Provision Language
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.
12. SITE VISIT GROUP
12.1 Site Visit Group. Wellcome may appoint a Site Visit Group, made up of a small team of independent experts and observers from Wellcome. The Company shall have ten (10) Business Days from notification by Wellcome to notify Wellcome of any concerns regarding the independence of the designated members of the Site Visit Group, which concerns Wellcome shall consider in good faith and reflect in the membership of the Site Visit Group. The Company approved Site Visit Group shall have reasonable access during normal working hours and at mutually agreed times to visit the premises where the Project is being conducted to consult informally with the Company’s researchers, consultants or contractors working on the Project, to evaluate progress, performance and key issues and to report back to Wellcome on their findings.
12.2 Recommendations. The Site Visit Group may make recommendations to Wellcome relating to the Project. The Company shall consider in good faith all recommendations of the Site Visit Group that are communicated to the Company in writing and the Company shall use Reasonable Efforts to address such recommendations in its future performance of the Project, provided that in any case, the Site Visit Group shall not be permitted to visit a Clinical Trial site without the presence of a Company representative.
14. PROJECT IPRS: EXPLOITATION
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14.6 In the event that the Parties acting in good faith are unable to agree the terms of the licences or assignments referred to in Clause 14.5 above in connection with the Project IPRs and the Products within the one hundred eighty (180) day time period, the Parties shall escalate the dispute for resolution by a senior executive of each Party, who shall attempt to resolve the dispute within a further thirty (30) days. If the Parties remain unable to resolve the dispute, any Party may refer the matter for resolution in accordance with Clause 16 prior to referral for final resolution under Clause 27.
14.7 Where any Wellcome nominee referred to in Clause 14.5 above is not acceptable to the Company (acting in good faith) on reasonable grounds, the Company shall notify Wellcome promptly in writing of the objection and the reasonable grounds, Wellcome shall not appoint such third party as its nominee (unless subsequently approved by an Expert) and Wellcome shall propose an alternative nominee. Where the Parties are unable to agree upon a mutually acceptable Wellcome nominees, the Parties shall escalate the dispute for resolution by a senior executive of each Party, who shall attempt to resolve the dispute within a further thirty (30) days. If the Parties remain unable to resolve the dispute, any Party may refer the matter for resolution in accordance with Clause 16 prior to referral for final resolution under Clause 27.
16. EXPERT DETERMINATION
16.1 Where any Clause of this Agreement provides for a matter to be referred for non-binding resolution by an expert, the expert appointed to resolve such matter (the “Expert“) shall be an independent expert whose appointment is agreed between the Parties.
16.2 If the Parties are unable to agree on an Expert within ten (10) Business Days of either Party serving details of a suggested expert on the other, either Party shall then be entitled to request the President for the time being of the Institute of Intellectual Property Licensing or of the Chartered Accountants in England and Wales (as is most applicable to the matter in dispute) to appoint an Expert of repute with appropriate qualifications, expertise, experience and skill in the issue in dispute.
16.3 The Parties shall be required to make submissions to the Expert with respect to the matter in dispute, which shall be limited to forty (40) pages, inclusive of exhibits, provided that with respect to any dispute referred to the Expert under Clause 14.6, each Party may include a draft of such Party’s proposed license agreement or license terms, which may be in excess of the foregoing 40-page limit. The Parties shall provide (or procure that others provide) the Expert with such assistance and documents as the Expert shall reasonably require for the purposes of making their determination. The Expert shall prescribe the time period in which the Parties will be required to provide such submissions, which shall not exceed thirty (30) Business Days following the Expert’s appointment.
16.4 The Expert shall be required to use their diligent efforts deliver a notice setting out his/her determination within thirty (30) Business Days following receipt of the Parties’ submissions. With respect to any dispute as to valuation, the Expert shall adopt a valuation method which he/she considers, in his/her absolute discretion, to be the most appropriate method for the matter upon which determination is required.
16.5 The Parties shall provide each other with such reasonable information as will enable them to make submissions under Clause 16.3.
16.6 The Expert shall act as an expert and not as an arbitrator and either Party shall have the right to refer the dispute, if not resolved on the basis of the Expert’s determination, to final resolution in accordance with Clause 27.
16.7 The costs of any reference to an Expert under this Clause 16 shall be borne by the Parties equally.
27. GOVERNING LAW
27.1 This Agreement (and any dispute, controversy, proceedings or claim of whatever nature arising out of this Agreement or its formation) shall be governed by and construed in accordance with the laws of England. Except as provided in Clause 16, the Parties irrevocably submit to the exclusive jurisdiction of the Courts of England, provided that nothing in this clause shall prevent either Party from seeking injunctive relief in any court of competent jurisdiction in respect of a breach or threatened breach of Clause 20 (Confidentiality).