Unexpected definition
Unexpected as used in this Section refers to a condition or development not listed in the current labeling or investigator’s brochure for Product, and includes an event that may be symptomatically and pathophysiologically related to an event listed in the labeling, but differs from the event because of increased frequency or greater severity or specificity.
Unexpected means (x) for a nonmarketed Product, an experience that is not identified in nature, severity or frequency in the current clinical investigator’s confidential information brochure, and (y) for a marketed product, an event which is not listed in the current labeling for such product, and includes an event that may be symptomatically and pathophysiologically related to an experience listed in the labeling but differs from the event because of increased frequency or greater severity or specificity. Each party further shall immediately notify the other party of any information received regarding any threatened or pending action by an agency that may affect the safety and efficacy claims of the Product. Upon receipt of any such information, the parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action; provided, however, that nothing contained herein shall restrict either party’s right to make a timely report of such matter to any government agency or take other action that it deems to be appropriate or required by applicable law, regulation or court order. Each party shall take all reasonable steps to protect the confidentiality of any patient health and medical information that it has access to and to comply with applicable state and federal privacy laws, as such laws apply to such party.
Unexpected as used in this Section 11.1 refers to (i) conditions or developments not previously submitted to governmental Agencies or encountered during clinical studies of the Products and not reflected in the Product Promotional Materials or the Product Labeling, or (ii) conditions or developments occurring with greater frequency, severity, or specificity than shown by information previously submitted to governmental Agencies or encountered during clinical studies of the Products and not reflected in the Product Promotional Materials or the Product Labeling. Each party shall also notify the other in a timely manner of any other adverse experience, i.e., any unfavorable and unintended change in the structure (signs), function (symptoms) or chemistry (laboratory data) of the body temporally associated with the use of the Products, whether or not considered related thereto.
Examples of Unexpected in a sentence
Unexpected hospitalization due to complications of pregnancy shall be covered.
Such information will include the Investigator's Brochure (IB) and information on Suspected Unexpected Serious Adverse Events (SUSARs) for unlicensed products or the Summary of Product Characteristics (SPC) for licensed products.
Unexpected and substantial price movements may lead to substantial fluctuations in the Net Asset Value per Share within a short period of t ime.
Unexpected and substantial price movements may lead to substantial fluctuations in the Net Asset Value per Share within a short period of time.
Unexpected reduction of work includes any partial day, or partial week’s downtime, except for partial week’s downtime scheduled by the customer during the prior week.
More Definitions of Unexpected
Unexpected means (x) for a nonmarketed Product, an experience that is not identified in nature, severity or frequency in the current clinical investigator's confidential information brochure, and (y) for a marketed Product, an experience which is not listed in the current labeling for such Product, and includes an event that may be symptomatically and pathophysiologically related to an event listed in the labelling but differs from the event because of increased frequency or greater severity or specificity. Each Party further shall immediately notify the other of any information received regarding any threatened or pending action by an agency which may affect the safety and efficacy claims of a Product. Upon receipt of any such information, the Parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action; provided, however, that nothing contained herein shall be construed as restricting either Party's right to make a timely report of such matter to any government agency or take other action that it deems to be appropriate or required by applicable law or regulation.
Unexpected means not anticipated or expected and occurring after the effective date of the Policy.
Unexpected means an expense arising from an event that is unforeseeable, accidental or unanticipated.
Unexpected means that the nature and severity of the adverse reaction are not consistent with the information about the study medication in question set out in the reference safety information.
Unexpected means a condition or development not listed in the then-current FDA-approved labeling for the Product, and includes those experiences that show a significant increase in incidence or severity over what appears on the labeling of the Product or in NADA trials or that are a failure of the Product to achieve claimed activity.
Unexpected means (x) for a non-marketed product, an experience that is not identified in nature, severity or frequency in the current clinical investigator's confidential information brochure, and (y) for a marketed product, an experience which is not listed in the current labeling for such product, and includes an event that may be symptomatically and pathophysiologically related to an event listed in the labeling but differs from the event because of increased frequency or greater severity or specificity. Each party shall further notify the other immediately of any information received regarding any threatened or pending action by any regulatory authority which may affect the safety and efficacy claims of the Product. Upon receipt of any such information, the parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action; provided, however, that nothing contained herein shall be construed as restricting either party's right to make a timely report of such matter to any regulatory authority or take other action that it deems to be appropriate or required by applicable law or regulation.
Unexpected as used in this Section 8.1 refers to (a) conditions or developments not previously submitted to governmental Agencies or encountered during clinical studies of the Products and not reflected in the Product Promotional Materials or the Product Labeling, or (b) conditions or developments occurring with greater frequency, severity, or specificity than shown by information previously submitted to governmental Agencies or encountered during clinical studies of the Products and not reflected in the Product Promotional Materials or the Product Labeling. Each party shall also notify the other in a timely manner of any other adverse experience, i.e., any unfavorable and unintended change in the structure (signs), function (symptoms) or chemistry (laboratory data) of the body temporally associated with the use of the Products, whether or not considered related thereto. Acorda has sole and exclusive right and authority to report any such Event to government authorities.