Common use of Diligence; Standards of Conduct Clause in Contracts

Diligence; Standards of Conduct. During the Licensed Period, Shionogi, itself or with any of its Related Parties, will use Commercially Reasonable Efforts to (a) perform the Development activities specified under each Development Plan approved by the JSC for a specific Licensed Product in the Field throughout the Shionogi Territory; and (b) Develop the T0 Products in the Lead Indication and in each Additional Indication throughout the Shionogi Territory. Without limiting the foregoing, Shionogi or any of its Related Parties shall (i) file a request for commencement of Clinical Studies with the PMDA for the T0 Products in the Field in Japan within [***] ([***]) months after the Option Exercise Date; (ii) Initiate Clinical Studies for the T0 Products in the Field in Japan within [***] ([***]) months after obtaining an agreement on the Clinical Study protocol for the T0 Products in the Field from PMDA, (iii) file a request for Regulatory Approval for the T0 Products in the Field in Japan within [***] ([***]) months after the last patient out of the first registration study performed for the T0 Products in the Field in Japan as required, and (iv) file a request for Regulatory Approval for the T0 Products in the Field in Taiwan within [***] ([***]) months after the Regulatory Approval is obtained in Japan on the assumption that the procedure to obtain the Regulatory Approval for the T0 Products in Taiwan is substantially the same as that for pharmaceutical products. The Parties shall discuss, in good faith at the JSC, the requirement of item (iv) if the procedure to obtain the Regulatory Approval for the T0 Products has been confirmed by the JSC and is substantially different from that for pharmaceutical products in Taiwan.

Diligence; Standards of Conduct. During With respect to each Licensed Product that is the Licensed Periodsubject of a Shionogi Territory Commercialization Plan (each, Shionogia “Commercialized Product”), itself Shionogi or with any of its Related Parties, Parties will use Commercially Reasonable Efforts to (a) perform the Development all Commercialization activities specified under each Development Plan approved by the JSC for a specific Licensed such Commercialized Product in the Field throughout the accordance with such Shionogi Territory; Territory Commercialization Plan and (b) Develop obtain Pricing Approval in the T0 Products Shionogi Territory for such Commercialized Product within a reasonable time after having received Regulatory Approval for such Commercialized Product in, as applicable, the Lead Indication or any Additional Indication that is the subject of such Regulatory Approval, and (c) begin to Commercialize such Commercialized Product in the Lead Indication and or such Additional Indication, as applicable, in each Additional Indication throughout the Shionogi TerritoryTerritory within [***] ([***]) months of having obtained such Pricing Approval. Without limiting the foregoing, Shionogi or any of its Related Parties shall (i) file a request for commencement of Clinical Studies with the PMDA for the T0 Products seek Pricing Approval in the Field in Japan within [***] ([***]) months after the Option Exercise Date; of receipt of Regulatory Approval for such Commercialized Product in Japan, (ii) Initiate Clinical Studies for commercially launch the T0 Products Product in the Field in Japan within [***] ([***]) months after obtaining an agreement on the Clinical Study protocol of receipt of Pricing Approval for the T0 Products such Commercialized Product in the Field from PMDAJapan, and (iii) file a request for Regulatory Approval for commercially launch the T0 Products in the Field in Japan within [***] ([***]) months after the last patient out of the first registration study performed for the T0 Products in the Field in Japan as required, and (iv) file a request for Regulatory Approval for the T0 Products Product in the Field in Taiwan within [***] ([***]) months after all of the Regulatory Approval is obtained in Japan on the assumption that the procedure to obtain the following requirements are fulfilled: (x) receipt of Regulatory Approval for the T0 Products Product in the Field in Taiwan; (y) the infrastructure setup for operating the T0 Product in the Field in Taiwan is substantially available to Shionogi (for clarity, such infrastructure may be located in or outside of the same as that Shionogi Territory); and (z) completion of the localized commercial versions of the T0 Product for pharmaceutical productsTaiwan. The In case Pricing Approval for such Commercialized Product is unable to be obtained in the Field in the Shionogi Territory, the Parties shall discuss, discuss in good faith at further Commercialization of such Commercial Product in the JSC, Field in the requirement of item (iv) if the procedure to obtain the Regulatory Approval for the T0 Products has been confirmed by the JSC and is substantially different from that for pharmaceutical products in TaiwanShionogi Territory.

Diligence; Standards of Conduct. During the Licensed Period, Shionogi, itself or with any of its Related Parties, will use Commercially Reasonable Efforts to (a) perform the Development activities specified under each Development Plan approved by the JSC for a specific Licensed Product in the Field throughout the Shionogi Territory; and (b) Develop the T0 TO Products in the Lead Indication and in each Additional Indication throughout the Shionogi Territory. Without limiting the foregoing, Shionogi or any of its Related Parties shall (i) file a request for commencement of Clinical Studies with the PMDA for the T0 TO Products in the Field in Japan within [***] ([***]) months after the Option Exercise Date; (ii) Initiate Clinical Studies for the T0 TO Products in the Field in Japan within [***] ([***]) months after obtaining an agreement receipt of feedback on the Clinical Study protocol design for the T0 TO Products in the Field from PMDA, (iii) file a request for Regulatory Approval for the T0 TO Products in the Field in Japan within [***] ([***]) months after the last patient out Completion of the first registration study performed Development Data Set for the T0 TO Products in the Field in Japan as requiredrequired by PMDA, and (iv) file a request for Regulatory Approval for the T0 TO Products in the Field in Taiwan within [***] ([***]) months after the Regulatory Approval is obtained in Japan on the assumption that the procedure to obtain the Regulatory Approval for the T0 TO Products in Taiwan is substantially the same as that for pharmaceutical products. The Parties shall discuss, in good faith at the JSC, the requirement of item (iv) if the procedure to obtain the Regulatory Approval for the T0 TO Products has been confirmed by the JSC and is substantially different from that for pharmaceutical products in Taiwan.

Diligence; Standards of Conduct. During With respect to each Licensed Product that is the Licensed Periodsubject of a Shionogi Territory Commercialization Plan (each, Shionogia “Commercialized Product”), itself Shionogi or with any of its Related Parties, Parties will use Commercially Reasonable Efforts to (a) perform the Development all Commercialization activities specified under each Development Plan approved by the JSC for a specific Licensed such Commercialized Product in the Field throughout the accordance with such Shionogi Territory; Territory Commercialization Plan and (b) Develop obtain Pricing Approval in the T0 Products Shionogi Territory for such Commercialized Product within a reasonable time after having received Regulatory Approval for such Commercialized Product in, as applicable, the Lead Indication or any Additional Indication that is the subject of such Regulatory Approval, and (c) begin to Commercialize such Commercialized Product in the Lead Indication and or such Additional Indication, as applicable, in each Additional Indication throughout the Shionogi TerritoryTerritory within [***] ([***]) months of having obtained such Pricing Approval. Without limiting the foregoing, Shionogi or any of its Related Parties shall (i) file a request for commencement of Clinical Studies with the PMDA for the T0 Products seek Pricing Approval in the Field in Japan within [***] ([***]) months after the Option Exercise Date; of receipt of Regulatory Approval for such Commercialized Product in Japan, (ii) Initiate Clinical Studies for commercially launch the T0 Products TO Product in the Field in Japan within [***] ([***]) months after obtaining an agreement on the Clinical Study protocol of receipt of Pricing Approval for the T0 Products such Commercialized Product in the Field from PMDAJapan, and (iii) file a request for Regulatory Approval for commercially launch the T0 Products in the Field in Japan within [***] ([***]) months after the last patient out of the first registration study performed for the T0 Products in the Field in Japan as required, and (iv) file a request for Regulatory Approval for the T0 Products TO Product in the Field in Taiwan within [***] ([***]) months after all of the Regulatory Approval is obtained in Japan on the assumption that the procedure to obtain the following requirements are fulfilled: (x) receipt of Regulatory Approval for the T0 Products TO Product in the Field in Taiwan; (y) the infrastructure setup for operating the TO Product in the Field in Taiwan is substantially available to Shionogi (for clarity, such infrastructure may be located in or outside of the same as that Shionogi Territory); and (z) completion of the localized commercial versions of the TO Product for pharmaceutical productsTaiwan. The In case Pricing Approval for such Commercialized Product is unable to be obtained in the Field in the Shionogi Territory, the Parties shall discuss, discuss in good faith at further Commercialization of such Commercial Product in the JSC, Field in the requirement of item (iv) if the procedure to obtain the Regulatory Approval for the T0 Products has been confirmed by the JSC and is substantially different from that for pharmaceutical products in TaiwanShionogi Territory.