Common use of Phase III Clause in Contracts

Phase III. Upon Commencement of the first Phase III trial in the United States, Europe or Japan by SuperGen for the first therapeutic clinical candidate covered under the Licensed Patents, not necessarily restricted to cancer indications, SuperGen will pay to Licensor the sum of one million five hundred thousand U.S. dollars ($1,500,000) in cash or SuperGen stock along with piggyback registration rights therefor. Upon Commencement of Phase III trial in the United States, Europe or Japan by SuperGen for subsequent therapeutic clinical candidates covered under the Licensed Patents, SuperGen will pay to Licensor the sum of seven hundred and fifty thousand U.S. dollars ($750,000) in cash or SuperGen stock along with piggyback registration rights therefor. In the event SuperGen undertakes a Phase II/III clinical trial , then Commencement of such Phase II/III trial, and not of a Phase III trial, shall trigger the payment described in this section. A Phase II/III trial is defined as a pivotal study in which a therapeutic clinical candidate is being tested in humans for safety and efficacy in an expanded patient population at geographically dispersed clinical sites on the basis of which SuperGen will seek regulatory approval in lieu of a Phase III trial. Determination that a clinical trial is a Phase II/III shall be exclusively by SuperGen after conferring with the appropriate regulatory authority. Commencement (“Commencement”) is defined as the dosing of the first patient under a protocol involving a therapeutic clinical candidate covered under the Licensed Patents, not necessarily restricted to cancer indications.

Phase III. Upon Commencement of the first Phase III trial in the United States, Europe or Japan by SuperGen for the first therapeutic clinical candidate covered under the Licensed Patents, not necessarily restricted to cancer indications, SuperGen will pay to Licensor the sum of one million five hundred thousand U.S. dollars ($1,500,000) in cash or SuperGen stock along with piggyback registration rights therefor. Upon Commencement of Phase III trial in the United States, Europe or Japan by SuperGen for subsequent therapeutic clinical candidates covered under the Licensed Patents, SuperGen will pay to Licensor the sum of seven hundred and fifty thousand U.S. dollars ($750,000) in cash or SuperGen stock along with piggyback registration rights therefor. In the event SuperGen undertakes a Phase II/III clinical trial trial, then Commencement of such Phase II/III trial, and not of a Phase III trial, shall trigger the payment described in this section. A Phase II/III trial is defined as a pivotal study in which a therapeutic clinical candidate is being tested in humans for safety and efficacy in an expanded patient population at geographically dispersed clinical sites on the basis of which SuperGen will seek regulatory approval in lieu of a Phase III trial. Determination that a clinical trial is a Phase II/III shall be exclusively by SuperGen after conferring with the appropriate regulatory authority. Commencement (“"Commencement”") is defined as the dosing of the first patient under a protocol involving a therapeutic clinical candidate covered under the Licensed Patents, not necessarily restricted to cancer indications.