Consents and Approvals. Each Permal Entity # shall have made all filings or declarations, provided all notices, obtained all authorizations, consents, waivers, approvals or exemptions, and taken all other actions required to be made, provided, obtained or taken by such Permal Entity to consummate the transactions, in each case, as set forth on Section 8.3(b) of the Permal Disclosure Schedule and # shall have delivered true, complete and correct copies of such filings, declarations, notices, authorizations, consents, waivers, approvals, exemptions and evidence of such other actions to the EnTrust Contributor.

Consents and Approvals. The execution, delivery and performance by Guarantor of this Guaranty Agreement do not require any consents or approvals of any governmental authority or any other person.

such actions, consents and approvals the failure of which to be obtained or made would not reasonably be expected to have a Material Adverse Effect; or

There shall not have been any material adverse change in the business, condition, assets, liabilities, operations or financial performance of [[Organization B:Organization]] since the date of this Agreement as determined by Cosmos in its discretion. Cosmos shall be satisfied in all respects with the results of its due diligence review of [[Organization B:Organization]]

Material Adverse Effect: # A material adverse change in, or a material adverse effect upon, the operations,

Due Qualification. It is duly qualified to do business, is in good standing as a foreign entity (or is exempt from such requirements) and has obtained all necessary licenses and approvals in each jurisdiction in which the performance of this Agreement requires such qualification, licenses or approvals, except where the failure to so qualify or obtain licenses or approvals would not reasonably be expected to have a Material Adverse Effect.

Adverse Change. A material adverse change occurs in Borrower’s financial condition, or Lender believes the prospect of payment or performance of the Loan is impaired.

“Material Adverse Change” means any material adverse change in the business, assets, operations or condition (financial or otherwise) of the Borrower and its Subsidiaries taken as a whole.

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.

Material Adverse Effect. The Agents shall have determined, in their reasonable judgment, that no event or development shall have occurred since December 31, 2017, which could reasonably be expected to have a Material Adverse Effect.