Pipeline-in-a-drug, page-98

TB - I think this question has been asked of him in a forum or perhaps he discussed in a presentation and the answer if I recall was something along the lines of "he was confident" that Neuren was going to be fine on this.

I was a lawyer in a former life, which makes this all the more galling cause I never bothered to take the time to read the contract properly, I just skimmed it.

The contract is clear in intent - the reference to NNZ 2591 Field speaks to that and the fact that Acadia has no say over NNZ 2591 field as part of the steering committee also speaks to the fact that Acadia is not really supposed to have any ability to hurt us when it comes to 2591, beyond Fragile X and Retts in North America

• The JSC’s powers in respect of NNZ-2591 Compound or NNZ‑2591 Product will only be in respect of any activities related solely to NNZ ‑2591 Compound or NNZ‑2591 Product in the NNZ‑2591 Field in the applicable Territory and the JSC will not have any power over any activities in respect of NNZ ‑2591 Compound or NNZ‑2591 Product which do not relate solely to the NNZ‑2591 Field in the applicable Territory.

• NNZ-2591 Field - means uses of the NNZ-2591 Compound or any NNZ-2591 Product solely in and for Rett Syndrome and Fragile X Syndrome and excludes any and all uses in and for any other indication (emphasis mine)”.

The intention of limiting 2591 restrictions to the NNZ 2591 Field is further supported in the early part of Clause 11.

"The parties acknowledge and agree that it is their intention that all their activities:

(i) for the Commercialization of the Trofinetide Compound and Trofinetide Product in the Trofinetide Field in the Territory; and

(ii) for the development or Commercialization of the NNZ-2591 Compound and NNZ‑2591 Product in the NNZ‑2591 Field in the Territory,

will be conducted through the JV.

However none of the above matters and the latter part of Clause 11 is clear as day - Neuren cannot develop 2591 in North America without Acadia's approval. This intent is expressly captured through the explicit reference to PMS, PHS, AMS and PWS being ok, as per the agreement but all other indications being off limits and it even contemplates that in subsection (g) when it talks about commercial sales. The intent is as clear as the wording.

If Neuren has commenced clinical development in the Initial Territory (North America) of a product for an indication and that indication subsequently becomes a New Indication in the Initial Territory, Neuren must halt clinical development for the New Indication in the Initial Territory, and may only reinitiate clinical development for that indication in the Initial Territory on the first to occur of:

(i) Neuren and ACADIA agreeing on the terms on which that product and New Indication can be included in the JV; and

(ii) the indication ceases to be classified as a New Indication pursuant to clause 6.2(e).

This clause 11.1(c) will not prevent, and Neuren will be entitled at all times, to develop and Commercialize the product for the New Indication outside the Initial Territory (outside North America).

(e) For the avoidance of doubt, the parties acknowledge and agree, that:

(ii) notwithstanding any other provision of this Agreement, Neuren retains the right to develop or Commercialize any compound or product (including NNZ‑2591) anywhere in the Territory for the treatment of Phelan-McDermid Syndrome, Pitt Hopkins Syndrome, Angelman Syndrome and Prader-Willi Syndrome.

(g) If Neuren generates any Commercial Sales of an NNZ-2591 Product in:

(i) the NNZ-2591 Field inside the Territory; or

(ii) the Initial Territory in a New Indication,

Neuren will pay to ACADIA the Gross Profits generated from those sales of that Product.