Clinical Updates definition
Clinical Updates means (a) a summary of any material updates with respect to the Clinical Trials, including the number of patients currently enrolled in each such Clinical Trial, the number of sites conducting each such Clinical Trial, the material progress of each such Clinical Trial, any material modifications to each such Clinical Trial, any adverse events in the Clinical Trials, (b) written plans to start new Clinical Trials, and (c) investigator brochures for a Product.
Clinical Updates means (a) a summary of any material updates with respect to the Clinical Trials, including the number of patients currently enrolled in each such Clinical Trial, the number of sites conducting each such Clinical Trial, the material progress of each such Clinical Trial, any material modifications to each such Clinical Trial, any adverse events in the Clinical Trials, (b) written plans to start new Clinical Trials, and (c) investigator brochures for the Product.
Clinical Updates means material information and developments with respect to each Clinical Trial.
Examples of Clinical Updates in a sentence
Sellers shall, subject to this Section 5.1, provide the Buyer: promptly following the end of the each calendar quarter of each calendar year, but in any event, in each case, no later than seventy (70) calendar days after the end of such calendar quarter, a reasonably detailed report (the “Quarterly Report”) setting forth, with respect to such calendar quarter, (a) the Intellectual Property Updates, (b) the Regulatory Updates, (c) the Clinical Updates, and (d) the Commercial Updates.
These include courses and events such as Masterclasses, Clinical Updates, New Horizons as well as journal access.
More Definitions of Clinical Updates
Clinical Updates means [***].
Clinical Updates means, with respect to each ongoing or proposed Clinical Trial, a summary of (a) the current status of enrollment, (b) the estimated completion date, (c) the status of any clinical hold imposed, or threatened to be imposed, by any Regulatory Authority, (d) any serious adverse event, unexpected fatal or life-threatening suspected adverse reaction, as that term is defined in 21 CFR 312.32 (or comparable regulations under other applicable law), and (e) any other material information and developments with respect to each such Clinical Trial, including any change or modification to or termination of such Clinical Trial.
Clinical Updates means material information and developments with respect to each Clinical Trial, including, without limitation, any serious adverse event in any Clinical Trial.
Clinical Updates means a summary of any material updates with respect to the Clinical Trials including (a) the progress of each Clinical Trial for the Product or any Related Product (including the number of patients currently enrolled in each such Clinical Trial, the number of sites conducting each such Clinical Trial, and any material modifications to each such Clinical Trial, and any serious adverse events), and (b) Sellers’ then-existing plans to start new Clinical Trials. Copies of internal presentations or reports of summaries of such material information or developments, and copies of presentations or reports received by the Sellers from any Third Party, may constitute Clinical Updates.
Clinical Updates means material information and developments with respect to each Clinical Trial, including, without limitation, any regulatory submissions made to, and correspondence received from, the FDA, or corresponding Governmental Entity in a foreign country, with respect to the number of patient deaths that have occurred in such Clinical Trial, including any patient deaths attributed to a Product, and requests to the FDA, or corresponding Governmental Authority in a foreign country, for any Regulatory Approval. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
Clinical Updates means a summary of any material updates with respect to the Clinical Trials conducted by or on behalf of the Seller or a counterparty to any Out-License, including (a) the progress of each Clinical Trial for the Product (including the number of patients currently enrolled in each such Clinical Trial, the number of sites conducting each such Clinical Trial, and any material modifications to each such Clinical Trial, and any serious adverse events attributed to the Product), and (b) the Seller’s then-existing plans to start new Clinical Trials, in each case since the later of the date hereof and the date of delivery of the prior Clinical Update.
Clinical Updates means (a) a summary of any material updates with respect to the Clinical Trials (other than those conducted pursuant to the CStone License that are not a Global Clinical Trial), including the number of patients currently enrolled in each such Clinical Trial, the number of sites conducting each such Clinical Trial, the material progress of each such Clinical Trial, any material modifications to each such Clinical Trial, including any changes to the primary and/or secondary endpoints or changes to the statistical analysis plan or any adverse events in the Clinical Trials, (b) written plans to start new Clinical Trials (other than those conducted pursuant to the CStone License that are not a Global Clinical Trial), and (c) investigator brochures for a Product (other than in respect of Clinical Trials conducted pursuant to the CStone License). Copies of internal presentations or reports of summaries of such material information or developments, and copies of presentations or reports received by the Seller from any Third Party, to the extent such presentations or reports include any applicable information required in the immediately preceding sentence, may constitute Clinical Updates with respect to such applicable information.