definiens: as that term is defined f or purposes of HIPAA, except as expressly permitted by Applicable Law and with prior notice to the other Party : 1 . A cumulative Matrix - M ™ safety brochure, to be up dated not less than annually and which will include : i. A brief summary of in - vitro or in - vivo data relating to the proposed mechanism of action of Matrix - M ™ ; ii . A summary of any substantive manufacturing chan ges since the last edition ; iii . A tabular summary of all known GLP - compliant n on - clinical safety studies with number of animals, species / strain, number and timing of doses and dose level of Matrix- M ™, antigen category ( e.g., recombinant protein, inactivated whole virus, etc . ) and summary results ; iv . A summary of any safety signals arising from an y GLP - compliant or non - GLP non - clinical safety stud ies, v. A tabular summary of all clinical trials using M atrix - M ™ ( whether sponsored by Novavax or a Collaborator ) with number of subjects, age and gender, number and timing of doses and dose level of Matrix- M ™, antigen category ( e.g., recombinant protein, in activated whole virus, etc . ) and status ( completed, in progress, etc . ) ; vi . A summary of local and systemic solicited react ogenicity in completed studies including Matrix- M ™ and carried out by Novavax ( so limited so as to utilize a consistent panel of solicited terms and grading scale ) ; vii