Common use of Tandem’s Testing and Regulatory Responsibilities Clause in Contracts

Tandem’s Testing and Regulatory Responsibilities. 4.1.1 Tandem will be responsible for performing and leading all regulatory testing and related tasks, including all Clinical Studies and all regulatory filings, for Combined System Implementations, including, as applicable the Tandem Diabetes Management Apps, but excluding DexCom CGM Apps, including all necessary related translations and all Clinical Studies required for all Regulatory Approvals, for the Combined Systems. 4.1.2 To the extent permitted by Applicable Laws and by the applicable Regulatory Authority, Tandem will, in the exercise of its commercially reasonable, good faith judgement and in a timely manner (and in any event with at least *** except where not reasonably feasible), *** with relevant Regulatory Authorities as necessary to support Regulatory Approval of the Combined System Implementations that are specific to *** (“Relevant Tandem Regulatory Meetings”). At the request of Xxxxxx, DexCom shall ***. Where reasonably feasible with the Regulatory Authority, Tandem shall *** reasonably in advance of such Relevant Tandem Regulatory Meeting. Tandem will endeavor to ***. Furthermore, in any meeting or teleconference with Regulatory Authorities (or portion thereof) that ***, Tandem shall (i) ***, and (ii) promptly (and in any event within ***) following the Relevant Tandem Regulatory Meeting, (a) *** and (b) ***, to the extent pertaining to ***. As soon as practicable following ***, the Parties shall ***.

Tandem’s Testing and Regulatory Responsibilities. 4.1.1 Tandem will be responsible for performing and leading all regulatory testing and related tasks, including all Clinical Studies and all regulatory filings, for Combined System Implementations, including, as applicable the Tandem Diabetes Management Apps, but excluding DexCom CGM Apps, including all necessary related translations and all Clinical Studies required for all Regulatory Approvals, for the Combined Systems. 4.1.2 To the extent permitted by Applicable Laws and by the applicable Regulatory Authority, Tandem will, in the exercise of its commercially reasonable, good faith judgement and in a timely manner (and in any event with at least [*** *] [***] except where not reasonably feasible), [*** *] [***] with relevant Regulatory Authorities as necessary to support Regulatory Approval of the Combined System Implementations that are specific to [*** *] (“Relevant Tandem Regulatory Meetings”). At the request of XxxxxxTandem, DexCom shall [***]. Where reasonably feasible with the Regulatory Authority, Tandem shall [*** *] reasonably in advance of such Relevant Tandem Regulatory Meeting. Tandem will endeavor to [***]. Furthermore, in any meeting or teleconference with Regulatory Authorities (or portion thereof) that [***], Tandem shall (i) [***], and (ii) promptly (and in any event within ***[five (5) days]) following the Relevant Tandem Regulatory Meeting, (a) [*** *] and (b) [***], to the extent pertaining to [***]. As soon as practicable following [***], the Parties shall [***].

Tandem’s Testing and Regulatory Responsibilities. 4.1.1 Tandem will be responsible for performing and leading all regulatory testing and related tasks, including all Clinical Studies and all regulatory filings, for Combined System ImplementationsSystems, including, as applicable the Tandem Diabetes Management Apps, but excluding DexCom CGM Apps, including all necessary related translations and all Clinical Studies required for all Regulatory Approvals, Approvals for the Combined Systems. 4.1.2 To the extent permitted by Applicable Laws and by the applicable Regulatory Authority, Tandem will, in the exercise of its commercially reasonable, good faith judgement and in a timely manner (and in any event with at least *** except where not reasonably feasible), *** with relevant Regulatory Authorities as necessary to support Regulatory Approval of the Combined System Implementations Systems that are specific to *** (“Relevant Tandem Regulatory Meetings”). At the request of Xxxxxx, DexCom shall ***. Where reasonably feasible with the Regulatory Authority, Tandem shall *** reasonably in advance of such Relevant Tandem Regulatory Meeting. Tandem will shall endeavor to ***. Furthermore, in any meeting or teleconference with Regulatory Authorities (or portion thereof) that ***, Tandem shall (i) ***, and (ii) promptly (and in any event within ***) * following the Relevant Tandem Regulatory Meeting, (a) *** and (b) ***, to the extent pertaining to ***. As soon as practicable following ***, the Parties shall ***.

Tandem’s Testing and Regulatory Responsibilities. 4.1.1 4.1.1. Tandem will be responsible for performing and leading all regulatory testing and related tasks, including all Clinical Studies and all regulatory filings, for Combined System ImplementationsSystems, including, as applicable the Tandem Diabetes Management Apps, but excluding DexCom CGM Apps, including all necessary related translations and all Clinical Studies required for all Regulatory Approvals, for the Combined Systems. 4.1.2 4.1.2. To the extent permitted by Applicable Laws and by the applicable Regulatory Authority, Tandem will, in the exercise of its commercially reasonable, good faith judgement and in a timely manner (and in any event with at least [*** *] [***] except where not reasonably feasible), [*** *] [***] with relevant Regulatory Authorities as necessary to support Regulatory Approval of the Combined System Implementations Systems that are specific to [*** *] (“Relevant Tandem Regulatory Meetings”). At the request of XxxxxxTandem, DexCom shall [***]. Where reasonably feasible with the Regulatory Authority, Tandem shall [*** *] reasonably in advance of such Relevant Tandem Regulatory Meeting. Tandem will shall endeavor to [***]. Furthermore, in any meeting or teleconference with Regulatory Authorities (or portion thereof) that [***], Tandem shall (i) [***], and (ii) promptly (and in any event within [***]) following the Relevant Tandem Regulatory Meeting, (a) [*** *] and (b) [***], to the extent pertaining to [***]. As soon as practicable following [***], the Parties shall [***].