but in any event if at any time through and including the First Closing Date) there occurred or occurs an event or development as a result of which any free writing prospectus prepared by or on behalf of, used by, or referred to by the Company conflicted or would conflict with the information contained in the Registration Statement or included or would include an untrue statement of a material fact or omitted or would omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances prevailing at such time, not misleading, the Company shall promptly amend or supplement such free writing prospectus to eliminate or correct such conflict so that the statements in such free writing prospectus as so amended or supplemented will not include an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances prevailing at such time, not misleading, as the case may be; provided, however , that prior to amending or supplementing any such free writing prospectus, the Company shall furnish to the Representatives for review, a reasonable amount of time prior to the proposed time of filing or use thereof, a copy of such proposed amended or supplemented free writing prospectus, and the Company shall not file, use or refer to any such amended or supplemented free writing prospectus without the Representatives’ prior written consent (not to be unreasonably withheld).

(d) Filing of Underwriter Free Writing Prospectuses. The Company shall not take any action that would result in an Underwriter or the Company being required to file with the Commission pursuant to Rule 433(d) under the Securities Act a free writing prospectus prepared by or on behalf of such Underwriter that such Underwriter otherwise would not have been required to file thereunder.

(e) Amendments and Supplements to Time of Sale Prospectus. If the Time of Sale Prospectus is being used to solicit offers to buy the Offered Shares at a time when the Prospectus is not yet available to prospective purchasers, and any event shall occur or condition exist as a result of which it is necessary to amend or supplement the Time of Sale Prospectus so that the Time of Sale Prospectus does not include an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances when delivered to a prospective purchaser, not misleading, or if any event shall occur or condition exist as a result of which the Time of Sale Prospectus conflicts with the information contained in the Registration Statement, or if, in the opinion of counsel for the Underwriters, it is necessary to amend or supplement the Time of Sale Prospectus to comply with applicable law, the Company shall (subject to Section 3(b) and Section 3(c) hereof) promptly prepare, file with the Commission and furnish, at its own expense, to the Underwriters and to any dealer upon request, either amendments or supplements to the Time of Sale Prospectus so that the statements in the Time of Sale Prospectus as so amended or supplemented will not include an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances when delivered to a prospective purchaser, not misleading or so that the Time of Sale Prospectus, as amended or supplemented, will no longer conflict with the information contained in the Registration Statement, or so that the Time of Sale Prospectus, as amended or supplemented, will comply with applicable law.

(f) Certain Notifications and Required Actions . After the date of this Agreement, the Company shall promptly advise the Representatives in writing of: (i) the receipt of any comments of, or requests for additional or supplemental information from, the Commission; (ii) the time and date of any filing of any post-effective amendment to the Registration Statement or any amendment or supplement to any preliminary prospectus, the Time of Sale Prospectus, any free writing prospectus or the Prospectus; (iii) the time and date that any post-effective amendment to the Registration Statement becomes effective; and

 

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(iv) the issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement or any post-effective amendment thereto or any amendment or supplement to any preliminary prospectus, the Time of Sale Prospectus or the Prospectus or of any order preventing or suspending the use of any preliminary prospectus, the Time of Sale Prospectus, any free writing prospectus or the Prospectus, or of any proceedings to remove, suspend or terminate from listing or quotation the Shares from any securities exchange upon which they are listed for trading or included or designated for quotation, or of the threatening or initiation of any proceedings for any of such purposes. If the Commission shall enter any such stop order at any time, the Company will use its best efforts to obtain the lifting of such order at the earliest possible moment. Additionally, the Company agrees that it shall comply with all applicable provisions of Rule 424(b), Rule 433 and Rule 430A under the Securities Act and will use its reasonable efforts to confirm that any filings made by the Company under Rule 424(b) or Rule 433 were received in a timely manner by the Commission.

(g) Amendments and Supplements to the Prospectus and Other Securities Act Matters. If any event shall occur or condition exist as a result of which it is necessary to amend or supplement the Prospectus so that the Prospectus does not include an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances when the Prospectus is delivered (whether physically or through compliance with Rule 172 under the Securities Act or any similar rule) to a purchaser, not misleading, or if in the opinion of the Representatives or counsel for the Underwriters it is otherwise necessary to amend or supplement the Prospectus to comply with applicable law, the Company agrees (subject to Section 3(b) and Section 3(c)) hereof to promptly prepare, file with the Commission and furnish, at its own expense, to the Underwriters and to any dealer upon request, amendments or supplements to the Prospectus so that the statements in the Prospectus as so amended or supplemented will not include an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances when the Prospectus is delivered (whether physically or through compliance with Rule 172 under the Securities Act or any similar rule) to a purchaser, not misleading or so that the Prospectus, as amended or supplemented, will comply with applicable law. Neither the Representatives’ consent to, nor delivery of, any such amendment or supplement shall constitute a waiver of any of the Company’s obligations under Section 3(b) or Section 3(c).

(h) Blue Sky Compliance . The Company shall cooperate with the Representatives and counsel for the Underwriters to qualify or register the Offered Shares for sale under (or obtain exemptions from the application of) the state securities or blue sky laws or Canadian provincial securities laws (or other foreign laws) of those jurisdictions designated by the Representatives, shall comply with such laws and shall continue such qualifications, registrations and exemptions in effect so long as required for the distribution of the Offered Shares. The Company shall not be required to qualify as a foreign corporation or to take any action that would subject it to general service of process in any such jurisdiction where it is not presently qualified or where it would be subject to taxation as a foreign corporation. The Company will advise the Representatives promptly of the suspension of the qualification or registration of (or any such exemption relating to) the Offered Shares for offering, sale or trading in any jurisdiction or any initiation or threat of any proceeding for any such purpose, and in the event of the issuance of any order suspending such qualification, registration or exemption, the Company shall use its best efforts to obtain the withdrawal thereof at the earliest possible moment.

(i) Use of Proceeds . The Company shall apply the net proceeds from the sale of the Offered Shares sold by it in the manner described under the caption “Use of Proceeds” in the Registration Statement, the Time of Sale Prospectus and the Prospectus.

(j) Transfer Agent . The Company shall engage and maintain, at its expense, a registrar and transfer agent for the Shares.

 

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(k) Earnings Statement . The Company will make generally available to its security holders and to the Representatives as soon as practicable an earnings statement (which need not be audited) covering a period of at least twelve months beginning with the first fiscal quarter of the Company commencing after the date of this Agreement that will satisfy the provisions of Section 11(a) of the Securities Act and the rules and regulations of the Commission thereunder.

(l) Continued Compliance with Securities Laws . The Company will comply with the Securities Act and the Exchange Act so as to permit the completion of the distribution of the Offered Shares as contemplated by this Agreement , the Registration Statement, the Time of Sale Prospectus and the Prospectus. Without limiting the generality of the foregoing, the Company will, during the period when a prospectus relating to the Offered Shares is required by the Securities Act to be delivered (whether physically or through compliance with Rule 172 under the Securities Act or any similar rule), file on a timely basis with the Commission and the NASDAQ all reports and documents required to be filed under the Exchange Act. Additionally, the Company shall report the use of proceeds from the issuance of the Offered Shares as may be required under Rule 463 under the Securities Act.

(m) Directed Share Program . In connection with the Directed Share Program, the Company will ensure that the Directed Shares will be restricted to the extent required by FINRA or its rules from sale, transfer, assignment, pledge or hypothecation for a period of three months following the date of the effectiveness of the Registration Statement. Jefferies will notify the Company as to which Participants will need to be so restricted. The Company will direct the transfer agent to place stop transfer restrictions upon such securities for such period of time. Should the Company release, or seek to release, from such restrictions any of the Directed Shares, the Company agrees to reimburse the Underwriters for any reasonable expenses (including, without limitation, legal expenses) they incur in connection with such release.

(n) Listing . The Company will use its best efforts to list, subject to notice of issuance, the Offered Shares on the NASDAQ.

(o) Company to Provide Copy of the Prospectus in Form That May be Downloaded from the Internet . If requested by the Representatives, the Company shall cause to be prepared and delivered, at its expense, within one business day from the effective date of this Agreement, to the Representatives an “ electronic Prospectus ” to be used by the Underwriters in connection with the offering and sale of the Offered Shares. As used herein, the term “ electronic Prospectus ” means a form of the Prospectus, and any amendment or supplement thereto, that meets each of the following conditions: (i) it shall be encoded in an electronic format, satisfactory to the Representatives, that may be transmitted electronically by the Representatives and the other Underwriters to offerees and purchasers of the Offered Shares; (ii) it shall disclose the same information as the paper Prospectus, except to the extent that graphic and image material cannot be disseminated electronically, in which case such graphic and image material shall be replaced in the electronic Prospectus with a fair and accurate narrative description or tabular representation of such material, as appropriate; and (iii) it shall be in or convertible into a paper format or an electronic format, satisfactory to Jefferies, that will allow investors to store and have continuously ready access to the Prospectus at any future time, without charge to investors (other than any fee charged for subscription to the Internet as a whole and for on-line time). The Company hereby confirms that it has included or will include in the Prospectus filed pursuant to EDGAR or otherwise with the Commission and in the Registration Statement at the time it was declared effective an undertaking that, upon receipt of a request by an investor or his or her representative, the Company shall transmit or cause to be transmitted promptly, without charge, a paper copy of the Prospectus.

[(p) Agreement Not to Offer or Sell Additional Shares . During the period commencing on and including the date hereof and continuing through and including the 180th day following the date of the

 

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Prospectus (such period being referred to herein as the “ Lock-up Period ”), the Company will not, without the prior written consent of Jefferies and Credit Suisse (which consent may be withheld in their sole discretion), directly or indirectly: (i) sell, offer to sell, contract to sell or lend any Shares or Related Securities (as defined below); (ii) effect any short sale, or establish or increase any “put equivalent position” (as defined in Rule 16a-1(h) under the Exchange Act) or liquidate or decrease any “call equivalent position” (as defined in Rule 16a-1(b) under the Exchange Act) of any Shares or Related Securities; (iii) pledge, hypothecate or grant any security interest in any Shares or Related Securities; (iv) in any other way transfer or dispose of any Shares or Related Securities; (v) enter into any swap, hedge or similar arrangement or agreement that transfers, in whole or in part, the economic risk of ownership of any Shares or Related Securities, regardless of whether any such transaction is to be settled in securities, in cash or otherwise; (vi) announce the offering of any Shares or Related Securities; (vii) file any registration statement under the Securities Act in respect of any Shares or Related Securities (other than as contemplated by this Agreement with respect to the Offered Shares); or (viii) publicly announce the intention to do any of the foregoing; provided, however , that the Company may (A) effect the transactions contemplated hereby, (B) issue Shares, options to purchase Shares or restricted stock units, or issue Shares upon exercise of options, pursuant to any stock option, stock bonus or other stock plan or arrangement described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, provided that the recipients thereof provide to the Representatives a signed Lock-Up Agreement in the form of Exhibit C hereto, (C) issue Shares pursuant to the conversion or exchange of convertible or exchangeable securities or the exercise of warrants or options, in each case outstanding on the date hereof, (D) file a registration statement on Form S-8 to register Shares issuable pursuant to the terms of a stock option, stock bonus or other stock plan or arrangement described in the Registration Statement, Time of Sale Prospectus and the Prospectus and (E) issue Shares in connection with any joint venture, commercial or collaborative relationship or the acquisition or license by the Company of the securities, businesses, property or other assets of another person or entity or pursuant to any employee benefit plan assumed by the Company in connection with any such acquisition; provided, however , that in the case of clause (E), (x) the sum of the aggregate number of shares of common stock of the Company so issued shall not exceed ten percent (10%) of the total outstanding shares of common stock of the Company immediately following the completion of this offering of Offered Securities and (y) the recipients thereof provide to the Representatives a signed Lock-Up Agreement in the form of Exhibit C hereto. For purposes of the foregoing, “ Related Securities ” shall mean any options or warrants or other rights to acquire Shares or any securities exchangeable or exercisable for or convertible into Shares, or to acquire other securities or rights ultimately exchangeable or exercisable for, or convertible into, Shares.

(q) Future Reports to the Representatives. During the period of five years hereafter, the Company will furnish to the Representatives, c/o Jefferies, at 520 Madison Avenue, New York, New York 10022, Attention: Global Head of Syndicate: (i) as soon as practicable after the end of each fiscal year, copies of the Annual Report of the Company containing the balance sheet of the Company as of the close of such fiscal year and statements of income, stockholders’ equity and cash flows for the year then ended and the opinion thereon of the Company’s independent public or certified public accountants; (ii) as soon as practicable after the filing thereof, copies of each proxy statement, Annual Report on Form 10-K, Quarterly Report on Form 10-Q, Current Report on Form 8-K or other public report filed by the Company with the Commission or any securities exchange; and (iii) as soon as available, copies of any report or communication of the Company furnished or made available generally to holders of its capital stock; provided, however, that the requirements of this Section 3(q) shall be satisfied to the extent that such reports, statement, communications, financial statements or other documents are available on EDGAR.

(r) Investment Limitation . The Company shall not invest or otherwise use the proceeds received by the Company from its sale of the Offered Shares in such a manner as would require the Company to register as an investment company under the Investment Company Act.

 

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(s) No Stabilization or Manipulation; Compliance with Regulation M . The Company will not take, and will ensure that no affiliate of the Company will take, directly or indirectly, without giving effect to activities by the Underwriters, any action designed to or that might cause or result in stabilization or manipulation of the price of the Shares or any reference security with respect to the Shares, whether to facilitate the sale or resale of the Offered Shares or otherwise, and the Company will, and shall cause each of its affiliates to, comply with all applicable provisions of Regulation M.

(t) Enforce Lock-Up Agreements . During the Lock-up Period, the Company will enforce all agreements between the Company and any of its security holders that restrict or prohibit, expressly or in operation, the offer, sale or transfer of Shares or Related Securities or any of the other actions restricted or prohibited under the terms of the form of Lock-up Agreement. In addition, the Company will direct the transfer agent to place stop transfer restrictions upon any such securities of the Company that are bound by such “lock-up” agreements for the duration of the Lock-Up Period, including, without limitation, the securities of the Company subject to the “lock-up” agreements entered into by the Company’s officers and directors pursuant to Section 6(i) hereof.

(u) Company to Provide Interim Financial Statements . Prior to the First Closing Date and each applicable Option Closing Date, the Company will furnish the Underwriters, as soon as practicable after they have been prepared by or are available to the Company, a copy of any unaudited interim financial statements of the Company for any period subsequent to the period covered by the most recent financial statements appearing in the Registration Statement and the Prospectus.

(v) Amendments and Supplements to Permitted Section 5(d)Communications . If at any time following the distribution of any Permitted Section 5(d) Communication, during the period when a prospectus relating to the Offered Shares is required by the Securities Act to be delivered (whether physically or through compliance with Rule 172 under the Securities Act or any similar rule), there occurred or occurs an event or development as a result of which such Permitted Section 5(d) Communication included or would include an untrue statement of a material fact or omitted or would omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances existing at that subsequent time, not misleading, the Company will promptly notify the Representatives and, upon the reasonable request of the Representatives, will promptly amend or supplement, at its own expense, such Permitted Section 5(d) Communication to eliminate or correct such untrue statement or omission.

(w) Emerging Growth Company Status . The Company will promptly notify the Representatives if the Company ceases to be an Emerging Growth Company at any time prior to the later of (i) the time when a prospectus relating to the Offered Shares is not required by the Securities Act to be delivered (whether physically or through compliance with Rule 172 under the Securities Act or any similar rule) and (ii) the expiration of the Lock-Up Period (as defined herein).

The Representatives, on behalf of the several Underwriters, may, in their sole discretion, waive in writing the performance by the Company of any one or more of the foregoing covenants or extend the time for their performance.

Section 4. Payment of Expenses. The Company agrees to pay all costs, fees and expenses incurred in connection with the performance of its obligations hereunder and in connection with the transactions contemplated hereby, including without limitation (i) all expenses incident to the issuance and delivery of the Offered Shares (including all printing and engraving costs), (ii) all fees and expenses of the registrar and transfer agent of the Shares, (iii) all necessary issue, transfer and other stamp taxes in connection with the issuance and sale of the Offered Shares to the Underwriters, (iv) all fees and expenses of the Company’s counsel, independent public or certified public accountants and other advisors, (v) all costs and expenses incurred in connection with the preparation, printing, filing, shipping and distribution of the

 

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Registration Statement (including financial statements, exhibits, schedules, consents and certificates of experts), the Time of Sale Prospectus, the Prospectus, each free writing prospectus prepared by or on behalf of, used by, or referred to by the Company, and each preliminary prospectus, each Permitted Section 5(d) Communication, and all amendments and supplements thereto, and this Agreement, (vi) all filing fees, attorneys’ fees and expenses incurred by the Company or the Underwriters in connection with qualifying or registering (or obtaining exemptions from the qualification or registration of) all or any part of the Offered Shares for offer and sale under the state securities or blue sky laws or the provincial securities laws of Canada, and, if requested by the Representatives, preparing and printing a “Blue Sky Survey” or memorandum and a “Canadian wrapper”, and any supplements thereto, advising the Underwriters of such qualifications, registrations and exemptions in an amount not to exceed $10,000, (vii) the costs, fees and expenses incurred by the Underwriters in connection with determining their compliance with the rules and regulations of FINRA related to the Underwriters’ participation in the offering and distribution of the Offered Shares, including any related filing fees and the legal fees of, and disbursements by, counsel to the Underwriters in an amount not to exceed $32,000 (excluding filing fees), (viii) the costs and expenses of the Company relating to investor presentations on any “road show”, any Permitted Section 5(d) Communication or any Section 5(d) Oral Communication undertaken in connection with the offering of the Offered Shares, including, without limitation, expenses associated with the preparation or dissemination of any electronic road show, expenses associated with the production of road show slides and graphics, fees and expenses of any consultants engaged in connection with the road show presentations with the prior approval of the Company, travel and lodging expenses of the representatives, employees and officers of the Company and any such consultants, and 50% of the cost of any aircraft chartered in connection with the road show the remaining 50% of the cost of such aircraft to be paid by the Underwriters, (ix) the fees and expenses associated with listing the Offered Shares on the NASDAQ, (x) all other fees, costs and expenses of the nature referred to in Item 13 of Part II of the Registration Statement and (xi) all costs and expenses of the Underwriters, including the fees and disbursements of counsel for the Underwriters, in connection with matters related to the Directed Shares which are designated by the Company for sale to Participants. Except as provided in this Section 4 or in Section 7, Section 9 or Section 10 hereof, the Underwriters shall pay their own expenses, including the fees and disbursements of their counsel and their own travel and lodging expenses.

Section 5. Covenant of the Underwriters. Each Underwriter severally and not jointly covenants with the Company not to take any action that would result in the Company being required to file with the Commission pursuant to Rule 433(d) under the Securities Act a free writing prospectus prepared by or on behalf of such Underwriter that otherwise would not, but for such actions, be required to be filed by the Company under Rule 433(d).

Section 6. Conditions of the Obligations of the Underwriters. The respective obligations of the several Underwriters hereunder to purchase and pay for the Offered Shares as provided herein on the First Closing Date and, with respect to the Optional Shares, each Option Closing Date, shall be subject to the accuracy of the representations and warranties on the part of the Company set forth in Section 1 hereof as of the date hereof and as of the First Closing Date as though then made and, with respect to the Optional Shares, as of each Option Closing Date as though then made, to the timely performance by the Company of its covenants and other obligations hereunder, and to each of the following additional conditions:

(a) Comfort Letter . On the date hereof, the Representatives shall have received from Crowe Horwath LLP, independent registered public accountants for the Company, a letter dated the date hereof addressed to the Underwriters, in form and substance satisfactory to the Representatives, containing statements and information of the type ordinarily included in accountant’s “comfort letters” to underwriters, delivered according to Statement of Auditing Standards No. 72 (or any successor bulletin), with respect to

 

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the audited and unaudited financial statements and certain financial information contained in the Registration Statement, the Time of Sale Prospectus, and each free writing prospectus, if any.

(b) Compliance with Registration Requirements; No Stop Order; No Objection from FINRA.

(i) The Company shall have filed the Prospectus with the Commission (including the information required by Rule 430A under the Securities Act) in the manner and within the time period required by Rule 424(b) under the Securities Act; or the Company shall have filed a post-effective amendment to the Registration Statement containing the information required by such Rule 430A, and such post-effective amendment shall have become effective.

(ii) No stop order suspending the effectiveness of the Registration Statement or any post-effective amendment to the Registration Statement shall be in effect, and no proceedings for such purpose shall have been instituted or threatened by the Commission.

(iii) FINRA shall have raised no objection to the fairness and reasonableness of the underwriting terms and arrangements.

(c) No Material Adverse Change . For the period from and after the date of this Agreement and through and including the First Closing Date and, with respect to any Optional Shares purchased after the First Closing Date, each Option Closing Date, in the judgment of the Representatives there shall not have occurred any Material Adverse Change.

(d) Opinion of Counsel for the Company . On each of the First Closing Date and each Option Closing Date the Representatives shall have received the opinion of Cooley LLP, counsel for the Company, dated as of such date, in substantially the form attached hereto as Exhibit A .

(e) Opinion of Perkins Coie LLP. On each of the First Closing Date and each Option Closing Date, the Representatives shall have received the opinion of Perkins Coie LLP, counsel for the Company with respect to intellectual property matters, dated as of such date, in substantially the form attached hereto as Exhibit B .

(f) Opinion of Counsel for the Underwriters . On each of the First Closing Date and each Option Closing Date the Representatives shall have received the opinion of Covington & Burling, LLP, counsel for the Underwriters in connection with the offer and sale of the Offered Shares, in form and substance satisfactory to the Underwriters, dated as of such date, with executed copies for each of the other Underwriters named on the Prospectus cover page.

(g) Officers’ Certificate . On each of the First Closing Date and each Option Closing Date, the Representatives shall have received a certificate executed by the Chief Executive Officer or President of the Company and the Chief Financial Officer of the Company, dated as of such date, to the effect set forth in Section 6(b)(ii) and further to the effect that:

(i) for the period from and including the date of this Agreement through and including such date, there has not occurred any Material Adverse Change;

(ii) the representations, warranties and covenants of the Company set forth in Section 1 of this Agreement are true and correct with the same force and effect as though expressly made on and as of such date; and

 

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(iii) the Company has complied with all the agreements hereunder and satisfied all the conditions on its part to be performed or satisfied hereunder at or prior to such date.

(h) Bring-down Comfort Letter . On each of the First Closing Date and each Option Closing Date the Representatives shall have received from Crowe Horwath, LLP, independent registered public accountants for the Company, a letter dated such date, in form and substance satisfactory to the Representatives, which letter shall: (i) reaffirm the statements made in the letter furnished by them pursuant to Section 6(a), except that the specified date referred to therein for the carrying out of procedures shall be no more than three business days prior to the First Closing Date or the applicable Option Closing Date, as the case may be; and (ii) cover certain financial information contained in the Prospectus.

(i) Lock-Up Agreements. On or prior to the date hereof, the Company shall have furnished to the Representatives an agreement in the form of Exhibit C hereto from each director and officer and from certain securityholders of the Company, representing at least 98% of the Company’s outstanding shares as of the date hereof on an as-converted, fully-diluted basis, and each such agreement shall be in full force and effect on each of the First Closing Date and each Option Closing Date.

(j) Rule 462(b) Registration Statement . In the event that a Rule 462(b) Registration Statement is filed in connection with the offering contemplated by this Agreement, such Rule 462(b) Registration Statement shall have been filed with the Commission on the date of this Agreement and shall have become effective automatically upon such filing.

(k) Approval of Listing . At the First Closing Date, the Offered Shares shall have been approved for listing on the NASDAQ, subject only to official notice of issuance.

(l) Additional Documents . On or before each of the First Closing Date and each Option Closing Date, the Representatives and counsel for the Underwriters shall have received such information, documents and opinions as they may reasonably request for the purposes of enabling them to pass upon the issuance and sale of the Offered Shares as contemplated herein, or in order to evidence the accuracy of any of the representations and warranties, or the satisfaction of any of the conditions or agreements, herein contained; and all proceedings taken by the Company in connection with the issuance and sale of the Offered Shares as contemplated herein and in connection with the other transactions contemplated by this Agreement shall be satisfactory in form and substance to the Representatives and counsel for the Underwriters.

If any condition specified in this Section 6 is not satisfied when and as required to be satisfied, this Agreement may be terminated by the Representatives by notice from Jefferies to the Company at any time on or prior to the First Closing Date and, with respect to the Optional Shares, at any time on or prior to the applicable Option Closing Date, which termination shall be without liability on the part of any party to any other party, except that Section 4, Section 7, Section 9 and Section 10 shall at all times be effective and shall survive such termination.

Section 7. Reimbursement of Underwriters’ Expenses . If this Agreement is terminated by the Representatives pursuant to Section 6, Section 11 or Section 12, or if the sale to the Underwriters of the Offered Shares on the First Closing Date is not consummated because of any refusal, inability or failure on the part of the Company to perform any agreement herein or to comply with any provision hereof, the Company agrees to reimburse the Representatives and the other Underwriters (or such Underwriters as have terminated this Agreement with respect to themselves), severally, upon demand for all out-of-pocket expenses that shall have been reasonably incurred by the Representatives and the Underwriters in connection with the proposed purchase and the offering and sale of the Offered Shares, including, but not limited to, fees and disbursements of counsel, printing expenses, travel expenses, postage, facsimile and telephone charges; provided , however, that in the event any such termination is effected after

 

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the First Closing Date but prior to any Option Closing Date with respect to the purchase of any Optional Shares, the Company shall only reimburse the Underwriters for all of their out-of-pocket expenses, including the reasonable fees and disbursements of counsel for the Underwriters, incurred after the First Closing Date in connection with the proposed purchase of any such Optional Shares.

Section 8. Effectiveness of this Agreement . This Agreement shall become effective upon the execution and delivery hereof by the parties hereto.

Section 9. Indemnification .

(a) Indemnification of the Underwriters . The Company agrees to indemnify and hold harmless each Underwriter, its affiliates, directors, officers, employees and agents, and each person, if any, who controls any Underwriter within the meaning of the Securities Act or the Exchange Act against any loss, claim, damage, liability or expense, as incurred, to which such Underwriter or such affiliate, director, officer, employee, agent or controlling person may become subject, under the Securities Act, the Exchange Act, other federal or state statutory law or regulation, or the laws or regulations of foreign jurisdictions where Offered Shares have been offered or sold or at common law or otherwise (including in settlement of any litigation, if such settlement is effected with the written consent of the Company), insofar as such loss, claim, damage, liability or expense (or actions in respect thereof as contemplated below) arises out of or is based upon (A) (i) any untrue statement or alleged untrue statement of a material fact contained in the Registration Statement, or any amendment thereto, or the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading; or (ii) any untrue statement or alleged untrue statement of a material fact included in any preliminary prospectus, the Time of Sale Prospectus, any free writing prospectus that the Company has used, referred to or filed, or is required to file, pursuant to Rule 433(d) of the Securities Act, any Marketing Material, any Section 5(d) Written Communication or the Prospectus (or any amendment or supplement to the foregoing), or the omission or alleged omission to state therein a material fact necessary in order to make the statements, in the light of the circumstances under which they were made, not misleading; or (B) the violation of any laws or regulations of foreign jurisdictions where Offered Shares have been offered or sold; and to reimburse each Underwriter and each such affiliate, director, officer, employee, agent and controlling person for any and all expenses (including the fees and disbursements of counsel) as such expenses are incurred by such Underwriter or such affiliate, director, officer, employee, agent or controlling person in connection with investigating, defending, settling, compromising or paying any such loss, claim, damage, liability, expense or action; provided, however , that the foregoing indemnity agreement shall not apply to any loss, claim, damage, liability or expense to the extent, but only to the extent, arising out of or based upon any untrue statement or alleged untrue statement or omission or alleged omission made in reliance upon and in conformity with information relating to any Underwriter furnished to the Company by the Representatives in writing expressly for use in the Registration Statement, any preliminary prospectus, the Time of Sale Prospectus, any such free writing prospectus, any Marketing Material, any Section 5(d) Written Communication or the Prospectus (or any amendment or supplement thereto), it being understood and agreed that the only such information consists of the information described in Section 9(b) below. The indemnity agreement set forth in this Section 9(a) shall be in addition to any liabilities that the Company may otherwise have.

(b) Indemnification of the Company, its Directors and Officers . Each Underwriter agrees, severally and not jointly, to indemnify and hold harmless the Company, each of its directors, each of its officers who signed the Registration Statement and each person, if any, who controls the Company within the meaning of the Securities Act or the Exchange Act, against any loss, claim, damage, liability or expense, as incurred, to which the Company, or any such director, officer or controlling person may become subject, under the Securities Act, the Exchange Act, or other federal or state statutory law or regulation, or at common law or otherwise (including in settlement of any litigation, if such settlement is effected with the written consent of such Underwriter), insofar as such loss, claim, damage, liability or expense (or actions in

 

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respect thereof as contemplated below) arises out of or is based upon (i) any untrue statement or alleged untrue statement of a material fact contained in the Registration Statement, or any amendment thereto, or any omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading or (ii) any untrue statement or alleged untrue statement of a material fact included in any preliminary prospectus, the Time of Sale Prospectus, any free writing prospectus, that the Company has used, referred to or filed, or is required to file, pursuant to Rule 433 of the Securities Act, any Section 5(d) Written Communication or the Prospectus (or any such amendment or supplement) or the omission or alleged omission to state therein a material fact necessary in order to make the statements, in the light of the circumstances under which they were made, not misleading, in each case to the extent, but only to the extent, that such untrue statement or alleged untrue statement or omission or alleged omission was made in the Registration Statement, such preliminary prospectus, the Time of Sale Prospectus, such free writing prospectus, such Section 5(d) Written Communication or the Prospectus (or any such amendment or supplement), in reliance upon and in conformity with information relating to such Underwriter furnished to the Company by the Representatives in writing expressly for use therein; and to reimburse the Company, or any such director, officer or controlling person for any and all expenses (including the fees and disbursements of counsel) as such expenses are incurred by the Company, or any such director, officer or controlling person in connection with investigating, defending, settling, compromising or paying any such loss, claim, damage, liability, expense or action. The Company hereby acknowledges that the only information that the Representatives have furnished to the Company expressly for use in the Registration Statement, any preliminary prospectus, the Time of Sale Prospectus, any free writing prospectus that the Company has filed, or is required to file, pursuant to Rule 433(d) of the Securities Act, any Section 5(d) Written Communication or the Prospectus (or any amendment or supplement to the foregoing) are the statements set forth in the first sentence of the third and fourth paragraph under the caption “Underwriting,” the first two sentences of the first paragraph below the title “Commission and Expenses,” the first sentence of the first paragraph, the third sentence of the second paragraph and the first sentence of the sixth paragraph below the title “Stabilization” and the first sentence of the paragraph below the title “Electronic Distribution”, in each case under the caption “Underwriting” in the Preliminary Prospectus and the Prospectus. The indemnity agreement set forth in this Section 9(b) shall be in addition to any liabilities that each Underwriter may otherwise have.

(c) Notifications and Other Indemnification Procedures . Promptly after receipt by an indemnified party under this Section 9 of notice of the commencement of any action, such indemnified party will, if a claim in respect thereof is to be made against an indemnifying party under this Section 9, notify the indemnifying party in writing of the commencement thereof, but the omission so to notify the indemnifying party will not relieve the indemnifying party from any liability which it may have to any indemnified party to the extent the indemnifying party is not materially prejudiced as a proximate result of such failure and shall not in any event relieve the indemnifying party from any liability that it may have otherwise than on account of this indemnity agreement. In case any such action is brought against any indemnified party and such indemnified party seeks or intends to seek indemnity from an indemnifying party, the indemnifying party will be entitled to participate in, and, to the extent that it shall elect, jointly with all other indemnifying parties similarly notified, by written notice delivered to the indemnified party promptly after receiving the aforesaid notice from such indemnified party, to assume the defense thereof with counsel reasonably satisfactory to such indemnified party; provided, however , that if the defendants in any such action include both the indemnified party and the indemnifying party and the indemnified party shall have reasonably concluded that a conflict may arise between the positions of the indemnifying party and the indemnified party in conducting the defense of any such action or that there may be legal defenses available to it and/or other indemnified parties which are different from or additional to those available to the indemnifying party, the indemnified party or parties shall have the right to select separate counsel to assume such legal defenses and to otherwise participate in the defense of such action on behalf of such indemnified party or parties. Upon receipt of notice from the indemnifying party to such indemnified party of such indemnifying party’s election so to assume the defense of such action and approval by the indemnified party of counsel, the

 

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indemnifying party will not be liable to such indemnified party under this Section 9 for any legal or other expenses subsequently incurred by such indemnified party in connection with the defense thereof unless (i) the indemnified party shall have employed separate counsel in accordance with the proviso to the preceding sentence (it being understood, however, that the indemnifying party shall not be liable for the fees and expenses of more than one separate counsel (together with local counsel), representing the indemnified parties who are parties to such action), which counsel (together with any local counsel) for the indemnified parties shall be selected by Jefferies (in the case of counsel for the indemnified parties referred to in Section 9(a) above) or by the Company (in the case of counsel for the indemnified parties referred to in Section 9(b) above)) or (ii) the indemnifying party shall not have employed counsel satisfactory to the indemnified party to represent the indemnified party within a reasonable time after notice of commencement of the action or (iii) the indemnifying party has authorized in writing the employment of counsel for the indemnified party at the expense of the indemnifying party, in each of which cases the fees and expenses of counsel shall be at the expense of the indemnifying party and shall be paid as they are incurred.

(d) Settlements . The indemnifying party under this Section 9 shall not be liable for any settlement of any proceeding effected without its written consent, but if settled with such consent or if there be a final judgment for the plaintiff, the indemnifying party agrees to indemnify the indemnified party against any loss, claim, damage, liability or expense by reason of such settlement or judgment. Notwithstanding the foregoing sentence, if at any time an indemnified party shall have requested an indemnifying party to reimburse the indemnified party for fees and expenses of counsel as contemplated by Section 9(c) hereof, the indemnifying party shall be liable for any settlement of any proceeding effected without its written consent if (i) such settlement is entered into more than 60 days after receipt by such indemnifying party of the aforesaid request and (ii) such indemnifying party shall not have reimbursed the indemnified party in accordance with such request prior to the date of such settlement. No indemnifying party shall, without the prior written consent of the indemnified party, effect any settlement, compromise or consent to the entry of judgment in any pending or threatened action, suit or proceeding in respect of which any indemnified party is or could have been a party and indemnity was or could have been sought hereunder by such indemnified party, unless such settlement, compromise or consent includes an unconditional release of such indemnified party from all liability on claims that are the subject matter of such action, suit or proceeding and does not include an admission of fault or culpability or a failure to act by or on behalf of such indemnified party.

(e) Indemnification for Directed Shares . In connection with the offer and sale of the Directed Shares, the Company agrees, promptly upon a request in writing, to indemnify and hold harmless the Underwriters from and against any and all losses, liabilities, claims, damages and expenses incurred by any of them as a result of the failure of the Participants to pay for and accept delivery of Directed Shares which, by the end of the first business day following the date of this Agreement, were subject to a properly confirmed agreement to purchase. The Company agrees to indemnify and hold harmless the Underwriters and their respective affiliates, directors, officers, employees and agents, and each person, if any, who controls any of the Underwriters within the meaning of the Securities Act or the Exchange Act against any loss, claim, damage, liability or expense, as incurred, to which the Underwriters or such controlling person may become subject, which is (i) caused by any untrue statement or alleged untrue statement of a material fact contained in any material prepared by or with the consent of the Company for distribution to Participants in connection with the Directed Share Program (including any prospectus wrapper material distributed in connection with the reservation and sale of Directed Shares) or caused by any omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading; (ii) caused by the failure of any Participant to pay for and accept delivery of Directed Shares that such Participant agreed to purchase; or (iii) related to, arising out of, or in connection with the Directed Share Program. The indemnity agreement set forth in this paragraph shall be in addition to any liabilities that the Company may otherwise have.

 

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Section 10. Contribution . If the indemnification provided for in Section 9 is for any reason held to be unavailable to or otherwise insufficient to hold harmless an indemnified party in respect of any losses, claims, damages, liabilities or expenses referred to therein, then each indemnifying party shall contribute to the aggregate amount paid or payable by such indemnified party, as incurred, as a result of any losses, claims, damages, liabilities or expenses referred to therein (i) in such proportion as is appropriate to reflect the relative benefits received by the Company, on the one hand, and the Underwriters, on the other hand, from the offering of the Offered Shares pursuant to this Agreement or (ii) if the allocation provided by clause (i) above is not permitted by applicable law, in such proportion as is appropriate to reflect not only the relative benefits referred to in clause (i) above but also the relative fault of the Company, on the one hand, and the Underwriters, on the other hand, in connection with the statements or omissions which resulted in such losses, claims, damages, liabilities or expenses, as well as any other relevant equitable considerations. The relative benefits received by the Company, on the one hand, and the Underwriters, on the other hand, in connection with the offering of the Offered Shares pursuant to this Agreement shall be deemed to be in the same respective proportions as the total proceeds from the offering of the Offered Shares pursuant to this Agreement (before deducting expenses) received by the Company, and the total underwriting discounts and commissions received by the Underwriters, in each case as set forth on the front cover page of the Prospectus, bear to the aggregate initial public offering price of the Offered Shares as set forth on such cover. The relative fault of the Company, on the one hand, and the Underwriters, on the other hand, shall be determined by reference to, among other things, whether any such untrue or alleged untrue statement of a material fact or omission or alleged omission to state a material fact relates to information supplied by the Company, on the one hand, or the Underwriters, on the other hand, and the parties’ relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission.

The amount paid or payable by a party as a result of the losses, claims, damages, liabilities and expenses referred to above shall be deemed to include, subject to the limitations set forth in Section 9(c), any legal or other fees or expenses reasonably incurred by such party in connection with investigating or defending any action or claim. The provisions set forth in Section 9(c) with respect to notice of commencement of any action shall apply if a claim for contribution is to be made under this Section 10; provided, however, that no additional notice shall be required with respect to any action for which notice has been given under Section 9(c) for purposes of indemnification.

The Company and the Underwriters agree that it would not be just and equitable if contribution pursuant to this Section 10 were determined by pro rata allocation (even if the Underwriters were treated as one entity for such purpose) or by any other method of allocation which does not take account of the equitable considerations referred to in this Section 10.

Notwithstanding the provisions of this Section 10, no Underwriter shall be required to contribute any amount in excess of the underwriting discounts and commissions received by such Underwriter in connection with the Offered Shares underwritten by it and distributed to the public. No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation. The Underwriters’ obligations to contribute pursuant to this Section 10 are several, and not joint, in proportion to their respective underwriting commitments as set forth opposite their respective names on Schedule A . For purposes of this Section 10, each affiliate, director, officer, employee and agent of an Underwriter and each person, if any, who controls an Underwriter within the meaning of the Securities Act or the Exchange Act shall have the same rights to contribution as such Underwriter, and each director of the Company, each officer of the Company who signed the Registration Statement, and each person, if any, who controls the Company within the meaning of the Securities Act and the Exchange Act shall have the same rights to contribution as the Company.

 

26


Section 11. Default of One or More of the Several Underwriters . If, on the First Closing Date or any Option Closing Date any one or more of the several Underwriters shall fail or refuse to purchase Offered Shares that it or they have agreed to purchase hereunder on such date, and the aggregate number of Offered Shares which such defaulting Underwriter or Underwriters agreed but failed or refused to purchase does not exceed 10% of the aggregate number of the Offered Shares to be purchased on such date, the Representatives may make arrangements satisfactory to the Company for the purchase of such Offered Shares by other persons, including any of the Underwriters, but if no such arrangements are made by such date, the other Underwriters shall be obligated, severally and not jointly, in the proportions that the number of Firm Shares set forth opposite their respective names on Schedule A bears to the aggregate number of Firm Shares set forth opposite the names of all such non-defaulting Underwriters, or in such other proportions as may be specified by the Representatives with the consent of the non-defaulting Underwriters, to purchase the Offered Shares which such defaulting Underwriter or Underwriters agreed but failed or refused to purchase on such date. If, on the First Closing Date or any Option Closing Date any one or more of the Underwriters shall fail or refuse to purchase Offered Shares and the aggregate number of Offered Shares with respect to which such default occurs exceeds 10% of the aggregate number of Offered Shares to be purchased on such date, and arrangements satisfactory to the Representatives and the Company for the purchase of such Offered Shares are not made within 48 hours after such default, this Agreement shall terminate without liability of any party to any other party except that the provisions of Section 4, Section 7, Section 9 and Section 10 shall at all times be effective and shall survive such termination. In any such case either the Representatives or the Company shall have the right to postpone the First Closing Date or the applicable Option Closing Date, as the case may be, but in no event for longer than seven days in order that the required changes, if any, to the Registration Statement and the Prospectus or any other documents or arrangements may be effected.

As used in this Agreement, the term “ Underwriter ” shall be deemed to include any person substituted for a defaulting Underwriter under this Section 11. Any action taken under this Section 11 shall not relieve any defaulting Underwriter from liability in respect of any default of such Underwriter under this Agreement.

Section 12. Termination of this Agreement . Prior to the purchase of the Firm Shares by the Underwriters on the First Closing Date, this Agreement may be terminated by Jefferies and Credit Suisse by notice given to the Company if at any time: (i) trading or quotation in any of the Company’s securities shall have been suspended or limited by the Commission or by NASDAQ, or trading in securities generally on either the NASDAQ or the New York Stock Exchange shall have been suspended or limited, or minimum or maximum prices shall have been generally established on any of such stock exchanges; (ii) a general banking moratorium shall have been declared by any of federal, New York or Delaware authorities; (iii) there shall have occurred any outbreak or escalation of national or international hostilities or any crisis or calamity, or any change in the United States or international financial markets, or any substantial change or development involving a prospective substantial change in United States’ or international political, financial or economic conditions, as in the judgment of Jefferies and Credit Suisse is material and adverse and makes it impracticable to market the Offered Shares in the manner and on the terms described in the Time of Sale Prospectus or the Prospectus or to enforce contracts for the sale of securities; (iv) in the judgment of Jefferies and Credit Suisse there shall have occurred any Material Adverse Change; or (v) the Company shall have sustained a loss by strike, fire, flood, earthquake, accident or other calamity of such character as in the judgment of Jefferies and Credit Suisse may interfere materially with the conduct of the business and operations of the Company regardless of whether or not such loss shall have been insured. Any termination pursuant to this Section 12 shall be without liability on the part of (a) the Company to any Underwriter, except that the Company shall be obligated to reimburse the expenses of the Representatives and the Underwriters pursuant to Section 4 or Section 7 hereof or (b) any Underwriter to the Company; provided, however, that the provisions of Section 9 and Section 10 shall at all times be effective and shall survive such termination.

 

27


Section 13. No Advisory or Fiduciary Relationship. The Company acknowledges and agrees that (a) the purchase and sale of the Offered Shares pursuant to this Agreement, including the determination of the public offering price of the Offered Shares and any related discounts and commissions, is an arm’s-length commercial transaction between the Company, on the one hand, and the several Underwriters, on the other hand, (b) in connection with the offering contemplated hereby and the process leading to such transaction, each Underwriter is and has been acting solely as a principal and is not the agent or fiduciary of the Company, or its stockholders, or its creditors, employees or any other party, (c) no Underwriter has assumed or will assume an advisory or fiduciary responsibility in favor of the Company with respect to the offering contemplated hereby or the process leading thereto (irrespective of whether such Underwriter has advised or is currently advising the Company on other matters) and no Underwriter has any obligation to the Company with respect to the offering contemplated hereby except the obligations expressly set forth in this Agreement, (d) the Underwriters and their respective affiliates may be engaged in a broad range of transactions that involve interests that differ from those of the Company, and (e) the Underwriters have not provided any legal, accounting, regulatory or tax advice with respect to the offering contemplated hereby and the Company has consulted its own legal, accounting, regulatory and tax advisors to the extent it deemed appropriate.

Section 14. Representations and Indemnities to Survive Delivery . The respective indemnities, agreements, representations, warranties and other statements of the Company, of its officers and of the several Underwriters set forth in or made pursuant to this Agreement will remain in full force and effect, regardless of any investigation made by or on behalf of any Underwriter or the Company or any of its or their partners, officers or directors or any controlling person, as the case may be, and, anything herein to the contrary notwithstanding, will survive delivery of and payment for the Offered Shares sold hereunder and any termination of this Agreement.

Section 15. Notices . All communications hereunder shall be in writing and shall be mailed, hand delivered or telecopied and confirmed to the parties hereto as follows:

 

If to the Representatives:    Jefferies LLC
   520 Madison Avenue
   New York, New York 10022
   Facsimile: (646) 619-4437
   Attention: General Counsel
   Credit Suisse Securities (USA) LLC
   Eleven Madison Avenue
   New York, New York 10010
   Attention: LCD-IBD
with a copy to:    Covington & Burling LLP
   620 Eighth Avenue
   New York, NY 10018
   Attention: Donald J. Murray
If to the Company:    Kite Pharma, Inc.
   2225 Colorado Avenue
   Santa Monica, CA 90904
   Facsimile: (310) 824-9994
   Attention: Cynthia M. Butitta

 

28


with a copy to:    Cooley LLP
   4401 Eastgate Mall
   San Diego, CA 92121-1909
   Facsimile: (858) 550-6420
   Attention: Charles S. Kim
                    Charles J. Bair

Any party hereto may change the address for receipt of communications by giving written notice to the others.

Section 16. Successors . This Agreement will inure to the benefit of and be binding upon the parties hereto, including any substitute Underwriters pursuant to Section 11 hereof, and to the benefit of the affiliates, directors, officers, employees, agents and controlling persons referred to in Section 9 and Section 10, and in each case their respective successors, and personal representatives, and no other person will have any right or obligation hereunder. The term “ successors ” shall not include any purchaser of the Offered Shares as such from any of the Underwriters merely by reason of such purchase.

Section 17. Partial Unenforceability . The invalidity or unenforceability of any section, paragraph or provision of this Agreement shall not affect the validity or enforceability of any other section, paragraph or provision hereof. If any section, paragraph or provision of this Agreement is for any reason determined to be invalid or unenforceable, there shall be deemed to be made such minor changes (and only such minor changes) as are necessary to make it valid and enforceable.

Section 18. Governing Law Provisions . This Agreement shall be governed by and construed in accordance with the internal laws of the State of New York applicable to agreements made and to be performed in such state. Any legal suit, action or proceeding arising out of or based upon this Agreement or the transactions contemplated hereby (“ Related Proceedings ”) may be instituted in the federal courts of the United States of America located in the Borough of Manhattan in the City of New York or the courts of the State of New York in each case located in the Borough of Manhattan in the City of New York (collectively, the “ Specified Courts ”), and each party irrevocably submits to the exclusive jurisdiction (except for proceedings instituted in regard to the enforcement of a judgment of any such court (a “ Related Judgment ”), as to which such jurisdiction is non-exclusive) of such courts in any such suit, action or proceeding. Service of any process, summons, notice or document by mail to such party’s address set forth above shall be effective service of process for any suit, action or other proceeding brought in any such court. The parties irrevocably and unconditionally waive any objection to the laying of venue of any suit, action or other proceeding in the Specified Courts and irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such suit, action or other proceeding brought in any such court has been brought in an inconvenient forum.

Section 19. General Provisions. This Agreement constitutes the entire agreement of the parties to this Agreement and supersedes all prior written or oral and all contemporaneous oral agreements, understandings and negotiations with respect to the subject matter hereof. This Agreement may be executed in two or more counterparts, each one of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument. This Agreement may not be amended or modified unless in writing by all of the parties hereto, and no condition herein (express or implied) may be waived unless waived in writing by each party whom the condition is meant to benefit. The section headings herein are for the convenience of the parties only and shall not affect the construction or interpretation of this Agreement.

Each of the parties hereto acknowledges that it is a sophisticated business person who was adequately represented by counsel during negotiations regarding the provisions hereof, including, without

 

29


limitation, the indemnification provisions of Section 9 and the contribution provisions of Section 10, and is fully informed regarding said provisions. Each of the parties hereto further acknowledges that the provisions of Section 9 and Section 10 hereof fairly allocate the risks in light of the ability of the parties to investigate the Company, its affairs and its business in order to assure that adequate disclosure has been made in the Registration Statement, any preliminary prospectus, the Time of Sale Prospectus, each free writing prospectus and the Prospectus (and any amendments and supplements to the foregoing), as contemplated by the Securities Act and the Exchange Act.

[signature pages follow]

 

30


If the foregoing is in accordance with your understanding of our agreement, kindly sign and return to the Company the enclosed copies hereof, whereupon this instrument, along with all counterparts hereof, shall become a binding agreement in accordance with its terms.

 

Very truly yours,
KITE PHARMA, INC.
By:  

 

Name:  
Title:  

 

31


The foregoing Underwriting Agreement is hereby confirmed and accepted by the Representatives in New York, New York as of the date first above written.

JEFFERIES LLC

CREDIT SUISSE SECURITIES (USA) LLC

Acting individually and as Representatives

of the several Underwriters named in

the attached Schedule A .

 

JEFFERIES LLC
By:  

 

Name:  
Title:  
CREDIT SUISSE SECURITIES (USA) LLC
By:  

 

Name:  
Title:  

 

32


Schedule A

 

Underwriters   

Number of

Firm Shares

to be Purchased

 
Jefferies LLC      [ ]   
Credit Suisse Securities (USA) LLC      [ ]   
Cowen and Company, LLC      [ ]   
Stifel, Nicolaus & Company, Incorporated      [ ]   
  

 

 

 

Total

             [ ]           
  

 

 

 


Schedule B

Free Writing Prospectuses Included in the Time of Sale Prospectus

[to be added]

Pricing Information Included in the Time of Sale Prospectus


Schedule C

Permitted Section 5(d) Communications

[to be added]


Exhibit A

Form of Opinion of Company Counsel

 

C1-1


Exhibit B

Form of Opinion of Perkins Coie

 

C1-2


Exhibit C

Form of Lock-up Agreement

[Date]

Jefferies LLC

Credit Suisse Securities (USA) LLC

As Representatives of the Several Underwriters

c/o Jefferies LLC

520 Madison Avenue

New York, New York 10022

and

c/o Credit Suisse Securities (USA) LLC

Eleven Madison Avenue

New York, New York 10010

 

RE: Kite Pharma, Inc. (the “Company”)

Ladies & Gentlemen:

The undersigned is an owner of shares of common stock, par value $.001 per share, of the Company (“Shares”) or of securities convertible into or exchangeable or exercisable for Shares. The Company proposes to conduct a public offering of Shares (the “Offering”) for which Jefferies LLC (“Jefferies”) and Credit Suisse Securities (USA) LLC (“Credit Suisse”) will act as the Representatives of the underwriters. The undersigned recognizes that the Offering will benefit each of the Company and the undersigned. The undersigned acknowledges that the underwriters are relying on the representations and agreements of the undersigned contained in this letter agreement in conducting the Offering and, at a subsequent date, in entering into an underwriting agreement (the “Underwriting Agreement”) and other underwriting arrangements with the Company with respect to the Offering.

Annex A sets forth definitions for capitalized terms used in this letter agreement that are not defined in the body of this agreement. Those definitions are a part of this agreement.

In consideration of the foregoing, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the undersigned hereby agrees that, during the Lock-up Period, the undersigned will not (and will cause any Family Member not to), without the prior written consent of Jefferies and Credit Suisse which may withhold their consentin their sole discretion:

 

    Sell or Offer to Sell any Shares or Related Securities currently or hereafter owned either of record or beneficially (as defined in Rule 13d-3 under the Exchange Act) by the undersigned or such Family Member,

 

    enter into any Swap,

 

D -1


    make any demand for, or exercise any right with respect to, the registration under the Securities Act of the offer and sale of any Shares or Related Securities, or cause to be filed a registration statement, prospectus or prospectus supplement (or an amendment or supplement thereto) with respect to any such registration, or

 

    publicly announce any intention to do any of the foregoing.

The foregoing will not apply to the registration of the offer and sale of the Shares, and the sale of the Shares to the underwriters, in each case as contemplated by the Underwriting Agreement. In addition, the foregoing restrictions shall not apply to (i) the transfer of Shares or Related Securities by gift, (ii) the transfer of Shares or Related Securities by will, other testamentary document or intestate succession to a legal representative, heir or beneficiary, (iii) the transfer of Shares or Related Securities to a trust whose beneficiaries consist exclusively of one or more of the undersigned and/or a Family Member, (iv) transfers or dispositions of the undersigned’s Shares or Related Securities to any corporation, partnership, limited liability company or other entity all of the beneficial ownership interests of which are held by the undersigned or any Family Member, (v) distributions of the undersigned’s Shares or Related Securities to partners, members, stockholders or trust beneficiaries of the undersigned, (vi) if the undersigned is a corporation, partnership, limited liability company, trust or other business entity, the transfer of Shares or Related Securities to another corporation, partnership, limited liability company, trust or other business entity that is a direct or indirect affiliate (as defined in Rule 405 promulgated under the Securities Act of 1933, as amended) of the undersigned; provided, however, that in any such case, it shall be a condition to such transfer that:

 

    each transferee executes and delivers to Jefferies and Credit Suisse an agreement in form and substance satisfactory to Jefferies and Credit Suisse stating that such transferee or distributee is receiving and holding such Shares and/or Related Securities subject to the provisions of this letter agreement and agrees not to Sell or Offer to Sell such Shares and/or Related Securities, engage in any Swap or engage in any other activities restricted under this letter agreement except in accordance with this letter agreement (as if such transferee or distributee had been an original signatory hereto), and

 

    prior to the expiration of the Lock-up Period, no public disclosure or filing under the Exchange Act by any party to the transfer (donor, donee, transferor or transferee) shall be required, or made voluntarily, reporting a reduction in beneficial ownership of Shares in connection with such transfer.

Furthermore, notwithstanding the restrictions imposed by this letter agreement, the undersigned may (i) exercise an option to purchase Shares granted under any equity incentive plan or stock purchase plan of the Company, provided that the Shares issued upon such exercise shall continue to be subject to the restrictions on transfer set forth in this letter agreement, (ii) establish a trading plan pursuant to Rule 10b5-1 under the Exchange Act for the transfer of Shares, provided that such plan does not provide for any transfers of Shares during the Lock-up Period and the entry into such plan is not publicly disclosed, including in any filing under the Exchange Act, during the Lock-up Period (iii) transfer or dispose of Shares acquired on the open market following the Offering, (iv) transfer Shares or Related Securities (A) as forfeitures to satisfy tax withholding obligations of the undersigned in connection with the vesting or exercise of equity awards by the undersigned pursuant to the Company’s equity incentive plan, (B) pursuant to a net exercise or cashless exercise by the undersigned of outstanding equity awards pursuant to the Company’s equity incentive plan, provided that any Shares acquired upon the net exercise or cashless exercise of equity awards described in this clause (B) shall be subject to the restrictions set forth in this letter agreement, (C) pursuant to a bona fide third-party tender offer for all outstanding shares of the Company, merger, consolidation or other similar transaction made to all holders of the Company’s securities involving a change of control of the Company (including, without limitation, the entering into any lock-up, voting or similar agreement pursuant to which the undersigned may agree to transfer, sell, tender or otherwise dispose of common stock or other such securities in connection with such transaction, or vote any common stock or other such securities in favor of

 

D -2


any such transaction), provided that in the event that such tender offer, merger, consolidation or other such transaction is not completed, such securities held by the undersigned shall remain subject to the provisions of this letter agreement, (C) by operation of law, including pursuant to a domestic order or negotiated divorce settlement, or (D) that may be deemed to have occurred as a result of the conversion of the outstanding preferred shares of the Company into shares of common stock or the exercise of warrants; provided that, in the case of a transfer pursuant to clause (A) above, if the undersigned is required to make a filing under the Exchange Act reporting a reduction in beneficial ownership of Shares during the Lock-up Period, the undersigned shall include a statement in such report to the effect that the purpose of such transfer was to cover tax obligations of the undersigned in connection with such exercise; and further provided that, in the case of a transfer pursuant to clause (iii) or clause (B) above, that no public disclosure or filing under the Exchange Act by any party to the transfer shall be required, or made voluntarily, during the Lock-up Period.

In addition, if the undersigned is an officer or director of the Company, (i) Jefferies and Credit Suisse agree that, at least three business days before the effective date of any release or waiver of the foregoing restrictions in connection with a transfer of Shares, Jefferies and/or Credit Suisse will notify the Company of the impending release or waiver, and (ii) the Company (in accordance with the provisions of the Underwriting Agreement) will announce the impending release or waiver by press release through a major news service at least two business days before the effective date of the release or waiver. Any release or waiver granted by Jefferies and Credit Suisse hereunder to any such officer or director shall only be effective two business days after the publication date of such press release. The provisions of this paragraph will not apply if both (a) the release or waiver is effected solely to permit a transfer not for consideration and (b) the transferee has agreed in writing to be bound by the same terms described in this letter agreement that are applicable to the transferor to the extent and for the duration that such terms remain in effect at the time of the transfer.

The undersigned also agrees and consents to the entry of stop transfer instructions with the Company’s transfer agent and registrar against the transfer of Shares or Related Securities held by the undersigned and the undersigned’s Family Members, if any, except in compliance with the foregoing restrictions.

With respect to the Offering only, the undersigned waives any registration rights relating to registration under the Securities Act of the offer and sale of any Shares and/or any Related Securities owned either of record or beneficially by the undersigned, including any rights to receive notice of the Offering.

The undersigned confirms that the undersigned has not, and has no knowledge that any Family Member has, directly or indirectly, taken any action designed to or that might reasonably be expected to cause or result in the stabilization or manipulation of the price of any security of the Company to facilitate the sale of the Shares. The undersigned will not, and will cause any Family Member not to take, directly or indirectly, any such action.

Whether or not the Offering occurs as currently contemplated or at all depends on market conditions and other factors. The Offering will only be made pursuant to the Underwriting Agreement, the terms of which are subject to negotiation between the Company and the underwriters.

The undersigned hereby represents and warrants that the undersigned has full power, capacity and authority to enter into this letter agreement. This letter agreement is irrevocable and will be binding on the undersigned and the successors, heirs, personal representatives and assigns of the undersigned.

If (i) the Company notifies the Representatives in writing that it does not intend to proceed with the Offering, (ii) the Underwriting Agreement is not executed before December 31, 2014, (iii) the purchase of Firm Shares (as defined in the Underwriting Agreement) does not occur by December 31, 2014 or (iv) the Underwriting Agreement (other than the provisions thereof that survive termination) terminates or is terminated prior to

 

D -3


payment for and delivery of the Firm Shares, then in each case, this letter agreement shall automatically, and without any action on the part of any other party, terminate and be of no further force and effect, and the undersigned shall automatically be released from the obligations under this letter agreement.

This letter agreement shall be governed by, and construed in accordance with, the laws of the State of New York.

 

Very truly yours,

 

Name of Security Holder (Print exact name )
By:  

 

  Signature
If not signing in an individual capacity:

 

Name of Authorized Signatory (Print )

 

Title of Authorized Signatory (Print )
(indicate capacity of person signing if signing as custodian, trustee, or on behalf of an entity)

 

D -4


Annex A

Certain Defined Terms

Used in Lock-up Agreement

For purposes of the letter agreement to which this Annex A is attached and of which it is made a part:

 

    “Call Equivalent Position” shall have the meaning set forth in Rule 16a-1(b) under the Exchange Act.

 

    “Exchange Act” shall mean the Securities Exchange Act of 1934, as amended.

 

    “Family Member” shall mean the spouse of the undersigned, an immediate family member of the undersigned or an immediate family member of the undersigned’s spouse, in each case living in the undersigned’s household or whose principal residence is the undersigned’s household (regardless of whether such spouse or family member may at the time be living elsewhere due to educational activities, health care treatment, military service, temporary internship or employment or otherwise). “Immediate family member” as used above shall have the meaning set forth in Rule 16a-1(e) under the Exchange Act.

 

    “Lock-up Period” shall mean the period beginning on the date hereof and continuing through the close of trading on the date that is 180 days after the date of the Prospectus (as defined in the Underwriting Agreement).

 

    “Put Equivalent Position” shall have the meaning set forth in Rule 16a-1(h) under the Exchange Act.

 

    “Related Securities” shall mean any options or warrants or other rights to acquire Shares or any securities exchangeable or exercisable for or convertible into Shares, or to acquire other securities or rights ultimately exchangeable or exercisable for or convertible into Shares.

 

    “Securities Act” shall mean the Securities Act of 1933, as amended.

 

    “Sell or Offer to Sell” shall mean to:

 

    sell, offer to sell, contract to sell or lend,

 

    effect any short sale or establish or increase a Put Equivalent Position or liquidate or decrease any Call Equivalent Position

 

    pledge, hypothecate or grant any security interest in, or

 

    in any other way transfer or dispose of,

in each case whether effected directly or indirectly.

 

    “Swap” shall mean any swap, hedge or similar arrangement or agreement that transfers, in whole or in part, the economic risk of ownership of Shares or Related Securities, regardless of whether any such transaction is to be settled in securities, in cash or otherwise.

Capitalized terms not defined in this Annex A shall have the meanings given to them in the body of this lock-up agreement.

 

D -5

Exhibit 10.9

July 17, 2013

Margo Roberts, Ph.D.

511 Tulip Tree Ct

Charlottesville, VA 22903

 

Re: Employment Letter

Dear Dr. Roberts:

Kite Pharma, Inc. (“Kite” or the “Company”) is pleased to offer you the position of Vice President, Research on the following terms and conditions:

 

  1. Title; Reporting; Duties .

 

  (a) You shall serve as VP, Research for the Company and shall have such powers and perform such duties as are customarily performed by the VP, Research of a similarly situated company including, but not limited to:

 

  (i) Developing and executing the Company’s basic, translational, pre-clinical and product research activities including the development of strategic and tactical research and development plans;

 

  (ii) Developing relationships with external scientific academic and industry leaders in appropriate research fields to identify new technologies, targets and product ideas as well as potential problem areas, and arranging for scientific advisory meetings;

 

  (iii) Working closely with the clinical, process development, quality and regulatory teams to bring progress product candidates through the development program in preparation for IND submissions;

 

  (iv) Developing an infrastructure to support research objectives consistent with the Company’s business plans;

 

  (v) Preparing research and development and timelines for each project,

 

  (vi) Recruiting and managing research team and assuming responsibility for financial resources within approved plans and budgets;

 

  (vii) Gaining knowledge of competitors and other developments in relevant therapeutic areas;

 

  (viii) Representing the Company at scientific conferences, presentations, industry and investment groups;

 

  (ix) Establishing partnerships with the international scientific communities; and

 

  (x)

Participating and representing the Company as necessary in regulatory, partnering


  and financing activities (presentations, due diligence, etc.).

 

  (b) You shall also have such other powers and duties as may be from time to time directed by the Chief Executive Officer of Kite.

 

  (c) You shall devote substantially all of your business time, attention and energies to the business and affairs of Kite and shall not during the term of your employment be actively engaged in any other business activity, whether or not such business activity is pursued for gain, profit or other pecuniary advantage, that will interfere with the performance of your duties or your availability to perform such duties or that will adversely affect, or negatively reflect upon, Kite.

 

  (d) You shall report directly to Kite’s President and Chief Executive Officer.

 

  (e) Your duties shall be performed primarily at Kite’s office, which is currently located 2225 Colorado Avenue, Santa Monica, CA 90404.

 

  (f) Notwithstanding the foregoing, the Company may change your title, position, duties, supervisor and work location from time to time as it deems appropriate.

 

  2. Start Date . Your employment shall commence on August 19, 2013, or such other date as may be agreed to by you and Kite.

 

  3. Base Salary . You shall receive an annual base salary equal to Two Hundred Fifty Thousand Dollars ($250,000) minus all required deductions and withholdings, payable in accordance with Kite’s payroll practices.

 

  4. Performance Bonus . You shall be entitled to receive an annual cash bonus in an amount up to twenty percent (20%) of your Base Salary in the event of exceptional performance and successful achievement of agreed upon performance goals and milestones.

 

  5. Options . Kite shall grant to you an incentive stock option to purchase One Hundred Fifty Thousand (150,000) shares of the Kite’s common stock pursuant to Kite’s 2009 Stock Option Plan (the “Options”). The Options shall have an exercise price per share equal to the fair market value of Kite’s common stock, as determined by Kite’s Board of Directors. The Options shall be subject to the terms and conditions of the Plan and shall vest and become exercisable as follows:

 

  (a) 25% of the Options shall vest upon the first anniversary date of your Start Date (as defined below); and thereafter

 

  (b) The remaining Options shall vest in 36 equal monthly installments as of each subsequent one-month anniversary of the Effective Date.

 

  6. Expenses .

 

  (a) Kite will reimburse you for all normal, usual and necessary expenses incurred in furtherance of the business and affairs of Kite upon timely receipt by Kite of appropriate vouchers or other proof of your expenditures and otherwise in accordance with any expense reimbursement policy as may from time to time be adopted by Kite.

 

2


  (b) Kite shall reimburse you in an amount up to $20,000 for covered/allowable expenses incurred in connection with your relocating to an area in closer proximity to Kite’s office location subject to receipt of appropriate documentation of such expenses.

 

  7. Benefits . You shall be entitled to health, dental, disability and any other benefits made available to senior executives of Kite.

 

  8. Vacation . During each year of your employment you shall be entitled to three (3) weeks of vacation in addition to company recognized holidays. Notwithstanding the foregoing, you shall not be entitled to take more than two consecutive weeks of vacation.

 

  9. Non-Solicitation . During the term of your employment with Kite, and for a period of one year thereafter, you will not, directly or indirectly, without Kite’s prior written consent, solicit or induce any employee of Kite or any of its subsidiaries to leave the employ of Kite or such subsidiaries.

 

  10. Representations and Warranties . You hereby represent and warrant as follows:

 

  (a) Neither the execution and delivery of this letter nor the performance of your duties and other obligations hereunder violate or will violate any statute or law or conflict with or constitute a default or breach of any covenant or obligation, including without limitation any non-competition restrictions, under any prior employment agreement, contract, or other instrument to which you are a party or by which you are bound (whether immediately, upon the giving of notice or lapse of time or both).

 

  (b) You have the full right, power and legal capacity to enter and deliver this agreement and to perform your duties and other obligations hereunder. This agreement constitutes the legal, valid and binding obligation of the parties enforceable against each in accordance with its terms. No approvals or consents of any persons or entities are required for you to execute and deliver this letter agreement or perform your duties and other obligations hereunder.

 

  11. Conditions to Employment . This offer of employment is contingent upon, and your employment shall be subject to:

 

  (a) execution of Kite’s form of Proprietary Information and Invention Assignment Agreement attached hereto as Exhibit A , which prohibits unauthorized use or disclosure of Kite’s proprietary information;

 

  (b) completion of a background examination to the reasonable satisfaction of Kite; and

 

  (c) satisfying the requirements of the Immigration Control and Reform Act, which may be accomplished by showing your proof of right to work in the U.S. within three days of commencing employment (e.g., an original drivers license and social security card, or a passport).

 

  (d) Notwithstanding the foregoing, this offer may be withdrawn by Kite at any time prior to its execution by Kite’s Chief Executive Officer.

 

  12.

Termination . Your employment shall be at-will. Accordingly, you may terminate your employment with Kite at any time and for any reason whatsoever, simply by notifying Kite in

 

3


  writing. Similarly, Kite may terminate your employment at any time and for any reason whatsoever, with or without cause or advance notice. This at-will relationship cannot be changed except in a writing signed by the Chief Executive Officer of Kite. The employment terms contained in this letter agreement supersede any other agreements and promises made to you by Kite, whether oral or written.

 

  13. Severance . In the event that your employment is terminated by Kite without Cause (as defined below) during the first year of your employment, then upon such termination Kite shall pay you any accrued but unpaid Base Salary and any accrued and unused vacation benefits through the date of termination, at the rate in effect at the time of termination. In addition, Kite shall continue to pay your Base Salary at the rate in effect at the time of termination for a period of 180 days following termination. For purposes of this Agreement, “Cause” shall mean any of the following:

 

  (a) Your willful failure to adequately perform the material duties or obligations hereunder, or your willful misconduct in respect of such duties or obligations, including, without limitation, your willful failure, disregard or refusal to abide by specific objective and lawful directions received in writing from Kite’s Chief Executive Officer;

 

  (b) any willful, intentional or grossly negligent act by you having the reasonably foreseeable effect of actually and substantially injuring, whether financial or otherwise, the business reputation of Kite;

 

  (c) Your indictment of any felony;

 

  (d) Your being convicted of a misdemeanor involving moral turpitude that causes, or could reasonably be expected to cause, substantial harm to Kite or its reputation;

 

  (e) the determination by Kite, after a reasonable and good-faith investigation following a written allegation by another employee of Kite, that you engaged in some form of harassment prohibited by law (including, without limitation, age, sex or race discrimination); provided, however, that Cause shall not exist under this Section 13(e) unless Kite gives you written notice where such notice describes with particularity the alleged act(s) at issue and has given you an opportunity to be heard at a meeting with Kite’s senior management with or without counsel, and Kite provides you with a summary of its findings;

 

  (f) any misappropriation or embezzlement of the property of Kite or its affiliates (whether or not a misdemeanor or felony) by you; or

 

  (g) a material breach by you of Section 9 or 10 of this letter agreement or the Proprietary Information and Invention Assignment Agreement.

 

  14.

Governing Law; Arbitration . The terms of this offer letter shall be governed by, and construed and interpreted in accordance with, the laws of the State of California without regard to such State’s principles of conflict of laws. Any dispute arising out of, or relating to, this letter agreement shall be exclusively decided by binding arbitration conducted in Los Angeles, California in accordance with the rules of the American Arbitration Association (the “ AAA ”) then in effect before a single arbitrator appointed in accordance with such rules. The arbitrator shall have authority to grant any form of appropriate relief, whether legal or equitable in nature, including specific performance. Each of the parties agrees that service of

 

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  process in such arbitration proceedings shall be satisfactorily made upon it if sent by registered mail addressed to it at the address referred to in clause below. Judgment upon any award rendered therein may be entered and enforcement obtained thereon in any court having jurisdiction.

 

  15. Miscellaneous .

 

  (a) This agreement, and your rights and obligations hereunder, may not be assigned. Kite may assign its rights, together with its obligations, hereunder in connection with any sale, transfer or other disposition of all or substantially all of its business or assets provided the assignee entity which succeeds to Kite expressly assumes the Kite’s obligations hereunder and complies with the terms of this Agreement.

 

  (b) This agreement cannot be amended orally, or by any course of conduct or dealing, but only by a written agreement signed by the parties hereto.

 

  (c) The failure of either party to insist upon the strict performance of any of the terms, conditions and provisions of this agreement shall not be construed as a waiver or relinquishment of future compliance therewith, and such terms, conditions and provisions shall remain in full force and effect. No waiver of any term or condition of this agreement on the part of either party shall be effective for any purpose whatsoever unless such waiver is in writing and signed by such party.

 

  (d) This agreement sets forth the entire agreement and understanding of the parties relating to the subject matter hereof; and supersedes all prior agreements, arrangements and understandings, written or oral, relating to the subject matter hereof. No representation, promise or inducement has been made by either party that is not embodied in this agreement, and neither party shall be bound by or liable for any alleged representation, promise or inducement not so set forth.

[Signature Page follows]

 

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If you wish to accept employment at Kite Pharma, Inc., under the terms described above, please sign and date this letter, and return it to me.

We look forward to your favorable reply and to a productive and enjoyable working relationship.

 

Very truly yours,
By:  

/s/ Aya J. Jakobovits, Ph.D.

Name:   Aya J. Jakobovits, Ph.D.
Title:   President and Chief Executive Officer
Date:  
Agreed and Accepted:
By:  

/s/ Margo Roberts, Ph.D.

Name:   Margo Roberts, Ph.D.
Date:   July 17, 2013

 

6

Exhibit 10.17

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Section 200.80(b)(4) and Rule 406 of the

Securities Act of 1933, as amended.

LICENSE AGREEMENT

THIS LICENSE AGREEMENT (this “Agreement”) dated as of December 12, 2013 (the “ Effective Date ”), is entered into between Cabaret Biotech Ltd. (“Cabaret”), a company incorporated in Israel with an address at 14 Marva St., Rehovot 7630950, Israel, Dr. Zelig Eshhar (“Dr. Eshhar”), an individual, and KITE PHARMA, INC. (“ Kite ”), a Delaware corporation, with an address at 10924 Le Conte Avenue, Los Angeles, California 90024, USA.

WHEREAS, Dr. Eshhar has assigned to Cabaret all of his rights, title and interest in and to the Licensed IP Rights and In Licenses and Cabaret solely owns or exclusively controls the Licensed IP Rights (all as defined below).

WHEREAS, Kite desires to obtain an exclusive license under Cabaret’s rights in the Licensed IP Rights in the Field on the terms and conditions set forth below.

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, the parties hereby agree as follows:

 

  1. DEFINITIONS

For purposes of this Agreement, the terms defined in this Section 1 shall have the respective meanings set forth below:

1.1 “ Affiliate ” shall mean, with respect to any Person, any other Person which directly or indirectly controls, is controlled by, or is under common control with, such Person. A Person shall be regarded as in control of another Person if it owns, or directly or indirectly controls; at least fifty percent (50%) of the voting stock or other ownership interest of the other Person, or if it directly or indirectly possesses the power to direct or cause the direction of the management and policies of the other Person by any means whatsoever.

1.2 “ Commencement ” shall mean with respect to a clinical trial of a Licensed Product, the first administration to a patient of such Licensed Product in such clinical trial.

1.3 “ Commercially Reasonable Efforts ” shall mean the efforts, expertise and resources normally used by a Party to develop, use, Manufacture and commercialize a product owned by it or to which it has rights, which is of similar market potential at a similar stage in its development or product life, taking into account issues of safety and efficacy, product profile, difficulty in developing the product, competitiveness of the marketplace for the product, the proprietary position of the product, the regulatory structure involved, the availability and level of reimbursement for such treatment by Third Party payors or health insurance plans, the potential total profitability of the applicable product(s) marketed or to be marketed and other relevant factors affecting the


cost, risk and timing of Development and the total potential reward to be obtained if a product is commercialized.

1.4 “ Competent Authority(ies) ” shall mean, collectively, (a) the governmental entities in each country or supranational organization that is responsible for the regulation of any Licensed Product intended for use in the Field or the establishment (including the FDA and the EMEA), or (b) any other applicable regulatory or administrative agency in any country or supranational organization that is comparable to, or a counterpart of, the foregoing.

1.5 “ EMEA ” shall mean the European Agency for the Evaluation of Medicinal Products of the European Union, or the successor thereto.

1.6 “ FDA ” shall mean the Food and Drug Administration of the United States, or the successor thereto.

1.7 “ Field ” shall mean, collectively, (a) all oncology applications and (b) all other applications, as mutually agreed in writing by the parties and attached as an amendment to this Agreement.

1.8 “ First Commercial Sale ” shall mean, with respect to any Licensed Product in a country, the first commercial sale of such Licensed Product in such country after all applicable marketing and pricing approvals (if any) have been granted by the applicable governing health authority of such country. Sales for clinical trial purposes or compassionate or similar use shall not be considered to constitute a First Commercial Sale.

1.9 “ Generic Product ” shall mean, with respect to a Licensed Product, any competing product for the same Indication within the Field based on […***…] as such Licensed Product and is approved for sale to the general public by a Competent Authority in the applicable territory as (a) a generic product (i.e., a product that contains the same active pharmaceutical ingredient as and is bioequivalent to the originator (comparator) Licensed Product), (b) a biosimilar (i.e., a biotherapeutic product that is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic Licensed Product), or (c) the counterpart thereof, if not defined specifically as either a generic product or a biosimilar in the applicable territory as determined by the Competent Authority; and with respect to each of (a), (b) or (c) which could not have been sold absent a license obtained directly or indirectly from Kite if patent or other exclusivity rights covering the Licensed Product would have been in full force and effect. A product shall not be considered as a Generic Product if Kite or any of its Affiliates or sublicensees, directly or indirectly, offers for sale, sells or otherwise commercializes such product.

1.10 “ Indication ” shall mean a generally acknowledged disease or condition, a significant manifestation of a disease or condition, or symptoms associated with a disease or condition or a risk for a disease or condition. For the avoidance of

 

***Confidential Treatment Requested


doubt, all clinical variants of a single disease or condition, whether classified by sub-indication, sub-type, stage, severity or patient population, shall be the same Indication for purposes of this Agreement.

1.11 “ In-Licenses ” shall mean all agreements (as modified, amended or restated as of the Effective Date), pursuant to which Cabaret derives any right, title or interest in or to the Licensed IP Rights.

1.12 “ IND ” shall mean an Investigational New Drug application, or similar application to commence human clinical testing of a Licensed Product for use in the Field submitted to the FDA, or its foreign equivalent.

1.13 “ IMPD ” shall mean an Investigational Medicinal Product Dossier, or similar application to commence human clinical testing of a Licensed Product for use in the Field submitted to the EMEA, or its equivalent.

1.14 “ Licensed IP Rights ” shall mean, collectively, the Licensed Patent Rights and the Licensed Know-How Rights.

1.15 “ Licensed Know-How Rights ” shall mean all trade secret and other non-public know-how rights in and to all confidential and proprietary data, information, compositions and other technology (including, but not limited to, formulae, procedures, protocols, techniques and results of experimentation and testing) in which Cabaret heretofore has an ownership or (sub)licensable interest and which may be reasonably required to exploit the subject matter claimed or described in the Licensed Patent Rights in the Field.

1.16 “ Licensed Patent Rights ” shall mean (a) the patents and patent applications listed on Exhibit A, (b) all divisions, continuations, and continuations-in-part (but only to the extent of claims in such continuations-in-part that are supported in the specification of the parent application), that claim priority to, or common priority with, the patent applications described in clause (a) above or the patent applications that resulted in the patents described in clause (a) above, and (c) all patents that have issued or in the future issue from any of the foregoing patent applications, including utility models, design patents and certificates of invention, together with any reissues, renewals, extensions or additions thereto.

1.17 “ Licensed Product ” shall mean any product or service, procedure, or process, for use in the Field that if Manufactured, made, used, performed, commercialized, offered for sale or sold absent the license granted hereunder would infringe a Valid Claim, or that otherwise uses or incorporates the Licensed Know-How Rights.

1.18 “ Manufacturing ” or “ Manufacture ” shall mean any activities associated with the production, manufacture, supply, processing, filling, packaging or labeling of a product or any components thereof, including process and formulation development, process validation, stability testing, manufacturing scale-up, development


and commercial manufacture and analytical development, product characterization, quality assurance and quality control development, testing, and release.

1.19 “ Major European Country ” shall mean France, Germany, Italy, Spain, the Netherlands, Belgium, Sweden, Switzerland or the United Kingdom.

1.20 “ NDA ” shall mean a New Drug Application, Biologics License Application or similar application for marketing approval of a Licensed Product for use in the Field submitted to the FDA, or its European equivalent.

1.21 “ Net Sales ” shall mean, with respect to any Licensed Product, the gross sales price of such Licensed Product invoiced by Kite, its Affiliates, sublicensees or their respective Affiliates to customers who are not Affiliates (or are Affiliates but are the end users of such Licensed Product) in bona fide arms -length transactions, less, […***…] such Licensed Product. If any sales of Licensed Products are made in transactions that are not at arm’s length, the gross amount for such Licensed Products to be included in the calculation of Net Sales […***…]. Net Sales shall be determined from the books and records of Kite or its Affiliates or Sublicensees, maintained in accordance with U.S. generally accepted accounting principles, consistently applied, or in the case of Sublicensees, such similar accounting principles, consistently applied.

1.22 “ Person ” shall mean an individual, corporation, partnership, limited liability company, trust, business trust, association, joint stock company, joint venture, pool, syndicate, sole proprietorship, unincorporated organization, governmental authority or any other form of entity not specifically listed herein.

1.23 “ Phase II Clinical Trial ” shall mean the second phase of a human clinical trial that is intended to initially evaluate the effectiveness of a Licensed Product for a particular Indication or Indications in patients with the disease or Indication under study and satisfy the requirements of 21 CFR 312.21(b) in the United States, or its European equivalent.

1.24 “ Phase III Clinical Trial ” shall mean the third phase of a human clinical trial in any country, the results of which could be used to establish safety and efficacy of a Licensed Product as a basis for an NDA or would otherwise satisfy requirements of 21 CFR 312.21(c) in the United States, or its European equivalent.

 

***Confidential Treatment Requested


1.25 “ Royalty Term ” shall mean, with respect to each Licensed Product in each country, the longer of (a) the term for which the last to expire Valid Claimremains in effect and would be infringed but for the license granted by this Agreement, by the development, Manufacture, use, offer for sale, sale or import of such Licensed Product in such country, and (b) […***…], after the First Commercial Sale of such Licensed Product in such country.

1.26 “ Sublicense ” shall mean any right granted, sublicense conferred or agreement entered into, between Kite and a Third Party permitting any use of the Licensed IP Rights, directly or indirectly, to make, or have made, develop, offer for sale, sell or otherwise commercialize any Licensed Product; provided, however, that a Sublicense shall exclude a bona fide agreement for the evaluation, testing, research, development on behalf of Kite or its Affiliates, or manufacturing on behalf of Kite or its Affiliates, or a distributor or reseller agreement, all pursuant to which no Sublicense Revenues are paid to Kite.

1.27 “ Sublicense Revenues ” shall mean, with respect to a Sublicense, the aggregate cash (or cash equivalent) or stock or securities (or their equivalent) consideration received by Kite or its Affiliates to the extent in consideration for such Sublicense, including consideration for an option to obtain such Sublicense. Such consideration shall include without limitation any upfront, license initiation or signing fees, license maintenance fees, milestone payments, unearned portion of any minimum annual royalty payment or equity. Sublicense Revenues shall exclude […***…].

1.28 “ Successful Completion ” means, with respect to a specified human clinical trial, the achievement (as determined by the sponsor of such trial) of the primary clinical endpoint identified in the protocol for such trial, the outcome of which is not to recommend any additional study, or impose any other requirement or activity that would materially and/or negatively impact the proposed development plan.

1.29 “ Third Party ” shall mean any Person other than Dr. Eshhar, Cabaret, Kite and their respective Affiliates.

1.30 “ Valid Claim ” shall mean a claim of an issued and unexpired patent included within the Licensed Patent Rights, which has not been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise.

 

***Confidential Treatment Requested


  2. REPRESENTATIONS AND WARRANTIES

2.1 Kite Representations and Warranties . Kite (on behalf of itself and its Affiliates) hereby represents and warrants to Cabaret as follows:

2.1.1 Kite (a) has the power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder, and (b) has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. This Agreement has been duly executed and delivered on behalf of Kite, and constitutes a legal, valid, binding obligation, enforceable against Kite in accordance with its terms.

2.1.2 All necessary consents, approvals and authorizations of all governmental authorities and other Persons required to be obtained by Kite in connection with this Agreement have been obtained.

2.1.3 The execution and delivery of this Agreement and the performance of Kite’s obligations hereunder (a) do not conflict with or violate any requirement of applicable laws or regulations, and (b) do not conflict with, or constitute a default under, any contractual obligation thereof.

2.1.4 During the term of this Agreement, it shall carry out the Manufacturing, testing, development, promotion and marketing of the Licensed Products and its other obligations and activities hereunder in accordance with (i) the terms of this Agreement, (ii) accepted industry practices and (iii) applicable legal requirements.

2.2 Cabaret’s Representations and Warranties . Cabaret hereby represents and warrants to Kite as follows:

2.2.1 Cabaret (a) has the power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder, and (b) has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. This Agreement has been duly executed and delivered by Cabaret, and constitutes a legal, valid, binding obligation, enforceable against Cabaret in accordance with its terms.

2.2.2 All necessary consents, approvals and authorizations of all persons or entities (including without limitation inventors) required to be obtained by Cabaret in connection with this Agreement have been obtained.

2.2.3 The execution and delivery of this Agreement and the performance of Cabaret’s obligations hereunder (a) to Cabaret’s knowledge do not conflict with or violate any requirement of applicable laws or regulations, and (b) do not conflict with, or constitute a default under, any contractual obligation thereof.

2.2.4 Cabaret (a) solely owns or exclusively controls the Licensed IP Rights (other than as set forth herein, noting particularly Section 3.2 and 3.4 below), and except as Cabaret has expressly informed Kite in writing prior to the date of


this Agreement, has not granted to any Third Party any license or other interest in the Licensed IP Rights in the Field, and (b) has obtained from all persons or entities (including without limitation the National Institutes of Health (“NIH”), The Regents of the University of California (“The Regents”), Yeda Research and Development Company Ltd., the Weizmann Institute of Science, BioSante Pharmaceuticals, Inc. (“BioSante”), Cell Genesys, Inc. and their respective Affiliates and employees – all referred to herein as “Licensors”) all right, title and interest in and to (or the exclusive control of) the Licensed IP Rights. For the avoidance of doubt, nothing in this Agreement shall confer any warranties on part of the Regents. For the further avoidance of doubt, Kite acknowledges that US 8,211,422 is currently unenforceable and may remain unenforceable during the life of that patent and that any patent issuing on […***…] may be expired before it issues.

2.2.5 Cabaret has provided Kite with complete and correct copies of all In-Licenses, and as of the date of this Agreement there have been no modifications, amendments or restatements other than as provided to Kite prior to the Effective Date. The In-Licenses are in full force and effect in accordance with their terms. After giving effect to this Agreement, there exist no breaches or defaults by Cabaret, and Cabaret has no knowledge of any breaches or defaults by any other party to any In-License, or other events, which would (with the giving of notice, the passage of time or both) give rise to a breach, default or other right to terminate or modify any In-License. Cabaret has not transferred or granted, and Cabaret shall not transfer or grant, to any Third Party any license or other interest in the In-Licenses.

2.3 Dr. Eshhar’s Representations and Warranties . Dr. Eshhar hereby represents and warrants to Kite as follows:

2.3.1 Dr. Eshhar has the capacity and the legal right to enter into this Agreement and to perform its obligations hereunder. This Agreement has been duly executed and delivered by Dr. Eshhar, and constitutes a legal, valid, binding obligation, enforceable against Dr. Eshhar in accordance with its terms.

2.3.2 All necessary consents, approvals and authorizations of all persons or entities (including without limitation inventors) required to be obtained by Dr. Eshhar in connection with this Agreement have been obtained.

2.3.3 The execution and delivery of this Agreement and the performance of Dr. Eshhar’s obligations hereunder (a) to Dr. Eshhar’s knowledge do not conflict with or violate any requirement of applicable laws or regulations, and (b) do not conflict with, or constitute a default under, any contractual obligation thereof

2.3.4 Dr. Eshhar has duly and validly assigned and transferred to Cabaret all of his rights, title and interest in and to the Licensed IP Rights and In Licenses and Cabaret solely owns or exclusively controls the Licensed IP Rights (other than as set forth herein, noting particularly Section 3.2 and 3.4 below).

 

***Confidential Treatment Requested


  3. LICENSE GRANT

3.1 Licensed IP Rights . Subject to Section 3.2 below, Cabaret hereby grants to Kite an exclusive (other than as set forth in Section 3.2 and 3.4 below) worldwide royalty bearing license (with the right to grant sublicenses through multiple tiers as set forth hereunder) under the Licensed IP Rights to research, have researched, develop , have developed, make, have made, use, offer for sale, sell, import, export, commercialize and otherwise exploit Licensed Products for use in the Field. Subject to the conditions set forth in Section 3.9 the foregoing license includes the right to grant sublicenses under the Licensed IP Rights, provided that, with respect to sublicenses granted under, Kite shall (a) grant such sublicenses only for consideration and at arm’s-length transactions, and (b) grant such sublicenses only pursuant to written agreements that contain such terms and conditions as may be required for Kite to comply with this Agreement.

3.2 License Restrictions. The license granted in Section 3.1 above is and shall remain at all times subject to the following restrictions (and Kite shall ensure that any of its Sublicensee’s shall be subject such restrictions): (i) Dr. Eshhar, the Regents and the Government of the United States (the “Government”) reserve the right to use the Patents Rights and associated technology licensed under the Inter-Institutional Agreement last executed on June 22, 2012 (“UCSF IIA”), between Dr. Eshhar, BioSante and The Regents, and disclosed to Kite under Section 2.2.5 above, and the Inter-institutional Agreement dated 19.11.2013 (“NIH Agreement”), for educational and research purposes; (ii) nothing in this Agreement shall confer by estoppel, implication or otherwise, any license or rights under any patents of the Regents other than those patents rights detailed in the USCF IIA, regardless of whether such patents are dominant or subordinate to the Patents Rights defined in the UCSF IIA; (iii) Kite shall not use the name or trademark or logo of the University of California or any campus thereof; in each case to the extent required by the UCSF HA; (iv) the license is subject to the provisions of 37 C.F.R. Part 401 and the rights retained by the Government under the NIH Agreement; and (v) until the last to expire of U.S. Patent 8,211,422 issued July 3, 2012 from Patent Application 08/547,263 filed October 24, 1995 entitled “Chimeric Receptor Genes and Cells Transformed Therewith” and US Patent Application 13/281,560 filed October 26, 2011 entitled “Chimeric Receptor Genes and Cells Transformed Therewith” (hereinafter referred to as the “NIH Patent Estate”) any products embodying the Licensed Patent Rights, or produced through use of the Licensed Patent Rights, shall be manufactured substantially in the United States unless a waiver is granted by the NIH; provided that NIH may waive this requirement upon Kite’s written request which shall not be unreasonably denied; (vi) until the last to expire of the NIH Patent Estate, the Government shall have the irrevocable, royalty-free, paid-up right to practice and have practiced the NIH Patent Estate and Eshhar patents 5,906,936 and 7,741,465, throughout the world by or on behalf of the Government and on behalf of any foreign government or international organization pursuant to any existing or future treaty or agreement to which the Government is a signatory; (vii) until the last to expire of the NIH Patent Estate, the NIH reserves the right to require Cabaret, or its licensees, to grant sublicenses to the patent rights to responsible applicants, on terms that are reasonable under the circumstances when necessary to fulfill health or safety needs or when necessary to meet


requirements for public use specified by Federal regulations; and (viii) until the last to expire of the NTH Patent Estate, in addition to the reserved right of Section 3.2(vi), the NIH reserves the right to require Cabaret to grant research licenses to the patent rights on reasonable terms and conditions, for the purpose of encouraging basic research, whether conducted at an academic or corporate facility.

3.3 Notice to NIH . Until the last to expire of any patent of the NIH Patent Estate, Kite shall supply to the following mailing address with inert samples of the licensed products or licensed process as covered by the NTH Patent Estate (as defined above), or their packaging for educational and display purposes only.

Chief, Monitoring & Enforcement Branch

Office of Technology Transfer

National Institutes of Health

6011 Executive Boulevard, Suite 325

Rockville, Maryland 20852-3804 U.S.A

E-mail: LicenseNotices_Reportsmail.nih.gov

3.4 No implied licenses are set forth herein . Except for those licenses expressly granted hereunder in the Field, Cabaret does not grant to Kite any other licenses, either within or without the Field. Kite specifically understands and agrees that except as explicitly set forth herein, Cabaret reserves all rights under the Licensed IP Rights to make, have made, use, sell, offer for sale, import, export, distribute and otherwise exploit products incorporating the Licensed IP Rights outside the Field. Without derogating from the generality in Section 3.2 above, Dr. Eshhar and Cabaret reserve the right to use all Licensed IP Rights licensed hereunder for educational and noncommercial research purposes in any and all fields.

3.5 In-Licenses . Cabaret shall timely pay in full all amounts required to be paid by Cabaret, and timely perform in full all obligations required to be performed by Cabaret, under all In-Licenses. Cabaret promptly shall provide Kite with copies of all notices and other deliveries received under the In-Licenses. Without the prior express written consent of Kite, Cabaret shall not (and shall take no action or make no omission to) modify or waive any provision of any In-License that could impair the value of the licenses to Kite herein, or to terminate or have terminated any In-License. If any In-License is terminated for any reason, Cabaret shall make all reasonable efforts to ensure that the Licensor thereunder shall grant a direct license under the Licensed IP Rights thereunder to Kite containing terms and conditions no less favorable to Kite than the terms (including the payment terms) of such In-License, and Kite shall have the right to offset all payments thereunder against any amounts owing to Cabaret hereunder.

3.6 Availability of the Licensed IP Rights . Cabaret shall provide Kite with a copy of all information available to Cabaret relating to the Licensed IP Rights or Licensed Products.


3.7 Technical Assistance . Cabaret and Dr. Eshhar shall provide such technical assistance to Kite as Kite reasonably requests regarding the Licensed IP Rights. Kite shall pay to Cabaret and Dr. Eshhar their documented reasonable out-of-pocket costs of providing such technical assistance.

3.8 Right of First Offer . In the event that Cabaret proposes to enter into an agreement with any Third Party for the grant to any Third Party of any license, immunity, right or interest of any type whatsoever in or under the Licensed Patent Rights outside the Field, Cabaret shall as soon as practicable notify Kite of such intention (the “Company Notice”), and Kite shall have the right, to be exercised by notice to Cabaret to express its interest to negotiate with Cabaret regarding receipt of such license within a period of […***…] after the date of the Company Notice (such period, the “Negotiation Period”). During the Negotiation Period, Kite will notify Cabaret within […***…] of its interest to negotiate with Cabaret, and in such event Cabaret shall negotiate in good faith with Kite regarding receipt of such license. To the extent that Kite notified Cabaret of its interest to negotiate with Cabaret, as set forth above, prior to the expiration of the Negotiation Period, Cabaret shall not enter into any definitive binding agreement of any kind with a Third Party in relation to such license (other than relating to access to information).

3.9 Sublicenses . Kite shall be entitled to grant Sublicenses, provided, however, that all Sublicenses shall be subject to the following conditions:

3.9.1 Kite shall execute a written sublicense with each Sublicensee, which mirrors the restrictive terms hereof and shall provide Cabaret with a copy of each such written sublicense within […***…] of execution (and all amendments and modifications thereto within […***…] of execution). Kite shall report pursuant to the terms of this Agreement Net Sales of the Licensed Product by all Sublicensees and

3.9.2 Kite shall use reasonable efforts to add to the Sublicense agreement a clause stating that, in case of a default of payment due by Kite of royalties owing on Net Sales by a Sublicensee, which is not cured within […***…] after notice in accordance with this Agreement, then upon the written request of Cabaret, such Sublicensee will make future royalty payments and furnish the reports and documents that are required to be paid or furnished by Kite pursuant to this Agreement with respect to Net Sales by such Sublicensee directly to Cabaret.

3.9.3 Kite shall, and by this Agreement herewith does, agree to cause its Sublicensees to assume and agree to perform all of the relevant covenants and obligations of Kite to Cabaret contained in this Agreement as fully and to the same extent as if its Sublicensees were Kite hereunder and guarantees Cabaret that its Sublicensees shall abide by each and every applicable provision of this Agreement.

 

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  4. FINANCIAL CONSIDERATIONS

4.1 License Fees . On or before the Effective Date, Kite shall pay to Cabaret a one-time upfront license fee of twenty-five thousand United States dollars (US$25,000). On or before each anniversary of the Effective Date until First Commercial Sale of the first Licensed Product, Kite shall pay to Cabaret an annual license fee of thirty thousand dollars (US$30,000).

4.2 Sponsored Research Agreement . Kite, The Medical Research, Infrastructure, and Health Services Fund of the Tel Aviv Medical Center shall execute a mutually acceptable sponsored research agreement, pursuant to which such institution shall conduct research, according to a mutually agreed research workplan, to be funded by Kite according to a mutually agreed budget of at least US$60,000 per year, according to a mutually agreed funding schedule for a period of not less than three (3) years on the terms and conditions thereof.

4.3 Royalties .

4.3.1 Royalty Rate . During the applicable Royalty Term for a Licensed Product, subject to the terms and conditions of this Agreement, Kite shall pay to Cabaret royalties, with respect to each Licensed Product, equal to […***…] percent ([…***…]%) of Net Sales of such Licensed Product by Kite, its sublicensees and their respective Affiliates; provided, however, if the Licensed Product is made, used, or sold in such country where such Licensed Product would not infringe a Valid Claim, then the applicable royalty rate for such Licensed Product in such country shall be reduced to […***…] percent ([…***…]%) of Net Sales of such Licensed Product. Only one royalty shall be owing for a Licensed Product regardless of how many Valid Claims cover such Licensed Product.

4.3.2 Third Party Royalties . If Kite, its Affiliate or Sublicensee is required to pay royalties in consideration for a license to such Third Party IP to any Third Party in order to exercise its rights hereunder to make, have made, use, sell, offer to sale or import any Licensed Product, then Kite shall have the right to credit […***…] percent ([…***…]%) of such Third Party IP royalty payments against the royalties owing to Cabaret under Section 4.3.1 with respect to sales of such Licensed Product in such country; provided, however, that Kite shall not reduce the amount of the royalties paid to Cabaret under Section 4.3.1 by reason of this Section 4.3.2, with respect to sales of such Licensed Product in such country, to less than […***…] percent ([…***…]%) of Net Sales of such Licensed Product in such country.

4.3.3 Generic Product . On a country-by-country and Licensed Product-by-Licensed Product basis, if at any time during the applicable Royalty Term, one or more Generic Products are commercially launched by a Third Party (other than a Third Party sublicensee) in a country, then the applicable royalty rate for such Licensed Product in such country shall be reduced to […***…] percent ([…***…]%) of Net Sales of such Licensed Product beginning from the launch of such Generic Product and continuing so long as such Generic Product is being sold in such country. Notwithstanding anything to

 

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the contrary set forth in this Agreement, to the extent that Kite has entered into a Sublicense Agreement pursuant to which Kite is not entitled to receive royalties in a country in which a Generic Product has been commercially launched, Kite shall have no obligation to pay, and Cabaret shall have no right to receive, royalties with respect to sales of Licensed Product in such country.

4.3.4 Combination Products . If a Licensed Product either (a) is sold together with another active ingredient product or device product which is not covered by a Valid Claim for a single price, or (b) consists of components that are covered by a Valid Claim and an active ingredient or device component that is not covered by a Valid Claim, then (except in the case where (i) the other active ingredient or device product or component which is not covered by Valid Claim also is not covered by any other valid patent claim, and (ii) a sublicensee pays to Kite a royalty which is not subject to an adjustment for such other active ingredient or device product or component) for purposes of the royalty payments under Section 4.3 for Net Sales of such Licensed Products, such Net Sales, prior to the royalty calculation set forth in Section 4.3, first shall be multiplied by the fraction A/(A+B), where A is […***…], and B is […***…]. If the parties cannot reach an agreement as to the Value of each of the products or components then a Third Party arbitrator who is an industry expert shall be appointed to provide such determination which shall be binding on the parties. The parties shall equally share all costs associated which such determination. Until such determination is made Kite shall make payment under Section 4.3 to Cabaret in accordance with its own determination and if following the Third Party arbitrator’s decision an increase in payments is required Kite shall make such adjustment payments retroactively.

4.4 Milestones . Within […***…] following the first achievement of each of the following milestones with respect to each Licensed Product, Kite shall provide Cabaret with written notice thereof, and shall pay to Cabaret the corresponding one-time non-refundable milestone payment (all such amounts non-creditable against royalties payable under Section 4.3):

 

Fee   

Event

US$100,000    Acceptance of the first IND for such Licensed Product
[…***…]    […***…]
[…***…]    […***…]
[…***…]    […***…]
[…***…]    […***…]

 

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[…***…]    Receipt of the required marketing approval from the applicable governing health authority to market such Licensed Product in the first Major European Country

For purposes of this Section 4.4, a Licensed Product shall be a different Licensed Product (and thus bearing an additional set of milestone payments) than another Licensed Product if such Licensed Product (a) either is for a different Indication or contains a different CAR, and (b) requires a separate regulatory approval by a Competent Authority. For purpose of clarity, a different Licensed Product could be a different product for the same Indication or a similar product (same CAR) for a different Indication.

Notwithstanding the foregoing, the foregoing milestone payments shall apply with respect to the first […***…] Licensed Products. Following the first […***…] Licensed Products for each additional Licensed Products to achieve each milestone event, Kite shall pay Cabaret reduced milestone payments equal to […***…] percent ([…***…]%) of the milestone payments set forth above.

4.5 Sublicense Fees . Subject to the terms and conditions of this Agreement, with respect to each Sublicense with respect to a Licensed Product, Kite shall pay to Cabaret sublicense fees equal to the applicable percentage set forth below of the Sublicense Revenue therefrom (based on the effective date of such Sublicense) (“Sublicense Fees”):

 

Percentage   

Effective Date of Such Sublicense

[…***…]    […***…]
[…***…]    […***…]
[…***…]    […***…]
[…***…]    […***…]

Notwithstanding the foregoing, with respect to any Sublicense Fees paid to Cabaret on account of Sublicense Revenues received by Kite from a Sublicensee in connection with the achievement of any technical, development, regulatory through commercial launch milestone event for a Licensed Product, Kite shall deduct from such Sublicense Fees the milestone payments made by Kite to Cabaret pursuant to Section 4.5 above with respect to the same Licensed Product.

 

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4.6 Reimbursement of Past Patent Costs . Upon execution of this Agreement Kite shall reimburse Dr. Eshhar an amount equal to US$350,000 representing the documented out-of-pocket costs incurred by Dr. Eshhar, or for which Dr. Eshhar otherwise is legally obligated, to prepare, file, prosecute and maintain the Licensed Patent Rights prior to the Effective Date.

 

  5. ROYALTY REPORTS AND ACCOUNTING

5.1 Royalty Reports . Within […***…] after the end of each calendar quarter during the term of this Agreement following first to occur of the First Commercial Sale of a Licensed Product or the receipt by Kite or its Affiliates of Sublicense Revenues, Kite shall furnish to Cabaret a quarterly written report showing in reasonably specific detail (a) the calculation of all royalties owing under Sections 4.3 and 4.5; (b) the withholding taxes, if any, required by law to be deducted with respect to such sales; and (c) the exchange rates, if any, used in determining the amount of United States dollars. With respect to sales of Licensed Products invoiced in United States dollars, the gross sales, Net Sales and royalties payable shall be expressed in United States dollars. With respect to (i) Net Sales invoiced in a currency other than United States dollars and (ii) cash consideration paid in a currency other than United States dollars by Kite’s sublicensees hereunder, all such amounts shall be expressed both in the currency in which the distribution is invoiced and in the United States dollar equivalent. The United States dollar equivalent shall be calculated using the average of the exchange rate (local currency per US$1) published in The Wall Street Journal , Western Edition, under the heading “Currency Trading” on the last business day of each month during the applicable calendar quarter.

5.2 Audits .

5.2.1 During the Term of this Agreement and for […***…] thereafter, upon the written request of Cabaret and not more than once in each calendar year, Kite shall permit an independent certified public accounting firm of nationally recognized standing selected by Cabaret and reasonably acceptable to Kite, at Cabaret’s expense, to have access during normal business hours to such of the financial records of Kite and its Affiliates as may be reasonably necessary to verify the accuracy of the payment reports hereunder for the […***…] immediately prior to the date of such request (other than records for which Cabaret has already conducted an audit under this Section 5.2.

5.2.2 If such accounting firm concludes that additional amounts were owed during the audited period, Kite shall pay such additional amounts within […***…] after the date Cabaret delivers to Kite such accounting firm’s written report so concluding. The fees charged by such accounting firm shall be paid by Cabaret; provided, however, if the audit discloses that the royalties payable by Kite for such period are more than […***…] percent ([…***…]%) of the royalties actually paid for such period, then Kite shall pay the reasonable fees and expenses charged by such accounting firm.

 

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5.2.3 Cabaret shall cause its accounting firm to retain all financial information subject to review under this Section 5.2 in strict confidence. The accounting firm shall disclose to Cabaret only whether the reports are correct or not and the amount of any discrepancy. No other information shall be shared. Cabaret shall treat all such financial information as Kite’s Confidential Information.

5.3 Records . Kite shall, and shall cause its Affiliates to, keep and maintain for […***…] after payment of payment pursuant to Sections 4.3 and 4.5 complete and accurate books and records in sufficient detail so that all payments payable hereunder can be properly verified.

 

  6. PAYMENTS

6.1 Payment Terms . Royalties shown to have accrued by each royalty report provided for under Section 5.1 shall be due on the date such royalty report is due. Payment of royalties in whole or in part may be made in advance of such due date. All payments made by pursuant to this Agreement shall be made in immediately available funds by wire transfer to such bank and account of Cabaret or Dr. Eshhar (as applicable) as may be designated in writing from time to time by Cabaret. Interest shall be due on all payments not paid when due. Interest shall be payable at a rate per annum equal to the prime rate of interest, as published in The Wall Street Journal , plus […***…] percent ([…***…]%) or, if lower, the maximum amount required by law.

6.2 Withholding Taxes . Kite shall be entitled to deduct the amount of any withholding taxes with respect to such amounts, other than United States taxes, payable by Kite, its Affiliates or their respective sublicensees, or any taxes required to be withheld by Kite, its Affiliates or their respective sublicensees, to the extent Kite, its Affiliates or their respective sublicensees pay to the appropriate governmental authority on behalf of Cabaret such taxes, levies or charges. Kite shall use reasonable efforts to minimize any such taxes, levies or charges required to be withheld on behalf of Cabaret by Kite, its Affiliates or their respective sublicensees. Kite promptly shall deliver to Cabaret proof of payment of all such taxes, levies and other charges, together with copies of all communications from or with such governmental authority with respect thereto. To the extent that the Parties determine that the tax laws of any jurisdiction other than the United States may impose an obligation on Kite to withhold from any payment made by Kite hereunder an amount for taxes attributable to the sale or use by Kite of the Licensed Products in such jurisdiction, then the Parties shall reasonably cooperate in good faith and shall take such reasonable and lawful actions, as may be necessary or desirable to minimize the amount of any such withholding taxes in such jurisdiction.

 

  7. RESEARCH, DEVELOPMENT AND MARKETING OBLIGATIONS

7.1 Research and Development Efforts . Kite shall use its Commercially Reasonable Efforts to conduct such research, development and preclinical and human clinical trials as are necessary to obtain regulatory approval to manufacture and market Licensed Products, and shall use good faith efforts to obtain regulatory approval to market, and following approval to commence marketing and market each

 

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such Licensed Product in such countries as Kite determines are commercially feasible. Kite, shall be responsible, at its sole cost and expense, for the development of Licensed Products in the Field. Kite, shall be responsible for: clinical trials with respect to the Licensed Products and filing required regulatory submissions and dealings with Regulatory Authorities with respect to Licensed Products. Kite shall also be responsible for reporting to the appropriate regulatory authorities adverse events related to Licensed Products as required by applicable law. Kite, shall also be responsible for communications with the FDA regarding such filings and Licensed Products; provided that Cabaret shall be consulted regarding any discussions or meetings with the FDA regarding Licensed Products, and following each meeting between the FDA and Kite regarding a Licensed Product, Kite shall provide Cabaret with a written summary of such meeting. Kite undertakes to use its Commercially Reasonable Efforts to ensure that the Licensed Products marketed by it will, and it shall, in carrying out its obligations hereunder, comply with all legal requirements. Kite shall notify Cabaret within […***…] after Kite becomes aware of the First Commercial Sale of a Licensed Product in each country. Kite shall have the right to perform all such obligations on its own behalf, or through an Affiliate, Sublicensee or contractor (which shall constitute performance by Kite hereunder).

7.2 Records . Kite shall maintain records, in sufficient detail and in good scientific manner, which shall reflect all work done and results achieved in the performance of its research and development regarding the Licensed Products.

7.3 Reports . Within […***…] following the end of each June and December during the term of this Agreement, Kite shall prepare and deliver to Cabaret a written summary report which shall describe (a) the research performed to date employing the Licensed IP Rights, (b) the progress of the development, and testing of Licensed Products in clinical trials, and (c) the status of obtaining regulatory approvals to market and its commercialization activities for Licensed Products. Kite promptly shall notify Cabaret upon the initiation of any formal investigation, review or inquiry of Kite by regulatory authorities or governmental authorities concerning (i) non-clinical or clinical research relating to a Licensed Product; or (ii) the distribution, promotion or sale of a Licensed Product.

 

  8. CONFIDENTIALITY

8.1 Confidential Information . During the term of this Agreement, and for a period of […***…] following the expiration or earlier termination hereof, each party shall maintain in confidence all information of the other party that is disclosed by the other party and identified as, or acknowledged to be, confidential at the time of disclosure (the “ Confidential Information ”), and shall not use, disclose or grant the use of the Confidential Information except on a need-to-know basis to those directors, officers, affiliates, employees, permitted licensees, permitted assignees and agents, consultants, clinical investigators or contractors, to the extent such disclosure is reasonably necessary in connection with performing its obligations or exercising its rights under this Agreement. To the extent that disclosure is authorized by this Agreement, prior to disclosure, each party hereto shall obtain agreement of any such Person to hold in

 

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confidence and not make use of the Confidential Information for any purpose other than those permitted by this Agreement. Each party shall notify the other promptly upon discovery of any unauthorized use or disclosure of the other party’s Confidential Information.

8.2 Terms of this Agreement . Cabaret and Dr. Eshhar and Kite shall not disclose any terms or conditions of this Agreement, including without limitation, the existence and details of this Agreement and any other agreements disclosed related to this Agreement, the persons and entities involved in the deal contemplated under this agreement and the person and entities signing this Agreement, to any Third Party without the prior consent of the other party; provided, however, that without such consent, (a) Cabaret may disclose this Agreement to its Licensors (subject to the same confidentiality obligations as set forth in this Section 8.2), and (b) Kite shall have the right to make press releases and other public disclosures relating to this Agreement provided that Kite shall obtain Dr. Eshhar’s pre-approval for use of Dr. Eshhar’s name, and shall not disclose the financial terms of this Agreement.

8.3 Permitted Disclosures . The confidentiality obligations contained in this Section 8 shall not apply to the extent that (a) any receiving party (the “ Recipient ”) is required (i) to disclose information by law, regulation or order of a governmental agency or a court of competent jurisdiction, or (ii) to disclose information to any governmental agency for purposes of obtaining approval to test or market a product, provided in either case that the Recipient shall provide written notice thereof to the other party and sufficient opportunity to object to any such disclosure or to request confidential treatment thereof; or (b) the Recipient can demonstrate that (i) the disclosed information was public knowledge at the time of such disclosure to the Recipient, or thereafter became public knowledge, other than as a result of actions of the Recipient in violation hereof; (ii) the disclosed information was rightfully known by the Recipient (as shown by its written records) prior to the date of disclosure to the Recipient by the other party hereunder; (iii) the disclosed information was disclosed to the Recipient on an unrestricted basis from a source unrelated to any party to this Agreement and not under a duty of confidentiality to the other party; or (iv) the disclosed information was independently developed by the Recipient without use of the Confidential Information disclosed by the other party. Notwithstanding any other provision of this Agreement, Kite may disclose information to any Person with whom Kite has, or is proposing to enter into, a business relationship (including without limitation an investment in Kite, license, collaboration or other commercial agreement), as long as such Person has entered into a confidentiality agreement with Kite.

8.4 Publications . Notwithstanding anything herein to the contrary, Dr. Eshhar shall have the right to publish articles relating to the Licensed IP in scientific publications or posters or to give lectures or seminars to third parties relating to the Licensed IP, provided that, to the extent that the information to be disclosed is not in the public domain, publication thereof as aforesaid shall not take place unless the text thereof has been submitted to Kite at least […***…] prior to intended date of submission of the article for publication, so as to give Kite a reasonable opportunity (a) to check for Confidential Information of Kite, which upon request by Kite, Dr. Eshhar shall remove

 

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prior to submission for publication or presentation, and (b) to check patentability of the information and to request the filing of a patent application relating to the subject matter of the publication or presentation.

 

  9. PATENTS

9.1 Patent Prosecution and Maintenance .

9.1.1 Kite shall, at its sole cost, be responsible for all the preparation, filing, prosecution and maintenance after the Effective Date of the Licensed Patent Rights listed under the heading Eshhar patents listed on Exhibit A or related thereto (the “Eshhar Patent Rights”). Kite shall give Cabaret an opportunity to review and comment on the text of each patent application subject to this Section 9.1.1 before filing, and shall supply Cabaret with a copy of such patent application as filed, together with notice of its filing date and serial number. Cabaret shall, at Kite’s expense, cooperate with Kite, execute all lawful papers and instruments and make all rightful oaths and declarations as may be necessary in the preparation, prosecution and maintenance of all patents and other filings referred to in this Section 9.1.1. If Kite, in its sole discretion, decides to abandon the preparation, filing, prosecution or maintenance of any patent or patent application subject to this Section 9.1.1, then Kite shall notify Cabaret in writing thereof and following the date of such notice (a) Cabaret shall be responsible for and shall control, at its sole cost, the preparation, filing, prosecution and maintenance of such patents and patent applications, and (b) Kite thereafter shall have no license under this Agreement to such patent or patent application.

9.1.2 To the extent Cabaret is permitted to grant such rights to Kite, Kite shall have all rights of Cabaret regarding the preparation, filing, prosecution and maintenance after the Effective Date of all patents and patent applications within the Licensed Patent Rights other than the Eshhar Patent Rights.

9.2 Notification of Infringement . Each party shall notify the other party of any substantial infringement known to such party of any Licensed Patent Rights and shall provide the other party with the available evidence, if any, of such infringement.

9.3 Enforcement of Patent Rights . Kite, at its sole expense, shall have the right to determine the appropriate course of action to enforce Licensed Patent Rights or otherwise abate the infringement thereof, to take (or refrain from taking) appropriate action to enforce Licensed Patent Rights, to defend any declaratory judgments seeking to invalidate or hold the Licensed Patent Rights unenforceable, to control any litigation or other enforcement action and to enter into, or permit, the settlement of any such litigation, declaratory judgments or other enforcement action with respect to Licensed Patent Rights, and shall consider, in good faith, the interests of Cabaret in so doing. Kite shall bring any such enforcement action in Kite’s own name; provided, however, if necessary for standing purposes only, (a) Kite shall have, subject to Cabaret prior consent which shall not be unreasonably withheld, delayed for more than […***…] after written request by Kite, or conditioned, the right to bring such action in the name of

 

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Cabaret (all costs to be borne by Kite) if Cabaret is the party with legal standing, and (b) Cabaret shall make all reasonable efforts to enable Kite to bring such enforcement action in the name of any Licensor that is the party with legal standing. If Kite does not, within […***…] of receipt of notice from Cabaret, abate the infringement or file suit to enforce the Licensed Patent Rights against at least one infringing party, Cabaret shall have the right to take whatever action it deems appropriate to enforce the Licensed Patent Rights; provided, however, that, within […***…] after receipt of notice of Cabaret’s intent to file such suit, Kite shall have the right to jointly prosecute such suit and to fund up to […***…] the costs of such suit. The party controlling any such enforcement action shall not settle the action or otherwise consent to an adverse judgment in such action that diminishes the rights or interests of the non-controlling party without the prior written consent of the other party. All monies recovered upon the final judgment or settlement of any such suit to enforce the Licensed Patent Rights shall be used (a) first, to reimburse the costs and expenses (including reasonable attorneys’ fees and costs) of Kite and Cabaret; and (b) second, (i) if Cabaret is the controlling party in such action, any remaining recovery shall be divided equally between Kite and Cabaret, or (ii) if the controlling party is Kite, any remaining recovery shall be divided between Kite and Cabaret in shares that reflect the damages incurred by each party to reflect the applicable royalty to Cabaret hereunder for lost sales, and the lost profits (net of such royalties) to Kite for lost sales , provided that in any case the amount paid to Cabaret shall not be less than the applicable royalty rate if such recovery was received as Net Sales.

9.4 Cooperation . In any suit to enforce and/or defend the License Patent Rights pursuant to this Section 9, the party not in control of such suit shall, at the request and expense of the controlling party, reasonably cooperate and, to the extent possible, have its employees testify when requested and make available relevant records, papers, information, samples, specimens, and the like.

 

  10. TERMINATION

10.1 Expiration . Subject to this Section 10 below, this Agreement shall expire, on a Licensed Product-by-Licensed Product and country-by-country basis, on the date on which Kite, its Affiliates and sublicensees permanently cease to research, develop, sell and commercialize the Licensed Product in such country (the “ Term ”).

10.2 Termination for Convenience . Kite may terminate this Agreement, in its sole discretion, upon thirty (30) days prior written notice to Cabaret and Dr. Eshhar.

10.3 Termination for Cause . Except as otherwise provided in Section 12, each party may terminate this Agreement upon or after the breach of any material provision of this Agreement by the other party if the other party has not cured such breach within sixty (60) days (or such longer period as such party may reasonably agree if said breach is incapable of cure within such sixty (60) days) after receipt of express written notice thereof by such party.

 

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10.4 Insolvency . This Agreement may be terminated by Cabaret in the event of an Insolvency Event occurring in relation to Kite, by giving a notice of termination to Kite. The termination shall take effect upon delivery of the notice of termination by Cabaret. “Insolvency Event” shall mean that, with respect to Kite, any of the following occurs: (i) Kite makes any arrangement or composition with or any assignment for the benefit of its creditors generally; (ii) a petition is presented that is not dismissed within 120 days or a court order is made or a resolution is passed for the winding up of Kite or for the making of an administration order or for the appointment of a provisional liquidator or a judicial factor or similar officer in relation to Kite; (iii) an encumbrancer takes possession of or a trustee, receiver, liquidator, provisional liquidator, administrator, manager ad interim, administrative receiver, judicial factor or similar officer is appointed, in each case for all or substantially all of Kite’s intellectual property rights and such appointment materially prejudices Cabaret’s rights under this Agreement; or (iv) Kite does, or suffers to be done in relation to it, any analogous action or proceeding in any jurisdiction anywhere in the world (including without limitation any actions or proceedings relating to bankruptcy law of any nature in the United States of America).

10.5 Effect of Expiration or Termination . Expiration or termination of this Agreement shall not relieve the parties of any obligation accruing prior to such expiration or termination, and the provisions of Sections 5.2, 8, 10.5, 10.6, 11 and 13 shall survive the expiration or termination of this Agreement. Upon any termination of this Agreement, all licenses granted herein shall terminate, nevertheless, Cabaret shall grant a direct license to any Sublicensee of Kite hereunder having the same scope as such sublicense and on terms and conditions no less favorable to such Sublicensee than the terms and conditions of this Agreement, provided that such Sublicensee is not in default of any applicable obligations under this Agreement and agrees in writing to be bound by the terms and conditions of such direct license.

10.6 Termination Fee . In the event that Kite terminates this Agreement termination for convenience under Section 10.2 prior to the third (3 rd ) anniversary of the Effective Date, Kite shall pay to Cabaret a termination fee in an amount equal to US$500,000 within thirty (30) days of such termination.

 

  11. INDEMNIFICATION

11.1 Indemnification . Kite shall defend, indemnify and hold Dr. Eshhar, Cabaret, its Affiliates, and each of their respective directors, officers, employees, and agents, and if applicable Yeda, NIH, BioSante and the Regents and sponsors of the research conducted under the UCSF IIA, harmless from all losses, liabilities, damages and expenses (including attorneys’ fees and costs) incurred as a result of any claim, demand, action or proceeding to the extent resulting from (a) any breach of this Agreement by Kite or its Sublicensees, (b) the gross negligence or willful misconduct of Kite or its Sublicensees in the performance of its obligations under this Agreement, or (c) the Manufacture, development, use or sale of Licensed Products by Kite or its Sublicensees under this Agreement, except in each case to the extent arising from the


gross negligence or willful misconduct of Cabaret or Dr. Eshhar or the breach of this Agreement by Dr. Eshhar or Cabaret.

11.2 Procedure . Dr. Eshhar or Cabaret as applicable, promptly shall notify Kite of any liability or action in respect of which Dr. Eshhar or Cabaret intends to claim such indemnification, and Kite shall assume the defense thereof with counsel selected by Kite. The indemnity agreement in this Section 11 shall not apply to amounts paid in settlement of any loss, claim, damage, liability or action if such settlement is effected without the consent of Kite, which consent shall not be withheld unreasonably. The failure to deliver notice to Kite within a reasonable time after the commencement of any such action, if prejudicial to its ability to defend such action, shall relieve Kite of any liability to Dr. Eshhar and Cabaret under this Section 11, but the omission so to deliver notice to Kite will not relieve it of any liability that it may have to Dr. Eshhar or Cabaret otherwise than under this Section 11. Dr. Eshhar and Cabaret under this Section 11, its employees and agents, shall cooperate fully with Kite, at Kite’s expense, and its legal representatives in the investigation and defense of any action, claim or liability covered by this indemnification.

11.3 Insurance . Kite shall maintain product liability insurance with respect to the research, development, manufacture and sales of Licensed Products by Kite in such amount as Kite customarily maintains with respect to the research, development, manufacture and sales of its similar products. Kite shall maintain such insurance for so long as it continues to research, develop, manufacture or sell any Licensed Products, and thereafter for so long as Kite customarily maintains insurance covering the research, development, manufacture or sale of its similar products.

 

  12. FORCE MAJEURE

Neither party shall be held liable or responsible to the other party nor be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement to the extent, and for so long as, such failure or delay is caused by or results from causes beyond the reasonable control of the affected party including but not limited to fire, floods, embargoes, war, acts of war (whether war be declared or not), acts of terrorism, insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, acts of God or acts, omissions or delays in acting by any governmental authority.

 

  13. MISCELLANEOUS

13.1 Notices . Any consent, notice or report required or permitted to be given or made under this Agreement by one of the parties hereto to the other party shall be in writing, delivered by any lawful means to such other party at its address indicated below, or to such other address as the addressee shall have last furnished in writing to the addressor and (except as otherwise provided in this Agreement) shall be effective upon receipt by the addressee.


If to Dr. Eshhar:    Dr. Zelig Eshhar
   Department of Immunology
   Weizmann Institute
   Rehovot POB. 26
   Israel 76100
If to Cabaret:    Cabaret Biotech Ltd,
   14 Marva St., Rehovot 7630950, Israel
with a copy to:    Browdy and Neimark, PLLC
   1625 K Street, NW
   Suite 1100
   Washington, DC 20006
   Attention: Roger L. Browdy
If to Kite:    Kite Pharma, Inc.
   10924 Le Conte Avenue
   Los Angeles, California 90024, USA
   Attention: President
with a copy to:    Morrison & Foerster LLP
   12531 High Bluff Drive, Suite 100
   San Diego, California 92130, USA
   Attention: Mark R. Wicker

13.2 Governing Law . This Agreement shall be governed by and construed in accordance with the laws of the State of New York, without regard to the conflicts of law principles thereof.

13.3 Arbitration . Any dispute, controversy or claim initiated by either party arising out of or relating to this Agreement, its negotiations, execution or interpretation, or the performance by either party of its obligations under this Agreement (other than (a) any dispute, controversy or claim regarding the validity, enforceability, claim construction or infringement of any patent rights, or defenses to any of the foregoing, or (b) any bona fide Third Party action or proceeding filed or instituted against a party to this Agreement), 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 prompt written notice to that effect to the other party. Any such arbitration shall be conducted in the English language under the International Dispute Resolution Procedures and Arbitration Rules of the American Arbitration Association (the “Rules”) by a panel of three (3) arbitrators appointed in accordance with such Rules. Any such arbitration shall be held in Los Angeles, California. The method and manner of discovery in any such arbitration proceedings shall be governed by the Rules. The arbitrators shall have the authority to grant specific performance and to allocate between the parties the costs of arbitration (including attorneys’ fees and expenses of the parties) 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. Notwithstanding the above, either Party may bring an action for an injunction or other equitable relief with respect to any actual or threatened breach of this Agreement.

13.4 Assignment . Kite shall not assign its rights or obligations under this Agreement without the prior written consent of Cabaret; provided, however, that Kite may, without such consent, assign this Agreement and its rights and obligations hereunder (a) to any Affiliate, or (b) in connection with the transfer or sale of all or substantially all of its business or in the event of its merger, consolidation, change in control or similar transaction. Each party shall give the other party prompt written notice of any permitted assignment of this Agreement, and any permitted assignee shall assume all obligations of its assignor under this Agreement. Any assignment or attempted assignment by either Party in violation of the terms of this Section 13.4 shall be null, void and of no legal effect.

13.5 Waivers and Amendments . No change, modification, extension, termination or waiver of this Agreement, or any of the provisions herein contained, shall be valid unless made in writing and signed by duly authorized representatives of the parties hereto.

13.6 Entire Agreement . This Agreement embodies the entire agreement between the parties and supersedes any prior representations, understandings and agreements between the parties regarding the subject matter hereof. There are no representations, understandings or agreements, oral or written, between the parties regarding the subject matter hereof that are not fully expressed herein.

13.7 Severability . Any of the provisions of this Agreement which are determined to be invalid or unenforceable in any jurisdiction shall be ineffective to the extent of such invalidity or unenforceability in such jurisdiction, without rendering invalid or unenforceable the remaining provisions hereof and without affecting the validity or enforceability of any of the teens of this Agreement in any other jurisdiction.

13.8 Waiver . The waiver by either party hereto of any right hereunder or the failure to perform or of a breach by the other party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other party whether of a similar nature or otherwise.


13.9 Further Assurance . Each party shall reasonably cooperate, execute such further documents and instruments and take such further actions, as necessary or appropriate to effectuate transactions contemplated by this Agreement.

13.10 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.

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

 

CABARET BIOTECH LTD.
By:  

ZELIG ESHHAR

Title:  

 

/s/ Zelig Eshhar

Dr. ZELIG ESHHAR
KITE PHARMA, INC.
By:  

/s/ Arie Belldegrun, M.D.

Title:  

Chairman


EXHIBIT A

LICENSED PATENT RIGHTS

Eshhar patents:

US 5,906,936, issued May 25, 1999

US 7,741,465, Eshhar et al, isUSsued June 22, 2010.

Eshhar-NIH patent:

US 8,211,422, Eshhar et al, issued July 3, 2012

Eshhar-NIH pending application:

[…***…]

Patents included with the Eshhar/Regents of University of California/Biosante agreement:

US 6,319,494, Capon et al, issued November 20, 2001

US 5,712,149, Roberts, issued January 27, 1998

US 5,741,899, Capon et al, issued April 21, 1998

US 6,077,947, Capon et al, issued June 20, 2000

US 5,843,728, Seed et al, issued December 1, 1998

US 5,851,828, Seed et al, issued December 22, 1998

US 5,912,170, Seed et al, issued June 15, 1999

US 6,004,811, Seed et al, issued December 21, 1999

 

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Exhibit 10.19

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Section 200.80(b)(4) and Rule 406 of the

Securities Act of 1933, as amended.

THE NATIONAL INSTITUTES OF HEALTH

PATENT LICENSE AGREEMENT – EXCLUSIVE

COVER PAGE

For NIH internal use only:

License Number:                     

License Application Number: A-265-2013

Serial Number(s) of Licensed Patent(s) or Patent Application(s):

 

  1. [ …***…]

 

  2. PCT Application No. PCT/US13/042162 filed May 22, 2013 entitled ‘‘Murine anti-NY–ESO–1 T cell receptors’’ [HHS Ref No. E–105–2012/0–PCT–02]

Licensee: Kite Pharma, Inc.

Cooperative Research and Development Agreement (CRADA) Number (if a subject invention):

Additional Remarks:

Public Benefit(s): Clinical data from NCI Surgery Branch and other academic centers have demonstrated that patient’s engineered T cells engineered with T cell receptors (TCRs) or chimeric antigen receptors (CARs), when administered back to the patient, can traffic to the tumor, become activated upon engagement with the tumor antigen and selectively eradicate the tumors. This Autologous Cell Therapy (ACT) approach has shown the potential to result in a significant and durable clinical benefit to patients with advanced, metastatic tumors. New York Esophageal Antigen-1 (“NY-ESO-1”) is an attractive target for application of the engineered ACT technology due to their expression in different tumor types and lack of expression in vital normal tissues. Therefore, development of the ACT TCR product directed to NY-ESO-1 by the Licensee , in partnership with the NIH , has the potential to generate new efficacious and safe therapies for patients that have not responded to all other therapies.

This Patent License Agreement, hereinafter referred to as the “ Agreement ”, consists of this Cover Page, an attached Agreement , a Signature Page, Appendix A (List of Patent(s) or Patent Application(s)), Appendix B (Fields of Use and Territory), Appendix C (Royalties), Appendix D (Benchmarks and Performance), Appendix E (Commercial Development Plan), Appendix F (Example Royalty Report), and Appendix G (Royalty Payment Options). The Parties to this Agreement are:

 

  1) The National Institutes of Health (“ NIH ”) an agency within the Department of Health and Human Services (“ HHS ”); and

 

  2) The person, corporation, or institution identified above or on the Signature Page, having offices at the address indicated on the Signature Page, hereinafter referred to as the “ Licensee ”.

 

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The NIH and the Licensee agree as follows:

 

1. BACKGROUND

 

  1.1 In the course of conducting biomedical and behavioral research, the NIH or the FDA investigators made inventions that may have commercial applicability.

 

  1.2 By assignment of rights from NIH or FDA employees and other inventors, HHS , on behalf of the Government , owns intellectual property rights claimed in any United States or foreign patent applications or patents corresponding to the assigned inventions. HHS also owns any tangible embodiments of these inventions actually reduced to practice by the NIH or the FDA .

 

  1.3 The Secretary of HHS has delegated to the NIH the authority to enter into this Agreement for the licensing of rights to these inventions.

 

  1.4 The NIH desires to transfer these inventions to the private sector through commercialization licenses to facilitate the commercial development of products and processes for public use and benefit.

 

  1.5 The Licensee desires to acquire commercialization rights to certain of these inventions in order to develop processes, methods, or marketable products for public use and benefit.

 

2. DEFINITIONS

 

  2.1 Affiliate(s) ” means a corporation or other business entity, which directly or indirectly is controlled by or controls, or is under common control with the Licensee . For this purpose, the term “control” shall mean ownership of more than fifty percent (50%) of the voting stock or other ownership interest of the corporation or other business entity, or the power to elect or appoint more than fifty percent (50%) of the members of the governing body of the corporation or other business entity.

 

  2.2 Benchmarks ” mean the performance milestones that are set forth in Appendix D.

 

  2.3 Combination Product ” means a product that contains a Licensed Product(s) and at least one other active therapeutic component or device other than a Licensed Product(s) that is not claimed or covered by the Licensed Patent Rights .

 

  2.4 Commercial Development Plan ” means the written commercialization plan attached as Appendix E.

 

  2.5 FDA ” means the United States Food and Drug Administration or its successor.

 

  2.6 First Commercial Sale ” means the initial transfer by or on behalf of the Licensee , its Affiliates , or sublicensees of Licensed Products or the initial practice of a Licensed Process by or on behalf of the Licensee , its Affiliates , or sublicensees in a country, in each case, after all applicable marketing and pricing approvals (if any) have been granted by the applicable governing regulatory authority in such country, in exchange for cash or some equivalent consideration to which value can be assigned for the purpose of determining Net Sales .

 

  2.7 Government ” means the Government of the United States of America.

 

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  2.8 Licensed Field of Use ” means the fields of use identified in Appendix B.

 

  2.9 Licensed Patent Rights ” shall mean:

 

  (a) Patent applications (including provisional patent applications and PCT patent applications) or patents listed in Appendix A, all divisions and continuations of these applications, all patents issuing from these applications, divisions, and continuations, and any reissues, reexaminations, and extensions of these patents;

 

  (b) to the extent that the following contain one or more claims directed to the invention or inventions disclosed in 2.9(a):

 

  (i) continuations-in-part of 2.9(a);

 

  (ii) all divisions and continuations of these continuations-in-part;

 

  (iii) all patents issuing from these continuations-in-part, divisions, and continuations;

 

  (iv) priority patent application(s) of 2.9(a); and

 

  (v) any reissues, reexaminations, and extensions of these patents;

 

  (c) to the extent that the following contain one or more claims directed to the invention or inventions disclosed in 2.9(a): all counterpart foreign and U.S. patent applications and patents to 2.9(a) and 2.9(b), including those listed in Appendix A; and

 

  (d) Licensed Patent Rights shall not include 2.9(b) or 2.9(c) to the extent that they contain one or more claims directed to new matter which is not the subject matter disclosed in 2.9(a).

 

  2.10 Licensed Processes ” means processes which, in the course of being practiced, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

 

  2.11 Licensed Products ” means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

 

  2.12 Licensed Territory ” means the geographical area identified in Appendix B.

Net Sales ” means the total gross receipts for sales of Licensed Products or practice of Licensed Processes by or on behalf of the Licensee , its Affiliates , or sublicensees and from leasing, renting, or otherwise making Licensed Products available to others without sale or other dispositions, whether invoiced or not, less [ …***…]

 

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[ …***…]. No deductions shall be made for […***…]. If the Licensee , its Affiliates or sublicensees sell a Combination Product , the Net Sales […***…]. If the Licensed Product is not sold separately, then Net Sales for such Combination Product […***…].

 

  2.13 Practical Application ” means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and in each case, under these conditions as to establish that the invention is being utilized and that its benefits are to the extent permitted by law or Government regulations available to the public on reasonable terms.

 

  2.14 Research License ” means a nontransferable, nonexclusive license to make and to use Licensed Products or Licensed Processes as defined by the Licensed Patent Rights solely for purposes of internal research and not for any commercial purposes or distribution in lieu of purchase.

 

3. GRANT OF RIGHTS

 

  3.1 The NIH hereby grants and the Licensee accepts, subject to the terms and conditions of this Agreement , an exclusive license under the Licensed Patent Rights in the Licensed Territory to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import any Licensed Products in the Licensed Field of Use and to practice and have practiced any Licensed Processes in the Licensed Field of Use .

 

  3.2 This Agreement confers no license or rights by implication, estoppel, or otherwise under any patent applications or patents of the NIH other than the Licensed Patent Rights regardless of whether these patents are dominant or subordinate to the Licensed Patent Rights .

 

4. SUBLICENSING

 

  4.1 Upon written approval, which shall include prior review of a copy of any sublicense agreement by the NIH and which shall not be unreasonably withheld, the Licensee may enter into sublicensing agreements under the Licensed Patent Rights . With respect to any proposed sublicense agreement, if the NIH does not provide the Licensee with written rejection thereof within […***…] after the date the NIH receives a copy thereof from the Licensee , the NIH shall be deemed to have given its approval of such sublicense agreement and the Licensee shall have the right to enter into such sublicense agreement.

 

  4.2 The Licensee agrees that any sublicenses granted by it shall provide that the obligations to the NIH of Paragraphs 5.1-5.4, 8.1, 10.1, 10.2, 12.5, and 13.8-13.10 of this Agreement shall be binding upon the sublicensee as if it were a party to this Agreement . The Licensee further agrees to attach copies of these Paragraphs to all sublicense agreements.

 

  4.3

Any sublicenses granted by the Licensee shall provide for the termination of the sublicense, or the conversion to a license directly between the sublicensees and the NIH , at the option of the sublicensee, upon termination of this Agreement under Article 13. This conversion is subject to

 

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  NIH approval and contingent upon acceptance by the sublicensee of the remaining provisions of this Agreement .

 

  4.4 The Licensee agrees to forward to the NIH a copy of each fully executed sublicense agreement postmarked within [ …***…] of the execution of the agreement. To the extent permitted by law, the NIH agrees to maintain each sublicense agreement in confidence.

 

  4.5 The Licensee’s right to grant sublicenses hereunder is further subject to the limitation that there shall not exist, at any time in any country, more than […***…] sublicense then in effect for the Licensed Field of Use .

 

5. STATUTORY AND NIH REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS

 

5.1        (a)         The NIH reserves on behalf of the Government an irrevocable, nonexclusive, nontransferable, royalty-free license for the practice of all inventions licensed under the Licensed Patent Rights throughout the world by or on behalf of the Government and on behalf of any foreign government or international organization pursuant to any existing or future treaty or agreement to which the Government is a signatory. Prior to the First Commercial Sale , the Licensee agrees to provide the NIH with reasonable quantities of Licensed Products or materials or procedures associated with the Licensed Products or materials made through the Licensed Processes for the NIH research use. Given the nature of the envisioned Licensed Products as personalized autologous cell therapy products, if any Licensed Products and/or materials made through the Licensed Processes are not available in reasonable quantities for NIH research use, they shall not be subject to the foregoing obligation; and

 

  (b) In the event that the Licensed Patent Rights are Subject Inventions made under a Cooperative Research and Development Agreement ( “CRADA” ), the Licensee grants to the Government , pursuant to 15 U.S.C. §3710a(b)(1)(A) , a nonexclusive, nontransferable, irrevocable, paid-up license to practice Licensed Patent Rights or have Licensed Patent Rights practiced throughout the world by or on behalf of the Government In the exercise of this license, the Government shall not publicly disclose trade secrets or commercial or financial information that is privileged or confidential within the meaning of 5 U.S.C. §552(b)(4) or which would be considered as such if it had been obtained from a non-Federal party. Prior to the First Commercial Sale , the Licensee agrees to provide the NIH reasonable quantities of Licensed Products or materials made through the Licensed Processes for the NIH research use. Given the nature of the envisioned Licensed Products as personalized autologous cell therapy products, if any Licensed Products and/or materials made through the Licensed Processes are not available in reasonable quantities for NIH research use, they shall not be subject to the foregoing obligation.

 

  5.2 The Licensee agrees that products used or sold in the United States embodying Licensed Products or produced through use of Licensed Processes shall be manufactured substantially in the United States, unless a written waiver is obtained in advance from the NIH .

 

  5.3

The Licensee acknowledges that the NIH may enter into future CRADA s under the Federal Technology Transfer Act of 1986 that relate to the subject matter of this Agreement . The Licensee agrees not to unreasonably deny requests for a Research License from future collaborators with the NIH when acquiring these rights is necessary in order to make a CRADA

 

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  project feasible. The Licensee may request an opportunity to join as a party to the proposed CRADA .

 

5.4        (a)         In addition to the reserved license of Paragraph 5.1, the NIH reserves the right to grant Research Licenses directly or to require the Licensee to grant Research Licenses on reasonable terms. In the exercise of this reserved right, the NIH shall not publicly disclose trade secrets or commercial or financial information that is privileged or confidential within the meaning of 5 U.S.C. §552(b)(4) or which would be considered as such if it had been obtained from a non-Federal party. The purpose of these Research Licenses is to encourage basic research, whether conducted at an academic or corporate facility. In order to safeguard the Licensed Patent Rights , however, before granting to commercial entities a Research License or providing to them research samples of materials made through the Licensed Processes , (i) the NIH shall give to the Licensee advance written notice of any commercial party to which the NIH proposes to grant a Research License , (ii) the NIH shall provide the Licensee reasonable opportunity to raise objections thereto and comment thereon, and (iii) the NIH shall consult with the Licensee to consider in good faith the objections and comments of the Licensee ; and

 

  (b) In exceptional circumstances, and in the event that Licensed Patent Rights are Subject Inventions made under a CRADA , the Government , pursuant to 15 U.S.C. §3710a(b)(1)(B) , retains the right to require the Licensee to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the Licensed Patent Rights in the Licensed Field of Use on terms that are reasonable under the circumstances, or if the Licensee fails to grant this license, the Government retains the right to grant the license itself. The exercise of these rights by the Government shall only be in exceptional circumstances and only if the Government determines:

 

  (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by the Licensee ;

 

  (ii) the action is necessary to meet requirements for public use specified by Federal regulations, and these requirements are not reasonably satisfied by or on behalf of the Licensee ; or

 

  (iii) the Licensee has failed to comply with an agreement containing provisions described in 15 U.S.C. §3710a(c)(4)(B) ; and

 

  (c) The determination made by the Government under this Paragraph 5.4 is subject to administrative appeal and judicial review under 35 U.S.C. §203(b) ; and

 

  (d)

The NIH acknowledges and agrees that a Research License or other right granted pursuant to this Paragraph 5.4 shall only pertain to the Licensed Patent Rights and shall not include a right or license to any patent or other intellectual property right solely owned or solely controlled by the Licensee or its Affiliates other than the Licensed Patent Rights . Without limiting the foregoing, except as expressly provided herein, nothing contained in this Agreement shall be construed as granting, by implication, estoppel or otherwise, any licenses or

 

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  rights under any patents or other intellectual property rights other than the Licensed Patent Rights .

 

  5.5 Notwithstanding anything to the contrary set forth in this Agreement , except as set forth in Section 5.4(b), the NIH shall not grant any rights under the Licensed Patent Rights within the Licensed Field of Use and shall not provide any Licensed Products or materials made through the Licensed Processes to any third party for any commercial purpose within the Licensed Field of Use .

 

6. ROYALTIES AND REIMBURSEMENT

 

  6.1 The Licensee agrees to pay the NIH a noncreditable, nonrefundable license issue royalty as set forth in Appendix C.

 

  6.2 The Licensee agrees to pay the NIH a nonrefundable, fully creditable (against earned royalties due for sales made in that specific year under Paragraph 6.3, below) minimum annual royalty as set forth in Appendix C.

 

  6.3 The Licensee agrees to pay the NIH earned royalties as set forth in Appendix C.

 

  6.4 The Licensee agrees to pay the NIH benchmark royalties as set forth in Appendix C.

 

  6.5 The Licensee agrees to pay the NIH sublicensing royalties as set forth in Appendix C.

 

  6.6 A patent or patent application licensed under this Agreement shall cease to fall within the Licensed Patent Rights for the purpose of computing earned royalty payments in any given country on the earliest of the dates that:

 

  (a) the application has been abandoned and not continued;

 

  (b) the patent expires or irrevocably lapses, or

 

  (c) the patent has been held to be invalid or unenforceable by an unappealed or unappealable decision of a court of competent jurisdiction or administrative agency.

 

  6.7 No multiple royalties shall be payable because any Licensed Products or Licensed Processes are covered by more than one of the Licensed Patent Rights .

 

  6.8 On sales of Licensed Products by the Licensee to its Affiliates or sublicensees, or on sales made in other than an arms-length transaction, the value of the Net Sales attributed under this Article 6 to this transaction shall be that which would have been received in an arms-length transaction, based on sales of like quantity and quality products on or about the time of this transaction.

 

  6.9 With regard to unreimbursed expenses associated with the preparation, filing, prosecution, and maintenance of all patent applications and patents included within the Licensed Patent Rights and paid by the NIH prior to the effective date of this Agreement , the Licensee shall pay the NIH , as an additional royalty, an amount equivalent to these unreimbursed expenses previously paid by the NIH in accordance with the following schedule:

 

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  (a) [ …***…] percent ([…***…]%) of these unreimbursed expenses will be paid by the Licensee to the NIH within […***…] of the NIH’s submission of a statement and request for payment to the Licensee ; and

 

  (b) […***…] percent ([…***…]%) of these unreimbursed expenses will be paid by the Licensee to the NIH on or before the […***…] anniversary of the effective date of this Agreement or upon termination of this Agreement , whichever occurs sooner.

 

  (c) A good faith estimate of the unreimbursed expenses previously paid by the NIH is set forth in Appendix C.

 

  6.10 With regard to unreimbursed expenses associated with the preparation, filing, prosecution, and maintenance of all patent applications and patents included within the Licensed Patent Rights and paid by the NIH on or after the effective date of this Agreement , the NIH , at its sole option, may require the Licensee :

 

  (a) to pay the NIH on an annual basis, within […***…] of the NIH’s submission of a statement and request for payment, a royalty amount equivalent to these unreimbursed expenses paid during the previous calendar year(s) provided, however, that if the NIH grants a commercialization license under the Licensed Patent Rights to one or more third parties, then the Licensee shall pay the NIH a pro-rated portion of such unreimbursed expenses calculated by dividing the total patent costs paid during the previous calendar year(s) by the number of commercialization licensees of record whose licenses have a Licensed Field of Use which includes the development of therapeutic or diagnostic products and falls within the scope of the Licensed Patent Rights as of the date of this statement. For avoidance of doubt, if the Licensee is the only commercialization licensee of record whose license has a Licensed Field of Use which includes the development of therapeutic or diagnostic products and falls within the scope of the Licensed Patent Rights as of the date of this statement, the Licensee shall pay NIH a royalty amount equivalent to […***…] percent ([…***…]%) of these unreimbursed expenses paid during the previous calendar year(s);

 

  (b) to pay these unreimbursed expenses directly to the law firm employed by the NIH to handle these functions. However, in this event, the NIH and not the Licensee shall be the client of the law firm; or

 

  (c) in limited circumstances, the Licensee may be given the right to assume responsibility for the preparation, filing, prosecution, or maintenance of any patent application or patent included with the Licensed Patent Rights . In that event, the Licensee shall directly pay the attorneys or agents engaged to prepare, file, prosecute, or maintain these patent applications or patents and shall provide the NIH with copies of each invoice associated with these services as well as documentation that these invoices have been paid.

 

  6.11

The NIH agrees, upon written request, to provide the Licensee with summaries of patent prosecution invoices for which the NIH has requested payment from the Licensee under Paragraphs 6.9 and 6.10. The Licensee agrees that all information provided by the NIH related to

 

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  patent prosecution costs shall be treated as confidential commercial information and shall not be released to a third party except as required by law or a court of competent jurisdiction.

 

  6.12 The Licensee may elect to surrender its rights in any country of the Licensed Territory under any of the Licensed Patent Rights upon […***…] written notice to the NIH and owe no payment obligation under Paragraph 6.10 for patent-related expenses paid in that country after […***…] of the effective date of the written notice.

 

7. PATENT FILING, PROSECUTION, AND MAINTENANCE

 

  7.1 Except as otherwise provided in this Article 7, the NIH agrees to take responsibility for, but to consult with, the Licensee in the preparation, filing, prosecution, and maintenance of any and all patent applications or patents included in the Licensed Patent Rights and shall, on an ongoing basis, furnish copies of relevant patent-related documents to the Licensee .

 

  7.2 Upon the NIH’s written request, the Licensee shall have the right to assume the responsibility for the preparation, filing, prosecution, and maintenance of any and all patent applications or patents included in the Licensed Patent Rights and shall, on an ongoing basis, promptly furnish copies of all patent-related documents to the NIH . In this event, the Licensee shall, subject to the prior approval of the NIH , select registered patent attorneys or patent agents to provide these services on behalf of the Licensee and the NIH . The NIH shall provide appropriate powers of attorney and other documents necessary to undertake this action to the patent attorneys or patent agents providing these services. The Licensee and its attorneys or agents shall consult with the NIH in all aspects of the preparation, filing, prosecution and maintenance of patent applications and patents included within the Licensed Patent Rights and shall provide the NIH sufficient opportunity to comment on any document that the Licensee intends to file or to cause to be filed with the relevant intellectual property or patent office.

 

  7.3 At any time, the NIH may provide the Licensee with written notice that the NIH wishes to assume control of the preparation, filing, prosecution, and maintenance of any and all patent applications or patents included in the Licensed Patent Rights . If the NIH elects to reassume these responsibilities, the Licensee agrees to cooperate fully with the NIH , its attorneys, and agents in the preparation, filing, prosecution, and maintenance of any and all patent applications or patents included in the Licensed Patent Rights and to provide the NIH with complete copies of any and all documents or other materials that the NIH deems necessary to undertake such responsibilities. The Licensee shall be responsible for all costs associated with transferring patent prosecution responsibilities to an attorney or agent of the NIH’s choice.

 

  7.4 Each party shall promptly inform the other as to all matters that come to its attention that may affect the preparation, filing, prosecution, or maintenance of the Licensed Patent Rights and provide sufficient opportunity, when possible, to the other party to provide comments and suggestions with respect to the preparation, filing, prosecution, and maintenance of Licensed Patent Rights , which comments and suggestions shall be considered in good faith by the other party.

 

8. RECORD KEEPING

 

  8.1

The Licensee agrees to keep accurate and correct records of Licensed Products made, used, sold, or imported and Licensed Processes practiced under this Agreement appropriate to determine the amount of royalties due to the NIH . These records shall be retained for at least […***…] following a given reporting period and shall be available during normal business hours, but not

 

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  more than once in any […***…] period, for inspection, at the expense of the NIH , by an accountant or other designated auditor selected by the NIH for the sole purpose of verifying reports and royalty payments hereunder. The accountant or auditor shall only have the right to audit those records that have not previously been audited pursuant to this Paragraph 8.1, unless NIH determines that there is just cause for an additional audit, and shall only disclose to the NIH information relating to the accuracy of reports and royalty payments made under this Agreement . If an inspection shows an underreporting or underpayment in excess of […***…] percent ([…***…]%) for any […***…] period, then the Licensee shall reimburse the NIH for the cost of the inspection at the time the Licensee pays the unreported royalties, including any additional royalties as required by Paragraph 9.8. All royalty payments required under this Paragraph shall be due within […***…] of the date the NIH provides the Licensee notice of the payment due. The Licensee shall have the right to require that any accountant or auditor, prior to conducting an audit under this Paragraph 8.1, enter into an appropriate non-disclosure agreement with the Licensee regarding such financial information.

 

9. REPORTS ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS

 

  9.1 Prior to signing this Agreement , the Licensee has provided the NIH with the Commercial Development Plan in Appendix E, under which the Licensee intends to bring the subject matter of the Licensed Patent Rights to the point of Practical Application . This Commercial Development Plan is hereby incorporated by reference into this Agreement . Based on this plan, performance Benchmarks are determined as specified in Appendix D.

 

  9.2 The Licensee shall provide written summary annual reports on its product development progress or efforts to commercialize under the Commercial Development Plan for each of the Licensed Field of Use within […***…] after December 31 of each calendar year. These progress reports shall include, but not be limited to: progress on research and development, status of applications for regulatory approvals, establishment of manufacturing sites for Licensed Product(s), and status of sublicensing, marketing, importing, and sales during the preceding calendar year, as well as, plans for the present calendar year. The NIH also encourages these reports to include information on any of the Licensee’s public service activities that relate to the Licensed Patent Rights . If reported progress differs from that projected in the Commercial Development Plan and Benchmarks , the Licensee shall explain the reasons for these differences. In the annual report, the Licensee may propose amendments to the Commercial Development Plan , acceptance of which by the NIH may not be denied unreasonably. The Licensee agrees to provide any additional information reasonably required by the NIH to evaluate the Licensee’s performance under this Agreement . The Licensee may amend the Benchmarks at any time upon written approval by the NIH , which approval shall not be unreasonably withheld. The NIH shall not unreasonably withhold approval of any request of the Licensee to extend the time periods of this schedule if the request is supported by a reasonable showing by the Licensee of diligence in its performance under the Commercial Development Plan and toward bringing the Licensed Products to the point of Practical Application as defined in 37 C.F.R. §404.3(d) . The Licensee shall amend the Commercial Development Plan and Benchmarks at the request of the NIH to address any Licensed Field of Use not specifically addressed in the plan originally submitted.

 

  9.3 The Licensee shall report to the NIH the dates for achieving Benchmarks specified in Appendix D and the First Commercial Sale in each country in the Licensed Territory within […***…] days of such occurrences.

The Licensee shall submit to the NIH , within […***…] after each calendar half-year ending June 30 and December 31, a royalty report, as described in the example in Appendix F, setting forth for the preceding half-year period the amount of the Licensed Products sold or

 

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Licensed Processes practiced by or on behalf of the Licensee in each country within the Licensed Territory , the Net Sales , and the amount of royalty accordingly due. With each royalty report, the Licensee shall submit payment of earned royalties due. If no earned royalties are due to the NIH for any reporting period, the written report shall so state. The royalty report shall be certified as correct by an authorized officer of the Licensee and shall include a detailed listing of all deductions made under Paragraph 2.13 to determine Net Sales made under Article 6 to determine royalties due. The royalty report shall also identify the site of manufacture for Licensed Product(s) sold in the United States.

 

  9.4 The Licensee agrees to forward […***…] to the NIH a copy of these reports received by the Licensee from its sublicensees during the preceding half-year period as shall be pertinent to a royalty accounting to the NIH by the Licensee for activities under the sublicense.

 

  9.5 Royalties due under Article 6 shall be paid in U.S. dollars and payment options are listed in Appendix G. The United States dollar equivalent shall be calculated using the average of the exchange rate (local currency per US$1) published in The Wall Street Journal , Western Edition, under the heading “Currency Trading” on the last business day of each month during the applicable half-year. Any loss of exchange, value, taxes, or other expenses incurred in the transfer or conversion to U.S. dollars shall be paid entirely by the Licensee . The royalty report required by Paragraph 9.4 shall be mailed to the NIH at its address for Agreement notices indicated on the Signature Page.

 

  9.6 The Licensee shall be solely responsible for determining if any tax on royalty income is owed outside the United States and shall pay the tax and be responsible for all filings with appropriate agencies of foreign governments.

 

  9.7 Additional royalties may be assessed by the NIH on any payment that is more than […***…] overdue at the rate of […***…] percent ([…***…]%) per month. This […***…] percent ([…***…]%) per month rate may be applied retroactively from the original due date until the date of receipt by the NIH of the overdue payment and additional royalties. The payment of any additional royalties shall not prevent the NIH from exercising any other rights it may have as a consequence of the lateness of any payment.

 

  9.8 All plans and reports required by this Article 9 and marked “confidential” by the Licensee shall, to the extent permitted by law, be treated by the NIH as commercial and financial information obtained from a person and as privileged and confidential, and any proposed disclosure of these records by the NIH under the Freedom of Information Act (FOIA), 5 U.S.C. §552 shall be subject to the predisclosure notification requirements of 45 C.F.R. §5.65(d).

 

10. PERFORMANCE

 

  10.1 The Licensee shall use its reasonable commercial efforts to bring the Licensed Products and Licensed Processes to Practical Application . “Reasonable commercial efforts” for the purposes of this provision shall include adherence to the Commercial Development Plan in Appendix E and performance of the Benchmarks in Appendix D. The efforts of a sublicensee shall be considered the efforts of the Licensee .

 

  10.2 Upon the First Commercial Sale , until the expiration or termination of this Agreement , the Licensee shall use its reasonable commercial efforts to make Licensed Products and Licensed Processes reasonably accessible to the United States public.

 

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  10.3 The Licensee agrees, after its First Commercial Sale and as part of its marketing and product promotion, to develop reasonable educational materials (e.g., brochures, website, etc.) directed to patients and physicians reasonably detailing the Licensed Products or medical aspects of the prophylactic and therapeutic uses of the Licensed Products .

 

  10.4 The Licensee agrees to supply, to the Mailing Address for Agreement notices indicated on the Signature Page, the Office of Technology Transfer, NIH with inert samples of the Licensed Products or Licensed Processes or their packaging for educational and display purposes only.

 

11. INFRINGEMENT AND PATENT ENFORCEMENT

 

  11.1 The NIH and the Licensee agree to notify each other promptly of each infringement or possible infringement of the Licensed Patent Rights , as well as, any facts which may affect the validity, scope, or enforceability of the Licensed Patent Rights to the extent a party becomes aware of such infringement or facts.

 

  11.2 Pursuant to this Agreement and the provisions of 35 U.S.C. Part 29 , the Licensee may:

 

  (a) bring suit in its own name, at its own expense, and on its own behalf for infringement of presumably valid claims in the Licensed Patent Rights ;

 

  (b) in any suit, enjoin infringement and collect for its use, damages, profits, and awards of whatever nature recoverable for the infringement; or

 

  (c) settle any claim or suit for infringement of the Licensed Patent Rights provided, however, that the NIH and appropriate Government authorities shall have the first right to take such actions; and

 

  (d) If the Licensee desires to initiate a suit for patent infringement, the Licensee shall notify the NIH in writing. If the NIH does not notify the Licensee of its intent to pursue legal action within [ * …***…], the Licensee shall be free to initiate suit. The NIH shall have a continuing right to intervene in the suit at its own expense. The Licensee shall take no action to compel the Government either to initiate or to join in any suit for patent infringement; provided, however, that the Government will participate in the suit if, and only if, required for legal standing purposes. The Licensee may request the Government to initiate or join in any suit if necessary to avoid dismissal of the suit. Should the Government be made a party to any suit brought by the Licensee , the Licensee shall reimburse the Government for any costs, expenses, or fees which the Government incurs as a result of the motion or other action, including all costs incurred by the Government in opposing the motion or other action. In all cases, the Licensee agrees to keep the NIH reasonably apprised of the status and progress of any litigation. Before the Licensee commences an infringement action, the Licensee shall notify the NIH and give careful consideration to the views of the NIH and to any potential effects of the litigation on the public health in deciding whether to bring suit.

In the event that a declaratory judgment action alleging invalidity or non-infringement of any of the Licensed Patent Rights shall be brought against the Licensee or raised by way of counterclaim or affirmative defense in an infringement suit brought by the Licensee under

 

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Paragraph 11.2, pursuant to this Agreement and the provisions of 35 U.S.C. Part 29 or other statutes, the Licensee may:

 

  (e) defend the suit in its own name, at its own expense, and on its own behalf for presumably valid claims in the Licensed Patent Rights ;

 

  (f) in any suit, ultimately to enjoin infringement and to collect for its use, damages, profits, and awards of whatever nature recoverable for the infringement; and

 

  (g) settle any claim or suit for declaratory judgment involving the Licensed Patent Rights provided, however, that the NIH and appropriate Government authorities shall have a continuing right to intervene in the suit at its own expense; and

 

  (h) If the NIH does not notify the Licensee of its intent to respond to the legal action within a reasonable time, the Licensee shall be free to do so. The Licensee shall take no action to compel the Government either to initiate or to join in any declaratory judgment action. The Licensee may request the Government to initiate or to join any suit if necessary to avoid dismissal of the suit. Should the Government be made a party to any suit by motion or any other action brought by the Licensee , the Licensee shall reimburse the Government for any costs, expenses, or fees, which the Government incurs as a result of the motion or other action. If the Licensee elects not to defend against the declaratory judgment action, the NIH , at its option, may do so at its own expense. In all cases, the Licensee agrees to keep the NIH reasonably apprised of the status and progress of any litigation. Before the Licensee commences an infringement action, the Licensee shall notify the NIH and give careful consideration to the views of the NIH and to any potential effects of the litigation on the public health in deciding whether to bring suit.

 

  11.3 Except as otherwise set forth above, in any action under Paragraphs 11.2 or 11.3 the expenses including costs, fees, attorney fees, and disbursements, shall be paid by the Licensee . The value of any recovery made by the Licensee through court judgment or settlement, after first reimbursing the Licensee for such expenses paid by the Licensee , shall be treated as Net Sales and subject to earned royalties.

 

  11.4 The NIH shall cooperate fully with the Licensee in connection with any action under Paragraphs 11.2 or 11.3. The NIH agrees promptly to provide access to all necessary documents and to render reasonable assistance in response to a request by the Licensee .

 

12. NEGATION OF WARRANTIES AND INDEMNIFICATION

 

  12.1 The NIH offers no warranties other than those specified in Article 1.

 

  12.2 The NIH does not warrant the validity of the Licensed Patent Rights and makes no representations whatsoever with regard to the scope of the Licensed Patent Rights , or that the Licensed Patent Rights may be exploited without infringing other patents or other intellectual property rights of third parties.

 

  12.3

The NIH MAKES NO WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF ANY SUBJECT MATTER DEFINED BY

 

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  THE CLAIMS OF THE LICENSED PATENT RIGHTS OR TANGIBLE MATERIALS RELATED THERETO.

 

  12.4 The NIH does not represent that it shall commence legal actions against third parties infringing the Licensed Patent Rights .

 

  12.5 The Licensee shall indemnify and hold the NIH , its employees, students, fellows, agents, and consultants harmless from and against all liability, demands, damages, expenses, and losses, including but not limited to death, personal injury, illness, or property damage to the extent arising out of any suit or proceeding brought by a third party for:

 

  (a) the use by or on behalf of the Licensee , its sublicensees, Affiliates , or their respective directors, employees, or third parties (on behalf of the Licensee , its sublicensees or Affiliates ) of any Licensed Patent Rights ; or

 

  (b) the design, manufacture, distribution, or use of any Licensed Products , Licensed Processes or other materials, products or processes developed by or on behalf of the Licensee , its sublicensees or Affiliates in connection with or arising out of the Licensed Patent Rights .

 

  12.6 The Licensee agrees to maintain a liability insurance program consistent with sound business practice.

 

13. TERM, TERMINATION, AND MODIFICATION OF RIGHTS

 

  13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.16 are not fulfilled, and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 13.

 

  13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement , including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act .

 

  13.3 In the event that the Licensee , files a petition in bankruptcy, or has such a petition filed against it, the Licensee shall immediately notify the NIH in writing. Furthermore, to the extent allowed under applicable law, the NIH shall have the right to terminate this Agreement immediately upon the Licensee s receipt of written notice; provided, however, that with respect to any petition filed against the Licensee , the NIH shall not have the right to terminate this Agreement if the Licensee is able to resolve or obtain the dismissal of such petition within […***…] following the date of such notice.

 

  13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any Licensed Field of Use in any country or territory by giving the NIH sixty (60) days written notice to that effect.

 

  13.5 The NIH shall specifically have the right to terminate or modify, at its option, this Agreement by written notice to the Licensee , if the NIH determines in good faith that the Licensee :

 

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  (a) is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes ;

 

  (b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;

 

  (c) has willfully made a false statement of, or willfully omitted a material fact in the license application or in any report required by this Agreement ;

 

  (d) has committed a material breach of a covenant or agreement contained in this Agreement that has not been remedied within the ninety (90) days period set forth in Paragraph 13.2 above;

 

  (e) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; or

 

  (f) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2 unless waived.

 

  13.6 In making the determination referenced in Paragraph 13.5, the NIH shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to remedy the items referenced in Paragraphs 13.5(a)-13.5(g). If the Licensee fails to alleviate the NIH’s concerns as to the items referenced in Paragraphs 13.5(a)-13.5(g) within ninety (90) days following written notice from the NIH or otherwise fails to initiate corrective action to the NIH’s satisfaction, the NIH may terminate this Agreement upon written notice to the Licensee .

 

  13.7 When the public health and safety so require and after written notice to the Licensee providing the Licensee a sixty (60) day opportunity to respond, the NIH shall have the right to require the Licensee to grant sublicenses to responsible applicants, on reasonable terms, in any of the Licensed Field of Use under the Licensed Patent Rights , unless the Licensee can reasonably demonstrate that the granting of the sublicense would not materially increase the availability to the public of the subject matter of the Licensed Patent Rights . The NIH shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with the Licensee .

 

  13.8 The NIH reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement upon written notice to the Licensee if it is determined that this action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee within ninety (90) days following written notice from the NIH .

 

  13.9

Within thirty (30) days after receipt of written notice of the NIH’s unilateral decision to modify or terminate this Agreement , the Licensee may, consistent with the provisions of 37 C.F.R. §404.11 , appeal the decision by written submission to the designated NIH official. The decision of the

 

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  designated NIH official shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be available.

 

  13.10 Within […***…] after expiration or termination of this Agreement under this Article 13, a final report shall be submitted by the Licensee . Any royalty payments, including those incurred but not yet paid (such as the full minimum annual royalty), and those related to patent expense, due to the NIH shall become immediately due and payable upon termination or expiration. If terminated under this Article 13, sublicensees may elect to convert their sublicenses to direct licenses with the NIH pursuant to Paragraph 4.3. Unless otherwise specifically provided for under this Agreement , upon termination of this Agreement , the Licensee shall have the right to offer for sale and sell any existing inventory of Licensed Products for […***…] following the effective termination date of this Agreement , subject to the royalty obligations as set forth in Appendix C. After this […***…] period, the Licensee shall return all remaining Licensed Products or other materials included within the Licensed Patent Rights to the NIH or provide the NIH with certification of the destruction thereof. The Licensee may not be granted additional NIH licenses if the final reporting requirement is not fulfilled.

 

14. GENERAL PROVISIONS

 

  14.1 Neither party may waive or release any of its rights or interests in this Agreement except in writing. The failure of a party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right by that party or excuse a similar subsequent failure to perform any of these terms or conditions by the other party.

 

  14.2 This Agreement constitutes the entire agreement between the parties relating to the subject matter of the Licensed Patent Rights , Licensed Products and Licensed Processes , and all prior negotiations, representations, agreements, and understandings are merged into, extinguished by, and completely expressed by this Agreement .

 

  14.3 The provisions of this Agreement are severable, and in the event that any provision of this Agreement shall be determined to be invalid or unenforceable under any controlling body of law, this determination shall not in any way affect the validity or enforceability of the remaining provisions of this Agreement .

 

  14.4 If either party desires a modification to this Agreement , the parties shall, upon reasonable notice of the proposed modification by the party desiring the change, confer in good faith to determine the desirability of the modification. No modification shall be effective until a written amendment is signed by the signatories to this Agreement or their designees.

 

  14.5 The construction, validity, performance, and effect of this Agreement shall be governed by Federal law as applied by the Federal courts in the District of Columbia.

 

  14.6 All Agreement notices required or permitted by this Agreement shall be given by prepaid, first class, registered or certified mail or by an express/overnight delivery service provided by a commercial carrier, properly addressed to the other party at the address designated on the following Signature Page, or to another address as may be designated in writing by the other party. Agreement notices shall be considered timely if the notices are received on or before the established deadline date or sent on or before the deadline date as verifiable by U.S. Postal Service postmark or dated receipt from a commercial carrier. Parties should request a legibly dated U.S. Postal Service postmark or obtain a dated receipt from a commercial carrier or the U.S. Postal Service. Private metered postmarks shall not be acceptable as proof of timely mailing.

 

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  14.7 This Agreement shall not be assigned or otherwise transferred (including any transfer by legal process or by operation of law, and any transfer in bankruptcy or insolvency, or in any other compulsory procedure or order of court) without the prior written consent or approval of the NIH except to the Licensee’s Affiliate(s) or in connection with the transfer or sale of all or substantially all of its business (including without limitation by means of merger, consolidation or change of control) relating to operations which concern this Agreement. The Licensee shall notify NIH within […***…] of any assignment of this Agreement .

 

  14.8 The Licensee agrees in its use of any NIH -supplied materials to comply with all applicable statutes, regulations, and guidelines, including the NIH and HHS regulations and guidelines. The Licensee agrees not to use the materials for research involving use of the Licensed Products in human subjects (including clinical trials) in the United States without complying with 21 C.F.R. Part 50 and 45 C.F.R. Part 46 . The Licensee agrees not to use the materials for research involving use of the Licensed Products in human subjects (including clinical trials) outside of the United States without notifying the NIH , in writing, of the research or trials and complying with the applicable regulations of the appropriate national control authorities. Written notification to the NIH of such research involving human subjects or clinical trials outside of the United States shall be given no later than […***…] prior to commencement of the research or trials.

 

  14.9 The Licensee acknowledges that it is subject to and agrees to abide by the United States laws and regulations (including the Export Administration Act of 1979 and Arms Export Control Act ) controlling the export of technical data, computer software, laboratory prototypes, biological material, and other commodities. The transfer of these items may require a license from the appropriate agency of the U.S. Government or written assurances by the Licensee that it shall not export these items to certain foreign countries without prior approval of this agency. The NIH neither represents that a license is or is not required or that, if required, it shall be issued.

 

  14.10 The Licensee agrees to mark the Licensed Products or their packaging or containers in accordance with the applicable patent marking laws.

 

  14.11 By entering into this Agreement , the NIH does not directly or indirectly endorse any product or service provided, or to be provided, by the Licensee whether directly or indirectly related to this Agreement . The Licensee shall not state or imply that this Agreement is an endorsement by the Government , the NIH , any other Government organizational unit, or any Government employee. Additionally, the Licensee shall not use the names of NIH , FDA , or HHS or the Government or their employees in any advertising, promotional, or sales literature in connection with this Agreement or the Licensed Patent Rights without the prior written approval of the NIH .

 

  14.12 The parties agree to attempt to settle amicably any controversy or claim arising under this Agreement or a breach of this Agreement , except for appeals of modifications or termination decisions provided for in Article 13. The Licensee agrees first to appeal any unsettled claims or controversies to the designated NIH official, or designee, whose decision shall be considered the final agency decision. Thereafter, the Licensee may exercise any administrative or judicial remedies that may be available. Notwithstanding anything to the contrary in this Agreement , the Licensee shall have the right, without waiving any right or remedy available 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 the Licensee , pending any such settlement or the determination of any such appeal.

 

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  14.13 Nothing relating to the grant of a license, nor the grant itself, shall be construed to confer upon any person any immunity from or defenses under the antitrust laws or from a charge of patent misuse, and the acquisition and use of rights pursuant to 37 C.F.R. Part 404 shall not be immunized from the operation of state or Federal law by reason of the source of the grant.

 

  14.14 Any formal recordation of this Agreement required by the laws of any Licensed Territory as a prerequisite to enforceability of this Agreement in the courts of any foreign jurisdiction or for other reasons shall be carried out by the Licensee at its expense, and appropriately verified proof of recordation shall be promptly furnished to the NIH .

 

  14.15 Paragraphs 4.3, 8.1, 9.5-9.7, 12.1-12.5, 13.9, 13.10, 14.12 and 14.15 of this Agreement shall survive termination of this Agreement .

 

  14.16 The terms and conditions of this Agreement shall, at the NIH’s sole option, be considered by the NIH to be withdrawn from the Licensee’s consideration and the terms and conditions of this Agreement , and this Agreement itself to be null and void, unless this Agreement is executed by the Licensee and a fully executed original is received by the NIH within […***…] from the date of the NIH signature found at the Signature Page.

SIGNATURES BEGIN ON NEXT PAGE

 

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NIH PATENT LICENSE AGREEMENT – EXCLUSIVE

SIGNATURE PAGE

 

For the NIH :    

 

   

 

Richard U. Rodriguez     Date
Director, Division of Technology Development and Transfer    
Office of Technology Transfer    
National Institutes of Health    

Mailing Address or E-mail Address for Agreement notices and reports:

Chief, Monitoring & Enforcement Branch

Office of Technology Transfer

National Institutes of Health

6011 Executive Boulevard, Suite 325

Rockville, Maryland 20852-3804 U.S.A.

E-mail: LicenseNotices_Reports@mail.nih.gov

For the Licensee (Upon, information and belief, the undersigned expressly certifies or affirms that the contents of any statements of the Licensee made or referred to in this document are truthful and accurate.):

 

by:    

 

   

 

Signature of Authorized Official     Date

Arie Belldegrun

   
Printed Name    

Chairman, President and Chief Executive Officer

   
Title    

 

  I.   Official and Mailing Address for Agreement notices:    
   

Arie Belldegrun

   
    Name    
   

Chairman, President and Chief Executive Officer

   
    Title    
    Mailing Address    

 

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Kite Pharma, Inc.

   
   

10924 Le Conte Avenue

   
   

Los Angeles, CA 90024

   
    Email Address:  

arie@kitepharma.com

 
    Phone:  

310-824-9999 x201

 
    Fax:  

310-824-9994

 
  II.   Official and Mailing Address for Financial notices (the Licensee’s contact person for royalty payments)
   

Arie Belldegrun

   
    Name    
   

Chairman, President and Chief Executive Officer

   
    Title    
    Mailing Address    
   

Kite Pharma, Inc.

   
   

10924 Le Conte Avenue

   
   

Los Angeles, CA 90024

   
    Email Address:  

arie@kitepharma.com

 
    Phone:  

310-824-9999 x201

 
    Fax:  

310-824-9994

 

Any false or misleading statements made, presented, or submitted to the Government , including any relevant omissions, under this Agreement and during the course of negotiation of this Agreement are subject to all applicable civil and criminal statutes including Federal statutes 31 U.S.C. §§3801-3812 (civil liability) and 18 U.S.C. §1001 (criminal liability including fine(s) or imprisonment).

 

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APPENDIX A – PATENT(S) OR PATENT APPLICATION(S)

Patent(s) or Patent Application(s):

 

I. […***…]

 

II. PCT Application No. PCT/US13/042162 filed May 22, 2013 entitled ‘‘Murine anti-NY–ESO–1 T cell receptors’’ [HHS Ref No. E–105–2012/0–PCT–02]

 

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APPENDIX B – LICENSED FIELD OF USE AND TERRITORY

 

I. Licensed Field of Use:

 

a) Development, manufacture and commercialization of New York Esophageal Antigen-1 (“NY-ESO-1”) T cell receptor (TCR)-based autologous peripheral blood T cell therapy product as set forth in the Licensed Patent Rights for the treatment of NY–ESO–1-expressing cancers.

 

b) For purposes of this Agreement , “autologous peripheral blood T cell therapy products” shall mean T cell or precursor products and compositions derived from blood, bone marrow, lymph nodes and thymus and, for the avoidance of doubt, shall exclude tumor-infiltrating lymphocytes (TILs).

 

c) If NIH receives a license application with a complete commercial development plan from a third party for commercial development of a Licensed Product(s) or Licensed Processes , as they pertain to Licensed Patent Rights for which the proposed commercial development is not reasonably addressed in Licensee’s then-current Commercial Development Plan , NIH shall notify Licensee , in writing, of the existence of the third party’s license application, identifying the scientific, clinical or technical basis for its belief that such commercial development should occur. Upon receipt of such written notice, Licensee shall either: (a) within one-hundred and eighty (180) days amend its Commercial Development Plan in a manner reasonably acceptable to NIH to include a clinical research and development program for the proposed third party’s commercial development of said Licensed Product(s) or Licensed Processes including revised Benchmarks , acceptance of said amendment to said Commercial Development Plan by NIH shall take into account Licensee ’s ongoing efforts and normal drug development standards for obtaining FDA approval for multiple indication prophylactic and therapeutic products; or (b) amend its Commercial Development Plan within one-hundred and eighty (180) days in a manner reasonably acceptable to NIH to include an offer to enter into a commercially reasonable and customary joint pre-clinical research and development program with the third party for the proposed third party’s commercial development of said Licensed Product(s) or Licensed Processes ; or (c) within one-hundred and eighty (180) days offer to grant a sublicense under commercially reasonable and customary terms to said third party under Licensed Patent Rights ; or both (b) and (c). If Licensee does not (a) amend its Commercial Development Plan in a manner reasonably acceptable to NIH to include a clinical research and development program for the proposed commercial development of said Licensed Product(s) or Licensed Processes of such third party including revised Benchmarks ; or (b) amend its Commercial Development Plan in a manner reasonably acceptable to NIH to include a joint pre-clinical research and development program with the third party for the proposed commercial development of said Licensed Product(s) or Licensed Processes ; or (c) grant a sublicense within one hundred eighty (180) days under commercially reasonable terms to said third party under Licensed Patent Rights , for such commercial development; or both (b) and (c), NIH shall remove said Licensed Product(s) or Licensed Processes from Licensed Fields of Use in this Agreement , NIH shall be free to license said Licensed Product(s) or Licensed Processes to said third party solely for the unaddressed indication(s) that were the subject of such license application, and Licensee’s Licensed Product(s) or Licensed Processes from Licensed Fields of Use shall be limited to the remaining indications.

 

II. Licensed Territory:

Worldwide

 

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APPENDIX C – ROYALTIES

Royalties:

 

I. The Licensee agrees to pay to the NIH a noncreditable, nonrefundable license issue royalty in the amount of one hundred and fifty thousand dollars ($150,000.00) in two installments as follows:

 

  (a) The first installment of one hundred thousand dollars ($100,000) shall be payable within sixty (60) days from the effective date of this Agreement ; and

 

  (b) The second installment of fifty thousand dollars ($50,000) shall be payable (i) on or before the eighteen (18) month anniversary of the effective date of this Agreement or (ii) on or before the termination date of this Agreement , whichever occurs sooner.

 

II. The Licensee agrees to pay to the NIH a nonrefundable minimum annual royalty in the amount of twenty thousand dollars ($20,000.00) as follows:

 

  (a) The first minimum annual royalty is due within sixty (60) days following the expiration date of Cooperative Research and Development Agreement (CRADA) Ref. No. C-064-2012/0 (NCI Ref. No. 02716) between the National Cancer Institute (NCI) and the Licensee that includes further research and development of technologies related to the Licensed Patent Rights . This first minimum annual royalty may be prorated according to the fraction of the calendar year remaining between the expiration date of the aforementioned CRADA and the next subsequent January 1; and

 

  (b) Subsequent minimum annual royalty payments are due and payable on January 1 of each calendar year and may be credited against any earned royalties due for sales made in that year.

 

III. The Licensee agrees to pay the NIH earned royalties of […***…] percent ([…***…]%) on Net Sales by or on behalf of the Licensee and its sublicensees, subject to the following adjustment:

 

  (a) The Licensee shall be entitled to a credit of […***…] percent ([…***…]%) against the earned royalty rate for each percent point in excess of […***…] percent ([…***…]%) that the Licensee must pay to an unaffiliated licensor for the manufacture, use, offer for sale, sale or import of Licensed Product(s). Said credit, however, shall not reduce the earned royalty due to NIH for Licensed Product(s) below […***…] percent ([…***…]%).

 

IV. The Licensee agrees to pay the NIH Benchmark royalties within […***…] of achieving each Benchmark :

 

  (a) Fifty thousand dollars ($50,000.00) upon commencement of the first Licensee -sponsored human clinical study for the first indication in the Licensed Field of Use .

 

  (b) […***…] dollars ($[…***…]) for […***…].

 

  (c) […***…] dollars ($[…***…]) for […***…].

 

  (d) […***…] dollars ($[…***…]) for […***…] .

 

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  (e) […***…] dollars ($[…***…]) for […***…].

 

  (f) […***…] dollars ($[…***…]) upon FDA approval or foreign equivalent for a Licensed Product or Licensed Process for the first indication in the Licensed Field of Use . A foreign equivalent to the FDA (United States) shall mean the EMEA (Europe), Japanese Ministry of Health and Welfare (Japan), SFDA (China), or the Ministry of Health and Welfare (India).

 

  (g) […***…] dollars ($[…***…]) upon[…***…]. A foreign equivalent to the FDA (United States) shall mean the EMEA (Europe), Japanese Ministry of Health and Welfare (Japan), SFDA (China), or the Ministry of Health and Welfare (India).

 

  (h) The first time the aggregate Net Sales of all Licensed Products achieve the following thresholds, the Licensee pays the following one-time Benchmark royalties:

 

  (1) […***…] dollars ($[…***…]) when the aggregate Net Sales of all Licensed Products reaches […***…] dollars ($[…***…]).

 

  (2) […***…] dollars ($[…***…]) when the aggregate Net Sales of all Licensed Products reaches […***…] dollars ($[…***…]).

 

  (3) […***…] dollars ($[…***…]) when the aggregate Net Sales of all Licensed Products reaches one billion dollars ($1,000,000,000.00).

For purposes of this Agreement , “successful completion of a Licensee -sponsored Phase 3 clinical study” shall mean, with respect to a specified construct, formulation and dose of a specified Licensed Product in a specified cancer indication, the statistical demonstration in a pivotal Phase 3 clinical study of safety and efficacy, sufficient to support a BLA submission by the Licensee for such specified construct, formulation and dose of such specified Licensed Product for the treatment of such specified cancer indication.

 

V. The Licensee agrees to pay the NIH the following additional sublicensing royalties on the fair market value of any consideration received for granting each sublicense in accordance with Article 4 of this Agreement , within […***…] of the execution of each sublicense:

 

  (a) […***…] percent ([…***…]%) for a sublicense granted […***…].

 

  (b) […***…] percent ([…***…]%) for a sublicense granted […***…].

 

  (c) […***…] percent ([…***…]%) for a sublicense granted[…***…]. A foreign equivalent to the FDA (United States) shall mean the EMEA (Europe), Japanese Ministry of Health and Welfare (Japan), SFDA (China), or the Ministry of Health and Welfare (India).

 

  (d) […***…] percent ([…***…]%) for a sublicense granted […***…]. A foreign equivalent to the FDA (United States) shall mean the EMEA (Europe), Japanese Ministry of Health and Welfare (Japan), SFDA (China), or the Ministry of Health and Welfare (India).

 

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Such sublicense royalties are in lieu of, and not in addition to, the Benchmark royalties and earned royalties on Net Sales above, and shall not exceed the following caps:

 

  (1) Sublicensing royalties on consideration received for events occurring […***…].

 

  (2) Sublicensing royalties on consideration […***…].

 

  (3) Sublicensing royalties on Net Sales consideration received shall not exceed the […***…].

 

VI. The estimated amount of the royalty due under Paragraph 6.9 is Thirty Thousand dollars ($30,000) as of May 22, 2014. This is only a good faith estimate and Licensee will be responsible for reimbursement of all unreimbursed expenses as stipulated in Paragraph 6.9.

 

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APPENDIX D – BENCHMARKS AND PERFORMANCE

The Licensee agrees to the following Benchmarks for its performance under this Agreement and, within [ …***…] of achieving a Benchmark , shall notify the NIH that the Benchmark has been achieved.

The Licensee will initiate its first Phase 2 clinical study for the first Licensed Product for the first cancer indication within the Licensed Field of Use within twenty (20) months after demonstration by the National Cancer Institute’s Surgery Branch within the NIH of the proof-of-concept of the first Licensed Product in such cancer indication from the Licensed Field of Use , and the National Cancer Institute’s Surgery Branch within the NIH delivers to the Licensee the final clinical study report and all clinical data for the applicable clinical study demonstrating proof of concept.

The Licensee will initiate its first Phase 2 clinical study for the first Licensed Product for any additional cancer indication (after the first cancer indication) within the Licensed Field of Use within […***…] to […***…] after demonstration by the National Cancer Institute’s Surgery Branch within the NIH of the proof-of-concept of the first Licensed Product in such cancer indication from the Licensed Field of Use , and the National Cancer Institute’s Surgery Branch within the NIH delivers to the Licensee the final clinical study report and all clinical data for the applicable clinical study demonstrating proof of concept.

 

  (a) The Licensee will initiate its first Phase 3 clinical study for the first Licensed Product for the first cancer indication within the Licensed Field of Use within […***…] after successful completion of a Licensee -sponsored Phase 2 clinical study for the first Licensed Product in such cancer indication from the Licensed Field of Use .

 

  (b) The Licensee will initiate its first Phase 3 clinical study for the first Licensed Product for any additional cancer indication (after the first cancer indication) within the Licensed Field of Use within […***…] to […***…] after successful completion of a Licensee -sponsored Phase 2 clinical study for the first Licensed Product in such cancer indication from the Licensed Field of Use .

For purposes of this Ag reement , “initiate” shall mean (i) with respect to a Phase 2 clinical study, the Licensee , its Affiliate or sublicensee having filed a company sponsored IND necessary to commence such Phase 2 clinical study, and (ii) with respect to a Phase 3 clinical study, the Licensee , its Affiliate or sublicensee having submitted to the FDA a pivotal clinical trial protocol for such Phase 3 clinical study.

For purposes of this Ag reement , “proof-of-concept” shall mean, with respect to a specified construct, formulation and dose of a specified Licensed Product for the treatment of a specified cancer indication, the demonstration in a Phase 1/Phase 2A or Phase 2A clinical study of safety and efficacy, sufficient to enable the Licensee to commence multi-center Phase 2 clinical studies without further studies, for such specified construct, formulation and dose of such specified Licensed Product for the treatment of such specified cancer indication.

For purposes of this Ag reement , “successful completion of a Licensee -sponsored Phase 2 clinical study” shall mean, with respect to a specified construct, formulation and dose of a specified Licensed Product in a specified cancer indication, the statistical demonstration in multi-center Phase 2 clinical studies of safety and efficacy, sufficient to enable the Licensee to commence pivotal Phase 3 clinical studies without further studies, for such specified construct, formulation and dose of such specified Licensed Product for the treatment of such specified cancer indication.

 

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APPENDIX E – COMMERCIAL DEVELOPMENT PLAN

[ …***…]

[…***…] As of the date of this licensee, NY-ESO-1 expressing tumors can be found in the following cancers: Sarcoma, Urothelial carcinoma, Esophageal carcinoma, Lung (NSCLC), Breast carcinoma, Ovarian carcinoma, Prostate carcinoma, Multiple Myeloma, Hepatocellular carcinoma, Gastric cancer, Head and neck cancer, Pancreatic carcinoma, Brain cancer, Colorectal carcinoma, and Melanoma.

[…***…]

[…***…]

[…***…]

[…***…]

 

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APPENDIX F – EXAMPLE ROYALTY REPORT

Required royalty report information includes:

 

  OTT license reference number (L-XXX-200X/0)

 

  Reporting period

 

  Catalog number and units sold of each Licensed Product (domestic and foreign)

 

  Gross Sales per catalog number per country

 

  Total Gross Sales

 

  Itemized deductions from Gross Sales

 

  Total Net Sales

 

  Earned Royalty Rate and associated calculations

 

  Gross Earned Royalty

 

  Adjustments for Minimum Annual Royalty (MAR) and other creditable payments made

 

  Net Earned Royalty due

Example

 

Catalog Number

   Product Name   

Country

   Units Sold      Gross Sales
(US$)
 

1

   A    US      250         62,500   

1

   A    UK      32         16,500   

1

   A    France      25         15,625   

2

   B    US      0         0   

3

   C    US      57         57,125   

4

   D    US      12         1,500   
           

 

 

 
     

Total Gross Sales

  

     153,250   
     

Less Deductions:

  

  
     

[…***…]

  

     3,000   
     

[…***…]

  

     7,000   
     

Total Net Sales

  

     143,250   
     

Royalty Rate

  

     […***… ]% 
     

Royalty Due

  

     […***…
     

Less Creditable Payments

  

     […***…
     

Net Royalty Due

  

     […***…

 

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APPENDIX G – ROYALTY PAYMENT OPTIONS

The OTT License Number MUST appear on payments, reports and correspondence.

Automated Clearing House (ACH) for payments through U.S. banks only

The NIH encourages our licensees to submit electronic funds transfer payments through the Automated Clearing House (ACH). Submit your ACH payment through the U.S. Treasury web site located at: https://www.pay.gov. Locate the “ NIH Agency Form” through the Pay.gov “Agency List”.

Electronic Funds Wire Transfers

The following account information is provided for wire payments. In order to process payment via Electronic Funds Wire Transfer sender MUST supply the following information within the transmission:

Drawn on a U.S. bank account via FEDWIRE should be sent directly to the following account:

 

Beneficiary Account:    […***…]
Bank:    […***…]
ABA#    […***…]
Account Number:    […***…]
Bank Address:    […***…]
Payment Details:    […***…]
   […***…]

Drawn on a foreign bank account should be sent directly to the following account. Payment must be sent in U.S. Dollars (USD) using the following instructions:

 

Beneficiary Account:    […***…]
Bank:    […***…]
SWIFT Code:    […***…]
Account Number:    […***…]
Bank Address:    […***…]
Payment Details (Line 70):    […***…]
   […***…]
   […***…]
Detail of Charges (line 71a):    […***…]

 

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Checks

All checks should be made payable to “NIH Patent Licensing”

Checks drawn on a U.S. bank account and sent by US Postal Service should be sent directly to the following address:

National Institutes of Health ( NIH )

P.O. Box 979071

St. Louis, MO 63197-9000

Checks drawn on a U.S. bank account and sent by overnight or courier should be sent to the following address:

US Bank

Government Lockbox SL-MO-C2GL

1005 Convention Plaza

St. Louis, MO 63101

Phone: 314-418-4087

Checks drawn on a foreign bank account should be sent directly to the following address:

National Institutes of Health ( NIH )

Office of Technology Transfer

Royalties Administration Unit

6011 Executive Boulevard

Suite 325, MSC 7660

Rockville, Maryland 20852

 

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