Regulatory Data definition
Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing and control data, preclinical data, clinical data and all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product (including any applicable Drug Master Files (“DMFs”), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).
Regulatory Data means any and all regulatory data (including studies, data, raw data, efficacy data, reports, physical samples, reviews (including business risk reviews), opinions, self-GRAS determinations, information or other compliance requirements, including safety, risk and exposure assessments and modeling for product contamination or impurity issues), in written, electronic, computerized, digital, or other tangible or intangible media, actually submitted to, or maintained to support a submission to (whether submitted or not), a Governmental Entity or a Third Party to seek, obtain or maintain a Governmental Approval or demonstrate regulatory compliance.
Regulatory Data means proprietary data or personal information that a Participant provides to Tradition SEF for the purpose of fulfilling its regulatory obligations.
Examples of Regulatory Data in a sentence
Licensee may only use the Regulatory Materials and Regulatory Data provided by Dermira hereunder in accordance with the rights granted to Licensee under Section 2.1.
More Definitions of Regulatory Data
Regulatory Data has the meaning set forth in Section 3.7.2(i).
Regulatory Data means all information with respect to a product made, collected or otherwise generated under or in connection with clinical studies and such other tests and studies in patients that are (a) required by applicable Law, or otherwise recommended by Regulatory Authorities, to obtain or maintain Regulatory Approvals, or (b) conducted solely in support of pricing or reimbursement for such product or are not otherwise strictly required in order to obtain or maintain Regulatory Approval for such product (including epidemiological studies, modeling and pharmacoeconomic studies, post-marketing surveillance studies, investigator sponsored studies and health economics studies).
Regulatory Data means the medical, toxicological, pharmacological and clinical data included within Technical Information to the extent necessary to, required for, or included in any Governmental Entity filing to obtain or maintain regulatory approval to market a Product, Finished Product and Implanter in the Territory.
Regulatory Data means data related to the status of systems matching orders in financial instruments, including information about circuit breakers, trading halts, and opening and closing prices of those financial instruments;’
Regulatory Data means regulatory information, data and results relating to the Product which are necessary for Product Approvals, including in-vitro Product testing data and study data, data queries, data tables reports and case report forms generated during any pre-clinical or clinical study or registry study, for the Product.
Regulatory Data means the medical, clinical and other scientific data necessary to, required for, or included in any regulatory filing to obtain or maintain any Government Approval to market the Products including pre-approval and post-approval reports, filings and submissions, other than reports of Adverse Device Events and related summaries.
Regulatory Data has the meaning set forth in Section 8.4.