Reliance by Patheon. 3.5.1 Depomed understands and acknowledges that Patheon will rely on the Maximum Firm Orders and Forecasts in ordering Materials sufficient to meet the Purchase Orders. In addition, Depomed understands that, to ensure an orderly supply of the Materials, Patheon may want to purchase the Materials in sufficient volumes to meet the production requirements for Product during the ensuing Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission. [***] of the Forecast or to meet the production requirements of any longer period agreed to by Patheon and Depomed, in writing. Accordingly, Depomed authorizes Patheon to purchase Materials sufficient for it to supply all Product forecasted for the [***] of the most recent Forecast given by Depomed under Section 3.1. Patheon may make other purchases of Materials to meet anticipated manufacturing requirements, based on forecasts for longer periods, if agreed to in writing by the Parties. Depomed has authorized Patheon to order Materials for any launch quantities of Product requested by Depomed. If Materials ordered by Patheon to meet Depomed’s Purchase Orders issued in accordance with Section 3.4.2 or as permitted under this Section 3.5.1 are not included in Product manufactured prior to their expiration dates through no fault of Patheon, then Depomed will pay to Patheon all costs incurred by Patheon for the purchase and handling of such Materials. Patheon shall promptly notify Depomed of the identity of any Materials that have been purchased in accordance with this Section 3.5 and that have expired or become obsolete, and any costs to be charged to Depomed therefor, in accordance with this Section 3.5. Reimbursement of such costs by Depomed shall be due, where applicable, within [***] after its receipt of Patheon’s reconciliation report and calculation of such costs prepared in accordance with Section 5.6. Patheon shall provide pricing information sufficient to show the costs of such Materials, where reimbursement is requested by Patheon.
Appears in 1 contract
Samples: Commercial Manufacturing Services Agreement (Depomed Inc)
Reliance by Patheon. 3.5.1 Depomed Avanir understands and acknowledges that Patheon will rely on the Maximum Firm Orders and Forecasts rolling forecasts submitted pursuant to Sections 5.1(a) and (b) in ordering the Components and Packaging Materials sufficient required to meet the Purchase such Firm Orders. In addition, Depomed Avanir understands that, that to ensure an orderly supply of the such Components and Packaging Materials, it may be desirable for Patheon may want to purchase the such Components and Packaging Materials in sufficient volumes to meet the production requirements for Product Products during the ensuing Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission. [***] part or all of the Forecast forecasted periods referred to in Section 5.1(a) or to meet the production requirements of any longer period agreed to by Patheon and Depomed, in writingAvanir. Accordingly, Depomed Avanir authorizes Patheon to purchase Components and Packaging Materials sufficient in order to satisfy the production requirements for it to supply all Product forecasted Products for the [***] of first six months contemplated in the most recent Forecast given forecast provided by Depomed under Avanir pursuant to Section 3.1. 5.1(a) and agrees that Patheon may make such other purchases of Components and Packaging Materials to meet anticipated manufacturing requirements, based on forecasts for production requirements during such longer periods, if periods as may be agreed to in writing from time to time by Avanir at the Partiesrequest of Patheon or Avanir. Depomed has authorized Patheon to order shall manage the use of Components and Packaging Materials for any launch quantities of Product requested by Depomedin accordance with cGMP “First in-first out” (FIFO) rules. If Components or Packaging Materials ordered by Patheon pursuant to meet Depomed’s Purchase Firm Orders issued in accordance with Section 3.4.2 or as permitted under this Section 3.5.1 5.2 are not included in Product manufactured prior to their expiration dates through no fault finished Products purchased by Avanir within six months after the forecasted month in respect of Patheonwhich such purchases have been made (or such longer period as the parties may agree) (“Dated Components and Packaging Materials”) or if such Components or Packaging Materials have expired during such period (“Expired Components and Packaging Materials”), then Depomed will Avanir shall pay to Patheon its costs therefor (including all costs incurred by Patheon for in connection with the purchase and handling of such Dated and Expired Components and Packaging Materials. Patheon shall promptly notify Depomed of use commercially reasonable efforts to return Dated Components and Packaging Materials or use Dated Components and Packaging Materials for Third Party products manufactured by Patheon. In the identity of any event Dated Components and Packaging Materials that have been purchased in accordance with this Section 3.5 are returned to the supplier for which Patheon receives a credit or refund, Avanir will receive a credit equal to the credit or refund received by Patheon from its supplier for such returned Dated Components and that have expired or become obsolete, Packaging Materials and any costs to be charged to Depomed thereforrestocking penalties or other charges which may apply. In the event Dated Components and Packaging Materials are incorporated into Products subsequently purchased by Avanir or into Third Party products manufactured by Patheon and subsequently purchased by a Third Party, in accordance with this Section 3.5. Reimbursement of such costs by Depomed shall be due, where applicable, within [***] after its receipt of Patheon’s reconciliation report and calculation of such costs prepared in accordance with Section 5.6. Patheon shall provide pricing information sufficient to show the Avanir will receive credit for any costs of such MaterialsDated Components and Packaging Materials previously paid to Patheon by Avanir. Avanir acknowledges and agrees that Patheon’s ability to disclose information regarding a Component or Packaging Material may be limited by obligations of confidentiality between Patheon and its supplier(s). In such a case, where reimbursement is Patheon shall use commercially reasonable efforts to obtain its supplier’s consent to disclose such information and Avanir agrees to provide such supplier with reasonable assurances as may reasonably be requested by Patheonthe supplier in a confidentiality agreement, or such other written document intended to protect the confidentiality of supplier’s sensitive information.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Avanir Pharmaceuticals)
Reliance by Patheon. 3.5.1 Depomed (a) Client understands and acknowledges that Patheon will rely on the Maximum Firm Orders and Forecasts rolling forecasts submitted under Sections 5.1(a) and (b) in ordering Materials sufficient the Components (other than Client-Supplied Components) required to meet the Purchase Firm Orders. In addition, Depomed Client understands that, that to ensure an orderly supply of the MaterialsComponents, Patheon may want to purchase the Materials Components in sufficient reasonable volumes to meet the production requirements for Product Products during the ensuing Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission. [***] part or all of the Forecast forecasted periods referred to in Section 5.1(a) or to meet the production requirements of any longer period agreed to in writing by Patheon and Depomed, in writingClient. Accordingly, Depomed Client authorizes Patheon to purchase Materials sufficient Components in quantities reasonably needed to satisfy the Manufacturing Services requirements for it to supply all Product forecasted Products for the first […***…] of months contemplated in the most recent Forecast forecast given by Depomed Client under Section 3.15.1(a). Patheon may make other purchases of Materials Components to meet anticipated manufacturing requirements, based on forecasts Manufacturing Services requirements for longer periods, periods if agreed to in writing by the Parties. Depomed has authorized The Client will give Patheon written authorization to order Materials Components for any launch quantities of Product requested by DepomedClient which will be considered a Firm Order when accepted by Patheon. If Materials Components ordered by Patheon to meet Depomed’s Purchase under Firm Orders issued in accordance with Section 3.4.2 or as permitted under this Section 3.5.1 5.2(a) are not included in Product finished Products manufactured prior to their expiration dates through no fault of Patheonfor Client within […***…] months after the forecasted month for which the purchases have been made (or for a longer period as the Parties may agree) or if the Components have expired during the period, then Depomed Client will pay to Patheon its costs therefor (including all reasonable costs incurred by Patheon for the purchase and handling of such Materialsthe Components). Patheon shall promptly notify Depomed of the identity of any Materials that have been purchased in accordance with this Section 3.5 and that have expired or become obsolete, and any costs to be charged to Depomed therefor, in accordance with this Section 3.5. Reimbursement of such costs by Depomed shall be due, where applicable, within [But if these ***] after its receipt of Confidential Treatment Requested Master Manufacturing Services Agreement Components are used in Products subsequently manufactured for Client or in third party products manufactured by Patheon’s reconciliation report and calculation of such costs prepared in accordance with Section 5.6. Patheon shall provide pricing information sufficient to show the , Client will receive credit for any costs of such Materialsthose Components previously paid to Patheon by Client or, where reimbursement is requested at Client’s election, a refund in an amount equal to these costs. On a Quarterly basis, Patheon will provide a report summarizing the Inventory held by Patheon.
Appears in 1 contract
Reliance by Patheon. 3.5.1 Depomed (a) New River understands and acknowledges that Patheon will rely on the Maximum rolling forecasts and Firm Orders submitted pursuant to Sections 5.1(a) and Forecasts (b) in ordering Materials sufficient the Components required to meet the Purchase such Firm Orders. In addition, Depomed New River understands that, that to ensure an orderly supply of the Materialssuch Components, it may be desirable for Patheon may want to purchase the Materials such Components in sufficient volumes to meet the production requirements for Product Products during the ensuing Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission. [***] part or all of the Forecast forecasted periods referred to in Section 5.1(a) or to meet the production requirements of any longer period agreed to by Patheon and Depomed, in writingNew River. Accordingly, Depomed New River authorizes Patheon to purchase Materials sufficient Components in order to satisfy the production requirements for it to supply all Product forecasted Products for the [***] of contemplated in the most recent Forecast given forecast provided by Depomed under New River pursuant to Section 3.1. 5.1(a) and agrees that Patheon may make such other purchases of Materials Components to meet anticipated manufacturing requirements, based on forecasts for production requirements during such longer periods, if periods as may be agreed to in writing from time to time by New River at the Partiesrequest of Patheon or New River. Depomed has authorized New River shall provide Patheon with its written authorization to order Materials for Components in respect of any launch quantities of Product requested by DepomedNew River, which upon acceptance by Patheon shall constitute a Firm Order. If Materials Components ordered by Patheon pursuant to meet Depomed’s Purchase Firm Orders issued in accordance with Section 3.4.2 or as permitted under this Section 3.5.1 5.2 are not included in Product manufactured prior to their expiration dates through no fault finished Products purchased by New River after the forecasted month in respect of Patheonwhich such purchases have been made (or such longer period as the parties may agree) or if such Components have expired during such period, then Depomed will New River shall pay to Patheon its costs therefor (including all costs incurred by Patheon for in connection with the purchase and handling of such Materials. Components) within reason; provided, however, that in the event such Components are incorporated into Products subsequently purchased by New River or into third party products manufactured by Patheon shall promptly notify Depomed of the identity of and subsequently purchased by a third party, New River will receive credit for any Materials that have been purchased in accordance with this Section 3.5 and that have expired or become obsolete, and any costs to be charged to Depomed therefor, in accordance with this Section 3.5. Reimbursement of such costs by Depomed shall be due, where applicable, within [***] after its receipt of Patheon’s reconciliation report and calculation of such costs prepared in accordance with Section 5.6. Patheon shall provide pricing information sufficient to show the costs of such Materials, where reimbursement is requested Components previously paid to Patheon by PatheonNew River.
Appears in 1 contract
Samples: Manufacturing Services Agreement (New River Pharmaceuticals Inc)
Reliance by Patheon. 3.5.1 Depomed (a) Client understands and acknowledges that Patheon will rely on the Maximum Firm Orders and Forecasts rolling forecasts submitted under Sections 5.1(a) and (b) in ordering Materials sufficient the Components (other than Client-Supplied Components) required to meet the Purchase Firm Orders. In addition, Depomed Client understands that, that to ensure an orderly supply of the MaterialsComponents, Patheon may want to purchase the Materials Components in sufficient reasonable volumes to meet the production requirements for Product Products during the ensuing Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission. [***] part or all of the Forecast forecasted periods referred to in Section 5.1(a) or to meet the production requirements of any longer period agreed to in writing by Patheon and Depomed, in writingClient. Accordingly, Depomed Client authorizes Patheon to purchase Materials sufficient Components in quantities reasonably needed to satisfy the Manufacturing Services requirements for it to supply all Product forecasted Products for the first […***…] of months contemplated in the most recent Forecast forecast given by Depomed Client under Section 3.15.1(a). Patheon may make other purchases of Materials Components to meet anticipated manufacturing requirements, based on forecasts Manufacturing Services requirements for longer periods, periods if agreed to in writing by the Parties. Depomed has authorized The Client will give Patheon written authorization to order Materials Components for any launch quantities of Product requested by DepomedClient which will be considered a Firm Order when accepted by Patheon. If Materials Components ordered by Patheon to meet Depomed’s Purchase under Firm Orders issued in accordance with Section 3.4.2 or as permitted under this Section 3.5.1 5.2(a) are not included in Product finished Products manufactured prior to their expiration dates through no fault of Patheonfor Client within […***…] months after the forecasted month for which the purchases have been made (or for a longer period as the Parties may agree) or if the Components have expired during the period, then Depomed Client will pay to Patheon its costs therefor (including all reasonable costs incurred by Patheon for the purchase and handling of such Materialsthe Components). Patheon shall promptly notify Depomed of the identity of any Materials that have been purchased But if these Master Manufacturing Services Agreement Components are used in accordance with this Section 3.5 and that have expired Products subsequently manufactured for Client or become obsoletein third party products manufactured by Patheon, and Client will receive credit for any costs of those Components previously paid to be charged Patheon by Client or, at Client’s election, a refund in an amount equal to Depomed thereforthese costs. On a Quarterly basis, in accordance with this Section 3.5. Reimbursement of such costs by Depomed shall be due, where applicable, within [***] after its receipt of Patheon’s reconciliation Patheon will provide a report and calculation of such costs prepared in accordance with Section 5.6. Patheon shall provide pricing information sufficient to show summarizing the costs of such Materials, where reimbursement is requested Inventory held by Patheon.
Appears in 1 contract
Reliance by Patheon. 3.5.1 Depomed (a) The Client understands and acknowledges that Patheon will rely on the Maximum Firm Orders and Forecasts rolling forecasts submitted pursuant to Sections 5.1(a) and (b) in ordering Materials sufficient the Components required to meet the Purchase such Firm Orders. In addition, Depomed the Client understands that, that to ensure an orderly supply of the Materialssuch Components and/or to achieve economies of scale in costs, it may be necessary for Patheon may want to purchase the Materials such Components in sufficient volumes to meet the production requirements for Product Products during the ensuing Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission. [***] part of the Forecast forecasted periods referred to in Section 5.1(a) or to meet the production requirements of any longer period agreed to in writing by Patheon and Depomed, in writingthe Client. Accordingly, Depomed the Client authorizes Patheon to purchase Materials sufficient Components in order to satisfy the Manufacturing requirements for it to supply all Product forecasted Products for the [***] of * contemplated in the most recent Forecast given forecast provided by Depomed under the Client pursuant to Section 3.15.1(a) **** CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. or in order to satisfy the vendor’s minimum order quantity for such Components, whichever is greater, and agrees that Patheon may make such other purchases of Materials Components to meet anticipated manufacturing requirements, based on forecasts for Manufacturing requirements during such longer periods, if periods as may be agreed to in writing from time to time by the Parties. Depomed has authorized Client at the request of Patheon to order Materials for any launch quantities of Product requested by Depomedor the Client. If Materials Components ordered by Patheon pursuant to meet Depomed’s Purchase Firm Orders issued or this Section 5.2 are not included in finished Products manufactured for the Client within **** after the forecasted month in respect of which such purchases have been made (or such longer period as the parties may agree) or if such Components have expired during such period, then the Client shall pay to Patheon ****. If the parties are unable to agree on what costs incurred by Patheon are reasonable, then the parties shall resolve such issue in accordance with Section 3.4.2 or as permitted under this Section 3.5.1 are not included 12.1 Patheon shall use commercially reasonable efforts to use such Components in Product manufactured prior to their expiration dates through no fault of Patheon, then Depomed will pay to Patheon all costs incurred by Patheon for the purchase and handling of such Materialsconnection with third party clients. Patheon shall promptly notify Depomed be responsible for obtaining material safety data sheets (“MSDS”) and certificates of analysis or compliance of all Raw Materials purchased by Patheon pursuant to this Agreement. The MSDS and certificates of analysis or compliance will be used to establish conformance of the identity of Raw Materials to the Specifications and to advise Patheon as to any Materials that have been purchased in accordance with this Section 3.5 and that have expired safety or become obsolete, and any costs special handling requirements related to be charged to Depomed therefor, in accordance with this Section 3.5. Reimbursement of such costs by Depomed shall be due, where applicable, within [***] after its receipt of Patheon’s reconciliation report and calculation of such costs prepared in accordance with Section 5.6. Patheon shall provide pricing information sufficient to show the costs of such Raw Materials, where reimbursement is requested by Patheon.
Appears in 1 contract
Samples: Manufacturing Agreement (Vanda Pharmaceuticals Inc.)
Reliance by Patheon. 3.5.1 Depomed (a) Client understands and acknowledges that Patheon will rely on the Maximum Firm Orders and Forecasts rolling forecasts submitted under Sections 5.1(a) and (b) in ordering Materials sufficient the Components (other than Client-Supplied Components) required to meet the Purchase Firm Orders. In addition, Depomed Client understands that, that to ensure an orderly supply of the MaterialsComponents, Patheon may want to purchase the Materials Components in sufficient reasonable volumes to meet the production requirements for Product Products during the ensuing Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission. [***] part or all of the Forecast forecasted periods referred to in Section 5.1(a) or to meet the production requirements of any longer period agreed to in writing by Patheon and Depomed, in writingClient. Accordingly, Depomed Client authorizes Patheon to purchase Materials sufficient Components in quantities reasonably needed to satisfy the Manufacturing Services requirements for it to supply all Product forecasted Products for the first […***…] of months contemplated in the most recent Forecast forecast given by Depomed Client under Section 3.15.1(a). Patheon may make other purchases of Materials Components to meet anticipated manufacturing requirements, based on forecasts Manufacturing Services requirements for longer periods, periods if agreed to in writing by the Parties. Depomed has authorized The Client will give Patheon written authorization to order Materials Components for any launch quantities of Product requested by DepomedClient which will be considered a Firm Order when accepted by Patheon. If Materials Components ordered by Patheon to meet Depomed’s Purchase under Firm Orders issued in accordance with Section 3.4.2 or as permitted under this Section 3.5.1 5.2(a) are not included in Product finished Products manufactured prior to their expiration dates through no fault of Patheonfor Client within […***…] months after the forecasted month for which the purchases have been made (or for a longer period as the Parties may agree) or if the Components have expired during the period, then Depomed Client will pay to Patheon its costs therefor (including all reasonable costs incurred by Patheon for the purchase and handling of such Materialsthe Components). Patheon shall promptly notify Depomed of the identity of any Materials that have been purchased But if these Components are used in accordance with this Section 3.5 and that have expired Products subsequently manufactured for Client or become obsoletein third party products manufactured by Patheon, and Client will receive credit for any costs of those Components previously paid to be charged Patheon by Client or, at Client’s election, a refund in an amount equal to Depomed thereforthese costs. On a Quarterly basis, in accordance with this Section 3.5Patheon will provide a report summarizing the Inventory held by Patheon. Reimbursement of such costs by Depomed shall be due, where applicable, within [***] after its receipt of Patheon’s reconciliation report and calculation of such costs prepared in accordance with Section 5.6. Patheon shall provide pricing information sufficient to show the costs of such Materials, where reimbursement is requested by Patheon.Confidential Treatment Requested Master Manufacturing Services Agreement
Appears in 1 contract