Common use of Development Planning Clause in Contracts

Development Planning. Prior to initiating clinical testing with the Licensed Product, BMI has provided BII a copy of the first clinical protocol for a Phase II clinical trial for the indication of treating viral hepatitis. Such protocol is attached to this Agreement as Appendix D. Both BII and BMI acknowledge that such protocol is subject to regulatory approval and to agreement with clinical investigators. Prior to initiating additional clinical trials for viral hepatitis or clinical testing for any other indication, BMI will also provide to BII a suitably detailed protocol or protocol outline for any other said clinical trial. BII will have the right but not the obligation to provide comments on each protocol or protocol outline to BMI. BMI may, at BMI’s discretion, modify any protocol in response to the comments or suggestions made by BII.

Development Planning. Prior to initiating clinical testing with the Licensed Product, BMI has provided BII a copy of the first clinical protocol for a Phase II clinical trial for the indication of treating viral hepatitis. Such protocol is attached to this Agreement as Appendix D. Both BII and BMI acknowledge that such protocol is subject to regulatory approval and to agreement with clinical investigators. Prior to initiating additional clinical trials for viral hepatitis or clinical testing for any other indication, BMI will also provide to BII a suitably detailed protocol or protocol outline for any other said clinical trial. BII will have the right but not the obligation to provide comments on each protocol or protocol outline to BMI. BMI may, at BMI’s 's discretion, modify any protocol in response to the comments or suggestions made by BII.