Common use of Facility Maintenance; Inspection; Reports Clause in Contracts

Facility Maintenance; Inspection; Reports. (a) The Manufacturer shall, at all times, maintain and operate, or cause its contractors to maintain and operate, all facilities where Supply Products are manufactured, packaged, tested, stored, warehoused or shipped, and implement such quality control procedures, as is reasonably required so as to be able to perform its obligations hereunder in accordance with all applicable Governmental Rules, including without limitation, the cGMP Requirements. Not more than [****] (or more often for follow‑up audits or inspections directed at significant or critical quality issues observed during the regular audit or brought to the Buyer’s attention through customer complaints or claims or by Governmental Entities), the Manufacturer shall permit, or cause its contractors to permit, quality assurance representatives of the Buyer or designated third parties to inspect such facilities, operations, documents, and records related to the handling, manufacture, testing, inspection, packaging, storage, disposal and transportation of the Supply Products by the Manufacturer or the applicable contractor upon reasonable notice (which shall not be less than [****]), during normal business hours and on a confidential basis. The Manufacturer shall also permit, and cause its contractors to permit, representatives of the FDA to inspect such facilities as requested by the FDA. The Manufacturer shall promptly provide, or cause its contractor to provide, the Buyer with a copy of any FDA Form 483s received at the conclusion of an inspection relating to any Supply Product or any facility where any Supply Product is Manufactured (to the extent the observation affects the Manufacture of the Supply Product). [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions. (b) The Manufacturer shall maintain adequate and accurate records consistent with the applicable Specifications, including records covering quality control testing and release of the Supply Products and all other Manufacturing services provided hereunder in material compliance with the cGMP Requirements and any other relevant Governmental Rules, at all times during the performance of the Manufacturing services and for a period as required by Governmental Rules. (c) The Manufacturer shall promptly notify Buyer of any FDA inspection of the Manufacturing facilities (but in any event no later than [****] after the commencement of such inspection) if such inspection pertains to any Supply Product and, in such case, shall make all such records available to the FDA as required by applicable Governmental Rules. The Manufacturer shall promptly notify Buyer of any such disclosure and shall provide copies of any records made available to FDA, but only if and to the extent the same relate to the Supply Products and the Manufacturer’s obligations hereunder (redacted as appropriate to reflect any confidential information of the Manufacturer and its other customers); provided that any such disclosure shall be for this limited purpose and Buyer shall hold such information in confidence, and may not share any such information with any third parties except as required by a Governmental Entity or by Governmental Rules. (d) Subject to the foregoing record maintenance requirement and only with respect to any Supply Product that is supplied by the Manufacturer, the Manufacturer shall notify Buyer before destroying any records developed under this Supply Agreement and maintained in accordance with Section 2.4(b), it being understood that in respect of any Supply Product that is supplied by the Manufacturer pursuant to a retained ANDA, the Manufacturer shall only be required to notify Buyer before destroying any records to the extent the records relate to the Supply Products purchased by Buyer under this Supply Agreement. In such case, Buyer shall have the option of having the records shipped to Buyer in accordance with Buyer’s reasonable instructions and at Buyer’s sole cost and expense. Buyer shall also have the option, at any time not later than [****] after the termination date of this Supply Agreement, of having one copy of any records developed under this Supply Agreement shipped to Buyer in accordance with Buyer’s reasonable instructions and at Buyer’s sole cost and expense.

Facility Maintenance; Inspection; Reports. (a) The Manufacturer Licensor shall, at all times, maintain and operate, or cause its contractors to maintain and operate, all facilities where Supply Products are manufacturedManufactured, packaged, tested, stored, warehoused or shipped, and implement such quality control procedures, as is reasonably required so as to be able to perform its obligations hereunder in accordance with all applicable Governmental Rules, including without limitation, the cGMP Requirements. Not more than [****] once every twelve (12) months (or more often for follow‑up follow-up audits or inspections directed at significant or critical quality issues observed during the regular audit or brought to the Buyer’s Licensee's attention through customer complaints or claims or by Governmental Entities), the Manufacturer Licensor shall permit, or cause its contractors to permit, quality assurance representatives of the Buyer Licensee or designated third parties to inspect such facilities, operations, documents, and records related to the handling, manufacture, testing, inspection, packaging, storage, disposal and transportation of the Supply Products by the Manufacturer Licensor or the applicable contractor upon reasonable notice (which shall not be less than [****]ten (10) days), during normal business hours and on a confidential basis. The Manufacturer Licensor shall also permit, and cause its contractors to permit, representatives of the FDA to inspect such facilities as requested by the FDA. The Manufacturer shall promptly provide, or cause its contractor to provide, the Buyer with a copy of any FDA Form 483s received at the conclusion of an inspection relating to any Supply Product or any facility where any Supply Product is Manufactured (to the extent the observation affects the Manufacture of the Supply Product). [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions. (b) The Manufacturer Licensor shall maintain adequate and accurate records consistent with the applicable Specifications, including records covering quality control testing and release of the Supply Products and all other Manufacturing services provided hereunder in material compliance with the cGMP Requirements and any other relevant Governmental Rules, at all times during the performance of the Manufacturing services and for a three (3) years after the date of Manufacture, or such longer period as required by Governmental Rules. (c) The Manufacturer shall promptly notify Buyer of any FDA inspection of the Manufacturing facilities (but in any event no later than [****] after the commencement of such inspection) if such inspection pertains to any Supply Product and, in such case, shall make all such records available to the FDA as required by applicable Governmental Rules. The Manufacturer shall promptly notify Buyer of any such disclosure and shall provide copies of any records made available to FDA, but only if and to the extent the same relate to the Supply Products and the Manufacturer’s obligations hereunder (redacted as appropriate to reflect any confidential information of the Manufacturer and its other customers); provided that any such disclosure shall be for this limited purpose and Buyer shall hold such information in confidence, and may not share any such information with any third parties except as required by a Governmental Entity or by Governmental Rules. (d) Subject to the foregoing record maintenance requirement and only with respect to any Supply Product that is supplied by the Manufacturer, the Manufacturer shall notify Buyer before destroying any records developed under this Supply Agreement and maintained in accordance with Section 2.4(b), it being understood that in respect of any Supply Product that is supplied by the Manufacturer pursuant to a retained ANDA, the Manufacturer shall only be required to notify Buyer before destroying any records to the extent the records relate to the Supply Products purchased by Buyer under this Supply Agreement. In such case, Buyer shall have the option of having the records shipped to Buyer in accordance with Buyer’s reasonable instructions and at Buyer’s sole cost and expense. Buyer shall also have the option, at any time not later than [****] after the termination date of this Supply Agreement, of having one copy of any records developed under this Supply Agreement shipped to Buyer in accordance with Buyer’s reasonable instructions and at Buyer’s sole cost and expense.

Facility Maintenance; Inspection; Reports. (a) The Each Manufacturer shall, at all times, maintain and operate, or cause its contractors to maintain and operate, all facilities where Supply Products are manufactured, packaged, tested, stored, warehoused or shipped, and implement such quality control procedures, as is reasonably required so as to be able to perform its obligations hereunder in accordance with all applicable Governmental Rules, including without limitation, the cGMP Requirements. Not more than [****] (or more often for follow‑up audits or inspections directed at significant or critical quality issues observed during the regular audit or brought to the Buyer’s attention through customer complaints or claims or by Governmental Entities), the each Manufacturer shall permit, or cause its contractors to permit, quality assurance representatives of the Buyer or designated third parties to inspect such facilities, operations, documents, and records related to the handling, manufacture, testing, inspection, packaging, storage, disposal and transportation of the Supply Products by the each Manufacturer or the applicable contractor upon reasonable notice (which shall not be less than [****]), during normal business hours and on a confidential basis. The Each Manufacturer shall also permit, and cause its contractors to permit, representatives of the FDA to inspect such facilities as requested by the FDA. The Each Manufacturer shall promptly provide, or cause its contractor to provide, the Buyer with a copy of any FDA Form 483s received at the conclusion of an inspection relating to any Supply Product sold by it or any facility where any Supply Product is Manufactured (to the extent the observation affects the Manufacture of the Supply Product). [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions. (b) The Each Manufacturer shall maintain adequate and accurate records consistent with the applicable Specifications, including records covering quality control testing and release of the Supply Products and all other Manufacturing services provided hereunder in material compliance with the cGMP Requirements and any other relevant Governmental Rules, at all times during the performance of the Manufacturing services and for a period as required by Governmental Rules. (c) The Each Manufacturer shall promptly notify Buyer of any FDA inspection of the Manufacturing facilities (but in any event no later than [****] after the commencement of such inspection) if such inspection pertains to any Supply Product and, in such case, shall make all such records available to the FDA as required by applicable Governmental Rules. The Each Manufacturer shall promptly notify Buyer of any such disclosure and shall provide copies of any records made available to FDA, but only if and to the extent the same relate to the Supply Products and the such Manufacturer’s obligations hereunder (redacted as appropriate to reflect any confidential information of the such Manufacturer and its other customers); provided that any such disclosure shall be for this limited purpose and Buyer shall hold such information in confidence, and may not share any such information with any third parties except as required by a Governmental Entity or by Governmental Rules. (d) Subject to the foregoing record maintenance requirement and only with respect to any Supply Product that is supplied by the a Manufacturer, the such Manufacturer shall notify Buyer before destroying any records developed under this Supply Agreement and maintained in accordance with Section 2.4(b), it being understood that in respect of any Supply Product that is supplied by the such Manufacturer pursuant to a retained ANDA, the such Manufacturer shall only be required to notify Buyer before destroying any records to the extent the records relate to the Supply Products purchased by Buyer under this Supply Agreement. In such case, Buyer shall have the option of having the records shipped to Buyer in accordance with Buyer’s reasonable instructions and at Buyer’s sole cost and expense. Buyer shall also have the option, at any time not later than [****] after the termination date of this Supply Agreement, of having one copy of any records developed under this Supply Agreement shipped to Buyer in accordance with Buyer’s reasonable instructions and at Buyer’s sole cost and expense.

Facility Maintenance; Inspection; Reports. (a) The Manufacturer shall, at all times, maintain and operate, or cause its contractors to maintain and operate, all facilities where Supply Products are manufacturedManufactured, packaged, tested, stored, warehoused or shipped, and implement such quality control procedures, as is reasonably required so as to be able to perform its obligations hereunder in accordance with all applicable Governmental Rules, including including, without limitation, the cGMP Requirements. Not more than [****] (or more often for follow‑up follow-up audits or inspections directed at significant or critical quality issues observed during the regular audit or brought to the Buyer’s attention through customer complaints or claims or by Governmental Entities), the Manufacturer shall permit, or cause its contractors to permit, quality assurance representatives of the Buyer or designated third parties to inspect such facilities, operations, documents, and records related to the handling, manufacture, testing, inspection, packaging, storage, disposal and transportation of the Supply Products by the Manufacturer or the applicable contractor upon reasonable notice (which shall not be less than [****]), during normal business hours and on a confidential basis. The Manufacturer shall also permit, and cause its contractors to permit, representatives of the FDA to inspect such facilities as requested by the FDA. The Manufacturer shall promptly provide, or cause its contractor to provide, the Buyer with a copy of any FDA Form 483s received at the conclusion of an inspection relating to any Supply Product or any facility where any Supply Product is Manufactured (to the extent the observation affects the Manufacture manufacture of the Supply Product). [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions. (b) The Manufacturer shall maintain adequate and accurate records consistent with the applicable Specifications, including records covering quality control testing and release of the Supply Products and all other Manufacturing services provided hereunder in material compliance with the cGMP Requirements and any other relevant Governmental Rules, at all times during the performance of the Manufacturing services and for a period as required by Governmental Rules. (c) The Manufacturer shall promptly notify Buyer of any FDA inspection of the Manufacturing facilities facilities, as far in advance as reasonably possible (but in any event no later than [****] after the commencement of such inspection) if such inspection pertains to any Supply Product and, in such case, shall make all such records available to the FDA as required by applicable Governmental Rules. The Manufacturer shall promptly notify Buyer of any such disclosure and shall provide copies of any records made available to FDA, but only if and to the extent the same relate to the Supply Products and the Manufacturer’s obligations hereunder (redacted as appropriate to reflect any confidential information of the Manufacturer and its other customers); provided that any such disclosure shall be for this limited purpose and Buyer shall hold such information in confidence, and may not share any such information with any third parties except as required by a Governmental Entity or by Governmental Rules. (d) Subject to the foregoing record maintenance requirement and only with respect to any Supply Product that is supplied by the ManufacturerManufacturer pursuant to an ANDA that is not a retained ANDA, the Manufacturer shall notify Buyer before destroying any records developed under this Supply Agreement and maintained in accordance with Section 2.4(b), it being understood that in respect of any Supply Product that is supplied by the Manufacturer pursuant to a retained ANDA, the Manufacturer shall only be required to notify Buyer before destroying any records to the extent the records relate to the Supply Products purchased by Buyer under this Supply Agreement. In such case, Buyer shall have the option of having the records shipped to Buyer in accordance with Buyer’s reasonable instructions and at Buyer’s sole cost and expense. Buyer shall also have the option, at any time not later than [****] after the termination date of this Supply Agreement, of having one copy of any records developed under this Supply Agreement shipped to Buyer in accordance with Buyer’s reasonable instructions and at Buyer’s sole cost and expense.