Document:

EX 10.2 - 2014.9.30

Exhibit 10.2

CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

FIRST AMENDMENT TO COMMERCIAL MANUFACTURING AND SUPPLY AGREEMENT

This First Amendment to the Commercial Supply Agreement (as defined below) (the "First Amendment") is made and entered into as of 12th day of September 2014 (“First Amendment Effective Date”).  

BETWEEN:

(1)    Alkermes Science One Limited, a company incorporated under the laws of Ireland, having its registered office at Connaught House, 1 Burlington Road, Dublin 4, Ireland, which has changed its name to Daravita Limited (“Daravita”); AND 

(2)    Zogenix, Inc., a Delaware corporation, having its principal place of business at 12400 High Bluff Drive, Ste. 650, San Diego, California, USA 92130 (“Zogenix”).

RECITALS:

WHEREAS Alkermes Pharma Ireland Limited (“APIL”) and Zogenix entered into a commercial manufacturing and supply agreement on November 2, 2012 (“Commercial Supply Agreement”), wherein APIL would supply Zogenix commercial quantities of the Commercial Product, on the terms and conditions set forth in the Commercial Supply Agreement (capitalized terms used in this First Amendment but not defined herein shall have the meaning set forth in the Commercial Supply Agreement); and 
WHEREAS on May 8, 2014, pursuant to Clause 21.1 of the Commercial Supply Agreement, APIL assigned all of its rights and obligations to the Commercial Supply Agreement to its Affiliate, Daravita; and

WHEREAS Zogenix and Daravita desire to amend the Commercial Supply Agreement as set forth herein, subject to the terms and conditions set forth herein.  

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Daravita and Zogenix hereby agree as follows:

		
	1.
	Amendments.  As of the First Amendment Effective Date, Daravita and Zogenix hereby amend the following sections of the Commercial Supply Agreement:

		
	1.1.
	 The following definitions are as set forth below:

“ “Altus” means Altus Formulation Inc., and its successors, assigns or transferees under the Altus Agreement.”

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“ “Altus Agreement” means (a) as of the First Amendment Effective Date, the Development and Option Agreement dated November 1, 2013 between Altus and Zogenix, as amended or supplemented pursuant to the terms thereof (the “D&O Agreement”), and (b) following the exercise by Zogenix of the Option under the D&O Agreement, includes the License Agreement (as defined in the D&O Agreement), as amended or supplemented pursuant to the terms thereof (the “Altus License Agreement”).” 

“ “Altus Product” means Licensed Product (as defined in the Altus Agreement).”

“ “Option” means the option set forth in Section 2.2 of the D&O Agreement.”

		
	1.2.
	Clause 17.1 as set forth below:

“ Term.  This Agreement shall be deemed to have come into force on the Effective Date and, subject to the rights of termination outlined in this Clause 17 and the provisions of applicable laws, will continue in force until the expiry or termination of the License Agreement (the “Term”).  

		
	1.3.
	A new Clause 17.3 as set forth below:

“17.3    Termination by Zogenix.  Following initiation of the commercial launch of the Altus Product in the Territory and Zogenix’s decision to cease commercializing the Product in the Territory, Zogenix will be entitled to terminate this Agreement by twelve (12) months prior written notice to Alkermes.  For clarity, if Zogenix does not exercise the Option under the D&O Agreement, Zogenix shall not be entitled to terminate this Agreement pursuant to this Clause 17.3.”

		
	1.4.
	A new Clause 17.4 as set forth below:

“17.4    Termination by Alkermes.  Following initiation of the commercial launch of the Altus Product in the Territory, if Zogenix [***] in any given calendar quarter, then Alkermes will be entitled to terminate this Agreement by one hundred eighty (180) days prior written notice to Zogenix.”

		
	1.5.
	A new Clause 18.3 as set forth below:

“18.3    Additional Consequences of Termination by Zogenix under Clause 17.3.  Notwithstanding Clause 18.2.3 above, in the event that Zogenix provides notice of termination of this Agreement under Clause

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 17.3, and thereafter, but prior to the effective date of termination of this Agreement (e.g., twelve (12) months thereafter), Zogenix decides to cease commercializing the Product in the Territory, Zogenix may cancel any Confirmed Orders but shall reimburse Alkermes for all costs (including raw material costs) that Alkermes has incurred in connection with any such Confirmed Orders as well as any reasonable costs that Alkermes has incurred in connection with the preparation to manufacture Commercial Products based on forecasts delivered prior to Alkermes’ receipt of the notice of termination pursuant to Clause 17.3.  Zogenix shall not be required to pay to Alkermes either the Initial Fee or the Final Fee for any Confirmed Orders which are cancelled pursuant to this Clause 18.3. “ 

		
	1.6.
	Clause 21.1 as set forth below:

“The provisions of Clauses 16.2, 16.3, 16.4 and 16.5 of the License Agreement shall apply mutatis mutandis.  For clarity, the term “this Agreement” in such provisions shall apply herein to this Agreement. “ 

		
	2.
	Good Faith Negotiations.  Following exercise by Zogenix of the Option under the D&O Agreement, Zogenix and Daravita shall discuss in good faith, through the Supply Committee, any necessary adjustments to the provisions of Section 5 (Forecasting, Ordering and Capacity) to address the possible commercial sale of the Altus Product in the Territory. 

		
	3.
	Simultaneous Amendment to License Agreement.  In connection with this First Amendment, Daravita and Zogenix shall enter into an amendment to the License Agreement.

		
	4.
	No Other Amendments.  All other terms and conditions of the Commercial Supply Agreement remain unchanged and continue to be in full force and effect.

		
	5.
	Counterparts; Signatures.  This First Amendment may be executed in any number of counterparts, each of which when so executed shall be deemed to be an original and all of which when taken together shall constitute this First Amendment.  Signatures provided by facsimile transmission or in AdobeTM Portable Document Format (PDF) sent by electronic mail shall be deemed to be original signatures.

		
	6.
	Governing Law; Jurisdiction.  This First Amendment shall be governed by and construed in accordance with the laws of the State of New York, without regard to its conflict of laws rules, and shall be subject to the exclusive jurisdiction of the State and Federal Courts located in New York, New York.

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IN WITNESS WHEREOF Daravita and Zogenix have caused this First Amendment to be executed by their duly authorized representatives to be effective as of the First Amendment Effective Date.

DARAVITA LIMITED

By: /s/ Tom Riordan                                             

Title: Director                                                       

ZOGENIX, INC.

By: /s/ Roger L. Hawley                                       

Title: CEO                                                             

4EX 10.3 - 2014.9.30

Exhibit 10.3

CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

AMENDMENT NO. 2 - DEVELOPMENT AND OPTION AGREEMENT
THIS AMENDMENT NO. 2 – DEVELOPMENT AND OPTION AGREEMENT (the “Amendment No. 2”) is made as of September 15th, 2014 (the “Amendment No. 2 Effective Date”), by and between ALTUS FORMULATION INC., a Quebec company, having its principal place of business at 17800 Rue Lapointe, Mirabel Quebec J7J 1P3, Canada (“Altus”), and ZOGENIX, INC., a Delaware corporation, having its principal place of business at 12400 High Bluff Drive, Suite 650, San Diego, CA  92130 USA (“Zogenix”).  Each of Altus and Zogenix are sometimes referred to herein individually as a “Party” and together as the “Parties”.
WHEREAS, the Parties entered into a Development and Option Agreement dated as of November 1, 2013 (the “Agreement”), regarding their collaboration on the development of certain licensed products; 
WHEREAS, the Parties previously amended the terms of the Agreement pursuant to that certain Amendment No. 1 dated March 10, 2014 ("Amendment No. 1"); 
WHEREAS, the Parties wish to further amend certain terms of the Agreement and the initial Work Plan (the “Work Plan”), on the terms and subject to the conditions set forth herein.
NOW, THEREFORE, in consideration of the premises and the mutual promises and covenants contained herein, and for good and valuable consideration, the Parties hereby agree as follows:
1.DEFINITIONS. Unless otherwise indicated, capitalized terms used but not defined herein shall have the respective meanings assigned to such terms in the Agreement.
2.    AMENDMENT TO WORK PLAN.  The Work Plan executed by the Parties shall be amended in accordance with the terms set forth in Exhibit A attached hereto.    
3.    AMENDMENT OF THE DEVELOPMENT AND FINANCIAL MILESTONES. Section 4.1 of the Agreement shall be amended and restated in its entirety as follows;
“4.1    Development Milestones. Upon the first achievement of each of the milestones below, Zogenix shall pay to Altus the corresponding non-refundable, non-creditable Development milestone payments set forth below:
	
			
	Milestone
	 
	Milestone Payment

	1.    [***]
	 
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The payments  of the  amounts  set  forth  opposite  each Development  milestone  in this Section 4.1 shall be payable within [***] after achievement  of the applicable milestone.   Each of the milestone payments set forth above shall be payable [***], [***]. Development  milestone  5 above ([***]) shall be paid, even if [***],  if Zogenix  has  [***].
4.2    Manner and Place of Payment. All payment amounts specified in this Agreement are stated, and all payments hereunder shall be payable, in [***]. All payments owed under this Agreement shall be made by wire transfer to a bank and account designated in writing by Altus, unless otherwise specified in writing by Altus."
4MISCELLANEOUS.
4.1    Entire Agreement.  Amendment No.1, this Amendment No. 2 and the Agreement, including any and all Work Plans shall constitute the entire agreement between the parties on the subject matter hereof and shall supersede all other written or oral communication, proposals, drafts, amendments, agreements and representations between the Parties hereto with respect to the subject matter hereof.  
4.2    No Other Changes.  Except as expressly amended herein, all other provisions of the Agreement remain unchanged and in full force and effect.
4.3    Conflict.  In the event of a conflict between the provisions of the Agreement and this Amendment No. 2, the terms of this Amendment No. 2 shall prevail.
4.4    Counterparts.  This Amendment No. 2 may be executed in counterparts, each of which shall be deemed an original document, and all of which, together with this writing, shall be deemed one instrument.  This Amendment No. 2 may be executed by facsimile or PDF signatures, which signatures shall have the same force and effect as original signatures.
[Signature page follows]

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

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IN WITNESS WHEREOF, the Parties have duly executed this Amendment No. 2 as of the Amendment No. 2 Effective Date.
	
		
	Zogenix, Inc.
	Altus Formulation Inc.

	By: /s/ Stephen J. Farr   
Name: Stephen J. Farr
Title: President
	By: /s/ Damon Smith      
Name: Damon Smith
Title: CEO

Confidential

Exhibit A
WORK PLAN NO. 2 - DEVELOPMENT AND OPTION AGREEMENT
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