Example ContractsClausesAdverse Events Reporting
Remove:

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.

# shall comply with Applicable Laws with regard to timely reporting of adverse events and deficiencies of Products, and shall immediately (and in any event within twenty-four (24) hours) notify of any such adverse events. shall respond directly to Customer complaints regarding the performance of the Products. shall keep a record of all Customer complaints and shall immediately (and in any event within twenty-four (24) hours) notify of any such Customer complaints. shall be solely responsible for any required reporting of adverse events to regulatory authorities.

Furnish with prompt written notice of # any lapse or other termination of any Necessary Consent issued to any Loan Party by any Governmental Body or any other Person that is material to the operation of any Loan Party's business, # any refusal by any Governmental Body or any other Person to renew or extend any such Necessary Consent; and # copies of any periodic or special reports filed by any Loan Party with any Governmental Body or Person, if such

Reporting. Commercializing Party shall keep Licensor reasonably informed of Commercializing Party’s and its sublicensees’ Commercialization activities concerning the Licensed Protocol, the Kaufmann Name and/or the Kaufmann Intellectual Property. Without limiting the foregoing, within thirty (30) days following the end of each calendar quarter (commencing for the calendar quarter ending ), Commercializing Party shall provide Licensor with a written report summarizing the significant Commercialization activities performed with respect to the Licensed Protocol, the Kaufmann Name and/or the Kaufmann Intellectual Property since the date of the last report. Such reports must be at a level of detail reasonably requested by Licensor.

Reporting. The Company will maintain, for itself and each Subsidiary, a system of accounting enabling it to provide, and will furnish to the Lenders:

Reporting. Borrower will deliver to Agent (and if so requested by Agent, with copies for each Lender) each of the reports set forth on [Schedule 5.2] at the times specified therein.

Reporting. Manager shall provide Provider with billing and collection reports about Provider that Manager typically provides.

Reporting. Each L/C Issuer will report in writing to the Administrative Agent # on the first Business Day of each calendar month, the aggregate face amount of Letters of Credit issued by it and outstanding as of the last Business Day of the preceding calendar month (and on such other dates as the Administrative Agent may request), # on or prior to each Business Day on which such L/C Issuer expects to issue, amend, renew or extend any Letter of Credit, the date of such issuance or amendment, and the aggregate face amount of Letters of Credit to be issued, amended, renewed or extended by it and outstanding after giving effect to such issuance, amendment, renewal or extension (and such L/C Issuer shall advise the Administrative Agent on such Business Day whether such issuance, amendment, renewal or extension occurred and whether the amount thereof changed), # on each Business Day on which such L/C Issuer makes any L/C Disbursement, the date and amount of such L/C Disbursement and # on any Business Day on which the Borrower fails to reimburse an L/C Disbursement required to be reimbursed to such L/C Issuer on such day, the date and amount of such failure.

Borrowers shall provide Administrative Agent with the following documents in a form reasonably satisfactory to Administrative Agent:

Collateral Reporting. Provide Agent (and if so requested by Agent, with copies for each Lender) with each of the reports set forth on [Schedule 5.2] at the times specified therein. In addition, each Borrower agrees to use commercially reasonable efforts in cooperation with Agent to facilitate and implement a system of electronic collateral reporting in order to provide electronic reporting of each of the items set forth on such Schedule.

Load more...
Select clause to view document information.

Draft better contracts
faster with AllDrafts

AllDrafts is a cloud-based editor designed specifically for contracts. With automatic formatting, a massive clause library, smart redaction, and insanely easy templates, it’s a welcome change from Word.

And AllDrafts generates clean Word and PDF files from any draft.