Material Adverse Effect. A Material Adverse Effect shall have occurred, as determined by [[Organization B:Organization]] in its sole good faith discretion and not been waived in writing; or

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 Parent and the Company shall promptly advise the Purchaser in writing of the occurrence of any matter or event occurring on or after the date of this Agreement and prior to each Closing that may reasonably be expected to result in a Material Adverse Effect.

No Adverse Amendments. The Company shall not amend, alter, waive or repeal any provision (including by merger, consolidation, division, transfer or conveyance of all or substantially all of its assets or otherwise) of the A&R LPA, Certificate of Designations, or any similar organizational documents of the Company or any Subsidiary, if such amendment, alteration, waiver or repeal would adversely affect the rights, of any Holder.

There is no action, suit, proceeding, or arbitration (irrespective of whether purportedly on behalf of any Loan Party) at law or in equity, or before or by any federal, state, municipal, or other governmental department, commission, board, bureau, agency, or instrumentality, domestic or foreign, pending or, to the actual knowledge of Borrower, threatened in writing against or affecting any Loan Party, that could reasonably be expected to have a Material Adverse Effect on the Loan Parties, taken as a whole, or could reasonably be expected to materially and adversely affect such Person’s ability to perform its obligations under the Loan Documents to which it is a party (including Borrower’s ability to repay any or all of the Loans when due);

Material Adverse Effect. Since January 31, 2019, there has been no event or circumstance, either individually or in the aggregate, that has had or could reasonably be expected to have a Material Adverse Effect.

No Adverse Changes. Except as set forth on [Schedule 4.17], since December 31, 2018, [[Organization A:Organization]] has not suffered or incurred any loss, damage, destruction, or other event that has caused or given rise to any Material Adverse Effect.

Material Adverse Changes. Except as disclosed in the Prospectus and the Time of Sale Information, # in the reasonable judgment of the Agent there shall not have occurred any Material Adverse Change; and # there shall not have occurred any downgrading, nor shall any notice have been given of any intended or potential downgrading or of any review for a possible change that does not indicate the direction of the possible change, in the rating accorded any securities of the Company or any of its subsidiaries by any “nationally recognized statistical rating organization” as such term is defined for purposes of Section 3(a)(62) of the Exchange Act.

No Adverse Claim. The Seller hereby warrants, acknowledges, and agrees that no events have taken place and no circumstances exist at the date hereof that would give the Seller a basis to assert a defense, offset, or counterclaim to any claim of the Agent or the Buyers with respect to the Seller’s obligations under the Repurchase Agreement as amended by this Amendment.

Material Adverse Effect. (a) Except as set forth on the Seller Disclosure Schedule (as defined in the Purchase and Sale Agreement), since December 31, 2014 through the date of the Purchase and Sale Agreement, there shall not have occurred any event that would reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect (as defined in the Purchase and Sale Agreement) and # between the date of the Purchase and Sale Agreement and the Closing Date (as defined in the Purchase and Sale Agreement), there shall have been no event, circumstance, development, change or effect that would reasonably be expected to have a Material Adverse Effect (as defined in the Purchase and Sale Agreement). Any disclosure with respect to a section or schedule of the Purchase and Sale Agreement (including any section of the Seller Disclosure Schedule (as defined in the Purchase and Sale Agreement)) shall be deemed to have been disclosed for other sections and schedules of the Purchase and Sale Agreement (including a section of the Seller Disclosure Schedule (as defined in the Purchase and Sale Agreement)) where the relevance of such disclosure would be reasonably apparent.