Stopping Criteria Sample Clauses

Stopping Criteria. Given the uncontrolled nature of the study, and the small sample size, it is not practical to provide a quantitative stopping rule. Moreover, given the severely ill nature of the patients who will be enrolled in the study (those with large myocardial infarction and substantial LV dysfunction), adverse cardiac outcomes, including fatal ones, are to be expected in this population, regardless of participation in the study. The study will be stopped when any of the following occur:
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Stopping Criteria. Close monitoring of the patients during the study will be performed. Any decision to stop the clinical trial will be immediately communicated to all Investigators and to the FDA and competent authorities of any other participating countries as applicable. Individual patient dosing will be stopped if:  A patient exhibits a treatment-emergent adverse event of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher and not likely related to the underlying disease. A patient will be discontinued if they exhibit an:  Unexplained fever (> 38.5°C) for > 24 hours. The study will be halted and FDA will be consulted if:  One or more unexpected drug-related deaths.  Onset of one or more drug-related cases of: - Heart failure (NYHA Class II or greater); - Respiratory failure (Type 1 or Type 2); - Acute liver failure (associated with an international normalized ratio (INR) of greater than 1.5, and any degree of mental alteration (encephalopathy) in a patient without preexisting cirrhosis); - Malignant hypertension (i.e., Diastolic blood pressure > 140 mmHg); - Nephrotic syndrome which includes protein in the urine (more than 3.5 grams per day) and one or more of the following clinically significant symptoms: low blood protein levels and/or high cholesterol levels and/or high triglyceride levels and/or edema.
Sample 1

Related to Stopping Criteria

  • Certain Limited Exclusions Notwithstanding anything herein or in any other Secured Debt Document to the contrary, in no event shall the Collateral include or the security interest granted under Section 2.1 hereof attach to (a) any lease, license, contract or agreement to which any Grantor is a party, and any of its rights or interest thereunder, if and to the extent that a security interest is prohibited by or in violation of (i) any law, rule or regulation applicable to such Grantor, or (ii) a term, provision or condition of any such lease, license, contract or agreement (unless such law, rule, regulation, term, provision or condition would be rendered ineffective with respect to the creation of the security interest hereunder pursuant to Sections 9-406, 9-407, 9-408 or 9-409 of the UCC (or any successor provision or provisions) of any relevant jurisdiction or any other applicable law (including the Bankruptcy Code) or principles of equity); provided, however, that the Collateral shall include (and such security interest shall attach) immediately at such time as the contractual or legal prohibition shall no longer be applicable and to the extent severable, shall attach immediately to any portion of such lease, license, contract or agreement not subject to the prohibitions specified in (i) or (ii) above; provided, further, that the exclusions referred to in clause (a) of this Section 2.2 shall not include any Proceeds of any such lease, license, contract or agreement; (b) in any of the outstanding voting Equity Interests of a Foreign Subsidiary or a Disregarded Domestic Subsidiary in excess of 65% of the voting power of all classes of Equity Interests of such Foreign Subsidiary or Disregarded Domestic Subsidiary entitled to vote; provided that immediately upon the amendment of the Internal Revenue Code to allow the pledge of a greater percentage of the voting power of Equity Interests in a Foreign Subsidiary or a Disregarded Domestic Subsidiary without adverse tax consequences, the Collateral shall include, and the security interest granted by each Grantor shall attach to, such greater percentage of Equity Interests of each Foreign Subsidiary or Disregarded Domestic Subsidiary, as applicable; (c) any “intent-to-use” application for registration of a Trademark filed pursuant to Section 1(b) of the Xxxxxx Act, 15 U.S.C. § 1051, prior to the filing of a “Statement of Use” pursuant to Section 1(d) of the Xxxxxx Act or an “Amendment to Allege Use” pursuant to Section 1(c) of the Xxxxxx Act with respect thereto, solely to the extent, if any, that, and solely during the period, if any, in which, the grant of a security interest therein would impair the validity or enforceability of any registration that issues from such intent-to-use application under applicable federal law; and (d) Equity Interests in any joint venture or any entity that is not a Subsidiary, other than proceeds thereof, but only to the extent that (x) the creation of a security interest in such Equity Interests is prohibited or restricted by the Organizational Documents of such entity or by any contractual restriction contained in any agreement with third party holders of the other Equity Interests in such entity which holders are not Affiliates of a Grantor (except to the extent any such prohibition or restriction is deemed ineffective under the UCC or other applicable law), in each case, in existence prior to the date hereof and (y) the Grantors used their commercially reasonable efforts, and did not succeed, to remove such prohibition or restriction. Notwithstanding anything set forth in this Agreement to the contrary, the Grantor shall not be required to register, or disclose any information which would result in a Regulatory Exception, provided that Grantor provide notice to Collateral Agent of any such determination along with such additional information as the Collateral Agent may reasonably request to verify to their satisfaction that such information is subject to a Regulatory Exception.

  • Report of Assessment of Compliance with Servicing Criteria As defined in Section 4.02(a) of the Servicing Agreement.

  • Annual Report of Assessment of Compliance with Servicing Criteria (a) The Servicer shall cause a firm of independent certified public accountants, who may also render other services to the Servicer, the Depositor or their Affiliates, to deliver to the Issuing Entity, the Indenture Trustee and the Owner Trustee on or before March 15 of each year, beginning March 15, 2016 (or if such day is not a Business Day, the next succeeding Business Day), a report (the “Report of Assessment of Compliance with Servicing Criteria”) delivered to the Board of Directors of the Servicer and to the Indenture Trustee and the Owner Trustee that satisfies the requirements of Rule 13a-18 or Rule 15d-18 under the Exchange Act and Item 1122 of Regulation AB, as applicable, on the assessment of compliance with Servicing Criteria with respect to the prior calendar year. The certificates and reports referred to in Section 4.01(a), Section 4.01(b) and this Section 4.02(a) shall be delivered within 120 days after the end of each calendar year if the Issuing Entity is not required to file periodic reports under the Exchange Act or any other law, beginning April 30, 2017.

  • Commercial Milestones In partial consideration of the rights granted by AstraZeneca to Licensee hereunder, Licensee shall pay to AstraZeneca the following payments, which shall be non-refundable, non-creditable and fully earned upon the first achievement of the applicable milestone event:

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