Amifostine Manufacturing And Supply Agreement

Exhibit 10.20


AMIFOSTINE MANUFACTURING AND SUPPLY AGREEMENT

This Agreement (" Agreement" ), entered into as of the 1st day of January, 2001 (the " Effective Date" ), by and between MedImmune Oncology, Inc. (formerly U.S. Bioscience, Inc., hereinafter referred to as " MedImmune Oncology" ), a corporation duly formed and existing under the laws of the State of Delaware, having a place of business at One Tower Bridge, 100 Front Street, West Conshohocken, Pennsylvania 19428, and PPG Industries, Inc., having a place of business as One PPG Place, Pittsburgh, Pennsylvania 15272, USA, and its wholly-owned subsidiary PPG-Sipsy, having a place of business at Z.I. la Croix Cadeau, B.P. 79, 49242 Avrille Cedex, France (Individually & Collectively " PPG" ), a corporation duly formed and existing under the laws of the State of Pennsylvania.

WITNESSETH

WHEREAS, the parties to this Agreement are parties to a Manufacturing and Supply Agreement between U.S. Bioscience, Inc. and Sipsy, S.A. (the " Prior Agreement" ) relating to the manufacture of amifostine;

WHEREAS, MedImmune Oncology has certain proprietary technical information (including, without limitation, patents, patent applications and trade secrets) relating to the Product which has been disclosed, in part, to PPG under the terms of the Prior Agreement and which will be disclosed, in part, to PPG under the terms of this Agreement;

WHEREAS, the parties desire to have this Agreement supersede the Prior Agreement from and after the Effective Date;

WHEREAS, MedImmune Oncology desires to contract with PPG for the continued manufacture of amifostine (hereinafter defined in Section 1.4 and referred to as the " Product" ); and

WHEREAS, PPG desires to manufacture the Product for MedImmune Oncology and represents that it possesses the requisite expertise, personnel and facilities for the manufacture and supply of Product on the terms and in the quantities contemplated by this Agreement.

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

ARTICLE I

DEFINITIONS

For purpose of this Agreement:

Section 1.1 " cGMPs" shall mean the current Good Manufacturing Practices promulgated by the United States Food and Drug Administration (" FDA" ) and other applicable government regulatory agencies. MedImmune Oncology shall keep PPG regularly informed about any amendment or modification to relevant portions of its regulatory registrations for the Product.

Section 1.2 " Confidential Information" shall have the meaning set forth in Section 7.1.

Section 1.3 " Preparation" and/or " Prepare" shall mean any and all steps and operations required in the sourcing of raw material, synthesis, manufacture, processing, subdividing, quality control, quality assurance, testing, storage and packaging of Product for shipment.

Section 1.4 " Product" shall mean Amifostine Drug Substance together with changes, modifications and improvements instituted during the term hereof as described more fully on Exhibit " C" attached and made a part hereof.

Section 1.5 " Specifications" shall have the meaning set forth in Section 4.1 hereof.

Section 1.6 " Contract Year" shall mean a calendar year under this Agreement.

ARTICLE II

SALE AND DELIVERY OF PRODUCT

Section 2.1 Subject to the terms and conditions set forth in this Agreement, PPG agrees to Prepare and sell, and MedImmune Oncology agrees to purchase from PPG, the Product as follows: Prior to the beginning of each calendar quarter, MedImmune Oncology shall provide to PPG, in writing, a (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) forecast of its requirements for deliveries of the Product during the next (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) (hereinafter the " Delivery Schedule" ). The quantities forecast for delivery in the (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) in a Delivery Schedule shall be firm commitments to purchase and sell; and the (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) included in a Delivery Schedule shall be for planning purposes and may be revised up or down by MedImmune Oncology. Exhibit " A" sets forth MedImmune Oncology' s non-binding requirements forecast for the Contract Years 2001-2003.


Section 2.2 PPG agrees, at the request of MedImmune Oncology, to provide Product at the agreed upon price set forth in the Price Schedule attached hereto as Exhibit " B" and subject to the provisions of Section 3.1.

Section 2.3 Subject to Section 2.5, PPG shall provide (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) to (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) of MedImmune Oncology' s requirements for the Product, at MedImmune Oncology' s option. Subject to Section 2.5, MedImmune Oncology shall purchase from PPG a minimum of (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) to (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) of MedImmune Oncology' s global requirements for the Product, provided however, that PPG may elect to qualify a second manufacturing location for production of Product by informing of its intent to do so in writing. Within 90 days of such notification, PPG will provide to MedImmune documentation which describes PPG' s qualification protocols and validation plans. PPG and MedImmune will cooperate to complete such qualification in a timely manner. Upon successful qualification of the alternate manufacturing location by MedImmune, MedImmune shall be obligated to purchase (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) of MedImmune Oncology' s global requirement for Product.

Section 2.4 PPG shall at all times maintain a minimum inventory of at least (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) of the amount of the Product purchased by MedImmune Oncology during the preceding (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED). PPG shall at all times maintain a minimum annual capacity reserved for production of the Product for MedImmune Oncology of the quantity of Product specified for delivery in the most recent Delivery Schedule. Notwithstanding anything to the contrary in this Section 2.3, should PPG be required to replace Product pursuant to its obligations in Article 4, PPG may utilize the inventory of the Product even though that may result in a temporary situation in which inventory is less than required by this Section 2.4. PPG shall rebuild the inventory to once again meet the requirements of this Section 2.4 within (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) days of removing Product to use as replacement Product.

Section 2.5 If PPG has not qualified an alternative manufacturing site subject to Section 2.3, MedImmune Oncology may qualify an alternative source(s) of supply other than PPG and may secure Product from such alternative source(s) for amounts in excess of (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) of its requirements. MedImmune Oncology shall not make the alternative source(s) MedImmune Oncology' s principal supplier of Product unless PPG has materially failed to meet MedImmune Oncology' s orders in a period of more than (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) or this Agreement is terminated or has by its terms expired. After (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) in which PPG has materially failed to meet MedImmune Oncology' s orders, both parties agree that MedImmune Oncology may use an alternate source to supply MedImmune Oncology' s needs until PPG is able to again furnish MedImmune Oncology' s needs.

Section 2.6 PPG agrees to sell the Product exclusively to MedImmune for pharmaceutical applications. PPG agrees that during the term of this Agreement and for a period of (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) thereafter, it will not compete, or assist third parties to compete, directly or indirectly with MedImmune Oncology in the sale of the Product.

Section 2.7 MedImmune Oncology shall submit purchase orders for Product to PPG at least (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) prior to the date of shipment specified therein. MedImmune Oncology' s purchase orders shall (i) reference this Agreement; (ii) be submitted in writing; (iii) state the quantity of Product ordered; (iv) specify the delivery location; and (v) state the desired date of shipment. In no event shall the use of any form of purchase order be effective to vary, alter, modify or add to the terms and provisions of this Agreement; nor will the acceptance of any such purchase order have the effect of substituting the provisions set forth on such form for the provisions contained in this Agreement. MedImmune Oncology may reschedule such purchase order no later than (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)

prior to the date of scheduled manufacturing. In no event shall MedImmune Oncology' s right to reschedule such Purchase Order abrogate any of its obligations under Section 2.1.

Section 2.8 PPG shall exercise reasonable, diligent efforts to ship Product in the quantities and on the dates specified in MedImmune Oncology' s purchase orders. Sales of Product by PPG to MedImmune Oncology shall be made CIP (as in Incoterms 1990), to MedImmune Oncology' s facility in Nijmegen, the Netherlands, or such other location as may be specified by MedImmune Oncology to PPG from time to time hereunder.

ARTICLE III

PAYMENT TERMS

Section 3.1 The Base Prices to be paid by MedImmune Oncology for quantities of Product purchased pursuant to this Agreement are set forth in Exhibit " B" , except for freight and insurance which will be billed (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED). The prices set forth on Exhibit " B" shall be subject to the following adjustments, as applicable:

PPG and MedImmune Oncology will adjust the prices in Exhibit B such that any benefit or loss due to the change in exchange rate will be shared equally by the parties according to the following:

Average Exchange Rate (" AER" ) is defined as the average Euro per US$ exchange rate which has prevailed for the previous (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) prior to the date of invoicing.

" Invoice Price" is defined as such:

For invoices for which the AER is greater than or equal to (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) Euro per US$ and less than or equal to (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) per US$ the Invoice Price is equal to (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) divided by the AER multiplied by the Base Price then in effect

For invoices for which the AER is greater than (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) the Invoice Price is equal to (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) multiplied by the Base Price then in effect.

For invoices for which the AER is less than (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) the Invoice Price is equal to (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) multiplied by the Base Price then in effect.

In summary:

For AER>(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) Invoice price = (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) x Base Price in effect For (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) < AER < (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) Invoice price= (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) /AER x Base Price in effect For AER<(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) Invoice price = (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) x Base Price in effect

In the event that MedImmune Oncology makes changes to the Specifications which result in material increases in the cost to PPG to Prepare the Product, PPG and MedImmune Oncology shall negotiate in good faith an appropriate and reasonable price adjustment. In the event that the regulatory authorities other than the regulatory authorities of the United States, the EC countries or Japan, require additional cGMP requirements or changes to the Specifications in order to allow commercialization of Product in their respective countries, the parties shall negotiate in good faith an appropriate and reasonable price adjustment relating solely to quantities of Product for which such changes are necessary.

In the event that the parties do not agree on such price adjustment, then both parties will appoint a mutually acceptable independent expert whose findings will be binding on both PPG and MedImmune Oncology. Said expert shall transmit to both parties its findings within three months from the date of its appointment. If the parties are unable to agree on an independent expert, the matter shall be settled in accordance with Section 12.3 hereof.

Section 3.2 All prices of Product shall be on the basis of (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) as in Incoterms 1990.

Section 3.3 The purchase price for Product shall be paid to PPG no later than (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) days after the date of PPG' s invoice to MedImmune Oncology. In no event shall PPG invoice MedImmune Oncology for the Product prior to delivery. All invoices from PPG to MedImmune Oncology covering Product shipped to MedImmune Oncology shall be stated in, and all payments to PPG by MedImmune Oncology shall be made in United States Dollars (US$). However, the parties hereto may agree at the beginning of each Contract Year that such invoices and payments will be in European Monetary Units (Euro), provided, however, that said prices may be adjusted by mutual agreement of the parties by an amount sufficient to cover PPG' S currency exchange risk and costs.

In the event that the Euro to US$ exchange rate is greater than (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) or less than (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) for more than (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) , then either party may request a renegotiation of the Base Prices in Exhibit " B" in writing to the other party. Both parties will commence such negotiations within 30 days of receipt of the written request. If the parties fail to agree to a modification of the base prices within 60 days of commencement of the negotiation, then the dispute will be settled in accordance with Section 12.3.

Section 3.4 Payments due to PPG shall be made by wire transfer or by a mutually agreeable method to the bank account of PPG of which PPG shall advise MedImmune Oncology from time to time.

ARTICLE IV

MANUFACTURE AND SUPPLY

Section 4.1 Prior to the date of the Prior Agreement, MedImmune Oncology (then U.S. Bioscience, Inc.) transferred to PPG, and PPG hereby acknowledges receipt of, copies of MedImmune Oncology' s specifications for the manufacture and testing of the Product, and such specifications have been revised from time to time under the Prior Agreement. The current specifications for the Product are attached hereto as Exhibit " C" and made a part hereof (such specifications, as revised in accordance with this Section 4.1, hereinafter being defined as the " Specifications" ). The Preparation of the Product shall be carried out by PPG in accordance with applicable cGMPs and established quality standards. The Product shall meet Specifications. MedImmune Oncology shall provide PPG with all revisions to the Specifications in a timely manner after such revisions are approved by MedImmune Oncology, as appropriate, such revisions to be reasonably required for the Product. All revisions or deviations from Specifications for Product must be made in accordance with the Change Control Procedures set forth in Exhibit " D" .

Section 4.2 PPG shall prepare and make available to MedImmune Oncology for review and comment comprehensive and complete documentation ...