Manufacturing and Supply of Therapies Sample Clauses

Manufacturing and Supply of Therapies. 4.1 GENERAL UNDERSTANDING. (a) EXISTING SUPPLY AGREEMENTS. Pursuant to the BI Pharma Agreements, McKesson Agreement, and Nordion Agreements (the "Existing Supply Agreements"), Corixa has the ability to have Tositumomab and Iodine I 131 Tositumomab manufactured, stored and supplied to it and its licensees. Under this Agreement, Corixa will provide Therapies to GSK Canada for GSK Canada's use in the Territory in accordance with the terms of this Agreement. GSK Canada acknowledges and understands that Corixa's ability to supply Therapies to GSK Canada under this Agreement is limited by the BI Pharma Agreements, the McKesson Agreement, and the Nordion Agreements and Corixa's agreements with other suppliers and other licensees, including SB and Amersham PLC. Except to the extent that Section 4.3, 4.5 or 4.7 specifically requires GSK Canada to deal directly with Corixa rather than BI Pharma, Nordion or McKesson, GSK Canada hereby agrees to comply with all provisions of the Existing Supply Agreements (including any amendments thereof entered into in accordance with Section 4.1(b)) and all other agreements with Corixa suppliers as may exist in the future (and are entered into in accordance with Section 4.1(b)), to the extent that such provisions are applicable to Products intended for use in the Territory. The Parties agree that the foregoing does not require GSK Canada to fulfill obligations arising under such agreements as a result of the manufacture, storage or distribution of Products intended for use in the Corixa Territory. (b) NEW SUPPLY AGREEMENTS. Corixa shall notify GSK Canada in writing prior to entering, during the term of this Agreement, into any new supply agreement(s) relevant to the manufacture, storage or distribution of Products intended for use in the Territory or amending any Existing Supply Agreement in a manner that alters the manufacture, storage or distribution of Products intended for use in the Territory. Corixa shall provide GSK Canada with a reasonable time, after such notification, to review and comment upon any such supply agreement(s) or amendment(s), and Corixa shall make reasonable efforts to implement all reasonable GSK Canada comments, provided that such comments do not benefit GSK Canada at the expense of Corixa or any of Corixa's licensees or corporate partners in the Corixa Territory. Following the execution of any such new supply agreement(s) or amendment(s) of any Existing Supply Agreement, the Parties shall amend this Agree...
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Manufacturing and Supply of Therapies 
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Related to Manufacturing and Supply of Therapies

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time.

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Manufacturing Rights Manufacturing Rights will be governed by Attachment 6.

  • Supply Agreement The Supply Agreement shall have been executed on behalf of the Seller and delivered to the Purchaser.

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