Common use of Inspection; Access Clause in Contracts

Inspection; Access. Buyer shall have the right to have employees and other representatives of Buyer (including external auditors and representatives of Buyer’s notified body) present at any plant or production facility relating to or used in connection with the manufacturing of Product during normal business hours to conduct an initial and periodic inspections of such facilities and manufacturing procedures for compliance with ISO, cGMP and QSR, and the Specifications and to inspect Seller’s inventory of Products, work-in-process, raw materials to be used for Products, production records, design history file, quality manuals, regulatory dossiers and such other matters as may be pertinent to proper quality assurance of Products to be delivered hereunder. Buyer agrees to give Seller ** ** Business Days’ prior notice of any such inspection “for cause” and ** ** prior notice for any other inspection. Seller shall immediately use its best efforts to take such action as is required to correct any deficiencies identified by Buyer or its representatives relating to the production of any Product. Seller is not currently a party to, and shall not enter into, any third-party manufacturing agreement relating to any Product that does not grant to Buyer and its representatives, as third-party beneficiaries, rights to inspect the plant or plants at which Product components or materials are manufactured on the terms set forth in this Section. Seller further agrees to use its best efforts to provide such documentation or conduct such analyses as Buyer or its representatives may reasonably request in connection with any regulatory submission or audit hereunder. In accordance with applicable laws and regulations governing regulatory inspections, Seller shall permit authorized representatives of relevant regulatory authorities, including FDA, to inspect any plant and production facilities relating to or used in connection with the manufacture of any Product.

Inspection; Access. Buyer shall have the right to have employees and other representatives of Buyer (including external auditors and representatives of Buyer’s notified body) present at any plant or production facility relating to or used in connection with the manufacturing of Product during normal business hours to conduct an initial and periodic inspections of such facilities and manufacturing procedures for compliance with ISO, cGMP and QSR, and the Specifications and to inspect Seller’s inventory of Products, work-in-process, raw materials to be used for Products, production records, design history file, quality manuals, regulatory dossiers and such other matters as may be pertinent to proper quality assurance of Products to be delivered hereunder. Buyer agrees to give Seller ** ** Business Days’ prior notice of any such inspection “for cause” and ** ** prior notice for any other inspection. Seller shall immediately use its best efforts to take such action as is required to correct any deficiencies identified by Buyer or its representatives relating to the production of any Product. Seller is not currently a party to, and shall not enter into, any third-third- party manufacturing agreement relating to any Product that does not grant to Buyer and its representatives, as third-party beneficiaries, rights to inspect the plant or plants at which Product components or materials are manufactured on the terms set forth in this Section. Seller further agrees to use its best efforts to provide such documentation or conduct such analyses as Buyer or its representatives may reasonably request in connection with any regulatory submission or audit hereunder. In accordance with applicable laws and regulations governing regulatory inspections, Seller shall permit authorized representatives of relevant regulatory authorities, including FDA, to inspect any plant and production facilities relating to or used in connection with the manufacture of any Product.

Inspection; Access. Buyer shall have the right to have employees and other representatives of Buyer (including external auditors and representatives of Buyer’s notified body) present at any plant or production facility relating to or used in connection with the manufacturing of Product during normal business hours to conduct an initial and periodic inspections of such facilities and manufacturing procedures for compliance with ISO, cGMP and QSR, and the Specifications and to inspect Seller’s inventory of Products, work-in-process, raw materials to be used for Products, production records, design history file, quality manuals, regulatory dossiers and such other matters as may be pertinent to proper quality assurance of Products to be delivered hereunder. Buyer agrees to give Seller ** ** a minimum of two (2) Business Days’ prior notice of any such inspection “for cause” and ** ** ten (10) Business Days’ prior notice for any other inspection. Seller shall immediately use its best efforts to take such action as is required to correct any deficiencies identified by Buyer or its representatives relating to the production of any Product. Seller is not currently a party to, and shall not enter into, any third-party manufacturing agreement relating to any Product that does not grant to Buyer and its representatives, as third-party beneficiaries, rights to inspect the plant or plants at which Product components or materials are manufactured on the terms set forth in this Section. Seller further agrees to use its best efforts to provide such documentation or conduct such analyses as Buyer or its representatives may reasonably request in connection with any regulatory submission or audit hereunder. In accordance with applicable laws and regulations governing regulatory inspections, Seller shall permit authorized representatives of relevant regulatory authorities, including FDA, to inspect any plant and production facilities relating to or used in connection with the manufacture of any Product.