Common use of Clinical Investigators’ Research and Development Activities Clause in Contracts

Clinical Investigators’ Research and Development Activities. Although this CRADA does not grant to Collaborator any rights to Inventions made or Raw Data generated by ICD’s contractors or grantees, as they are not parties to this CRADA, ICD agrees that: 8.8.1 Subject to the other provisions of Article 8 of this CRADA, ICD will maintain, to the extent permitted by law, all Clinical Data in ICD’s Possession and Control as Confidential Information, and make them available to Collaborator for its own use and for exclusive use in obtaining regulatory approval for the commercial marketing of Test Article and related CRADA Subject Inventions. 8.8.2 With regard to Collaborator’s Confidential Information, ICD will require the Clinical Investigators to agree to confidentiality provisions at least as restrictive as those provided in this CRADA and to Collaborator’s use of data in accordance with Paragraph 8.8.1 for obtaining regulatory approval for marketing Test Article. 8.8.3 If Collaborator wants access to Raw Data or any other data in the possession of the Clinical Investigators working with Test Article, Collaborator must first contact the CRADA PI. Collaborator will bear any costs associated with Raw Data provided in formats customized for Collaborator. 8.8.4 Collaborator’s right to access Clinical Data in ICD’s Possession and Control under Paragraph 8.8 is dependent upon Collaborator’s continued development and commercialization of Investigational Agent. If Collaborator fails to continue development or commercialization of Investigational Agent without the transfer of its development efforts to another party within ninety (90) days of discontinuation, ICD has the right to make Clinical Data in ICD’s Possession and Control available to a third party.

Clinical Investigators’ Research and Development Activities. Although this CRADA does not grant to Collaborator any rights to Inventions made or Raw Data generated by ICD’s contractors or grantees, as they are not parties to this CRADA, ICD agrees that: 8.8.1 Subject to the other provisions of Article 8 of this CRADA, ICD will maintain, to the extent permitted by law, all Clinical Data in ICD’s Possession and Control as Confidential Information, and make them available to Collaborator for its own use PHS ECT-CRADA CRADA Ref. No.02663 MODEL ADOPTED June 18, 2009 Page 15 of 24 and for exclusive use in obtaining regulatory approval for the commercial marketing of Test Article and related relied CRADA Subject Inventions. 8.8.2 With regard to Collaborator’s Confidential Information, ICD will require the Clinical Investigators to agree to confidentiality provisions at least as restrictive as those provided in this CRADA and to Collaborator’s use of data in accordance with Paragraph 8.8.1 for obtaining regulatory approval for marketing Test Article. 8.8.3 If Collaborator wants access to Raw Data or any other data in the possession of the Clinical Investigators working with Test Article, Collaborator must first contact the CRADA PI. Collaborator will bear any costs associated with Raw Data provided in formats customized for Collaborator. 8.8.4 Collaborator’s right to access Clinical Data in ICD’s Possession and Control under Paragraph 8.8 is dependent upon Collaborator’s continued development and commercialization of Investigational Agent. If Collaborator fails to continue development or commercialization of Investigational Agent without the transfer of its development efforts to another party within ninety (90) […***…] days of discontinuation, ICD has the right to make Clinical Data in ICD’s Possession and Control available to a third party.

Clinical Investigators’ Research and Development Activities. Although this CRADA does not grant to Collaborator any rights to Inventions made or Raw Data generated by ICD’s contractors or grantees, as they are not parties to this CRADA, ICD ICD) agrees that: 8.8.1 Subject to the other provisions of Article 8 of this CRADA, ICD will maintain, to the extent permitted by law, all Clinical Data in ICD’s Possession and Control as Confidential Information, and make them available to Collaborator for its own use and for exclusive use in obtaining regulatory approval for the commercial marketing of Test Article and related CRADA Subject Inventions. 8.8.2 With regard to Collaborator’s Confidential Information, ICD will require the Clinical Investigators to agree to confidentiality provisions at least as restrictive as those provided in this CRADA and to Collaborator’s use of data in accordance with Paragraph 8.8.1 for obtaining regulatory approval for marketing Test Article. 8.8.3 If Collaborator wants access to Raw Data or any other data in the possession of the Clinical Investigators working with Test Article, Collaborator must first contact the CRADA PI. Collaborator will bear any costs associated with Raw Data provided in formats customized for Collaborator. 8.8.4 Collaborator’s right to access Clinical Data in ICD’s Possession and Control under Paragraph 8.8 is dependent upon Collaborator’s continued development and commercialization of Investigational Agent. If Collaborator fails to continue development or commercialization of Investigational Agent without the transfer of its development efforts to another party within ninety (90) days of discontinuation, ICD has the right to make Clinical Data in ICD’s Possession and Control available to a third party.

Clinical Investigators’ Research and Development Activities. Although this CRADA does not grant to Collaborator any rights to Inventions made or Raw Data generated by ICDby, IC’s contractors or granteesGrantees, as they are not parties to this CRADA, ICD IC agrees that: 8.8.1 Subject to the other provisions of Article 8 of this CRADA, ICD IC will maintain, to the extent permitted by law, all Clinical CRADA Data, and Raw Data in ICD’s Possession and Control its possession, as Confidential Information, and will make them CRADA Data available to Collaborator upon Collaborator’s request, for its own use and for exclusive use in obtaining regulatory approval for the commercial marketing of Test Article and related CRADA Subject Inventions.. PHS ECT-CRADA Case Ref. No. DK#12-0424_MODEL ADOPTED December 8, 2010 rev August 2012 8.8.2 With regard to Collaborator’s Confidential Information, ICD IC will require the Clinical Investigators and other Grantees to agree to confidentiality provisions at least as restrictive as those provided in this CRADA and to Collaborator’s use of data in accordance with Paragraph 8.8.1 for obtaining regulatory approval for marketing Test Article. 8.8.3 If Collaborator wants access to The Data Coordination Center will transfer all Raw Data or any other data in the possession of the Clinical Investigators or other Grantees working with Test ArticleArticle to Collaborator upon Collaborator’s request for regulatory purposes (or as otherwise agreed by the Data Coordination Center and Collaborator), Collaborator must first contact and in any event at the CRADA PIcompletion or earlier termination of the Clinical Trial. Collaborator will bear any costs associated with Raw Data provided in formats customized for Collaborator. 8.8.4 Collaborator’s right to access Clinical Data in ICD’s Possession and Control under Paragraph 8.8 is dependent upon Collaborator’s continued development and commercialization of Investigational Agent. If Collaborator fails to continue abandons development or commercialization of Investigational Agent other than for safety concerns without the transfer of its development efforts to another party within ninety (90) days [...***...] of discontinuation, ICD IC has the right to make Clinical CRADA Data in ICD’s Possession and Control available to a third party.

Clinical Investigators’ Research and Development Activities. Although this CRADA does not grant to Collaborator any rights to Inventions made or Raw Data generated by ICDIC’s contractors or grantees, as they are not parties to this CRADA, ICD IC agrees that: 8.8.1 8.9.1 Subject to the other provisions of Article 8 of this CRADA, ICD IC will maintain, to the extent permitted by law, all Clinical Data in ICDIC’s Possession and Control as Confidential Information, and make them available to Collaborator for its own use and for exclusive use in obtaining regulatory approval for the commercial marketing of Test Article and related CRADA Subject Inventions. 8.8.2 8.9.2 With regard to Collaborator’s Confidential Information, ICD IC will require the Clinical Investigators to agree to confidentiality provisions at least as restrictive as those provided in this CRADA and to Collaborator’s use of data in accordance with Paragraph 8.8.1 for obtaining regulatory approval for marketing Test Article. 8.8.3 8.9.3 If Collaborator wants access to Raw Data or any other data in the possession of the Clinical Investigators working with Test Article, Collaborator must first contact the NIH CRADA PIExtramural Investigator/Officer(s). Collaborator will bear any costs associated with Raw Data provided in formats customized for Collaborator. 8.8.4 8.9.4 Collaborator’s right to access Clinical Data in ICDIC’s Possession and Control under Paragraph 8.8 is dependent upon Collaborator’s continued development and commercialization of Investigational Agent. If Collaborator fails to continue development or commercialization of Investigational Agent without the transfer of its development efforts to another party within ninety (90) days of discontinuation, ICD IC has the right to make Clinical Data in ICDIC’s Possession and Control available to a third party.

Clinical Investigators’ Research and Development Activities. Although this CRADA does not grant to Collaborator any rights to Inventions made or Raw Data generated by ICD’s contractors or grantees, as they are not parties to this CRADA, ICD agrees that: 8.8.1 Subject to the other provisions of Article 8 of this CRADA, ICD will maintain, to the extent permitted by law, all Clinical Data in ICD’s Possession and Control as Confidential Information, and make them available to Collaborator for its own use and for exclusive use in obtaining regulatory approval for the commercial marketing of Test Article and related CRADA Subject Inventions. 8.8.2 With regard to Collaborator’s Confidential Information, ICD will require the PHS ECT-CRADA Case Ref. No. _______ MODEL ADOPTED 2005 [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Clinical Investigators to agree to confidentiality provisions at least as restrictive as those provided in this CRADA and to Collaborator’s use of data in accordance with Paragraph 8.8.1 for obtaining regulatory approval for marketing Test Article. 8.8.3 If Collaborator wants access to Raw Data or any other data in the possession of the Clinical Investigators working with Test Article, Collaborator must first contact the CRADA PI. Collaborator will bear any costs associated with Raw Data provided in formats customized for Collaborator. 8.8.4 Collaborator’s right to access Clinical Data in ICD’s Possession and Control under Paragraph 8.8 is dependent upon Collaborator’s continued development and commercialization of Investigational Agent. If Collaborator fails to continue development or commercialization of Investigational Agent without the transfer of its development efforts to another party within ninety (90) days of discontinuation, ICD has the right to make Clinical Data in ICD’s Possession and Control available to a third party.

Clinical Investigators’ Research and Development Activities. Although this CRADA does not grant to Collaborator any rights to Inventions made or Raw Data generated by ICDIC’s contractors or grantees, as they are not parties to this CRADA, ICD IC agrees that: 8.8.1 Subject to the other provisions of Article 8 of this CRADA, ICD IC will maintain, to the extent permitted by law, all Clinical Data in ICDIC’s Possession and Control as Confidential Information, and make them available to Collaborator for its own use and for exclusive use in obtaining regulatory approval for the commercial marketing of Test Article and related CRADA Subject Inventions. 8.8.2 With regard to Collaborator’s Confidential Information, ICD IC will require the Clinical Investigators to agree to confidentiality provisions at least as restrictive as those provided in this CRADA and to Collaborator’s use of data in accordance with Paragraph 8.8.1 for obtaining regulatory approval for marketing Test Article. 8.8.3 If Collaborator wants access to Raw Data or any other data in the possession of the Clinical Investigators working with Test Article, Collaborator must first contact the NIH CRADA PIExtramural Investigator/Officer(s). Collaborator will bear any costs associated with Raw Data provided in formats customized for Collaborator. 8.8.4 Collaborator’s right to access Clinical Data in ICDIC’s Possession and Control under Paragraph 8.8 is dependent upon Collaborator’s continued development and commercialization of Investigational Agent. If Collaborator fails to continue development or commercialization of Investigational Agent without the transfer of its development efforts to another party within ninety (90) days of discontinuation, ICD IC has the right to make Clinical Data in ICDIC’s Possession and Control available to a third party.