Rationale and Definition Sample Clauses

Rationale and Definition. Novavax and Collaborator agree to mutually disclose confidential clinical and non-clinical safety data (the “Safety Data”) as specified below. Sharing Safety Data ensures a high level of safety for the clinical trial subjects and complies with the current international and local guidelines for pharmacovigilance and risk management. Both parties may be required to inform Regulatory Authorities, ethical review boards, clinical investigators and in some cases clinical trial subjects of new and important safety information related to the Matrix-M™ adjuvant in connection with vaccines containing any formulation of the Matrix-M™ adjuvant. Sharing this Safety Data facilitates the maintenance of a comprehensive database of safety data to generate and submit information to Regulatory Authorities and for the information of clinical trial investigators and clinical trial subjects. This Safety Data information will be deemed to be “Confidential Information” subject to Article 8 of the License Agreement. Letters of authorization to cross reference Drug Master Files (DMFs), Investigational New Drug Applications (INDs) and IND amendments, Clinical Trial Applications (CTAs), or other clinical/regulatory filing will be provided so that regulatory agencies may review data solely for the exercise of each Party’s rights and the performance of each Party’s obligations under the License Agreement.
Sample 1
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