Authorization of the Manufacturing Facility Sample Clauses

Authorization of the Manufacturing Facility. RTU shall be responsible for providing information that may be used in, or referenced by, an application filed by SPE with the regulatory authority in its territory for purposes of ensuring that the RTU manufacturing facility is authorized to manufacture the Drug Substance and Drug Product to be supplied under this Agreement. SPE shall have no obligation to purchase any Drug Product from RTU if they are produced in a manufacturing facility that is not, in any material respect, in compliance with all applicable legal and regulatory requirements.
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Related to Authorization of the Manufacturing Facility

  • Emergency Work Authorizations The State, at its sole discretion, may accept the Engineer's signature on a faxed copy of the work authorization as satisfying the requirements for executing the work authorization, provided that the signed original is received by the State within five business days from the date on the faxed copy.

  • Manufacture 2.1. The LED(s) on the LED module shall be equipped with suitable fixation elements. 2.2. The fixation elements shall be strong and firmly secured to the LED(s) and the LED module.

  • Inspection Testing Authorization and Right of Access 2.1 Equipment Testing and Inspection 2.2 Authorization Required Prior to Parallel Operation

  • 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. (b) The Supplier shall not change any process, material, component, packaging or manufacturing location without the Purchaser’s express prior written approval.

  • Outage Authority and Coordination Developer and Connecting Transmission Owner may each, in accordance with NYISO procedures and Good Utility Practice and in coordination with the other Party, remove from service any of its respective Attachment Facilities or System Upgrade Facilities and System Deliverability Upgrades that may impact the other Party’s facilities as necessary to perform maintenance or testing or to install or replace equipment. Absent an Emergency State, the Party scheduling a removal of such facility(ies) from service will use Reasonable Efforts to schedule such removal on a date and time mutually acceptable to both the Developer and the Connecting Transmission Owner. In all circumstances either Party planning to remove such facility(ies) from service shall use Reasonable Efforts to minimize the effect on the other Party of such removal.

  • Authorization Required Prior to Parallel Operation 2.2.1 The NYISO, in consultation with the Connecting Transmission Owner, shall use Reasonable Efforts to list applicable parallel Operating Requirements in Attachment 5 of this Agreement. Additionally, the NYISO, in consultation with the Connecting Transmission Owner, shall notify the Interconnection Customer of any changes to these requirements as soon as they are known. The NYISO and Connecting Transmission Owner shall make Reasonable Efforts to cooperate with the Interconnection Customer in meeting requirements necessary for the Interconnection Customer to commence parallel operations by the in-service date. 2.2.2 The Interconnection Customer shall not operate its Small Generating Facility in parallel with the New York State Transmission System or the Distribution System without prior written authorization of the NYISO. The NYISO, in consultation with the Connecting Transmission Owner, will provide such authorization once the NYISO receives notification that the Interconnection Customer has complied with all applicable parallel Operating Requirements. Such authorization shall not be unreasonably withheld, conditioned, or delayed.

  • 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 License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Manufacturing Rights (a) If QED fails to supply Product ordered by ViewRay in accordance with the terms of this Agreement regarding the quantity or quality of Products supplied to ViewRay, then QED shall within fifteen (15) Business Days of said failure present ViewRay with a plan to remedy the problem and shall use Commercially Reasonable Efforts to execute such plan and remedy the problem or QED shall secure an alternative source of supply within a reasonable time at no additional cost to ViewRay. Any such alternative source of supply shall be on terms substantially identical with the terms of this Agreement. If QED is unable to provide a plan to remedy the problem or secure an alternative source of supply within [***] after its initial failure to supply, then QED shall consult with ViewRay and the parties shall work together to remedy the problem. If QED 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 QED, manufacture the Products itself or through a third party in accordance with the provisions of Section 3.10(b). [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (b) If ViewRay notifies QED pursuant to Section 3.10(a), above, that ViewRay will manufacture the Products itself or through a third party, QED shall (i) deliver to ViewRay within thirty (30) days media embodying or disclosing all Program technology and Program proprietary or intellectual property rights necessary to enable ViewRay or its designee to manufacture Products conforming with the Specifications; and (ii) provide ViewRay or its designee, upon request, with reasonable assistance in establishing a back-up manufacturing line. ViewRay shall require any third party ViewRay designates to manufacture Products pursuant to this Section 3.10, to agree in writing to observe the terms of this Agreement relating to confidentiality and the manufacture of Products. Notwithstanding any provision of this Section 3.10 to the contrary, in no case shall QED be required to pay ViewRay in respect of any Products purchased by ViewRay from a third party operating a back-up manufacturing line established pursuant to this Section 3.10 or manufactured by ViewRay or its Affiliates pursuant to this Section 3.10.

  • 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.

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