CRADA Data Sample Clauses

CRADA Data. Collaborator and ICD will use reasonable efforts to keep descriptions of CRADA Materials confidential until published or until corresponding Patent Applications are filed. Collaborator acknowledges that the basic research mission of PHS includes sharing with third parties for further research those research resources made in whole or in part with NIH funding. Consistent with this mission and the tenets articulated in “Sharing of Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts,” December 1999, available at ▇▇▇▇://▇▇▇.▇▇▇.▇▇▇.gov/policy/research_tool.aspx, following publication either Party may make available to third parties for further research those CRADA Materials made jointly by both PHS and Collaborator. Notwithstanding the above, if those joint CRADA Materials are the subject of a pending Patent Application or a Patent, or were created using a patent-pending or patented material or technology, the Parties may agree to restrict distribution or freely distribute them. Collaborator appreciates the need of ICD to advance its basic cancer research mission, and therefore will permit ICD to distribute jointly developed CRADA Materials, irrespective of patent protection, to academic institutions under material transfer agreements subject to review of the proposed research by Collaborator. Either Party may distribute those CRADA Materials made solely by the other Party only upon written consent from that other Party or that other Party’s designee.

CRADA Data. Collaborator and NCI will use reasonable efforts to keep CRADA Data confidential until published. To the extent permitted by law, each Party will have the right to use any and all CRADA Data in and for any regulatory filing by or on behalf of the Party. However, any unpublished CRADA Data provided by NCI or directly by NCI Investigators to Collaborator will be treated by Collaborator as Confidential Information until published.

CRADA Data. (a) NCI will share CRADA Data with Collaborator in the following manner: i. Collaborator will receive safety data and regular study reports during the conduct of the study as described in Article 4. ii. Upon completion of a Protocol and approval by NCI and the DSMB if applicable, Collaborator can contract with the NCI Network as appropriate for access to additional data to support regulatory filings. iii. Upon completion of the Protocol and publication of the primary endpoint by NCI Investigators, Collaborator may request access to additional CRADA Data at Collaborator’s expense. Collaborator will also receive a copy of the Dataset as below defined to be submitted to publicly accessible databases prior to submission to these databases following the timeline as described in Paragraph 8.1.1 (c). (b) Collaborator and NCI will use reasonable efforts to keep CRADA Data confidential until published. To the extent permitted by law, each Party will have the right to use any and all CRADA Data in and for any regulatory filing by or on behalf of the Party. Collaborator may use such unpublished CRADA Data for any regulatory purposes in accordance with Paragraph 8.1.1 (a) ii as long as the applicable regulatory authority will treat it confidentially. However, any unpublished CRADA Data provided by NCI or directly by NCI Investigators to Collaborator will be treated by Collaborator as Confidential Information until first published by the NCI Investigators. As described above in Section 8.1.1(a)(iii), within six (6) months after publication of the primary endpoint data of a NCTN Study that includes Collaborator Investigational Agent, Collaborator will receive a complete de-identified dataset (“Dataset”) with the underlying data that support the publication from the Network Group and/or NCI Investigators and/or NIH Intramural Investigators (collectively, the “NCI Network”) conducting the NCTN Study. In accordance with Section 8.2, this Dataset will be entered into the “NCTN/NCORP Data Archive” (a controlled access database that takes requests from the general research community) six (6) months, but no later than eighteen (18) months after the Collaborator receives the Dataset, unless the Parties agree to an extended time period for completion of regulatory filings to health authorities; however, in no case will the time period extend beyond a total of thirty-six (36) months with extensions made in 6-month increments after the original 12-month extension period to eightee...