Clinical Updates definition
Clinical Updates means (a) a summary of any material updates with respect to any 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, 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, [***].
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, 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 Agency, (d) any 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 such Clinical Trial, including any change or modification to or termination of such Clinical Trial. “Closing Date” means May 12, 2023. “Code” means the Internal Revenue Code of 1986, as amended from time to time. “Collateral” has the meaning set forth in the Security Agreement. “Commercial Updates” means material information and developments with respect to the Obligors’ Commercialization plans and prospects for the Included Products. “Commercialization” means any and all activities, other than manufacturing, directed to the preparation for sale of, or sale of the Included Products, including activities related to marketing, promoting, distributing, and importing the Included Products, and interacting with Regulatory Agencies regarding any of the foregoing. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization, and “Commercialized” has a corresponding meaning. “Common Stock” means Parent’s common stock, par value $0.0001 per share. “Company” has the meaning set forth in the first paragraph hereof. “Competitor” means, at any time of determination, any Person (and each other Person that owns or controls, directly or indirectly, such Person, or that controls or is controlled by or is under common control with such Person) that is an operating company and that directly and primarily engaged in the same, substantially the same, or similar line of business as the Company and its Subsidiaries, taken as a whole, as of such time. As used in this definition, “control” means (a) direct or indirect beneficial ownership of at least fifty percent (50%) (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) of the voting share capital or other equity interest in a Person or (b) the power to direct or cause the direction of the management of such Person by contract or otherwise. “Compliance Certificate” means that certain certificate in the form attached hereto as Exhibit A. “Co...
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. “Closing” means the closing of the sale, transfer, assignment and conveyance of the Revenue Participation Right hereunder. “Closing Date” means the date on which the Closing occurs pursuant to Section 3.1. “CMC” means chemistry, manufacturing and controls with respect to the Product. “CoC Agreement” is defined in Section 6.2(c)(i). “CoC Date” is defined in Section 6.2(c)(i). “CoC Payment” is defined in Section 6.2(c)(i). “Code” means the Internal Revenue Code of 1986, as amended. “Combination Product” means: (a) a single pharmaceutical formulation (whether co-formulated or administered together via the same administration route) containing as its active ingredients both the Product and one or more other therapeutically or prophylactically active pharmaceutical or biologic ingredients (each an “Other Component”), or (b) a combination therapy comprised of the Product and one or more Other Component(s), whether priced and sold in a single package containing such multiple products, packaged separately but sold together for a single price, or sold under separate price points but labeled for use together, in each case, including all dosage forms, formulations, presentations, and package configurations. Drug delivery vehicles, adjuvants and excipients will not be deemed to be “active ingredients”, except in the case where such delivery vehicle, adjuvant or excipient is recognized by the FDA as an active ingredient in accordance with 21 C.F.R. 210.3(b)(7). All references to Products in this Agreement shall be deemed to include Combination Products. “Commercial Updates” means a summary of material updates with respect to the Seller’s
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.