API Facility definition
Examples of API Facility in a sentence
Site cGMP API Facility Fermentor (s) 30 L (22L working) 500-1000 L (350-650 L working) Time 7 days Documentation Batch records, QC test methods and procedures.
Site cGMP API Facility, Class 100K clean room Centrifuge Westfalia Microfluidizer Microfluidics Time 17 days Documentation Batch records and notebooks to prepare product against target specifications, QC test methods and procedures.
Site cGMP API Facility, Class 100K clean room Time 2 days Documentation Preliminary batch records and notebooks to prepare product against target specifications, draft QC test methods and procedures.
Site cGMP API Facility, Class 100K clean room Time 2 days Documentation Batch records and notebooks to prepare product against target specifications, QC test methods and procedures.
The Facility, which will be an expansion of the site where the API Facility is located, will be approximately [***] square feet in area, to be confirmed after completion of conceptual engineering design work.
API has not permitted or conducted, and is not aware of, any Hazardous Activity conducted with respect to any API Facility or any other property or assets (whether real, personal or mixed) in which API has or had an interest except in compliance with all applicable Environmental Laws.
If determined by Keryx (in its sole discretion), Keryx shall have the right to include a designation of BioVectra and the API Facility as a manufacturer and manufacturing site of Product in the applicable Health Registrations.
BioVectra will ship and be responsible for the shipping costs for shipment of Product from the API Facility to LSU, or if so requested by Keryx, BioVectra will ship Product directly to Keryx’s designated storage site.
If the Company adopts a stock bonus, stock option or executive bonus program, Employee shall be entitled to participate in such program on the same terms applicable to other executives of the Company of a similar compensation level.
During the Term of this Agreement, Keryx shall be allowed, during reasonable times while manufacturing activities are occurring, to have representatives on site at the API Facility and access to all applicable portions of the API Facility provided that accessing the API Facility does not put manufacturing at risk, and all associated Records, for the purpose of observing, reporting on, and consulting as to any manufacturing activities hereunder.