DEFINITE Sample Clauses

DEFINITE. Whenever used in this Agreement, the following terms shall have the meaning ascribed to them below :
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DEFINITE. The temporal relationship of the clinical event to study treatment (drug related or device related) makes a causal relationship definite, and other drugs, therapeutic interventions or underlying conditions can provide a definitive explanation for the observed event.
DEFINITE must be certain and clear, not vague or speculative so that the liability (or rights) of the parties may be exactly fixed because it is necessary that the acceptance be identical with the offer to create a contract without any further act on the part of the offeror (De Xxxx, 511);
DEFINITE. An AE that follows a reasonable temporal sequence from administration of a marketed drug (including the course after withdrawal of the drug) and that satisfies any of the following: • Reappearance of a similar reaction by repeated exposure (rechallenge) • Positive results in drug sensitivity tests (skin test, etc.) • Toxic level of the drug revealed by measurement of drug concentrations in blood or another bodily fluid Probable An AE that follows a reasonable temporal sequence from administration of the drug (including the course after withdrawal of the drug) and for which involvement of factors other than the drug, such as underlying diseases, complications, concomitant drugs or concurrent treatments, can reasonably be excluded. Possible An AE that follows a reasonable temporal sequence from administration of the drug (including the course after withdrawal of the drug) and for which possible involvement of the drug can be argued*, although factors other than the drug, such as underlying diseases, complications, concomitant drugs or concurrent treatments, may also be responsible. * For example, there have been similar reports in the past, including reports on its analogues, or the occurrence of the event could be predicted from the pharmacological actions/chemical structure of the drug. Not related An AE that does not follow a reasonable temporal sequence from administration of the drug or that can be reasonably explained by other factors, including underlying diseases, complications, concomitant drugs or concurrent treatments. Lack of data Lack of data, such as temporal sequence of an AE from administration of the drug (including the course after withdrawal of the drug), underlying diseases, complications, concomitant drugs or concurrent treatments, considered necessary for evaluation. As regards the causal relationship between an investigational drug and an adverse event, assessment shall be made using a four-category (Definite, Probable, Possible or Not Related) system. Attachment 3 Causal Relationship Between an AE and a Marketed Drug YES Terms such as possibly, probably, definitely, or most likely will be interpreted and reported as “possibly related.” NO Terms such as remotely, unlikely, doubtfully related, will be interpreted and reported as “not related.” Unassessed (or Unknown) The reporter’s assessment is actively sought in each case, however, where not provided, or unknown, the general principle of suspected causality by the reporter is adopted ...
DEFINITE. The event follows a reasonable temporal sequence from the time of drug administration, follows a known response pattern to the study drug, cannot be reasonably explained by other factors such as the participant’s condition, therapeutic interventions, or concomitant drugs, AND occurs immediately following study drug administration, improves upon stopping the drug, or reappears on re-exposure.
DEFINITE. There is a clinically plausible time sequence between the onset of the AE and the administration of investigational product; when the event responds to withdrawal of investigational product and/or recurs with re-administration of investigational product • Probable: There is a clinically plausible time sequence between the onset of the AE and the administration of investigational product; the AE is unlikely to be caused by the concurrent/underlying illness, other drugs or procedures • Possible: There may or may not be a clinically plausible time sequence between the onset of the AE and the administration of investigational product and a cause cannot be ruled out • Unrelated: There is not a temporal or causal relationship to investigational product administration

Related to DEFINITE

  • Contract As used in this document, “Contract” (whether or not capitalized) shall, unless the context requires otherwise, include this document and all incorporated Exhibits, which set forth the entire understanding of the Parties and supersedes all prior agreements. All modifications to this Contract must be in writing and signed by all Parties. All Contract Exhibits listed below are incorporated in their entirety into, and form part of, this Contract. The Contract document and Exhibits shall have priority in the following order:

  • Hiring Customer agrees not to solicit, offer to employ, or enter into consultant relationships with any HP employee involved in the performance of services under this Agreement for 1 year after the date he or she ceases to perform such services. However, Customer may hire any such employee who responds to a general hiring program conducted in the ordinary course of business, and not specifically directed to HP employees.

  • At-Will Employment Executive and the Company agree that Executive’s employment with the Company constitutes “at-will” employment. Executive and the Company acknowledge that this employment relationship may be terminated at any time, upon written notice to the other party, with or without good cause or for any or no cause, at the option either of the Company or Executive. However, as described in this Agreement, Executive may be entitled to severance benefits depending upon the circumstances of Executive’s termination of employment.

  • Scope of Service Interconnection Service shall be provided to the Interconnection Customer at the Point of Interconnection (a), in the case of interconnection of the Customer Facility of a Generation Interconnection Customer, up to the Maximum Facility Output, and (b), in the case of interconnection of the Customer Facility of a Transmission Interconnection Customer, up to the Nominal Rated Capability. The location of the Point of Interconnection shall be mutually agreed by the Interconnected Entities, provided, however, that if the Interconnected Entities are unable to agree on the Point of Interconnection, the Transmission Provider shall determine the Point of Interconnection, provided that Transmission Provider shall not select a Point of Interconnection that would impose excessive costs on either of the Interconnected Entities and shall take material system reliability considerations into account in such selection. Specifications for the Customer Facility and the location of the Point of Interconnection shall be set forth in an appendix to the Interconnection Service Agreement and shall conform to those stated in the Facilities Study.

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