Reliance by Patheon. The Client understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted pursuant to Sections 5.2(a) and (b) in ordering the Components required to meet such Firm Orders. In addition, the Client understands that to ensure an orderly supply of such Components and to achieve economies of scale in the costs, it may be desirable for Patheon to purchase such Components in sufficient volumes to meet the production requirements for Drug Product during part or all of the forecasted periods referred to in Section 5.2(a) or to meet the production requirements of any longer period agreed to by Patheon and the Client. Accordingly, the Client authorizes Patheon to purchase Components in order to satisfy the production requirements for Drug Product for the first six months contemplated in the most recent forecast provided by the Client pursuant to Section 5.2(a), and agrees that Patheon may make such other purchases of Components to meet production requirements during such longer periods as may be agreed to in writing from time to time by the Client at the request of Patheon. If Components ordered by Patheon pursuant to Firm Orders or this Section 5.3 are not included in finished Drug Product purchased by 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), the Client shall pay to Patheon its costs therefor (including all costs incurred by Patheon in connection with the purchase and handling of such Components) and, in the event such Components are incorporated into Drug Product subsequently purchased by the Client or into third party products manufactured by Patheon and subsequently purchased by a third party, the Client will receive credit for any costs of such Components previously paid to Patheon by the Client.
Appears in 5 contracts
Samples: Manufacturing Services Agreement, Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.)
Reliance by Patheon. The (a) Client understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted pursuant to under Sections 5.2(a) 5.1(a), and (b) in ordering the Components (other than Client- Supplied Components) required to meet such the Firm Orders. In , in addition, the Client understands that to ensure an orderly supply of such Components and to achieve economies of scale in the costsComponents, it Patheon may be desirable for Patheon want to purchase such the Components in sufficient volumes to meet the production requirements for Drug Product Products during part or all of the forecasted periods referred to in Section 5.2(a5.1(a) or to meet the production requirements of any longer period agreed to by Patheon and the Client. Accordingly, the Client authorizes Patheon to purchase Components in order to satisfy the production Manufacturing Services requirements for Drug Product Products for the first six months contemplated set forth in the most recent forecast provided given by the Client pursuant to under Section 5.2(a5.1(a), and agrees that . Patheon may make such other purchases of Components to meet production Manufacturing Services requirements during such for longer periods as may be if agreed to in writing from time to time by the parties. The Client at will give Patheon written authorization to order Components for any launch quantities of Product requested by Client which will be considered a Firm Order when accepted by Patheon.
(b) Client will reimburse Patheon for the request cost of Patheon. If Components ordered by Patheon pursuant to under Firm Orders or this under Section 5.3 5.2(a) that are not included in finished Drug Product purchased by the Products 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 may agree) or if the Components have expired or are rendered obsolete due to changes in artwork or applicable regulations during the period (collectively, “Obsolete Stock”), . This reimbursement will include Patheon’s cost to purchase (plus a [***] handling fee) and destroy the Client shall pay to Patheon its costs therefor (including all costs incurred by Patheon in connection with the purchase and handling of such Components) and, in the event such Obsolete Stock. If any non-expired Components are incorporated into Drug Product used in Products subsequently purchased by the manufactured for Client or into in third party products manufactured by Patheon and subsequently purchased by a third partyPatheon, the Client will receive credit for any costs of such those Components previously paid to Patheon by Client.
(c) If Client fails to take possession or arrange for the destruction of non-expired Components within 12 months of purchase or, in the case of the delivery of conforming finished Product not accepted by Client within one month of manufacture, Client will pay Patheon [***] per pallet, per month thereafter for storing the Components or finished Product. Storage fees for Components or Product which contain controlled substances or require refrigeration will be charged at [***] per pallet per month. Storage fees are subject to a one pallet minimum charge per month. Patheon may ship finished Product held by it longer* than one month to the Client at Client’s expense on 14 days written notice to the Client.
Appears in 3 contracts
Samples: Master Manufacturing Services Agreement (Osmotica Pharmaceuticals PLC), Master Manufacturing Services Agreement (Osmotica Pharmaceuticals LTD), Master Manufacturing Services Agreement (Osmotica Pharmaceuticals LTD)
Reliance by Patheon. The (a) Client understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted pursuant to under Sections 5.2(a5.1(a) and (b) in ordering the Components (other than Client-Supplied Components) required to meet such the Firm Orders. In addition, the Client understands that to ensure an orderly supply of such Components and to achieve economies of scale in the costsComponents, it Patheon may be desirable for Patheon want to purchase such the Components in sufficient reasonable volumes to meet the production requirements for Drug Product Products during part or all of the forecasted periods referred to in Section 5.2(a5.1(a) or to meet the production requirements of any longer period agreed to in writing by Patheon and the Client. Accordingly, the Client authorizes Patheon to purchase Components in order quantities reasonably needed to satisfy the production Manufacturing Services requirements for Drug Product Products for the first six […***…] months contemplated in the most recent forecast provided given by the Client pursuant to under Section 5.2(a5.1(a), and agrees that . Patheon may make such other purchases of Components to meet production Manufacturing Services requirements during such for longer periods as may be if agreed to in writing from time to time by the Parties. The Client at the request will give Patheon written authorization to order Components for any launch quantities of Product requested by Client which will be considered a Firm Order when accepted by Patheon. If Components ordered by Patheon pursuant to under Firm Orders or this Section 5.3 5.2(a) are not included in finished Drug Product purchased by the Products 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)) or if the Components have expired during the period, the then Client shall will pay to Patheon its costs therefor (including all reasonable costs incurred by Patheon in connection with for the purchase and handling of such the Components) and, in the event such ). But if these Components are incorporated into Drug Product used in Products subsequently purchased by the manufactured for Client or into in third party products manufactured by Patheon and subsequently purchased by a third partyPatheon, the Client will receive credit for any costs of such those Components previously paid to Patheon by Client or, 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.
(b) If Client fails to take possession or arrange for the destruction of Components purchased by Patheon in accordance with Section 5.2(a) within 12 months of purchase or, in the case of finished Product that is not the subject of a Deficiency Notice, within three months of manufacture, Client will pay Patheon $100.00 per pallet, per month thereafter for storing the Components or finished Product. Storage fees for Components or Product which contain controlled substances or require refrigeration will be charged at $200.00 per pallet per month. Storage fees are subject to a one pallet minimum charge per month. Patheon may ship finished Product that is not the subject of a Deficiency Notice held by it longer than three months to the Client at Client’s expense on 14 days’ prior written notice to the Client in accordance with the Specifications.
Appears in 3 contracts
Samples: Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc), Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc), Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc)
Reliance by Patheon. The Client understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted pursuant to Sections 5.2(a5.1(a) and (b) in ordering the Components required to meet such Firm Orders. In addition, the Client understands that to ensure an orderly supply of such Components and to achieve economies of scale in the costsComponents, it may be desirable for Patheon to purchase such Components in sufficient volumes to meet the production requirements for Drug Product during part or all [ * ] of the forecasted periods referred to in Section 5.2(a5.1(a) or to meet the production requirements of any longer period agreed in writing to by Patheon and the [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Client. Accordingly, the Client authorizes Patheon to purchase Components in order to satisfy the production requirements for Drug Product for the first six months [ * ] contemplated in the most recent forecast provided by the Client pursuant to Section 5.2(a), 5.1(a) and agrees that Patheon may make such other purchases of Components to meet production requirements during such longer periods as may be agreed to in writing from time to time by the Client at the request of PatheonPatheon or the Client. If Components ordered by Patheon pursuant to Firm Orders or under this Section 5.3 5.2 are not included in finished Drug Product purchased by the Client within six months [ * ] after the forecasted month date of the Firm Order 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, the Client shall pay to Patheon its costs therefor (including all costs incurred by Patheon in connection with the purchase and handling of such Components) andthen [ * ]; provided, however, that in the event such Components are incorporated into Drug Product subsequently purchased by the Client or into third party products manufactured by Patheon and subsequently purchased by a third party, the Client will receive credit for any costs [ * ] of such Components previously paid [ * ]. Patheon shall provide Client, initially upon execution of this Agreement and thereafter on an annual basis, with a listing of all Components which Patheon anticipates purchasing pursuant to the terms of this Agreement in the form set out in Schedule J (the "Components Purchasing Summary"). Patheon will advise the Client in writing which Components have a limited shelf-life and which are subject to minimum order quantities specified by the Clientsupplier. [ * ] for the [ * ] Components [ * ] purchased by Patheon in accordance with the terms of this Agreement but not used to perform the Manufacturing Services prior to the expiry of the Component’s shelf life, so long as such Components have expiration dating of at least [ * ] from the date of purchase by Patheon. If Patheon is able to use such Components in activities other than the Manufacturing Services, Patheon will [ * ] the Client any [ * ] for such Components.
Appears in 3 contracts
Samples: Manufacturing Services and Supply Agreement, Manufacturing Services and Supply Agreement (Jazz Pharmaceuticals Inc), Manufacturing Services and Supply Agreement (Jazz Pharmaceuticals Inc)
Reliance by Patheon. The Client understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted pursuant to Sections 5.2(aSection 5.1(a) and (b) in ordering the Components required to meet such Firm Orders. In addition, the Client understands that to ensure an orderly supply of such Components and and/or to achieve economies of scale in the costs, it may be desirable for Patheon to purchase such Components in sufficient volumes to meet the production requirements for Drug Product Products during part or all of the first [**] of the forecasted periods referred to in Section 5.2(a5.1(a) or to meet the production requirements of any longer period agreed to by Patheon and the Client. Accordingly, the Client authorizes Patheon to purchase Components in order to satisfy the production requirements for Drug Product Products for the first six months [**] contemplated in the most recent forecast provided by the Client pursuant to Section 5.2(a5.1(a), and agrees that Patheon may make such other purchases of Components to meet production requirements during such longer periods as may be agreed to in writing from time to time by the Client at the request of PatheonPatheon or the Client. Any requests made by Client for product launch quantities of Product not contemplated in forecasts or Firm Orders shall only be accepted by Patheon if made in writing by the Client for the purposes of ordering Components and thereafter shall be treated as a Firm Order. If Components ordered by Patheon pursuant to Firm Orders or this Section 5.3 5.2 are not included in finished Drug Product Products purchased by 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)) or if such Components have expired during such period, then the Client shall pay to Patheon its costs therefor (including all costs incurred by Patheon in connection with the purchase and plus an additional [**]% handling of such Components) andfee); provided, however, that in the event such unexpired Components are incorporated into Drug Product Products subsequently purchased by the Client or into third party products manufactured by Patheon and subsequently purchased by a third party, the Client will receive credit for any costs of such Components previously paid to Patheon by the Client.
Appears in 2 contracts
Samples: Manufacturing Services Agreement (Critical Therapeutics Inc), Manufacturing Services Agreement (Critical Therapeutics Inc)
Reliance by Patheon. The (a) Client understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted pursuant to under Sections 5.2(a) 5.1(a), (b), and (bc) in ordering the Components required to meet such the Firm Orders. In additionAccordingly, the Client understands that to ensure an orderly supply of such Components and to achieve economies of scale in the costs, it may be desirable for Patheon to purchase such Components in sufficient volumes to meet the production requirements for Drug Product during part or all commencing upon Patheon’s receipt of the forecasted periods referred Commercial Supply Notice from Client pursuant to in Section 5.2(a) or to meet the production requirements of any longer period agreed to by Patheon and the Client. Accordingly5.1(b), the Client authorizes Patheon to purchase Components in order to satisfy the production Manufacturing Services requirements for Drug Product Products for the first six months [***] contemplated in the most recent forecast provided given by the Client pursuant to under Section 5.2(a5.1(a), and agrees that . Patheon may make such other purchases of Components to meet production Manufacturing Services requirements during such for longer periods as may be if agreed to in writing from time to time by the parties. The Client at the request will give Patheon written authorization to order Components for any launch quantities of Product requested by Client which will be considered a Firm Order when accepted by Patheon. If Components ordered by Patheon pursuant to under Firm Orders or this Section 5.3 5.2 are not included in finished Drug Product purchased by the Products 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 may agree)) or if the Components have expired during the period, the then Client shall will pay to Patheon its costs therefor (including all costs incurred by Patheon in connection with the purchase and handling of such Components) and, in the event such [***]. But if these Components are incorporated into Drug Product used in Products subsequently purchased by the manufactured for Client or into in third party products manufactured by Patheon and subsequently purchased by a third partyPatheon, the Client will receive credit for any costs of such those Components previously paid to Patheon by Client.
(b) If Client fails to take possession or arrange for the destruction of Components within 12 months of purchase or, in the case of finished Product, within three months of manufacture, [***]. Patheon may ship finished Product held by it longer than three months to the Client at Client’s expense on 14 days written notice to the Client.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Acura Pharmaceuticals, Inc)
Reliance by Patheon. The Client understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted pursuant to Sections 5.2(a) and (bSection 5.1(b) in ordering the Components required to meet such Firm Orders. In addition, the Client understands that to ensure an orderly supply of such Components and to achieve economies of scale in the costs, it may be desirable for Patheon to purchase such Components in sufficient volumes to meet the production requirements for Drug Product Products during part or all of the forecasted periods referred to in Section 5.2(a5.1(a) or to meet the production requirements of any longer period agreed to by Patheon and the Client. Accordingly, the Client authorizes Patheon to purchase Components in order to satisfy the production requirements for Drug Product Products for the first six [ ** ] months contemplated in the most recent forecast provided by the Client pursuant to Section 5.2(a5.1(a), and agrees that Patheon may make such other purchases of Components to meet production requirements during such longer periods as may be agreed to in writing from time to time by the Client at the request of Patheon. If Components ordered by Patheon pursuant to Firm Orders or this Section 5.3 5.2 are not included in the finished Drug Product Products purchased by 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), the Client shall pay to Patheon its the cost that portion of the Components not included in the finished Product plus the costs therefor (including of all costs expenses incurred by Patheon in connection with for the purchase and handling destruction of such Components) unused Components and, in the event such Components are incorporated into Drug the Product subsequently purchased by the Client or into third party products manufactured by Patheon and subsequently purchased by a third partyClient, the Client will receive credit for any costs of such Components previously paid to Patheon by the Client.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Axcan Intermediate Holdings Inc.)
Reliance by Patheon. The (a) Client understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts 100% binding portion of the Forecasts submitted pursuant to under Sections 5.2(a) and 5.1 (b), 5.1(c), and 5.1(d) in ordering the Components (other than Client-Supplied Components) required to meet such the Firm Orders. In addition, the Client understands that to ensure an orderly supply of such Components and to achieve economies of scale in the costsComponents, it Patheon may be desirable for Patheon want to purchase such the Components in sufficient volumes to meet the production requirements for Drug Product Products during part or all of the forecasted periods referred to in Section 5.2(a5.1(a) or to meet the production requirements of any longer period agreed to by Patheon and the Client. Accordingly, the Client authorizes Patheon to purchase Components in order (other than Client Supplied Components) to satisfy the production Manufacturing Services requirements for Drug Product Products for the first six months contemplated in the most recent forecast provided 100% binding portion of any Forecast given by the Client pursuant to Section 5.2(aunder Sections 5.1(b), and agrees that 5.1(c) or 5.1(d) to the extent such purchase is reasonable in light of Patheon’s existing inventory of such Components. Patheon may make such other purchases of Components (other than Client Supplied Components) to meet production Manufacturing Services requirements during such for longer periods as may be if agreed to in writing from time to time by the parties. The Client at the request will give Patheon written authorization to order Components for any launch quantities of Product requested by Client which will be considered a Firm Order when accepted by Patheon. If .
(b) Client will [**], provided that Patheon has placed open purchase orders for such Components ordered by Patheon pursuant to Firm Orders or this Section 5.3 are that may not included in finished Drug Product purchased by 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), the Client shall pay to Patheon its costs therefor (including all costs incurred by Patheon in connection with the purchase be cancelled and handling of such Components) and, in the event such Components are incorporated into Drug Product subsequently purchased by the Client or into third party not used in products manufactured by Patheon for itself or any third party (collectively, “Obsolete Stock”). [**]
(c) If Client fails to take possession or arrange for the destruction of finished Product in the case of the delivery of conforming finished Product not accepted by Client within one month of manufacture and subsequently purchased by a third partyrelease, the Client will receive credit for any costs of such Components previously paid to pay Patheon by the Client[**].
Appears in 1 contract
Samples: Manufacturing Services Agreement (Synageva Biopharma Corp)
Reliance by Patheon. The Client understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted pursuant to Sections 5.2(aSection 5.1(a) and (b) in ordering the Components required to meet such Firm Orders. In addition, the Client understands that to ensure an orderly supply of such Components and and/or to achieve economies of scale in the costs, it may be desirable for Patheon to purchase such Components in sufficient volumes to meet the production requirements for Drug Product Products during part or all of the first [**] of the forecasted periods referred to in Section 5.2(a5.1(a) or to meet the production requirements of any longer period agreed to by Patheon and the Client. Accordingly, the Client authorizes Patheon to purchase Components in order to satisfy the production requirements for Drug Product Products for the first six months [**] contemplated in the most recent forecast provided by the Client pursuant to Section 5.2(a5.1(a), and agrees that Patheon may make such other purchases of Components to meet production requirements during such longer periods as may be agreed to in writing from time to time by the Client at the request of PatheonPatheon or the Client. Any requests made by Client for product launch quantities of Product not contemplated in forecasts or Firm Orders shall only be accepted by Patheon if made in writing by the Client for the purposes of ordering Components and thereafter shall be treated as a Firm Order. If Components ordered by Patheon pursuant to Firm Orders or this Section 5.3 5.2 are not included in finished Drug Product Products purchased by 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)) or if such Components have expired during such period, then the Client shall pay to Patheon its costs therefor (including all costs incurred by Patheon in connection with the purchase and plus an additional [**]% handling of such Components) andfee); provided, however, that in the event such unexpired Components are incorporated into Drug Product Products -13- <PAGE> subsequently purchased by the Client or into third party products manufactured by Patheon and subsequently purchased by a third party, the Client will receive credit for any costs of such Components previously paid to Patheon by the Client.. -14- <PAGE> 5.3
Appears in 1 contract
Samples: Manufacturing Services Agreement
Reliance by Patheon. The Client understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted pursuant to Sections 5.2(a5.1(a) and (b) in ordering the Components required to meet such Firm Orders. In addition, the Client understands that to ensure an orderly supply of such Components and and/or to achieve economies of scale in the costs, it may be desirable necessary for Patheon to purchase such Components in sufficient volumes to meet the production requirements for Drug Product Products during part or all of the forecasted periods referred to in Section 5.2(a5.1(a) or to meet the production requirements of any longer period agreed to in writing by Patheon and the Client. Accordingly, the Client authorizes Patheon to purchase Components in order to satisfy the production Manufacturing requirements for Drug Product Products for the first six months **** contemplated in the most recent forecast provided by the Client pursuant to Section 5.2(a), 5.1(a) and agrees that Patheon may make such other purchases of Components to meet production Manufacturing requirements during such longer periods as may be agreed to in writing from time to time by the Client at the request of PatheonPatheon or the Client. If Components of the Product unique to the Client (e.g., packaging labels), ordered by Patheon pursuant to Firm Orders or this Section 5.3 5.2 are not included in finished Drug Product purchased by Products 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)) or if such unique Components have expired during such period, then the Client shall pay to Patheon its costs therefor ****. Patheon shall be responsible for obtaining material safety data sheets (including “MSDS”) of all costs incurred Components purchased by Patheon in connection with pursuant to this Agreement. The MSDS will be used to establish conformance of the purchase Components to the Specifications and to advise Patheon as to any safety or special handling of such requirements related to the Components) and, in the event such Components are incorporated into Drug Product subsequently purchased by the Client or into third party products manufactured by Patheon and subsequently purchased by a third party, the Client will receive credit for any costs of such Components previously paid to Patheon by the Client.
Appears in 1 contract
Samples: Manufacturing Agreement (Vanda Pharmaceuticals Inc.)
Reliance by Patheon. The Client MDCO understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted pursuant to Sections 5.2(a5.1(a) and (b) in ordering the Components required to meet such Firm Orders. In addition, the Client MDCO understands that to ensure an orderly supply of such Components and to achieve economies of scale in the costsComponents, it may be desirable for Patheon to purchase such Components in sufficient volumes to meet the production requirements for Drug Product Products during part or all of the forecasted periods referred to in Section 5.2(a5.1(a) or to meet the production requirements of any longer period agreed to by Patheon and the ClientMDCO. Accordingly, the Client MDCO authorizes Patheon to purchase Components in order to satisfy the production Manufacturing Services requirements for Drug Product Products for the first six (6) months contemplated in the most recent forecast provided by the Client MDCO pursuant to Section 5.2(a), 5.1(a) and agrees that Patheon may make such other purchases of Components to meet production Manufacturing Services requirements during such longer periods as may be agreed to in writing from time to time by the Client MDCO at the request of PatheonPatheon or MDCO. If Components ordered by Patheon pursuant to Firm Orders or this Section 5.3 5.2 are not included in finished Drug Product purchased by the Client Products manufactured for MDCO within six twelve (12) months after the forecasted month in respect of which such purchases have been made (or such longer period as the parties Parties may agree)) or if such Components have expired during such period, the Client then MDCO shall pay to Patheon its costs therefor therefore (including all costs incurred by Patheon in connection with the purchase and handling of such Components) and); provided, however, that in the event such Components are incorporated into Drug Product Products subsequently purchased by the Client manufactured for MDCO or into third party products manufactured by Patheon and subsequently purchased by for a third party, the Client MDCO will receive credit for any costs of such Components previously paid to Patheon by the ClientMDCO.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Medicines Co /De)