The Parties will negotiate and enter into a Safety Data Exchange Agreement for the Products in a form mutually agreed to before the Launch of the first Product. AYTU shall prepare all adverse drug experience reports to be filed with the FDA pursuant to 21 CFR §§ 314.80(b) and (c) and provide copies to TRIS prior to the date required to be filed pursuant to such regulations, and where practicable at least five (5) days prior to such date. AYTU as the Product NDA holder shall file such reports with the FDA. AYTU will comply with [Schedule 7.11] of the Asset Sale Agreement (dealing with pharmacovigilance) as if it were TRIS and provide to TRIS copies of all written communications provided to or by it by Former Owner and TRIS will provide to AYTU all information provided to it pursuant to such schedule by the Former Owner. Until May 31, 2019, AYTU will timely provide to TRIS, field alerts, warning letters and adverse event reports, and other information reasonably requested by TRIS to enable TRIS to comply with its monthly reporting obligations under the last sentence of [Section 7.12] of the Asset Sale Agreement.

No Material Adverse Event. Since December 31, 2022, there shall not have occurred any event, condition or state of facts which could reasonably be expected to result in a Material Adverse Event.

Notice of Material Adverse Event. As soon as possible and in any event within five (5) days after the occurrence thereof, written notice of any event or circumstance that could reasonably be expected to result in a Material Adverse Event;

Adverse Experiences. Prior to [[Organization A:Organization]] proceeding with the In-Licensing, ​ shall have responsibility (either itself or with the support of Third Party subcontractors) for communications with all Regulatory Authorities regarding the safety of the Lead Compound, including submitting or causing to be submitted to all Regulatory Authorities reports of adverse experiences and other required safety information and reports in accordance with all requirements of Applicable Laws. ​ shall provide a copy of any and all such reports and other required safety information to [[Organization A:Organization]] within […​…] after regulatory submission.

Adverse Claims. If at any time during the Term of this Agreement it appears that one or more private third parties may have a claim of economic interest or ownership in the Properties or the Lease Applications (or Leases acquired thereby), ALY may claim Force Majeure for a period of time equal to the time necessary to resolve such claim(s) of economic interest or ownership in the Properties or the Lease Applications (or Leases acquired thereby).

Audit Reports. Promptly upon receipt thereof, one copy of each audit report, if any, submitted to any and all Borrowers by independent public accountants in connection with any annual, interim, or special audit or examination made by them of the books of such Borrower.

Annual Reports. Within ninety (90) days after the close of each of the Company’s fiscal years (or such earlier date on which such statements are required to be filed with the Commission), annual audited consolidated financial statements for the Company and its Subsidiaries, including a consolidated balance sheet as of the end of such period, related statement of consolidated income, statement of consolidated shareowners’ equity, and statement of cash flows, all prepared in accordance with Agreement Accounting Principles, accompanied by an unqualified audit report of independent auditors acceptable to the Lenders;

SEC Reports. The ​ shall have filed all reports and other documents required to be filed by ​ under the U.S. federal securities laws through the Closing Date.

Furnish [[Organization B:Organization]], concurrently with the delivery of the financial statements referred to in [Sections 9.7, 9.8, and 9.9]9]9] with a Compliance Certificate signed by an Authorized Officer of Borrowing [[Organization B:Organization]] stating, to the best of his knowledge after reasonable due inquiry, that each Loan

Furnish [[Organization B:Organization]] as soon as available, but in any event within ten (10) days after the issuance thereof, without duplication, # with copies of such financial statements, reports and returns as each Loan Party shall send to its stockholders or members and # copies of all notices, reports, financial statements and other materials sent pursuant to any Junior Lien Documents.