Facility Visits and Audits Sample Clauses

Facility Visits and Audits. Dyax's representatives may visit the Facility to observe the progress of, or to audit the Services ("Routine Visits"). Dyax may also have the Facility audited and inspected by competent authorities as required by CGMP. Dyax shall request an appointment for such visits with Xxxx a minimum of [*****] calendar days before and the Parties will agree on the dates and the scope. Such audit, in excess of [*****] in duration by [*****] per year, [*****], unless agreed otherwise by the Parties in writing. The Parties agree that audits and inspections by Regulatory Authorities can be agreed upon by the Parties within a shorter timeframe. In addition to such Routine Visits, Dyax shall have the right to, and Xxxx will without undue delay allow for, audits caused by events which could put the quality of Dyax' Product at risk ("For-Cause Audits"). Xxxx will have the right to audit any sites or laboratories used by Dyax (except for Dyax's contract manufacturers) or any Third Party analytical subcontractor engaged by Dyax in connection with any materials provided by or on behalf of Dyax to Xxxx as part of the Services.

Facility Visits and Audits. Customer’s representatives may visit the Facility to observe the progress of the Program or to audit the Facility as set forth in the Quality Agreement. In addition, Gallus will have the right to audit any sites (including Customer sites) or laboratories used by Customer (except for Customer’s contract manufacturers) or any Third Party analytical subcontractor engaged by Customer in connection with any release assays.

Facility Visits and Audits. With reasonable advance notice, Discovery's representatives (including its employees, directors, consultants and other subcontractors) may visit the Facility at appropriate times consistent with the Program to observe the progress of the Program or to audit the Program subject to the access limitations set forth in Appendix 5 to this Agreement. Laureate will not be held responsible or liable for the performance of any Third Party retained by Discovery to perform services related to the Program, including, without limitation, distributors, consultants and testing entities. (a) Laureate shall have the right at reasonable business hours and to the greatest reasonable extent that may be provided by Discovery to audit any sites or laboratories used by Discovery (except for Discovery's contract manufacturers) or any Third Party engaged by Discovery directly in connection with the manufacture of any Materials, the Drug Product, Drug Substance and other materials provided by or on behalf of Discovery to Laureate.

Facility Visits and Audits. (a) Customer's representatives may visit the Facility at appropriate times consistent with the Program to observe the progress of the Program or to audit the Program, such access and audit being subject to the limitations provided in Appendix 6 hereto. Following each audit, Customer shall discuss its observations and conclusions with Laureate, and, if necessary, corrective actions shall be negotiated by Customer and Laureate within [******* (**)] days thereafter. Laureate shall implement mutually agreed upon corrective action within [******* (**)] days after the parties reach such agreement, unless otherwise agreed in writing by the parties. Laureate will have the right at reasonable times and upon reasonable notice to audit the quality control laboratories used by Customer (except for Customer's contract manufacturers), or any Third Party analytical subcontractor engaged by Customer, in connection with any Materials or the Cell Line provided by or on behalf of Customer to Laureate under this Agreement.

Facility Visits and Audits. Synageva’s representatives may visit Cytovance’s facilities during normal business hours and with prior written notice to ensure conformance with cGMPs and to observe the progress of the Project, provided that such access does not compromise cGMP compliance or safety. Cytovance will assist Synageva in scheduling such visits, which will be in compliance with Cytovance’s requirement to protect confidentiality of Cytovance’s other clients. Synageva may conduct one (1) quality assurance audit per calendar year at no cost in accordance with the provisions of the Quality Agreement unless an audit results in adverse findings in which case Synageva shall be entitled to re-audit Cytovance with respect to such adverse findings without reference to the once per calendar year limitation. Additional audits within a calendar year not related to adverse findings will be invoiced separately on a time and materials basis at the then current rate for such services.

Facility Visits and Audits. Customer’s representatives may visit the Facility at appropriate times consistent with the Program to observe the progress of the Program or to audit the Program subject to the limitations provided in Appendix 6 to this Agreement. In addition, Laureate will have the right to audit any Third Party or Customer sites or laboratories used by Customer or any Third Party analytical subcontractor engaged by Customer in connection with any Materials, a Cell Line, or other materials provided by or on behalf of Customer to Laureate; [***].

Facility Visits and Audits. The Ordering Party, or its representatives, may conduct one (1) annual quality audit lasting not more than three (3) days, or additionally for cause, in either case as scheduled in advance by mutual agreement of the Parties. While on Provider’s premises, the Ordering Party will comply with any and all safety, security, and confidentiality measures required by Provider.

Facility Visits and Audits