Inspection of Manufacturing Facilities a. SUPPLIER shall permit SPONSOR and its agents, during business hours and upon notice to SUPPLIER, to inspect the Facilities where the Product is manufactured, handled, stored or tested, as well as all processes relating to the manufacture, handling, storage, or testing of the Product, as well as all manufacturing, handling, storage, and test records regarding the Product.
b. SUPPLIER shall extend the same inspection privileges set forth above to agents of the FDA or any other government agency, as required, and shall promptly notify SPONSOR of any such inspection. SUPPLIER shall provide SPONSOR with copies of any and all inspection reports from the FDA or other relevant government agency regarding the manufacture of the Product within [**] working days of receipt of such reports.
c. SUPPLIER warrants and agrees that it will correct, at its own expense and within a reasonable amount of time from the date of notification, all deficiencies and/or nonconformances found during a SPONSOR, FDA, or other government agency audit; and that it will correct or issue an approved plan, including timetable, to correct all deficiencies and/or non-conformances within no more than [**] days of such notification.
Inspection of Manufacturing Facilities. (a) ESTABLISHMENT shall permit APOLLO and its agents, during business hours and upon notice to ESTABLISHMENT, to inspect the Facilities where the Product is manufactured, handled, stored or tested, as well as all processes relating to the manufacture, handling, storage, or testing of the Product, as well as all test records regarding the Product.
Inspection of Manufacturing Facilities. DURA or its subcontractor shall permit Xxxxxx Corp. II and its duly authorized agents, at Xxxxxx Corp. II's sole expense, to enter DURA's or its subcontractor's premises, upon reasonable notice during normal working hours, for the purpose of inspecting the manufacturing processes and components used in the manufacture of the Xxxxxx Products and the quality thereof.
Inspection of Manufacturing Facilities. (a) Supplier shall permit Kala and its agents, during business hours and upon an agreed notice to Supplier, to inspect the Facilities where the Product is manufactured, handled, stored or tested, as well as all processes relating to the manufacture, handling, storage, or testing of the Product, as well as all manufacturing, handling, storage, and test records regarding the Product. When required by applicable law, regulatory agency, or when deemed an emergency, Kala and its agents shall be permitted such access shall be granted within [**] business days of request.
(b) Supplier shall extend the same inspection privileges set forth above to agents of the FDA or any other Ministry of Health, as required.
(c) Supplier warrants and agrees that it will correct, at its own expense and within a reasonable amount of time from the date of notification, all accepted deficiencies and/or non-conformances found during a Kala, FDA, or Ministry of Health audit; and that it will correct or issue an approved plan, including timetable, to correct all deficiencies and/or non-conformances within no more than [**] days following such notification. The lack of acceptance of the deficiencies and/or non-conformances found during a Kala, FDA, or Ministry of Health audit will be fully justified by Supplier.
Inspection of Manufacturing Facilities. Allied agrees to provide access, upon reasonable advance notice, to its facilities to Sofsource personnel who shall have the right of visiting within the various facilities where Product is being manufactured or materials or Inventory are stored. Any confidential information relating to Allied or any of its customers, other than Sofsource, gained as a result of such access shall be held in strict confidence and Sofsource and any such customer shall execute such documents evidencing such obligations as Allied's counsel may reasonably request.
Inspection of Manufacturing Facilities. Subject to Section 5.1.4, OWNER or its representatives will be permitted to enter and inspect, at reasonable times during business hours and with at least 24 hours prior written notice, LICENSEE’s plants and warehouses, and those of its contract manufacturers where the LICENSED PRODUCT are being manufactured or stored. OWNER has the right to request copies of LICENSEE’s quality assurance and control processes, data and records at any time; and copies of such processes, data and records will be provided to OWNER within 10 calendar days of the request.
Inspection of Manufacturing Facilities. The relevant Purchaser may inspect, and where practicable test, the Products in the course of their production or installation and may for this purpose enter upon the premises of the Supplier from time to time. The Supplier cannot revoke the relevant Purchaser’s rights of entry under this clause during the term of this Agreement. Any such inspection does not relieve the Supplier of any of its obligations under this Agreement. Purchaser must provide reasonable notice in writing to Supplier of any inspection under this Agreement, and must comply with Supplier’s reasonable security requirements while on the Supplier’s premises. Each party must bear its own costs associated with such an inspection. Purchaser must not cause unreasonable disruption in the course of carrying out such an inspection.
Inspection of Manufacturing Facilities. In the event that during the period of Neurocrine’s supply of Clinical Drug Product or bulk Indiplon API hereunder, the Regulatory Authorities in the Territory requests inspection of Neurocrine’s (or its contract manufacturers’) facilities, premises and operation relating to the Clinical Drug Product or bulk Indiplon API supplied by Neurocrine hereunder and such inspection is reasonably required to obtain and maintain the Regulatory Approval, Neurocrine shall receive such inspection. Neurocrine shall cooperate with DSP in the preparation of the inspection to the extent possible. Additionally, DSP may, upon reasonable notice to Neurocrine, have person(s) appointed by DSP visit the manufacturing facilities, premises and operation of Neurocrine and/or its contract manufacturers relating to manufacture of the Clinical Drug Product or bulk Indiplon API during normal business hours to observe and assure the quality of the Clinical Drug Product or bulk Indiplon API. Such visit shall not be more than once in any calendar year, unless otherwise agreed upon between the Parties, and shall be conducted on dates mutually agreed upon by the Parties. DSP shall bear traveling, sojourn and other expenses incurred for such DSP’s visit.
Inspection of Manufacturing Facilities. License recognizes The right of The Lacansover to inspect the quality of the product and through it the manufacture and assembly of licensed products made by Licensed. The license will be granted, and its specific confidential information contained in this document, marked by bracket sealed and separately with the Securities and Exchange Commission, as per the 24B-2 rule of the Securities Exchange Act of 1934. 5 Agents, at their own price of Lacansaur, join the license factory in the ten (10) calendar day notice and the manufacture or sale of licensed products for such periods The license is made by the license during the appropriate and normal business hours to visit the offices to meet the standard of the licensed products on a secret basis. The inspection will be led by the license representative and will be conducted in accordwith with the standard procedure of the license.
Inspection of Manufacturing Facilities. ONCOVIR shall permit GENOCEA, at GENOCEA’s sole expense, to visit Manufacturer’s premises, upon ten (10) day’s prior notice, during normal working hours, for the purpose of inspecting the manufacturing processes and components used in the manufacture of Product to determine whether the Product is being manufactured in accordance with the Specifications, GENOCEA’s Purchase Order requirements and Regulatory Standards (or Regulatory Requirements, when applicable). The inspector shall be entitled to access to ONCOVIR Proprietary Information as required to certify the compliance or non-compliance of the Product and the Manufacturer to the Specifications, GENOCEA’s Purchase Order requirements, Regulatory Standards (or Regulatory Requirements, when applicable). If the inspector is not covered by the confidentiality obligations of GENOCEA hereunder, the inspector shall be required to execute a confidentiality agreement on commercially reasonable terms acceptable to ONCOVIR (such acceptance not to be unreasonably withheld) before reviewing any ONCOVIR Proprietary Information. The inspector shall not copy ONCOVIR Proprietary Information or remove such from the Manufacturer’s premises. Subject to the foregoing, and to the extent necessary for regulatory compliance by GENOCEA and the safety of patients exposed to a Combination Product, the inspector may reveal to the Parties hereunder: (a) whether the manufacture of the Product complies with the requirements set forth herein or under Applicable Law; and (b) a summary and description of the type of non-compliance with the requirements set forth herein or under any Applicable Law. In all cases, GENOCEA shall treat all non-public information subject to review or made available as a result of or in connection with this Section 7.3 as ONCOVIR Proprietary Information and shall cause its authorized agents to retain all such information in confidence (subject to the following), and shall not use any such information, or cause or allow any such information to be used, for any purpose other than regulatory compliance or patient safety.
