Common use of Regulatory Submission Clause in Contracts

Regulatory Submission. It is understood and acknowledged by the Parties that positive Clinical Data could be used to obtain label changes for the Compounds, and each Party may propose a Subsequent Study (as defined below) in connection therewith in accordance with Section 3.14.

Appears in 5 contracts

Samples: Clinical Trial Collaboration and Supply Agreement (ONCOSEC MEDICAL Inc), Clinical Trial Collaboration and Supply Agreement (Nugenerex Immuno-Oncology, Inc.), Clinical Trial Collaboration and Supply Agreement (ONCOSEC MEDICAL Inc)

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Regulatory Submission. It is understood and acknowledged by the Parties that positive Clinical Data could be used to obtain label changes for the Compounds, and each Party may propose a Subsequent Study (as defined below) in connection therewith in accordance with Section 3.143.15.

Appears in 4 contracts

Samples: Clinical Trial Collaboration and Supply Agreement (RAPT Therapeutics, Inc.), Clinical Trial Collaboration and Supply Agreement (RAPT Therapeutics, Inc.), Clinical Trial Collaboration and Supply Agreement (Adaptimmune Therapeutics PLC)

Regulatory Submission. It is understood and acknowledged by the Parties that positive Clinical Data could may be used to obtain label changes for the Compounds, and each Party may propose a Subsequent Study (as defined below) in connection therewith in accordance with Section 3.14.

Appears in 2 contracts

Samples: Clinical Trial Collaboration and Supply Agreement (IO Biotech, Inc.), Clinical Trial Collaboration and Supply Agreement (AUM Biosciences LTD)

Regulatory Submission. It is understood and acknowledged by the Parties that positive Clinical Data could be used to obtain label changes for the Compounds, and each Party may propose a Subsequent Study (as defined below) [***] in connection therewith in accordance with Section 3.14.

Appears in 1 contract

Samples: Clinical Trial Collaboration and Supply Agreement (Rexahn Pharmaceuticals, Inc.)

Regulatory Submission. It is understood and acknowledged by the Parties that positive Clinical Data could be used to obtain label changes for the Compounds, and each Party may propose a Subsequent subsequent Study (as defined below) in connection therewith in accordance with Section 3.14. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.

Appears in 1 contract

Samples: Clinical Trial Collaboration and Supply Agreement (Edge Therapeutics, Inc.)

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Regulatory Submission. It is understood and acknowledged by the Parties that positive Clinical Data could be used to obtain label changes for the Compounds, and each Party may propose a Subsequent Study (as defined below) in connection therewith in accordance with Section 3.14.

Appears in 1 contract

Samples: Clinical Trial Collaboration and Supply Agreement (Intensity Therapeutics, Inc.)

Regulatory Submission. It is understood and acknowledged by the Parties that positive Clinical Data could be used to obtain label changes for the Compounds, and each Party may propose a Subsequent subsequent study or Study (as defined below) expansion in connection therewith in accordance with Section 3.14therewith.

Appears in 1 contract

Samples: Clinical Trial Collaboration and Supply Agreement (Array Biopharma Inc)

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