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).
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.
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: