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SECOND AMENDMENT TO DEVELOPMENT AND SUPPLY AGREEMENT

Requirements Supplier Agreement

SECOND AMENDMENT TO DEVELOPMENT AND SUPPLY AGREEMENT | Document Parties: CUBIST PHARMACEUTICALS INC | Hospira Worldwide, Inc You are currently viewing:
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CUBIST PHARMACEUTICALS INC | Hospira Worldwide, Inc

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Title: SECOND AMENDMENT TO DEVELOPMENT AND SUPPLY AGREEMENT
Date: 8/4/2008
Industry: Biotechnology and Drugs     Sector: Healthcare

SECOND AMENDMENT TO DEVELOPMENT AND SUPPLY AGREEMENT, Parties: cubist pharmaceuticals inc , hospira worldwide  inc
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Exhibit 10.2

 

CONFIDENTIAL TREATMENT

 

SECOND AMENDMENT TO DEVELOPMENT AND SUPPLY AGREEMENT

 

THIS SECOND AMENDMENT TO DEVELOPMENT AND SUPPLY AGREEMENT (this “ Second Amendment ”) is entered into as of the 26th day of June, 2008 (“Second Amendment Effective Date”) by and between Cubist Pharmaceuticals, Inc., a Delaware corporation (“ Cubist ”) and Hospira Worldwide, Inc., a Delaware corporation (“ Hospira ”) to amend the terms of that certain Development and Supply Agreement, as amended, between Abbott Laboratories, predecessor in interest to Hospira, and Cubist (the “ Agreement ”).

 

Whereas , the parties desire to amend the terms of the Agreement to reflect, among other items, the validation of Hospira’s facility in Liscate, Italy, the manufacture of Product at such site, changes to minimum purchases of Product and applicable pricing.

 

Now, therefore in consideration of the mutual promises and agreements contained herein, the parties agree to amend the Agreement as follows:

 

1.                Incorporation of the Agreement .     All capitalized terms which are not defined herein shall have the same meanings as set forth in the Agreement, and the Agreement is incorporated herein by this reference as though the same was set forth in its entirety.  Except as specifically set forth herein, the Agreement shall remain in full force and effect and its provisions shall be binding on the parties hereto .

 

2.                Definitions .

 

a.                As used herein Product shall refer to both the []* and D500 configurations of CUBICIN ® (daptomycin for injection)

 

b.               “[]*” shall mean CUBICIN in a []* configuration

 

c.                “D500” shall mean CUBICIN in a 500mg configuration.

 

d.               As used in the Agreement, the term “Affiliate” shall mean any corporation or non-corporate business entity which controls, is controlled by, or is under common control with a party to this Agreement; A corporation or non-corporate business entity shall be regarded as in control of another corporation or non-corporate business entity if it owns, or directly or indirectly controls, in excess of fifty percent (50%) of the voting stock of the other corporation, or (a) in the absence of the ownership of in excess of fifty percent (50%) of the voting stock of a corporation or (b) in the case of a non-corporate business entity, if it possesses, directly or indirectly, the power to direct or cause the direction of the management.

 

3.                Validation of the Liscate, Italy Facility .

 

a.                D500 is currently manufactured at Hospira’s facility in McPherson, Kansas (“McPherson”).  The parties shall work jointly and in good faith to complete the Feasibility Document and Plant Certification Protocol, outlines of which are attached hereto at Exhibit A, in accordance with the Technology Transfer Documents that were emailed by []* of Cubist to []* of Hospira on August 9, 2007 (the Feasibility Document, Plant Certification Protocol and Technology Transfer Document, each a “Document” and collectively the “Documents”).  For

 

*Confidential Treatment Requested.  Omitted portions filed with the Securities and Exchange Commission. (the “Commission”).

 



 

the avoidance of doubt, the Feasibility Document and Plant Certification Protocol shall each be considered “complete” when both parties have agreed in writing to the content of such Document, such agreement not to be unreasonably withheld, delayed or conditioned.  The parties shall use the Feasibility Document to determine if there are any major obstacles to Hospira validating the Liscate, Italy site (“Liscate”) as a manufacturing site for the []* and D500 Products in accordance with the Technology Transfer Document and as further set forth in Section 3.b. and on Exhibit B (the “Liscate Validation Program”).  The parties shall complete the Feasibility Document and the Plant Certification Protocol and perform the activities in the Plant Certification Protocol prior to Hospira’s initiation of the Liscate Validation Program.  If (a) the Feasibility Document is not completed and signed on or before []* after the Second Amendment Effective Date; (b) the Plant Certification Protocol is not completed and signed on or before []* after completion of the Feasibility Document; or (c) Cubist reasonably determines that the Liscate Validation Program is not technically feasible, Sections 4 through 8 of this Amendment shall become null and void and, from that date forward, the minimums and pricing shall revert to those detailed in the June 1, 2006 First Amendment to Development and Supply Agreement (the “Amendment One”); such minimums and pricing shall be referred to as the “Existing Terms”; provided that Hospira shall continue to package and label Product at []* if McPherson has already been qualified for packaging and labeling pursuant to the Labeling and Packaging Program.

 

b.               Upon completion of the Documents, Hospira shall complete the Liscate Validation Program in accordance with the Documents and Exhibit B.  Hospira shall be responsible for all reasonable costs associated with the validation of the []* and D500 Products at Liscate as outlined in the Documents and Exhibit B, provided that Cubist shall supply all Bulk Drug necessary for such validation activities, and (ii) Cubist shall issue Purchase Orders in accordance with the Agreement for all lots of Product manufactured under the Liscate Validation Program.

 

4.                Labeling and Packaging.

 

a.                Hospira currently supplies Product to Cubist in bulk packaging.  The parties intend to qualify both McPherson and Liscate to label and package Product as outlined in the June 3, 2008 letter from []* (the “Labeling and Packaging Program”, attached hereto as Exhibit C).

 

5.                Location of Manufactur


 
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