Common use of Supply of Product Clause in Contracts

Supply of Product. (a) For the consideration provided herein and in accordance with all terms, conditions, representations and warranties set forth herein, and for the term hereof, Mallinckrodt will provide DAS with such amounts of Product as DAS shall request. DAS agrees that it shall purchase [******] Mallinckrodt hereunder during every Contract Year during the term of this Agreement. For purposes of the preceding sentence "Contract Year" shall mean (i) for the first year of this Agreement, the period beginning on June 9, 2000 and ending on June 30, 2001, and (ii) for each year thereafter during the term of this Agreement, the twelve (12) month period beginning on July 1 and ending on June 30. All Product supplied hereunder shall be manufactured by Mallinckrodt strictly in accordance with the Specifications (defined below) and current Good Manufacturing Practices ("cGMP") as determined by the United States Food and Drug Administration ("FDA") using the manufacturing process described in Mallinckrodt's Drug Master File. If and as applicable, Mallinckrodt shall comply with the cGMP of those countries outside the United States represented on Exhibit B. (b) The specifications for Product (including, without limitation, specifications for all components and raw materials, whether active or inactive) are described on Exhibit A attached hereto ("Specifications"). (c) Notwithstanding anything to the contrary herein and if, for any Contract Year after the first Contract Year of this Agreement, Mallinckrodt [******] hereunder, [******] thereafter, shall be [******] sold by Mallinckrodt to all unaffiliated parties and to other Mallinckrodt business [*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. units in such subsequent Contract Year as the [******] business units in such immediately previous Contract Year.

Appears in 1 contract

Samples: Supply Agreement (Drugabuse Sciences Inc)

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Supply of Product. (a) For the consideration provided herein and in accordance with all terms, conditions, representations and warranties set forth herein, and for the term hereof, Mallinckrodt will provide DAS with such amounts of Product as DAS shall request. DAS agrees that it shall purchase [******] Mallinckrodt hereunder during every Contract Year during the term of this Agreement. For purposes of the preceding sentence "Contract Year" shall mean (i) for the first year of this Agreement, the period beginning on June 9, 2000 and ending on June 30, 2001, and (ii) for each year thereafter during the term of this Agreement, or for as long as CIMA manufactures any of the twelve (12) month period beginning on July 1 Products hereunder, whichever is shorter, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] agrees to purchase from CIMA and ending on June 30. All CIMA agrees to supply [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] with all of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] requirements for the Products, Product supplied hereunder shall be manufactured samples and Product placebos for their subsequent use, sale, lease or transfer by Mallinckrodt strictly in accordance with the Specifications (defined below) and current Good Manufacturing Practices ("cGMP") as determined by the United States Food and Drug Administration ("FDA") using the manufacturing process described in Mallinckrodt's Drug Master File. If and as applicable[***CONFIDENTIAL TREATMENT REQUESTED, Mallinckrodt shall comply with the cGMP of those countries outside the United States represented on Exhibit B.PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. (b) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] agrees to initiate purchases of the Products, Product samples and Product placebos hereunder by issuing CIMA binding purchase orders not less than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] prior to the required shipping date set forth therein. CIMA agrees to accept any order issued in accordance with this Section 5.1(b) and to meet the delivery dates specified thereon. All purchase orders hereunder shall be on [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] standard purchase order form (a copy of which is attached as Schedule 5.1(b) hereto and which shall not, for purposes of this Agreement only, be modified in any material respect without CIMA's prior written consent, such consent not to be unreasonably withheld or delayed) and shall be directed to CIMA at the address set forth below. The specifications for terms and conditions of purchase enumerated on the reverse side of such standard purchase order form shall prevail over any inconsistent or conflicting language as may exist on invoices, confirmation or order acknowledgment forms of CIMA, provided, however, that in the event any terms thereof are in conflict, or are inconsistent with any terms of this Agreement, the terms and conditions hereof shall prevail. No Product delivered by CIMA shall have a shelf life that is more than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE EXHIBIT 10.25 COMMISSION.***] less than the maximum shelf life of such Product (includingother than batches that were under investigation and batches for validation which shall have not more than [***CONFIDENTIAL TREATMENT REQUESTED, without limitationPORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] less than the maximum shelf life of such Product upon delivery to [***CONFIDENTIAL TREATMENT REQUESTED, specifications for all components and raw materials, whether active or inactive) are described on Exhibit A attached hereto ("Specifications"PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]). (c) Notwithstanding anything to Purchase order quantities shall be in full batch sizes that are mutually agreed by the contrary herein and if, for any Contract Year after the first Contract Year of this Agreement, Mallinckrodt parties. (d) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] hereunder, shall cause the amount of API that CIMA requires to perform its obligations pursuant to Schedule 3.1 and Sections 5.1 and 5.5 to be provided at no charge to CIMA [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] thereafterprior to date of tablet manufacture, shall be as well as [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] sold by Mallinckrodt of safety stock. API must conform to all unaffiliated parties and to other Mallinckrodt business [*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN **CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. units in such subsequent Contract Year as the [***.***] business units in such immediately previous Contract Yearthen current raw materials specifications. CIMA shall not be accountable for production or shipment delays due to lack of API. (e) EXCEPT AS SPECIFICALLY PROVIDED HEREIN, INCLUDING, WITHOUT LIMITATION, SECTION 7.8, THE PRODUCT WILL BE SUPPLIED BY CIMA WITH NO WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

Appears in 1 contract

Samples: Master Development, License and Supply Agreement (Cima Labs Inc)

Supply of Product. (a) For the consideration provided herein and in accordance with all terms, conditions, representations and warranties set forth herein, and for the term hereof, Mallinckrodt will provide DAS with such amounts of Product as DAS shall request. DAS agrees that it shall purchase [******] Mallinckrodt hereunder during every Contract Year during the term of this Agreement. For purposes of the preceding sentence "Contract Year" shall mean (i) for the first year of this Agreement, the period beginning on June 9, 2000 and ending on June 30, 2001, and (ii) for each year thereafter during the term of this Agreement, or for as long as CIMA manufactures any of the twelve (12) month period beginning on July 1 Products hereunder, whichever is shorter, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] agrees to purchase from CIMA and ending on June 30. All CIMA agrees to supply [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] with all of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]'s requirements for the Products, Product supplied hereunder shall be manufactured samples and Product placebos for their subsequent use, sale, lease or transfer by Mallinckrodt strictly in accordance with the Specifications (defined below) and current Good Manufacturing Practices ("cGMP") as determined by the United States Food and Drug Administration ("FDA") using the manufacturing process described in Mallinckrodt's Drug Master File. If and as applicable[***CONFIDENTIAL TREATMENT REQUESTED, Mallinckrodt shall comply with the cGMP of those countries outside the United States represented on Exhibit B.PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]. (b) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] agrees to initiate purchases of the Products, Product samples and Product placebos hereunder by issuing CIMA binding purchase orders not less than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] prior to the required shipping date set forth therein. CIMA agrees to accept any order issued in accordance with this Section 5.1(b) and to meet the delivery dates specified thereon. All purchase orders hereunder shall be on [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]'s standard purchase order form (a copy of which is attached as Schedule 5.1(b) hereto and which shall not, for purposes of this Agreement only, be modified in any material respect without CIMA's prior written consent, such consent not to be unreasonably withheld or delayed) and shall be directed to CIMA at the address set forth below. The specifications for terms and conditions of purchase enumerated on the reverse side of such standard purchase order form shall prevail over any inconsistent or conflicting language as may exist on invoices, confirmation or order acknowledgment forms of CIMA, provided, however, that in the event any terms thereof are in conflict, or are inconsistent with any terms of this Agreement, the terms and conditions hereof shall prevail. No Product delivered by CIMA shall have a shelf life that is more than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] less than the maximum shelf life of such Product (includingother than batches that were under investigation and batches for validation which shall have not more than [***CONFIDENTIAL TREATMENT REQUESTED, without limitationPORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] less than the maximum shelf life of such Product upon delivery to [***CONFIDENTIAL TREATMENT REQUESTED, specifications for all components and raw materials, whether active or inactive) are described on Exhibit A attached hereto ("Specifications"PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]). (c) Notwithstanding anything to Purchase order quantities shall be in full batch sizes that are mutually agreed by the contrary herein and if, for any Contract Year after the first Contract Year of this Agreement, Mallinckrodt parties. (d) [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] hereunder, shall cause the amount of API that CIMA requires to perform its obligations pursuant to Schedule 3.1 and Sections 5.1 and 5.5 to be provided at no charge to CIMA [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] thereafterprior to date of tablet manufacture, shall be as well as [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] sold by Mallinckrodt of safety stock. API must conform to all unaffiliated parties and to other Mallinckrodt business [*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN **CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. units in such subsequent Contract Year as the [.******] business units in such immediately previous Contract Year]'s then current raw materials specifications. CIMA shall not be accountable for production or shipment delays due to lack of API. (e) EXCEPT AS SPECIFICALLY PROVIDED HEREIN, INCLUDING, WITHOUT LIMITATION, SECTION 7.8, THE PRODUCT WILL BE SUPPLIED BY CIMA WITH NO WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABLILITY OR FITNESS FOR A PARTICULAR PURPOSE.

Appears in 1 contract

Samples: Master Development, License and Supply Agreement (Cima Labs Inc)

Supply of Product. (a) For Subject to the consideration provided herein terms and conditions of this Agreement, ADMA shall purchase exclusively from BPC, ADMA’s worldwide requirements of the Product. (b) All Product supplied to ADMA shall be in accordance with all terms, conditions, representations and warranties bulk form as set forth hereinin the Specifications in Exhibit B and any additional specifications that may be mutually agreed upon in writing by the Parties, and for shall include, without limitation, all Product yield. (c) Except to the term hereofextent the Parties may otherwise agree with respect to a particular shipment, Mallinckrodt will provide DAS with such amounts the Product shall be ordered pursuant to section 2.3. (d) BPC shall supply the Product resulting from processing of Product as DAS shall request. DAS agrees that it shall purchase [***] liters, or if requested by ADMA, [***] Mallinckrodt hereunder liters, as specified in the Purchase Order, of Plasma supplied by ADMA and shall deliver such Product to ADMA within [***] of the delivery dates specified in such purchase order. There shall be a purchase order for each Lot. (e) All Product will be packaged, in bulk, in accordance with ADMA’s requirements, as set forth in Exhibit “C”. (f) All Product shall be delivered to ADMA’s designated carrier at the Facility. (g) In the event the Purchase Order, as defined below, conflicts with or adds to the Specifications in Exhibit B, the Specifications shall prevail, unless otherwise agreed to in writing by the Parties. In the event that any terms of a Purchase Order conflict with or add to the Agreement, the Agreement shall prevail unless otherwise agreed to in writing by the Parties. ADMA shall purchase and BPC shall supply a minimum of [***] during every Contract Year each calendar year after the Finished Product is approved by the FDA, provided, however, that if ADMA requests any additional Lots during any calendar year, during the term of this Agreement. For purposes of the preceding sentence "Contract Year" shall mean (i) for the first year Term of this Agreement, after the period beginning on June 9, 2000 and ending on June 30, 2001, and (ii) for each year thereafter during the term of this Agreement, the twelve (12) month period beginning on July 1 and ending on June 30. All Finished Product supplied hereunder shall be manufactured by Mallinckrodt strictly in accordance with the Specifications (defined below) and current Good Manufacturing Practices ("cGMP") as determined is approved by the United States Food FDA, BPC agrees to manufacture and Drug Administration ("FDA") using supply to ADMA a minimum of [***] of the manufacturing process described Product in Mallinckrodt's Drug Master File. If and as applicable, Mallinckrodt shall comply with each calendar year after receipt of Regulatory Approval for the cGMP of those countries outside the United States represented on Exhibit B. (b) The specifications for Product (including, without limitation, specifications for all components and raw materials, whether active or inactive) are described on Exhibit A attached hereto ("Specifications")Finished Product. (ch) Notwithstanding anything to the contrary herein and if, for any Contract Year after the first Contract Year of in this Agreement, Mallinckrodt to the extent that BPC is unable to supply Product in the quantities as ordered by ADMA pursuant to a Firm Purchase Order, during any annual period, BPC shall provide prompt notification to ADMA of such and ADMA shall have the right to seek regulatory approval for an alternative facility to manufacture the Product. Upon obtaining regulatory approval for the alternative facility, thereafter ADMA shall have the right to manufacture and/or purchase [******] hereunderof its annual Product requirements, [******] thereafteras set forth in the Final Forecast, from the alternative facility during each annual period. All Products produced at the alternative facility shall be [******] sold by Mallinckrodt subject to all unaffiliated parties the Royalty obligations pursuant to Article 4 and to other Mallinckrodt business [*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. units in such subsequent Contract Year as the [******] business units in such immediately previous Contract Yearset forth hereunder.

Appears in 1 contract

Samples: Manufacturing, Supply and License Agreement (Adma Biologics, Inc.)

Supply of Product. 3.1 In accordance with the terms of this Agreement, GENSIA SICOR (athrough SICOR) For shall supply all of PURCHASER'S ordered requirements for Product in bulk form for use by PURCHASER in the consideration provided herein and Territories in accordance with all terms, conditions, representations and warranties set forth herein, and for the term hereof, Mallinckrodt will provide DAS with such amounts of Product as DAS shall request. DAS agrees that it shall purchase [******] Mallinckrodt hereunder during every Contract Year during the term provisions of this Agreement. For purposes The right and license of the preceding sentence "Contract Year" shall mean (i) for the first year of this AgreementPURCHASER to obtain, the period beginning on June 9, 2000 use and ending on June 30, 2001, and (ii) for each year thereafter during the term of this Agreement, the twelve (12) month period beginning on July 1 and ending on June 30. All Product supplied hereunder shall be manufactured by Mallinckrodt strictly in accordance with the Specifications (defined below) and current Good Manufacturing Practices ("cGMP") as determined by the United States Food and Drug Administration ("FDA") using the manufacturing process described in Mallinckrodt's Drug Master File. If and as applicable, Mallinckrodt shall comply with the cGMP of those countries outside the United States represented on Exhibit B. (b) The specifications for distribute Product (including, without limitation, specifications the right to make or have made Product) from GENSIA SICOR and SICOR shall be (i) non-exclusive in the Non-exclusive Territory, and (ii exclusive in the Exclusive Territory; provided, however, that the rights and licenses set forth in clause (ii) above shall be co-exclusive in each jurisdiction in which GENSIA SICOR (or ALCO or SICOR, as the case may be) has binding written agreements, or binding written commitments that will lead to binding written agreements, to sell Product on the Restatement Date (which is limited to only those [ * ] and the [ * ] with whom GENSIA SICOR has commitments that are in existence on the Restatement Date), but only with respect to such third parties and only until the earlier of expiration or termination of such agreements; and provided, further that GENSIA SICOR shall use all diligent efforts (without any obligation to violate or alter the terms of such agreements existing on the Restatement Date) to provide PURCHASER with exclusive rights and licenses to sell the Products in the Territory as soon as possible. All Product hereunder shall be manufactured at SICOR's GMP facilities at Rho, Italy, the facility identified in Exhibit 9 hereto, the Santxx Xxxility and additional (as necessary and as provided in Section 6 below) GMP qualified facilities that are approved in advance by PURCHASER (which approval will not be unreasonably withheld). In addition, all Product shall be manufactured (A) in accordance with drug substance manufacturing and quality control procedures existing on the Effective Date, which drug substance manufacturing and quality control procedures have been included in manufacturer's Abbreviated Antibiotic Drug Application ("AADA") submitted to the FDA in 1996, and that will be submitted to other Regulatory Authorities in the Territory (which AADA shall include at least the elements set forth in the Drug Master File) in accordance with U.S. FDA current Good Manufacturing Practices, and (B) to the Q/C Specifications. GENSIA SICOR shall cause SICOR to use its diligent efforts to [ * ] in order to produce and supply all Product ordered by Purchaser hereunder and to meet the Product [ * ] that will be set forth in Schedule 1 hereto within [ * ] after the Restatement Date. In addition, GENSIA SICOR agrees to the following (and GENSIA SICOR agrees to cause SICOR to undertake): (i) Within [ * ] after PURCHASER submits an [ * ] (i.e., [ * ]) for all components and raw materialsits Cyclosporine Formulation, whether active GENSIA SICOR shall submit a [ * ] for the Product to [ * ] for the [ * ];* (ii) Within [ * ] days of notice from PURCHASER that PURCHASER intends to file a registration for a Cyclosporine Formulation with a Regulatory Authority or inactiveRegulatory Authorities, it shall file in each [ * ], a [ * ] or [ * ] with the ---------------------- * Confidential Treatment Requested; confidential portion has been filed separately with the SEC. (iii) are described GENSIA SICOR shall maintain the party identified on Exhibit A attached hereto 9, or such other party as PURCHASER approves in its reasonable discretion, ("Specifications"and provide PURCHASER with evidence that is reasonably satisfactory to PURCHASER of such designation) to manufacture and supply Product to PURCHASER pursuant to this Agreement. 3.2 GENSIA SICOR (through SICOR) shall deliver the Product in quantities comprised of single, Q/C-released lots in accordance with Firm Orders established pursuant to Article 4 hereof; provided, however, that PURCHASER may, prior to any shipment, waive the requirement that such shipment be comprised of a single, Q/C-released lot. In addition, in the event that a Firm Order for Product is not in a multiple of [ * ] or [ * ], PURCHASER acknowledges that any quantity of a Q/C-released lot (within a Firm Order) greater and additional to the minimum batch size then in effect may be delivered as a separate lot under such Firm Order. The packaging specifications will be established by the parties based on results of stability testing of the Product, which testing shall be completed by no later than December 31, 1995, and shall be set forth in Exhibit 3 hereto; the parties may revise and update such specifications by separate agreement between the parties hereto. 3.3 GENSIA SICOR (through SICOR) shall satisfy all of PURCHASER's requirements for Product. GENSIA SICOR (through SICOR) shall make all Product produced and sold to PURCHASER as per validated processes and procedures. GENSIA SICOR (through SICOR) shall not change, deviate from or otherwise modify any aspect of the procedures or processes employed in manufacturing the Product using a process or procedure different from the procedures and processes filed with the Regulatory Authorities (including, without limitation, the FDA) or as otherwise specified herein without the prior written consent of PURCHASER and PURCHASER agrees to promptly respond to any request for consent from GENSIA SICOR (through SICOR). 3.4 In the event that GENSIA SICOR (cthrough SICOR) Notwithstanding anything is unable to supply the full amount of Product which shall be the subject of any Firm Order (as defined in Article 4 below) in accordance with any delivery schedule provided for in Article 4 below, GENSIA SICOR (through SICOR) shall notify the PURCHASER of such situation as soon as possible and shall supply to PURCHASER an allocation of Product at least equal to the contrary herein ratio of (i) the amount supplied from the [ * ] during the [ * ] of [ * ] to such inability, to (ii) the [ * ]. In no event shall PURCHASER [ * ] with respect to the [ * ] and if, for any Contract Year after the first Contract Year [ * ] and [ * ] of this Agreement, Mallinckrodt [******] hereunder, [******] thereafter, shall be [******] sold by Mallinckrodt to all unaffiliated parties and to other Mallinckrodt business [*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. units in such subsequent Contract Year as the [******] business units in such immediately previous Contract YearProduct than [ * ].

Appears in 1 contract

Samples: Supply and License Agreement (Sangstat Medical Corp)

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Supply of Product. (a) For VeriChip agrees to sell the consideration provided herein and in accordance with all terms, conditions, representations and warranties set forth hereinProduct exclusively to Medcomp during the Term of this Agreement, and for the term hereof, Mallinckrodt will provide DAS with such amounts of Product as DAS shall request. DAS agrees that it shall purchase [******] Mallinckrodt hereunder during every Contract Year during not manufacture or sell the term Product, or any product using or incorporating the same, or substantially similar technology, to any other manufacturer, seller or distributor of this Agreementvascular access products. For purposes Notwithstanding the foregoing, VeriChip may use or sell a product substantially equivalent to the Product so long as such use or sale is not in connection with vascular access products (that compete with Medcomp, directly or indirectly). VeriChip agrees that it will seek a similar exclusivity from the manufacturer of the preceding sentence "Contract Year" shall mean (i) for Product. In the first year of this Agreement, the period beginning on June 9, 2000 and ending on June 30, 2001, and (ii) for each year thereafter event VeriChip becomes insolvent or otherwise ceases operations during the term of this Agreement, and has no successor which is bound by the terms of this Agreement, Medcomp shall be able to maintain said exclusivity with the manufacturer of the Product. Medcomp agrees during the Initial Term of this Agreement, that it will purchase not less than the following number of Products (the “Minimum Purchase Requirements”): (i) *** in the first Product Purchase Year, (ii) *** in the second Product Purchase Year, (iii) *** in the third Product Purchase Year, (iv) *** in the fourth Product Purchase Year and (v) *** in the fifth Product Purchase Year. For the purpose of this Agreement, the “Product Purchase Years” are the five (5) respective consecutive twelve (12) month period periods beginning on July 1 the date of the last to occur of the following: (i) the Product being ready for production; or (ii) 510k approval of the Product. In the event Medcomp fails to meet the Minimum Purchase Requirements for a Product Purchase Year, Medcomp shall, within thirty (30) days of written demand from VeriChip, make a payment to VeriChip equal to *** times the number of Products by which Medcomp failed to meet the Minimum Purchase Requirement for the Product Purchase Year at issue. Medcomp shall be released from the Minimum Purchase Requirements should the FDA issue a recall of the Product, for more than thirty (30) days. (b) Medcomp’s original order for the Product shall be submitted within ten (10) days of 510k approval of the Product and ending Medcomp shall order the Product on June 30a quarterly basis thereafter. All orders for the Product supplied hereunder shall be manufactured by Mallinckrodt strictly in writing and shall specify (i) the number of units of each of the Product to be purchased (in accordance with the Specifications (defined belowterms and conditions of the Agreement) and (ii) the destination to which the Product is to be shipped. With each order of the Product, Medcomp shall also provide a forecast of the number of Products it will be purchasing for the next six (6) months. VeriChip will deliver no less than ninety percent (90%) of the first order for Products within eight (8) weeks of full production commencing. Thereafter, VeriChip agrees to deliver no less than ninety percent (90%) of the Products ordered by Medcomp within less than thirty (30) days of the order date provided that the number of Products (i) does not exceed one-hundred twenty percent (120%) of the immediately previous order or, (ii) alone, or in conjunction with the immediately previous order, does not exceed the then current Good Manufacturing Practices six ("cGMP"6) as determined by the United States Food and Drug Administration ("FDA") using the manufacturing process described in Mallinckrodt's Drug Master Filemonth forecast of Medcomp. If and as applicablethe number of Products ordered (i) does exceed one-hundred twenty percent (120%) of the immediately previous order or, Mallinckrodt shall comply (ii) alone, or in conjunction with the cGMP immediately previous order, exceeds the then current six (6) month forecast of those countries outside Medcomp, VeriChip agrees to deliver no less than ninety percent (90%) ordered within sixty (60) days of the United States represented on Exhibit B. order date. VeriChip shall be permitted a thirty (b30) The specifications day cure period for Product (including, without limitation, specifications any missed delivery deadline. VeriChip shall not be liable for all components and raw materials, whether active or inactive) are described on Exhibit A attached hereto ("Specifications")any consequential damages as result of a failure to meet delivery deadlines. Medcomp shall be released from the Minimum Purchase Requirements of any particular year if its inability to meet the minimum purchase requirements of that particular year was due to VeriChip’s inability to make delivery pursuant to the schedule set forth above. (c) Notwithstanding anything VeriChip agrees, during the Term, to make its other products that are compatible with the contrary herein and if, for any Contract Year after the first Contract Year of this Agreement, Mallinckrodt [Product available to Medcomp on commercially reasonable terms. ******] hereunder, [******] thereafter, shall be [******] sold by Mallinckrodt to all unaffiliated parties and to other Mallinckrodt business [*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION, . CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. units in such subsequent Contract Year as the [******] business units in such immediately previous Contract YearPORTION.

Appears in 1 contract

Samples: Development and Supply Agreement (VeriChip CORP)

Supply of Product. (a) For the consideration provided herein and in accordance with all terms, conditions, representations and warranties set forth herein, and for the term hereof, Mallinckrodt will provide DAS with such amounts of Product as DAS shall request. DAS agrees that it shall purchase at least [******] of its requirements for Product from Mallinckrodt hereunder during every Contract Year during the term of this Agreement. For purposes of the preceding sentence "Contract Year" shall mean (i) for the first year of this Agreement, the period beginning on June 9, 2000 and ending on June 30, 2001, and (ii) for each year thereafter during the term of this Agreement, the twelve (12) month period beginning on July 1 and ending on June 30. All Product supplied hereunder shall be manufactured by Mallinckrodt strictly in accordance with the Specifications (defined below) and current Good Manufacturing Practices ("cGMP") as determined by the United States Food and Drug Administration ("FDA") using the manufacturing process described in Mallinckrodt's Drug Master File. If and as applicable, Mallinckrodt shall comply with the cGMP of those countries outside the United States represented on Exhibit B. (b) The specifications for Product (including, without limitation, specifications for all components and raw materials, whether active or inactive) are described on Exhibit A attached hereto ("Specifications"). (c) Notwithstanding anything to the contrary herein and if, for any Contract Year after the first Contract Year of this Agreement, Mallinckrodt [******] is unable to supply DAS with such quantities of Product as DAS shall order hereunder, [******] the minimum amount of Product that Mallinckrodt shall be obligated to supply to DAS in any given Contract Year thereafter, shall be that amount of Product ordered by DAS in any such subsequent Contract Year which represents the [******] sold by Mallinckrodt to all unaffiliated parties and to other Mallinckrodt business [*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. units in such subsequent Contract Year as the [******] in the immediately previous Contract Year bears to the [******] of all forms of [******] to all [******] and to [******] business units in such immediately previous Contract Year.

Appears in 1 contract

Samples: Supply Agreement (Drugabuse Sciences Inc)

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