CAUSALITY DEFINITIONS Sample Clauses

CAUSALITY DEFINITIONS. For purposes of safety data exchange and regulatory reporting, the following causality definitions shall apply: Study Drug-Related AE: An AE shall be considered “Study Drug related” for studies if the investigator or its designee assesses that there is a reasonable causal relationship, based on facts and evidence, between the Study Drug and the AE. In assessing causality, the investigator or sponsor should indicate whether the AE is related to the Study Drug. Whenever the investigator’s assessment is unknown or unclear, the AE(s) shall be treated as Study Drug-related for the purposes of reporting to the other Party. An AE shall be considered “not Study Drug-related” for studies if the investigator assesses that there is no reasonable possibility of a causal relationship, based on facts and evidence, between the Study Drug and the AE. Protocol-Related AE: AEs from the Study that are not Study Drug-related might nevertheless be considered by the investigator to be “protocol-related.” For example, a protocol-related AE may be an experience occurring in a washout period or related to a procedure required by the protocol. For purposes of data exchange, these shall be handled in the same manner as Study Drug-related experiences and reported to applicable regulatory authorities as required.
Sample 1
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CAUSALITY DEFINITIONS. For purposes of safety data exchange and regulatory reporting, the following causality definitions shall apply: An AE shall be considered related to "investigational medicinal product ("IMP")" if the principal investigator, designee or the sponsor assesses that there is a reasonable causal relationship, based on facts and evidence, between the IMP and the AE.
Sample 1

Related to CAUSALITY DEFINITIONS

  • Key Definitions As used herein, the following terms shall have the following respective meanings:

  • Seniority Definition Seniority is the Layoff Service Date which is the date the employee began state service (except as a temporary appointee) as adjusted for break(s)-in-service. (See Letter of Agreement 70.00-09-179 in Appendix A).

  • Amendments to Equity Definitions (i) Section 12.6(a)(ii) of the Equity Definitions is hereby amended by (1) deleting from the fourth line thereof the word “or” after the word “official” and inserting a comma therefor, and (2) deleting the semi-colon at the end of subsection (B) thereof and inserting the following words therefor “or (C) the occurrence of any of the events specified in Section 5(a)(vii)(1) through (9) of the ISDA Master Agreement with respect to that Issuer.”

  • Other Adjustments Pursuant to the Equity Definitions Notwithstanding anything to the contrary in this Confirmation, solely for the purpose of adjusting the Cap Price, the terms “Potential Adjustment Event,” “Merger Event,” and “Tender Offer” shall each have the meanings assigned to such term in the Equity Definitions (as amended by Section 10(i)(i)), and upon the occurrence of a Merger Date, the occurrence of a Tender Offer Date, or declaration by Counterparty of the terms of any Potential Adjustment Event, respectively, as such terms are defined in the Equity Definitions, the Calculation Agent shall determine in a commercially reasonable manner whether such occurrence or declaration, as applicable, has had a material economic effect on the Transactions and, if so, may, in its commercially reasonable discretion, adjust the Cap Price to preserve the fair value of the Options to Dealer; provided that in no event shall the Cap Price be less than the Strike Price; provided further that any adjustment to the Cap Price made pursuant to this Section 10(x) shall be made without duplication of any other adjustment hereunder (including, for the avoidance of doubt, adjustment made pursuant to the provisions opposite the captions “Method of Adjustment,” “Consequences of Merger Events / Tender Offers” and “Consequence of Announcement Events” in Section 3 above).

  • Amendments to the Equity Definitions (A) Section 11.2(a) of the Equity Definitions is hereby amended by deleting the words “a diluting or concentrative” and replacing them with the words “an”; and adding the phrase “or Warrants” at the end of the sentence.

  • Seniority Defined Seniority is defined as the length of continuous service as a regular employee in the bargaining unit. Seniority shall operate on a bargaining-unit-wide basis unless otherwise specifically provided by this Agreement.

  • DPA Definitions The definition of terms used in this DPA is found in Exhibit “C”. In the event of a conflict, definitions used in this DPA shall prevail over terms used in any other writing, including, but not limited to the Service Agreement, Terms of Service, Privacy Policies etc.

  • Property Defined The Land, the Improvements, the Personal Property, the Leases and the Intangibles are hereinafter sometimes referred to collectively as the "Property."

  • Tax Definitions The following terms, as used herein, have the following meanings:

  • 000 DEFINITIONS 6.100 Maintenance shall be work performed for the repair, renovation, revamp and upkeep of property, machinery and equipment within the limits of the plant property.

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