Common use of Reliance by Patheon Clause in Contracts

Reliance by Patheon. Avanir understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted pursuant to Sections 5.1(a) and (b) in ordering the Components and Packaging Materials required to meet such Firm Orders. In addition, Avanir understands that to ensure an orderly supply of such Components and Packaging Materials, it may be desirable for Patheon to purchase such Components and Packaging Materials in sufficient volumes to meet the production requirements for Products during part or all of the forecasted periods referred to in Section 5.1(a) or to meet the production requirements of any longer period agreed to by Patheon and Avanir. Accordingly, Avanir authorizes Patheon to purchase Components and Packaging Materials in order to satisfy the production requirements for Products for the first six months contemplated in the most recent forecast provided by Avanir pursuant to Section 5.1(a) and agrees that Patheon may make such other purchases of Components and Packaging Materials to meet production requirements during such longer periods as may be agreed to in writing from time to time by Avanir at the request of Patheon or Avanir. Patheon shall manage the use of Components and Packaging Materials in accordance with cGMP “First in-first out” (FIFO) rules. If Components or Packaging Materials ordered by Patheon pursuant to Firm Orders or this Section 5.2 are not included in finished Products purchased by Avanir within six months after the forecasted month in respect of which 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 Avanir shall pay to Patheon its costs therefor (including all costs incurred by Patheon in connection with the purchase and handling of such Dated and Expired Components and Packaging Materials. Patheon shall 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 event Dated Components and Packaging Materials 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 Packaging Materials and any restocking 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, Avanir will receive credit for any costs of such Dated 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, 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 the 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)

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Reliance by Patheon. Avanir (a) Client understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted pursuant to under Sections 5.1(a) and (b) in ordering the Components and Packaging Materials (other than Client-Supplied Components) required to meet such the Firm Orders. In addition, Avanir Client understands that to ensure an orderly supply of such Components and Packaging Materialsthe Components, it Patheon may be desirable for Patheon want to purchase such the Components and Packaging Materials in sufficient reasonable volumes to meet the production requirements for Products during part or all of the 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 AvanirClient. Accordingly, Avanir Client authorizes Patheon to purchase Components and Packaging Materials in order quantities reasonably needed to satisfy the production Manufacturing Services requirements for Products for the first six […***…] months contemplated in the most recent forecast provided given by Avanir pursuant to Client under Section 5.1(a) and agrees that ). Patheon may make such other purchases of Components and Packaging Materials to meet production Manufacturing Services requirements during such for longer periods as may be if agreed to in writing from time by the Parties. The Client will give Patheon written authorization to time order Components for any launch quantities of Product requested by Avanir at the request of Patheon or Avanir. Patheon shall manage the use of Components and Packaging Materials in accordance with cGMP “First in-first out” (FIFO) rulesClient which will be considered a Firm Order when accepted by Patheon. If Components or Packaging Materials ordered by Patheon pursuant to under Firm Orders or this Section 5.2 5.2(a) are not included in finished Products purchased by Avanir manufactured for Client within six […***…] months after the forecasted month in respect of for which such the purchases have been made (or such for a longer period as the parties Parties may agree) (“Dated Components and Packaging Materials”) or if such the Components or Packaging Materials have expired during such period (“Expired Components and Packaging Materials”)the period, then Avanir shall Client will pay to Patheon its costs therefor (including all reasonable costs incurred by Patheon in connection with for the purchase and handling of such Dated and Expired the Components). But if these ***Confidential Treatment Requested Master Manufacturing Services Agreement Components and Packaging Materials. Patheon shall use commercially reasonable efforts to return Dated Components and Packaging Materials are used in Products subsequently manufactured for Client or use Dated Components and Packaging Materials for Third Party in third party products manufactured by Patheon. In the event Dated Components and Packaging Materials 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 Packaging Materials and any restocking 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, Avanir Client will receive credit for any costs of such Dated those Components and Packaging Materials previously paid to Patheon by AvanirClient or, at Client’s election, a refund in an amount equal to these costs. Avanir acknowledges and agrees that Patheon’s ability to disclose information regarding On a Component or Packaging Material may be limited by obligations of confidentiality between Patheon and its supplier(s). In such a caseQuarterly basis, Patheon shall use commercially reasonable efforts to obtain its supplier’s consent to disclose such information and Avanir agrees to will provide such supplier with reasonable assurances as may reasonably be requested a report summarizing the Inventory held by the supplier in a confidentiality agreement, or such other written document intended to protect the confidentiality of supplier’s sensitive informationPatheon.

Appears in 1 contract

Samples: Product Agreement (Acadia Pharmaceuticals Inc)

Reliance by Patheon. Avanir 3.5.1 Depomed understands and acknowledges that Patheon will rely on the Maximum Firm Orders and rolling forecasts submitted pursuant to Sections 5.1(a) and (b) Forecasts in ordering the Components and Packaging Materials required sufficient to meet such Firm the Purchase Orders. In addition, Avanir Depomed understands that that, to ensure an orderly supply of such Components and Packaging the Materials, it Patheon may be desirable for Patheon want to purchase such Components and Packaging the Materials in sufficient volumes to meet the production requirements for Products Product during part or all the ensuing Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission. [***] of the forecasted periods referred to in Section 5.1(a) Forecast or to meet the production requirements of any longer period agreed to by Patheon and AvanirDepomed, in writing. Accordingly, Avanir Depomed authorizes Patheon to purchase Components and Packaging Materials in order sufficient for it to satisfy the production requirements for Products supply all Product forecasted for the first six months contemplated in [***] of the most recent forecast provided Forecast given by Avanir pursuant to Depomed under Section 5.1(a) and agrees that 3.1. Patheon may make such other purchases of Components and Packaging Materials to meet production requirements during such anticipated manufacturing requirements, based on forecasts for longer periods as may be periods, if agreed to in writing from time by the Parties. Depomed has authorized Patheon to time order Materials for any launch quantities of Product requested by Avanir at the request of Patheon or Avanir. Patheon shall manage the use of Components and Packaging Materials in accordance with cGMP “First in-first out” (FIFO) rulesDepomed. If Components or Packaging Materials ordered by Patheon pursuant to Firm meet Depomed’s Purchase Orders issued in accordance with Section 3.4.2 or as permitted under this Section 5.2 3.5.1 are not included in finished Products purchased by Avanir within six months after the forecasted month in respect Product manufactured prior to their expiration dates through no fault of which 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”)Patheon, then Avanir shall Depomed will pay to Patheon its costs therefor (including all costs incurred by Patheon in connection with for the purchase and handling of such Dated and Expired Components and Packaging Materials. Patheon shall use commercially reasonable efforts to return Dated Components promptly notify Depomed of the identity of any Materials that have been purchased in accordance with this Section 3.5 and Packaging Materials that have expired or use Dated Components and Packaging Materials for Third Party products manufactured by Patheon. In the event Dated Components and Packaging Materials are returned to the supplier for which Patheon receives a credit or refundbecome obsolete, Avanir will receive a credit equal to the credit or refund received by Patheon from its supplier for such returned Dated Components and Packaging Materials and any restocking penalties or other charges which may applycosts to be charged to Depomed therefor, in accordance with this Section 3.5. In 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 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, Avanir will receive credit for any costs of such Dated 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 caseMaterials, 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 where reimbursement is requested by the supplier in a confidentiality agreement, or such other written document intended to protect the confidentiality of supplier’s sensitive informationPatheon.

Appears in 1 contract

Samples: Commercial Manufacturing Services Agreement (Depomed Inc)

Reliance by Patheon. Avanir (a) New River understands and acknowledges that Patheon will rely on the rolling forecasts and Firm Orders and rolling forecasts submitted pursuant to Sections 5.1(a) and (b) in ordering the Components and Packaging Materials required to meet such Firm Orders. In addition, Avanir New River understands that to ensure an orderly supply of such Components and Packaging MaterialsComponents, it may be desirable for Patheon to purchase such Components and Packaging Materials in sufficient volumes to meet the production requirements for Products during part or all of the forecasted periods referred to in Section 5.1(a) or to meet the production requirements of any longer period agreed to by Patheon and AvanirNew River. Accordingly, Avanir New River authorizes Patheon to purchase Components and Packaging Materials in order to satisfy the production requirements for Products for the first six months [***] contemplated in the most recent forecast provided by Avanir New River pursuant to Section 5.1(a) and agrees that Patheon may make such other purchases of Components and Packaging Materials to meet production requirements during such longer periods as may be agreed to in writing from time to time by Avanir New River at the request of Patheon or AvanirNew River. New River shall provide Patheon with its written authorization to order Components in respect of any launch quantities of Product requested by New River, which upon acceptance by Patheon shall manage the use of Components and Packaging Materials in accordance with cGMP “First in-first out” (FIFO) rulesconstitute a Firm Order. If Components or Packaging Materials ordered by Patheon pursuant to Firm Orders or this Section 5.2 are not included in finished Products purchased by Avanir within six months New River after the forecasted month in respect of which 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”)period, then Avanir New River shall pay to Patheon its costs therefor (including all costs incurred by Patheon in connection with the purchase and handling of such Dated and Expired Components and Packaging Materials. Patheon shall 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 Components) within reason; provided, however, that in the event Dated such Components and Packaging Materials 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 Packaging Materials and any restocking penalties or other charges which may apply. In the event Dated Components and Packaging Materials are incorporated into Products subsequently purchased by Avanir New River or into Third Party third party products manufactured by Patheon and subsequently purchased by a Third Partythird party, Avanir New River will receive credit for any costs of such Dated 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, 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 the supplier in a confidentiality agreement, or such other written document intended to protect the confidentiality of supplier’s sensitive informationNew River.

Appears in 1 contract

Samples: Manufacturing Services Agreement (New River Pharmaceuticals Inc)

Reliance by Patheon. Avanir (a) Client understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted pursuant to under Sections 5.1(a) and (b) in ordering the Components and Packaging Materials (other than Client-Supplied Components) required to meet such the Firm Orders. In addition, Avanir Client understands that to ensure an orderly supply of such Components and Packaging Materialsthe Components, it Patheon may be desirable for Patheon want to purchase such the Components and Packaging Materials in sufficient reasonable volumes to meet the production requirements for Products during part or all of the 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 AvanirClient. Accordingly, Avanir Client authorizes Patheon to purchase Components and Packaging Materials in order quantities reasonably needed to satisfy the production Manufacturing Services requirements for Products for the first six […***…] months contemplated in the most recent forecast provided given by Avanir pursuant to Client under Section 5.1(a) and agrees that ). Patheon may make such other purchases of Components and Packaging Materials to meet production Manufacturing Services requirements during such for longer periods as may be if agreed to in writing from time by the Parties. The Client will give Patheon written authorization to time order Components for any launch quantities of Product requested by Avanir at the request of Patheon or Avanir. Patheon shall manage the use of Components and Packaging Materials in accordance with cGMP “First in-first out” (FIFO) rulesClient which will be considered a Firm Order when accepted by Patheon. If Components or Packaging Materials ordered by Patheon pursuant to under Firm Orders or this Section 5.2 5.2(a) are not included in finished Products purchased by Avanir manufactured for Client within six […***…] months after the forecasted month in respect of for which such the purchases have been made (or such for a longer period as the parties Parties may agree) (“Dated Components and Packaging Materials”) or if such the Components or Packaging Materials have expired during such period (“Expired Components and Packaging Materials”)the period, then Avanir shall Client will pay to Patheon its costs therefor (including all reasonable costs incurred by Patheon in connection with for the purchase and handling of such Dated and Expired the Components). But if these Master Manufacturing Services Agreement Components and Packaging Materials. Patheon shall use commercially reasonable efforts to return Dated Components and Packaging Materials are used in Products subsequently manufactured for Client or use Dated Components and Packaging Materials for Third Party in third party products manufactured by Patheon. In the event Dated Components and Packaging Materials 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 Packaging Materials and any restocking 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, Avanir Client will receive credit for any costs of such Dated those Components and Packaging Materials previously paid to Patheon by AvanirClient or, at Client’s election, a refund in an amount equal to these costs. Avanir acknowledges and agrees that Patheon’s ability to disclose information regarding On a Component or Packaging Material may be limited by obligations of confidentiality between Patheon and its supplier(s). In such a caseQuarterly basis, Patheon shall use commercially reasonable efforts to obtain its supplier’s consent to disclose such information and Avanir agrees to will provide such supplier with reasonable assurances as may reasonably be requested a report summarizing the Inventory held by the supplier in a confidentiality agreement, or such other written document intended to protect the confidentiality of supplier’s sensitive informationPatheon.

Appears in 1 contract

Samples: Product Agreement (Acadia Pharmaceuticals Inc)

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Reliance by Patheon. Avanir (a) Client understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted pursuant to under Sections 5.1(a) and (b) in ordering the Components and Packaging Materials (other than Client-Supplied Components) required to meet such the Firm Orders. In addition, Avanir Client understands that to ensure an orderly supply of such Components and Packaging Materialsthe Components, it Patheon may be desirable for Patheon want to purchase such the Components and Packaging Materials in sufficient reasonable volumes to meet the production requirements for Products during part or all of the 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 AvanirClient. Accordingly, Avanir Client authorizes Patheon to purchase Components and Packaging Materials in order quantities reasonably needed to satisfy the production Manufacturing Services requirements for Products for the first six […***…] months contemplated in the most recent forecast provided given by Avanir pursuant to Client under Section 5.1(a) and agrees that ). Patheon may make such other purchases of Components and Packaging Materials to meet production Manufacturing Services requirements during such for longer periods as may be if agreed to in writing from time by the Parties. The Client will give Patheon written authorization to time order Components for any launch quantities of Product requested by Avanir at the request of Patheon or Avanir. Patheon shall manage the use of Components and Packaging Materials in accordance with cGMP “First in-first out” (FIFO) rulesClient which will be considered a Firm Order when accepted by Patheon. If Components or Packaging Materials ordered by Patheon pursuant to under Firm Orders or this Section 5.2 5.2(a) are not included in finished Products purchased by Avanir manufactured for Client within six […***…] months after the forecasted month in respect of for which such the purchases have been made (or such for a longer period as the parties Parties may agree) (“Dated Components and Packaging Materials”) or if such the Components or Packaging Materials have expired during such period (“Expired Components and Packaging Materials”)the period, then Avanir shall Client will pay to Patheon its costs therefor (including all reasonable costs incurred by Patheon in connection with for the purchase and handling of such Dated and Expired the Components). But if these Components and Packaging Materials. Patheon shall use commercially reasonable efforts to return Dated Components and Packaging Materials are used in Products subsequently manufactured for Client or use Dated Components and Packaging Materials for Third Party in third party products manufactured by Patheon. In the event Dated Components and Packaging Materials 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 Packaging Materials and any restocking 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, Avanir Client will receive credit for any costs of such Dated those Components and Packaging Materials previously paid to Patheon by AvanirClient or, at Client’s election, a refund in an amount equal to these costs. Avanir acknowledges and agrees that Patheon’s ability to disclose information regarding On a Component or Packaging Material may be limited by obligations of confidentiality between Patheon and its supplier(s). In such a caseQuarterly basis, Patheon shall use commercially reasonable efforts to obtain its supplier’s consent to disclose such information and Avanir agrees to will provide such supplier with reasonable assurances as may reasonably be requested a report summarizing the Inventory held by the supplier in a confidentiality agreement, or such other written document intended to protect the confidentiality of supplier’s sensitive information.Patheon. ***Confidential Treatment Requested Master Manufacturing Services Agreement

Appears in 1 contract

Samples: Product Agreement (Acadia Pharmaceuticals Inc)

Reliance by Patheon. Avanir (a) The Client understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted pursuant to Sections 5.1(a) and (b) in ordering the Components and Packaging Materials required to meet such Firm Orders. In addition, Avanir the Client understands that to ensure an orderly supply of such Components and Packaging Materialsand/or to achieve economies of scale in costs, it may be desirable necessary for Patheon to purchase such Components and Packaging Materials in sufficient volumes to meet the production requirements for Products during part or all of the 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 Avanirthe Client. Accordingly, Avanir the Client authorizes Patheon to purchase Components and Packaging Materials in order to satisfy the production Manufacturing requirements for Products for the first six months **** contemplated in the most recent forecast provided by Avanir the Client pursuant to Section 5.1(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 Components and Packaging Materials to meet production Manufacturing requirements during such longer periods as may be agreed to in writing from time to time by Avanir the Client at the request of Patheon or Avanir. Patheon shall manage the use of Components and Packaging Materials in accordance with cGMP “First in-first out” (FIFO) rulesClient. If Components or Packaging Materials ordered by Patheon pursuant to Firm Orders or this Section 5.2 are not included in finished Products purchased by Avanir manufactured for the Client within six months **** after the forecasted month in respect of which 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”)period, then Avanir the Client shall pay to Patheon its costs therefor (including all ****. If the parties are unable to agree on what costs incurred by Patheon are reasonable, then the parties shall resolve such issue in connection accordance with the purchase and handling of such Dated and Expired Components and Packaging Materials. Section 12.1 Patheon shall use commercially reasonable efforts to return Dated use such Components in connection with third party clients. Patheon shall be responsible for obtaining material safety data sheets (“MSDS”) and Packaging certificates of analysis or compliance of all Raw Materials purchased by Patheon pursuant to this Agreement. The MSDS and certificates of analysis or use Dated Components and Packaging compliance will be used to establish conformance of the Raw Materials for Third Party products manufactured by Patheon. In the event Dated Components and Packaging Materials are returned to the supplier for which Specifications and to advise Patheon receives a credit as to any safety or refund, Avanir will receive a credit equal special handling requirements related to the credit or refund received by Patheon from its supplier for such returned Dated Components and Packaging Materials and any restocking 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, Avanir will receive credit for any costs of such Dated 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, 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 the supplier in a confidentiality agreement, or such other written document intended to protect the confidentiality of supplier’s sensitive informationRaw Materials.

Appears in 1 contract

Samples: Manufacturing Agreement (Vanda Pharmaceuticals Inc.)

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