Provision Language
10. OBLIGATIONS OF THE COMPANY
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10.8 Clinical trials. The Alto Neuroscience shall procure that the Clinical Trial which is undertaken by the Company, its collaborators, sub-contractors or service providers under the Project; must be conducted in accordance with Wellcome’s Clinical Trial Policy included in Schedule 8 and in accordance with good clinical practice guidelines in the countries in which the Clinical Trial takes place.
10.9 Clinical Trial Cover. It is envisaged that the Project shall include research including human participants. The Company shall procure that prior to the commencement of such research, it shall take out and maintain, or procure adequate insurance cover (“Clinical Trial Cover”) which must be effective from the commencement date of such research until at least three (3) years after the completion of such research. The adequacy of such Clinical Trial Cover shall be considered in relation to generally accepted industry standards. If the relevant research is carried out by the Company’s collaborators, sub-contractors or service providers, the Company shall procure that such collaborator, sub-contractor or service provider (as appropriate) confirms in writing that it shall comply with this Clause 10.9 as if it was the Company; written confirmation of this shall be promptly provided by the Company to Wellcome.
11. PROJECT REPORTING AND OVERSIGHT
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11.2 CTSC. Within sixty (60) days following the receipt of the first tranche of the Loan, the Company shall establish a clinical trial steering committee (“CTSC”), which shall be independent of the project team, to operate for the duration of the Clinical Trial and continue operating until publication of the results of the Clinical Trial. The Company shall ensure that the CTSC is kept informed of all material developments and progress made concerning the Clinical Trial (except for any information that should remain blinded to the CTSC to ensure the integrity of the Clinical Trial, or information which is deemed by the Company in its sole discretion to be material non-public information). The Company shall procure that the CTSC shall have the right to:
(a) review the study protocol and investigator’s brochure relating Clinical Trial;
(b) review certain correspondence with regulatory authorities relating to the design or conduct of the Clinical Trial;
(c) monitor the conduct of the Clinical Trial and progress through periodic reports provided by the Company;
(d) approve the composition and charter of the DSMB and review all correspondence with the DSMB and minutes of meetings of the DSMB (excluding any information which should remain blinded to the CTSC to ensure integrity of the Clinical Trial);
(e) identify potential weaknesses in the Clinical Trial, which will be duly considered by the Company;
The Company shall ensure that the CTSC has no right or power to amend or vary the terms of this Agreement or alter the fundamental scope or objectives of the Clinical Trial. For clarity, the Company shall only be required to consider any recommendations made by the CTSC in good faith, and shall retain full authority and the right to make the final decision with regards to the Clinical Trial.
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11.5 Safety Issues. The Company shall notify Wellcome as soon as reasonably practicable:
(a) on receipt of any information that raises any material concerns regarding the safety or efficacy of the Product in the Field;
(b) where any data arising from the Project discloses a serious adverse event;
(c) where a serious adverse event arising from the Project is suspected;
(d) on the occurrence of a serious adverse event, serious adverse reaction, or any other material safety signal from the performance of the Project; or
(e) of any recommendations from the DSMB to end the Clinical Trial;
(together, the “Safety Issues”).