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AMENDED AND RESTATED SUPPLY AGREEMENT

Supply Agreement

AMENDED AND RESTATED SUPPLY AGREEMENT

 
 | Document Parties: IMCOR PHARMACEUTICAL CO | Genzyme Corporation | Photogen Technologies, Inc You are currently viewing:
This Supply Agreement involves

IMCOR PHARMACEUTICAL CO | Genzyme Corporation | Photogen Technologies, Inc

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Title: AMENDED AND RESTATED SUPPLY AGREEMENT
Governing Law: New York     Date: 7/27/2005
Industry: Biotechnology and Drugs     Sector: Healthcare

AMENDED AND RESTATED SUPPLY AGREEMENT

 
, Parties: imcor pharmaceutical co , genzyme corporation , photogen technologies  inc
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CONFIDENTIAL TREATMENT REQUESTED: Certain portions of this document have been omitted pursuant to a request for confidential treatment and, where applicable, have been marked with an asterisk (“ [****] ”) to denote where omissions have been made. Note that four pages of this exhibit contain omitted material pursuant to this request. The confidential material has been filed separately with the Securities and Exchange Commission.

 

genzyme

 PHARMACEUTICALS

GENZYME CORPORATION

CNE KENDALL SQUARE

CAMBRIDGE, MA 02139-1562, USA

617-252-7500

FAX 617-252-7772

www.genzyme.com

 

AMENDED AND RESTATED SUPPLY AGREEMENT

 

THIS AMENDED AND RESTATED SUPPLY AGREEMENT (“Agreement”) dated as of October 8, 2003, is by and between Genzyme Corporation, with principal offices located at One Kendall Square, Cambridge, Massachusetts 02139 ("Vendor") and Photogen Technologies, Inc., through its IMCOR Pharmaceutical Division, a Nevada corporation with its principal offices located at 6175 Lusk Boulevard, San Diego, California 92121 ("IMCOR").

 

WHEREAS, Vendor entered into a Supply Agreement with Alliance Pharmaceutical Corp. dated as of May 16, 2000 (the "Original Supply Agreement");

 

WHEREAS, Photogen Technologies, Inc. has acquired the business of Alliance Pharmaceutical Corp. to which the Original Supply Agreement relates;

 

WHEREAS, IMCOR and Vendor now desire to modify the terms of their relationship and amend and restate the Original Supply Agreement as provided herein;

 

WHEREAS, Vendor has by virtue of its proprietary technologies and know-how developed and manufactures or by virtue of its distribution relationship with the manufacturer has adequate access to the material described on Exhibit "A" attached hereto (the "Material"); and

 

WHEREAS, IMCOR desires to secure a long-term supply of commercial quantities of the Material for its product described on Exhibit "A" (the "Product") if and when such Product is approved by the FDA and Vendor is willing to supply such quantities of its Material to IMCOR as IMCOR's exclusive supplier of the product.

 

NOW, THEREFORE, in consideration of the mutual promises and covenants set forth herein, the parties agree as follows.

 

1.      Supply. During the term of this Agreement, IMCOR shall purchase all of its requirements of Material for commercial manufacturing from Vendor and Vendor shall sell to IMCOR such quantities of the Material as ordered from time to time by IMCOR. Nothing herein shall limit Vendor's ability to supply Material to other customers.

 

2.      Duration. This Agreement shall have effect upon execution and shall remain in effect for the initial term indicated on Exhibit "A" (the "Term") Thereafter, this Agreement shall be renewed automatically for successive two-year periods unless terminated by either party by written notice not later than eighteen months prior to expiration of the initial term or any renewal period.

 

3.      Specification and Quality Control Standards; GMP Compliance.

 

3.1      The quantities of the Material to be supplied hereunder shall be manufactured by Vendor in accordance with all applicable laws, rules and regulations, and in conformity with the specification and quality control standards set forth in Exhibit "B" attached hereto (collectively, the "Specifications"). If IMCOR wishes to change the Specifications, Vendor shall use its reasonable endeavors to carry out such change subject to agreement on a reasonable change (increase or decrease) in price, if appropriate, to reflect any costs or savings consequent thereon. Vendor shall consult with and must obtain written consent from IMCOR reasonably in advance of making any changes in the Specifications, or other aspect of the production, storage, and transport of Material which would or might:

 

 

 


[****] Represents material which has been redacted pursuant to a request for confidential treatment pursuant to Rule 24B-2 under the Securities Exchange Act of 1934, as amended. The confidential materials have been filed separately with the SEC.

 

 

(a)

Cause a potential change in the Material purity profile;

 

 

(b)

Require IMCOR to revalidate its own process or methods;

 

 

(c)

Require IMCOR to re-audit Vendor,

 

 

(d)

Require IMCOR or Vendor to submit or resubmit any documentation to the FDA.

 

Subject to the foregoing, Vendor may otherwise alter the Specifications upon sixty days prior written notice to IMCOR.

 

3.2      Vendor shall make available to IMCOR such data and information in relation to Material as is reasonably necessary to ascertain compliance with this Agreement and to qualify the use of Material in the Product with appropriate regulatory authorities. However, nothing here shall be construed as placing Vendor under an obligation to disclose to IMCOR any data relating to the actual production or purification of the Material except as Vendor deems appropriate for IMCOR to satisfy itself regarding the security or quality of supply of the Material or unless IMCOR is required to supply any such data to any appropriate regulatory authorities, in which case Vendor shall provide such information to IMCOR or arrange for direct disclosure to such regulatory authorities at IMCOR's expense. IMCOR may visit and inspect Vendor's facilities used in the Manufacture and testing of the Material once per year with reasonable prior notice.

 

3.3      Vendor shall carry out the production and purification of the Material to be supplied hereunder in accordance with the U.S. Food and Drug Administration ("FDA") and Good Manufacturing Practice ("GMP") regulations and shall allow inspection of Vendor facilities by U.S. or foreign regulatory authority representatives to enable the said representatives to verify Vendor's compliance with GMP and all other relevant regulations. Vendor may altar the production and purification processes for the Material upon prior written notice to IMCOR but only if Vendor follows all appropriate regulatory procedures and obtains any relevant regulatory approvals and there is no change to the specification and quality control standards for the Material.

 

4.      Estimates and Orders. As soon as practical after the effective date of this Agreement, and within the last [****] days of each calendar quarter thereafter, IMCOR shall deliver to vendor a [****]   month rolling Forecast (the "Forecast") of the quantity of material to be purchased by IMCOR. The [****] of such Forecast will be considered a firm commitment for production quantities and the remainder of the Forecast shall be advisory only. Accordingly, the [****] quantity in each subsequent Forecast shall be identical to the  [****]  quantity in the previous "Forecast" unless the parties otherwise agree in writing. Within [****] days of delivery of each Forecast, IMCOR shall submit to Vendor a written delivery "Order" for the Material which shall represent the [****] firm commitment as illustrated by the Forecast.

 

 

 


[****] Represents material which has been redacted pursuant to a request for confidential treatment pursuant to Rule 24B-2 under the Securities Exchange Act of 1934, as amended. The confidential materials have been filed separately with the SEC.

 

5.      Delivery. The Material shall be supplied D.D.U. San Diego, California with any and all freight and packaging expenses being prepaid by Vendor and added to Vendor's invoice to IMCOR for payment by IMCOR. Title to and risk of loss of the Material shall pass to IMCOR at the time of delivery to a carrier designated by IMCOR or, if not delivered but stored by Vendor at IMCOR's request, at the time such Material is actually segregated and stored in facilities reasonably designed and maintained for storage of the materials. All shipments shall meet the specifications set forth in Exhibit "B" and be accompanied by a Certificate of Analysis. Material Orders shall be delivered to IMCOR in accordance with a delivery schedule provided by IMCOR in the Order, provided that no delivery be required to be made within one hundred and twenty (120) days of such Order.

 

6.      Prices and Payment.

 

6.1      IMCOR shall pay the prices specified in Exhibit "C" for the Material delivered by Vendor.

 

6.2      The price does not include sales, use, excise or any other similar taxes imposed by Federal, state or local governments, and accordingly such taxes shall be paid by IMCOR.

 

6.3      Invoices for Material shall be sent to IMCOR on or after the date of shipment of Material. Payment shall be made by IMCOR as follows: (1)  [****] of the payment for the Material in the Order (the "Order Payment") shall be paid upon submission of the Order pursuant to Section 4 hereof, (2)  [****] of the Order Payment shall be due upon delivery of the Material and (3)  [****] of the Order Payment shall be due within [****] days from the date of invoice, net of any and all invoice fees or other fees or charges, other than those specified in this Agreement.

 

6.4      IMCOR shall pay Vendor a fee of [****] United States dollars [****]  per calendar quarter (the "Regulatory Fee") for costs incurred by Vendor that are associated with the filing and maintenance of the Drug Master File (DMF) and all supporting documentation. The first quarterly Regulatory Fee shall be due upon execution and delivery of this Agreement and the remaining quarterly Regulatory Fees shall be due on the first day of each calendar quarter thereafter; provided however, that if IMCOR's total Orders in any calendar year exceed [****] United States dollars [****] , IMCOR's obligation to pay the Regulatory Fee as set forth in this Section 6.4 shall terminate.

 

7.      Confidentiality. Each party hereto (a "Recipient") recognizes that the other party hereto and its subsidiaries and affiliated corporations (a "Discloser") own or have licensed certain confidential information, including but not limited to secret or confidential data, proprietary information, trade secrets, technology, formulae, processes, procedures, scientific studies, regulatory submissions, business plans, information and the like, whether all of the same be in writing or not, and that Discloser has disclosed or may disclose to Recipient portions of such confidential information (all of which is referred to as "Confidential Information"). Use of the Confidential Information shall be solely for the purposes of complying with this Agreement. Recipient agrees to maintain the confidential status of such Confidential Information and not to disclose the same to persons not authorized herein or otherwise authorized in writing by Discloser to receive such Confidential Information. Confidential Information shall not include information that was (4) in the public domain prior to the time of its disclosure under this Agreement; (5) e


 
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