Common use of The Research Clause in Contracts

The Research. 2.1 In consideration of the first Work Order the Parties agree that if, during the Term, Quotient will perform any particular trial, study and/or services for the Customer, a document in substantially the form set out in Schedule 1 to this Agreement will be completed and issued by Quotient in relation to such trial, study and/or services, and will be signed by both Parties. Each such Work Order will constitute a separate contract between the Parties for the performance by Quotient and its Service Providers of the Research, and the payment by the Customer of the amounts set out in the Proposal (and the performance by the Customer of it’s other obligations), under this Agreement and the Work Order (to the exclusion of any other terms and/or conditions which the Customer may attempt or purport to impose). 2.2 Quotient and its Service Providers shall carry out all Research in accordance with the Agreement, the Work Order, relevant Clinical Protocol and with reasonable skill and care and in accordance with the Regulations appropriate to the jurisdiction where the Research is to be performed including, Good Clinical Practice, Good Manufacturing Practice, and according to all relevant ICH guidelines 2.3 Quotient must inform Customer within 2 days of any serious adverse events and significant deviations from, or breaches of the standards applied to the Services including Regulations, the Clinical Protocol and a Work Order of this Agreement, to enable Customer to meet its requirements for reporting such events to the applicable Regulatory Authority. 2.4 Quotient shall use its reasonable endeavours to carry out all Research and to deliver the Research Output in accordance with the Proposal. 2.5 All services to be provided by Quotient under this Agreement and any Work Order will be deemed provided at the Customer’s request and the Customer accepts that it is responsible for verifying that those services are suitable for its own needs. 2.6 The Customer may prior to and/or during the performance of any Work Order under this Agreement and for the requisite period thereafter, audit Quotient’s performance of any Research upon giving Quotient reasonable prior written notice. The Customer shall use its reasonable endeavours not to cause any disruption to Quotient’s business in carrying out such audit. 2.7 The Customer shall ensure that its employees co-operate fully with Quotient and any Service Providers in relation to the provision of any Research (including without limitation complying with Quotient’s normal and reasonable codes of staff and security practice whilst at Quotient’s sites). The Customer shall comply with its obligations as set out in any Proposal promptly. 2.8 The Customer shall provide to Quotient: (a) all information and support necessary to enable Quotient to fulfil its obligations under the Regulations in relation to the Research including completing any necessary applications or notifications to the regulatory authority under the Regulations, any Ethics Committee, any other investigator, any medical practitioner and/or any person subject to or connected with the Research; and (b) during the Research and during preparing any report relating to the same, with all information and data relating to the safety and safe usage of the Materials, including and in particular all relevant preclinical and clinical pharmacovigilance information and data which it has in its possession and that relates to or may affect the Research, Materials, and/or the health and safety of any individual whether before after or during any clinical trial. The Customer warrants that all such data and information is and will at all times be accurate, complete and not false or misleading. 2.9 Subject to this Clause 2.9, if a Work Order provides that Quotient will act as the Legal Representative of the Customer for the Research, Schedule 2 shall apply to that Work Order. To avoid doubt, the Customer agrees that it shall be the Sponsor in relation to all Research and that Quotient is not taking on any Sponsor obligations under this Agreement or any Work Order. The Customer shall ensure that it complies with its obligations under the Regulations and with all other applicable laws and regulations. The Customer acknowledges that it shall be solely responsible for ensuring that it has all licences, permissions and authorisations necessary to carry out and to allow Quotient to carry out all Research and that any Clinical Protocol reflects all the requirements of the Regulations.

The Research. 2.1 In consideration of the first Work Order the Parties parties agree that if, at any time during the Term, it is agreed that Quotient Clinical will perform any particular trial, study and/or services for the Customer, a document in substantially the form set out in Schedule schedule 1 to this Agreement will be completed and issued by Quotient Clinical in relation to such trial, study and/or services, and will be signed by both Partiesparties. Each such Work Order will constitute a separate contract between the Parties parties for the performance by Quotient and its Service Providers Clinical of the relevant Research, and the payment by the Customer of the amounts set out in the relevant Proposal (and the performance by the Customer of it’s its other obligations), under in accordance with the terms of this Agreement and the relevant Work Order (to the exclusion of any other terms and/or conditions which the Customer may attempt or purport to impose). 2.2 Quotient and its Service Providers Clinical shall carry out all Research in accordance with the Agreement, the Work Order, relevant Clinical Protocol and with reasonable due skill and care in accordance with industry best practice and strictly in accordance with the Proposal, the Regulations appropriate to the jurisdiction where the Research is to be performed includingand all other applicable laws, Good Clinical Practice, Practice and Good Manufacturing Practice, and according to all relevant ICH guidelines 2.3 . Quotient Clinical must inform Customer within 2 days 24 hours of any serious adverse events and significant deviations from, or breaches of the standards applied to the Services including Regulations, the Clinical Protocol and a Work Order of this AgreementServices, to enable Customer to meet its requirements for reporting such events to the applicable Regulatory Authority. 2.4 Quotient shall use its reasonable endeavours to carry out all Research and to deliver the Research Output in accordance with the Proposal. 2.5 2.3 All services to be provided by Quotient Clinical under this Agreement and any Work Order will be deemed to be provided at the Customer’s request and the Customer accepts that it is responsible for verifying that those services are suitable for its own needs. 2.6 2.4 The Customer may prior to and/or during the performance of any Work Order under this Agreement and for the requisite period thereafter, inspect and/or audit QuotientQuotient Clinical’s performance of any Research upon on giving Quotient reasonable prior Clinical at least 48 hours written notice. The Customer shall use its reasonable endeavours not to cause any disruption to QuotientQuotient Clinical’s business in carrying out such inspection or audit. 2.7 2.5 The Customer shall ensure that its employees co-operate fully with Quotient Clinical and any Service Providers in relation to the provision of any Research (including without limitation complying with QuotientQuotient Clinical’s normal and reasonable codes of staff and security practice whilst at Quotient’s sitespractice). The Customer shall comply with its obligations as set out in any Proposal promptlyin a timely manner. 2.8 2.6 The Customer shall provide to QuotientQuotient Clinical: (a) all information and support necessary to enable Quotient Clinical to fulfil all of its obligations under the Regulations in relation to the any Research including for the avoidance of doubt completing any necessary applications or notifications to the regulatory licensing authority under the Regulations, any Ethics Committeeethics committee, any other investigator, any medical practitioner and/or any person subject to or connected with the Researchrelevant clinical trial; and (b) a copy of the Investigator’s Brochure and where available, the Investigational Medicinal Product Dossier for the relevant pharmaceutical product and at all times during the any Research and during preparing the preparation of any report relating to the same, also promptly provide Quotient Clinical with all written notifications containing details of any applicable and relevant new information and data (as it emerges) relating to the safety and safe usage of the Materials, relevant Materials including any new and in particular all relevant preclinical and clinical pharmacovigilance pharmacovigilence information and data which it has in its possession and that relates to or may affect the Research, Materials, and/or the health and safety of any individual whether before after or during any clinical trialdata. The Customer warrants and undertakes to Quotient Clinical that all such data and information is and will at all times be to the best of its knowledge accurate, complete and not false or misleading. 2.9 2.7 Subject to this Clause 2.9clause 2.7, if where it states in a Work Order provides that Quotient Clinical will act as the Legal Representative of the Customer for the Researchpurposes of the relevant Research and to facilitate the parties’ compliance with the Regulations, Schedule the provisions of schedule 2 shall apply to that Work Order. To avoid For the avoidance of doubt, the Quotient Clinical shall be responsible for ensuring that Regulatory authorisations (clinical trial approval and ethics committee Approval) are in place on behalf of Customer. The Customer acknowledges and agrees that it shall be the Sponsor in relation to all Research and that Quotient Clinical is not taking on any Sponsor obligations under pursuant to this Agreement or any Work Order. The Customer shall ensure that it complies with its obligations under the Regulations and with all other applicable laws and regulations. The In particular, the Customer acknowledges that it shall be solely responsible for ensuring that it has all licencesnecessary intellectual property rights, licences and permissions and authorisations necessary in relation to carry out and its pharmaceutical products to allow Quotient Clinical to carry out all Research and Research. Quotient Clinical shall otherwise ensure that at all times any Clinical Protocol reflects all the requirements of the Regulations. Subject to Quotient Clinical’s compliance with this clause 2.7, the Customer shall indemnify and keep indemnified Quotient Clinical against all losses, claims, costs, expenses, damages and liabilities arising out of a breach by the Customer of any laws or regulations in relation to any Research and/or the relevant Materials including its obligations as Sponsor of any Research pursuant to the Regulations. 2.8 Should Quotient Clinical become aware of any mistake or error or failure by it (or its Service Provider) to comply in any way with this Agreement (collectively called “Quality Breaches”) Quotient Clinical must immediately notify Customer in writing. If in the reasonable opinion of Customer, a Quality Breach (whether notified by Quotient Clinical or otherwise ascertained by Customer) has or will render (on its own or together with any other Quality Breach) any Research Data or work performed by Quotient Clinical inaccurate, unusable or requiring repetition (“Major Quality Breach”), then Quotient Clinical will at the Customer’s election either (i) repeat the relevant part or parts of a Work Order (or the whole Work Order, if the nature or scale of the Quality Breaches in the reasonable opinion of Customer necessitate this) as soon as possible at Quotient Clinical’s cost in accordance with the agreed specification or Protocol (as applicable); or (ii) refund to Customer the sums paid to Quotient Clinical on account of the the relevant part or parts of the Work Order or the whole Work Order, as applicable. The foregoing shall not be Customer’s sole remedy in the event of such failure by Quotient and Customer shall retain its right to seek all other remedies available under law or equity.