Common use of Manufacturing Audits by Celltech Clause in Contracts

Manufacturing Audits by Celltech. Upon sixty (60) days prior written notice for cause, or with one hundred eighty (180) days written notice for an annual audit, Celltech or a representative thereof shall have the right, if within the power of Orphan Medical to grant such right, to participate in the conduct of compliance or other inspections, audits and/or investigations of the operations and facilities where the Product and the raw materials and components used to manufacture, package, inspect, test, store and supply the Product, including, without limitation, the API and the Components, are manufactured, packaged, inspected, tested and stored. Such inspections, audits and/or investigations shall take place during normal business hours at the relevant manufacturing site(s) in the presence of Celltech and Orphan Medical’s representatives and Celltech shall abide by any confidentiality requirements or security procedures of Orphan Medical’s suppliers. Orphan Medical shall facilitate and lead the audit, and it shall be Orphan Medical’s responsibility to discuss any audit findings with its sub-contractors and suppliers. Celltech and Orphan Medical along with any other licensing partner will agree upon a final single audit report that will be sent to the vendor by Orphan Medical. In the event of any disagreement among the parties relating to the audit report, Orphan Medical shall be the deciding entity and will finalize the audit report. Orphan Medical shall require its sub-contractors and suppliers to take all reasonably necessary corrective actions identified by Celltech as necessary to comply with cGMP requirements and Registrations in the Territory. In the case where a vendor will not allow Celltech to accompany Orphan Medical during such audit, Orphan Medical will either audit on behalf of Celltech, or will jointly, with Celltech engage an independent third party to audit the supplier on behalf of both parties. Orphan Medical is generally allowed one audit each year of each vendor. If additional costs are imposed due to accompaniment of Celltech with Orphan Medical during such audits, Celltech shall bear the burden of any additional costs.

Manufacturing Audits by Celltech. Upon sixty (60) days prior written notice for cause, or with one hundred eighty (180) days written notice for an annual audit, Celltech or a representative thereof shall have the right, if within the power of Orphan Medical to grant such right, to participate in the conduct of compliance or other inspections, audits and/or investigations of the operations and facilities where the Product and the raw materials and components used to manufacture, package, inspect, test, store and supply the Product, including, without limitation, the API and the Components, are manufactured, packaged, inspected, tested and stored. Such inspections, audits and/or investigations shall take place during normal business hours at the relevant manufacturing site(s) in the presence of Celltech and Orphan Medical’s 's representatives and Celltech shall abide by any confidentiality requirements or security procedures of Orphan Medical’s 's suppliers. Orphan Medical shall facilitate and lead the audit, and it shall be Orphan Medical’s 's responsibility to discuss any audit findings with its sub-contractors and suppliers. Celltech and Orphan Medical along with any other licensing partner will agree upon a final single audit report that will be sent to the vendor by Orphan Medical. In the event of any disagreement among the parties relating to the audit report, Orphan Medical shall be the deciding entity and will finalize the audit report. Orphan Medical shall require its sub-contractors and suppliers to take all reasonably necessary corrective actions identified by Celltech as necessary to comply with cGMP requirements and Registrations in the Territory. In the case where a vendor will not allow Celltech to accompany Orphan Medical during such audit, Orphan Medical will either audit on behalf of Celltech, or will jointly, with Celltech engage an independent third party to audit the supplier on behalf of both parties. Orphan Medical is generally allowed one audit each year of each vendor. If additional costs are imposed due to accompaniment of Celltech with Orphan Medical during such audits, Celltech shall bear the burden of any additional costs.