Atea shall also be solely responsible for all regulatory affairs related to the conduct of the Atea Ongoing Studies until hand-over of responsibility therefor to Roche as determined by the JSC, any Unilateral Studies conducted by Atea in the Roche Territory, and all Clinical Studies of Products in the Roche Territory for the Retained Indications. Atea shall provide reasonable advance notice of any meeting with any Regulatory Authority in the Roche Territory related to the Atea Ongoing Studies or Unilateral Studies conducted by Atea, and Roche shall have the right, at its own discretion, to participate in any such meeting with Regulatory Authorities in the Roche Territory.

The term “Atea Ongoing Studies” shall mean the non-clinical studies and Clinical Studies that are being conducted by Atea with respect to Compounds and Products as of the Effective Date, ​. The Atea Ongoing Studies are described in [Appendix 1.9].

Atea shall have the responsibility for supplying API for technical development, as well as for clinical supply of the Products for the Field in the Territory for ​, and ​ of such supply by Atea, other than for the Atea Ongoing Studies and any Unilateral Study conducted by Atea, shall be ​. Notwithstanding the foregoing, Roche will have the right to take over any part of the manufacture and supply of the Product for the Field in the Roche Territory at any time during ​. The Parties will meet during ​ to discuss and decide on a hand-over plan of supply responsibilities in order to ensure a seamless continuation of manufacturing and supply beyond ​.

Ongoing Clinical Studies. ​ shall remain responsible for and shall complete ​ all ongoing Clinical Studies as of the Effective Date that are listed in EXHIBIT 3, including all analysis and reports that are reasonably necessary to obtain, extend or update the Marketing Authorization of the Product with the EMA, and shall remain responsible for contracting with and managing any Third Party that may be involved with such Clinical Studies (each, an “Ongoing Clinical Study”).

Roche shall also be solely responsible for all regulatory affairs related to the conduct of any Unilateral Studies conducted by Roche in the Atea Territory. Roche shall provide reasonable advance notice of any meeting with any Regulatory Authority in the Atea Territory related to the Unilateral Studies conducted by Roche, and Atea shall have the right, at its own discretion, to participate in any such meeting with Regulatory Authorities in the Atea Territory.

Atea shall, ​, use Commercially Reasonable Efforts to conduct and complete the Atea Ongoing Studies. Atea shall provide Roche ​ updates at interim analysis points and at least once ​ regarding the progress and status of the Atea Ongoing Studies, including ​.

​, after ​, Atea will remain responsible, at its own expense, for the manufacture and supply of clinical supplies of the Products for any Unilateral Study conducted by Atea and any Atea Ongoing Studies, and Roche shall be responsible at its own expense for the manufacture and supply of clinical supplies of the Products for sites included in the Clinical Studies conducted pursuant to the Global Development Plan other than any Atea Ongoing Studies, and for all sites for any Unilateral Study conducted by Roche. Notwithstanding the foregoing, the Parties will use Commercially Reasonable Efforts to ensure that the clinical supply of Products for use in the Field is obtained in a manner that is cost efficient and practical, which may include utilizing the other Party or the other Party’s CMO or other Third Manufacturer, as applicable.

Roche shall have the right and the responsibility for all regulatory affairs related to Products in the Roche Territory, including the preparation and filing of applications for Regulatory Approval in the Roche Territory (other than for Unilateral Studies, Clinical Studies for the Retained Indications and, until hand-over of responsibility to Roche as determined by the JSC, Atea Ongoing Studies, in each case conducted by Atea in the Roche Territory). Atea shall have the right to participate in all regulatory interactions, as well as in the preparations therefor, as an observer, where permitted by such Regulatory Authority. All regulatory filings for all Products in all countries of the Roche Territory (other than regulatory filings for the Atea Ongoing Studies conducted by Atea in the Roche Territory prior to hand-over, and all Clinical Studies for the Retained Indications) and all data related thereto shall be owned by Roche, its Affiliates or licensees.

The term “HCV Combination Studies” shall mean non-clinical studies, Clinical Studies, Post-Approval Commitment Studies and Phase IV Studies conducted by Atea that relate solely to the HCV Combination Use, ​.

From time to time as agreed by the JSC, Roche shall transfer to Atea # copies of all relevant historical clinical data for the Product in Roche’s possession or control, # copies of all material correspondence with the Regulatory Authorities for the Product in the Field in the Roche Territory, # copies of regulatory dossiers containing information necessary or useful to Atea in connection with its regulatory filings for all Products, including, but not limited to clinical trial dossiers, regulatory correspondence, Regulatory Authority meeting minutes and study reports from completed non-clinical and clinical studies, and # comprehensive electronic Clinical Study, Post-Approval Commitment Study and Phase IV Study data relevant to the Products in an appropriate format. For all completed study reports so transferred to Atea, Roche shall provide necessary documentation to confirm data reliability, including, but not limited to original author signatures, raw data lists, GLP and GCP compliance information. Roche shall assist Atea in conducting any required GMP audit related to the above-mentioned documentation. Atea shall have the right to use all data and documents provided to Atea under this paragraph in its own filings and interactions with Regulatory Authorities for the Product in the Field in the Atea Territory, and for Unilateral Studies, Clinical Studies for the Retained Indications, and Atea Ongoing Studies until hand-over of responsibility to Roche, in each case conducted by Atea in the Roche Territory, also in the Roche Territory.