Pipeline-in-a-drug, page-122

Those clauses in 5.4 (f) are not applicable EagleO - at least not in my view.

The issue is not who makes the final decision in relation to 2591, whether in the Territory or not, whether in NNZ 2591 Field or not. The issue relates solely to New Indications, how they are designated and managed.

Work the problem backwards.

1. Can Neuren advance 2591 (excluding Retts and FX) outside North America - Yes the Territory (North America)
2. Can Neuren advance 2591 (excluding Retts and FX) in North America - Yes, as long as it does not conflict with a New Indication. (Clause 11)
3. What is a Proposal? - A Proposal for Trofinetide in an indication other than Retts or FX as approved by the Joint Steering Committee. (Clause 6)
4. When does a Proposal become a New Indication? - When the Joint Steering Committee approves the Proposal and providing it is not for PMS, PHS, AMS, PWS OR an indication for which we have marketing authorisation in North America for NNZ 2591. (Clause 6.2(d))
5. What is the Joint Steering Committee and who has final say? - Committee governed equally by reps from Neuren and Acadia with one vote each. In the event of a dispute relating to Trofinetide or a New Indication, Acadia has the final say (Clause 5.4(f)(i).
6. What decision making powers does Neuren have on the JSC? - Neuren will have the final decision-making authority with respect to all other uses of NNZ-2591 Compound or NNZ‑2591 Product including uses of NNZ-2591 Compound or NNZ‑2591 Product outside of the NNZ-2591 Field or that relate to uses of NNZ-2591 Compound or NNZ‑2591 Product both within and without the NNZ-2591 Field.

Yes Neuren makes the decision regarding 2591 (excluding Retts and FX) on the JSC but I don't think that is the issue here.

Clause 11 is clear - The minute Acadia decides to progress a New Indication, Neuren can't progress development of 2591 in that same indication without their permission. Who controls the designation and decisions around New Indications? The JSC. How will that decision be made - Acadia have the final decision-making authority on the JSC for New Indications and with that, we are snookered.

As soon as the New Indication designation is made by the JSC, we are in trouble. Its immaterial who makes the final decisions for 2591.