You are here: Agreements > Manufacturing Agreement > CONFIDENTIAL AMENDMENT NO. 1 TO MANUFACTURING AND SUPPLY AGREEMENT

SITE SEARCH
AGREEMENTS / CONTRACTS
(optional)
(optional)
Try our advanced search >>
CLAUSES Search Contract Clauses >>
Browse Contract Clause Library>>

Confidential Amendment No. 1 To Manufacturing And Supply Agreement

Manufacturing Agreement

Legal Documents
You are currently viewing:

 This Manufacturing Agreement involves

ALEXZA PHARMACEUTICALS INC. | Autoliv ASP, Inc

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.
 

Title: CONFIDENTIAL AMENDMENT NO. 1 TO MANUFACTURING AND SUPPLY AGREEMENT
Date: 7/26/2010
Industry: Biotechnology and Drugs     Sector: Healthcare

join now
50 of the Top 250 law firms use our Products every day

Exhibit 10.4

 

[*]

 =   

Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

CONFIDENTIAL

AMENDMENT NO. 1 TO MANUFACTURING AND SUPPLY AGREEMENT

This Amendment No. 1 to Manufacturing and Supply Agreement (“Amendment”) is made and entered into as of June 30, 2010 (the “Effective Date of the Amendment”) by and between Alexza Pharmaceuticals, Inc., a Delaware corporation having an address at 2091 Stierlin Court, Mountain View, CA 94043 (“Alexza”) and Autoliv ASP, Inc., an Indiana corporation having an address at 3350 Airport Road, Ogden, Utah 84405 (“Autoliv”).

WHEREAS Alexza and Autoliv are parties to a Manufacturing and Supply Agreement dated November 2, 2007 (the “Agreement”);

WHEREAS the parties now wish to amend the Agreement;

NOW, THEREFORE, in consideration of the foregoing and the covenants and promises contained in this Amendment and in accordance with and subject to the terms and conditions specified below, the parties agree as follows:

Amendment of the Agreement

The parties hereby agree to amend the Agreement as of the Effective Date of the Amendment as provided below. Capitalized terms used in this Amendment that are not otherwise defined herein shall have the meaning ascribed to them in the Agreement.

 

1.

 

Section 1.31 (“ Pilot Production Line ”) is hereby deleted and replaced with the following:

 

 

 

“‘Commercial Production Line’ means a production line for the commercial manufacture of the Chemical Heat Packages, and all modifications thereof, which is located at Autoliv’s manufacturing site and is comprised of two (2) cells, each of which has a nominal production capacity of [ * ] ([ * ]) Chemical Heat Packages per year. If Autoliv does not achieve such output (i.e., each cell fabricated hereunder shall have a nominal production capacity of [ * ] ([ * ]) Chemical Heat Packages per year) following the completion, installation and qualification of each cell, then Autoliv shall, at no additional cost to Alexza, have additional run time (hours) in order to achieve such output.”

 

 

2.

 

The following sentence is hereby added to Section 2.1 after the first sentence:

 

 

 

“If Alexza assigns the Agreement in whole or in part, or any interest hereunder, to one or more Third Parties to whom Alexza has granted Finished Product marketing rights (each, a “Marketing Partner”) pursuant to Section 13.1, or if Alexza delegates or subcontracts

1.


 

CONFIDENTIAL

 

 

 

any or all of its rights and/or obligations under the Agreement to one or more Marketing Partners pursuant to Section 2.2, then the parties further agree that Autoliv shall manufacture, assemble and test, the Chemical Heat Packages in conformance with the Specifications and in compliance with the terms and conditions of this Agreement (including the Quality Terms), for sale solely to: (i) the Marketing Partner, if Alexza assigns the entire Agreement to such Marketing Partner or if Alexza delegates or subcontracts all of its rights and obligations under the Agreement to such Marketing Partner, or (ii) Alexza and one or more Marketing Partners, if Alexza only assigns the Agreement in part, or any interest hereunder, to one or more Marketing Partners, or only delegates or subcontracts some of its rights and/or obligations under the Agreement to one or more Marketing Partners.”

 

 

3.

 

Section 2.2 is hereby amended in its entirety as follows:

 

 

 

Non-delegable Responsibility . Each party’s rights and obligations under this Agreement may not be subcontracted to any Third Party, without the prior written consent of the other party, except that Alexza may subcontract or delegate any or all of its rights and/or obligations under the Agreement to one or more Marketing Partners without the prior written consent of Autoliv; provided, however, that Alexza will remain liable and responsible for the performance and observance of all its duties and obligations hereunder.”

 

 

4.

 

Section 2.5 is hereby amended as follows:

 

(i)

 

The first sentence of Section 2.5(a) is hereby amended by the deletion of the words “by mutual written agreement”.

 

 

(ii)

 

The first sentence of Section 2.5(b) is hereby amended by the deletion of the words “by mutual written agreement”, and by the addition of the following words to the end of the sentence: “or unless Alexza assigns the Agreement in whole or in part, or any interest hereunder, to one or more Marketing Partners pursuant to Section 13.1, or Alexza delegates or subcontracts any or all of its rights and/or obligations under the Agreement to one or more Marketing Partners pursuant to Section 2.2.”

 

[*]

 =   

Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

2.


 

CONFIDENTIAL

 

5.

 

Section 5.4 is hereby amended in its entirety as follows:

 

 

 

 

Expense Reimbursement .

 

(i)

 

The parties acknowledge that Autoliv has made a substantial commitment pursuant to the terms of the Development Agreement and will make a substantial investment in capital equipment, personnel and facilities to provide up to three (3) Commercial Production Lines with a total nominal capacity of [ * ] ([ * ]) Chemical Heat Packages per year pursuant to the terms of this Agreement. Alexza shall compensate Autoliv for its investment in capital equipment, personnel and facilities to provide up to three (3) Commercial Production Lines described above as set forth in this Section 5.4.

 

 

(ii)

 

Upon the signing of this Amendment by both parties, Alexza shall pay Autoliv four million dollars ($4,000,000) for the completion, installation and qualification of the first cell of the first Commercial Production Line, and as payment in full for Autoliv’s investment in capital equipment, personnel and facilities through January 2010 in support of its commercialization efforts to manufacture and supply Chemical Heat Packages for commercial use, including all materials, components, supplies and services provided by or on behalf of Autoliv in connection therewith. The parties shall, within thirty (30) days after the payment by Alexza to Autoliv of the four million dollars ($4,000,000) provided for herein, mutually agree in writing upon the completion, installation and qualification schedule for the second and final cell of the first Commercial Production Line in accordance with the then current production forecast for the Chemical Heat Packages. Upon the payment by Alexza to Autoliv of the four million dollars ($4,000,000) provided for herein, Alexza shall own all right, title and interest in and to the first cell of the first Commercial Production Line, free and clear of any and all claims, encumbrances, liens and security interests, and Autoliv hereby assigns its entire right, title and interest in and to the first cell of the first Commercial Production Line, and all manufacturers warranties, guarantees and indemnitees, to Alexza.

 

 

(iii)

 

Concurrently with entering into this Amendment, Alexza shall issue to Autoliv an unsecured promissory note in the amount of four million dollars ($4,000,000) (the “Note”). Upon (a) the completion, installation and qualification of the second cell of the first Commercial Production Line, and (b) the final payment by Alexza to Autoliv

 

[*]

 =   

Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

3.


 

CONFIDENTIAL

 

 

 

under the Note, Alexza shall own all right, title and interest in and to the second cell of the first Commercial Production Line, free and clear of any and all claims, encumbrances, liens and security interests, and Autoliv hereby assigns its entire right, title and interest in and to the second cell of the first Commercial Production Line, and all manufacturers warranties, guarantees and indemnitees, to Alexza. Autoliv shall cease work on the second cell of the first Commercial Production Line upon the receipt of written notice from Alexza to that effect. If Alexza notifies Autoliv to cease work on the second cell of the first Commercial Production Line, or if for any reason the second cell of the first Commercial Production Line is not completed, the parties will discuss in good faith and agree upon an equitable reduction of the principal amount of the Note.

 

 

(iv)

 

In the event and to the extent that Alexza requests in writing that Autoliv shall provide any subsequent cells or Commercial Production Lines following the completion, installation and qualification of the entire first Commercial Production Line, provided that Alexza’s written request gives Autoliv a reasonable amount of time to fabricate any such subsequent cells or Commercial Production Lines in order to meet Alexza’s production demand for Chemical Heat Packages, Autoliv shall complete, install and fully qualify such subsequent cells and Commercial Production Lines in accordance with the terms and conditions of this Agreement, subject to the following:

 

 

(a)

 

Autoliv estimates that the completion, installation and full qualification of each of the second and third Commercial Production Lines will cost two million four hundred thousand dollars ($2,400,000), which amount is inclusive of all fees, taxes, tariffs, customs, duties and other charges and assessments. Therefore, if Autoliv shall provide any subsequent cells or Commercial Production Lines, then Autoliv shall invoice Alexza, on a milestone basis, for Autoliv’s actual fully burdened cost of each such cell or Commercial Production Line (as the case may be), not to exceed a total cost to Alexza of two million four hundred thousand dollars ($2,400,000) for the completion, installation and full qualification of each of the second and third Commercial Production Lines. For the purposes hereof, “milestone basis” means that Autoliv will invoice

 

[*]

 =   

Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

4.


 

CONFIDENTIAL

 

 

 

Alexza, for each additional Commercial Production Line: (1) a deposit of thirty percent (30%) of the estimated total cost, assuming the total cost will be two million four hundred thousand dollars ($2,400,000); (2) twenty-five percent (25%) of the estimated total cost after all of the materials for such Commercial Production Line have been purchased by Autoliv, as evidenced by Autoliv’s receipts therefor, copies of which have been furnished to Alexza with the invoice for the second milestone payment; (3) twenty-five percent (25%) of the estimated total cost after all of the assembly of the Commercial Production Line has been completed and debugged, as evidenced by documentation of the completion of qualification of the Commercial Production Line, copies of which have been furnished to Alexza with the invoice for the third milestone payment; and (4) twenty percent (20%) of the estimated total cost after final production release of the Commercial Production Line, which shall be deemed to have occurred following the completion of the design review for the Commercial Production Line to Alexza’s reasonable satisfaction. If the actual total cost of the completion, installation and full qualification of the second or third Commercial Production Line is less than two million four hundred thousand dollars ($2,400,000), and the total of the milestone payments described herein for the second or third Commercial Production Line exceeds such actual total cost because such milestone payments were based on an estimated total cost of two million four hundred thousand dollars ($2,400,000) per Commercial Production Line, then either the milestone payments shall be adjusted by the parties to reflect the actual total cost, or Autoliv shall promptly refund to Alexza any amounts paid by Alexza in excess of the actual total cost.

 

 

(b)

 

For the purposes hereof, Autoliv’s actual fully burdened cost means the pu


continue to document