SUSARs Sample Clauses

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. Any SUSAR to the Licensed Product must be reported to Xxxxx within 72 hours of Simcere becoming aware, even if full information is not available, so that Xxxxx may satisfy its regulatory obligations to FDA and other Regulatory Authorities. Simcere will reasonably cooperate with Xxxxx to investigate any SUSARs, and to resolve any queries from Regulatory Authorities.
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
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.
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 […***…].
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 xx xxxx). 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 xxxxx případu Zadavatele a příslušné informace budou při jejich předání Společnosti jasně označeny jako počáteční nebo následné hlášení. Xxxx bude na hlášeních jasně uvedeno počáteční datum obdržení Zadavatelem, interní referenční xxxxx 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. Xxxx Zadavatel zajistí podporu pro slaďování všech hlášení ICSR, minimálně na konci Studie. Pokud Zadavatel obdrží hlášení, kdy se xxxx xxxxxxx 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.
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. Reata will promptly inform BXLS of any Serious Safety Issue following its awareness of the same.
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.

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 With respect to the stock options (the “Stock Options”) granted pursuant to the stock-based compensation plans of the Company and its subsidiaries (the “Company Stock Plans”), (i) each Stock Option intended to qualify as an “incentive stock option” under Section 422 of the Internal Revenue Code of 1986, as amended (the “Code”) so qualifies, (ii) each grant of a Stock Option was duly authorized no later than the date on which the grant of such Stock Option was by its terms to be effective (the “Grant Date”) by all necessary corporate action, including, as applicable, approval by the board of directors of the Company (or a duly constituted and authorized committee thereof) and any required stockholder approval by the necessary number of votes or written consents, and the award agreement governing such grant (if any) was duly executed and delivered by each party thereto, (iii) each such grant was made in accordance with the terms of the Company Stock Plans, the Exchange Act and all other applicable laws and regulatory rules or requirements and (iv) each such grant was properly accounted for in accordance with GAAP in the financial statements (including the related notes) of the Company and disclosed in the Company’s filings with the Commission in accordance with the Exchange Act and all other applicable laws. The Company has not knowingly granted, and there is no and has been no policy or practice of the Company of granting, Stock Options prior to, or otherwise coordinating the grant of Stock Options with, the release or other public announcement of material information regarding the Company or its subsidiaries or their results of operations or prospects.

  • 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.

  • Restricted Stock Shares of restricted stock granted to the Executive by the Company which have not become vested as of the date of termination of the Executive’s employment, as provided in Section 7(b), shall immediately become vested on a pro rata basis upon the Release becoming irrevocable. The number of such additional shares of restricted stock that shall become vested as of the date of the Executive’s termination of employment shall be that number of additional shares that would have become vested through the date of such termination of employment at the rate(s) determined under the vesting schedule applicable to such shares had such vesting schedule provided for the accrual of vesting on a daily basis (based on a 365-day year). The pro rata amount of shares vesting through the date of non-renewal shall be calculated by multiplying the number of unvested shares scheduled to vest in each respective vesting year by the ratio of the number of days from the date of grant through the date of non-renewal, and the number of days from the date of grant through the original vesting date of the respective vesting tranche. Any shares of restricted stock remaining unvested after such pro rata acceleration of vesting shall automatically be reacquired by the Company in accordance with the provisions of the applicable restricted stock agreement, and the Executive shall have no further rights in such unvested portion of the restricted stock. In addition, the Company shall waive any reacquisition or repayment rights for dividends paid on restricted stock prior to Executive’s termination of employment.

  • Stock Awards “Stock Awards” means all stock options, restricted stock and such other awards granted pursuant to the Company’s stock option and equity incentive award plans or agreements and any shares of stock issued upon exercise thereof.

  • Performance Awards With respect to any Performance Award, the length of any Performance Period, the Performance Goals to be achieved during the Performance Period, the other terms and conditions of such Award, and the measure of whether and to what degree such Performance Goals have been attained will be determined by the Board.

  • Company Stock Options At the Effective Time, each Company Stock --------------------- Option shall be deemed to have been assumed by Evergreen, without further action by Evergreen, and shall thereafter be deemed an option to acquire, on the same terms and conditions as were applicable under such Company Stock Option, that number of shares of Surviving Corporation Common Stock that would have been received in respect of such Company Stock Option if it had been exercised immediately prior to the Effective Time (such Company Stock Options assumed by Evergreen, the "Assumed Chancellor Stock Options"); provided, however, that, for -------- ------- each optionholder, (i) the aggregate fair market value of Surviving Corporation Common Stock subject to Assumed Chancellor Stock Options immediately after the Effective Time shall not exceed the aggregate exercise price thereof by more than the excess of the aggregate fair market value of Company Common Stock subject to Company Stock Options immediately before the Effective Time over the aggregate exercise price thereof and (ii) on a share-by-share comparison, the ratio of the exercise price of the Assumed Chancellor Stock Option to the fair market value of the Surviving Corporation Common Stock immediately after the Effective Time is no more favorable to the optionholder than the ratio of the exercise price of the Company Stock Option to the fair market value of the Company Common Stock immediately before the Effective Time; and provided, -------- further, that no fractional shares shall be issued on the exercise of such ------- Assumed Chancellor Stock Option and, in lieu thereof, the holder of such Assumed Chancellor Stock Option shall only be entitled to a cash payment in the amount of such fraction multiplied by the closing price per share of Surviving Corporation Common Stock on the Nasdaq National Market on the business day immediately prior to the date of such exercise.

  • Performance Share Units The Committee may, in its discretion, grant to Executive performance share units subject to performance vesting conditions (collectively, the “Performance Units”), which shall be subject to restrictions on their sale as set forth in the Plan and an associated Performance Unit Grant Letter.

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