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 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 TO Products in the Field in Japan within [***] ([***]) months after the Option Exercise Date; (ii) Initiate Clinical Studies for the TO Products in the Field in Japan within [***] ([***]) months after receipt of feedback on the Clinical Study design for the TO Products in the Field from PMDA, (iii) file a request for Regulatory Approval for the TO Products in the Field in Japan within [***] ([***]) months after Completion of the Development Data Set for the TO Products in the Field in Japan as required by PMDA, and (iv) file a request for Regulatory Approval for the 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 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 TO Products has been confirmed by the JSC and is substantially different from that for pharmaceutical products in Taiwan.
Appears in 1 contract
Samples: Option and Collaboration Agreement (Social Capital Suvretta Holdings Corp. I)
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 TO 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 TO 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 TO Products T0 Product in the Field in Japan within [***] ([***]) months after of receipt of feedback on the Clinical Study design Pricing Approval for the TO Products such Commercialized Product in the Field from PMDAJapan, and (iii) file a request for Regulatory Approval for commercially launch the TO Products in the Field in Japan within [***] ([***]) months after Completion of the Development Data Set for the TO Products in the Field in Japan as required by PMDA, and (iv) file a request for Regulatory Approval for the TO Products T0 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 TO Products T0 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 JSCField in the Shionogi Territory.
4. The following sentence is hereby added to the end of paragraph 1.1.13: For the avoidance of doubt, the requirement term “Akili Licensed Know-How” includes, but is not limited to, T0 Product data from Akili’s clinical studies in the United States as well as Akili’s Python libraries and tools that enable access to and manipulation of item such data.
5. The following sentence is hereby added to the end of paragraph 11.2.2: Further, the Parties agree that the term “New Akili IP” shall include, but is not limited to, any derivatives of or improvements to any Akili Licensed Technology, regardless of whether any such derivatives or improvements are first developed or conceived: (ivi) if the procedure to obtain the Regulatory Approval for the TO Products has been confirmed solely by Akili; (ii) solely by Shionogi; or (iii) jointly by Shionogi and Akili.
6. Paragraph 11.2.3.3 is hereby deleted in its entirety and shall no longer have any force or effect.
7. Paragraph 1.1.81 (“Improvement IP”) is hereby deleted in its entirety and shall no longer have any force or effect.
8. Paragraph 11.2.3.4 is hereby deleted in its entirety and replaced by the JSC and is substantially different from that for pharmaceutical products in Taiwan.following:
Appears in 1 contract
Samples: Option and Collaboration Agreement (Social Capital Suvretta Holdings Corp. I)
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 TO 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 TO T0 Products in the Field in Japan within [***] ([***]) months after the Option Exercise Date; (ii) Initiate Clinical Studies for the TO T0 Products in the Field in Japan within [***] ([***]) months after receipt of feedback obtaining an agreement on the Clinical Study design protocol for the TO T0 Products in the Field from PMDA, (iii) file a request for Regulatory Approval for the TO T0 Products in the Field in Japan within [***] ([***]) months after Completion the last patient out of the Development Data Set first registration study performed for the TO T0 Products in the Field in Japan as required by PMDArequired, and (iv) file a request for Regulatory Approval for the TO 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 TO 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 TO T0 Products has been confirmed by the JSC and is substantially different from that for pharmaceutical products in Taiwan.
3. Paragraph 4.3 is hereby deleted in its entirety and replaced by the following paragraph:
Appears in 1 contract
Samples: Option and Collaboration Agreement (Social Capital Suvretta Holdings Corp. I)
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 TO 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 TO 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 TO Products Product in the Field in Japan within [***] ([***]) months after of receipt of feedback on the Clinical Study design Pricing Approval for the TO Products such Commercialized Product in the Field from PMDAJapan, and (iii) file a request for Regulatory Approval for commercially launch the TO Products in the Field in Japan within [***] ([***]) months after Completion of the Development Data Set for the TO Products in the Field in Japan as required by PMDA, and (iv) file a request for Regulatory Approval for the TO 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 TO Products 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 TO Products has been confirmed by the JSC and is substantially different from that for pharmaceutical products in TaiwanShionogi Territory.
Appears in 1 contract
Samples: Option and Collaboration Agreement (Social Capital Suvretta Holdings Corp. I)