Facility and Records. Spark shall maintain its manufacturing facilities used in manufacturing the Products in accordance with cGMP and all other applicable Legal Requirements. Spark shall keep and maintain documents and records associated with the performance of Manufacturing Services as required by Legal Requirements. Spark will maintain all materials, data and documentation obtained or generated by Spark in the course of performing the Manufacturing Services, including all reference standards, retained samples of Product and key intermediates, and computerized records and files (the “Records”) in a secure area reasonably protected from fire, theft and destruction for the longer of (a) a period of [**] years following expiration or termination of this Agreement or (b) [**] years past the last expiration date of Product supplied under this Agreement, or, in each case, such longer period as is required by applicable law (the “Retention Period”). At the end of the Retention Period, all Records will, at Genable’s option, either be (x) delivered to Genable or to its designee, at Genable’s cost, in such form as is then currently in the possession of Spark or (y) disposed of, at the cost, direction and written request of Genable. In no event will Spark dispose of or destroy all copies of a particular Record without first giving Genable at least [**] days’ prior written notice of its intent to do so and an opportunity to have the Records transferred to Genable. While in the possession and control of Spark, Records will be available during audits or at other mutually agreed times for inspection, examination or review by Genable and its representatives as provided herein. Notwithstanding anything in this Section 4.1 to the contrary, Spark may retain copies of any Records as necessary to comply with Legal Requirements, subject to the obligations of confidentiality of Spark under this Agreement and as consistent with Spark policies and practices.
Facility and Records. CHOP shall maintain its manufacturing facilities used in manufacturing the Products in accordance with cGMP. CHOP shall keep and maintain documents and records associated with the performance of the Services as required by applicable cGLP and cGMP regulations, as applicable. CHOP will maintain all materials, data and documentation obtained or generated by CHOP in the course of performing the manufacturing Services under this Agreement, including all reference standards, retained samples of Product and key intermediates, and computerized records and files (the “Records”) in a secure area reasonably protected from fire, theft and destruction for the longer of (a) a period of [**] years following expiration or termination of this Agreement or (b) [**] years past the last expiration date of Product supplied under this Agreement, or, in each case, such longer period as is required by Applicable Law (the “Retention Period”). At the end of the Retention Period, all Records will, at AAVT’s option, either be (x) delivered to AAVT or to its designee, at AAVT’s cost, in such form as is then currently in the possession of CHOP, (y) retained by CHOP, at AAVT’s cost, until further disposition instructions are received or (z) disposed of, at the cost, direction and written request of AAVT. In no event will CHOP dispose of or destroy all copies of a particular Record without first giving AAVT at least [**] days’ prior written notice of its intent to do so and an opportunity to have the Records transferred to AAVT. While in the possession and control of CHOP, Records will be available during audits or at other mutually agreed times for inspection, examination, review or copying by AAVT and its representatives as provided herein. Notwithstanding anything in this Section 3.1 to the contrary, CHOP may retain copies of any Records as necessary to comply with Legal Requirements, subject to the obligations of confidentiality of CHOP under this Agreement and as consistent with CHOP policies and practices.
Facility and Records. Section 3.1 is hereby amended by deleting in subsection (b) of the third sentence the word “expiration” and replacing it with the word “certification”.
