SAEs definition
SAEs has the meaning set forth in Section 5.2.
SAEs means serious adverse events.
SAEs shall have the meaning given in the Protocol.
More Definitions of SAEs
SAEs. (Serious Adverse Event(s)) shall mean (with respect to any Product) reference to any adverse experience (within the meaning of the then current versions of ICH E6: Good Clinical Practice: Consolidated guideline, CPMP/ICH/135/95 and ICH E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting CPMP/ICH/377/95), occurring during clinical trials of the drug or thereafter, in connection with the administration of such Product to a patient at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening or require hospitalization may be considered an adverse experience for purposes of the foregoing sentence when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
SAEs. (Serious Adverse Event(s)) shall mean (with respect to the Product) reference to any adverse experience (within the meaning of the then current versions of ICH E6: Good Clinical Practice: Consolidated guideline, CPMP/ICH/135/95 and ICH E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting CPMP/ICH/377/95), occurring during clinical trials of the drug or thereafter, in connection with the administration of the Product to a patient at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
SAEs. “SAE” shall mean Serious Adverse Event(s) Znamená závažné nežádoucí příhody “SUKL” “SUKL” shall mean State Institute for Control of Drugs Znamená Státní ústav pro kontrolu léčiv “Study” “Studie” shall mean the clinical trial conducted in accordance with this Agreement and the Protocol, with protocol; EudraCT number: ▇▇▇▇-▇▇▇▇▇-▇▇/LYMRIT-37-01/ A phase I/II study of 177Lu-HH1 (Betalutin™) radioimmunotherapy for treatment of relapsed CD37+ non- Hodgkin lymphoma (LYMRIT-37-01). Znamená klinické hodnocení prováděné v souladu s touto Smlouvou a Protokolem, dle Protokolu; EudraCT č.: ▇▇▇▇-▇▇▇▇▇-▇▇/LYMRIT-37-01/ Fáze I/II klinické studie 177Lu-HH1 (Betalutin™) v léčbě recidivujícího CD37+ non- Hodgkinova lymfomu(LYMRIT-37-01). “Sub-investigators” “Spolupracující zkoušející” shall mean any individual designated and supervised by the Investigator to perform critical Study-related procedures and/or make important Study related decisions in accordance with this Agreement and the Protocol Znamená jakoukoliv osobu stanovenou a dozorovanou Zkoušejícím v souvislosti se stěžejními postupy souvisejícími se studií a/nebo s činěním významných rozhodnutí souvisejících se Studií a v souvislosti s touto Smlouvou a Protokolem “Subjects” “Subjekty” shall mean subjects recruited into the Study znamená Subjekty náboru pro tuto Studii “Target Number” “Cílový počet” shall mean the number of subjects to be randomised pursuant to section 4.4 of this Agreement Znamená počet Subjektů, které se mají randomizovat dle odstavce 4.4 této Smlouvy
SAEs to cease all use of the designation "ITT" in any fashion or combination, as well as eliminate the use of any other designation indicating affiliation with ITTI or ITT Corporation or any of their respective Subsidiaries, as soon as practicable after the Closing Date, but not more than 90 days after the Closing Date; provided, however, that with respect to stationery, checks, contracts, purchase orders, agreements and other business forms and writings which could result after the Closing Date in a legal commitment of ITTI or ITT Corporation or any of their Subsidiaries, Purchaser shall cease or shall cause the Designated Purchasers, each Electrical Company and AES Mexico to cease and shall use its best efforts to cause SAES to cease immediately after the Closing Date any use of the designation "ITT" as well as of any other designation indicating affiliation after the Closing Date with ITTI or ITT Corporation or any of their respective Subsidiaries, except to the extent that applicable law requires such person to continue such use until such name change is effected, in which case until such time, but in no event later than one year following the Closing Date. Within ten business days after the Closing Date, Purchaser shall notify or shall cause the Designated Purchasers to notify, in writing, all customers, suppliers and financial institutions having current business relationships with the Electrical Companies that the Electrical Companies have been acquired from the Sellers by the Designated Purchasers.
SAEs means serious adverse events;
SAEs has the meaning set forth in Section 5.2. 1.75. “Samples” means biological specimens collected from subjects participating in the Study, including urine, blood and tissue samples. 1.76. “Sample Testing” means the analyses to be performed by each Party using the applicable Samples, as described in the Sample Testing Schedule. 1.77. “Sample Testing Results” means those data and results arising from the Sample Testing performed by or on behalf of a Party. 1.78. “Sample Testing Schedule” means the schedule attached hereto as Schedule II. 1.79. “Specifications” means the requirements to which the MSD Compound and the Novocure Device must conform for use in the Study. The Specifications for the MSD Compound will be set forth in the certificate of analysis accompanying each batch of MSD Compound supplied for use in the Study and the Specifications for the Novocure Device shall be set forth in Schedule III.
SAEs means Serious Adverse Events as defined in the Protocol.