Clinical Data. As more fully outlined in Schedule A, UHN shall utilize the Clinical Data (as such term is defined below in Subsection 5.1(a)) to undertake the analysis under the Research Program and shall collaborate with MBI in analyzing the results of such analysis. Notwithstanding the foregoing, the disclosure to MBI of the raw Clinical Data is in the sole discretion of UHN. Also notwithstanding the foregoing, UHN shall in good faith deliver to MBI, or directly to the relevant patent or regulatory agencies under assurances of confidentiality, the Clinical Data reasonably required to be disclosed in any Patent or regulatory filings, including, in respect of the latter, that under the Clinical Laboratory Improvement Amendments regulations and program for the regulation in the United States of laboratory testing administered by the Centers for Medicare & Medicaid Services (CMS), or the United States Food and Drug Administration regulations, or any successor agencies thereof, or other regulations in the United States or other jurisdictions, in respect of the submission for, or the receipt of, regulatory approval or clearance of a Licensed Product.
Appears in 3 contracts
Sources: Sponsored Research Agreement (Med BioGene Inc.), Sponsored Research Agreement (Med BioGene Inc.), Sponsored Research Agreement (Med BioGene Inc.)
Clinical Data. As more fully outlined in Schedule A, UHN shall utilize the Clinical Data (as such term is defined below in Subsection 5.1(a)) to undertake the analysis under the Additional Research Program and shall collaborate with MBI in analyzing the results of such analysis. Notwithstanding the foregoing, the disclosure to MBI of the raw Clinical Data is in the sole discretion of UHN. Also notwithstanding the foregoing, UHN shall in good faith deliver to MBI, or directly to the relevant patent or regulatory agencies under assurances of confidentiality, the Clinical Data reasonably required to be disclosed in any Patent or regulatory filings, including, in respect of the latter, that under the Clinical Laboratory Improvement Amendments regulations and program for the regulation in the United States of laboratory testing administered by the Centers for Medicare & Medicaid Services (CMS), or the United States Food and Drug Administration regulations, or any successor agencies thereof, or other regulations in the United States or other jurisdictions, in respect of the submission for, or the receipt of, regulatory approval or clearance of a Licensed Product.
Appears in 3 contracts
Sources: Additional Sponsored Research Agreement (Med BioGene Inc.), Additional Sponsored Research Agreement (Med BioGene Inc.), Additional Sponsored Research Agreement (Med BioGene Inc.)