Backup Manufacturing Rights Sample Clauses

Backup Manufacturing Rights. Notwithstanding any of the foregoing in this Article VI, upon request by the purchasing Party at any time following the selection of a development candidate pursuant to Section 4.4 hereof, and at such purchasing Party’s cost, the supplying Party shall enable the purchasing Party to purchase API Bulk Drug Substance, Delivery Compound, Formulated Bulk and Finished Product (as applicable) directly from the supplying Party’s existing Third Party suppliers in such a manner that such purchasing Party shall be assured of a secondary source of API Bulk Drug Substance, Delivery Compound, Formulated Bulk and Finished Product (as applicable) unless and until Manufacturing responsibility is transitioned to one Party under Section 6.3 or the supplying Party is relieved of its Manufacturing obligations pursuant to Section 6.3(e). If a Third Party supplier for the API Bulk Drug Substance, Delivery Compound, Formulated Bulk and Finished Product (as applicable) does not exist or has not yet been established at the time of such request, or the purchasing Party reasonably determines that the supplying Party is otherwise unable to procure direct supply from such secondary source (e.g., due to the Third Party supplier’s refusal to enter into a direct supply arrangement with the purchasing Party or due to the supplying Party’s failure to promptly undertake necessary action), the supplying Party shall, upon the purchasing Party’s request and at the supplying Party’s cost, transfer all relevant Manufacturing Technology Controlled by such supplying Party and used in the Manufacture of API Bulk Drug Substance, Delivery Compound, Formulated Bulk and Finished Product (as applicable) as of the date of such request by the purchasing Party to a Third Party designated by the purchasing Party and reasonably acceptable to the supplying Party (such acceptance not to be unreasonably withheld, conditioned or delayed) to enable such Third Party designated manufacturer to supply to such purchasing Party the API Bulk Drug Substance, Delivery Compound, Formulated Bulk and Finished Product (as applicable) as a secondary source and solely for purposes of this Agreement.
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Backup Manufacturing Rights. (a) At the time of or reasonably prior to Regulatory Approval for the Product in the KKC Territory, Amgen will provide KKC with reasonable support (including the provision of necessary records, documents, data and other Know-How) to enable Amgen’s manufacturing facilities or a contract manufacturer used by Amgen, in each case reasonably acceptable to KKC (such facility or contract manufacturer, a “Backup Manufacturer”), to be [***]. In the event that such Backup Manufacturer is not qualified to be registered as a backup site, Amgen shall provide reasonable cooperation to take steps as may be necessary to [***], and KKC shall reimburse reasonable and customary expenses actually incurred by Amgen in doing so.
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Backup Manufacturing Rights 
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Related to Backup Manufacturing Rights

  • Manufacturing Rights (a) If Tesla fails to supply Product ordered by ViewRay in accordance with the Section 3.3, in accordance with the terms of this Agreement regarding the quantity or quality of Products supplied to ViewRay, then Tesla shall use Commercially Reasonable Efforts to remedy the problem or secure an alternative source of supply within [***] at no cost to ViewRay, and any such alternative source of supply shall be on terms substantially identical with the terms of this Agreement. If Tesla is unable to remedy the problem or secure an alternative source of supply within [***] after its initial failure to supply, then Tesla shall consult with ViewRay and the parties shall work together to remedy the problem. If Tesla is unable to remedy the supply problem after [***] (or longer as agreed in writing by the parties), commencing with the date upon which such failure to supply began, then ViewRay may at its option, and upon notice to Tesla, manufacture the Products itself or through a third party in accordance with the provisions of Section 3.10(b).

  • 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 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 [***].

  • Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.

  • 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 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.

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

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

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.

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