| ● | Development Milestone Payments: Up to US$90m payable to TRIMT upon meeting various milestones: | | Milestones | | Requirements | | Payment to TRIMT | | | 1. | | Commencement of Phase 3 diagnostic clinical trial for (68Ga-TRIVEHEXIN) (Diagnostic) | | US$ | 2m | | | 2. | | Any Marketing Approval in Japan, China, Hong Kong or the United States of (68Ga-TRIVEHEXIN) for diagnostic application (Diagnostic) | | US$ | 3m | | | 3. | | Last patient Phase 1 (Therapeutic) | | US$ | 5m | | | 4. | | First patient Phase 2 (Therapeutic) | | US$ | 10m | | | 5. | | Last patient Phase 2 (Therapeutic) | | US$ | 10m | | | 6. | | First patient Phase 3 (Therapeutic) | | US$ | 15m | | | 7. | | Last patient Phase 3 (Therapeutic) | | US$ | 15m | | | 8. | | Any Marketing Approval in the Territory other than in Australia (Therapeutic) | | US$ | 30m | | | ● | Development Milestone Payments: Up to US$123.5m payable to the Diaprost upon meeting various milestones: | | Milestones | | Requirements | | Payment to Diaprost | | | 1. | | The earlier of (i) first ethics approval, or (ii) notice of allowance of Investigational New Drug application (Therapeutic) or (iii) an equivalent of either of these that is sufficient to allow dosing in humans in any country in the Territory | | US$ | 3m | | | 2. | | Last patient Phase 1 | | US$ | 5m | | | 3. | | First patient Phase 2 | | US$ | 11m | | | 4. | | Last patient Phase 2B | | US$ | 12.5m | | | 5. | | First patient Pivotal Study | | US$ | 15m | | | 6. | | Upon the dosing of the final patient in a Pivotal Study | | US$ | 15m | | | 7. | | FDA submission | | US$ | 7m | | | 8. | | FDA approval | | US$ | 25m | | | 9. | | EMA approval | | US$ | 10m | | | 10. | | PMDA approval | | US$ | 5m | | | 11. | | Second indication, approval at first of FDA, EMA, PMDA | | US$ | 10m | | | 12. | | Approval at first of FDA, EMA, PMDA for Diagnostic trials. | | US$ | 5m | | | ● | Development Milestone Payments: Up to US$18m payable in shares to the NanoMab upon meeting various milestones: | | Milestones | | Requirements | | Payment to
Nanomab | | | 1. | | IND allowance by the U.S. FDA or the EMA or the NMPA (for either the HER-2 or the TROP-2 Therapeutic) | | US$ | 5m | * | | 2. | | IND allowance by the U.S. FDA or the EMA or the NMPA (for the PKT-7 Therapeutic) | | US$ | 0.5m | * | | 3. | | First patient dosed in the first Phase 1 therapeutic clinical trial | | US$ | 1m | * | | 4. | | First patient dosed in the first Phase 2 therapeutic clinical trial | | US$ | 2m | * | | 5. | | First patient dosed in the first Phase 3 therapeutic clinical trial, or approval of a Licensed Product | | US$ | 3m | * | Additionally, the group signed an amendment with NanoMab Technology Limited that included the additional milestones. | Milestones | | Requirements | | Payment to
Nanomab | | | 1.1 | | IND submission to the U.S. FDA or the EMA or the NMPA for PDL-1 Therapeutic) – binding license agreement with a third-party to improve Camelid PDL-1 therapeutic index | | US$ | 0.25m | | | 1.2 | | IND submission to the U.S. FDA or the EMA or the NMPA for PDL-1 Therapeutic) - IND submission for the Camelid PDL-1 New Formulation | | US$ | 0.25m | * | | 2. | | First patient dosed in the first Phase 1 therapeutic clinical trial | | US$ | 1m | * | | 3. | | First patient dosed in the first Phase 2 therapeutic clinical trial | | US$ | 2m | * | | 4. | | First patient dosed in the first Phase 3 therapeutic clinical trial | | US$ | 3m | * | | ● | Development Milestone Payments: Up to £35.78m payable to CRT upon meeting various milestones: Diagnostic development milestones: | | Milestones | | Requirements | | Payment to
CRT | | | 1. | | Phase 1 clinical trial commencement limited to each of the 1st indication | | £ | 45k | | | 2. | | Phase 2 clinical trial commencement limited to each of the 1st 3 indications | | £ | 225k | | | 3. | | Phase 3 clinical trial commencement limited to each of the 1st 3 indications | | £ | 630k | | | 4. | | Grant of US Regulatory Approval | | £ | 900k | | | 5. | | Grant of EU (or UK) Regulatory Approval | | £ | 450k | | | 6. | | First commercial sale | | £ | 900k | | | 7. | | Aggregate Net Sales worldwide exceeding £10m | | £ | 630k | | | 8. | | Aggregate Net Sales worldwide exceeding £50m | | £ | 3.15m | | Therapeutic development milestones: | Milestones | | Requirements | | Payment to
CRT | | | 1. | | Clearing of IND in the US or any country in Territory | | £ | 90k | | | 2. | | Phase 1 clinical trial/pivotal study commencement, limited to each of the 1st indication | | £ | 225k | | | 3. | | Phase 2 clinical trial/pivotal study commencement, limited to each of the 1st 3 indications | | £ | 630k | | | 4. | | Phase 3 clinical trial/pivotal study commencement, limited to each of the 1st 3 indications | | £ | 1.8m | | | 5. | | Grant of US Regulatory Approval | | £ | 3.6m | | | 6. | | Grant of MA in the EU (or UK) | | £ | 1.8m | | | 7. | | First commercial sale | | £ | 4.5m | | | 8. | | Aggregate Net Sales worldwide exceeding £100m | | £ | 2.7m | | | 9. | | Aggregate Net Sales worldwide exceeding £500m | | £ | 13.5m | | | ● | Development Milestone Payments: Up to US$72.28m payable to Mab upon meeting various milestones: | | Event | | Requirements | | Payment to MD
Anderson for
Licenced
products
that target
B7-H3
and/or are
covered by
B7-H3
patent rights | | | Payment to MD
Anderson for
any other
licenced
product | | | 1 | | Initiation of Phase I Clinical Trial of a Licensed Product | | US$ | 75k | | | US$ | 50k | | | 2 | | Initiation of Phase II Clinical Trial of a Licensed Product | | US$ | 275k | | | US$ | 200k | | | 3 | | Initiation of Phase III Clinical Trial of a Licensed Product | | US$ | 525k | | | US$ | 400k | | | 4 | | Filing of BLA (or equivalent in a non-US jurisdiction) for a Licensed Product | | US$ | 850k | | | US$ | 750k | | | 5 | | Regulatory Approval of a BLA for a Licensed Product by the FDA | | US$ | 5.15m | | | US$ | 5.00m | | | 6 | | Regulatory Approval of a BLA (or equivalent in a non-US jurisdiction) for a Licensed Product by the European Union equivalent of the FDA | | US$ | 4.00m | | | US$ | 3.00m | | | 7 | | Regulatory Approval of a BLA (or equivalent in a non-US jurisdiction) for a Licensed Product by the Japanese equivalent of the FDA | | US$ | 3.50m | | | US$ | 2.50m | | | 8 | | Regulatory Approval of a BLA (or equivalent in a non-US jurisdiction) for a Licensed Product by the Chinese equivalent of the FDA | | US$ | 3.50m | | | US$ | 2.50m | | | ● | Development Milestone Payments: Up to US$2.3m payable to Pharma15 upon meeting various milestones: | | Event | | Requirements | | Payment | | | 1. | | FDA IND allowance for a therapeutic product | | US$ | 2.3m | * |
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