Maintenance of Regulatory Approval. AYTU shall be responsible for all fees in connection with the transfer of a Product NDA (whether arising prior to or upon such transfer and whether relating to Tuzistra XR or CCP-08), including fees arising in connection with additional documents required to be filed prior to, in anticipation of or upon transfer of the NDA. AYTU shall be responsible for the PDUFA Program Fee for the 2019 FDA Fiscal Year and for the PDUFA Program Fees for all subsequent FDA Fiscal Years during the Term, it being understood that such PDUFA Program Fee for the 2019 FDA Fiscal Year has been paid by TRIS with respect to Tuzistra XR and as a result AYTU shall pay the same to TRIS on the Effective Date. Following such transfer of ownership of a Product NDA (whether relating to Tuzistra XR or CCP-08), AYTU shall during the Term of a Product, at its sole expense, be responsible for maintaining and shall use Commercially Reasonable Efforts to maintain the NDA for such Product (other than the DMFs with respect thereto), including the filing of all annual and other reports or filings required by the FDA or any other Governmental Authority, the performance and submission of stability studies on batches of such Product as may be required under FDA regulations (it being understood that such studies will be conducted by TRIS) and the preparation and filing of any notices, amendments or supplements as may be required to change or add another source of supply of the APIs for such Product and the payment of PDUFA Program Fees (in addition to the 2019 PDUFA Program Fee as aforesaid) and all other fees payable to the FDA (other than the PDUFA submission/application fee for CCP-08). To the extent not already held by TRIS, AYTU shall promptly provide TRIS (other than with respect to pharmacovigilance which will be governed by Section 2.4 and the Safety Data Exchange Agreement contemplated therein) with complete copies of all applications, submissions, filings and regulatory correspondence to or from the FDA or other Regulatory Authority relating to a Product. AYTU will file and maintain the Product drug listing under its labeler code and will submit all marketing materials to OPDP (formerly DDMAC) with a copy to TRIS. For the avoidance of doubt all post-marketing clinical trials and commitments with respect to Products shall be the sole responsibility, and at the sole cost and expense of AYTU. Notwithstanding anything to the contrary contained in this Agreement, changes to a Product NDA that relate in any respect to the information in TRIS’ DMF, as the same may be amended, shall be made solely as directed by TRIS and AYTU agrees to promptly make such changes and associated FDA filings as directed by TRIS. For the avoidance of doubt, if changes made or proposed to be made by TRIS in its DMF relating to CMC for a Product, are also required to be reflected in other parts of the NDA, or otherwise reported to the FDA, then AYTU will make such filings in the form and on the timetable requested by TRIS, at AYTU’s expense.

TRIS shall use Commercially Reasonable Efforts to # obtain Regulatory Approval of an NDA for CCP-08; and # interact with the FDA regarding such Product. TRIS, at all times until Regulatory Approval for such Product, shall remain the owner of the NDA for the Product. On a Fiscal Quarter basis during the Term until Regulatory Approval, and at such additional times as AYTU may reasonably request in writing, TRIS shall advise AYTU of the status of receipt of FDA approval of the NDA for such Product. Unless otherwise agreed to by the Parties in writing, TRIS shall bear the costs and expenses relating to the Development of the Product and obtaining any Regulatory Approval. Without limiting the generality of the foregoing, TRIS shall pay the human drug application and supplement fees, assessed under [Section 736(a)(1)] of the FD&C Act, related to the filing and prosecution of Regulatory Approval of the CCP-08 Product until the FDA’s granting of approval to Market the Product in the United States. TRIS will provide notice to AYTU within three Business Days of receipt of Regulatory Approval of CCP-08. Within ten (10) Business Days of TRIS’ delivery of such notice, AYTU shall pay to TRIS ​ in immediately available funds (“NDA Approval Milestone”). For the avoidance of doubt, TRIS shall be responsible for payment of all fees payable with regard to CCP-08 up to and including Regulatory Approval, including the NDA submission PDUFA fee for CCP-08, but excluding any PDUFA Program Fee assessed upon approval. Following receipt of the NDA Approval Milestone, and as consideration for the NDA Approval Milestone TRIS shall transfer the CCP-08 Product NDA to AYTU and shall # send to the FDA (with a copy to AYTU) any required properly executed forms (i.e., FDA Forms 356h and 1571, if applicable) and a letter transferring the NDA for such Product to AYTU and # transfer the TRIS Regulatory Documentation related to such Product, excluding any DMFs or the contents thereof to AYTU.