Common use of Inspections by Merck During POC Term Clause in Contracts

Inspections by Merck During POC Term. (i) During the SAV POC Term, to the extent Merck has not already conducted a quality audit and an EHS audit of the Collaboration SAV Manufacturing Facility(ies) identified by Moderna pursuant to Section 6.1(c) in the preceding [***] period, Merck shall have a reasonable opportunity to conduct a quality audit and EHS audit of such Collaboration SAV Manufacturing Facility(ies) prior to initiation of cGMP Manufacturing; provided, however, such [***] limitation shall not apply in the event that [***]. Quality audits under this Section may include an audit of [***]. (ii) At least [***] days prior to the anticipated expiration of the POC Term for a given Program, Merck, in each such instance, shall have the right, during normal business hours [***] and with reasonable advance notice, to [***] with respect to the applicable Collaboration Products, solely for the purposes of assisting Merck in determining [***]; [***]. Moderna will support such [***] by Merck by making appropriate resources available to provide the information, data, and records, and to answer questions from Merck. In connection with such [***]. With respect to any SAV Program, if Merck identifies any audit observations in connection with any audits under this Section 6.1(d)(ii), the Parties will discuss in good faith suitable approaches for correcting such observations and will prepare a plan for correcting such observations for such SAV Program; [***]. (iii) With respect to an SAV Program and an audit by Merck of Collaboration SAV Manufacturing Facility(ies) in accordance with Section 6.1(d)(i), if Merck identifies any audit observations, the Parties will discuss in good faith suitable approaches for correcting such observations and the Parties will prepare a plan for correcting such observations for such SAV Program, [***]. (iv) Notwithstanding Section 6.1(d)(i) and Section 6.1(d)(iii), the Parties hereby acknowledge and agree that Merck has conducted, as of the Amended Effective Date, a quality audit and EHS audit with respect to the Collaboration SAV Manufacturing Facility(ies) designated to date for the Manufacture of Collaboration SAV Products for the KRAS Program. As of the Amended Effective Date, as set forth on Schedule 6.1(d)(iv), Moderna and Merck have agreed to the timing and scope of the required corrective actions resulting from such quality and EHS audits. [***] Merck acknowledges that the batches of mRNA-5671 Manufactured by Moderna in such Collaboration SAV Manufacturing Facility(ies) are suitable, as of the Amended Effective Date, for use in Clinical Studies for the KRAS Program, subject to [***].