GMP Facility Clause Samples

The GMP Facility clause defines the requirement that certain activities, such as manufacturing or processing, must take place in a facility that complies with Good Manufacturing Practice (GMP) standards. This means the facility must meet specific regulatory guidelines for cleanliness, quality control, and operational procedures to ensure product safety and consistency. By mandating the use of a GMP-compliant facility, the clause helps ensure that products are manufactured to a recognized standard, reducing the risk of contamination or quality issues and ensuring regulatory compliance.
GMP Facility. Agila represents and warrants that prior to the Completion Date it will complete the construction and qualification of the [*] Facility (as defined in section 1.9 of the JDLA) with the capacity to supply all then-existing JVC Products in accordance with GMP and other Applicable Laws. It is understood that Agila’s failure to complete the construction and qualification of the [*] Facility with adequate capacity prior to the Completion Date will not be deemed a breach of this Agreement if: (i) Agila has used all reasonable efforts to achieve such goal and the delay is caused by circumstances beyond Agila’s reasonable control, and (ii) prior to completing the construction and qualification of the [*] Facility with adequate capacity, Agila will supply JVC’s requirements of all the JVC Products (including both clinical supply and commercial supply) in accordance with GMP and other Applicable Laws through any Affiliate(s) of Agila or any Acceptable Third Party Supplier(s) at the Interim Transfer Price. For purposes of the foregoing, the “Interim Transfer Price” shall mean [*] percent ([*]%) less than the average price quoted for the supply of the applicable JVC Product(s) quoted by three (3) independent Third Party manufacturers of international repute and having capabilities, to manufacture and supply such JVC Product(s) in accordance with GMP and other Applicable Laws (which Third Party manufacturers are chosen by the Board).
View SourceView Similar (3)
GMP Facility. Intermediate and Drug Substance shall be Manufactured in Fujifilm’s GMP Facility. Fujifilm shall operate the GMP facility in compliance with Applicable Law and any requirements provided for in the Quality Agreements. Fujifilm shall not permit debarred persons to participate in any Program. Fujifilm shall undertake reasonable steps to prevent such participation.
View SourceView Similar (2)
GMP Facility. Revance will construct the GMP Facility in Newark, California. Section 1.6 of the License Agreement is hereby amended and replaced in its entirety with the following:
View SourceView Similar (2)

Related to GMP Facility

  • 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.

  • Generating Facility The Interconnection Customer’s device for the production of electricity identified in the Interconnection Request, but shall not include the Interconnection Customer’s Interconnection Facilities.

  • Interconnection Facilities Engineering Procurement and Construction Interconnection Facilities, Network Upgrades, and Distribution Upgrades shall be studied, designed, and constructed pursuant to Good Utility Practice. Such studies, design and construction shall be based on the assumed accuracy and completeness of all technical information received by the Participating TO and the CAISO from the Interconnection Customer associated with interconnecting the Large Generating Facility.

  • As-Built Drawings Within thirty (30) Days of the successful completion of the Acceptance Test, Seller shall provide for Company review a set of the proposed as‑built drawings for the Company-Owned Interconnection Facilities constructed by Seller (and/or its Contractors). Within thirty (30) Days of Company's receipt of the proposed as‑built drawings, Company shall provide Seller with either (i) its comments on the proposed as‑built drawings or (ii) notice of acceptance of the proposed as‑built drawings as final as‑built drawings. If Company provides comments on the proposed as‑built drawings, Seller shall incorporate such comments into a final set of as‑built drawings and provide such final as‑built drawings to Company within twenty (20) Days of Seller's receipt of Company's comments.

  • Interconnection Facilities 4.1.1 The Interconnection Customer shall pay for the cost of the Interconnection Facilities itemized in Attachment 2 of this Agreement. The NYISO, in consultation with the Connecting Transmission Owner, shall provide a best estimate cost, including overheads, for the purchase and construction of its Interconnection Facilities and provide a detailed itemization of such costs. Costs associated with Interconnection Facilities may be shared with other entities that may benefit from such facilities by agreement of the Interconnection Customer, such other entities, the NYISO, and the Connecting Transmission Owner. 4.1.2 The Interconnection Customer shall be responsible for its share of all reasonable expenses, including overheads, associated with (1) owning, operating, maintaining, repairing, and replacing its own Interconnection Facilities, and