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. 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.

Assignment of Regulatory Filings. Unless otherwise agreed by the Parties, no later than ​, if ITEOS holds, in its name, any Regulatory Filings (including INDs) with respect to any Licensed Products as of such date, unless otherwise agreed by the Parties, ITEOS will assign to GSK all rights, title, and interests in and to each such Regulatory Filing (including INDs) filed in the Territory, and will transfer to GSK copies (in electronic or other format) of those Regulatory Filings owned by ITEOS or its Affiliates that are necessary to assign such INDs to GSK, provided, however, that ITEOS will not assign Regulatory Filings (including INDs) to GSK regarding Additional Development Activities being conducted by ITEOS in accordance with [Section 3.4] (Additional Development) until # such Additional Development Activities are added to the Global Development Plan pursuant to [Section 3.4.3(b)] (Proof of Concept Data) or # the applicable Regulatory Approval is obtained in connection with such Additional Development Activities, as described in [Section 3.4.3(c)] (Receipt of Regulatory Approval), in each case, which assignment of Regulatory Filings shall be in a manner and on the timelines to be agreed by the Parties.

Simultaneous with the execution of this Agreement, [[DURECT:Organization]] shall transfer and assign to INNOCOLL IND No. 66,086, NDA No. 204803, any supplements thereof and all correspondence to or from and all submissions to the FDA with respect to the IND and/or NDA. To the extent there are other Regulatory Materials Controlled by [[DURECT:Organization]] and obtained or maintained by [[DURECT:Organization]] that are necessary or reasonably useful for the Exploitation of Licensed Product in the Field in the Licensed Territory, the Parties will take reasonable steps to ensure that INNOCOLL has access to such Regulatory Materials. Accordingly, from and after such transfer and assignment, INNOCOLL shall use ​, at its sole cost, to maintain the NDA Approval. For clarity, [[DURECT:Organization]] shall have no obligation to transfer or assign the ​ DMF. Following the assignment of the above Regulatory Materials, ​ shall have the right to list or delist applicable Patents, including Licensed Patents, in the FDA Approved Drug Product List with Therapeutic Equivalence Evaluations (the “Orange Book”) for the Licensed Product(s).

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. 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. 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.

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. 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. 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.