Failure to Develop or Commercialize Clause Samples
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Failure to Develop or Commercialize. (a) If, in any Region, ACADIA ceases, for a period of at least […***…] at any time after the Relevant Date, all activities, in each case in relation to the Trofinetide Product in Rett Syndrome, and provided that such cessation was not:
(i) directly attributable to circumstances outside the reasonable control of ACADIA (including delays due to regulatory or legal reasons); or
(ii) due to ACADIA’s determination not to conduct activities in the applicable Region during that […***…] period for a commercially reasonable reason (after giving effect to all applicable factors such as commercially reasonable sequencing of activities across Regions, issues affecting pricing and reimbursement, and having clearly communicated these reasons to Neuren), Neuren may give notice in writing to ACADIA requiring ACADIA to provide a written report within […***…] of receipt of such notice detailing the steps and activities currently being undertaken and that ACADIA plans to undertake within the following […***…]. The Relevant Date will be:
(iii) with respect to the Initial Territory, following receipt of Marketing Authorisation and applicable regulatory approvals, the date on which any of the following events occurs:
(A) a Change of Control of ACADIA;
(B) ACADIA publicly discloses that it has abandoned Development and Commercialization of Trofinetide Compound or Trofinetide Product; or
(C) ACADIA reports holding “cash and cash equivalents” and “investment securities available for sale” of less than US$[…***…] in the aggregate in its most recent consolidated balance sheet filed with the U.S. Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended;
(iv) with respect to […***…], the […***…];
(v) with respect to […***…], the […***…]; and
(vi) for any territory in […***…], […***…].
(b) If ACADIA:
(i) fails to provide the required report in the applicable timeframe; or
(ii) does not use Commercially Reasonable Efforts to undertake the steps or activities set forth in the report during the subsequent […***…] period, then
(iii) if the cessation of activities occurs with respect to the Initial Territory, Neuren may terminate this Agreement in accordance with clause 22.1, or
(iv) if the cessation of activities occurs with respect to any part of the New Territory, at the request of N▇▇▇▇▇, ACADIA will discuss with Neuren in good faith the circumstances affecting commercially reasonable development and Commercialization of the Trofinetide Product in Rett Sy...
Failure to Develop or Commercialize. (a) If, for a period of at least […***…], ACADIA ceases all development activities required by clause 5 (other than as a result of the failure of the Phase III Clinical Study for Rett Syndrome) or, following Marketing Authorisation and applicable regulatory approvals, all commercialization activities required by clause 7, in each case in relation to Rett Syndrome, and provided that such cessation was not directly attributable to circumstances outside the reasonable control of ACADIA (including delays due to regulatory or legal reasons), Neuren may give notice in writing to ACADIA requiring ACADIA to provide a written report within […***…] days of receipt of such notice detailing the steps and activities currently being undertaken and which will be undertaken by ACADIA within the following […***…] days to resume those activities required by clause 5 or clause 7, as applicable; provided, however, that this clause 3.8(a) shall only become effective upon the occurrence of one of the following events: (i) a Change of Control of ACADIA, (ii) ACADIA publicly discloses that it has abandoned Development of trofinetide, or (iii) ACADIA reports holding “cash and cash equivalents” and “investment securities available-for-sale” of less than US$[…***…] in the aggregate in its most recent consolidated balance sheet filed with the U.S. Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended.
Failure to Develop or Commercialize. If LICENSOR alleges that EDESA has failed to use commercially reasonable efforts to Develop or Commercialize the Product, LICENSOR shall notify EDESA of its intention to terminate this Agreement. EDESA shall have three hundred and sixty days (360) from receipt of notification from LICENSOR to demonstrate and satisfy LICENSOR that commercially reasonable efforts are being used by EDESA to Develop and Commercialize the Product, and if EDESA fails to demonstrate and satisfy LICENSOR that commercially reasonable efforts are being used by EDESA to Develop and Commercialize the Product, then LICENSOR may terminate this Agreement.