Common use of Test Article Delivery and Usage Clause in Contracts

Test Article Delivery and Usage. Collaborator will ship the Test Article and, if required, Placebo to ICD in containers marked in accordance with 21 C.F.R. § 312.6 for all clinical studies in accordance with their respective obligations under Sections 3.8 and 10.3 where Collaborator holds the IND. ICD agrees that the Clinical Investigators will keep appropriate records and take reasonable steps to ensure that the Test Article is used in accordance with the Protocol(s) and applicable FDA regulations. In addition, ICD agrees that the Test Article provided by the Collaborator (and all Confidential Information supplied by Collaborator relating to the Test Article) will be used solely for the conduct of the CRADA research and development activities. Furthermore, ICD agrees that no analysis or modification of the Test Article provided by the Collaborator will be performed without Collaborator’s prior written consent. At the completion of the Research Plan, any unused quantity of Test Article will be disposed unless otherwise mutually agreed by the parties. Pharmacy contacts at ICD will be determined by ICD and communicated to Collaborator.

Appears in 2 contracts

Samples: Research and Development Agreement (Kite Pharma, Inc.), Research and Development Agreement (Kite Pharma, Inc.)

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Test Article Delivery and Usage. Collaborator will ship the Test Article and, if required, Placebo to ICD IC or its designee in containers marked in accordance with 21 C.F.R. § 312.6 for all clinical studies in accordance with their respective obligations under Sections 3.8 and 10.3 where Collaborator holds the IND312.6. ICD IC agrees that the Clinical Investigators will keep appropriate records and take reasonable steps to ensure that the Test Article is used in accordance with the Protocol(s) Protocol and applicable FDA regulations, and shall ensure that any contractor or grantee or Clinical Research Site performing research and development activities under this CRADA shall only use the Test Article in accordance with the Protocol and applicable FDA regulations. In addition, ICD IC agrees that the Test Article provided by the Collaborator (and all Confidential Information supplied by Collaborator relating to the Test Article) will be used solely for the conduct of the CRADA research and development activities. Furthermore, ICD IC agrees that no analysis or modification of the Test Article provided by the Collaborator will be performed without Collaborator’s prior written consent. At the completion of the Research Plan, any unused quantity of Test Article will be returned to Collaborator or disposed unless otherwise mutually agreed as directed by the partiesCollaborator. Pharmacy contacts at ICD IC or its designee will be determined by ICD IC and communicated to Collaborator.

Appears in 1 contract

Samples: Raptor Pharmaceutical Corp

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Test Article Delivery and Usage. Collaborator will ship the Test Article and, if required, Placebo to ICD in containers marked in accordance with 21 C.F.R. § 312.6 for 312.6for all clinical studies in accordance with their respective obligations under Sections 3.8 and 10.3 where Collaborator holds the IND. ICD agrees that the Clinical Investigators will keep appropriate records and take reasonable steps to ensure that the Test Article is used in accordance with the Protocol(s) and applicable FDA regulations. In addition, ICD agrees that the Test Article provided by the Collaborator (and all Confidential Information supplied by Collaborator relating to the Test Article) will be used solely for the conduct of the CRADA research and development activities. Furthermore, ICD agrees that no analysis or modification of the Test Article provided by the Collaborator will be performed without Collaborator’s prior written consent. At the completion of the Research Plan, any unused quantity of Test Article will be disposed unless otherwise mutually agreed by the parties. Pharmacy contacts at ICD will be determined by ICD and communicated to Collaborator.

Appears in 1 contract

Samples: Research and Development Agreement (Kite Pharma, Inc.)

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