Common use of Preparation of Regulatory Materials Clause in Contracts

Preparation of Regulatory Materials. (a) Licensee shall have the sole right and responsibility, and shall exercise Commercially Reasonable Efforts, to prepare, obtain, and maintain, as applicable, the Regulatory Materials in the Territory, including the Product INDs and other submissions, and to conduct communications with the relevant Regulatory Authorities, related to or needed for the Commercialization of Product in the Field in the Territory. Notwithstanding the foregoing, Takeda or its applicable Affiliate, or sublicensees, any of their Third Party contractors, will be solely responsible for all Regulatory Materials related to (i) the Designated Clinical Trial, and any other Clinical Trials in the Territory consented to by Licensee pursuant to the last sentence of Section 4.1, (ii) Takeda’s, or any of its Affiliates or sublicensees’ or any of their Third Party contractors’ Development or Manufacture activities in the Territory. Except with respect to the Designated Clinical Trial, and any other Clinical Trials in the Territory consented to by Licensee pursuant to the last sentence of Section 4.1, all Product INDs generated after the Effective Date with respect to the Product in the Field in the Territory under this Agreement shall be owned by, and shall be the sole property and held in the name of, Licensee or its designee. (b) Licensee shall provide Takeda with an opportunity to review and comment on [***] in each case reasonably in advance of when Licensee or any of its Affiliates or sublicensees intends to submit such Regulatory Materials to the applicable Regulatory Authority. Takeda shall provide its comments within [***], or such other period of time mutually agreed to by the Parties. Licensee shall consider in good faith any such comments of Takeda. Licensee shall provide Takeda with a copy in electronic form of all material Regulatory Materials filed related to the use of the Products in the Field. Licensee shall be the MAH with respect to Regulatory Approvals in the Territory. Takeda, its Affiliates, and/or their sublicensees or designees shall be the MAH for any and all Regulatory Approvals outside of the Territory. (c) Notwithstanding the above, Takeda shall file an application for United States Adopted Name (USAN) at its own expense.

Preparation of Regulatory Materials. (a) Licensee shall have The regulatory strategy for the sole right and responsibility, and shall exercise Commercially Reasonable Efforts, to prepare, obtain, and maintain, as applicable, Takeda Territory will be consistent with the overall objectives of facilitating Regulatory Approval of the Vaccine in the Takeda Territory in accordance with the Development Plan. All Regulatory Materials in the Territory, (including the Product INDs and other submissions, and to conduct communications with the relevant Regulatory Authorities, related to or needed for the Commercialization of Product in the Field in the Territory. Notwithstanding the foregoing, Takeda or its applicable Affiliate, or sublicensees, any of their Third Party contractors, will be solely responsible for all Regulatory Materials related to (iApprovals) the Designated Clinical Trial, and any other Clinical Trials in the Territory consented to generated by Licensee pursuant to the last sentence of Section 4.1, (ii) Takeda’s, or any of its Affiliates or sublicensees’ or any of their Third Party contractors’ Development or Manufacture activities in the Territory. Except Takeda with respect to the Designated Clinical Trial, and any other Clinical Trials Vaccine in the Territory consented to by Licensee pursuant to the last sentence of Section 4.1, all Product INDs generated after the Effective Date with respect to the Product in the Field in the Takeda Territory under this Agreement shall be owned by, and shall be the sole property and held in the name of, Licensee Takeda or its designee. As of the Effective Date, Takeda shall have the sole responsibility and discretion, with respect to ▇▇▇▇▇▇▇ in the Takeda Territory, to: (i) develop and implement the overall regulatory strategy; (ii) prepare all Regulatory Materials, including to obtain and maintain all Regulatory Filings and Regulatory Approvals; and (iii) conduct all meetings and other communications with the Regulatory Authorities, including all discussions with MHLW or PMDA on regulatory pathway toward earliest possible marketing authorization. (b) Licensee Takeda shall provide Takeda Novavax with an opportunity to review and comment on [***] in each case all material Regulatory Filings reasonably in advance of when Licensee or any of its Affiliates or sublicensees Takeda intends to submit such Regulatory Materials to the applicable Regulatory AuthorityFiling. Takeda Novavax shall provide its comments within [***]] (provided that DB2/ 50302435.21 Takeda shall notify Novavax in writing [***] before submitting any such Regulatory Filing to Novavax for comment), or such other period of time mutually agreed to by the Parties. Licensee Parties or reasonably requested by ▇▇▇▇▇▇ and ▇▇▇▇▇▇ shall consider in good faith give due consideration to any such comments of Takeda. Licensee shall provide Takeda with a copy in electronic form of all material Regulatory Materials filed related to the use of the Products in the Field. Licensee shall be the MAH with respect to Regulatory Approvals in the Territory. Takeda, its Affiliates, and/or their sublicensees or designees shall be the MAH for any and all Regulatory Approvals outside of the Territoryprovided by ▇▇▇▇▇▇▇. (c) Notwithstanding To the aboveextent not prohibited by Applicable Laws and not expressly prohibited by the applicable Regulatory Authority, each Party shall notify the other Party within [***] after making or receiving any request for a meeting or substantive telephone conference call with a Regulatory Authority in a Reference Country, European Economic Area (EEA) or the Takeda Territory with respect to any Regulatory Filings related to the Vaccine. To the extent not prohibited by Applicable Laws and not expressly prohibited by the applicable Regulatory Authority, the other Party shall have the right to have one (1) employee observe, at its cost and expense, any such meeting or conference call. The foregoing rights and obligations apply with respect to meetings or conferences initiated by Novavax, Takeda or by the FDA or the PMDA. To the extent not prohibited by Applicable Laws and not expressly prohibited by the applicable Regulatory Authority in a Reference Country, European Economic Area (EEA) or the Takeda Territory, each Party shall file an application for United States Adopted Name promptly furnish the other Party with copies of all substantive correspondence it has had with a Regulatory Authority in a Reference Country, European Economic Area (USANEEA) at its own expenseor the Takeda Territory, and contact reports concerning substantive conversations or minutes from any substantive meetings with a Regulatory Authority in a Reference Country, European Economic Area (EEA) or the Takeda Territory with respect to the Vaccine. Takeda shall be the holder of all Regulatory Approvals (including the MAA) in the Takeda Territory. Novavax shall be the holder of all Regulatory Approvals in the Novavax Territory.

Preparation of Regulatory Materials. 94065460_6 (a) Licensee shall have The regulatory strategy for the sole right and responsibility, and shall exercise Commercially Reasonable Efforts, to prepare, obtain, and maintain, as applicable, Takeda Territory will be consistent with the overall objectives of facilitating Regulatory Approval of the Vaccine in the Takeda Territory in accordance with the Development Plan. All Regulatory Materials in the Territory, (including the Product INDs and other submissions, and to conduct communications with the relevant Regulatory Authorities, related to or needed for the Commercialization of Product in the Field in the Territory. Notwithstanding the foregoing, Takeda or its applicable Affiliate, or sublicensees, any of their Third Party contractors, will be solely responsible for all Regulatory Materials related to (iApprovals) the Designated Clinical Trial, and any other Clinical Trials in the Territory consented to generated by Licensee pursuant to the last sentence of Section 4.1, (ii) Takeda’s, or any of its Affiliates or sublicensees’ or any of their Third Party contractors’ Development or Manufacture activities in the Territory. Except Takeda with respect to the Designated Clinical Trial, and any other Clinical Trials Vaccine in the Territory consented to by Licensee pursuant to the last sentence of Section 4.1, all Product INDs generated after the Effective Date with respect to the Product in the Field in the Takeda Territory under this Agreement shall be owned by, and shall be the sole property and held in the name of, Licensee Takeda or its designee. As of the Effective Date, Takeda shall have the sole responsibility and discretion, with respect to Vaccine in the Takeda Territory, to: (i) develop and implement the overall regulatory strategy; (ii) prepare all Regulatory Materials, including to obtain and maintain all Regulatory Filings and Regulatory Approvals; and (iii) conduct all meetings and other communications with the Regulatory Authorities, including all discussions with MHLW or PMDA on regulatory pathway toward earliest possible marketing authorization. (b) Licensee Takeda shall provide Takeda Novavax with an opportunity to review and comment on [***] in each case all material Regulatory Filings reasonably in advance of when Licensee or any of its Affiliates or sublicensees Takeda intends to submit such Regulatory Materials to the applicable Regulatory AuthorityFiling. Takeda Novavax shall provide its comments within [***]] (provided that Takeda shall notify Novavax in writing [***] before submitting any such Regulatory Filing to Novavax for comment), or such other period of time mutually agreed to by the Parties. Licensee Parties or reasonably requested by Takeda and Takeda shall consider in good faith give due consideration to any such comments of Takeda. Licensee shall provide Takeda with a copy in electronic form of all material Regulatory Materials filed related to the use of the Products in the Field. Licensee shall be the MAH with respect to Regulatory Approvals in the Territory. Takeda, its Affiliates, and/or their sublicensees or designees shall be the MAH for any and all Regulatory Approvals outside of the Territoryprovided by Novavax. (c) Notwithstanding To the aboveextent not prohibited by Applicable Laws and not expressly prohibited by the applicable Regulatory Authority, each Party shall notify the other Party within [***] after making or receiving any request for a meeting or substantive telephone conference call with a Regulatory Authority in a Reference Country, European Economic Area (EEA) or the Takeda Territory with respect to any Regulatory Filings related to the Vaccine. To the extent not prohibited by Applicable Laws and not expressly prohibited by the applicable Regulatory Authority, the other Party shall have the right to have one (1) employee observe, at its cost and expense, any such meeting or conference call. The foregoing rights and obligations apply with respect to meetings or conferences initiated by Novavax, Takeda or by the FDA or the PMDA. To the extent not prohibited by Applicable Laws and not expressly prohibited by the applicable Regulatory Authority in a Reference Country, European Economic Area (EEA) or the Takeda Territory, each Party shall file an application for United States Adopted Name promptly furnish the other Party with copies of all substantive correspondence it has had with a Regulatory Authority in a Reference Country, European Economic Area (USANEEA) at its own expenseor the Takeda Territory, and contact reports concerning substantive conversations or minutes from any substantive meetings with a Regulatory Authority in a Reference Country, European Economic Area (EEA) or the Takeda Territory with respect to the Vaccine. Takeda shall be the holder of all Regulatory Approvals (including the MAA) in the Takeda Territory. Novavax shall be the holder of all Regulatory Approvals in the Novavax Territory.