Common use of XXXXXXX’S RESPONSIBILITIES Clause in Contracts

XXXXXXX’S RESPONSIBILITIES. Affimed shall control and be primarily responsible for the Development of the Combination Therapy in accordance with this Agreement and the Development Plan. Subject to the terms and conditions of this Agreement and the oversight of the JSC, Affimed shall (i) act as the sponsor of the Combination Therapy Trials as set forth in Section 6.1(a), and (ii) manage and be primarily responsible for the conduct of the applicable Combination Therapy Trial, including (A) managing the operations of the Combination Therapy Trials in accordance with the applicable Protocol, including overseeing compliance by any subcontractor (including clinical research organizations) engaged by Affimed for the Combination Therapy Trials; and (B) concluding all necessary agreements with Third Party subcontractors (including clinical research organizations) and clinical trial sites and ensuring that these agreements (1) are consistent with the relevant terms of this Agreement, including confidentiality and intellectual property provisions consistent with those set forth in this Agreement, and (2) permit Affimed to audit trial sites for quality assurance, to inspect and copy all data, documentation and work products relating to the Combination Therapy Trials and to share audit results relating to the Combination Therapy Trials with Artiva. Affimed shall perform all Combination Therapy Trials in accordance with this Agreement, the Protocol, and all Applicable Laws, including GCP. Without limiting the generality of the foregoing in this Section 5.3(a), Affimed shall use Commercially Reasonable Efforts to (x) file an IND for the Combination Therapy with the FDA [***]; and (y) dose the first subject in a Phase I Clinical Trial of the Combination Therapy [***]. Affimed shall ensure that all Regulatory Approvals from any Regulatory Authority or ethics committee with jurisdiction over the Combination Therapy Trials are obtained prior to initiating performance of such Combination Therapy Trials.

Appears in 2 contracts

Samples: Collaboration Agreement (Artiva Biotherapeutics, Inc.), Collaboration Agreement (Artiva Biotherapeutics, Inc.)

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XXXXXXX’S RESPONSIBILITIES. Affimed shall control and be primarily responsible for the Development of the Combination Therapy in accordance with this Agreement and the Development Plan. Subject to the terms and conditions of this Agreement and the oversight of the JSC, Affimed shall (i) act as the sponsor of the Combination Therapy Trials as set forth in Section 6.1(a), and (ii) manage and be primarily responsible for the conduct of the applicable Combination Therapy Trial, including (A) managing the operations of the Combination Therapy Trials in accordance with the applicable Protocol, including overseeing compliance by any subcontractor (including clinical research organizations) engaged by Affimed for the Combination Therapy Trials; and (B) concluding all necessary agreements with Third Party subcontractors (including clinical research organizations) and clinical trial sites and ensuring that these agreements (1) are consistent with the relevant terms of this Agreement, including confidentiality and intellectual property provisions consistent with those set forth in this Agreement, and (2) permit Affimed to audit trial sites for quality assurance, to inspect and copy all data, documentation and work products relating to the Combination Therapy Trials and to share audit results relating to the Combination Therapy Trials with Artiva. Affimed shall perform all Combination Therapy Trials in accordance with this Agreement, the Protocol, and all Applicable Laws, including GCP. Without limiting the generality of the foregoing in this Section 5.3(a), Affimed shall use Commercially Reasonable Efforts to (x) file an IND for the Combination Therapy with the FDA [*****]; and (y) dose the first subject in a Phase I Clinical Trial of the Combination Therapy [*****]. Affimed shall ensure that all Regulatory Approvals from any Regulatory Authority or ethics committee with jurisdiction over the Combination Therapy Trials are obtained prior to initiating performance of such Combination Therapy Trials.

Appears in 1 contract

Samples: Collaboration Agreement (Affimed N.V.)

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XXXXXXX’S RESPONSIBILITIES. Affimed shall control and be primarily responsible for the Development of the Combination Therapy in accordance with this Agreement and the Development Plan. Subject to the terms and conditions of this Agreement and the oversight of the JSC, Affimed shall (i) act as the sponsor of the Combination Therapy Trials as set forth in Section 6.1(a), and (ii) manage and be primarily responsible for the conduct of the applicable Combination Therapy Trial, including (A) managing the operations of the Combination Therapy Trials in accordance with the applicable Protocol, including overseeing compliance by any subcontractor (including clinical research organizations) engaged by Affimed for the Combination Therapy Trials; and (B) concluding all necessary agreements with Third Party subcontractors (including clinical research organizations) and clinical trial sites and ensuring that these agreements (1) are consistent with the relevant terms of this Agreement, including confidentiality and intellectual property provisions consistent with those set forth in this Agreement, and (2) permit Affimed to audit trial sites for quality assurance, to inspect and copy all data, documentation and work products relating to the Combination Therapy Trials and to share audit results relating to the Combination Therapy Trials with Artiva. Affimed shall perform all Combination Therapy Trials in accordance with this Agreement, the Protocol, and all Applicable Laws, including GCP. Without limiting the generality of the foregoing in this Section 5.3(a), Affimed shall use Commercially Reasonable Efforts to (x) file an IND for the Combination Therapy with the FDA [*****]; and (y) dose the first subject in a Phase I Clinical Trial of the Combination Therapy [*****]. Affimed shall ensure that all Regulatory Approvals from any Regulatory Authority or ethics committee with jurisdiction over the Combination Therapy Trials are obtained prior to initiating performance of such Combination Therapy Trials.

Appears in 1 contract

Samples: Collaboration Agreement (Affimed N.V.)

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