Adverse Reaction Information definition

Adverse Reaction Information includes without limitation information relating to any experience that (a) suggests a significant hazard, contraindication, side effect or precaution, (b) is fatal or life threatening, (c) is permanently disabling, (d) requires or prolongs inpatient hospitalization, (e) involves a congenital anomaly, cancer or overdose or (f) is one not identified in nature, specificity, severity or frequency in the current investigator brochure or the United States labeling for the Collaboration Product.
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Adverse Reaction Information is defined in Section 7.12(c).
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Adverse Reaction Information means information relating to any experience with respect to the Product in the Territory that is an adverse drug experience as defined in 21 C.F.R. 314.80(a), as that regulation may be amended or superseded from time to time, whether or not considered serious or unexpected. Reliant agrees to share relevant information it receives (either directly or indirectly) with Oscient in a timely manner so as to allow Oscient to comply with its responsibility to process pharmacovigilance information under this Section 7.11(b).
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Examples of Adverse Reaction Information in a sentence

  • Each of BioMarin and Genzyme shall notify the other Parties of any Adverse Reaction Information relating to any Collaboration Product within twenty-four (24) hours of the receipt of such information and as necessary for compliance with regulatory requirements.

  • Each of BioMarin and Genzyme -------------------------- shall notify the other Parties of any Adverse Reaction Information relating to any Collaboration Product within twenty-four (24) hours of the receipt of such information and as necessary for compliance with regulatory requirements.

  • After the Closing, each Party shall report to the other Party any actual or alleged Adverse Reaction Information with respect to the Product of which it becomes aware promptly after initial receipt of the information by or on behalf of such Party.

  • Each of MethylGene and EVP shall notify the other Parties of any Adverse Reaction Information relating to any Collaboration Product within twenty-four (24) hours of the receipt of such information and as necessary for compliance with regulatory requirements.

  • During the Term, each Party shall report to the other Party any actual or alleged Adverse Reaction Information with respect to the Product and/or any Additional Products of which it becomes aware promptly after initial receipt of the information by such Party; provided, however, that neither Party shall be obligated to report such information to the other Party prior to the time that, or in other than the form in which, it is required to report such information to the FDA.


More Definitions of Adverse Reaction Information

Adverse Reaction Information has the meaning set forth in Section 6.3.9.
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Related to Adverse Reaction Information

  • Location information means information concerning the location of an electronic device that, in whole or in part, is generated or derived from or obtained by the operation of an electronic device on a cellular telephone network or a location information service rather than obtained from a service provider.

  • Transaction Information means any information provided to any Rating Agency, in each case, to the extent related to such Rating Agency providing or proposing to provide a rating of any Notes or monitoring such rating including, without limitation, information in connection with the Borrower, the Originator, the Servicer or the Receivables.

  • Supplier's Confidential Information means any information, however it is conveyed, that relates to the business, affairs, developments, trade secrets, Know-How, personnel and suppliers of the Supplier, including IPRs, together with information derived from the above, and any other information clearly designated as being confidential (whether or not it is marked as "confidential") or which ought reasonably to be considered to be confidential;

  • Seller Confidential Information has the meaning set forth in Section 6.4.3.

  • Buyer Confidential Information shall have the meaning set forth in Section 5.1.

  • Customer Confidential Information means Confidential Information of the Customer provided to Computershare.

  • Purchaser Confidential Information means all confidential or proprietary documents and information concerning the Purchaser or any of its Representatives; provided, however, that Purchaser Confidential Information shall not include any information which, (i) at the time of disclosure by the Company, the Seller Representative or any of their respective Representatives, is generally available publicly and was not disclosed in breach of this Agreement or (ii) at the time of the disclosure by the Purchaser or its Representatives to the Company, the Seller Representative or any of their respective Representatives, was previously known by such receiving party without violation of Law or any confidentiality obligation by the Person receiving such Purchaser Confidential Information. For the avoidance of doubt, from and after the Closing, Purchaser Confidential Information will include the confidential or proprietary information of the Target Companies.

  • Business Confidential Information has the meaning set forth in Section 5.04(a).

  • Identification Information means, for an individual - the passport/ID information specified while the Client Registration.

  • Information has the meaning specified in Section 10.07.

  • Seller Information As defined in Subsection 34.04(a).

  • Program Information is defined in Section 13.8(a)(i).

  • Appendix Information means the information which must be provided for the selected modules as set out in the Appendix of the Approved EU SCCs (other than the Parties), and which for this Addendum is set out in:

  • Keeping information confidential means using discretion in disclosing information as well as guarding against unlawful or inappropriate access by others. This includes:

  • State Confidential Information means any and all State Records not subject to disclosure under CORA. State Confidential Information shall include, but is not limited to, PII, PHI, PCI, Tax Information, CJI, and State personnel records not subject to disclosure under CORA. State Confidential Information shall not include information or data concerning individuals that is not deemed confidential but nevertheless belongs to the State, which has been communicated, furnished, or disclosed by the State to Contractor which (i) is subject to disclosure pursuant to CORA; (ii) is already known to Contractor without restrictions at the time of its disclosure to Contractor; (iii) is or subsequently becomes publicly available without breach of any obligation owed by Contractor to the State; (iv) is disclosed to Contractor, without confidentiality obligations, by a third party who has the right to disclose such information; or (v) was independently developed without reliance on any State Confidential Information.

  • Fund Confidential Information means Confidential Information for which the Fund is the Disclosing Party.

  • Third Party Information means confidential or proprietary information subject to a duty on the Company’s and its affiliates’ part to maintain the confidentiality of such information and to use it only for certain limited purposes.

  • Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  • User Information means User Compliance Information and User Financial Information.

  • Installation Information for a User Product means any methods, procedures, authorization keys, or other information required to install and execute modified versions of a covered work in that User Product from a modified version of its Corresponding Source. The information must suffice to ensure that the continued functioning of the modified object code is in no case prevented or interfered with solely because modification has been made.

  • ABS Informational and Computational Material means any written communication as defined in Item 1101(a) of Regulation AB under the 1933 Act and the 1934 Act, as may be amended from time to time.