Examples of approved facility in a sentence
Impax shall maintain the Approved Facility and shall conduct all Manufacturing in compliance with all applicable laws, rules and regulations, including cGMPs, and the Impax Know-How at all times during the term of this Agreement.
Schering shall have the right, during normal business hours (and after normal business hours if reasonably requested and in connection with a production run commenced during the normal business hours) and with reasonable advance notice, to visit the Approved Facility for the purpose of observing the Manufacturing, packaging, testing, and storage of the Product, and to inspect for compliance to cGMPs and other applicable regulatory requirements.
Impax shall be responsible for all costs and expenses related to the compliance of the Approved Facility with such laws, rules and regulations and with the Impax Know-How.
Impax agrees to notify Schering within thirty-six (36) hours after the initiation of any inquiries, notifications, or inspection activity by any Regulatory Authority in regard to the Product or the Approved Facility.
During the term of this Agreement, ARC will enable a representative of MacroCure to serve, on Marcocure’s behalf, as a “Person in the Plant” (PIP) at the Approved Facility, who will be allowed to follow and monitor ARC activities in connection with the Services provided hereunder and ARC shall make all the appropriate arrangements to accommodate such PIP.