Common use of Manufacturing Services Clause in Contracts

Manufacturing Services. Patheon will perform the Manufacturing Services and supply to Client Product intended for marketing and sale in the Territory for the fees specified in Schedules B and C. The parties acknowledge that they intend to negotiate an amendment to this Agreement to add ARX-01 in Finished Product Packaging as a Product. If the parties enter into this amendment, Client will still have the right to purchase Product in Bulk Tablet Packaging from Patheon and have a third party package the Product into Finished Product Packaging for distribution or sale outside of the Territory. Schedule B sets forth a list of cost items that are included in the Price for Product; all cost items required for the manufacture of Product that are not included in this list are excluded from the Price and are subject to reasonable additional fees to be paid by the Client. All Manufacturing Services will be performed by Patheon at the Manufacturing Site. Patheon may change the Manufacturing Site for the Product only with the prior written consent of Client, this consent not to be unreasonably withheld. During the period commencing on the Effective Date up through the Initial Term, Patheon will supply 100% of the Client’s requirements for Product offered for sale by Client in the Territory so long as Patheon is in material compliance with its obligations to Client under this Agreement. But if (a) Patheon fails to meet its supply obligations to Client for three consecutive Firm Orders, (b) in any consecutive six month period, 30% or more of the aggregate quantities of Product to be delivered by Patheon pursuant to Firm Orders during such six month period are not delivered by the due dates specified in the applicable Firm Orders, or (c) Patheon does not fulfill a Firm Order within 90 days after the Delivery Date specified therein then, in each case, Client may obtain up to 20% of its requirements for Product offered for sale in the Territory from an alternate supplier, regardless of whether any such occurrence is attributable to a Force Majeure Event. After the Initial Term, Client will only be required to obtain 80% of its requirements for Product offered for sale in the Territory from Patheon. In performing the Manufacturing Services, Patheon and Client agree that:

Appears in 2 contracts

Samples: Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc), Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc)

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Manufacturing Services. Patheon will perform the Manufacturing Services for Products to be distributed and supply to sold by Client Product intended for marketing and sale in the Territory for the fees specified in Schedules B and C. The parties acknowledge that they intend C to negotiate an amendment to this Agreement to add ARX-01 in Finished the relevant Product Packaging as a Product. If the parties enter into this amendment, Client will still have the right to purchase Product in Bulk Tablet Packaging from Patheon and have a third party package the Product into Finished Product Packaging for distribution or sale outside of the TerritoryAgreement. Schedule B to each Product Agreement sets forth a list of cost items that are included in the Price for ProductProducts; all cost items required for the manufacture of Product that are not included in this list are excluded from the Price and are subject to reasonable additional fees to be paid by the Client. All Patheon may amend the fees set out in Schedules B and C to a Product Agreement as set forth in Article 4. Patheon will perform the Manufacturing Services will be performed by Patheon solely at the Manufacturing Site, unless otherwise agreed in writing by Client. Patheon may change If the Manufacturing Site for the Product only with the prior written consent of Client, this consent not to be unreasonably withheld. During the period commencing on the Effective Date up through the Initial Term, parties agree that Patheon will supply 100% supply, and Client will purchase, at least a specified minimum percentage of the Client’s requirements for a Product offered for sale by under a Product Agreement (the “Required Percentage”), then the applicable Product Agreement will set forth the Required Percentage and the time period during which the obligation will apply (the “Required Period”). But this obligation (if any) will cease to apply to Client in with respect to the Territory so long as Product if Patheon is fails to remain in material compliance with its obligations to Client under this Agreement. But if (a) Patheon fails to meet its supply obligations to Client for three consecutive Firm Orders, (b) in any consecutive six month period, 30% Agreement or more of the aggregate quantities of Product to be delivered by Patheon pursuant to Firm Orders during such six month period are not delivered by the due dates specified in the applicable Firm OrdersProduct Agreement, or (c) Patheon does not fulfill a Firm Order within 90 days after suspends performance under this Agreement or the Delivery Date specified therein then, applicable Product Agreement in each case, Client may obtain up to 20% of its requirements for Product offered for sale in the Territory from an alternate supplier, regardless of whether any such occurrence is attributable to connection with a Force Majeure EventEvent or where Patheon is or will be prevented from supplying the Product as a result of the action of a Regulatory Authority. After Subject to its obligation (if any) to purchase the Initial TermRequired Percentage of a Product during the Required Period, Client will only be required may, at any time, obtain Product from a third party or may, at any time, qualify a third party to obtain 80% of its requirements perform Manufacturing Services for Product offered for sale in the Territory from PatheonProduct. In performing the Manufacturing Services, Patheon and Client agree that:

Appears in 2 contracts

Samples: Product Agreement (Jaguar Animal Health, Inc.), Master Manufacturing Services Agreement (Jaguar Animal Health, Inc.)

Manufacturing Services. Patheon will perform the Manufacturing Services and supply to Client Product intended for marketing and sale as set out in the Territory relevant Product Agreement for the fees specified in Schedules B and C. The parties acknowledge that they intend to negotiate an amendment to this Agreement to add ARX-01 in Finished Product Packaging as a Product. If the parties enter into this amendment, Client will still have the right to purchase Product in Bulk Tablet Packaging from Patheon and have a third party package the Product into Finished Product Packaging for distribution or sale outside of the Territory. Schedule B sets forth a list of cost items that are included in the Price for Product; all cost items required for the manufacture of Product that are not included in this list are excluded from the Price and are subject to reasonable additional fees to be paid by the Client. All Manufacturing Services will be performed by Patheon at the Manufacturing Site. Patheon may change the Manufacturing Site for the Product only in accordance with the prior written consent terms and conditions of Clientthis Agreement, this consent not such Product Agreement and the Quality Agreement. Subject to be unreasonably withheld. During the period commencing on the Effective Date up through the Initial Termpreceding sentence, Patheon will supply 100% convert API and Components into Product, and provide supportive Manufacturing Services such as quality assurance (for example quality controls, analytical testing, and stability programs), primary and secondary packaging, and any other related Manufacturing Services as agreed between the parties under the relevant Product Agreement. Patheon (and its applicable Affiliates) will perform all Manufacturing Services in accordance with all Applicable Laws. For each Product for which the Parties (or their respective Affiliates) have entered into a Product Agreement, and unless otherwise expressly agreed in a Product Agreement, and except as otherwise provided in this Agreement, Patheon will be a non-exclusive manufacturer during the term of the Client’s requirements for applicable Product Agreement of the Products offered for sale by Client or its Affiliates, provided that, Client agrees to order and purchase from Patheon, and Patheon agrees to manufacture and supply hereunder, [***] of Client’s requirements for Products for commercial sale in the United States (as provided in Client’s rolling forecasts); provided further that, for clarity, the foregoing does not apply to manufacture of any API or Components. Except as otherwise provided in the Product Agreement covering manufacture of particular Product for Client, for each Product that is covered by a Product Agreement during the term of this Agreement, Patheon shall maintain, commencing on the date that is twelve months after the launch of commercial sales of such Product in the Territory so long for such Product (or at such later date as Patheon is agreed in material compliance with its obligations writing, as to Client under this Agreementa particular Product), at least two separate and distinct manufacturing sites that are fully qualified and able to perform the Manufacturing Services set forth herein (“Manufacturing Redundancy”). But if (a) The details of the allocation of the manufacturing services between such sites, for a Product, shall be as agreed reasonably by the Parties at the time of qualification. In the event Patheon fails to meet its supply obligations to Client maintain, for three a consecutive Firm Orders, (b) period of [***] in any consecutive six twelve month period, 30% or more the required Manufacturing Redundancy for a June 27, 2019 Master Manufacturing Services Agreement between Patheon and Cara Therapeutics Inc. Confidential Page 10 of the aggregate quantities of 47 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED. particular Product to be delivered covered by Patheon pursuant to Firm Orders during such six month period are not delivered by the due dates specified in the applicable Firm Ordersa Product Agreement, or (c) Patheon does not fulfill a Firm Order within 90 days after the Delivery Date specified therein then, in each case, then Client may obtain up to 20% of its requirements for Product offered for sale in the Territory from an alternate supplier, regardless of whether any such occurrence is attributable to a Force Majeure Event. After the Initial Term, Client will only shall no longer be required to obtain 80% use Patheon as the manufacturer of its at least [***] of Client’s requirements for such Product offered for sale in under the Territory from Patheon. In performing the Manufacturing Services, Patheon and Client agree that:relevant Product Agreement.

Appears in 1 contract

Samples: Product Agreement (Cara Therapeutics, Inc.)

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Manufacturing Services. Patheon will perform the Manufacturing Services and supply to Client Product intended for marketing and sale in the Territory for the fees specified in Schedules B and C. The parties acknowledge that they intend C to negotiate an amendment manufacture Products for Client and supply the Products to this Agreement to add ARX-01 Client, in Finished Product Packaging as a Product. If accordance with the parties enter into this amendmentSpecifications, Client will still have the right to purchase Product in Bulk Tablet Packaging from Patheon cGMPs, and have a third party package the Product into Finished Product Packaging for distribution or sale outside of the Territoryall Applicable Laws. Schedule B sets forth a list of cost items that are included in the Price for ProductProducts; all cost items required for the manufacture of Product that are not included in this list are excluded from the Price and are subject to reasonable additional fees to be paid by the Client. All Manufacturing Services will be performed by Patheon at the Manufacturing Site. Patheon may change the Manufacturing Site for the Product Products only with the prior written consent of Client, this consent not to be unreasonably withheld. During If Manufacturing Services have not started on or before [*], (i) Patheon shall have the period commencing on right to request an amendment to the Effective Date up through fees set out in Schedules B and C and no such amendment shall be binding unless approved in writing by Client and (ii) Client shall have the Initial Termright to terminate this Agreement, effective upon written notice to Patheon. Patheon will supply 100% be the sole manufacturer of the Client’s requirements for Product Products offered for sale by Client in the Territory so long as Patheon is in material compliance with its obligations to Client under for the Initial Term of this Agreement. But if Notwithstanding the foregoing, Client shall be entitled, at its sole cost and expense, to qualify a single alternative manufacturer (a“Backup Manufacturer”) Patheon fails to meet its supply obligations manufacture Products, and may take all actions reasonably necessary in connection with the same, including without limitation purchasing small quantities or Products necessary to qualify such Backup Manufacturer. Client shall be permitted to sell any Product that results from the required qualification, validation and maintenance production runs from the Backup Manufacturer(s), provided that the batch sizes of such qualification, validation or maintenance runs do not exceed the maximum batch size validated for three consecutive Firm Orders, (b) the Product by Patheon. Any units from an increase in any consecutive six month period, 30% or more of the aggregate quantities of Product to be delivered by Patheon pursuant to Firm Orders during such six month period are not delivered batch size by the due dates specified in the applicable Firm OrdersBackup Manufacturer may be used for non-commercial activities. Patheon agrees to cooperate with Client and provide all assistance, or (c) at Client’s expense, as may reasonably be requested by Client to qualify a Backup manufacturer, provided that Patheon does not fulfill a Firm Order within 90 days after the Delivery Date specified therein thenmay, in each caseits sole discretion, Client may obtain up refuse to 20% permit access to the Manufacturing Site by any direct competitor of its requirements for Product offered for sale in the Territory from an alternate supplier, regardless of whether any such occurrence is attributable to a Force Majeure Event. After the Initial Term, Client will only be required to obtain 80% of its requirements for Product offered for sale in the Territory from Patheon. In performing the Manufacturing Services, Patheon and Client agree that:

Appears in 1 contract

Samples: Manufacturing Services Agreement (Chelsea Therapeutics International, Ltd.)

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