The Lead Party shall be responsible for submitting and maintaining all such Regulatory Filings and shall act as the point of contact for regulatory communications with each applicable Regulatory Authority with respect to each Co-Funding Product. The Lead Party (or its designee) shall own all such regulatory materials, including all INDs and Approvals with respect to Co-Funding Products. Without limiting the foregoing, the Lead Party will be responsible for, and will use Commercially Reasonable Efforts in applying for, obtaining and maintaining the applicable Approval or other Registration Filing for each Co-Funding Product, subject to the oversight of the JSC. The Lead Party shall perform all such activities in accordance with the Plans and all Applicable Laws.

Regulatory Filings. As between the Parties, Lilly shall have the sole right and responsibility for, at its sole expense, # preparing (subject to Section 4.1.2), filing and maintaining all Regulatory Filings for Products in its own name in the Territory and # reporting to Regulatory Authorities all Adverse Events and Serious Adverse Events occurring in any Clinical Trial conducted by or on behalf of Lilly related to Products, to the extent required by Applicable Laws.

Regulatory Filings. To the extent permitted by Law, EISAI will promptly assign to [[EPIZYME:Organization]] all Regulatory Approvals, Regulatory Dossiers and Regulatory Materials for Licensed Products in the EISAI Territory. If EISAI is restricted under Law from transferring ownership of any of the foregoing items to [[EPIZYME:Organization]] (including in order to continue to conduct any transition activities as contemplated in this [Section 12.5.1], including the conduct of clinical Development activities, if applicable, pursuant to [Section 12.5.1(e)] above), EISAI shall grant [[EPIZYME:Organization]] (or its designee) a right of reference or use to such item (it being understood that EISAI shall use Commercially Reasonable Efforts to transfer the same to [[EPIZYME:Organization]] after the completion of such transition activities). EISAI shall take all actions reasonably necessary to effect such transfer or grant of right of reference or use to [[EPIZYME:Organization]], including by making such filings as may be required with Regulatory Authorities and other Governmental Authorities in the Territory that may be necessary to record such assignment or effect such transfer.

Regulatory Filings. Except as provided in [Section 8.1.2] above, as between the Parties, SAVARA shall be solely responsible for obtaining and maintaining such Regulatory Filings as are necessary for SAVARA to sell and/or distribute API Manufactured by GEMA or Products comprising or incorporating such API.

Regulatory Filings. The Development Plan shall include a coordinated Development and regulatory strategy, including the Parties’ respective roles in the development of the registration dossier and Regulatory Filings for the Products, and the countries in which Clinical Trials of the Products will occur. All costs associated with regulatory activities in connection with Regulatory Filings and obtaining MAA Approval for Products in the Licensee Territory shall be borne solely by Licensee.

Regulatory Filings. The Lead Regulatory Party for a country shall provide the other Party with a copy of all proposed material Regulatory Material submissions to be submitted to any Regulatory Authority in the country for a [[Unknown Identifier]] Co-Co Product for the other Party’s review and comment sufficiently in advance of, but in any event, unless not practicable, at least ​ prior to, the Lead Regulatory Party’s submission thereof, and the Lead Regulatory Party for the country shall reasonably consider incorporating any reasonable comments received from the other Party into such Regulatory Materials.

Regulatory Filings. Each Party shall be solely responsible for preparing, maintaining, formatting, and filing Regulatory Filings for Product(s) in its respective Territory; provided that # to the extent reasonably practicable and subject to Section 3.3.2, any such Regulatory Filing shall be aligned with the Global Registration Strategy, and # Ono shall use Commercially Reasonable Efforts to submit any MAA in the Ono Territory after receiving and considering in good faith [[Forty Seven:Organization]]’s comments on the content of such MAA filing. Each Party shall from time to time provide the other Party with an update on the status of such Regulatory Filings and any material correspondences relating thereto.

Regulatory Filings. For the purpose of this Agreement, Newsoara shall be responsible for, and be the owner of all Regulatory Filings in any Region of the Territory in connection with the Compound or Products. Newsoara will and will require its Related Parties to keep vTv informed of regulatory developments related to the Products in the Territory and will promptly notify vTv in writing of any decision by a Regulatory Authority in the Territory regarding any Product. Newsoara will and will require its Related Parties to notify vTv of any Regulatory Filings submitted to or received from any Regulatory Authority in the Territory and will provide vTv copies thereof (along with a brief summary in English if the original language is not English) within five (5) days after submission or receipt. vTv will notify Newsoara of any Regulatory Filings of vTv or its Related Parties submitted to or received from any Regulatory Authority outside the Territory and will provide Newsoara copies thereof (along with a brief summary in English if the original language is not English) within five (5) days after submission or receipt.

Regulatory Filings. Within 30 days following the Effective Date, ARScience Bio will assign to Coya all Regulatory Filings filed by ARScience Bio or any of its Affiliates or licensees with any Regulatory Authority that relate to the Licensed Compound and all associated supporting documents and data, including the Regulatory Filings described in [Schedule 3.4.2] (Regulatory Filings).

Regulatory Filings. Counterparty covenants that it will make all regulatory filings that it is required by law or regulation to make with respect to the Transaction including, without limitation, as may be required by [Section 13] or Section 16 under the Exchange Act and, assuming the accuracy of Counterparty’s Repurchase Notices (as described under “Repurchase Notices” below) any sales of the Recycled Shares will be in compliance therewith.