SUSARs Sample Clauses

The SUSARs clause defines the procedures and responsibilities related to the reporting of Suspected Unexpected Serious Adverse Reactions during a clinical trial. It typically requires investigators and sponsors to promptly identify, document, and communicate any such adverse reactions to regulatory authorities and ethics committees, often within strict timelines. This clause ensures that all parties are aware of and respond quickly to serious and unforeseen risks, thereby protecting participant safety and maintaining regulatory compliance.
SUSARs. Pursuant to a sponsor’s safety reporting obligations under 21 CFR 312.32(c)(1), Pfizer will report to the Principal Investigator all Serious Unexpected Suspected Adverse Reactions (“SUSARs”). Principal Investigator will receive and review SUSAR reports. Pfizer shall report to the responsible IRB/IEC any SUSARs for the Investigational Drug in the given Clinical Trial taking place in the territory of the Czech Republic. Institution will retain SUSAR reports consistent with Section 11.3 of this Agreement. 19.4
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SUSARs. Reata will promptly inform BXLS of any Serious Safety Issue following its awareness of the same.
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SUSARs. When Sponsor receives a SUSAR, it shall transmit the final CIOMS report of that event to Company within twenty four (24) hours of submitting that report to the applicable regulatory authority. hlášené AE, kritérium závažnosti, hlášené posouzení kauzality a Zadavatelovo posouzení kauzality (pokud ▇▇ ▇▇▇▇). U všech SUSAR bude (budou) také prohlášení o kauzalitě dle definice v SOP Zadavatele. Zadavatel bude při sdělování ICSR Společnosti používat formuláře CIOMS nebo MedWatch (nebo ekvivalentní). Ke všem ICSR a souvisejícím informacím (zdrojové dokumenty nebo elektronický soubor, formuláře Medwatch nebo CIOMS) bude přiřazeno jedinečné ▇▇▇▇▇ případu Zadavatele a příslušné informace budou při jejich předání Společnosti jasně označeny jako počáteční nebo následné hlášení. ▇▇▇▇ bude na hlášeních jasně uvedeno počáteční datum obdržení Zadavatelem, interní referenční ▇▇▇▇▇ Studie Společnosti a název IMP. Společnost Zadavateli dodá příslušný „průvodní list“, který bude třeba kompletně vyplnit a přiložit jej ke všem ICSR předávaným Společnosti e-mailem nebo faxem. ICSR bude Zadavatel předávat buď prostřednictvím E2B, nebo faxem či e-mailem, a to dle níže popsaného postupu. Nehledě na výše uvedené platí, že pokud Zadavatel zmiňovaná hlášení nebude předávat prostřednictvím E2B, budou tato předána faxem, pakliže Zadavatel nezavedl metodu zabezpečeného přenosu (například přes virtuální privátní síť), která umožňuje předání příslušných e-mailových zpráv Společnosti v zabezpečeném prostředí. Společnost má právo periodicky provádět rekonciliaci hlášení ICSR vytvořených v průběhu Studie a Zadavatel zajistí pro dané slaďování podporu v dobré víře. ▇▇▇▇ Zadavatel zajistí podporu pro slaďování všech hlášení ICSR, minimálně na konci Studie. Pokud Zadavatel obdrží hlášení, kdy se ▇▇▇▇ ▇▇▇▇▇▇▇ týká POUZE přípravků, jež Společnost dodává na trh, které ale nepředstavují hodnocený přípravek, ohlásí Zadavatel tento případ buď příslušnému úřadu v členském státě, kde k účinku došlo, nebo Společnosti, nikoliv ale úřadu a Společnosti zároveň, aby se zamezilo duplicitnímu hlášení.
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SUSARs. Pursuant to a sponsor’s safety reporting obligations under 21 CFR 312.32(c)(1), Pfizer will report to the Principal Investigator all Serious Unexpected Suspected Adverse Reactions (“SUSARs”). Principal Investigator will receive and review SUSAR reports. Institution will retain SUSAR
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SUSARs. Pursuant to a sponsor’s safety reporting obligations under 21 CFR 312.32(c)(1), Pfizer will report to the Principal Investigator all Serious Unexpected Suspected Adverse Reactions (“SUSARs”). Principal Investigator will receive and review SUSAR reports. Pfizer shall report to the responsible 19.4 Hlášení SUSAR. V souladu s povinností bezpečnostního hlášení zadavatele podle 21 CFR 312.32(c)(1), bude společnost Pfizer hlásit Hlavnímu zkoušejícímu všechna Podezření na závažné neočekávané nežádoucí účinky (Serious Unexpected Suspected Adverse Reactions, IRB/IEC any SUSARs for the Investigational Drug in the given Clinical Trial taking place in the territory of the Czech Republic. Institution will retain SUSAR reports consistent with Section 11.3 of this Agreement. „SUSAR“). Hlavní zkoušející obdrží hlášení SUSAR a seznámí se s nimi. Společnost Pfizer bude hlásit odpovědné IRB/IEC SUSARy hodnoceného léčivého přípravku z daného klinického hodnocení, ke kterému došlo na území České republiky. Instituce uchová hlášení SUSAR v souladu s článkem 11.3 této Smlouvy.
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SUSARs. Pursuant to a sponsor’s safety reporting obligations under 21 CFR 312.32(c)(1), Pfizer will report to the Principal Investigator all Serious Unexpected Suspected Adverse Reactions (“SUSARs”). Principal Investigator will receive and review SUSAR reports. Institution will retain SUSAR reports consistent with Section 11.3 of this Agreement. 19.4 Podozrenia na neočakávané a závažné nežiaduce reakcie. Vzhľadom na povinnosť zadávateľa podávať správy o bezpečnosti v súlade so smernicou 21 CFR 312.32(c)(1) (Kodifikácia federálnych predpisov Spojených štátov amerických, ďalej “CFR”) spoločnosť Pfizer oznámi hlavnému skúšajúcemu všetky podozrenia na neočakávané závažné nežiaduce reakcie (Serious Unexpected Suspected Adverse Reactions, ďalej „SUSAR“). Hlavnému skúšajúcemu budú doručené správy o SUSAR, ktoré posúdi. Inštitúcia bude uchovávať správy o SUSAR v súlade s časťou 11.3 tejto zmluvy.
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SUSARs. Pursuant to a sponsor’s safety reporting obligations under 21 CFR 312.32(c)(1), Pfizer will report to the Principal dobu tří let po jejím ukončení Instituce neprodleně vyrozumí CRO, pokud bude na základě nových informací nutné kterékoli z těchto potvrzení doplnit.
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SUSARs. Any SUSAR to the Licensed Product must be reported to ▇▇▇▇▇ within 72 hours of Simcere becoming aware, even if full information is not available, so that ▇▇▇▇▇ may satisfy its regulatory obligations to FDA and other Regulatory Authorities. Simcere will reasonably cooperate with ▇▇▇▇▇ to investigate any SUSARs, and to resolve any queries from Regulatory Authorities.
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SUSARs. When Institution receives a SUSAR judged to be reasonably related to the Study Drug or Study Protocol (as defined in Section 1.3 above), it shall transmit the final CIOMS report of that event to Amgen within […***…] of […***…].
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Related to SUSARs

  • Performance Shares Each Performance Share is a bookkeeping entry that records the equivalent of one Share. Upon the vesting of the Performance Shares as provided in Section 2, the vested Performance Shares will be settled as provided in Section 3.

  • Stock Options (a) Subject to Section 5.5(b), at the Effective Time, all rights with respect to Company Common Stock under each Company Option then outstanding shall be converted into and become rights with respect to Parent Common Stock, and Parent shall assume each such Company Option in accordance with the requirements of Section 424(a) of the Code (as in effect as of the date of this Agreement) and the terms of the stock option plan under which it was issued and the stock option agreement by which it is evidenced. From and after the Effective Time, (i) each Company Option assumed by Parent may be exercised solely for shares of Parent Common Stock, (ii) the number of shares of Parent Common Stock subject to each such Company Option shall be equal to the number of shares of Company Common Stock subject to such Company Option immediately prior to the Effective Time multiplied by the Exchange Ratio, rounding down to the nearest whole share (with cash, less the applicable exercise price, being payable for any fraction of a share), (iii) the per share exercise price under each such Company Option shall be adjusted by dividing the per share exercise price under such Company Option by the Exchange Ratio and rounding up to the nearest cent and (iv) any restriction on the exercise of any such Company Option shall continue in full force and effect and the term, exercisability, vesting schedule and other provisions of such Company Option shall otherwise remain unchanged; provided, however, that each Company Option assumed by Parent in accordance with this Section 5.5(a) shall, in accordance with its terms, be subject to further adjustment as appropriate to reflect any stock split, stock dividend, reverse stock split, reclassification, recapitalization or other similar transaction subsequent to the Effective Time. (b) Notwithstanding anything to the contrary contained in this Section 5.5, in lieu of assuming outstanding Company Options in accordance with Section 5.5(a), Parent may, at its election, cause such outstanding Company Options to be replaced by issuing equivalent replacement stock options in substitution therefor that are substantially the same. (c) The Company shall take all action that may be necessary (under the plans pursuant to which Company Options are outstanding and otherwise) to effectuate the provisions of this Section 5.5 and to ensure that, from and after the Effective Time, holders of Company Options have no rights with respect thereto other than those specifically provided in this Section 5.5.

  • Performance Share Awards On the Performance Share Vesting Date next following the Executive's date of death, the number of Performance Shares that shall become Vested Performance Shares shall be determined by multiplying (a) that number of shares of Company Common Stock subject to the Performance Share Agreement that would have become Vested Performance Shares had no such termination occurred; provided, however, in no case shall the number of Performance Shares that become Vested Performance Shares exceed 100% of the Target Number of Performance Shares set forth in the Performance Share Agreement, by (b) the ratio of the number of full months of the Executive's employment with the Company during the Performance Period (as defined in the Performance Share Agreement) to the number of full months contained in the Performance Period. Vested Common Shares shall be issued in settlement of such Vested Performance Shares on the Settlement Date next following the Executive’s date of death.

  • Restricted Stock Awards Each Encompass Restricted Stock Award that is outstanding as of immediately prior to the Effective Time shall be treated as follows: (i) If the holder is an Encompass Group Employee, such award shall be converted, as of the Effective Time, into a Post-Separation Encompass Restricted Stock Award, and shall, except as otherwise provided in this Section 4.02, be subject to the same terms and conditions (including with respect to vesting) after the Effective Time as were applicable to such Encompass Restricted Stock Award immediately prior to the Effective Time; provided, however, that from and after the Effective Time, the number of Encompass Shares subject to such Post-Separation Encompass Restricted Stock Award shall be equal to the sum of all the Encompass Shares subject to all tranches of the Award where the number of Encompass Shares subject to each tranche is equal to the product, rounded up to the nearest whole number of shares for each such tranche, obtained by multiplying (A) the number of Encompass Shares subject to such tranche of the corresponding Encompass Restricted Stock Award immediately prior to the Effective Time, by (B) the Encompass Ratio. (ii) If the holder is an Enhabit Group Employee, such award shall be converted, as of the Effective Time, into an Enhabit Restricted Stock Award, and shall, except as otherwise provided in this Section 4.02, be subject to the same terms and conditions (including with respect to vesting) after the Effective Time as were applicable to such Encompass Restricted Stock Award immediately prior to the Effective Time; provided, however, that from and after the Effective Time, the number of Enhabit Shares subject to such Enhabit Restricted Stock Award shall be equal to the sum of all the Enhabit Shares subject to all tranches of the Award where the number of Enhabit Shares subject to each tranche is equal to the product, rounded up to the nearest whole number of shares for each such tranche, obtained by multiplying (A) the number of Encompass Shares subject to such tranche of the corresponding Encompass Restricted Stock Award immediately prior to the Effective Time, by (B) the Enhabit Ratio.

  • RSUs The Continuing Stock Units shall continue to vest in accordance with the terms of the Original RSU Award Documents, on the same basis as such stock units would have become vested if Executive had remained employed under this Agreement through the Scheduled Expiration Date. Except as otherwise expressly provided herein, all such Continuing Stock Units shall be subject to, and administered in accordance with, the Original RSU Award Documents. Any of Executive’s restricted stock unit awards that have not become vested on or before the Termination Date, and that are outstanding at the Termination Date, but which are not Continuing Stock Units, shall automatically terminate on the Termination Date. Notwithstanding any term or provision of the Original RSU Award Documents: (A) any provisions in such Original RSU Award Documents relating to disability shall not be applicable to any such Continuing Stock Units after the Termination Date; and (B) in the event of Executive’s death after the Termination Date but prior to the Scheduled Expiration Date, the terms and provisions of the Original RSU Award Documents shall be interpreted and applied in the same manner with respect to such Continuing Stock Units as if Executive were an active employee on the date of Executive’s death. (C) to the extent that, under the Company’s compensation practices and policies, any tranche of Continuing Stock Units is subject to the achievement of performance conditions which were imposed solely because Executive was an executive officer of the Company who could have been a covered employee within the meaning of Section 162(m) at the time payment in respect of such award was expected to be made (the “Applicable 162(m) Criteria”) and such Applicable 162(m) Criteria relate, in whole or in part, to any performance period continuing after the end of the Company’s fiscal year in which the Termination Date occurs, such Applicable 162(m) Criteria shall be waived as of the Termination Date with respect to such tranche of the Continuing Stock Units; provided, however, that this Paragraph 5(d)(iii)(C) shall not be applicable if and to the extent, in the reasonable opinion of tax counsel to the Company, the presence of such provision would cause any stock units intended to be qualified as other performance based compensation within the meaning of Section 162(m) of the Code to fail to be so qualified at any time prior to Executive’s Termination Date.