Facility Validation Sample Clauses

Facility Validation. Except as expressly provided in this Agreement, and excluding process validation and validation of Bioverativ-owned equipment, Biogen shall perform at no additional cost to Bioverativ and on an on-going basis the necessary Facility validation activities required by cGMPs or Applicable Law in connection with the regular course of manufacturing the product.
Sample 1Sample 2
AutoNDA by SimpleDocs
Facility Validation. Atara will be responsible for performing all validation of any Atara Equipment, unless otherwise agreed in any Work Order. Manufacturer will be responsible for performing all validation of the Facility, Equipment and cleaning and maintenance processes employed in the Manufacturing Process in accordance with cGMP (if applicable), Manufacturer’s SOPs, the applicable Quality Agreement (if any), Applicable Law, and in accordance with any other validation procedures established by Atara and agreed to in writing by Manufacturer, and the applicable Work Order.
Sample 1
Facility Validation. Cognate will be responsible for performing all necessary validation of all Equipment, unless otherwise agreed in an SOW. Cognate will be responsible for performing any required validation of the Facility and cleaning and maintenance processes employed in the Manufacturing Process in accordance with cGMP (if applicable), the applicable Quality Agreement, and any other validation procedures established by the parties and agreed to in writing by Cognate.
Sample 1
Facility Validation. Prior to commencing the Manufacture and supply of the Material under this Agreement and throughout the Term of the Agreement, the CAMBRIDGE Facility shall be appropriately validated for commercial activities in accordance with cGMPs, the regulations of the FDA or any applicable Regulatory Authority. In the event regulatory approval is sought in countries outside the United States in accordance with Section 2.3 hereof, CAMBRIDGE shall use commercially reasonable efforts to meet and maintain any such country’s requirements for validation of the CAMBRIDGE Facility in accordance with the regulations of any applicable Regulatory Authority. Furthermore, CAMBRIDGE shall complete validation of its chemical processes, methods and equipment used in the Manufacture, packaging, storage, testing and release of the Material in conformance with all MSDSs and current FDA or any Regulatory Authority regulations as applicable to the Material, and will review such validation annually and through effective change control procedures assure that the validation is kept current throughout the Term of this Agreement. [*] = 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 24b-2 of the Securities Exchange Act of 1934, as amended.
Sample 1

Related to Facility Validation

  • Interconnection Request This Section 3 shall not apply to any proposed modifications by Interconnection Customer to its facilities for which Interconnection Customer must make an Interconnection Request under the Tariff. In such circumstances, the Interconnection Customer and Transmission Provider shall follow the requirements of Subpart A of Part IV of the Tariff.

  • Provisioning Line Splitting and Splitter Space 3.8.1 The Data LEC, Voice CLEC or BellSouth may provide the splitter. When Southern Telecom or its authorized agent owns the splitter, Line Splitting requires the following: a non-designed analog Loop from the serving wire center to the NID at the End User’s location; a collocation cross connection connecting the Loop to the collocation space; a second collocation cross connection from the collocation space connected to a voice port; the high frequency spectrum line activation, and a splitter. The Loop and port cannot be a Loop and port combination (i.e. UNE-P), but must be individual stand-alone Network Elements. When BellSouth owns the splitter, Line Splitting requires the following: a non designed analog Loop from the serving wire center to the NID at the End User’s location with CFA and splitter port assignments, and a collocation cross connection from the collocation space connected to a voice port. 3.8.2 An unloaded 2-wire copper Loop must serve the End User. The meet point for the Voice CLEC and the Data LEC is the point of termination on the MDF for the Data LEC's cable and pairs. 3.8.3 The foregoing procedures are applicable to migration to Line Splitting Service from a UNE-P arrangement, BellSouth Retail Voice Service, BellSouth High Frequency Spectrum (CO Based) Line Sharing. 3.8.4 For other migration scenarios to line splitting, BellSouth will work cooperatively with CLECs to develop methods and procedures to develop a process whereby a Voice CLEC and a Data LEC may provide services over the same Loop.

  • Documentation Required The certificates and endorsements shall be received and approved by the District before Work commences. As an alternative, the Contractor may submit certified copies of any policy that includes the required endorsement language set forth herein.

  • Facility Prudential is willing to consider, in its sole discretion and within limits which may be authorized for purchase by Prudential Affiliates from time to time, the purchase of Shelf Notes pursuant to this Agreement. The willingness of Prudential to consider such purchase of Shelf Notes is herein called the “Facility”. At any time, the aggregate principal amount of Shelf Notes stated in Section 1.2, minus the aggregate principal amount of Shelf Notes purchased and sold pursuant to this Agreement prior to such time, minus the aggregate principal amount of Accepted Notes (as hereinafter defined) which have not yet been purchased and sold hereunder prior to such time, is herein called the “Available Facility Amount” at such time. NOTWITHSTANDING THE WILLINGNESS OF PRUDENTIAL TO CONSIDER PURCHASES OF SHELF NOTES BY PRUDENTIAL AFFILIATES, THIS AGREEMENT IS ENTERED INTO ON THE EXPRESS UNDERSTANDING THAT NEITHER PRUDENTIAL NOR ANY PRUDENTIAL AFFILIATE SHALL BE OBLIGATED TO MAKE OR ACCEPT OFFERS TO PURCHASE SHELF NOTES, OR TO QUOTE RATES, SPREADS OR OTHER TERMS WITH RESPECT TO SPECIFIC PURCHASES OF SHELF NOTES, AND THE FACILITY SHALL IN NO WAY BE CONSTRUED AS A COMMITMENT BY PRUDENTIAL OR ANY PRUDENTIAL AFFILIATE.

  • Facility Use The Employer shall allow individuals the use of gender- segregated facilities, such as restrooms, locker rooms, and dressing rooms that are consistent with that individual's gender expression or gender identity. In such facilities where undressing in the presence of others occurs, the Employer shall allow access to and use of a facility consistent with that individual's gender expression or gender identity.

  • Modification of the Small Generating Facility The Interconnection Customer must receive written authorization from the NYISO and Connecting Transmission Owner before making any change to the Small Generating Facility that may have a material impact on the safety or reliability of the New York State Transmission System or the Distribution System. Such authorization shall not be unreasonably withheld. Modifications shall be done in accordance with Good Utility Practice. If the Interconnection Customer makes such modification without the prior written authorization of the NYISO and Connecting Transmission Owner, the Connecting Transmission Owner shall have the right to temporarily disconnect the Small Generating Facility. If disconnected, the Small Generating Facility will not be reconnected until the unauthorized modifications are authorized or removed.

  • Completion of a Utilisation Request (a) Each Utilisation Request is irrevocable and will not be regarded as having been duly completed unless: (i) the proposed Utilisation Date is a Business Day within the Availability Period; (ii) the currency and amount of the Utilisation comply with Clause 5.3 (Currency and amount); and (iii) the proposed Interest Period complies with Clause 9 (Interest Periods). (b) Only one Loan may be requested in each Utilisation Request.

  • Installation requirements We (if we install the System) or our contractor (if we procure a contractor to install the System) must:

  • Food Service Waste Reduction Requirements Contractor shall comply with the Food Service Waste Reduction Ordinance, as set forth in San Francisco Environment Code Chapter 16, including but not limited to the remedies for noncompliance provided therein.

  • Construction Requirements (a) All Life and Safety and applicable Building Codes will be strictly enforced (i.e., tempered glass, fire dampers, exit signs, smoke detectors, alarms, etc.). Prior coordination with the Building Manager is required. (b) Electric panel schedules must be brought up to date identifying all new circuits added. (c) All electrical outlets and lighting circuits are to be properly identified. Outlets will be labeled on back side of each cover plate. (d) All electrical and phone closets being used must have panels replaced and doors shut at the end of each day’s work. Any electrical closet that is opened with the panel exposed must have a work person present. (e) All electricians, telephone personnel, etc. will, upon completion of their respective projects, pick up and discard their trash leaving the telephone and electrical rooms clean. If this is not complied with, a clean-up will be conducted by the building janitors and the general contractor will be back-charged for this service. (f) Welding or burning with an open flame will not be done without prior approval of the Building Manager. Fire extinguishers must be on hand at all times. (g) All “anchoring” of walls or supports to the concrete are not to be done during normal working hours (7:30 AM—6:00 PM, Monday through Friday). This work must be scheduled before or after these hours during the week or on the weekend. (h) All core drilling is not to be done during normal working hours (7:30 AM—6:00 PM, Monday through Friday). This work must be scheduled before or after these hours during the week or on the weekend. (i) All HVAC work must be inspected by the Building Engineer. The following procedures will be followed by the general contractor: i) A preliminary inspection of the HVAC work in progress will be scheduled through the Building Office prior to the reinstallation of the ceiling grid. ii) A second inspection of the HVAC operation will also be scheduled through the Building Office and will take place with the attendance of the HVAC contractor’s Air Balance Engineer. This inspection will take place when the suite in question is ready to be air-balanced. [***] = CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THIS OMITTED INFORMATION. iii) The Building Engineer will inspect the construction on a periodic basis as well. (j) All existing thermostats, ceiling tiles, lighting fixtures and air conditioning grilles shall be saved and turned over to the Building Engineer.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!