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 , 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 , 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. Manager shall provide Provider with billing and collection reports about Provider that Manager typically provides.
Reporting. Unless otherwise requested by the Administrative Agent, each L/C Issuer shall # provide to the Administrative Agent copies of any notice received from the Borrower pursuant to [Section 2.03(b)] no later than the next Business Day after receipt thereof and # report in writing to the Administrative Agent # on or prior to each Business Day on which such L/C Issuer expects to issue, amend or extend any Letter of Credit, the date of such issuance, amendment or extension, and the aggregate face amount of the Letters of Credit to be issued, amended or extended by it and outstanding after giving effect to such issuance, amendment or extension occurred (and whether the amount thereof changed), and such L/C Issuer shall be permitted to issue, amend or extend such Letter of Credit if the Administrative Agent shall not have advised such L/C Issuer that such issuance, amendment or extension would not be in conformity with the requirements of this Agreement, # on each Business Day on which such L/C Issuer makes any L/C Advance, the date of such L/C Advance and the amount of such L/C Advance and # on any other Business Day, such other information with respect to the outstanding Letters of Credit issued by such L/C Issuer as the Administrative Agent shall reasonably request.
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. 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. 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. 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. 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.
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