Example ContractsClausesAdverse Event Reporting and Safety Data Exchange
Adverse Event Reporting and Safety Data Exchange
Adverse Event Reporting and Safety Data Exchange contract clause examples

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.

BBTR Exchange Data. BBTR shall be solely responsible for making arrangements for the acquisition of and continued access to all necessary BBTR Exchange Data necessary for utilization of the BBTR System and the timely payment of all applicable Exchange Fees required for the operation, maintenance and use of the BBTR System. BBTR Exchange Data shall be made available for utilization by the BBTR System in the format and meeting the specifications prescribed by Blackbox. All such Exchange Fees shall be paid upon the terms and as required by the provider of the data for each of the BBTR Exchanges.

Safety Agreements. Promptly after the Effective Date, but in any event no later than the date of Initiation of the first Clinical Trial of a Development Candidate in the Territory, the Parties will enter into one or more safety agreement(s) requiring # Unum to be responsible for the global safety database that are specific to the ACTR T-cells within the Development Candidates and Products, # SGI to be responsible for the global safety database that are specific to the SGI Antibodies within the Development Candidates and Products, and # either Unum or SGI to be responsible for the global safety database for Development Candidates and Products, such Party to be determined by the JSC by reference to any requirements under Applicable Law (if any), whether the expected safety needs of the applicable Development Candidate and Product are more likely attributable to the applicable ACTR T-cells or the SGI Antibody, prior experiences in interacting with Regulatory Authorities regarding those applicable ACTR T-cells and SGI Antibody, and other relevant factors. The safety agreement(s) will govern the responsibilities of the Parties and include # safety data exchange procedures governing the coordination of collection, investigation, reporting and exchange of information concerning any adverse experiences, and any product quality and product complaints associated with adverse experiences, related to such Development Candidates and Products sufficient to enable each Party to comply with its legal and regulatory obligations, and # obligations on the Party responsible for such global safety database for Development Candidates and Products to make such database readily available to the other Party in such format and in a timely manner as the other Party may reasonably request and any in event in a manner sufficient for such other Party to comply with any other product safety requirements, including those required by Applicable Law. In addition, as appropriate, such safety agreement(s) will include the safety data exchange procedures governing the exchange of information affecting the class (e.g., serious adverse events, emerging safety issues).

Safety. Service Provider will be solely responsible for conforming to safety practices dictated by the nature and condition of the Services while at the Site, including compliance with OSHA of 1970. Service Provider and its Representatives must be trained in accordance with applicable OSHA Standards. Within a reasonable time following a specific request by Owners, Service Provider shall provide Owners copies of training records for its Representatives concerning a particular safety and health standard and/or particular substantive or technical training requirement of the job.

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.

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.

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. 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. 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 December 31, 2021), 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. 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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