Awareness Date definition

Awareness Date or “Clock Date” means the date on which a Party first becomes aware of an Adverse Event or a Suspected Adverse Drug Reaction and, in relation to a third party Representative of a Party, such as clinical research organizations or distributors, that have contractual and/or regulatory obligations to report Adverse Events or a Suspected Adverse Drug Reaction to that Party, the date on which such Third Parties first become aware of that Adverse Event or a Suspected Adverse Drug Reaction. For both Parties this is considered day zero.

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Awareness Date means the first date that a Party’s Personnel first becomes aware of information on a Reportable Event related to the Product, and, using its best professional judgment, determines that it meets the Minimum Criteria for reportability to a Regulatory Authority under Applicable Law. For the avoidance of doubt, the Awareness Date will be determined according to the time zone of the location of such Party’s Personnel at the moment a determination about reportability is made pursuant to the terms of this Agreement.

Awareness Date means, subject to any amendment pursuant to the ICH from time to time, the date on which that Party first becomes aware of an Adverse Event and in relation to a third Party Representative of a Party, such as clinical research organizations or distributors, that have contractual and/or regulatory obligations to report Adverse Events to that Party, the date on which such third Parties first become aware of that Adverse Event.

Examples of Awareness Date in a sentence

• Within 24 hours from the Licensee Awareness Date of a Product Complaint, Licensee will send by secure email a Valid Report(s) to Licensor for any Product Complaint(s) identified by Licensee as Product-related, that reference a Product or that, in Licensee’s reasonable judgment, appear to involve a Product (collectively, “Product Complaint”).

• If Licensee believes that there is a safety issue that could result in a Serious Adverse Event (“SAE”), it will immediately notify Licensor of such issue but in no event shall it notify Licensor later than 24 hours from the Licensee Awareness Date.

• A Sponsor Party shall report any SAEs or AEs that have resulted in death, have been life-threatening and that have occurred during the course of such Sponsor Party’s clinical trial to the Non-Sponsor Party within twenty-four (24) hours of the Awareness Date.

• For clarity, the Awareness Date shall be counted as day zero for safety data exchange.

• Oscient will provide Pfizer with a completed CIOMS report within 10 days from the Awareness Date.

• CMS shall complete and submit such MDR to the RMC within (a) two (2) days of its Awareness Date for Reportable Events that must be reported to the FDA within five (5) days of the relevant Awareness Date; or (b) twenty (20) days of its Awareness Date for Reportable Events that must be reported to the FDA within thirty (30) days of the relevant Awareness Date.

• The Sponsor Party shall assess and process the SAE information and will forward completed SAE reports to the Non-Sponsor Party within seven (7) calendar days after the Awareness Date.

• Should the search result in an AE, CUMBERLAND will prepare the MedWatch form FDA3500A, and, in the case of an SAE, GEL will prepare the 15-day alert cover letter ready for submission by GEL within five (5) business days of CUMBERLAND’s Initial Awareness Date of the literature based SAE.

• AE, SAE, ICSR or SS ▇-▇▇▇-▇▇▇-▇▇▇▇ ▇-▇▇▇-▇▇▇-▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇▇▇@▇▇▇▇▇▇▇▇.▇▇▇ The Awareness Date and the MAH’s report reference number must be recorded on each report sent to LMI by MAH.

More Definitions of Awareness Date

Awareness Date means the first date (according to the receiving party’s time zone) that either Party or either Party’s agent first becomes aware of information on an AE that is reported with the use of the Product and meets the Minimum Criteria for reporting. The Awareness Date shall be counted as day zero (0) for safety data exchange and regulatory reporting purposes.

Awareness Date or “Clock Date” means the date on which a Party first becomes aware of an Adverse Event or a Suspected Adverse Drug Reaction and, in relation to a third party Representative of a Party, such as clinical research organizations or distributors, that have contractual and/or regulatory obligations to report Adverse Events or a Suspected Adverse Drug Reaction to that Party, the date on which such third parties first become aware of that Adverse Event or a Suspected Adverse Drug Reaction. For both Parties this is considered day zero. “Business Day” means a day (other than a Saturday or Sunday) on which banks in the United States are open for business. “Confidential Information” means all secret, confidential or proprietary information or data, whether provided in written, oral, graphic, video, computer, electronic or other form, provided pursuant to this Agreement or generated pursuant to this Agreement. “Effective Date” has the meaning given to it in the Acquisition and License Agreement. “Marketing Authorization” means any authorization granted by a Regulatory Authority required to permit the commercial marketing and sale of the Product in the Territory. “Medical Information” means information about the Product including, but not limited to, clinical and technical matters such as therapeutic uses for both the licensed and unlicensed indications, drug interactions, drug-disease information, Adverse Events, product stability and other product characteristics. “Periodic Safety Report” means a safety report generated at set times and in accordance with FDA guidelines for the purpose of demonstrating the current risk/benefit analysis of the Product according to present knowledge and produced to provide a historical perspective on the safety issues surrounding the Product. “Product” has the meaning given to it in the Acquisition and License Agreement. “Reference Safety Information” means the recognized Adverse Reactions to the Product contained in all or any one of Shire’s Developmental Core Safety Information (DCSI) in an investigator’s brochure, Shire’s Company Core Safety Information (CCSI) in a marketed product Company Core Data Sheet (CCDS) and Shire’s official local product labeling (including the local Summary of Product Characteristics (SPC)).

Awareness Date means the first date (according to the receiving Party’s time zone) that either Party first receives reportable information on an AE, including an SAE, that is associated with the use of the Compound. For clarity, the Awareness Date shall be counted as day zero for safety data exchange purposes.

Awareness Date is the date that MAH personnel first becomes aware of information on an AE associated with the use of a Product and determines that it meets the minimum criteria. For the avoidance of doubt, the date will be determined according to the time zone of the location of such personnel at that moment. The Awareness Date shall be counted as day zero for Safety Data exchange and regulatory reporting purposes. “Minimum Criteria” are the four criteria that are required to record an AE in the safety database: · Identifiable patient (i.e., a reporter has confirmed the patient exists); patient identifiers are not required; · Identifiable reporter (at least the reporter type should be known, e.g., consumer or physician); · Adverse event (including events to be treated in the same manner, e.g., overdose, abuse, misuse, medication errors, occupational exposure, pregnancy, breastfeeding, or transmission of infectious agents); and · Identifiable drug (i.e., LMI brand name or active pharmaceutical ingredient where a brand name is not available). “Product Quality Complaint” (PQC) is defined as an oral or written report, originating from an external or internal source, stating that a commercial product marketed by LMI is not meeting the customer’s expectations in relation to identity, quality, effectiveness or performance of the product. Examples include a non-functioning device, a generator unable to elute, cracked or broken needles, a cracked vial, leakage of product into packaging prior to dosing, a piece of stopper in the vial, non-visualization of a target organ, or a product that arrives in damaged condition. “Serious Adverse Event” (SAE) is an AE that is fatal, life-threatening, requires hospitalization or prolongs an existing hospitalization, results in- persistent or significant disability, is a congenital anomaly/birth defect or is medically significant. Examples include hospitalization due to a heart attack, stroke, or a life-threatening allergic reaction. Transmission of an infectious agent is always considered serious.