Indications. (a) The Parties acknowledge and agree that the initial Development Plan existing on the Execution Date covers four primary indications for Licensed Product, namely Triple-Negative Breast Cancer (“TNBC”), Non-Small-Cell Lung Cancer (“NSCLC”), Small-Cell Lung Cancer (“SCLC”), and Urothelial Cancer (“UC”) (the “First Indications”). The initial Development Plan includes the Phase I/II Study of IMMU-132 in Patients With *** (XxxxxxxxXxxxxx.xxx Identifier: NCT01631552) (the “Existing Study”). (b) On an ongoing basis during the term of the Agreement, while the JSC continues, the Parties shall, via the JSC or the JDC, further review and ***, including both other types of *** approved (for example, ***, etc.) and (ii) ***. (c) may, from time to time, propose additional potential indications and/or potential combination therapies to the JSC, which proposal shall include a reasonably detailed description of (i) the rationale for pursuing such indication or combination therapy and (ii) the clinical trial(s) that *** would recommend undertaking in order to pursue such indication or combination therapy. The JSC shall consider these proposals in good faith and in a timely manner, ***. The JSC may, in its sole discretion, ***. Notwithstanding the foregoing, the JSC shall not be required to consider, and may in its sole decision decline, any proposal relating to a Terminated Indication.
Appears in 3 contracts
Samples: Development and License Agreement (Immunomedics Inc), Development and License Agreement (Immunomedics Inc), Development and License Agreement (Immunomedics Inc)
Indications. (a) The Parties acknowledge and agree that the initial Development Plan existing on the Execution Date covers four primary indications for Licensed Product, namely Triple-Negative Breast Cancer (“TNBC”), Non-Small-Cell Lung Cancer (“NSCLC”), Small-Cell Lung Cancer (“SCLC”), and Urothelial Cancer (“UC”) (the “First Indications”). The initial Development Plan includes the Phase I/II Study of IMMU-132 in Patients With **[ * ] (XxxxxxxxXxxxxx.xxx Identifier: NCT01631552) (the “Existing Study”).
(b) On an ongoing basis during the term of the Agreement, while the JSC continues, the Parties shall, via the JSC or the JDC, further review and ***[ * ], including both other types of **[ * ] approved (for example, ***[ * ], etc.) and (ii) ***[ * ].
(c) [ * ] may, from time to time, propose additional potential indications and/or potential combination therapies to the JSC, which proposal shall include a reasonably detailed description of (i) the rationale for pursuing such indication or combination therapy and (ii) the clinical trial(s) that **[ * ] would recommend undertaking in order to pursue such indication or combination therapy. The JSC shall consider these proposals in good faith and in a timely manner, ***[ * ]. The JSC may, in its sole discretion, ***[ * ]. Notwithstanding the foregoing, the JSC shall not be required to consider, and may in its sole decision decline, any proposal relating to a Terminated Indication.
Appears in 1 contract
Samples: Development and License Agreement (Seattle Genetics Inc /Wa)
Indications. (a) The Parties acknowledge and agree that the initial Development Plan existing on the Execution Date covers four primary indications for Licensed Product, namely Triple-Negative Breast Cancer (“TNBC”), Non-Small-Cell Lung Cancer (“NSCLC”), Small-Cell Lung Cancer (“SCLC”), and Urothelial Cancer (“UC”) (the “First Indications”). The initial Development Plan includes the Phase I/II Study of IMMU-132 in Patients With [*** ] (XxxxxxxxXxxxxx.xxx Identifier: NCT01631552) (the “Existing Study”).
(b) On an ongoing basis during the term of the Agreement, while the JSC continues, the Parties shall, via the JSC or the JDC, further review and [***], including both other types of [*** ] approved (for example, [***], etc.) and (ii) [***].
(c) [*] may, from time to time, propose additional potential indications and/or potential combination therapies to the JSC, which proposal shall include a reasonably detailed description of (i) the rationale for pursuing such indication or combination therapy and (ii) the clinical trial(s) that [*** ] would recommend undertaking in order to pursue such indication or combination therapy. The JSC shall consider these proposals in good faith and in a timely manner, [***]. The JSC may, in its sole discretion, [***]. Notwithstanding the foregoing, the JSC shall not be required to consider, and may in its sole decision decline, any proposal relating to a Terminated Indication.
Appears in 1 contract
Samples: Development and License Agreement (Seattle Genetics Inc /Wa)