The 2018 Licence Agreement 5.5 Other Activities (a) From time to...

The 2018 Licence Agreement

5.5 Other Activities
(a) From time to time, either party may submit a proposal for further development of any Compound in an indication other than Rett Syndrome or Fragile X Syndrome in the Territory or on a coordinated worldwide basis to the JSC.
(b) Neuren will inform the JSC and ACADIA of any additional activities it is proposing to undertake outside the Territory with respect to any Compound, including any further clinical development of the Compound in additional indications. If:
(i) such activities are in respect to a Compound or Product, not being a Compound or Product in the same dosage form and amount for the same indication in which ACADIA is developing such Compound or Product in the Territory; and
(ii) ACADIA believes any such additional activities would have a material negative effect (e.g., safety or pricing) on any Compound or Product in the Territory,
then within […***…] Business Days of notification, ACADIA shall have the right to have the JSC review such proposed activities prior to Neuren undertaking any such activities outside the Territory. The JSC will review in detail the potential studies and development activities to identify whether the studies or activities would be reasonably likely to materially adversely impact the Development and Commercialization of any Compound or Product in the Territory. In the event that the JSC determines that such studies or activities would be reasonably likely to materially adversely impact the Development or Commercialization of any Compound or Product in the Territory, then Neuren shall not undertake such activities; provided that if Neuren disputes the JSC determination, then such dispute shall be referred to the CEOs who will use Commercially Reasonable Efforts to reach mutually acceptable resolutions on all such disputed matters within […***…] Business Days. If the CEOs are unable resolve such dispute within […***…] Business Days after the dispute is first referred to them, then the dispute shall be resolved by an expedited arbitration process with one mutually agreed independent expert arbitrator with at least 15 years of experience and expertise with respect to clinical development and commercialization with respect to the matter in dispute. The arbitration shall be conducted in accordance with ICC Rules of Arbitration and conducted in San Francisco, California, with the decision of such expert arbitrator with respect to the additional development activities as final and binding on the parties. In no event may the arbitrator make a decision that the JSC would not have the authority to make. For clarity, this clause 5.5(b) will not apply to any studies or activities referred to in clause 4.4(f)(ii).
(c) ACADIA will inform and seek the approval of the JSC for any additional development activities it is proposing to undertake in the Territory with respect to any Compound or Product in additional indications. The JSC will review in detail the potential studies and development activities to identify a basis for proceeding, taking into consideration the commercial, scientific and clinical potential for such proposed additional development activities.
(d) The JSC will assess any proposals for further development activities with any Compound or Product in additional indications and decide whether to continue and fund any such further development. For clarity, the JSC shall not be obligated to approve any further development of any Compound or Product in an additional indication that would adversely impact the development or commercialization of any Compound or Product in the Territory.


Acadia 8-K SEC filing on 18 July

Pursuant to the License Agreement, Neuren granted to the Company a worldwide, exclusive license to develop and commercialize any product developed by or on behalf of Neuren or the Company containing a trofinetide compound as an active ingredient (a “Trofinetide Product” for all indications. In addition, pursuant to the License Agreement, Neuren granted to the Company a worldwide, exclusive license to develop and commercialize any product developed by or on behalf of Neuren or the Company containing a NNZ-2591 compound as an active ingredient (a “NNZ-2591 Product” for the treatment of Rett syndrome and Fragile X syndrome (the “Acadia NNZ-2591 Field”. Neuren may conduct development and commercialization of NNZ-2591 outside of the Acadia NNZ-2591 Field. The joint steering committee established under the Initial License will be and become the joint steering committee under the License Agreement, and will oversee efforts by the parties.


Neuren Q2 2023 report today

Neuren has an obligation not to develop NNZ-2591 or any other product for North America in an indication for which Acadia develops trofinetide, except for Phelan-McDermid, Pitt Hopkins, Angelman and Prader-Willi syndromes.


Neuren - Presentation 18 July



I think the Neuren 18 July presentation graphic probably spells out the situation most clearly.

My interpretation, fwiw:

Neuren, or any licensee or acquirer of Neuren, cannot develop or sell NNZ-2591 for Rett syndrome or Fragile-x syndrome anywhere in the world.

Neuren, or any licensee or acquirer of Neuren, can develop or sell NNZ-2591 in Phelan McDermid, Pitt Hopkins, Angelman and Prader-Willi syndromes anywhere in the world.

Neuren, or any licensee or acquirer of Neuren, can develop or sell NNZ-2591 in any other indication outside of the United States.

For any other proposed NNZ-2591 indication, in the United States only, Neuren, its licensee or acquirer cannot develop NNZ-2591 if Acadia is developing trofinetide in that indication.

As argued by Neuren in the 18 July presentation, the value of NNZ-2591 has been enhanced by the new agreement with Acadia because

(1) There were previously restrictions on Neuren or a licensee or acquirer developing NNZ-2591 in Rett syndrome or Fragile-x anywhere in the world. The new agreement allows value to be extracted from NNZ-2591 in these two indications.

(2) There were previously potential restrictions on Neuren or a licensee or acquirer developing NNZ-2591 in Phelan McDermid, Pitt Hopkins, Angelman and Prader-Willi syndromes in the United States, if Acadia were to develop trofinetide in the same indications. That restriction has now been lifted in these four indications.