▇▇▇▇▇▇ ACCESS TO DATA. Promptly after the Effective Date and throughout the term of this Agreement, SuperGen shall provide to ▇▇▇▇▇▇, within a reasonable time, a shared database so that ▇▇▇▇▇▇ shall have ready access to all preclinical and clinical and manufacturing documentation, information and data resulting from SuperGen's Product research and development activities in the Territories which ▇▇▇▇▇▇ requires for regulatory filings in the Territories or which ▇▇▇▇▇▇ may reasonably request, including but not limited to the studies set forth in Exhibit 3.1, case report forms, monitoring documents, patient informed consents, institutional review board approvals, medical and statistical programming and study reports for individual studies, clinical data summaries, and expert reports. Upon ▇▇▇▇▇▇'▇ request, SuperGen shall provide ▇▇▇▇▇▇ with copies of such documentation and data. If at any time during this Agreement SuperGen fails to provide ▇▇▇▇▇▇ with such database (including but not limited to any updates thereof) or any such access in a reasonable timely fashion, and if SuperGen does not provide such database and/ or access to ▇▇▇▇▇▇ within sixty (60) days of ▇▇▇▇▇▇'▇ notice to SuperGen of such failure, then ▇▇▇▇▇▇ shall have the option to thereafter assume all development and registration activities for the Product in the Territories, including but not limited to conducting or having conducted, and completing or having completed, all clinical studies and other activities required for Regulatory Approvals under the Development Plan. ▇▇▇▇▇▇ shall use reasonable efforts to pursue such development and registration activities under the Development Plan with the objective of filing applications for Regulatory Approval throughout the Territories. In the event that ▇▇▇▇▇▇ exercises its option under this Section 3.10, (i) ▇▇▇▇▇▇ shall develop the Product at SuperGen's sole cost and expense and SuperGen shall transfer to ▇▇▇▇▇▇ all of the filing materials and information in SuperGen's possession or control necessary for ▇▇▇▇▇▇ to develop the Product and file for Regulatory Approvals.
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Sources: Sales, Distribution, and Development Agreement (Abbott Laboratories), Sales, Distribution, and Development Agreement (Supergen Inc)
▇▇▇▇▇▇ ACCESS TO DATA. Promptly after the Effective Date and throughout the term of this Agreement, SuperGen shall provide to ▇▇▇▇▇▇, within a reasonable time, a shared database so that ▇▇▇▇▇▇ shall have ready access to all preclinical and clinical and manufacturing documentation, information and data resulting from SuperGen's Product research and development activities in the Territories which ▇▇▇▇▇▇ requires for regulatory filings in the Territories or which ▇▇▇▇▇▇ may reasonably request, including 16 <PAGE> CONFIDENTIAL TREATMENT REQUESTED but not limited to the studies set forth in Exhibit 3.1, case report forms, monitoring documents, patient informed consents, institutional review board approvals, medical and statistical programming and study reports for individual studies, clinical data summaries, and expert reports. Upon ▇▇▇▇▇▇'▇ request, SuperGen shall provide ▇▇▇▇▇▇ with copies of such documentation and data. If at any time during this Agreement SuperGen fails to provide ▇▇▇▇▇▇ with such database (including but not limited to any updates thereof) or any such access in a reasonable timely fashion, and if SuperGen does not provide such database and/ or access to ▇▇▇▇▇▇ within sixty (60) days of ▇▇▇▇▇▇'▇ notice to SuperGen of such failure, then ▇▇▇▇▇▇ shall have the option to thereafter assume all development and registration activities for the Product in the Territories, including but not limited to conducting or having conducted, and completing or having completed, all clinical studies and other activities required for Regulatory Approvals under the Development Plan. ▇▇▇▇▇▇ shall use reasonable efforts to pursue such development and registration activities under the Development Plan with the objective of filing applications for Regulatory Approval throughout the Territories. In the event that ▇▇▇▇▇▇ exercises its option under this Section 3.10, (i) ▇▇▇▇▇▇ shall develop the Product at SuperGen's sole cost and expense and SuperGen shall transfer to ▇▇▇▇▇▇ all of the filing materials and information in SuperGen's possession or control necessary for ▇▇▇▇▇▇ to develop the Product and file for Regulatory Approvals.. ARTICLE 4: CO-PROMOTION AND PROMOTION 4.1
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