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;
Reporting. Each day (or at such other intervals as the Administrative and the applicable Issuing Bank shall agree), the applicable Issuing Bank shall provide to the Administrative a schedule of the Letters of Credit issued by it, in form and substance reasonably satisfactory to the Administrative , showing the date of issuance of each Letter of Credit, the account party, the original face amount (if any), the expiration date, and the reference number of any Letter of Credit outstanding at any time during such month, and showing the aggregate amount (if any) payable by the to such Issuing Bank during such month.
Reporting. On the Wednesday of each week, by no later than 5:00 p.m. (Central Time), or such other time and day of the week as Borrowers and Administrative Agent may agree, Loan Parties shall provide Administrative Agent (in form and detail satisfactory to Administrative Agent and certified by the chief financial officer of Borrowers) with: # a calculation of Actual Liquidity as of the end of the last Business Day of the prior week, and # a variance report that details Loan Parties' actual receipts and expenditures through the end of the immediately preceding week, on a line-item by line-item basis, against the Budget for the preceding week, on a cumulative basis for the preceding four-weeks,.
Reporting. Spero shall provide to Northern a written report for each calendar quarter, which shall adequately describe the status of the development and commercialization of the Licensed Compounds and Licensed Products (including for the avoidance of doubt any Combination Product), including at a minimum: results and data of any clinical or non-clinical studies and . All such reports and their contents shall constitute Confidential Information of Spero.
Reporting. Within days after the end of each calendar year and until First Commercial Sale, Surface shall furnish Harbour with a written report summarizing the efforts during the immediately preceding calendar year to develop and commercialize Licensed Products.
Reporting. Unless otherwise requested by the Administrative Agent, each Issuing Bank will # provide to the Administrative Agent copies of any notice received from the Borrowers pursuant to [Section 2.05(2)] no later than the next Business Day after receipt thereof and # report in writing to the Administrative Agent as follows:
Reporting. Within thirty (30) days after the conclusion of each Calendar Quarter commencing with the first Calendar Quarter in which Net Sales are generated or Non-Royalty Income is received, Licensee shall deliver to Harvard a report containing the following information (in each instance, with a Product-by-Product breakdown):
Reporting. Nothing in this Agreement, including the Non-Disparagement provision in Section 10(b) above, shall be construed to prohibit Executive from reporting conduct to, providing truthful information to or participating in any investigation or proceeding conducted by any federal or state government agency or self-regulatory organization.
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