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EXHIBIT 10.1 PROGENICS SUPPLY AGREEMENT

Supply Agreement

EXHIBIT 10.1 PROGENICS SUPPLY AGREEMENT | Document Parties: PROGENICS PHARMACEUTICALS INC | Pharmaceutical Group of Mallinckrodt Inc. You are currently viewing:
This Supply Agreement involves

PROGENICS PHARMACEUTICALS INC | Pharmaceutical Group of Mallinckrodt Inc.

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Title: EXHIBIT 10.1 PROGENICS SUPPLY AGREEMENT
Date: 5/10/2005
Industry: Biotechnology and Drugs     Sector: Healthcare

EXHIBIT 10.1 PROGENICS SUPPLY AGREEMENT, Parties: progenics pharmaceuticals inc , pharmaceutical group of mallinckrodt inc.
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EXHIBIT 10.1

PROGENICS SUPPLY AGREEMENT

This supply agreement (the “Supply Agreement”) is made and entered into effective on and as of the 1st day of January, 2005 (the “Effective Date”), by and between the Pharmaceutical Group of Mallinckrodt Inc. (“Mallinckrodt”) and Progenics Pharmaceuticals, Inc. (“Progenics”).

WHEREAS, Progenics has need of a certain pharmaceutical compound known as Methylnaltrexone (hereinafter “MNTX” or “Product”) and is desirous of having MNTX manufactured by Mallinckrodt and of purchasing a portion of its needs for MNTX from Mallinckrodt, on the terms and conditions set forth herein; and

WHEREAS, Mallinckrodt is capable and desirous of undertaking the supply of MNTX for Progenics in accordance with the terms and conditions set forth herein;

NOW, THEREFORE, in consideration of the promises, covenants and representations of the parties set forth herein, and other good and sufficient consideration receipt of which is hereby acknowledged, Progenics and Mallinckrodt agree as follows:

1.

Supply of MNTX .

 

 

 

 

           (a)     For the consideration provided herein and in accordance with all terms, conditions, representations and warranties set forth herein, and for the Term (as defined in Section 15(a) below), Mallinckrodt will provide Progenics with such amounts of MNTX as Progenics shall order. Progenics, for its part, agrees that it will purchase [*] of its Requirements for MNTX from Mallinckrodt hereunder during every Contract Year hereof [*]. For purposes of the immediately preceding sentence, (i) “Contract Year” shall mean and refer to each consecutive [*] period during the Term coinciding with the calendar year and (ii) “Requirements” shall mean all of Progenics’ requirements for the commercial sale or non-commercial use of MNTX by Progenics during any given Contract Year including that portion of its requirements that Progenics flight be capable of producing for itself or sourcing from any of its affiliates.

 

 

 

           (b)     The price to Progenics for MNTX Delivered (as defined below in this subsection (b)) pursuant to the terms of this Agreement shall be determined in accordance with the provisions of Section 4 hereof. The term “Delivered” shall mean, with respect to any MNTX ordered by Progenics, “delivery” of MNTX by Mallinckrodt and “acceptance” of such MNTX by Progenics, as such terms are defined in paragraphs (i) and (ii) below. For purposes of this Supply Agreement,

 

 

 

 

 

           (i)     delivery of a shipment of MNTX shall occur upon Progenics’ receipt of (A) such shipment of MNTX and (B) a certificate of analysis from Mallinckrodt relating to such shipment; and

 

 

 

 

 


 

 

* CONFIDENTIAL TREATMENT REQUESTED

 

 

 


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           (ii)     acceptance shall be deemed to occur upon the earlier of (A) written notice of acceptance by Progenics after delivery or (B) [*] after delivery; provided Progenics is not required to accept any Defective Product (as defined in Section 6(a) herein) or any Product shipped to Progenics with respect to which testing samples of Product in designated containers have not been shipped simultaneously, in accordance with Progenics’ shipment instructions (including, but not limited to, amount, packaging and shipment of Product), to a testing laboratory designated by Progenics to test the Product.

 

 

 

 

           (c)     The specifications and testing methods for MNTX, including without limitation the packaging specifications (such specifications and testing methods being referred to herein as the “Specifications”) are set forth on Exhibit A attached hereto, which Specifications will also be attached to the quality agreement between Progenics and Mallinckrodt, the final form of which shall be negotiated by the parties in good faith and executed concurrently with the execution of this Supply Agreement (the “Quality Agreement”), and shall be attached hereto as Exhibit B. In the event of any conflict or inconsistency between the terms of this Supply Agreement and the Quality Agreement, the former shall prevail in every case.

 

 

 

 

           (d)     The Specifications may be modified from time to time by the mutual agreement of Mallinckrodt and Progenics; provided that, if Progenics requests that any amendment be made to the Specifications in order to conform to current guidelines and the requirements of the Food and Drug Administration (“FDA”) and substantially comparable regulations of the European Union (“EU”), Canada and Japan, Mallinckrodt will not withhold or delay its agreement to any such amendment to the Specifications; provided further that, if Progenics requests that any amendment be made to the Specifications in order to conform to current guidelines and the requirements of any other governmental regulatory agency, which has jurisdiction to regulate products such as MNTX in any country where MNTX is submitted for approval for commercial sale, Mallinckrodt will use its [*]  to comply with any such amendment to the Specifications. Mallinckrodt warrants and represents that all MNTX supplied to Progenics hereunder shall be manufactured and stored in accordance with the Specifications in effect at the time of such manufacture and in accordance with the terms of the Quality Agreement.

 

 

 

 

           (e)     Mallinckrodt warrants and represents that all MNTX supplied hereunder shall be manufactured by Mallinckrodt in full compliance with current Good Manufacturing Practices (“cGMP”) as determined by the FDA and substantially comparable regulations of the EU, Canada, Japan or any other foreign regulatory authority (collectively referred hereinafter as “Regulatory Agencies”) using the manufacturing process described in Mallinckrodt’s Drug Master Files (“Product DMF”).

 

 

 

 

           (f)     Mallinckrodt warrants and represents that the Product DMF currently on file for MNTX complies with all Regulatory Agencies’ rules and regulations and that any Product DMF for MNTX filed in the future will be filed and maintained in accordance with all Regulatory Agency’s rules and regulations. Mallinckrodt shall notify Progenics in writing as soon as it becomes aware and as far in advance as is reasonably possible under the circumstances, of any proposed changes related to the Product DMF, such notification to be in conformance with Regulatory Agencies’ guidelines, and the Drug Master File regulations contained in 21 CFR 314,420(c). In addition, Mallinckrodt shall obtain prior approval from Progenics before making any “major (prior approval supplement) changes” to Mallinckrodt’s DMF for MNTX as specified in the FDA’s Guidance for Industry Changes to an Approved NDA or ANDA dated April 2004, unless any such changes would prevent Mallinckrodt from remaining in compliance with the rules, regulations and directions of U.S. governmental regulatory agencies that have jurisdiction over Mallinckrodt’s DMF.

 


 

 

* CONFIDENTIAL TREATMENT REQUESTED

 

 

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           (g)     The parties acknowledge that Mallinckrodt has validated its primary manufacturing facility at the St. Louis, Missouri plant. With respect to previous purchase orders accepted by Mallinckrodt prior to execution of this Supply Agreement, Mallinckrodt has validated the manufacturing process for MNTX manufacture, in batches of [*] , at a secondary manufacturing center located at Mallinckrodt’s St. Louis, Missouri plant. Such validation shall be completed prior to execution of this Supply Agreement. Mallinckrodt agrees that it shall produce and supply orders for MNTX only at the St. Louis facility in manufacturing centers validated for MNTX in [*]  batch sizes or other batch sizes as agreed by Progenics, that are fully cGMP compliant and which have no FDA approved pharmaceutical ingredient (“API”) violations. In addition, Mallinckrodt may not subcontract the manufacture of MNTX to any subcontractor.

 

 

 

 

           (h)     Both Mallinckrodt and Progenics agree to monitor new requirements concerning, and work with the FDA on steps to reduce the potential levels of, [*] with respect to all Product produced pursuant to the terms of this Agreement after [*], unless an earlier time is specified by the FDA or other regulatory agency of the EU, Canada or Japan. In addition, Mallinckrodt agrees to monitor the next [*] production lots of MNTX and work on [*].

 

 

 

 

           (i)     Notwithstanding Progenics’ purchase obligations set forth in Section 1(a) above, in the event (i) Mallinckrodt fails to deliver the amount of MNTX specified in a binding purchase order within [*] of the delivery date specified in such binding purchase order on [*] occasions in any Contract Year, (ii) Progenics determines that any MNTX is not in compliance with the Specifications or the equivalent requirements of any Regulatory Agency, (iii) Progenics determines that any MNTX is Defective Product in accordance with Section 6 or (iv) Progenics determines that it is unable to use Product because of Mallinckrodt’s violation of Section 1(f) hereunder, then Progenics shall have the right to purchase from another source without penalty an aggregate amount of MNTX equal to the shortfall in supply or to the amount of defective or non-compliant Product as specified in (i), (ii), (iii) and (iv) above, as applicable. Any third party source supplying Product hereunder shall be given a reasonable amount of lead time to prepare and deliver the Product. The quantity of MNTX purchased by Progenics from other sources shall not be included when calculating Progenics’ Requirements of MNTX for purposes of determining whether Progenics has met its Minimum Purchase Obligation pursuant to Section 1(a) herein.

 

 

 

2.

Raw Materials .

Subject to the provisions of Section 4 below, all raw materials and other resources required in connection with the production of MNTX to be supplied hereunder shall be provided by Mallinckrodt at its cost and expense. Mallinckrodt warrants and represents that it has access to all necessary raw materials in order to produce MNTX in accordance with the Specifications. To the extent permitted by applicable laws and regulations, Mallinckrodt shall, at all times during the Term, maintain on hand an approximate [*] supply of MNTX raw materials or a combination of MNTX raw materials and finished MNTX sufficient to cover the first [*] of each Rolling Forecast (as defined below). Such raw materials and/or finished MNTX shall meet the requirements set forth in this Supply Agreement.


 

 

* CONFIDENTIAL TREATMENT REQUESTED

 

 

3


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3.

Quality Control .

 

 

 

 

           (a)     Mallinckrodt will ensure that it has the facilities, equipment, instrumentation, resources and trained personnel to provide all raw materials, in-process and product assays, analysis and other testing as compliance with Regulatory Agencies’ standards may require in connection with Mallinckrodt’s supply of MNTX hereunder. Mallinckrodt shall provide a complete certificate of analysis and any other document required by the Quality Agreement for each lot of finished MNTX supplied hereunder at the time of shipment.

 

 

 

 

           (b)     Mallinckrodt shall maintain complete and accurate documentation of all validation data, stability testing data, batch records, quality control and laboratory testing and any other data required under Regulatory Agencies’ requirements in connection with the supply of MNTX hereunder. Further, Mallinckrodt shall make all such documentation available to Progenics, upon reasonable request, to the extent required to complete an audit pursuant to Section 9(a) below.

 

 

 

           (c)     Mallinckrodt shall perform stability studies and supply to Progenics a stability summary report. In addition, upon written request by Progenics, Mallinckrodt shall supply to Progenics stability data requested by the FDA for compliance with the requirements of any New Drug Application or any Investigational New Drug Application. In addition, Mallinckrodt shall notify Progenics if a stability test failure occurs. In addition, Progenics may review all stability data during any audits carried out pursuant to Section 9(a) below.

 

 

 

 

 

           (d)     Mallinckrodt agrees that it will not engage in any act which causes any packaged and labeled MNTX produced by Mallinckrodt to become adulterated or misbranded within the meaning of the federal Food, Drug and Cosmetic Act, as amended or equivalent regulation of any Regulatory Agency.

 

 

 

4.

Compensation for Services Performed by Mallinckrodt .

 

 

 

 

           (a)     Progenics shall pay Mallinckrodt, for MNTX Delivered in any particular Contract Year during the Term, in accordance with the prices set forth on the attached Schedule 1. Such prices are referred to herein as “Product Prices” or, individually, as a “Product Price”.

 

 

 

 

           (b)     [*]

 

 

 

 

           (c)     [*]

 

 

 

 

           (d)     [*]

 

 

 

 

           (e)    [*]

 

 

 

 

           (f)    [*]

 


 

 

* CONFIDENTIAL TREATMENT REQUESTED

 

 

4


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5.

Forecasts, Order Placement and Delivery .

 

 

 

 

           (a)     Progenics will submit to Mallinckrodt, in writing before the commencement of each calendar quarter commencing after the date of execution of this Agreement and during the Term, a forecast of the anticipated amount of its orders for MNTX hereunder during each of the [*] beginning with the first day of each calendar quarter that follows the calendar quarter in which a forecast is submitted (the “Rolling Forecast”). Mallinckrodt shall provide Progenics with written notice as soon as reasonably practicable if it cannot meet Progenics’ stated demand in any Rolling Forecast. Progenics may submit one or more purchase orders for MNTX, in the form attached as Exhibit C hereto, during the [*] (the “Binding Period”) in an amount not to exceed [*] of the amount forecasted in such Rolling Forecast for each such [*]. Such purchase orders (provided they are consistent with the terms hereof) shall be firm and binding on Progenics and Mallinckrodt. All purchase orders submitted by Progenics pursuant to this Section 5(a) shall be hereinafter referred to as “Binding Purchase Order(s)”. Mallinckrodt shall acknowledge in writing its receipt of each Binding Purchase Order within [*] of receipt of any such Binding Purchase Order.

 

 

 

 

           (b)     The amount forecasted for the [*] (the “Non-Binding Period”) shall be considered non-binding and shall be used by Mallinckrodt only for production planning purposes; provided that, Progenics may issue additional purchase orders during the Binding Period for any amount forecasted in the Non-Binding Period (“Additional Purchase Order(s)”). If Mallinckrodt accepts any such Additional Purchase Order, it shall acknowledge its acceptance in writing within [*] of receipt of any such Additional Purchase Order. Except as provided in Section 6 hereunder, an executed Additional Purchase Order shall be binding on Mallinckrodt and Progenics.

 

 

 

 

           (c)     MNTX shall be ordered by Progenics only in writing and in the form attached hereto as Exhibit C. Mallinckrodt will not accept verbal orders of any kind for the production of MNTX. Any purchase order will contain the following information: (i) the precise quantity of MNTX desired, (ii) the dates by which the ordered MNTX must be ready for release by Progenics’ quality assurance function for shipment, (iii) the anticipated shipping destination for any MNTX and (iv) such other information as mutually agreed to by the parties.

 

 

 

 

           (d)     Notwithstanding any other provision hereof, the terms of any purchase order, confirmation or any other document submitted by either party in connection herewith shall have no force or effect to the extent they are in conflict or inconsistent with the terms of this Supply Agreement.

 

 

 

 

           (e)     Mallinckrodt shall fulfill and deliver each Binding Purchase Order and each accepted Additional Purchase Order by the date specified in any such purchase order. MNTX shall be delivered [*]. Title to MNTX and risk of loss shall [*].

 

 

 

6.

Acceptance and Resection and Recalls .

 

 

 

 

           (a)     Upon delivery, Progenics shall have the right, but not the obligation, to inspect and test MNTX. If Progenics reasonably determines that any MNTX is defective in material or workmanship, not in conformance with the Specifications or the equivalent requirement of any Regulatory Agency (if and as applicable), is adulterated or misbranded, or is otherwise not in conformity with both this Supply Agreement and the Quality Agreement (any such MNTX is hereinafter referred to as “Defective Product”), then Progenics, in addition to any other rights it may have under this Supply Agreement, may reject and return such Defective Product to Mallinckrodt. At the time of any such rejection, Progenics shall provide Malli


 
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